Teleflex Medical Devices S.A.R.L.

Patent Trials and Appeals Board

Jun 17, 2021

IPR2020-00128 (P.T.A.B. Jun. 17, 2021)

PUBLIC VERSION
Trials@uspto.gov
571-272-7822
Paper
Date:
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
MEDTRONIC, INC. and MEDTRONIC VASCULAR, INC.,
Petitioner,
v.
TELEFLEX INNOVATIONS S.À.R.L.
Patent Owner.
IPR2020-00128
Patent RE45,380
Before SHERIDAN K. SNEDDEN, JON B. TORNQUIST, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
TORNQUIST, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining No Challenged Claims Unpatentable
Not Deciding Patent Owner’s Contingent Motion to Amend
35 U.S.C. § 318(a)
ORDERS
Denying Petitioner’s Motion to Exclude (Paper 111)
37 C.F.R. § 42.64(c)
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I. INTRODUCTION
Medtronic, Inc. and Medtronic Vascular, Inc. (collectively
“Petitioner”) filed a Petition (Paper 1, “Pet.”) requesting an inter partes
review of claims 1–4, 6–10, 12–21, and 23 of U.S. Reissue Patent
RE45,380E (Ex. 1001, “the ’380 patent”). Teleflex Innovations S.À.R.L.
(“Patent Owner”) 1 filed a Preliminary Response to the Petition (Paper 8).
Upon review of the Petition and Preliminary Response, we instituted an inter
partes review of all claims on all grounds asserted in the Petition (Paper 22,
“Inst. Dec.” or “Institution Decision”).
Patent Owner subsequently filed a Patent Owner Response (Paper 43,
“PO Resp.”) (redacted version available at Paper 44), Petitioner filed a
Reply (Paper 83, “Pet. Reply”) (redacted version available at Paper 82), and
Patent Owner filed a Sur-Reply (Paper 103, “Sur-Reply”) (redacted version
available at Paper 104).
With prior authorization of the Board, Patent Owner filed a
Consolidated Response Addressing Conception and Reduction to Practice
(Paper 39, “PO CRTP Resp.”), to which Petitioner filed Reply (Paper 78,
“Pet. CRTP Reply”) (redacted version available at Paper 79), Patent Owner
filed a Sur-Reply (Paper 97, “PO CRTP Sur-Reply”), and Petitioner filed a
Sur-Sur-Reply (Paper 112, “Pet. CRTP Sur-Sur-Reply”).
Patent Owner also filed a Contingent Motion to Amend (Paper 38).
The Motion requests that if claims 1 or 12 of the ’380 patent are determined
1 Patent Owner represents that “Teleflex Innovations S.A.R.L. merged into
Teleflex Medical Devices S.A.R.L,” which subsequently “transferred
ownership of [the ’380 patent] to Teleflex Life Sciences Limited.” Paper 7,
2.
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to be unpatentable, that the Board replace the unpatentable claim(s) with
proposed substitute claims 43 and 44. Motion 1. Petitioner filed an
Opposition to the Motion to Amend (Paper 85), to which Patent Owner filed
a reply (Paper 106), and Petitioner filed a sur-reply (Paper 114).
An oral hearing was held on March 8, 2021, and a transcript of the
hearing is included in the record. Paper 126 (“Tr.”) (redacted version
available at Paper 125).
A. Real Parties in Interest
Petitioner identifies Medtronic, Inc. and Medtronic Vascular, Inc., as
the real parties-in-interest, and notes that “Medtronic plc is the ultimate
parent of both entities.” Pet. 5.
Patent Owner identifies the real parties-in-interest for itself as
Teleflex Medical Devices S.À.R.L., Vascular Solutions LLC, Arrow
International, Inc., and Teleflex LLC, and notes that “Teleflex Incorporated
is the ultimate parent of the entities listed above.” Paper 4, 2.
B. Related Matters
The parties indicate that the ’380 patent is the subject of litigation in
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 19-cv-01760
(D. Minn.) and QXMedical, LLC v. Vascular Solutions, LLC, No. 17-cv-
01969 (D. Minn). Pet. 5–6; Paper 4, 2. The ’380 patent is also at issue in
IPR2020-00129, IPR2020-00130, and IPR2020-00131 (institution denied).
Paper 4, 3; Pet. 6.
The following proceedings before the Board also involve the same
parties and related patents: IPR2020-00126 (U.S. Patent No. 8,048,032 B2),
IPR2020-00127 (U.S. Patent No. 8,048,032 B2), IPR2020-00132 (U.S.
Patent No. RE45,760 E1), IPR2020-00134 (U.S. Patent No. RE45,760 E1),
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IPR2020-00135 (U.S. Patent No. RE45,776 E1), IPR2020-00136 (U.S.
Patent No. RE45,776 E1), IPR2020-00137 (U.S. Patent No. RE47379 E1),
IPR2020-00138 (U.S. Patent No. RE47379 E1).
C. The ’380 Patent
The ’380 Patent is a reissue of U.S. Patent 8,292,850, and claims
priority as a division of application No. 11/416,629, filed on May 3, 2006,
now U.S. Patent 8,048,032. Ex. 1001, codes (62), (64). The ’380 patent
relates to catheters used in interventional cardiology procedures and, in
particular, to “methods and apparatus for increasing backup support for
catheters inserted into the coronary arteries from the aorta.” Id. at 1:31–35.
“In coronary artery disease the coronary arteries may be narrowed or
occluded by atherosclerotic plaques or other lesions.” Id. at 1:44–46. This
narrowing is referred to as stenosis. Id. at 1:48–49. To treat a stenosis, “it is
commonly necessary to pass a guidewire or other instruments through and
beyond the occlusion or stenosis of the coronary artery.” Id. at 1:49–52. In
this method, a guide catheter is inserted through the aorta and into the
ostium of the coronary artery where it is typically seated into the opening or
ostium of the artery to be treated. Id. at 1:53–57. A guidewire or other
instrument is then passed through the lumen of the guide catheter and
inserted into the artery beyond the stenosis. Id. at 1:39–41, 1:57–59.
Crossing the tough lesions, however, may create enough backwards force to
dislodge the guide catheter from the ostium of the artery being treated,
making it difficult or impossible to treat certain forms of coronary artery
disease. Id. at 1:59–63.
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Figures 1 and 2 of the ’380 patent are reproduced below:
Figure 1 is a schematic depiction of a coaxial guide catheter and a tapered
inner catheter and Figure 2 is a schematic depiction of these two elements
assembled together. Id. at 5:40–45. As shown in Figure 1, coaxial guide
catheter 12 includes tip portion 16, reinforced portion 18, and rigid portion
20. Id. at 6:34–35. Tapered inner catheter 14 includes tapered portion 46 at
a distal end thereof and straight portion 48. Id. at 7:16–17. Clip 54
releasably joins tapered inner catheter 14 to coaxial guide catheter 12. Id. at
7:21–23.
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Figure 8 of the ’380 patent is reproduced below:
Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial guide
catheter, and a tapered inner catheter located in the aortic arch and coronary
artery. Id. at 5:61–64. In Figure 8, “coaxial guide catheter 12 with tapered
inner catheter 14 is passed through guide catheter 56 and over guidewire 64
into coronary artery 62 after the guide catheter 56 has been placed in the
ostium 60 of coronary artery 62.” Id. at 8:6–10. The ’380 patent explains
that “[c]oaxial guide catheter 12, with tapered inner catheter 14, provides an
inner support member for proper translation over guidewire 64.” Id. at
8:10–14. “Once coaxial guide catheter 12 is in place, tapered inner catheter
14 is removed from the inside of coaxial guide catheter 12.” Id. at 8:14–17.
At this point, coaxial guide catheter 12 is ready to accept a treatment
catheter such as a stent or balloon catheter. Id. at 8:18–19. The ’380 patent
explains that coaxial guide catheter 12 provides additional backup support to
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resist dislodging of guide catheter 56 from ostium 60 when force is applied
to guidewire 64 to pass through stenotic lesion 66. Id. at 8:23–30.
D. Illustrative Claim
Independent claim 1 is illustrative of the challenged claims and is
reproduced below.
1. A system for use with interventional cardiology devices
adapted to be insertable into a branch artery, the system
comprising:
a guide catheter having a continuous lumen extending for a
predefined length from a proximal end at a hemostatic valve
to a distal end adapted to be placed in the branch artery, the
continuous lumen of the guide catheter having a circular
cross-sectional inner diameter sized such that interventional
cardiology devices are insertable into and through the
continuous lumen of the guide catheter; and
a device adapted for use with the guide catheter, including:
a flexible tip portion defining a tubular structure and having a
circular cross-section and a length that is shorter than the
predefined length of the continuous lumen of the guide
catheter, the tubular structure having a cross-sectional
outer diameter sized to be insertable through the cross-
sectional inner diameter of the continuous lumen of the
guide catheter and defining a coaxial lumen having a
cross-sectional inner diameter through which
interventional cardiology devices are insertable; and
a substantially rigid portion proximal of and operably
connected to, and more rigid along a longitudinal axis than
the flexible tip portion and defining a rail structure without
a lumen having a maximal cross-sectional dimension at a
proximal portion that is smaller than the cross-sectional
outer diameter of the flexible tip portion and having a
length that, when combined with the length of the flexible
distal tip portion, defines a total length of the device along
the longitudinal axis that is longer than the length of the
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continuous lumen of the guide catheter, such that when at
least a distal portion of the flexible tip portion is extended
distally of the distal end of the guide catheter, at least a
portion of the proximal portion of the substantially rigid
portion extends proximally through the hemostatic valve
in common with interventional cardiology devices that are
insertable into the guide catheter;
wherein the tubular structure includes a flexible cylindrical
distal tip portion and a flexible cylindrical reinforced portion
proximal to the flexible cylindrical distal tip portion and
wherein the flexible cylindrical distal tip portion is more
flexible than the flexible cylindrical reinforced portion.
Ex. 1001, 10:47–11:24 (limitations added by reissue in italics).
E. Prior Art and Asserted Grounds
We instituted review of claims 1–4, 6–10, 12–21, and 23 of the ’380
patent on the following grounds (Inst. Dec. 7, 30):
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
1–4, 6–10, 12–20, 23 102 Itou2
3, 14, 15 103 Itou, Ressemann3
21 103 Itou, Berg4
In support of its arguments, Petitioner relies on the expert declarations
of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1902), Dr. Richard A.
Hillstead (Exs. 1042, 1905, 1907), Mr. Michael Jones (Ex. 1807), and Dr.
Paul Zalesky (Exs. 1755, 1830, 1919). Patent Owner relies on the
declarations of Ms. Amy Welch (Ex. 2044) (redacted), Ms. Deborah
Schmalz (Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg Sutton (Ex.
2 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
3 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
(“Ressemann”).
4 Berg, US 5,911,715, issued June 15, 1999 (Ex. 1051) (“Berg”).
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2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex. 2121), Mr.
Steve Erb (Ex. 2122), Mr. Peter T. Keith (Ex. 2123, 2124, 2138, 2243), Dr.
John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Mr. Steve
Jagodzinkski (Ex. 2152 (redacted), 2153 (confidential)), Ms. Heather S.
Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
II. ANALYSIS
A. Priority Date of the ’380 Patent
The AIA’s first-to-file provisions apply to patent applications “that
contain[] or contained at any time a claim to a claimed invention that has an
effective filing date” on or after March 16, 2013. AIA § 3(n)(1). The
application for reissue for the ’380 patent was filed November 1, 2013 and
sought reissue of US Patent No. 8,292,850, which issued October 23, 2012
from an application filed January 26, 2012. Ex. 1001, codes (22), (64).
Petitioner contends that because there is no written description support for
the subject matter of at least claim 27 of the ’380 patent, the ’380 patent has
an effective filing date after March 16, 2013. Pet. 14. Thus, according to
Petitioner, the ’380 patent is subject to the AIA’s first-to-file provisions,
which precludes Patent Owner’s from attempting to swear behind Itou’s
filing date. Id.
“The effective filing date for a claimed invention in an application for
reissue or reissued patent shall be determined by deeming the claim to the
invention to have been contained in the patent for which reissue was
sought.” 35 U.S.C. § 100(i)(2) (2018). As the “patent for which reissue was
sought” in this case was issued October 23, 2012, we are not persuaded that
AIA’s first-to-file provisions apply to the ’380 patent. Indeed, Petitioner
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provides no legal support for the proposition that claims in a reissue patent
are not entitled to a filing date as if they appeared in the original patent for
which reissue was sought.5
B. Level of Ordinary Skill in the Art
We consider the asserted grounds of unpatentability in view of the
understanding of a person of ordinary skill in the art (“POSITA”). Petitioner
provides two alternative definitions of a person of ordinary skill in the art.
First, Petitioner asserts that if a person of ordinary skill in the art “was a
medical doctor, s/he would have had (a) a medical degree; (b) completed a
coronary intervention training program, and (c) experience working as an
interventional cardiologist.” Pet. 15. Alternatively, Petitioner asserts that if
a person of ordinary skill in the art was “an engineer, s/he would have had
(a) an undergraduate degree in engineering, such as mechanical or
biomedical engineering; and (b) at least three years of experience designing
medical devices, including catheters or catheter-deployable devices.” Id.
Additionally, Petitioner contends that “[e]xtensive experience and technical
training might substitute for education, and advanced degrees might
substitute for experience.” Id.
Patent Owner “does not dispute Petitioner’s proposed definition of a
POSITA.” PO Resp. 9.
Upon review of the parties’ arguments and supporting evidence, we
adopt Petitioner’s definitions for a person of ordinary skill in the art,
5 To the extent the original patent for which reissue was sought does not
contain written description support for a reissue claim, that claim may be
invalid. But this is a question we may not address in an IPR. 35 U.S.C.
§ 311(b).
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allowing experience as a medical doctor or as an engineer, as they are
undisputed and consistent with the level of skill reflected in the prior art and
the written description of the ’380 patent. See Okajima v. Bourdeau, 261
F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the
appropriate level of ordinary skill in the art).
C. Claim Construction
We interpret a claim “using the same claim construction standard that
would be used to construe the claim in a civil action under 35 U.S.C.
282(b).” 37 C.F.R. § 42.100(b)(2019). This standard requires that we
construe a claim “in accordance with the ordinary and customary meaning of
such claim as understood by one of ordinary skill in the art and the
prosecution history pertaining to the patent.” Id.
Upon review of the parties’ arguments and supporting evidence, we
determine that it is not necessary to construe any claim terms to resolve the
disputed issues for purposes of this Final Written Decision. See Vivid
Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 295, 803 (Fed. Cir. 1999)
(holding that “only those terms need to be construed that are in controversy,
and only to the extent necessary to resolve the controversy”).
D. Status of Itou as Prior Art - Conception and Reduction to
Practice
Before reaching the merits of the grounds in the Petition, we address
whether Petitioner’s primary reference, Itou, which is relied upon for all
grounds in the Petition, qualifies as prior art.
Itou was filed on September 23, 2005, published on March 30, 2006,
and issued on June 15, 2010. Ex. 1007, codes (22), (45), (65). Petitioner
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contends that Itou is prior art under pre-AIA § 102(e). Pet. 19–20.6 In the
Conception and Reduction to Practice (CRTP) briefing that we separately
authorized for these proceedings, Patent Owner argues that Itou does not
qualify as prior art based on research and development related to the claimed
invention that took place at Vascular Solutions, Inc. (“VSI”), Patent Owner’s
predecessor-in-interest, starting around early 2005 and continuing through
the May 3, 2006, filing of the original priority application for the ’380
patent. See generally PO CRTP Resp.; PO CRTP Sur-Reply. Petitioner
disputes these contentions. See generally Pet. CRTP Reply; Pet. CRTP Sur-
Sur-Reply.
In its CRTP Response, Patent Owner identifies the evidence on which
it relies to antedate Itou, including certain inventor testimony, non-inventor
testimony, and other documentary evidence. PO CRTP Resp. 2. As to
inventor testimony, Patent Owner relies on the respective declarations of co-
inventors Howard Root (Ex. 2118) and Gregg Sutton (Ex. 2119). As to non-
inventor testimony, Patent Owner relies on the declaration of its expert Peter
T. Keith (Ex. 2123), the declarations of VSI employees Steven Erb (Ex.
2122) and Deborah Schmalz (Ex. 2039), and the declarations of employees
of third-party vendors, Amanda O’Neil (Ex. 2121) and Mark Goemer (Ex.
2120). As to documentary evidence, Patent Owner relies on nearly seventy-
five exhibits. These documents include inventor lab notebooks and
handwritten notes (Exs. 2002, 2004); internal company memoranda,
6 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
in IPR2020-00126, -00129, -00132, -00134, -00135, and -00137. Our
analysis regarding the prior art status of Itou is similar for each of these
proceedings.
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presentations, and other similar documents (Exs. 2003, 2005, 2017–2018,
2024, 2025, 2036–2038, 2040–2041, 2099–2100, 2105, 2109, 2127–2134);
invoices, sales orders, and certificates of completion from technical
equipment vendors (Exs. 2006–2011, 2013, 2016, 2020–2021, 2026–2035,
2089–2095, 2097, 2104, 2106–2108, 2110–2112); a photograph (Ex. 2014);
deposition transcripts (Exs. 2015, 2116); communications with and
documents from VSI’s outside patent counsel (Exs. 2019, 2023, 2096, 2098,
2101–2103, 2117); and engineering drawings (Exs. 2022, 2113–2115).
We have considered this evidence and other rebuttal evidence offered
by Petitioner. For the following reasons, we conclude that a preponderance
of the evidence demonstrates that Patent Owner conceived the subject matter
recited in the challenged claims before the date on which Itou is effective as
prior art (i.e., September 23, 2005) and either actually reduced the invention
to practice prior to the critical date or diligently worked towards constructive
reduction to practice until the first priority application for the ’380 patent
was filed on May 3, 2006. Accordingly, we conclude that Itou does not
qualify as prior art to the ’380 patent.
For our analysis, we first set forth the relevant legal standards,
followed by our fact findings and analysis on conception, actual reduction to
practice, and diligence towards constructive reduction to practice.
1. Legal Standards
“To antedate (or establish priority) of an invention, a [patent owner]
must show either an earlier reduction to practice, or an earlier conception
followed by a diligent reduction to practice.” Purdue Pharma L.P. v.
Boehringer Ingelheim GmbH, 237 F.3d 1359, 1365 (Fed. Cir. 2001).
“Conception is the formation, in the mind of the inventor, of a definite and
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permanent idea of the complete and operative invention, as it is thereafter to
be applied in practice.” Cooper v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir.
1998). “A reduction to practice can be either a constructive reduction to
practice, which occurs when a patent application is filed, or an actual
reduction to practice.” Id. “In order to establish an actual reduction to
practice, the [patent owner] must prove that: (1) [the inventors] constructed
an embodiment or performed a process that met all the limitations of the
[claimed invention]; and (2) [the inventors] determined that the invention
would work for its intended purpose.” Id.
If a patent owner has not shown actual reduction to practice prior to
the “critical date” of a reference, the patent owner may nonetheless antedate
the reference by establishing prior conception and reasonable diligence
towards a constructive reduction to practice. Purdue Pharma, 237 F.3d at
1365. “Reasonable diligence must be shown throughout the entire critical
period, which begins just prior to the competing reference’s effective date
and ends on the date of the invention’s reduction to practice.” Arctic Cat
Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1331 (2019). However, the
“diligence need not be perfectly continuous—only reasonably continuous.”
Id.
To be persuasive, an inventor’s testimony of conception and reduction
to practice must be corroborated by other independent evidence.
“Conception must be proved by corroborating evidence which shows that
the inventor disclosed to others his completed thought expressed in such
clear terms as to enable those skilled in the art to make the invention.” REG
Synthetic Fuels, LLC v. Neste Oil Oyj, 841 F.3d 954, 962 (Fed. Cir. 2016)
(internal quotation marks omitted). “However, there is no final single
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formula that must be followed in proving corroboration.” Id. (quotation
marks omitted); see also Kolcraft Enters., Inc. v. Graco Children’s Prods.,
Inc., 927 F.3d 1320, 1324 (Fed. Cir. 2019); Medichem, S.A. v. Rolabo, S.L.,
437 F.3d 1157, 1169–70 (Fed. Cir. 2006).
“In the final analysis, each corroboration case must be decided on its
own facts with a view to deciding whether the evidence as a whole is
persuasive.” Berges v. Gottstein, 618 F.2d 771, 776 (CCPA 1980).
Corroborating evidence may consist of “testimony of a witness, other than
the inventor,” or “evidence of surrounding facts and circumstances
independent of information received from the inventor.” Medichem, 437
F.3d at 1171. “Even the most credible inventor testimony is a fortiori
required to be corroborated by independent evidence, which may consist of
documentary evidence as well as the testimony of non-inventors.” Id. at
1171–72. We assess whether evidence corroborates conception and
reduction to practice under a “rule of reason” analysis. Cooper, 154 F.3d at
1330.
In an inter partes review, 35 U.S.C. § 316(e) imposes the ultimate
burden persuasion to “prove unpatentability by a preponderance of the
evidence” onto the petitioner. This burden never shifts to the patent owner.
Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378
(Fed. Cir. 2015). However, when the patent owner attempts to antedate the
prior art, “[a] second and distinct burden, the burden of production” can shift
between the petitioner and the patentee. Id. at 1379; see In re Magnum Oil
Tools Int’l, Ltd., 829 F.3d 1364, 1375–76 (Fed. Cir. 2016). Specifically, the
patent owner “bears the burden of establishing that its claimed invention is
entitled to an earlier priority date than an asserted prior art reference.”
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Magnum Oil Tools, 829 F.3d at 1375–76. Once the patent owner establishes
it is entitled to an earlier priority date, the burden of production then shifts
back to the petitioner “to convince the court that [the patent owner] is not
entitled to the benefit” of the earlier priority date. Dynamic Drinkware, 800
F.3d at 1379 (citing Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316,
1328 (Fed. Cir. 2008)).
2. Conception
To show prior conception, Patent Owner relies primarily upon
Mr. Root’s testimony submitted in support of its CRTP Response. Ex. 2118
(Root Declaration in support of CRTP).7,8 Mr. Root was the founder and
Chief Executive Officer of VSI from 1997 to 2017. Id. ¶¶ 1–2. Patent
Owner also relies upon the testimony of co-inventor Mr. Sutton, who was
Vice President, Research & Development at VSI from 2004 until mid-2006.
Ex. 2119 (Sutton Declaration in support of CRTP). As additional
documentary corroboration for this inventor testimony, Patent Owner relies
7 Patent Owner previously submitted a declaration by Mr. Root with its
Preliminary Response (Ex. 2001), but withdrew that declaration in favor of
Ex. 2118. PO CRTP Resp. 2 n.1.
8 The testimonial evidence that Patent Owner presents in support of
conception is largely undisputed. Indeed, during a teleconference addressing
Patent Owner’s request to present live testimony from Mr. Root in these
proceedings, Petitioner’s counsel acknowledged that Mr. Root’s testimony
was not disputed in a manner that would require our credibility assessment.
See Ex. 1920, 11:10–11 (“And I don’t think we have, you know, directly
said Mr. Root is lying on this topic.”); id. at 17:17–18 (“We don’t have any
issue at play here that goes to credibility.”). Accordingly, in view of our
conclusion that “the credibility of Mr. Root is not in question,” we denied
Patent Owner’s request to present live testimony from Mr. Root at the oral
hearing. See Paper 110, 4–5 (distinguishing K-40 Elecs., LLC v. Escort,
Inc., IPR2013-00203, Paper 34 (PTAB May 21, 2014) (precedential)).
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upon certain pages from Mr. Sutton’s laboratory notebook dated January 4,
2005 (Ex. 2002), a “market feasibility” memorandum from Mr. Root dated
February 4, 2005 (Ex. 2003), and some additional handwritten notes and
drawings from Mr. Root dated February 7, 2005 (Ex. 2004). We first set
forth the relevant facts based on these declarants’ testimony and
corroborating evidence, and then address any disputed issues of material fact
and legal issues as needed in our analysis.
a) Fact Findings for Conception
In his declaration, Mr. Root attests that conception started around the
time he attended the Transcatheter Cardiovascular Therapeutics (TCT)
conference from September 27 to October 1, 2004, by which time he had
recognized the issue of “guide catheter backout” that physicians were
experiencing when performing complex interventional coronary procedures.
Ex. 2118 ¶ 5. Accordingly, Mr. Root asserts that he recognized a need for a
solution “that provided better guide positioning, device delivery, and
procedural conveniences” than what previously existed in the market. Id.
To solve this problem, Mr. Root indicates that he came up with “the idea for
a guide extension catheter that would provide improved back-up support
with rapid exchange delivery, which would offer far more convenience than
other options available at the time.” Id. ¶ 6. And “[s]ometime after the TCT
conference, but before 2005,” Mr. Root met with his co-inventors, including
Mr. Sutton, to discuss more particular ideas for how to make this device. Id.
The “guide extension catheter” device that the inventors had thought
of at this time included certain key features. It was to be used within a
standard guide catheter that was one “French size” larger than the “guide
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extension catheter,” and was parsed into two distinct portions—a
substantially rigid proximal portion comprising a “rail” structure and a distal
tubular portion with a lumen—which together were longer than a standard
guide catheter. Id. ¶ 7. During an operation, after the standard guide
catheter was inserted into the vasculature so its distal end was in the ostium
of a cardiac artery, the guide extension catheter would be inserted into the
lumen until the distal end of the tubular portion went past the distal end of
the guide catheter and into the cardiac artery. Id. With both catheters in
place, an interventional cardiology device could be thereafter inserted
through the standard guide catheter (running along the rail of the guide
extension catheter) until it reached the distal end of the distal tubular portion
of the guide extension catheter, thereby entering the cardiac artery. Id.
The device they undertook to develop was initially called the “Guide-
Liner” device, but the hyphen was later dropped and it became known as the
“GuideLiner” device. Id. ¶ 9. Although the original idea for the GuideLiner
was a “rapid exchange” (“RX”) version of the guide extension catheter,
“[s]ometime between February and June of 2005, a decision was made to
concurrently pursue development of an over-the-wire (‘OTW’) version of
GuideLiner.” Id. ¶ 19. Mr. Root acknowledges, however, that “[t]he OTW
GuideLiner was not part of the inventions of the [challenged] patents,” but
instead was more akin to the “mother-in-child” design that was known in the
prior art and discussed in the background of the challenged patents. Id.
(citing Ex. 1001, 2:17–44).9
9 It is undisputed that the work done in developing the RX GuideLiner, not
the OTW GuideLiner, must provide the basis for conception and reduction
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Mr. Sutton in his own declaration sets forth a story consistent with
that set forth by Mr. Root. He attests that “[s]tarting in late-2004 until [he]
left VSI, [he] performed research and development work on what became
the GuideLiner guide extension catheter.” Ex. 2119 ¶ 2. Although VSI did
not retain all of its files from that time, Mr. Sutton recalls, based on his
memory and documents he reviewed, that “we knew very early on that the
GuideLiner rapid exchange device would work for its intended purpose,”
and that “[t]he research and development that followed our original
conception of the GuideLiner rapid exchange was to optimize materials,
dimensions, and design details that would allow us to manufacture and bring
the product to market in a way that would be commercially viable.” Id. ¶ 6.
The earliest documentary evidence that corroborates this testimony is
Mr. Sutton’s laboratory notebook pages relating to the concept for a “Guide-
Liner” device. Ex. 2002. Mr. Sutton signed the relevant pages on January 4,
2005, and Jeffrey Welch, another co-inventor and engineer at VSI, witnessed
those pages on March 2, 2005. Id. at 7–8; see Ex. 2119 ¶ 7.
A portion of one page from Mr. Sutton’s notebook is reproduced
below:
to practice of the claimed invention. PO CRTP Resp. 13 n. 3; Pet. CRTP
Reply 1.
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Ex. 2002, 7. As shown above, Mr. Sutton’s notebook sets forth an “idea”
that “relates to interventional coronary procedures and specifically to
accessing & crossing tough or chronic occlusions,” which “is to provide a
guide or support catheter more distally into the coronary to provide more
back-up support for the stent device.” Id.; Ex. 2118 ¶ 9. Mr. Sutton’s lab
notebook also includes drawings of the cross section of various portions of
the guide extension catheter and a drawing of how the Guide-Liner would be
used that are similar to figures included in the challenged patents. Cf. Ex.
1001, Figs. 1, 2, 5, 6 (depicting patent drawings of the guide extension
catheter that are similar to Mr. Sutton’s drawings). For example, his
notebook includes a drawing of a “5F” (5-French) Guide-Liner in operation
and notes that the Guide-Liner a) “is used where there is difficulty crossing
lesions,” b) “allows back-up support distally,” c) “allows for Rapid X
change,” and d) “would fit std. 6F Guides.” Ex. 2002, 8. The notebook
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pages also describe the main features of the device, including: 1) an inner
tube/dilator that “fits snugly” within a stainless steel (“SS”) half-tube; 2) a
reinforced distal tube section with a braided “PTFE/SS/PEBAX” material
that is “soft for coronaries”; and 3) a design that “allows for rapid
exchange.” Id. at 7. Additionally, the notebook identifies the “5F Design
Specs,” including an overall device length of between 105 cm and 115 cm.
Id. Both Mr. Root and Mr. Sutton authenticate the contents of the notebook
pages and Mr. Sutton attests that his notebook was “issued and maintained in
the regular course of VSI’s business.” Ex. 2118 ¶¶ 9–11; Ex. 2119 ¶¶ 7–14.
By early February 2005, Mr. Root realized this device would have
“substantial market potential,” so he wrote a “Market Feasibility”
memorandum (memo) for GuideLiner catheters, dated February 4, 2005.
Ex. 2118 ¶ 11; Ex. 2003 (confidential); Ex. 2127 (public). Mr. Root attests
that he would only have drafted this kind of memo if he “had developed high
confidence that a concept would work,” so that non-inventors in the
company (e.g., regulatory personnel and engineers) could join a project to
bring the new product to market. Ex. 2118 ¶ 11. The memo itself
recognizes the “substantial market potential” for the RX GuideLiner device
based on an estimated 30,000 procedures a year. Ex. 2003, 1. The memo
indicates that three versions were anticipated (i.e., a “5in6,” a “6in7,” and a
“7in8” GuideLiner), and notes problems with the prior art OTW methods.
Id. The memo also generally describes the RX GuideLiner in a manner
consistent with the description in Mr. Sutton’s notebook including, among
other features, that: it would be delivered within a standard guide catheter
for interventional cardiology procedures; it had a short distal tube segment to
allow for rapid exchange delivery; it was inserted through the existing
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hemostatic valve; and it was one French size smaller than the standard guide
catheter. Id. at 2.
Mr. Root also references his own handwritten notes, dated February 7,
2005. 10 Ex. 2118 ¶¶ 12–14; Ex. 2004. These notes show certain features of
the RX GuideLiner device, including a “side opening” section that appears
in the transition from a partial-round proximal portion to a full round portion
connected to a distal tube section. Ex. 2004. The first drawing from Mr.
Root’s handwritten notes, reproduced below, is similar to Figure 1 of the
’380 patent:
Ex. 2004, 1. As shown above, a “side opening” to allow for the RX
capability is reflected through “crude shading” between the rail structure and
tubular portion above the notation reading “tapered ≈ 10 cm,” and was
10 Although only the first page of these notes is dated, Mr. Root attests he
made the notes on the other two pages “contemporaneously with [his] notes
on page 1.” Ex. 2118 ¶ 14. Petitioner contends that the third page, in
addition to being undated and unwitnessed, appears to come from “a
different set of notes” because, unlike the first two pages, the paper is lined.
Pet. CRTP Reply 7 n.4. Petitioner also points out that Mr. Sutton testified
that he had not seen the third page until his deposition in the stayed district
court litigation. Id. (citing Ex. 1108, 41:1–6, 46:7–47:3). Mr. Sutton,
however, is not the author of these notes. Although we recognize that the
type of paper used to record the notes may have been different, we find that
the content of page 3 seem to be otherwise consistent with the remainder of
the notes and Patent Owner’s other conception documents. We therefore
find no basis to question Mr. Root’s testimony that all his notes from Exhibit
2004 were made contemporaneously on or about February 7, 2005.
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considered by Mr. Root to be “an important feature of GuideLiner.”
Ex. 2118 ¶ 13. Mr. Root testifies that the side opening “facilitates entry of
interventional cardiology devices into the proximal end of the tubular
portion.” Id.
The third page of Mr. Root’s notes depicts another drawing,
reproduced below, that also shows the side opening concept:
Ex. 2004, 3. According to Mr. Root, the sketch above “shows a side
opening structure that is cut-away in several segments including, from left
(distal) to right (proximal): a full round portion; a first angled transition
portion; a first partial round portion; a second angled transition portion;
and a second partial round portion.” Ex. 2118 ¶ 14. The notes also list
dimensions for the contemplated sizes of the GuideLiner. Id. ¶ 12;
Ex. 2004, 1–3.
Beyond these “core” conception documents (Exs. 2002–2004), Patent
Owner also relies on certain engineering drawings as further corroboration
for the inventors’ testimony. PO CRTP Sur-Reply 3–5 (citing Exs. 2022,
2113, 2114). Patent Owner annotates two of these drawings to highlight
features of the depicted GuideLiner, namely the “Side Opening,” “Rail
Structure,” “Machined End for Connecting to Tubular Portion,” “Soft Tip,”
and “Reinforced Pebax Tubular Portion.” Id. at 4 (citing Ex. 2114), 5 (citing
Ex. 2022). The drawings are dated March 2005 (Ex. 2113, 1), June 28, 2005
(Ex. 2114), and August 1, 2005 (Ex. 2022, 1). We have taken these
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documents into account in determining whether the inventors conceived of
the claimed invention prior to the September 23, 2005 critical date.
b) Analysis for Conception
We first consider whether Patent Owner’s proffered evidence
corroborates the inventors’ testimony of conception. Patent Owner does not
assert a specific date of conception. See Tr. 60:4–6 (“Our story from day
one has been that the exact date of conception doesn’t matter.”). We agree
that we need not determine the exact date on which conception took place.
Nonetheless, before we can move on to the question of reduction to practice,
we must determine that conception—as legally defined to be the formation
of “a definite and permanent idea of the complete and operative invention,”
Cooper, 154 F.3d at 1321—was finalized at some point prior to the critical
date of Itou. From the evidence Patent Owner relies upon, we can distill
Patent Owner’s broad theory of conception as having occurred either by
February 2005, as corroborated by the core conception documents
(Exs. 2002–2004), or by August 2005 during the course of building and
testing prototypes, as further corroborated by the engineering drawings
(Exs. 2113, 2114, 2022).
Petitioner argues that Patent Owner’s core documentary evidence—
Mr. Sutton’s notebook pages, the market feasibility memo, and Mr. Root’s
handwritten notes—cannot be used to corroborate inventor testimony insofar
as they all originated from the inventors themselves as opposed to some
other independent source. Pet. CRTP Reply 4. Petitioner relies principally
on three cases as support for this argument. Id. at 3–4.
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First, Petitioner cites Apator Miitors ApS v. Kamstrup A/S, 887 F.3d
1293 (Fed. Cir. 2018), to argue the documents relied upon by Patent Owner
are “inventor documents” that cannot be used to corroborate an inventor’s
testimony on conception. Id. at 4. The problem for the patent owner in
Apator was that it was “stuck in a catch-22 of corroboration” because the
evidence that was proffered to corroborate the inventor’s testimony could
“only provide that corroboration with help from [the same inventor’s]
testimony.” 887 F.3d at 1296. For instance, in the bodies of the emails that
were relied upon, the inventor indicated that he attached certain files related
to his invention, but nothing in any part of the emails indicated what files
were attached or what such attachments disclosed. Id. The court agreed
with the Board’s finding that the inventor’s testimony was the only evidence
proffered to establish the existence and substance of the attachments. Id. at
1296–97. And though the drawings set forth dates that were after the
reference’s critical date, the inventor’s testimony about certain file naming
conventions was the only evidence offered by the patent owner to
demonstrate that the drawings were actually created on an earlier date. Id. at
1294–95, 1296–97. The court rejected the patent owner’s argument that the
emails and drawings should still have “some corroborative value,” like
unwitnessed laboratory notebooks. Id. at 1297. The court acknowledged
that the rule of reason permits “‘a notebook entry’ or other writing ‘[that]
has not been promptly witnessed,’” id. (citing Singh v. Brake, 222 F.3d
1362, 1370 (Fed. Cir. 2000)), “to aid in corroborating witness testimony
alongside other, more persuasive, evidence.” Id. (citing examples where the
Federal Circuit and one of its predecessors, the Court of Customs and Patent
Appeals, permitted unwitnessed documents to contribute to corroboration of
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conception). But the court clarified that “an unwitnessed laboratory
notebook, alone, cannot corroborate an inventor’s testimony of conception.”
Id. (citing Brown v. Barbacid, 276 F.3d 1327, 1335 (Fed. Cir. 2002)
(concluding there was no error in denying corroboration by “an inventor’s
own unwitnessed documentation”); Procter & Gamble Co. v. Teva Pharms.
USA, Inc., 566 F.3d 989, 998–99 (Fed. Cir. 2009) (concluding a laboratory
notebook that “was unwitnessed and was not corroborated by any other
evidence” could not corroborate inventor testimony of conception)).
Second, Petitioner cites Kolcraft, 927 F.3d at 1320, in support of its
argument that the documents relied upon by Patent Owner lack
corroborative value because they all “‘originated with the inventors.’” Pet.
CRTP Reply 4. In Kolcraft, the Federal Circuit observed that the evidence
at issue—which it characterized as “even weaker than the evidence
presented in Apator”—comprised a redacted inventor declaration, the
inventor’s deposition testimony, and undated photos attached to the inventor
declaration. 927 F.3d at 1325. Of this evidence, the court noted that “[o]nly
the Inventor Declaration, i.e., inventor testimony, supports the purported
dates showing [prior] conception,” but this was deemed insufficient because
“[i]nventor testimony alone cannot prove conception.” Id.
Third, Petitioner cites a non-precedential Board decision, Curt
Manufacturing, LLC v. Horizon Global Americas Inc., IPR2019-00625,
2020 WL 4687044, at *7 (PTAB Aug. 11, 2020), for the proposition that
“[o]ne inventor cannot corroborate another.” Pet. CRTP Reply 4; see also
Tr. 38:20–39:13 (Petitioner’s counsel citing Curt for the same proposition).
In Curt, the Board stated that “[o]ne consequence of the independence
requirement is that testimony of one co-inventor cannot be used to help
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corroborate the testimony of another.” Pet. CRTP Reply 4 (citing Lacks
Indus., Inc. v. McKechnie Vehicle Components USA, Inc., 322 F.3d 1335,
1350 (Fed. Cir. 2003) (emphases added) (approving refusal to accept cross-
corroboration of oral testimony by interested witnesses)).11 The Board
further noted that “an inventor’s unwitnessed laboratory notebooks, emails,
and drawings, without other independent evidence, cannot corroborate an
inventor’s testimony.” Curt, 2020 WL 4687044, at * 7 (emphases added)
(citing Kolcraft, 927 F.3d at 1325–26; Apator, 887 F.3d at 1297; Brown, 276
F.3d at 1335). In a footnote quoting Brown, the Board highlighted the
importance of two issues: whether the documentary evidence was witnessed
and whether there is other corroborating evidence in the record. Id. at *7 n.7
(reiterating that physical evidence from an inventor does not need
corroboration to demonstrate its contents, but the inventor’s unwitnessed
documentation “may not single-handedly corroborate” the inventor’s
testimony) (quoting Brown, 276 F.3d at 1335) (other emphases omitted).
Lastly, the Board concluded that, “[n]otwithstanding this clear guidance, the
law also recognizes that . . . a notebook entry or other writing that has not
been promptly witnessed does not necessarily disqualify it in serving as
corroboration of conception under a rule of reason analysis.” Id. at *7
(citing Apator, 887 F.3d at 1297 (referring to cases where unwitnessed
11 The Federal Circuit, however, has not categorically prohibited “cross-
corroboration” of testimony by interested witnesses at least in other contexts.
See Nobel Biocare Servs. AG v. Instradent USA, Inc., 903 F.3d 1365, 1378
(Fed. Cir. 2018) (“The testimony of one witness may corroborate the
testimony of another witness.”).
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documentary evidence was considered alongside other evidence to
corroborate inventor testimony)).
Considering the evidence of record as a whole, we reject Petitioner’s
arguments that the inventors’ testimony on conception is not adequately
corroborated. We find the case law cited by Petitioner to be distinguishable.
We first note that Mr. Sutton’s laboratory notebook was witnessed
shortly after the date of entry of the relevant pages. Specifically, the
notebook pages presented here were witnessed by another inventor, Jeffery
Welch, Ex. 2002. Because the notebook is dated and witnessed, we may
properly consider it for its probative value in corroborating Mr. Root’s and
Mr. Sutton’s testimony. See Singh, 222 F.3d at 1369–70 (holding that a
belatedly witnessed lab notebook may serve as corroboration of conception);
Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1378 (Fed.
Cir. 1986) (same). Indeed, as noted above, even an unwitnessed notebook
page may have some corroborative value under the rule of reason when
considered in combination with other more persuasive evidence. Apator,
887 F.3d at 1297. Moreover, we discern no per se rule from the case law to
suggest that a laboratory notebook witnessed by a co-inventor cannot be
used to corroborate another inventor’s testimony about conception. In this
regard, we find that the witnessed notebook pages avoid the “catch-22 of
corroboration” noted in Apator because the notebook pages do not depend
upon either Mr. Root’s or Mr. Sutton’s testimony for an explanation of their
content. The notebook pages also avoid the issue that arose in Kolcraft and
Curt because Patent Owner has not relied upon only the inventors’ testimony
to prove conception. We note that, aside from whether the notebook pages
can legally qualify as corroborative evidence of the date of conception,
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Petitioner has not disputed the authenticity or veracity of the content shown
on those pages. As such, we have considered the content of the notebook
pages at face value in our analysis.
We have also taken into account the market feasibility memo and Mr.
Root’s handwritten notes in our corroboration assessment. Ex. 2003;
Ex. 2004. We recognize that these documents appear to have been authored
by Mr. Root, and no witness other than Mr. Root has provided testimony
about their content. As such, if considered in isolation, these conception
documents may be more analogous to the type of “catch-22” documents
found insufficient for corroborating the date of conception under Apator.
Nonetheless, applying the rule of reason, we do not categorically exclude
them from the corroboration analysis because they can still “aid in
corroborating witness testimony alongside other, more persuasive,
evidence.”12 Apator, 887 F.3d at 1297.
Because we conclude that the notebook pages, along with the market
feasibility memo and Mr. Root’s handwritten notes, may be properly
considered in our corroboration analysis, we next address whether these
documents are in fact sufficiently corroborative of the inventors’ testimony
to show conception of the claimed invention prior to the critical date. On
this point, Mr. Root includes as appendices to his declaration claim charts
showing how certain VSI prototypes developed at the time meet the
12 Like the notebook pages, Petitioner has not disputed the authenticity or
veracity of the content of the market feasibility memo and Mr. Root’s
handwritten notes, and thus we have also considered the content of these
documents at face value.
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limitations of the challenged claims. Ex. 2118, App’x A–E.13 The primary
argument raised by Petitioner is that Patent Owner’s core conception
documents do not disclose the “side opening” feature recited in numerous
challenged claims.14 Pet. CRTP Reply 5–7. According to Petitioner,
without this demonstration, Patent Owner fails to establish conception of
“every feature or limitation of the claimed invention.” 15 Id. at 3 (quoting
13 Petitioner contends that Mr. Root’s claim charts amount to an improper
incorporation by reference in violation of 37 C.F.R. § 42.6(a)(3) and a
circumvention of our word limits. Pet. CRTP Reply 2. However, in view of
the commonality of the CRTP issues across these related proceedings, we
authorized the parties to submit consolidated briefing on the issue. Paper 26
(Consolidated Scheduling Order), 2–3. Moreover, Petitioner also submitted
similar rebuttal claim charts by its expert Dr. Zalesky as appendices to his
expert report. Ex. 1755, App’x A–E. Under the circumstances, we are not
persuaded that the manner in which Patent Owner presented its claim-by-
claim arguments were a violation of our rules.
14 For instance, claim 3 of the ’380 patent recites
The device of claim 2, wherein the proximal portion of the
tubular structure further comprises structure defining a
proximal side opening extending for a distance along the
longitudinal axis, and accessible from a longitudinal side
defined transverse to the longitudinal axis, to receive the
interventional cardiology devices into the coaxial lumen while
the proximal portion remains within the lumen of the guide
catheter.
Ex. 1001, 11:33–40. Claim 14 of the ’380 patent also recites “the
substantially rigid portion further includes a partially cylindrical portion
defining an opening extending for a distance along a side thereof,” which the
parties agree also refers to the “side opening” feature. Id. at 12:57–65.
15 According to Petitioner’s table in its CRTP Sur-Sur-Reply, the side-
opening limitation appears in the following claims: claims 3 and 4 of the
’032 patent; claims 3, 4, 36 of the ’380 patent; claims 25, 52, and 53 of the
’776 patent; and claims 25, 48, 51, and 53 of the ’760 patent. Pet. CRTP
Sur-Sur-Reply 14–15.
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REG Synthetic Fuels, 841 F.3d at 962). We are not persuaded that the
evidence fails to show that the RX GuideLiner device that the inventors had
conceived of and were developing at the time included all the features of the
challenged claims, including a side opening feature to allow for rapid
exchange.16
As noted above, Mr. Root attests that the first and third pages of his
handwritten notes each depict a drawing that includes a side opening.
Ex. 2118 ¶¶ 12–14 (citing Ex. 2004, 1, 3). In particular, Mr. Root asserts
that
[a]n important feature of GuideLiner is a “side opening”
at the transition between the proximal rail structure and the
distal tubular portion that facilitates entry of interventional
cardiology devices into the proximal end of the tubular portion.
This feature is reflected in the crude shading between the rail
structure and the tubular portion shown in the sketch above
from my February 7, 2005 notes.
Id. ¶ 13. We credit this testimony and find that it is corroborated by the
drawings themselves.
Petitioner contends that the lab notebook pages, as confirmed by
Mr. Sutton’s deposition testimony, only show an “end opening,” rather than
a side opening for the device. Pet. CRTP Reply 5 (citing Ex. 1108, 70:18–
71:23, 79:14–80:24). To further dispute the disclosure of a side opening,
Petitioner relies on the declaration of its expert Dr. Zalesky. Id. at 6 (citing
Ex. 1755 ¶¶ 83–84). Dr. Zalesky contends that the “crude shading” on the
16 In its Sur-Sur-Reply, Petitioner also contends that Patent Owner is missing
evidence that the RX prototypes satisfy certain additional claim limitations.
Pet. CRTP Sur-Sur-Reply 14–15. We consider this in addressing the actual
reduction to practice issue below.
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drawing on the first page of Dr. Root’s notes “does not appear to show an
angled opening at the proximal end of the tubular portion” and that
Mr. Root’s notes on the page do not refer to a side opening. Ex. 1755 ¶ 83.
Dr. Zalesky further contends that the drawing on the third page of
Mr. Root’s notes “does not appear to correspond to any of the figures in the
Root patents,” is “quite crude,” making it “difficult to tell what it represents,
if anything,” and “does not appear to show a side opening.” Id. ¶ 84.
Although we recognize that Mr. Sutton testified that Figure 1 of the
’380 patent does not depict an angled side opening, it does not appear that
Mr. Sutton categorically stated that the inventors had not conceived of a
device that included the side opening feature or otherwise directly
contradicted Mr. Root’s testimony on this point. We further note that the
first drawing in Mr. Root’s notes appears to closely match Figure 1 of the
challenged patent (which depicts an unassembled coaxial guide catheter and
tapered inner catheter), while the first drawing in Mr. Sutton’s notes appears
to closely match Figure 2 of the challenged patent (which depicts the
assembled device). Compare Ex. 2004, 1, with Ex. 1001, Fig. 1; compare
Ex. 2002, 7, with Ex. 1001, Fig. 2. We agree with Dr. Zalesky that the
sketches included in Mr. Root’s handwritten notes are “crude” and not a
model of clarity. Nonetheless, taking into account both the documentary
evidence and inventor testimony as a whole, we find that a preponderance of
the evidence supports the conclusion that the inventors conceived of a device
that included the side opening and all other claimed features prior to the
critical date.
To the extent that the earlier core conception documents alone do not
support prior conception, we have also taken into account the evidence
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proffered by Patent Owner with respect to the prototypes that were built
between February and August 2005. See PO CRTP Sur-Reply 3 (explaining
that if the early 2005 documents “were disregarded,” other pre-Itou evidence
“undisputedly show[s] conception of the entire invention, including the side
opening” (emphasis added)). To support its theory, Patent Owner cites
Dr. Zalesky’s testimony, where he confirms that the engineering drawings
depict a side opening. Ex. 2237, 211:11–16 (agreeing that “a side opening
can be found in the hypotubes that were cut down by Spectralytics,
specifically Exhibit 2113 and 2114”), 250:9–13 (agreeing that “Exhibit 2022
sets forth the concept for the rapid exchange GuideLiner”). Petitioner
acknowledges the probative value of the August 2005 drawing in showing
conception prior to the critical date: “[a]t best, [Patent Owner] shows
conception in August 2005, a mere month before Itou and after VSI’s
purported prototype work in April and July.” Pet. CRTP Sur-Reply 2.
Much of this evidence is also relied upon by Patent Owner to demonstrate
that there was actual reduction to practice prior to the critical date. Given
the overlap, we also address this evidence as part of our actual reduction to
practice analysis.
In sum, Patent Owner’s core documentary evidence—Mr. Sutton’s lab
notebook, the market feasibility memo, and Mr. Root’s handwritten notes—
sufficiently corroborate the stories of conception set forth in Mr. Root’s and
Mr. Sutton’s declarations. These corroborating documents add credibility to
the inventors’ conception timelines. And even if Petitioner were correct that
not every feature was conceived on or about February 2005, we find that
additional evidence of record with respect to the prototypes, as discussed
below, demonstrates conception no later than August 2005.
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3. Actual Reduction to Practice
Patent Owner contends that actual reduction to practice also took
place before the critical date of Itou. In support of this contention, Mr. Root
attests in his declaration that employees at VSI, led by co-inventors
Mr. Sutton and Mr. Welch, built and tested RX GuideLiner prototypes
between January and August 2005.17 Ex. 2118 ¶ 15. Mr. Sutton, as well as
two non-inventors employed by VSI at the time, Steve Erb and Deborah
Schmalz, also testify about relevant details of the research and development
done with regard to the GuideLiner prototypes. Ex. 2039 (Schmalz
Declaration); Ex. 2119 (Sutton Declaration); Ex. 2122 (Erb Declaration).
Patent Owner also presents the declarations of Mark Goemer and Amanda
O’Neil, who were employed by outside vendors from whom VSI purchased
components to build the prototypes. Ex. 2120 (Goemer Declaration);
Ex. 2121 (O’Neil Declaration). Additionally, Patent Owner has submitted
an expert declaration by Mr. Peter Keith in further support of this
contention. Ex. 2123 (Keith Declaration in support of CRTP). Patent
Owner relies upon purchase invoices, engineering schematics, and other
documentary evidence from as early as January 2005 through the September
2005 critical date of Itou in order to corroborate the fact declarants’
testimony regarding actual reduction to practice.18 We once again set forth
17 Mr. Root explains that Patent Owner does not have many development
documents from 2005, and it obtained many of the documents relevant to
actual reduction to practice from VSI’s vendors and patent prosecution firm.
Ex. 2118 ¶ 20.
18 Patent Owner includes some documentary evidence created after Itou’s
critical date. See, e.g., Ex. 2106 (invoices dated April 2006); Exhibit 2115
(engineering drawing dated Nov. 1, 2005). We do not find this post-critical
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the relevant facts based on these declarants’ testimony and corroborating
evidence, and then address any disputed issues of material fact and legal
issues as needed in our analysis for actual reduction to practice.
a) Fact Findings for Actual Reduction to Practice
After the inventors came up with the initial idea for the device (as set
forth in the conception discussion above), VSI proceeded with the
development of both the OTW and RX versions of the GuideLiner
concurrently. Ex. 2118 ¶ 19; Ex. 2119 ¶ 15. Although it was based on
existing technology, VSI decided to pursue the OTW version based on the
belief that it could be brought to market more quickly with fewer regulatory
challenges than the RX version. Ex. 2118 ¶ 19; Ex. 2119 ¶ 15. Nonetheless,
the RX version remained a priority for continued development at VSI.
Ex. 2118 ¶ 19; Ex. 2119 ¶ 15. Consistent with Mr. Root’s testimony,
Mr. Sutton testifies that the RX GuideLiner was reduced to practice before
September 2005, although further work towards commercialization of the
product continued until he left the company. Ex. 2119 ¶¶ 6, 15. According
to Mr. Sutton, work for the OTW prototype “paled in comparison” to work
required for the RX prototype because the OTW prototype “required very
little engineering and was relatively easy to build because it was based on
existing technology.” Id. ¶ 15. In their declarations, Mr. Root and
Mr. Sutton focus on two distinct sets of prototypes of the RX version that
date evidence to support Patent Owner’s contentions regarding actual
reduction to practice. However, we have considered some of this evidence
in our analysis of whether there was diligence towards constructive
reduction to practice (see discussion, infra), as well as to address Petitioner’s
argument that the continuing work done at VSI with respect to the
GuideLiner demonstrates a lack of actual reduction to practice before Itou.
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were built and tested before Itou’s critical date: the “April 2005” prototypes
and the “July 2005” prototypes. Ex. 2118 ¶ 48; Ex. 2119 ¶¶ 21–22.19 As
noted above, Mr. Root includes claim charts identifying how the April and
July 2005 prototypes satisfied the limitations of the challenged claims.
Ex. 2118, App’x A–E; see also Ex. 2123 ¶ 28 (Mr. Keith opining that the
April and July 2005 prototypes satisfy the claim limitations based on these
claim charts).
In developing these prototypes, a VSI technician and machinist
Mr. Erb worked with the inventors to mechanically cut down stainless steel
or nitinol “hypotubes” used for the proximal portion of an RX prototype.
Ex. 2118 ¶ 16; Ex. 2119 ¶ 20; Ex. 2122 ¶¶ 8–10. The profile of some of
these hypotubes started at full circumference at the distal end, then
progressed to roughly half-round at the proximal end. Ex. 2118 ¶ 16. The
hypotubes were combined with a polymer distal section to create the first
RX GuideLiner prototypes. Id. At this time, the distal tubular portion was
sometimes built by cutting a standard guide catheter to the appropriate
length. Id. ¶ 24. The earliest prototypes, made in January or February 2005,
largely comprised stock components modified through VSI’s in-house
machining capabilities. Id. ¶¶ 18, 20. However, by April 2005, the VSI
engineers progressed to building more formal prototypes using custom-
ordered materials from outside vendors for the proximal and distal portions
19 Although Mr. Root refers to the likelihood that other sets of prototypes
were also built, the bulk of Patent Owner’s evidence and arguments relate to
the April and July 2005 prototypes. Ex. 2118 ¶ 48. As such, we focus on
these prototypes in determining whether there was actual reduction to
practice.
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of the device. Ex. 2122 ¶ 12. A spend report details at least some of the
expenses that VSI incurred on purchases of the components used to build
GuideLiner prototypes from February 11, 2005, to June 30, 2006. Ex. 2005;
Ex. 2118 ¶¶ 21–22. According to Mr. Root, the fact that they had opened an
account specific to the “Guideliner project” in May 2005, as reflected in this
spend report, indicates that development had advanced to the point that they
were confident with proceeding towards commercialization. Ex. 2118 ¶ 22.
With respect to the proximal portions, Patent Owner presents invoices
and other documents reflecting VSI’s purchases of laser-cut hypotubes from
three outside vendors MicroGroup, Mountain Machine, Inc., and
SPECTRAlytics. Ex. 2118 ¶¶ 23, 27, 29, 30, 32, 33, 40, 43 (citing Exs.
2006, 2007, 2009, 2010, 2013, 2020, 2091, 2094, 2095, 2110, 2111);
Ex. 2119 ¶¶ 24–31 (discussing similar purchases); see also Ex. 2122 ¶ 7
(discussing purchases of stainless steel and nitinol hypotubes as reflected in
Ex. 2110).20 Because some of these invoices show purchases of the
hypotubing by the foot, Mr. Root asserts that the materials were likely used
for early evaluations of the RX GuideLiner concept. Ex. 2118 ¶ 23.
Mr. Sutton similarly asserts that the hypotubing that was purchased at this
time was used to make RX GuideLiner prototypes, as the OTW version
never involved such hypotubing. Ex. 2119 ¶¶ 23, 25. The ranges of the
inner and outer diameters, wall thickness, and the overall length of the
20 Although both stainless steel and nitinol hypotubes were ordered,
Mr. Sutton asserts that nitinol was significantly more expensive and required
additional post-processing steps as compared to stainless steel, and these
factors ultimately weighed against using nitinol for the proximal portion of
the RX GuideLiner. Ex. 2119 ¶ 28.
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hypotubes that were ordered were consistent with what VSI would have
needed at the time for prototyping the RX GuideLiner. Id. ¶¶ 24, 26.
Mr. Root and Mr. Sutton also reference the following annotated
engineering schematics of the proximal portion of the RX GuideLiner that
were drawn by a VSI engineer Jim Kauphusman on February 4, 2005:
Ex. 2113; Ex. 2118 ¶ 34; Ex. 2119 ¶ 30. The drawings above show a design
of the proximal portion with multiple angled transition regions bookending
non-inclined regions, and Patent Owner’s annotations to the drawings—
which were added for this proceeding, see PO CRTP Sur-Reply 13—identify
a “machined end for connecting to tubular portion,” a “side opening,” and a
“rail structure.” Id. These drawings were submitted as “prints” to
SPECTRAlytics in order to specify the parameters for the hypotubes that
were custom ordered, and include a drawing number “SS HYPO X04” that
correlates to a purchase completed on April 4, 2005. Ex. 2118 ¶ 34;
Ex. 2120 ¶ 9; Ex. 2095. Additional engineering drawings for the proximal
portions were submitted to SPECTRAlytics around June 2005. Ex. 2118
¶ 41; Ex. 2120 ¶ 11; Ex. 2114. Some of the engineering drawings are
similar to figures included in the challenged patent. Cf. Ex. 1001, Figs. 12–
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16.21 Mr. Goemer verifies and authenticates some of the purchase
documents and the engineering drawings retrieved from SPECTRAlytics’s
files. Ex. 2120 ¶¶ 6–12.
Additionally, Mr. Root and Mr. Sutton refer to purchases of distal
tubular portions and the distal forming tips from vendors Medical
Engineering & Design Inc. (“MED”) and Farlow’s Scientific Glassblowing
Inc. between February and July 2005. Ex. 2118 ¶¶ 28, 31, 44, 45 (citing
Exs. 2011, 2021, 2090, 2092); Ex. 2119 ¶¶ 32–34, 36 (additionally citing
Exs. 2032, 2033, 2034, 2035, 2089, 2097, 2112). Ms. O’Neil, who is
employed by MED’s successor TE Connectivity (“TE”), verifies and
authenticates some of these purchase documents, and notes that the
documents were retrieved from the files of TE, but originated with MED in
2005. Ex. 2121 ¶¶ 5–6.
One of the documents from MED also includes engineering
schematics for the distal portion that were drawn on February 10, 2005, by
Mr. Kauphusman, as shown below:
21 Mr. Sutton faxed these drawings to VSI’s outside patent counsel on March
21, 2006. Ex. 2118 ¶ 42; Ex. 2019.
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Ex. 2089, 8; Ex. 2118 ¶ 25; Ex. 2119 ¶ 32. The drawing above shows the
distal portion with Patent Owner’s annotations, see PO CRTP Resp. 9,
identifying a “soft tip,” “three reinforced Pebax portions,” the “distal end,”
and the “proximal end.” Id. Although Exhibit 2089 does not specify that
the tubing was for the RX version of the GuideLiner, Mr. Root and Mr.
Sutton assert that the drawings and specifications were in fact specific to an
RX device based on the notation that the proximal end should be “counter
bored” (a requirement to facilitate attachment to the cut-down hypotube) as
well as the overall length of 11.8 inches (because if this part were for an
OTW device, it would have been significantly longer). Ex. 2118 ¶ 25; Ex.
2119 ¶ 32. The order for distal portions as shown in Exhibit 2089 was
placed on February 17, 2005, and the parts were shipped from MED and
delivered to VSI on or about April 5, 2005. Ex. 2118 ¶ 25; Ex. 2119 ¶ 33.
An update to the drawing shown in Exhibit 2089 was made on April 6, 2005,
as shown in Exhibit 2092, with only minor changes, namely slightly reduced
inner and outer diameters to fit a guide catheter and a slightly shortened tip.
Ex. 2092, 8; Ex. 2118 ¶ 44. An order for distal tubular portions based on the
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updated design was placed on April 12, 2005 and those parts were delivered
to VSI on or about June 16, 2005. Id.
The proximal and distal portions that were custom ordered and
purchased from the outside vendors were thereafter combined in-house at
VSI to form the prototypes of the complete RX GuideLiner. Ex. 2118 ¶ 24
(“From the earliest stages of the project, the plan was to combine the
substantially rigid proximal portion of the rapid exchange GuideLiner with a
distal polymer tubular portion that would be at least partially reinforced with
coil or braid.”); Ex. 2119 ¶ 34 (“[W]e combined these distal sections from
MED with the proximal stainless steel sections discussed above to form
prototypes of the GuideLiner rapid exchange in April and July 2005.”). For
example, the first set of formal prototypes (the April prototypes) appear to
have been made by combining the laser-cut hypotubes from SPECTRAlytics
with the distal tubular sections from MED that were shipped around April 5,
2005. Ex. 2118 ¶ 35 (citing Exs. 2011,2089). Additional prototypes (the
July prototypes) appear to have been built using the hypotubes from
MicroGroup shipped around April 20, 2005, and/or the hypotubes from
SPECTRAlytics shipped around July 18, 2005, in combination with the
updated distal portions from MED shipped around June 16, 2005. Id. ¶¶ 39,
40, 46 (citing Exs. 2114, 2020, 2021, 2092, 2094). In making these
prototypes, VSI “used an in-house thermal process to fuse the distal tubing
sections from MED to the cut-down hypotubes.” Ex. 2119 ¶ 35. VSI had
the materials and equipment available to assemble the device at their
facilities. Id.
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As further evidence of an assembled device, inventors Mr. Root and
Mr. Sutton reference the following engineering CAD schematics from
August 1, 2005:
Ex. 2118 ¶ 49; Ex. 2119 ¶ 39; Ex. 2022. The drawings above show a
version of the complete RX GuideLiner, as well as a cross-sectional view of
the device with Patent Owner’s annotations, see PO CRTP Resp. 16,
identifying the “soft tip,” the “reinforced Pebax tubular portion,” the “side
opening,” and the “rail structure.” Ex. 2118 ¶ 50. The schematics are
labeled “GuideLiner Rapid Exchange/Preliminary Design Assumptions/Rev
X03,” which according to Mr. Root was an indication that VSI had moved
past prototyping and into commercialization. Id. Mr. Sutton attests that the
“X03” indicates that this was the third version of the CAD drawings, and
that they had built and tested prototypes of the RX GuideLiner device shown
in these drawings. Ex. 2119 ¶ 39. The document also references the same
part number (20-0658) as those identified in certain purchase documents for
distal tubular portions from MED. Ex. 2118 ¶ 51 (citing Ex. 2021, Ex. 2089,
Ex. 2092). These drawings are nearly identical to Figures 3 and 4 of the
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patent. Cf. Ex. 1001, Figs. 3–4 (depicting patent drawings that resemble the
CAD drawings).
The prototypes were tested using bench-top coronary models,
including two-dimensional (“2D”) acrylic heart models and three-
dimensional (“3D”) glass heart models, to simulate the native anatomy and
environment. Ex. 2118 ¶¶ 17, 38, 47; Ex. 2119 ¶¶ 37–38, 41. These types
of models were commonly used by VSI and other medical device companies
to test interventional cardiology devices. Ex. 2118 ¶ 17; Ex. 2123 ¶ 21 (Mr.
Keith noting that he had used similar models to test catheter designs during
his time at Scimed and Boston Scientific Corporation). A sales presentation
from July 2005 shows an example of a 2D coronary model. Ex. 2018, 12;
Ex. 2129 (redacted version of same presentation). While this particular
presentation depicts testing of the OTW version of the GuideLiner
concurrently under development, Mr. Root asserts that a similar model was
used to test the RX version. Ex. 2118 ¶¶ 18, 38. The testing done using this
model included performing pull tests as well as simulations comprising the
following steps: a) inserting a standard guide catheter into the coronary
model; b) advancing the prototype into the guide catheter until the
prototype’s distal end extended beyond the guide catheter’s distal end; and
c) delivering a stent or balloon catheter into and through both devices. Id.
¶ 18. Although “more qualitative than quantitative,” these tests enabled the
inventors to observe the prototype’s durability and the forces exerted on the
prototype. Ex. 2118 ¶¶ 18, 47; Ex. 2119 ¶¶ 23, 41. Both Mr. Root and
Mr. Sutton attest that this testing was sufficient to confirm that the RX
GuideLiner would work for its intended purpose, namely facilitating
delivery of interventional cardiology devices into challenging coronary
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anatomy by providing increased backup support as compared to a guide
catheter alone. Ex. 2118 ¶¶ 18, 47; Ex. 2119 ¶¶ 23, 41.
Patent Owner also presents other documentary evidence as
corroboration of the testimony of inventors Mr. Root and Mr. Sutton. We
have taken these documents into account, but find them somewhat less
probative in showing actual reduction to practice.
For instance, a June 23, 2005, market feasibility memo (Ex. 2017),
similar to the earlier memo from February 4, 2005 (Ex. 2003), confirms that
the RX GuideLiner prototype was continuing to be developed, although the
OTW version had been added to the development project at that point.
Ex. 2118 ¶ 37; see Ex. 2017, 1 (noting that “it is possible to make the
GuideLiner in an Over-the-Wire version, a Rapid Exchange version, or
both”).
A “Product Requirements” document, dated August 24, 2005, sets
forth the safety and performance requirements for both the OTW and RX
guide catheter support systems. Ex. 2118 ¶ 54; Ex. 2119 ¶ 44; Ex. 2024.22
The document notes that “[t]hese safety and performance features are the
minimal requirements for the device to be acceptable for its intended clinical
use,” and that the “[a]pplicable clinical use is for increase[d] guide catheter
back-up support.” Ex. 2024, 1. Mr. Root asserts that this document marked
the start of the formal quality process for the RX and OTW GuideLiner
22 Exhibit 2024 is the subject of Petitioner’s motion to exclude. Paper 111.
For the reasons we state below in addressing the motion to exclude (see
discussion, infra), we decline to exclude Exhibit 2024 but have considered
Petitioner’s arguments in determining the weight to be given to this piece of
evidence.
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catheters. Ex. 2118 ¶ 54. Both Mr. Root and Mr. Sutton, as well as
Ms. Schmalz (VSI’s Vice President of Regulatory and Clinical Affairs at the
time), testify that that this document would have been created only after the
product was tested, demonstrated to work, and ready to proceed with
regulatory approval and commercialization. Ex. 2118 ¶ 54; Ex. 2119 ¶ 44;
Ex. 2039 ¶ 7. Ms. Schmalz specifically recalls that a working prototype of
the RX version was created prior to the creation of this document. Ex. 2039
¶ 7. Although this document sets forth several user requirements for the
device, it does not identify the product specifications and test methods
correlating to those requirements. Ex. 2024, 2–4. The revision history of
the document also indicates it is “pre-release,” thereby suggesting that it
may not have been finalized at the time. Id. at 4.
Mr. Root, Mr. Sutton, and Ms. Schmalz each also discuss two other
documents both dated August 26, 2005—a Clinical Technical Report (Ex.
2025) and a staff meeting memo (Ex. 2040)—as further evidence that work
continued on the RX GuideLiner and that VSI was ready to seek regulatory
approval for the device from the Food and Drug Administration (“FDA”).
Ex. 2039 ¶¶ 9–10; Ex. 2118 ¶¶ 55– 57; Ex. 2119 ¶¶ 45–46. The Clinical
Technical Report states that VSI “has developed, and is currently
manufacturing four types of catheters . . . [including] the GuideLiner
Catheter Support System used to provide physicians with additional guide
catheter support allowing access to more difficult anatomy,” and goes on to
describe both the RX and OTW versions of GuideLiner. Ex. 2025, 2–3, 5–6.
We note, however, that the text discussing GuideLiner devices appears to be
“redline” edits and does not include any signatures for “document
approvals,” thus suggesting that the document submitted as Exhibit 2025
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may have only been a draft. See id. The staff memo refers to clinical
literature reviews for the GuideLiner devices (both RX and OTW), which
Mr. Root asserts was part of VSI’s regulatory strategy for a “510(k)”
submission to the FDA.23 Ex. 2118 ¶ 57.
b) Analysis for Actual Reduction to Practice
To establish actual reduction to practice, Patent Owner must
demonstrate two things: (1) that it constructed an embodiment that met all
the limitations of the invention claimed in the patents at issue; and (2) that it
determined that the invention would work for its intended purpose. Cooper,
154 F.3d at 1327. Having considered the evidence and arguments of record,
including the testimonial and documentary evidence summarized above, we
find that Patent Owner has met this burden with respect to the challenged
claims based on the prototypes of the RX GuideLiner that were built and
tested at VSI prior to September 2005. We address Petitioner’s arguments to
the contrary.
The first issue raised by Petitioner is whether there is sufficient
corroborating documentary evidence to support the inventors’ testimony on
reduction to practice. As with conception, “a party seeking to prove an
actual reduction to practice must proffer evidence corroborating [an
inventor’s] testimony.” Raytheon Co. v. Sony Corp., 727 F. App’x 662, 668
(Fed. Cir. 2018) (citing Medichem, 437 F.3d at 1169–71). The sufficiency
23 A 510(k) submission is a premarket notification to demonstrate that the
device to be marketed is as safe and effective, that is, substantially
equivalent, to a legally marketed device. See FDA, Premarket Notification
510(k), (accessed June 1, 2021), https://www.fda.gov/medical-
devices/premarket-submissions/premarket-notification-510k.
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of this corroboration is once again determined using a “rule of reason”
analysis. Id.
Petitioner contends that “[n]o document shows that VSI built, much
less tested, RX prototypes.” Pet. CRTP Reply 8. Petitioner points to the
lack of photographs, assembly instructions, subassembly drawings, and
notebook pages (other than Mr. Sutton’s initial conception pages) to
corroborate the work done on the RX prototype in 2005. Id. By contrast,
Petitioner asserts that VSI kept more documents, including notes from
Mr. Kauphusman (the VSI engineer who led the GuideLiner project),
relating to the OTW prototypes from that time. Id. at 9–10 (citing Ex. 1760,
86–87). Petitioner also contends that Patent Owner cannot justify VSI’s
failure to retain these reduction-to-practice documents because it “runs
contrary to federal law and industry practice.” Id. at 11 (citing Ex. 1755 ¶¶
66–74, 143–145). Among the documentary evidence presented, Petitioner
contends that at most four documents relate to particular prototypes, and the
rest are irrelevant insofar as they concern purchases of generic component
parts untethered to particular projects or prototypes. Id. at 11–14. Petitioner
further contends the documents do not show that VSI actually assembled the
RX prototypes. Id. at 16–17.
We are not persuaded that the record lacks sufficient corroborating
evidence of actual reduction to practice. “In order to corroborate a reduction
to practice, it is not necessary to produce an actual over-the-shoulder
observer. Rather, sufficient circumstantial evidence of an independent
nature can satisfy the corroboration requirement.” Cooper, 154 F.3d at 1330
(citing Knorr v. Pearson, 671 F.2d 1368, 1373 (CCPA 1982)).
“Furthermore, an actual reduction to practice does not require corroboration
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for every factual issue contested by the parties.” Id. (citing Ethicon, Inc. v.
U.S. Surgical Corp., 135 F.3d 1456, 1464 (Fed. Cir. 1998); Mann v. Werner,
347 F.2d 636, 640 (CCPA 1965) (“This court has rejected the notion that
each individual act in the reduction to practice of a count must be proved in
detail by an unbroken chain of corroboration.”)). Put another way, the law
“does not require that evidence have a source independent of the inventors
on every aspect of conception and reduction to practice; such a standard is
the antithesis of the rule of reason.” E.I. du Pont De Nemours & Co. v.
Unifrax I LLC, 921 F.3d 1060, 1077 (Fed. Cir. 2019) (internal quotations
omitted).
As discussed above, Mr. Root and Mr. Sutton each provide detailed
and consistent testimony explaining the work done at VSI towards building
and testing the April and July 2005 prototypes of the RX GuideLiner.
Critical aspects of this testimony are corroborated by other (non-inventor)
testimony from Ms. Schmalz (recounting the regulatory and quality process
at VSI), Mr. Erb (recounting how they built early prototypes), Mr. Goemer
(verifying purchases from SPECTRAlytics), and Ms. O’Neil (verifying
purchases from MED). This testimony is further corroborated by a
significant amount of documentary evidence, including purchase documents
and engineering drawings, as set forth above. To the extent that there may
have been other more detailed evidence with regard to the OTW GuideLiner,
we do not find that such evidence detracts from or otherwise contradicts the
evidence presented for the RX GuideLiner. Nor do we require Patent Owner
to establish actual reduction to practice by retaining and then proffering the
same type of documents that the FDA would have required Patent Owner to
submit to gain approval of a medical device. See Ex. 2237, 63:20–64:9
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(Dr. Zalesky acknowledging that “[t]he testing requirement for regulatory
submission such as a 510(k) is quite extensive,” and “a very significantly
different level than that required to demonstrate reduction to practice.”);
Petitioner contends that the purchased parts reflected in Patent
Owner’s documentary evidence could have been used for other VSI projects
under development in 2005. Pet. CRTP Reply 12–16. We do not find that
the evidence supports Petitioner’s conjecture in this regard. For example,
Petitioner cites the testimony of Dr. Zalesky to assert that the purchased
hypotubing (and other parts) could have been used for VSI’s Twin-Pass,
Skyway, and Pronto V3 products, in addition to the OTW GuideLiner. Id.
(citing Ex. 1755 ¶¶ 121–132, 153, 166, 203). But Dr. Zalesky does not point
to any supporting evidence showing that these other VSI products used the
same type of hypotubing as what would have been required for the RX
GuideLiner. See Ex. 2237, 156:3–158:10, 173:10–174:12 (Dr. Zalesky
admitting that he did not have any evidence that hypotubes were used in
other products, but stating his opinion was based on “informed speculation”
or “reasonable speculation”). Rather than Dr. Zalesky’s speculation, we
credit the testimony of Mr. Root, Mr. Sutton, and Mr. Erb, each of whom
had first-hand involvement in the project and independently attest that at
least some of the purchased hypotubes were specific for the RX GuideLiner.
Ex. 2118 ¶ 23; Ex. 2119 ¶ 23; Ex. 2122 ¶ 7.
The corroborating documents confirm that the purchases were for the
RX GuideLiner, not a general ledger expense that would suggest the parts
could be used for other products. See, e.g., Ex. 2005 (spend report for
accounts related to “new modalities” and “Guideliner project”). The sole
document Petitioner cites to posit that the purchased hypotubes could have
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been used for OTW devices is an engineering schematic that bears
November 2005 and January 2006 dates, which were later than the April and
July 2005 prototypes. Ex. 1763, 6. Furthermore, the hypotube shown in the
OTW drawing differs in materials and dimensions from the hypotubes
purchased for the RX prototypes. The hypotube in the OTW drawing is
nitinol and roughly 19 cm, quite different than the 100 cm stainless steel
hypotubes used for the GuideLiner prototypes. Id. The 43-inch distal
section in the OTW drawing also differs dramatically from the 11.8-inch
distal section for the RX prototype. Ex. 2237, 164:24–167:19 (Dr. Zalesky
agreeing that the distal portion shown in Exhibit 2089 is not the same as the
distal portion of Exhibit 1763); compare Ex. 1763, 6 with Exs. 2089 and
2092.
With regard to whether the purchased components were actually
assembled into an RX prototype, we find that the engineering schematic
from August 2005 is strongly corroborative of an assembled device.
Ex. 2022. Dr. Zalesky acknowledges that it “doesn’t make a lot of sense”
for VSI not to have assembled the purchased parts together. Ex. 2237,
208:10–25. A preponderance of the evidence supports the conclusion that
the assembled RX prototypes met each of the limitations of the challenged
claims, as set forth in the Appendices to Mr. Root’s declaration. Ex. 2118,
App’x A–E. In its Sur-Sur-Reply, Petitioner identifies certain claim
limitations that were allegedly not met by the prototypes, but Petitioner does
not point to any evidence to contradict Mr. Root’s testimony on this point.
Pet. CRTP Sur-Sur-Reply 14–15. We likewise find the charts included as
Appendices to Dr. Zalesky’s declaration to be insufficient in this regard.
Ex. 1755, App’x A–E. Rather than identifying any specific technical reason
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why the prototype components reflected in the purchase documents could
not have met the claim limitations, Dr. Zalesky’s rebuttal claim charts
appears to focus on whether there was sufficient corroborating evidence
(which we have already discussed above). Id. As such, we find the
evidence presented in this case to be more detailed than that found
insufficient in Valencell, Inc. v. Fitbit, Inc., 784 F. App’x 1005, 1009 (Fed.
Cir. 2019), cited by Petitioner. Pet. CRTP Reply 16. There, no evidence—
testimonial or documentary—addressed key claims limitations, which stands
in contrast to the detailed testimony and corroborating documents cited in
Mr. Root’s and Mr. Sutton’s declarations.
Having found that Patent Owner constructed embodiments that met all
limitations of the challenged claims, we move on to the second issue:
whether Patent Owner demonstrated that those embodiments worked for the
intended purpose of the invention.
We begin this inquiry by identifying the “intended purpose” of the
invention. Patent Owner puts forth a broad intended purpose. Initially,
Patent Owner asserted testing was done to show that the prototypes “could
serve their intended purpose of being placed in a standard guide catheter and
deliver interventional cardiology devices alongside the rail segment, into the
side opening and distal tubular portion, and then out the distal end of the
distal tubular portion and into challenging coronary anatomy.” PO CRTP
Resp. 25 (citing Ex. 2118 ¶¶ 17–18, 38, 47; Ex. 2119 ¶ 41; Ex. 2123 ¶¶ 20–
24). In its Sur-Reply, Patent Owner clarifies that the intended purpose was
“to increase backup support for delivery of interventional cardiology
devices, including procedures involving tough or chronic total occlusions.”
PO CRTP Sur-Reply 9 (citing Exs. 2002, 2003, 2024). By contrast,
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Petitioner argues for a narrower intended purpose, asserting that the intended
purpose was “providing backup support necessary for accessing and crossing
tough or chronic occlusions.” Pet. CRTP Reply 17 (citing Ex. 2002; Ex.
2118 ¶ 18; Ex. 2119 ¶ 9; Ex. 1762, 47:11–52:17 (Root Deposition)). Citing
Patent Owner’s Sur-Reply, Petitioner contends that the parties ostensibly
“agree” that the intended purpose was “to increase backup support for
accessing and crossing tough occlusions.” Pet. CRTP Sur-Sur-Reply 7
(citing PO CRTP Sur-Reply 9); see also Tr. 49:3–12 (“Teleflex agrees the
intended purpose was to increase back-up support for accessing and crossing
tough or chronic total occlusions.”).
We agree with Patent Owner’s position on what constitutes the
intended purpose of the invention. Petitioner is certainly correct that several
of the documents we have considered refer to crossing “tough” or “chronic”
occlusions when discussing the idea behind the invention. See, e.g.,
Ex. 2002. But when considering all of the pertinent evidence, we find that
inventors were concerned with a broader primary purpose, namely generally
providing improved backup support for a guide catheter, with crossing tough
or total occlusions being one specific benefit or application of the device. In
other words, we do not find that the RX GuideLiner had applicability only
when there were tough or chronic occlusions in the artery that needed to be
crossed. Indeed, the challenged patent itself recognizes this broader purpose
when discussing the field and background of the invention. See Ex. 1001,
1:32–35 (“More particularly the present invention relates to methods and
apparatus for increasing backup support for catheters inserted into coronary
arteries from the aorta.”); id. at 3:1–5 (“Thus, the interventional cardiology
art would benefit from the availability of a system that would be deliverable
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through standard guide catheters for providing backup support by providing
the ability to effectively create deep seating in the ostium of the coronary
artery.”)
The documentary evidence we have considered and discussed above
further supports this broader intended purpose. For example, while
Mr. Sutton’s lab notebook expresses the idea for the GuideLiner device as
“relat[ing] to interventional coronary procedures and specifically to
accessing & crossing tough or chronic total occlusions,” it also more broadly
notes that “[t]he idea is to provide a guide or support catheter more distally
into the coronary to provide more back-up support for the stent device.”
Ex. 2002, 7. Mr. Sutton’s lab notebook also contains two additional notes
related to the invention: “Guide-Liner is used when there is difficulty
crossing lesions”; and “Guide-Liner allows back-up support distally.” Id. at
8. Similarly, in the February 4, 2005 Market Feasibility memo, Mr. Root
describes the purpose of the RX GuideLiner as “provid[ing] the ability to
create a deep seating of the guide for added support in the interventional
procedure.” Ex. 2003, 1. Mr. Root explains that “[b]y safely deep seating
the guide catheter, the physician can then have the added support for pushing
a wire through a chronic total occlusion or advancing a balloon or stent
through a tight stenosis.” Id. The August 24, 2005 Products Requirement
document indicates the “[a]pplicable clinical use” for both the RX and OTW
GuideLiners to be “increas[ing] guide catheter back-up support.” Ex. 2024,
1.
Additionally, Patent Owner’s expert’s testimony supports this
conclusion. Patent Owner’s expert, Mr. Keith, declares that testing the RX
GuideLiner prototypes would be sufficient for reduction to practice if the
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testing showed the prototype “(a) could be delivered through a guide
catheter so that the distal end of the tubular portion extended beyond the
distal end of the guide catheter while being tracked over a winding path;”
and “(b) allowed a stent delivery catheter or balloon catheter to pass into the
tubular portion and out the far end of the tubular portion while located
within the guide catheter.” Ex. 2123 ¶ 22.
The testimony of inventors Mr. Root and Mr. Sutton cited by the
parties also supports this conclusion. Mr. Root declares that the intended
purpose of the RX GuideLiner was to “deliver interventional cardiology
devices, such as a stent or balloon catheter, alongside the rail segment, into
the side opening and distal tubular portion, and then out the distal end of the
distal tubular portion and into challenging coronary anatomy.” Ex. 2118 ¶
18; see also id. ¶ 47 (describing the intended purpose as “facilitat[ing] the
delivery of balloon catheters and stents deep into coronary arteries while
providing increased backup support”). During Mr. Root’s deposition,
counsel for Petitioner inquired about Mr. Root’s understanding of the
intended purpose. Ex. 1762, 47:11–52:17. Mr. Root repeatedly stated that
accessing and crossing tough or chronic occlusions was not the sole intended
purpose. Id. at 47:11–20 (identifying that Petitioner’s asserted intended
purpose was “one of them” but “not all of them”), 50:10–12 (“The important
thing is this is not just a chronic total occlusion device. This can apply to
much broader coronary interventions.”). Mr. Sutton’s declaration quotes the
purpose identified in his notes in his lab notebook, discussed above. Ex.
2119 ¶ 9 (quoting Ex. 2002, 7, 8). Mr. Sutton also declares that he and his
team tested the prototypes qualitatively “to determine that [they] provided
backup support,” “to ensure that [stents and balloon catheters] could safely
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be delivered and would not snag or get caught on the device,” and “to
deliver interventional cardiology devices and provide additional backup
support compared to the guide catheter alone.” Id. ¶ 41.
In sum, the pertinent evidence demonstrates that the intended purpose
of the claimed invention, as embodied in the RX GuideLiner, was to
increase backup support for delivery of interventional cardiology devices.
Although crossing tough or total occlusions is one noted benefit of the
invention, we do not find it to be the only or primary purpose of the
invention.
We next consider whether the testing conducted at VSI was sufficient
to determine that the RX GuideLiner prototypes would work for the intended
purpose of increasing backup support for delivery of interventional
cardiology devices. “Depending on the character of the invention and the
problem it solves, determining that the invention will work for its intended
purpose may require testing.” Cooper, 154 F.3d at 1327 (citing Mahurkar v.
C.R. Bard Inc., 79 F.3d 1572, 1578 (Fed. Cir. 1996)). “When testing is
necessary, the embodiment relied upon as evidence of priority must actually
work for its intended purpose.” Id. (citing Scott v. Finney, 34 F.3d 1058,
1061 (Fed. Cir. 1994)). “[T]he testing requirement depends on the particular
facts of each case, with the court guided by a common sense approach in
weighing the sufficiency of the testing.” Scott, 34 F.3d at 1061. “This
common sense approach prescribes more scrupulous testing under
circumstances approaching actual use conditions when the problem includes
many uncertainties,” but “permits little or no testing to show the soundness
of the principles of operation of the invention” “when the problem to be
solved does not present myriad variables.” Id. at 1063. “In tests showing
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the invention’s solution of a problem, the courts have not required
commercial perfection nor absolute replication of the circumstances of the
invention’s ultimate use.” Id. “[T]ests performed outside the intended
environment can be sufficient to show reduction to practice if the testing
conditions are sufficiently similar to those of the intended environment.”
DSL Dynamic Scis. Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122,
1125 (Fed. Cir. 1991) (citing Tomecek v. Stimpson, 513 F.2d 614, 618
(CCPA 1975)). For medical device inventions, a showing of actual
reduction to practice does not require human testing in actual use conditions.
Scott, 34 F.3d at 1063 (“Testing for the full safety and effectiveness of a
prosthetic device is more properly left to the Food and Drug Administration
(FDA). Title 35 does not demand that such human testing occur within the
confines of Patent and Trademark Office (PTO) proceedings.”).
Patent Owner relies on inventor and expert testimony, as well as
documentary evidence, to establish that use of benchtop models was
sufficient to test that the products were suitable for the intended purpose
described above.24 PO CRTP Resp. 11–12, 24–25. Mr. Root asserts that
benchtop coronary models, as depicted in the July 2005 sales presentation,
were commonly used at VSI and other medical device companies to test
interventional cardiology catheters. Ex. 2118 ¶ 17 (citing Exs. 2018, 2129).
24 Referring to Petitioner’s expert’s testimony regarding a person of ordinary
skill in the art’s knowledge pertaining to Itou, Patent Owner also contends
that no testing would have been required to know the RX GuideLiner would
have worked for its intended purpose. See PO CRTP Sur-Reply 9 (citing Ex.
2116, 110:20–113:24; Ex. 2238, 87:18–89:5). Because we determine that
the evidence demonstrates that testing in benchtop models was sufficient, we
do not address this theory.
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Citing its expert’s declaration, Patent Owner asserts that “[c]atheter
inventions are routinely determined to work using benchtop models, and
without human testing.” PO CRTP Resp. 25 (citing Ex. 2123 ¶¶ 20–24;
Ex. 1010). Applied to this invention, Patent Owner asserts that its benchtop
model emulated the cardiac anatomy, and was used to show that the RX
GuideLiner could be “placed in a standard guide catheter and deliver
interventional cardiology devices alongside the rail segment, into the side
opening and distal tubular portion, and then out the distal end of the distal
tubular portion and into challenging coronary anatomy.” Id. (citing Ex.
2118 ¶¶ 17–18, 38, 47; Ex. 2119 ¶ 41; Ex. 2123 ¶¶ 20–24).
Petitioner’s argument against Patent Owner’s testing evidence
depends on its narrower intended purpose, i.e., “using simulated tough
lesions.” Pet. CRTP Reply 18; see also Pet. CRTP Sur-Sur-Reply 7–9. In
light of our rejection of the narrower intended purpose identified by
Petitioner, we likewise reject Petitioner’s argument that the testing evidence
presented by Patent Owner is insufficient. Moreover, Petitioner
acknowledges that benchtop models could have been used to test a device
like the RX GuideLiner. Pet. CRTP Reply 17–18. The testimony of
Mr. Root, Mr. Sutton, Mr. Erb, and Mr. Keith, corroborated by the
photograph of the model in the sales presentation, confirm that VSI utilized
benchtop coronary models that were considered the standard for testing
interventional cardiology device such as catheters. See Ex. 2018; Ex. 2118
¶¶ 17, 38, 47; Ex. 2119 ¶¶ 23, 37–38, 41; Ex. 2122 ¶ 11; Ex. 2123 ¶¶ 21–24.
We consider this benchtop testing to be similar to the “countertop” testing
that was found sufficient to show actual reduction to practice in Mahurkar.
See Mahurkar, 79 F.3d at 1578 (determining for claims related to a double
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lumen catheter that flow and pressure drop tests conducted in the inventor’s
kitchen, using glycerine to simulate blood, was sufficient for actual
reduction to practice because they “showed, to the limit of their design, the
utility of his claimed invention”). As noted by Petitioner, Mr. Root
indicated during his deposition that to reduce to practice, VSI needed to “(1)
navigate RX through a guide catheter and out its distal end in a benchtop
model, (2) deliver an interventional cardiology device, and (3) retrieve RX
in one piece.” Pet. CRTP Reply 18 (citing Ex. 1762, 100:1–102:3). We find
that the “pull tests” done using the benchtop models demonstrated that the
RX GuideLiner was capable of accomplishing at least this much, even if the
tests were not conducted in an in vivo or in vitro environment that simulated
tough lesions. Ex. 2118 ¶¶ 17, 38, 47. This is not a situation where there
were significant variables or uncertainties that needed to be assessed in order
to determine whether the RX device would work properly, and thus the
“qualitative” testing done by VSI using the benchtop models was sufficient.
Ex. 2119 ¶ 41; Ex. 2123 ¶¶ 21–22. Accordingly, a preponderance of the
evidence supports the conclusion that the testing done at VSI demonstrated
that the RX GuideLiner would work for its intended purpose.
In our assessment of whether there was actual reduction to practice
prior to the critical date, we have considered Petitioner’s argument that the
GuideLiner project was still in “early-stage concept development” in mid-to-
late 2005, and that VSI was still experimenting in 2006 and did not have a
working prototype even by 2008. Pet. CRTP Reply 22–27.
In support of this argument, Petitioner points to continuing changes to
the RX design as evidence that the design was not completed before the
critical date. Id. For example, a July 2005 Research & Development (R&D)
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Update notes that “[t]he initial design is an over-the-wire configuration, with
a rapid exchange version to follow.” Ex. 2130, 3.25 In contrast to the
incomplete August 2005 Product Requirements document relied upon by
Patent Owner (Ex. 2024), Petitioner contends that the official, completed
version of the Product Requirements document for the GuideLiner project
was not created until April 2009. Ex. 1767. A “2006 Strategic Objectives”
document, dated December 1, 2005, indicates that the “rapid exchange
version requires additional engineering and is not included in our 2006
forecasts.” Ex. 2131, 10. Likewise, Petitioner points to a GuideLiner team
meeting memo from May 2, 2006 that includes as agenda items “1) Review
Initial Design and Intended Use,” and “2) Determine what can be
completed/started prior to design lock.” Ex. 2109. According to another
document, a “design freeze” for the GuideLiner device was expected to only
take place May 30, 2007. Ex. 1769, 1. Indeed, an R&D update from July
2008 notes with respect to the GuideLiner device:
Throughout this project, timelines have been pushed out due to
drastic design changes and resource constraints. To date we
have prototyped and tested a new design. This new design is
more robust and cost effective. We are planning on an August
2008 design freeze with a 510k submission in November 2008.
Ex. 2132, 7.
25 We recognize that this document appears to contradict Mr. Root’s
recollection that the original idea was for the RX GuideLiner, and that the
decision was later made to concurrently pursue development of the OTW
version. Ex. 2118 ¶ 19. We do not find the issue of whether the initial idea
was for the RX version or the OTW version to be material to our analysis on
reduction to practice. Nonetheless, we note Mr. Sutton’s original notebook
pages suggest that the original idea was indeed for the RX version rather
than the OTW version. Ex. 2002.
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We have taken the foregoing evidence into account, but do not find
that it detracts from Patent Owner’s evidence concerning reduction to
practice based on building and testing the April and July 2005 prototypes
discussed above. To be sure, the post-critical date documents highlighted by
Petitioner make it clear that significant design revisions for the RX
GuideLiner continued well into 2008, and these additional design changes
may well have been required for FDA regulatory approval and/or
commercialization of the device. Indeed, Patent Owners’ declarants attest
that additional engineering work was conducted to refine the product for
regulatory purposes and commercialization. See Ex. 2118 ¶ 59 (Mr. Root
attesting that “[f]rom September of 2005 forward, I and others at VSI
continued to act diligently to bring the rapid exchange GuideLiner to
market.”); Ex. 2119 ¶ 44 (Mr. Sutton attesting that, after the August 24,
2005, Product Requirements document, “we continued to refine prototypes
of the GuideLiner Rapid Exchange for purposes of manufacturability and
commercialization”); Ex. 2122 ¶ 13 (Mr. Erb attesting that work continued
on “develop[ing] manufacturing processes that were reproducible and a
refined design that was able to be commercialized”). But we see no basis to
conclude that these additional engineering and design changes were an
indication that the April and July 2005 prototypes failed to demonstrate that
the RX GuideLiner was capable of achieving increased backup support.
Ultimately, the RX GuideLiner was not commercialized until 2009,
which we recognize is far later than the initial projected timeframe of late
2005/early 2006 and the date of actual reduction to practice. Ex. 2118 ¶ 89.
Mr. Root asserts that one reason for this delay was due to turnover in R&D
personnel. Id. Under the circumstances, we do not find that the additional
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engineering and design work done with respect to the RX GuideLiner to
achieve regulatory approval and commercialization indicates a lack of actual
reduction to practice prior to the critical date. See Loral Fairchild Corp. v.
Matsushita Elec., 266 F.3d 1358, 1362–63 (Fed. Cir. 2001) (“Once the
invention has been shown to work for its intended purpose, reduction to
practice is complete. Further efforts to commercialize the invention are
simply not relevant to determining whether a reference qualifies as prior art
against the patented invention.”).
In sum, we find that Patent Owner has demonstrated actual reduction
to practice prior to Itou’s critical date by a preponderance of the evidence
based on the work done at VSI in building and testing the April and July
2005 prototypes of the RX GuideLiner. Nonetheless, to the extent that this
evidence is not sufficient for actual reduction to practice, we find that it
demonstrates at least conception of the claimed invention prior to the critical
date.
4. Constructive Reduction to Practice
In addition to asserting actual reduction to practice, Patent Owner
alternatively relies upon a theory of constructive reduction to practice.
Antedating based on this theory would require Patent Owner to demonstrate
diligence from just before the date Itou was filed until the date Patent Owner
filed its priority application for the GuideLiner patents,26 i.e., from
September 23, 2005 to May 3, 2006. See Perfect Surgical Techniques, Inc.
26 We use term “GuideLiner patents,” in the same manner as the parties’
declarants, to refer to the patents challenged in IPR2020-00126, -00128, -
00129, -00132, -00134, -00135, and -00137. See, e.g., Ex. 2118 ¶ 1;
Ex. 2119 ¶¶ 1, 3; Ex. 2123 ¶ 1.
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v. Olympus America, Inc., 841 F.3d 1004, 1007 (Fed. Cir. 2016) (requiring
diligence for the “entire critical period, which begins just prior to the
competing reference’s effective date and ends on the date of the invention’s
reduction to practice”).
To demonstrate diligence, Patent Owner again relies on testimony
from its inventor and non-inventor declarants, as well as correspondences
with VSI’s outside patent counsel at the Patterson Law Firm and documents
reflecting further engineering and development work done during this
period. PO CRTP Resp. 18–19; PO CRTP Sur-Reply 12.
According to Mr. Root, following the initial conception and the
building of the April and July 2005 prototypes, he and others at VSI
continued from September 2005 onward to bring the RX GuideLiner to
market. Ex. 2118 ¶ 59. This project was one of VSI’s primary development
initiatives at the time, and they worked on it continuously until they brought
it to market in 2009. Id.; see id. ¶ 89. Thus, they worked continuously at
least until the May 3, 2006 application date. Id. ¶ 76. Ms. Schmalz likewise
testifies that “[a]t no time between the start of the regulatory process for
GuideLiner in August of 2005 and the filing of the patent application in May
2006 was the rapid exchange GuideLiner project abandoned or paused.”
Ex. 2039 ¶ 12.
Mr. Sutton sent a fax to the Patterson Law Firm on March 21, 2006,
which includes drawings that are similar to the proximal portion of the RX
GuideLiner depicted in Exhibit. 2114. Ex. 2118 ¶ 42 (citing Ex. 2019). The
firm also possessed the August 1, 2005, CAD drawing of a complete RX
GuideLiner prototype. Id. ¶¶ 49–50 (citing Ex. 2022).
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Upon Mr. Root’s request, the firm opened a matter to conduct a
patentability search for the GuideLiner on August 11, 2005. Id. ¶ 52 (citing
Ex. 2023). Mr. Root provided the firm with the full prototype drawing in
Ex. 2022 to conduct the search. Id. Mr. Root testifies that he would not
engage in freedom-to-operate searching until after he had made a full
prototype that was shown to work for its intended purpose and ready to
move forward to commercialization. Id. An invoice from the firm
demonstrates work performed for a “patent search for guide liner” in August
2005. Id. ¶ 53 (citing Ex. 2096).
In his declaration, Mr. Root then sets forth the timeline of events with
documentary and circumstantial evidence during the critical period for
diligence, i.e., from September 23, 2005, to May 3, 2006.
For September 2005, Mr. Root refers to invoices dated September 7,
2005, and a check for forming tips that would have been used for the distal
tip of the GuideLiner prototype. Id. ¶ 60 (citing Ex. 2097). He refers to
these documents to demonstrate that VSI was continuing to refine the
prototypes during this period. Mr. Root also refers to a copy of the Patterson
Law Firm’s privilege log showing that a partner of the firm sent Mr. Root a
confidential letter dated September 14, 2005, pertaining to prior art related to
the GuideLiner. Id. ¶ 61 (citing Ex. 2098).
For October 2005, Mr. Root refers to a business update presented to
VSI’s Board of Directors during its October 2005 meeting. Id. ¶ 62 (citing
Exs. 2041 (confidential), 2133 (public)). Mr. Root declares this update
included extremely favorable reviews of the RX GuideLiner from VSI’s
physician advisors. Id. Mr. Root further declares the update included
projected timelines for regulatory filings, with intentions to file in the end of
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2005 for OTW and early 2006 for RX. Id. Mr. Root also refers to the
matter the Patterson Law Firm opened this month for work leading towards
the initial GuideLiner patent application. Id. (citing Ex. 2023).
For November 2005, Mr. Root declares that they continued refining
the proximal portion of the RX GuideLiner. Id. ¶ 63. Mr. Root refers to
engineering drawings obtained from SPECTRAlytics, including one dated
November 2005, which closely resembles Figure 10 of the GuideLiner
patents. Id. (citing Ex. 2115). Mr. Root also refers to a VSI R&D planning
document for 2006, which was drafted by Mr. Sutton on November 22,
2005. Id. ¶ 64 (citing Ex. 2099). The planning document demonstrates
VSI’s intent, as of late November 2005, to continue with the regulatory
approval process for the RX GuideLiner in 2006. Id.
For December 2005, Mr. Root refers to a VSI Strategic Objectives
document for 2006, which was drafted on December 1, 2005. Id. ¶ 65
(citing Ex. 2100). The document indicates that the RX GuideLiner required
additional work for commercialization, which would continue through the
end of 2006. Id. Mr. Root also refers to an invoice from the Patterson Law
Firm, which shows the time invested in preparing the GuideLiner patent
application during December 2005. Id. ¶ 66 (citing Ex. 2117).
For January 2006, Mr. Root refers to another invoice from the
Patterson Law Firm, which shows time invested in preparing the GuideLiner
patent application during January 2006. Id. (citing Ex. 2101). Mr. Root also
refers to a fax sent from Mr. Sutton to the law firm on January 23, 2006. Id.
¶ 67 (citing Ex. 2102). The fax contains three figures that illustrate
examples of the problem to be solved by the RX GuideLiner, and which are
nearly identical to Figures 7, 8, and 9 of the GuideLiner patents. Id.
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For March 2006, Mr. Root refers to a Patterson Law Firm invoice
showing time invested in preparing the GuideLiner patent application during
March 2006. Id. ¶ 68 (citing Ex. 2103). Mr. Root also refers to purchase
records for stainless steel tubing from Vita Needle Company on March 24,
2006. Id. ¶ 69 (citing Ex. 2104). Mr. Root declares that VSI used this
tubing to refine the RX GuideLiner for commercialization. Id. Mr. Root
also refers to a March 30, 2006, engineering drawing from
SPECTRAlytics’s files. Id. ¶ 70 (citing Ex. 2115). The drawing, which is
similar to the photographs of RX GuideLiner prototypes depicted in Exhibit
2014, shows VSI’s attempt to reduce manufacturing costs by cutting two
proximal portions from a single hypotube. Id.
For April 2006, Mr. Root refers to a Budget to Actual Variances
report provided to the VSI Board of Directors for its April 2006 meeting. Id.
¶ 71 (citing Ex. 2105). The report shows GuideLiner R&D expenses by that
time had been more than double the amount that was budgeted. Id.
Mr. Root refers to purchase records for laser-cut and electropolished
GuideLiner hypotubes from LSA, with an invoice dated April 7, 2006. Id.
¶ 72 (citing Ex. 2106). These hypotubes were used to refine the RX
GuideLiner during commercialization. Id. Mr. Root refers to purchase
records for twenty hypotubes from MicroGroup, with an invoice dated April
18, 2006. Id. ¶ 73 (citing Ex. 2107). These hypotubes were used to refine
the RX GuideLiner during commercialization. Id. Mr. Root refers to other
purchase records, including an April 19, 2006, invoice for cut GuideLiner
hypotubes from LSA, which were used to commercialize the RX
GuideLiner. Id. ¶ 74 (citing Ex. 2108).
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For May 2006, other than the filing of the application on May 3, 2006,
Mr. Root refers to notes from a GuideLiner team meeting held May 2, 2006,
which confirm they were still working towards commercializing the RX
GuideLiner. Id. ¶ 75 (citing Ex. 2109).
Mr. Sutton’s diligence timeline, including the documents he refers to,
largely matches Mr. Root’s. For essentially the same reasons as Mr. Root,
Mr. Sutton refers to: the drawing of the fully-assembled RX GuideLiner, Ex.
2119 ¶ 39 (citing Ex. 2022); his fax sent March 21, 2006, to the Patterson
Law Firm, including the drawings similar to Figures 12 through 16 of the
patents, id. ¶ 40 (citing Ex. 2019); his fax sent on January 23, 2006, to the
Patterson Law Firm, which contains three figures that illustrate examples of
the GuideLiner situated in the aorta, which are nearly identical to Figures 7,
8, and 9 of the GuideLiner patents, id. ¶ 42 (citing Ex. 2102); the VSI R&D
planning document for 2006, dated November 22, 2005, id. ¶ 48 (citing Ex.
2099); the VSI marketing document dated December 1, 2005, id. ¶ 49 (citing
Ex. 2100); the Vita Needle purchase records for stainless steel hypotubes
shipped on March 24, 2006, which were used for the RX GuideLiners, id.
¶ 51 (citing Ex. 2104); and the April 2006 VSI budget report, indicating
expenses on commercializing the RX GuideLiner more than doubled the
amount VSI budgeted, id. ¶ 52 (citing Ex. 2105). Mr. Sutton also refers to
the January 2006 R&D Update that he prepared for the VSI Board of
Directors, id. ¶ 50 (citing Ex. 2134). In that update, Mr. Sutton reported to
VSI’s Board that both GuideLiner projects were still planned, with OTW
regulatory filings next up at the time. Id.
In addition to testimony from inventors Mr. Root and Mr. Sutton,
Patent Owner also points to testimony from Ms. Schmalz, Mr. Erb, and
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Mr. Keith. Ms. Schmalz declares that, from “the start of the regulatory
process for GuideLiner in August of 2005 and the filing of the patent
application in May 2006,” the RX GuideLiner “was always a high priority
project during [her] time at VSI” and was never “abandoned or paused.”
Ex. 2039 ¶ 12. Mr. Erb declares that VSI was “continually working to
optimize the design of the RX GuideLiner for commercialization. Ex. 2122
¶ 13. As an example, he recalls the weighing of advantages and
disadvantages between stainless steel and nitinol for the proximal portion
during the commercialization stage. Id. ¶ 14. Mr. Keith explains his
understanding that further commercialization work was performed after
August 2005. Ex. 2123 ¶¶ 25–27.
Patent Owner contends that the evidence it relies on to prove
conception and reduction to practice shows that “VSI worked steadily on the
GuideLiner invention from conception through the date the patent was
filed.” PO CRTP Resp. 28 (citing id. at 3–19). Patent Owner acknowledges
that it took more time and resources than anticipated, but that this delay
should have “no bearing whatsoever on the [diligence] analysis.” Id. at 28–
29.
Petitioner argues Patent Owner’s response “does not contain any
detail showing diligence.” Pet. CRTP Reply 28. Petitioner deems the
“handful” of events identified by Patent Owner during the critical period—
opening a patent application file, working on the patent application,
exchanging emails, and buying parts—to be insufficient evidence of
diligence. Id. at 28–29. It appears from Petitioner’s visual timeline of
Patent Owner’s events that two periods in particular allegedly represent a
lack of diligence: from September 23, 2005, to the end of November 2005,
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during which there was only a component design change; and the month of
February 2006, during which there were no diligence-related events.
Id. at 29 (citing Ex. 2115). Petitioner also faults Patent Owner’s delay in
regulatory submissions for the RX GuideLiner, which were initially planned
for late 2005 and 2006 but were postponed until 2008. Id. (citing Ex. 1762,
131:3–133:3; Ex. 2132, 7).
When evaluating diligence, we are mindful of recent Federal Circuit
admonitions clarifying that we must not apply a standard that is “too
exacting” or “too rigid.” Perfect Surgical, 841 F.3d at 1008; Arctic Cat, 919
F.3d at 1331. Though “[p]eriods of inactivity within the critical period do
not automatically vanquish a patent owner’s claim of reasonable diligence,”
Arctic Cat, 919 F.3d at 1331, “[m]erely asserting diligence is not enough”
and a party must “account for the entire period during which diligence is
required.” In re Meyer Mfg. Corp., 411 F. App’x 316, 320 (Fed. Cir. 2010).
“[D]iligence need not be perfectly continuous—only reasonably
continuous.” Arctic Cat, 919 F.3d at 1331. The key question for diligence
is whether, “in light of the evidence as a whole, the invention was not
abandoned or unreasonably delayed.” Id. (internal quotations omitted).
Applying this standard, we conclude that Patent Owner sufficiently
demonstrates reasonably continuous diligence throughout the critical period.
The evidence demonstrates that Patent Owner did not unreasonably
delay the RX GuideLiner project. As both parties acknowledge, there were
indeed delays in the project. Petitioner asserts “VSI prioritized other
projects in late 2005 and 2006 and postponed RX regulatory submissions
through 2008.” Pet. CRTP Reply 29 (citing Ex. 1762, 131:3–133:3; Ex.
2132, 7). But the cited portion of Mr. Root’s deposition testimony
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sufficiently explains why the delay was reasonable. As noted by Mr. Root,
OTW GuideLiner regulatory submissions came first “[b]ecause it was much
easier to get regulatory approval and do the testing.” Ex. 1762, 131:3–8.
“[T]ransition in personnel” also complicated the project. Id. at 131:12–17.
And as for the RX version, Mr. Root explained that commercialization took
longer due to “vendor optimization,” id. at 132:25–133:9, which tracks the
greater difficulty associated with bringing the RX GuideLiner to market.
Ms. Schmalz further corroborates this explanation with her declaration that
RX GuideLiner “was always a high priority project during [her] time at
VSI.” Ex. 2039 ¶ 12.
Nor does it appear that Patent Owner abandoned the RX GuideLiner
invention. For one thing, Patent Owner engaged counsel to prepare its
GuideLiner patent application, which was ultimately filed on May 3, 2006.
The Patterson Law Firm opened a patent search on August 11, 2005 (Ex.
2023, 5) then reported the results to VSI on September 14, 2005 (Ex. 2098,
2). On October 10, 2005, the firm opened a patent prosecution matter for the
GuideLiner. Ex. 2023, 5. There is evidence in the record of the firm
working on preparing the application in December 2005 (Ex. 2117, 20),
January 2006 (Ex. 2102, 1), and March 2006 (Ex. 2103, 6). There is also
evidence of communications between the firm and VSI, namely Mr. Root
and Mr. Sutton, in January 2006 and March 2006. Ex. 2102; Ex. 2098, 4;
Ex. 2019. To be sure, there is not an abundance of documents in the record
related to preparing the application, including drafts of the specification and
claims, but Patent Owner clarified at oral argument that it lacks many
documents due to the passage of time, not the refusal to waive attorney-
client privilege. Tr. 64:8–21. A lack of documents due to the passage of
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time does not foreclose sufficient corroboration. See, e.g., NFC Tech., LLC
v. Matal, 871 F.3d 1367, 1374 (Fed. Cir. 2017) (concluding there was
sufficient corroboration of conception based on circumstantial evidence,
“particularly considering the amount of time that ha[d] passed”).
Moreover, the other documents Patent Owner proffers provide
additional circumstantial evidence that VSI was working on and did not
abandon the RX GuideLiner project throughout this time. Petitioner again
faults Patent Owner for not providing direct evidence. Pet. CRTP Reply 28
(pointing out lack of events “related to actual work on an RX device”); id. at
29 (arguing Patent Owner “cannot tie the component parts purchases to
RX”). But, as we noted above, direct evidence is not required for adequate
corroboration. Internal VSI documents, such as updates for VSI’s Board and
budget documents, show that work on the RX project continued from
October 2005 through April 2006. Ex. 2133, 4, 7; Ex. 2099; Ex. 2100, 8–9;
Ex. 2105, 4–5. Additionally, there are engineering drawings and invoices
related to supplies that support the testimony of inventors Mr. Root and Mr.
Sutton regarding continued work on the RX GuideLiner in March 2006 and
April 2006. Ex. 2104; Ex. 2005, 5; Ex. 2115; Ex. 2106, 3; Ex. 2107;
Ex. 2108, 4–5. All of this evidence corroborates Mr. Root’s and
Mr. Sutton’s testimony that VSI worked diligently and continuously on the
RX GuideLiner project without abandoning the project.
Finally, we are not convinced that the periods from September 23,
2005, to the end of November 2005 or in February 2006 demonstrate lack of
diligence. Petitioner’s argument for these periods is conclusory, and
contradicted by the reasonable commercialization delays that we addressed
above.
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Considering all of the pertinent evidence, we find that Patent Owner
did not abandon or unreasonably delay the RX GuideLiner project during the
critical period. Petitioner’s arguments implying the need for direct evidence
and scouring the timeline for periods of inactivity are unpersuasive. We
therefore conclude that Patent Owner demonstrates, by a preponderance of
the evidence, that VSI was reasonably continuous in its diligence during the
critical period. Because we have also found that Patent Owner demonstrated
conception prior to Itou’s critical date, Patent Owner has met its burden to
successfully demonstrate that Itou is not prior art to the challenged claims of
the ’380 patent.
E. Challenges Based on Itou
Petitioner contends that claims 1–4, 6–10, 12–20, 23 are anticipated
by Itou (Pet. 19–65), claims 3, 14, 15 would have been obvious over Itou
and Ressemann (id. at 65–76), and claim 21 would have been obvious over
Itou and Berg (id. at 76–80). Because Itou is not prior art to the ’380 patent,
Petitioner’s challenges based on Itou are not persuasive. Accordingly,
Petitioner has not demonstrated by preponderance of the evidence that
claims 1–4, 6–10, 12–21, and 23 are unpatentable over the Itou-based
grounds asserted in the Petition.
III. CONTINGENT MOTION TO AMEND
Patent Owner’s Motion to Amend requests that if either of claims 1 or
12 of the ’380 patent is determined to be unpatentable, that the Board
substitute those claims with proposed substitute claims 43 and 44,
respectively. Motion 1. Because we do not find any of the challenged
claims unpatentable in this proceeding, we do not reach the merits of the
Motion to Amend.
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IV. CONSTITUTIONAL CHALLENGE
Patent Owner argues that the Petition should be denied because “the
manner in which administrative law judges are appointed is
unconstitutional.” PO Resp. 63 (citing Arthrex, Inc. v. Smith & Nephew,
Inc., 941 F.3d 1320, 1325 (Fed. Cir. 2019)). Patent Owner further argues
that the remedy in the Arthrex decision “severing certain removal
protections, is insufficient to cure the constitutional defect, because, e.g., it
still does not give a properly appointed principle office the power to review
administrative law judge decisions.” Id. (citing Lucia v. SEC, 138 S. Ct.
2044, 2055 (2018)). We decline to consider Patent Owner’s constitutional
argument because the Federal Circuit addressed this issue in
Arthrex. Arthrex, 941 F.3d at 1328.
V. MOTION TO EXCLUDE
Petitioner has moved to exclude Exhibit 2024, which is the August 24,
2005 Product Requirements document. Paper 111. Petitioner contends that
Exhibit 2024 is unreliable on its face and that none of Patent Owner’s
witnesses can authenticate the document. Id. at 2–9. Patent Owner responds
that Exhibit 2024 is authenticated under Federal Rule of Evidence 901 based
on the declaration and/or deposition testimony of Mr. Peters (Ex. 1926 ¶ 18),
Ms. Schmalz (Ex. 2039 ¶¶ 6–7), Mr. Root (Ex. 2118 ¶ 54), and Mr. Sutton
(Ex. 2119 ¶ 44). Paper 115.
Documents are authenticated by evidence “sufficient to support a
finding that the item is what the proponent claims it is.” Fed. R. Evid.
901(a); see Fox Factory v. SRAM, LLC, IPR2016-01876, Paper 59 at 63
(PTAB Apr. 2, 2018) (quoting same). “Authenticity is, therefore, not an
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especially high hurdle for a party to overcome.” Fox Factory, Paper 59 at 63
(citing United States v. Patterson, 277 F.3d 709, 713 (4th Cir. 2002)).
We determine that Exhibit 2024 has been authenticated under Federal
Rule of Evidence 901. In addition, Petitioner’s arguments go to the weight
of the evidence and not its admissibility. Accordingly, we deny Petitioner’s
Motion to Exclude. We note, however, that even if we were to exclude
Exhibit 2024, it would not change the outcome or our general analysis of
this case.
VI. CONCLUSION
After reviewing the arguments and evidence of record, we determine
that Petitioner has not demonstrated by a preponderance of the evidence that
claims 1–4, 6–10, 12–21, and 23 of the ’380 patent are unpatentable on the
grounds asserted in the Petition.
In summary:
Claims 35
U.S.C. §
Reference(s)/Basis Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–4, 6–
10, 12–
20, 23
102 Itou
1–4, 6–10,
12–20, 23
3, 14, 15 103 Itou, Ressemann 3, 14, 15
21 103 Itou, Berg 21
Outcome 1–4, 6–10,
12–21, 23
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The table below summarizes our conclusions as to Patent Owner’s
Revised Motion to Amend the claims.
Motion to Amend Outcome Claim(s)
Original Claims Cancelled by Amendment
Substitute Claims Proposed in the Amendment 43, 44
Substitute Claims: Motion to Amend Granted
Substitute Claims: Motion to Amend Denied
Substitute Claims: Not Reached 43, 44
VII. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–4, 6–10, 12–21, and 23 have not been
shown to be unpatentable;
FURTHER ORDERED that we do not reach Patent Owner’s
Contingent Motion to Amend;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.
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FOR PETITIONER:
Cyrus Morton
Sharon Roberg-Perez
Christopher Pinahs
William E. Manske
Emily J. Tremblay
ROBINS KAPLAN LLP
cmorton@robinskaplan.com
sroberg-perez@robinskaplan.com
cpinahs@robinskaplan.com
wmanske@robinskaplan.com
etremblay@robinskaplan.com
FOR PATENT OWNER:
Derek Vandenburgh
Dennis Bremer
CARLSON, CASPERS, VANDENBURGH & LINDQUIST, P.A.
dvandenburgh@carlsoncaspers.com
dbremer@carlsoncaspers.com
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