Teleflex Medical Devices S.A.R.L.

Patent Trials and Appeals Board

Jun 17, 2021

IPR2020-00137 (P.T.A.B. Jun. 17, 2021)

PUBLIC VERSION
Trials@uspto.gov Paper
571-272-7822 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.
IPR2020-00137
Patent RE47,379E
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 Addressing Patent Owner’s Motion to Amend
35 U.S.C. § 318(a)
ORDERS
Denying Petitioner’s Motion to Exclude (Paper 112)
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 25, 26, 29–40, and 42–45 of U.S. Reissue Patent
RE47,379E (Ex. 1001, “the ’379 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 82, “Pet. Reply”) (redacted version available at Paper 83), and
Patent Owner filed a Sur-Reply (Paper 104, “Sur-Reply”) (redacted version
available at Paper 105).
With prior authorization of the Board, Patent Owner filed a
Consolidated Response Addressing Conception and Reduction to Practice
(Paper 39, “PO CRTP Resp.” or “PO CRTP Response”), to which Petitioner
filed Reply (Paper 78, “Pet. CRTP Reply”) (redacted version available at
Paper 79), Patent Owner filed a Sur-Reply (Paper 98, “PO CRTP Sur-
Reply”), and Petitioner filed a Sur-Sur-Reply (Paper 113, “Pet. CRTP Sur-
Sur-Reply”).
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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Patent Owner also filed a contingent motion to amend (Paper 38) and
a Corrected Contingent Motion to Amend (Paper 97, “Motion”). The
Motion requests that if any of claims 25, 29, 30, 38, 43, or 45 of the ’379
patent is determined to be unpatentable, that the Board substitute those
claim(s) with proposed substitute claims 46–51.. Motion 1. Petitioner filed
an opposition to the Corrected Contingent Motion to Amend (Paper 103),
Patent Owner filed a reply (Paper 107), and Petitioner filed a sur-reply
(Paper 115).2
An oral hearing was held on March 8, 2021, and a transcript of the
hearing is included in the record. Paper 127 (“Tr.”) (redacted version
available at Paper 126).
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 ’379 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-
2 Patent Owner’s filed an original, contingent motion to amend (Paper 38) to
which Petitioner filed an Opposition (Paper 85). These documents were
superseded by the corrected Motion to Amend and Patent Owner’s
Opposition to the Corrected Motion to Amend, identified above.
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01969 (D. Minn). Pet. 5; Paper 4, 2. The ’379 patent is also at issue in
IPR2020-00138 (institution granted). IPR2020-00138, Paper 20.
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), IPR2020-00128 (U.S.
Patent No. RE45,380 E1), IPR2020-00129 (U.S. Patent No. RE45,380 E1),
IPR2020-00130 (U.S. Patent No. RE45,380 E1), IPR2020-00132 (U.S.
Patent No. RE45,760 E1), IPR2020-00134 (U.S. Patent No. RE45,760 E1),
IPR2020-00135 (U.S. Patent No. RE45,776 E1), IPR2020-00136 (U.S.
Patent No. RE45,776 E1).
C. The ’379 Patent
The ’379 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.” Ex. 1001, 1:43–47. “In coronary artery disease the coronary arteries
may be narrowed or occluded by atherosclerotic plaques or other lesions.”
Id. at 1:57–59. This narrowing is referred to as stenosis. Id. at 1:61. To
diagnose or 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 1:61–65. 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
1:66–2:3. 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
2:1–5. Crossing tough lesions, however, may create enough backwards
force to dislodge the guide catheter from the ostium of the artery being
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treated, making it difficult or impossible to treat certain forms of coronary
artery disease. Id. at 2:6–10.
Figures 1 and 2 of the ’379 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 5:57–62. As shown in Figure 1, coaxial guide
catheter 12 includes tip portion 16, reinforced portion 18, and rigid portion
20. Id. at 6:50–51. Tapered inner catheter 14 includes tapered portion 46 at
a distal end thereof and straight portion 48. Id. at 7:36–37. Clip 54
releasably joins tapered inner catheter 14 to coaxial guide catheter 12. Id. at
7:41–44.
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Figure 8 of the ’379 patent is reproduced below:
“Figure 8 is a schematic view of a guide catheter, a guidewire, a coaxial
guide catheter, catheter in accordance with the present invention and a
tapered inner catheter located in the aortic arch and coronary artery.” Id. at
6:11–14. 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 8:26–32. “Coaxial guide catheter 12, with
tapered inner catheter 14, provides an inner support member for proper
translation over guidewire 64.” Id. at 8:32–36. “Once coaxial guide catheter
12 is in place, tapered inner catheter 14 is removed from the inside of
coaxial guide catheter 12.” Id. at 8:36–38. At this point, coaxial guide
catheter 12 is ready to accept a treatment catheter such as a stent or balloon
catheter. Id. at 8:39–40. The ’379 patent explains that the “combination of
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improved distal anchoring and stiffening of the guide catheter 56/coaxial
guide catheter 12 combination provides additional back up support to resist
dislodging of guide catheter 56 from ostium 60 when force is applied to
guidewire 64 to pass through stenotic lesion 66 or another lesion.” Id. at
8:47–52.
D. Illustrative Claim
Independent claim 25 is illustrative of the challenged claims and is
reproduced below.
25. A method of forming a device adapted for use with a standard
guide catheter having a continuous lumen extending for a predefined
length, the method comprising:
providing a flexible tip segment having a lumen therethrough;
providing a reinforced segment having a lumen therethrough,
including one or more metallic elements covered with a
polymer, and extending from a proximal end portion to a
distal end portion;
providing a substantially rigid segment extending from a
proximal end portion to a distal end portion, wherein the
substantially rigid segment is more rigid along a longitudinal
axis than the flexible tip segment;
defining a side opening portion, including forming, in a proximal
to distal direction, an arcuate cross-sectional shape and a
hemicylindrical cross-sectional shape;
eccentrically positioning the distal end portion of the
substantially rigid segment relative to a longitudinal axis of
the proximal end portion of the reinforced segment; and
coaxially aligning the distal end portion of the reinforced
segment and a proximal end portion of the flexible tip
segment,
wherein providing the substantially rigid segment, the reinforced
segment, and the flexible tip segment includes forming a
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device length that is longer than the predefined length of the
continuous lumen of the guide catheter such that when a distal
end portion of the flexible tip segment is extended distally of
a distal end of the guide catheter, the proximal end portion of
the substantially rigid segment extends proximally of a
proximal end of the guide catheter.
Ex. 1001, 13:61–14:25.
E. Prior Art and Asserted Grounds
We instituted review of claims 25, 26, 29–40, and 42–45 of the ’379
patent on the following grounds (Inst. Dec. 7, 31):
Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis
25, 26, 29–31, 33–40, 42,
43, 45 102 Itou
3
26, 38–40, 43–45 103 Itou, Ressemann4
32 103 Itou
44 103 Itou, Kataishi5
44 103 Itou, Enger6
In support of its arguments, Petitioner relies on the expert declarations
of Dr. Stephen Jon David Brecker (Exs. 1005, 1806, 1901), Dr. Richard A.
Hillstead (Exs. 1042, 1905), Mr. Michael Jones (Ex. 1807), Dr. Paul Zalesky
(Exs. 1755, 1830, 1919). Patent Owner relies on the declarations of Ms.
Deborah Schmalz (Ex. 2039), Mr. Howard Root (Ex. 2118), Mr. Gregg
3 Itou, US 7,736,355 B2, issued June 15, 2010 (Ex. 1007) (“Itou”).
4 Ressemann, US 7,604,612 B2, issued October 20, 2009 (Ex. 1008)
(“Ressemann”).
5 Kataishi, US 2005/0015073 A1, published January 20, 2005 (Ex. 1025)
(“Kataishi”).
6 Enger, US 5,980,486, issued November 9, 1999 (Ex. 1050) (“Enger”).
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Sutton (Ex. 2119), Mr. Mark Goemer (Ex. 2120), Ms. Amanda O’Neil (Ex.
2121), Mr. Steve Erb (Ex. 2122), Mr. Peter T. Keith (Exs. 2123, 2124, 2138,
2243), Dr. John J. Graham (Ex. 2145), Dr. Lorenzo Azzalini (Ex. 2151), Ms.
Heather S. Rosecrans (Ex. 2205), and Dr. Craig Thompson (Ex. 2215).
II. ANALYSIS
A. Priority Date of the ’379 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 ’379 patent was filed December 30, 2015 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 claims 27 and 44 of the ’379 patent in the
applications to which the ’379 patent claims priority, the ’379 patent has an
effective filing date after March 16, 2013. Pet. 15. Thus, according to
Petitioner, the ’379 patent is not supported by a pre-March 16, 2013
application making it subject to the AIA’s first-to-file provisions. 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). As the ’379 patent, the “patent for which
reissue was sought” in this case, was issued October 23, 2012, we are not
persuaded that the AIA’s first-to-file provisions apply to the ’379 patent.
Indeed, Petitioner provides no legal support for the proposition that claims in
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a reissue patent are not entitled to the filing date as if they appeared in the
original patent for which reissue was sought.7
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. 16. 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 Medtronic’s proposed definition of a
POSITA.” PO Resp. 10.
Upon review of the parties’ arguments and supporting evidence, we
adopt both of Petitioner’s definitions for a person of ordinary skill in the art,
allowing either experience as a medical doctor or as an engineer, as they are
7 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 for lack of written description support. But this is a question we may
not address in an IPR. See 35 U.S.C. § 311(b).
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undisputed and consistent with the level of skill reflected in the prior art and
the written description of the ’379 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
In this proceeding, the claims of the ’379 patent are construed “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).
Under that standard, the words of a claim are generally given their “ordinary
and customary meaning,” which is the meaning the term would have had to
a person of ordinary skill at the time of the invention, in the context of the
entire patent including the specification. Phillips v. AWH Corp., 415 F.3d
1303, 1312–13 (Fed. Cir. 2005) (en banc).
Upon review of the parties arguments and supporting evidence, we
determine that no claim terms of the ’379 patent require express construction
for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad
Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid
Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)
(“[O]nly those terms need 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 Itou is prior art under pre-AIA § 102(e). Pet. 20–21.8 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 ’379
patent. See generally PO CRTP Response; 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 75
exhibits. These documents include inventor lab notebooks and handwritten
notes (Exs. 2002, 2004); internal company memoranda, presentations, and
8 In addition to this Petition, Petitioner similarly asserts Itou in the petitions
in IPR2020-00126, -00128, -00129, -00132, -00134, and -00135. Our
analysis regarding the prior art status of Itou is similar for each of these
proceedings.
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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 (Ex.
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 Itou’s “critical date” (i.e., September
23, 2005) and either actually reduced the invention to practice prior to the
critical date or diligently worked to constructively reduce to practice the
invention on May 3, 2006, in the form of the first priority application for the
’379 patent. Accordingly, we conclude that Itou does not qualify as prior art
to the ’379 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)
(citations and quotation marks omitted). “However, ‘there is no final single
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formula that must be followed in proving corroboration.’” Id. (citations and
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 of 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 the “bears the burden of establishing that its claimed
invention is entitled to an earlier priority date than an asserted prior art
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reference.” 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).9,10 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
9 Patent Owner previously submitted a declaration by Mr. Root with its
Preliminary Response (Ex. 2001), but withdrew that declaration in favor of
Ex. 2118. Paper 39, 2 n.1.
10 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 111, 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 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 extension
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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).11
11 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. Ex. 2002, 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, he
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.” Ex. 2002, 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. Ex. 2118 ¶¶ 9–11; Ex. 2119 ¶¶ 7–14. Mr. Sutton attests
that his notebook was “issued and maintained in the regular course of VSI’s
business.” Ex. 2119 ¶ 7.
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
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to allow for rapid exchange delivery”; it was inserted through the existing
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. 12 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. Id. The first drawing from Mr. Root’s
handwritten notes, reproduced below, is similar to Figure 1 of the ’379
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
12 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 seems 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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tubular portion above the notation reading “tapered ≈ 10 cm,” and was
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
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these 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 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. Pet. CRTP Reply 4. In Apator, the problem for
the patent owner in that case 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
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unwitnessed documents to contribute to corroboration of 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 Enterprises, Inc. v. Graco Children’s
Products, Inc., 927 F.3d 1320 (Fed. Cir. 2019), 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,
Paper 31 (PTAB Aug. 11, 2020) (Final Written Decision), 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
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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 corroborate the testimony of another.” Curt., Paper 31 at 16
(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)13 The
Board further noted that “an inventor’s unwitnessed laboratory notebooks,
emails, and drawings, without other independent evidence, cannot
corroborate an inventor's testimony.” Id. (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 16–17 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 ommitted). 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
13 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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corroboration of conception under a rule of reason analysis.” Id. (citing
Apator, 887 F.3d at 1297 (referring to cases where unwitnessed
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, Jeffrey
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. To be sure, the notebook pages presented here were
witnessed by another inventor, Jeffrey Welch, who has not provided any
independent testimony in this proceeding. Ex. 2002. But 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
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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, 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.”14 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
14 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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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
limitations of the challenged claims. Ex. 2118, App’x A–E.15 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. Pet. CRTP Reply 5–7.16 According to Petitioner,
without this demonstration, Patent Owner fails to establish conception of
“every feature or limitation of the claimed invention.”17 Id. at 3 (quoting
15 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.
16 As Petitioner acknowledges, this argument only applies to certain claims.
See Tr. 159:5–12. 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. We note, however, that claim 25 of the
’379 patent also recites: “defining a side opening portion, including forming,
in a proximal to distal direction, an arcuate cross-sectional shape and a
hemicylindrical cross-sectional shape.” Ex. 1001, cl. 25.
17 In its Sur-Sur-Reply, Petitioner also contends that Patent Owner is missing
evidence that the RX prototypes satisfy certain additional claim limitations.
Id. We consider this in addressing the actual reduction to practice issue
below.
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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.
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
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 Root’s
notes “does not appear to correspond to any of the figures in the Root
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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 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 appear 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, 1
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
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
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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.” Id. 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.
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
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between January and August 2005.18 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 Dr. 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.19 We once again set forth the relevant facts based on
these declarants’ testimony and corroborating evidence, and then address
18 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.
19 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
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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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. Id.
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 ¶ 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. In
their declarations, Mr. Root and Mr. Sutton focus on two distinct sets of
prototypes of the RX version that were built and tested before Itou’s critical
date: the “April 2005” prototypes and the “July 2005” prototypes. Ex. 2118
¶ 48; Ex. 2119 ¶¶ 21–22.20 As noted above, Mr. Root includes claim charts
20 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
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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 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,
these prototypes in determining whether there was actual reduction to
practice.
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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).21 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. The ranges of the inner and outer
diameters, wall thickness, and the overall length of the 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:
21 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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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 MED component,” 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. 12–16.22
Mr. Goemer verifies and authenticates some of the purchase documents and
the engineering drawings retrieved from SPECTRAlytics’s files. Ex. 2120
¶¶ 6–12.
22 Mr. Sutton faxed these drawings to VSI’s outside patent counsel on March
21, 2006. Ex. 2118 ¶ 42; Ex. 2019.
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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:
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
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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). Id. 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 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
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with the distal tubular sections from MED that were shipped around April 5,
2005. Ex. 2118 ¶ 35 (citing Exs. 2011 and 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.
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
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identifying the “soft tip,” the “reinforced Pebax tubular portion,” the “side
opening,” and the “rail structure.” Ex. 2118 ¶ 49. 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
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
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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
anatomy by providing increased backup support as compared to a guide
catheter alone. Id.
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 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
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guide catheter support systems. Ex. 2118 ¶ 54; Ex. 2119 ¶ 44; Ex. 2024.23
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. Mr. Root asserts that this document marked
the start of the formal quality process for the RX and OTW GuideLiner
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
23 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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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 appear to be
“redline” edits and does not include any signatures for “document
approvals,” thus suggesting that the document submitted as Exhibit 2025
may have only been a draft. 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.24 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,
24 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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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
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
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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 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 quotation 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
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(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. 1755, 63:20–64:9 (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 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, 161, 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”
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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
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
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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
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. 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,
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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,
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). 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 the
inventors were concerned with a broader primary purpose, namely generally
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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,
1:44–47 (“More particularly the present invention relates to methods and
apparatus for increasing backup support for catheters inserted into the
coronary arteries from the aorta.”); id. at 3:18–22 (“Thus, the interventional
cardiology art would benefit from the availability of a system that would be
deliverable 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
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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
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
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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
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
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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)). “The 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 (citations
omitted). “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 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 the use of benchtop models was
sufficient to test that the products were suitable for the intended purpose
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described above.25 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).
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 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
25 Referring to Petitioner’s expert’s testimony regarding a person of ordinary
skill in the art’s knowledge pertaining 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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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 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 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
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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)
Update notes that “[t]he initial design is an over-the-wire configuration, with
a rapid exchange version to follow.” Ex. 2130, 3.26 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
26 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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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.
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 is 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
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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
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.
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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,27 i.e., from
September 23, 2005 to May 3, 2006. See Perfect Surgical Techniques, Inc.
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 working 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. Thus, they worked
27 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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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 Ex. 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).
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
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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
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
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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.
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
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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).
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.
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¶ 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 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
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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,
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 “periods 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
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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) (emphasis in original). But the cited portion of Mr. Root’s
deposition testimony 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., 131:12–17. And as for the RX, Mr. Root explained that
commercialization took longer due to “vendor optimization,” id., 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
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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, 7), 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
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 invoices related to supplies that
support the testimony of inventors Mr. Root and Mr. Sutton regarding
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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 theMr. 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.
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 ’379 patent.
E. Challenges Based on Itou
Petitioner contends claims 25, 26, 29–31, 33–40, 42, 43, and 45 are
anticipated by Itou (Pet. 20–60), claims 26, 38–40, and 43–45 would have
been obvious over Itou and Ressemann (id. at 60–74), claim 32 would have
been obvious over Itou (id. at 74–77), claim 44 would have been obvious
over Itou and Kataishi (id. at 77–82), and claim 44 would have been obvious
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over Itou and Enger (id. at 82–87). Because Itou is not prior art to the ’379
patent, Petitioner’s challenges relying on Itou, in whole or in part, are not
persuasive. Accordingly, Petitioner has not demonstrated by a
preponderance of the evidence that claims 25, 26, 29–40, and 42–45 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 claims 25, 29, 30,
38, 43, or 45 of the ’379 patent are determined to be unpatentable, that the
Board substitute those claims with proposed substitute claims 46–51.
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.
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. 51 (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.
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V. MOTION TO EXCLUDE
Petitioner has moved to exclude Exhibit 2024, which is the August 24,
2005 Product Requirements document. Paper 112. 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 116.
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
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 our general analysis or the outcome in 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 25, 26, 29–40, and 42–45 are unpatentable.
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In summary:
The table below summarizes our conclusions as to Patent Owner’s
Revised Motion to Amend the claims.
Motion to Amend Outcome Claims
Original Claims Cancelled by Amendment
Substitute Claims Proposed in the Amendment 25, 29, 30, 38, 43, 45
Substitute Claims: Motion to Amend Granted
Substitute Claims: Motion to Amend Denied
Substitute Claims: Not Reached 25, 29, 30, 38, 43, 45
VII. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that Petitioner has not demonstrated that challenged
claims 25, 26, 29–40, and 42–45 are unpatentable;
FURTHER ORDERED that we do not address Patent Owner’s
Corrected Contingent Motion to Amend;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied;
and
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Claims 35
U.S.C.
§
Reference(s)/
Basis
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
25, 26, 29–31,
33–40, 42, 43,
45
102 Itou
25, 26, 29–31,
33–40, 42, 43,
45
26, 38–40,
43–45 103
Itou,
Ressemann
26, 38–40,
43–45
32 103 Itou 32
44 103 Itou, Kataishi 44
44 103 Itou, Enger 44
Outcome 25, 26, 29–40,
42–45
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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.
PUBLIC VERSION
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Patent RE47,379E
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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