Ex Parte BROPHY et al

Patent Trials and Appeals Board

May 28, 2019

14188993 - (D) (P.T.A.B. May. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/188,993 02/25/2014
108197 7590 05/30/2019
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
FIRST NAMED INVENTOR
Colleen M. BROPHY
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
VBLT.P0164US.D1 1575
EXAMINER
BEL YA VSKYI, MICHAIL A
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
05/30/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte COLLEEN M. BROPHY, PAD MINI KO MALA VILAS,
JOYCE CHEUNG-FLYNN, KYLE M HOCKING, and SUSAN S EAGLE 1
Appeal2018-002083
Application 14/188,993
Technology Center 1600
Before ULRIKE W. JENKS, TA WEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a vein
transplant kit, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the real party in interest as Vanderbilt University.
(Appeal Br. 3.)
Appeal2018-002083
Application 14/188,993
STATEMENT OF THE CASE
"Human greater saphenous vein (HSV) remains the most commonly
used conduit for coronary and peripheral arterial bypass grafting." (Spec.
2:22-23.) The Specification states that "[i]njury to the vein graft during
harvest leads to vasospasm and intimal hyperplasia, which cause the grafts
to occlude," and therefor, "it would be of great benefit to identify new
surgical methods and therapeutics to prevent injury to the graft during
harvest and subsequent intimal hyperplasia." (Id. at 3:26-29.)
The Specification explains that harvested veins are "marked with a
surgical skin marker to optimize orientation during implantation" and that
such surgical skin marking may reduce viability of the harvested vein, for
instance when markers comprising isopropyl alcohol are used. (Id. at 2:29-
30, 9: 16-21, 11 :7-9 .) The Specification also explains that P2X7 receptors
are found on human saphenous vein smooth muscle and that "[a]ctivation of
the P2X7 receptor can ... ultimately lead to cell death due to autolysis and
apoptosis." (Id. at 15: 11-16.) According to the Specification, "an aspect of
the invention includes a marker that contains a non-toxic dye to mark the
vein," and certain such non-toxic dyes are also P2X7 receptor antagonists
that are "protective of harvest techniques that are injurious to saphenous
veins." (Id. at 16:10-15.)
Claims 24--29, 34,2 45-53, and 55---60 are on appeal. Claim 24 is
illustrative and reproduced below:
2 The Examiner and Appellants state in the Final Rejection and the Appeal
Brief, respectively, that claims 24--29, 31-34, 45-53, and 55-60 are
pending. (Final Act. 2; Appeal Br. 3.) However, claims 31-33 have been
cancelled. (Amendment and Request for Reconsideration under 35 U.S.C.
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24. A vein transplant kit comprising:
(a) a P2X7 receptor antagonist;
(b) a physiologic buffered solution or reagents for
making such; and
( c) a tissue marking pen.
(Appeal Br. 18 (Claims App'x).)
The Examiner rejects claims 24, 25, 27-29, 34, and 56-60 under pre-
AIA 35 U.S.C. § I03(a) as being unpatentable over Carroll3 and
Concepcion. 4' 5 (Final Act. 2.)
The Examiner rejects claims 24, 26, and 45 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and Rudra. 6 (Final
Act. 4.)
The Examiner rejects claims 24, 26, and 46 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and Nicolosi. 7
(Final Act. 5.)
§ 1.111 ("Amendment") 6 (Jan. 30, 2017).) Thus, we understand that claims
31-33 are not on appeal.
3 Carroll et al., U.S. 7,241,776 B2, issued July 10, 2007.
4 Concepcion et al., WO 2005/019182 Al, published Mar. 3, 2005.
5 In the Final Rejection, the Examiner states that claims 24, 25, 27-29, 31,
and 56-60 stand rejected under pre-AIA 35 U.S.C. § I03(a) as being
obvious over Carroll and Concepcion. (Final Act. 2.) However, later in the
rejection the Examiner states that claims 27-29, 34, and 56-60 are included
in the rejection over Carroll and Concepcion. Appellants state in the Appeal
Brief that claims 24, 25, 27-29, 31, 34, and 56-60 are rejected as obvious
over Carroll and Concepcion. (Appeal Br. 4.) As discussed above, claim 31
has been cancelled. (Amendment 6.) Accordingly, we understand that it is
claim 34, rather than claim 31, that is included in the Examiner's
obviousness rejection over Carroll and Concepcion.
6 Rudra et al., WO 2008/111010 Al, published Sept. 18, 2008.
7 Nicolosi et al., US 2015/0079176 Al, published Mar. 19, 2015.
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Application 14/188,993
The Examiner rejects claims 24, 26, and 47 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and King. 8 (Final
Act. 6.)
The Examiner rejects claims 24, 26, 48, and 52 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Carroll, Concepcion, and
Xie. 9 (Final Act. 7 .)
The Examiner rejects claims 24, 26, 49, and 52 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Carroll, Concepcion, and
Wachter. 10, 11 (Final Act. 8.)
The Examiner rejects claims 24, 26, 50, and 52 under pre-AIA
35 U.S.C. § I03(a) as being unpatentable over Carroll, Concepcion, and
Gojon-Romanillos. 12 , 13 (Final Act. 9.)
8 King et al., WO 2009/129509 A2, published Oct. 22, 2009.
9 Xie et al., US 8,519,121 B2, issued Aug. 27, 2013.
10 Wachter, US 8,397,713 B2, issued Mar. 19, 2013.
11 In the Final Rejection, the Examiner states that claims 24, 26, 48, and 52
stand rejected as obvious over Carroll, Concepcion, and Wachter. (Final
Act. 8.) However, the Examiner cites Wachter as teaching an anti-
inflammatory agent such as corticosteroid, which relates to limitations in
claim 49. (Id.; Appeal Br. 19 (Claims App'x).) Thus, we understand that
the Examiner's obviousness rejection over Carroll, Concepcion, and
Wachter is directed to claim 49 rather than claim 48.
12 Gojon-Romanillos, US 2013/0136725 Al, published May 30, 2013.
13 In the Final Rejection, the Examiner states that claims 24, 26, 48, and 52
stand rejected as obvious over Carroll, Concepcion, and Gojon-Romanillos.
(Final Act. 9.) However, the Examiner cites Gojon-Romanillos as teaching
endothelial function preservative such as metformin, which relates to
limitations in claim 50. (Id.; Appeal Br. 19 (Claims App'x).) Thus, we
understand that the Examiner's obviousness rejection over Carroll,
Concepcion, and Gojon-Romanillos is directed to claim 50 rather than claim
48.
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Application 14/188,993
The Examiner rejects claims 24, 26, and 51 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and Caplan. 14
(Final Act. 10.)
The Examiner rejects claims 24, 26, and 53 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and Gleave. 15
(Final Act. 11.)
The Examiner rejects claims 24, 26, and 55 under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Carroll, Concepcion, and Yaffe. 16
(Final Act. 12.)
DISCUSSION
Issue
The same issues are dispositive for all of the rejections; we therefore
discuss them together. As to claim 24, the sole independent claim on appeal,
the Examiner finds that both Carroll and Concepcion teach that "a
physiologic buffered solution comprising a P2X7 receptor antagonist can be
administered to the patients for treating and [providing] prophylaxis
[against] various diseases, such as pain, rheumatoid arthritis, myoblastic
leukaemia, [] etc." (Final Act. 3.) The Examiner concludes that,
[t]hough the prior art references does not explicitly recite[] a
tissue marking pen, it is the Examiner's position that the only
active essential ingredient in claimed kit is a P2X7 receptor
antagonist. The presence of tissue marking pen carries little
patentable weight. Moreover, as has been discussed supra, it
can read on special medical device, such as syringe or catheter
14 Caplan et al., US 6,608,038 B2, issued Aug. 19, 2003.
15 Gleave et al., US 2009/0281166 Al, published Nov. 12, 2009.
16 Yaffe et al., US 9,023,787 B2, issued May 5, 2015.
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for example and thus it would be immediately obvious to one
skill in the art, to use such device for administering.
(Id.)
Appellants contend that the cited combination of references does not
disclose "any reasonable basis for suggesting the combination of a P2X7
receptor antagonist with a tissue marking pen." (Appeal Br. 11.)
The issue with respect to all of the rejections is whether a
preponderance of the evidence of record supports the Examiner's conclusion
that the combination of Carroll and Concepcion renders obvious a kit
comprising a P2X7 receptor antagonist and a tissue marking pen.
Analysis
On balance, we find Appellants to have the better argument. In
particular, while we agree with the Examiner that Carroll and Concepcion
teaches using P2X7 receptor antagonist for treatment and/or prophylaxis of
various conditions and diseases, the Examiner fails to explain why such
teaching would make it obvious to include a tissue marking pen in a kit with
the P2X7 receptor antagonist. "'[R]ejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness."' KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
The Examiner notes that the claims are drawn to a product rather than
a method of delivering the P2X7 receptor antagonist and asserts that explicit
recitation of tissue marking pen in the prior art is not necessary, because "the
only active essential ingredient in [the] claimed kit is a P2X7 receptor
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antagonist" and "[t]he presence of tissue marking pen carries little patentable
weight." (Final Act. 3; see also Ans. 3, 5.)
We are not persuaded. We agree with the Examiner that the product
claims on appeal do not require any particular method of delivering the P2X7
receptor antagonist. Nevertheless, "obviousness requires a suggestion of all
limitations in a claim." CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 490 F.2d 981, 985
( CCP A 197 4) ). The Examiner has not persuasively shown that the claim
language relating to "tissue marking pen" is non-limiting based on existing
precedent, for instance because it is merely a statement of purpose or
intended result.
While "[a] claim can be obvious even where all of the claimed
features are not found in specific prior art references," that is the case only
"where 'there is a showing of a suggestion or motivation to modify the
teachings of [the prior art] to the claimed invention."' Ormco Corp. v. Align
Tech. Inc., 463 F.3d 1299, 1307 (Fed. Cir. 2006) (citation omitted). The
Examiner has not provided sufficient "articulated reasoning with some
rational underpinning" why a skilled artisan would have found it obvious to
include a tissue marking pen in a kit with the P2X7 receptor antagonists
taught by Carroll and Concepcion. KSR, 550 U.S. at 418 (internal quotation
marks and citation omitted). 17
17 The Examiner asserts that KSR "forecloses the argument that a specific
teaching, suggestion, or motivation [is] required to support a finding of
obviousness." (Final Act. 4; see also Ans. 4--5.) KSR indeed holds that
obviousness analysis "need not seek out precise teachings directed to the
specific subject matter of the challenged claim" and that the analysis "can
take account of the inferences and creative steps that a person of ordinary
skill in the art would employ." KSR, 550 U.S. at 418. However, KSR also
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The Examiner next asserts that, because the Specification provides no
"teaching or guidance or definition of 'tissue marking pen"' and because
during prosecution "the claims must be interpreted as broadly as their terms
reasonably allow," "'tissue marking pen' can read on special medical
device[s] such as syringe or catheter," especially in light of Appellants'
assertion that "tissue marking pen was used for administering P2X7
receptor antagonist" and "in the absence of evidence to the contrary." (Final
Act. 3--4; see also Ans. 3 (stating that "when claim 24 is given its broadest
reasonable interpretation it can read on a kit comprising P2X7 receptor
antagonist, a physiologic buffer solution and syringe as a tissue marking
pen"), 5---6.) The Examiner cites Klein 18 as further support, asserting that
Klein shows that a skilled artisan would have known that "a syringe is
suitable for tissue marking" at the time of invention. (Ans. 3.)
Given the above claim construction, and given the Examiner's finding
that Carroll and Concepcion both teach administering P2X7 receptor
antagonists with a needle and syringe, the Examiner concludes that "it would
be immediately obvious to one skill[ ed] in the art that [ either Carroll or
Concepcion] teaches the combination of P2X7 receptor antagonist with
syringe," i.e., a "tissue marking pen." (Id. at 4; see also id. at 6.)
explains that a claim "composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art," and that an explicit analysis should be made as to
"whether there [is] an apparent reason to combine ... known elements in the
fashion claimed by the patent at issue." Id. Thus, the Examiner's
conclusory statement that "[t]he presence of tissue marking pen carries little
patentable weight" does not meet the standard set forth in KSR.
18 Klein, US 6,394,985 B 1, issued May 28, 2002.
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We are not persuaded. While we give claim terms their broadest
reasonable interpretation during examination, such interpretation
nevertheless "cannot be divorced from the specification and the record
evidence." In re NTP, Inc., 654 F.3d 1279, 1288 (Fed. Cir. 2011); see also
In re Suitco Surface, Inc., 603 F.3d 1255, 1260 (Fed. Cir. 2010) (explaining
broadest reasonable construction must be "' consistent with the
specification,"' and "'claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art"').
In this case, the Examiner has not persuasively shown that a skilled
artisan, in light of the Specification, would have interpreted "tissue marking
pen" to encompass a syringe. The Examiner first asserts that this
interpretation is reasonable because Appellants contend that "tissue marking
pen was used for administering P2X7 receptor antagonist." (Final Act. 4.)
However, the Examiner fails to explain how Appellants' contention
evidences how a skilled artisan would interpret the term "tissue marking
pen." For example, the Examiner has cited no evidence that a skilled artisan
would understand that all devices capable of administering P2X7 receptor
antagonists are "tissue marking pens" or that syringes are the only device
capable of administering such antagonists.
The Examiner also asserts that an interpretation of "tissue marking
pen" as encompassing a syringe is reasonable because a skilled artisan
would understand, based on prior art references such as Klein, that a syringe
may be used for tissue marking. (Ans. 3.) While we agree with the
Examiner that Klein teaches a method of tissue marking using a syringe and
microparticles (Klein Abstract, 2: 10-16), we are not persuaded by the
Examiner's reasoning because the Examiner appears to have read the term
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"pen" out of the claims. In particular, the Examiner fails to provide
evidence or reasoning as to why a skilled artisan would consider a syringe to
be a "tissue marking pen" merely because it is capable of marking tissue.
We note that the Specification teaches marking tissues using a non-
toxic dye (rather than the microparticles taught by Klein) in order to, e.g.,
optimize orientation of a harvested saphenous vein during implantation of
the vein in bypass grafting. (Spec. 2:29-30, 16: 10-22.) The Examiner does
not explain why, in light of such disclosures in the Specification, a skilled
artisan would not understand the broadest reasonable interpretation of the
term "tissue marking pen" to be "'an implement for writing or drawing with
ink or similar fluid' that is capable of marking the surface of a tissue," or
why such an implement would be understood to encompass syringes such as
those taught in Klein for injecting microparticles or useful for administering
the P2X7 receptor antagonists taught in Carroll and Concepcion. 19
Accordingly, on the record before us, we reverse the Examiner's
rejection of claim 24. We likewise reverse the Examiner's rejections of
claims 25-29, 34, 45-53, and 55---60, which depend directly or indirectly
from claim 24. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992)
("[D]ependent claims are nonobvious if the independent claims from which
they depend are nonobvious.").
19 See, e.g., "pen." MERRIAM-WEBSTER, https://www.merriam-
webster.com/dictionary/pen (last visited May 16, 2019) (defining pen among
other things as "an implement for writing or drawing with ink or a similar
fluid"); "pen." DICTIONARY.COM, https://www.dictionary.com/browse/pen
(lasted visited May 16, 2019) ( defining pen as "any of various instruments
for writing or drawing with ink or a similar substance").
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SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 24--29, 34, 45-53, and 55---60.
REVERSED
11