Ex Parte Sullivan et al

Patent Trial and Appeal Board

Feb 6, 2019

14153609 (P.T.A.B. Feb. 6, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/153,609 01/13/2014
20792 7590
MYERS BIGEL, P.A.
PO BOX 37428
RALEIGH, NC 27627
02/07/2019
FIRST NAMED INVENTOR
Christopher A. Sullivan
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.
9865-84TSDV 5472
EXAMINER
PARK, HAEJIN S
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
02/07/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER A. SULLIVAN, STEVE J. HODGES,
ANTHONY ATALA, and JAMES J. YOO
Appeal2018-001642
Application 14/153,609 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejection of claims 24, 34--41, and 43. We have jurisdiction
under 35 U.S.C. § 6(b ). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification describes biomedical devices for insertion or
implantation into a subject, comprising a substrate and a collagen inhibitor
on or in the substrate. Spec. 2:15-16.
Claim 24 is illustrative, and recites:
1 Appellants identify the real party in interest as Wake Forest University
Health Sciences. Appeal Br. 2.
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Application 14/153,609
24. A barrier material for preventing adhesions in a subject,
comprising a preformed or in situ formable barrier substrate and
a collagen inhibitor on or in said substrate,
wherein said collagen inhibitor is selected from the group
consisting of: mithramycin, mitomycin-c, tranilast,
halofuginone and analogs thereof, and
wherein said collagen inhibitor is configured to elute from said
barrier material for a period of up to 8 days.
Appeal Br. 10 (Claims Appendix).
REJECTION MAINTAINED ON APPEAL
Claims 24, 34--41, and 43 stand rejected under 35 U.S.C. § I03(a)
(pre-AIA) as unpatentable over Hunter. 2 Ans. 2.
DISCUSSION
The Examiner finds that "Hunter does not disclose a single
embodiment with all of the limitations arranged precisely as recited in claim
24" (Final Action 5), but that claim 24 nonetheless would have been obvious
over Hunter, because:
Hunter expressly teaches (see title; abstract; paras. 0006-07;
0971) compositions for
"prevention of surgical adhesions" ( abstract; para. 0971 ),
(a) "formed in-situ when precursors thereof are delivered to a
site in the body, or a site on an implant" (para. 0006), with
(b) a collagen inhibitor, e.g., halofuginone, or "the
pharmacologically active fibrosis-inhibiting compound is a
collagen antagonist" (para. 0310), and discloses at length that
the compositions may be "loaded with ... a fibrosis-inhibiting
agent" (para. 0995; passim, see, e.g., paras. 0999, 0958 ("the
2 Hunter et al., US 2005/0208095 Al, published Sept. 22, 2005.
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Application 14/153,609
tissue reactive polymer may be applied initially and then the
fibrosis-inhibiting agent may then be applied to the coated
tissue").
Id.; see also id. at 3--4. The Examiner acknowledges that Hunter "is lengthy
and encompasses many known precursors, collagen inhibitors, fibrosis-
inhibiting compounds, and other therapeutic agents that may be used in its
adhesion preventing compositions" (id.), but finds that the ordinarily skilled
artisan would have needed to rely on "no more than routine experimentation,
entirely within Hunter's express teachings, to use collagen inhibitor in
Hunter's compositions" (id. at 5-6).
Having reviewed Appellants' arguments, we are not persuaded of any
reversible error in the Examiner's rejection of claim 24. Appellants focus
largely on Hunter's length, breadth, and repetition (see Appeal Br. 4--5; see
also Reply Br. 2), and conclude the Examiner's rejection is the product of
impermissible hindsight bias (see Appeal Br. 7; see also Reply Br. 2). But a
prior art reference is prior art for all that it teaches, including embodiments
that are not "preferred" or actually reduced to practice. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004). This is so even when a reference
teaches "a multitude of effective combinations." Merck & Co. v. Biocraft
Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); cf In re Mills, 470 F.2d 649,
651 ( CCP A 1972) ("We find no merit in appellants' contention that the
disclosure of propylene is so submerged in Cooper, and the teaching of the
use of ethylene so predominant, that Cooper cannot be said to place foams
composed of the claimed ingredients in the possession of the public.").
Here, we find that the Examiner has applied Hunter not in a piecemeal
or hindsight-driven manner, but by logically weaving together interrelated
parts, following Hunter's structure and categories. In such a comprehensive
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Application 14/153,609
reference, it is not especially surprising that the disclosure of therapeutic
agents (as relevant here, halofuginone hydrobromide (Hunter ,r 79), 3
mitomycin-C (id. ,r,r 172, 187), mithramycin (id. ,r 188) and, more generally,
collagen antagonists (id. ,r,r 327-328)) appears many pages away from the
discussion of dosages (see id. ,r,r 387-88) and prevention of surgical
adhesions (see id. ,r,r 877-978). As the Examiner explains:
Here, Hunter teaches "[ c ]ompositions comprising anti-fibrotic
agent(s) and/or polymeric compositions ... used in various
medical applications including prevention of surgical
adhesions, ... " (Abstract, emphases added; see paras. 0006-
07). Hunter discusses "Adhesion Prevention" (paras. 0971-
1070, pages 101-25) in different procedures: (i) spinal and
3 Appellants point out that Hunter lists this halofuginone derivative as an
angiogenesis inhibitor. Appeal Br. 5. The import of this discussion is unclear,
but to the extent Appellants are implying that Hunter does not recognize
halofuginone as a collagen inhibitor because halofuginone hydrobromide is
not listed as an exemplary collagen inhibitor in Hunter, this is not persuasive.
A chemical composition cannot be separated from its properties. See In re
Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) ("Products of identical chemical
composition can not have mutually exclusive properties."); see also In re
Prindle, 297 F.2d 251, 254 (CCPA 1962) ("Mere recognition of those latent
properties does not render the otherwise obvious [ claimed subject matter]
unobvious and thereby patentable."). Furthermore, as the Examiner points
out:
paragraph [0077] explains that "[ n ]umerous therapeutic
compounds capable of inhibiting fibrosis have been identified
that are of utility in the invention including:" (para. 0077,
emphasis added). Thus Hunter does not discuss halofuginone,
disparate from anti-fibrotic agents or collagen inhibitors, but as
the first among "therapeutic compounds capable of inhibiting
fibrosis" (para. 0077), i.e., excessive scar tissue that surgical
adhesion is (para. 0076: "agents which inhibit one or more
aspects of the production of excessive fibrous (scar) tissue").
Ans. 4.
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Application 14/153,609
neurosurgical (from para. 0986), (ii) gynecological (from para.
1009), (iii) orthopedic (from para. 1042), ... , (vi)
reconstructive and cosmetic (from para. 1053), as well as (vii)
agents and dosages of fibrosis-inhibitors (para. 1069-70).
Therefore the Office cannot agree that Hunter does not "fairly
suggest or direct" the skilled person to the "barrier material for
preventing adhesions ... " in claim 24 as Appellant argues.
Ans. 3.
Appellants also argue that there would have been no reason for the
ordinarily skilled artisan to focus on the "relatively rapid release" of the
collagen inhibitor (i.e., the elution period of "up to 8 days" recited in claim
24 ), so as not to affect the wound healing process, out of the elution times of
up to 180 days discussed in Hunter. Appeal Br. 6. To the contrary, the
Examiner points to Hunter's teaching that "[a]dhesions generally begin to
form within the first several days after surgery" (Final Action 4 ( emphasis
omitted) ( quoting Hunter ,r 977)) as motivation for the ordinarily skilled
artisan to design the release duration accordingly, thus arriving within the
claimed period of "up to 8 days" through the exercise of ordinary skill (see
id. (discussing Hunter Abstract, ,r 977)). Appellants assert that this
statement in Hunter is "isolated" and taken "out of context" (Appeal Br. 7),
but we disagree. Paragraph 977 of Hunter is rooted within a larger
discussion of "Adhesion Prevention" beginning at paragraph 971. And
notwithstanding Appellants' suggestion to the contrary (see Appeal Br. 7),
nothing in the subsequent paragraph (i.e., Hunter ,r 978) erodes support for,
or is otherwise inconsistent with, the disclosure in paragraph 977 of Hunter.
For these reasons and those already of record, we sustain the
Examiner's rejection of claim 24.
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Appellants argue claims 34--41 under a separate heading, but limit
their specific arguments to claims 38, 40, and 41. See Appeal Br. 8. These
specific arguments return to the theme of Hunter's large, broad disclosure:
as to the biodegradable polymers recited in claim 38, "Hunter teaches a great
number of polymeric materials" without guidance to the ordinarily skilled
artisan; as to the recitation of halofuginone in claims 40 and 41, "Hunter
provides an enormous number of 'therapeutic agents."' Id. As discussed
above with respect to claim 24, the sheer volume of Hunter's disclosure is
no barrier to its usefulness as a prior art disclosure. Again, as with claim 24,
we likewise disagree with respect to claims 3 8, 40, and 41 that the Examiner
has applied Hunter's comprehensive teachings in a piecemeal or otherwise
problematic fashion. Accordingly, we sustain the Examiner's rejection of
claims 38, 40, and 41. Claims 34--37 are not argued separately, and fall with
claims 38, 40, and 41. See 37 C.F.R. § 4I.37(c)(l)(iv).
Appellants also separately argue claim 43, which recites an elution
time of up to 5 days, asserting the Examiner failed to articulate a reason
sufficient to support the rejection of this claim. See Appeal Br. 8. As
discussed above with respect to claim 24, we agree with the Examiner (see
Ans. 6) that Hunter's explanation that "[a]dhesions generally begin to form
within the first several days after surgery" (Hunter ,r 977) would have
motivated the ordinarily skilled artisan to design elution times falling within
this post-surgical timeframe (including "up to 5 days" as in claim 43), to
prevent the formation of surgical adhesions. Accordingly, we sustain the
Examiner's rejection of claim 43.
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CONCLUSION
We sustain the Examiner's rejection of claims 24, 34--41, and 43.No
time period for taking any subsequent action in connection with this appeal
maybe extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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