Ex Parte Gross et al

Patent Trial and Appeal Board

Aug 27, 2018

13883066 (P.T.A.B. Aug. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/883,066 08/07/2013
135715 7590 08/29/2018
EthiconLLC
c/o Frost Brown Todd LLC
3300 Great American Tower
301 East Fourth Street
Cincinnati, OH 45202
FIRST NAMED INVENTOR
Jeffrey M. Gross
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.
ETH5706USPCT.0651907 5563
EXAMINER
SCHWIKER, KATHERINE H
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
08/29/2018 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):
patents@fbtlaw.com
lgroves@fbtlaw.com
jdewar@fbtlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEFFREY M. GROSS, LEV DRUBETSKY,
ALEXANDER NAIMAGON, RUI A VELAR,
WILLIAM L. D'AGOSTINO, KEVIN DON NELSON, BRENT B. CROW,
and NICKOLAS B. GRIFFIN 1
Appeal2017-008192
Application 13/883,066
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RICHARD J. SMITH, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a suture comprising a filament
and a drug associated with the filament. The Examiner rejected the claims
as obvious under 35 U.S.C. § 103. Appellants appeal the rejection pursuant
to 35 U.S.C. § 134. We have jurisdiction under 35 U.S.C. § 6(b ). The
rejections are affirmed.
STATEMENT OF THE CASE
Claims 1, 2, 6-8, 11, 13, 14, 16, 19, and 20 stand rejected by the
Examiner as follows (Ans. 2):
1 The Appeal Brief ("Br.") 3 lists Ethicon, Inc., as the real party in interest.
Appeal2017-008192
Application 13/883,066
1. Claims 1, 6, and 16 under pre-AIA 35 U.S.C. § I03(a) as obvious
in view of Stopek et al. (U.S. Pat. Appl. Publ. 2008/0058869 Al, published
Mar. 6, 2008) ("Stopek") and McKay (U.S. Pat. Appl. Publ. 2010/0021516
Al, published Jan. 28, 2010) ("McKay-516). Final Act. 2
2. Claims 1, 7, and 11 under pre-AIA 35 U.S.C. § I03(a) as obvious
in view of McClain (U.S. Pat. Appl. Publ. 2010/0030261 Al, published Feb.
4, 2010) ("McCain"), Hunter et al. (U.S. Pat. Appl. Publ. 2008/0009902 Al,
published Jan. 10, 2008) ("Hunter"), and McKay-516. Final Act. 5.
3. Claims 2, 8, and 13 under pre-AIA 35 U.S.C. § I03(a) as obvious
in view of McClain, Hunter, McKay-516, and Cichocki Jr. (U.S. Pat. Appl.
Publ. 2005/0125035 Al, published Jun. 9, 2005). Final Act. 8.
4. Claim 14 under pre-AIA 35 U.S.C. § I03(a) as obvious in view of
Stopek, McKay-516, and McKay (U.S. Pat. Appl. Publ. 2007/0243228 Al,
published Oct. 18, 2007) ("McKay-228"). Final Act. 10.
5. Claims 19 and 20 under pre-AIA 35 U.S.C. § I03(a) as obvious in
view of McClain, McKay-516, Stephenson (U.S. Pat. No. 4,024,871, issued
May 24, 1977) ("Stephenson"), and Mayer et al. (U.S. Pat. Appl. Publ.
2008/0281355 Al, published Nov. 13, 2008). Final Act. 12.
Appellants only provided arguments for Rejection 1 based on Stopek
and McKay-516. Appellants did not address the rejected dependent claims
separately. With regard to Rejections 2-5, Appellants stated that the
additionally cited publications did not address the deficiencies of McKay-
516. Br. 7, 8.
Independent claim 1, which is illustrative of the rejected claims, reads
as follows:
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Application 13/883,066
1. A suture comprising:
a filament;
a drug associated with the filament;
a plurality of tissue retainers formed in the filament;
wherein kinetics of the release of the drug is determined
by a distribution of the drug in at least one of the filament
and the retainer, and wherein first order burst in-vitro
release kinetics are such that at least 80% of the drug is
released from the filament in the first five days after
implantation.
REJECTIONS
There are two independent claims on appeal, claims 1 and 19. Both
independent claims are directed to a suture comprising a filament, where a
drug is associated with the filament and the drug is released by "first order
burst in-vitro release kinetics ... such that at least 80% of the drug is
released from the filament in the first five days after implantation."
The Examiner cited each of Stopek, McCain, and Hunter for
describing a suture with a filament, where the filament is described as being
associated with a drug as required by rejected claims 1 and 19. Final Act. 3,
5, 13. Because the Examiner found that each of Stopek, McCain, and
Hunter are silent with respect to the kinetics of release of the drug, the
Examiner cited McKay-516 for teaching the specifically recited release
kinetics "such that at least 80% of the drug is released from the filament in
the first five days after implantation." Id. at 3, 7, 13.
McKay-516
The Examiner cited the following disclosure from McKay-516 to
support the finding that McKay-516 teaches the claimed release
characteristics:
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Appeal2017-008192
Application 13/883,066
In various embodiments, the depot can be designed to cause an
initial burst dose of one or more therapeutic agents within the
first 24 hours after implantation. "Initial burst" or "burst effect"
or "bolus dose" or "pulse dose" refer to the release of
therapeutic agent from the depot during the first 24 hours after
the depot comes in contact with an aqueous fluid.
McKay-516 ,r 58.
The burst effect with respect to the region or depot, in various
embodiments, can be designed so that a larger initial dose may
be released over a short period of time to achieve the desired
effect. For example, if a drug depot is designed to release 15 mg
of morphine per 48 hours, then the initial burst dose or bolus
dose region or depot will be designed to release a percentage of
the dose within the first 24 hours ( e.g., 10 mg of morphine or
66% of the 48 hour dose within 24 hours). Thus, the burst effect
of the drug depot or region releases more therapeutic agent than
the sustained release region or depot.
McKay-516 ,r 59.
A region or depot that utilizes a burst effect or bolus dose will
release more therapeutic agent (e.g., analgesic and/or anti-
inflammatory) than the sustained release region or depot. For
example, particularly with painful chronic conditions ... the
initial burst effect of the drug depot or region of the drug depot
will be advantageous as it will provide more immediate pain
and/or inflammation relief as a bolus dose of drug will be
released at or near the target tissue site and provide the desired
reducing, or alleviation of signs or symptoms of pain and/or
inflammation. For example, the drug depot or region of the
drug depot may release 51 %, 52%, 53%, 54%, 55%, % 56%,
57%, 58%, 59%, 60%, 61 %, 62%, 63%, 64%, 65%, 66%, 67%,
68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%,
79%, 80%, 81 %, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%,
90%, 91 %, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or
100% of the daily dose within the first one to twelve hours to
reduce, prevent or treat pain and/or inflammation. The pain
and/or inflammation may also be postoperative pain following
surgery.
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Appeal2017-008192
Application 13/883,066
McKay-516 ,r 60.
Discussion
Appellants contend that McKay-516 is directed to "drug depots," and
not sutures as claimed. Br. 5.
This argument is not persuasive. The Examiner relied upon Stopek,
McCain, and Hunter for teaching sutures associated with drug. McKay-516
was cited for teaching desirable drug release characteristics from a drug
depot which the skilled worker would have recognized is applicable to a
suture comprising a drug when such suture serves as a drug depot as
described in Stopek, McCain, and Hunter.
Appellants contend that in McKay-516 "the 'burst' or 'bolus' effect is
completed within the 'first one to twelve hours' contrasted with the drug
release profile of the current invention wherein the drug's 'first order burst
in-vitro release kinetics are such that at least 80% of the drug is released
from the filament in the first five days after implantation'." Br. 5.
Appellants state that McKay-516 discloses an immediate release in a matter
of hours "as opposed to the steady release profile of the claimed invention of
at least 80% of the drug being released from the filament in the first five
days after implantation and as supported by Fig.7B of the current invention."
Id. at 6.
The claims recite "that at least 80% of the drug is released from the
filament in the first five days after implantation." While Figure 7B of the
Specification shows a steady release of drug over five days in which the
80% release is achieved at day five, the claims do not require the 80% to be
reached at day five. Rather, the claims recite that "at least 80% of the drug
is released from the filament in the first five days after implantation." As
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Application 13/883,066
found by the Examiner, a release of 80% "within the first one to twelve
hours" as taught by McKay-516 at paragraph 60 (reproduced above) is a
release "in the first five days after implantation" because a release of drug in
a 1-12 hour period is "in the first five days" as recited in the claims.
Appellants are distinguishing the claim by a feature, namely about 80%
released achieved at day five, which does not appear in the claims. While
we agree that the claims encompass the release rate shown in Figure 7B of
the Specification, Appellants have not explained why the claims should be
interpreted to read only on the release rate of Figure 7B and not on the
release rate of McKay-516.
As discussed by the Examiner, Appellants are importing limitations
from the Specification in the claims. Ans. 4. "[A] particular embodiment
appearing in the written description may not be read into a claim when the
claim language is broader than the embodiment." SuperGuide Corp. v.
DirecTV Enters., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). "[L]imitations
are not to be read into the claims from the specification." In re Van Geuns,
988 F.2d 1181, 1184 (Fed. Cir. 1993). See also Enzo Biochem, Inc. v.
Applera Corp., 599 F.3d 1325, 1342 (Fed. Cir. 2010) ("'it is improper to
read limitations from a preferred embodiment described in the specification
- even if it is the only embodiment - into the claims absent a clear indication
in the intrinsic record that the patentee intended the claims to be so
limited."'). Thus, while an embodiment disclosed in the Specification is of a
suture achieving 80% release on day five after implantation, the claims are
not limited to this embodiment.
Accordingly, the obviousness rejections of claims 1 and 19 are
affirmed. Dependent claims 2, 6-8, 11, 13, 14, 16, and 20 fall with claims 1
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Application 13/883,066
and 19 because Appellants did not provide separate arguments for their
patentability. 37 C.F.R. §4I.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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