Ex Parte Luck et al

Patent Trial and Appeal Board

Feb 12, 2019

12155897 (P.T.A.B. Feb. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/155,897 06/11/2008
90679 7590 02/14/2019
Finnegan/Perring, B.V.
901 New York A venue, N.W.
Washington, DC 20001
FIRST NAMED INVENTOR
Martin Luck
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.
13214.0029-00 6986
EXAMINER
RAWLINGS, STEPHEN L
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
02/14/2019 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARTIN LUCK and PIERRE BROQUA 1
Appeal2017-007506
Application 12/155,897
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to an injectable pharmaceutical composition. Claims 76, 77, 79--82, 84--86,
and 88-97 are on appeal as rejected under 35 U.S.C. § 112, first paragraph,
and§ 103. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as "Perring B.V." Appeal Br.
3. Oral argument was heard on February 7, 2019; a transcript of which will
be made a part of the record on appeal.
Appeal2017-007506
Application 12/155,897
STATEMENT OF THE CASE
Independent claim 76 is representative and is reproduced below:
7 6. An injectable pharmaceutical compos1t10n
comprising a pharmaceutically acceptable solvent and a GnRH
antagonist peptide according to formula 1 or a pharmaceutically
acceptable salt thereof Ac-DNal-Dcpa-Dpal-Ser-Aph(X1)-
DAph(X2)-Leu-Lys(iPr)-Pro-DAla-NH2
1
wherein X1 is L-Hor and X2 is CONH2,
wherein the composition does not form a gel depot within
30 minutes of formation of the composition and the
concentration of the peptide or salt thereof in the solvent is:
(1) 20 mg/ml, provided that it is administered to a
patient within 24 hours of formation of the composition;
(2) 40 mg/ml, provided that it is administered to a
patient within 24 hours of formation of the composition;
(3) 60 mg/ml, provided that it is administered to a
patient within 8 hours of formation of the composition; or
( 4) 80 mg/ml, provided that it is administered to a
patient within 1 hour of formation of the composition,
wherein the composition achieves a gel depot upon
administration to a patient for release of the peptide or salt
thereof over a period of at least two weeks.
Appeal Br. 26 (Claims Appendix).
The following rejections are appealed:
Claims 76, 77, 79--82, 84--86, 88, and 89 stand rejected under 35
U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement. Final Action 7.
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Claims 76, 77, 79--82, 84--86, 88, and 89-97 stand rejected under 35
U.S.C. § 103(a) over Jiang. 2 Id. at 11.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief and properly presented
in the Reply Brief have been considered in this Decision; arguments not so-
presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015);
see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) ("Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.").
I. WRITTEN DESCRIPTION
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must "clearly allow persons of ordinary skill in the art to
recognize that [ the inventor] invented what is claimed." In other
words, the test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the
art that the inventor had possession of the claimed subject matter
as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
( en bane) ( citation omitted, alteration in original). "[T]he written description
requirement does not demand either examples or an actual reduction to
2 Guangcheng Jiang et al., GnRH Antagonists: A New Generation of Long
Acting Analogues Incorporating p-Ureido-phenylalanines at Positions 5 and
6, 44 J. MED. CHEM. 453---67 (2001) ("Jiang").
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Application 12/155,897
practice; a constructive reduction to practice that in a definite way identifies
the claimed invention can satisfy the written description requirement." Id. at
1352; see also Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006).
"The 'written description' requirement must be applied in the context
of the particular invention and the state of the knowledge." Capon v.
Eshhar, 418 F.3d 1349, 1358 (Fed. Cir. 2005). "It is not necessary that
every permutation within a generally operable invention be effective in order
for an inventor to obtain a generic claim, provided that the effect is
sufficiently demonstrated to characterize a generic invention." Id. at 1359.
The Examiner determined:
Water is the only solvent that is described that can be used to
formulate stable solutions of the peptide or salt thereof, which
lack the observed propensity to form gels when the concentration
of the peptide in the solvent exceeds 0.25 mg/ml. Inasmuch as
the claims are not limited to solutions comprising water, it would
appear the specification fails to adequately describe with the
requisite clarity and particularity the claimed genus of solvents
that can be used to make the claimed injectable pharmaceutical
composition comprising the solution of the peptide at the
requisite concentrations.
Final Action 10. The Examiner explained in the Answer the differences in
types of solvents; it is the Examiner's position that, without providing
evidence to support that the various solvents listed in Appellants'
Specification will dissolve or re-suspend FE200486 (the claimed active
compound), the skilled artisan would not recognize a disclosure of the
solvent limitation (without further testing examples) because the only
solvent described as working was water. Answer 34--45.
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Application 12/155,897
Appellants argue the claims' solvent limitation is described in the
Specification at page 6, where it states:
The peptide or pharmaceutically acceptable salt is preferably
comprised in a solution in a pharmaceutically acceptable solvent.
Examples of such pharmaceutically acceptable solvents are
water, an alcohol (for example ethanol), N-methylpyrrolidone or
dimethylsulfoxide. In a preferred embodiment of the invention
the solvent is water or a mixture of water and a second solvent,
such as alcohol, N-methylpyrrolidone or dimethylsulfoxide, such
that the water constitutes at least 90% by weight of the solvent
mixture.
Appeal Br. 14 ( emphasis original). Further, Appellants point to the
Specification's Examples 2---6, which include water and 5% mannitol as a
solvent, thus, describing working solvents that were not only water. Id. at
15. Appellants also argue that
the term "pharmaceutically acceptable solvent" is a common
term used in the art. The Office does not argue, and cannot argue,
that a person of ordinary skill would not be led to a known class
of solvents by the term "pharmaceutically acceptable solvent" or
that Appellants' specification does not provide enough guidance
to the class of solvents encompassed by the term.
Reply Br. 6.
We conclude that the balance of evidence favors Appellants' position.
Appellants have not identified only a single solvent for their invention, but
have listed several specifically and described a class of solvents for
consideration-those that are pharmaceutically acceptable. Here, this is a
sufficient disclosure to apprise the skilled artisan of what type of solvent
component is included in the claimed invention. "A patent need not teach,
and preferably omits, what is well known in the art." Spectra-Physics, Inc.
v. Coherent, Inc., 827 F.2d 1524, 1534 (Fed. Cir. 1987). The Examiner's
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Application 12/155,897
explanation of solvent types and properties provided in the Answer at pages
3 6-3 7, which does not cite any particular source, is not merely informative,
but appears to be illustrative of the kind of basic knowledge the skilled
artisan would have had when considering solvents for the claimed invention
( e.g., no sources were cited for such information by the Examiner, hence we
understand such to be common knowledge).
For these reasons, the written description rejection is reversed.
IL OBVIOUSNESS
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "In determining
whether the subject matter of a patent claim is obvious, neither the particular
motivation nor the avowed purpose of the patentee controls. What matters is
the objective reach of the claim. If the claim extends to what is obvious, it is
invalid under§ 103." Id. at 419. "[T]he question is whether there is
something in the prior art as a whole to suggest the desirability, and thus the
obviousness, of making the combination, not whether there is something in
the prior art as a whole to suggest that the combination is the most desirable
combination available." In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004)
( citation omitted).
The Examiner determined the claimed invention would have been
obvious over Jiang. Final Action 11-21. Specifically, the Examiner
determined Jiang taught or suggested the compound "FE200486," which is a
synthetic peptide having the same structure as that claimed. Id. at 12.
Further, the Examiner determined that Jiang disclosed a composition having
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a 50 mg/mL concentration of FE200486 (which Jiang called compound 31)
in water, or water and 5% mannitol, as a solvent, which provided an
initially-clear and free-flowing liquid and presented no gel formation
initially (but, upon storage at ambient temperature, had signs of turbidity at
24 hours and some sediment at 1 week). Id. at 12-13; see also Jiang 460
(Table 2). Further, the Examiner determined Jiang taught and suggested
injecting such a composition into a subject (rat). Final Action 12-13.
Further, the Examiner determined that Jiang suggests that, after
administration to a subject (rat), the injected FE200486 composition formed
a gel depot because Jiang disclosed an extended duration of action following
such administration, consistent with such gel formation. Final Action 13;
Answer 23-24; see also Jiang 461 ("results strongly suggest that the very
long duration of action of 31 ... after sc administration ... is the result of
the peptide's bioavailability at, and distribution from, the injection site rather
than one of stability in the circulation.").
We discern no error in the Examiner's determinations. We address
Appellants' arguments below.
Appellants argue "Jiang fails to teach a composition of an injectable
pharmaceutical composition according to Appellants' claim 7 6." Appeal Br.
17. This argument is not persuasive. It is clear from Jiang that its aqueous
formulations including the compound FE200486, which Appellants do not
contest is the claimed compound, were injected into rats. Moreover, the
formulations disclosed by Jiang's Table 2 fall within the scope of the claims
and would have been injectable, particularly within 24 hours of their
preparation, i.e., before the appearance of any turbidity.
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Appellants argue Jiang teaches away from the claimed invention
because the reference notes that increasing dosage of FE200486 increases
the drug's duration of action, which is different from Appellants' discovery
that concentration is the key variable relating to the active compound's
duration of action. Appeal Br. 19. This argument is also not persuasive.
Appellants' claims do not require controlling a pharmaceutical formulation's
duration of action by manipulating its drug concentration. In any event,
Jiang expressly states that the duration of action of its disclosed GnRH
antagonist formulations was both concentration-dependent and dose-
dependent See Jiang 461. Jiang' s focus on dosage is not a teaching away of
the importance of concentration.
Appellants argue Jiang teaches away from gel depot formation ( after
injection) because "[t]here is no teaching in Jiang that [its] solutions form a
gel depot upon administration" and the skilled artisan "would consider Jiang
to teach that gel formation is an adverse quality for GnRH antagonist
peptides." Appeal Br. 21. This argument is also not persuasive. Jiang does
not teach away from post-injection gel formation of its compositions. As
discussed above, Jiang implies that such gel formation inherently occurs
because its formulations exhibit a very long duration of action because the
active agent does not enter the subject's circulation, but maintains its
bioavailability at the injection site. Jiang 461. Moreover, "[p ]roducts of
identical chemical composition can not have mutually exclusive properties."
In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
Appellants argue Jiang does not teach a GnRH antagonist peptide
composition that releases over a period of at least two weeks and Jiang fails
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Application 12/155,897
to teach the claimed administration of injectable composition within the time
intervals after composition formation, as claimed. Appeal Br. 23. This
argument is also not persuasive. Jiang discloses that its formulations exhibit
a very long duration of action. For example, Jiang states:
in rats injected sc with FE200486 (2 mg/kg), plasmatic
concentrations of FE200486 remained above 5 ng/mL until day
41, and the time after which they dropped below 3 ng/mL and
plasma LH levels started rising until full recovery was reached at
day 84 with levels of FE200486 hovering around 1 ng/mL.
Jiang 453. This far exceeds the claimed two-week period. Moreover, as
discussed above, Jiang teaches that its 50 mg/mL FE200486 formulations,
whether in just water or a 5% mannitol solution as solvent, were initially not
gels, but were clear and either slightly viscous or free-flowing, but exhibited
some signs of turbidity at 24 hours. Jiang 460 (Table 2). This suggests that
injection can and should be performed with such formulations before 24
hours after preparation, as claimed, so that a non-turbid formulation is used
for injection.
For the reasons set forth above, we are unpersuaded that the Examiner
erred in presenting a prima facie case for obviousness. The balance of
evidence on appeal favors the Examiner's position and we affirm the
rejection.
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SUMMARY
The rejection for lack of written description rejection under 35 U.S.C.
§ 112 is reversed.
The obviousness rejection under 35 U.S.C. § 103 is affirmed.
TIME PERIOD FOR RESPONSE
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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