Ex Parte Sherman

Patent Trial and Appeal Board

Feb 25, 2016

11801834 (P.T.A.B. Feb. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111801,834 05/11/2007
128691 7590
Nash & Titus, LLC
21402 Unison Road
Middleburg, VA 20117
02/26/2016
FIRST NAMED INVENTOR
Kenneth Sherman
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.
Army 160A 5503
EXAMINER
BOESEN, AGNIESZKA
ART UNIT PAPER NUMBER
1648
MAILDATE DELIVERY MODE
02/26/2016 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 KENNETH SHERMAN1
Appeal2013-002953
Application 11/801,834
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition that have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellant, the real party in interest is the U.S. Government as
represented by the Secretary of the Army. (Br. 2.)
Appeal2013-002953
Application 11/801,834
STATEMENT OF THE CASE
Background
"A treatment modality for [Hepatitis C Virus] infections has been
devised comprising the administration to mammals of immune system-
potentiating doses of one or more thymosins in combination with interferon
therapy." (Spec. 12, 11. 1-4.)
Claims on Appeal
Claims 25-33 are on appeal. (Claims Appendix, Br. 7-8.)
Independent claim 25 is illustrative2 and reads as follows:
25. A composition comprising a pharmaceutical dosage unit of a
pharmaceutically acceptable carrier, 900-1200µg/m2 of body surface area of
thymosin-a or 1500-1700 µg/m2 thymosin-a and/or fragments of thymosin-a
in combination with 1-3 million units (MU) of at least one a-interferon, said
pharmaceutical dosage unit being capable of promoting in vivo inactivation
of hepatitis C virus when administered to mammals infected with said virus.
Examiner's Rejection
Claims 25-33 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Huang,3 Hoofnagle,4 and Moody. 5 (Ans. 5.)
2 The Examiner notes that claim 25 submitted with the Brief recites "1500-
1700 µg/m2 thymosin-a," but that claim 25 was amended on August 17,
2011, to delete "m2" so that the phrase should read "1500-1700 µg
thymosin-a." (Ans. 3, citing Response filed Aug. 17, 2011.)
3 Huang et al., Follow-up Observation on the Antiviral Effect of Combined
Treatment of Small Dosage of Interferon and Thymosin in Patients with
Chronic Hepatitis B, 5 VIROLOGICA SINICA 69-73 (1990) (pages 1-12 in
translation) ("Huang").
4 Hoofnagle et al., Treatment of Chronic Type C Hepatitis with Alpha
Interferon, 9 (4) SEMINARS IN LIVER DISEASE 259-263 (1989)
("Hoofnagle").
5 Moody, US Patent No. 5,273,963, issued Dec. 28, 1993 ("Moody").
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Application 11/801,834
Appellant presented arguments for the patentability of claims 25-33
as a group. (Br. 3-6.) Therefore, we limit our discussion to claim 25 as
representative of those claims.
ISSUE
Whether a preponderance of evidence of record supports the
Examiner's conclusion that claim 25 is obvious based on Huang, Hoofnagle,
and Moody.
ANALYSIS
The Examiner's obviousness conclusion is based on the finding that a
"person of ordinary skill in the art would have been motivated to provide
Huang's composition comprising interferon-a and thymosin, wherein the
interferon is a-2b interferon in the amount of 1-3 MU and the thymosin is
thymosin a-1 in the amount of 900-1200µg/m2 of body surface area or 1500-
1700 µg," because Hoofnagle teaches using interferon a-2b in the amount of
2-5 MU, and because it would have been within the skill of the ordinary
artisan (routine) to adjust the dosages of thymosin. (Ans. 6.) The
conclusion is also based on the Examiner's finding that it would have been
obvious to use Moody's thymosin a-1 fragments in Huang's composition,
and the Examiner's finding that one would have had a reasonable
expectation of success in providing Huang's composition with Moody's
thymosin a-1 fragments and Hoofnagle's interferon a-2b. (Id.)
We adopt as our own the findings and reasons set forth by the
Examiner in (1) the action from which this appeal is taken (Final Act. 2-5)6
and (2) the Examiner's Answer in response to Appellant's Brief (Ans. 5-13),
6 Office Action dated Nov. 1, 2011.
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Application 11/801,834
and concur with the conclusions reached by the Examiner. Moreover, the
Examiner has satisfied the burden of showing "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). The
Examiner has therefore established a prima facie case of obviousness and, as
discussed below, Appellant has not overcome that prima facie case.
Hepatitis B versus Hepatitis C
Appellant argues that the combination of Huang and Hoofnagle is
improper because Huang "is directed to a treatment for Hepatitis B" whereas
Hoofnagle was cited "for treating Hepatitis C." (Br. 3--4.) In particular,
Appellant argues that "Hepatitis B and Hepatitis C are completely different
biological organisms having different physical characteristics, pathologies
and reproductive methods." (Id. at 3.) Appellant buttresses this argument
with a Declaration7 purportedly "establishing that a number of antiviral
agents that are effective against Hepatitis B virus have no effect on Hepatitis
C virus and vice versa." (Br. 6; Deel. ,-i 7.)
We are not persuaded. As the Examiner points out, Huang and
Hoofnagle teach that interferon-a is effective in treating hepatitis C as well
as hepatitis B. (Ans. 7.) Furthermore, while the Sherman Declaration
indicates that certain agents may be active only against hepatitis B or C, it
confirms the Examiner's finding that interferon-a is active against both
hepatitis B and hepatitis C. (Deel. ,-i 7.) Thus, the Examiner properly found
that "[b ]ecause thymosin-a acts to induce more interferon-a and to activate
7 Declaration under 35 U.S.C. 1.132 [sic, 37 C.F.R. § 1.132] by Kenneth E.
Sherman, dated August 1 7, 2010 ("Sherman Declaration" or "Deel.").
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Application 11/801,834
T cells ... the skilled artisan knowing that interferon-a effectively treats
hepatitis C infection would have been motivated to add thymosin-a ... to
provide a composition comprising interferon-a and thymosin- a."8 (Ans. 8)
(emphasis added); see In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing
cases) (the test for obviousness is "what the combined teachings of the
references would have suggested to those of ordinary skill in the art").
Dosage Optimization
Appellant argues that Hoofnagle does not suggest "what the proper
dosage unit of thymosin would be" and "does not provide the requisite
motivation" for a dosage of 1-3 MU of a-interferon because it discloses a
different range (2-5 MU) and the range is for treating with interferon alone.
(Br. 4.) Furthermore, Appellant argues that there is no "proof or expected
degree of success for the use of the combination of thymosin with interferon
in the claimed dosages." (Id. at 5.)
We are not persuaded. We agree with the Examiner's finding that "it
would have been within the skill of the ordinary artisan to adjust the dosages
of thymosin in the composition." (Ans. 6.) "[W]here the general conditions
of a claim are disclosed in the prior art, it is not inventive to discover the
optimum or workable ranges by routine experimentation." In re Aller, 220
F.2d 454, 456 (CCPA 1955). Moreover, the section of Appellant's
8 A similar argument regarding the differences between hepatitis B and
hepatitis C was rejected in a prior decision involving Application
09/544, 108, the parent application to the present Application 11/801,834.
See DECISION ON APPEAL, Appeal No. 2009-009125 (BPAI 2009), at 4-
9. While the Sherman Declaration was submitted after that Decision, we
remain unpersuaded by the argument that the claims are nonobvious because
hepatitis B and hepatitis Care different diseases. See id. at 8-9.
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Application 11/801,834
Specification entitled DESCRIPTION OF THE RELATED ART references
at least one prior patient trial where thymosin ai was administered "at a dose
of 900 µgrams/m2."9 (Spec. 10, 11. 1-6.) This dose overlaps the claimed
dose of900-1200µg/m2, thereby establishing a prima facie case of
obviousness. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Furthermore, as stated by the Examiner, "unless Appellant shows
unexpected results ... dose optimization is considered a routine procedure
for those of ordinary skill in the art." 10 (Ans. 8.); see also Peterson, 315
F.3d at 1330-31 (overlapping range may be patentable upon showing
criticality of the claimed range by evidence of unexpected results). See also
Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989),
stating with respect to the obviousness issue that
the experimentation needed to arrive at the claimed dosages was
nothing more than routine. [] Reached by means of routine
procedures, and producing only predictable results, the recited
dosages therefore do not distinguish the claims of the '430
patent from the amiloride/hydrochlorothiazide combination that
the district court properly found was disclosed in the '813 patent.
(Id. at 809.)
Similarly, the claimed dosage range of a-interferon is obvious because
it overlaps the range taught by Hoofnagle. See Peterson, 315 F.3d at 1329.
Furthermore, with the respective dosages of thymosin-a and a-interferon
9 Citing Schulof et al., A randomized trial to evaluate the immunorestorative
properties of synthetic thymosin a1 in patients with lung cancer, 4 J BIOL
RESPONSE MODIFIERS 147-158 (1985).
10 We also note that the presently claimed ranges for thymosin were claimed
by inventors other than Appellant. See US Patent No. 5,849,696, issued
Dec. 15, 1998, claims 3 and 4.
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Application 11/801,834
obvious, one of skill in the art would have had a reasonable expectation of
success in combining thymosin-a and a-interferon in those dosages given
the teaching of the combination in the prior art. See In re O'Farrell, 853
F.2d 894, 903 (Fed. Cir. 1988) ("Obviousness does not require absolute
predictability of success. Indeed, for many inventions that seem quite
obvious, there is no absolute predictability of success until the invention is
reduced to practice.").
Hindsight
Appellant also argues that "the Examiner combines the [cited
references] using the benefit of hindsight only." (Br. 4.) We are not
persuaded. Rather than using hindsight, the Examiner points to specific
disclosures in the prior art that describe the limitations of Appe11ant' s
claimed composition. (Ans. 5---6.) \Ve therefore find that the Examiner's
obviousness conclusion is based on sufficiently articulated reasoning that
overcomes any concen1s about hindsight bias. See KSR, 550 U.S. at 418.
CONCLUSION OF LAW
A preponderance of evidence of record supports the Examiner's
conclusion that claim 25 is obvious under 35 U.S.C. § 103(a). Claims 26-33
were not argued separately and therefore fall with claim 25.
37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of all claims on appeal.
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. § l.136(a).
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Application 11/801,834
AFFIRMED
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