Ex Parte Kabra

Patent Trial and Appeal Board

Mar 30, 2017

12716385 (P.T.A.B. Mar. 30, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/716,385 03/03/2010 Bhagwati P. Kabra PAT903562-US-NP 1648
1095 7590 04/03/2017
NOVARTIS PHARMACEUTICAL CORPORATION
INTELLECTUAL PROPERTY DEPARTMENT
ONE HEALTH PLAZA 433/2
EAST HANOVER, NJ 07936-1080
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
04/03/2017 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):
phip.patents@novartis.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BHAGWATI P. KABRA1
Appeal 2016-006096
Application 12/716,385
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD H. SMITH,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to methods
for treating ocular disorders, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification discloses a method for treating pathological states
that arise or are exacerbated by ocular angiogenesis, inflammation, and
vascular leakage. Spec. 1,11. 11—13. The method involves treating the eye
1 Appellant identifies the Real Party in Interest as Novartis AG. Appeal Br.
2.
Appeal 2106-006096
Application 12/716,385
with a composition comprising an aqueous suspension of a compound
having poor water solubility and polyethylene glycol (“PEG”) having a
molecular weight of greater than 2000 as a suspension agent. Spec. 4,1. 24 —
5,1. 11.
Claims 31, 32, and 41—57 are on appeal. Claim 31 is the sole
independent claim and reads as follows:
31. A method for treating an ocular disorder associated with
microvascular pathology, increased vascular permeability or
intraocular neovascularization, said method comprising:
administering to the eye of a patient suffering from said
ocular disorder an aqueous ophthalmic suspension, the
ophthalmic suspension comprising:
i. a poorly water soluble active agent at a concentration in
the suspension of from 0.01 % to 20%, the active agent being
effective in treating the ocular disorder; and
ii. polyethylene glycol (PEG) at a concentration in the
suspension of from 5% to 50% wherein the PEG consists
essentially of one or more PEGs having a molecular weight of
at least 3000;
wherein the PEG suspends the active agent as particles
within the suspension and wherein administering of the
suspension includes injecting the composition into the vitreous
of the eye.
Claims 31, 32, and 41—57 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Han2 in view of Ghosh3 in further view of Takeuchi.4
2 Han et al., US 2007/0173538 Al, published July 26, 2007 (“Han”).
3 Ghosh et al., US 2007/0149593 Al, published June, 2007 (“Ghosh”).
4 Takeuchi et al., US 5,756,552, issued May 26, 1998 (“Takeuchi”).
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Application 12/716,385
DISCUSSION
Issue
The issue is whether a preponderance of evidence supports the
Examiner’s finding that claims 31, 32, and 41—57 would have been obvious
over Han combined with Ghosh and Takeuchi.
The Examiner finds that Han discloses a method for treating of ocular
angiogenic disorders using a composition comprising a poorly water soluble
active agent and a PEG with a molecular weight of 1500—8000. Final Act. 3.
The Examiner finds that Ghosh teaches an ophthalmic composition
comprising a poorly water soluble active agent and PEG with the PEG
having a molecular weight of at least 2000. Id. The Examiner finds that
Takeuchi teaches PEG having molecular weight of up to 20000 in
combination with an active agent for ophthalmic use. Final Act. 3-4. The
Examiner finds that
[i]t would have been obvious to a person skilled in the art to
add PEG 20000 to the composition of Ghosh et al., motivated
by the teachings of Takeuchi et al., which teaches the addition
of PEG 20,000 in combination with a pharmaceutically active
agent for ophthalmic use as old and well known. The
determination of particle size is considered to be within the skill
of the artisan. Applicant has presented no evidence to establish
the unexpected or unobvious nature of the claimed invention,
and as such, claims 31, 32, and 41-54 are properly rejected
under 35 U.S.C. 103 (a).
Final Act. 4.
Appellant contends that Han does not relate to an aqueous suspension
but rather Han describes an erodible gel formed substantially of PEG and
active agent. Appeal Br. 8. Appellant argues that one skilled in the art
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would not seek to modify the gel of Han to create an aqueous suspension as
it would change the nature of the composition of Han. Appeal Br. 9.
Appellant argues that Ghosh teaches away from the current invention in that
Ghosh teaches using lower molecular weight PEG and Ghosh teaches using
PEG as a co-solvent and not as suspension agent. Appeal Br. 10. Appellant
argues that the Examiner has offered no reasoning why one skilled in the art
would combine Han and Ghosh. Appeal Br. 11. Finally, Appellant argues
that there is sufficient evidence of unexpected results to overcome an
obviousness rejection. Appeal Br. 11—13.
Findings of Fact
We adopt as our own the Examiner’s findings and analysis. The
following findings are included for emphasis and reference convenience.
FF1. Han discloses composition for treating ocular diseases due to
angiogenesis and increased vascular permeability comprising an active
ingredient and a co-solvent comprising PEG with a molecular weight of
from 1500 to 8000. Han 110.
FF2. Han teaches that the active ingredients can include poorly water
soluble active agents. Hanl 19.
FF3. Ghosh teaches an aqueous intravitreal pharmaceutical
composition comprising a poorly water soluble active ingredient and a co­
solvent. Ghosh Abstract and Tables 3 and 4.
FF4. Ghosh teaches that the co-solvent can be PEG having a
molecular weight of from 200 to 2500 and be present in amounts of from 1
to 30%. Ghosh 134.
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Application 12/716,385
FF5. The active ingredient in Ghosh is present in amounts from 0.1 to
10%. Ghosh Example 3.
FF6. Takeuchi teaches the use of PEG having a molecular weight of
up to 20000 in pharmaceutical compositions. Takeuchi col. 2,11. 48—57.
Principles of Law
A proper § 103 analysis requires “a searching comparison of the
claimed invention—including all its limitations—with the teaching of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995).
“In cases involving overlapping ranges, we and our predecessor court
have consistently held that even a slight overlap in range establishes a prima
facie case of obviousness. . . . We have also held that a prima facie case of
obviousness exists when the claimed range and the prior art range do not
overlap but are close enough such that one skilled in the art would have
expected them to have the same properties.” In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003).
“The prior art’s mere disclosure of more than one alternative does not
constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
“To be particularly probative, evidence of unexpected results must
establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention.” Bristol-Myers
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
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“[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997) (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
“The evidence presented to rebut a prima facie case of obviousness
must be commensurate in scope with the claims to which it pertains.” In re
Dill, 604 F.2d 1356, 1361 (CCPA 1979).
“Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it takes into
account only knowledge which was within the level of ordinary skill at the
time the claimed invention was made and does not include knowledge
gleaned only from applicant’s disclosure, such a reconstruction is proper.”
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Analysis
Claim 31 is representative of the rejected claims and is directed to a
method of treating an ocular condition by administering a poorly water
soluble active agent in an aqueous suspension using PEG to suspend the
active agent.
We agree with the Examiner that the subject matter of claim 31 would
have been obvious to one of ordinary skill in the art at the time the invention
was made. Han teaches a pharmaceutical composition comprising a poorly
water soluble active agent and PEG with a molecular weight which overlaps
with the instant claims. FFland2. Ghosh teaches a pharmaceutical
composition for administration into the eye which comprises 0.1 to 10 % of
a poorly water soluble active agent and 1 to 30 % of PEG. FF4 and 5. We
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agree with the Examiner that it would have been obvious to one skilled in
the art to combine the teachings of Han with Ghosh to create the invention
recited in claim 31. Final Act. 4.
Appellant contends that one skilled in the art would not combine the
teachings of Han and Ghosh as it would defeat the purpose of Han. Appeal
Br. 8—9. We are unpersuaded. Both Han and Ghosh are directed to
delivering a poorly water soluble active agent into the eye of a patient. FF1-
4. Ghosh teaches an aqueous composition containing PEG and an active
agent. FF3 and 4. The molecular weight ranges recited in the claims
overlap with those of Han and are very close to those recited in Ghosh,
supporting a prima facie case of obviousness. See In re Peterson, 315 F.3d
at 1329.
Appellant contends that Ghosh teaches away from using a higher
molecular weight PEG in that it places an upper limit of 2500 for PEGs to be
used. Appeal Br. 10. We remain unpersuaded. The teaching of an upper
limit by Ghosh cannot be said to teach away from the claimed invention in
that is does not “criticize, discredit, or otherwise discourage” using higher
molecular weights. In re Fulton, 391 F.3d at 1201.
Appellant argues that there is evidence of unexpected results which
supports a conclusion of non-obviousness. We have considered Appellant’s
evidence and find it unpersuasive. Appellant contends that Example 5
represents a formulation that is similar to the composition of Han. Appeal
Br. 13. We do not agree. The composition in Example 5 uses PEG with a
molecular weight of on 400 whereas Han teaches PEG with a molecular
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weight of from 1500 to 8000. Thus the comparison is not with the closest
prior art. Bristol-Myers Squibb Co.., 752 F.3d at 977.
We also find that Appellant has offered no evidence, other than
attorney argument, that the results achieved by the claimed invention are
unexpected. Appeal Br. 13. Attorney argument is insufficient to establish
that the results would have been unexpected to one skilled in the art. In re
Geisler, 116 F.3d at 1470.
With respect to claim 50, we disagree with Appellant’s contention that
the Examiner used impermissible hindsight in selecting Takeuchi for the
teaching of PEG with a molecular weight of at least 20000. Appeal Br. 14.
We find that the Examiner has not engage in impermissible hindsight
because the Examiner has only taken into account “knowledge which was
within the level of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant’s disclosure.”
In re McLaughlin, 443 F.2d at 1395. As the Examiner has demonstrated, the
rejection is based solely on the teachings of the references and not on any
teaching in Applicant’s disclosure. See Ans. 6—7.
Appellant’s hindsight argument rests largely on Appellant’s
contention that Han and Ghosh teach away from using higher molecular
weights. Appeal Br. 13. As discussed above, neither Han nor Ghosh can be
read as teaching away as there is nothing in either reference which
“criticize[s], discredits], or otherwise discourage[s] the solution claimed.”
In re Fulton, 391 F.3d at 1201.
With respect to claims 32, 41-49, 56, and 57 while these claims have
been argued separately, the arguments presented are the same as for claims
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31 and 50 discussed above. Appeal Br. 13—15. For the reasons discussed
above, we affirm the rejection of these claims.
Claims 51—55s, have not been argued separately and therefore fall
with claim 31.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s finding that claims 31, 32, and 41—57 would have been obvious
over Han combined with Ghosh and Takeuchi under 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
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).
AFFIRMED
5 We note that at page 15 of Appellant’s Brief under the heading CLAIMS
51-55, Appellant refers to claims 15—19 being patentable for the same
reasons as claim 14. None of these claims are the subject of this appeal. No
arguments are presented for claims 51—55.
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