Ex Parte Kabra

Patent Trial and Appeal Board

Jan 25, 2017

12630399 (P.T.A.B. Jan. 25, 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.
12/630,399 12/03/2009 Bhagwati P. Kabra PAT903481-US-NP 9660
1095 7590 01/27/2017
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
01/27/2017 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 2016-000616
Application 12/630,399
Technology Center 1600
Before JOHN G. NEW, SHERIDAN K. SNEDDEN, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
pharmaceutical suspension. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellant, the real party in interest is Novartis AG. (Appeal
Br. 2.)
Appeal 2016-000616
Application 12/630,399
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—26 are on appeal. (Claims Appendix, Appeal Br. 17—20.)
Independent claim 1 is illustrative and reads as follows:
Claim 1: A pharmaceutical suspension, comprising:
an aqueous solution that includes high molecular weight polyethylene
glycol, polyethylene oxide or both as a suspending agent, the high molecular
weight polyethylene glycol, when included, having a molecular weight that
is at least 2000; and
a therapeutic agent that is suspended by the high molecular weight
polyethylene glycol, polyethylene oxide or both within the solution wherein:
i. the polyethylene oxide, when included in the suspension,
is in the suspension at a concentration that is at least 0.5
w/v% but less that 10 w/v% and has a molecular weight
of 100,000 to 8,000,000; and
ii. the polyethylene glycol, when included in the suspension,
is in the suspension at a concentration that is at least 15
w/v% but less that 50 w/v%.
Examiner’s Rejection
Claims 1—26 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Takeuchi,2 Naka,3 and Castillo.4 (Ans. 3—5.)
FINDINGS OF FACT
FF 1. Takeuchi states that
The concentration of PEG is within the range of 0.5 to 13
(W/v)%. This is because if the concentration of PEG is less
than 0.5 (W/V)%, the resulting composition becomes hard to
form gel at a local region and hence loses practical value,
while if the concentration is more than 13 (w/v)%, the
composition shows high viscosity in the sol state.
(Takeuchi col. 3,11. 13—18.)
2 Takeuchi et al., US 5,756,552, issued May 26, 1998 (“Takeuchi”).
3 Naka et al., US 6,624,193 Bl, issued Sept. 23, 2003 (“Naka”).
4 Castillo et al., US 6,743,439 Bl, issued June 1, 2004 (“Castillo”).
2
Appeal 2016-000616
Application 12/630,399
FF 2. Takeuchi states that
The weight-average molecular weight of PEG used in the
present invention is preferably 1000 to 50,000. This is
because if the weight-average molecular weight is less than
1000, the resulting composition tends to be hard to form gel
at a local region, while if it is more than 50,000, the viscosity
thereof in the liquid state is too high.
{Id. at col. 2,11. 58—63.)
FF 3. The Examiner finds that “polyethylene glycol and polyethylene
oxide are synonyms, and PEG’S at the molecular weight of less than 100,000
are called polyethylene glycol and at the higher molecular weights are called
polyethylene oxide.” (Ans. 6.)
DISCUSSION
Issue
Whether a preponderance of evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
The Examiner states that “[t]he prior art clearly teaches a suspension
of a drug and the high molecular weight polyethylene glycol, polyethylene
oxide. Such composition is expected to have all the characteristics of the
claimed composition, considering that all the components are the same.”
(Final Act. dated July 18, 2014, at 3.) The Examiner also states that
Takeuchi “teaches the concentration of 0.5-13% for polyethylene glycol,
which is close to the claimed lower limit concentration.” {Id. at 4; FF 1.) In
the Answer, the Examiner states that Takeuchi “might teach away from
using the concentration of polyethylene glycol above 13%, but it still reads
on the concentration and molecular weight of polyethylene oxide as claimed
herein.” (Ans. 6.)
3
Appeal 2016-000616
Application 12/630,399
Appellant argues that Takeuchi “specifically teach[es] away from
moving outside of the range of PEG of 0.5 to 13%.” (Appeal Br. 9.)
Appellant argues further that “the lower molecular weight limit for
polyethylene glycol [sic oxide] is 100,000. Takeuchi [] teach[es] toward
using a weight-average molecular weight of half of 100,000.” (Reply Br. 5;
see FF 2.)
We find that the Appellant has the better position. Takeuchi teaches
polyethylene glycol (PEG) with a concentration within the range of 0.5 to 13
(w/v)% and a molecular weight of 1,000 to 50,000. (FF 1, 2.) Moreover,
Takeuchi discourages the use of polyethylene glycol having a concentration
or molecular weight outside those ranges. (Id.) Even if we assume that the
polyethylene glycol taught by Takeuchi includes polyethylene oxide (see FF
3),5 Takeuchi teaches the concentration of the claimed polyethylene oxide
(but not the molecular weight) and the molecular weight of the claimed
polyethylene glycol (but not the concentration). (FF 1, 2.) Stated another
way, Takeuchi does not teach or suggest (1) polyethylene glycol with a
molecular weight of at least 2000 and a concentration of at least 15 w/v%
but less than 50 w/v%, or (2) polyethylene oxide with a molecular weight of
100,000 to 8,000,000 and a concentration of at least 0.5 w/v% but less than
10 w/v%.6
5 The Examiner’s apparent assumption that Takeuchi also teaches
polyethylene oxide, due to its reference to a few commercially available
PEGs that may have molecular weights greater than 100,000 (Ans. 6), does
not appear to be sound in light of its clear teaching of molecular weight less
than 100,000 (FF 2). (See Appeal Br. 8, n.l (“[Appellant] finds no
suggestion of polyethylene oxide in Takeuchi.”)).
6 Claim 21, the only other independent claim on appeal, includes limitations
similar to claim 1. (Appeal Br. 19.)
4
Appeal 2016-000616
Application 12/630,399
The Examiner bears the initial burden of establishing a prima facie
case of obviousness and has not done so. See In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992). Here, the Examiner fails to explain why a person
skilled in the art would modify either the concentration or molecular weight
of Takeuchi to meet the limitations of the claimed polyethylene oxide or
polyethylene glycol, particularly in the face of clear discouragement against
doing so. (FF 1, 2.) See KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 418
(2007) (Examiner has burden of showing “some articulated reasoning with
some rational underpinning to support the legal conclusion of
obviousness.”); see also In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)
(a reference may teach away by discouraging the claimed invention).
Accordingly, we reverse.
Conclusion of Law
A preponderance of evidence of record fails to support the Examiner’s
conclusion that claims 1—26 are obvious under 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejection of all claims on appeal.
REVERSED
5