Ex Parte Grunenberg et al

Patent Trial and Appeal Board

Feb 14, 2017

12444974 (P.T.A.B. Feb. 14, 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.
12/444,974 03/04/2010 Alfons Grunenberg BAYSCH-0205 4096
23599 7590 02/16/2017
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
REESE, HEIDI L
ART UNIT PAPER NUMBER
1625
NOTIFICATION DATE DELIVERY MODE
02/16/2017 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALFONS GRUNENBERG, JUERGEN STIEHL,
KATHARINA TENBIEG, and BIRGIT KEIL1
Appeal 2016-001066
Application 12/444,974
Technology Center 1600
Before ELIZABETH A. LaVIER, RICHARD J. SMITH, and
DAVID COTTA, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
compound. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellants, the real party in interest is Bayer Intellectual
Property GMBH. (Appeal Br. 1.)
Appeal 2016-001066
Application 12/444,974
STATEMENT OF THE CASE
Claims on Appeal
Claims 45—50 are on appeal.2 (Claims Appendix, Appeal Br. 6.)
Claims 45 and 46 are illustrative and read as follows:
45. The compound of the formula (II)
which shows in the X-ray difffactometry a peak maximum of the 2 Theta
angle of 21.2.
46. The compound of claim 45 which shows in the FIR spectrum a peak
maximum of 353 cm'1.
Examiner’s Rejection
Claims 45—50 stand rejected under 35 U.S.C. § 112(a) or 35 U.S.C.
§112 (pre-AIA), first paragraph, as failing to comply with the written
description requirement. (Ans. 2-4.)
ISSUE
Whether the Specification’s description shows that Appellants were in
possession of the subject matter recited in claims 45—50.
2 Claims 47—50 recite a composition and methods, and depend directly or
indirectly on claim 46.
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Appeal 2016-001066
Application 12/444,974
DISCUSSION
Examiner’s Position
The Examiner contends that “the claimed invention has not been
described with sufficient particularity,” and the form of the monohydrate
possessed by Appellants “is not uniquely characterized by one XRPD peak
or by one FT-IR peak.” (Final Act. 3.)3 In particular, the Examiner finds
that “claims 45—50 all read on multiple chemical entities — namely, a
plurality of possible crystalline forms of the depicted monohydrate.
However, Appellants have described with particularity only one chemical
entity— that one of those crystalline forms whose X-ray diffractogram
appears in the specification as Fig. 2.” (Ans. 3.)
The Examiner further states that
Two premises, based on teaching in the art, underlie the analysis
for this rejection: i) the presumption that a given organic
compound or its hydrate has multiple distinct crystalline forms —
i.e. polymorphs; and ii) that one peak in X-ray powder diffraction
(“XRPD”) is not sufficient to characterize any particular
crystalline form.
(Id. at 4.)
The Examiner supports these premises by reference to articles by
Bhattacharya4 and Ivanisevic.5 (Id.) In particular, the Examiner relies on
Bhattacharya for the proposition that “except for small and symmetrical
3 Office Action dated Jan. 28, 2015.
4 Bhattacharya et al., Thermoanalytical and Crystallographic Methods,
Polymorphism in Pharmaceutical Solids, (Brittain, H., 2nd ed.), 318-35
(2009) (“Bhattacharya”).
5 Ivanisevic et al., Uses of X-ray Powder Diffraction in the Pharmaceutical
Industry, Pharmaceutical Formulation & Quality, 30-33 (2011)
(“Ivanisevic”).
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Appeal 2016-001066
Application 12/444,974
compounds, organic compounds are expected to have multiple crystalline
forms.” (Id.) The Examiner relies on both Bhattacharya and Ivanisevic for
the proposition that “characterization of a particular crystalline form requires
several XRPD peaks — certainly more than one peak.” (Id.)
Appellants ’ Position
Appellants respond by arguing that there is no evidence to support the
allegation that “the form possessed by [Appellants] is not uniquely
characterized by one XRPD peak or by one FT-IR peak.” (Appeal Br. 3.)
Appellants further respond to the Examiner’s “two premises” position by
arguing that the Examiner’s presumption i) “provides no evidence that other
crystalline forms of the monohydrate exist and are not adequately described
in the specification.” (Reply Br. 5.) As to the Examiner’s contention ii) that
one peak in XRPD is not sufficient to characterize any particular crystalline
form, Appellants argue that
there is no basis for finding any crystalline form encompassed by
claim 45 inadequately described. While one XRPD peak or by
one FT-IR peak may not uniquely characterize all crystalline
forms, one peak is sufficient to identify the crystalline forms of
monohydrate of formula II encompassed by the claims, which is
all that is necessary to satisfy the requirements [of] 35 USC 112,
first paragraph.
(Id. at 6.)
Analysis
To meet the initial burden of establishing a prima facie case of
unpatentability based on a lack of written description, the Examiner must
“present[] evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996) (quoting In re
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Appeal 2016-001066
Application 12/444,974
Wertheim, 541 F.2d 257, 263 (CCPA 1976)). On this record, we find that
the Examiner has not met that burden. While the Examiner presents
evidence that organic compounds generally are expected to have multiple
crystalline forms, and that for a given compound it may be necessary or
desirable to have more than one peak for its characterization, no evidence is
provided that the particular claimed compound has more than one
polymorph having “a peak maximum of the 2 Theta angle of 21.2.” (Appeal
Br. 6.) That is, the Examiner failed to present evidence or reasons why
persons skilled in the art “would not recognize in the disclosure a description
of the invention defined by the claims.” Alton, 76 F.3d at 1175.
CONCLUSION
Because we find on this record that the Examiner failed to establish a
prima facie case of unpatentability based on lack of written description, the
rejection of claims 45—50 under 35U.S.C. § 112, first paragraph, is reversed.
SUMMARY
We reverse the rejection of claims 45—50 under 35 U.S.C. § 112, first
paragraph, for failing to comply with the written description requirement.
REVERSED
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