Ex Parte Griffith et al

Patent Trial and Appeal Board

Aug 28, 2018

13843579 (P.T.A.B. Aug. 28, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/843,579 03/15/2013
20995 7590 08/30/2018
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
David C. Griffith
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.
REMPEX.092A 3735
EXAMINER
WANG, SHENGTIJN
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
08/30/2018 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):
j ayna.cartee@knobbe.com
efiling@knobbe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID C. GRIFFITH,
MICHAEL N. DUDLEY, and OLGA RODNY
(APPLICANT: REMPEX PHARMACEUTICALS, INC.)
Appeal2017-001749 1
Application 13/843,5792
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
TA WEN CHANG, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1-3, 6-8, 11-
13, 16-18, 21, and 22 (Final Act. 3 1). Examiner entered a rejection under
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b ). We REVERSE.
1 Oral hearing held August 23, 2018.
2 Appellants identify "Rempex Pharmaceuticals, Inc[.]" as the real party in
interest (App. Br. 3). During the August 23, 2018 Oral Hearing Appellants'
representative stated that, notwithstanding Appellants' statement in the
Appeal Brief, Rempex Pharmaceuticals, Inc. is a subsidiary of Melinta
Therapeutics.
3 Office Action mailed July 16, 2015.
Appeal2017-001749
Application 13/843,579
STATEMENT OF THE CASE
Appellants' disclosure "relates to antimicrobial compounds,
compositions, their use and preparation as therapeutic agents" (Spec. ,r 2).
Independent claim 1 is representative and reproduced below:
1. A method for treating a bacterial infection in a human,
comprising administering to a subject in need thereof a
composition comprising Compound I or a pharmaceutically
acceptable salt thereof and a carbapenem antibacterial agent to
achieve an in vivo Compound I plasma concentration Cmax from
about 50 mg/L to about 200 mg/L, wherein [C]ompound I has
the structure:
I \
s~
o I
~/
~
HN~-,
HO>~--o~.COiH (Compound I), and
wherein Compound I is administered in a dose range from
about 15 mg/kg to about 50 mg/kg of body weight.
(App. Br. 21.)
The claims stand rejected as follows:
Claims 1-3, 6-8, 11-13, 16-18, 21, and 22 stand rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claims of Hirst. 4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
4 Hirst et al., US 8,680,136 B2, issued Mar. 25, 2014.
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Appeal2017-001749
Application 13/843,579
ANALYSIS
Based on Hirst, Examiner concludes that "it would have been prima
facie obvious to a person of ordinary skill in the art, at the time the claimed
[] invention was made, to use the pharmaceutical composition claimed in
[Hirst] for treating bacterial infection with [] B-lactam antibiotics, such as
Biapenem" (Ans. 3). In reaching this conclusion, Examiner finds that Hirst
"does not claim expressly a method of treating bacterial infection
comprising administering compound I and a carbapenem antibacterial agent,
such as Biapenem, [or] the particular effective dosage range" required by
Appellants' claims (id. at 2). To bridge the distance between Appellants'
claimed invention and the claims of Hirst, Examiner asserts that "the
disclosed utility of [Hirst' s] cyclic boronic acid compound is [ as an]
antibacterial agent against various bacteria in combination with other
antimicrobial agents, particularly, B-bactam antibiotics, such as Biapenem"
(Ans. 4). In support of this assertion, Examiner finds that,
the only pharmaceutical utilities disclosed in [Hirst] are to be
used as antimicrobial agent or potentiator. ([Hirst,] col. 2,
line[ s] 42-45). In preferred embodiments, the compound is
used as [an] antibacterial agent against various bacteria, in
combination with other antimicrobial agents, particularly, B-
lactam antibiotics, such as Biapenem ([Hirst,] col. 6 to col. 8,
col. 6, line 64 in particular; col. 45, line 32 to col. 46, line 4).
The dosage is generally in the range of 0.25 mg/kg to about 120
mg[/]kg or more of the bodyweight. See, [Hirst,] col. 40, lines
16 to 43.
(Id. at 3.) Thus, Examiner concludes that Appellants' "claimed invention []
is no more than the practice [ of] the disclosed utility of the compound
claimed in [Hirst]" (id. at 4). We are not persuaded.
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Appeal2017-001749
Application 13/843,579
As Appellants explain, obviousness-type double patenting
determinations may rely upon a prior patent document's "specification ... as
a dictionary to learn the meaning of a term in the claim" and for a
"disclosure of utility" (App. Br. 9). Thus, an application claiming a "method
of using a composition is not patentably distinct from ... [a] claim to the
identical composition in a patent disclosing" that the utility of the
composition is for the same method set forth in the application's claim.
Geneva Pharmaceuticals, Inc., v. GlaxoSmithKline, PLC, 349 F.3d 1373,
1385-1386 (Fed. Cir. 2003) (emphasis added); see also Sun Pharmaceutical
Industries, Ltd. V. Eli Lilly and Co., 611 F.3d 1381, 1389 (Fed. Cir. 2010)
("In light of the earlier '614 patent's description of gemcitabine's use in
treating cancer, the asserted claims of the later '826 patent, which recite a
method of using gemcitabine to treat cancer, are not patentably distinct from
the '614 patent's claim to gemcitabine" (emphasis added)). As the Sun
Court explained, "[t ]he asserted claims of the later '826 patent simply claim
the anticancer use disclosed in the specification of the '614 patent as a
method of use claim." Id. at 1389, citing Pfizer, Inc. v. Teva
Pharmaceuticals USA, Inc., 518 F.3d 1353, 1363 (Fed. Cir. 2001); Geneva,
349 F.3d at 1385. In each of the foregoing cases, identical compounds or
compositions were set forth in each set of application -patent claims. This,
however, is not true of the facts in evidence on this record.
As Appellants make clear,
claims 1-2 5 and 2 7 of . . . [Hirst] are compound claims and
claim 26 of ... [Hirst] is directed to a pharmaceutical
composition comprising the compound of claim 1. None of
[Hirst's] claims recite Compound I in combination with another
antibacterial agent, let alone the combination [ of Compound I
4
Appeal2017-001749
Application 13/843,579
in combination] with a carbapenem antibacterial agent as
recited in [Appellants'] Claims 1 and 11.
(Reply Br. 5.) Although Examiner expands the search through Hirst's
disclosure beyond that outlined in Sun, Geneva, and Pfizer, to find a
disclosure in Hirst' s specification of a preferred embodiment disclosing a
composition that may include Compound I in combination with a
carbapenem, we decline Examiner's invitation to expand our reviewing
court's precedent. To the contrary, we find that because Hirst's claims are
directed to a compound or composition that is not identical to the
composition required by Appellants' claimed method, the obviousness-type
double patenting rejection on this record cannot be sustained (see e.g., Reply
Br. 5 ("because a carbapenem antibacterial agent is not recited in any claims
of ... [Hirst], the disclosure in ... [Hirst] with respect to any carbapenem
antibacterial agents would not be used to construe [Appellants'] claim")).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
supports a conclusion of obviousness-type double patenting. The rejection
of claims 1-3, 6-8, 11-13, 16-18, 21, and22 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
the claims of Hirst is reversed.
REVERSED
5