Ex Parte Spakevicius et al

Patent Trial and Appeal Board

Apr 21, 2017

13318591 (P.T.A.B. Apr. 21, 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.
13/318,591 03/22/2012 Danguole Spakevicius UTSC.P1144US 6757
108197 7590 04/25/2017
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
Austin, TX 78746
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
04/25/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANGUOLE SPAKEVICIUS and HATICE OZSOY
Appeal 2016-004192
Application 13/318,5911
Technology Center 1600
Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating or reducing inflammation. The Examiner rejected claims 78 and
82 on appeal under 35 U.S.C. § 103(a) as obvious.
We reverse.
1 According to Appellants, the real party in interest is the Board of Regents,
The University of Texas System. App. Br. 2.
Appeal 2016-004192
Application 13/318,591
STATEMENT OF THE CASE
Claims 78 and 82 are on appeal. Claim 78 is illustrative and reads as
follows:
1. A method of treating or reducing inflammation in a subj ect
in need thereof, said method comprising administering to said
subject a composition comprising a construct in an amount
effective to treat or reduce said inflammation, wherein said
construct is selected from the group consisting of:
(a) a volatile anesthetic dissolved in a solution,
wherein said solution further comprises at least one
extractive solvent in an amount effective to reduce
volatility of said volatile anesthetic, and
(b) a micro-droplet suspension comprising a sphere
of a volatile anesthetic surrounded by a stabilizing
layer of a phospholipid;
wherein said administration is topical, mucosal, rectal,
vaginal, or buccal; and wherein the at least one extractive solvent
is selected from the group consisting of dimethyl sulfoxide
(DMSO), dimethylformamide (DMF), dimethylacetamide
(DMA), N-methyl-2-pyrrolidone (NMP), dimethylisosorbide,
ethanol, propanol, PEG-400, PEG-300, diethylene glycol
monoethyl ether, and isopropanol, and
wherein said volatile anesthetic is selected from the group
consisting of isoflurane, halothane, enflurane, sevoflurane,
desflurane, methoxyflurane, and mixtures thereof.
App. Br. 13.
In response to a species election requirement, Appellants elected
species construct “a)” (i.e. volatile anesthetic in a solution comprising an
extractive solvent). Ans. 2. However, the Examiner mistakenly examined
species “b)” (i.e., a micro-droplet suspension comprising a sphere of volatile
anesthetic). Id. The Examiner informed Appellants of this mistake and
provided the opportunity to reopen prosecution. Id. Appellants elected not
to reopen prosecution and proceeded based on examination of species “b)”.
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Appeal 2016-004192
Application 13/318,591
Accordingly, for purposes of this appeal, we limit our consideration of the
merits of the appealed rejection to species “b)”. See Ex parte Ohs aka, 2
USPQ2d 1460, 1461 (BPAI 1987).
The Examiner rejected claims 78 and 82 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Haynes I2 and Haynes II.3
ANALYSIS
The Examiner found that Haynes I disclosed micro-droplet
suspensions comprising a volatile anesthetic surrounded by a stabilizing
layer of phospholipid. Final Act. 3. The Examiner also found that Haynes I
disclosed administration of the micro-droplet suspensions to treat
inflammation. Id. at 3^4. While Haynes I discloses a “variety of suggested
administration routes,” the Examiner found that Haynes I did not disclose
“topical, mucosal, rectal, vaginal, or buccal” administration. Id. at 4.
The Examiner found that Haynes II disclosed compositions
incorporating crystalline, water-insoluble drugs in phospholipid micro­
droplets and that the “most advantageous route of administration for the
composition includes topical administration.” Id.
Based on the combined disclosures of Haynes I and Haynes II, the
Examiner concluded:
it would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was
made to modify the method of treatment taught by
Haynes [I] by administering the composition topically as
taught by [Haynes II] because [Haynes II] teaches that in
addition to injection, the composition of Haynes [I] and
other types of phospholipid-coated constructs, which
2 Haynes, US Patent No. 4,622,219, issued Nov. 11, 1986 (“Haynes I”).
3 Haynes, US Patent No. 5,091,188, issued Feb. 25, 1992 (“Haynes II”).
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Appeal 2016-004192
Application 13/318,591
contain water-insoluble drugs (e.g., volatile anesthetics)
[] may be administered topically and one of ordinary skill
in the art could have selected topical administration from
the finite preferred routes of administration to yield
nothing more than predictable results.
Id. at 5.
Appellants argue, inter alia, that Haynes I “indicates that
administration of a volatile anesthetic to the skin should be avoided, since
volatile anesthetics are not absorbed well through the skin.” App. Br. 4.
Appellants further argue that Haynes II “relates only to pharmaceutical
preparations containing microcrystals . . . [and] does not relate to the
instantly claimed anesthetics, which would immediately be recognized by
one of skill in the art to be liquid and volatile at room temperature, i.e., non­
crystalline.” Id. Because Haynes I and Haynes II relate to different and
unrelated classes of drugs, Appellants argue, “one skilled in the art would
not have been motivated by Haynes II... to modify the teachings in Haynes
I [so] as to arrive at the present invention.” Id. at 6. We find that Appellants
have the better position.
Haynes I does not teach the use of volatile anesthetics to treat
inflammation. Rather Haynes I uses volatile general anesthetics as local
anesthetics (Haynes I, col. 1,11. 39—41) and as the “organic phase” of the
microdroplet. Id. at col. 4,11. 32-48. In finding that Haynes I taught
treatment of inflammation, the Examiner relied on the disclosure in Haynes I
that a variety of drug substances can be incorporated in the microdroplets
formed by this process, including anti-inflammatory agents like
phenylbutazone, acetaminophen and colchicine. Ans. 4 (citing Haynes I,
col. 7,11. 42—50). Since the organic phase of the microdroplet may include
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Application 13/318,591
volatile anesthetics {Id. at col. 4,11. 42-48), a construct of Haynes I
including an anti-inflammatory agent as the active pharmaceutical agent
meets the claim requirement for a construct comprising a volatile anesthetic.
The Examiner used Haynes II as evidence that the volatile-anesthetic-
containing composition of Haynes I could be administered topically. Ans.
8—9. The Examiner, however, does not identify any teaching in Haynes II
that would have caused a skilled artisan to expect that a construct employing
a volatile general anesthetic as the active ingredient could be administered
topically to treat inflammation. Nor does the Examiner identify any
teaching in Haynes II that would have caused the skilled artisan to expect the
microdroplets of Haynes I, formulated to incorporate an anti-inflammatory
agent as the active ingredient, could be administered topically to treat
inflammation.
The Examiner contends that there is “a reasonable expectation of
success to modify the composition construct of Haynes [I] for topical
administration because [Haynes II] teaches that in addition to injection, the
composition of Haynes [I] and other types of phospholipid-coated
constructs, which contain water-insoluble drugs (e.g., volatile anesthetics)
may be advantageously administered topically.” Ans. 9. But the teaching of
Haynes II relates to the phospholipid construct, not the drug contained
within the construct. The teaching that crystalline drugs can be coated with
phospholipids (as taught by Haynes II) does not provide sufficient reason for
the skilled artisan to expect that any phospholipid coated drug can be
administered topically to treat inflammation.
The Examiner notes that Example 14 of Haynes II discloses a
microdroplet including methoxyflurane — a volatile anesthetic. Ans. 8.
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Application 13/318,591
There is, however, no indication that the composition of Example 14 was
administered to treat inflammation. Indeed, the methoxyflurane in the
example was used as a solvent to solubilize the active, a muscle relaxant.
Haynes II, col. 31,1. 62 — col. 32,1. 4 (Example 14).
Accordingly, we reverse the Examiner’s decision to reject claims 78
and 82 under 35 U.S.C. § 103(a) as obvious over the combination of Haynes
I and Haynes II.
SUMMARY
For the reasons provided herein the Examiner’s decision to reject
claims 78 and 82 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Haynes I and Haynes II is reversed.
REVERSED
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