Ex Parte Miller

Patent Trial and Appeal Board

Jun 23, 2016

12451814 (P.T.A.B. Jun. 23, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/451,814 11130/2009 Warren Kenyon Miller
24197 7590 06/27/2016
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET
SUITE 1600
PORTLAND, OR 97204
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.
8191-92872-01 8231
EXAMINER
FUBARA, BLESSING M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
06/27/2016 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):
tanya.harding@klarquist.com
docketing@klarquist.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WARREN KENYON MILLER
Appeal2013-004680
Application 12/451,814
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
TA WEN CHANG, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a pharmaceutical composition
comprising nanoparticles which comprise a poorly water soluble drug.
Appellant appeals from the Examiner's final rejection of claims 1-12 as
obvious under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C.
§ 134. The obviousness rejection is reversed because Appellant antedated
one of the cited publications upon which the rejection is based.
STATEMENT OF CASE
Claims 1-12 are pending. The Examiner rejected claims 1-12 under
35 U.S.C. § 103(a) as obvious in view of Zhao (US 2007/0128289 Al,
Appeal2013-004680
Application 12/451,814
published Jun. 7, 2007), Desai (US 2006/0263434 Al, published Nov. 23,
2006), and Bernard (US 2006/0240108 Al, published Oct. 26, 2006).
Claim 1 is the only independent claim on appeal. Claim 1 is
reproduced below:
1. A pharmaceutical composition comprising nanoparticles,
said nanoparticles comprising:
(a) a poorly water soluble drug having a solubility in
water of less than 5 mg/mL over the pH range of 6.5 to 7 .5 at
25°C, at least 90 wt% of said drug in said nanoparticles being
non-crystalline;
(b) a poorly aqueous soluble non-ionizable cellulosic
polymer having an ether- or ester-linked alkyl substituent; and
( c) tocopheryl polyethylene glycol succinate (TPGS);
wherein said nanoparticles have an average size of less than 500
nm; and said drug, said non-ionizable cellulosic polymer, and
said TPGS collectively constitute at least 60 wt% of said
nanoparticles.
REJECTION
The Examiner found that Zhao describes a nano-particulate
composition comprising components (a) and (c) as recited in claim 1. Final
Rej. 2-3. The Examiner further found that Zhao teaches the presence of a
cellulosic polymer, but not one which has an ether- or ester-linked alkyl
substituent as recited for component (b) of claim 1. Id. at 3. However, the
Examiner found that Desai describes similar compositions to Zhao, but
which contain cellulose polymers with an alkyl methyl group. Id. The
Examiner cited Bernard for a similar teaching to Desai. Id. at 3--4. The
Examiner determined it would have been obvious to one of ordinary skill in
the art to have replaced cellulosic polymer in Zhao's composition with the
cellulosic carriers described in Desai and Bernard. Id. at 4.
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Appeal2013-004680
Application 12/451,814
Appellant contends that the cited prior art publications do not teach
the claimed requirement that at least 90 wt% of the poorly water soluble
drug is non-crystalline and that the collective wt% of drug, cellulosic
polymer, and TPGS is at least 60 wt%. Appeal Br. 4. Appellant also
provided a declaration under 3 7 C.F .R. § 1.131 by the inventor Warren K.
Miller to establish invention of the claimed subject matter prior to the
effective date of Zhao and eliminate it as prior art. Id. at 2.
Under37 C.F.R. § 1.131,
(a) When any claim of an application ... is rejected, the
inventor of the subject matter of the rejected claim ... may
submit an appropriate oath or declaration to establish invention
of the subject matter of the rejected claim prior to the effective
date of the reference or activity on which the rejection is based.
Mr. Miller provided laboratory notebooks showing the preparation of
three different nanoparticle compositions. Each preparation contained
components (a) through ( c) of claim 1, i.e., (a) a poorly water soluble drug
(Valdecoxib; [2R,4S]-4-[ acetyl-(3 ,5-bis-trifluoromethyl-benzyl)-amino ]-2-
ethyl-6-trifluoromethyl-3 ,4-dihydro-2H-quinoline-1-carboxylic acid
isopropyl ester; or Celecoxib ); (b) ethylcellulose; and ( c) TPGS. Miller
Deel. i-f 2. In each composition, the collective wt% of three components was
60% and the drug was at least 90 wt% non-crystalline as required by the
claims. Id. Mr. Miller provided evidence that each of the drugs was poorly
water soluble and within the scope of claim 1. Id. at i-fi-13--4. Mr. Miller
stated that the work was conducted "prior to December 2005," id. at i-f 2,
which is prior to the Dec. 7, 2005 effective date of Zhao. Thus, Mr. Miller's
declaration shows the invention of three different nanoparticle
pharmaceutical compositions within the scope of claim 1 prior to Zhao.
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Appeal2013-004680
Application 12/451,814
The Examiner did not consider Mr. Miller's declaration sufficient to
antedate Zhao. The Examiner stated that the declaration "failed to provide
the date the invention was conceived or reduced to practice or failed to
identify the date appellant is swearing behind." Answer 8. The Examiner
also considered the declaration inadequate because none of the drugs
described in Mr. Miller's declaration are the same as those utilized in Zhao' s
nanoparticle compositions. Id. at 9. Furthermore, the Examiner stated the
declaration was ineffective because:
Id.
iv) the evidence species of the claimed generic poorly soluble
drug is not claimed in any of the appealed claims; v) the
evidence species of the generic poorly soluble drug is not what
the Zhao reference teaches; vi) the evidence drug species
cannot be predictable from the reference drug species; the
valdecoxib or celecoxib anti-inflammatory agents are not
obvious variants of the immunosuppressant drugs and the anti-
neoplastic drug species of the reference, neither would the
celecoxib and valdecoxib drug species of the evidence be
predictable of the reference drug species, the functions are
different.
DISCUSSION
To antedate a reference under 37 C.F.R. § 1.131, an inventor is
required to show as much of the invention as the reference shows. In re
Stempel, 241 F.2d 755, 759 (1957); In re Stryker, 435 F.2d 1340, 1341-1342
(CCPA 1971). In this case, we must determine what Zhao shows and what
the inventor must show to antedate it.
The Examiner relied upon Zhao for its teaching of "(a) a poorly water
soluble drug having a solubility in water of less than 5 mg/mL over the pH
range of 6.5 to 7.5 at 25°C." While the Examiner focused on the specific
drugs utilized in Zhao, and the failure of Mr. Miller to show these drugs, the
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Appeal2013-004680
Application 12/451,814
claims are not limited to a specific drug. For this reason, in making the
rejection, the Examiner only had to establish that Zhao describes a poorly
water soluble drug with the specifically claimed characteristics to meet the
claim limitation. What specific drug Zhao teaches is unimportant, since the
claim is not limited to a specific species. Accordingly, we conclude that
what Zhao shows for purposes of the invention is a poorly water soluble
drug within the scope of claim 1.
The inventor must show only as much as the reference shows. Zhao
shows a poorly water soluble drug. Mr. Miller, the inventor, was therefore
only required to show a poorly water soluble drug, and not a specific species
of it as found by the Examiner. Mr. Miller did just that, showing three
different compositions within the scope of claim 1, each comprising a poorly
water soluble drug with the characteristics recited in limitation (a) of the
claim. The Examiner erred in not finding this evidence of invention
effective to antedate Zhao.
Even if Zhao' s teaching is considered to be of a genus of poorly water
soluble drugs, Mr. Miller's disclosure of three nanoparticle compositions
comprising three different poorly water soluble drugs would have been
recognized by one of ordinary skill in the art of a showing of the same genus
as described in Zhao, i.e., showing as much of the invention as the reference
shows.
We also disagree with the Examiner that Mr. Miller's declaration is
inadequate to antedate Zhao because Mr. Miller did not provide the date the
invention was made nor the date of the publication he is attempting to
antedate.
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Appeal2013-004680
Application 12/451,814
First, Mr. Miller clearly states that the work described in the notebook
pages was done prior to December 2005. Miller Deel. i-f 2. The Examiner
did not cite the rule or a case which would require a specific date to have
been disclosed in the declaration to comply with 37 C.F .R. § 1.131. Rather,
the rule states that the declaration must "establish invention of the subject
matter of the rejected claim prior to the effective date of the reference or
activity on which the rejection is based." Id. There is no requirement that a
specific date of the invention be disclosed.
Second, the date that Mr. Miller is attempting to antedate is clear from
the record because Zhao lists its filing date as Dec. 7, 2005. Mr. Miller
made the correct statement that the work was done before this date, namely,
the "work shown in Exhibit B was conducted at Bend Research prior to
December 2005." Miller Deel. i-f 2.
Accordingly, we conclude that the Examiner erred in finding the
declaration by Mr. Miller insufficient to antedate Zhao. Because the Miller
declaration antedates Zhao, we are compelled to reverse the obviousness
rejection of claims 1-12 based on it.
REVERSED
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