Ex Parte King

Patent Trial and Appeal Board

Mar 28, 2017

13721744 (P.T.A.B. Mar. 28, 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.
13/721,744 12/20/2012 Kristina KING PLOVIN-0023-D01 4975
23599 7590 03/30/2017
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
03/30/2017 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 KRISTINA KING1
Appeal 2016-007716
Application 13/721,744
Technology Center 1600
Before ROBERT A. POLLOCK, RICHARD J. SMITH, and
DAVID COTTA Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the final rejection of
claims 55—69 and 71—81. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
“The present invention relates to solid pharmaceutical compositions,
in particular to oral contraceptives, comprising a tetrahydrofolic acid, such
as calcium 5-methyl-(6S)tetrahydrofolate.” Spec. 1:7—9. The claims on
appeal are reproduced in the Claims Appendix of Appellant’s Brief.
1 Appellant identifies the real party-in-interest as Bayer Pharma AG. App.
Br. 1
Appeal 2016-007716
Application 13/721,744
STATEMENT OF THE REJECTION
Claims 55—69 and 71—81 stand rejected for nonstatutory double
patenting over claims 1—11 ofU.S. Patent No. 8,617,597 (“the ’597
Patent”).2
ANALYSIS
Claim 55
Claim 55 is illustrative of the claims on appeal and recites “[a] tablet
core comprising a solid pharmaceutical composition” having certain
dissolution and stability properties and the following pharmaceutical
components:
3 mg of drospirenone,
0.02 or 0.03 mg of ethinyl estradiol,
10-90 wt%, which is based on tablet core total weight, of
microcrystalline cellulose,
optionally 20-80 wt%, which is based on tablet core total
weight, of lactose monohydrate, and
0.42-0.49 mg of an alkaline earth metal salt of 5-methyl-(6S)-
tetrahydrofolic acid.
Claim 1 of the ’597 Patent recites a tablet core comprising a solid
pharmaceutical composition having certain dissolution and stability
properties and the following pharmaceutical components:
particles comprising 3 mg of micronized drospirenone,
0.02 or 0.03 mg of ethinyl estradiol,
25-36 wt % (based on tablet core total weight) of
microcrystalline cellulose,
2 The Examiner has withdrawn the rejection of claim 81 under 35 U.S.C. §
112, first and second paragraphs. Ans. 3.
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Application 13/721,744
52—63 wt% (based on tablet core total weight) of lactose
monohydrate, and
0.42-0.49 mg of an alkaline earth metal salt of 5-methyl-(6S)-
tetrahydrofolic acid.
With respect to the rejected claims generally, the Examiner states:
Although the claims at issue are not identical, they are not
patentably distinct from each other because they both claim a
tablet core comprising drospirenone, ethinyl estradiol,
microcrystalline cellulose, lactose monohydrate, an alkaline
earth metal salt of 5-methyl-(6S)-tetrahydrofolic acid, having
the same dissolution profile and stability of folic acid. The
claims read on each other in an obvious way insofar as the
claimed amounts for the microcrystalline cellulose and lactose
monohydrate overlap. However, the amounts for the actives are
exactly the same.
Ans. 2; see also id. at 4 (“[A] prima facie case of obviousness exists here
insofar as the claimed amounts of the microcrystalline cellulose and the
lactose monohydrate of the ‘597 patent lie inside claimed amounts of the
microcrystalline cellulose and the lactose monohydrate of the instant
claims.”).
Appellant contends that the rejection is in error because claim 55
recites a tablet core containing 10-90 wt% of microcrystalline cellulose and
optionally 20—90 wt% of lactose monohydrate, whereas neither limitation is
taught or suggested by the claims of the ’597 Patent. See App. Br. 3 (“The
test is not whether there is overlap among the claims, but rather whether the
present claims are obvious over the claims of the reference patent, the claims
of which do not recite the ranges or range combinations present in the
current claims.”).
We do not find Appellant’s argument persuasive. A claim is
presumed obvious where it claims ranges that “overlap or lie inside ranges
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Application 13/721,744
disclosed by the prior art,” In re Wertheim, 541 F.2d 257, 267 (CCPA 1976),
and even a slight overlap in range may establish obviousness unless there is
evidence of unexpected results to show criticality in the claimed range. See
In re Peterson, 315 F.3d 1325, 1329, 1330 (Fed. Cir. 2003). Thus, “while a
change in the proportions of a combination shown to be old, such as is here
involved, may be inventive, such changes must be critical as compared with
the proportions used in prior processes, producing a difference in kind rather
than degree.” In re Lilienfeld, 67 F.2d 920, 924 (C.C.P.A. 1933). Moreover,
where the general conditions of a claim are disclosed in the art, “it is not
inventive to discover the optimum or workable ranges by routine
experimentation.” In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed.
Cir. 2012) (citing In re Aller, 20 F.2d 454, 456 (C.C.P.A. 1955)).
In the present case the 10—90 wt% of microcrystalline cellulose in
claim 55 overlaps with the 25—36 wt % of this component recited in claim 1
of the ’597 Patent. With respect to lactose monohydrate, we interpret the
language “optionally 20—80 wt%” as encompassing zero wt% and 20-80%
wt% of this component. 20—80 wt% lactose monohydrate overlaps with the
52-63 wt% lactose monohydrate of claim 55. As Appellant has not
presented evidence of unexpected results, or otherwise argued that the
claimed ranges are critical, we affirm the Examiner’s rejection of claim 55.
See In re Scherl, 156 F.2d 72, 74—75 (CCPA 1946) (“Where the issue of
criticality is involved, the applicant has the burden of establishing his
position by a proper showing of facts upon which he relies.”).
Appellant does not argue claims 56—71 separately and they fall for the
same reasons claim 55. C.F.R. § 41.37(c)(l)(vii).
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Application 13/721,744
Claim 72
Claim 72, recites a tablet core according to claim 55, with the proviso
that the tablet core does not comprise the dissolution and stability properties
set forth in claim 55 or
particles comprising 3 mg of micronized drospirenone,
0.02 or 0.03 mg of ethinyl estradiol,
25-36 wt% (based on tablet core total weight) of
microcrystalline cellulose,
52-63 wt% (based on tablet core total weight) of lactose
monohydrate, and
0.42-0.49 mg of an alkaline earth metal salt of 5-methyl-(6S)-
tetrahydrofolic acid.
Appellant contends that the rejection is in error because claim 72
“completely provisos out the subject matter of the claims of the reference
patent” such that there is “no overlap at all” between the ranges of claim 72
and those of the ’597 Patent. App. Br. 4. Appellant further argues that the
rejection fails for lack of the “‘articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness’” required
under KSR Int 7 Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Reply Br. 4.
We do not find Appellant’s argument persuasive. Although Appellant
faults the Examiner’s citation to MPEP 2131.03 (see Reply Br. 1—4), we
note that MPEP 2144.05 discusses a host of cases supporting the proposition
that a prima facie case of obviousness exists where the claimed ranges or
amounts do not overlap with the prior art but are merely close. In Titanium
Metals, for example, the Federal Circuit held as proper a rejection of a claim
directed to an alloy of having 0.8% nickel, 0.3% molybdenum, up to 0.1%
iron, balance titanium as obvious over a reference disclosing alloys of 0.75%
nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31%
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molybdenum, balance titanium because “[t]he proportions are so close that
prima facie one skilled in the art would have expected them to have the same
properties.” Titanium Metals Corp. of America v. Banner, 778 F.2d 775,
783, (Fed. Cir. 1985).
The Examiner in the present case similarly finds that the range of
claim 72 would be so close to those of the reference patent claims that one of
ordinary skill would expect the compounds to have the same properties. See
Ans. 2—3, 4—5. In our view, the Examiner has set forth sufficient rational
underpinning to support a prima facie case of obviousness, which Appellant
has not rebutted. See In re Spada, 911 F.2d 705, 708 (Fed.Cir. 1990)
(“[W]hen the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.”). The rejection of claim 72 is affirmed.
Appellant does not argue claims 75, 76, 78, or 79 separately and they
fall for the same reasons claim 72. C.F.R. § 41.37(c)(l)(vii).
Claims 73, 74, 77, 80 and 81
Depending from claim 55, claim 73 specifies that the tablet core “does
not contain lactose monohydrate,” claim 74 specifies that the drospirenone is
non-micronized, claim 77 limits the microcrystalline cellulose to “50 to 90
wt%,” claim 80 limits the lactose monohydrate to “20 to 45 wt%,” and claim
81 provides that the ethinyl estradiol is in the form of a solvate or hydrate.
According to the Examiner,
Claim[s] 73, 74, 77, 80 and 81 are close enough to claim 1 of
the reference patent to reasonably expect the same properties
insofar as claims 73, 74, 77, 80 and 81 depend from claim 55
having the same active agents, dissolution rate and storage
stability, i.e. “wherein the in vitro dissolutions of drospirenone
and the salt of 5-methyl-(6S)-tetrahydrofolic acid ... after
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storage in a closed container for 12 months at 25°C and 60%
relative humidity”.
Ans. 5.
Claim 73
With respect to claim 73, Appellant argues that the Examiner
impermissibly relied on the disclosure of the reference patent in setting forth
the rejection for obviousness-type double patenting. Reply Br. 7 (citing
Ans. 8). “Because nonstatutory double patenting compares earlier and later
claims, an earlier patent’s disclosure is not available to show nonstatutory
double patenting.” Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d
1373, 1385 (Fed. Cir. 2003) (citation omitted). However, where a claim,
standing alone, does not adequately disclose the patentable bounds of the
invention, the fact finder may examine the specifications of both patents to
ascertain any overlap in the claim scope for the double patenting
comparison. See id.
Here, the Examiner looks to the specification of the ’597 Patent to
show that ‘“microcrystalline cellulose may be the only or sole filler present
in the composition’ (col. 8, lines 23-25), which means that lactose
monohydrate was not required.” Ans. 6. In our view, this analysis is
impermissible in an obviousness-type double patenting analysis as it is not
directed to determining the scope of claim 1 of the ’597 Patent.
Accordingly, we agree with Appellant that the Examiner has not
adequately explained why it would have been obvious to modify claim 1 of
the ’597 Patent to omit lactose monohydrate. See App. Br. 6. The rejection
of claim 73 is reversed.
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Claim 74
With respect to claim 74, we agree with Appellant that the Examiner
impermissibly relies on the definition of the term “micronized” in the ’597
Patent to establish that “[t]his property [] does not appear to be necessary
given similar dissolution rate and storage stability between the two claim
sets.” Reply Br. 9. Moreover, even were we to agree that an obviousness-
type double patenting analysis permits the Examiner to reference the ’597
Specification for the definition of “micronized” as having a “particle size
distribution . . . [wherein] at least 90% of the particles have a particle
diameter of less than 30 pm,” the Examiner does not explain, and we fail to
discern, how this definition supports a finding of obviousness. See Ans. 6
(citing ’597 4:23-26).
Thus, as with claim 73, we agree with Appellant that the Examiner
has not adequately explained why it would have been obvious to use non-
micronized drospirenone as set forth in claim 74.
Claim 81
Appellant argues that the Examiner impermissibly looks to the
specification of the ’597 Patent to show that it defines “estrogen” to
encompass the hydrates and solvates recited in claim 81. Reply Br. 11—12
(referencing Ans. 6). The ’597 Specification makes clear that term “ethinyl
estradiol” is a preferred estrogen, and that estrogens encompass “all isomeric
and physical forms of the estrogens including hydrates [and] solvates.” See
’597 Spec. 3:21—28 (reproduced at page 11 of Appellant’s Reply Brief).
Thus, the Examiner’s recourse to the ’597 Specification properly determines
that scope of claim 1 of the reference patent encompasses “ethinyl estradiol
[] in the form of a solvate or hydrate,” as set forth in claim 81. Accordingly,
the rejection of claim 81 is sustained.
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Claims 77 and 80
Claim 77 limits microcrystalline cellulose to “50 to 90 wt%,” which
does not overlap with the 25-36 wt % limitation in claim 1 of the ’597
Patent. Claim 80 similarly limits lactose monohydrate to “52 to 63 wt%,”
which does not overlap with the 20 to 45 wt % limitation for this element in
claim 1 of the ’597 Patent.
Appellant argues that the Examiner fails to present any analysis
explaining why these distinctly non-overlapping ranges are “close enough”
to render claims 77 and 80 obvious. We agree with Appellant that the
Examiner has not carried his burden to establish obviousness of this claim.
The rejection of claims 77 and 80 are reversed.
SUMMARY
I. We affirm the rejection of claims 55—72, 75, 76, 78, 79 and 81 for
nonstatutory double patenting over claims 1—11 of U.S. Patent No.
8,617,597.
II. We reverse the rejection of claims 73, 74, 77, and 80 for nonstatutory
double patenting over claims 1—11 of U.S. Patent No. 8,617,597.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED-IN-PART
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