Ex Parte Glaser

Patent Trial and Appeal Board

Apr 26, 2018

12620725 (P.T.A.B. Apr. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/620,725 11/18/2009 Rebecca L. Glaser
29694 7590 04/30/2018
Leech Tishman Fuscaldo & Lampl
525 William Penn Place
28th Floor
PITTSBURGH, PA 15219
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.
RLG-1/Al 1113
EXAMINER
JEAN-LOUIS, SAMIRA JM
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
04/30/2018 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):
IPDocket@leechtishman.com
dstevenson@leechtishman.com
trath@leechtishman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REBECCA L. GLASER
Appeal2016-005437
Application 12/620,725
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from the
Examiner's decision to reject the claims directed to a subcutaneous implant
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
"[B]locking the enzyme 'aromatase,' anastrozole inhibits the
conversion of testosterone to estradiol thus preventing the stimulation of
breast tissue and breast cancer cells by estradiol. Oral anastrozole has been
1 Appellant identifies the real party in interest as Rebecca L. Glaser.
Appeal Br. 3.
Appeal2016-005437
Application 12/620,725
used in male patients to prevent the conversion of testosterone to estradiol,
thus raising testosterone levels and lowering estradiol levels." Spec. i-f 4.
Claims 1-3, 5, 6, 8, and 10-23 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A pharmaceutical dosage comprising a subcutaneous
implant containing testosterone or an ester thereof and an
aromatase inhibitor in a weight ratio of testosterone or the ester
thereof to the inhibitor of about 5:1to30:1 wherein the implant
is capable of administering testosterone or the ester thereof in a
pharmaceutically effective serum blood level, the implant is
capable of releasing the testosterone or the ester thereof and the
aromatase inhibitor into the blood at a controlled rate for a
period of at least 30 days, and the dosage is suitable for
administration in an amount that provides an estradiol level in
the blood serum less than about 30 pg/ml.
Appeal Br. 14 (Claims Appendix) (emphasis added).
Appellant requests review of the following grounds of rejection made by
the Examiner:
I. Claims 1-3, 5, 6, 8, 10-19, and 21under35 U.S.C. § 103(a) as
unpatentable over Chwalisz2 in view of Runkel. 3
II. Claim 20 under 35 U.S.C. § 103(a) as unpatentable over Chwalisz and
Runkel and further in view of Rathbone. 4
III. Claims 22 and 23 under 35 U.S.C. § 103(a) as unpatentable over
Chwalisz and Runkel and further in view ofFoster. 5
2 Chwalisz et al., US 5,906,987, issued May 25, 1999 ("Chwalisz").
3 Runkel et al., US 5,035,891, issued July 30, 1991 ("Runkel").
4 Rathbone et al., Controlled Release Veterinary Drug Release: Biological
and Pharmaceutical Considerations 36-38 (2000).
5 Foster et al., US 2001/0041697 Al, publ. Nov. 15, 2001 ("Foster").
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IV. Claims 1-3, 5, 6, 8, 10-19, and 21under35 U.S.C. § 103(a) as
unpatentable over Birrell 6 in view of Runkel.
V. Claim 20 under 35 U.S.C. § 103(a) as unpatentable over Birrell and
Runkel and further in view of Rathbone.
VI. Claims 8, 22, and 23 under 35 U.S.C. § 103(a) as unpatentable over
Birrell and Runkel and further in view of Foster.
I-III. Obviousness over Chwalisz and Runkel
The obviousness rejections 1.-111., are premised, in whole or in part,
on the teachings of Chwalisz and Runkel together or in combination with
either Rathbone or Foster; because the same issue is dispositive for all three
rejections we will discuss them together.
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Chwalisz and Runkel not
only teach a subcutaneous delivery product for administering testosterone
and an aromatase inhibitor but also that the product achieves the stated
reduction in estradiol concentration?
Findings of Fact
FF 1. Chwalisz teaches pharmaceutical composition for the treatment of
climacterium (climacteric symptoms) in aging males. Chwalisz 4:20-
21. The composition contains a nitric oxide synthase substrate and a
nitric oxide donor in conjunction with "an androgen (e.g., testosterone
or testosterone ester) and an aromatase inhibitor (e.g., atamestane)."
Id. at 4:29-31.
6 Birrell, US 2009/0215731 Al, publ. Aug. 27, 2009.
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FF2. Chwalisz teaches that "[t]ypical dosages of aromatase inhibitors are
those bioequivalent to 20-200 mg/day of atamestane, optionally
together with an androgen at a daily dosage bioequivalent to about 1-
10 mg of testosterone per day transdermally." Id. at 7:14--18, see also
id. at 10: 15-25. Testosterone can also be delivered at different
dosages depending on administration route. For example at dosage
ranging 10-250 mg i.m every 2--4 weeks or a dosage of 20-200
mg/day p.o. Id. at 6:4--10.
FF3. Chwalisz teaches combination therapy that produces "blood plasma
levels of about 50-5000 µmolar L-arginine, and about 100-600 mg/dl
testosterone. For the aromatase inhibitors, the dosage should be
effective to raise the endogenous testosterone levels by at least 30%."
Id. at 8:25-29.
FF4. Chwalisz teaches various parenteral applications for the actives
including implants. Id. at 7:44.
FF5. Runkel teaches implants in the form of pellets containing "estradiol
benzoate ... in combination with progesterone, testosterone
propionate, or trenbolone acetate." Id. at 6:40--43. The pellets or
plurality of pellets can contain 20-1000 mg of testosterone
propionate. Id. at 8:9-11. Runkel exemplifies a testosterone implant
for administration to humans containing 9 mg testosterone. Id. at
14:54--15:9.
FF6. Runkel teaches subcutaneous implants having zero-order release of
the active compounds. Id. at 5:30. Plasma levels of the steroid were
measured in the animals on days 0, 28, 56, 84, 112, 140, 168, and 196.
See id. at 5:39--44.
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Principle of Law
A rejection for obviousness must include "articulated reasoning with
some rational underpinning to support the legal conclusion." KSR Int 'l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007), quoting In re Kahn, 441F.3d977,
988 (Fed. Cir. 2006).
Analysis
The Examiner finds that Chwalisz teaches administering combination
compositions comprising testosterone and an aromatase inhibitor for
"treating the symptoms of climacterium in male mammals." Final Act. 3;
FF 1. The Examiner acknowledges that Chwalisz does "not specifically
teach that the weight ratio of testosterone to the inhibitor is about 5: 1 to
3 0: 1. . . . Chwalisz [also] does not teach that the dosage provides
approximately zero order release of testosterone or that the implant is
subcutaneous." Final Act. 5. The Examiner further finds that Chwalisz
teaches testosterone and aromatase inhibitors in overlapping amounts. Final
Act. 6; FF2. The Examiner relies on Runkel to teach subcutaneous implants
for the delivery of testosterone, including "zero-order release of greater than
90% of encapsulated biologically active compound that is effected." Final
Act. 6; FF5 and FF6.
The Examiner concludes:
While Chwalisz et al. do not teach that the estradiol level
in the blood serum is lower than 30 pg/ml, the examiner
contends that achieving such low level estradiol in the blood
serum is within the purview of the skilled artisan as an
aromatase inhibitor would prevent conversion of testosterone to
estradiol and thus manipulating the amount of aromatase
inhibitor that leads to decreased testosterone's conversion to
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estradiol is within the skill of the artisan and can be determined
during routine experimentation.
Final Act. 7.
Appellant contends that it is not apparent from the art "[t]hat the
aromatase inhibitor can be administered in an implant simultaneously with
the testosterone and maintain low estradiol blood serum levels." Appeal
Br. 8. In other words, there is no reason to manipulate the individual
components to provide a "blood serum level of estradiol less than 30 pg/ml."
Appeal Br. 8, 10.
Having considered all of the arguments and evidence submitted by
both the Examiner and Appellant, we conclude that Appellant has the better
position. "An examiner bears the initial burden of presenting a prima facie
case of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
We do not disagree with the Examiner that the record sufficiently
supports that combination therapy using testosterone and an aromatase
inhibitor is suggested by Chwalisz, and that the references also supports
administering each component in overlapping ranges. See FF 1-FF3. The
Examiner's position is the individual ranges taught in Chwalisz could
potentially be manipulated to meet the 5: 1 to 30: 1 testosterone:aromatase
inhibitor weight ratio as claimed. The problem with the rejection is that the
Examiner states "that achieving such low level estradiol in the blood serum
is within the purview of the skilled artisan" without providing support for
that statement. Final Act. 7. The Examiner also does not provide an
articulated explanation, nor directs the artisan, to any other factual support in
the record to establish why the artisan would seek to manipulate the
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components in order to achieve the result of reducing the serum level of
estradiol to less than 30 pg/ml. A rejection for obviousness must include
"articulated reasoning with some rational underpinning to support the legal
conclusion." KSR, 550 U.S. at 418, quoting Kahn, 441 F.3d at 988. Just
because an artisan could manipulate the components to meet a particular
therapeutic profile does not provide a reason why the artisan would want to
do so. Because the Examiner has not explained why based on the combined
references one of ordinary skill would have found it obvious to lower serum
levels of estradiol to less than 30 pg/ml as claimed while simultaneously
administering testosterone therapy, we agree with Appellant's position that
the Examiner has not sufficiently articulated a rationale to support a
conclusion of obviousness based on the combination of Chwalisz and
Runkel.
As the Examiner has failed to adequately articulate any other rationale
explaining how the combination of references discloses a reason to lower
estradiol level in the blood serum to less than about 30 pg/ml, we are
constrained to reverse each rejection that relies on the combination of
Chwalisz and Runkel.
IV.-VI. Obviousness over Birrell and Runkel
The obviousness rejections IV.-VI., are premised, in whole or in part,
on the teachings of Birrell and Runkel together or in combination with either
Rathbone or Foster; because the same issue is dispositive for all three
rejections we will discuss them together.
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Birrell and Runkel not
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only teach a subcutaneous delivery product for administering testosterone
and an aromatase inhibitor but also that the product achieves the stated
reduction in estradiol concentration?
Findings of Fact
FF7. Birrell teaches that aromatase enzyme converts testosterone to
estradiol and aromatase inhibitors prevent such conversion. Birrell
i-f 6. Birrell teaches "reducing side effects in post-menopausal women
with breast cancer already being treated with aromatase inhibitor
comprising administering an effective amount of an androgenic
agent." Id. i-f 2.
FF8. Birrell teaches compositions comprising "(a) an effective amount of
an androgenic agent and (b) an effective amount of an aromatase
inhibitor." Id. i-f 14, see id. ff 78, 148, 157. Birrell teaches that "an
effective amount of testosterone may be between about 2 to about 80
mg." Id. i-f 59, see id. i-f 157. Birrell teaches that an effective amount
of aromatase ranges from 1 mg to 100 mg. See id i-f 69 ("an effective
amount per day for Aromasin® ... may be between about 5 to about
100 mg"), see id. i-f 70 ("[a]n effective amount per day of Arimidex®
... may be between about 0.1 mg to about 5 mg").
FF9. Birrell administers combination therapy containing aromatase
inhibitor (Arimidex®, anastrozole at 1 mg orally once a day) and an
androgenic agent (testosterone undecanoate at 40 mg once a day
orally) upon serum hormone levels in post-menopausal patients. See
id. i-fi-128, 148. Administering this combination therapy shows a
serum estradiol drop from 15 pmol/L to 5 pmol/L. See i-f 149,
referencing Fig. 2 (not shown). Birrell interprets that under the tested
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condition the "testosterone aromatization to estradiol is almost
completely ablated during aromatase inhibitor therapy." Id. i-f 149
(emphasis added).
FF 10. Birrell also teaches that the pharmaceutical compositions can be
administered continuously or intermittently. Id. i-f 97. Birrell teaches
that the length of treatment can range from 3 months to 10 years. Id.
,-r 99.
Principle of Law
"Obviousness does not require absolute predictability of success ...
all that is required is a reasonable expectation of success." In re Drage, 695
F.3d 1334, 1338 (Fed. Cir. 2012) (quoting In re Kubin, 561F.3d1351, 1360
(Fed. Cir. 2009) (citing In re O'Farrell, 853 F.2d 894, 903---04 (Fed. Cir.
1988)).
Analysis
The Examiner finds that Birrell teaches testosterone and aromatase
combination therapy. See Final Act. 11; see Ans. 12; see FF7-FF9. The
Examiner finds that Birrell' s combination therapy uses overlapping
concentrations of testosterone and aromatase inhibitors. See Final Act. 11-
12; see Ans. 12; FF8. The Examiner acknowledges that
Birrell does not specifically teach that the pharmaceutical
composition is formulated as a subcutaneous implant.
Additionally, Birrell does not teach that the excipient is capable
of releasing the testosterone and aromatase inhibitor at a
controlled rate for a period of at least 30 days or that the
amount of estradiol in the blood serum is less than 30 pg/ ml or
that the excipient is in an amount of 5% by weight.
Final Act. 12; Ans. 13-14; FF9. The Examiner relies on Runkel to teach
subcutaneous administration of testosterone and formulating the
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encapsulated material so that the compound has a zero-order release profile.
See Final Act. 13; see Ans. 14; FF6.
While Birrell and Runkel do not teach that the estradiol
level in the blood serum is lower than 30 pg/ml, the examiner
contends that achieving such low level is within the purview of
the skilled artisan as an aromatase inhibitor would prevent
conversion of testosterone to estradiol and thus manipulating
the amount of aromatase inhibitor that leads to decreased
testosterone's conversion to estradiol is within the skill of the
artisan and can be determined during routine experimentation.
Final Act. 14; FF7. The Examiner further finds that "administration of the
composition of Birrell as a small implant would avoid gastrointestinal
problems associated with oral administration since such side effects can be
dependent on the composition as disclosed by Birrell." Final Act. 15; see
Ans. 14; FF7.
Appellant contends that testosterone and aromatase inhibitors have
different solubility. Appeal Br. 7, citing Zava Deel. 7 i-f 6; see Reply Br. 3
("the two drugs have very different properties"), see id. ("'incorporating
anastrazole with testosterone, chemically it cannot be achieved due to the
fact that anastrazole is not soluble in the base that we use [to incorporate
testosterone]"' citing Frank Bardani's letter). Appellant contends that
changing the route of administration of a drug oral vs. subcutaneous is not
reliably predictable. Appeal Br. 7, citing Zava Deel. i-f 8-9. Appellant
contends that routine optimization does not apply because the reference does
not provide the PK/PD teaching that underlies the claimed invention.
Appeal Br. 12, citing Eurand v. Mylan, 676 F.3d 1063 (Fed. Cir. 2012).
7 Declaration under 37 C.F.R. § 1.132 by David T. Zava, Ph.D., signed Jan.
17, 2013 ("Zava Deel.").
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Having considered all of the arguments and evidence submitted by
both the Examiner and Appellant, we conclude that based on this particular
combination of Birrell and Runkel the Examiner has the better position.
Birrell teaches that aromatase is the enzyme responsible for converting
testosterone to estradiol. FF7. Birrell teaches that the conversion of
estradiol form testosterone is ablated by the administration of an aromatase
inhibitor. FF9. The ablation of estradiol conversion is reasonably interpreted
to mean that no estradiol is converted from either androstenedione or
testosterone. See Birrell i-f 6, citing Fig. 1. In other words, the inhibition of
aromatase with any of the listed inhibitors in Birrell reasonably supports
meeting the low level of estradiol now claimed.
The claims recite achieving estradiol levels of less than 30 pg/ml
which can be reasonably interpreted to mean range between 0 to 30 pg/ml.
While Birrell does not recite measuring estradiol levels in pg/ml the
reference does measure the estradiol level in pmol/L and further indicates
that the conversion to estradiol is ablated by the administration of an
aromatase inhibitor. FF9. Based on this disclosure in Birrell it is reasonable
to conclude that the complete inhibition of aromatase would lead to serum
estradiol levels that approach zero and therefore it would be meet the
claimed range of 0 to 30 pg/ml.
The Examiner's position is that "the discovery of a previously
unappreciated property of a prior art composition, or of a scientific
explanation for the prior art's functioning, does not render the old
composition patentably new to the discoverer." Atlas Powder Co. v. Ireco,
Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999); see Ans. 24--25. In other words,
the recitation of estradiol levels at 30 pg/ml or less is merely a numeric
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disclosure of a result that is expected when the enzyme aromatase is
inhibited to the point that there is no conversion of testosterone to estradiol.
The evidence in Birrell supports that the oral administration
anastrozole at 1 mg orally once a day results in a drop of serum estradiol
from 15 pmol/L to 5 pmol/L, which is interpreted in Birrell to represent a
complete ablation of testosterone conversion to estradiol. FF9. On this
record, we find that the evidence disclosed in Birrell sufficiently supports
the Examiner's position that the prior art teaches complete inhibition of
aromatase when applying the oral combination therapy and this level of
inhibition reasonably meets the numeric serum estradiol range as now
claimed.
We recognize, but are not persuaded by, Appellant's contention that
changing the route of administration of a drug oral vs. subcutaneous is not
reliably predictable. Appeal Br. 7. "Obviousness does not require absolute
predictability of success ... all that is required is a reasonable expectation of
success." Drage, 695 F.3d at 1338 (quoting Kubin, 561 F.3d at 1360 (citing
O'Farrell, 853 F.2d at 903---04). Runkel teaches the administration of
testosterone by subcutaneous implant, and teaches that a plurality of pellets
can be applied for administering different components. See Ans. 14--15;
FF6. Birrell teaches that the composition can be administered continuously
or intermittently. FF 10. One way of administering a composition
continuously would be by administering a prolonged release subcutaneous
composition, such as with the pellets taught in Runkel. FF5. Birrell is
directed at reducing side effects of aromatase treatment by administering
testosterone concurrently. FF7. The Examiner finds that "administration of
the composition of Birrell as a small implant would avoid [side effects such
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as] gastrointestinal problems associated with oral administration" of the
composition. Ans. 16. We agree with the Examiner that the reduction of
side effects would not only motivate an artisan to contemplate combination
therapy (see FF7) but also would motivate applying different routes of
administration to avoid side effects.
We are also not persuaded by Appellant's contention that routine
optimization does not apply with this combination because the references do
not provide the PK/PD values of the compounds. Appeal Br. 12, citing
Eurand v. Mylan, 676 F.3d 1063 (Fed. Cir. 2012). The present facts differ
from those presented in Eurand. Ans. 25. Unlike Eurand, the present
claims do not require fine tuning of the release of the active agents
themselves in order to maintain a narrow therapeutic window having upper
and lower limit of the active. The present claims are met by administering
both testosterone and aromatase inhibitor above a threshold level without
having an upper limit. The art teaches therapeutic doses of testosterone
formulated for subcutaneous administration. FF5 and FF6. Providing a
patient receiving a subcutaneous testosterone formulation with an aromatase
inhibitor guarantees that any added testosterone is not converted to estradiol.
See FF7.
The only component that needs optimization on this record is the
formulation of the aromatase inhibitor as a subcutaneous implant rather than
providing the inhibitor as an oral medicine. See FF8-FF10. The claims
recite the byproduct of the aromatase inhibition in this case the level
estradiol during treatment. This estradiol level would reasonably be met by
administering an excess of aromatase to prevent testosterone aromatization.
See FF9. The claim is not directed to fine tuning the serum concentration of
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aromatase inhibitor, rather the claim requires having a minimum amount of
inhibitor present but does not cite an upper limit. Furthermore, one of
ordinary skill in the implant art would know to initially overdose with a drug
in order to prolong the therapeutic interval. See Runkel 5: 54--56
("overdosing during the first year in order to maintain sufficient levels for
contraception during the following years"). On this record, we agree with
the Examiner's conclusion that optimization of an aromatase inhibitor for
subcutaneous administration was within the skill of the ordinary artisan
based on "the desired outcome [of almost completely ablating aromatase] as
taught by Birrell." Ans. 22; FF9.
We are also not persuaded by Appellant's contention that testosterone
and aromatase inhibitors have different solubility and different properties
and therefore could not be formulated together. See Appeal Br. 7; see Reply
Br. 3 ("the two drugs have very different properties"), see id.
("'incorporating anastrazole with testosterone, chemically it cannot be
achieved due to the fact that anastrazole is not soluble in the base that we use
[to incorporate testosterone]"' citing Frank Bardani's letter). There is no
requirement in the claim that the testosterone and aromatase must be
formulated in the same base. "[L ]ike the term 'comprising,' the claim term
'containing' ... is open-ended." Mars, Inc. v. H.J. Heinz Co., 377 F.3d
1369, 1365 (Fed. Cir. 2004). Claim 1 recites "[a] pharmaceutical dosage
comprising a subcutaneous implant containing testosterone ... and an
aromatase inhibitor." The language in claim 1 is open ended and thereby
encompasses multiple particles within the implant similar to the different
pellets described in Runkel. FF5; see also Appeal Br. 15 (Claims Appendix)
(claim 23 "[a] pharmaceutical dosage comprising one or more subcutaneous
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pellet implants"). Because the implant can be made of multiple pellets the
argument that testosterone and aromatase have different solubility is not
persuasive because the ordinary artisan would know to formulate each
component into a base that is compatible with the active agent.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1. "When prima facie
obviousness is established and evidence is submitted in rebuttal, the
decision-maker must start over." In re Rinehart, 531F.2d1048, 1052
(CCPA 1976);InreHedges, 783F.2d1038, 1039 (Fed. Cir. 1986) ("Ifa
prima facie case is made in the first instance, and if the applicant comes
forward with reasonable rebuttal, whether buttressed by experiment, prior art
references, or argument, the entire merits of the matter are to be
reweighed").
Appellant submits the Zava Declaration to support the position that a
unitary implant provides improved function. See Appeal Br. 7. There has to
be a nexus between the unexpected property and the claimed invention. See
Huai-Hung Kao, 639 F.3d at 1068 ("Where the offered secondary
consideration actually results from something other than what is both
claimed and novel in the claim, there is no nexus to the merits of the claimed
invention."). In addition, "when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991 ). Here, the Zava Declaration discusses implants that are not
commensurate in scope with the claims. As discussed above, the
independent claims (1 and 23) both are directed to subcutaneous implants
that may encompass multiple pellets and there is no limitation in the claims
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that each pellet must contain both testosterone and aromatase inhibitor. The
Zava Declaration explains that "[t]he combination implant assures consistent
release of both the testosterone and the anastrozole, and more importantly
consistent absorption simultaneously of both testosterone and anastrozole.
This is critical. Not even two separate implants (testosterone alone,
anastrozole alone) would accomplish this because each drug implant would
have a separate rate of release and separate rate of absorption." Zava Deel.
i-f 11, see also i-f 12. ("Mixing the active ingredients together in a
combination implant eliminates differential release and differential
absorption"). The implant discussed in the Zava Declaration is not
commensurate in scope with the claims, because the claims encompass
implants that can have different pellets and each pellet can contain a single
active agent. In other words, the claims do not require that the testosterone
and aromatase inhibitor are in the same base (i.e., in the same pellet).
Therefore, we do not find the evidence presented in the Zava Declaration
persuasive because there is no nexus between the properties discussed in the
declaration and the claims.
In summary, we agree with the Examiner that the cited references
support a prima facie case of obviousness. Appellant's rebuttal, however, is
not commensurate with the full scope of the embodiments encompassed by
the claims and therefore, when balanced with the prima facie case, the
rebuttal does not render the claims nonobvious. Accordingly, we affirm the
rejection of claim 1 under 35 U.S.C. § 103(a) over Birrell in view of Runkel.
Claims 2, 3, 5, 6, 8, 10-19, and 21 we not separately argued and fall with
claim 1. Appellant did not provide additional arguments with respect to
claim 20 based on the combination Birrell, Runkel, and Rathbone, or claims
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22 and 23 based on the combination of Birrell, Runkel, and Foster therefore
we affirm those rejections for the same reason set out by the Examiner and
the reasons discussed above with respect to claim 1.
SUMMARY
We reverse the rejection of claims 1-3, 5, 6, 8, 10-19, and 21 under
35 U.S.C. § 103(a) over Chwalisz in view of Runkel.
We reverse the rejection of claim 20 under 35 U.S.C. § 103(a) over
Chwalisz and Runkel and further in view of Rathbone.
We reverse the rejection of claims 22 and 23 under 35 U.S.C. § 103(a)
over Chwalisz and Runkel and further in view of Foster.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over
Birrell in view of Runkel. Claims 2, 3, 5, 6, 8, 10-19, and 21 we not
separately argued and fall with claim 1.
We affirm the rejection of claim 20 under 35 U.S.C. § 103(a) over
Birrell and Runkel and further in view of Rathbone.
We affirm the rejection of claims 22 and 23 under 35 U.S.C. § 103(a)
over Birrell and Runkel and further in view of Foster
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
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