Ex Parte Walker

Patent Trial and Appeal Board

Mar 14, 2017

13399960 (P.T.A.B. Mar. 14, 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.
13/399,960 02/17/2012 Patricia Walker 069611-1101 8851
93764 7590 03/16/2017
Kythera Biopharmaceuticals, Inc.
c/o Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
FAN, LYNN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
03/16/2017 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):
ipdocketing @ foley. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PATRICIA WALKER1
Appeal 2015-001687
Application 13/399,960
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a cosmetic formulation. Claims 1—9, 11—15, and 17—30
are on appeal as rejected under 35 U.S.C. §§ 102 and 103(a). We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 We understand the Real Party in Interest to be Kythera
Biopharmaceuticals, Inc. Br. 2.
Appeal 2015-001687
Application 13/399,960
STATEMENT OF THE CASE
The Specification indicates:
Fat accumulation under the chin is a unique phenomenon, which
can often occur in individuals who are not otherwise overweight.
This area around the neck can be resistant to weight reduction
measures, with liposuction being the primary intervention.
Deoxycholic acid or a salt thereof represents a promising
nonsurgical treatment for unwanted submental fat deposition.
Spec. 13.
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claims 1, 2, and 19 are independent claims; claim 1 is
representative and reads as follows:
1. A non-surgical method for the reduction of submental fat in a
subject, said method comprising a plurality of subcutaneous
injections of a solution of deoxycholic acid or a salt thereof into
said submental fat, each injection of said plurality administering
about 1 mg to about 2 mg of said deoxycholic acid or salt thereof
per square centimeter of the skin area over said submental fat,
wherein the volume for each injection is about 0.1 ml to about
0.2 ml.
Br. 20 (Claims App’x).
2
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Application 13/399,960
The following rejections are on appeal2:
Claims 1,18, and 24—30 stand rejected under 35 U.S.C. § 102 over
Kolodney.3 Final Action 3.
Claims 1—5, 18, 19, 24, and 28—30 stand rejected under 35 U.S.C.
§ 103(a) over Rotunda.4 Id. at 5.
Claims 1, 3, 5, 9, and 11—15 stand rejected under 35 U.S.C. § 103(a)
over Rotunda and Kythera.5 Id. at 7.
Claims 1 and 5—8 stand rejected under 35 U.S.C. § 103(a) over
Rotunda and Klein.6 Id. at 9.
Claims 1 and 17 stand rejected under 35 U.S.C. § 103(a) over
Rotunda and Small.7 Id. at 11.
2 Appellant requests rejoinder of certain claims. Br. 18. The propriety of a
restriction or election of species requirement is a petitionable matter
reviewable by petition to the Technology Center Director. See 37 C.F.R.
§ 1.144; MPEP §§ 818.03(c), 1002.02(c)(2), and 1201. Petitionable issues
are not subject to review by the Board. See In re Berger, 279 F.3d 975,
984—85 (Fed. Cir. 2002). Accordingly, we do not address this issue.
3 International Patent Application Pub. No. WO 2005/112942 A1 (published
Dec. 1, 2005) (hereinafter “Kolodney”).
4 Adam M. Rotunda, MD et al., Randomized Double-Blind Clinical Trial of
Subcutaneously Injected Deoxycholate Versus a Phosphatidylcholine-
Deoxycholate Combination for the Reduction of Submental Fat, 35
Dermatol. Surg. 792—803 (2009) (hereinafter “Rotunda”).
5 Kythera Biopharmaceuticals, Kythera Newsroom, available at
http://www.kytherabiopharma.com/newsroom/ article/entry20, visited Jan.
30, 2013 (hereinafter “Kythera”).
6 S.M. Klein et al., A New Method to Quantify the Effect After Subcutaneous
Injection of Lipolytic Substances, 32 Aesth Plast Surg 667—72 (2008)
(hereinafter “Klein”).
7 Donald M. Small, Size and Structure of Bile Salt Micelles, Influence of
Structure, Concentration, Counterion Concentration, pH, and Temperature,
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Claims 1, 20, 21, 25, and 26 stand rejected under 35 U.S.C. § 103(a)
over Rotunda and Moriarty.8 Id. at 12.
Claims 1, 20, 22, and 23 stand rejected under 35 U.S.C. § 103(a) over
Rotunda and Prasad.9 Id. at 14.
Claims 1 and 27 stand rejected under 35 U.S.C. § 103(a) over
Rotunda and Hasengschwandtner.10 Id. at 15.
Oral Argument was heard from counsel on Appellant’s behalf on
March 7, 2017. The transcript of that hearing is a part of the record on
appeal.
The anticipation rejection of claims 1, 18, and 24—30 over Kolodney.
Findings of Fact
Except as otherwise indicated, we adopt the Examiner’s findings of
fact, reasoning on scope and content of the prior art, and conclusions set out
in the Final Action and Answer. The facts set out below highlight certain
evidence.
in Molecular Association in Biological and Related Systems 31-52
(1968) (hereinafter “Small”).
8 U.S. Patent Application Pub. No. US 2008/0318870 A1 (published Dec.
25, 2008) (hereinafter “Moriarty”).
9 U.S. Patent Application Pub. No. US 2009/0270642 A1 (published Oct. 29,
2009) (hereinafter “Prasad”).
10 Franz Hasengschwandtner, Phosphatidylcholine Treatment to Induce
Lipolysis, 4 J. Cosmetic Dermatology 308-13 (2005) (hereinafter
“Hasengschwandtner”).
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FF1. Kolodney is directed to and discloses “[compositions and
methods useful in the reduction of localized fat deposits in patients.”
Kolodney Abstract; see also Final Action 4 (discussing Kolodney).
FF2. Kolodney discloses sodium deoxycholate, or deoxycholic
acid as a preferred composition for treating patients as indicated in
FF1, supra. Kolodney 60, 75; see also Final Action 4 (discussing
Kolodney).
FF3. Kolodney discloses compositions having 0.001—8 g of
detergent, e.g., sodium deoxycholate. Kolodney 1 68; see also Final
Action 4 (discussing Kolodney).
FF4. Kolodney discloses “[i]n embodiments of the present
invention, the pharmacologically active detergent composition is
administered by subcutaneous injection directly into fat tissue,” for
example, “under [the] chin.” Kolodney H 73—74; see also Final
Action 4 (discussing Kolodney).
FF5. Kolodney discloses “embodiments contemplate
administration of. . . 0.1-0.2 mL total solution to a target site.”
Kolodney 1 82; see also Final Action 4 (discussing Kolodney).
FF6. Kolodney discloses:
the present invention contemplates methods for reducing amount
of subcutaneous fat in a mammal by administering to the
mammal an effective amount of a fat-solubilizing composition
that comprises, consists essentially of, or consists of one or more
pharmacologically active detergents. The above is preferably
administered transdermally or subcutaneously, via e.g., a
subcutaneous injection using a syringe to a target site. A target
site can be for example 0.1 cm x 0.1 cm, to about 5 cm x 5 cm.
The compositions herein may be administered at the same,
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adjacent, or nearby target sites at various intervals, dosages,
volumes, as disclosed herein.
Kolodney 1145; see also Final Action 4 (discussing Kolodney).
FF7. Kolodney discloses “[t]he above may be administered once
or multiple times into the target site,” and that such administrations
can occur monthly, weekly, daily, or hourly. Kolodney 1149; see
also Final Action 4 (discussing Kolodney).
Discussion
The Examiner determined that Kolodney anticipated claim 1 because
it disclosed the submental fat treatment method recited thereby, using
injections of deoxycholic acid in amounts of 1—2 mg, at volumes of 0.1—
0.2 ml, where the injections are made one per square centimeter. FF1—FF7;
Final Action 4. Appellant took exception to the Examiner’s finding with
respect to the spacing of injections being one per square centimeter,
contending that, in view of Atofina v. Great Lakes Chem. Corp., 441 F.3d
991, 999 (Fed. Cir. 2006), Kolodney’s disclosure of “[a] target site [of] for
example 0.1 cm x 0.1 cm, to about 5 cm x 5 cm,” is not sufficient to
anticipate the claim element “administering . . . said deoxycholic acid . . .
per square centimeter of the skin area over said submental fat.” Br. 9—11.
Specifically, Appellant argues that the target site size range disclosed by
Kolodney is 2500-fold (i.e., 0.01—25 cm2), which does not sufficiently
describe a 1 cm2 target size to anticipate. Id. at 10-11.
In Atofina, our reviewing court established that a prior art reference’s
disclosure of a range that is broader than that recited by a claim may not
anticipate the claimed range if “no reasonable fact finder could conclude that
the prior art describes the claimed range with sufficient specificity.”
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Atofina, 444 F.3d at 999. In Atofina, the prior art’s disclosure of a range was
just that, disclosure of a range and not any specific point (there, temperature)
within that range or at its endpoints and, so, the Federal Circuit found the
claim element not anticipated. Id. at 1000.
The Atofina decision was further clarified by ClearValue, Inc. v. Pearl
River Polymers, Inc., 668 F.3d 1340 (Fed. Cir. 2012), which distinguished
its facts from the Atofina case in reversing a district court’s determination of
no anticipation. In ClearValue, the Federal Circuit found the patent holder
had not argued the claim element at issue (“50 ppm limitation”) was critical
or that the claimed method worked differently at different points within the
prior art’s disclosed range. Id. at 1345. Without such evidence the Federal
Circuit found that, unlike Atofina, in ClearValue “there is no ‘considerable
difference between the claimed range and the range in the prior art,”’ which
compelled a reversal of the lower court’s finding that the prior art did not
anticipate. Id. (citing Atofina, 441 F.3d at 999). Further, in Ineos USA LLC
v. Berry Plastics Corp., 783 F.3d 865, 871 (Fed. Cir. 2015), the Federal
Circuit discussed Atofina and ClearValue and confirmed “that when the
prior art discloses a range, rather than a point, the court must evaluate
whether the patentee has established that the claimed range is critical to the
operability of the claimed invention,” e.g., “operability [of the invention]
would be improved by the claimed range,” when determining anticipation.
Here, Appellant submits the Declaration of Paul F. Lizzul as Exhibit
A to the Appeal Brief. Lizzul states, inter alia:
Based on preclinical studies in pigs, varying distance and
concentration of deoxycholate injections unexpectedly showed
that the relative effective zone of diffusion for deoxycholate
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extended to approximately 1 cm from the injection site. As a
result the inventors conclude that 1 cm distance between
injections are optimal and a 1 cm2 area subcutaneously treated
via small volume injections of concentrations as [sic] claimed in
this patent application. The design of this study and its outcome
are not routine and its outcomes are not predicted: the results are
surprising and unexpected.
Lizzul Decl. 114. We find that, in view of Atofina, ClearValue, and Ineos,
discussed, supra, this evidence shows the 1 cm2 value recited by claim 1 is
critical to the invention and, so, is not disclosed in Kolodney’s (FF6) broader
range. In view of this, we reverse the Examiner’s rejection for anticipation.
The obviousness rejections over Rotunda.
Appellant presents arguments for non-obviousness with respect to
Rotunda only and, so, we also focus our decision on this reference. Only
those arguments made by Appellant in the Briefing have been considered in
this Decision. Arguments not presented in Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015).
Findings of Fact
Except as otherwise indicated, we adopt the Examiner’s findings of
fact, reasoning on scope and content of the prior art, and conclusions set out
in the Final Action and Answer. The facts set out below highlight certain
evidence.
FF8. Rotunda discloses a clinical trial using subcutaneously
injected deoxycholate for the reduction of submental fat. Rotunda
792 (title, abstract); see also Final Action 5—18, and Ans. 17—19
(discussing Rotunda).
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FF9. Rotunda disclosed that its study “produced minimal
aesthetic improvement overall,” but “[e]nhanced neck profiles in
several subjects demonstrate a proof of concept that warrants further
study utilizing a validated, submental profile grading scale and
methods to optimize dose and technique.” Rotunda 792 (abstract);
see also Final Action 5—18, and Ans. 17—19 (discussing Rotunda).
FF10. Rotunda disclosed “subjects received 2 mL per treatment
arm, divided over six separate injections (approximately 0.33 mL
each). Three injections were 1.0 cm apart in the anterior chin, and
three injections were 1.0 cm apart spaced approximately 2 cm
posterior to the more anterior row of injections.” Rotunda 794 (left
col.); see also Final Action 5—18, and Ans. 17—19 (discussing
Rotunda).
FF11. Rotunda disclosed “[s]objects received a maximum of five
once-monthly treatments. Treatment ended earlier at the discretion
of the investigator or the subject” and “[c]linic visits occurred at 4-
week intervals to ensure that residual edema and any other local
effects had subsided.” Rotunda 794 (left col.); see also Final Action
5—18, and Ans. 17—19 (discussing Rotunda).
FF12. Rotunda disclosed visual evidence of improved appearance,
i.e., reduced appearance of double-chin or under-chin fat, after
injections of deoxycholic acid in submental fat. Rotunda figures 1—
8; see also Final Action 5—18, and Ans. 17—19 (discussing Rotunda).
FF13. Rotunda disclosed “[ujltrasound imaging using 0.2 mL of
0.5% . . . deoxycholate injected into abdominal fat produces an
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approximately 1.0 cm echogenic focus, which probably corresponds
with ablated or inflamed tissue. A minimum of 1.0 cm spacing with
at least 0.2 mL per site is an adequate starting point for additional
submental studies.” Rotunda 799 (left col.); see also Final Action
5—18, and Ans. 17—19 (discussing Rotunda).
FF14. The formulation disclosed by Rotunda as a proposed
starting point for additional submental fat studies, identified in the
immediately preceding finding of fact, teaches 1 mg deoxycholate as
determined by the following calculation:
Solution: 0.5% w/v sodium deoxycholate
0.5% w/v x 1/100 x 0.2 mL x 1000 mg/1 g = 1 mg.
Cf. Br. 14—15, n. 1 and 2 (Appellant’s calculations of deoxycholic
acid mass per injection).
FF15. Rotunda disclosed “[fjixing the medication volume without
consideration of fat volume may have negatively skewed our results.
It stands to reason that the amount of medication injected should be
commensurate with a patient’s submental fat volume.” Rotunda 799
(left col.); see also Final Action 5—18, and Ans. 17—19 (discussing
Rotunda).
Discussion
We find the Examiner has established that the claims would have been
obvious over Rotunda (see FF8—FF15) and, where applicable, Rotunda in
combination with Kythera, Klein, Small, Moriarty, Prasad, and
Hasengschwandtner, respectively. Appellant has not produced evidence
showing, or persuasively argued, that the Examiner’s determination of
obviousness is incorrect. We address Appellant’s arguments below.
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Appellant argues that Rotunda teaches away from the claimed
invention because, for its disclosed two tested deoxycholate injectable
solutions, it indicates “only modest treatment responses.” Br. 14. This
argument is not persuasive.
A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a
direction divergent from the path that was taken by the applicant.
The degree of teaching away will of course depend on the
particular facts; in general, a reference will teach away if it
suggests that the line of development flowing from the
reference’s disclosure is unlikely to be productive of the result
sought by the applicant.
In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). The facts here do not
present such a scenario.
While Rotunda, at certain points, indicates that the results of its
clinical testing were not outstanding and suggests some disappointment
therewith, the reference does not discourage the skilled artisan from
pursuing the claimed invention, but expressly encourages it. FF12—FF14.
Not only does Rotunda provide compelling visual evidence of some success
in mitigating submental fat, it suggests that the next course of action for the
skilled artisan is to use the amount and volume and injection pattern
distribution of claim 1. Id. “[Cjase law is clear that obviousness cannot be
avoided simply by a showing of some degree of unpredictability in the art so
long as there was a reasonable probability of success.” Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (citing In re Corkill, 111
F.2d 1496, 1500 (Fed. Cir. 1985)). Likewise, a reference does not teach
away from an invention merely because it indicates superior results were not
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achieved using a similar method where the reference suggests pursuing the
claimed method.
Appellant argues that Rotunda discloses different injection volumes
and amounts of deoxycholate than the claimed invention. Br. 15. This
argument is not persuasive.
As identified in the findings of fact, supra, (see, e.g., Final Action 6),
Rotunda teaches deoxycholic acid injections of 1 mg per square centimeter
of skin area and that the volume of each injection is 0.2 ml. FF13—FF14.
Looking to Rotunda’s express suggestion that follow-up testing should be
performed using “[a] minimum of 1.0 cm spacing with at least 0.2 mL per
site,” and to the reference’s immediately preceding disclosure of a 0.5%
deoxycholate injection formulation, which using Appellant’s own
exemplified calculations determines that the amount of deoxycholate is
within the claim limitations, it is apparent that Rotunda discloses and
suggests each element of claim 1 and, so, renders it obvious. FF13.
Appellant argues that the injection pattem(s) of Rotunda result in
injections every 1 cm x 1 cm x 2 cm rather than the claimed 1 cm x 1 cm.
Br. 15. This argument is not persuasive.
Appellant is correct that Rotunda disclosed injections every 1 cm x
lcm x 2 cm (FF10); however, Rotunda also disclosed that the “starting point
for additional submental studies” would be “[a] minimum of 1.0 cm
spacing” (FF13). This suggests the “per square centimeter” element of
claim 1 and, so, renders it obvious. Further, even though the actually tested
injections were conducted in two rows of 1 cm-spaced sites where the rows
were separated by 2 cm, each such row satisfies the one injection “per
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square centimeter” recited by claim 1 because no minimum number of
injections is required by claim 1. Thus two injections spaced by 1 cm would
satisfy the requirement for “a plurality of subcutaneous injections . . . per
square centimeter of the skin area,” as recited in claim 1.
In view of the above-discussed Appellant arguments, we note that
picking one of a finite number of known solutions to a known problem is
obvious. KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007):
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this leads
to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that it was obvious under § 103.
Here, although the entirety of Rotunda is relevant and discloses or
suggests aspects of the claimed therapy, in the span of a single paragraph
(see FF13—FF14) the reference identifies each element of claim 1 and
suggests that these parameters be the very next thing tried by those of skill in
the art. Thus, the claimed method was obvious to try and obvious.
Appellant argues that the parameters not expressly disclosed by
Rotunda, which would, therefore, need to be modified (alleged to be
decreased injection amount, volume, and 1 cm distance) were not recognized
by Rotunda as variables that would affect the results and so are not
optimizable under the decision in Ex parte Whalen II, 89 USPQ2d 1078,
1083—84 (BPAI 2008). This argument is not persuasive.
Rotunda is quite explicit that each of the parameters identified by
Appellant would have an effect on the results of the therapy; in fact,
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Rotunda indicates adjusting each of the injection amount, volume, and target
tissue distance variables. See, e.g., FF9, FF10, FF13; see also Rotunda 793—
94 and 799 (discussing adjusting injection amounts, volumes, and target
tissue site injection patterns). Rotunda expressly indicates that medication
volume can be optimized so as to be commensurate with a patient’s
submental fat volume (FF15) and that “study of dosing and injection
techniques . . . may be required to optimize results” (Rotunda 801).
Therefore, only mere routine optimization would be required to adjust the
injection amount, volume, and target tissue injection site distance parameters
of Rotunda, if they indeed even required adjusting from the expressly
disclosed values. However, this is not the case because, as discussed above,
Rotunda discloses such parameters already within the scope of the claims so
that optimization, while possible, would not be needed. See Ans. 19
(Examiner identifies same and indicates parameters are optimizable).
Appellant argues that evidence of unexpected results of the claimed
invention warrants reversal of the obviousness rejection, citing the Lizzul
Declaration’s indication that “smaller volumes and smaller injection
amounts of DCA achieved an ‘asthetically [sic] pleasing outcome’ —not
poorer outcomes as was either taught or suggested by Rotunda.” Br. 17.
This argument is not persuasive.
The extent of Appellant’s evidence of unexpected results is identified
as being paragraphs 12—14 of the Lizzul Declaration, which indicate: (1) Dr.
Lizzul’s experience in the relevant field supports his opinion that “the skilled
artisan would avoid cosmetically treating a large undefined area such as
submental fat in a haphazard fashion due to the likelihood of inconsistent
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results”; (2) “[ijnjecting increased concentrations and/or large volumes of
deoxycholate may lead to suboptimal aesthetic outcomes and or increased
adverse effects” and “distance and concentration of injections show no
‘dimpling’ or unevenness [compared to] methods characterized by larger
volumes, larger spacing paradigms or higher deoxycholate concentrations”;
and (3) “preclinical studies in pigs . . . unexpectedly showed that the relative
effective zone of diffusion for deoxycholate extended to approximately 1 cm
from the injection site” and “the inventors conclude that 1 cm distance
between injections are optimal. . . via small volume injections of
concentrations as claimed” and that this was “not routine . . . not predicted
. . . [and was] surprising and unexpected.” Lizzul Decl. H 12—14.
Lizzul’s point (1) noted above does not support that the claimed
invention produced unexpected results. That the skilled artisan would avoid
a methodology that is at odds with the more organized injection technique of
the claimed invention does not make the invention non-obvious, it suggest it
was obvious.
Further “an unexpected result or property does not by itself support a
finding of nonobviousness.” Bristol-Myers Squibb Co. v. Teva Pharms.
USA, Inc., 752 F.3d 967, 976 (Fed. Cir. 2014) (citing In re Dillon, 919 F.2d
at 693, 697, where “additional unexpected properties [] did not upset an
already established motivation to modify a prior art compound based on the
expected properties of the resulting compound”). “[B]y definition, any
superior property must be unexpected to be considered as evidence of non­
obviousness.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir.
2007). “To be particularly probative, evidence of unexpected results must
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establish that there is a difference between the results obtained and those of
the closest prior art, and that the difference would not have been expected by
one of ordinary skill in the art at the time of the invention.” Bristol-Myers,
752 F.3d at 977. Further, the “evidence [of unexpected results] must fail [if]
the record is devoid of any evidence of what the skilled artisan would have
expected,” as the Federal Circuit refused to make any presumptions on the
issue. Pfizer, 480 F.3d at 1371.
Because Rotunda indicates that some success was achieved (FF11) in
enhancing cosmetic appearance using deoxycholate injection therapy for
submental fat using similar parameters to those of the claims and also
suggests that the next therapy study to be attempted should use the amounts,
volumes, and injection spacing parameters recited by claim 1, improved
cosmetic results achieved would be expected from such therapy, not
unexpected. Moreover, Appellant does not present a comparison between
the results of the claimed invention and the closest prior art and we have no
evidence, other than extrapolating from Dr. Lizzul’s conclusions, of what the
skilled artisan would have reasonably expected of the claimed invention.
For each of these reasons we do not find Appellant’s evidence of unexpected
results supports non-obviousness.
Appellant very briefly singles out claim 2 as separately patentable
over Rotunda because it recites the sites for injection are at least about 1 cm
apart from each other. Br. 17—18. This argument is not persuasive.
Claim 2 recites “wherein the sites for injection are at least about 1 cm
apart from each other.” Br. 20 (Claims App’x.). As discussed, supra,
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Rotunda discloses both a 1 cm spacing and a 1 cm x 2 cm spacing for
injections, each of which makes this claim element obvious.
Appellant also very briefly singles out claim 19 as separately
patentable over Rotunda in that it recites a schedule for the injections. Br.
18. This argument is not persuasive.
Claim 19 recites the injection therapy “is performed in a plurality of
visits by said subject, said plurality of visits is according to the schedule
shown in FIG. 2.” Id. at 22. Appellant’s Specification’s Fig. 2 illustrates
weekly visits to receive injections (“dose[sj”) over the course of 20 weeks
and also includes patient visits between the dosing visits. Rotunda discloses
that deoxycholate injection treatments are performed as a series of clinic
visits, which can be spaced at intervals over several weeks with intervening
clinic visits to ensure side effects subside. FF11. Therefore, setting an
optimal schedule would be achieved by routine optimization and claim 19’s
recited schedule is obvious in view of Rotunda.
SUMMARY
The anticipation rejection of claims 1,18, and 24—30 over Kolodney
is reversed.
The obviousness rejection of claims 1—5, 18, 19, 24, and 28—30 over
Rotunda is affirmed.
The obviousness rejection of claims 1,3,5, 9, and 11—15 over
Rotunda and Kythera is affirmed.
The obviousness rejection of claims 1 and 5—8 over Rotunda and
Klein is affirmed.
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The obviousness rejection of claims 1 and 17 over Rotunda and Small
is affirmed.
The obviousness rejection of claims 1, 20, 21, 25, and 26 over
Rotunda and Moriarty is affirmed.
The obviousness rejection of claims 1, 20, 22, and 23 over Rotunda
and Prasad is affirmed.
The obviousness rejection of claims 1 and 27 over Rotunda and
Hasengschwandtner is affirmed.
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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