Ex Parte Levis et al

Patent Trial and Appeal Board

Aug 31, 2017

13035692 (P.T.A.B. Aug. 31, 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.
13/035,692 02/25/2011 William R. Levis R0659.70028US01 3353
23628 7590 09/05/2017
WOLF GREENFIELD & SACKS, P.C.
600 ATLANTIC AVENUE
BOSTON, MA 02210-2206
EXAMINER
SNYDER, STUART
ART UNIT PAPER NUMBER
1648
NOTIFICATION DATE DELIVERY MODE
09/05/2017 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):
Patents_eOfficeAction@WolfGreenfield.com
W GS_eOffice Action @ W olfGreenfield .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM R. LEVIS, LEONARD L. KAPLAN, and
JOHN G. CALLAHAN1
Appeal 2015-006484
Application 13/035,692
Technology Center 1600
Before TAWEN CHANG, RYAN H. FLAX, and TIMOTHY G. MAJORS,
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 method of treating a disease or disorder associated with
human papilloma virus infection in a human patient. Claims 1, 2, 4—8, 10,
21, 22, and 25 are on appeal as rejected under 35 U.S.C. § 103(a) and PCT
Article 33(3).2 We have jurisdiction under 35 U.S.C. § 6(b).
1 The Real Party in Interest is identified as “Hapten Pharmaceuticals, LLC.”
App. Br. 3.
2 Claim 3 is cancelled. App. Br. 5. Also, as the Examiner identifies, claim 9
was cancelled by amendment on July 7, 2014. Ans. 10. Moreover, while
claims 11—20, 23, and 24 are presently identified by Appellants as
“withdrawn,” the same July 7, 2014 amendment indicates that these claims
are cancelled.
Appeal 2015-006484
Application 13/035,692
We affirm-in-part. We enter NEW GROUNDS OF REJECTION for
claims 4—8, 10, and 25 under 35 U.S.C. § 103(a).
STATEMENT OF THE CASE
The Specification explains, “[t]he present invention provides a
method of sensitizing a subject to a therapeutic modality, comprising
administering a sensitizing dose of an immunomodulating gel composition
in combination with an effective challenge dose of the immunomodulating
gel composition to the subject. Preferably, the immunomodulating gel
composition comprises Diphenylcyclopropenone (DPCP).” Spec. 7:22—26.
The Specification also states, “[t]he present invention is based on the
discovery that a low sensitizing dose of about 0.4% DPCP gel compared to
the standard sensitizing dose of 2.0% DPCP used in the art prevents the
subject from becoming overly hypersensitive to the challenge dose.” Id. at
7:30-8:1. Further, the Specification states, “[cjontrary to prior art methods,
the present invention allows for a higher challenge dose of about 0.04%
DPCP compared to the prior art challenge dose of 0.002% DPCP.” Id. at
8:7-8.
Claims 1, 21, 22, and 25 are the independent claims, are
representative, and are reproduced below:
1. A method of treating a disease or disorder associated
with human papilloma virus infection in a human patient, the
method comprising administering to a first site on the skin of said
human patient a sensitizing immunomodulating gel composition
comprising about 0.4% (w/w) diphenylcyclopropenone (DPCP),
and subsequently administering to a second site on the skin of
said patient a challenge immunomodulating gel composition
comprising about 0.04% (w/w) to about 0.1 % (w/w) DPCP.
2
Appeal 2015-006484
Application 13/035,692
21. A method of treating a disease or disorder associated
with human papilloma vims infection in a human patient, the
method comprising administering to the skin of said human
patient a sensitizing composition comprising about 0.4% (w/w)
DPCP, followed by administering a challenge composition
comprising about 0.04% (w/w) DPCP at 14 days, and then
administering a challenge composition comprising about 0.04%
(w/w) DPCP weekly for at least 6 weeks.
22. A method of treating a disease or disorder associated
with human papilloma vims infection in a human patient, the
method comprising administering to the skin of said human
patient a sensitizing composition comprising about 0.4% (w/w)
DPCP, followed by administering a challenge composition
comprising about 0.04% (w/w) DPCP at 14 days, and then
administering a challenge composition comprising about 0.04%
(w/w) DPCP biweekly for at least 6 weeks.
25. A method of enhancing an immune response in a
human patient in need thereof, the method comprising
administering to a first site on the skin of said human patient a
sensitizing immunomodulating gel composition comprising
about 0.4% (w/w) diphenylcyclopropenone (DPCP), and
subsequently administering to a second site on the skin of said
patient a challenge immunomodulating gel composition
comprising about 0.04% (w/w) to about 0.1 % (w/w) DPCP.
App. Br. 40, 43 (Claims App’x).
The following rejections are on appeal:
Claims 1 and 2 stand rejected under 35 U.S.C. § 103(a) over Upitis3
and Kaplan 136.4 Final Act. 3.
3 Jennifer A. Upitis and Alfons Krol, The Use of Diphenylcyclopropenone in
the Treatment of Recalcitrant Warts, J. Cutaneous Med. and Surgery
214—17 (2002) (“Upitis”).
4 US 2005/0260136 A1 (published Nov. 24, 2005) (“Kaplan 136”).
3
Appeal 2015-006484
Application 13/035,692
Claims 3—8 stand rejected under PCT Article 33(3) as obvious over
Upitis, Kaplan 136, and Buckley.5 Id. at 11.
Claims 9 and 10 stand rejected under PCT Article 33(3) as obvious
over Upitis, Kaplan 136, and Kaplan 766.6 Id. at 18.
Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) over
Kaplan 766 and Buckley. Id. at 23.
Claim 25 stands rejected under 35 U.S.C. § 103(a) over Kumamoto7
and Kaplan 766. Id. at 28.
FINDINGS OF FACT
Except where otherwise indicated in this decision, we agree with and
adopt the Examiner’s findings of fact and determinations as to the scope and
content of the prior art. We identify the following facts to highlight certain
evidence of record.
FF1. Upitis discloses “[t]he treatment of recalcitrant
palmoplantar and periungual warts using topical immunotherapy with
diphenylcyclopropenone (DPC[P]),” where, in a specified therapy, 2%
DPCP was used “[t]o sensitize the patient, [where] DPC[P] was
applied to the left medial arm skin,” and “then [after three weeks,]
treatment began with a[n] extremely thin layer of 1% DPC[P] applied
directly to the wart with occlusion,” where “[t]he cure rate for this
study was 135/154 (87.7%).” Upitis 214, 215; see also Final Action
5 D.A. Buckley and A.W.P. Du Vivier, The Therapeutic use of Topical
Contact Sensitizers in Benign Dermatoses, 145 Brit. J. Dermatology 395—
405 (2001) (“Buckley”).
6 US 2006/0211766 A1 (published Sept. 21, 2006) (“Kaplan 766”).
7 US 7,067,254 B2 (issued June 27, 2006) (“Kumamoto”).
4
Appeal 2015-006484
Application 13/035,692
3—8, 10-11, 13—23 and Ans. 2-4, 6—11 (discussing Upitis). As
determined by the Examiner, based on this, “[i]t is without dispute
that Upitis . . . teaches a method of treatment of HPV-related disease
comprising administering both a sensitizing and challenge dose of
DPCP” at respective first and second sites and “[t]he difference
between the method of Upitis . . . and the present claim [1] is solely
the concentration of DPCP applied to the patient’s skin in the first and
second steps.” Ans. 3; Final Action 8.
FF2. Upitis discloses “[t]he concentration [of DPCP] was
increased or decreased to maintain a good clinical response with
minimal side effects.” Upitis 215; see also Final Action 3—8, 10-11,
13—23 and Ans. 2—4, 6—11 (discussing Upitis). Thus, as determined
by the Examiner, Upitis identifies motivation to adjust DPCP dosages
in sensitization/challenge treatment therapy. Ans. 4.
FF3. Upitis discloses that after sensitizing, “[ljarger reactions
or a vesicular reaction indicated increased sensitivity to the therapy
and DPC[P] treatment began at [the adjusted dose of] 0.5%.” Upitis
215; see also Final Action 3—8, 10-11, 13—23 and Ans. 2-4, 6—11
(discussing Upitis). Thus, Upitis teaches that, where appropriate, the
treatment (i.e., challenge) dose of DPCP can be increased or reduced.
FF4. Upitis discloses treating/challenge doses of DPCP of,
inter alia, 0.01—1.0% resulting in a 62% cure rate; 0.001—3.0%
resulting in a 60% cure rate; and 0.01—6.0% resulting in an 88% cure
rate. Upitis 216 (Table 1); see also Final Action 3—8, 10-11, 13—23
and Ans. 2-4, 6—11 (discussing Upitis). Thus, as determined by the
Examiner, Upitis suggests varying the treatment (i.e., challenge) dose
5
Appeal 2015-006484
Application 13/035,692
of DPCP within the disclosed ranges, which include the claimed
challenge dose of about 0.04%, and also suggests that doing so would
be reasonably expected to be successful. See Ans. 3—5.
FF5. Upitis discloses DPCP therapy continued for “at least 6
treatments,” “over 6 months.” Upitis 215; see also Final Action 3—8,
10-11, 13—23 and Ans. 2-4, 6—11 (discussing Upitis).
FF6. Kaplan 136 discloses:
compositions and methods of this invention are used to assess the
level of immune competence of tested individuals based on the
degree of immune response as a surrogate marker of CD4 T Cell
lymphocytes as measured by the intensity of the resultant skin
reaction score following controlled topical application of a
unique anhydrous composition containing a contact sensitizer.
The results of assessment are useful in determining appropriate
treatment of immuno-compromised patients. Preferred
compositions contain, but are not limited to, Diphenylcycl-
propenone [DPCP] as a preferred embodiment of the class of
contact sensitizing agents applied to the skin in an optimally
prepared formulation preferably containing about 0.4% of the
contact sensitizer.
Kaplan 136 abstract; see also Final Action 3—5, 8—11, 13—23, and
Ans. 3—11 (discussing Kaplan 136).
FF7. Kaplan 136 discloses experimental examples used to
determine an effective threshold dosage concentration for DPCP as a
contact sensitizer and identifies that a concentration of 0.4% DPCP
was the lowest concentration tested that reliably evoked a skin
reaction indicating an immune response in patients capable of so­
reacting. Kaplan 136 H 18—34; see also Final Action 3—5, 8—11, 13—
23, and Ans. 3—11 (discussing Kaplan 136). Thus, as determined by
the Examiner, the skilled artisan, motivated by Upitis to identify a
6
Appeal 2015-006484
Application 13/035,692
dose of DPCP for effective stimulation while also minimizing side
effects, would look to Kaplan 136, which identifies the lowest reliable
threshold dosage of DPCP for an immune-response-evoking,
sensitizing application. See, e.g., Ans. 9.
FF8. Further to the immediately preceding finding of fact,
Kaplan 136 also discloses that, in testing, a DPCP dosage of (about)
0.05% never evoked a visible skin reaction (i.e., blisters, spontaneous
flare, vesicles, cutaneous induration erythema, or erythema) in
patients. Kaplan 136 Tfl[ 21—22, 26, 33, 34; see also Final Action 3—5,
8—11, 13—23, and Ans. 3—11 (discussing Kaplan 136). Kaplan 136,
nevertheless, recites a dosage of about 0.05% DPCP as within the
scope of its invention. Kaplan claims 4 and 10.
FF9. Buckley discloses the treatment of “[v]iral warts [where]
[s]ensitization [with] 2% DPCP is carried out on a 1-cm2 area of skin
on the inner upper arm. . . . DPCP is then [after 1—2 weeks,] applied
to the warts (pared down where possible) at an initial concentration of
0.1%” and “[r]epeat treatments are carried out at intervals of 1—4
weeks” for “six or more treatments.” Buckley 387—88 (emphasis
omitted); see also Final Action 11—18, 23—27, and Ans. 9—14
(discussing Buckley).
FF10. Buckley teaches that “[t]he concentration of DPCP is
adjusted,” e.g., from 0.1% up to 6.0%. Buckley 388; see also Final
Action 11—18, 23—27, and Ans. 9—14 (discussing Buckley).
FF11. Buckley discloses treating doses of DPCP of, inter alia,
0.1—1% daily or weekly for up to 9 months resulting in improvement
or cure in 6 of 6 patients completing treatment; 0.004—1% daily or
7
Appeal 2015-006484
Application 13/035,692
weekly for up to 8.6 months resulting in improvement or cure in 28 of
45 patients completing treatment; 0.001—3% weekly for up to 8 weeks
resulting in improvement or cure in 64 of 112 patients completing
treatment; and 0.01—6% weekly, biweekly, every 3 weeks, or every 4
weeks for 6 or more treatments resulting in improvement or cure in 42
of 48 patients completing treatment. Buckley 389 (Table 1); see also
Final Action 11—18, 23—27, and Ans. 9—14 (discussing Buckley).
FF12. Kaplan discloses DPCP in gel delivery systems with “a
first co-solvent selected from the group consisting of polyoxyethylene
20 monoleate, palmitate and stearate, and a second co-solvent
consisting of isopropyl myristate or[]isopropyl palmitate, and a
gelling agent polyoxyl 40 stearate.” Kaplan 766 claim 2; see also
Final Action 18—30, and Ans. 10-12, 14—15 (discussing Kaplan 766).
FF13. Kaplan discloses “the preferred delayed type contact
sensitizer hapten embodiment is diphenylcyclopropenone comprised
from about 0.001% to 4.000% by weight.” Kaplan 766 claim 4,119;
see also Final Action 18—30, and Ans. 10-12, 14—15 (discussing
Kaplan 766).
FF14. Kaplan discloses treating warts caused by human
papilloma virus by applying an immunomodulating gel as a
sensitizing dose followed by a lower concentration of treatment doses,
e.g., over an 8 week period. Kaplan Abstract, || 13—22; see also
Final Action 18—30, and Ans. 10-12, 14—15 (discussing Kaplan 766).
8
Appeal 2015-006484
Application 13/035,692
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015).
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result,” and
“[t]he combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing U.S. v.
Adams, 383 U.S. 39, 50-51 (1966)). “Aprima facie case of obviousness
typically exists when the ranges [or a point therein] of a claimed
composition overlap the ranges disclosed in the prior art.” In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003). “Selecting a narrow range [or point]
from within a somewhat broader range disclosed in a prior art reference is no
less obvious than identifying a range that simply overlaps a disclosed
range.” Id. at 1329—30.
“[T]he existence of overlapping or encompassing ranges shifts the
burden to the applicant to show that his invention would not have been
obvious.” Id. at 1330. “[W]here there is a range disclosed in the prior art,
and the claimed invention falls within that range, there is a presumption of
obviousness. But the presumption will be rebutted if it can be shown:
(1) [t]hat the prior art taught away from the claimed invention, In re Geisler,
116 F.3d 1465, 1471 (Fed. Cir. 1997); or (2) that there are new and
unexpected results relative to the prior art, In re Woodruff, 919 F.2d 1575,
9
Appeal 2015-006484
Application 13/035,692
1578 (Fed. Cir. 1990).” Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d
1317, 1322 (Fed. Cir. 2004). To show criticality of a claimed range, ‘“it is
not inventive to discover the optimum or workable ranges by routine
experimentation.’ In re Aller, 220 F.2d 454, 456 (CCPA 1955). Only if the
‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be
obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620
(CCPA 1977).” Geisler, 116 F.3d at 1469.
As to motivation to combine separately disclosed subject matter, “‘the
question is whether there is something in the prior art as a whole to suggest
the desirability, and thus the obviousness, of making the combination.’” In
re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation omitted). “The
normal desire of artisans to improve upon what is already generally known
can provide the motivation to optimize variables such as the percentage of a
known [chemical] for use in a known [therapy].” See Peterson, 315 F.3d at
1330; see also KSR, 550 U.S. at 421 (“A person of ordinary skill is also a
person of ordinary creativity, not an automaton.”).”
Claims 1 and 2
We find, under the above-cited precedent and the evidence of record,
the Examiner has established a prima facie case that claim 1 would have
been obvious over Upitis and Kaplan 136. Claim 2 depends from claim 1
and falls therewith.
For example, as the Examiner determines, Upitis discloses the entirety
of the subject matter of claim 1, except the specific recited dosages of DPCP
used for sensitization and challenge treatments. FF1. The Examiner is also
correct that Upitis suggests adjusting such dosages for clinical results and to
10
Appeal 2015-006484
Application 13/035,692
minimize side effects. FF2. For treatment dosages of DPCP, Upitis teaches
that, even for its disclosed treatment of focus, the dosage could be optimized
to 0.5% DPCP (adjusted from 1%), and also discloses DPCP treatment
dosages spanning 0.001% to 6.0% achieved significant cure rates in patients.
FF3, FF4.
We agree with the Examiner that the skilled artisan looking to tailor a
DPCP sensitizing dose to maximize clinical effect and minimize side effects
would look to Kaplan 136, which is directed to ascertaining the immune
system competency of an individual by topically applying DPCP to observe
skin reactivity and specifically identifies that a DPCP sensitizing dose of
about 0.4% is the lowest reliable sensitizing dose. FF6, FF7.
Thus, in view of the teachings of Upitis and Kaplan 136, it would
have been obvious to use a sensitizing dose of about 0.4% DPCP at a first
site and a challenge dose (or several) of about 0.04% DPCP to treat warts
(caused by human papilloma virus infection). Further, there would have
been reasonable motivation to combine the references because they are in
the same field of endeavor (sensitizing DPCP dosing) and use the same
treating agents, and there would have been a reasonable expectation of
successfully making the combination because of the successes reported by
each reference. Further, while not relied upon by the Examiner or to
specifically support this Decision, we note that Kaplan 136 also identifies
that a DPCP dosage of (about) 0.05%, while not a reliable sensitizing dose,
is nevertheless useful (FF8), which further supports that optimizing a
(challenge) dosage of DPCP to be about 0.04%, when presented with the
treatment dosage ranges taught by Upitis, would have been obvious to the
skilled artisan.
11
Appeal 2015-006484
Application 13/035,692
Appellants have not produced persuasive evidence showing, or
persuasively argued, that the Examiner’s determinations are incorrect. We
address Appellants’ arguments below.
Appellants argue that the combination of Upitis and Kaplan 136 fails
to teach sensitizing a patient with about 0.4% DPCP and treating the subject
with a challenging dose of about 0.04% DPCP because Upitis teaches only
sensitizing with 2% DPCP and Kaplan 136 does not teach a sensitizing step.
App. Br. 14—15. This argument is not persuasive. As we discussed above,
Upitis and Kaplan 136, combined, teach and suggest a treatment where a
sensitizing dose of about 0.4% DPCP is used, followed by challenge doses
of about 0.04% DPCP, because Upitis teaches the general
sensitizing/challenge dose therapy, Kaplan 136 teaches a sensitizing dose of
about 0.4%, and Upitis teaches successfully using ranges of challenge doses
encompassing about 0.04%.
Appellants argue that there would have been no motivation to
combine Upitis and Kaplan 136 to achieve the claimed invention because
Upitis does not suggest changing DPCP doses from its disclosed therapy of
focus, which does not use the claimed doses, because the data of Upitis cited
by the Examiner, i.e., the DPCP treatment doses of Table 1, do not show a
clear correlation to cure and because Kaplan 136 is directed to only HIV
treatment. App. Br. 15—16. These arguments are not persuasive. Although
Upitis is not explicit about what specific dosages of DPCP disclosed in its
Table 1 were found to cure patients of warts, it both teaches that DPCP
concentrations should be adjusted in view of clinical response and side
effects, and discloses ranges of doses encompassing the claimed challenge
dose and reports that there was significant success achieved therewith. FF2,
12
Appeal 2015-006484
Application 13/035,692
FF4. This provides sufficient reason for the skilled artisan to optimize
DPCP challenge dosing within Upitis’s reported successful ranges. Also,
while Kaplan 136 is most specifically directed to determining whether HIV
patients have a competent immune system, the reference discloses evoking
an immune response by topically applying DPCP, which relates to effective
sensitizing doses of DPCP and, therefore, would reasonably be considered
by the skilled artisan when attempting to optimize a DPCP sensitizing dose
as suggested by Upitis.
Appellants argue the skilled artisan would not have had a reasonable
expectation of success in combining Upitis and Kaplan 136, because Kaplan
136 is not directed to treating warts and because Upitis’s Table 1 does not,
with adequate specificity, correlate DPCP concentrations with cure rates.
App. Br. 16—18. These arguments are not persuasive. As discussed above,
whether Kaplan 136 is directed to treating warts is not determinative.
Kaplan 136 teaches a skilled artisan, having Upitis in hand, how a reliable
sensitizing dose of DPCP can be made as low as possible in view of the
objective of evoking an immunological response and minimizing side
effects. Moreover, as discussed above, Upitis may not be specific as to what
DPCP challenge doses correlate to cure, but it does identify ranges that
achieve significant success rates and encompass the claimed about 0.04%
challenge dose.
Appellants also argue that their Specification provides “evidence of
unexpected result over the prior art.” App. Br. 35—37 (citing Spec. 7—9, 43—
44, and Upitis 215). Appellants contend the Specification describes that the
prior art’s use of 2.0% DPCP as a sensitizing dose “was ‘in essence an
‘overdose”” and that the Specification describes using a “low DPCP
13
Appeal 2015-006484
Application 13/035,692
concentration (about 0.4% (w/w) DPCP) prevents the subject from
becoming overly hypersensitive to the challenge dose.” Id. at 36.
Appellants further argue that the Specification describes “subjects submitted
to the methods of the invention experienced very high clinical responses and
improvements (80% to 100%), and no significant side effects other than skin
rash at the sensitization site.” Id. This evidence is considered, but is not
persuasive in overcoming the evidence of obviousness.
“To be particularly probative, evidence of unexpected results must
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
Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
Here, Appellants’ evidence shows that, when using the therapy of the
invention, “4/5 subjects (80%) in the DPCP group obtained a clinical
response/improvement” with “[cjomplete clearance occur[ing] in 4/6 (67%
of the treated warts,” and “[n]o significant side effects were reported other
than skin rash at the sensitization site.” Spec. 43 44. We compare this
evidence to Upitis (at 215), as did Appellants, which discloses for one
therapy methodology using a sensitizing dose of 2% DPCP and
challenge/treatment doses of 0.5%, 1%, 2%, up to 4% DPCP, which
achieved a cure rate of 87.7% and also caused “side effects, including
pruritus [itch], eczema [rash], and vesicular reaction [rash].”
In comparison, Appellants’ invention was not reported to achieve
even as high a cure rate as the prior art and its side effects were described as
similar to the prior art (e.g., rashes). Moreover, Upitis specifically suggests
that adjusting the sensitizing dose can reduce side effects and also that
14
Appeal 2015-006484
Application 13/035,692
challenge doses of DPCP encompassing the claimed about 0.04%
successfully cured warts in patients (e.g., 62—88% of patients). FF2—FF4.
Therefore, we do not find Appellants’ evidence to show unexpected results
in view of the prior art sufficient to rebut the Examiner’s prima facie case
for obviousness.
For the reasons above, we affirm this rejection.
Claims 4—8
The Examiner rejected claims 4—8 under PCT Article 33(3) as obvious
over Upitis, Kaplan 136, and Buckley. Final Action 11. Appellants treated
this rejection as having been made over the cited prior art combination, but
under 35 U.S.C. § 103(a). App. Br. 18. The Examiner’s citation to the PCT
as the basis for the rejection is not proper, but we treat it as an obviousness
rejection under 35 U.S.C. § 103(a), as did Appellants, and designate it as a
new ground of rejection.
We find, under the above-cited precedent and the evidence of record,
the Examiner has established a prima facie case that claims 4—8 would have
been obvious over Upitis, Kaplan 136, and Buckley. These claims depend
from independent claim 1, discussed above, and the Examiner cites Upitis
and Kaplan 136 for the same reasons as for the rejection of claim 1 over
these references. We will not restate these references’ relevance or
teachings here. Additionally, the Examiner determines Buckley, like Upitis,
discloses successful doses of DPCP for challenge applications as claimed
and, further, various schedules for such treatments that render the claimed
treatment schedules obvious. See Final Action 12; FF9—FF11.
15
Appeal 2015-006484
Application 13/035,692
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Regarding claim 4, Appellants argue Buckley does not teach the
specific sensitizing and challenge compositions recited by claim 1. App. Br.
19. As discussed above, this subject matter is disclosed by Upitis and
Kaplan 136. See FF1—FF8. However, we note Buckley does suggest
adjusting the dosing of DPCP and discloses successful DPCP treatment
doses ranging from 0.001% to 6%, which encompasses the claimed about
0.04%. FF11.
Appellants argue there would have been no motivation to combine the
cited prior art and no reasonable expectation of successfully doing so,
restating their arguments presented for claim 1. These arguments are not
persuasive for the same reasons as discussed above regarding the rejection of
claim 1. Further, Buckley is directed to the same field of endeavor as Upitis
and, so, would have been obvious to combine therewith.
Appellants separately set out claims 5, 6, 7, and 8 in their brief, but do
not present separate arguments for these claims different from those
presented for claim 4. Therefore, these claims fall with claims 1 and 4.
For the reasons above, we affirm the Examiner’s rejection, but
designate it as a NEW GROUND OF REJECTION under 35 U.S.C.
§ 103(a).
Claim 10
The Examiner rejected claim 10 under PCT Article 33(3) as obvious
over Upitis, Kaplan 136, and Kaplan 766. Final Action 18. As with the
16
Appeal 2015-006484
Application 13/035,692
rejection discussed immediately above, Appellants treated this rejection as
having been made over the cited prior art combination, but under 35 U.S.C.
§ 103(a). App. Br. 22. The Examiner’s citation to the PCT as the basis for
the rejection is, again, not proper, but we treat it as an obviousness rejection
under 35 U.S.C. § 103(a), as did Appellants, and designate it as a new
ground of rejection.
We find, under the above-cited precedent and the evidence of record,
the Examiner has established a prima facie case that claim 10 would have
been obvious over Upitis, Kaplan 136, and Kaplan 766. This claim depends
from independent claim 1, discussed above, and the Examiner cites Upitis
and Kaplan 136 for the same reasons as for the rejection of claim 1 over
these references. We will not restate these references’ relevance or
teachings here. Additionally, the Examiner finds Kaplan 766 discloses the
specific gel formulation of claim 10 and also disclosed sensitizing doses of
DPCP ranging from about 0.001% to about 4.000%, which encompasses the
claimed sensitizing dose of about 0.4% and bolsters the obviousness case for
this claim limitation. FF12—FF14.
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
As indicated above, claim 10 depends from independent claim 1.
Appellants essentially restate their arguments made for the patentability of
claim 1 in support of the patentability of claim 10. These arguments are not
persuasive, as discussed above.
17
Appeal 2015-006484
Application 13/035,692
For the reasons above, we affirm the Examiner’s rejection, but
designate it as a NEW GROUND OF REJECTION under 35 U.S.C.
§ 103(a).
Claims 21 and 22
We find, under the above-cited precedent and the evidence of record,
the Examiner has established a prima facie case that claims 21 and 22 would
have been obvious over Kaplan 766 and Buckley. For example, the
Examiner determined that the claimed sensitizing dose of about 0.4% DPCP
is taught by Kaplan 766 (e.g., Kaplan 766 teaches sensitizing with DPCP at
0.001 4.000%) and that the claimed general treatment methodology and
challenge dosing of about 0.04% DPCP is taught by Buckley (Buckley
teaches successful treatment/challenge doses of 0.001% to 6%), and that
Buckley teaches or suggests the claim elements directed to the schedule of
challenge dosing (Buckley teaches challenge doses given daily, weekly,
biweekly, every 3 weeks, or every 4 weeks, beginning 1—2 weeks post-
sensitizing, for up to 6 treatments or up to 9 months, for example). FF9—
FF14.
Thus, in view of the teachings of Kaplan 766 and Buckley, it would
have been obvious to use a sensitizing dose of about 0.4% DPCP at a first
site and a challenge dose (14 days later) of about 0.04% DPCP at a second
site to treat warts (caused by human papilloma virus infection), and to
schedule continuing challenge doses every week or biweekly thereafter for
at least 6 weeks. We agree with the Examiner that there would have been
motivation to combine the references because they are in the same field of
endeavor and use the same treating agents, and that there would have been a
18
Appeal 2015-006484
Application 13/035,692
reasonable expectation of successfully making the combination because of
the successes (FF11) reported by Buckley.
Appellants have not produced persuasive evidence showing, or
persuasively argued, that the Examiner’s determinations are incorrect. We
address Appellants’ arguments below.
Appellants present the same arguments for claims 21 and 22.
Appellants argue Kaplan 766 does not teach the claimed DPCP
concentrations, i.e., about 0.4% sensitizing dose and about 0.04% to about
0.1% challenge dose, and Buckley does not cure this deficiency. App. Br.
26,29. This is not persuasive. As discussed above, Kaplan 766 discloses
sensitizing DPCP doses of 0.001^4.000%, which encompasses the claimed
dose. Buckley discloses challenge DPCP doses of 0.001% to 6%, which
encompasses the claimed dose. Under the above-cited precedent, the narrow
claimed ranges (or points) are within the broader ranges of the prior art and,
therefore, are obvious because Appellants have not shown the prior art
teaches away from the claimed dosages and have not convincingly
established unexpected results. See Peterson 315 F.3d at 1329—30; Iron
Grip Barbell, 392 F.3d at 1322.
Appellants argue there would be no motivation to combine the cited
prior art and no reasonable expectation of successfully doing so, restating
their arguments presented for claim 1, but inserting Kaplan 766 and Buckley
in place of Upitis and Kaplan 136. App. Br. 26—28, 30-32. Like Upitis and
Kaplan 136, Kaplan 766 and Buckley are directed to the same general
endeavor and, so, there would be reasonable motivation to combine their
teachings. And, like Upitis, Buckley discloses significant success using
treatment doses of DPCP encompassing the claimed range. So, there would
19
Appeal 2015-006484
Application 13/035,692
have been a reasonable expectation of successfully making the prior art
combination to achieve the claimed subject matter.
For the reasons above, we affirm this rejection.
Claim 25
The Examiner rejected claim 25 over Kumamoto and Kaplan 766,
finding that Kumamoto taught a sensitizing dose of 1.23% oxazolone and a
challenge dose of 0.5% oxazolone and that Kaplan 766 taught a DPCP
sensitizing dose (i.e., 0.001—4.000%), as discussed above. Appellants take
issue with the fact that Kumamoto is directed to a wholly different active
agent, i.e., oxazolone, than the claimed DPCP. App. Br. 32—33. We are
persuaded and agree that the combination of Kumamoto and Kaplan 766
does not render the claimed method obvious.
As argued by Appellants, there is no evidence that oxazolone and
DPCP are equivalent chemicals such that the dosages of either are
interchangeable. Reply Br. (part V). Further, even were these two
chemicals interchangeable, the Examiner cites Kumamoto as teaching
sensitizing and challenge doses not recited by claim 25. Even if we include
Kaplan 766’s disclosure of the claimed sensitizing dose, the prior art
combination is still deficient in teaching the claimed challenge dose. For
these reasons, we reverse the Examiner’s rejection and enter a new ground
of rejection of claim 25, as discussed below.
Claim 25 defines essentially the same invention as, if slightly broader
than, claim 1. We affirmed the Examiner’s rejections of claim 1 and
dependent claims 4—8 as obvious over Upitis and Kaplan 136, and also
including Buckley in the case of the dependent claims. We designate a new
20
Appeal 2015-006484
Application 13/035,692
ground of rejection of claim 25 under 35 U.S.C. § 103(a) over Upitis and
Kaplan 136, and optionally also including Buckley. As discussed in detail
above, this prior art combination teaches and suggests a sensitizing dose of
about 0.4% DPCP at a first site and a challenge dose of about 0.04% (or up
to about 0.01%) DPCP at a second site on the skin to treat a patient by
evoking an immune response. FF1—FF11. Therefore, for the same rationale
supporting the Examiner’s rejections over claims 1 and 4—8 over this prior
art combination and for our reasons in affirmance thereof, supra, we
conclude claim 25 would also be obvious over Upitis and Kaplan 136, and
also, optionally, Buckley, and enter a NEW GROUND OF REJECTION.
SUMMARY
The rejection of claims 1 and 2 under 35 U.S.C. § 103(a) over Upitis
and Kaplan 136 is affirmed.
The rejection of claims 4—8 under 35 U.S.C. § 103(a) over Upitis,
Kaplan 136, and Buckley is affirmed as a new ground of rejection.
The rejection of claim 10 under 35 U.S.C. § 103(a) over Upitis,
Kaplan 136, and Kaplan 766 is affirmed as a new ground of rejection.
The rejection of claims 21 and 22 under 35 U.S.C. § 103(a) over
Kaplan 766 and Buckley is affirmed.
The rejection of claim 25 under 35 U.S.C. § 103(a) over Kumamoto
and Kaplan 766 is reversed.
A new ground of rejection of claim 25 under 35 U.S.C. § 103(a) over
Upitis, Kaplan, and, optionally, Buckley is designated.
21
Appeal 2015-006484
Application 13/035,692
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). Section 41.50(b) provides, “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.” Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate amend­
ment of the claims so rejected or new Evidence relating to the
claims so rejected, or both, and have the matter reconsidered by
the examiner, in which event the prosecution will be remanded
to the examiner. The new ground of rejection is binding upon
the examiner unless an amendment or new Evidence not
previously of Record is made which, in the opinion of the
examiner, overcomes the new ground of rejection designated in
the decision. Should the examiner reject the claims, appellant
may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
AFFIRMED-IN-PART; 37 C.F.R, $ 41,501b)
22