Ex Parte OBI

Patent Trial and Appeal Board

Feb 16, 2017

13932445 (P.T.A.B. Feb. 16, 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.
31632ZY 2023
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
13/932,445 07/01/2013
24230 7590 0
Ream Law Firm, L.L.C.
210 W. TECUMSEH STREET
OTTAWA, KS 66067
Justice E. OBI
02/17/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUSTICE E. OBI1
Appeal 2017-000275
Application 13/932,445
Technology Center 1600
Before ULRIKE W. JENKS, TIMOTHY G. MAJORS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of treating papillomavirus infection. The Examiner rejects the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant, the Real Party in Interest is Graceland Biogenesis
International Catalyst, LLC. Appeal Br. 2.
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Application 13/932,445
STATEMENT OF THE CASE
The Specification describes methods of treating papilloma virus
infections in mammalian hosts. Spec. 1:10—12. The Specification explains
that many of the current methods “include burning or freezing away the wart
(using chemicals or an electrical current), which can often be a painful
process, and in any event can leave unsightly scarring.” Id. 2:27—29. The
Specification explains that agents that “treat disorders of the immune
system, also have utility in treating infections of the human and other
mammalian papillomaviruses, and in particular, in treating and inhibiting
replication of such viruses.” Id. 9:4—6.
Claims 1—5, 10, 13, 25, and 31—61 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 1 is illustrative of the
claims on appeal, and reads as follows:
1. A method of topically treating an existing papillomavirus
infection in a mammalian subject in need thereof, comprising
administering topically to a localized area of infection of said
mammalian subject a therapeutically effective amount of at least
one compound selected from the group consisting of
chloroquine, hydroxychloroquine, amodiaquine as the only
active ingredient and respective pharmaceutically acceptable
salts thereof, wherein said mammalian subject receives said
topical administration once or twice a day for about two days to
about two weeks.
Appeal Br. 9
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Appellant seeks review of the Examiner’s rejection of claims 1—5, 10,
13, 25, and 31—61 under 35 U.S.C. § 103(a) as unpatentable over Wilson2 in
view of Baldwin3 and Albahri.4
As Appellant does not argue the claims separately (see Appeal Br. 8),
we focus our analysis on claim 1, and claims 2—5, 10, 13, 25, and 31—61
stand or fall with that claim. 37 C.F.R. § 41.37 (c)(l)(iv).
The Examiner finds that
(1) Wilson teaches the use of antimalarial agent,
hydroxychloroquine, for treating viral warts; (2) Baldwin et al.
teaches that chloroquine (including the phosphate, hydrochloride
and free base forms); hydroxychloroquine; amodiaquine
(including the hydrochloride and free base forms) are well-
known antimalarial agents, therefore functionally equivalent;
and (3) chloroquine, hydroxychloroquine, and amodiaquine are
structurally equivalent since Baldwin et al. teaches all three to be
4-aminoquinolines.
Final Act. 5.5
The Examiner concludes that based on the combination of references
the ordinary artisan would have had “a reasonable expectation of success in
treating viral warts with not only hydroxychloroquine, but also chloroquine
and amodiaquine and in the claimed amounts and ratios.” Id. The Examiner
relies on Albahri for teaching “parenteral administration of an antiviral
composition for treating viral-induced tumors, lesions, and diseases in
humans caused by Human Papillomavirus (abstract)” wherein the
2 Wesley W. Wilson, Clinical evaluation of Intralesional Administration of
Hydroxychloroquine Sulfate in Several Diseases, 56 Southern Medical
Journal 794—796 (1963).
3 Baldwin et al., US 5,021,426, issued June 4, 1991 (“Baldwin”).
4 Albahri, US 2004/0109899 Al, issued June 10, 2004.
5 Final Office Action, dated March 15, 2016 (“Final Act.”).
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compositions “may be formulated for topical or subcutaneous application on
the afflicted tumor (wart) of the human.” Id. at 6. The Examiner concludes
that
it would have been prima facie obvious to a person of ordinary
skill in the art, at the time the claimed invention was made, to
have formulate the antiviral composition comprising
chloroquine, hydroxychloroquine, and amodiaquine, as taught by
Wilson and Baldwin et al., for topical administration in the form
of a patch, cream, aerosol, spray, or gel in the method of treating
verrucae warts, flat warts, plantar warts, or anogenital warts in a
human with a papillomavirus infection, as taught by Albarhi.
Id.
Appellant contends that “Wilson does not disclose topical
administration of chloroquine and amodiaquine, and in the claimed amounts
and administration conditions,” and that Baldwin “is not directed to the
treatment of papillomavirus, or even the treatment of viral skin diseases.”
Appeal Br. 5. Appellant contends that
[njowhere does Albahri suggest that topical formulation would
be appropriate for other medicaments, and especially not the
claimed compounds. And neither Wilson nor Baldwin
discusses topical formulation of the compounds either. Just
because one means of topically treating a virus was successful
does not mean that all other compounds can be topically
formulated with any reasonable expectation of success.
Id. at 7.
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that the combination of references renders the
claims obvious?
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Findings of Fact
FF1. Wilson teaches treating 637 warts in a total of 182 patients with
intralesional injection of hydroxychloroquine sulfate into virus warts
(Verruca vulgaris). Wilson 795. The hydroxychloroquine “was
supplied in 3 cc. ampules each cc containing 40 mg of
hydroxychloroquine sulfate.” Id. at 794. “In most patients from 0.1
to 0.5 cc per sq. cm. could be given without discomfort.” Id. “In
many patients only one injection was required, and in most 2 or 3
injections produced a cure.” Id.
FF2. The Examiner acknowledges that “Wilson fails to specifically disclose
topical administration of chloroquine” or hydroxychloroquine sulfate.
Final Act. 4.
FF3. Baldwin teaches “4-Aminoquinolines: chloroquine (including the
phosphate, hydrochloride and free base forms); hydroxychloroquine
[sic]; amodiaquine (including the hydrochloride and free base
forms)”. Baldwin 8:8—11.
FF4. Baldwin teaches that each “individual patient may present a wide
variation in severity of symptoms and each drug has its unique
therapeutic characteristics, it is up to the practitioner to determine the
patient’s response to treatment and vary the dosages accordingly.”
Baldwin 7:50-54.
FF5. Albahri discloses the production of antiviral medicaments for the
treatment of papilloma virus infections. See Albahri, Title and
Abstract.
A wart (also known as verrucas) is a small flesh colored
usually hard tumorous growth of the skin which is characterized
by circumscribed hypertrophy of the papillae of the corium, with
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Application 13/932,445
thickening of the malpighian, granulation and keratin layers of
the epidermis. Verucca vulgaris, a subset of warts or verruca, is
characterized by infection of the keratinocytes with human
papillomavirus.
Id. 15 (emphasis added).
FF6. Albahri discloses preparation of liquid extracts derived from mixing
ground sheep kidney distilled water in equal volumes. Albahri 1145.
“A typical usage example for the medicament is to apply a kidney or
extract either pure or embodied in a carrier directly to the infected
area of the skin at least once every day for a period of two weeks.” Id.
1150.
FF7. Albahri discloses:
Creams, lotions, soaps, shampoos, detergents, and gels are
especially preferred for their ability to keep the prophylactic and
therapeutic compositions in prolonged contact with the skin
and/or tumor for a sufficient period of time. Further formulations
may be in the form of a lipstick balm, embodied in a patch, or
directly injected into the wart with a needle.
Id. 1122 (emphasis added).
Principle of Law
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007). “Obviousness does not require absolute
predictability of success. ... For obviousness under § 103, all that is
required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d
894, 903-904 (Fed. Cir. 1988).
Analysis
To summarize, claim 1 is directed to treating a papillomavirus
infection, also known as a wart, in a mammalian subject by topically
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administering hydroxychloroquine one to two times a day for a period of
two to 14 days. Claim 1 lists two other therapeutic compounds, chloroquine
or amodiaquine, as alternatives to hydroxychloroquine. The Examiner relies
on the teaching of Wilson to establish that at the time of the invention it was
known in the art to treat warts by intralesionally administering
hydroxychloroquine. FF1. The Examiner acknowledges that Wilson does
not teach topically applying hydroxychloroquine to an affected area. FF2.
The Examiner looks to the teaching of Albahri to establish that at the time of
the invention it was known to topically administer other compositions for the
purpose of treating warts in a mammalian subject. See FF5—FF7. The
Examiner concludes that based on the combination of references
it would have been prima facie obvious to a person of ordinary
skill in the art, at the time the claimed invention was made, to
have formulate the antiviral composition comprising
chloroquine, hydroxychloroquine, and amodiaquine, as taught by
Wilson and Baldwin et al., for topical administration in the form
of a patch, cream, aerosol, spray, or gel in the method of treating
verrucae warts, flat warts, plantar warts, or anogenital warts in a
human with a papillomavirus infection, as taught by Albahri.
Final Act. 6; see FF1—FF7.
We have reviewed Appellant’s contentions that the Examiner erred in
rejecting claim 1 as obvious over the cited art. Appeal Br. 5—8. We disagree
with Appellant’s contentions and adopt the findings concerning the scope
and content of the prior art set forth in the Examiner’s Answer and the Final
Action, dated March, 15, 2016. For emphasis, we highlight and address the
following:
Appellant contends that:
the treatment of viral warts was a concern for a number of years
prior to the claimed invention, had it been obvious to those of
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ordinary skill in the art to use the claimed compounds for the
topical treatment of HPV as suggested by the examiner,
someone surely would have done so.
Appeal Br. 6. Appellant is arguing the age of the references and the time
span between the publications of the references. See Reply Br. 3.
Appellant’s arguments do not persuade us. “The mere age of the
references is not persuasive of the unobviousness of the combination of their
teachings, absent evidence that, notwithstanding knowledge of the
references, the art tried and failed to solve the problem.” In re Wright, 569
F.2d 1124, 1127 (CCPA 1977). Here, there is no evidence that the art tried,
but failed, to solve the problem of administering hydroxychloroquine
topically for the purpose of treating warts. Indeed, Wilson teaches that the
administration of hydroxychloroquine via intralesional injection is
successful. FF1. We find no evidence in this record that formulating
hydroxychloroquine into a topical formulation would be detrimental to the
stability of the compound itself. Wilson teaches that intralesional injection
of hydroxychloroquine is successful to treat warts, and there is no suggestion
in Wilson that topical application was tried and failed to work. Id. Just
because this line of treatment was not further pursued after that initial
publication does not in and of itself suggest that the treatment would have
been expected to fail or that the references teach away from topically
administering hydroxychloroquine.
With respect to the problem of treating warts, Albahri explains that
“[pjart of the explanation for the lack of unified treatment strategies for
controlling or curing patients of papillomavirus infections is because they
are type specific; a composition that is very effective in treating one type
may be completely ineffective in treating another.” Albahri |45. In other
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words, Albahri explains that a one-size-fits-all treatment for warts is not
likely because there may be many differences in the underlying papilloma
virus infection. Albahri also explains that “[s]ome types of HPV infections
such as common warts generally regress spontaneously over extended
periods of time.” Albahri |44. Here, Wilson’s treatment was directed to
common warts, Verruca vulgaris, with intralesional injection of
hydroxychloroquine. Wilson 794; FF1. The fact that intralesional injection
can be painful, coupled with the knowledge that these types of warts often
spontaneously regress, may have been factors in why the treatment path was
not further pursued at the time. However, the failure to pursue without more
does not establish that the topical application of hydroxychloroquine is not
obvious. “Absent a showing of long-felt need or the failure of others, the
mere passage of time without the claimed invention is not evidence of
nonobviousness.” In re Kahn, 441 F. 3d 977, 990-91 (Fed. Cir. 2006)
(quotations and citations omitted). See also, In re McGuire, 416 F.2d 1322,
1327—28 (CCPA 1969) (“Appellants argue the century-old status of the
references but this argument does not impress us, absent some showing that
the art tried and failed to solve some problem notwithstanding its presumed
knowledge of the references. For aught that appears, as soon as the need for
an inside tubing cutter was perceived it was produced out of the accumulated
skill of the art.”).
Appellant contends that “there was a long-felt but unsolved need for
the claimed invention, as previous topical treatments had been largely
unsuccessful (see Albahri at || [0043]—[0049]) and intralesional treatment is
invasive, painful, and time consuming with multiple trips to the healthcare
provider.” Appeal Br. 8.
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We are not persuaded. To establish a long-felt need, three elements
must be proven: First, the need must have been a persistent one that was
recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538
(CCPA 1967). Second, the long-felt need must not have been satisfied by
another before Appellant’s invention. See Newell Companies, Inc. v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[o]nce another
supplied the key element, there was no long-felt need or, indeed, a problem
to be solved . . . .”). Third, the invention must, in fact, satisfy the long-felt
need. In re Cavanagh, 436 F.2d 491, 496 (CCPA 1971).
Based on the totality of the evidence presented, we find that Appellant
has not sufficiently established that the second prong of the long felt need
inquiry, namely that the need for treatment of papilloma virus infections was
not previously satisfied by others. See Newell Companies, Inc. v. Kenney
Mfg. Co., 864 F.2d at 768. The passages in Albahri cited by Appellant do
not establish this long felt need prong. Indeed the reference discloses that,
depending on the type of infection, spontaneous regression can occur. See
Albahri 144. First, if spontaneous regression of the warts is possible, there
may be no real need to treat the disease. Second, the issue highlighted by
Albahri, is that the currently marketed over the counter wart treatments often
“result in significant local side effects such as scarring and necrosis of the
tumor and the surrounding tissue.” Albahri |48. Even though Albahri
established that the known treatments have side effects, the problem of
treating papilloma virus infections, such as those caused by Verruca
vulgaris, has nevertheless already been solved. Simply because the known
treatments have side effects does not mean the problem of treating viral wart
infections has not been already been solved. Thus, based on the totality of
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the evidence, papilloma vims treatments are known and effective even if
there is room to improve the current treatments so that side effects are
minimized or eliminated.
Appellant contends that “[ajctive agents that are effective
intralesionally are not necessarily effective when administered topically, and
vice versa. To suggest otherwise is simply incorrect and unsupported by
evidence.” Appeal Br. 7; Reply Br. 3 (“Just because one compound can be
formulated for successful treatment topically does not mean that all
compounds can be so formulated”).
We are not persuaded by Appellant’s contention that it would not
have been obvious to formulate Wilson’s hydroxychloroquine treatment into
a topical application. “Warts are caused by various human papillomavimses
through direct contact with the vimlent particle. Warts are infectious and
can be autoinoculated and spread to other individuals by direct contact.”
Albahri |7. For the treatment to be effective, the compound must come into
contact with those cells that are still actively replicating the vims and
producing new particles. Albahri’s treatment recognizes that in addition to
being topically applied it could also be “directly injected into the wart with a
needled FF7. Therefore, the art recognizes that these different routes of
administering wart treatments are recognized as interchangeable
administration protocols. See Albahri |133. Thus, the combination of
references would suggest that the application of hydroxychloroquine as a
topical treatment for the purpose of reducing a papilloma vims infection is
reasonable considering that Wilson teaches that direct injection into the wart
lesion produces the desirable effect and Albahri teaches that topical
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application in addition to injection is an accepted route for administering
such medicaments. FF1.
Appellant contends that “substantial evidence of secondary
consideration [was previously provided] but that this evidence has been
completely ignored by the examiner. Specifically, Applicant provided
extensive arguments in its initial response, filed June 6, 2014.” Reply Br. 4.
While Appellant presents arguments directed to secondary
considerations in the Reply Brief (pgs. 4—15), we note that absent a showing
of good cause, the Board is not required to address arguments in the Reply
Brief that could have been presented in the principal Brief. See Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (“informative”).
Nevertheless, our review of the current record establishes that the Examiner
has fully addressed the issues identified by Appellant in the Reply Brief.
“Although secondary considerations must be taken into account, they do not
necessarily control the obviousness conclusion.” Pfizer, Inc. v. Apotex, Inc.,
480 F.3d 1348, 1372 (Fed. Cir. 2007) (citing Newell Cos., Inc. v. Kenney
Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) and holding “Here, the record
establishes such a strong case of obviousness that Pfizer’s alleged
unexpectedly superior results are ultimately insufficient.”). Specifically, the
Examiner responds to the issues of secondary consideration raised by
Appellant in the prior Office Action.6 There the Examiner explained that
Appellant’s contention with respect to long felt need and failure of others “is
not persuasive because the failure of others to develop Applicant’s invention
and the long intervening time are not reasons for patentability. The fact that
6 Office Action mailed June 27, 2014 (“Office Act.”).
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multiple references teach otherwise, does not take away the fact that the
combined prior art references make obvious the claimed invention.” Office
Act. 15. And finally, the Examiner explained that the Broker7 Declaration is
insufficient to overcome the prima facie case of obviousness “because the
Broker Declaration merely shows that the claimed invention works as
intended or is fully enabled. There is no data or evidence that is surprising
or unexpected.” Office Act. 16. We agree with the Examiner’s rationale
and conclusions as articulated in the Office Action of June 27, 2014.
Appellant’s duplication in the Reply Brief of a prior response submitted to
the Office and fully addressed by the Examiner in the Office Action of June
27, 2014 does not persuade us the Examiner erred in rejecting the claims as
articulated.
Accordingly, for the reasons discussed, we are not persuaded that the
Examiner failed to make out a prima facie case of obviousness with respect
to claim 1. We are also not persuaded that the evidence advanced by
Appellant to show unexpected results or otherwise outweighs the evidence
of obviousness. We thus affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as being obvious. As claims 2—5, 10, 13, 25, and 31—61 fall with
that claim, we affirm the rejection as to those claims as well. 37 C.F.R.
§ 41.37(c)(1).
7 Declaration by Thomas R. Broker, Ph.D. under 37 C.F.R. §1.132, signed
June 5, 2014.
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SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. 1103(a) over the
combination of Wilson, Baldwin, and Albahri. Claims 2—5, 10, 13, 25, and
31—61 were not separately argued and fall with claim 1. 37 C.F.R.
§41.37 (c)(l)(iv).
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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