Ex Parte Sokol et al

Patent Trials and Appeals Board

Apr 18, 2019

14014448 - (D) (P.T.A.B. Apr. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/014,448 08/30/2013 Brian Vincent Sokol
16375 7590 04/22/2019
Medley, Behrens & Lewis, LLC
6100 Rockside Woods Blvd.
Suite 440
Independence, OH 44131
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.
OASP-0014 4621
EXAMINER
ROBERTS, LEZAH
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
04/22/2019 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):
tbehrens@medleybehrens.com
nlewis@medleybehrens.com
admin-docketing@medleybehrens.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN VINCENT SOKOL and
AFIF MAHMOUD GHANNOUM
Appeal 2018-002485
Application 14/014,448 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of preventing infections disease in a host, which have been rejected as
obvious and for obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse the obviousness rejection and affirm the remaining
obviousness-type double patenting rejections.
1 Appellants identify the real party in interest as ARMS Pharmaceutical,
LLC. (Appeal Br. 2.) The Appeal Brief does not include page numbers.
We cite to the first page of the reference as page 1, and the remaining pages
as if numbered consecutively.
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Application 14/014,448
STATEMENT OF THE CASE
"There has been a longstanding need for devices, compositions, and
other treatments that will effectively prevent communicable diseases."
(Spec. ,r 3.) "[A]ttempts to prevent infection have included large amounts of
zinc, vitamins, or herbs that are theorized to work internally to boost the
body's immune system." (Id. ,r 4.) "While numerous solutions exist for
killing microorganisms once they have contacted a person or animal, the
effectiveness of such solutions is dependent on quick recognition of the
germ contact and application of the germ-killing composition prior to the
microorganism binding to a mucosa, whereby it would enter the body and
infect the individual." (Id.)
According to Appellants' Specification "[ c ]ompositions have been
developed for forming blocking barriers topically on human skin or in the
oral or internal cavities. However, such compositions are not for preventing
infection of communicable diseases." (Id. ,r 7.) Appellants invention is
directed to "a method for blocking, neutralizing, or killing microorganisms
that cause infectious disease in a mammal prior to or during the mammal
encountering a contaminated environment or item" by administering a
therapeutically effective amount of a barrier-forming composition to a
mucosa of the mammal (Id. ,r 8.)
Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28 are on appeal. Claim 1 is
representative and reads as follows:
1. A method for prevention of infectious disease in a host, the
method comprising:
administering by spraying or mouthwash delivery, a
therapeutically effective amount of a composition to a mucosa
of the host;
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Application 14/014,448
the composition comprising:
about 0.01 % :SC :S 0.4%;
about 7% :S H :S about 65%; and
0.050% < A;
wherein all percentages are by weight of the total
composition;
wherein C is a carbohydrate gum; H is a humectant; and
A is an antimicrobial agent;
wherein the infectious disease is caused by
microorganisms that cause one or more upper respiratory
infections, one or more cold viruses, or influenza viruses;
wherein the composition forms a barrier on the mucosa
that is active to trap, and kill or neutralize microorganisms.
(Appeal Br. "VI. CLAIMS APPENDIX" at 1.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28 under 35 U.S.C. § I03(a)
as unpatentable over Jacob. 2
Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28 on the ground ofnon-
statutory obviousness-type double patenting as being unpatentable over
claims 1-35 of US Patent 8,535,646.
Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28, provisionally, on the
ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-23 of US Application 13/448,957. US
2 Jacob et al., US 2002/0168334 Al, published Nov. 14, 2002.
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Application 14/014,448
13/448,957 issued as US Patent 8,992,893, on March 31, 2015. Thus, the
rejection is no longer considered provisional. 3
DISCUSSION
Obviousness
The Examiner finds that Jacob discloses viscous, mucoadhesive
"liquid formulations for the prevention and treatment of mucosal diseases
and disorders" that are applied, such as by spraying, to coat the respiratory
tract, providing a "layer on the surface of the mucosa for an extended period
of time." (Final Action 2-3.) The Examiner notes that Jacob discloses that
the solutions can include "a pharmaceutical active" such as a bactericide or
disinfectant, e.g., cetylpyridinum chloride ("CPC"). (Id. at 3.) According to
the Examiner "Jacob discloses CPC and therefore one would be motivated to
use CPC." (Id. at 7.)
The Examiner finds that Jacob further discloses that its formulations
may include carboxymethyl cellulose, a polymer that may be included as a
mucoadhesive, and that other "[ c ]omponents include benzyl alcohol, citric
acid, glycerin, polysorbate 60, and saccharin." (Id. at 3.) The Examiner
further finds that the "pharmaceutical comprises 0.001 to 30% by weight of
the composition" that "[g]lycerin may comprise 5% of the composition" and
that "[m]ucoadhesives comprise 0.1 w/w% to about 3.0 w/w%." (Id.)
3 Claims 1, 3, 6--8, 10--13, 15-25, 27, and 28, were also provisionally
rejected, on the ground of non-statutory obviousness-type double patenting
as being unpatentable over claims 1-23 of US 13/655,365 and 1-30 of US
13/734,470. Neither application is pending any longer, having been
abandoned. Thus, these rejections are dismissed as moot.
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Application 14/014,448
The Examiner contends that, although Jacob "does not disclose the
exact claimed values about 0.01 % to 0.4%" of the carbohydrate gum, the
disclosure of 0.1 to 3% disclosed for the mucoadhesive overlaps that
claimed range and that such a disclosed "overlap in range establishes a
primafacie case of obviousness." (Id. at 3--4.) In addition, the Examiner
contends that the disclosed use of 5% glycerin meets the "about 7%" lower
limit of the claimed humectant. (Id. at 3.)
With respect to the method part of the claim, the Examiner asserts that
"prevention" means that "the subject is not required to have the infectious
disease." (Id. at 4.) According to the Examiner, "[t]herefor[e,]
administering the compositions of Jacob et al. to the oral cavity or
respiratory tract would 'prevent' the infections of the instant claims." (Id. at
6.)
The Examiner contends that "[ o ]ne of ordinary skill in the art would
conclude the actives will kill or neutralize microorganisms because they are
the same actives recited by the instant claims" and notes that "the
compositions stay on the surface an extended period of time" and thus one of
ordinary skill in the art "would conclude that [ the composition] will have the
same cidal and static activity and reduction of microbial burden" as recited
by the claims even though Jacob is directed to a method of treating mouth
ulcers. (Id. at 4, 6.) According to the Examiner, "CPC is an active
component (paragraph O 106). The pharmaceutically active compound
comprises 0.005 to 20%. Therefore there is disclosure that there is a
sufficient amount of antimicrobial or CPC for prevention of the diseases
listed in claim 1." (Id. at 6-7.)
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We disagree with the Examiner's conclusion that Jacob renders the
pending claims obvious. The Examiner's rejection is premised on the
assertion that when CPC is used in the 0.001 to 30% range taught by Jacob
in the mucoadhesive composition as taught by Jacob, the composition would
inherently "'prevent' the infectious disease of the present claim absent of
evidence to the contrary." (Ans. 21; see also Final Action 3--4 (
One of ordinary skill in the art would conclude the actives will
kill or neutralize microorganisms because they are the same
actives recited by the instant claims, cetylpyridinium chloride a
quaternary ammonium, recited by the instant claims. In regard
to the length of antimicrobial cidal or static activity duration
and the microbial burden, the compositions stay on the surface
an extended period of time and comprise the same
antimicrobial. Therefore one would conclude that it will have
the same cidal and static activity and reduction of microbial
burden for the same amount of time recited by the instant
claims.).)
We disagree that the Examiner has established that the claimed
therapeutically effective amount of active would have been inherent or
obvious from the teachings of Jacob.
As the Examiner acknowledged (Final Action 2-3), Jacob teaches a
composition that is directed at preventing and/or treating mucosal diseases
and disorders, such as lesions. (Jacob ,r,r 1, 80.) Jacob further explains that
a pharmaceutically active compound can be included in the mucoadhesive
composition to provide additional benefit in prevention and treatment of
mucosal disorders either topically or by delivery through the mucosal lining
for systemic delivery. (Id. ,r,r 1, 86, 100.) The use of the composition is,
thus, different from that which is claimed by Appellants. In particular, claim
1 is a method claim directed at prevention of infectious disease of a host that
requires administering a therapeutically effective amount of a composition
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that includes a carbohydrate gum, a humectant, and an antimicrobial agent,
where the therapeutically effective amount is to prevent infectious disease
caused by microorganisms that cause one or more upper respiratory
infections, one or more cold viruses, or influenza viruses. The Examiner did
not establish that a mucosal disease or disorder described in Jacob is, or
encompasses an "infectious disease is caused by microorganisms that cause
one or more upper respiratory infections, one or more cold viruses, or
influenza viruses" as required by the rejected claims. Thus, there is
insufficient evidence from which one can conclude from the fact of Jacob
treating a mucosal disease or disorder with the claimed composition that the
same composition would inherently include a therapeutically effective
amount of a composition that would also treat an infectious disease caused
by microorganisms that cause one or more upper respiratory infections, one
or more cold viruses, or influenza viruses.
Moreover, Jacob provides a long and varied categorization of active
compounds that can be used in the Jacob composition to provide additional
benefit in prevention and treatment of mucosal disorders either topically or
by delivery through the mucosal lining for systemic delivery, each category
further including a list of possible compounds. (Id. ,r,r 101-113.) The
categories include anti-inflammatories (id. ,r 101 (e.g., hydrocortisone)),
antibiotics (id. ,r 110, (e.g., penicillin)), antivirals (id. ,r 112 (protease
inhibitors)), antihistamines (id. ,r 104 (e.g., diphenhydramine
hydrochloride)), local anesthetics (id. ,r 105 (e.g., dibucain hydrochloride)),
as well as bactericides and disinfectant (id. ,r 106 (e.g., CPC.)
In addition, the amount of active to be added for Jacob's expressed
purpose is a large range, between "0.001 to 30% by weight of the
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formulation, and more preferably between 0.005 and 20% by weight." (Id. ,r
114.) That range for the amount of active is for all of the varied
pharmaceutical active categories disclosed by Jacob for providing additional
benefit in prevention and treatment of mucosal disorders either topically or
by delivery through the mucosal lining for systemic delivery.
"It is well established that the disclosure of a genus in the prior art is
not necessarily a disclosure of every species that is a member of that genus.
See, e.g., In re Baird, 16 F.3d 380,382 (Fed. Cir.1994)." Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006); accord Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (noting the
prior art disclosed "a handful of different compositions" for topically
applying to the skin and the ranges of the fatty acid ester to be used in the
prior art was entirely encompassed, and did not significantly deviate from
the claimed ranges). While it is true that CPC is specifically identified as a
chemical for use in a composition that includes a mucoadhesive and that
may include a humectant (id. ,r 122), there are many and varied compounds,
most of which are not antibacterials, that are identified that could be used in
such a composition, besides CPC, and for a very different purpose than the
therapeutic effect claimed here. Those facts coupled with the overlapping
nature of the large range in which any of the identified pharmaceutically
actives may be added in Jacob leads us to the conclusion that Jacob does not
disclose with sufficient specificity the greater than 0.050% of active
claimed, much less such that the claimed composition would achieve the
claimed therapeutic effect. See, e.g., Atofina, 441 F.3d at 999-1000 (finding
that (1) even though the claimed temperature range, 330-450 QC was entirely
within the disclosed range, 100-500 QC there was a considerable difference
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in the temperature range such that "no reasonable fact finder could conclude
that the prior art describes the claimed range with sufficient specificity to
anticipate" the limitation, and (2) a disclosure of a molar ratio of two
ingredients O.001 to 1. 0 percent that overlapped the claimed range O .1 to 5. 0
was not an anticipatory disclosure of the entire claimed range or of
individual points in the range.).
That there may be a particular amount of CPC or range of CPC within
the range of pharmaceutical actives taught by Jacob that when combined
with a mucoadhesive described in Jacob and a humectant described in Jacob
in a particular amount may result in the therapeutic effectiveness claimed is
not a sufficient disclosure for inherency. "The mere fact that a certain thing
may result from a given set of circumstances is not sufficient [ to establish
inherency]." In re Rijckaert, 9 F.3d 1531, 1533-34 (Fed. Cir. 1993).
"Inherency ... may not be established by probabilities or possibilities." In
re Oelrich, 666 F.2d 578,581 (CCPA 1981).
Much like the case in Perricone v. Medicis Pharmaceutical Corp.,
432 F.3d 1368 (Fed. Cir. 2012), with respect to a claim directed to a method
of preventing sunburn, the Examiner's "inherency analysis goes astray
because it assumes what [Jacob] neither disclosed nor rendered inherent."
Perricone, 432 F.3d at 1379 (indicating that the claim of"treatment of skin
sunburn" was not anticipated by the disclosed prior art teaching of a lotion to
be topically applied to the skin where that same prior art did not disclose
sunburn prevention or treatment benefits or even any mechanism behind
sunburn prevention, nor topical application to skin sunburn). For the
foregoing reasons, we do not find that Jacob inherently anticipates the
required therapeutically effective amount limitation.
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Furthermore, the Examiner has not established with sufficient
evidence that the claimed therapeutically effective amount would have been
obvious in light of Jacob's teachings. "Obviousness cannot be predicated on
what is unknown." In re Shetty, 566 F.2d 81, 86 (CCPA 1977). As
discussed above, Jacob teaches addition of a pharmaceutical active to
provide additional benefit in prevention and treatment of mucosal disorders
either topically or by delivery through the mucosal lining for systemic
delivery. (Jacob ,r,r 1, 86, and 100.) Although it is possible that some of the
foregoing categories of actives could be used to treat or alleviate symptoms
of infectious disease caused by microorganisms that cause one or more
upper respiratory infections, one or more cold viruses, or influenza viruses,
such as CPC that Appellants' Specification teaches can be used, nothing in
Jacob's disclosure teaches the addition of the pharmaceutical active for that
purpose. Nor has the Examiner provided evidence that CPC was known to
be used for that purpose at the time of the invention. In addition, the amount
of active to be added for Jacob's expressed purpose is a large range, between
"0.001 to 30% by weight of the formulation, and more preferably between
0.005 and 20% by weight." (Id. ,r 114.) As discussed above, that range for
the amount of active is for all of the varied pharmaceutical active categories
disclosed by Jacob for providing additional benefit in prevention and
treatment of mucosal disorders either topically or by delivery through the
mucosal lining for systemic delivery. Thus, while the Jacob range includes
within its ambit .05% or greater, nothing in Jacob's disclosure points to the
addition of the pharmaceutical active in such an amount from the disclosed
0.001 to 30% or 0.005 to 20% by weight to achieve the claimed purpose.
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In short, we find nothing in the Jacob disclosure that would direct one
of ordinary skill in the art to select and use an active in an amount in
combination with a mucoadhesive and humectant to prevent infectious
disease caused by microorganisms that cause one or more upper respiratory
infections, one or more cold viruses, or influenza viruses.
For the foregoing reasons, we reverse the Examiner's rejection of
claim 1 as being obvious over Jacob.
Independent claims 23 and 24 also require administration of
therapeutically effective amounts of the recited compositions. In claim 23,
the amount must be effective to reduce risk of infectious disease in a host
from microorganisms encountered subsequent to application of a barrier-
forming composition where the infectious disease is caused by a
microorganism selected from a particular group. In claim 24, the
therapeutically effective amount must be effective to inhibit the contraction
of infectious disease in a host and the antimicrobial agent must be present
from 0.05% to 1 % (a much more specific and narrower range than disclosed
in Jacob, as well as the ingredient being used for a different purpose). For
the reasons discussed above, we also conclude that the Examiner failed to
establish a prima facie case of obviousness as to these other independent
claims. Furthermore, "[ d]ependent claims are nonobvious under section 103
if the independent claims from which they depend are nonobvious." In re
Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988)
Thus, for the reasons above, we reverse the Examiner's obviousness
rejection of claims 3, 6-8, 10-13, 15-25, 27, and 28, as well.
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II
Obviousness-Type Double Patenting
As discussed above, two obviousness-type double patenting rejections
made by the Examiner remain pending in this application, and neither of
them are provisional rejections.
After setting forth the rejection, the Examiner pointed out that request
has been made by Applicants during prosecution to "defer these issues until
the application is otherwise in condition for allowance." (See, e.g., Final
Action 13.) Appellants do not address in their Appeal Brief the Examiner's
rejections of the claims on the ground of nonstatutory obviousness-type
double patenting. Accordingly, we summarily affirm the Examiner's
uncontested nonstatutory obviousness-type double patenting rejections.
SUMMARY
We reverse the rejection of claims 1, 3, 6-8, 10-13, 15-25, 27, and 28
under 35 U.S.C. § 103(a) as unpatentable over Jacob.
We affirm the rejection of Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28
on the ground of non-statutory obviousness-type double patenting as being
unpatentable over claims 1-35 of US Patent 8,535,646.
We affirm the rejection of Claims 1, 3, 6-8, 10-13, 15-25, 27, and 28,
provisionally, on the ground of non-statutory obviousness-type double
patenting as being unpatentable over claims 1-23 of US Patent 8,992,893.
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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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