Ex Parte Cunningham

Patent Trial and Appeal Board

Feb 14, 2017

13133882 (P.T.A.B. Feb. 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.
13/133,882 06/09/2011 Emmett M. Cunningham NLS-0003-US 6270
23550 7590 02/16/2017
HOFFMAN WARNTOK T T C EXAMINER
540 Broadway
4th Floor
WEBB, WALTER E
ALBANY, NY 12207 ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
02/16/2017 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):
PTOCommunications@hoffmanwarnick.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EMMETT M. CUNNINGHAM
Appeal 2016-002482
Application 13/133,882
Technology Center 1600
Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
of treating a viral infection in an individual. The Examiner rejected the
claims as lacking descriptive support and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“The present invention relates generally to the treatment or prevention
of infection and, more particularly, to the treatment or prevention of viral
1 Appellant identifies the Real Party in Interest as Nevoa Life Sciences, LLC
(see App. Br. 1).
Appeal 2016-002482
Application 13/133,882
infection by chlorination using a liquid or gelled Electro-Chemically
Activated Water (ECAW)” (Spec. 1).
The Claims
Claims 1—7, 9, 12—18, 20, 21, and 23—28 are on appeal. Claim 1 is
representative and reads as follows:
1. A method of treating viral infection in an individual, the
method comprising:
administering to the individual, via at least one nasal cavity,
nebulized Electro-Chemically Activated Water (ECAW) having a pH
between about 5 and about 7 and containing hypochlorous acid
(HOC1) and hypochlorite ion (OC1), each at a concentration between
about 35 parts per million (ppm) and about 200 ppm, wherein the
hypochlorite ion (OC1) has a concentration less than that of the HOC1.
The issues
A. The Examiner rejected claims 1—7, 9, 12—18, 20, and 21 under
35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement (Ans. 2—3).
B. The Examiner rejected claims 1—7, 9, 12—18, 20, 21, and 23—28 under
35 U.S.C. § 103(a) as obvious over Alimi2 (Ans. 3—5).
A. 35 U.S.C. § 112, first paragraph
The Examiner finds
The claims recite the phrase “wherein the hypochlorite
ion (OC1) has a concentration less than that of the HOC1”. The
phrase constitutes new matter insofar as it does not appear to
have been supported by the disclosure as originally filed. The
instant specification merely discloses preferred ranges of each,
2 Alimi, US 2005/0142157 A2, published June 30, 2005.
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Application 13/133,882
stating: “the EC AW contains between about 35 ppm and about
200 ppm HOC1 and between about 35 ppm and about 200 ppm
OC1” (p. 4, lines 3rd full paragraph). However, there is no
written description of any relationship between these
ranges/values in a general sense, i.e., there is no support for a
concentration of hypochlorite being “less than” the
concentration of hypochlorous acid in a general sense.
(Ans. 3).
Appellant contends
the specification very clearly states that the ranges of the HOC1
and OC1" may be between about 35 ppm and about 200 ppm,
while also making it quite clear that, as would be recognized by
one skilled in the art, the concentrations of HOC1 and OC1' will
vary depending on the pH of the solution. That is, the
concentrations of HOC1 and OC1 will vary within the recited
ranges depending on the pH of the solution.
Therefore, the Examiner’s allegation that “there is no
written description of any relationship between these
ranges/values in a general sense, i.e., there is no support for a
concentration of hypochlorite being ‘less than’ the
concentration of hypochlorous acid in a general sense” is
without merit, just as it was without merit previously.
(Reply Br. 3).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that the phrase in claim 1
“wherein the hypochlorite ion (OC1-) has a concentration less than that of
the HOC1” lacks descriptive support in the Specification?
Findings of Fact
1. The Specification teaches: “In some embodiments of the
invention, the EC AW contains between about 35 ppm and about 200 ppm
HOC1 and between about 35 ppm and about 200 ppm OCT, depending on
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Appeal 2016-002482
Application 13/133,882
the pH of the solution. In some embodiments, the ECAW according to the
invention has a pH between about 5 and about 8” (Spec. 4).
2. Exhibit B of the Emmons Declaration3 teaches “ANOLYTE
CONSTITUENTS AT VARIOUS pH LEVELS” and a portion of the first
table in Exhibit B is reproduced, in part, below:
ai A:i::lyH->
pH of Solution
6.5 7.0 7.5 8.0
H2G water 99.96500% 99.96500% 99.96500% 99.96500%
NaCI salt 0.03135% 0.03135% 0.03135% 0.03135%
HCIO hypochtofouts add 0.00323% 0.00277% 0.00191% 0.00097%
OCL* hypochlorite ion 0.00027% 0.00073% 0.00159% 0,00253%
(Emmons Decl., Exhibit B, table 1).
Principles of Law
To satisfy the written description requirement, “the missing
descriptive matter must necessarily be present in the [original] application’s
specification such that one skilled in the art would recognize such a
disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998).
Analysis
We find that the Examiner has the better position. As recognized by
Appellant, “the concentrations of HOC1 and OC1' will vary depending on the
pH of the solution” (Reply Br. 3). However, the Specification teaches that
the pH range may vary between 5 and 8 (FF 1). Because the Emmons
Declaration demonstrates that the OC1' concentration is less than HOC1 at
pH 6.5 but at pH 8 OC1' is greater than HOC1 (FF 2), the Electro-Chemically
Activated Water disclosed in the Specification does not necessarily have an
OC1' concentration less than that of the HOC1 as recited in claim 1.
3 Declaration of Stuart A. Emmons, dated April 10, 2013.
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Appeal 2016-002482
Application 13/133,882
Even if the recitation were obvious over the disclosure of the
Specification, that is not the standard for satisfaction of the written
description requirement. See In re Huston, 308 F.3d 1267, 1277 (Fed. Cir.
2002) (‘“Entitlement to a filing date does not extend to subject matter which
is not disclosed, but would be obvious over what is expressly disclosed.’”).
Appellant has not demonstrated that a skilled artisan would
understand that the inventor was in possession of the claimed invention
based on an objective inquiry into the Specification. There is simply nothing
in the Specification that describes “wherein the hypochlorite ion (OC1-) has
a concentration less than that of the HOC1.” A “description that merely
renders the invention obvious does not satisfy the [written description]
requirement.” AriadPharms, Inc. v. EliLilly & Co., 598 F.3d 1336, 1352
(Fed. Cir. 2010).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
phrase in claim 1 “wherein the hypochlorite ion (OC1-) has a concentration
less than that of the HOC1” lacks descriptive support in the Specification.
B. 35 U.S.C. § 103(a) over Alimi
The Examiner finds Alimi teaches “a stable solution of an oxidative
reduction potential (ORP) water” that comprises “a ‘ratio of hypochlorous
acid to hypochlorite ion’” with ranges of 15 ppm to 35 ppm and a pH range
“preferably ‘between about 6.2 and about 7.8’” (Final Act. 4). The
Examiner finds Alimi teaches the composition may be administered by
nebulization and “is useful for treating viruses” (id.).
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Application 13/133,882
The Examiner acknowledges that “Alimi does not teach nebulized
gelled electro-chemically activated water” but that “Alimi teaches ‘using
ORP water or ORP water in gel form’” (id.).
The Examiner finds it obvious “to administer nebulized gelled electro-
chemically activated water, since the prior art teaches a gel form for
administration to patients ... as well as administration to patients by
nebulization” (Ans. 4). The Examiner also finds the ratio of hypochlorite
and hypochlorous acid obvious because “Alimi teaches a pH falling within
the claimed range (the pH range of Alimi about 6.2 and about 7.8 falls
within the claimed range of about 5 and about 7)” (Ans. 5).
The issue with respect to these rejections is: Does the evidence of
record support the Examiner’s conclusion that Alimi renders claim 1
obvious?
Findings of Fact
3. Alimi teaches the “method of the present invention also can be
used for the prevention or treatment of an infection, which is treatable with
the ORP [oxidative reduction potential] water solution of the present
invention. The infection can be caused by one or more infectious pathogens
such as . . . viruses” (Alimi 132).
4. Alimi teaches “the ORP water solution of the present invention
can be administered by aerosolization, nebulization or atomization” (Alimi
121).
5. Alimi teaches “the ORP water solution may contain chlorine
(e.g., free chlorine and bound chlorine). . . Free chlorine typically includes,
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Application 13/133,882
but is not limited to, hypochlorous acid (HCIO), hypochlorite ions (CIO')”
(Alimi 1145^46).
6. Alimi teaches the “ratio of hypochlorous acid to hypochlorite
ion is dependent upon pH. At a pH of 7.4, hypochlorous acid levels are from
about 25 ppm to about 75 ppm” (Alimi 146).
7. Alimi teaches:
The total amount of free chlorine species is generally between
about 10 ppm and about 400 ppm, preferably between about 50
ppm and about 200 ppm, and most preferably between about 50
ppm and about 80 ppm. The amount of hypochlorous acid is in
the generally between about 15 ppm and about 35 ppm.
(Alimi 1 69).
8. Alimi teaches the “[pjreferably, the pH of the ORP water
solution is between about 6.2 and about 7.8 .... An exemplary ORP water
solution of the present invention can comprise . . . from about 15 ppm to
about 35 ppm hypochlorous acid ... a pH of from about 6.2 to about 7.8,
and is stable for at least one week” (Alimi 171).
9. Table 2 of Alimi is reproduced below:
JABLE 2
Phvsical dialacteiisties of ORP W: ler solulsoti/bl each cotngxxsiti.ons
pH ORP
IbtJij Cl"'
(ppm)
H(. X i Cl
(ppm)
Xkd 0
(ppm)
Peroxide
(ppm)
lift. 4 8,92 ■I'789 1248 62 n,d. n.d.
Ex, 5 0 ! +782 2610 104 n ,d - :rlL
6 9.69 +743 4006 tt.;:L r>.d.
Si's. 7 0,8 0 +730 4800 48 tl,d. h-d,-
Ex, 8 9.80 +737 5000 50 n ,d r md.
Ex, 9 7.06 +9011 64 X? 2.8 35
Es. 10 6.06 +914 51 26 2/7 35
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Appeal 2016-002482
Application 13/133,882
“The physical characteristics of these samples were determined, specifically
pH . . . hypochlorous acid (HC10-) content, chlorine dioxide content
and peroxide content, and are set forth in Table 2” (Alimi 1143).
10. Alimi teaches “using ORP water or ORP water in gel form”
(Alimi 1159).
11. The third table in Exhibit B of the Emmons Declaration, with a
250 ppm target, is reproduced, in part, below:
CtillsiiltlSfils DfAnotyi®
pH of Solution
6.0 6.5 ] 7.0 7.5
mo water 997,500 907,500 907,500 907,500
flaCI salt 2,239 2.230 2.239 2.239
HeCIQ tiypocWtoraus sod 244 231 103 137
OCL- twsscchlorite ion O 10 1 52 113
(Emmons Decl., Exhibit B, table 3).
Principles of Law
“The 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).
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Ans. 3—5; FF 3—9) and agree that the claimed method would
have been obvious over the teachings of Alimi. We address Appellant’s
arguments below.
Appellant contends “Alimi is not enabled as to the construction the
Examiner has given its specification. Specifically, Appellant previously
argued— and continues to argue— that ‘Alimi discloses a range of
hypochlorous acid levels for the ORP water at only a single pH,’ i.e., the 7.4
pH noted above” (App. Br. 4). Appellant contends that, based on the
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Appeal 2016-002482
Application 13/133,882
Emmons Declaration, “given the total chlorine content and hypochlorous
acid concentration ranges of Alimi, ‘the pH of the solution would have to be
7.4 or higher and, at a pH slightly above 7.5, the concentration of the
hypochlorite ion would be greater than the concentration of the
hypochlorous acid’” (id.). Appellant concludes that “despite Alimi’s
reference to a broad pH range, the ORP water disclosed cannot have the total
chlorine content and hypochlorous acid concentrations mentioned as well as
a pH less than 7.4, much less a pH from 5 to 7, as claimed by Applicant”
(id.).
We do not find this argument persuasive because Alimi teaches that
the amount of free chlorine species, which includes hypochlorous acid and
hypochlorite ions, may range up to 400 ppm (FF 7). While Alimi prefers
hypochlorous acid ranges from 15 to 35 ppm (FF 7) or 25 to 75 ppm (FF 6),
Alimi exemplifies hypochlorous acid levels at 32 ppm and as high as 104
ppm (FF 9) at various pH values.
The Emmons Declaration demonstrates that at a 250 ppm free
chlorine concentration and at a pH of 7.0, there is 198 ppm hypochlorous
acid and 52 ppm hypochlorite ion (FF 11). This result falls within the
claimed requirements including a pH range of 5 to 7, a 35 to 200 ppm
concentration range for hypochlorous acid and hypochlorite ion, and a
hypochlorite ion concentration that is less than the hypochlorous acid
concentration.
Therefore, a subrange of Alimi that falls within the scope of the claim
is the 250 ppm free chlorine species at a pH 7.0 range as evidenced by the
Emmons Declaration (FF 11).
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Application 13/133,882
Additional variability is permitted by the “about” language in claim 1,
with endpoints of “about 35” or “about 200” ppm for the range of
hypochlorous acid and hypochlorite ion concentrations and with pH values
“about 7.” The Emmons Declaration demonstrates that values between 6.5
and 7.5 are reasonably interpreted as falling within the range of claim 1 with
pH 6.5 having 231 ppm hypochlorous acid and 19 ppm hypochlorite ion and
pH 7.5 having 137 ppm hypochlorous acid and 113 ppm hypochlorite ion
(FF 11). While the Emmons Declaration does not provide values for pH
values of 6.6, 6.7, 6.8, 6.9, 7.1, 7.2, 7.3, or 7.4, the data as presented
supports the Examiner’s position that there is substantial overlap between
the ranges disclosed by Alimi and the requirements of claim 1 (FF 11; cf.
Final Act. 5).
Thus, Alimi teaches overlapping ranges of pH and free chlorine
concentrations that will necessarily result in overlapping subranges that
satisfy each of the requirements of claim 1. “A prima facie case of
obviousness typically exists when the ranges of a claimed composition
overlap the ranges disclosed in the prior art.” In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003). Appellant provides no evidence for any secondary
consideration that would require reconsideration of the Examiner’s
obviousness position.
We recognize, but find unpersuasive, Appellant’s contention that “if
the Examiner chooses to rely on Alimi’s recitation of ‘preferably between
about 50 ppm and about 200 ppm’ free chlorine, the Examiner must
similarly accept that same paragraph’s note that ‘[t]he amount of
hypochlorous acid is in the generally between about 15 ppm and about 35
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Appeal 2016-002482
Application 13/133,882
ppm’” (App. Br. 5). The broadest range of free chlorine in Alimi is between
10 ppm and 400 ppm (FF 7) and as discussed above, the Emmons
Declaration evidences that there are free chlorine concentrations within that
range at pH values “about 7” that satisfy the requirements of claim 1. That
there may be specific embodiments that also do not fall within the scope of
claim 1 does not matter, because Alimi does not criticize, discredit, or
otherwise discourage hypochlorous acid concentrations in ranges from about
35 to about 200 ppm. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004) (“The prior art’s mere disclosure of more than one alternative does not
constitute a teaching away from any of these alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed.”)
Appellant “asserts that the Examiner similarly cannot ignore the fact
that Alimi has taken a position contrary to the Examiner’s and that this
contrary position makes clear that these features described by Alimi are
made in reference to different embodiments of the methods described” (App.
Br. 4—5).
We have reviewed the prosecution history of Alimi and do not find
this argument persuasive. In the Jan. 8, 2014 response by Alimi in US
10/916,566, Alimi argued that the prior art Selkon reference applied by the
Examiner “teaches away from a pH greater than 7” because a higher pH
value “exhibited inhibition of human dermal fibroblast cells” and “[sjince
inhibition of cell growth would be detrimental to wound healing, one of
ordinary skill in the art would have been directed away from a pH of greater
than 5.4” (Resp. to Office Action in US 10/916,566 01/08/2014 at 4).
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Application 13/133,882
Thus, Alimi limits the pH to higher values to avoid the prior art, not
because other pH values will not work. The concerns in Selkon regarding
wound healing are inapplicable to the teachings of either Alimi, drawn to
treating viral infections (FF 3) or the instant claim, neither of which is
concerned with inhibition of wound healing.
Similarly, in the July 30, 2014 response by Alimi in US 10/916,566,
Alimi stated that the claims were amended to “define more clearly the
differences between the present invention and the disclosure of Selkon”
(Resp. to Office Action in US 10/916,566 07/30/2014 at 10). Indeed, Alimi
amended the claims because “[w]ith respect to pH, the Office contends that
‘about 7.4’ includes values such as 7.0” (id.). If “about 7.4” includes a pH
of 7.0 in the Alimi prosecution, then it is equally reasonable to interpret
“about 7” in instant claim 1 as including a pH of 7.4 in the instant situation.
More significantly, the reason Alimi amended was to avoid prior art,
not because Alimi did not teach or enable lower pH values including pH
ranges from 6.2 to 7.8 (FF 8). Thus, the prosecution history of Alimi does
not support Appellant’s position that the Examiner is misinterpreting the
disclosure of Alimi.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that Alimi
renders claim 1 obvious.
SUMMARY
In summary, we affirm the rejection of claims 1—7, 9, 12—18, 20, and
21 under 35 U.S.C. § 112, first paragraph as failing to comply with the
written description requirement.
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Application 13/133,882
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) as
obvious over Alimi. Claims 2—7, 9, 12—18, 20, 21, and 23—28 fall with
claim 1.
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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