Ex Parte Rennie et al

Board of Patent Appeals and Interferences

Jan 3, 2012

10979498 (B.P.A.I. Jan. 3, 2012)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/979,498 11/02/2004 Paul John Rennie 9801 2956
27752 7590 01/03/2012
THE PROCTER & GAMBLE COMPANY
Global Legal Department - IP
Sycamore Building - 4th Floor
299 East Sixth Street
CINCINNATI, OH 45202
EXAMINER
CARTER, KENDRA D
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
01/03/2012 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PAUL JOHN RENNIE,
JAYANT EKANTH KHANOLKAR, and GEORGE WILLIAM JESSEN
__________

Appeal 2011-007358
Application 10/979,498
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to methods
of treating upper respiratory tract viral infections. The Examiner has
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Claims 1, 2, 4-15, 17-19, 21-28, and 30-34 are on appeal. Claim 1 is
representative and reads as follows:
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1. A method of treating upper respiratory tract viral infections by
encapsulating, inactivating, and removing viruses, the method comprising
administering a nasal spray composition to the nasal cavity, wherein the
nasal spray composition comprises:
(a) from about 0.01% to about 30% by weight of a rheological agent
selected from the group consisting of a cellulose derivative, a
thermoreversible polymer, and mixtures thereof; wherein said
thermoreversible polymer is selected from the group consisting of
poloxamers, ethylhydroxy ethylcelluloses, and mixtures thereof, and
(b) from about 0.01% to about 20% by weight of a virus inactivation
agent;
wherein the nasal spray composition has a viscosity of from about
1 cps to about 2000 cps and a pH of from about 3.0 to about 5.5.

The claims stand rejected 35 U.S.C. § 103(a) as follows:
I. Claims 1, 2, 4, 6, 10-13, 17-19, 21, 23-28, and 30-34 in view of
Rudy1 and Betbeder;2
II. Claims 7-9 and 14 in view of Rudy, Betbeder and Gelber;3
III. Claim 15 in view of Rudy, Betbeder and Kamishita;4
IV. Claims 1, 2, 4, 6-10, 12-15, 17, and 18 in view of Kamishita,
Betbeder and Gelber; and
V. Claim 11 in view of Kamishita, Betbeder, Gelber, and Pan.5
We affirm rejections I, II, and III and vacate rejections IV and V.6

1 Rudy, US 5,466,680, issued Nov. 14, 1995.
2 Betbeder et al., US 6,017,513, issued Jan. 25, 2000
3 Gelber et al., US 2001/0044410 A1, issued Nov. 22, 2001
4 Kamishita et al., US Patent Publication 5,158,761, issued Oct. 27, 1992
5 Pan et al., US 5,912,007, issued June 15, 1999
6 We vacate the rejection based on Kamishita, Betbeder, and Gelber and the
rejection based on Kamishita, Betbeder, Gelber, and Pan as we find that
these rejections are cumulative in view of the affirmed rejections.
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I.
Issue
The Examiner has rejected claims 1, 2, 4, 6, 10-13, 17-19, 21, 23-28
and 30-34 under 35 U.S.C. § 103(a) as being obvious in view of Rudy and
Betbeder. The claims have not been argued separately and therefore stand or
fall together. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Rudy discloses “a method of treatment of
irritation and inflammation due to the common cold, influenza and other
upper respiratory infections” using nasal spray compositions that have a pH
from 4 to 10 and a viscosity of 5 to 500,000 cps (Answer 4). The Examiner
finds that Rudy discloses that the compositions may contain viscosity
increasing agents such as carboxymethylcellulose (id. at 5), as well as
chelating agents, including citric acid and EDTA, which are virus
inactivating agents (id.).
The Examiner concludes that “it is obvious that when one treats an
upper respiratory tract infection[ ] … virus will be encapsulated and
inactivated. After treatment, upon sneezing and/or blowing the nose, the
encapsulated virus would be removed” (id. at 6). The Examiner finds that
Betbeder discloses poloxamers “for the use in a nasal … mucosal
administration … to reduce the effect of a virus infection” (id. at 7). The
Examiner concludes that it would have been obvious to use Betbeder’s
poloxamers in the composition of Rudy because poloxamers are known
rheological agents for use in nasal compositions (id.).
Appellants contend that none of the cited references disclose or
suggest treating an infection “through the encapsulation, inactivation, and
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removal of viruses” and that the Examiner has not established that these
effects would be inherent in the methods and compositions disclosed or
suggested by the cited references (Appeal Br. 6-7). Appellants also contend
that the cited references do not disclose or suggest the pH range recited in
claim 1 (id. at 7-8).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the method of treating upper
respiratory tract viral infections of claim 1 would have been obvious in view
of the cited references?
Findings of Fact
1. Rudy discloses “viscous-liquid and liquid compositions … used for
application to the nasal mucosal surfaces” (Rudy, col. 16, ll. 60-61) for “the
treatment of irritation and inflammation due to the common cold, hay fever,
influenza and other upper respiratory infections” (id. at col. 17, ll. 22-25).
2. Rudy discloses that its composition comprises
(a) an energy source for white blood cells; (b) a source of
cations…; (c) a source of anions…; wherein the pH of said
composition is from about 4 to about 10 and the osmolality of
said composition is from about 140 mOsm/kg to about 2,000
mOsm/kg.
(Id. at col. 2, ll. 35-48.)
4. Rudy discloses that the pH is preferably “from about 5.5 to about
9.0” for nasal mucosa applications (id. at col. 10, ll. 58).
5. Rudy discloses that the composition has a viscosity of at least 5 cps
(id. at col. 13, ll. 1-3).
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6. Rudy discloses that the composition may contain water soluble
polymers, such as carboxymethylcellulose, as viscosity increasing agents (id.
at col. 13, ll. 34-49).
7. Rudy discloses that the composition can be stabilized by the
addition of a chelating agent such as “citric acid, saccharic acid, [or]
ethylenediaminetetraacetic acid (EDTA)” (id. at col. 14, ll. 30-40).
8. Rudy exemplifies a composition which contains
carboxymethylcellulose and citric acid, and which has a pH of 6.4 and a
viscosity of 35 centipoise (id. at col. 23, ll. 40-55).
9. The Examiner finds that in the composition of FF 8 “the citric acid
is present in 0.72g (1.7% by weight) and carboxymethylcellulose … is
present in 6.0g (14.5% by weight)” (Answer 5). Appellants do not dispute
this finding.
10. The Specification discloses that “polymeric cellulose derivatives
suitable for use as a preferred rheological agent herein include …
carboxymethyl cellulose (CMC) polymers” (Spec. 7: 3-7).
11. The Specification discloses that virus “inactivation agents …
include metal compounds, surfactants, chelating agents, pyroglutamic acid,
and mixtures thereof” (id. at 7: 32-33).
Principles of Law
“[I]t is elementary that the mere recitation of a newly
discovered function or property, inherently possessed by things
in the prior art, does not cause a claim drawn to those things to
distinguish over the prior art. Additionally, where the Patent
Office has reason to believe that a functional limitation… may,
in fact, be an inherent characteristic of the prior art, it possesses
the authority to require the applicant to prove that the subject
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matter shown to be in the prior art does not possess the
characteristic relied on.”
In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977) (quoting In re Swinehart,
439 F.2d 210, 212-13 (CCPA 1971)).
Analysis
Claim 1 is directed to a method of treating upper respiratory tract viral
infections by administering to the nasal cavity a composition that comprises
0.01-30% of a rheological agent, which may be a cellulose derivative, and
0.01-20% of a virus inactivation agent, where the composition has a
viscosity of 1-2000 cps and a pH of about 3.0-5.5.
Rudy discloses a method for treating viral infections of nasal mucosa
by contacting the mucosa with a composition that may comprise
carboxymethylcellulose as a viscosity-enhancing polymer and citric acid as a
chelating agent. The Specification discloses that virus inactivating agents
include chelating agents, and that cellulose derivatives useful as rheological
agents include carboxymethyl cellulose.
Rudy exemplifies a composition which contains carboxymethyl-
cellulose and citric acid in amounts which the Examiner finds, and
Appellants do not dispute, are 1.7% and 14.5%, respectively. Rudy also
discloses that its compositions have a viscosity of at least 5 cps, which
would have made obvious viscosities within the claimed range of 1-2000
cps, and that the optimal pH range for application to the nasal mucosa is
about 5.5 to about 9.0, which overlaps the claimed pH range.
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Thus, Rudy suggests a method of treating an upper respiratory viral
infection that meets all of the express limitations of claim 1.7
Appellants argue, however, that the cited references do not disclose or
suggest treating an infection “through the encapsulation, inactivation, and
removal of viruses” and that the Examiner has not established that the
encapsulation, inactivation, and removal of viruses would be an inherent
feature of the methods and compositions disclosed or suggested by the cited
references (Appeal Br. 6-7).
This argument is not persuasive. Rudy does not explicitly disclose the
encapsulation, inactivation, and removal of viruses. However, as recognized
by the Examiner, “the method and composition of Rudy and … Applicant’s
method and composition are substantially identical, so the effect and
mechanism of the composition will also be the same” (Answer 6). That is,
since Rudy discloses a composition comprising the same components (a
rheological agent and virus inactivation agent) in the same amounts as
claimed, and suggests a pH and viscosity within the claimed range, it is
reasonable to expect that Rudy’s composition would have the same effects
as the composition of claim 1 when applied to virus particles infecting the
nasal mucosa.
Thus, the Examiner has provided sound reasoning to support the
conclusion that “encapsulating, inactivating, and removing viruses” would
be the inherent result of the prior art method, and Appellants have not
provided any reasoning or evidence to rebut that conclusion.

7 The disclosure of Betbeder is cumulative with respect to claim 1.
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Appellants also contend that the cited references do not disclose or
suggest the pH range recited in claim 1 because “Rudy states that the pH of
the composition is preferred at a range of from about 5.5 to about 9.0 for
nasal mucosa” (Appeal Br. 8).
This argument is not persuasive because the claimed pH range (“about
3.0 to about 5.5”) overlaps with the pH range of Rudy (“about 5.5 to about
9.0”). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima
facie case of obviousness typically exists when the ranges of a claimed
composition overlap the ranges disclosed in the prior art.”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
method of treating upper respiratory tract viral infections of claim 1 would
have been obvious in view of the cited references.
II.
Issue
The Examiner has rejected claims 7-9 and 14 under 35 U.S.C.
§ 103(a) as being obvious in view of Rudy, Betbeder and Gelber. The
claims have not been argued separately8 and, therefore, stand or fall with
claim 7. 37 C.F.R. § 41.37(c)(1)(vii).

8 Appellants state: “Claims 7-9 specify the identity of a metal compound
which may be selected as a virus inactivation agent. Claim 14 is directed to
inclusion of an aromatic plant extract.” (Appeal Br. 8.) However, a
“statement which merely points out what a claim recites will not be
considered an argument for separate patentability of the claim.” 37 C.F.R.
§ 41.37(c)(1)(vii).
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The Examiner relies on Rudy and Betbeder as discussed above. The
Examiner finds that Gelber discloses a composition to treat a “condition
caused by an immune response to a virus” that can be applied as a nasal
spray (Answer 8-9). The Examiner finds that Gelber discloses that preferred
ingredients “include zinc acetate, zinc gluconate” (id. at 9). The Examiner
also finds that Gelber discloses that “herbal extracts such as garlic can be
added” (id.). The Examiner concludes that it would have been obvious to
one of ordinary skill in the art to combine Rudy’s method with Gelber’s zinc
compounds because Gelber “teaches that zinc and its bioactive salts act as
immune boosters in the treatment of the common cold” and that it would
have been obvious to combine Rudy’s method with Gelber’s antioxidant
garlic extract in order to make the composition more effective (id. at 10).
Appellants contend that it would not have been obvious to combine
Gelber’s nutraceutical compounds with Rudy’s composition for the
treatment of nasal mucosa because all of Gelber’s compositions are ingested,
not administered as nasal sprays (Appeal Br. 10). Appellants also argue that
“[a]lthough Gelber discloses antioxidants, there is no suggestion, motivation,
predictability, or expectation of success found in Gelber that would have led
one of skill in the art to add a plant extract and/or antioxidant to the
compositions of Rudy” (id. at 10-11).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that it would have been obvious to
combine Gelber’s nutraceutical compounds with Rudy’s nasal spray
composition and method?
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Additional Findings of Fact
12. Gelber discloses “formulations which combine …
pharmaceuticals along with … nutraceuticals to produce an improved effect
which not only treats a current ailment more effectively, but also functions
to prevent the recurrence of illness” (Gelber 1, ¶ 0006).
13. Gelber discloses that “medication for treating a cold, the flu, or a
related symptom may be prepared by combining at least one of the …
decongestant pharmaceuticals … with at least one of the immune-boosting,
antioxidant, and/or liver protective nutraceuticals” (id. at 4, ¶ 0040).
14. Gelber discloses that “[z]inc and its bioactive salts, such as zinc
gluconate and zinc acetate, also act as immune boosters in the treatment of
the common cold” (id. at 3, ¶ 0030).
15. Gelber discloses that its “invention relates to a nasal decongestant
spray . . . which can be administered topically onto the nasal mucosa” (id. at
7, ¶ 0069).
16. Gelber discloses that preferred “Immune Boosting and/or Anti-
Viral Nutraceuticals” for use in nasal decongestant sprays include zinc
gluconate, zinc acetate, and zinc oxide (id. at 7, Table 7).
17. Gelber discloses that preferred “Antioxidant Nutraceuticals” for
use in nasal decongestant sprays include garlic and its extracts (id. at 7,
Table 7).
Analysis
Claim 7 depends from claim 1 and further requires that the virus
inactivation agent is selected from a specified group including a metal
compound, “wherein the metal compound is selected from the group
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consisting of … acetates, … [and] gluconates.” The full text of claim 7 is
reproduced in Appellants’ Claims Appendix (Response to Notice of Non-
Compliant Appeal Brief, filed Oct. 14, 2010, page 3).
Gelber discloses nasal decongestant sprays for the treatment of a cold
or flu that contain a decongestant compound in combination with “Immune
Boosting and/or Anti-Viral Nutraceuticals,” including zinc gluconate and
zinc, and “Antioxidant Nutraceuticals,” including garlic and garlic extracts.
Since both Rudy and Gelber disclose nasal spray compositions to treat cold
and flu symptoms caused by viral infections, it would have been obvious to
one of ordinary skill in the art to include Gelber’s zinc gluconate or zinc
acetate compounds and Gelber’s garlic extract in Rudy’s nasal spray
composition in order to obtain the additional beneficial effects of these
components.
Appellants argue that Gelber does not cure the deficiencies of the
combination of Rudy and Betbeder in suggesting the invention of
independent claim 1. This argument is not persuasive for the reasons
discussed above.
Appellants also argue that “Gelber does not disclose or suggest that
the compositions described therein could be administered to the nasal cavity
as a spray. Rather, the compositions of Gelber are ingested.” (Appeal Br.
11.)
This argument is not persuasive. Gelber expressly discloses nasal
decongestant sprays (FF 15) that contain nutraceuticals including zinc
compounds and garlic extract antioxidants, as discussed above.
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Appellants further argue that “[a]lthough Gelber discloses
antioxidants, there is no suggestion, motivation, predictability, or
expectation of success found in Gelber that would have led one of skill in
the art to add a plant extract and/or antioxidant to the compositions of Rudy”
(id. at 10-11).
This argument is not persuasive. Gelber expressly discloses that the
antioxidant effect of garlic extract is beneficial for the treatment of cold or
flu symptoms, and suggests that garlic extract can be administered as a nasal
spray. Thus, one of ordinary skill in the art would have expected that this
beneficial effect could also be obtained by adding the garlic extract to
Rudy’s nasal spray compositions. “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,
903-04 (Fed. Cir. 1988).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that it
would have been obvious to combine Gelber’s nutraceutical compounds
with Rudy’s nasal spray composition and method.
III.
The Examiner has rejected claim 15 under 35 U.S.C. § 103(a) as
being obvious in view of Rudy, Betbeder and Kamishita. Claim 15 depends
from claim 1 and further requires that the composition comprises a nasal
secretion agent selected from a specified group that includes a hypertonic
solution, “wherein the hypertonic solution is selected from the group
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consisting of sodium chloride at concentrations with an osmolarity of from
about 280 milliosmoles to about 450 milliosmoles, and mixtures thereof.”
The full text of claim 15 is reproduced in Appellants’ Claims Appendix
(Response to Notice of Non-Compliant Appeal Brief, filed Oct. 14, 2010,
page 4).
The Examiner relies on Rudy and Betbeder as discussed above. The
Examiner finds that Kamishita discloses polymer-based spray gel
compositions useful for clinical applications such as an influenza vaccine
(Answer 11). The Examiner finds that Kamishita further discloses that
changes in osmotic pressure should be taken into account in adjusting the
viscosity of the formulation (id.). The Examiner concludes that it would
have been obvious to one of ordinary skill in the art to adjust the osmolarity
of Rudy’s composition to have an osmolarity “of from about 280
milliosmoles to about 450 milliosmoles,” as recited in claim 15, because,
among other things, Kamishita discloses that osmolarity is a consideration in
adjusting compositions for physiologic applications.
We agree with the Examiner’s conclusion that the composition of
claim 15 would have been obvious in view of the cited references. Rudy
discloses that its composition has an osmolality of “from about 140
mOsm/kg to about 2,000 mOsm/kg” (FF 2). Thus, Rudy’s osmolality range
encompasses the claimed osmolarity range, and would have made it prima
facie obvious. In re Peterson, 315 F.3d at 1330 (“[T]he existence of
overlapping or encompassing ranges shifts the burden to the applicant to
show that his invention would not have been obvious.”). The disclosures of
Betbeder and Kamishita are cumulative.
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Appellants argue that because Kamishita discloses that sodium
chloride adjustments would affect both osmotic pressure and viscosity and
Rudy discloses that sodium chloride adjustments would not affect viscosity,
one of skill in the art would not have combined the disclosure of Kamishita
with the disclosure of Rudy (Appeal Br. 14).
This argument is not persuasive since the method of claim 15 would
have been obvious in view of Rudy alone, and therefore the disclosure of
Kamishita is cumulative.
SUMMARY
We affirm the rejection of claims 1, 2, 4-15, 17-19, 21-28 and 30-34
under 35 U.S.C. § 103(a).
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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