Ex Parte New

Patent Trial and Appeal Board

Feb 7, 2017

12688455 (P.T.A.B. Feb. 7, 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.
12/688,455 01/15/2010 Kent C. NEW 0076999-000004 3631
21839 7590 02/09/2017
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA, VA 22313-1404
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
02/09/2017 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):
ADIPDOCl@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KENT C. NEW
Appeal 2015-000436
Application 12/688,455
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
DAVID COTTA, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2015-000436
Application 12/688,455
STATEMENT OF CASE
According to the Specification, the invention is directed to the use of a
virucidal preparation on an area of the face for prevention of transmission or
contraction of viral illnesses, or to shorten the duration of, or lessen the
severity of viral illnesses. Spec. 1.
The following claims are representative.
1. A method of reducing the chance of contraction of a viral upper
respiratory illness, said method comprising:
applying a virucidal preparation to the nares, and
reducing the chance of contraction of a viral upper respiratory illness,
the preparation comprising an antiviral agent, which is the only active
antiviral agent, and one or more carrier agents,
wherein the antiviral agent consists of one or more organic acids,
wherein at least one organic acid is malic acid,
wherein the malic acid is at a concentration of up to 2% w/v.
15. A method of reducing the chance of contraction or transmission of
a viral upper respiratory illness, said method comprising:
applying a virucidal preparation to the conjunctiva, and
reducing the chance of contraction or transmission of a viral
upper respiratory illness,
the preparation comprising an antiviral agent, which is the only active
antiviral agent, and one or more carrier agents,
wherein the virucidal preparation further comprises one or more
surfactants,
wherein the antiviral agent consists of one or more organic acids,
wherein at least one organic acid is malic acid,
wherein the malic acid is at a concentration of up to 2% w/v,
wherein the carrier agent is suitable for application to the eyes, and
wherein the virucidal preparation is applied to the eyes one or more
times a day.
17. A method of shortening the duration of a viral upper respiratory
illness or lessening the severity of a viral upper respiratory illness, said
method comprising:
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Application 12/688,455
applying a virucidal preparation to the nares, and
shortening the duration of a viral upper respiratory illness or lessening
the severity of a viral upper respiratory illness,
the preparation comprising an antiviral agent, which is the only active
antiviral agent, and one or more carrier agents,
wherein the antiviral agent consists of one or more organic acids,
wherein at least one organic acid is malic acid,
wherein the malic acid is at a concentration of up to 2% w/v.
26. A method comprising:
applying a virucidal preparation to the nares of an individual; and
reducing or inhibiting access for active viral particles causing viral
upper respiratory illness to nasal mucous membranes,
the preparation comprising an antiviral agent, which is the only active
antiviral agent, and one or more carrier agents,
wherein the antiviral agent consists of one or more organic acids,
wherein at least one organic acid is malic acid,
wherein the malic acid is at a concentration of up to 2% w/v.
Cited References
Hossain et al. US 4,897,304 Jan. 30, 1990
(“Hossain”)
Winterton et al. US 2006/0251696 Al Nov. 9, 2006
(“Winterton”)
Taylor et al. US 2008/0267904 Al Oct. 30, 2008
(“Taylor”)
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Appeal 2015-000436
Application 12/688,455
Grounds of Rejection
1. Claims 1-3, 8, 11-14, 17-19, 21, 23-26, 31, 33, and 34 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over
Hossain in view of Taylor.
2. Claims 15, 28\ and 32 are rejected under pre-AIA 35 U.S.C.
§ 103(a) as being unpatentable over Hossain in view of Taylor and
Winterton.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 3—12. The following facts are highlighted.
1. The Specification 119 states that
Nares, as used in this disclosure, refer to the skin at the entrance to
the nostril. The nasal mucous membranes are not considered part
of the nares, though application of a preparation to the nares may
result in application to a small part of the nasal mucous
membranes.
2. Hossain discloses that, “[i]n addition, the class of virucidal
compositions comprising this invention may also be incorporated
into nasal sprays, facial creams, hand lotions...” Col. 1,11. 21—23.
3. The Examiner finds that
Nasal spray medications are sprayed into the nostrils and
nares are external opening to the nostrils. Further, in
Henderson’s Dictionary of Biological Terms (copyright
1979), “nares” are defined as “nostrils; ....nostrils” being
defined as “the external openings of the nose.” “Nares” are
1 Claim 28 was cancelled via an Amendment filed October 15, 2013.
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Application 12/688,455
defined as “the pair of opening of the nose” in Merriam-
Webster’s Medical Dictionary (copyright
2010).
Ans. 3.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“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).
Rejection 1
Appellant has separately argued claims 1,17 and 26 in the Appeal
Brief. Each of these claims is controlled by the same dispositive issue, so
we consider them together. App. Br. 6, 20, 21. We agree with the
Examiner’s fact finding, statement of the rejection and responses to
Appellant’s arguments as set forth in the Answer. We find that the
Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner’s argument set forth in the Final Rejection and Answer.
We acknowledge that there has been an election of species in the
present case, and that Appellant has elected the species of “dipropylene
glycol” as the carrier agent. Final Act. 2. When the examiner has required
the applicant to elect single chemical species for examination, the issue on
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Application 12/688,455
appeal is the patentability of the single elected species and it is appropriate
to limit discussion to that single issue and take no position respecting the
patentability of the broader generic claims, including the remaining, non-
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987)
Hossain and Taylor
Hossain teaches a method, composition, and product for annihilating
harmful respiratory viruses and inhibiting the spread of diseases, including
the common cold and preventing the spread of the virus-related illness
(Abstract). The reference teaches that the product includes one or more
carboxylic acids such as citric, malic, etc. in an effective amount and may
also include a surfactant (see Abstract). Final Act. 4. Hossain teaches that
the virucidal composition may be administered as a nasal spray, or facial
cream, or similar preparation. Col. 1,1. 17—24. Hossain does not expressly
teach the elected species dipropylene glycol as the carrier in the
composition. Final Act. 5.
The Examiner relies on Taylor for teaching
a method of reducing virus population comprising contacting
the surface with a composition comprising an antimicrobial
agent, surfactant (0.1-15% by weight), and a virucidally
effective amount of an organic acid, hydric solvent (2-25%)
(see claim 1). The reference further claims malic acid, citric
acid, ... etc. as the organic acids that can be formulated in the
composition (see claims 28 and 29). The reference further
teaches hydric solvent include diols such as dipropylene glycol
(see claim 21). The reference teaches in para 0011 that
rhinovirus (important etiological agent for common cold, see
para 0010) can survive on environmental surfaces for hours
after initial contamination, and infection is readily transmitted
by fmger-to-fmger contact, and by contaminated environmental
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Application 12/688,455
surface-to-fmger contact, if the newly contaminated finger then
is used to mb an eye or touch the nasal mucosa.
Final Act. 5. The Examiner concludes that it would have been obvious to
one of ordinary skill in the art to include the dipropylene glycol solvent of
Taylor in the composition of Hossain. Final Act. 7—8. The Examiner
particularly finds that a person of ordinary skill
would have been motivated to formulate the composition
comprising an antiviral agent (as the only active agent) and a
carrier and use it in a method of reducing the chance of
contraction of a viral upper respiratory illness (infection by
rhino vims) because (1) the composition comprising malic acid
has been shown to be effective as a vimcidal agent and is safe
to use in human in the prior art (2) to protect an individual
against infection by rhinoviruses as taught by Taylor.
Final Act. 7—8.
Appellant argues that Hossain does not teach application to the nares,
defined in Specification 119 as the “skin at the entrance to the nostril.”
App. Br. 7 (emphasis omitted). Appellant acknowledges that, “Hossain
teaches that a vimcidal composition may be incorporated in nasal sprays (see
column 1, line 23). However, a nasal spray is applied to the nasal mucosa,
not to the nares.” App. Br. 7.
The Examiner responds, arguing that
Nasal spray medications are sprayed into the nostrils and nares
are external opening to the nostrils. Further, in Henderson's
Dictionary of Biological Terms (copyright 1979), “nares” are
defined as “nostrils; .... nostrils” being defined as “the external
openings of the nose.” “Nares” are defined as “the pair of
opening of the nose” in Merriam- Webster’s Medical
Dictionary (copyright 2010).
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Ans. 3.
ANALYSIS
In the battle over the definition of “nares,” Appellant has chosen to be
his own lexicographer, and we conclude that the definition of “nares”
provided in the Specification is controlling. In re Bigio, 381 F.3d 1320,
1325 (Fed. Cir. 2004). That being said, we have before us an obviousness
rejection, not an anticipation rejection. In addition, we have a claim using
the transitional phrase “comprising.” Consistent with Appellant’s definition
of nares in the Specification, “application of a preparation to the nares may
result in application to a small part of the nasal mucous membranes.” App.
Br. 7. Thus, application of a composition to the nares that also results in
application of the composition to the mucous membranes is encompassed by
the claims, e.g. a nasal spray or cream applied to the face. Put another way,
application of a composition to the mucous membranes (as in the nasal spray
of Hossain) that may result in application of the composition to the nares
(via solution migration or direct application) is also encompassed by the
claims.
We agree with the Examiner, that application of a nasal spray and/or
facial cream, as in Hossain, would necessarily result in application to the
nares (e.g., a nasal spray applied to the mucous membrane of the nose
migrates to either the anterior or posterior nares and a cream applied to the
face is applied to the nose/nares on the face) (cf. Ans. 3 (“the virucidal
formulation of Hossain when applied to nostrils would be applied to the
nares as well. Also when nostrils are wiped with a tissue or applied as a
facial cream containing the virucidal formulation of Hossain such
formulation is applied to the nares as well.”). Hossain also discloses a
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Application 12/688,455
facemask comprising a virucidally effective amount of malic acid that would
necessarily place malic acid in contact with the nares. Hossain Claim 6.
Thus, we find that the Examiner has established a prima facie case of
obviousness on the evidence before us.
Appellant argues that
The Third Declaration of Dr. Kent New shows test results that
prove that a tissue with a[] virucidal preparation of an organic
acid (7.5% citric acid) and a surfactant (2.02% SDS - sodium
cumene sulfonate) did not an transfer and apply an amount
effective to reduce the chance of contraction of a viral upper
respiratory illness.
App. Br. 9.
In response, the Examiner concludes that
There is no direct comparison of the claimed invention with the
prior art malic acid composition. In other words Swype Shield
product needs to be compared with a composition comprising
malic acid. The results shown by the Appellants [are]
commensurate in scope for the following reasons: (1)
Appellants have shown data with only one composition, Swype
Shield product, 0.2% malic acid and 0.1% bioterge (surfactant,
Sodium olefin sultanate). However the Kleenex antiviral tissue
compared has 7.5% citric acid and SDS where Appellants’
Swype shield composition comprise malic acid and bioterge
(surfactant). (2) Appellants claim encompass malic acid up to
2% w/v, and antiviral agent consisting] of one or more organic
acids [] with one or more carrier agents which include[]
different types of surfactants. Excepting for malic acid the
claims are not limited to any specific additional organic acid,
their amounts, to any surfactants and their amounts.
Ans. 5. We find that the Examiner has the better argument. “[Unexpected
results must be established by factual evidence.” In re De Blauwe, 736 F.2d
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699, 705 (Fed. Cir. 1984). “[W]hen unexpected results are used as evidence
of nonobviousness, the results must be shown to be unexpected compared
with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392
(Fed. Cir. 1991). In the present case, Appellant has failed to provide
comparative evidence with the closest prior art, the nasal spray or face cream
application of malic acid as in the disclosure of Hossain. The claims require
a malic acid is at a concentration of up to 2% w/v. Claim 1. Hossain
discloses a composition comprising a surfactant and at least 2 percent malic
acid. Hossain, claim 1. Appellant’s third Declaration of Dr. New (dated
October 14, 2013) compared the Appellant’s Swype Shield product (0.4%
malic acid and a surfactant — bioterge, sodium olefin sulfonate) with a 2%
citric acid and sodium lauryl sulphate impregnated antiviral tissue.
Appellant failed to compare the Swype Shield product, with the closest prior
art, a 2% malic and surfactant composition formulated as a nasal spray, face
cream or tissue. Nor has Appellant provided comparative results using 2%
malic acid and dipropylene glycol (the elected species of surfactant) as the
carrier agent in combination with malic acid.
Appellant argues that they have presented evidence of “long felt need”
in the Declarations of Dr. Kent New.2 App. Br. 14. We are not persuaded.
An affidavit addressing long felt need may be insufficient if it does not
provide evidence that if persons skilled in the art who were presumably
working on the problem knew of the teachings of the above cited
references, they would still be unable to solve the problem. See MPEP
§ 716.04. Hossain specifically indicates that
2 Declarations of Dr. Kent New dated June 23, 2010 and Oct. 14, 2013.
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A facial tissue, containing a fast-acting, efficacious
virucidal composition would offer a simple
means of accomplishing the tasks mentioned above.
A long-felt need has existed for a safe and inexpensive
virucidal agent effective against common respiratory
viruses. Simple household germicides are not effective
against rhino- and adenoviruses.
Col. 2,11. 18—25. Thus, Hossain alleges that they were the ones to meet the
long felt need using a composition comprising malic acid and a carrier in the
form of a nasal spray, face cream or tissue. Appellant provides no evidence
that one of ordinary skill in the art reading Hossain and Taylor would still
have been unable to solve the problem of providing a method of reducing the
chance of contraction of a viral upper respiratory illness, as claimed.
Rejection 1 is affirmed for the reasons of record.
Rejection 2
We select claim 15 as representative for rejection 2. With respect to
rejection 2, Appellant argues that
The Examiner asserts that Taylor teaches that an
infection is spread by rubbing the eyes. However, the Examiner
ignores that Taylor teaches that the solution to this problem is
to disinfect the hands. There is no teaching or suggestion to
apply the claimed virucidal composition to the eyes.
The Examiner relies on Winterton to allegedly teach
applying malic acid to the eyes for the purposes of hydration.
However, the Examiner cites to no teaching or suggestion in
Winterton to [] apply a preparation containing malic acid, a
carrier agent and a surfactant to the eyes. Moreover, there is no
teaching or suggestion in Winterton to apply malic acid for the
purposes of reducing the chance of contraction or transmission
of a viral upper respiratory illness.
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App. Br. 22—23.
In response, the Examiner argues that
Winterton has not been modified to include the claimed carrier
agent and a surfactant. Hossain teach [a] virucidal preparation
comprising organic acids such as malic acid that can range from
0.2-10% and a surfactant that can formulated in wipe, nasal
spray, ointment etc., Taylor teach that dipropylene glycol is a
carrier that can be added to an antiviral preparation comprising
an organic acid such as malic acid. Winterton has been cited to
show that malic acid has ophthalmic benefits indicating that it
is safe to be applied to the eyes. A person of ordinary skill in
the art at the time of the invention would have found it obvious
to use Hossain’s formulations to use in conjunctiva because
Hossain’s virucidal comprises organic acids, a carrier and a
surfactant and has been found to be safe to be administered as
nasal spray, wipes (hands), facial creams, face mask, lipstick,
garments (drape, pillowcases, etc.). Obviousness does not
require absolute predictability, only a reasonable expectation of
success, i.e., a reasonable expectation of obtaining similar
properties. See, e.g., In re O'Farrell, 853 F.2d 894, 903, 7
USPQ2d 1673, 1681 (Fed. Cir. 1988).
Ans. 13.
We find that the Examiner has failed to set forth a rationale supporting
a prima facie case of obviousness for claims 15 and 32. The Examiner’s
rationale given for modification of Hossain and Taylor by Winterton is that
“Winterton has been cited to show that malic acid has ophthalmic benefits
indicating that it is safe to be applied to the eyes.” Ans. 13. We agree with
Appellant that neither Hossain nor Taylor suggests a method of reducing the
chance of contraction or transmission of a viral upper respiratory illness,
said method comprising: applying a virucidal preparation to the conjunctiva.
Claim 15. A teaching that a substance is safe to be applied to the eyes is not
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a clear suggestion of its application to the conjunctiva to reduce the chance
of contraction or transmission of a viral upper respiratory illness. Under §
103, “there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” KSR Int 7 Co.
v. Teleflex, Inc., 550 U.S. 398, 418 (2007) (citation omitted).
On this record, we do not find that the Examiner’s rationale based on
Winterton provides a sufficient nexus to the method of reducing the chance
of contraction or transmission of a viral upper respiratory illness, as claimed,
Rejection 2 is reversed.
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection 1,
which is affirmed for the reasons of record. Obviousness rejection 2 is
reversed. Our decision is restricted to the elected species.
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)(1).
AFFIRMED-IN-PART
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