Ex Parte KAWA et al

Patent Trial and Appeal Board

Nov 20, 2018

13932088 (P.T.A.B. Nov. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/932,088 07/01/2013 Gertrud KAW A
16375 7590 11/23/2018
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-0036 3270
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/23/2018 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 GERTRUD KAW A, SHIREEN UPP AL,
and DAVID URQUHART
Appeal2017-007464
Application 13/932,088 1
Technology Center 1600
Before JEFFREY N. FREDMAN, RYAN H. FLAX and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating xerostomia or mouth dryness. The Examiner rejected the claims
on appeal under 35 U.S.C. § 103(a) as obvious.
We reverse.
1 According to Appellants, the real parties in interest are GlaxoSmithKline
Consumer Healthcare GmbH & Co KG, Glaxo Group Limited, and Oasis
Consumer Healthcare, LLC. App. Br. 2.
Appeal2017-007464
Application 13/932,088
STATEMENT OF THE CASE
The Specification discloses that "[ x ]erostomia, or dry mouth, is a
condition in which an excessive dryness within the oral cavity occurs."
Spec. 1. "Xerostomia is not itself a disease, but a symptom of various
medical conditions, a side effect of radiation to the head and neck, or a side
effect of a variety of medications." Id. "Xerostomia is often a contributing
factor for both minor and serious health problems; it can affect nutrition and
dental, as well as psychological health." Id. "[I]t would be advantageous to
provide compositions for oral use as a lubricant to alleviate the discomfort
associated with xerostomia." Id. The Specification teaches that "the
symptoms of dry mouth may be reduced by the use of an oral care
composition comprising a combination of polyvinyl pyrrolidone (PVP) or a
derivative thereof with an anionic mucoadhesive polymer." Id. at 2.
Claims 9-12 and 21-36 are on appeal. Claims 9, 29, and 35, the only
independent claims on appeal, are illustrative and read as follows:
9. A method of treating xerostomia or mouth dryness by
administering to a person in need thereof a liquid composition
compnsmg:
(A) ingredients in effective amounts for treating
xerostomia or mouth dryness consisting of:
(i) polyvinyl pyrrolidone or a derivative thereof
and
(ii) an anionic mucoadhesive polymer; and
(B) one or more orally acceptable carriers or excipients
selected from the group consisting of: flavoring agents,
humectants, binders, sweetening agents, surfactants,
preservatives, buffering agents, coloring agents and water.
29. A method of treating xerostomia or mouth dryness by
administering to a person in need thereof a liquid composition
compnsmg:
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Application 13/932,088
0.1 to 20% by weight polyvinyl pyrrolidone or a
derivative thereof; and
an anionic mucoadhesive polymer;
wherein the weight ratio of the polyvinyl pyrrolidone or
derivative thereof to the anionic mucoadhesive polymer is from
4: 1 to 2: 1;
wherein the liquid composition is exclusive of abrasive
polishing materials.
3 5. A method of treating xerostomia or mouth dryness by
administering to a person in need thereof a liquid composition
consisting of:
0.1 to 20% by weight polyvinyl pyrrolidone or a
derivative thereof;
an anionic mucoadhesive polymer;
one or more orally acceptable carriers or excipients
selected from the group consisting of: flavoring agents,
humectants, binders, sweetening agents, surfactants,
preservatives, buffering agents, coloring agents and water;
optionally, additional ingredients selected from the group
consisting of: antimicrobial agents, moisturizing agents, breath
freshening agents, and desensitising agents;
wherein the weight ratio of the polyvinyl pyrrolidone or
derivative thereof to the anionic mucoadhesive polymer is from
4: 1 to 2: 1.
Claim App'x.
The claims stand rejected as follows. 2
Claims 9-12, 22-32, and 35 were rejected under 35 U.S.C. § I03(a)
as obvious over Bannister. 3
2 In the Examiner's Answer, the Examiner withdrew the pending rejection of
claims 9-12 and 21-36 under 35 U.S.C. § 112 for failing to comply with the
written description requirement. Ans. 4. This rejection is thus no longer
part of this appeal.
3 Bannister, WO 2004/000252 Al, published Dec. 31, 2003 ("Bannister").
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Application 13/932,088
Claims 9--12 and 21-36 were rejected under 35 U.S.C. § I03(a) as
obvious over the combination of Bannister and Majeti. 4
OBVIOUSNESS OVER BANNISTER
Claims 9-12 and 21-28
The Examiner finds that Bannister discloses "a method for treating
xerostomia comprising administering an oral lubricant composition to the
oral cavity." Final Act. 4. The Examiner concludes that the method
disclosed in Bannister renders the method of claim 9 obvious. Id.
Appellants argue that claim 9 is not obvious because the compositions
Bannister uses to treat dry mouth include phosphoprotein and it would not
have been obvious to remove phosphoprotein from Bannister's
compositions. App. Br. 5. We find that Appellants have the better position.
We begin by construing the claims. Claim 9 requires "ingredients in
effective amounts for treating xerostomia or mouth dryness consisting of ...
polyvinyl pyrrolidone ... [and] an anionic mucoadhesive polymer." It is
well settled that the transitional phrase "consisting of' is closed to elements
not recited. Aiultila_yer Stretch Cling Film Holdings, Inc. v. Ben:v Plastics
Corp., 831 F.3d 1350, 1358 (Fed. Cir. 2016). Here, the transitional phrase
"consisting of" appears in the body of the claim in a clause identifying
ingredients effective for treating xerostomia or mouth drvness. It is (._., .. __ , J
preceded by the transitional phrase "comprising" in the preamble.
Accordingly, we construe the transitional phrase "consisting of' in the
clause at issue to lirnit the ingredients that are effective for treating
xerostomia or mouth dryness to those recited in the claim, but not to limit
4 Majeti et al., US Patent Publication No. 2003/0124065 Al, published July
3, 2003 ("Majeti").
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Application 13/932,088
other method steps. A{annesmann Dernag Cmp. v. Engineered Afetal
Products Co., 793 F.2d 1279, (Fed. Cir. 1986) (finding that "[t]he district
court correctly observed that the phrase 'consisting of' appears in clause (a),
not the preamble of the claim, and thus limits only the element set forth in
clause (a)").
The compositions disclosed in Bannister include phosphoproteins as
an active ingredient for treating xerostomia. See, e.g., Bannister 2 ("The
present invention provides formulations for use as an oral lubricant and for
use as saliva substitutes in humans or animals, wherein said formulations
comprise phosphoproteins. Further, the present invention provides
formulations that are particularly useful for treating humans or animals with
xerostomia."). As discussed above, claim 9 limits the ingredients that are
effective for treating xerostomia or mouth dryness to those recited in the
claim. Because phosphoproteins are effective for treating xerostomia, and
because they are not among the ingredients listed in claim 9, they are
excluded from the claim.
The Examiner argues that phosphoproteins are not excluded because
"a phosphoprotein may be anionic and mucoadhesive." Ans. 5. We are not
persuaded because, as Appellants point out (Reply Br. 3 ), the Examiner does
not provide evidence to support this assertion.
The Examiner a1so argues that it would have been obvious to remove
phosphoprotein and replace it with C'fv1C (carboxymethyl cellulose) or PVP
(polyvinylpyn-olidone) because phosphoprotein, C'fv1C, and PVP are all
taught to be viscosity modifiers. Ans. 5. The Examiner contends that
"phosphoprotein is merely a preferred embodiment rather than a critical
ingredient" and thus "substituting the phosphoprotein for PVP and Cl\1 C
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would not change the performance of the cornposition given that
phosphoprotein, PVP and Cl\1C are all taught by Bannister as equivalents for
the same purpose." id. at 6. \Ve are not persuaded.
Even if we were to credit the Examiner's assertion that CJ\.1C, and
PVP are all taught to be viscosity modifiers, 5 the Examiner still failed to
cany the burden to demonstrate that it would have been obvious to substitute
ClvIC and PVP for Bannister's phosphoproteins because the Examiner does
not identify any teaching that Cl\tfC and PVP are equivalent to
phosphoproteins as oral lubricants. Bannister repeatedly describes
phosphoprotein as the critical lubricating component See e.g., Bannister, 1
("This invention relates to formulations containing phosphoprotein, designed
for use as oral lubricant or as artificial saliva, and methods of using the
formulations."); id. ("Phosphoproteins have been described for use in
formulations for the treatment or prevention of diseases resulting from the
action of bacteria in the oral cavity, for example, caries and gingivitis.
However, such formulations have not been described for use as an oral
lubricant or as a saliva substitute."); id. at 2 ("The present invention provides
formulations for use as an oral lubricant and for use as saliva substitutes in
humans or animals, wherein said formulations comprise phosphoproteins.");
id. at 4 ("Typically, the formulation may comprise any two or more of the
phosphoproteins disclosed herein. Inclusion of casein phosphoprotein in a
5 Bannister discloses "proteins" among a list of suitable viscosity modifiers
(Bannister 7), but the Examiner does not identify anything in Bannister
specifically identifying phosphoproteins as viscosity modifiers. We do not
reach the issue of whether Bannister discloses CMC, PVP, and
phosphoproteins as equivalent viscosity modifiers because it is not necessary
to our decision.
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formulation for lubrication of the oral cavity provides improved lubrication,
for example by providing a more effective lining of the surfaces of the oral
cavity compared to formulations in which casein phosphoprotein is
absent."). The Examiner does not identify, and we do not find, anything in
Bannister to suggest that CMC or PVP can be substituted for phosphoprotein
as an oral lubricant.
Accordingly, we reverse the Examiner's rejection of claim 9 as
obvious over Bannister. Claims 10-12, and 22-28 depend from claim 9 and
we reverse the Examiner's rejection of these claims for the reasons discussed
in connection with claim 9.
Claims 29-36
Independent claims 29 and 35 both require that "the weight ratio of
the polyvinyl pyrrolidone ... to the anionic mucoadhesive polymer is from
4: 1 to 2: 1." In finding that Bannister renders the claimed weight ratio
obvious, the Examiner relied principally on Bannister's disclosure that PVP
and CMC were both viscosity modifiers. The Examiner explained:
Bannister teaches using PVP and CMC as viscosity modifiers.
Thus, the prior art recognizes that a combination of PVP and
CMC will provide viscosity modification to a composition.
Specifically, Bannister teaches the use of these viscosity
modifiers ... to replicate the viscosity of natural saliva.
Applicants have provided no evidence of unexpected results or
criticality of the claimed range. One of ordinary skill in the art
would find it prima facie obvious to follow the teachings of
Bannister and combine known viscosity modifiers in amounts
sufficient to replicate natural saliva.
Final Act. 6-7. We are not persuaded.
We acknowledge that Bannister discloses both PVP and CMC as two
among a long list of viscosity modifiers that may be present in Bannister's
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Application 13/932,088
compositions in a concentration between 0.001 % and 20%. Bannister 7.
However, the Examiner does not identify, and we do not find in Bannister,
any reason to include PVP and CMC in the specific ratio recited in the
claims. The Examiner asserts that it would be obvious to combine viscosity
modifiers in amounts sufficient to replicate natural saliva, but does not
explain why replicating saliva would lead one to use PCP and CMC in the
claimed ratio. Because the Examiner has not persuasively explained why
the skilled artisan would combine PVP and CMC in the claimed ratio, we
reverse the Examiner's rejection of claims 29 and 35 as obvious over
Bannister. Claims 30-34 depend from claim 29 and claim 36 depends from
claim 35. We reverse the Examiner's rejection of these claims for the
reasons discussed in connection with claims 29 and 35.
OBVIOUSNESS OVER BANNISTER AND MAJETI
Claims 9-12 and 21-28
In rejecting claims 9-12 and 21-28 as obvious over the combination
of Bannister and Majeti, the Examiner applied Bannister in the same manner
discussed above with respect to the rejection over Bannister alone.
Accordingly we reverse the Examiner's rejection of claim 9-12 and 21-28
for the reasons discussed above with respect to the rejection over Bannister.
Claims 29-36
As discussed above, independent claims 29 and 35 both require that
"the weight ratio of the polyvinyl pyrrolidone ... to the anionic
mucoadhesive polymer is from 4: 1 to 2: 1." In finding these claims obvious,
the Examiner relies on Bannister's disclosure that both PVP and CMC are
viscosity modifiers. Final Act. 9. This is not persuasive for the reasons
discussed above. In addition, the Examiner relies on Majeti's disclosure of
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"an oral dentifrice composition comprising 3% PVP/VA, 0.8% sodium
carboxymethylcellulose (NaCMC) and 0.5% xanthan gum (Example IVB)"
which the Examiner concludes is a ratio of PVP to CMC of 3.75:1. Final
Act. 9. Appellants argue that Majeti discloses compositions for cleaning
teeth and that a skilled artisan would not have reason to combine such a
composition with Bannister's composition for treating dry mouth. App. Br.
8. We find that Appellants have the better position.
Majeti discloses "oral care compositions and methods for overall
cleaning, whitening and preventing, reducing or removing surface deposited
stains on natural teeth and dental prosthesis." Majeti Abstract. The
Examiner asserts that it would have been obvious to combine Bannister and
Majeti because they are both oral compositions and oral compositions
"clearly treat dry mouth." Final Act. 8 ("given that oral compositions
clearly treat dry mouth, it would have been prima facie obvious to combine
two compositions that would treat dry mouth to form a third composition for
the same purpose"). The Examiner, however, does not identify any evidence
to support the general proposition that oral compositions treat dry mouth.
Nor does the Examiner offer evidence to support the more specific
proposition that the compositions disclosed in Majeti treat dry mouth.
Accordingly, the Examiner has not carried the burden to establish that it
would have been obvious to combine the compositions of Majeti and
Bannister because they are both useful for treating dry mouth.
The Examiner also asserts that it would have been obvious to combine
the teachings of Majeti and Bannister because Majeti teaches that using a
derivative form of PVP provides greater retention on oral surfaces. Id.
From this, the Examiner concludes that "[t]he ability to form a coating on
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oral surfaces would be expected to treat xerostomia as one symptom of
xerostomia is damaged teeth. Thus, protection of teeth is, in the broad sense,
'treating' xerostomia." Id. (internal citations omitted). We agree with
Appellants that this connection is too attenuated and that a skilled artisan
"would not reasonably consider treating tooth and dental prosthesis stains as
a treatment for xerostomia or dry mouth." App. Br. 9. Accordingly, we
reverse the Examiner's rejection of claims 29-36.
SUMMARY
In summary, we reverse the Examiner's rejection of claims 9-12, 22-32,
and 35 under 35 U.S.C. § 103(a) as obvious over Bannister
We reverse the Examiner's rejection of claims 9-12 and 21-36 under
35 U.S.C. § 103(a) as obvious over the combination of Bannister and Majeti.
REVERSED
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