Ex Parte Doyle et al

Patent Trial and Appeal Board

Nov 16, 2012

10454843 (P.T.A.B. Nov. 16, 2012)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.
10/454,843 06/05/2003 MATTHEW JOSEPH DOYLE 8147R

EXAMINER

THE PROCTER & GAMBLE COMPANY 
GLOBAL LEGAL DEPARTMENT‐IP 
SYCAMORE BUILDING‐4TH FLOOR 
299 EAST SIXTH STREET 
CINCINNATI, OH 45202 

GITOMER RALPH J
ART UNIT PAPER NUMBER
1657
MAIL DATE DELIVERY MODE

11/16/2012 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MATTHEW JOSEPH DOYLE,
STEPHEN JOSEPH HUNTER-RINDERLE,
WILLIAM MICHAEL GLANDORF, and DONALD JAMES WHITE JR.
__________

Appeal 2011-006126
Application 10/454,843
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN and STEPHEN WALSH,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-3, 6, 7, and 9-12. We have jurisdiction
under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as follows
(emphasis added):
1. A method of controlling bacterial infection in the oral cavity in human
and animal subjects and reducing risk of developing an oral bacteria induced
systemic disease, comprising topically administering to an oral cavity of a
subject in need thereof, a topical oral composition comprising:
a. an amount of a stannous ion source effective to control bacterial
infection in the oral cavity and inhibit spread into the bloodstream of
pathogenic oral bacteria and associated bacterial toxins, endotoxins,
resultant inflammatory cytokines and mediators,
b. a polymeric mineral surface active agent which is a condensed
polyphosphate having an average chain length of about 4 or more in an
amount to provide a molar ratio of phosphate anion to stannous ion of from
about 0.2: 1 to about 5: 1 effective to bind stannous while maintaining
stannous therapeutic efficacy with minimal side effects of tooth staining, and
c. a pharmaceutically acceptable oral carrier,
wherein the total water content is up to about 20% by weight of the
composition for polyphosphate stability and wherein the oral bacteria-
induced systemic disease is one or more of cardiovascular disease, stroke,
atherosclerosis, diabetes, respiratory infections, premature births and low
birth weight, post-partum dysfunction in neurologic and developmental
functions.

The following grounds of rejection are before us for review:
I. Claims 1-3, 6, 7, and 9-12 stand rejected under 35 U.S.C. § 103(a)
as being rendered obvious by the combination of Singer,1

1 Singer et al., US Pat No. 5,364,616, issued November 15, 1994.
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McClanahan,2 Sanker,3 Michael ’080,4 Michael ’553,5 and Michael
’554.6
II. Claims 1-3, 6, 7, and 9-12 stand rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the enablement
requirement.

We affirm.

ISSUE (Priority and § 103(c))
Does the preponderance of the evidence of record support the
Examiner’s finding that the claims are entitled to an effective filing date of
November 12, 1999?

FINDINGS OF FACT
FF1. The instant application claims the following priority:
This application is a continuation-in-part of application
Serial No. 09/607,240, filed June 30, 2000 pending; application
Serial No. 10/351,205 filed January 24, 2003, now US. Patent
6,821’507, which is a divisional of application Serial No.
09/710, 440 filed November 10. 2000, now U.S. Patent
6,555,094; and application Serial No. 10/039,620, filed October
24, 2001, now U.S. Patent 6,667,027, which is a divisional of
U.S. application Serial No. 09/451,420 filed November 30,
1999, now U.S. Patent 6,350436, which is a continuation-in-

2 McClanahan et al., US Pat No. 6,190,644 B1, issued February 20, 2001.
3 Sanker et al., US Pat No. 5,980,869, issued November 9, 1999.
4 Michael et al., US Pat No. 5,939,080, issued August 17, 1999.
5 Michael, US Pat No. 5,885,553, issued March 23, 1999.
6 Michael et al., US Pat No. 5,885,554, issued March 23, 1999.
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part of application Serial No. 09/203,216, filed November 30,
1998, abandoned, which is a continuation-in-part of application
Serial No. 08/754,577, filed November 21, 1996, now U.S.
Patent 5,939,052, all herein incorporated by reference.

(Spec. 17.)
FF2. The Examiner finds:
Benefit of priority is previously granted to 11/12/1999
based on 60/165,350 which appears to be the first publication in
the priority chain to teach the specifically claimed condensed
polyphosphate polymer in combination with stannous ions in a
dentifrice composition for the presently claimed function.

(Ans. 4.)
FF3. Application Serial No. 09/710,440, claims priority to 60/165,350.
FF4. The present application and the McClanahan, Sanker, Michael ’080,
Michael ’553, and Michael ’554 references, cited by the Examiner were
“made, owned by, or subject to an obligation of assignment to, The Proctor
& Gamble Company” (App. Br. 17).
FF5. According Appellants, priority should be granted to Application Serial
No. 09/203,216, filed November 30, 1998 (App. Br. 8).
FF6. Application Serial No.09/203,216 does not disclose the use of the
topical oral composition required by the claimed method for “controlling
bacterial infection in the oral cavity in human and animal subjects and
reducing risk of developing an oral bacteria induced systemic disease,
comprising topically administering to an oral cavity of a subject in need
thereof,” as required by the instant claims.

7 Specification as amended June 13, 2007.
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FF7. McClanahan was published February 20, 2001, and was filed on
November 21, 1996.
FF8. Sanker was published November 9, 1999, and was filed on April 28,
1997.
FF9. Michael ’080 was published August 17, 1999, and was filed on
January 10, 1997.
FF10. Michael ’553 was published March 23, 1999, and was filed on
January 10, 1997.
FF11. Michael ’554 was published March 23, 1999, and was filed on
January 10, 1997.

PRINCIPLES OF LAW
35 U.S.C. § 103(c)(1) states:
Subject matter developed by another person, which qualifies as
prior art only under one or more of subsections (e), (f), and (g)
of section 102 of this title, shall not preclude patentability under
this section where the subject matter and the claimed invention
were, at the time the claimed invention was made, owned by the
same person or subject to an obligation of assignment to the
same person.

ANALYSIS
Appellants assert that “Application Serial No. 09/203,216 supports
each and every element of the present claims in a manner required by 35
U.S.C. § 112” (App. Br. 9). Appellants argue that Application Serial No.
discloses the topical oral composition required by the claimed method, and
its topical administration to the oral cavity (id. at 9-10). According to
Appellants:
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It is stated that the claimed method is not fully supported
in the priority application because the priority application does
not recite the systemic diseases that are mediated by the oral
bacterial infection. . . . . . However, the present application
claims are entitled to a priority date of November 30, 1998 for
the above specified elements, namely topical administration of
a composition comprising the combination of stannous ions and
long-chain polyphosphate at the specified molar ratio and up to
20% by weight water to provide efficacy with minimal side
effects of staining due to stannous ions.

(Id. at 11.) Appellants assert that the “recitation of specific oral bacteria-
mediated systemic diseases in the present claims does not affect the
functioning of the present claimed method, but simply define the resulting
effects or benefits of the claimed method” (id.).
Appellants’ arguments are not convincing. As noted by the Examiner,
and not disputed by Appellants, the 09/203,216 Application does not
disclose the claimed use of the method, that is “[a] method of controlling
bacterial infection in the oral cavity in human and animal subjects and
reducing risk of developing an oral bacteria induced systemic disease.”
Thus, we agree with the Examiner that the instant claims are entitled to an
effective filing date of November 12, 1999.
Thus, McClanahan is not available as prior art under § 103(c), as it
was published after the effective filing date and qualifies only under
§ 102(e). However, each of Sanker, Michael ’080, Michael ’553, and
Michael ’554 have publication dates before November 12, 1999, making
them available as art under § 102(a).

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CONCLUSION OF LAW
We conclude that the preponderance of the evidence of record
supports the Examiner’s finding that the claims are entitled to an effective
filing date of November 12, 1999.

ISSUE (Obviousness)
Has the Examiner established by a preponderance of the evidence that
the combination of Singer, Sanker, Michael ’080, Michael ’553, and
Michael ’554 renders claim 1 obvious?

FINDINGS OF FACT
FF12. According to the Specification, the “invention relates to promoting
and enhancing whole body health or overall systemic health in humans and
other animals, by use of topical oral compositions comprising an
antimicrobial agent, in particular stannous salts, such as stannous fluoride
and stannous chloride in combination with a polymeric mineral surface
active agent such as condensed polyphosphates or polyphosphonates” (Spec.
1). 37 C.F.R. § 41.37(c)(1)(vii).
FF13. The Specification teaches further, “[i]n particular, the present
invention relates to methods of using the present topical oral compositions to
reduce the risk in development of cardiovascular disease, stroke,
atherosclerosis, diabetes, severe respiratory infections, premature births and
low birth weight, post-partum dysfunction in neurologic and developmental
functions, and associated increased risk of mortality” (id.).
FF14. The Specification teaches:
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The present invention relates to a method of promoting
whole body or systemic health in human and animal subjects
comprising topically administering to the subject’s oral cavity a
safe and effective amount of a composition comprising an
antimicrobial agent, specifically stannous ions in combination
with a polymeric mineral surface active agent and a
pharmaceutically acceptable carrier. The compositions are
effective in inhibiting the spread into the bloodstream of
pathogenic oral bacteria, associated bacterial toxins and
endotoxins, and resultant inflammatory cytokines and
mediators, which are etiologic factors in a number of systemic
diseases, such as heart disease. The topical oral compositions
preferably comprise a stannous ion source that provides at least
about 3,000 ppm stannous ions and from about 1 % to about
35% polymeric mineral surface active agent.

(Id. at 7.)
FF15. The Examiner rejects claims 1-3, 6, 7, and 9-12 over the combination
of Singer, Sanker, Michael ’080, Michael ’553, and Michael ’554 (Ans. 5).
As Appellants do not argue the claims separately, we focus our analysis on
claim 1, and claims 2, 3, 6, 7, and 9-12 stand or fall with that claim.
FF16. The Examiner finds that Singer teaches all of the components of the
composition required by claim 1 (Ans. 5-6).
FF17. The Examiner also notes that claim 1 requires “a polyphosphate
having an average chain length of about 4 or more,” and that the “about 4”
reads on three, which is specifically disclosed by Singer (id. at 11).
FF18. Singer relates to methods and compositions for the prevention and
treatment of gingivitis and soft tissue effects of periodontitis, wherein the
compositions contain a selective histamine-2 receptor antagonist compound
(Singer, col. 2, ll. 32-37).
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FF19. Singer teaches that water is an optional component, and may comprise
2% to 99%, and more preferably from 20% to 95% of the composition (id. at
col. 15, l. 60-col. 16, l. 4).
FF20. Singer also teaches that anticalculus agents, such as a polyphosphate,
may be used in the composition (id. at col. 17, l. 63-col. 18, l.2), wherein the
anticalculus agent may comprise 0.2% to about 13% of the composition (id.
at col. 18, ll. 26-28).
FF21. Singer also teaches the use of antimicrobial antiplaque agents, such as
stannous ion agents in an amount of 0.1% to about 5% (id. at col. 18, l. 48-
col. 19, l. 7)
FF22. The Examiner notes that Singer does not teach that the
polyphosphates have a chain length of four or more (Ans. 6).
FF23. The Examiner relies on Sanker, Michael ’080, Michael ’553, and
Michael ’554 for teaching oral care compositions containing stannous ions
and polyphosphates that have a chain length of four or more, such as
Sodaphos, Hexaphos, and Glass H (id. at 6-7).
FF24. The Examiner concludes that using the composition of Singer to
prevent periodontal disease “would inherently control systemic disease”
(Ans. 7).
FF25. The Examiner also concludes that it would have been obvious to use a
longer chain polyphosphate, such as Sodaphos, Hexaphos, or Glass H, as
taught by Sanker, Michael ’080, Michael ’553, and Michael ’554 in the
composition of Singer because each of Sanker, Michael ’080, Michael ’553,
and Michael ’554 teach their use in oral care compositions containing
stannous ions.
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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.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. In determining whether obviousness is established
by combining the teachings of the prior art, “the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). Under the correct
obviousness analysis, “any need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” KSR, 550 U.S. at 420.
Thus, for a prima facie case of obviousness to be established, the references
need not recognize the problem solved by Appellants. In re Kemps, 97 F.3d
1427, 1430 (Fed. Cir. 1996); In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir.
1992); Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Int. 1985) (“The
fact that appellant has recognized another advantage which would flow
naturally from following the suggestion of the prior art cannot be the basis
for patentability when the differences would otherwise be obvious.”)

ANALYSIS
Appellants argue that “Singer discloses a method that employs a
totally different composition than presently claimed,” as it relies on H2-
antagonists for efficacy, the stannous fluoride is optional, and “has no
teaching of polyphosphates having a chain length of 4 or more” (App. Br.
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14). Appellants assert that “Singer only discloses pyrophosphate (n=2) and
tripolyphosphate (n=3) as optional anticalculus agents,” and that no
criticality for any particular polyphosphate is disclosed by Singer (id.).
Appellants assert that “the present compositions require longer-chain
polyphosphates, i.e., having more than one internal phosphate group in
addition to the two phosphate end groups, i.e., four or more total phosphate
groups in the polymer chain, in order to bind stannous and retain biological
activity while inhibiting stannous derived aesthetic negatives” (id.).
Appellants argue further that there is no teaching or suggestion of
combining polyphosphate with stannous ions in a ratio of 0.2:1 to about 5:1,
asserting that “molar ratio is critical for the polyphosphate to effectively
bind stannous ions to minimize stannous-derived staining, while maintaining
stannous therapeutic efficacy” (id. at 15). Appellants argue that the
compositions of Singer may have a water content of up to 99%, and Singer
does not teach or suggest “to limit the total water content of the composition
to no more than 20% by weight, in order that the longer-chain polyphosphate
will be stabilized against hydrolysis” (id. at 16).
Appellants argue that the remaining references relied upon by the
Examiner do not remedy the deficiencies of Singer (id.). Appellants assert
that “none of the . . . references provide any basis or motivation to
specifically combine long-chain polyphosphates and stannous ions at the
specified molar ratio of polyphosphate ions to stannous ions in a
composition having a water content of no more than about 20% to provide a
non-staining product having efficacy against oral bacterial infection from
stannous ions” (id. at 18).
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Appellants argue further that there is no reason to combine the long-
chain polyphosphates of any of Sanker, Michael ’080, Michael ’553, and
Michael ’554 with Sinker, and that the Examiner’s combination relies on
improper hindsight reasoning (id. at 19). Specifically, Appellants assert that
“[t]here is no teaching or suggestion in any of Singer or the secondary
references of using a composition having an amount of a stannous ion source
to provide stannous ions effective to control bacterial infection in the oral
cavity and inhibit spread into the bloodstream of pathogenic oral bacteria
and associated bacterial toxins, endotoxins, resultant inflammatory cytokines
and mediators” (id. at 20). Appellants further assert that none of the
references address the issue of stannous staining, and do not teach or suggest
a molar ratio of polyphosphate ions of from about 0.2:1 to about 5:1 (id.).
Appellants’ arguments have been carefully considered, but are not
found to be convincing. As found by the Examiner, Singer teaches all of the
components of the composition, and its use to treat gingivitis or periodontics
(FFs 16-21). While Singer requires the use of a histamine-2 receptor
antagonist compound (FF18), claim 1 uses the transitional phrase
“comprising,” and thus does not exclude the use of that compound in the
topical oral care composition. As found by the Examiner, Singer teaches a
composition that may include all of the components of the topical care
composition required by claim 1 (FF16).
As to Appellants argument that Singer does not teach the use of longer
chain polyphosphates, as noted by the Examiner (FF17), claim 1 recites “an
average chain length of about 4 or more,” and thus encompasses the
polyphosphate with a chain length of three as taught by Singer. Moreover,
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Singer teaches the use of polyphosphates as anticalculus agents (FF20), and
each of Sanker, Michael ’080, Michael ’553, and Michael ’554 teach oral
care compositions containing stannous ions and polyphosphates that have a
chain length of four or more, such as Sodaphos, Hexaphos, and Glass H
(FF23). Thus, we agree with the Examiner that the references as combined
would have suggested to the ordinary artisan the use of the longer chain
polyphosphates, such as Sodaphos, Hexaphos, and Glass H, in the oral care
composition of Singer. While Appellants argue that the longer chain
polyphosphates are required in order to bind stannous and retain biological
activity while inhibiting stannous derived aesthetic negatives, the reason for
combining the references need not be the same as that of Appellants. To the
extent that Appellants are arguing that the longer chain polyphosphates, it is
well settled that results must be established by factual evidence. Mere
argument or conclusory statements in the specification does not suffice. In
re DeBlauwe, 736 F.2d 699, 705, (Fed. Cir. 1984).
Similarly, as to Appellants’ assertion that there is no teaching or
suggestion of combining polyphosphate with stannous ions in a ratio of 0.2:1
to about 5:1, Appellants have pointed to no evidence or record
demonstrating that ratio provides for unexpected results. In addition, as
noted by the Examiner (Ans. 11), the range of polyphosphate to stannous ion
required by claim 1 is very broad, and encompasses the proportions taught
by the Singer reference.
Appellants also argue that the Examiner’s rejection is based on
inherency in stating the composition taught by the references would
inherently control systemic disease, and cite Ex parte Schrickner, 56
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USPQ2d 1723 (BPAI 2000) for the proposition that inherency and
obviousness do not mix (Reply Br. 5).
Again, Appellants arguments are not convincing. The combination of
references relied upon by the Examiner teaches the composition of the
method of claim 1, as well as its use as a topical oral care composition.
Thus, the steps of the claimed method and the method taught by the
combination of the references is the same, whether the composition is being
applied to treat gingivitis and soft tissue effects of periodontitis, or to
improve whole body health. See Bristol-Myers Squibb Co. v. Ben Venue
Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the
context of a claimed process that was drawn to the same use comprising the
same steps of the prior art, “[n]ewly discovered results of known processes
directed to the same purpose are not patentable because such results are
inherent.”).

CONCLUSION OF LAW
We conclude that the Examiner has established by a preponderance of
the evidence that the combination of Singer, Sanker, Michael ’080, Michael
’553, and Michael ’554 renders claim 1 obvious.

ISSUE (Enablement)
Has the Examiner established by a preponderance of the evidence that
the claims are not enabled by the Specification?

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FINDINGS OF FACT
FF26. The Examiner notes that the “claims are directed to a method for
reducing the risk of developing an oral bacteria induced systemic disease
including diabetes, post-partum dysfunction, and in neurological and
developmental functions by topically administering a stannous ion source
and polyphosphate to the oral cavity” (Ans. 8).
FF27. According to the Examiner, those “results are not believable on their
face, no evidence is provided that the claimed composition orally applied
would prevent or treat any of these disorders, and the breadth of the claimed
disorders as related to any oral findings is incredulous” (id.).
FF28. The Examiner concludes that “[i]n the absence of statistically
significant data, it would appear highly unlikely that the claimed
composition would produce any measurable reduction in preventing the
disorders encompassed by the claimed method” (id.).
FF29. The Examiner notes that the Offenbacher Declaration was first
submitted in the instant case with the Appeal Brief, and thus should not be
admitted. See 37 C.F.R. § 41.33(d).

PRINCIPLES OF LAW
“When rejecting a claim under the enablement requirement of section
112, the PTO bears an initial burden of setting forth a reasonable explanation
as to why it believes that the scope of protection provided by that claim is
not adequately enabled by the description of the invention provided in the
specification of the application.” In re Wright, 999 F.2d 1557, 1561-62 (Fed.
Cir. 1993). “[A] specification disclosure which contains a teaching of the
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manner and process of making and using the invention in terms which
correspond in scope to those used in describing and defining the subject
matter sought to be patented must be taken as in compliance with the
enabling requirement of the first paragraph of § 112 unless there is reason to
doubt the objective truth of the statements contained therein which must be
relied on for enabling support.” In re Marzocchi, 439 F.2d 220, 223 (CCPA
1971) (emphasis in original). “[It] is incumbent upon the Patent Office,
whenever a rejection on this basis is made, to explain why it doubts the truth
or accuracy of any statement in a supporting disclosure and to back up
assertions of its own with acceptable evidence or reasoning which is
inconsistent with the contested statement.” Id. at 224.

ANALYSIS
Appellants argue that the enablement rejection is in error, as the
Specification “not only teaches how to make and use the claimed
compositions for topical treatment of the oral cavity, but the enablement of
the claimed invention is also established by the Offenbacher Declaration
(App. Br. 23).
We conclude that the Examiner has failed to set forth a prima case of
lack of enablement, as the Examiner has only made conclusory statements,
without going through any analysis, such as weighing of the pertinent Wands
factors, in making the enablement rejection. See In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1988).

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CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the claims are not enabled by the
Specification.

SUMMARY
We affirm the rejection of claim 1 Claims 1-3, 6, 7, and 9-12 stand
rejected under 35 U.S.C. § 103(a) as being rendered obvious by the
combination of Singer, Sanker, Michael ’080, Michael ’553, and Michael
’554. As Appellants did not argue claims 2, 3, 6, 7, and 9-12 separately,
they fall with claim 1.
We reverse the rejection of claims 1-3, 6, 7, and 9-12 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the enablement requirement.
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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