Ex Parte Zielinski et al

Patent Trial and Appeal Board

Jun 12, 2018

14844219 (P.T.A.B. Jun. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/844,219 09/03/2015
31625 7590 06/14/2018
BAKER BOTTS L.L.P.
PA TENT DEPARTMENT
98 SAN JACINTO BL VD., SUITE 1500
AUSTIN, TX 78701-4039
FIRST NAMED INVENTOR
Jan Zielinski
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.
079289.0150 6410
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
06/14/2018 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):
tracy .engberg@bakerbotts.com
juli. tran@BakerBotts.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAN ZIELINSKI, THOMAS RUSSELL MOON, and
EDWARD P. ALLEN
Appeal2018-002834
Application 14/844,219
Technology Center 1600
Before ULRIKE W. JENKS, CHRISTOPHER G. P AULRAJ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant 1 appeals from Examiner's
decision to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
According to the Specification, periodontal disease often begins with
the death of a few oral cells. In the process of trying to clear away damaged
cells, the inflammatory response damages surrounding cells, which often
1 Appellant is the Applicant, PERIO SCIENCES LLC, which, according to
the Brief, is the real party in interest. Br. 3.
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Application 14/844,219
causes more harm than the original oxidative damage. Spec. 2: 11-15.
Therefore, "a need exists for effective methods to treat periodontal disease
and other soft oral tissue diseases resulting from oxidative damage or to
prevent such periodontal disease all together." Id. at 2: 22-23.
Claims 49, 59---61, 66, 68, 69, and 74--77 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claim 49 is
representative of the claims on appeal, and reads as follows:
49. A method of treating gingivitis or periodontitis, or both
comprising applying topically to a soft oral tissue an oral
antioxidant composition in an amount and for a time sufficient
to increase migration of a gingival cell or periodontal cell, or
both in the soft oral tissue, thereby treating the gingivitis or
periodontitis, or both, the antioxidant composition comprising:
between 0.0001 % and 5.0 % w/w cinnamic acid;
between 0.0001 % and 5.0% w/w phloretin; and
an orally pharmaceutically acceptable carrier,
wherein the pH of the oral antioxidant composition is at
least 5.0, and
wherein the cinnamic acid and phloretin have a
synergistic effect to increase migration of the gingival cell or
periodontal cell, or both more than migration is increased for
the same type of cell or cells by a composition with the same
amount of cinnamic acid alone or phloretin alone.
Appellant requests review of the following grounds of rejection made
by the Examiner:
I. Claims 49, 59, 66, 68, 69, and 74--77 under 35 U.S.C. § I03(a) as
unpatentable over Hideko2 in view of Kim. 3
2 Hideko et al., JP 5I 17145(A), published May 14, 1993 ("Hideko"). All
references to Hideko in this opinion are to the machine translation of record.
See form 892 mailed October 5, 2017.
3 Kim et al., WO 03/037315 Al, published May 8, 2003 ("Kim").
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II. Claims 49, 59---61, 66, 68, 69, and 74--77 under 35 U.S.C. § 103(a) as
unpatentable over Hideko in view of Kim, and further in view of
Ichimura. 4
I. Obviousness over Hideko in view of Kim
Examiner finds that the Hideko teaches administering a dentifrice
containing caffeic acid, i.e. a cinnamic acid, for the purpose of treating
periodontal disease. Final Act. 4. Examiner finds that Kim teaches a
composition comprising chalcone or derivatives thereof such as phloretin for
the purpose of inhibiting matrix metalloproteinases (MMP). Id. at 5.
"Destruction of collagen in the periodontal matrix by MMP leads to gingival
recession, pocket formation and tooth movement ... , i.e. periodontal
disease." Id. Examiner concludes that "one of ordinary skill in the art
would have found it obvious to combine disclosed amounts of two agents
such as phloretin and caff eic acid known for treating periodontal diseases by
inhibiting collagenase activity." Id.
Appellant contends that neither Hideko nor Kim disclose treatment
that is based on the antioxidant effect of the chemical compositions recited
in the claim. See Br. 7-8. Appellant contends that there is no motivation to
combine the antioxidants disclosed by Hideko and Kim. Id. at 8.
4 Isao et al., JP2000-247900 A, published Sept. 12, 2000 ("Ichimura"). We
note that the first named inventor is not Ichimura, but because both
Examiner and Appellant refers to this reference as Ichimura we will do the
same in this opinion. All references to Ichimura are made to the machine
translation of record. See form 892, mailed February 11, 2016.
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The issue is: Does the preponderance of evidence of record support
Examiner's conclusion that the combination of references renders obvious
the claimed method of treating gingivitis or periodontitis?
Findings of Fact
We generally agree with and adopt Examiner's findings of fact and
reasoning regarding the scope and content of the prior art set out in the Non-
Final Action mailed February 11, 2016 ("Non-Final Act") and Answer
mailed October 5, 2017 ("Ans."). For emphasis only we highlight the
following:
FF 1. Hideko teaches treating periodontal disease by providing a
collagenase activity inhibitor in the form of a gum, mouth cleaning
agent, or dentifrice. Hideko, Abstract, ,r,r 6, 9.
FF2. Hideko teaches that caffeic acid, or its salt form, can be used in an
amount between 0.001-5 % by weight in the composition. Hideko,
,r 16. Caffeic acid can be used either alone or in combination with
ascorbic acid or erythorbic acid to inhibit collagenase. Id., Abstract.
FF3. Hideko exemplifies creating an 8% solution by weight of caffeic acid
that is eventually diluted 200-20000 times with the trischloride buffer
solution having a pH of 7.5. Id. ,r 29.
FF4. Kim teaches that matrix metalloproteinases (MMPs) belong to the
collagenase subfamily as well as to the gelatinous family of enzymes.
See Kim, Abstract. Kim teaches that chalcone and derivatives inhibit
the activity of matrix metalloproteinases. Id. Kim teaches that the
"MMP activity is highly enhanced in response to the bacterial
infection and inflammation in gingival crevicular fluid taken from
patients with periodontal disease. Destruction of collagen in the
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periodontal matrix by MMP leads to gingival recession, pocket
formation and tooth movement." Id. 3:26 to 4:3.
FF5. Kim teaches that chalcone derivatives include phloretin. See id. 5: 12-
16. Kim teaches that these chalcone derivatives can be used to treat
disease such as gingivitis and periodontal disease. See id. 6: 1-8.
FF6. Kim teaches pharmaceutical formulations such as oral dosage forms
in the form of aqueous medicine, syrup, and elixirs, as well as topical
preparation such as cream ointment, lotion, gel, and spray solution
among others. Id. 9:8-12. Kim teaches that a daily dose of chalcone
in these preparations is in an amount ranging from 5 mg to 2 g and
they can be administered as a single dose or a divided dose per day.
See id. 9: 16-19. Kim teaches that solutions containing chalcone or its
derivatives in the topical formulations can be from 0.001-20%, and
preferably 0.05-10%. Id. 8:9-10.
FF7. The Specification discloses that antioxidants may be "cinnamic acid
derivative such as trans-ferulic acid (including its antioxidant
pharmacore 2,6-dihydroxyacetophenome ), caffeic acid, p-coumaric
acid, and sinapinic acid." Spec. 13:27-30 (emphasis added).
FF8. The Specification discloses that "the antioxidant composition may be
added to mouthwashes, chewing gum, breath fresheners, lipstick or lip
balm, toothpaste, dental floss, fluoride rinses, teeth whitener kits, and
the like." Spec. 20:32 to 21:1.
Principle of Law
It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose, in order to form a third composition which is to be
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used for the very same purpose .... [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)(citations omitted).
Analysis
We agree with Examiner's fact finding, statement of the rejection and
responses to Appellant's arguments as set forth in the Non-Final Action and
Answer. We find that the preponderance of the evidence supports a prima
facie case of obviousness. We provide the following additional comment to
arguments set forth in the Appeal Brief.
Appellant contends that neither Hideko nor Kim disclose treatment
based on an antioxidant effect. Br. 7. Specifically, Appellant contends
Hideko "does not disclose any treatment via an antioxidant effect." Id. at 8.
Appellant contends that "collagenases work via hydrolysis, a reaction that
has no apparent connection to antioxidant effects." Id.
We are not persuaded by this argument. "[T]he discovery of a
previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art's functioning, does not render the old
composition patentably new to the discoverer .... " Atlas Powder Co. v.
IRECO Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999). Here, the art may have
not have recognized the beneficial effect of the antioxidant properties of
caffeic acid, but Hideko, nevertheless, teaches applying caffeic acid in the
form of dentifrice or mouth wash into the oral cavity as part of a
composition in the amounts between 0.001 to 5% by weight. See FF1-FF3.
Therefore, Appellant's argument that Hideko does not appreciate the
antioxidant properties of caffeic acid is not persuasive.
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Appellant makes similar arguments with respect to Kim. We are also
not persuaded because Kim teaches applying a matrix metalloproteinase
inhibitor such as phloretin into the oral cavity for the purpose of treating
gingivitis and periodontal disease. See FF4--FF6. Although, the fact that
phloretin may also have antioxidant properties is not expressly recognized
by Kim, that does not dissuade us from the reasonableness of Examiner's
combination of caffeic acid and phloretin for the purpose of treating
periodontal disease. See Ans. 5---6.
Appellant contends that there is no motivation to combine Hideko and
Kim for their antioxidant effects. Br. 8.
We are not persuaded by Appellant's contention because the law does
not require that the references be combined for the same reasons as
contemplated by Appellant's. See In re Kemps, 97 F.3d 1427, 1430 (Fed.
Cir. 1996) ("[T]he motivation in the prior art to combine the references does
not have to be identical to that of the applicant to establish obviousness.").
Here, the Examiner has established that both caffeic acid taught in Hideko
and phloretin taught in Kim are inhibitors of collagenases. See Ans. 5---6;
FF1-FF6. We agree with Examiner's rationale that "[t]he artisan would
have reasonably expected that phloretin and caffeic acid would provide
another composition useful for treating periodontal disease as both are
taught separately as useful therapeutic agents for same." Ans. 5; see
Kerkhoven, 626 F .2d at 850.
Appellant contends that neither Hideko nor Kim disclose that
"cinnamic acid and phloretin have a synergistic effect to increase migration
of the gingival cell or periodontal cell." Br. 9.
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We are not persuaded by Appellant's contention. "Products of
identical chemical composition cannot have mutually exclusive properties."
In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). Here, Examiner
established that Hideko teaches the use of caffeic acid, a cinnamic acid (see
FF7), in the requisite concentration to treat periodontitis. FF1-FF2.
Examiner also established that Kim teaches the use of phloretin in the
requisite concentrations to treat gingivitis and periodontal disease. FF5-
FF6. Therefore, when combining each of these components into one
composition, one of ordinary skill in the art would have reasonably expected
that the combination would also treat gingivitis and periodontal disease. The
claimed synergistic effect on cell migration is an inherent property of the
active components when placed onto tissue in the oral cavity as suggested by
the references.
Appellant contends that the combination of Hideko and Kim does not
appreciate the difference in the processes and their effects on cell migration.
See Br. 8, see also id. at 7 ("applying topically to a soft oral tissue an oral
antioxidant composition in an amount and for a time sufficient to increase
migration of a gingival cell or periodontal cell").
We are not persuaded. As explained by the Examiner,
the sufficient time [element] is interpreted broadly and includes
periods of time that the composition is contacting the oral tissue
during periods of rinsing and/ or brushing, unless Appellant
provides clear objective evidence that migration is not increased
when phloretin and a cinnamic acid are administered to soft oral
tissue together at certain periods of time.
Ans. 12. Here, the Specification contemplates using the antioxidants in
mouthwashes, chewing gum, or breath fresheners among others. FF8.
Based on these contemplated applications, we find that contacting the oral
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tissue for periods of time that encompass brushing or rinsing would
reasonably be considered a "sufficient" time to achieve cell migration as
claimed. We agree with the Examiner that the property of increasing
migration of cells as recited in the claims is an intrinsic element attributable
to the action of phloretin and a caffeic acid and their application to oral
tissue in the form of mouth wash or gels as contemplated in Hideko and
Kim. See FFl and FF6.
We note that claim 49 does not further limit the active method step
defined by the claim, namely topically applying the composition to soft oral
tissue. "A 'whereby' clause that merely states the result of the limitations in
the claim adds nothing to the patentability or substance of the claim." Texas
Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed.
Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc.,
336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim
is not given weight when it simply expresses the intended result of a process
step positively recited.").
In this case, claim 49 uses the term "wherein", rather than "whereby",
but we conclude that they should be treated the same. The process steps that
are positively recited in the claim leads to an increase in cell migration.
Specifically, the claim recites, "wherein the cinnamic acid and phloretin
have a synergistic effect to increase migration of the gingival cell or
periodontal cell, or both more than migration is increased for the same type
of cell or cells by a composition with the same amount of cinnamic acid
alone or phloretin alone." This "wherein" clause does not change anything
about the recited active steps but simply states a characterization of the
results of those steps; i.e., the effect of contacting the oral tissue with the
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antioxidants. Cf Minton, 336 F.3d at 1381 ("The term 'efficiently' [in the
whereby clause] on its face does not inform the mechanics of how the trade
is executed .... Rather, the term 'efficiently' is a laudatory one
characterizing the result of the executing step."). Similarly here, the wherein
clause does not inform the artisan of how the "applying" and "treating" steps
are performed; rather, the wherein clause merely characterizes the results of
those steps. Therefore, we determine that the "wherein" clause is not
entitled to weight in construing the claim.
Even if we were to give weight to the "synergistic effect" limitation as
recited in the claim, the plain language of that limitation only requires that
the effect is greater than that attributable to either component individually.
We find this to be the reasonable expectation that one of ordinary skill in the
art would have in applying two compositions each taught in the art to be
useful for the same purpose. In other words, contrary to the Examiner's
interpretation of synergism (Ans. 16), the data presented in the Specification
appears to show a synergistic effect as defined by the claims. We find,
however, that these results are not unexpected, which is necessary in order to
overcome a prima facie case of obviousness. Accordingly, we determine
that the evidentiary support in the Specification relied upon by Appellant is
not sufficient to overcome the prima facie case of obviousness based on the
teachings of the combined references.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 49, and Appellant has not
provided sufficient evidence of secondary considerations that outweighs the
evidence supporting the prima facie case. As Appellant does not argue the
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claims separately, claims 59, 66, 68, 69, and 74--77 fall with claim 49.
37 C.F.R. § 4I.37(c)(l)(iv).
II. Obviousness over Hideko, Kim, and Ichimura
Appellant's arguments do not persuade us that the preponderance of
the evidence fails to support Examiner's prima facie case of obviousness.
With respect to this rejection Appellant relies on the discussion of the
Hideko in view of Kim and the alleged deficiencies of these references as
they apply to claim 49. See Br. 10. Having found no error with the
combination of the Hideko and Kim, we similarly affirm the rejection
including Ichimura. As Appellant does not argue claims 60 and 61 directed
to ferulic acid and trans-ferulic acid separately, we rely on our analysis of
claim 49 discussed above, and conclude that claims 60 and 61 are obvious
for the same reason as claim 49.
SUMMARY
We affirm the rejection of all claims.
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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