Ex Parte Jaracz et al

Patent Trial and Appeal Board

Oct 5, 2017

13333209 (P.T.A.B. Oct. 5, 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.
13/333,209 12/21/2011 Stanislav Jaracz 9478-OO-OC 3103
23909 7590 10/10/2017
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
10/10/2017 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):
Paten t_Mail @ colpal. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STANISLAV JARACZ, GUOFENG XU, STEVEN MILLER,
LEONORA LEIGH, GUILLAUME PIQUET,
and LAURENCE DU-THUMM1
Appeal 2016-001357
Application 13/333,209
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN E. SCHNEIDER,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of applying to the oral cavity an antibacterially effective amount of a gallate
or gallamide compound. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Colgate-Palmolive
Company. (App. Br. 2.)
Appeal 2016-001357
Application 13/333,209
STATEMENT OF THE CASE
As “[background,” the Specification describes polyphenols as a
family of compounds found in plants, fruit, and vegetables, and states that
these compounds have attracted attention due to potential health benefits.
(Spec. 11.) The Specification discloses that “[gjreen tea is relatively high in
polyphenols, including epigallocatechin gallate (EGCG),” which “is known
for its antioxidant properties and also for its antibacterial properties.” (Id.)
The Specification also discloses, “[b]y suppressing oral bacteria, EGCG can
suppress gingivitis, and oral care products comprising EGCG are known.”
(Id.) According to the Specification, “there is a need for compounds having
antibacterial activity similar to or better than EGCG, but which are cheaper
to manufacture and are more stable in formulations.” (Id. 15.)
Claims 15 and 20-24 are on appeal. Claim 15 is illustrative:
15. A method to (i) inhibit microbial biofilm formation in the
oral cavity, (ii) reduce plaque accumulation, (iii) reduce or
inhibit gingivitis, (iv) reduce or inhibit formation of dental caries,
(v) reduce, repair or inhibit pre-carious lesions of the enamel, (vi)
clean the teeth and oral cavity, and/or (vii) promote whole body
health; comprising applying to the oral cavity an antibacterially
effective amount of a composition according to claim 1.
(App. Br. 15 (Claims App.).)
As can be seen, claim 15 is a method requiring applying “a
composition according to claim 1.” Although claim 1 is withdrawn, as
reproduced at page 13 of the Appeal Brief, claim 1 recites:
1. A composition for topical use comprising an
antibacterially effective concentration of a gallate or gallamide
compound which is a polysubstituted cycloalkyl or
heterocycloalkyl wherein the substituents are selected from
hydroxy, hydroxymethyl, fluoro, chloro, amino, nitro, or a
moiety of formula -X-(CO)-(3,4,5-trihydroxyphenyl), wherein X
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is selected from O and NH, provided that the substituents
comprise at least two moieties of formula -X-(CO)-(3,4,5-
trihydroxyphenyl) attached to adjacent carbons; in free or in
orally or topically acceptable salt form.
Appellants previously elected claims of Group II (claims 15 and 20-
24) and elected a species for the compound recited in withdrawn claim 1.
Specifically, Appellants elected the compound U.v-l ,2-cyclohexanediol
digallate (“CHDG”). (See Aug. 6, 2013 Resp. to Restriction Req. 1—2.) We
limit our analysis of the claims to the patentability of the elected species.
See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
Claims 15 and 20-24 stand rejected under 35 U.S.C. § 103(a) over
Ny2 and Lawrence.3
DISCUSSION
Issue
Has the Examiner established by a preponderance of the evidence that
claims 15 and 20-24 would have been obvious over Ny and Lawrence?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 2—7 of the Final Action dated June 6, 2014. (See also
Ans. 2—12 and Adv. Act. 2.) The following findings are provided for
emphasis and convenient reference.
2 Ny et al., US 2010/0028321 Al, published Feb. 4, 2010.
3 Lawrence et al., WO 2008/131047 A2, published Oct. 30, 2008.
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FF 1. Ny teaches “[pjeriodontal disease is a chronic inflammatory
disease that affects the tissues that support and anchor the teeth” and that
“[i]t is caused by the imbalanced interplay between specific subgingival
microorganisms and the host immune and inflammatory response.” (Ny 13;
see also id. 6, 65.)
FF 2. Ny teaches the
use of a component of the plasminogen-activating pathway and
use of compounds which have the capacity to activate
plasminogen directly or via the plasminogen-activating pathway,
for prophylaxis, prevention and treatment of periodontal disease
including peri-implantitis, healing of periodontal wounds and
prompting oral health in human and non-human subjects.
{Id. Abstract; see also id. 1, 39.)
FF 3. Ny further teaches
administration of plasminogen and/or other members of the
plasminogen activation pathway or compounds with the capacity
to activate plasminogen play a pluripotent role in protecting
against bacterially induced infection and promoting healing of
periodontal wounds by activating inflammatory cells,
accelerating migration of keratinocytes, killing bacteria,
removing necrotic tissue and enhancing cytokine expression.
{Id. 124.)
FF 4. Ny teaches “[pjreferably, the active agent is selected from
plasminogen activators, tPA, uPA . . . and variants of the components of the
plasminogen activating pathway.” {Id. 125; see also id. (active agents also
include plasmin and plasminogen).) Ny teaches “[pjlasmin is the key
component of the PA [plasminogen-activation] system.” {Id. ^fl[ 13—14.) Ny
teaches “Plasmin is formed from the zymogen plasminogen through
proteolytic cleavage by either of two physiological PAs, tPA or uPA. {Id.
114.) According to Ny, “regulation of the PA system occurs mainly at the
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level of synthesis and activity of the PAs.” (Id.) Ny teaches “[t]he activity
of PAs is regulated by PAI-1, which inhibits both uPA and tPA.” (Id.) Ny
teaches “[i]n the case of modulators such as PAs, activity can refer to the
ability of the modulator to inhibit or promote, increase or decrease, up- or
down-regulate, the rate of reaction or the amount of product formed from the
reaction.” (Id. 174.)
FF 5. Ny teaches “[t]he composition may be part of a gel, lotion,
balm, paste (toothpaste), gargling solution (mouth-wash solution) or wound
dressing.” (Id. 125.)
FF 6. Lawrence discloses inhibitors of plasminogen activator
inhibitor I (PAI-1) and “uses of these inhibitors for the treatment of many
conditions, diseases or disorders associated with PAI-1 activity” including,
but not limited to, “inflammation, cell migration and migration-driven
proliferation of cells, and angiogenesis or thrombosis.” (Lawrence 13.)
FF 7. Lawrence teaches PAI-1 “is the principal inhibitor of both
urokinase type plasminogen activator (uPA) and tissue type PA (tPA).” (Id.
14.) Lawrence further teaches “PAI-1 can also directly inhibit plasmin.”
(Id.; see also id. 1 8 (“Oxidative inactivation of PAI-1 . . . may inactivate
P AI-1 and thus facilitate the generation of plasmin at sites of infection or in
areas of tissue remodeling.”)
FF 8. Lawrence identifies CHDG as one of the PAI-1 inhibitor
compounds of Lawrence’s invention. (Id. 1 51 (compound with formula
“XXI”); see also id. 22 (“PAI-1 inhibitors include ... any of the
compounds of Formulas I-XXXIV.”), 53 (Table 1 (CDE-031, Formula
XXI), and claim 56.)
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FF 9. Lawrence teaches that for oral administration “a PAI-1 inhibitor
may be incorporated with excipients and used in the form of non-ingestible
mouthwashes and dentifrices.” (Id. 1 87.) According to Lawrence, “[t]he
active ingredient may also be dispersed in dentifrices, including: gels, pastes,
powders and slurries . . . [and] may be added in a therapeutically effective
amount to a paste dentifrice that may include water, binders, abrasives,
flavoring agents, foaming agents, and humectants.” (Id.)
FF 10. Lawrence teaches “[a] typical dosage may range from about
0.1 pg/kg to up to about 100 mg/kg or more” depending on factors including
the patient’s age and general health, among others. (Id. 191.)
Analysis
Appellants do not argue the claims separately. We select claim 15 as
representative of the claims on appeal.
The Examiner finds that “Ny teaches treating periodontal diseases
(e.g., gingivitis and periodontitis) by locally administering oral care
compositions such as toothpaste and mouthwash containing components of
the PA system such as PAs (e.g., tPA, uPA), plasminogen, and plasmin.”
(Ans. 4.) According to the Examiner, Ny teaches these compositions play a
pluripotent role in preventing or treating periodontal disease, including
killing bacteria and promoting oral and general health. (Id. at 3 4.) The
Examiner finds that, while Ny teaches that PAI-1 is the primary inhibitor of
tPA and uPA, “Ny does not expressly teach a compound of formula (I)f
such as Appellants’ elected compound. (Id. at 3 4.)
The Examiner turns to Lawrence and finds it teaches compositions
containing PAI-1 inhibitors, including Appellants’ elected compound
(CHDG), for treatment of inflammation. (Id. at 4.) The Examiner further
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finds that Lawrence teaches PAI-1 inhibitors inhibit tPA and uPA, that
compositions including PAI-1 inhibitors may be administered orally,
including in the form of a mouthwash or dentifrice (e.g., toothpaste), and
that a “typical dosage [of the active agent] may range from about 0.1 pg/kg
to up to about 100 mg/kg or more.” (Id. at 4—5.) The Examiner further finds
that Lawrence suggests inhibition of PAI-1 facilitates plasmin generation.
(Id. at 8—9.)
The Examiner concludes it would have been obvious to combine Ny’s
and Lawrence’s teachings, and include the elected PAI-1 inhibitor with Ny’s
active agents in an orally administered composition for the uses (e.g.,
reducing gingivitis) recited in method claim 15. (Id. at 6; see also id. at 7—
9.) The Examiner points out that Ny and Lawrence suggest the use of the
active agents (e.g., tPA and uPA in Ny, and CHGD in Lawrence) for use in
toothpastes or mouthwashes, and that Lawrence’s composition may be used
to treat inflammatory diseases. (Id. at 5—6.)4
As discussed further below, we are unpersuaded of error in the
Examiner’s conclusion that claim 15 would have been obvious. Lawrence
teaches that Appellants’ elected compound is a PAI-1 inhibitor useful for
treating inflammation that may be orally administered in a toothpaste or
mouthwash. (PL 6—9.) As periodontal disease is known to be associated
with inflammation, Lawrence thus provides an express reason to include
Appellants’ elected compound in the toothpaste or mouthwash of Ny. (PL
1-5.)
4 As the Examiner notes, “gingivitis and periodontitis [] involve
inflammation.” (Ans. 6; PL 1.)
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Below we address Appellants’ argument and evidence.
Appellants argue the Examiner relies on hindsight as “the rejection is
not based on the facts gleaned from the cited references, but instead is reliant
on inferences and speculations not supported by the references.” (App. Br.
3—4.) In support, Appellants contend “Ny discloses the use of certain
compounds in the plasminogen pathway or which activate the plasminogen
pathway to treat periodontal disease” but “does not disclose CHDG.” (Id. at
4.) Appellants further contend “Lawrence discloses many compounds which
inhibit plasminogen activator inhibitor 1 (PAI-1), including CHDG . . . [but]
Lawrence does not equate inhibition of PAI-1 with plasminogen activation,
nor disclose the use of PAI-1 inhibitors to treat periodontal diseases.” (Id.)
Appellants also contend biological systems are complex, the PA system is
highly regulated, and that the role of PAI-1 in disease development is
unclear. (Id. 5—6.)
Appellants’ argument is unpersuasive. As the Supreme Court has
explained, the obviousness “analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007). The Examiner, in reasoning that the skilled artisan
would include an inhibitor of PAI-1 (to help counteract inhibition of tPA,
uPA, and plasmin) and improve Ny’s compositions is taking account of an
inference the skilled artisan would have reasonably drawn from the prior art,
and to treat periodontal disease, which is an inflammatory condition. True,
as Appellants point out, the role of PAI-1 in the development of certain
diseases may not have been well understood. However, given the broad
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teaching in Lawrence, and Appellants’ failure to provide persuasive rebuttal
arguments or evidence that PAI-1 inhibition would have not been considered
useful to treat periodontal disease, we conclude the Examiner established the
obviousness of using such inhibitor in Ny’s composition. Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007) (“[T]he expectation of
success need only be reasonable, not absolute.”). Also, the fact that Ny does
not expressly disclose CHDG, and that Fawrence does not expressly teach
treating periodontal diseases is not decisive because the rejection relies on
the combined teachings of the references. In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references.”).
Furthermore, even absent the connection between inflammation and
periodontal disease, Fawrence expressly teaches using a PAI inhibitor, such
as CHDG, in a dentifrice, providing a reason to have modified the Ny
dentifrice with it. The reasons for combining the references need not be the
same as the reasons that apparently prompted the inventors here —
antimicrobial activity of PAI-1 inhibitors. 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.”); see also KSR, 550 U.S. at 419 (“In determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls.”)
Appellants next argue the Examiner has not established a reasonable
expectation of success in combining Ny and Fawrence, and that the skilled
person would not have combined the references. (App. Br. 7—8.) Appellants
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again emphasize that biological systems are complex and contend that
inhibiting PAI-1 “could have a multitude of effects.” (Id. at 7.) Appellants
contend Ny does not teach administering a PAI-1 inhibitor for prophylaxis
of periodontal disease, and Appellants contend Lawrence does not teach that
PAI-1 inhibitors have antibacterial activity or utility for topical application
in oral care products. (Id. at 8.)
We remain unpersuaded. As already explained, Ny teaches the
importance of the plasminogen activating pathway in treating periodontal
disease. FF 2. The Examiner thus reasonably inferred that the skilled
person would include compounds that would be expected to help activate
(and not inhibit) the pathway. (See, e.g., Ans. 6—9.) Appellants have not
provided persuasive argument or evidence that this inference is defective or
in error. The references teach that PAI-1 is the primary inhibitor of tPA and
uPA, which are the two physiological activators of the PA system. (FF 4, 7.)
And the Examiner is relying on these known aspects of the interaction
between PAI-1, tPA, uPA, and the plasminogen-activation system in
supporting the skilled person’s reasonable — not absolute — expectation of
success.
Appellants argue the Examiner selected CHDG from among a
“multitude of compounds” disclosed in Lawrence, with “no blazemarks”
pointing to CHDG in particular. (App. Br. 8—9.) According to Appellants,
“[t]he Examiner must explain why one of ordinary skill in the art faced with
13 pages of compounds disclosed in Lawrence, would have specifically
turned to” CHDG. (Id. at 9.) In support, Appellants cite Ex parte
Subramanyam, Appeal 2010-0024631, 2010 WL 1253713 (BPAI 2010)
(non-precedential).
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Appellants’ argument is unpersuasive. Lawrence discloses 34
formulas, and formula 21 is the compound CHDG. (FF 8.) Lawrence
teaches that CHDG is part of Lawrence’s invention and a suitable inhibitor
of PAI-1, thus suggesting its use in the manner proposed by the Examiner.
(Id.) And it is not necessary that the Examiner limit the obviousness
analysis to only certain embodiments or compounds described in working
examples. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (“[I]n a section 103 inquiry, the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered”) (citation and internal quotation marks omitted.)
We are also unpersuaded the decision in Subramanyam is applicable.
The panel’s decision in that case related to whether it was obvious to make
specific molecular modifications to the chemical structure of a “lead
compound” disclosed in the art to produce a new compound that was
claimed. Subramanyam, 2010 WL 1253713 at * 1^4. Here, however, there
is no new compound and no need to modify CHGD’s chemical structure.
(Ans. 11.) To the contrary, CHDG is simply being added to Ny’s toothpaste
or other dentifrice composition, and is being used as a PAI-1 inhibitor
precisely as taught in Lawrence. (FF 8—9.)
In Appellants’ Reply Brief, Appellants argue that neither Lawrence
nor Ny teaches or suggests an antibacterially effective amount of CHDG.
(Reply Br. 2.) We are, however, unpersuaded. As the Examiner pointed
out, Appellants acknowledge that compounds of the invention, including
CHDG, have “intrinsic antibacterial activity.” (Ans. 10 (quoting Spec. 117
(“compounds of formula 1 do have intrinsic antibacterial activity . . . due to
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their induction of the release of the antibacterial peptide LL-37 from
epithelial cells.”).) Appellants also define an “antibacterially effective
concentration” — according to Appellants, “by ‘antibacterially effective
concentration’ of a compound of formula 1 is meant a concentration
effective to induce release of the antibacterial peptide LL-37 by human
epithelial cells.” (Spec. 112.) No particular amount of LL-37 that must be
released or particular efficacy (killing effect) is specified. Accordingly, and
absent persuasive evidence to the contrary, adding CHDG in the dosages
specified in Lawrence (FF 10) as proposed by the Examiner would induce
the release of some LL-37, and thus satisfy the requirement of an
antibacterially effective amount of the compound.5
Finally, Appellants argue they have provided evidence of unexpected
results that shows claim 15 is nonobvious. (App. Br. 10-11; Reply Br. 4—5.)
Appellants contend that, even assuming the indications for use of
Lawrence’s compounds overlapped with the claimed indications, “the
selected compound CHDG would still show surprising advantages.” (App.
Br. 10.) Appellants cite Table 2 in the Specification, which Appellants
contend shows “CHDG is much more potent than EGGC in inducing
expression of the antimicrobial peptides LL-37 and P-defensin, by
approximately two orders of magnitude.” (Id.)
We have considered Appellants’ evidence but, on the record presently
before us, we are unpersuaded it overcomes the evidence of obviousness.
As noted by the Examiner:
5 Appellants’ data is consistent in that it indicates that small amounts of
CHDG (e.g., 0.5% solution) induce the release of LL-37. (Spec. 141.)
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The results show differences in the effect of induction between
the compounds but does not make a clear case for any
unexpected results. The issue here is not whether there is a
difference but whether the difference is unexpected or whether it
is a difference of degree or of kind.
(Ans. 11.)
What is missing is sufficient persuasive evidence that Appellants’
results are unexpected or surprising to one of ordinary skill in the art.
Appellants direct us to no statement to that effect in the Specification. See
In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995) (“[W]hen an applicant
demonstrates substantially improved results . . . and states that the results
were unexpected, this should suffice to establish unexpected results in the
absence of evidence to the contrary.”) Neither did Appellants submit any
declaration from a skilled person to evidence that the results shown in Table
2 were unexpected or surprising. The issue is not whether the results might
surprise Appellants’ lawyer, but that they are unexpected or surprising to the
skilled person in this field.6
The Examiner also rejected as insufficient the Appellants’ alleged
unexpected results as “not commensurate” in scope with the claims. (Ans.
12.) The Examiner does not, however, further explain this assertion.
Appellants’ results do compare the elected compound with multiple
compounds, including EGCG, for ability to induce LL-37 release, which, as
6 In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997) (finding counsel’s
statements that the results were “surprising” cannot take the place of
evidence); In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (“[I]t is well
settled that unexpected results must be established by factual evidence.
Mere argument or conclusory statements in the specification does not
suffice.”).
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described above, is how Appellants’ have defined an “antibacterially
effective concentration.” (See Spec. Tflf 12, 41.) Appellants also provide
data for the respective compounds at multiple concentrations and at multiple
times. (Id.^4\.) It is unclear what additional “scope” of testing the
Examiner is demanding of Appellants, and we do not find this reason for
rejecting Appellants’ results to be persuasive.
Conclusion of Law
For the above reasons, and having considered the arguments and
evidence of record in this appeal, we conclude the Examiner established by a
preponderance of the evidence that claim 15 would have been obvious over
Ny and Lawrence. Claims 20-24 have not been argued separately and fall
with claim 15. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 15 and 20—24 as obvious over Ny
and Lawrence.
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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