Ex Parte Zaidel et al

Patent Trial and Appeal Board

Aug 2, 2016

13262015 (P.T.A.B. Aug. 2, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/262,015 09/29/2011
23909 7590 08/04/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Lynette Zaidel
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.
8408-00-0C 1031
EXAMINER
WEBB, WALTERE
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
08/04/2016 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):
Patent_Mail@colpal.com
uspto@thebellesgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LYNETTE ZAIDEL, MICHAEL PRECIPE,
and SUMAN K. CHOPRA1
Appeal2014-007519
Application 13/262,015
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to oral care
compositions including a bioactive glass and a bioadhesive polymer which
have been rejected as anticipated, obvious, and indefinite. 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.)
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Application 13/262,015
STATEMENT OF THE CASE
"The invention encompasses oral care compositions comprising one
or more active components and one or more bioadhesive polymers, which
cause the active component to adhere to a tooth surface." (Spec. i-f 1.) "In
certain embodiments, the active agent is an occlusion agent" that helps
"prevent or alleviate tooth sensitivity." (Id.) "In certain embodiments, the
occlusion agent is bioactive glass." (Id. at i-f 6).
Claims 6-8, 17-24, and 27-30 are on appeal. Claim 23 is illustrative:
23. An oral care composition comprising an occlusion
agent, the occlusion agent comprising bioactive glass;
and one or more bioadhesive polymer components
comprising PEG/PPG copolymers,
polyvinylmethylether/maleic acid, cross-linked PVP,
shellac, ester gum, and combinations thereof
wherein the oral care composition provides a fluid flow
rate of no greater than about 45%, of the fluid flow rate
of etched dentin.
(App. Br. 19 (Claims App'x).) Appellants elected bioactive glass as the
occlusion agent and polyvinylmethylether/maleic acid as the bioadhesive
polymer. (See Resp. to Restriction Req. dated Feb. 27, 2013 at 1.) The
elected polymer is also known as "Gantrez[ ®]." (Spec. i-f 51.)
The claims stand rejected as follows:
I. Claim 8 is rejected under 35 U.S.C. § 112, second paragraph as
being indefinite due to lack of antecedent basis for the limitation "the one or
more occlusion agents."
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II. Claims 6-8 and 17-24 are rejected under 35 U.S.C. § 102(e) as
anticipated by Muscle et al. (US 2009/0324516 A 1, publ. Dec. 31, 2009)
("Muscle").
III. Claims 6-8 and 17-24 are rejected under 35 U.S.C. § 103(a) over
Muscle or Napolitano (WO 2004/045446 Al, publ. June 3, 2004)
("Napolitano").
IV. Claims 27-30 are rejected under 35 U.S.C. § 103(a) over Muscle
or Napolitano, in combination with Greenspan et al. (US 2007 /0264291 Al,
publ. Nov. 15, 2007) ("Greenspan").
REJECTION I - INDEFINITENESS
Appellants did not request review of the rejection of claim 8 under 35
U.S.C. § 112, second paragraph, for lacking proper antecedent basis. (See
Final Act. 2; App. Br. 3.) We thus summarily affirm Rejection I. We
decline to consider arguments concerning this rejection raised for the first
time in the Appellants' Reply Brief. (Reply Br. 2.)
REJECTIONll-ANTICIPATION
The Examiner rejected claims 6-8 and 17-24 as anticipated by
Muscle.
According to the Examiner,
Muscle et al. teaches a dental varnish (p. 2, para. [0012])
composition comprising 0.5%-15% Bioactive Glass
(anti caries/ desentizing agent; elm. 8, 1 7, 20) and 0-7 5%
Colophony resin (ester gum; bioadhesive polymer; claim 6,
?)(Abstract).
(Final Act. 3.) In other words, as in claim 23, the Examiner finds that
Muscle teaches a bioactive glass, and that the "bioadhesive polymer"
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element is satisfied by Muscle's disclosure of "colophony resin," which the
Examiner interprets as "ester gum" - one of the bioadhesive polymers
recited in the claim. 2 Because the Examiner finds the prior art discloses
compositions with the same ingredients in the same relative proportions, the
Examiner reasons that the compositions "would be expected to inherently
possess the same chemical and physical properties, such as providing a fluid
flow rate of no greater than about 45% of the fluid flow rate of etched
dentin" as recited in claim 23. (Ans. 2-3.)
Initially, we note, as does the Examiner, that ester gum is not the
elected species on this record. (See Final Act. 5.) Nevertheless, assuming
arguendo that ester gum was the elected species, Appellants argue that
Muscle "fails to show the identical invention in as complete detail as is
contained in [claim 23.]" (App. Br. 4.) Moreover, Appellants contend the
"colophony resin" in Muscle is optional (because Muscle teaches it may be
included in a range of 0-7 5%) and that it is not an "ester gum" as recited in
claim 23. (Reply Br. 2-3 ("Colophony resin is a natural resin derived from
living trees . . . . Ester gum is not a natural product derived from trees, but is
rather a semi-synthetic produced obtained by forming the glycerol ester of a
wood rosin (e.g., colophony resin).")
Appellants have the better position. "[U]nless a prior art reference
discloses within the four comers of the document not only all of the
2 The Examiner also acknowledges that "[Muscle] is not anticipatory insofar
as it does not require the elected species polyvinylmethlether/maleic acid,
but its selection would have been obvious given its plain enumeration by
[Muscle]." (Final Act. 5.)
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limitations claimed but also all of the limitations arranged or combined in
the same way as recited in the claim, it cannot be said to prove prior
invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C.
§ 102." Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir.
2008). Here, the Examiner has not adequately explained how the
composition of bioactive glass and colophony resin in Muscle satisfies each
claim element. In particular, we are not persuaded that the colophony resin
in Muscle is the same as the ester gum in claim 23. It may be that it would
be obvious to prepare ester gum from colophony resin - especially when
Muscle teaches that "[f]or oral care applications, an esterification process is
often used to modify the physical properties of the colophony resin" (Muscle
i-f 72). But the Examiner has not made such findings, and that is not the basis
of the rejection before us.
For these reasons, we reverse the Examiner's rejection of claim 23 as
anticipated by Muscle. Because Muscle does not anticipate claim 23, it does
not anticipate the dependent claims, so we reverse as to claims 6-8 and 17-
22, and 24 as well.
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REJECTION III & IV - OBVIOUSNESS
Rejection III- Claim 23
Issue
The Examiner rejected claims 6---8 and 17-24 over Muscle or
Napolitano. 3 Appellants argue the patentability of the claims as a group.
We thus select claim 23 as representative.
The issue is whether the Examiner established, by a preponderance of
the evidence, that claim 23 would have been obvious over Muscle or
Napolitano.
Findings of Fact (FF)
FF 1. The Examiner's findings of fact and statement of the rejections
of claims 6---8 and 17-24 over Muscle or Napolitano may be found at pages
3-5 and 7-8 of the Final Rejection dated August 26, 2013. (See also, Ans.
3-5, 7.) We adopt the Examiner's findings and provide the following for
emphasis.
FF 2. Muscle teaches "an oral care composition, which comprises
bioactive glass and fluoride." (Muscle Abstract.) Muscle teaches a number
of working examples, indicating the concentration ranges for its ingredients.
For example, in one "exemplary formulation," Muscle teaches that the
concentration ofbioactive glass is 0.5-15 weight percent of the composition.
(Id. at i-f 19.) As another example, Muscle teaches a dental varnish having a
3 We recognize that Appellants argued the obviousness rejections over
Muscle and Napolitano under separate headings. (App. Br. 4--9; Reply Br.
4--6.) Based on the overlap in the arguments, however, we address them
together on appeal.
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bioactive glass concentration of 5-20%, and a colophony resin concentration
of 25-7 5%, along with other ingredients. (Id. i-f 71.) Muscle further teaches
the chemical concentration (e.g., 40-86% Si02, 0-35% Na20, etc.)
comprising a representative bioactive glass. (Id. at i-f 31.)
FF 3. Muscle also teaches that "[t]he oral care composition may also
comprise other agents conventionally used in oral care composition
formulations at appropriate levels" including whitening agents, anti-plaque
agents, and "polymer enhancing agents, for example Gantrez® may also be
present if required." (Id. at i-f 47.) Muscle teaches that "[i]n general, such
agents will be a minor amount or in proportion to the formulation, usually
present in from about 0.001 to 5 weight percent of the composition." (Id.)
FF 4. Napolitano teaches a "controlled-dissolution composition for
the oral cavity that adheres to hard dental surfaces, such as natural teeth ...
and which creates a physical barrier to painful stimuli associated with dental
hypersensitivity." (Napolitano Abstract.) Napolitano teaches that its
compositions comprise "at least one water-swellable or water-soluble
polymer" such as "alkylvinylether/maleic acid or anhydride copolymer
('Gantrez®')." (Id. at 6, 11. 14--21; see also, id. at 16, claim 2) In working
examples, Napolitano discloses formulations that include concentrations of
Gantrez® from 0.3-15% by weight. (Id. at 11-12, 14 (Examples 3, 7, 10).)
Napolitano teaches that its compositions may include additional "agents
capable of occluding the dentinal tubules ... through a process called
mineralization" and that suitable agents include a "bioactive glass" among
others. (Id. at 7, 11. 31-37; see also, id. at 16, claims 5---6.) Napolitano
teaches the "tubule blocking agent/occlude is incorporated in this
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composition in a desensitizing tubule occluding amount" such as "in an
amount of about 0.1 to 15 wt%, preferably 0.4% to 10% and most preferably
from about 2 to 8 wt%." (Id. at 8, 11. 13-21.) However, according to
Napolitano, "[l]arger amounts of the tubule blocking agent can also be
employed if desired." (Id.)
Analysis
The Examiner finds that both Muscle and Napolitano disclose oral
care compositions with the same ingredients as in claim 23, and in same
relative proportions that overlap with other dependent claims on appeal.
(Final Act. 4--5; Ans. 2-5.) Based on the overlapping ingredients and
concentrations disclosed in the prior art, the Examiner concludes that claim
23 would have been obvious. To the extent modification of concentration
ranges would have been required, the Examiner finds the skilled artisan
would have done so through routine optimization. (Final Act. 4.)
Appellants make several counterarguments. First, Appellants argue
that "[g]iven the number of possible combinations of elements from
[Napolitano or Muscle] one of ordinary skill in the art would not have
arrived at [the] specific combination of elements [of claim 23]." (App. Br.
5, 8.) Second, Appellants argue the Examiner did not sufficiently
"reestablish" a case of prima facie obviousness in light of Appellants'
arguments and evidence presented during prosecution. (Id. at 5---6, 8.)
Third, Appellants argue they "provided evidence of unexpected results" that
was not accorded proper weight. (Id. at 7-9.)
Appellants' arguments are unpersuasive as discussed below.
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We are not persuaded that the number of combinations possible in
Muscle or Napolitano is so large that the claim would have been
nonobvious. Moreover, contrary to Appellants' arguments, the fact that
neither Muscle nor Napolitano discloses a working example that specifically
combines a bioactive glass and the elected polymer, Gantrez®, is not
decisive. (Reply Br. 4---6). This is a rejection based on obviousness, not
anticipation. So, we consider the prior art for all that it teaches and suggests.
Merck & Co. 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.") (Internal quotation marks
omitted). Here, each of Muscle and Napolitano teach the skilled artisan that
they may include a bioactive glass and Gantrez® in an oral care
composition. (FF 2--4.) Napolitano, for example, expressly teaches it is
desirable to include both a water-soluble or water-swellable polymer and a
mineralizing agent in an oral care composition for essentially the same
purpose as the present invention - to relieve hypersensitive teeth. (FF 4;
Napolitano 16, claim 5.) Gantrez® and a bioactive glass are among the
polymers and mineralizing agents that Napolitano teaches are suitable for its
composition. (FF 4; Napolitano 16, claims 2 and 6.) Merck, 874 F.2d at 807
("[D]isclos[ing] a multitude of effective combinations does not render any
particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art.")
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Appellants next argue that prima facie holdings "must be
reestablished" in view of its arguments and evidence. But it is not apparent
that the Examiner failed to do so. To the contrary, the record shows the
Examiner considered Appellants' arguments and evidence. (See, e.g., Ans. 4
(discussing and responding to Appellants' argument that "neither the
bioactive glass nor [Gantrez®] ... could act as the component which
achieves sustained or controlled dissolution as desired by Napolitano.");
Ans. 7 (discussing and responding to Appellants' evidence of secondary
considerations).) We recognize Appellants' arguments and evidence as
well and, like the Examiner, find that Muscle or Napolitano would have
made obvious the subject matter of Appellants' claim 23.
Appellants argue the bioactive glass and elected polymer (Gantrez®)
in claim 23 would not "achieve[]" the properties allegedly desired in either
of Napolitano or Muscle- sustained/controlled release and increased
fluoride uptake respectively. (App. Br. 6, 8.) This is unpersuasive. Muscle
and Napolitano both teach that bioactive glass and Gantrez® may be
included in their oral care compositions. (FF 2--4.) In addition, Napolitano
and Muscle suggest the inclusion of other ingredients for desirable purposes,
such as fluoride, as suggested by Muscle. (FF 2, 4.) Thus, insofar as
Appellants' argument suggests the ingredients in claim 23 are somehow
"incompatible" with the compositions of Muscle or Napolitano, the record
evidence shows that is incorrect. 4 (App. Br. 6.) So too, claim 23 is not
4 Appellants argue that, in Napolitano, bioactive glass is mentioned only
"within the context of being one of many 'incompatible compound[ s ]' which
could be selected." (App. Br. 6.) As discussed, Appellants have not
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limited to a composition including only a bioactive glass and the elected
polymer Gantrez®. For example, claim 18, which depends from claim 23,
adds that the composition includes "a fluoride source." (App. Br. 18-19
(Claims App'x).) Accordingly, the fact that Muscle and Napolitano each
suggest compositions that include a bioactive glass and Gantrez, as well as
other ingredients, does not distinguish the claims over the prior art. In
addition, there is no persuasive argument or evidence on this record to
support a conclusion that including other ingredients in the composition
suggested by Muscle or Napolitano would prevent the composition from
achieving the claimed properties.
Appellants also attempt to distinguish their invention from Napolitano
and Muscle based on the concentrations of ingredients. (Reply Br. 4---6.)
For example, Appellants contend Muscle teaches the polymer Gantrez may
be included in concentrations from 0.001 to 5 weight percent, but
"Appellant's Table 1 shows that these bioadhesive polymers are present in
the various formulations in amounts ranging from 20 to 69% weight percent
of the total composition." (Reply Br. 5.)
This argument fails as well based on the overlap of the claimed
concentrations compared to the concentrations disclosed in the prior art.
Appellants' Specification discloses embodiments where "the bioadhesive
polymer component comprises 0.1 wt.% to 70 wt.% by weight of the
composition." (Spec. i-f 31.) The claims likewise recite broad polymer
provided persuasive argument or evidence to establish that there is anything
"incompatible" about including a bioactive glass or Gantrez® in the
compositions of either Muscle or Napolitano.
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ranges, such as 0.1-70% in claim 6. (App. Br. 17 (Claims App'x).) The
scope of the claims thus overlaps with the range of Gantrez® disclosed in
the art (0.001-5% in Muscle and 0.3-15% in Napolitano). (FF 2, 4.) The
claimed range of the bioactive glass also overlaps with the bioactive glass
concentrations disclosed in the prior art. (Compare FF 2, 4 with claim 8.)
This overlap supports the prima facie case. In re Peterson, 315 F .3d
1325, 1329 (Fed. Cir. 2003) ("In cases involving overlapping ranges, we and
our predecessor court have consistently held that even a slight overlap in
range establishes a prima facie case of obviousness.") Moreover, in view of
the overlapping ingredients and concentration ranges, and without objective
evidence to the contrary, it is reasonable to conclude that the prior art
compositions would exhibit the same properties (e.g., fluid flow rate) as the
claimed compositions. 5
Finally, like the Examiner, we do not find Appellants' evidence of
secondary considerations persuasive. (Final Act. 7-8; Ans. 6-7.)
Appellants, relying on Example 6 of their Specification, argue that testing of
"a toothpaste with the elected bioactive glass vs. a conventional silica
containing toothpaste" showed "unexpected results." (App. Br. 7.) In
5 "Where ... the claimed and prior art products are identical or substantially
identical ... the PTO can require an applicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product. Whether the rejection is based on 'inherency' under 35
U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is evidenced
by the PTO' s inability to manufacture products or to obtain and compare
prior art products." In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations
and footnote omitted).
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particular, Appellants contend that "dentin conductance" was improved
(measured by % reduction conductance) with the toothpaste containing
bioactive glass that was "immediate from the first treatment (44.03% vs.
26.05%), but [also] is maintained over 10 treatments (84.30% vs. 37.17%)."
(Id.; see also, Spec. i-f 152.)
We are not persuaded. First, as correctly pointed out by the
Examiner, in testing against non-occlusive conventional compositions (i.e.,
without bioactive glass), Appellants' evidence does not demonstrate
unexpected results against the closest prior art such as Muscle, which
discloses specific formulations including occlusive bioactive glass. (Final
Act. 7; FF 2-3.) "[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 addition, Appellants' evidence does not persuasively demonstrate
that the results were, in fact, unexpected. As the Examiner finds, the skilled
person would have reasonably expected occlusive bioactive glass
compositions to provide different results compared to "conventional non-
occlusion silica toothpaste." (Spec. i-f 152; Ans. 7.) Indeed, Napolitano
teaches that bioactive glass occludes dentinal tubules. (FF 4.) Thus, based
on the teachings of the prior art of record, the skilled artisan would have
expected a greater reduction in dentinal conductance compared to a product
containing a non-occlusive ingredient -just as shown in the results from
Example 6 of the Specification. In re Skoner, 517 F.2d 947, 950 (CCPA
1975) ("Expected beneficial results are evidence of obviousness of a claimed
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invention.") Although Appellants argue the results in Example 6 were
"unexpected," the Specification does not refer to them as such and
Appellants have provided no persuasive evidence or argument to
substantiate their contention. 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.").
Conclusion of Law
We conclude the Examiner established, by a preponderance of the
evidence, that claim 23 would have been obvious over Muscle or
Napolitano. Claims 6-8, 17-22, and 24 have not been argued separately and
therefore fall with claim 23.
Rejection IV - Claim 27
Issue
The Examiner rejected claims 27-30 over Muscle or Napolitano, in
combination with Greenspan. 6 Appellants argue the patentability of the
claims as a group. We thus select claim 27 as representative.
The issue is whether the Examiner established, by a preponderance of
the evidence, that claim 27 would have been obvious over Muscle or
Napolitano, in further view of Greenspan.
6 We recognize that Appellants argued the obviousness rejections over
Muscle and Greenspan, and Napolitano and Greenspan under separate
headings. (App. Br. 10-12, 13-15; Reply Br. 6.) Based on the overlap in
the arguments, however, we address them together on appeal.
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Findings of Fact (FF)
FF 5. The Examiner's findings of fact and statement of the rejections
of claims 27-30 over Muscle or Napolitano, in further view of Greenspan
may be found at pages 5-6 of the Final Rejection dated August 26, 2013.
(See also, Ans. 5-7.) We adopt the Examiner's findings and incorporate the
Findings of Fact above related to Rejection III.
Analysis
Claim 27 depends from claim 23, but adds that the bioactive glass is a
glass comprising certain concentrations of chemicals ( 40-60 wt. % Si02,
10-30 wt.% Ca02, 10-35 wt.% Na20, etc.). (App Br. 19-20 (Claims
App'x).)
Appellants repeat the arguments concerning claim 23 and rejections
over Muscle and Napolitano discussed above. To the extent separately
argued, Appellants argue that Greenspan does not remedy the deficiencies of
Muscle or Napolitano. (See, e.g., App. Br. 15 ("mention of the various
minerals by Greenspan, without more, would not have remedied [the]
deficiencies [of Muscle or Napolitano] to teach or suggest the inventions of
claim 23, as limited by claims 27 and/or 28.")
For the reasons discussed above, we are not persuaded by Appellants'
arguments that there are deficiencies in Muscle and Napolitano. (App. Br.
10-12, 13-15.) Moreover, we agree with the Examiner that the skilled
person would have reasonably incorporated within the compositions of
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Muscle or Napolitano a bioactive glass having the "typical ranges" of
chemical concentrations disclosed in Greenspan. (Ans. 6-7.)7
Also, for the reasons discussed above, we are not persuaded by
Appellants' arguments and evidence concerning secondary considerations.
(App. Br. 10-12, 13-15.)
Conclusion of Law
We conclude the Examiner established, by a preponderance of the
evidence, that claim 27 would have been obvious over Muscle or
Napolitano, in combination with Greenspan. Claims 28-30 have not been
argued separately and therefore fall with claim 27.
SUMMARY
We affirm rejections I, III, and IV and reverse rejection II.
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
7 Examiner and Appellants appear to have overlooked that Muscle, in fact,
discloses the chemicals and concentration ranges for a bioactive glass that
overlap with the chemicals and concentrations recited in claims 27 and 28.
(FF 2; Muscle i-f 31.) This disclosure in Muscle underscores the Examiner's
finding that these chemicals and concentrations for a bioactive glass as
recited in Greenspan are typical.
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