Ex Parte Karlinsey

Patent Trial and Appeal Board

Nov 13, 2017

13105268 (P.T.A.B. Nov. 13, 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.
13/105,268 05/11/2011 Robert L. Karlinsey 44-10907 2898
77741 7590 11/15/2017
Rrannnn Sowers; Rr rYarraft PP
EXAMINER
47 South Meridian Street WEBB, WALTER E
Suite 400
Indianapolis, IN 46204 ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
11/15/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT L. KARLINSEY
Appeal 2017-004907
Application 13/105,2681
Technology Center 1600
Before FRANCISCO C. PRATS, TIMOTHY G. MAJORS, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
SAWERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1, 8, and 56—61. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies Robert L. Karlinsey as the real party in interest.
Appeal Br. 3.
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Application 13/105,268
STATEMENT OF THE CASE
Claims 1, 8, and 56—61 are on appeal. Claim 58 stands rejected as
unpatentable under 35 U.S.C. § 112, first paragraph, for lack of written
description. Final Act. 2—3. Claims 1, 8, 56, 57, 60, and 61 stand rejected
under 35 U.S.C. § 102(b) for anticipation by Reynolds.2 Id. at 3—5. Claims
1,8, and 56—61 stand rejected under 35 U.S.C. § 102(b) for anticipation by
Chaput.3 Id. at 5—6. Claims 1, 8, and 56—61 stand rejected under 35 U.S.C.
§ 103(a) for obviousness over Chaput. Id. at 6—7. We choose independent
claim 1 and dependent claim 8 as representative. See 37 C.F.R.
§ 41.37(c)(l)(iv). Claim 1 provides:
1. A method of repairing weakened teeth, comprising:
a) combining a quantity of functionalized molecules having
both organic and inorganic chemical characteristics with
a fluoridated formulation to define a dental repair system;
b) applying the dental repair system to the weakened teeth; and
c) remineralizing dentition with the functionalized molecules;
wherein the functionalized molecules are hybrid
molecules having characteristics of both organic and inorganic
materials; and wherein the functionalized molecules are
compatible with the fluoride such that both calcium and
fluoride are bioavailable minerals.
Appeal Br. 19.
2 Eric C. Reynolds, WO 98/40406 (Sept. 17, 1998) (“Reynolds”).
3 Cyril Chaput & Anabelle Rodrigues El Zein, US 2003/0199615 A1
(Oct. 23, 2003) (“Chaput”).
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Claim 8 provides:
8. The method of claim 1 and further comprising: after
a) and before b), adding the hybrid system to a member of the
group comprising toothpaste, dental gel, varnish, and oral rinse.
Id.
DISCUSSION
Written Description
The Examiner rejects claim 58 under 35U.S.C. § 112, first paragraph,
for lack of written description. Final Act. 2—3. The first paragraph of § 112
requires that the specification contain a written description of the claimed
invention. 35 U.S.C. § 112, 1 (2011). “[T]he hallmark of written
description is disclosure.” AriadPharms., Inc. v. Eli Lilly and Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement
is met when the specification “conveys to those skilled in the art that the
inventor had possession of’ and “actually invented” the claimed subject
matter. Id.
A written-description question often arises when an applicant, after
filing a patent application, subsequently adds “new matter” not present in the
original application. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed.
Cir. 1991). When an applicant amends or adds claims during prosecution,
for example, the newly claimed subject matter must find written description
support in the original specification. Id.', see also TurboCare Div. of Demag
Delavel Turbomachinery Corp. v. Gen. Elec. Co., 264 F.3d 1111, 1118 (Fed.
Cir. 2001). Without written description support, claims containing new
matter are properly rejected under § 112. Ariad, 598 F.3d at 1348. This
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required compliance with § 112 ensures that the applicant fully possessed
the entire scope of the claim as of the original filing date. TurboCare, 264
F.3d at 1118.
In this case, Appellant added claim 58 during prosecution to recite
that the “inorganic moieties are crystalline calcium phosphate.” Final
Act. 3. The Examiner states that the claims lack written description support
because “there is no recitation [in the Specification] for the state of the
calcium phosphate, i.e. crystalline.” Ans. 2. The Examiner acknowledges
that the Specification refers to “crystalline TCP [tricalcium phosphate],” but
states that this “species does not account for description of the generic
‘crystalline calcium phosphate’ insofar as calcium phosphate is not limited
to TCP.” Id. (citing Spec. 14,1. 3).
In response, Appellant points out that the Specification “recites that a
typical inorganic material might include [‘]a calcium phosphate mineral such
as calcium phosphate tribasic, calcium phosphate dibasic, dicalcium
phosphate, and the like.[’]” Reply Br. 3 (citing Spec. 11,11. 12—21 & 15,
11. 18—21). Appellant asserts that an ordinarily skilled artisan would
understand a calcium phosphate mineral to include the state of being
crystalline because:
[T]he term mineral may be defined as “[a] naturally occurring
substance with a characteristic chemical composition expressed
by a chemical formula; may occur as individual crystals or may
be disseminated in some other mineral or rock; most
mineralogists include the requirements of inorganic origin and
internal crystalline structure.”
Id. (quoting Dictionary of Scientific and Technical Terms, 4th Ed., 7th Ed.,
McGraw-Hill, 1989, 2016). Thus, Appellant asserts, “crystalline calcium
phosphate” does not constitute new matter. Id.
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We agree with Appellant that the Specification, as filed, adequately
describes “crystalline calcium phosphate” for the purpose of § 112, first
paragraph. At the outset, we note that “[t]he level of detail required to
satisfy the written description requirement” necessarily “varies depending on
the nature and scope of the claims and on the complexity and predictability
of the relevant technology.” Ariad, 598 F.3d at 1351. Here, the Examiner
has not provided us with evidence that an ordinarily skilled artisan would
consider the physical state of a calcium phosphate mineral to be an
unpredictable or complex matter. Instead, the dictionary evidence submitted
by Appellant shows that an ordinarily skilled artisan would, in fact, consider
a mineral to exist in the crystalline state. Reply Br. 3 (citing Dictionary of
Scientific and Technical Terms, 4th Ed., 7th Ed., McGraw-Hill, 1989, 2016).
Moreover, although the Examiner is correct that Reynolds evidences
that calcium phosphate may also exist in an amorphous state, Ans. 2,
Reynolds also teaches that amorphous calcium phosphate, without a
stabilizing phosphopeptide, “will precipitate out of solution and transform
within minutes to the most stable calcium phosphate phase, crystalline
hydroxyapatite.” Reynolds 3,11. 12—14. Thus, at most, Reynolds shows that
calcium phosphate may exist in both physical states. But here, the
Specification expressly discloses crystalline tricalcium phosphate as an
example of an inorganic material useful in the claimed method. Spec. 14,1.
3. In our view, an ordinarily skilled artisan would recognize that the
disclosure of the crystalline tricalcium phosphate species shows that the
genus of calcium phosphate minerals exists in the crystalline state. Other
than reference to Reynolds, the Examiner has not presented us with
persuasive evidence to the contrary.
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For all these reasons, we find that the Specification’s disclosure of
calcium phosphate mineral, Spec. 11, adequately describes “crystalline
calcium phosphate,” as recited in claim 58. Thus, we reverse the Examiner’s
rejection of claim 58 under 35U.S.C. § 112, first paragraph.
Anticipation
The Examiner rejects claims 1, 8, 56, 57, 60, and 61 under 35 U.S.C.
§ 102(b) as anticipated by Reynolds, and claims 1, 8, and 56—61 as
anticipated by Chaput. Final Act. 4—5. “Anticipation requires the presence
in a single prior art disclosure of all elements of a claimed invention
arranged as in the claim.” Therasense, Inc. v. Becton, Dickinson & Co., 593
F.3d 1325, 1332 (Fed. Cir. 2010). We address each rejection individually
below.
Reynolds
In response to this rejection, Appellant asserts that he attempted to
amend claim 1 to distinguish over Reynolds, and argues that the Examiner
erred in issuing an Advisory Action refusing to enter Appellant’s proposed
amendments. Appeal Br. 10—12. As the Examiner explains, however, we
lack authority to review the propriety of the Examiner’s refusal to enter
Appellant’s proposed amendments, which may only be addressed by petition
to the Director. 37 C.F.R. § 1.181; see also Ans. 3. Thus, we affirm the
rejection of claims 1, 8, 56, 57, 60, and 61 for anticipation by Reynolds.
Chaput
Chaput discloses self-setting compositions for “the formation of
hardened bio-materials having a broad range of properties and
performances.” Chaput, Abstract. The compositions comprise a self-gelling
liquid component and a solid powder component consisting of at least two
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calcium phosphate sources. Id. Chaput teaches that the compositions “may
be useful for medical and dental indications.” Id. 1149. In particular,
Chaput teaches that the compositions may be used to, inter alia, “promote
regeneration and/or repair of bone,” “protect or cap the dental pulp,” and
“fill permanently or temporarily enamel and dentin.” Id. 150, 154, &
155.
Chaput teaches preparing the compositions by mixing the liquid and
solid powder components. Id. 1131. As the solid component, Chaput lists
as examples a mixture of alpha-tricalcium phosphate and apatitic calcium
phosphate, id. 1134, and a mixture of alpha-tricalcium phosphate and an
octacalcium phosphate, id. 1135. Chaput also teaches that the solid
component “also comprises an organic salt,” and “an acid source.” Id.
1139. Chaput provides examples of specific embodiments where the solid
phase (powder component) comprises tricalcium phosphate (TCP) and citric
acid. Id. 196 (Table 9), 234 (Table 16). Finally, Chaput also teaches that
the powder component may include “at least one fluoride.” Id. 1138, 22
(claim 26),
The Examiner finds that Chaput “is anticipatory insofar as it teaches
applying functionalized molecules with a fluoridated formulation to
weakened teeth.” Final Act. 6. The Examiner points to the TCP-citric acid
hybrid disclosed in Table 16 as a “functionalized molecule having both
organic and inorganic chemical characteristics.” Id. In response, Appellant
argues that “Chaput does not teach remineralization with functionalized
molecules,” as recited in the independent claims. Appeal Br. 14. In
particular, Appellant asserts that Chaput teaches a cement that “does not
qualify as the required functionalized molecules” because any
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“inorganic/organic hybrid materials that may have been present in
[Chaput’s] solid phase have been dissolved and no longer exist as such to
satisfy Appellant’s requirement of ‘remineralizing dentition with the
functionalized molecules.’” Id. (quoting claim 1).
As to dependent claim 8, Appellant also argues that “the suggestion
that, because Chaput’s self-setting phosphate cement is, for a short time,
liquid enough that it can be topically applied to teeth is sufficient for it to
satisfy the requirements of a section 102 reference is absurd.” Id. at 15.
Appellant contends that “no sane person” would apply “Chaput’s self-setting
cement directly to teeth as a toothpaste or rinse,” and the Examiner’s
assertion otherwise “is poppycock” and “ridiculous,” especially given
“Chaput’s general warning that phosphate cements react exothermically and
that such exothermic reactions may damage living tissue.” Id. (citing
Chaput 132).
Upon consideration of the Examiner’s rejection and Appellant’s
arguments in the Appeal Brief and Reply Brief, we find that the
preponderance of the evidence supports the Examiner’s finding of
anticipation by Chaput. As the Examiner explains, “functionalized
molecules,” as set forth in the claims, refers to “hybrid molecules having
characteristics of both organic and inorganic materials” along with a
fluoridated formulation. Ans. 4; see also Appeal Br. 19 (claim 1). We agree
with the Examiner that Chaput’s compositions satisfy that definition.
Specifically, Chaput discloses a composition comprising, as the solid
component, both an inorganic (TCP) and an organic (citric acid) component.
Chaput || 196 (Table 9), 234 (Table 16). Chaput also discloses adding “at
least one fluoride” to the composition. Id. (claim 26). Because the
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Specification teaches TCP as a suitable organic component, and citric acid
as a suitable organic component, Spec. 11—12; see also Ans. 4, Chaput’s
compositions “hav[e] both organic and inorganic chemical characteristics
with a fluoridated formulation,” as currently claimed. See Appeal Br. 19
(claim 1).
We also agree with the Examiner that Chaput adequately teaches
“remineralizing dentition” with those functionalized molecules. Ans. 4.
Specifically, Chaput expressly teaches that the compositions may be used
“to protect or cap dental pulp,” “to fill permanently or temporarily enamel
and dentin,” and “to favor the repair of fractured bones” or “fix bone
fragments.” Chapin || 149-158.
We are not persuaded by Appellant’s attorney argument that Chaput
does not anticipate because the “inorganic/organic hybrid materials have
been dissolved and no longer exist” to “remineralize dentition.” Appeal
Br. 14. As the Examiner points out, Appellant has presented no persuasive
evidence showing that the Chaput’s functionalized molecules “no longer
exist” in combination with the liquid component. See Ans. 4—5 (stating that
“arguments of counsel cannot take place of evidence in the record”); see
also In re Schulze, 346 F.2d 600, 602 (CCPA 1965) (accord). Moreover, as
the Examiner reasonably explains, Chaput teaches that the solid component
of the disclosed compositions dissolve, but then reprecipitate, in the liquid
component. Ans. 5 (citing Chaput 195). The Examiner has set forth a
reasonable explanation that the “reprecipitated solid component includes the
organic/inorganic hybrid,” Ans. 5, and Appellant has presented us with no
persuasive evidence to the contrary.
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Finally, we find Appellant’s argument that Chaput’s “hybrid”
compositions are “not a molecular system” unclear, unsupported by the
evidence, and not directed to the actual claim language. See Reply Br. 4.
Again, Appellant’s claims set forth “functionalized molecules” as “hybrid
molecules having both organic and inorganic chemical characteristics with a
fluoridated formulation.” Appeal Br. 19 (claim 1). Chaput teaches such
molecules even if associated with a polymer component in a “biphasic
system,” which is not excluded by the plain language of Appellant’s claims.
Chaput | 89. Thus, we find that Appellant has not adequately rebutted the
Examiner’s prima facie anticipation rejection.
As to dependent claims 8, 57, and 61, we again agree with the
Examiner that Appellant has provided no credible evidence showing that
Chaput’s compositions cannot be applied to teeth as a toothpaste, dental gel,
varnish, or rinse, especially given that Chaput states that the compositions
have a “thermos-gelling character” and may be in the form of a “paste,” and
may be applied to teeth, for example, “to protect or cap the dental pulp.”
Ans. 5—6 (citing Chaput || 39, 144, & 154). Appellant’s attorney arguments
to the contrary are not persuasive, as noted above. See Schulze, 346 F.2d at
602.
Obviousness
The Examiner rejects claims 1, 8, and 56—61 under 35 U.S.C. § 103(a)
for obviousness over Chaput. Final Act. 6—7. A claimed invention is
unpatentable if the differences between it and the prior art are “such that the
subject matter as a whole would have been obvious at the time the invention
was made to a person having ordinary skill in the art.” 35 U.S.C. § 103(a)
(pre-AIA). To assess whether the subject matter would have been obvious,
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the Board follows guidance in Graham v. John Deere Co., 383 U.S. 1 (1966)
and KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under that
guidance, the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416. 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, 550 U.S. at 418.
After considering the entirety of the evidence and Appellant’s arguments, we
conclude that the preponderance of the evidence favors the Examiner’s
conclusion of obviousness.
As an initial matter, to the extent that Appellant’s arguments as to
obviousness mainly repeat those as to anticipation, see, e.g., Reply Br. 5, we
again find them unpersuasive. See In re Fracalossi, 681 F.2d 792, 794
(CCPA 1982) (“[Ajnticipation is the epitome of obviousness.”). Even so,
we find that the Examiner has sufficiently showed that Chaput teaches all
the features of the Appellant’s claims, see supra at 6—10, and Appellant’s
arguments otherwise again are not directed to the actual claim language. For
example, neither claim 1 nor claim 8 are limited to toothpastes or
“mechanochemical reactions,” and therefore Appellant’s arguments that
Chaput does not teach a toothpaste or compositions that rely on
mechanochemical reactions, Appeal Br. 16—18, is insufficient to show that
the Examiner erred. We agree with and adopt the Examiner’s Answer as to
Appellant’s remaining arguments. See Ans. 5—6. Moreover, Appellant’s
attorney argument that Chaput’s compositions are not “bioavailable” and
therefore would not “remineralize or otherwise repair weakened teeth,”
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Reply Br. 5, lacks support in the record, given that Chaput expressly teaches
using the disclosed compositions to, inter alia, “promote regeneration and/or
repair of bone,” “protect or cap the dental pulp,” and “fill permanently or
temporarily enamel and dentin,” Chaput H 150, 154, & 155.
Finally, we agree with the Examiner that Chaput does not teach away
from the subject matter of claims 58 and 59. A reference is said to teach
away “when a person of ordinary skill, upon reading the reference, would be
discouraged from following the path set out in the reference, or would be led
in a direction divergent from the path that was taken” in the claim.
Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013).
Appellant argues that Chaput “teaches away from the formation of any
functionalized hybrids that have inorganic moieties” because Chaput teaches
“that it is important to avoid any reactions between dry ingredients during
the mixing phase.” Appeal Br. 17. This is not a teaching away, because
Chaput “does not criticize, discredit, or otherwise discourage investigation
into” the claimed invention. Galderma, 737 F.3d at 738. In fact, Chaput
expressly teaches examples of compositions comprising the inorganic
moiety tricalcium phosphate (including P-TCP as recited in claim 59).
Chaput 11196 (Table 9), 234 (Table 16).
For these reasons, we affirm the Examiner’s rejection of claims 1, 8,
and 56—61 under 35 U.S.C. § 103(a) for obviousness over Chaput.
SUMMARY
We affirm the rejection of claims 1, 8, and 56—61.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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