Covidien LP

Patent Trials and Appeals Board

Nov 9, 2020

15255263 - (D) (P.T.A.B. Nov. 9, 2020)

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.
15/255,263 09/02/2016 Valentino Tramontano H-
US-02770.USC1(1603-88CO
9232
50855 7590 11/09/2020
Covidien LP
60 Middletown Avenue
Mailstop 54, Legal Dept.
North Haven, CT 06473
EXAMINER
WHITE, EVERETT
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
11/09/2020 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):
docket@carterdeluca.com
rs.patents.two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte VALENTINO TRAMONTANO,
PHILLIP BLASKOVICH, RACHIT OHRI,
DANIEL S. COSTA, JOSHUA KENNEDY, and
SAJIDA FAROOQI1
________________

Appeal 2020-002413
Application 15/255,263
Technology Center 1600
________________

Before FRANCISCO C. PRATS, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the term “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.142. Appellant identifies Covidien LP as the real party-in-
interest. App. Br. 1.
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Application 15/255,263

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 25–27, 32–34, 38–42, 49, and 51 as
unpatentable under 35 U.S.C. § 103 as being obvious over the combination
of Gehrke et al. (US 5,603,955, February 18, 1997) (“Gehrke”), Blaskovich
et al. (US 8,518,440 B2, August 27, 2013) (“Blaskovich”), and Hubbard et
al. (US 7,060,287 B1, June 13, 2006) (“Hubbard”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s claimed invention is directed to a process for dissolving
modified cellulose comprising contacting modified cellulose solution with at
least one non-solvent to form a plurality of modified cellulose particles.
Abstr.

REPRESENTATIVE CLAIM
Independent claim 25 is representative of the claims on appeal
and recites:
25. A process for forming a gel comprising:

forming an oxidized cellulose solution;

forming a precipitating composition; and

contacting the oxidized cellulose solution and the
precipitating composition at a tissue treatment site thereby
precipitating oxidized cellulose from the oxidized cellulose
solution and forming the gel.
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App. Br. 8.

ISSUES AND ANALYSES
We adopt the Examiner’s findings, reasoning, and conclusion that the
claims on appeal are prima facie obvious over the combined cited prior art.
We address the arguments raised by Appellant below.

Issue

Appellant argues that the Examiner erred because the combined cited
prior art references neither teach nor suggest the limitation of claim 25
reciting “contacting the oxidized cellulose solution and the precipitating
composition at a tissue treatment site thereby precipitating oxidized cellulose
from the oxidized cellulose solution and forming the gel,” as recited in
independent claim 25. App. Br. 6.

Analysis
The Examiner finds that Gehrke teaches preparation of cross-linked
gels, in which the cross-linkers for cellulose ethers are multifunctional
carboxylic acids. Final Act.4 (citing Gehrke, Abstr., col. 12, ll. 61–63). The
Examiner also finds that the multifunctional carboxylic acids taught by
Gehrke thus teaches the claimed cross-linkable composition, which is
covalently cross-linkable with the oxidized cellulose solution, as described
in Appellant’s claim 33. Id. The Examiner also finds that Gehrke teaches
cephalexin as an example of an antibiotic that can be loaded into the cross-
linked gels, as recited in Appellant’s claims 34 and 49. Id. (citing Gehrke
col. 17, l. 47)
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The Examiner acknowledges that Appellant’s claimed process for
forming a cross-linked gel differs from the cross-linked gel compositions
taught by Gehrke in reciting that the polymer is oxidized cellulose, rather
than Gehrke’s cellulose ethers. Final Act. 4. The Examiner reasons,
however, that it would have been within the skill of an ordinary practitioner
of the art to substitute oxidized cellulose for a cellulose ether, as taught by
Blaskovich. Id. The Examiner finds that Blaskovich teaches hydrogel
precursors including cellulose ethers such as carboxymethylcellulose,
hydroxyethyl-cellulose, hydroxymethylcellulose, and oxidized cellulose. Id.
at 4–5 (citing Blaskovich col. 4, ll. 54– 63). The Examiner further points out
that Blaskovich teaches that these hydrogel precursors are cross-linkable.
Id. at 5 (citing Blaskovich col. 5, ll. 15–16).
The Examiner also notes that, prior to the Final Office Action,
Appellant amended the claims to recite that the oxidized cellulose solution
and cross-linkable composition are contacted at a tissue treatment site. Final
Act. 5. The Examiner finds that Hubbard teaches the use of polysaccharide
gels to improve the delivery of augmentation material at a tissue site. Id.
The Examiner finds that Hubbard teaches that oxidized cellulose may be
selected as the polysaccharide used in this method. Id. (citing Hubbard col.
10, ll. 13–16, 38). The Examiner therefore finds that Hubbard teaches that
the delivery of oxidized cellulose, in gel form and combined with other
materials, to a tissue site was known in the art at the time of invention. Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to substitute the cellulose ether used as the
polymer in the cross-linked gels taught by Gehrke, with oxidized cellulose
as taught by Blaskovich, at a tissue treatment site, as taught by Hubbard.
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Final Act. 5. The Examiner further concludes that a skilled artisan would
have been motivated to use the hydrogel precursors at the treatment site
because they possess biologically inert and water soluble cores that increase
the effectiveness of the polymers as gels. Id.
Appellant argues that, in the Final Office Action, the Examiner
allegedly failed to establish that any of the cited references teach or suggest
the disputed limitation of claim 25. App. Br. 4. Rather, argues Appellant,
all of the reasoning articulated by the Examiner pertains solely to the cross-
linked gel recited in claims 33 and 34. Id. Appellant asserts that the Final
Office Action does not mention the claim term “precipitating composition,”
nor do any of the cited references teach or suggest such a composition for
contacting oxidized cellulose, as recited in claim 25. Id.
Appellant points to the Advisory Action, filed July 22, 2019, in which
the Examiner stated:
Applicant argue [sic] that “precipitation composition” is not
mentioned in the Final rejection of the claims. This argument is
not persuasive since it is not clear what the precipitation
composition is comprises [sic]. Withdrawn Claim 28 recite that
the precipitating composition may be selected as water, saline,
buffered saline, which appears to [be] any salt containing
solution, which is mentioned in the Gehrke et al patent.

App. Br. 5 (quoting Adv. Act. 2). Appellant notes that the Examiner did not
make any rejections with respect to the definiteness of the claims, such as
under 35 U.S.C. § 112, second paragraph. Id. Appellant therefore argues
that, absent any such rejection by the Examiner, the recitation “precipitation
composition” is definite. Id. Appellant asserts that, in applying the broadest
reasonable interpretation of the claim term, words of the claim must be given
their plain meaning, unless such meaning is inconsistent with the
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Specification. Id. According to Appellant, the plain meaning of a term
means the ordinary and customary meaning given to the term by those of
ordinary skill in the art at the time of the invention. Id. (citing In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997) (holding that “the USPTO
looks to the ordinary use of the claim terms taking into account definitions
or other ‘enlightenment’ contained in the written description”).
Furthermore, argues Appellant, the disclosures of the Specification are
consistent with the ordinary and customary meaning of the claim term
“precipitation composition” and provide sufficient description of the term in
paragraphs [0280]–[0283] of the Specification. App. Br. 5. Appellant
points in particular to paragraph [0283], which discloses:
Upon contact of the oxidized cellulose solution with the
precipitating composition, the gel is formed in situ by the dilution
of the solvent used to form the oxidized cellulose solution and
the subsequent precipitation of the oxidized cellulose. Since the
polar solvent of the oxidized cellulose solution is miscible with
water and/or organic solvents described above, oxidized
cellulose precipitates out in the form of a gel due to the dilution
of the solvent.

Appellant contends that the Examiner’s finding that Gehrke teaches a
“precipitation composition,” because Gehrke teaches the use of saline, which
is recited in claim 28 as one possible precipitation composition, is also
improper. Final Act. 5. According to Appellant, Gehrke teaches saline as
one of the “substances which can serve as pharmaceutically-acceptable
carriers,” rather than as a substance “contacting the oxidized cellulose
solution and the precipitating composition at a tissue treatment site thereby
precipitating oxidized cellulose from the oxidized cellulose solution and
forming the gel,” as recited in claim 25. Id.
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Appellant argues further that that independent claim 33 is patentable
over the combination of Gehrke, Blaskovich, and Hubbard, because none of
these references, alone or in combination, teaches or suggests the limitation
reciting “contacting the oxidized cellulose solution and the cross-linkable
composition at a tissue treatment site thereby forming the cross-linked gel by
convergently applying the oxidized cellulose solution and the cross-linkable
composition onto the tissue treatment site,” as recited in independent claim
33. App. Br. 4. Similarly, Appellant contends that the combined references
neither teach nor suggest “contacting the oxidized cellulose solution and the
gelation composition at a tissue treatment site thereby forming the gel by
convergently applying the oxidized cellulose solution and the gelation
composition onto the tissue treatment site,” as recited in independent claim
38. Id.
Appellant contends that, as with respect to claim 25, the Examiner did
not make any indefiniteness rejection under 35 U.S.C. § 112, second
paragraph, of claims 33 and 38. App. Br. 6. Appellant contends that, absent
an actual rejection by the Examiner, the claim term “crosslinkable
composition” and “gelation composition” are definite. Appellant asserts that
the Specification is consistent with the ordinary and customary meaning of
the claim terms, and provides sufficient descriptive support for the claim
terms recitation in paragraphs [0273], [0279], and [0280]–[0281]. Id.
We are not persuaded by Appellant’s arguments. Before proceeding
to the merits of the Examiner’s rejection, we are obliged to make several
initial points.
First of all, Appellant does not accurately state the correct standard for
construing the claim terms. In the absence of an express definition of a
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claim term in the Specification, the Board “determines the scope of claims in
patent applications not solely on the basis of the claim language, but upon
giving claims their broadest reasonable construction ‘in light of the
specification as it would be interpreted by one of ordinary skill in the art.’”
Phillips v. AWH Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re
Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Nor
does Appellant correctly represent the holding of Morris, which states that:
Since it would be unreasonable for the PTO to ignore any
interpretive guidance afforded by the applicant’s written
description, either phrasing connotes the same notion: as an
initial matter, the PTO applies to the verbiage of the proposed
claims the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary
skill in the art, taking into account whatever enlightenment by
way of definitions or otherwise that may be afforded by the
written description contained in the applicant’s specification.

127 F.3d at 1054. Consequently, we construe claim terms by giving them
their broadest reasonable definition in light of Appellant’s Specification, and
not by the “ordinary and customary meaning of the claim term,” as
suggested by Appellant. See App. Br. 5.
Furthermore, with respect to Appellant’s arguments concerning claims
33 and 38, and specifically, with respect to Appellant’s arguments
concerning the obviousness of the claims over the combined cited prior art,
our reviewing court has held that “the Board reasonably interpret[s] Rule
41.37 to require more substantive arguments in an appeal brief than a mere
recitation of the claim elements and a naked assertion that the corresponding
elements were not found in the prior art.” In re Lovin, 652 F.3d 1349, 1357
(Fed. Cir. 2011). We are currently not persuaded by Appellant’s arguments
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concerning those claims. Appellant’s arguments that certain terms in the
claim are definite (or “clear” as Appellants put it), are largely irrelevant,
because, as Appellant argues, the Examiner made no such rejection on the
basis of indefiniteness under 35 U.S.C. § 112, second paragraph. This
reasoning similarly applies to Appellant’s same arguments with respect to
claim 25.
Turning to the merits, Appellant’s Specification provides no express
definition of the claim term “precipitating composition.” However,
Appellant’s Specification discloses a number of examples of “precipitating
compositions,” which, although not definitive, are instructive in our
construction of the claims. Specifically, paragraphs [0106]–[0109] of the
Specification disclose:
According to an aspect of the above embodiment, the
precipitating composition is selected from the group consisting
of water, saline, phosphate buffered saline, and combinations
thereof.

According to an aspect of the above embodiment, the
precipitating composition is an aqueous solution of
carboxymethylcellulose, wherein the carboxymethylcellulose is
present from about 0.5% by weight of the solution to about 5%
by weight of the solution.

According to an aspect of the above embodiment, the
precipitating composition is a solution of an acrylic polymer
based on at least one of methyl methacrylate, hydroxyethyl
acrylate, hydroxyethyl methacrylate, glyceryl acrylate, glyceryl
methacrylate, acrylic acid, methacrylic acid, acrylamide, or
methacrylamide, and combinations thereof.

According to an aspect of the above embodiment, the
precipitation composition solution includes a solvent selected
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from the group consisting of acetone, ethyl acetate, dimethyl
ether, and combinations thereof.

(Emphasis added). Furthermore, Appellant’s Specification discloses that
Dissolved oxidized cellulose may also be utilized to form in situ
gels. Oxidized cellulose solution may be prepared using the
methods, e.g., solvents, conditions, etc., outlined above. The
oxidized cellulose solution may have a pH from about 7.0 to
about 10.0, in embodiments from about 8.0 to about 9.5. The
oxidized cellulose solution may be combined with a gelation
composition that, upon contacting the oxidized cellulose
solution, forms a gel.

Spec. ¶ 272 (emphasis added).
Given these disclosures, and mindful that the broadest reasonable
definition of the term must be consistent with the Specification, we can
define the claim term “precipitating composition” as meaning “any
composition, including at least those listed in paragraphs [0106]–[0109],
which, when combined with oxidized cellulose, causes it to precipitate in the
form of a gel.” See, e.g., ¶ 279 (the “oxidized cellulose precipitates out in
the form of a gel”), see also, e.g., ¶ 283.
The Examiner states that:
[T]he Blaskovich et al[.] patent teach[es] mixing of a
macromolecule solution which can be oxidized cellulose and
crosslinker solution to produce a hydrogel, which can be done in
situ (see 6th paragraph of column 1, 3rd and 5th paragraphs of
column 4), for example by injecting in two chambers of a dual
syringe. The process of crosslinking the macromolecule to form
a gel can reasonably be interpreted as falling under the definition
of precipitating or gelation as recited in Claims 25 and 38 as well
as crosslinking, since it results in the formation of a gel.

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Ans. 6. We agree. With respect to the formation of the hydrogels,
Blaskovich teaches that:
In embodiments, components which may be utilized for foaming
hydrogels…. These precursor(s) may form “in situ”, meaning
formation occurs in a living animal or human body. In general,
this may be accomplished by utilizing precursors that can be
activated at the time of application to tissue to form an in situ
forming material, in embodiments a hydrogel.

Blaskovich col. 2, ll. 2 31–39. More specifically, Blaskovich teaches that:
In embodiments the hydrogel may be formed from single
precursors or multiple precursors. For example, where the
hydrogel is formed from multiple precursors, for example two
precursors, the precursors may be referred to as a first and second
hydrogel precursor. The terms “first hydrogel precursor” and
“second hydrogel precursor” each mean a polymer, functional
polymer, macromolecule, small molecule, or crosslinker that can
take part in a reaction to form a network of crosslinked
molecules, e.g., a hydrogel.

Id. at col. 4, ll. 24–33 (emphasis added). We conclude that a person of
ordinary skill in the art would recognize that the first or second precursor
molecules that “take part in a reaction to form a network of crosslinked
molecules, e.g., a hydrogel,” would correspond to a “precipitating
composition” under the broadest reasonable definition of the term consistent
with Appellant’s Specification, and as we have construed it supra.
We acknowledge the Examiner’s finding that Gehrke neither teaches
nor suggests the use of oxidized cellulose as a polymer. However,
Blaskovich teaches that:
The first and second hydrogel precursors may have biologically
inert and water soluble cores. When the core is a polymeric
region that is water soluble [i.e., a hydrogel], suitable polymers
that may be used include: polyethers, for example, polyalkylene
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oxides such as polyethylene glycol (“PEG”),…
carboxymethylcellulose, oxidized cellulose, hydroxyethyl-
cellulose, hydroxymethylcellulose, ….

Blaskovich col. 4, ll. 54–65 (emphasis added). We agree with the Examiner
that a person of ordinary skill would have found it obvious to substitute
oxidized cellulose for the cellulose polymer ethers taught by Gehrke. See
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (holding that “[t]he
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results”; see also id. at
417 “If a person of ordinary skill can implement a predictable variation, §
103 likely bars its patentability”). In this instance, the substitution of
oxidized cellulose for the other cellulose ethers does no more than result in a
predictable end, viz., the formation of a hydrogel, a species of gel.
We consequently conclude that the combined cited prior art teaches or
suggests the disputed limitation, and we affirm the Examiner’s rejection of
the claims.

CONCLUSION
The Examiner’s rejection of claims 25–27, 32–34, 38–42, 49, and 51
under 35 U.S.C. § 103 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R. §
1.136(a)(1)(iv).
AFFIRMED

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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
25–27, 32–
34, 38–42,
49, 51
103 Gehrke,
Blaskovich,
Hubbard

25–27,
32–34,
38–42, 49,
51