Ex Parte Falcone et al

Patent Trial and Appeal Board

Oct 28, 2015

11998048 (P.T.A.B. Oct. 28, 2015)

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.
11/998,048 11/28/2007 Samuel J. Falcone FZIO-01102US0 4703
66936 7590 10/28/2015
BORSON LAW GROUP, PC
1078 CAROL LANE, #200
LAFAYETTE, CA 94549
EXAMINER
YOON, TAE H
ART UNIT PAPER NUMBER
1762
MAIL DATE DELIVERY MODE
10/28/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SAMUEL J. FALCONE and RICHARD A. BERG
____________

Appeal 2014-002163
Application 11/998,048
Technology Center 1700
____________

Before JEFFREY T. SMITH, KAREN M. HASTINGS, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

COLAIANNI, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

This is an appeal under 35 U.S.C. § 134 from a final rejection of
claims 16–19, 21–24, and 26–28. We have jurisdiction under 35 U.S.C. § 6.
We AFFIRM.
Appellants’ invention is directed to a method of using a polyethylene
glycol (PEG)/carboxymethylcellulose (CMC) composition. App. Br. 4–5.
Claim 16 is illustrative of the subject matter on appeal and is reproduced
below:
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16. A method of using a PEG/CMC composition,
comprising the steps:

providing a PEG/CMC composition comprising

a carboxymethyl cellulose having an average
molecular weight of about 700 kD or greater (CMC-A);
and

a polyethylene glycol (PEG) having a molecular
weight between about 500 Daltons and about 8000
Daltons, and having two epoxide moieties, said PEG
linked to said CMC-A via an addition reaction of said
epoxide moiety to a carboxyl or an alcohol moiety of said
CMC-A forming a cross-linked PEG/CMC-A
composition soluble in physiologically compatible
aqueous medium having a carboxymethyl
anhydroglucose unit (CMAG) to epoxide (EP) ratio of
between about 3.6 and about 14.3, said composition,
when in a 3% (wt./vol/) aqueous solution, has a tan δ of
<0.5 throughout the frequency range of about 1.0 rad/sec
to about 70 rad/sec; and

introducing said composition into a portion of a subject's
body in need thereof.

Appellants (App. Br. 4) request review of the following rejections
from the Examiner’s Final Action:
I. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
II. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 112, first paragraph, as failing to provide an enabling disclosure for all of
kinds of pressure sensitive and heat sensitive adhesives as claimed.
III. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 112, second paragraph, as being indefinite for failing to particularly point
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out and distinctly claim the subject matter which applicant regards as the
invention.
IV. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 103(a) as unpatentable over Voigts (US 2007/0184087 A1, published
August 9, 2007).
V. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 103(a) as unpatentable over Voigts and Hunter (US 7,166,570 B2, issued
January 23, 2007).
VI. Claims 16–19, 21–24, and 26–28 rejected under 35 U.S.C.
§ 103(a) as unpatentable over Voigts and Chenite (US 7,098,194 B2, issued
August 29, 2006).

OPINION
Rejection under 35 U.S.C. § 112, first paragraph (written description)
(Rejection I)

We AFFIRM.
Independent claim16 is directed to a method of using a polyethylene
glycol (PEG)/ carboxymethylcellulose (CMC) composition having a specific
CMC component designated by Appellants as CMC-A, identified by
Appellants as Hercules CMC grade 7H PH lot # 82666. Spec. 7.
Independent claim 16 also requires the composition to have a tan δ of <0.5
throughout the frequency range of about 1.0 rad/s to about 70 rad/s.
The Examiner found the Specification provides no descriptive support
for the subject matter of claim 16 “tan δ of <0.5 throughout the frequency
range of about 1.0 rad/s to about 70 rad/s.” Final Act. 2. With respect to
claim 16, Appellants argue the disputed language is supported by Figures 6
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and 8.1 App. Br. 6. According to Appellants, curve B of Figure 6 shows a
dried composition of CMC-A/PEG having a ratio of CMAG/EP units of
3.57, when dissolved in aqueous medium, has a tan δ <0.4 over a frequency
range of about 1.0 rad/sec and about 70 rad/sec and the tan δ < 0.5 at all
frequencies tested. Id. Appellants also argue curve B of Figure 8 shows a
CMC-A/PEG composition having a ratio of CMAG/EP units of 3.6 and
having a tan δ below 0.5 at all frequencies between about 1.0 rad/sec and
about 70 rad/s. Id.
We are unpersuaded by these arguments and agree with the
Examiner’s finding that the Specification fails to provide descriptive support
for the disputed language of independent claim 16. Ans. 6. As noted by the
Examiner, the Specification as originally filed does not support a tan δ range
of less than 0.5. Final Act. 3; Ans. 6–8. Specifically, curves B and C of
Figure 8, representative of the claimed compositions, only show data starting
at a tan δ of 0.3. Spec. 40. There is no disclosure of data for tan δ values
between 0.2 and 0.3, much less 0.0–0.3, in either Figures 6 or 8. Further,
Appellants do not direct us to any portion of the Specification providing
descriptive support for the entire claimed range of tan δ values. See Appeal

1 As noted, claim 16 is limited only to the use of CMC-A as the CMC
component of the PEG/CMC composition. Appellants rely on Figures 3, 6,
8, 10, and 14 to show support for the disputed language in claim 16. App.
Br. 6. Of these, only Figures 3, 6, and 8 relate to CMC-A containing
compositions. Spec. 37, 39, 40. Figures 10 and 14 relate to other CMC
components, CMC-B and CMC-C, respectively. Id. at 41, 44. Further,
while Figure 3 is directed to CMC-A containing compositions, Appellants
do not discuss the significance of this evidence with respect to the subject
matter of claim 16 in the Appeal Brief. See Appeal Brief, generally. Thus,
we limit consideration of Appellants’ arguments with respect to only Figures
6 and 8.
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Brief, generally. Thus, one skilled in the art would be unable to ascertain
that the inventors were in possession of the claimed invention.
The Examiner additionally found no descriptive support for the
subject matter in claim 27 “said concentration of said composition in
solution being 3% wt./vol to 15% wt./vol.” Id. at 4. According to the
Examiner, the “3% wt./vol to 15% wt./vol” disclosed on page 21 of the
Specification is related only to the CMC-A component of the PEG/CMC
composition and not the PEG/CMC composition itself. Id.
Appellants do not address the Examiner’s rejection of claim 27 or
otherwise show reversible error with it. Ans. 6; see Appeal Brief, generally;
Final Act. 4.Accordingly we affirm the Examiner’s rejection of claims 16–
19, 21–24, and 26–28 under 35 U.S.C. § 112, first paragraph for the reasons
presented by the Examiner and given above.

Rejection under 35 U.S.C. § 112, first paragraph (enablement)
(Rejection II)

We AFFIRM.
The Examiner asserts that the Specification does not enable one
skilled in the art to make or use the invention because it does not adequately
describe the claimed range of tan δ values of <0.5. Final Act. 4–5.
Appellants rely principally on data presented in Figure 10 in
addressing the Examiner’s position. App. Br. 7. Figure 10 is directed to
compositions containing a CMC-B component, which is different from the
claimed compositions containing a CMC-A component. Spec. 7. For
example, the Specification discloses CMC-A has an average Mn of
~700,000 Da while CMC-B has an average Mn of 200,000 Da. Id. at 23.
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Appellants have not adequately explained why or how the data of Figure 10,
related to CMC-B containing compositions, addresses the enablement issues
raised by the Examiner with respect to CMC-A containing compositions.
Moreover, as noted by the Examiner, Appellants have not adequately
shown where the Specification supports the claimed language “tan δ of <0.5
throughout the frequency range of about 1.0 rad/s to about 70 rad/s.” Ans. 9.
Thus, Appellants have not adequately explained how the Specification
teaches those skilled in the art how to make and to use the full scope of the
claimed invention, that is, how to use a composition having the claimed
range of tan δ values of <0.5, without undue experimentation. In re Wands,
858 F.2d 731, 737 (Fed. Cir. 1988); see also In re Wright, 999 F.2d 1557,
1561 (Fed. Cir. 1993).
Accordingly we affirm the Examiner’s rejection of claims 16–19, 21–
24, and 26–28 under 35 U.S.C. § 112, first paragraph for lack of enablement
for the reasons presented by the Examiner and given above.

Rejection Under 35 U.S.C. § 112, 2nd Paragraph (Rejection III)
We AFFIRM.
The Examiner found the language "(wt./vol/)" in claim 16 unclear to
one skilled in the art. Final Act. 5.
Appellants argue one skilled in the art would know the meaning of all
of the objected terms in the rejected claims. App. Br. 8.
We are unpersuaded by this argument and agree with the Examiner’s
determination that the language “(wt./vol/)” in claim 16 is indefinite. Final
Act. 5. Appellants have not adequately explained why one skilled in the art
would understand the meaning of this disputed language. While Appellants
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refer to the Examples as showing volumetric and weight measures for
components (App. Br. 9; Spec. 36–38 (Example 1–2)), Appellants have not
adequately explained how these Examples provide a basis for understanding
the language "(wt./vol/)" in claim 16.
However, after consideration of the positions expressed by Appellants
and the Examiner, we agree with Appellants that one skilled in the art would
understand the meaning of the language “aqueous solution” and would know
how to prepare an aqueous solution for a given purpose. Final Act. 5–6;
App.Br. 8.
In addition, we agree with Appellants that claims 27 and 28 are not
indefinite because the claimed concentration is directed to the crosslinked
diepoxy-PEG/CMC-A composition and not the CMC-A component of the
composition. Final Act. 6; App. Br. 8–9. The Examiner found the language
indefinite because the disputed language lacks support in the Specification.
Final Act. 6. Such an issue is best addressed under the 35 U.S.C. § 112, first
paragraph written description requirement.
Accordingly, we affirm the Examiner’s rejection of claim 16 and its
dependent claims 17–19, 21–24, and 26–28 under 35 U.S.C. § 112, second
paragraph, based on the disputed language “(wt./vol/)” of independent claim
16 for the reasons presented above and given by the Examiner.

Prior Art Rejections IV–VI2

2 We address rejections IV–VI together given that Appellants only argued
the primary reference Voigts, common to all rejections. See Appeal Brief,
generally. Thus, we focus our discussion on Rejection IV with the
understanding that it also applies to Rejections V and VI. We limit our
discussion to independent claim 16.
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After review of the respective positions provided by Appellants and
the Examiner, we REVERSE the Examiner’s prior art rejections of claims
16–19, 21–24, and 26–28 under 35 U.S.C. § 103(a) (Rejections IV–VI) for
the reasons presented by Appellants.
The loss tangent (tan δ) is defined as the ratio of the loss modulus to
the storage modulus (G"/G') and is dimensionless. Voigts Abstract, ¶ 62. It
is a measure of the ratio of energy lost to energy stored in a cycle of
deformation and provides a comparative parameter that combines both the
elastic and the viscous contribution to the system. Id. A tan δ greater than 1
means the fluid is more liquid. A tan δ less than 1 means the fluid is more
solid. Id.
As noted above, independent claim 16 requires the composition to
have a tan δ of <0.5 throughout the frequency range of about 1.0 rad/s to
about 70 rad/s.
The Examiner found Voigts teaches a method of using a
polysaccharide gel composition in medical applications. Nonfinal Act. 43;
Voigts Abstract, ¶¶ 66, 67, 80, 85. The Examiner found Voigts discloses the
polysaccharide gel composition as a PEG/CMC composition where
polyethyleneglycol diglycidyl ether is used as a crosslinker. Nonfinal Act.
4; Voigts ¶¶ 66, 67, 78. The Examiner found Voigts teaches crosslinking
through the carbonyl or hydroxide functionality of the polysaccharide
backbone (CMC) with poly-functional epoxy compound such as
polyethylene glycol diglycidy ether (PEGDGE). Final Act. 10. The
Examiner found Voigts also teaches the tan δ of human vocal fold is 0.1-0.5.

3 All references to a Nonfinal Action in this decision are to the Nonfinal
Action dated February 8, 2012.
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Final Act 11; Voigts Table 1. The Examiner relied upon Figure 10 of Voigts
to find the disclosed tan δ of human vocal fold would be present at least at
the frequencies of 0.1 Hz (0.63 rad/s) to 10 Hz (63 rad/s). Final Act 11;
Voigts Figure 10, Example 10. The Examiner found the claimed invention
and Voigts are very similar other than the recited molecular weight of PEG
and the ratio of CMAG and EP. Final Act. 9. The Examiner found one of
ordinary skill in the art would have been able to choose the molecular weight
of PEG and ratio of CMAG and EP yielding the recited tan δ of 0.1-0.5
without undue experimentation. Id. at 11. Thus, the Examiner found it
would have been obvious to one skilled in the art to arrive to the claimed
invention given Voigts’ disclosure. Nonfinal Act. 4.
Relying on the Declaration under 37 C.F.R. § 1.132 of Samuel J.
Falcone, Ph.D. dated July 21, 2011, Appellants argue Voigts’ Examples 1–
14 and Figures 1–14 are directed to formulations containing CMC and not
CMC/PEGDGE crosslinked compositions. App. Br. 9–10; Decl. ¶ 17; Voigt
¶¶ 86–100.
We agree. We also note the Examiner agreed with Appellants’
arguments that Voigts’ Figures are not directed to CMC/PEGDGE
crosslinked compositions and, thus, found them to lack probative value.
Ans. 15. Yet, the Examiner’s rejection is premised on Voigts teaching the
tan δ of human vocal fold of 0.1-0.5 in Table 1 at the claimed range of
frequencies for the claimed PEG/CMC compositions based on Voigts’
Figure 10 and Example 10. Final Act 11; Voigts ¶¶ 80, 96. Given that the
Examiner has indicated that Voigts’ Figures, Figure 10 inclusive, lacks
probative value for reasons presented by Appellants (Ans. 15), the Examiner
has not adequately explained why one skilled in the art would have
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understood Voigts’ tan δ values of human vocal fold of 0.1-0.5 are measured
at the frequencies illustrated in Figure 10, much less at the claimed
frequency range of 1–70 rads/s. Moreover, the Examiner directs us to no
portion of Voigts that discloses the specific frequencies at which the tan δ
values of human vocal fold of 0.1-0.5 are measured. At best, Table 1 of
Voigts generally indicates that some measurements of Voigts’ tan δ values
of human vocal fold were taken at low frequencies and others at high
frequencies without providing any information as to what these frequencies
are. Thus, the Examiner’s reasoning for the rejection is not adequately
supported by Voigts.
Under these circumstances, we cannot conclude that the Examiner has
met the minimum threshold of establishing a prima facie case of obviousness
under 35 U.S.C. § 103(a). In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992).
Accordingly, we reverse the Examiner’s prior art rejections of claims
16–19, 21–24, and 26–28 under 35 U.S.C. § 103(a) (Rejections IV–VI) for
the reasons presented by Appellants and given above.

ORDER
The Examiner’s rejections of claims 16–19, 21–24, and 26–28 under
35 U.S.C. § 112, first paragraph (written description and enablement) are
affirmed.
The Examiner’s rejection of claims 16–19, 21–24, and 26–28 under
35 U.S.C. § 112, second paragraph is affirmed.
The Examiner’s prior art rejections of claims 16–19, 21–24, and 26–
28 under 35 U.S.C. § 103(a) are reversed.
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TIME PERIOD
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).

AFFIRMED

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