Ex Parte Nyte

Patent Trial and Appeal Board

Jun 22, 2015

11232688 (P.T.A.B. Jun. 22, 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.
11/232,688 09/22/2005 Christopher Philip Nyte 187100/US 6287
7590 06/22/2015
WESTERN PATENT GROUP
6020 TonkowaTrail
Georgetown, TX 78628
EXAMINER
HOUSTON, ELIZABETH
ART UNIT PAPER NUMBER
3773
MAIL DATE DELIVERY MODE
06/22/2015 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 CHRISTOPHER PHILIP NYTE1
____________________

Appeal 2012-011869
Application11/232,688
Technology Center 3700
____________________

Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

HARLOW, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method and system for treatment of internal nasal valves. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1 According to Appellant, the Real Party in Interest is E. Antonio Mangubat
(App. Br. 3).
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STATEMENT OF THE CASE
Non-surgical methods of internal nasal valve repair may “reduce
morbidity, eliminate hospital stays, and shorten recovery periods” relative to
prior art surgical techniques (Spec. at 2 ¶ 6). The Specification teaches a
non-surgical treatment for internal nasal valve collapse that includes
“injecting a biomaterial filler into the internal nasal valve of the patient” to
increase the “internal nasal valve angle” (id. at 2 ¶ 7). The Specification
discloses that the “biomaterial filler may be a gel cartilage matrix” (id. at
2 ¶ 9).
Claims 1–7 and 10 are on appeal.2 Claim 1, the only independent
claim on appeal, reads as follows (emphasis added):
A method for treating an internal nasal valve of a
patient comprising, injecting a biomaterial filler
from a syringe and through a needle into the
internal nasal valve of the patient, said biomaterial
filler being present in a flowable state sufficient to
enable its passage from said syringe, through said
needle and into said internal nasal valve,
wherein the injected biomaterial filler in the
internal nasal valve increases an internal nasal
valve angle.
Claims 2–7 and 10, the remaining claims on appeal, each depend from
claim 1. The claims stand rejected as follows:
I. Claims 1–7 and 10 stand rejected under 35 U.S.C. § 112 first
paragraph as failing to comply with the written description requirement.
II. Claims 1–7 and 10 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hurbis3 and Krueger.4

2 The Examiner has withdrawn the rejection with respect to claims 8, 9, and
11 (Ans. 5).
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I.
Issue
The Examiner has rejected claims 1–7 and 10 under 35 U.S.C. § 112
first paragraph as failing to comply with the written description requirement.
The Examiner finds that the Specification does not disclose that “the
biomaterial filler is in a ‘flowable state’” (Ans. 2).
Appellant contends that repeated reference in the Specification to
“aliquots of biomaterial filler to be injected through a syringe . . . the
aliquots being expressed by volume in milliliters, and described as being
injected from a syringe through a needle” (App. Br. 7) demonstrates
possession of the claimed invention.
The issue presented is whether the Specification satisfies the written
description requirement as to the “said biomaterial filler being present in a
flowable state sufficient to enable its passage from said syringe, through said
needle and into said internal nasal valve” aspect of claim 1.
Principles of Law
The test for determining whether a specification is sufficient to
support a particular claim “is whether the disclosure of the application relied
upon ‘reasonably conveys to the artisan that the inventor had possession at
that time of the later claimed subject matter.’” Ralston Purina Co. v. Far-
Mar-Co, Inc., 772 F.2d 1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow,
707 F.2d 1366, 1375 (Fed. Cir. 1983)).

3 Hurbis, US 6,106,541, issued Aug. 22, 2000.
4 Krueger et al., US 6,899,105 B2, issued May 31, 2005 (hereinafter
“Krueger”).
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“It is not necessary that the application describe the claim limitations
exactly, but only so clearly that persons of ordinary skill in the art will
recognize from the disclosure that appellants invented processes including
those limitations.” In re Wertheim, 541 F.2d 257, 262 (CCPA 1976)
(citation omitted); see also Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d
1320, 1323 (Fed. Cir. 2000) (“In order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.”).
Analysis
We agree with Appellant that the Examiner has not pointed to
evidence or provided sound reasoning to show that the Specification fails to
satisfy the written description requirement for the “said biomaterial filler
being present in a flowable state sufficient to enable its passage from said
syringe, through said needle and into said internal nasal valve” aspect of
claim 1.
During the course of prosecution, claim 1, which recited a
“biomaterial filler” was amended to include the requirement “said
biomaterial filler being present in a flowable state sufficient to enable its
passage from said syringe, through said needle and into said internal nasal
valve” (see Aug. 31, 2011, Amendment at 2). Appellant entered this
amendment to traverse the Examiner’s obviousness rejection over Hurbis
and Krueger (id.).
We agree with Appellant that “the recitation of ‘flowable state’ in
claim 1 as it now reads does not introduce any new matter into the
Application, nor does the narrowing claim amendment that introduced
‘flowable state’ as a qualifier cause the specification to become lacking in its
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written description” (App. Br. 5). The Specification is replete with
references to a biomaterial filler that is “present in a flowable state sufficient
to enable its passage from said syringe, through said needle and into said
internal nasal valve,” as recited in claim 1. For example, the Specification
teaches that “[b]iomaterial fillers may include a gel cartilage matrix or
calcium hydroxylapatite (CaHA) filler material. . . . Biomaterial used in
embodiments of the present invention are injectable through a needle.”
(Spec. at 5 ¶ 22).
The Specification also discloses injecting biomaterial filler in
milliliter aliquots. For example, the Specification teaches, “[i]n another
embodiment of the present invention, biomaterial filler, such as CaHA gel, is
injected in small aliquots, e.g., 0.05 ml aliquots, at points along the upper
lateral cartilage and septum junction in order to produce a stiff scaffolding
effect similar to surgically placed septal or conchal cartilage grafting” (Spec.
at 6 ¶ 26).
We find that the Specification’s description of numerous examples of
using milliliter aliquots of gels for injection via needle and syringe in
performing the claimed method is sufficient to convey to a skilled artisan
that the inventor had possession of the subject matter set forth in claim 1.
See Ralston Purina, 772 F.2d at 1575.
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that claim 1 does not satisfy the written description
requirement. Because they depend from claim 1, the rejection of claims 2–7
and 10 is also reversed. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir.
1988).
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II.
Issue
The Examiner has rejected claims 1–7 and 10 under § 103(a) as being
obvious over Hurbis and Krueger. The Examiner finds that Hurbis discloses
every aspect of claim 1, except that it “is silent regarding the filler being
compressed in a needle” (Ans. 3). The Examiner finds, however, that
Krueger teaches “using a needle/syringe (col. 2, ll. 36-38) with a compressed
implant (Fig. 8)” to correct snoring (Ans. 3). The Examiner further finds
that
[i]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to use the needle of Krueger
to implant the filler of Hubris as Hubris uses something to
insert the implant/filler (col. 3, ll. 2-12) and using a needle for
implantation and compression is common in the art for
delivering compressed implants and aids in correct placement
of the implant/filler.
(Ans. 3.)
Appellant contends that there is no motivation to combine Hurbis and
Krueger. Appellant asserts that the Examiner failed to articulate any
reasoning or rational underpinning to support combining the cited
references. Appellant argues that the Hurbis “implants are in the solid, non-
flowable state, and are surgically implanted (col. 1, lines 52-53),” rather than
injectable (App. Br. 13). Appellant further asserts that it would be
physically impossible to inject the Hurbis implants through a needle and into
a patient’s internal nasal valve, and notes that “[t]he Hurbis specification is
devoid of the words ‘syringe’ and ‘needle’, and Hurbis’ implants are
inserted into patients using surgical techniques.” (Reply Br. 3.)
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The issue presented is whether the Examiner erred in rejecting claims
1–7 and 10 as being obvious because the combination of Hurbis and Krueger
is improper.
Principles of Law
While the analysis under 35 U.S.C. § 103 allows flexibility in
determining whether a claimed invention would have been obvious, KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418–419 (2007), it still requires
showing that “there was an apparent reason to combine the known elements
in the fashion claimed by the patent at issue.” Id. at 418.
Analysis
We agree with Appellant that the Examiner has not pointed to
evidence or provided sound reasoning that one skilled in the field at the time
of invention would have been motivated to combine Hurbis and Krueger.
In addressing the motivation to combine the cited references, the
Examiner found that
[i]t would have been obvious to one of ordinary skill in the art
at the time the invention was made to use the needle of Krueger
to implant the filler of Hubris as Hubris uses something to
insert the implant/filler (col. 3, II. 2-12) and using a needle for
implantation and compression is common in the art for
delivering compressed implants and aids in correct placement
of the implant/filler.
(Ans. 3.) The Examiner did not offer any additional analysis regarding the
motivation to combine Hurbis and Krueger in response to Appellant’s
nonobviousness arguments (see Ans. 5).
On this record, we agree with Appellant that the Examiner’s
motivation to combine the cited references is conclusory and falls short of
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the “articulated reasoning with some rational underpinning” required to
support a conclusion of obviousness. KSR, 550 U.S. at 418 (quoting In re
Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The Examiner has not
adequately identified the factual basis for concluding that a person having
ordinary skill in the field would reasonably have expected that the Hurbis
surgical implant could be inserted into a patient’s internal nasal valve using
Krueger’s needle. Neither has the Examiner adequately explained how the
cited teachings are to be combined to practice the claimed method. Indeed,
Appellant’s argument that “[g]iven the description in Hurbis in the second
paragraph of Hurbis’ Detailed Description section, [it is] apparent that the
needle of [Krueger] cannot place the implant of Hurbis in a patient in the
mechanically-biased fashion taught by Hurbis” stands unchallenged by the
Examiner. (App. Br. 15).
Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that the combination of Hurbis and Krueger renders
claim 1 obvious. Because they depend from claim 1, the rejection of claims
2–7 and 10 is also reversed. See In re Fine, 837 F.2d at 1076.

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SUMMARY
We reverse the rejection of claims 1–7 and 10 under 35 U.S.C. § 112
first paragraph for failure to comply with the written description requirement
We reverse the rejection of claims 1–7 and 10 under 35 U.S.C. § 103
based on Hurbis and Krueger.

REVERSED
cdc