Ex Parte Fukumoto et al

Patent Trials and Appeals Board

Jun 3, 2019

13504989 - (D) (P.T.A.B. Jun. 3, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/504,989 07/10/2012 Takumi Fukumoto
33432 7590 06/03/2019
KIL YK & BOWERSOX, P.L.L.C.
400 HOLIDAY COURT
SUITE 102
WARRENTON, VA 20186
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.
3190-178 7423
EXAMINER
MARMOR II, CHARLES ALAN
ART UNIT PAPER NUMBER
3791
MAIL DATE DELIVERY MODE
06/03/2019 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
Exparte TAKUMI FUKUMOTO, TSUTOMU OBATA,
YOSHITAKA TAGAMI, EIICHI UEMURA, and
MICHIKO MANABE1
Appeal2017-009755
Application 13/504,989
Technology Center 3700
Before BENJAMIN D. M. WOOD, BRETT C. MARTIN, and
ANNETTE R. REIMERS, Administrative Patent Judges.
1 Appellants state that the real parties in interest are National University
Corporation Kobe University, Kanai Juyo Kogyo Co., Ltd., and Alfresca
Pharma Corporation. App. Br. 3.
Appeal2017-009755
Application 13/504,989
WOOD, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134 from a rejection of claims 1-
5, 10, 11, and 21-24. An oral hearing in accordance with 37 C.F.R. § 41.47
was held on May 21, 2019. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
THE INVENTION
The claims are directed to a spacer for protecting non-target tissue
during ionizing radiation therapy. Sole independent claim 1, reproduced
below, is illustrative of the claimed subject matter:
1. A method of avoiding exposure of a non-target
tissue adjacent a target tissue subject to
ionizing radiation therapy comprising:
placing a spacer between the target tissue
and the non-target tissue, wherein at placing,
the spacer comprising a fiber assembly
obtained by three-dimensionally entangling a
fibrous material formed of a biocompatible
synthetic polymeric material wherein the fiber
assembly includes voids and optionally
aqueous liquid absorbed therein before the
placing;
allowing the spacer to absorb aqueous
liquid after the placing if not absorbed therein
before the placing, wherein after the placing
and the allowing the spacer consisting of a
fiber assembly obtained by three-
dimensionally entangling a fibrous material
2
Appeal2017-009755
Application 13/504,989
formed of a biocompatible synthetic polymeric
material wherein the fiber assembly having
voids therein which store the absorbed aqueous
liquid, wherein the spacer absorbs the aqueous
liquid to provide an aqueous liquid content of
at least 90 wt.% based on the combined dry
weight of the spacer and the weight of the
aqueous liquid contained by the spacer; and
performing ionizing radiation therapy on
the target tissue after the placing and the
allowing.
3
Appeal2017-009755
Application 13/504,989
Richter
Strong
Butterworth
Francescatti
Porto
Popowski
Cuypers
REFERENCES
us 3,961,629
us 5,523,134
us 5,648,141
US 7,726,318 B2
US 8,343,135 B2
US 8,696,539 B2
US 2009/0075542 Al
REJECTIONS
June 8, 1976
June 4, 1996
July 15, 1997
June 1, 2010
Jan. 1, 2013
Apr. 15, 2014
Mar. 19, 2009
Claims 1-5, 10, 11, and 21-24 are rejected under pre-AIA 35 U.S.C.
§ 112, second paragraph, as indefinite.2
Claims 1-5 and 21 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Francescatti, Butterworth, and Richter. 3
Claim 10 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Francescatti, Butterworth, Richter, and Porto.
Claim 11 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Francescatti, Butterworth, Richter, and Cuypers
Claim 22 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Francescatti, Butterworth, Richter, and Strong.
Claims 23 and 24 are rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Francescatti, Butterworth, Richter, and Popowski.
2 Because Appellants' application was filed before September 16, 2012, the
effective date of the amendments to 35 U.S.C. § 112 enacted by the Leahy-
Smith America Invents Act (AIA), we apply the pre-AIA version of the
statute. See AIA, Pub. L. No. 112-29, § 4(e), 125 Stat. 284,297 (2011).
3 Because Appellants' application was filed before March 16, 2013, the
effective date of the amendments to 35 U.S.C. § 103 enacted by the AIA, we
apply the pre-AIA version of§ 103. Pub. L. No. 112-29, § 3(n)(l), 125
Stat. 284, 293 (2011 ).
4
Appeal2017-009755
Application 13/504,989
ANALYSIS
Claims 1-5, 10, 11, and 21-24-Rejected as Indefinite
Claim 1
For independent claim 1, the Examiner determines that the step of
"performing ionizing radiation therapy on the target tissue after the placing
and the allowing" renders claim 1 indefinite because "'the allowing,' refers
to a step recited as a conditional limitation." Ans. 2. According to the
Examiner, "the claim language suggests that the steps of allowing the spacer
to absorb aqueous liquid, and, therefore, the step of performing ionizing
radiation therapy, are required only if aqueous liquid is not absorbed before
placing the spacer between the target tissue and the non-target tissue." Id. at
2-3. Appellants respond that "[t]he claim step of 'allowing the spacer to
absorb aqueous liquid' has a natural and reasonable construction as applying
to either the 'after the placing option or the 'before the placing' option
recited in the claim." Reply Br. 3.
We agree with the Examiner that the "allowing" step is conditional, in
that allowing the spacer to absorb aqueous liquid is required only if aqueous
liquid is not absorbed in the spacer before the spacer is placed between
target tissue and non-target tissue. We further agree with the Examiner that,
because the step of performing ionizing radiation therapy is done "after the
placing and the allowing," this performing step must also be conditional: it
is not required if the allowing step is not performed. In fact, claim 1 is
sufficiently clear in this regard that we decline to sustain the Examiner's
indefiniteness rejection of claim 1. See Nautilus, Inc. v. Biosig Instruments,
Inc., 572 U.S. 898, 910 (2014) (holding that to satisfy the definiteness
requirement of 35 U.S.C. § 112, second paragraph, "a patent's claims,
5
Appeal2017-009755
Application 13/504,989
viewed in light of the specification and prosecution history, [must] inform
those skilled in the art about the scope of the invention with reasonable
certainty").
Appellants' interpretation of the claim, that the "allowing" step
applies to either before or after the placing step, is contrary to the express
claim language. Claim 1 specifically recites that "allowing the spacer to
absorb aqueous liquid" occurs "after the placing," so the allowing step refers
to the absorption of liquid after the placing step, not before.
Claim 22
Claim 22 depends from claim 1 and additionally recites "wherein the
allowing the spacer to absorb the aqueous liquid comprises absorbing the
aqueous liquid into the fiber assembly before the placing of the spacer
between the target tissue and the non-target tissue." The Examiner
determines that claim 22' s additional limitation "render[ s] the claim
indefinite, as it attempts to further limit claim 1 by allowing for absorption
before the placing, when the claim language already suggests that the only
condition under which the step is intended to be performed is when the
aqueous liquid is not absorbed before the placing." Ans. 12. We agree. It is
illogical on its face to include in the allowing step the condition that, if
present, excludes the allowing step from taking place. Therefore, we sustain
the Examiner's rejection of claim 22 as indefinite.4
4 For the rejection under 35 U.S.C. § 103, the Examiner interprets claim 1
"to intend that in instances wherein the aqueous liquid is absorbed in the
voids before placing, ionizing radiation is performed after the placing."
Final Act. 3. We do likewise.
6
Appeal2017-009755
Application 13/504,989
Claims 1-5 and 21-Unpatentability-
Francescatti, Butterworth, and Richter
The Examiner finds that Francescatti teaches all of the limitations of
claim 1, except that it does not teach, inter alia, that the spacer absorbs
aqueous liquid. Final Act. 4. The Examiner therefore relies on Butterworth
to teach a fiber assembly for placement in a body cavity that absorbs
aqueous liquid. Id. at 4-5.5 The Examiner determines that it would have
been obvious to modify Francescatti's patch so that it absorbs aqueous liquid
because Francescatti discloses "that patch structures appropriate where
spatial separation is desired can include non-woven fabrics of synthetic
materials, including fibrous materials that are biocompatible and practical in
use," and Butterworth' s debridement sponges "are formed of a non-woven,
biocompatible, synthetic fabric that is more resilient than cotton gauze when
wet, and tends to resist hardening during use, exhibiting capabilities superior
to a woven gauze sponge." Id. at 5 (citing Francescatti, 3:33-39;
Butterworth, 1:52-67, 2:9-20, 3:30-40).
Appellants respond that Francescatti teaches away from using woven
or non-woven fabrics for radiation shielding because it teaches such fabrics
are "appropriate where only padding or spatial separation is desired." App.
Br. 19-20 (quoting Francescatti, 3:33-39) (emphasis omitted). Appellants
further argue that Butterworth does not teach that its debridement sponge is
suitable for use in radiation therapy. Id. at 21-22.
We are not persuaded that one of ordinary skill in the art would have
had reason to combine Francescatti and Butterworth as the Examiner
5 Richter, which was relied on to teach the quantity of absorbed aqueous
liquid (Final Act. 6-7), is not material to this discussion.
7
Appeal2017-009755
Application 13/504,989
proposes. As Appellants note, Francescatti teaches using woven or non-
woven fabrics "where only padding or spatial separation is desired."
Francescatti, 3:33-39. Because Francescatti otherwise teaches a patch that
provides radiation shielding, teaching the use of woven or non-woven fabric
"only" for padding and spatial separation strongly implies that woven or
non-woven fabrics, by themselves, are not suitable for radiation shielding.
Further, neither Francescatti nor Butterworth teaches that the characteristics
that make Butterworth's sponge superior to a woven gauze sponge for
debriding and packing wounds-e.g., resisting hardening during use-would
be helpful in shielding radiation. To the extent that one of ordinary skill in
the art would have combined Francescatti's and Butterworth's teachings, we
are not persuaded that the resulting patch would be used in a process that
includes providing ionizing radiation therapy. Therefore, we do not sustain
the Examiner's rejection of claim 1, and claims 2-5 and 21, which
ultimately depend therefrom, as unpatentable over Francescatti, Butterworth,
and Richter.
Remaining Re} ections
The rejections of claims 10, 11, and 22-24, which ultimately depend
from claim 1, are based on the erroneous determination that claim 1 is
unpatentable over Francescatti, Butterworth, and Richter. Final Act. 8-11.
The additional references relied upon in those rejections do not cure the
deficiencies noted with respect to the rejection of claim 1. Id. Accordingly,
we do not sustain the rejections of claims 10, 11, and 22-24 under 35 U.S.C.
§ 103.
8
Appeal2017-009755
Application 13/504,989
DECISION
For the above reasons, we affirm the rejection of claim 22 under 3 5
U.S.C. § 112, second paragraph. We reverse the rejection of claims 1-5, 10,
11, 21, 23, and 24 under 35 U.S.C. § 112, second paragraph, and reverse the
rejectionofclaims 1-5, 10, ll,and21-24under35U.S.C. § 103.
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a). See 3 7 C.F .R.
§ l.136(a)(l )(iv).
AFFIRMED-IN-PART
9