Ex Parte MCCLOSKEY et al

Patent Trial and Appeal Board

Nov 30, 2018

14566956 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/566,956 12/11/2014 Jenny Colleen MCCLOSKEY
23552 7590 12/04/2018
MERCHANT & GOULD P.C.
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903
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.
13353.0llOFPDl 9311
EXAMINER
MEDWAY,SCOTTJ
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
12/04/2018 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):
USPT023552@merchantgould.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JENNY COLLEEN MCCLOSKEY and RICHARD ALAN FOX
Appeal 2018-004576
Application 14/566,956
Technology Center 3700
Before JENNIFER D. BAHR, MICHELLE R. OSINSKI, and
BRANDON J. WARNER, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jenny Colleen McCloskey ("Appellant") 1 appeals under 35 U.S.C.
§ 134(a) from the Examiner's decision rejecting claims 49 and 52-54. See
Br. 5. Claims 1-26, 50, and 51 have been canceled, and claims 27--48 have
been withdrawn. See id. We have jurisdiction over the appeal under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
Jenny Colleen McCloskey is the applicant, as provided in 37 C.F.R.
§ 1.46, and is identified as the real party in interest. Br. 3.
Appeal 2018-004576
Application 14/566,956
CLAIMED SUBJECT MATTER
Appellant's disclosed invention "relates generally to the inactivation
ofpapillomavirus." Spec., p. 1, 11. 15-16. Claim 49, reproduced below, is
the sole independent claim and is representative of the subject matter on
appeal.
49. An anal treatment apparatus for treatment of early
papillomavirus infection of an anal canal of a human body,
compnsmg:
a stem adapted for insertion along the anal canal, where
the anal canal comprises an inner end and an opposing outer
end, and further comprises an anorectal ring at the inner end
and an anal verge at the outer end;
an upper occlusion device and a lower occlusion device;
wherein the upper occlusion device is a fluid expandable
balloon carried by the stem that when expanded can occlude the
anorectal ring at the inner end of the anal canal;
wherein the lower occlusion device is a conical plug that
can occlude the anal verge at the outer end of the anal canal;
whereby the fluid expandable balloon when expanded
and the conical plug are spaced and dimensioned to effectively
engage and occlude the anorectal ring and anal verge,
respectively, whereby to define a treatment cavity in the anal
canal about the stem;
a passage in the stem that can deliver fluid to the balloon
to expand the balloon; and
another passage in the stem that can deliver to the
treatment cavity an effective amount of an agent for
inactivation of papillomavirus for application to the surfaces of
the anal canal bounding the treatment cavity.
2
Appeal 2018-004576
Application 14/566,956
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Elmore
Lary
Lazarovitz
us 3,916,897
US 2003/0120256 Al
US 6,716,252 B2
REJECTIONS
The following rejections are before us for review:
Nov. 4, 1975
June 26, 2003
Apr. 6, 2004
I. Claim 54 stands rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the written description requirement.
Final Act. 3--4.
II. Claims 49 and 53 stand rejected under 35 U.S.C. § I02(b) as
anticipated by Lazarovitz. Id. at 4--5.
III. Claim 52 stands rejected under 35 U.S.C. § I03(a) as being
unpatentable over Lazarovitz and Lary. Id. at 6.
IV. Claim 54 stands rejected under 35 U.S.C. § I03(a) as being
unpatentable over Lazarovitz and Elmore. Id. at 7.
ANALYSIS
Rejection I - Claim 54 as failing to comply with
the written description requirement
The stated basis for the Examiner's rejection under 35 U.S.C. § 112,
first paragraph, is that Appellant's Specification provides insufficient written
description support for "only the upper occlusion device is expandable," as
recited in claim 54. See Final Act. 4. The Examiner explained that "[t]he
3
Appeal 2018-004576
Application 14/566,956
[S]pecification does not disclose that the lower occlusion device is non-
expandable (or that only the upper occlusion device is expandable)." Id.
Appellant argues that "the [S]pecification and figures (particularly
page 8, lines 9-19 and Figure 2) clearly imply that the conical plug can be
non-expandable." Br. 15. Appellant asserts that the Specification describes
that the upper occlusion device is expandable, but "uses different terms to
describe a lower occlusion device ('conical plug')[,] and further explains
why it is not necessary for the lower occlusion device to be expandable." Id.
(citing Spec., p. 8, 11. 16-19). We are not persuaded by this argument.
The recitation in claim 54 that, "of the upper occlusion device and the
lower occlusion device, only the upper occlusion device is expandable," is
effectively a negative limitation (in other words, the lower occlusion device
is non-expandable) because it excludes the lower occlusion device from
being expandable. Our reviewing court has held that "[ n ]egative limitations
are adequately supported when the [S]pecification describes a reason to
exclude the relevant limitation." Santarus, Inc. v. Par Pharm., Inc., 694
F.3d 1344, 1351 (Fed. Cir. 2012).
Here, Appellant's Specification describes that "expansible
balloon 214 is ... expanded to a larger size to engage the anorectal ring 62
at the inner end of the anal canal 60." Spec., p. 8, 11. 11-12. The
Specification also describes that "outer occlusion means 216 is a conical
plug to engage the anal verge 64, having a handle 217 to prevent the device
being inserted too far." Id., 11. 15-16. Although the Specification explicitly
describes that expansible balloon 214 (i.e., upper occlusion device) is
expandable, the Specification is silent as to whether conical plug 216 (i.e.
lower occlusion device) is expandable, and does not describe any reason to
4
Appeal 2018-004576
Application 14/566,956
exclude conical plug 216 from being expandable. The Specification, at
most, describes a reason to exclude the use of conical plug 216 (i.e., a form
of artificial occlusion) at the anal verge. See id., 11. 16-17 (describing that
"[ a ]rtificial occlusion at the anal verge may not be necessary as the outer
orifice is generally self-closing").
With respect to Figure 2 of the Drawings, we are not persuaded by
Appellant's contention that this figure shows that conical plug 216 is non-
expandable. See Br. 15 ( asserting that "Figure 2 depicts a conical
plug (216), but shows no passage in stem (212) terminating inside the
conical plug (216)," and, thus, "the conical plug has no opening through
which an inflation fluid could be delivered in order to expand the plug").
Even if the depiction of conical plug 216 in Figure 2 does not include an
opening to deliver inflation fluid, the lack of such an opening does not
establish that conical plug 216 necessarily is non-expandable. Rather, as the
Examiner explains, "the lower occlusion device may still be expandable
even if it lacks an opening through which inflation fluid is conveyed, since
such devices can expand by numerous other means." Ans. 4. In this regard,
Appellant does not offer any evidence or persuasive technical reasoning to
refute the Examiner's position.
For the reasons discussed supra, Appellant does not apprise us of
error in the Examiner's finding that the disclosure of the Specification fails
to convey to those skilled in the art that Appellant had possession of the
subject matter of claim 54 as of the filing date, thereby failing to comply
with the written description requirement of 35 U.S.C. § 112, first paragraph.
See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
5
Appeal 2018-004576
Application 14/566,956
2010) (en bane). Accordingly, we sustain the Examiner's rejection of
claim 54 under 35 U.S.C. § 112, first paragraph.
Rejection II- Claims 49 and 53 as anticipated by Lazarovitz
Independent claim 49 recites, inter alia, that "the fluid expandable
balloon when expanded and the conical plug are spaced and dimensioned to
effectively engage and occlude the anorectal ring and anal verge,
respectively, whereby to define a treatment cavity in the anal canal about the
stem." Br. 29, Claims App. Appellant argues that "there is nothing in
Lazarovitz indicating that its urethral stent could successfully serve as an
anal treatment apparatus without modification[,] [a]nd[,] by asserting
otherwise, the Examiner is improperly relying on mere speculation
unsupported by the reference." Id. at 16; see also id. at 18 ( asserting that
"those of ordinary skill in the art would readily appreciate that an anal canal
substantially differs from a urethra at least in terms of the types of tissue that
are present and the diameter of the opening ( a urethra generally being far
narrower than an anal canal)"). For the reasons that follow, Appellant's
argument is persuasive of error.
In rejecting independent claim 49, the Examiner found that Lazarovitz
discloses, in relevant part, "an upper expandable occlusion device (fluid
expandable balloon 52; see also col. 10, line 60) carried by the stem (see
fig. 19A) that when expanded can occlude the anorectal ring at the inner end
of the anal canal," and "a lower occlusion device in the form of a conical
plug 22 that can occlude the anal verge at the outer end of the anal canal."
Final Act. 5. The Examiner found "the location and structure of these
elements [ to be] capable of being used functionally as claimed to define a
6
Appeal 2018-004576
Application 14/566,956
treatment cavity (see structure of fig. 19A)." Id. According to the
Examiner, "the claims recite an intended use of a treatment apparatus"
(Ans. 4 (underlining omitted)), and "[t]he Lazarovitz device would
expectedly be capable of performing the intended use of occluding the
claimed body portions" (id. at 6).
We disagree with the Examiner's interpretation that the claim
language regarding the expandable balloon and conical plug being spaced
and dimensioned to effectively engage and occlude the anorectal ring and
anal verge amounts to a recitation of intended use. See Ans. 4---6. Instead,
the claim language recites a functional limitation that the apparatus structure
must be capable of performing in its current state (i.e., without further
modification). It is not apparent, and the Examiner has not made sufficient
evidentiary findings, nor set forth adequate technical reasoning to explain,
how the apparatus of Lazarovitz would be capable, without modification, of
effectively engaging and occluding the anorectal ring and anal verge to
define a treatment cavity in the anal canal. In other words, the Examiner has
not established a reasonable basis that Lazarovitz is capable of performing
the claimed function of effectively engaging and occluding the anorectal
ring and anal verge, respectively, to define a treatment cavity in the anal
canal. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (holding
that once the PTO establishes a reasonable basis that the prior art is capable
of performing the claimed function, the burden shifts to the applicant to
show that the prior art structure is not capable of performing the claimed
function).
Accordingly, based on the record before us-because an anticipation
rejection requires a finding in a single reference of each and every limitation
7
Appeal 2018-004576
Application 14/566,956
as set forth in the claims-we do not sustain the rejection of independent
claim 49 and its dependent claim 53 under 35 U.S.C. § 102(b) as anticipated
by Lazarovitz.
Rejections III and IV- Claims 52 and 54 as unpatentable over
Lazarovitz and one of Lary and Elmore
Regarding Rejections III and IV, we note that these rejections are
premised on the same purported disclosure from Lazarovitz discussed above
for Rejection II, and the Examiner relied on Lary (Rejection III) and Elmore
(Rejection IV) for teaching additional features, but not to cure the above-
noted deficiency of Lazarovitz. See Final Act. 6-7. Accordingly, for the
same reasons, we likewise do not sustain the rejections of claims 52 and 54
under 35 U.S.C. § 103(a).
DECISION
We AFFIRM the Examiner's decision rejecting claim 54 under
35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement.
We REVERSE the Examiner's decision rejecting claims 49 and 53
under 35 U.S.C. § 102(b) as anticipated by Lazarovitz.
We REVERSE the Examiner's decision rejecting claim 52 under
35 U.S.C. § 103(a) as being unpatentable over Lazarovitz and Lary.
We REVERSE the Examiner's decision rejecting claim 54 under
35 U.S.C. § 103(a) as being unpatentable over Lazarovitz and Elmore.
8
Appeal 2018-004576
Application 14/566,956
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
9