Ex Parte Scampini et al

Patent Trial and Appeal Board

Jan 22, 2019

13738225 (P.T.A.B. Jan. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/738,225 01/10/2013 Steven A. Scampini
41696 7590 01/24/2019
VISTA IP LAW GROUP LLP
2160 Lundy Ave.
Suite 230
San Jose, CA 95131
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.
11.121011 us 7804
EXAMINER
MCCROSKY, DAVID J
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/24/2019 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):
nnr@viplawgroup.com
sp@viplawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN A. SCAMPINI
and RYAN P. OLIVA 1
Appeal2018-001315
Application 13/738,225
Technology Center 3700
Before MICHAEL L. HOELTER, LEE L. STEPINA, and
BRENT M. DOUGAL, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from the
Examiner's Non-Final Rejection of claims 1, 3, 8, 13, and 14. App. Br. 2.
We have jurisdiction under 35 U.S.C. § 6(b ). For the reasons explained
below, we REVERSE the Examiner's rejections of these claims.
THE CLAIMED SUBJECT MATTER
The disclosed subject matter pertains "to devices used for biological
specimen collection, and more particularly, to a swab assembly for
1 "The real party in interest in this appeal is Hologic, Inc .... " App. Br. 2.
Accordingly, for purposes of this appeal, we understand Ho logic, Inc. is the
Appellant.
Appeal2018-001315
Application 13/738,225
collecting a biological specimen from a urethra, a cervix, or the like." Spec.
,r 1. System claims 1 and 13, and method claim 8, are independent. Claim 1
is illustrative of the claims on appeal and is reproduced below.
1. A swab assembly for collecting a specimen from a
human urethra, comprising:
an elongated shaft having a proximal end and a distal
end, the elongated shaft having a notch therein between its
proximal and distal ends;
a sheath having a proximal end and a distal end, the
sheath defining a lumen extending between its proximal and
distal ends, wherein at least a portion of the elongated shaft is
disposed within the sheath lumen, and the sheath is slidable
relative to the elongated shaft, the sheath being sized and
shaped for insertion into a human urethra; and
a compressible collection tip coupled to the distal end of
the elongated shaft and configured for obtaining the specimen,
wherein the sheath is slidable between a first position in
which the shaft notch is disposed within the sheath lumen and
wherein the sheath protects the elongated shaft from breaking at
the notch, and a second position in which the shaft notch is
exposed out of the sheath lumen, and wherein the sheath does
not protect the elongated shaft from breaking at the notch,
wherein the collection tip is configured to be compressed
and positioned entirely within the sheath lumen during insertion
of the sheath into the urethra, and
wherein the collection tip expands when the collection tip
is exposed out of the sheath lumen when the sheath is
positioned at or near a specimen collection site within the
urethra.
REFERENCES RELIED ON BY THE EXAMINER
Marshall
Sak
Burg
us 4,027,658
us 5,787,891
US 2008/0077046 Al
2
June 7, 1977
Aug. 4, 1998
Mar. 27, 2008
Appeal2018-001315
Application 13/738,225
THE REJECTIONS ON APPEAL
Independent claims 1, 8, and 13, and the claims dependent therefrom,
are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with
the written description requirement.
Claims 1, 3, 8, 13, and 14 (i.e., all the claims) are rejected under pre-
AIA 35 U.S.C. § 103(a) as unpatentable over Marshall, Sak, and Burg.
ANALYSIS
The re} ection of independent claims 1, 8, and 13
as failing to comply with the written description requirement
The Examiner states that each of" [ c] laims 1, 8 and 13 recite 'a human
urethra'" and acknowledges that "[t]he specification uses the term 'urethra'
throughout." Non-Final Act. 2; see also Ans. 7. However, the Examiner
states that Appellant's Specification "does not refer to a human" and that the
"specification is not so specific as to describe collecting a specimen from a
human urethra." Non-Final Act. 2; Ans. 7. The Examiner states, "a swab is
used for collecting a specimen from urethrae that do not belong to humans"
in the prior art. Non-Final Act. 2; Ans. 7 (reference omitted). Thus, the
Examiner reasons:
A human urethra and the size and shape of the swab assembly
relative to the human urethra were not described in the
specification so as to reasonably convey to one skilled in the
relevant art that a joint inventor, at the time the application was
filed, had possession of the claimed invention.
Non-Final Act. 2-3; see also Ans. 7-8.
Appellant disagrees with this analysis referring "to the prior-submitted
Declaration of Damon Getman, Ph.D." App. Br. 4; see also Reply Br. 1-2.
One argument so presented is that when the Specification refers to a
"patient" (see Appellant's Specification generally), it "is universally
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Appeal2018-001315
Application 13/738,225
understood to mean a human subject seeking or receiving medical care."
App. Br. 5; Reply Br. 2; Deel. 2.
Appellant explains:
In addition, as stated in MPEP § 2163(II)(A)(3)(a) "if a
skilled artisan would have understood the inventor to be in
possession of the claimed invention at the time of filing, even if
every nuance of the claims is not explicitly described in the
specification, then the adequate description requirement is met.
See, e.g., Vas-Cath [Inc. v. Mahurkar], 935 F.2d [1555,] 1563,
19 USPQ2d at 1116 [(Fed. Cir. 1991)]; Martin v. Johnson, 454
F.2d 746,751, 172 USPQ 391,395 (CCPA 1972) (stating 'the
description need not be in ipsis verbis [i.e., "in the same
words"] to be sufficient')."
Reply Br. 2-3; see also App. Br. 4. Appellant thus concludes, "a skilled
artisan would have understood the inventor to be in possession of urethra
sampling instruments and methods to be used on human patients." Reply
Br. 3; see also App. Br. 4, 6.
The purpose of the written description requirement is to assure that
the public receives sufficient knowledge of the patented technology, and to
demonstrate that the patentee is in possession of the invention claimed. See
In re Skvorecz, 580 F.3d 1262, 1269 (Fed. Cir. 2009). There is no dispute
that Appellant's Specification is directed to swabbing a urethra of a
"patient." See, e.g., ,r,r 13-16 and 22-25. The question that remains is
whether the public has received sufficient knowledge to demonstrate that
Appellant was in possession of the swabbing of a "human" patient, as
presently claimed. We determine that it has.
For example, paragraph 2 of Appellant's Specification discusses the
Background of the claimed subject matter stating that swabs are currently
"used for the collection of specimens to test for sexually transmitted
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Appeal2018-001315
Application 13/738,225
diseases." See also Spec. ,r 13. We understand that this is a matter that
humans are particularly concerned with as is self-evident from a reading of
both general and more specialized literature. 2 Thus, from a review of
Appellant's Specification and the above guidance from our reviewing court,
we agree with Appellant that it would have been reasonable for one skilled
in the art to understand Appellant's discussion of swabbing a "patient"
("[t]he swab assembly 10 may be used for collecting cellular material that
may be used to test for sexually transmitted diseases" (Spec. 13)) to
encompass, or be directed to, a human patient.
Accordingly, and based on the above, the Examiner's repeated
assertion that "patient" might also refer to non-human patients (see Non-
Final Act. 2; Ans. 7), is not persuasive that Appellant lacked written
description support for the claims as presented. We reverse the Examiner's
rejection of independent claims 1, 8, and 13, and dependent claims 3 and 14,
for "failing to comply with the written description requirement." Non-Final
Act. 2.
The rejection of claims 1, 3, 8, 13, and 14
as unpatentable over Marshall, Sak, and Burg
Each independent claim, i.e., claims 1, 8, and 13, includes the
limitation of a collection tip and a sheath, with this collection tip being
configured to be compressed within the sheath. The Examiner primarily
relies on the teachings of Marshall for disclosing "a collection tip (13)" and
on Sak for teaching "wherein the collection tip is configured to be
2 An Internet search conducted January 14, 2019, and using the terms
"sexually transmitted diseases in humans" identified 16,200,000 results. A
different search engine identified about 71,700,000 results.
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Appeal2018-001315
Application 13/738,225
compressed and positioned entirely within the sheath." Non-Final Act. 3--4.
The Examiner reasons that it would have been obvious to combine the
teachings of Marshall and Sak "to protect the collection tip from touching
unwanted tissue until it is positioned at the collection site." Non-Final Act.
4 (referencing, e.g., Sak Figs. 7 and 8); Ans. 9. Appellant does not address
the teachings of Burg and thus we need not address the Examiner's reliance
on Burg for disclosing the recited notch. See Non-Final Act. 4--5.
Appellant addresses the compressibility of Marshall's tip 13 and also
states that "[n]o insertion sheath is provided or needed with Marshall's
solution." App. Br. 7. Appellant further addresses the fact that "the tip
taught by Marshall is not compressible." Reply Br. 4 (referencing Marshall
2:7-8 stating that tip 13 is "relatively inflexible"). Marshall further states
that the size of tip 13 is "preferably of about 3 mm, which is significantly
smaller than the average diameter of the male or female urethra of about 6
mm." Marshall 2:34--37. Appellant argues that not only is "the tip taught by
Marshall ... not compressible" but that "a sheath for compressing the tip is
not even necessary in the Marshall device" (Reply Br. 4) "or needed'' (App.
Br. 7).
Marshall clearly describes a tip that is "relatively inflexible" and
whose size is already about half that of a "male or female urethra." Marshall
2:7-8, 2:34--37. The Examiner does not make clear why one skilled in the
art would seek to compress Marshall's "relatively inflexible" tip when the
size of Marshall's tip is already more than adequate for insertion into a
urethra, as expressed in Marshall. Instead, the Examiner addresses a need to
protect the tip from contamination. Non-Final Act. 4; Ans. 9. However,
protecting a tip does not correlate to compressing a tip that is already
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Application 13/738,225
properly sized, and which has been described as being "relatively
inflexible." Instead, it appears the Examiner gleaned the need for
compression of the tip from Appellant's disclosure. See App. Br. 7; Reply
Br. 3.
As is well-known, "rejections on obviousness grounds cannot be
sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007) (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). The
Examiner's stated rationale lacks such articulated reasoning with rational
underpinning concerning the compressible tip, and as such, is insufficient to
support the legal conclusion of obviousness. We reverse the Examiner's
rejection of independent claims 1, 8, and 13, and also the rejection of
dependent claims 3 and 14, which are not separately argued.
DECISION
The Examiner's rejection of claims 1, 3, 8, 13, and 14 as failing to
comply with the written description requirement is reversed.
The Examiner's art rejection of claims 1, 3, 8, 13, and 14 is reversed.
REVERSED
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