Ex Parte Fitzgerald et al

Patent Trial and Appeal Board

Jan 4, 2019

13509035 (P.T.A.B. Jan. 4, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/509,035
90041 7590
Covidien LP
ATTN: IP Legal
5920 Longbow Drive
Mail Stop A36
05/10/2012
01/08/2019
Boulder, CO 80301-3299
FIRST NAMED INVENTOR
Rebecca C. Fitzgerald
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.
P034.WO.US (78704 ... ) 3046
EXAMINER
KREMER, MATTHEW
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
01/08/2019 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):
covidien@hollandhart.com
rs. patents. two@medtronic.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REBECCA C. FITZGERALD,
SUNI SUDARSHAN R. KADRI, and PIERRE LAO-SIRIEIX
Appeal2017-010225
Application 13/509,035
Technology Center 3700
Before JEFFREY N. FREDMAN, RYAN H. FLAX, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
swallowable cell sampling device. The Examiner rejected the claims as
indefinite, as obvious, and under the grounds of obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
1 The Real Party in Interest is identified as "Medtronic Inc." (see App. Br.
2).
2 We have considered and herein refer to the Specification of May 10, 2012
("Spec."); Final Office Action of Oct. 27, 2015 ("Final Act."); Appeal Brief
of Mar. 22, 2016 ("Br."); and Examiner's Answer of July 28, 2016 ("Ans.").
Appeal2017-010225
Application 13/509,035
"[T]he invention relates to a cell collection device for sampling cells
lining the oesophagus" (Spec. 1 :5-6).
Known devices typically operate by swallowing the abrasive
material in a compressed or stowed format. Upon reaching the
stomach cavity, the material retaining the device in a
compressed or stowed format is dissolved or weakened,
permitting expansion of the compressed material back to its
original size. Following this stage the device is then retrieved
by physically pulling it from the subject's mouth. This pulling
causes the device to travel out of the stomach cavity back up
through the oesophagus and out through the patient's buccal
cavity and mouth. In travelling along the subject's oesophagus,
cells from the oesophageal lining are collected in the abrasive
material part of the device.
(Id. at 1: 16-24). However, "known devices have typically had a cotton cord
attached as the means of retrieval. This is a problem since cotton cords can
shed fibres inside the subject. ... Furthermore, the known device has
suffered from the problem of loss inside the subject being sampled" (id. at
1 :30-35). Also, "known devices can be difficult to swallow due to friction
of the cord on the oropharynx" (id. at 1:36-37).
The Claims
Claims 1--4 and 6-17 are on appeal. Claim 1 is the sole independent
claim, is representative, and reads as follows:
1. A swallowable cell sampling device comprising:
an abrasive and sponge-like material capable of
collecting cells from a surface of a human esophagus;
a means for retrieval comprising a cord;
an attachment loop formed by looping the cord around a
central portion of the abrasive material; and
a hitch knot adjustably securing the attachment loop such
that during retrieval of the cell sampling device, tightening of
the attachment loop compresses the central portion of the
2
Appeal2017-010225
Application 13/509,035
abrasive material while an outer diameter of the abrasive
material remains substantially constant.
The Rejections
A. The Examiner rejected claims 1--4 and 6-17 under 35 U.S.C. § 112,
second paragraph as indefinite (Final Act. 3--4 ).
B. The Examiner rejected claims 1, 3, 4, 6-12, and 15 under 35 U.S.C.
§ I03(a) as obvious over Fitzgerald3 and Steiner4 (Final Act. 4--7).
C. The Examiner rejected claims 1, 3, 4, 6-12, and 15 under 35 U.S.C.
§ I03(a) as obvious over Fitzgerald and Henderson5 (Final Act. 8-11).
D. The Examiner rejected claims 1--4, 6-12, and 15 under 35 U.S.C.
§ I03(a) as obvious over Fitzgerald and Anderson6 (Final Act. 11-15).
E. The Examiner rejected claims 13 and 16 under 35 U.S.C. § I03(a) as
obvious over Fitzgerald, Steiner, and Williams 7 (Final Act. 15).
F. The Examiner rejected claims 14 and 17 under 35 U.S.C. § I03(a) as
obvious over Fitzgerald, Steiner, Mattson, 8 and Smith9 (Final Act. 15-16).
G. The Examiner rejected claims 13 and 16 under 35 U.S.C. § I03(a) as
obvious over Fitzgerald, Henderson, and Williams (Final Act. 16-17).
H. The Examiner rejected claims 14 and 17 under 35 U.S.C. § I03(a) as
obvious over Fitzgerald, Henderson, Mattson, and Smith (Final Act. 17).
3 Fitzgerald et al., WO 2007/045896 Al, published Apr. 26, 2007.
4 Steiner, US 2005/0177938 Al, published Aug. 18, 2005.
5 Henderson et al., US 2003/0234523 Al, published Dec. 25, 2003.
6 Anderson et al., US 3,593,369, issued July 20, 1971.
7 Williams et al., US 2004/0033502 Al, published Feb. 19, 2004.
8 Mattson et al., US 2003/0130235 Al, published July 10, 2003.
9 Smith, US 2004/0146907 Al, published July 29, 2004.
3
Appeal2017-010225
Application 13/509,035
I. The Examiner rejected claims 13 and 16 under 35 U.S.C. § 103(a) as
obvious over Fitzgerald, Anderson, and Williams (Final Act. 17-18).
J. The Examiner rejected claims 14 and 17 under 35 U.S.C. § 103(a) as
obvious over Fitzgerald, Anderson, Mattson, and Smith (Final Act. 18).
K. The Examiner rejected claims 1, 3, 4, 6-12, and 15 on the ground of
nonstatutory double patenting as being unpatentable over claims 6 and 11 of
U.S. Patent No. 8,709,736 with Fitzgerald, Steiner, Henderson (Final Act.
20-24).
L. The Examiner rejected claims 1--4, 6-12, and 15 on the ground of
nonstatutory double patenting as being unpatentable over claims 6 and 11 of
U.S. Patent No. 8,709,736 with Fitzgerald and Anderson (Final Act. 25-29).
A. 35 USC§ 112, second paragraph
The Examiner finds:
The term "substantially constant" in claim 1, line 10 is a
relative term which renders the claim indefinite. The term
"substantially" is not defined by the claim, the specification
does not provide a standard for ascertaining the requisite
degree, and one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention.
(Final Act. 4 ).
Appellants contend:
[T]he claim limitation "an outer diameter of the abrasive
material remains substantially constant" is definite because the
specification provides a standard for measuring the allowable
degree of variation such that one of ordinary skill in the art
would be able to determine the scope of the claim. In
particular, the Specification explains that "the lateral diameter
of the abrasive material remains substantially constant and
therefore remains effective in sampling the cells of the
4
Appeal2017-010225
Application 13/509,035
eosophagus [sic] during retrieval." Specification, p. 6,
11. 33-35. Thus, effective cell sampling is the standard by
which characteristics of the abrasive material, such as the
variance in diameter and level of abrasiveness, are to be
measured.
(Br. 13).
We agree with Appellants that the phrase "substantially constant" is
not indefinite because the relative term "substantially" does not render the
claim scope unclear to one skilled in the art. As noted above by Appellants,
the Specification describes the parameters necessary for a "substantially
constant" outer diameter as being constant enough to sample esophageal
cells during retrieval of the abrasive material (see Spec. 6:31-35). A person
of skill in the art would understand that the claim term is reasonably
interpreted to allow some degree of change in the diameter of the abrasive
material so long as the device remains effective to sample esophageal cells.
"This court has repeatedly confirmed that relative terms such as
'substantially' do not render patent claims so unclear as to prevent a person
of skill in the art from ascertaining the scope of the claim." Deere & Co. v.
Bush !log, 703 F.3d 1349, 1359 (Fed. Cir. 2012). We therefore reverse this
rejection.
B.-L. Obviousness and Obviousness-type double patenting
Because the same issue of analogous art is relevant to each of these
rejections, we will consider these rejections together.
The issue with respect to these rejections is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the knots of
5
Appeal2017-010225
Application 13/509,035
Steiner, Henderson, or Anderson are reasonably pertinent to the swallowable
abrasive device of Fitzgerald?
Findings of Fact
1. Fitzgerald teaches "a kit comprising a swallowable device
comprising abrasive material capable of collecting cells from the surface of
the oesophagus ... wherein said swallowable device comprises withdrawal
means such as string" (Fitzgerald 8: 10-30).
2. Fitzgerald teaches "cord is stitched into the material so that it
can be retrieved after swallowing. . . . The cord and stitching is sufficiently
strong and resistant to digestion so that it can be used to retrieve the device
after expansion" (Fitzgerald 30:13-19).
3. Figure 1 A of Steiner is reproduced below:
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