TARIS Biomedical LLC

Patent Trials and Appeals Board

Nov 20, 2020

2020003340 (P.T.A.B. Nov. 20, 2020)

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.
14/224,256 03/25/2014 Michael J. Cima 29449-0126 9174
29052 7590 11/20/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
OSINSKI, BRADLEY JAMES
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
11/20/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL J. CIMA and HEEJIN LEE
Appeal 2020-003340
Application 14/224,256
Technology Center 3700
Before DANIEL S. SONG, STEFAN STAICOVICI, and
ANNETTE R. REIMERS, Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–21, 24–31, 35, 36, and 38–41.2 We
have jurisdiction under 35 U.S.C. § 6(b). In addition to its Appeal Brief and

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). The Appellant identifies the real party in interest as Taris
Biomedical LLC. Appeal Br. 2.
2 The Appellant appeals claims 1–21 and 24–41, claims 22 and 23 having
been canceled by the Appellant. Appeal Br. 3. However, the double
patenting rejection of claims 32, 33, 34, and 37 has been withdrawn by the
Examiner, and these claims are not subject to another rejection. Ans. 15;
Reply Br. 3.
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Reply Brief, the Appellant also relies on a declaration filed under 37 C.F.R.
§ 1.132 by Christopher J. Cutie, M.D. A telephonic oral hearing was
conducted with the Appellant’s representative on November 10, 2020, a
transcript of which will be entered into the electronic record in due course.
We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed to an implantable device with intravesical
tolerability and methods of treatment. Claim 1, reproduced below, is
illustrative of the claimed subject matter:
1. A drug delivery device for deployment within the
bladder of a human patient which is well tolerated by the
patient, comprising:
an elongated elastic body comprising a first end, an
opposed second end, an annular portion disposed between the
first end and the second end, and a drug reservoir lumen defined
at least in part by the annular portion; and
a drug formulation loaded in the drug reservoir lumen,
the drug formulation comprising a drug,
wherein the device has a retention shape having
(i) dimensions that provide intravesical mobility and that
prevent voiding of the device through the urethra, and (ii)
dimensions, buoyancy, or both, that exclude the device from
entering the orifices of the ureters, wherein the retention shape
has a maximum dimension in any dimension of 6 cm or less
when in an uncompressed state, and wherein the device exerts a
maximum acting force less than 1 N when the device is
compressed from the retention shape to a shape having a
maximum dimension in any dimension of 3 cm.

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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Matsuura US 6,171,298 B1 Jan. 9, 2001
Yachia US 6,398,718 B1 June 4, 2002
Friedman US 2004/0260272 A1 Dec. 23, 2004
Rahe US 2006/0105010 A1 May 18, 2006
Lee US 2007/0202151 A1 Aug. 30, 2007
Cima US 9,586,035 B2 Mar. 7, 2017
REJECTIONS3
The Examiner rejects various claims under 35 U.S.C. § 103(a) as
follows:
1. Claims 1, 3, 5–11, 13–21, and 24–30 as unpatentable over Lee.4
Final Act. 3.
2. Claim 4 as unpatentable over Lee in view of Friedman. Final Act.
10.
3. Claims 2 and 12 as unpatentable over Lee in view of Matsuura.
Final Act. 10.
4. Claims 31, 35, 36, 38, and 39 as unpatentable over Lee in view of
Rahe. Final Act. 11.
5. Claims 40 and 41 as unpatentable over Lee in view of Matsuura
and Yachia. Final Act. 12.

3 As noted, the Examiner’s non-statutory double patenting rejection of
claims 1–21 and 24–41 has been withdrawn. Ans. 15. The Examiner does
not further reject claims 32, 33, 34, and 37.
4 As noted, claims 22 and 23 have been canceled by the Appellant. Appeal
Br. 3.
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OPINION
Rejection 1: Claims 1, 3, 5–11, 13–21, and 24–30
The Examiner rejects claims 1, 3, 5–11, 13–21, and 24–30 as
unpatentable over Lee. Final Act. 3. As to independent claim 1, the
Examiner finds that Lee discloses a drug delivery device substantially as
claimed, but fails to disclose dimensions that allow for intravesical mobility
but prevents voiding through the urethra or entering the ureters, and further
fails to disclose the limitation
maximum dimension in any dimension of 6 cm or less when in
an uncompressed state, and wherein the device exerts a
maximum acting force less than 1 N when the device is
compressed from the retention shape to a shape having a
maximum dimension in any dimension of 3 cm.
Final Act. 4.
However, the Examiner finds that Lee discloses, inter alia, that the
retention device should be buoyant, avoid irritation of the trigone region of
the bladder, have a small size within 1–10 cm, and that “one skilled in the art
can select appropriate materials of construction and an appropriate structure
design for the device.” Final Act. 4, citing Lee ¶¶ 53–54, 95–96; quoting
Lee ¶ 54. Based on these findings, the Examiner concludes that it would
have been obvious to one of ordinary skill in the art to have modified the
device of Lee to have the claimed properties, including the dimensions as
claimed “since it has been held that where the general conditions of a claim
are disclosed in the prior art, discovering the optimum or workable ranges
involves only routine skill in the art.” Final Act. 5.
The Appellant disagrees with the rejection of claim 1 and argues that
“[t]he Examiner’s reliance on the doctrine of routine optimization is
improper because Lee does not recognize acting force as being a variable
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that affects a result of tolerability.” Appeal Br. 7 (emphasis omitted); see
also Appeal Br. 11. According to the Appellant, “[f]or purposes of
determining obviousness with respect to a claimed range of a particular
parameter, the parameter must be recognized as a result-effective variable
for achieving a particular result,” and that “[t]he Examiner has not
established that Lee even recognizes or discusses any particular variable as
affecting a particular result of tolerability.” Appeal Br. 9–10 (emphasis
omitted); see also Reply Br. 6.
To the extent that the Appellant is asserting that result effective
variable must be explicitly disclosed in the prior art of record, we disagree.
A person of ordinary skill understands the art of which the applied reference
is representative, and such understanding is not limited to the four corners of
the document applied. See In re Jacoby, 309 F.2d 513, 516 (CCPA 1962)
(an artisan must be presumed to know something about the art apart from
what the references disclose); Custom Accessories, Inc. v. Jeffrey-Allan
Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986) (“The person of ordinary
skill is a hypothetical person who is presumed to be aware of all the
pertinent prior art.”). In that regard, we also disagree with the Appellant’s
rebuttal assertion that general physics or other general knowledge cannot be
relied upon to support the conclusion of obviousness based on result
effective variable analysis. See Reply Br. 4.
Substantively, we agree with the Examiner that the device of Lee “has
to have acting force” because it
requires the device to move reversibly between both states
(compressed and uncompressed) and to move the device from
the uncompressed state to the compressed state (to allow for
delivery, such as via a catheter or needle) the user has exert a
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force which overcomes the acting force, meaning too high of an
acting force and the user won’t be able to move the device from
the uncompressed state to the compressed state.
Ans. 16. Nonetheless, we ultimately agree with the Appellant that “mere
recognition that a device that can return to an initial shape from a
deployment shape may exert a restoring force is not sufficient.” Appeal Br.
9.
Although the Examiner concludes that “discovering the optimum
workable range of Lee [is] routine as Lee would not function (due to a lack
of retainment in the intended location) without a sufficient acting force (not
be too pliable so as to be voided),” there is insufficient basis that such an
optimum workable range of Lee would have encompassed the dimensions or
the acting force claimed. Ans. 17. Whereas Lee does disclose an implant of
1–10 cm, it is silent as to the magnitude of the force required to implant the
device or retain the device in the bladder, and is silent as to the magnitude of
any such force during the course of compression within any given range of
dimensions, much less the 6 cm to 3 cm explicitly recited in claim 1.
The Examiner also finds that the workable range for restoring the
device to an uncompressed state, “at its lower end, will thus overlap with
Applicant’s claimed less than 1 N since Appellant is claiming all of the
workable range less than 1 N,” this finding is not dispositive. Ans. 16. The
recited force in claim 1 is that of compression force, and is not restoring the
device to an uncompressed state, and is explicitly for a range of dimensions,
i.e., from 6 cm to 3 cm. Ans. 16. Indeed, as the Appellant points out, the
claims “recite the maximum acting force (which is a threshold for the acting
force, and is different from an instantaneous value of the acting force itself)”
and “relate this threshold-the maximum acting force-to compression of the
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device from a maximum dimension associated with an uncompressed state
to a dimension associated with a compressed state.” Reply Br. 4–5
(emphasis omitted); see also Reply Br. 6 (“Instead of analyzing the
threshold (maximum acting force) in the context of the compressed and
uncompressed dimensions, the Examiner discusses ‘forces’ in isolation.”).
In summary, the Examiner’s reasoning based on the real need for the device
of Lee to be implanted and retained in the bladder, and be tolerable, does not
adequately account for the recited maximum acting force of 1 N when the
device is compressed from the retention shape of 6 cm to a shape having a
maximum dimension of 3 cm. Accordingly, we also generally agree with
the Appellant that the rejection appears to be based on impermissible
hindsight reconstruction. Appeal Br. 14; Reply Br. 10.
Therefore, in view of the above considerations, we reverse the
Examiner’s rejection of independent claim 1 and of claims 3, 5–11, 13–21,
and 24–30 that either ultimately depend therefrom, or recite substantively
the same limitations at issue. The Appellant’s remaining arguments based
on expectation of success is moot. Appeal Br. 14.
Rejections 2 and 3: Claims 2, 4, and 12
Claims 2, 4, and 12 depend from independent claim 1. The Appellant,
inter alia, relies on dependency on claim 1 for patentability of these claims,
and correctly argues that the Examiner’s application of Friedman or
Matsuura does not address the above noted deficiency of Lee. Appeal Br.
17–18. Accordingly, we reverse these rejections as well.
Rejection 4: Claims 31, 35, 36, 38, and 39
Claims 31, 35, 36, 38, and 39 depend from independent claim 30. The
Appellant, inter alia, relies on dependency on claim 30 for patentability of
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these claims, and correctly argues that the Examiner’s application of Rahe
does not address the above noted deficiency of Lee. Appeal Br. 19.
Accordingly, we reverse these rejections as well.
Rejection 5: Claims 40 and 41
The Appellant relies on substantively the same arguments submitted
relative to claim 1 in support of patentability of claim 40, which recites
substantively the same limitations at issue, and relies on dependency for
patentability of claim 41. Appeal Br. 20–23. Indeed, the Examiner’s
application of Matsuura and Yachia does not address the above noted
deficiency of Lee. Accordingly, we reverse this rejection of claims 40 and
41 as well.
CONCLUSION
The Examiner’s rejections are reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 5–11,
13–21, 24–
30
103(a) Lee 1, 3, 5–11,
13–21, 24–
30
4 103(a) Lee, Friedman 4
2, 12 103(a) Lee, Matsuura 2, 12
31, 35, 36,
38, 39
103(a) Lee, Rahe 31, 35, 36,
38, 39
40, 41 103(a) Lee, Matsuura,
Yachia
40, 41
Overall
Outcome
1–21, 24–
31, 35, 36,
38–41
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REVERSED