DiPIERRO, Guy

Patent Trials and Appeals Board

Dec 23, 2019

15385665 - (D) (P.T.A.B. Dec. 23, 2019)

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.
15/385,665 12/20/2016 Guy DiPIERRO 13164-702.306 6496
66854 7590 12/23/2019
SHAY GLENN LLP
2755 CAMPUS DRIVE
SUITE 210
SAN MATEO, CA 94403
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/23/2019 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):
info@shayglenn.com
shayglenn_pair@firsttofile.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte GUY DIPIERRO1
____________

Appeal 2019-005188
Application 15/385,665
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Chrono Therapeutics Inc. as the real
party-in-interest. App. Br. 2.

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Application 15/385,665

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1–6 and 9 as unpatentable under 35
U.S.C. § 103(a)(pre-AIA) over the combination of Strausak et al. (US
5,370,635, December 6, 1994) (“Strausak”), Pickup et al. (US 2003/0065294
A1, April 3, 2003) (“Pickup”), and M. L. Gora, Nicotine Transdermal
Systems, 27 ANNALS OF PHARMACOTHERAPY 742–750 (1993).
The Examiner also rejected claims 2 and 3 under 35 U.S.C. § 112,
second paragraph as indefinite.2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a controlled drug delivery method
for transdermally delivering a drug according to a programmed
administration schedule that implements a desired dosage profile. Spec.
¶¶ 3, 29.

REPRESENTATIVE CLAIM
Claim 1 is representative of claims on appeal and recited below.
1. A method of delivering nicotine to a subject, the method
comprising:
wearing an automated transdermal drug delivery device
during the subject’s sleep such that a permeable

2 The Examiner determined that claims 8, 10–15, and 18 are allowable. Ans.
3.
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membrane of the automated transdermal drug delivery
device is in contact with skin of the subject; and
beginning to deliver a substance comprising nicotine from
a reservoir of the transdermal drug delivery device
to the permeable membrane during a one hour
period immediately prior to the subject’s waking to
transdermally administer nicotine to the subject.

App. Br. 8.
ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that that claims 2 and 3 are indefinite, and that the
claims are obvious over the cited prior art. We address below the arguments
raised by Appellant.

A. Rejection of claims 2 and 3 as indefinite
Issue
Appellant argues that a skilled artisan would understand the scope of
the claims, in view of the Specification, with reasonable certainty. App. Br.
4.

Analysis
Claim 2 recites: “The method of claim 1 further comprising delivering
the substance from the reservoir to the permeable membrane at a plurality of
times corresponding to expected nicotine cravings of the subject.” App. Br.
8. Claim 3 is similar, but the plurality of times correspond to the subject’s
meal times. Id. The Examiner finds claims 2 and 3 thus recite delivering
nicotine via the claimed method to an awake subject during waking periods.
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Final Act. 4. The Examiner finds claim 1, from which claims 2 and 3
directly depend, recites delivering nicotine to a subject during sleep. Id.
The Examiner determines that delivering nicotine to a sleeping subject is
incompatible with delivering nicotine to an awake subject, and therefore
concludes that the contradictory claims 2 and 3 are indefinite for failing to
particularly point out and distinctly claim the invention. Id.
Appellant argues that the indefiniteness rejection has been withdrawn
because the Examiner’s Answer does not mention the rejection. Reply Br. 2.
Appellant further argues that: “claim 1 is not limited to wearing the device
only while the subject is asleep.” App. Br. 4. Appellant argues that claims 2
and 3 add “a step that may be performed while the subject is asleep or
awake, as a skilled artisan would understand.” Id.
First, we address the status of the rejection, followed by our
substantive analysis. As acknowledged by Appellant, the Examiner did not
expressly withdraw the indefiniteness rejection under 35 U.S.C. § 112,
second paragraph. Reply Br. 2. However, the Examiner’s Answer expressly
states that: “every ground of rejection set forth in the Office action is being
maintained by the Examiner” unless expressly withdrawn. The rejection
therefore remains pending before us. See Ans. 3.
Turning to the merits, we are not persuaded by Appellant’s argument.
“As the statutory language of ‘particularity’ and ‘distinctness’ indicates,
claims are required to be cast in clear—as opposed to ambiguous, vague,
indefinite—terms.” In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014).
As argued by Appellant, claims 2 and 3 expand the scope of claim 1 to
encompass the wearing the automated transdermal device at times, when the
subject must necessarily be awake (i.e., experiencing nicotine cravings or at
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mealtimes). This interpretation directly contradicts claim 1’s recited
limitation of “wearing an automated transdermal drug delivery device during
the subject’s sleep.” In other words, “[a] dependent claim that contradicts,
rather than narrows, the claim from which it depends is invalid.” Multilayer
Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.3d 1350,
1362 (Fed. Cir. 2016). Because claims 2 and 3 directly conflict with the
language of claim 1, we sustain the Examiner’s rejection of the claims as
indefinite.

B. Rejection of claims 1–6 and 9 over Strausak, Pickup, and Gora
Issue 1
Appellant argues that the prior art does not teach the steps of wearing
the device during the subject’s sleep and beginning delivery of nicotine
during a one hour period immediately prior to the subject’s waking. App.
Br. 5.

Analysis
The Examiner finds Strausak teaches a device for periodically
administering nicotine from a reservoir to a subject’s skin through a
permeable membrane. Final Act. 6 (citing Strausak, col. 2, ll. 25–35, 51;
col. 6, ll. 61–68). The Examiner finds that Strausak teaches the device may
be worn for a whole day or more and may administer nicotine several times
per day. Ans. 4 (citing Strausak, col. 7, ll. 7–9). The Examiner finds Pickup
teaches an automated transdermal device for delivering active agents
including nicotine. Final Act. 6–7 (citing Pickup ¶¶ 21–23). The Examiner
finds Pickup teaches the device may be worn throughout the day or for
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multiple days and may be programmed to deliver an active agent at
particular times of the day. Id. (citing Pickup ¶ 23); Ans. 4 (citing Pickup ¶
55).
The Examiner finds Gora teaches transdermal administration of
nicotine during wakeful hours may be advantageous to closely mimic the
typical pattern of smoking. Final Act. 7 (citing Gora 744). The Examiner
find Gora teaches the importance of providing adequate early-morning
nicotine blood concentrations as the early-morning cigarette is the most
difficult to eliminate. Id. The Examiner finds one skilled in the art would
have been motivated to use a periodic delivery device to administer nicotine
just prior to the subject’s waking morning time to eliminate the early
morning nicotine craving taught by Gora. Id. Specifically, the Examiner
finds one skilled in the art would have been motivated “to program the
programmable transdermal device drawn from the combination of Strausak
and Pickup to deliver nicotine before waking of the subject so that by the
time the subject[] wakes up, a satisfying blood level of nicotine would be
achieved, and craving for morning smoking would be ceased.” Ans. 6.
Accordingly, the Examiner concludes claim 1 would have been obvious over
the prior art.
Appellant asserts that the Examiner has misconstrued the claims.
App. Br. 4. Appellant contends that the Examiner omits “the limitations of
wearing the device during the subject’s sleep and to begin delivery of
nicotine during a one hour period immediately prior to the subject’s
waking.” Id. at 5. Appellant emphasizes the difference between “delivering
during … during a one hour period immediately prior to the subject’s
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waking” and “beginning to deliver … during a one hour period immediately
prior to … waking.” Reply Br. 2–3.
We are not persuaded. The Examiner has identified methods for
periodic transdermal administration of nicotine at particular times over the
course of a whole day or more. Ans. 4. A whole day or more includes times
during which a subject is sleeping. Gora teaches that adequate nicotine
blood concentrations are especially required in the early-morning, i.e.,
immediately prior to a subject’s waking. Gora 744. As cited by the
Examiner, Strausak teaches periodically administering nicotine, e.g., by
automatically switching between a blocked state and a release state.
Strausak col. 6:61–7:9. Strausak teaches that the release state may include a
release time period lasting from 30 minutes to several hours. Id. A nicotine
release interval for nicotine that begins 30 minutes before waking teaches
the limitation of “beginning to deliver . . . during a one hour period
immediately prior to . . . waking,” thereby addressing Gora’s need for
adequate early-morning nicotine concentrations. Accordingly, we are not
persuaded that the Examiner has misconstrued the claims as compared to the
prior art.

Issue 2
Appellant argues that the Examiner “has not provided any rationale
supporting the obviousness to a skilled artisan of adding the missing subject
matter to the combined disclosures of Strausak, Pickup, and Gora.” App. Br.
5.

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Analysis
Appellant argues that “[t]he Examiner has not acknowledged the
limitations of claim 1 missing from the prior art and has not provided a
rationale supporting the obviousness of adding this missing subject matter to
the combined disclosure of the prior art.” App. Br. 6–7. Additionally,
Appellant argues that “Gora’s discussion of the use of nicotine patches
teaches away from the day- and night-long administration of nicotine the
Examiner purports to find in Strausak and Pickup by describing the
downside of delivering nicotine while sleeping,” i.e., vivid dreams. Reply
Br. 3–4 (citing Gora 744). Thus, Appellant argues that the Examiner applies
impermissible hindsight by relying on Appellant’s disclosure rather than the
prior art. Id. at 4.
We are not persuaded. Appellant misconstrues the Examiner’s
rejection and the prior art. Gora teaches that continuous 24-hour
transdermal dosing of nicotine provides early-morning nicotine blood
concentrations, however suffers from the side effect of vivid dreams. Gora
744. Gora teaches that 16-hour dosing alleviates the side effect of vivid
dreams, but does not provide adequate early-morning nicotine, and thus does
not eliminate the “most difficult” cigarette. Id. Gora therefore teaches a
need for dosing nicotine at a subject’s waking time, without continuous
overnight dosing. The combination of Strausak and Pickup provides a
predictable solution to Gora’s problem, i.e., periodic dosing of nicotine set to
particular times during a 24-hour time period. “When there is a design need
or market pressure to solve a problem and there are a finite number of
identified, predictable solutions, a person of ordinary skill has good reason
to pursue the known options within his or her technical grasp. If this leads
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to the anticipated success, it is likely the product not of innovation but of
ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S.
398, 421 (2007).
The Examiner’s rejection “takes into account only knowledge which
was within the level of ordinary skill at the time the claimed invention was
made and does not include knowledge gleaned only from [Appellant’s]
disclosure.” In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212
(CCPA 1971). Therefore, we are not persuaded by Appellant’s argument
that the Examiner impermissibly relied on hindsight analysis.
Accordingly, we affirm the Examiner’s rejection of claim 1. Because
Appellant does not argue the dependent claims separately (see App. Br. 7),
we affirm the Examiner’s rejection of claims 2–6 and 9.

CONCLUSION

The rejection of claims 2 and 3 as unpatentable under 35 U.S.C.
§ 112, second paragraph is affirmed.
The rejection of claims 1–6 and 9 under 35 U.S.C. § 103(a) is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

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AFFIRMED

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
2, 3 112, second
paragraph
Indefiniteness 2, 3
1–6, 9 103(a) Strausak, Pickup, and
Gora
1–6, 9
Overall
Outcome
1–6, 9