Ex Parte Alfano

Patent Trial and Appeal Board

Mar 3, 2017

13842414 (P.T.A.B. Mar. 3, 2017)

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.
13/842,414 03/15/2013 Kenneth Mimnaugh Alfano 8036
109138 7590 03/06/2017
Kenneth Alfano
41635 Copper Creek Drive
Canton, MI 48187
EXAMINER
JAVIER, MELISSA L
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
03/06/2017 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KENNETH MIMNAUGH ALFANO
____________

Appeal 2015-008028
Application 13/842,414
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 11 and 16 (App.
Br. 3; see also id. at 1 (“This brief is submitted in support of pending
independent claims 11 and 16”)).2 We have jurisdiction under 35 U.S.C.
§ 6(b).
We AFFIRM–IN–PART.

1 Appellant identifies the real party in interest as “Kenneth Alfano
(Applicant/Inventor), owner of Tailorpill Technologies, LLC.” (App. Br. 1
2 Pending claims 12–15 and 17–20 stand rejected and withdrawn from
Appeal (App. Br. 1–3).
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STATEMENT OF THE CASE
Appellant’s “application relates to pharmaceuticals, and more
particularly, relates to patient-specific drug products having high drug loads
achievable by ‘micro-dosing’ dispensing technology with filler-free
capability for reducing diluent used” (Spec. ¶ 2). Appellant limits the issues
presented in this Appeal to whether: (1) claim 11 is anticipated by Kirsh or
Clarke and (2) claim 16 is anticipated by Komorowski (App. Br. 3).3
Claims 11 and 16 are reproduced below:
11. A customized multiple-unit-dose drug product, comprising:
two or more drug substances whose respective identities and
dose levels are customized for a particular patient and
combined in a single ingestible or otherwise orally-
administrable drug product comprising a capsule shell, wherein
at least one of said drug substances is not in formulation with
any non-therapeutic excipient, said non-therapeutic excipient
being any ingredient that essentially does not facilitate
pharmacokinetics or pharmacodynamics in vivo, and wherein
said at least one of said drug substances is not on a sheet or
other substrate; and
a barrier for limiting in vitro contact between at least two of
said two or more drug substances.
(App. Br. 9.)
16. A customized multiple-unit-dose drug product, comprising:
Two or more drug substances at dose levels essentially as
prescribed for a particular patient, combined in one capsule
drug product having an enteral or otherwise non-intravenous
route of administration, wherein at least one drug substance is

3 Appellant waived any appeal of the pending rejections under 35 U.S.C.
§ 112, second paragraph, 35 U.S.C. § 103(a) and the anticipation rejection of
claims 12, 14, 15, 18, and 19 (see Ans. 2–10). In addition, Appellant waived
any appeal of the pending rejections of claims 12, 14, 15, 18, and 19.
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).
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present without significant functional or non-functional
excipient, said at least one drug substance not having been
deposited as a liquid onto an intermediary substrate; and
a barrier for restricting contact between at least two drug
substances.
(App. Br. 10.)

The claims stand rejected as follows:
Claim 11 stands rejected under 35 U.S.C. § 102(b) as anticipated by
Kirsh4 or Clarke.5
Claim 16 stands rejected under 35 U.S.C. § 102(e) as anticipated by
Komorowski.6

ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Kirsh, Clarke, or Komorowski teaches Appellant’s
claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Kirsh “relates to a method for providing individualized, customized,
combined doses of two or more drugs to an individual” (Kirsh ¶ 1; Ans. 3–
4).
FF 2. Kirsh discloses a
pharmaceutical dosage form compris[ing] a plurality of drug-
containing sub-units connected together in the assembled
dosage form and being retained together by the connection at
least prior to administration to a patient, at least one of the

4 Kirsh et al., US 2009/0149507 A1, published June 11, 2009.
5 Clarke et al., US 2007/0087049 A1, published Apr. 19, 2007.
6 Komorowski, US 2010/0158956 A1, published June 24, 2010.
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subunits being a solid sub-unit comprising a solid matrix of a
polymer which contains a drug substance, the polymer being
soluble, dispersible or disintegrable in the patients
gastrointestinal environment to thereby release the drug
substance, and wherein the connection is provided by a weld
between parts of the assembled dosage form.
(Kirsh ¶ 84; see Ans. 4.)
FF 3. Clarke “relates to pharmaceutical formulations, being a dosage form
comprising two or more connected sub-units, particularly for oral dosing”
(Clarke ¶ 1; see Ans. 5).
FF 4. Clarke discloses
a multi-component dosage form [] which comprises a plurality
of drug substance––containing sub-units each selected from
capsule compartments which can release their drug substance in
the gastro-intestinal environment, and solid sub-units
comprising a solid matrix of a polymer which contains a drug
substance, the polymer being soluble, dispersible or
disintegrable in the patient’s gastro-intestinal environment to
thereby release the drug substance, the sub-units being
connected together in the assembled dosage form and being
retained together by the connection at least prior to
administration to a patient, wherein the connection is provided
by a weld between parts of the assembled dosage form.
(Clarke ¶ 7; see also id. ¶ 23; Ans. 5.)
FF 5. Kirsh and Clarke both disclose that “[p]harmaceutical dosage forms
are [] known which comprise a matrix of a solid polymer,” such as “a
polyethylene glycol (‘PEG’) matrix” (Kirsh ¶ 80; Clarke ¶ 4; see Ans. 11).
FF 6. Examiner asserts that “[p]olyethylene glycol is a known laxative
material (i.e. a therapeutic excipient)” (Ans. 11).
FF 7. Komorowski “relates to a formulation and treatment regime that
provides to a patient, in a single dosage form, a combination of a therapeutic
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drug and a nutritional component,” which are separated by a barrier layer
(Komorowski ¶ 3; see also id. at ¶¶ 8–14; see Ans. 6).
Komorowski discloses that
[t]he nutritional supplement and therapeutic agent,
pharmaceutically acceptable salts of the therapeutic agent and
pharmaceutically acceptable solvates of the therapeutic agent
can be co-formulated alone but, in human therapy, will
generally be administered in admixture with a suitable
pharmaceutical excipient[,] diluent or carrier selected with
regard to the intended route of administration and standard
pharmaceutical practice.
(Komorowski ¶ 37; Ans. 12.)
ANALYSIS
The anticipation rejection of claim 11 over Kirsh or Clarke:
Examiner finds that Kirsh or Clarke anticipates Appellant’s claimed
invention (Ans. 3–4 and 5; FF 1–4). In this regard Examiner asserts that
“[t]he art does not need to specifically teach the general exclusion of a non-
therapeutic excipient when the art of record teaches the combination of a
drug and a polyethylene glycol matrix,” because “[p]olyethylene glycol is a
known laxative material (i.e. a therapeutic excipient)” (Ans. 11–12; FF 6).
We are not persuaded. Examiner failed to establish an evidentiary basis on
this record to support a finding that PEG is a laxative material in general, or
specifically, at the concentration required to serve as a matrix material for a
pharmaceutical dosage form (see FF 5; cf. FF 6). Therefore, we are
compelled to agree with Appellant’s contention that “[b]ecause Examiner
has not explained how Kirsh or Clarke teach avoidance of non-therapeutic
excipient, Appellant submits that a prima fascia [sic] case of anticipation has
not been made” (App. Br. 5–6).
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We recognize, but are not persuaded by, Examiner’s reliance on
Xcelodose®S7 to support Examiner’s assertion that “it [was] known in the art
to fill API[8] directly into capsules, with no need for excipients with powder
micro-dosing systems” (Ans. 12). Examiner failed to establish an
evidentiary basis on this record to support a finding that the pharmaceutical
formulations of Kirsh or Clarke are or are amenable to powder micro-dosing
systems, such that the disclosure of Kirsh or Clarke inherently teaches, or
encompasses, Xcelodose®S’ powder micro-dosing systems (see Reply Br. 2–
3 (Xcelodose®S’ “‘microdosing’ dispensing technology had not been
directed to pharmaceutical compounding, particularly for customized
polypills”)). In order to support an anticipation rejection, a prior art
“reference must clearly and unequivocally disclose the claimed [invention]
or direct those skilled in the art to the [invention] without any need for
picking, choosing, and combining various disclosures not directly related to
each other by the teachings of the cited reference.” In re Arkley, 455 F.2d
586, 587 (CCPA 1972) (emphasis added).

The anticipation rejection of claim 16 over Komorowski:
Examiner finds that Komorowski anticipates Appellant’s claim 16
(Ans. 6; FF 7–8). Appellant does not dispute that Komorowski’s disclosure
of a formulation comprising a nutritional supplement and a therapeutic agent
reads on a multiple-unit-dose drug product, comprising two or more drug
substances (see App. Br. 6–8; Reply Br. 3; cf. FF 7–8). To the contrary,

7 Xcelodose®S, New Powder Mirco-dosing System brochure,
www.capsugel.com (2008).
8 Appellants’ Specification defines the acronym “API” as “the active
pharmaceutical ingredient” (Spec. ¶ 8).
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Appellant contends that “Komorowski does not appear to teach excipient
avoidance for an API in a compounded polypill” (App. Br. 7). In this
regard, Appellant recognizes “the fact cited by Examiner that certain
ingredients in Komorowski can be ‘co-formulated alone’,” but finds that this
teaching in Komorowski “is distinguishable from teaching that at least one
drug substance is present without any significant amount of an excipient”
(App. Br. 7; see FF 8). We are not persuaded.
Komorowski expressly discloses that “[t]he nutritional supplement
and therapeutic agent [] can be co-formulated alone” (FF 8).
Notwithstanding Appellant’s contention to the contrary, Komorowski
distinguishes between “co-formulated alone” and formulation in the
presence of “a suitable pharmaceutical excipient[,] diluent or carrier” (FF 8;
cf. App. Br. 7). Therefore, on this record, we find that Examiner has the
better position, wherein Examiner finds that Komorowski’s disclosure of
“co-formulated alone” means “without significant functional or non-
functional excipient” (see Ans. 12). For the foregoing reasons, we are not
persuaded by Appellant’s contention that “Examiner has not explained how
Komorowski teaches at least one drug substance lacking any significant
excipient in a custom polypill capsule (by any standard for significance) [or
that] a prima fascia [sic] case of anticipation has not been made” (App. Br.
8; see also Reply Br. 3).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Kirsh or Clarke teach Appellant’s claimed
invention. The rejection of claim 11 under 35 U.S.C. § 102(b) as anticipated
by Kirsh or Clarke is reversed.
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The preponderance of evidence on this record supports Examiner’s
finding that Komorowski teaches Appellant’s claimed invention. The
rejection of claim 16 under 35 U.S.C. § 102(e) as anticipated by
Komorowski is affirmed.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART