Ex Parte Melker et al

Patent Trial and Appeal Board

Feb 27, 2014

12064673 (P.T.A.B. Feb. 27, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE
THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte RICHARD J. MELKER,1
Donn Michael Dennis, Christopher D. Batich, and
Mark S. Gold
________________

Appeal 2012-008570
Application 12/064,673
Technology Center 1700
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Before BEVERLY A. FRANKLIN, LINDA M. GAUDETTE, and
MARK NAGUMO, Administrative Patent Judges.

NAGUMO, Administrative Patent Judge.

DECISION ON APPEAL
Richard J. Melker, Donn Michael Dennis, Christopher D. Batich, and
Mark S. Gold (“UFRFI”) timely appeal under 35 U.S.C. § 134(a) from the

1 The real parties in interest are listed as University of Florida Research
Foundation, Inc. (“UFRFI”), and their licensee, Xhale, Inc. (Appeal Brief,
filed 17 February 2012 (“Br.”), 2.)
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final rejection2 of claims 55-66.3 We have jurisdiction. 35 U.S.C. § 6. We
affirm.
OPINION
A. Introduction4
The subject matter on appeal relates to medications that permit
“breathalyzer” analysis of a patient to determine whether the patient has
taken the medication. In certain embodiments, a salt, excipient, or taggant
that has, as part of its molecular structure, an “exhaled drug ingestion marker
(EDIM)” is also present.
Sole independent claim 55 is representative and reads:
A medicament for medication adherence monitoring of a
subject, wherein the medicament contains
a therapeutic agent,
a therapeutic agent and a salt,
a therapeutic agent and an excipient,
or
a therapeutic agent and a taggant;
wherein at least one portion of the molecular structure
of the salt, excipient or taggant constitutes

2 Office action mailed 1 August 2011 (“Final Rejection”; cited as “FR”).
3 Remaining co-pending claims 39-44 and 51-54 have been withdrawn from
consideration. (FR 1, § 4a; Br. 2, § 3.)
4 Application 12/064,673, Medication Adherence Monitoring System,
filed 14 October 2008 as the national stage of PCT/US08/54755,
filed 22 February 2008, which claims benefit of 60/891,085,
filed 22 February 2007. The specification is cited as “Spec.”
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an exhaled drug ingestion marker (EDIM) which is
detectable in exhaled breath—
wherein, at least one portion of the molecular
structure of the salt, excipient or taggant is labeled
with at least one non-ordinary isotope such that an
exhaled drug ingestion marker (EDIM) containing
said non-ordinary isotope is detectable in exhaled
breath, in the event that said patient takes said
medication.
(Claims App., Br. 21; indentation, paragraphing, and emphasis added.)
The Examiner maintains the following grounds of rejection:5
A. Claims 55-60, 63, and 66 stand rejected under
35 U.S.C. § 103(a) in view of the combined teachings of
Melker6 and Katzman.7
A1. Claims 61, 62, and 65 stand rejected under
35 U.S.C. § 103(a) in view of the combined teachings of
Melker, Katzman, and Anderson.8
A2. Claim 64 stands rejected under 35 U.S.C. § 103(a) in view of
the combined teachings of Melker, Katzman, and Smith.9

5 Examiner’s Answer mailed 14 March 2012 (“Ans.”).
6 Richard J. Melker et al., Marker detection method and apparatus to
monitor drub compliance, U.S. Patent Application Publication
2005/0233459 Al (2005) (still undergoing examination).
7 Daniel E. Katzman, Breath test for detection of drug metabolism, U.S.
Patent 5,962,335 (1999).
8 David K. Anderson, II, et al., Method of identifying chemicals by use of
non-radioactive isotopes, U.S. Patent 5,474,937 (1995).
9 David Smith et al., On-line, simultaneous quantification of ethanol, some
metabolites and water vapour in breath following the ingestion of alcohol,
23 PHYSIOL. MEAS. 477-589 (2002).
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B. Discussion
Findings of fact throughout this Opinion are supported by a
preponderance of the evidence of record.
It is a fundamental consequence of the “peripheral” claiming system
of the United States Patent Laws, in which a claim sets the boundaries of the
claimed subject matter, that the demonstration of anticipation or obviousness
of a single embodiment within the scope of the claim negates patentability of
that claim.
In the present case, the medicament covered by independent claim 55
contains, in an embodiment, a therapeutic agent. For the purposes of this
Opinion, we may, without deciding, give weight to the preamble
requirement “for medication adherence monitoring of a subject,” as giving
“life and meaning to the claim,” there being no credible indication that
UFRFI seeks protection for medicaments generally.
As the Examiner points out, Melker describes expressly that “the
therapeutic drug marker can be made detectable in bodily fluids after the
therapeutic agent and/or additive is metabolized.” (Melker 8 [0098].)
Melker teaches that “the therapeutic agent can be absorbed in the
gastrointestinal tract (and, in certain instances, metabolized in the patient’s
body) so that a detectable metabolite of the drug (or metabolite of the
additive) is excreted in the lungs for notification that the therapeutic drug
has been taken by the patient.” (Id.; emphasis added.)
Thus, Melker describes an embodiment within the scope of appealed
claim 55.
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UFRFI presents arguments for the separate patentability of claims 61,
62, 64, and 65 (Br. 7-8), but all of these arguments are based on the
misapprehension that these claims, which depend from claim 55, are limited
to embodiments in which the medicament contains a therapeutic agent and
an isotopically labeled EDIM that is a salt, excipient, or taggant.
Section 112, fourth paragraph, in force when the 673 Application was filed,
requires that “a claim in dependent form shall contain a reference to a claim
previously set forth and then specify a further limitation of the subject matter
claimed. A claim in dependent form shall be construed to incorporate by
reference all the limitation of the claim to which it refers.”
35 U.S.C. § 112(4) (2008).10 None of the appealed claims dependent from
claim 55 exclude the therapeutic agent alone, recited in the third line of that
claim as reproduced supra. Thus, any errors the Examiner may have made
regarding the teachings of Katzman and the suggestive power of those
teachings in light of the teachings of Melker, are harmless.11

10 This section has been recodified as 35 U.S.C. § 112(d), without substantial
change in meaning.
11 In the event of further prosecution, we observe that it seems highly
plausible that a person having ordinary skill in the art, being taught by
Melker that additives, which would include commonly added
pharmaceutical materials (such as excipients) could be used as markers,
would have transferred Katzman’s teachings (that isotopically labeled drugs
are useful as markers) to the other additives suggested to be useful as
markers alongside the therapeutic agent by Melker. We emphasize that we
neither make nor imply any findings of fact in this regard, and that we leave
these factual determinations and the legal consequences that may be educed
from them to the Examiner and UFRFI in the first instance.
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UFRFI does not present arguments for the separate patentability of
any other claims.
We therefore affirm the rejections of claims 55-56.
C. Order
We affirm the rejection of claims 55-66.
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

cdc