Ex Parte Melker et al

Patent Trial and Appeal Board

May 21, 2014

12064673 (P.T.A.B. May. 21, 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 REQUEST FOR REHEARING
Richard J. Melker, Donn Michael Dennis, Christopher D. Batich, and
Mark S. Gold (“UFRFI”) timely request reconsideration2 of our Decision3

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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affirming the rejection of claims 55-66. UFRFI argues that we misread the
claims. UFRFI requests that we grant leave to amend the claims, and that
we consider the patentability of the amended claims. (Req. 1-2.)
We have reconsidered our Decision, but we deny the relief requested.
The proper construction of claim 55 lies at the heart of UFRFI’s
complaint. Claim 55 reads:
A medicament for medication adherence monitoring of a
subject, wherein the medicament contains
[a] a therapeutic agent,
[b] a therapeutic agent and a salt,
[c] a therapeutic agent and an excipient,
or
[d] a therapeutic agent and a taggant;
wherein at least one portion of the molecular structure
of the salt, excipient or taggant constitutes
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, square-bracketed labels,
and emphasis added.)

2 Request for rehearing under 37 C.F.R. § 41.52 (25 April 2014)
(“Request,” cited as “Req.”).
3 Opinion mailed 3 March 2014 (“Opinion”).
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More particularly, UFRFI urges that: (1) we have mis-read the
independent claim by reading option [a] as an alternative embodiment of the
claimed medicament, rather than as a nullity. UFRFI urges further, that
“under the totality of the circumstances, (the prosecution record prior to
consideration by the Board on Appeal),” our reading “is a completely new
read.” UFRFI urges further that (2) even if we have read claim 55 correctly,
we have mis-read the dependent claims as including option [a] as a
limitation. Consequently, UFRFI requests leave to amend the claims to
eliminate option [a], and requests further that we consider the patentability
of the claims as amended. (Request 2.)
We are not persuaded of harmful error in our Decision, and we deny
the requested relief for the following reasons.
Independent claim 55
The paragraphing [a]-[d], supra, is in compliance with
37 C.F.R. §1.75(i), which reads (emphasis added),
Where a claim sets forth a plurality of elements or steps, each
element or step of the claim should be separated by a line
indentation.
This section has been in effect, without alteration, since 23 September 1996.
61 Fed. Reg. 42790, 42803 (19 August 1996) (Final Rule),4 albeit, as here, it

4 The primary purpose of the rule-making was to “implement changes in
practice related to the publication of patent applications provided for in
H.R. 1733” (introduced in the House of Representatives on 25 May 1995).
(60 Fed. Reg. 42352, 42352 (15 August 1995) (Notice of Proposed
Rulemaking). The provisions of § 1.75(i) were intended “to facilitate the
digital image and/or OCR scanning of the claim into the electronic data
base.” (Id. at 42364.)
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is often observed in the breech. Presenting a claim in such a format helps to
make clear to the reader—and doubtless to the writer—what are the
elements (or, in this case, what are the alternative elements) of a claim, and
what are the properties of the elements and the relations among the various
elements required by the claim.
Notably, UFRFI does not offer an explanation, beyond an assertion of
intent (Req. 2, ¶ 3, last line), of how the medicament of appealed claim 55
can be read as not including, as an alternative, option [a], the therapeutic
agent. Put another way, UFRFI has not explained how appealed claim 55,
which includes option [a], can be read as an exact equivalent (e.g., with an
arguable ambiguity removed) to proposed amended claim 55 (presented in
the Claims Appendix to the Request), in which option [a] has been deleted.
Moreover, review of the prosecution history does not support the
reading urged by UFRFI.
Upon entry of the National Stage under 35 U.S.C. § 371, claim 1 read
in most relevant part,
A method for medication adherence monitoring comprising. [sic: ,]
(a) providing to a patient a therapeutic agent that is labeled
with an exhaled drug ingestion marker (EDIM) as part of the
molecular structure of the therapeutic agent, wherein the
EDIM is released from the therapeutic agent and is detectable
in exhaled breath upon metabolism of the therapeutic agent
by the patient;
WO 2008/103924, 549 (emphasis added). In this version, the therapeutic
agent is labeled and must be metabolized, whereupon the EDIM is released
and subsequently detected in the exhaled breath; in claim 7 the agent need
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not be metabolized (id. at 550) ; in claim 15, a salt provided with the
therapeutic agent is labeled (id. at 551), etc.
Thus, our supposedly improper reading of option [a] as one of the
options covered by the claims is consistent with the plain language of
claim 55, and also consistent with an original claim.
The Examiner required restriction among the eight independent claims
to methods,5 and UFRFI responded by cancelling claims 1-38 and 45-50,
and presenting amended claims 39-44 (drawn to methods) and newly
presented claims 55-66, drawn to a medicament.6 Claim 55 read:
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
therapeutic agent, salt, excipient or taggant constitutes an
exhaled drug ingestion marker (EDIM) which is detectable in
exhaled breath in the absence of a non-ordinary isotope, or,
wherein, at least one portion of the molecular structure of the
therapeutic agent, salt, excipient or taggant is labeled with at
least one non-ordinary isotope such that an exhaled drug
ingestion marker (EDIM) containing said nonordinary
isotope is detectable in exhaled breath, in the event that said
patient takes said medication.
(Amendment filed 16 December 2012, 3-4; emphasis added.)
As comparison of the italicized passages with original claim 1 shows, the
original recitation of a marked therapeutic agent was retained in newly

5 Office Action mailed 20 August 2010.
6 Response and Amendment filed 16 December 2010.
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presented medicament claim 55. Method claim 39 was amended to be
parallel with claim 55.
The Examiner required restriction between the method claims headed
by claim 39 and the medicament claims headed by claim 55,7 and UFRFI
elected the medicament claims with traverse, arguing that the method claims
had the same scope and should be recombined.8 Following the first action
on the merits,9 UFRFI amended claim 55 by deleting the underlined
passages, supra.10 Notably, the first recitation of “a therapeutic agent,” i.e.,
option [a], was left intact. Claim 39, though withdrawn from consideration,
was amended in parallel fashion, as were certain claims dependent from
claim 39; and claim 59, dependent from claim 55 (after correction of a
typographical error), was also amended to delete the term “therapeutic
agent”, so that only the metabolic product of the isotopically labeled salt,
taggant, or excipient would have to be detectable in the exhaled breath of the
subject. Clearly, UFRFI knows how to amend its claims to remove
recitation of a “therapeutic agent” when it wishes. Following the Final
Rejection,11 UFRFI again sought entry of the amendments proposed for
claim 39 et seq.,12 which the Examiner refused on the grounds that the

7 Office Action mailed 12 January 2011.
8 Response filed 14 February 2011.
9 Office Action mailed 4 March 2011.
10 Response and Amendment filed 5 July 2011, 3 [un-numbered].
11 Final Rejection mailed 1 August 2011 (“FR”).
12 Amendment and Response filed 29 September 2011.
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withdrawn claims were not under consideration and that the issues would not
be materially reduced or simplified for appeal.13
Incidentally, notwithstanding UFRFI’s consistent earlier practice of
presenting parallel amendments to withdrawn claim 39 (and certain
dependent claims), in order to present method claims having a scope
arguably comparable to the medicament claims, in its Request, UFRFI has
not amended claim 39 to delete option [a], the therapeutic agent. (Claims
Appendix to the Request, 1, Claim 39, ll. 3-4.)
The prosecution history reveals that a therapeutic agent, which we
have interpreted as being suitable for adherence monitoring (Op. 4,
3d para.), has been a constant option, in addition to the combination of a
therapeutic agent and an additional ingredient, e.g., a salt, wherein the salt is
marked in a particular way. Such a claim is not patentable over any prior art
that teaches or suggests either an appropriately marked therapeutic agent or
the combination of a therapeutic agent with an appropriately marked salt.
The dependent claims
We found (Op. 5), that although UFRFI presented arguments for the
separate patentability of dependent claims 61, 62, 64, and 65, those
arguments were premised on the misapprehension that those claims, which
further limited the combination of the therapeutic agent and the additional
ingredient, were limited to those further-limited combinations. This is legal
error.

13 Advisory Action mailed 4 October 2011 (“Adv.”), 1 ¶ 3(c).
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A claim dependent from claim 55 that does not include the therapeutic
agent recited in option [a] must exclude option [a] implicitly, e.g.,
A medicament according to claim 55, wherein the
medicament is a therapeutic agent and a salt, wherein [further
limitations]
or expressly, e.g.,
A medicament according to claim 55, wherein the
medicament is not a therapeutic agent by itself, wherein
[further limitations].
UFRFI’s arguments regarding claim 63 are belated, as UFRFI did not
argue claim 63 in the Principal Brief on appeal (or in the Reply Brief,
showing good cause for not having raised the argument in the Principal
Brief). UFRFI has not shown good cause why arguments for the separate
patentability of claim 63 were not made earlier. We decline to entertain
such arguments now.
The requested relief
UFRFI requests that it be allowed to “disclaim this reading,” by
elimination option [a], “a therapeutic agent,” urging that “[t]his amendment
could not have been previously made because the reading adopted by the
Board has never previously been advanced by the USPTO/Examiner.”
(Req. 3 [pages un-numbered], para. a, last sentence.)
This argument lacks merit. First, the USPTO regulation governing
amendments 37 C.F.R. § 1.121(a)14 is permissive, and does not require that

14 “Amendments in applications, other than reissue applications, are made
by filing a paper, in compliance with § 1.52, directing that specified
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an amendment be responsive to an Office Action. Preliminary amendments
(§ 1.115) and amendments after final rejection (§ 1.116), are not of right,
and all amendments are subject to review for compliance with the patent
statute, but these regulations do not otherwise limit the reason an applicant
may amend the specification, including the claims. There is no reason
UFRFI could not have amended the claims to exclude option [a].
Moreover, following our review of the prosecution history urged by
UFRFI, we discern more clearly than we did before the development of the
Examiner’s position from the Final Rejection, through the Advisory Action,
to the Examiner’s Answer15. In the Final Rejection, the Examiner found that
Katzman discloses that at least one portion (metabolite) of
the molecular structure of the therapeutic agent, 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
(see col. 4, lines 4-10). Katzman teaches that labeling the
EDIM with isotope is mostly preferred which enables a
EDIM to be detected in the exhaled breath (see col. 5,
lines 31-36).
(FR 3, ll. 7-13.) The characterization of the scope of Katzman’s teachings is
too broad, as Katzman does not teach labelling the salt, excipient, or taggant.

amendments be made.” 37 C.F.R. § 1.121(a) (currently, and at all times
during prosecution of this application).
15 Examiner’s Answer, mailed 14 March 2012 (“Answer”, cited as “Ans.”).
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In the Advisory Action, the Examiner corrected this finding, and
maintained the corrected findings in the Answer, as follows:
Katzman discloses that an Exhaled Drug Ingestion Marker
(EDIM) can be labeled with non-ordinary isotope and is
detectable in exhaled breath, in the event that said patient
takes said medication (see col. 4, lines 4-10). Katzman
teaches that labeling the EDIM with isotope is mostly
preferred which enables a EDIM to be detected in the
exhaled breath (see col. 5, lines 31-36).
(Adv. 3; Ans., para. bridging 4-5.)
In the Final Rejection and in the Answer, the Examiner cited
Melker [0098], with increasing specificity, finding that “Melker does not
specifically disclose that the excipient or taggant is labeled with non-
ordinary isotope.” (FR 3, ll. 6-7; Ans. 4, last para.) The two sentences of
Melker [0098] read, in full:
Thirdly, the therapeutic drug marker can be made detectable
in bodily fluids after the therapeutic agent and/or additive is
metabolized. For example, 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.
(Melker 8 [0098]; emphasis added.) Melker has two inventors in common
with the present inventors. Thus, there cannot be any “surprise” to UFRFI
regarding the teachings of Melker.
The Examiner concluded that it would have been obvious “to label
exhaled drug ingestion marker (i.e., active ingredient or additives as defined
by Melker) in a drug table with isotope in a method according to
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Melker . . . .” (Ans. 6, ll. 6-8.) The preponderance of the evidence supports
this conclusion.
Our error in footnote 11 of the Opinion, of which UFRFI complains
(Req. 8, 2d full para.), was to imply that the Examiner had failed to make
adequate factual findings regarding the obviousness of labelling additives
with isotopes. Reviewing the record, we are satisfied that the evidentiary
basis of a prima facie case of obviousness has been established. UFRFI’s
arguments that Katzman teaches away from labelling additives, rather than
the active therapeutic agent (Reply 2-3), are not persuasive because UFRFI
has not directed our attention to credible evidence of record supporting the
assertion that such additives would have been expected to be separated from
the active drug or metabolites of the drug. Indeed, Melker [0098] (quoted in
full by UFRFI in the Brief at 9) indicates that at least by 1 April 2005, this
“problem” could be addressed by persons having ordinary skill in the art.
UFRFI has not directed our attention to evidence to the contrary. Moreover,
Melker provides the suggestion that an additive to the therapeutic agent
could be labeled, so Katzman’s focus on labelling a therapeutic agent is not
the fatal flaw UFRFI argues. It is the combined teachings of the references
that must be considered.
Finally, UFRFI urges that our reading of the claim is novel, and that
“expedited prosecution and judicial economy” further support the grant of
the requested relief (id. at 2, ¶ 3, and at para. bridging 8-9).
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We are not persuaded of harmful error. Considerations of
patentability start with the analysis of the claims. As the Federal Circuit
explained in a similar situation,
We decline to attempt to harmonize the applicants’
interpretation with the application and prior art. Such an
approach puts the burden in the wrong place. It is the
applicants’ burden to precisely define the invention, not the
PTO’s. See 35 U.S.C. § 112 ¶ 2 (“The specification shall
conclude with one or more claims particularly pointing out
and distinctly claiming the subject matter which the applicant
regards as his invention.”). While it is true that the claims
were not rejected on the ground of indefiniteness, this section
puts the burden of precise claim drafting squarely on the
applicant.
In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997).
The claims on appeal evolved from the original claims in response to
the Examiner’s restriction requirements. UFRFI amended claim 55 by
deleting the express requirement that at least one part of the molecular
structure of the therapeutic agent be labeled isotopically, but did not remove
“option [a],” which provides that the medicament can contain a therapeutic
agent—which we have interpreted as necessarily being capable of being
used for adherence monitoring of a subject. Under these circumstances,
there is no credible “surprise” to UFRFI that the claims are broader than
intended. Cf. Hoganas AB v. Dresser Indus., Inc., 9 F.3d 948, 951 (Fed.
Cir. 1993) (if the patentee, “who was responsible for drafting and
prosecuting the patent, intended something different, it could have prevented
this result through clearer drafting.”)
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We are not unsympathetic to the desires of Appellants (and
Examiners) to obtain prompt decisions regarding appeals. But we cannot
ignore the plain language of the claims, and we are not persuaded of harmful
error in the Examiner’s conclusions, particularly in light of the scope of the
present claims. Resolving the patentability of substantially narrower claims
necessarily would require substantially closer consideration of the teachings
of the references, requiring more detailed and more precise findings of fact.
Due to the virtually inevitable new factual issues, we decline this
undertaking in the first instance.
Balancing these considerations against the conclusion that UFRFI has
not shown harmful error in the Examiner’s rejections leads us to deny
UFRFI’s request that we authorize the proposed amendments, and that we
examine the proposed claims. Procedures exist for UFRFI to pursue the
subject matter intended to be claimed.
Moreover, in light of our reconsideration of the Examiner’s analysis
of the teachings of Katzman combined with those of Melker, we have
affirmed the Examiner’s rejection, even though it is based on a reading that
overlooked the full scope of the claim.
C. Order
The request for relief is denied, and the appealed rejections are
affirmed.
REQUEST DENIED
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