Raghavan Rajagopalan

Patent Trials and Appeals Board

Apr 29, 2020

14499191 - (D) (P.T.A.B. Apr. 29, 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.
14/499,191 09/28/2014 Raghavan Rajagopalan DDD-NPU:0914-01 1038
86469 7590 04/29/2020
Raghavan Rajagopalan
204 City Gate Lane
St. Peters, MO 63303
EXAMINER
CRUZ, KATHRIEN ANN
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
04/29/2020 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 RAGHAVAN RAJAGOPALAN
Appeal 2018-007283
Application 14/499,191
Technology Center 1600
Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

SCHNEIDER, 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 1–3, 10, 12, and 13.2 We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Satara
Pharmaceuticals, LLC. Appeal Br. 3.
2 Claims 26–39 are pending in the application but have been withdrawn from
consideration. Final Act. 2.
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CLAIMED SUBJECT MATTER
The claims are directed to compositions which prevent the illicit
manufacture of methamphetamine. Spec. ¶ 1. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A pharmaceutically acceptable composition for deterring
illicit manufacture of methamphetamine, said composition
comprising:
(a) an active pharmaceutical ingredient, wherein the
active pharmaceutical ingredient is ephedrine or
pseudoephedrine; and
(b) an effective amount of an organoleptic excipient;
wherein the organoleptic excipient is selected from the group
consisting of pyrazines, pyrimidines, thiazolines, thiazolidines,
and thiazoles; wherein said organoleptic excipient inhibits the
chemical reduction of said active pharmaceutical ingredient to
methamphetamine with reducing agents; and wherein said
reducing agents comprise alkali metals, zinc, or phosphorous.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Giamalva et al. US 2007/0234140 A1 October 18, 2007
Takakura et al. US 2012/0052177 A1 March 1, 2012
Adams et al, The FEMA GRAS assessment of pyrazine derivatives used as
flavor ingredients, 40 Food and Chem. Toxicol. 429 (2002).

REJECTIONS
The Examiner has rejected the ending claims as follows:
Claims 1–3 and 10 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Giamalva in view of Adams.
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Claims 12 and 13 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Giamalva in view of Adams and Takakura.3
OPINION
Issue
Both rejections are based on the combined teachings of Giamalva and
Adams and Appellant does not argue the rejections separately. See Appeal
Br. 11. Therefore we shall address the rejection together.
The issue before us is whether a preponderance of the evidence
supports the Examiner’s conclusion that the subject matter of the claims
would have obvious to one of ordinary skill in the art at the time the
invention was made over Giamalva combined with Adams or Adams and
Takakura.
The Examiner finds that Giamalva teaches a pharmaceutically
acceptable composition comprising pseudoephedrine and an amine agent
that is effective in inhibiting the isolation of pseudoephedrine for use in
conversion to methamphetamine. Final Act. 16. The Examiner finds that
Giamalva does not teach that the amine agent is an organoleptic agent. Id. at
17.
The Examiner finds that Adams teaches amine odorants as
organoleptic agents including the compound recited in claim 3, which
depends from claim 1. Id. at 17

3 Appellant references a rejection based on Nelson, US 5,766,622, issued
June 16, 1998 and Lee, US 6,399,591 B1, issued June 4, 2002. See Appeal
Br. 11. These references are not at issue in this appeal as the Examiner
withdrew the rejection based on these references in light of Appellant’s
cancelation of claims 22 and 23. Final Act. 3.
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The Examiner concludes
It would have been obvious to one of ordinary skill in the
art to combine the teachings of Giamalva, wherein amine agents
as odorants, are used as abuse deterrent agents to prevent the
isolation of pure pseudoephedrine, with the organoleptic agents
disclosed by Adams, to formulate an abuse deterrent
composition wherein the isolation of pure pseudoephedrine is
hindered by the co-isolation of the organoleptic. Hence,
conversion of any pure pseudoephedrine to methamphetamine
is hindered with a reasonable expectation of success.

Id. at 17–18.
Appellant contends that the Examiner erred in making the rejections.
Appeal Br. 11. Appellant asserts six ground of error including:
(a) key prior art reference teaches away from the
invention;
(b) none of the cited references, except Murray, is
enabling under 35 USC 112;
(c) the Examiner erroneously rejected the claims based
on impermissible hind-sight determination of obviousness, and
on impermissible 'obvious to try' doctrine;
d) the Examiner improperly applied the principle of
inherence;
(e) the Examiner improperly imposed restriction
requirement4; and
(f) the Examiner failed to provide cogent, substantive,
technical reasons m response to applicant's arguments
supported by direct evidence, literature references, and expert
testimonies (declarations).

Id.

4 While Appellant has raised an issue regarding the restriction requirement in
it's Appeal Brief, we do not have jurisdiction to hear this issue. As the
Examiner points out, challenges to the restriction requirement must be made
by petition to the Director. Ans. 34; 37 C.F.R. § 1.144.
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Appellant also contends that the claimed invention fulfilled a long met
need in the industry. Id. at 11–12.
Finding of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF1. Giamalva teaches the preparation of a pharmaceutical
composition comprising pseudoephedrine and a volatile amine odorant.
Giamalva, Abstr.
FF2. Giamalva teaches
It has thus been found desirable to formulate
sympathomimetic amine-containing products in order to render
isolation of the sympathomimetic amine more difficult or
otherwise interfere with efforts to produce illegal drugs from
common OTC medications, e.g., by altering reactants used to
convert sympathomimetic amine to methamphetamine.

Id. ¶ 5.

FF3. Giamalva teaches
In certain embodiments of the invention, the codistillable
additive(s) of the present invention can be odorants, i.e.,
compounds which exhibit a characteristic odor, and in some
cases, a characteristic flavor as well, particularly during
purification and/or conversion of sympathomimetic amines in
illegal drug synthesis, or in the product of the illegal synthesis
itself. Odorants are especially useful inasmuch as they can be
effective when added in relatively small amounts as compared
to additives which are used solely as diluents or additives that
interfere with subsequent chemical reactions for converting
sympathomimetic amine compounds to illegal drugs.

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Id. ¶ 47.
FF4. Adams reports the result of safety evaluations of pyrazine based
flavoring ingredients. Adams, 429 (Summary).
FF5. Adams teaches “Pyrazines are monocyclic heteroaromatic
substances containing nitrogen atoms in the 1- and 4-position of the aromatic
ring.” Id. at 430.
FF6. Adams teaches “[p]yrazine derivatives exhibit a wide variety of
aromas in food.” Id.
FF7. Adams discloses the pyrazine derivative acetylpyrazine which
has the structure

Id., Table 1, compound 24.
FF8. The Specification teaches
One embodiment of the present invention relates to
pharmaceutically acceptable compositions ephedrine or
pseudoephedrine and one or more biocompatible pyrazine-
based excipient of Formula I,

wherein R1 to R4 are selected from the group consisting of
hydrogen, C1-C10 alkyl, C1-C10 acyl, C1-C10 hydroxyalkyl,
C1-C10 alkoxy, C1-C10 alkoxyalkyl, C1-C10 alkylthio, and
C1-C10 alkoxycarbonyl.
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Spec. ¶ 5.

Principles of Law
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant. After evidence or argument is submitted by the
applicant in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration to
persuasiveness of argument.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992).
“[T]he discovery of a previously unappreciated property of a prior art
composition, or of a scientific explanation for the prior art’s functioning,
does not render the old composition patentably new to the discoverer. . . .
This same reasoning holds true when it is not a property, but an ingredient,
which is inherently contained in the prior art.” Atlas Powder Co. v. IRECO
Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).
Analysis
We find the Examiner has established a prima facie showing that the
subject matter of the claims would have been obvious to a person of ordinary
skill in the art at the time the invention was made over Giamalva combined
with Adams or Adams and Takakura. Appellant has not produced evidence
showing, or persuasively argued, that the Examiner’s determinations on
obviousness are incorrect. Only those arguments made by Appellant in the
Briefs have been considered in this Decision. Arguments not presented in
the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv) (2015). We have
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identified claim 1 as representative; therefore, all claims fall with claim 1.
We address Appellant’s arguments below.
Appellant begins by noting that the present invention satisfies a long
felt need, namely an excipient which would chemically inhibit and attempt
to convert pseudoephedrine into methamphetamine. Appeal Br. 11–12.
Appellant contends that the prior art methods were mostly limited to
physical methods of prohibiting conversion of pseudoephedrine. Id.
We are not persuaded by this argument. Appellant has offered no
objective evidence to support its contention that there was a long-felt need
and that the present invention satisfied that need. See Prefect Web Tech.,
Inc., v. InfoUSA, Inc., 587 F3d 1324, 1332(Fed. Cir. 2009) (Long-felt need
argument by patentee failed because patentee failed to put forward evidence
to support contention.) Appellant has only presented attorney argument on
this point and attorney argument is insufficient. “Attorneys’ argument is no
substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581
(Fed. Cir. 1989).
Appellant contends that the references teach away from the claimed
invention. Appeal Br. 13–15. Appellant contends that Giamalva does not
teach or suggest the use of additives which would chemically inhibit
conversion of pseudoephedrine to methamphetamine and that some of the
additives suggested by Giamalva would actually promote conversion of
pseudoephedrine to methamphetamine. Id. at 14.
We have considered the arguments and evidence presented by
Appellant and are not persuaded. We begin by noting that the present claims
are to a composition comprising ephedrine or pseudoephedrine and an
organoleptic excipient and not a method for using the composition. Appeal
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Br. 23 (Claims App’x). Giamalva teaches the preparation of a composition
comprising pseudoephedrine and an amine based odorant which deters the
conversion of pseudoephedrine to methamphetamine. FF1–3. Adams
teaches that pyrazines are amine containing compounds that produce aromas
or smells and include a compound which has the structure taught by the
Specification. FF4–8. Appellant points to nothing in Giamalva or Adams,
which criticizes, discredits, or otherwise discourages using the compounds
of Adams in the composition of Giamalva. In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004.
With respect to the physical process versus the chemical process
argued by Appellant, as the Examiner noted “the fact that applicant has
recognized another advantage which would flow naturally from following
the suggestion of the prior art cannot be the basis for patentability when the
differences would otherwise be obvious.” Ans. 15. See Atlas Powder Co.,
190 F.3d at 1347.
Appellant next argues that the prior art does not enable the claimed
composition. Appeal Br. 15–17. Appellant contends that the compositions
taught by Giamalva do not inhibit the chemical conversion of
pseudoephedrine to methamphetamine. Id.
Once again, we are not persuaded by Appellant’s argument. We
begin by noting that the claim is directed to a composition and not a method.
As discussed above, Giamalva teaches a composition comprising
pseudoephedrine and an amine based odorant which interferes with the
conversion of pseudoephedrine. FF1–3. Adams teaches that pyrazines
including those having a chemical structure meeting the requirements of
formula I in the Specification, exhibit aromas. FF4–9. We agree with the
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Examiner that it would have been obvious to substitute the pyrazines of
Adams for the odorants of Giamalva. Ans. 18. “The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 416 (2007).
With respect to the ability of the composition to chemically inhibit the
conversion of pseudoephedrine to methamphetamine, the composition
resulting from the combination of Giamalva and Adams matches the claimed
composition. FF1–9. “Where . . . the claimed and prior art products are
identical or substantially identical . . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. . . . [The] fairness [of the burden-
shifting] is evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255
(CCPA 1977). Appellant has not offered any persuasive evidence why the
composition resulting from the combination of references would not possess
the same property.
Appellant contends that the Examiner engaged in impermissible
hindsight in making the rejections. Appeal Br. 17–18. Appellant argues that
because Giamalva does not teach any particular structure for the
organoleptic agent to be used and because Adams does not teach anything
relating to preventing illicit manufacture of methamphetamine, the Examiner
must have based the proposed combination on Applicant’s disclosure, an
impermissible use of hindsight. Id.
Appellant’s argument is unpersuasive. “Any judgment on
obviousness is in a sense necessarily a reconstruction based upon hindsight
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reasoning, but so long as it 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 applicant’s disclosure,
such a reconstruction is proper.” In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971).
As discussed above, the Examiner’s finding of obviousness is based
solely on the teachings of the references. Giamalva teaches the use of amine
based odorants as an additive to pseudoephedrine to prevent illicit
conversion of pseudoephedrine to methamphetamine. FF1–3. Adams
teaches that pyrazines are amine compounds which produce smells or
aromas. FF4–8. We discern nothing in the Examiner’s rejection that is
based on knowledge gleaned from Appellant’s disclosure.
Appellant contends that the Examiner’s rejection is based on an
improper “obvious to try” doctrine. Appeal Br. 19–20. Appellant contends
that one skilled in the art would not have had a reasonable expectation of
success in inhibiting production of methamphetamine by combining the
teachings of the references. Id.
We remain unpersuaded. As discussed above, the combination of
elements involves substitution of one known amine odorant for another,
which is prima facie obvious absent any evidence of unexpected results.
Appellant has not offered any evidence of unexpected results.
Appellant contends that the Examiner has improperly relied upon
inherency in making the rejection. Appeal Br. 20. Appellant contends that
the Examiner erred in finding that the undisclosed use of the claimed
composition, chemical inhibition of methamphetamine production, was
inherent in the claimed composition. Id. Appellant contends that the
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Examiner’s finding is contradicted by the Examiner’s own statements and
that Giamalva teaches away from the proposed combination. Id. Appellant
also argues that there is not structural similarity between the claimed
composition and the prior art. Id.
These arguments are unpersuasive. We agree with the Examiner that
the rejection is not one based on inherency but on the specific teachings of
the references. Ans. 32. We have addressed the issue of whether Giamalva
teaches away above and will not repeat that discussion here.
With respect to structural similarity, Adams teaches the odorant
acetylpyrazine which has a chemical structure meeting the definition of a
pyrazine organoleptic agent and having a structure matching the structure
recited in the Specification and recited in claims 3. FF4–9; Appeal Br. 24
(Claims App’x.). Clearly there is structural similarity between the
composition advanced by the Examiner and that recited in the claims.
Finally, Appellant contends that the Examiner summarily dismissed
Appellant’s arguments without providing and technical evidence or other
support to contradict Appellant’s arguments. Appeal Br. 22.
We are not persuaded by this argument. As shown from the
discussion above, the Examiner’s rejection is based on the clear teachings of
the references and applicable case law.
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that the subject matter of the rejected claims would
have been obvious over Giamalva combined with Adams or Adams and
Takakura.
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CONCLUSION
The Examiner’s rejections are affirmed

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 10 103(a) Giamalva, Adams 1–3, 10
12, 13 103(a) Giamalva, Adams,
Takakura
12, 13
Overall
Outcome
1–3, 10, 12,
13

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED