Ex Parte Bajpai

Patent Trial and Appeal Board

Mar 24, 2016

12054129 (P.T.A.B. Mar. 24, 2016)

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.
12/054,129 03/24/2008 Mangala P. Bajpai 5548
30621 7590 03/25/2016
JENSEN + PUNTIGAM, P.S.
2033 6th Ave, Suite 1020
SEATTLE, WA 98121
EXAMINER
MARTIN, PAUL C
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE
03/25/2016 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 MANGALA P. BAJPAI
__________

Appeal 2013-010566
Application 12/054,129
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, ULRIKE W. JENKS and
RICHARD J. SMITH, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for identifying medicinally active chemical entities. The Examiner rejected
the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

1 Appellant identifies the Real Party in Interest as Mukul Bajpai
(see Br. 3).
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Statement of the Case
Background
“This invention relates generally to methods of drug discovery and
development, and more specifically concerns such a method which is
substantially faster in identifying safe and effective drugs produced from
ethnobotanical substances than existing methods.” (Spec. 1, ll. 8–11).
The Claims
Claims 1–8, 12–24 and 28–42 are on appeal.2 Independent claim 1 is
representative and reads as follows:
1. A method for identifying medicinally active chemical
entities in ethnobotanical substances, comprising the steps
of:
(1) providing an ethnobotanical natural substance
occurring in nature, the ethnobotanical substance comprising
an existing land or marine plant source and extracts thereof
identified as having an active agent associated with a
medicinal effect on humans;
(2) performing an in-vitro assay with the
ethnobotanical substance with one or more of the following:
(a) human intestinal preparations and (b) human liver
preparations, thereby producing an array of human chemical
entities;
(3) performing an in-vitro assay of said ethnobotanical
substance using one or more of the following: (a) animal
intestinal preparations and (b) animal liver preparations from
at least one selected animal species to produce an array of
animal chemical entities;
(4) comparing the array of human chemical entities
with the array of animal chemical entities;

2 Claims 9–11 and 25–27 were withdrawn from consideration (see
Non-final Action 6/25/2010).
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(5) determining any matches between the human
chemical entities in the array of human chemical entities and
the animal chemical entities in the array of animal chemical
entities to identify a matched animal species;
(6) performing an in-vivo dosing of the ethnobotanical
substance with the matched animal species;
(7) obtaining a biological fluid sample from the
matched animal species following the in-vivo dosing;
(8) performing an analysis of the biological fluid
sample from the matched animal species to determine the
presence of chemical entities in the biological fluid sample;
and
(9) comparing the chemical entities in the biological
fluid sample with the human chemical entities from the in-
vitro assay and determining any matches between the
chemical entities in the biological fluid sample with the
human chemical entities from the in-vitro assay.

(Br. 11.)
The Issues3
A. The Examiner rejected claims 1, 2, 4–7, 12, 13, 15, 17, 18, 20–23, 28,
29, 31, 33, 34, 36–39, and 41 under 35 U.S.C. § 102(b)4 over Ireson5 (see
Non-Final Action 8/11/2011 at 9–11).

3 The Examiner withdrew the indefiniteness rejection before appeal
(see Adv. Action 9/19/2012). Therefore, this rejection is moot.
4 We take note that Appellant incorrectly identified the claims as
rejected under 35 U.S.C. § 102(a) (Br. 6).
5 Ireson et al., Characterization of Metabolites of the
Chemopreventive Agent Curcumin in Human and Rat Hepatocytes
and in the Rat in Vivo, and Evaluation of Their Ability to Inhibit
Phorbol Ester-induced Prostaglandin E2 Production, 61 CANCER
RES. 1058–1064 (2001).

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B. The Examiner rejected claims 1–7, 12, 13, 15, 17–23, 28, 29, 31, 33–
39, and 41 under 35 U.S.C. § 103(a) over Ireson (see Non-Final Action
8/11/2011 at 11–12).
C. The Examiner rejected claims 1–8, 12–15, 17–24, 28–31, and 33–41
under 35 U.S.C. § 103(a) over Ireson and Lu6 (see Non-Final Action
8/11/2011 at 13).
D. The Examiner rejected claims 1–7, 12, 13, 15, 16–23, 28, 29, 31–39,
41, and 42 under 35 U.S.C. § 103(a) over Ireson and Barnes7 (see Non-Final
Action 8/11/2011 at 14–15).

A. 35 U.S.C. § 102(b) over Ireson
The Examiner states that Ireson teaches, inter alia, “a method
comprising the steps of: providing the ethnobotanical substance curcumin
associated with anti-inflammatory and cancer chemopreventative activities,
which reads on step 1” (Non-Final Action 10).
Appellant concedes that Ireson teaches “using a previously identified
(i.e. known), purified single compound as a starting point for its drug
investigation . . . [which is] obtained as a processed and purified compound,
or as a chemically synthesized compound” (Br. 7). Appellant contends,

6 Lu et al., Comparison of Intrinsic Clearance in Liver Microsomes
and Hepatocytes from Rats and Humans: Evaluation of Free
Fraction and Uptake in Hepatocytes, 34 DRUG METABOLISM AND
DISPOSITION 1600–1605 (2006).
7 Barnes et al., Applications of LC-MS in the study of the uptake,
distribution, metabolism and excretion of bioactive polyphenols
from dietary supplements, 78 LIFE SCIENCES 2054–2059 (2006).
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however, that “[t]he claimed invention, on the other hand, starts with
ethnobotanical natural substances, specifically, unrefined and unpurified
natural substances which occur in nature” (id.).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Ireson teaches an extract of an
ethnobotanical natural substance, as required by claims 1, 17, and 33?
Findings of fact
1. The Specification teaches that “[t]he term ethnobotanical
substance used herein includes extracts thereof” (Spec. 4, ll. 23–24).
2. Ireson teaches that “[c]urcumin . . . is the major yellow pigment
extracted from turmeric, the powdered rhizome of the herb Curcuma longa”
(Ireson 1058, col. 1).
Principles of Law
“A single prior art reference that discloses, either expressly or
inherently, each limitation of a claim invalidates that claim by anticipation.”
Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir.
2005).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (see Non-Final Action 8/11/2011 at 9–11;
FF 1, 2) and agree that the claims are anticipated by Ireson. We address
Appellant’s arguments below.
During prosecution, the USPTO must interpret terms in a claim using
“the broadest reasonable meaning of the words in their ordinary usage as
they would be understood by one of ordinary skill in the art, taking into
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account whatever enlightenment by way of definitions or otherwise that may
be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Turning to the language of independent claims 1, 17, and 33
themselves we find that the claim language expressly recites “an
ethnobotanical natural substance . . . and extracts thereof identified as having
an active agent associated with a medicinal effect on humans”. The
specification teaches that “[t]he term ethnobotanical substance used herein
includes extracts thereof” (FF 1).
Having considered the plain language of the claims in light of the
Specification, and keeping in mind that Ireson teaches that “[c]urcumin . . .
is the major yellow pigment extracted from turmeric” (FF 2; emphasis
added), we conclude that Ireson teaches an extract of an ethnobotanical
natural substance, as required by independent claims 1, 17, and 33.
Appellant concedes that Ireson teaches “using a previously identified
(i.e. known), purified single compound as a starting point for its drug
investigation . . . [which is] obtained as a processed and purified compound,
or as a chemically synthesized compound” (Br. 7). Appellant contends,
however, that the “claimed invention, on the other hand, starts with
ethnobotanical natural substances, specifically, unrefined and unpurified
natural substances which occur in nature . . . These natural substances
always comprise a plurality of compounds, not just a single previously
identified compound which has been processed/purified/chemically
synthesized for specific investigation” (Br. 7).
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We are not persuaded. If Appellant wished to only claim unrefined
and unpurified natural substances which occur in nature, and are not extracts
thereof, they were free to amend the claims to exclude the phrase “and
extracts thereof” to further limit the method claim. See In re Zletz, 893 F.2d
319, 321 (Fed. Cir. 1989) (“[D]uring patent prosecution when claims can be
amended, ambiguities should be recognized, scope and breadth of language
explored, and clarification imposed.”)
There is no requirement in claims 1, 17, and 33 that the method
cannot be employed on previously identified substances, nor is there a
limitation in the claims excluding extracts composed of purified compounds.
See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments
fail from the outset because . . . they are not based on limitations appearing
in the claims.”)
Conclusion
The evidence of record supports the Examiner’s conclusion that
Ireson teaches an extract of an ethnobotanical natural substance, as well as
the other claim limitations, as required by claims 1, 17, and 33.

B-D. 35 U.S.C. § 102(b) over Ireson
Appellant does not separately argue the three obviousness rejections,
and contends that “the reasons provided above with respect to Ireson are
applicable to the rejection of the above claims under 35 U.S.C. § 103(a) (Br.
8–9). We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (see Non-Final Action 8/11/2011 at 11–
15). Having affirmed the rejection of claims 1, 17, and 33 over Ireson as
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anticipated, we necessarily affirm the three obviousness rejections for the
reasons stated above.
SUMMARY
We affirm the rejection of claim 1, 17 and 33 under 35 U.S.C.
§ 102(b) as anticipated by Ireson. Claims 2, 4–7, 12, 13, 15, 18, 22, 23, 28,
29, 31, 34, 36–39, and 41 fall with claims 1, 17 and 33. 37 C.F.R.
§ 41.37(c)(1)(iv).
We affirm the rejection of claims 1–7, 12, 13, 15, 17–23, 28, 29, 31,
33–39 under 35 U.S.C. § 103(a) over Ireson.
We affirm the rejection of claims 1–8, 12, 13–15, 17–24, 28–31, 33–
41, under 35 U.S.C. § 103(a) over Ireson and Lu.
We affirm the rejection of claims 1–7, 12, 13, 15, 16–23, 28, 29, 31–
39, 41, and 42 under 35 U.S.C. § 103(a) over Ireson and Barnes.

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