Ex Parte ZAWOROTKO et al

Patent Trial and Appeal Board

Jan 17, 2019

14533255 (P.T.A.B. Jan. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/533,255 11/05/2014 Michael John ZA WOROTKO
136746 7590 01/22/2019
Thomas Horstemeyer (USF)
3200 Windy Hill Road, SE
Suite 1600E
Atlanta, GA 30339
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
292104-1781 6923
EXAMINER
WEDDINGTON, KEVIN E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
01/22/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
uspatents@thomashorstemeyer.com
docketing@thomashorstemeyer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL JOHN ZAWOROTKO, HEATHER CLARK, ARORA
KAPILDEV, PAD MINI KA VURU, ROLAND DOUGLAS SHYTLE,
TWARITA PUJARI, LISSETTE MARSHALL, AND TIEN TENG ONG,
Appeal2017-011332
Application 14/533 ,255 1
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition comprising a co-crystal of a nutraceutical and a co-crystal
former, which have been rejected as anticipated. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
"Nutraceuticals refer to a food or food component claimed to human
health benefits." (Spec.~ 3.) "[N]utraceuticals may be amorphous, may
1 Appellants identify the real party in interest as the University of South
Florida Division of Patents and Licensing. (Appeal Br. 3.)
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Application 14/533,255
have different crystalline polymorphs, or may exist in different solvation or
hydration states. . . . [V]ariation of the crystalline state of a nutraceutical is
one of many ways in which to modulate the physical properties thereof."
(Id. ,I 7)
"A co-crystal is a multiple component crystal containing two or more
nonidentical molecules in which all components are solid under ambient
conditions ... when in their pure form." (Id. at ,r 8.) Appellants' invention
"is generally related to co-crystal compositions containing nutraceuticals."
(Id. ,I 2.)
Claims 1---6 and 16-18 are on appeal. Claim 1 is representative and
reads as follows:
1. A composition comprising a co-crystal of a
nutraceutical and a co-crystal former, the co-crystal with or
without impurities wherein
(i) the nutraceutical and the co-crystal former are
hydrogen bonded to each other,
(ii) the nutraceutical is selected from the group consisting
of vitamin B2 (riboflavin), glucosamine HCl, chlorogenic acid,
lipoic acid, catechin hydrate, creatine, acetyl-L-camitine HCl,
vitamin B6, pyridoxine, caffeic acid, naringenin, vitamin B 1
(thiamine HCl), baicalein, luteolin, hesperedin, rosmarinic acid,
epicatechin gallate, epigallocatechin, vitamin B9 (folic ),
genistein, methylvanillin, ethylvanillin, silibinin, diadzein,
melatonin, rutin hydrate, vitamin A, retinol, vitamin D2
( ergocalciferol), vitamin E (tocopherol), diosmin, menadione
(K3), vitamin D3 (caholecalciferol), phloretin, indole-3-
carbinol, fisetin, glycitein, chrysin, gallocatechin, vitamin B4
(adenine), vitamin B5 (pantothenic acid), vitamin B7 (biotin),
theobromine, quercetin, ferulic acid, ellagic acid, hesperitin,
and protocatechuic acid, and
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Application 14/533,255
(iii) a co-crystal former selected from the group
consisting of pharmaceutically acceptable carbohydrates,
amines, amides, sulfonamides, carboxylic acids, sulfonic acids,
phenols, polyphenols, aromatic heterocycles, xanthines and
alcohols.
(Appeal Br. 14.)2
The following ground of rejection by the Examiner is before us on
review:
Claims 1---6 and 16-18 under 35 U.S.C. § 102(b) as anticipated by
Almarsson. 3
DISCUSSION
According to the Examiner, Almarsson "teaches the same broad
composition [as] the applicants' present ... broad claim 1." (Ans. 4.) The
Examiner finds that Almarsson teaches a co-crystal of an API [(active
pharmaceutical ingredient)] and co-crystal former where the "API is
quercetin (page 375, Table IV) and the co-crystal former is caffeine, a
xanthine (page 96, Table 1)." (Id. at. 2-3.) The Examiner notes that in such
a composition, the API, which is a nutraceutical, and the co-crystal former
would necessarily be hydrogen bonded because the composition would have
the identical chemical structure claimed and a "composition and its
properties are inseparable." (Id.)
We disagree with the Examiner's conclusion that Almarsson
anticipates claim 1.
2 Formatting added for ease of understanding.
3 Almarsson et al., WO 2004/078163 A2, published Sept. 16, 2004.
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Application 14/533,255
"It is well established that the disclosure of a genus in the prior art is
not necessarily a disclosure of every species that is a member of that genus."
Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006).
While verbatim disclosure is not required to establish anticipation of a
chemical composition where the prior art disclosure provides for combining
lists of ingredients, our reviewing Court has explained that, in order to
anticipate, the prior art disclosure must be such that a person of ordinary
skill would "at once envisage" the specific claimed composition as being a
member of a limited class. See e.g., In re Petering, 301 F.2d 676, 687
(CCPA 1962); see also Nidec Motor Corp. v. Zhongsshan Broad Ocean
Motor, 851 F.3d 1270, 1274--75 (Fed. Cir. 2017) ("the relevant question [in
Kennametal Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376 (Fed. Cir.
2015) regarding anticipation] was 'whether the number of categories and
components disclosed in [the prior art reference] is so large that the
combination of ruthenium and PVD coatings would not be immediately
apparent to one of ordinary skill in the art.'").
In In re Schaumann, 572 F.2d 312 (CCPA 1978), anticipation was
found where the reference disclosed a genus limited to a single variable with
14 possibilities, (id. at 316), and in Petering, a vast number of permutations
of substituent groups under a generic chemical formula was reduced to a
subgenus of 20 compounds, including the claimed species, by recourse to
"preferences" disclosed in the reference, (301 F .2d at 681 ). In Kennametal,
"[t]he prior art reference disclosed five binding agents (one of which was
ruthenium) and three coating techniques ( one of which was PVD)" and
"taught that any of the five binding agents could be used with any of the
three coating techniques," which was deemed sufficient disclosure to
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Application 14/533,255
anticipate a claim that "required a ruthenium binding agent and a PVD
coating to be used together." Nidec, 851 F.3d at 1274 (explaining the
narrow decision in Kennametal).
As Appellants point out, Almarsson provides a list of possible API's
in table IV and a list of possible co-crystal formers in Table I and does not
specifically disclose the combination asserted by the Examiner. (Appeal Br.
11; Reply Br. 2.) Rather Almarsson states:
In a further embodiment the co-crystal comprises an API from
Table IV and a co-crystal former with a functional group of
Table III. In a further embodiment, the co-crystal is from Table
I or II.
( Almarsson at 3 3.)
Table IV, which lists possible API' s that one may select to combine
with a co-crystal former from Tables I, II or III spans over 200 pages and
includes well over 2000 compounds. (Id. at 174--434.) Almarsson states
that the API can have "at least one functional group selected from ether,
thioether, alcohol, thiol, aldehyde, ketone, thioketone, nitrate ester,
phosphate ester, thiophosphate ester, ester, thioester, sulfate ester, carboxylic
acid, phosphinic acid, phosphonic acid, sulfonic acid, amide, primary amine,
secondary amine, ammonia, tertiary amine, imine, thiocyanate, cyanamide,
oxime, nitrile diazo, organohalide, nitro, S-heterocyclic ring, thiophene, N-
heterocyclic ring, pyrrole, 0-heterocyclic ring, furan, epoxide, peroxide,
hydroxamic acid, imidazole, [and] pyridine." (Id. at 4.) The scope of that
list is quite broad. To the extent that Almarsson narrows that group, it
provides examples using the following API's: celecoxib (Example 1 and 2),
topiramate (Example 3 ), olanzapine (Example 4), itraconazole (Examples
5-9), modafinil (Examples 10-12), 5-fluorouracil (Example 13);
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Application 14/533,255
hydrochlorthiazide (Examples 14--16), acetaminophen (Example 17),
phenytoin (Example 18), acetylsalicylic acid (Example 19), ibuprofen
(Example 20), flurbiprofen (Examples 21 and 22), carbamazepine (Example
23-30). The structure of these chemicals are diverse and does not point to a
particular class of compounds or a subgenus of disclosed structures for the
API selection.
Almarsson does not contain a disclosure comparable to that in
Schaumann, Petering, or Kennametal such that one of ordinary skill in the
art would at once envisage a limited class of API' s that would fall within the
scope of claim 1, or specifically the nutraceutical quercetin, which the
Examiner selects from the vast listing in Table IV, to combine with a co-
crystal former resulting in a composition where the nutraceutical and the co-
crystal former are hydrogen bonded to each other. Thus, despite the fact that
claim 1 on appeal recites nutraceuticals with disparate chemical structures,
we conclude that the Examiner has failed to establish on the record before us
that Almarsson anticipates claim 1.
We note that obviousness is not a rejection on appeal. Thus, we do
not take an ultimate position on whether the invention of claim 1 would have
been prima facie obvious from the disclosure of Almarsson.
SUMMARY
We reverse the rejection of claims 1---6 and 16-18 under 35 U.S.C.
§ 102(b) as anticipated by Almarsson.
REVERSED
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