Ex Parte Robertson et al

Patent Trial and Appeal Board

Mar 22, 2019

14755390 (P.T.A.B. Mar. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/755,390 06/30/2015 Gavin P. Robertson
25006 7590 03/26/2019
DINSMORE & SHOHL LLP
900 Wilshire Drive
Suite 300
TROY, MI 48084
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.
PSTC-26107/47 6285
EXAMINER
JEAN-LOUIS, SAMIRA JM
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/26/2019 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):
MichiganPatTM@dinsmore.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GA VIN P. ROBERTSON, ARATI K. SHARMA,
ARUN K. SHARMA, SHANTU G. AMIN, and
DHIMANT H. DESAI 1
Appeal2018-001556
Application 14/755,390
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
RYAN H. FLAX, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a pharmaceutical composition.
The Examiner rejected the claims as obvious under 35 U.S.C. § 103 and for
obvious-type double-patenting. Pursuant to 35 U.S.C. § 134, Appellants
appeals the Examiner's determination that the claims are unpatentable. We
have jurisdiction for the appeal under 35 U.S.C. § 6(b). The Examiner's
decision is affirmed.
1 The Appeal Brief ("Br." entered April 18, 2017) lists The Penn State
Research Foundation as the real-parties-in-interest. Br. 1.
Appeal2018-001556
Application 14/755,390
STATEMENT OF THE CASE
Claim 7, 10, and 11 stand rejected by the Examiner as follows:
Claim 7 on the ground of nonstatutory obviousness-type double
patenting as being obvious in view of claim 1 of U.S. Patent No. 9,126,910
B2, published Sept. 8, 2015 ("Robertson"). Ans. 4.
Claims 7, 10, and 11 under 35 U.S.C. § I03(a) as obvious in view of
Lam et al. (U.S. Patent No. 6,703,524 B2, issued Mar. 9, 2004) ("Lam
'524"). Ans. 5.
Claims 7, 10, and 11 under 35 U.S.C. § I03(a) as obvious in view of
Lam et al. (U.S. Publication No. 2004/0158079 Al, published Aug. 12,
2004) ("Lam '079"). Ans. 8.
Claim 7, the only independent claim on appeal, is reproduced below:
7. A pharmaceutical composition, comprising
N~c=se
, where n is 6,
and a pharmaceutically acceptable carrier.
OBVIOUSNESS-TYPE DOUBLE-PATENTING
Because the Examiner established that claim 7 is prima facie obvious
in view of claim 1 of Robertson, and Appellants' did not provide arguments
as to why claim 7 is not obvious in view of Robertson or identify a
deficiency in the rejection, the rejection is affirmed for the reasons set forth
by the Examiner. Final Act. 5.
2
Appeal2018-001556
Application 14/755,390
OBVIOUSNESS BASED ON LAM PUBLICATIONS
Appellants stated that "the Examiner's comments relating to the two
cited [Lam] references appear to be substantially the same and therefore the
response is directed to both references, specific citations relating to U.S.
Patent No. 6,703,524 [Lam '524]." Br. 2. Thus, while the discussion below
cites only the disclosure in Lam '524, it applies equally to Lam '079.
The Examiner found that Lam '524 describes a genus of compounds
represented by formula (III) which encompasses the claimed species recited
in claim 7. Final Act. 7. While the formula does not explicitly recite that n
is 6 as required by claim 7, the Examiner found that 6 is suggested by Lam
'524's disclosure that the alkylene (CH2) can be Cl---C20. Final Act. 3.
The formula III compound of Lam '524 is reproduced below:
Lam '524 teaches that the formula III compound is a
xyleneisoselenocyanate. Lam '524, col. 3, 11. 31-33. R1 is "H, (alkylene )-
NCSe, or a blocking group" and R2 is (alkylene)-NCSe. Id. at col. 3, 11. 42-
43. "NCSe" corresponds to the same N=C=Se structure recited in
Appellants' claim 7. The Examiner found that when R1 is H ( one out of
three choices) and when R2 is (alkylene)-NCSe, the compound recited in
Appellants' claim 7 is met by Lam '524, where the alkylene has 6 carbons.
Final Act. 7, 9; Ans. 11.
3
Appeal2018-001556
Application 14/755,390
For the alkylene of n is 6, the Examiner cited Lam'524's disclosure
that "Linear alkylene chain lengths of about 1 to about 20 carbons (C 1-C
20) are preferred for ease of synthesis." Ans. 11 (citing Lam '524, col. 4, 11.
19-20).
Appellants argue that "there is no apparent specific teaching or
suggestion that n is 6 for R2 when R 1 is H in formula III of Lam et al. and
that given the huge number of compounds encompassed by the generic
disclosure of Lam et al., the specific composition of the instant claims is not
obvious." Br. 2. Appellants contend that the disclosure regarding the length
of the alkylene chain is with reference to the formula I and II compounds
comprising a heterocyclic ring, and not the formula III compound. Br. 2-3.
Appellants also argue:
Even if, arguendo, one considers that "linear alkylene chain
lengths of about 1 to about 20 carbons (Cl-C20) are preferred
for ease of synthesis" (Lam, col. 4, lines 19-20), a compound of
structure III, as described in col. 3, lines 32-42 (and taking into
account the definition of blocking groups at col. 4, lines 38-48),
encompasses thousands of individual structures and nowhere is
there any specific mention of the structure where n is 6 for R2
and RI is H of formula III of Lam.
Br. 3--4.
This argument does persuade us that the Examiner erred in rejecting
claim 7 as obvious in view of Lam '524. Lam '524 defines "alkylene" as a
divalent saturated hydrocarbon chain containing one or more carbon atoms,
which can be linear or branched. Lam '524, col. 3, 11. 65-67. Appellants
have not identified any disclosure in Lam '524 that this definition is
restricted to formula I and II compounds, when all three formula (I, II, and
III) precede this statement in Lam '524' s disclosure. Lam '524 also
discloses that the linear alkylene chain can have 1 to 20 carbon atoms. Lam
4
Appeal2018-001556
Application 14/755,390
'524, col. 4, 11. 19-20. Again, Appellants have not identified any disclosure
in Lam '524 which would limit the disclosure of C 1-C20 to formula I and II
compounds, and not formula III. Ans. 11-12, 14.
As found by the Examiner, formula III has only one choice for R2
(alkylene-NCSe) and three choices for R1, "H, (alkylene)-NCSe." IfH is
chosen, the only other choice is the length and structure (linear or branched)
of the alkylene chain for R2. Lam '524 describes utilizing a linear Cl---C20
for "ease of synthesis," providing one of ordinary skill a reason to have
chosen a linear alkylene with 1 to 20 carbon. Lam '524, col. 4, 11. 19-20.
Lam '524' s disclosure is not anywhere near the size of the genus in In re
Baird 16 F.3d 380, 382 (Fed. Cir. 1994) in which the court found that the
disclosed generic formula "contains a large number of variables" which it
estimated to encompass "more than 100 million different diphenols, only
one of which is [the claimed] bisphenol A." Indeed, Appellants only state
there are "thousands of individual structures" encompassed by the formula,
"taking into account the definition of blocking groups." Br. 3--4.
Petering addressed a prior art reference in an anticipation context that
disclosed a small genus of chemical compounds, finding:
A simple calculation will show that, excluding isomerism
within certain of the R groups, the limited class we find in
Karrer contains only 20 compounds. However, we wish to
point out that it is not the mere number of compounds in this
limited class which is significant here but, rather, the total
circumstances involved, including such factors as the limited
number of variations for R, only two alternatives for Y and Z,
no alternatives for the other ring positions, and a large
unchanging parent structural nucleus. With these circumstances
in mind, it is our opinion that Karrer has described to those with
ordinary skill in this art each of the various permutations here
5
Appeal2018-001556
Application 14/755,390
involved as fully as if he had drawn each structural formula or
had written each name.
In re Petering, 301 F.2d 676, 681---682 (CCPA 1962). Here, in an
obviousness context, we find that there is a limited number of choices - a
hydrogen, alkylene, and blocking group - and when hydrogen is chosen
from this small group, the only remaining choice is of alkylene - and Lam
'524 directs one of ordinary skill to choose a linear chain of 1 to 20 carbon
atoms, a limited group from which to pick 6 as the chain length. Thus, we
agree with the Examiner that the ordinary artisan would have envisaged as
obvious the limited members of a 1 to 20 alkylene group. See Ans. 12.
Appellants also argue:
no functional characteristics of the compounds of structure III
of Lam et al. appear to be disclosed at all and that even
compounds of structures I and II appear to have highly
unpredictable functional characteristics such that one of skill in
the art would not be able to sensibly extend any result shown in
Lam et al. to any compound of structure III and certainly not to
the presently claimed compound.
Br. 4. We do not agree that Lam '524 does not describe the functional
characteristics of compounds of formula III. The first sentence of the
"Summary" of Lam '524 states: "The invention provides novel
organoselenium compounds for use in cancer chemoprevention." Lam '524,
col. 2, 11. 27-28. The compounds of formula III are organoselenium
compounds and therefore have the chemoprevention function disclosed by
Lam '524.
Lam '524 describes a glutathione S-transferase ("GST") assay to
determine chemopreventive activity. Lam '524, col. 6, 11. 9-16. In the
experiments, Lam '524 states that "[a] compound that has greater than 40%
6
Appeal2018-001556
Application 14/755,390
and 80% GST increase in the liver and small bowel mucosa (SBM),
respectively, over the control level is generally regarded as worth further
investigation." Id. at col. 16, 11. 55-58. The experiments did not test a
compound of formula III.
Appellants argue that Tables 2 and 3 of Lam '524 which show results
of the GST assay "demonstrate unpredictability of functionality of the test
compounds" because not all of them achieve the 40% or 80% levels
described in Lam '524 as making them worthwhile for further investigation.
Br. 4--5.
The statement by Lam '524 about compounds meeting a certain
activity level for "further investigation" does not mean that a given
compound lacks activity. Rather, the statement indicates that when
compounds are active, only the most active are selected for further study.
This statement alone does make it unpredictable that a compound described
in Lam '524 would lack activity.
Appellants state that certain compounds in Tables 2 and 3 had less
than 40% or 80% activity, but do not show how much activity they possess
or the activity of other compounds in the table. No calculations are shown
by Appellants to substantiate the assertion. In sum, Appellants have not
provided adequate objective evidence to support their argument. An
argument made by counsel in a brief does not substitute for evidence lacking
in the record. Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed.
Cir. 1997).
Appellants also argue:
[T]he compounds tested are shown in Figure 1 of Lam et al.
(see col. 5, lines 24-35 for identification of names
corresponding to the structures of Figure 1 of Lam et al.) and
7
Appeal2018-001556
Application 14/755,390
Br. 5.
that it is apparent that the structures in Figure 1 are highly
related to each other. The wide variability in functional
characteristics in view of the structural relatedness of the tested
compounds further supports Appellant's assertion that one of
skill in the art would not find the presently claimed compound
obvious in view of Lam et al.
First, Appellants have not established the extent of the "wide
variability" of the so-called related structures. No data analysis was
provided to show the so-called "wide variability." Second, Appellants
have not established that any of the compounds in the tables lack
activity. Third, absolute predictability of success is not required to
establish obviousness. In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir.
2009). Therefore, even if there is variability in functional activity,
and some compounds lack activity, Appellants have not shown that
such differences, if any, are so great that one of ordinary skill in the
art would not have reasonably expected the claimed compound to lack
the disclosed chemoprevention activity.
For the foregoing reasons, the obviousness rejection based on
Lam '524 and Lam '079 of claim 7 is affirmed. Claims 10 and 11 fall
with claim 7 because separate reasons for patentability were not
provided. 37 C.F.R. § 4I.37(c)(l)(iv).
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
8