Ex Parte Dressman et al

Patent Trials and Appeals Board

Feb 13, 2019

14511669 - (D) (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/511,669 10/10/2014 Marlene Michelle Dressman
23550 7590 02/15/2019
HOFFMAN WARNICK LLC
540 Broadway
4th Floor
ALBANY, NY 12207
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.
VAND-0126-USl 1434
EXAMINER
PODGORSKI, DANIEL MICHAEL
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
02/15/2019 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):
PTOCommunications@hoffmanwarnick.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARLENE MICHELLE DRESSMAN,
MIHEAL H. POLYMEROPOULOS, and PAOLO BAROLDI 1
Appeal 2018-002176
Application 14/511,669
Technology Center 1600
Before ERICA A. FRANKLIN, JOHN G. NEW, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 from the Examiner's
rejections of claims directed to treating sleep disorders as obvious and for
1 Appellants identify the Real Party in Interest as Vanda Pharmaceuticals,
Inc. Br. 1.
2 We have considered and herein refer to the Specification of Oct. 10, 2014
("Spec."); Final Office Action of Feb. 22, 2017 ("Final Act."); Appeal Brief
of July 24, 2017 ("Br."); Examiner's Answer of Oct. 25, 2017 ("Ans."); and
Reply Brief ("Reply Br.") of Dec. 26, 2017.
Appeal 2018-00217 6
Application 14/511,669
non-statutory obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
The invention relates to a method for treating circadian rhythm or
sleeps disorders using tasimelteon. Abstract. The Specification describes a
method whereby tasimelteon is administered under fasting conditions. Spec.
1.
Claims 1-3, 5, 6, 9-11, and 13-24 are on appeal. Claim 1
representative and reads as follows:
1. A method of treating a human patient suffering from a
circadian rhythm disorder or a sleep disorder that
comprises orally administering to the patient an effective
dose of tasimelteon without food, wherein the effective
dose is 20 mg/ d.
The claims stand rejected as follows:
Claims 1-3, 5, 9-11, and 13-24 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Rajaratnam3 in view of Guidance. 4
3 Rajaratnam & Polymeropoulos., Melatonin agonist tasimelteon (VEC-162)
for transient insomnia after sleep-time shift: two randomised control
multicentre trials, 373 The Lancet 482-93 (2009) ("Rajaratnam").
4 Ctr. Drug Eval. & Res., Food & Drug Admin., Guidance for Industry:
Food-Effect Bioavailability and Fed Bioequivalence Studies, 1-9 (2002)
("Guidance").
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Application 14/511,669
Claims 6 and 14 have been rejected under 35 U.S.C. § 103(a) as
unpatentable over Rajaratnam in view of Guidance in further view of
Zisapel. 5
Claims 1-3, 5, 6, 9-11, 13, and 14 have been rejected fornon-
statutory obviousness-type double patenting over claim 1 ofUSSN
14/510,321 6 in view of Guidance.
Claims 1-3, 5, 6, 9-11, 13, and 14 have been rejected for non-
statutory obviousness-type double patenting over claims 67, 70, 71, 75, 78,
81, 84, and 87 ofUSSN 14/374,2577 in view of Guidance.
Claims 1-3, 5, 6, 9-11, 13, 14, and 15-24 have been rejected for non-
statutory obviousness-type double patenting over claim 1 of Dressman III8 in
view of Guidance.
DISCUSSION
Issue
In each of the rejections on appeal, the Examiner relies on the
teachings of Guidance to support the conclusion of obviousness or
5 N. Zisapel, Circadian Rhythm Sleep Disorders: Pathophysiology and
Potential Approaches to Management, 15 CNS Drugs (4) 311-328 (2001)
("Zisapel").
6 USSN 14/510,321 issued on Aug. 15, 2017 as US 9,730,910 B2, and lists
Dressman et al. as inventors. ("Dressman I").
7 USSN 14/374,257 issued on Jan. 24, 2017 as US 9,549,913 B2, and lists
Dressman et al. as inventors. ("Dressman II").
8 Dressman et al., US 8,785,492 B2, issued July 22, 2014 ("Dressman III").
We shall refer to Dressman I, II, and III collectively as "the Dressman
patents."
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Appeal 2018-00217 6
Application 14/511,669
obviousness-type double patenting. Final Act. 3--4, 11-12, and 14--15. The
issue therefore before us is whether the teachings of Guidance support the
Examiner's conclusion that the subject matter of the claims would have been
obvious or that the rejected claims are not patently distinct from the
Dressman patents.
The Examiner finds that Rajaratnam teaches the administration of
tasimelteon to treat transient insomnia in circadian rhythm sleep disorders.
Final Act. 3. The Examiner also finds that Rajaratnam teaches administering
tasimelteon orally in doses of 10, 20, 50, or 100 mg. Id.
With respect to the obviousness-type double patenting rejections, the
Examiner finds that each of the Dressman patents claim methods for treating
patients with a circadian rhythm sleep disorder using a 20 mg dose of
tasimelteon. Final Act. 11 and 13.
The Examiner finds that Guidance teaches that food can affect the
bioavailability of drugs resulting in clinically significant consequences.
Final Act. 3, 11, and 13. The Examiner finds that Guidance teaches testing
drug formulations under both fasting and fed conditions to determine what
effect these states have on bioavailability. Id.
The Examiner concludes
It would have been prima facie obvious to one of
ordinary skill in the art at the time of the invention to have
administered tasimelteon under fasted conditions (i.e. without
food; instant claims 2, 8, 10). One would have been motivated
to do so as Guidance teaches that food changes the
bioavailability of a drug and has clinically significant
consequences, such as altered bioavailability, drug
permeability, and systematic availability, and that the
magnitude and direction of such effects are impossible to
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Appeal 2018-00217 6
Application 14/511,669
determine without administration of a drug under fasted or fed
conditions. Therefore one of ordinary skill in the art would have
had a reasonable expectation of determining the optimal food
effects of administration conditions of tasimelteon to treat
circadian rhythm sleep disorders by administration of the drug
under fasted conditions (i.e. without food).
Final Act. 4, 13, and 15.
Appellants contend that one skilled in the art reading Guidance would
not have been led to administer tasimelteon under fasting conditions.
Appeal Br. 3. Appellants argue that Guidance does not teach or suggest that
fasting would have any effect on the bioavailability of tasimelteon. Id.
Appellants contend that without the study conducted by Appellants, one
skilled in the art could not predict what effect, if any, fasting would have on
the bioavailability of tasimelteon. Appeal Br. 4.
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 ofunpatentability. 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).
The test of obviousness is "whether the teachings of the prior art,
taken as a whole, would have made obvious the claimed invention." In re
Gorman, 933 F.2d 982, 986 (Fed. Cir. 1991).
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Application 14/511,669
"It is well-established that before a conclusion of obviousness may be
made based on a combination of references, there must have been a reason,
suggestion, or motivation to lead an inventor to combine those references."
Pro-Mold & Tool Co. v. Great Lakes Plastics Inc., 75 F.3d 1568, 1573,
(Fed. Cir. 1996).
"[T]he law of obviousness-type double patenting looks to the law of
obviousness generally. As ... explained in Amgen, '[t]his part of the
obviousness-type double patenting analysis is analogous to an obviousness
analysis under 35 U.S.C. § 103."' AbbVie Inc. v. The Mathilda and
Terrence Kennedy Inst. of Rheumatology Trust, 764 F.3d 1366, 1378-79
(Fed. Cir. 2014) (Emphasis in the original).
Analysis
We have considered the arguments advanced by the Examiner and
Appellants and find that Appellants have the better positon. While Guidance
suggests administration of a drug while fasting, that teaching is part of a test
design to see if food intake has an effect on bioavailability and
bioequivalence. Guidance 4--5. The Guidance explains that such test should
be carried out in "healthy volunteers drawn from the general population."
Id. at 5. The Guidance does not teach or suggest administering the drug
while fasting to treat a condition or to patients in need of such treatment.
Rather it teaches that the test described in the Guidance should be used to
determine if food affects bioavailability and bioequivalence. Id. at 1.
Indeed, the results of the test are not measured with respect to any treatment
effectiveness. Instead, the Guidance teaches that fluid samples, usually
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Application 14/511,669
plasma, should be collected "to permit characterization of the complete
shape of the plasma concentration-time profile" for the drug. Id. at 6. Thus,
we agree with Appellants that one skilled in the art would not be motivated
to combine the teachings of Rajaratnam and the Guidance to administer
tasimelteon after fasting to treat a patient suffering from a circadian rhythm
or a sleeping disorder, as required by the claims. Appeal Br. 4.
We note also that the Examiner has not asserted, nor do we see, that
Zisapel supplies such a motivation either.
Conclusion of Law
We conclude that the Examiner has not established that the subject
matter of the claims would have been obvious over Rajaratnam combined
with Guidance alone or in further view of Zisapel.
We also conclude that the Examiner has not established that the
present claims are not patently distinct from the claims of the Dressman
patents for the same reasons we have discussed regarding the deficiency in
the Examiner's obviousness rejection.
SUMMARY
We reverse the rejections under 35 U.S.C. § I03(a).
We reverse the rejections for non-statutory obviousness-type double
patenting.
REVERSED
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