Ex Parte Jochelson et al

Patent Trials and Appeals Board

Jan 31, 2017

13764467 - (D) (P.T.A.B. Jan. 31, 2017)

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.
13/764,467 02/11/2013 Philip Jochelson 106229-0703 7057
30542 7590 02/02/2017
FOT FY Rr T ARDNFR T T P
EXAMINER
3000 K STREET N.W. KIM, JENNIFER M
SUITE 600
WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
02/02/2017 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):
ipdocketing @ foley. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIP JOCHELSON, ROBERTA L. ROGOWSKI, and
NEIL B. KAVEY1
Appeal 2015-008192
Application 13/764,467
Technology Center 1600
Before DEMETRA J. MILLS, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
1 Appellants state the real party-in-interest is Pemix Therapeutics Holdings,
Inc.
Appeal 2015-008192
Application 13/764,467
STATEMENT OF CASE
The following claims are representative.
1. A method, comprising:
identifying a patient in need of pharmaceutical treatment of a
sleep disorder,
evaluating the importance to that patient of selecting a
pharmaceutical agent to minimize rebound insomnia as a side effect of
pharmaceutical treatment of said sleep; and
avoiding rebound insomnia in said patient by:
selecting doxepin therapy for treating the patient based at least
in part on its low incidence of rebound insomnia, and then
treating said sleep disorder with doxepin or a pharmaceutically
acceptable salt thereof in a daily dosage between about 0.5 milligram
and 6 milligrams.
8. A method, comprising:
identifying a patient in need of pharmaceutical treatment of a
sleep disorder and also evaluating the importance to that patient of
avoiding weight gain as a side effect of pharmaceutical treatment of
said sleep disorder;
selecting a doxepin therapy protocol for the patient to reduce
the risk of weight gain as a side effect; and
avoiding weight gain as a side effect of pharmaceutical
treatment of said sleep disorder in said patient by treating said sleep
disorder with doxepin or a pharmaceutically acceptable salt thereof in
a daily dosage between about 0.5 milligram and 6 milligrams.
Cited References
Kavey US 6,211,229 B1 Apr. 3, 2001
Rodenbeck et al., The sleep-improving effects of doxepin are paralleled by a
normalized plasma cortisol secretion in primary insomnia, 170
Psychopharmacology 423 428 (2003) (“Rodenbeck”).
2
Appeal 2015-008192
Application 13/764,467
Pinder et al., Doxepin Up-to-Date: A Review of its Pharmacological
Properties and Therapeutic Efficacy with Particular Reference to
Depression, 13 Drugs 161—218 (1977) (“Pinder”).
Grounds of Rejection
Claims 1—20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Kavey2 in view of Rodenbeck and Pinder.
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 2—8.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Rejection 1
Appellants argue the claims in the following groups: Group I, claims
1—7; Group 2, claims 8—20. We select claims 1 and 8 as representative of
2 The Examiner refers to the Kavey reference as Kavey-2 throughout the
Final Action and Answer. In this decision we use the terms “Kavey” and
“Kavey-2” as both referring to U.S. Patent No. 6,211,229 to Kavey.
3
Appeal 2015-008192
Application 13/764,467
these claim groupings, respectively. We agree with the Examiner’s fact
finding, statement of the rejection and responses to Appellants’ arguments as
set forth in the Answer. We find that the Examiner has provided evidence to
support a prima facie case of obviousness. We provide the following
additional comment to the Examiner’s argument set forth in the Final
Rejection and Answer.
With respect to claim 1, the Examiner finds that
Kavey-2 teaches a method for treating transient, chronic,
and non-chronic forms of insomnia comprising administration
of doxepin, or pharmaceutically acceptable forms of doxepin, in
an amount ranging from about 0.5 to 20 mg. (Abstract; column
1, lines 51-53). Kavey-2 explicitly teaches treatment
comprising administration of doxepin in an amount is about 10
mg or less (column 9, claim 3), 5 mg. or less (column 9, claim
4), and 2 mg. (column 4, line 27). Particularly, Kavey-2 teaches
that doxepin is administered for maintenance insomnia (column
2, lines 58-63), and to allow the patient to maintain normal
sleep (column 3, lines 51-55).
Kavey-2 does not expressly teach the evaluating the
importance of minimizing rebound insomnia as well as avoid
weight gain as side effects and thereby avoiding rebound
insomnia and the weight gain.
Final Act. 6.
Rodenbeck is relied upon for teaching that, “in some patients rebound
insomnia and specific side effects of doxepin must be considered, their
finding give a further rationale for the use of sedating antidepressants in the
treatment of primary insomnia (abstract, page 426 right-hand column last
full paragraph).” Final Act. 6.
Pinder teaches that the side-effects of doxepin generally
disappear by reduction of dosage (page 205 left-hand column
4
Appeal 2015-008192
Application 13/764,467
under Side-Effects). Pinder teaches that the studies have
examined the relationship of dosage to incidence of side-
effects. In general, side-effects tended to be dose-related in a
study involving males and well as females (page 207 under
Dosage and Incidence of Side-Effect). Pinder (page 207, under
Less Common Side-Effects) teaches that notable weight gain is
one of the less common side effects of doxepin.
Final Act. 6—7.
The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time the invention was made to recognize that
evaluations such as importance of minimizing rebound
insomnia was obviously achieve by Kavey-2 because it is
within the routine medical practice in the treatment of insomnia
by administration of doxepin that rebound insomnia and
specific side effects of doxepin must be considered in some
patient populations as taught by Rodenbeck. One of ordinary
skill in the art would recognize that Kevey-2 [sic] who is expert
in the treatment of insomnia comprising administration of
doxepin obviously would have included such evaluations that
are must be considered as routine practice as taught by
Rodenbeck. With regard to the evaluation regarding avoiding
weight gain as side effect, such is obvious because the side
effect of weight gain is less common but known adverse effect
of doxepin in view of Pinder. Further, such side effect can be
avoided by lowering the dose since it is dose related as taught
by Pinder. Kevey-2, [sic] who is in expert in the field of
treating insomnia comprising administering doxepin would
have recognized that the low-dose of doxepin employed by
Kevey-2 [sic] would have avoid any side effects including,
weight gain and it is well known by Pinder that the side-effect
of doxepin is generally disappear by reduction of dosage.
Final Act. 7.
5
Appeal 2015-008192
Application 13/764,467
Appellants contend that
The claimed method is predicated according to some
embodiments, at least in part, on the surprising discovery by the
inventors that, unlike many other hypnotic medications, as an
effective sleep medication, low dose doxepin caused little or no
rebound insomnia, which directs a practitioner to choose about
0.5 mg and 6 mg of doxepin, to patients prone to rebound
insomnia. See, e.g., paragraphs [0036] and [0041] of the
specification.
App. Br. 8. Appellants further contend that
The teaching of Rodenbeck that rebound insomnia must be
considered is not a teaching or suggestion and does not provide
a reasonable expectation that rebound insomnia can be avoided
by reducing the dosage. Rather, this indicates that, at 25 mg,
doxepin was known to cause rebound insomnia and other side
effects in some patients. Thus, based on Rodenbeck, a person
skilled in the art when treating a patient having a need to avoid
rebound insomnia would avoid using doxepin, rather than
administering doxepin to the patient. Therefore, Rodenbeck
actually discourages or teaches away from administering
doxepin (or at least 25 mg of doxepin) to patients having a need
to avoid rebound insomnia.
App. Br. 9. Furthermore, Appellants contend that
Pinder studied decreasing doxepin dosages from 300 mg to 75
mg. Even the lower dosage of 75 mg is still much higher than
the side-effect causing 25 mg dosage described in Rodenbeck
(three times of the dosage of Rodenbeck). Rodenbeck showed
that rebound insomnia and other side effects were still a
problem at dosages much lower than the lowest dosage studied
by Pinder, contradictory to Pinder’s general assumption as
alleged by the Examiner. In particular, in view that Rodenbeck
teaches that rebound insomnia is a side effect of concern caused
by 25 mg doxepin, the alleged reduction of totally different side
6
Appeal 2015-008192
Application 13/764,467
effects from 300 mg to 75 mg of doxepin is irrelevant to
rebound insomnia and would not provide a motivation to use
doxepin when rebound insomnia needs to be avoided.
App. Br. 10-11.
ANALYSIS
We are not convinced by Appellants’ arguments. We agree with the
Examiner that while Appellants may take issue with the larger dosages of
doxepin described by Pinder and Rodenbeck, Appellants fail to adequately
distinguish the disclosure of Kavey, describing a method of administering
dosages as low as 0.5 mg of doxepin for the treatment of insomnia. Ans. 3.
“It is a general rule that merely discovering and claiming a new benefit of an
old process cannot render the process again patentable.” In re Woodruff,
919 F.2d 1575, 1578 (Fed. Cir. 1990). “Newly discovered results of known
processes directed to the same purpose are not patentable because such
results are inherent.” Bristol-Myers Squibb v. Ben Venue Laboratories, 246
F.3d 1368, 1376 (Fed. Cir. 2001). In the present case, Kavey essentially
discloses the same method, administering the same drug, doxepin, in a
similar dosage, to the same patient population, an individual with insomnia,
who wants to reduce drug side effects suggested by Rodenbeck, including
rebound insomnia and weight gain.
In addition, the Examiner finds that Appellants statement that Figure 7
of Pinder “indicates more side effects for patients taking doxepin at the
lower dose” is a mischaracterization. Ans. 4; see also App. Br. 9; Pinder, p.
208. In fact, the Examiner concludes from Pinder, Figure 7, that Appellants’
arguments are not persuasive
7
Appeal 2015-008192
Application 13/764,467
because that two of the patients having lower dosages (i.e.
between 50mg and lOOmg) of doxepin compared to 300mg had
no side effects compared to all of the patients taking 300mg had
side-effects. Moreover, the patients started on 75mg per day
whose dosage was increased (Fig. 7, indicated as triangles), all
five patients had side effects. Accordingly, one of skill in the art
would have concluded that lowering dosage as a viable option
to reduce any side effects including the rebound insomnia
because such option is specifically shown by Pinder on Fig. 7.
Thus, Pinder reference would guide one of ordinary skill in the
art precisely to the use of doxepin in lower doses to avoid side
effect and would work for those patients who has importance of
selecting a pharmaceutical agent to minimize any side effect
including rebound insomnia.
Ans. 4. We agree with the Examiner that Pinder, Fig. 7, supports the
Examiner’s position that lower doses of doxepin are associated with reduced
side effects. Other arguments made by Appellants have been addressed
fully in the Final Action and Answer and we concur with the Examiner’s
responses for the reasons of record.
With respect to claim 8, Appellants contend that, “even assuming that
Pinder suggests the reduction in total side effects and that the total side
effects include weight gain, Pinder does not teach or suggest to a person
skilled in the art a reduction in weight gain with reduction of dosage.” App.
Br. 14. Neither we, nor the Examiner, are persuaded by Appellants’
arguments. We agree with the Examiner that
there is a reasonable expectation of successfully treating
insomnia with subject population concerned with any side-
effect of doxepin including weight gain or rebound insomnia
with the low dosages of doxepin taught by Kavey-2 because the
side-effect of doxepin in general is dose related and Kavey-2 ’s
effective dosages are very low compared with 25mg of
Rodenbeck’s amount for treatment of insomnia.
8
Appeal 2015-008192
Application 13/764,467
Ans. 6. Appellants provide no evidence to rebut the Examiner’s contention
that there would have been a reasonable expectation of treating insomnia
in the subject population concerned with any side-effect of doxepin
including weight gain or rebound insomnia with the low dosages of doxepin
taught by Kavey.
We affirm the rejection of claims 1 and 8 for the reasons of record.
Remaining claims 2—7 and 9—20 fall with representative claims 1 and 8.
CONCLUSION OF LAW
The cited references, and thus a preponderance of the evidence,
support the Examiner’s obviousness rejections, which are affirmed for the
reasons of record. All pending, rejected claims fall.
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
9