Ex Parte MONTI

Patent Trial and Appeal Board

Oct 11, 2018

14134906 (P.T.A.B. Oct. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/134,906 12/19/2013 LOUIS MONTI
89175 7590 10/15/2018
Hamilton DeSanctis & Cha, LLP
3239 El Camino Real, Suite 220
Palo Alto, CA 94306
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.
PHE.000007US 8582
EXAMINER
CRUZ, KATHRIEN ANN
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
10/15/2018 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):
sam.nguyen@hdciplaw.com
dcha@hdciplaw.com
kmcinnish@hdciplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LOUIS MONTI
Appeal2018-000651
Application 14/134,906
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS
and RYAN H. FLAX, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
Appeal2018-000651
Application 14/134,906
STATEMENT OF CASE
The following claim is representative below.
1. A method of treating a depressive disorder in an
individual suffering therefrom, comprising nasal
administration of a therapeutically effective amount of
pregn-4-en-20-yn-3-one.
Cited References
Berliner et al., US 5,563,131, issued Oct. 8, 1996 ("Berliner")
REMINGTON'S, THE SCIENCE AND PRACTICE OF PHARMACY, 21st ed., Chapters
16, 18, 20, 39, pp. 221,291, 747, Lippincott Williams & Wilkins,
Philadelphia, Pennsylvania, (2001) (hereinafter "Remington").
DJ Goldstein et al., Duloxetine in the treatment of major depressive disorder:
a double-blind clinical trial, Eli Lilly and Department of Pharmacology and
Toxicology, Clinical Trial, Phase II, Journal Article, Vol. 63, No. 3, 225-231
(2002) (hereinafter "Goldstein").
Gavin Andrews et al., Dimensionality and the category of major depressive
episode, 16(S 1) INT'L J. METHODS IN PSYCHIATRIC RES. S41-S51 (2007)
(hereinafter "Gavin").
Grounds of Rejection
1. Claims 1-13, 15-17 and 19-20 stand rejected under 35 U.S.C.
§ 103 as being unpatentable over Berliner and Andrew.
2. Claim 14 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Berliner, Andrew, and Goldstein.
3. Claim 18 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Berliner, Andrew, and Remington's.
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Application 14/134,906
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
3-22. The following facts are highlighted.
1. Berliner teaches the treatment of "moods" which is defined as
longer lasting feeling states such as guilt, sadness, hopelessness,
worthlessness, remorsefulness, misery, unhappiness, and
"Character traits" which are more permanent aspects of an
individual's personality. Typical negative character trains are
sensitivity, regretfullness, blameworthiness, stubbornness,
resentfulness, bitterness, timidness, laziness and the like ( column
6, lines 39-48). Ans. 3.
2. Berliner teaches the nasal the administration of pregnane and
pregnene steroids to affect a specific behavioral or physiological
response in human subjects, e.g., a reduction of negative affect,
mood, and character traits. Berliner, col. 6, 11. 39-48; Ans. 3.
3. Berliner teaches a known pregnane structure (column 18).
4. Berliner teaches the administration of pregnane and pregnene
steroids to the nasal cavity, the dosage is about 100 pico grams to
about 100 micrograms, preferably about 1 nano gram to about 10
micrograms, more preferably about 10 nano grams to 1 about
microgram. The frequency of administration is desirably in the
range of an hourly dose to a monthly dose, preferably from 8
times/day to once every other day, more preferably 1 to 3 times per
day ( column 52, lines 47-60). Ans. 5.
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Application 14/134,906
5. Andrews teaches (at abstract, p. S41) that Major depressive
episode (MDE) is a chronic disease typified by episodes that remit
and recur. It is a major contributor to the burden of disease. The
diagnosis of a disorder is an expert opinion that the disorder is
present. The nine symptoms of MDE exist on dimensions of
greater or lesser intensity, persistence over time, change in usual
state, distress and impairment. It is the clinician's task to judge
whether the elicited symptoms warrant the diagnosis. Ans. 5.
6. Declaration 1 of Liebowitz 1 states:
To a physician experienced in the treatment of depressive
disorders, the symptoms described in the parentheses
above "( e.g. guilt, sadness, hopelessness, worthlessness,
remorsefulness, misery, unhappiness, sensitivity,
regretfulness, blameworthiness, stubbornness,
resentfulness, bitterness, timidness, laziness)" represent a
mixture of moods or emotions (guilt, sadness,
hopelessness, worthlessness, remorsefulness, misery,
unhappiness), any one of which may be experienced by
many if not all people at some time, and character traits
(sensitivity, regretfulness, blameworthiness,
stubbornness, resentfulness, bitterness, timidness,
laziness), any one of which may be seen in many people
though not necessarily associated with the moods
mentioned, and they neither constitute nor define a
psychiatric disorder. A "depressive disorder[,]" as
defined in the patent application, such as Major
Depressive Disorder, by contrast, is a psychiatric disorder
in which there is a pathological level of depressive
activity ( characterized by Major Depressive Episode,
1 Declaration 1, Dr. Michael R. Liebowitz, M.D., dated September 12, 2015.
Declaration 2, Dr. Michael R. Liebowitz, M.D., dated March 30, 2016.
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Application 14/134,906
which requires the presence of at least five of the listed
symptoms to the point of causing clinically significant
distress or impairment - note my comment in paragraph
21 above on the full definition of Major Depressive
Episode), with negative consequences in life. Although
different people may experience different levels of
negative moods at different times, and depressive
disorders may be more or less severe, there is not a
continuous spectrum in which negative mood gradually
becomes a depressive disorder: physicians experienced
in the treatment of depressive disorders consider that
there is a qualitative rather than merely quantitative
distinction between negative moods and a depressive
disorder. In particular, Major Depressive Disorder is a
depressive disorder that may, without adequate treatment,
disable normal personal functioning; and, in its more
extreme forms, may be so life-threatening as to call for
in-patient treatment to prevent self-harm or suicide.
24. Also, (1) drugs that affect mood are not necessarily
antidepressant, and (2) antidepressant drugs do not
necessarily affect mood in non-depressed individuals. As
an example of (1 ), amphetamines affect mood - they will
temporarily alleviate sadness, increase energy, increase
optimism, and create transient euphoria, yet
amphetamines do not treat depressive disorders such as
Major Depressive Disorder. As an example of (2),
tricyclic antidepressants will alleviate Major Depressive
Disorder in many patients, yet do nothing to alter mood
states in normal individuals. Pharmacologically, there is
not a clear connection between mood-affecting drugs and
antidepressants.
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
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Application 14/134,906
(Fed. Cir. 1988) (Explaining the general evidentiary standard for
proceedings before the Office.).
Moreover, "obviousness requires a suggestion of all limitations in a
claim." CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981,985 (CCPA 1974)).
When the examiner has required the applicant to elect single chemical
species for examination, the issue on appeal is the patentability of the single
elected species. It is appropriate to limit discussion to that single issue and
take no position respecting the patentability of the broader generic claims,
including the remaining, non-elected species. See, Ex parte Ohsaka, 2
USPQ2d 1461 (Bd. Pat. App. Int. 1987). There was an election of species in
this Application on August 4, 2014. Appellant elected the species of the
treatment of Major Depressive Disorder. Response to Election, p. 2. Thus,
pursuant to ex parte Ohsaka, we focus our review on only this elected
species and take no position respecting the patentability of the broader
generic claims, including the non-elected species.
Obviousness Rejection 1
The Examiner cites Berliner as teaching the administration of specific
pregnanes to persons have mood or character traits and symptomology
which overlaps with major depressive disorder symptoms. Ans. 3. Andrews
is cited to define major depressive disorder and its symptoms. Ans. 5. The
Examiner concludes that
[i]t would have been obvious to one of ordinary skills in the art at the
time of the invention to employ pregn-4-en-20-yn-3-one in the nasal
cavity to treat major depressive disorder. One would have been
motivated to employ pregn-4-en-20-yn-3-one in the nasal cavity to
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Application 14/134,906
treat major depressive disorder because it is known in the art that
pregnane and pre gene steroids are useful in the treatment of the
symptoms ( e.g. guilt, sadness, hopelessness, worthlessness,
remorsefulness, misery, unhappiness, sensitivity, regretfullness,
blameworthiness, stubbornness, resentfulness, bitterness, timidness,
laziness) in which are overlapping symptoms of major depressive
disorder as taught by both Berliner and Andrews.
Ans. 6-7.
Appellants contend that, "Berliner et al. describe a number of
"moods" or "character traits[,]" such as sensitivity, regretfulness,
blameworthiness, stubbornness, resentfulness, bitterness, timidness, and
laziness, that find no correspondence in the symptoms that form part of the
diagnostic criteria for MDE." App. Br. 10.
Appellants further argue that,
The Berliner et al. and Andrews et al. documents themselves,
and uncontroverted evidence by expert Dr. Liebowitz, ... [shows] that
the overlap between the "moods" and "character traits" from Berliner
et al. with the symptoms that form part of the diagnostic criteria for an
MDE as described in Andrews et al., ... is exceedingly minor, and the
differences are great, so that a person of ordinary skill in the art would
not combine the two references.
App. Br. 11. Appellants argue that there is uncontroverted evidence from Dr.
Liebowitz that there would be a lack of expectation of success in using the
method of Berliner to treat Major Depressive Disorder. App. Br. 12.
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness.
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Application 14/134,906
Appellants have presented two Declarations of Michael R. Liebowitz,
M.D., stating that, based on his expertise, that there is insignificant overlap
between mood states described in Berliner and a clinical diagnosis of Major
Depressive Disorder. App. Br. 11-13.
In response, the Examiner reiterates that there is overlapping
symptomology in the disclosure of Berliner and MDD. Ans. 16-17. Facts
established by rebuttal evidence must be evaluated along with the facts on
which the earlier conclusion was reached, not against the conclusion itself.
"Though the tribunal must begin anew, a final finding of obviousness may of
course be reached, but such finding will rest upon evaluation of all facts in
evidence, uninfluenced by any earlier conclusion reached ... upon a
different record." In re Rinehart, 531 F.2d 1048, 1052, (CCPA 1976).
We do not find that the Examiner has adequately addressed
Appellant's arguments and the Declarations of Dr. Liebowitz (regarding the
understanding of one of skill in the art), stating that there is "no
correspondence in the symptoms that form part of the diagnostic criteria for
MDE." App. Br. 10; Declaration 2, ,r 32.
For this reason, obviousness rejection 1 is reversed.
Obviousness Rejections 2 and 3
Appellant submits that if the rejection of claim 1 is reversed, the
rejections of claims 14 and 18 also should be reversed because the premise
stated in these rejections, that pregn-4-en-20-yn- 3-one is known in the art to
be effective in the treatment of major depressive disorder, is similarly
incorrect. App. Br. 7. We agree with Appellant's position. For this reason,
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Application 14/134,906
and the rationale set forth above regarding Rejection 1, we also reverse
rejections 2 and 3.
DECISION
The cited references do not support the Examiner's obviousness
rejections 1-3 as set forth in the grounds of rejection, which are reversed.
Our decision is limited to the single elected species of Major Depressive
Disorder.
REVERSED
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