Ex Parte D

Patent Trial and Appeal Board

Feb 6, 2018

12599578 (P.T.A.B. Feb. 6, 2018)

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.
12/599,578 10/21/2010 Patrizia D'Alessio 5446-0105PUS1 1792
127226 7590 02/08/2018
BIRCH, STEWART, KOLASCH & BIRCH, LLP
8110 Gatehouse Road
Suite 100 East
Falls Church, VA 22042-1248
EXAMINER
KAROL, JODY LYNN
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
02/08/2018 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PATRIZIA D’ALESSIO
Appeal 2016-0037941
Application 12/599,578
Technology Center 1600
Before DEBORAH KATZ, ULRIKE W. JENKS, and DAVID COTTA,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 1—11 and 13—23 as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The Specification explains:
Stress can be defined as the sum of physical and mental
responses to an unacceptable disparity between real or imagined
1 An oral hearing was held on January 30, 2018.
2 Appellant is the Applicant, AISA THERAPEUTICS, which, according to
the Brief, is the real party in interest. Br. 1.
Appeal 2016-003794
Application 12/599,578
personal experience and personal expectations. Mental
responses to stress include adaptive stress, anxiety, and
depression. However, if stress persists, associated to the
inevitable process of aging, it may lead to various chronic
diseases, going from infectious to inflammatory diseases, from
cancer to degenerative and age-related diseases.
Spec. 1:5—10. The Specification explains that stress can manifest as
intellectual symptoms, physical symptoms, emotional symptoms, and
behavioral symptoms. See Spec. 6:17 to 7:6. The Specification provides
that stress can be further classified into pathological stress conditions and
non-pathological stress conditions. See Spec. 7:10 to 10:22.
Claims 1—11 and 13—23 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1 is representative of the claims on
appeal, and reads as follows:
1. A method for preventing or alleviating a stress condition in an
individual comprising orally administering an effective amount of a
monoterpene as active ingredient to the individual in need thereof,
wherein the monoterpene is selected from the group consisting of
limonene, geraniol, geranyl acetate, isomenthone, perillyl alcohol,
perillic acid, dihydroperillic acid and the respective methyl esters of
these acids, carvone, citral, menthol, wherein the effective amount
administered is a dose of monoterpene ranging between 1 mg/kg and
100 mg/kg.
Appellant requests review of the following grounds of rejection made
by the Examiner:
I. claims 1—6, 8—11, 13, 15—17, 19-21, and 23 under 35 U.S.C.
§ 103(a) as unpatentable over Pistolesi3; and
3 Pistolesi, US 2004/0052922 Al, Mar. 18, 2004 (“Pistolesi”).
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II. claims 7, 14, 18, and 22 under 35 U.S.C. § 103(a) as
unpatentable over Pistolesi in view of Franklin.4
I. Obviousness over Pistolesi
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that Pistolesi teaches administering monoterpene
in the amounts claimed to a patient population experiencing stress?
Findings of Fact
FF1. Pistolesi teaches administering dietary compositions for
both preventing and treating aging processes and related
conditions: atherosclerosis, hypertension, diabetes,
tumors, obesity and overweight, hypertriglyceridemia,
hypercholesterolemia, aging of the skin, alopecia,
panniculitis (cellulite ), osteoporosis, cerebral aging
(Alzheimer, Parkinson, senile dementia, etc.) and loss of
memory, stress, depression, menopausal syndromes,
benign prostate hypertrophy, and the like.
Pistolesi 11 (emphasis added), see 193.
FF2. Pistolesi’s dietary compositions contain: a) a lipidic mixture, b) one
or more terpenes, c) 1-piperoylpiperidine and/or capsaicin, and d) one
or more polycosanols and/or polycosanolic acids. Pistolesi 3—6.
FF3. Pistolesi teaches that the one or more terpenes, are preferably selected
from monoterpenes and/or sesquiterpenes. Id. 14. “Examples of
monoterpenes include d-limonene, P-caryophyllene, sabinene,
bomeol, carveol, carvone, eugenol, eugenol acetate, geraniol,
menthol, myrtanol, pinene, P-pinene, thymol, and the like.” Id. 110;
4 Franklin et al., US 2003/0228402 Al, published Dec. 11, 2003
(“Franklin”).
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see also id. Examples 1—6 (including terpenes such as d-limonene
among others in the formulations).
FF4. Pistolesi teaches that “[tjerpenes are present in amounts ranging from
0.01 to 100 mg, preferably from 0.5 and 10 mg per kg body weight.”
Id. 134.
FF5. The Specification discloses that symptoms of a pathological stress
condition include:
[AJnxiety, depression, problems with memory, inability
to concentrate, sleep alterations, insomnia or exaggerated
sleep, troubled sleep, eating problems, either bulimia or
anorexia, with no respect of feeding rhythms, recurrence
to drugs, comprehensive of cigarette smoking, chronic
fatigue, demotivation, resignation, and/or any symptom
able to reduce the performance of an individual having
no detectable pathology.
Spec. 7:20—25 (emphasis added).
Principle of Law
“If the claim extends to what is obvious, it is invalid under § 103.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007).
While a new and nonobvious method of using an existing (or
obvious) composition may itself be patentable, see Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed.Cir.2005), a
newly-discovered result or property of an existing (or obvious)
method of use is not patentable. See Abbott Labs. v. Baxter
Pharm. Prods., 471 F.3d 1363, 1368—69 (Fed.Cir.2006);
Brassica Prot. Prods. LLC v. Sunrise Farms (In re Cruciferous
Sprout Litig.), 301 F.3d 1343, 1350-51 & n. 4 (Fed.Cir. 2002);
Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368,
1376 (Fed.Cir. 2001).
Allergan, Inc. v. SandozInc., 726 F.3d 1286, 1295—1296 (Fed. Cir. 2013).
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Analysis
We begin by noting that Appellant does not present separate
arguments for the claims other than noting the “claims do not stand or fall
together.” Br. 7. We treat claim 1 as representative of claims 2—6, 8—11, 13,
15—17, 19-21, and 23, and these claims stand or fall with claim 1. See
37 C.F.R. §41.37 (c)(l)(iv).
Pistolesi teaches treating or preventing aging process and related
conditions by administering a dietary composition. FF1. Related conditions
encompass loss of memory, stress, and depression. Id. The dietary
composition taught in Pistolesi contains terpenes. FF2. Preferably the
terpenes are monoterpenes including, for example, d-limonene. FF3.
Pistolesi teaches administering the terpenes at a concentration of 0.01 to 100
mg per kilogram. FF4.
Applying the KSR standard of obviousness to the findings of fact, we
agree with the Examiner that it would have been obvious to treat patients
exhibiting age related conditions with a dietary composition including
terpenes in order to treat symptoms such as loss of memory, stress, and
depression, because Pistolesi explicitly instructs that this as an indicated use
of the composition. See FF1—FF4; see also Ans. 4 (“One of ordinary skill in
the art would have been motivated to prevent or treat stress by administering
the pharmaceutical or dietary composition containing a monoterpene such as
d-limonene taught by Pistolesi because it is obvious to use a composition for
its intended use. . . . [As] dietary compositions are useful for treating and
preventing aging process as related conditions such as stress”).
Appellant contends that “Pistolesi does not disclose or suggest the
presently claimed method for preventing or treating a stress condition.”
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Br. 8. Appellant acknowledges “that some patients administered with the
[Pistolesi] mixtures disclosed in Examples 1 and 2 may have been suffering
from stress and/or depression” the biological symptoms studied, however,
did not include those associated with stress. Br. 9.
We are not persuaded by Appellant’s contention. Claim 1 does not
require targeting a particular type of stress. Pistolesi teaches treating
“stress” associated with an age related condition which encompasses both
pathological and non-pathological conditions. See Ans. 5; FF1. According
to the Specification a pathological stress condition encompasses symptoms
such as depression and problems with memory. FF5; see also Spec. 1:8—10
(“if stress persists, associated to the inevitable process of aging, it may lead
to various chronic diseases, going from infectious to inflammatory diseases,
from cancer to degenerative and age-related diseases”). The fact that the
clinical trial in Pistolesi focused on symptoms other than stress does not
diminish the unequivocal teaching in Pistolesi that its compositions may be
administered to treat, inter alia, loss of memory, stress, and depression.
FF1. In reFritch, 972 F.2d 1260, 126A-65 (Fed. Cir. 1992) (“It is well
settled that a prior art reference is relevant for all that it teaches to those of
ordinary skill in the art.”).
Pistolesi teaches treating loss of memory, stress, and depression in an
aging population by administering compositions including terpenes in the
requisite amounts. FF1—FF4; see Ans. 5 (one of ordinary skill in the art
would expect that “the treatment of stress in a patient population, the stress
will be effectively treated regardless of whether the stress is pathological or
non-pathological”). Pistolesi teaches administering the same composition
(one containing monoterpenes), to the same patient population (subjects
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experiencing the aging process and related conditions), for treatment of the
same condition (subjects experiencing conditions such as stress associated
with aging). Therefore, the results of Pistolesi’s method are inherent. See In
re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Whether the rejection is based
on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness’ under
35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and
its fairness is evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products”).
We agree with the Examiner that Pistolesi’s method of administering
the composition will alleviate stress regardless of the type of stress, because
the active method step is the same. See Ans. 5. In this case the active
method step is orally administering terpenes in an amount ranging between
1 mg/kg to 100 mg/kg as claimed. See FF4 (“[tjerpenes are present in
amounts ranging from 0.01 to 100 mg” per kg body weight).
We compare the present facts to the simpler hypothetical in Catalina,
where the Federal Circuit explained:
Inventor A receives a patent having composition claims for shoe
polish. . . .
Suppose Inventor B discovers that the polish also repels water
when rubbed onto shoes. Inventor B could not likely claim a
method of using the polish to repel water on shoes because
repelling water is inherent in the normal use of the polish to shine
shoes. ... In other words, Inventor B has not invented a “new”
use by rubbing polish on shoes to repel water.
Catalina Mktg., Int'l v. Coolsavings.com, 289 F.3d 801, 809—10 (Fed. Cir.
2002). Just as the intended result of repelling water is not a new limiting use
of shoe polish on shoes in Catalina, the intended results recited in claim 1 of
“preventing or alleviating a stress condition” by administering a composition
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containing monoterpene in a dosage range of 1 mg/kg to 100 mg/kg do not
impose limitations on the method of treatment of the same patient population
with the same composition in the same amounts. “It is well settled that
‘anticipation is the epitome of obviousness.’” In re McDaniel, 293 F.3d
1379, 1385 (Fed. Cir. 2002) (citations omitted).
Appellant contends that “the reference at best provides a theoretical
disclosure according to which a composition comprising limonene might be
used for the treatment and prevention of stress. However, said hypothesis is
not demonstrated to enable one of ordinary skill in the art” to carry out the
inventions as now claimed. Br. 10 (emphasis omitted).
We are not persuaded by Appellant’s contention. The issue is whether
Pistolesi is “enabling in the sense that it describes the claimed invention
sufficiently to enable a person of ordinary skill in the art to carry out the
invention.” ImpaxLabs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1383
(Fed. Cir. 2006). “Newly discovered results of known processes directed to
the same purpose are not patentable because such results are inherent.”
Bristol-Myers Squibb, 246 F.3d at 1376. Here, as already discussed above,
Pistolesi teaches administering a composition that includes terpenes to a
patient population that displays symptoms associated with aging, including
those that are suffering from loss of memory, stress, and depression (FF1—
FF4), the same symptoms are disclosed in the Specification as being
associated with stress. See FF5. The burden was thus on Appellant to
establish inoperability of the reference. In re Sasse, 629 F.2d 675 (CCPA
1980).
Appellant contends that “none of the terpenes [in Pislolesi] has been
tested alone without olive oil.” Appeal Br. 11 (emphasis removed).
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We are not persuaded by Appellant’s argument and agree with the
Examiner that “the ‘comprising’ language of the instant claims is considered
to be broad and open-ended. Thus, the presence of a monoterpene as an
active ingredient does not preclude the presence of other active ingredient
components.” Ans. 13; see Genentech, Inc. v. Chiron Corp., 112 F.3d 495,
501 (Fed.Cir.1997) (“the open-ended term comprising ... means that the
named elements are essential, but other elements may be added”). Because
the claim is open ended and thereby can include other components, the art
does not have to disclose the effect of a single component as argued by
Appellant.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellant has not
provided sufficiently persuasive rebuttal evidence or evidence of secondary
considerations to outweigh the evidence supporting the Examiner’s
conclusion of obviousness. As Appellant does not argue the claims
separately, claims 2—6, 8—11, 13, 15—17, 19-21, and 23 fall with claim 1.
II. Obviousness over Pistolesi and Franklin
The Examiner rejected claims 7, 14, 18, and 22 as being obvious over
Pistolesi and Franklin. Claim 7 is representative and recites: “The method
according to claim 1, wherein the monoterpene is perillyl alcohol or perillic
acid.”
The issue is: Does the preponderance of evidence of record support
the Examiner’s conclusion that Pistolesi and Franklin teach administering
monoterpene, such as perillyl alcohol, in the requisite amounts to a patient
population experiencing stress?
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Findings of Fact
FF6. Franklin teaches using terpenes as a food preservative, for reducing
the incidence of gastrointestinal infections, for inhibiting bacterial and
fungal growth. See Franklin || 41, 77, 87. Terpenes include geraniol,
menthol, limonene, and perillyl alcohol, among others. Franklin 198;
see Ans. 6.
Analysis
The Examiner finds that “Pistolesi does not specifically teach perillyl
alcohol or perillic acid as the monoterpene.” Ans. 6. Franklin teaches
suitable terpene compounds that can be administered orally. “[Acceptable
terpenes include geraniol, menthol, limonene, perillyl alcohol,” among
others. Ans. 6.
Appellant contends that “Franklin does not overcome the deficiencies
of Pistolesi” and thereby the Examiner has not met the burden of presenting
a prima facie case. Br. 12.
Having found no error in the Examiner’s findings with respect to the
teachings and conclusions based on Pistolesi, we are not persuaded by
Appellant’s argument that the combination of Franklin with Pistolesi fails to
make up for any alleged deficiency. Franklin provides a list of terpenes that
can be used in their products. FF6; see Franklin 198 (for the full list of
suitable terpenes). We agree with the Examiner that it would be obvious to
substitute one terpene with another known in the art to be suitable for oral
administration and are recognized as equivalents. See Ans. 6 (“perillyl
alcohol is a known terpene compound suitable for oral administration”).
“Express suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.” In re Font, 675 F.2d 297, 301,
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(CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997)
(“Because the applicants merely substituted one element known in the art for
a known equivalent, this court affirms [the rejection for obviousness].”).
Accordingly, we affirm the obviousness rejection of claims 7, 14, 18, and 22
based on the combined teachings of Pistolesi and Franklin.
SUMMARY
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over
Pistolesi. Claims 2—6, 8—11, 13, 15—17, 19-21, and 22 fall with claim 1.
We affirm the rejection of claims 7, 14, 18, and 22 under 35 U.S.C.
§ 103(a) over Pistolesi in view of Franklin.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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