Ex Parte Huang et al

Patent Trial and Appeal Board

Nov 30, 2017

14147531 (P.T.A.B. Nov. 30, 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.
14/147,531 01/04/2014 Niu Huang NIBS 12-002-1US 1053
23379 7590 12/04/2017
RICHARD ARON OSMAN
530 Lawrence Expy # 332
Sunnyvale, CA 94085
EXAMINER
MCCOLLUM, ANDREA K
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
12/04/2017 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):
RICHARD @ SCI-TECH.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NIU HUANG, GANG ZHI, JIJIE CHAI, SHIMING PENG, and
NANNAN HOU
Appeal 2016-006719
Application 14/147,5311
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of treating obesity and a method of treating atherosclerosis, which have been
rejected as anticipated and/or obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We affirm-in-part.
1 Appellant is the Applicant, National Institute of Biological Sciences,
which, according to the Appeal Brief, is the real party in interest. (Br. 1.)
Appeal 2016-006719
Application 14/147,531
STATEMENT OF THE CASE
The gene FTO has been “identified to strongly associate with
obesity.” (Spec. 12.) The gene “is expressed in many tissues, especially in
hypothalamic nuclei controlling energy expenditure.” (Id.) “FTO protein is
an a—ketoglutarate and iron (II) dependent nucleic acid demethylase.” (Id.
13.) While this protein’s mechanism is not clear, it has been found “using
stmcture-based virtual screening method in combination with biological
activity measurements, including enzymatic activity, cellular activity and in
high-fat diet induced obesity (DIO) animal model” that entacapone is an
FTO inhibitor. (Id. 14) Appellant’s invention is directed at administering
entacpaone to obese persons or to persons with atherosclerosis to treat,
respectively, obesity or atherosclerosis. (Spec. Tflf 19-20 (claims 78 and
89).)
Claims 78—83, 86, 87, and 89-922 are on appeal. Claims 78 and 89
are representative and read as follows:
78. A method of treating obesity comprising administering to
an obese person in need thereof an effective amount of
entacapone ((2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-
N,N-diethylprop-2-enamide), or a pharmaceutically-acceptable
salt thereof.
89. A method of treating atherosclerosis comprising
administering to a person diagnosed with atherosclerosis and in
need thereof an effective amount of entacapone ((2E)-2-cyano-
3 -(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide),
or a pharmaceutically-acceptable salt thereof.
(Appeal Br. 19—20.)
2 Claims 84, 85, 88 and 93—97 are also pending but are allowable but for
being dependent on a rejected base claim. (Ans. 2.)
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The following grounds of rejection by the Examiner are before us on
review:
Claims 78, 80, and 81 under 35 U.S.C. § 102(b) as anticipated by
Shafa3 as evidenced by CDC Report.4
Claims 78—81 under 35 U.S.C. § 103(a) as unpatentable over Shafa as
evidenced by CDC Report.
Claims 78 and 80-82 under 35 U.S.C. § 103(a) as unpatentable over
Shafa, NHLBI,5 Gadde,6 and CDC Report.
Claims 78—83 under 35 U.S.C. § 103(a) as unpatentable over Shafa,
NHLBI, and CDC Report.
Claims 78, 81, 86, and 87 under 35 U.S.C. § 103(a) as unpatentable
over Shafa and Gadde.
Claim 89 under 35 U.S.C. § 102(b) as anticipated by Kranich.7
Claims 89 and 90 under 35 U.S.C. § 103(a) as unpatentable over
Kranich.
3 Shafa et al., US 2009/0012177 Al, published Jan. 8, 2009.
4 David S. Freedman, Obesity — United States 1988—2008, in Centers for
Disease Control and Prevention, Morbidity and Mortality Weekly Report,
Supplement Vol. 60, 73—77 (Jan. 14, 2011) (“CDC Report”).
5 Obesity, Waist Circumference, Treatment Overweight, The Practical
Guide: Identification, Evaluation, and Treatment of Overweight and Obesity
in Adults, NHLBI Obesity Education Initiative, National Institute of Health
(Oct. 2000), available at
http://www.nhlbi.nih.gov/files/docs/guidelines/prctgd_c.pdf, last visited
Nov. 2017.
6 Kishore M. Gadde et al., Combination therapy for obesity and metabolic
disease, Current Opinion in Endocrinology, Diabetes & Obesity, 16, 353—
358 (2009).
7 Kranich et al., US2010/0190851 Al, published July 29, 2010.
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Claims 89 and 91 under 35 U.S.C. § 103(a) as unpatentable over
Kranich and ACCF/AHA 2011 Report.8
DISCUSSION
I.
The Claimed Method of Treating Obesity is Anticipated by Shafa
The Examiner notes that claim 1 has been interpreted “to encompass
treatment of obesity by administering entacapone to an obese person.”
(Final Action 8.) The Examiner explains that the CDC categorizes people as
obese when their BMI is greater than or equal to 30.0 kg/m2. (Final Action
6.) The Examiner notes that “treatment” as used in the claim does not
require specific metrics for measuring the obesity benefit (id. at 7), and that
the term is broadly defined in Appellants’ Specification as including
prophylactic or therapeutic treatment that is intended to provide a resultant
improvement or amelioration of the corresponding condition or symptom in
the person being treated (see, e.g., Ans. 22—23, 28—29.)
The Examiner finds that Shafa teaches administration of entacapone
to individuals who suffer from obesity. (Final Action 7; Ans. 4, 28.) The
Examiner points out that while the patient who was administered entacapone
in Shafa suffered from other disorders, there were patients who were
recognized to be obese in addition to having the other disorders. (Final
8 Jeffrey L. Anderson et al., 2011 ACCF/AHA Focused Update
Incorporated Into the ACCF/AHA 2007 Guidelines for the Management of
Patients With Unstable Angina/Non-ST-Elevation Myocardial Infarction'. A
Report of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines, Circulation, Vol. 123, 2022-
60 (2011), available at http://circ.ahajoumals.org, last visited Nov. 11, 2017.
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Action 5—7; Ans. 28, 32.) The Examiner explains that Shafa discloses that
the administered entacapone resulted in a demonstrated benefit to obese
persons. (Ans. 28; Final Action 7.)
The Examiner further finds that Shafa discloses administering
entacapone to treat weight gain. (Final Action 5; Ans. 4.) The Examiner
additionally finds that Shafa teaches an intent to provide a therapeutic
benefit of treating weight gain associated with food cravings. (Ans. 28—29,
33—34.) The Examiner states: “[tjaken together, Shafa recognizes the
therapeutic benefit for treating weight gain associated with food cravings,
and provides documented administration of entacapone to obese
individuals.” (Id. at 29.)
In light of the foregoing, including the Examiner’s claim
interpretation, the Examiner concludes that Shafa’s teaching of providing
entacapone to obese patients where a demonstrated benefit to those persons
resulted inherently meets the claimed method of treating obesity. (Id. 30—
31.) The Examiner determined that the outcome here is compelled by
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005) where
claims directed to a method of treating skin damage or disorders through
topical application of a composition were found inherently anticipated by
prior art that disclosed topical application of compositions to skin that
included all the variously claimed ingredients in the concentrations recited in
the claimed composition. (Id.) The Examiner explains, here, “Shafa’s
administration of the same chemical compound, entacapone, to obese
individuals (i.e. the same population as recited in the instant claims) would
naturally result in the same claimed benefits of the instant method.)” (Id. at
31.)
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We agree with the Examiner’s factual findings and conclusion that
Shafa teaches the method of treating obesity recited by claim 78. The
recited treatment method simply requires administering entacapone to an
obese person in an amount that is effective. Although not specifically
recited, presumably the effective amount results in “treating obesity” as
recited in the claim preamble. As the Examiner noted, the claim is not
specific as to what is deemed “treating” and the Specification does not
provide any special definition of this term. We find that the Specification
supports the Examiner’s conclusion that inhibiting weight gain or promoting
weight loss would be treating embraced by the claim. (See, e.g., Spec. Tflf 6—
7, 27, and 53.) However, treating obesity is not so limited by the
Specification. We conclude that the Specification describes administering
entacapone to ameliorate or reduce the pathology or severity of or symptoms
of an obesity related disease, or reduce cholesterol etc. (Id. 1 6—7.) We find
such results would be a manner of treating an obese person, i.e., it would
provide a benefit to the obese person. In light of the foregoing we find that
the method of treating required by the claims is administering entacapone to
an obese person in an amount that provides some benefit to the obese person
being cared for whether it be promoting weight loss, reducing cholesterol, or
inhibiting weight gain, or reducing food cravings.
Appellant argues that because the preamble sets forth the objective of
the method (to treat obesity) and the body of the claim directing the method
be performed on “an obese person in need,” to anticipate, Shafa must
disclose that it administered entacpaone to an obese person with the
“intentional purpose” of treating obesity, which Shafa does not do because it
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teaches administering entacapone to treat a psychiatric disorder. (See, e.g.,
Appeal Br. 4—7.) We disagree with Appellant’s conclusion.
Consistent with the Jansen v. Rexall Sundown Inc., 342 F.3d 1329
(Fed. Cir. 2003) cited by Appellant, the claim is properly interpreted to mean
that entacapone must be administered to a human with a recognized need to
treat obesity. Jansen, 342 F.3d at 1334. The claim preamble recites a
benefit, i.e., “treating obesity” and a single positive step for achieving that
benefit. That positive step is administering entacapone to an obese person in
need of treatment, where the amount of entacapone administered is effective
to treat obesity. If Shafa discloses the very same method steps, “then the
particular benefits must naturally flow from [the method].” Perricone, 432
F.3d at 1378. That is true even if the person treated also receives a benefit
of treating a psychiatric disorder. That is true because the claims are not
limited to treating only obesity.
Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001), cited by
Appellant (Appeal Br. 5—6), does not compel a determination that the
method of treating recited here can only be anticipated where administration
of the drug was given with the sole intent to treat obesity. Rather, that case
merely indicates that claims that use the phrase “treatment of’ in a claim
preamble along with the phrase “to a patient in need of such treatment” in
the body of the claim require the preamble “treatment of’ to be treated as a
claim limitation. Rapoport, 254 F.3d at 1059-60. In other words, to
establish anticipation of such a claim, one would have to demonstrate that
there was administration of the active ingredient that resulted in “treatment
of’ the particular requisite patient population by the prior art. In Rapaport,
the court determined that the “treatment” at issue in that case required there
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to be curing of the underlying condition. Id. at 1060—61. The prior art in
that case only showed a proposed treatment for a symptom not the
underlying condition and not administering the active ingredient in any
specific amount to patients who had the condition. Id. Thus, the court found
that the prior art did not teach administering the active ingredient for the
“treatment” purpose required by the claim. Id. at 1061; see also Perricone,
432 F.3d at 1386 (Bryson, J. dissenting) (“In Rapoport, the prior art was a
method for treating anxiety by administering a certain dosage of a particular
drug three times a day, while the invention was a method for treating sleep
apnea by administering a larger dosage of the same drug at the time of
sleep.”)
Shafa explains that, with respect to patients who were administered
entacpaone in the clinical trials, “[n]ot only psychotic patients, but also a
vast majority of patients with drug dependency, obesity and depression were
benefited from this treatment.” (Shafa 1 64.) Thus, Shafa discloses that
entacapone was administered to patients who were obese, and that they were
benefitted. While achieving the particular benefit to these obese patients
may not have been intentional, it was nevertheless intentional to give
entacapone to those patients who were recognized to have comorbid obesity.
Thus, the requisite intent required by claim 78, i.e., that entacapone be
administered to a human with a recognized need to treat obesity, was there.
Moreover, the fact that there was some recognized benefit in the study
to the obese patient is sufficient to meet the claimed requirement that the
obesity was treated in light of our discussion above regarding the broadest
reasonable interpretation of treating and effective amount. That Shafa
teaches administering the entacapone treated a psychiatric disorder in
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addition to providing a benefit to obese persons who also suffer from a
psychiatric disorder does not detract from the fact that Shafa teaches a
treatment benefit was obtained for the obese patient to whom entacapone
was administered. In other words, the administration of the entacpaone had
the effect of treating obesity in its normal use.
Contrary to Appellant’s argument, claim 78 is not a new use for an old
product. We find the situation here to be unlike that in Perricone where the
Court found certain claims to be a new use for an old product. In particular,
there the Court found a claimed method for treating sunburn requiring the
topical application of the active ingredient to the skin sunburn was a new use
where the prior art did not teach applying the composition to sunburned skin
and did not “disclose any benefit directed to skin sunburn.” Perricone, 432
F.3d at 1376, 1378—79. Shafa, on the other hand, discloses that the
entacapone was provided to the relevant patient population, those who are
obese, notwithstanding that they have other disorders for which they are
being treated, and those patients obtained a treatment benefit from the
administration of the entacapone related to the comorbid obesity. We agree
with the Examiner that the situation with respect to claim 78 is similar to the
claims in Perricone that were found not to be a new use for an old product,
namely, claims directed to treating damaged skin by topically applying a
particular composition, where the prior art disclosed topically applying to
the skin a composition including the claimed ingredients and noting that the
active ingredient was a “skin benefit ingredient.” Id. at 1376—1377. As
discussed above, Shafa discloses the claimed step of administering
entacapone in a therapeutically effective amount to treat obesity and that the
entacapone was intentionally administered to patients who were obese.
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Thus, for the foregoing reasons, we disagree with Appellant that claim
78 is not directed to an “old or inherent use” (Appeal Br. 7). Consequently,
we affirm the Examiner’s rejection of claim 78 as being anticipated by
Shafa. Claims 80 and 81 have not been argued separately and therefore fall
with claim 78. 37 C.F.R. § 41.37(c)(l)(iv).
The Claimed Method of Treating Obesity, if not Anticipated, Is,
Nevertheless, Obvious over Shafa
Claim 79 requires administration of 1—5 g/day of entacapone. The
Examiner indicates that Shafa does not teach the dose of 1—5 g/day. (Final
Action 15.) The Examiner contends that “[t]he determination of dosage for
the composition in the instant composition, that would allow the component
to function as claimed, requires only routine experimentation for one of
ordinary skill in the art.” (Id. at 15—16, 19.) Thus, the Examiner concludes
“[i]t would have been obvious to one of skill in the art at the time of the
invention to optimize the dosing of the entacapone when treating patients in
order to achieve the best treatment outcome” where the prior art teaches
“administration of entacapone to obese patients” and Appellant fails to
establish “the indicated dose is critical to the method.” (Id.) We agree with
the Examiner.
Appellant argues that the “art provides no teaching or suggestion to
reach beyond the maximum disclosed dosage range” of 50—800 mg/day,
where the art was concerned with treating psychiatric disorders and
Parkinson’s disease. (Appeal Br. 13.) We do not find this argument
persuasive as it ignores the fact that Shafa teaches that entacapone has a
treatment effect for obesity as well. (Shafa 1 64.) It is clear also from Shafa
that the dosage amount of entacapone is result effective. (See e.g., id. 175
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describing dose escalation which achieved improved results for other
indications.) “[Discovery of an optimum value of a result effective variable
in a known process is ordinarily within the skill of the art.” In re Boesch,
617 F.2d 272, 276 (CCPA 1980). Moreover, the normal desire of ordinary
skilled artisans to improve upon what is already generally known can
provide the motivation to optimize. See In re Peterson, 315 F.3d 1325, 1330
(Fed. Cir. 2003); see also KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 421
(2007). Appellant fails to establish the claimed dosage range is critical to
the method of treating obesity, which is necessary where Shafa describes a
clinical study that generally used a dosage range of between 50-800 mg/day
and observed “a vast majority of patients with . . .obesity. . .were benefitted
from this treatment.” {Id. | 64.) Moreover, Appellant does not establish that
the recited range achieves an unexpectedly good result. In re Geisler, 116
F.3d 1465, 1469 (Fed. Cir. 1997) (“Only if the ‘results of optimizing a
variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed
critical range.”).
In addition to the foregoing, to the extent that one does not deem
Shafa anticipatory because the claims require an intent to administer
entacapone to obese patients to treat obesity and Shafa may not be
considered to describe administration with that intent, we determine that
Shafa renders claim 78 obvious. Shafa observes a treatment benefit to obese
persons taking entacpaone (Shafa 1 64) and indicates that entacpaone can be
used in a method “used to treat weight gain” (Shafa, claim 4). As discussed
above, the broadest reasonable interpretation of “treating” in light of
Appellant’s Specification includes inhibiting weight gain as well as
promoting weight loss. Thus, as the Examiner explained, “Shafa et al.
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clearly recognizes benefits for obese individuals, which, at very worst,
provides a prophetic disclosure for future application of entacapone for the
purpose of treating obesity.” (Final Action 10.) In other words, Shafa
would have suggested to one of ordinary skill in the art to treat obese
patients with entacapone to treat their obesity with a reasonable expectation
of success. “Scientific confirmation of what was already believed to be true
may be a valuable contribution, but it does not give rise to a patentable
invention.” PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342,
1363-64 (Fed. Cir. 2007).9
In light of the foregoing, Appellant does not persuade us that the
Examiner erred in rejecting claims 78—81 for obviousness over Shafa as
evidenced by CDC Report.
Appellant purports to argue the rest of the Examiner’s obviousness
rejections premised on Shafa addressing the remaining claims directed to
treating obesity (i.e., claims 83—88) separately. However, each of
Appellant’s arguments are premised on the argument that “[sjince there was
no suggestion to treat obesity with entacapone, there was no suggestion” to
reach the limitations recited in those remaining claims. (See, e.g., Appeal
Br. 15—16.) As discussed above, though, we disagree with Appellant’s
premise that Shafa does not teach or suggest treating obesity with
entacapone. Thus, we are not persuaded that the Examiner erred in the
9 Although the Examiner did not specifically identify a rationale for the
obviousness of claim 78, we note that the Examiner, nevertheless, rejected
claim 78 for obviousness. (See Final Action 15.) Thus, we do not deem the
analysis to be a new ground of rejection but rather additional reasoning
supporting the Examiner’s rejection.
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remaining rejections of the method of treating obese patient claims, i.e., the
rejection of
1. Claims 78 and 80-82 under 35 U.S.C. § 103(a) as unpatentable
over Shafa, NHLBI, Gadde, and CDC Report.
2. Claims 78—83 under 35 U.S.C. § 103(a) as unpatentable over
Shafa, NHLBI, and CDC Report.
3. Claims 78, 81, 86, and 87 under 35 U.S.C. § 103(a) as
unpatentable over Shafa and Gadde.
II
The Claimed Method of Treating Atherosclerosis Is Not Anticipated by
Kranich
The Examiner finds that Kranich teaches administration of entacpaone
for the treatment of atherosclerosis. (Final Action 11; Ans. 36.) In
particular, the Examiner contends that Kranich states that the compound of
formula (1) “which encompasses entacapone” may be used in “. . . a
pharmaceutical composition for the treatment, diagnosis or prophylaxis of
inflammatory diseases or conditions, in particular . . . atherosclerosis’ (see
paragraph [0093]).” (Final Action 12.)
We disagree with the Examiner’s reading of Kranich. As Appellant
points out, the paragraph to which the Examiner points regarding “treatment,
diagnosis or prophylaxis” states, in relevant part,
treatment, diagnosis, or prophylaxis of inflammatory diseases
or conditions, in particular chronic obstructive pulmonary
disease (COPD), acute lung injury (ALI), cardiopulmonary
bypass, acute respiratory distress syndrome (ARDS), septic
shock, sepsis, psoriasis, atopic dermatitis, and rheumatoid
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arthritis, and reperfusion injury that occurs following heart
attacks, strokes, atherosclerosis, and organ transplants.
(Appeal Br. 13 (quoting Kranich 193).) The treatment recited is not of
atherosclerosis, but rather, “reperfusion injury that occurs following”
conditions such as atherosclerosis, heart attacks and organ transplants.
While the Examiner contends Appellant concedes Kranich provides a
prophetic disclosure of administering entacapone to a patient with
atherosclerosis (Final Action 12), we disagree. Rather, Appellant notes,
after pointing out the laundry list of prophetically recited treatments in
Kranich, that Kranich does not teach or describe or suggest “in any
meaningful sense whatsoever, the use of entacapone for the treatment of
atherosclerosis, or wrinkles, or warts, or diabetes, or arthritis, or organ
failure, or cancer metastasis.” (Appeal Br. 12—13, Reply Br. 13.) We find
this statement a far cry from an admission by Appellant as to Kranich
teaching treatment of atherosclerosis by the administration of entacpone.
We agree with Appellant that “Kranich et al (US 2010/0190851) does not
describe administration entacapone for the treatment of atherosclerosis.”
(Reply Br. 11.)
Unlike the case with Shafa’s administration of entacpone to obese
patients, Kranich does not disclose administering entacapone to patients
having atherosclerosis. Nor does Kranich disclose any therapeutic benefit in
this regard.
Consequently, we reverse the Examiner’s anticipation rejection of
claim 89 over Kranich.
The Examiner’s obviousness rejection of claims 90 and 91 are
premised on the Examiner’s position that Kranich teaches administering
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entacapone to an atherosclerotic patient. (See, e.g., Final Action 23—24.)
However, we disagree for the reasons just discussed. Consequently, we
reverse the Examiner’s obviousness rejection of claims 89 and 90 over
Kranich, as well as the Examiner’s obviousness rejection of claims 89 and
91 over Kranich and the ACCF/AHA 2011 Report.
SUMMARY
We affirm the rejection of claims 78, 80, and 81 under 35 U.S.C.
§ 102(b) as anticipated by Shafa.
We affirm the rejection of claims 78 and 80—82 under 35 U.S.C.
§ 103(a) as unpatentable over Shafa, NHLBI, Gadde, and CDC Report.
We affirm the rejection of claims 78—83 under 35 U.S.C. § 103(a) as
unpatentable over Shafa, NHLBI, and CDC Report.
We affirm the rejection of claims 78, 81, 86, and 87 under 35 U.S.C.
§ 103(a) as unpatentable over Shafa and Gadde.
We reverse the rejection of claim 89 under 35 U.S.C. § 102(b) as
anticipated by Kranich.
We reverse the rejection of claims 89 and 90 under 35 U.S.C. § 103(a)
as unpatentable over Kranich.
We reverse the rejection of claims 89 and 91 under 35 U.S.C. § 103(a)
as unpatentable over Kranich and ACCF/AHA 2011 Report.
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-IN-PART
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