Ex Parte Terada et al

Patent Trial and Appeal Board

Feb 27, 2017

13416219 (P.T.A.B. Feb. 27, 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.
P-75925-US 1439
EXAMINER
DICUS, TAMRA
ART UNIT PAPER NUMBER
1791
MAIL DATE DELIVERY MODE
13/416,219 03/09/2012
7590 02/28/2017
PEARL COHEN ZEDEK LATZER, LLP
12th Floor
1500 Broadway
New York, NY 10036
Shin TERADA
02/28/2017 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHIN TERADA and SAYURI YAMAMOTO
Appeal 2015-002373
Application 13/416,2191
Technology Center 1700
Before ADRIENE LEPIANE HANLON, MICHAEL P. COLAIANNI, and
CHRISTOPHER L. OGDEN, Administrative Patent Judges.
OGDEN, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s
decision2 finally rejecting claims 5 and 6 in the above-identified application.
A hearing was held on February 14, 2017. We have jurisdiction pursuant to
35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify The Nisshin OilliO Group, Ltd. as the real party in
interest. Appeal Br. 1, May 22, 2014.
2 Office Action, July 31, 2013 [hereinafter Action]; Examiner’s Answer, Oct.
6, 2014 [hereinafter Answer],
Appeal 2015-002373
Application 13/416,219
BACKGROUND
Appellants’ invention “relates to an inhibitor of visceral fat loss
targeted to Parkinson’s disease patients. Spec. 1. Claim 5, the sole
independent claim, reads as follows:
5. A method for inhibiting visceral fat loss in a
subject having Parkinson's disease, the method comprising
administering to a subject having Parkinson's disease an
effective amount of a lipid obtained by subjecting a medium-
chain triglyceride that includes as a constitutive fatty acid at
least one of a saturated fatty acid having 8 carbon atoms and a
saturated fatty acid having 10 carbon atoms to a
transesterification reaction with a vegetable oil, to thereby
inhibit visceral fat loss in said patient.
Appeal Br. 12 (emphasis added). The only other claim on appeal is claim 6,
which depends from claim 5 and requires that “the lipid is obtained by
subjecting the medium-chain triglyceride to a transesterification reaction
with the vegetable oil at a ratio of 10:90 to 20:20.” Id.
The Examiner maintains the following grounds of rejection:
I. Claims 5 and 6 are rejected under 35U.S.C. § 112, first
paragraph, for failing to comply with the enablement requirement. See
Action 2-4.
II. Claims 5 and 6 are rejected under 35 U.S.C. § 102(b), (f) “as
being anticipated by applicants!”] admission on page 5 lines 5—10 of the
specification that ‘it is known that MLCT is known to have an effect of
visceral fat loss, first found in PCT 20040220493 to exhibit an effect of
inhibiting visceral fat loss on PD.’” See Action 4.
3 Shinohara et al., Inf 1 Patent Application Pub. No. WO/2004/022049
(published Mar. 18, 2004) [hereinafter Shinohara].
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Appeal 2015-002373
Application 13/416,219
DISCUSSION
Rejection I: Lack of Enablement
According to the Examiner, Appellants’ Specification “does not
reasonably provide enablement for a method to use medium chain
triglycerides (MCT) and administer [them] to human patients having
Parkinson’s Disease (PD) to cause inhibition of fat loss,” because Appellants
have “not met scientific requirements as [they] pertain[] to medicinal trials
to claim that the process has any responses on people.” Action 2—3. This
conclusion is based on the following findings:
For example, the specification lacks certain types of scientific
data as it relates to medicine that would be necessary to evaluate
the full effects on patients. Applicant has not demonstrated, alt­
hough the method for inhibiting fat loss was tested on lab rats,
that what would work on lab rats would also work on human pa­
tients. The instant specification lacks factors or data such as:
l)the extent of absorption, 2) tissue distribution, 3) pathways
and rates of metabolism, and 4) rate(s) of elimination of the par­
ent substance and any metabolites formed, 5) cognitive testing
and/or rates of cognitive functioning as it relates to PD patients
for all safety concerns and risk factors associated with such treat­
ment, and 6) the actual PD test subject (it appears the rats don't
have PD but a symptom of PD which was ascertained to use as a
PD model rat—Text Example 1 in the instant specification) (note
all aforesaid factors are not an exhaustive list of all issues).
Action 3. In addition, the Examiner finds that the claimed “effect of using
the fat mixture on PD patients is opposite to that observed ... for people not
suffering from PD.” Id. (citing Shinohara). In the Answer, the Examiner
adds that “there is no rat control group to show that rats without PD would
behave both differently from those that do and show that they behave the
same as humans who do not.” Answer 4. Therefore, the Examiner
concludes that “there is no support found because claims to [what are]
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Appeal 2015-002373
Application 13/416,219
essentially treatments require a surmountable amount of evidence as it
relates to patients and it is the Examiner’s belief that Applicant has not
invented a method of inhibiting visceral fat loss on PD patients. Further[,]
nothing special is noticed or expected by Applicant’s methods of treating by
feeding fat.” Action 4.
In making a rejection based on lack of enablement, the Examiner
bears the initial burden of setting forth reasons to doubt that the claims are
adequately enabled by the disclosure. See In re Wright, 999 F.2d 1557, 1562
(Fed. Cir. 1993). The Examiner must back up these reasons for doubt “with
acceptable evidence or reasoning which is inconsistent with the contested
statement.” In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971). This
evidence or reasoning must show that a person of ordinary skill in the art at
the time of filing would have been unable to make and use the invention
without undue experimentation. See In re Wands, 858 F.2d 731, 737 (Fed.
Cir. 1988). Factors to be considered include
(1) the quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence of
working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the
predictability or unpredictability of the art, and (8) the breadth of
the claims.
Id.
The Examiner’s rejection fails to meet the required initial burden.
The Examiner has not provided an analysis of the Wands factors, and has not
pointed to any positive evidence, or any persuasive, objective reason to
doubt the veracity of the experimental results in Appellants’ Specification.
In addition, we find no merit in the Examiner’s questioning of
whether Appellants’ animal testing would have enabled treatment of PD in a
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Appeal 2015-002373
Application 13/416,219
human patient. In general, showing that a compound exhibits a therapeutic
effect in a standard experimental animal model is sufficient to enable a
therapeutic invention directed toward humans. See In re Krimmel, 292 F.2d
948, 953 (CCPA 1961). This is because “one who has taught the public that
a compound exhibits some desirable pharmaceutical property in a standard
experimental animal has made a significant and useful contribution to the
art, even though it may eventually appear that the compound is without
value in the treatment of humans.” Id.
A “standard experimental animal” is “whatever animal is usually used
by those skilled in the art to establish the particular pharmaceutical
application in question.” Id. Appellants’ Specification presents therapeutic
effectiveness data using “Sprague-Dawley male rats.” Spec. 10. The
Examiner has not pointed to any evidence suggesting that this experimental
animal is not accepted in the field, for the type of experiments described in
the Specification, as an indicator that the therapy may have utility in
humans. Moreover, Appellants have cited evidence that Sprague-Dawley
male rats are used in the field as a model for investigating PD in humans.
See Appeal Br. 5 (citing Jennifer L. Tillerson et al., Forced Limb-Use Effects
on the Behavioral and Neurochemical Effects of 6-Hydroxy dopamine, 21 J.
Neuroscience 4427 (2001); Michael J. Zigmond & Edward M. Strieker,
Current Topics: 1. Parkinson’s Disease Studies with an Animal Model, 35
Life Sciences 5 (1984)).
For the above reasons, the Examiner reversibly erred in rejecting
claims 5 and 6 for lack of enablement.
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Application 13/416,219
Rejection II: Anticipation
The Examiner’s anticipation rejection is “solely based on the
admission in the specification,” and not on the Shinohara reference itself.
Action 4. This is evidently because, as the Examiner acknowledges,
Shinohara does not teach a method that has the effect of inhibiting visceral
fat loss in the patient as required by claim 5,4 and instead teaches the
opposite effect. See Appeal Br. 12.
What the Examiner quotes as Appellants’ admission is not a verbatim
quote from the Specification itself, either in its original form or as modified
by Appellants in an amendment. Although the original passage, Spec. 5:5—9,
Mar. 9, 2012, is somewhat unclear, we do not read it as an admission that
Shinohara teaches an effect of inhibiting visceral fat loss on PD patients,
especially given that Shinohara does not, in fact, disclose such an effect. In
any event, the Examiner accepted an amendment to the Specification that
clarifies the language and is clearly not an admission of anticipation. See
Am. Spec. 1, Dec. 18, 2013 (“The present invention is of significance in that
MLCT, which is known to have an effect of visceral fat loss on healthy
individuals (PCT International Publication No. 2004/022049), was first
found by the inventors hereof to exhibit an effect of inhibiting visceral fat
loss on Parkinson's disease patients.”).
4 We interpret claim 5 to require that the step of administering the lipid to the
patient actually has the therapeutic effect “to thereby inhibit visceral fat loss
in said patient,” and that this is not merely an intended result of the claimed
method. This is evidently the interpretation of both the Examiner, see
Answer 8 (“The claim effect is that there is an inhibition of visceral fat
loss.”), and Appellants, see Appeal Br. 6 (The claims “claim an effect on
Parkinson’s disease patients . . . .”).
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Application 13/416,219
For the above reasons, the Examiner reversibly erred in rejecting
claims 5 and 6 for anticipation.
DECISION
The Examiner’s decision is reversed.
REVERSED
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