Ex Parte Baron et al

Patent Trial and Appeal Board

Jul 19, 2017

12763926 (P.T.A.B. Jul. 19, 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.
12/763,926 04/20/2010 Alain BARON 2701/US/2 6345
28381 7590 07/21/2017
Arnold & Porter Kaye Scholer LLP
601 Massachusetts Ave., NW
Washington, DC 20001-3743
EXAMINER
ULM, JOHN D
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
07/21/2017 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 @ apks.com
ipdocketing @ aporter. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALAIN BARON, MARTIN R. BROWN,
and CHRISTOPHER R. G. JONES
Appeal 2015-006782
Application 12/763,9261
Technology Center 1600
Before DONALD E. ADAMS, RACHEL H. TOWNSEND and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a condition associated with a chemosensory receptor. The
Examiner rejected the claims on appeal under 35 U.S.C. § 112 (a) as failing
to comply with the written description and enablement requirements and
under 35 U.S.C. § 101 for lack of utility.
We reverse.
1 According to Appellants, the real parties in interest is Ambra BioScience
LLC. App. Br. 1.
Appeal 2015-006782
Application 12/763,926
STATEMENT OF THE CASE
The Specification discloses that it has been reported that “there are
taste receptors present on the L-cells and K-cells in the intestine.” Spec. | 6.
“Stimulation of these receptors by luminal nutrients results in apical
secretion of L-cell products such as GLP-1, PYY, oxyntomodulin and
glycentin, and K-cell products such as GIP.” Id. “Activation of taste
receptors, for example, activation of the sweet receptor by glucose
stimulation, has been reported to result in the release of GLP-1 and other
enteroendocrine cell products.” Id.2
The Specification further discloses that “[although many
nonmetabolized ‘tastants’ recognized by taste receptors have been identified,
there are currently none that have been approved for use in increasing
production (biosynthesis) of GLP-1 or related hormones.” Id. at 17. In
addition “a number of reports suggest that oral delivery of sweet tastants are
not associated with GLP-1 release.” Id. The Specification concludes, “it
would be of great value in the treatment of diabetes, metabolic syndrome,
obesity, and related disorders to determine how to use chemosensory
receptor ligands to treat disorders associated with chemosensory receptors
by modulating enteroendocrine cell hormones.” Id.
The Specification discloses: “Provided herein are compositions
having at least one chemosensory receptor ligand and methods of treatment
using the compositions. . . . The compositions described herein can be
2 “In a glucose-dependent manner, GLP-1 and GIP increase insulin release
from beta cells (an effect known as the incretin effect). In addition, GLP-1
inhibits glucagon release and gastric emptying. GLP-1, oxyntomodulin and
PYY 3-36 are considered to be satiety signals.” Spec. 1 6.
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delivered to the upper gastrointestinal tract, lower gastrointestinal tract, or
both.” Id. at | 8.
Claims 1—4, 9—14, 17, and 18 are on appeal. Claim 1 is illustrative
and reads as follows:
1. A method of treating a condition associated with a
chemosensory receptor in a subject comprising administering
a composition comprising at least one sweet receptor ligand
to the subject, wherein said composition is formulated to
release the sweet receptor ligand beyond the stomach.
App. Br. 13.
The claims stand rejected as follows:
Claims 1—4, 9—14, 17, and 18 were rejected under 35 U.S.C. § 112,
first paragraph as failing to comply with the written description requirement.
Claims 1—4, 9—14, 17, and 18 were rejected under 35 U.S.C. § 112,
first paragraph as failing to comply with the enablement requirement.
Claims 1—4, 9—14, 17, and 18 were rejected under 35 U.S.C. § 101 as
failing to comply with the utility requirement.
WRITTEN DESCRIPTION
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must ‘“clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’” Ariad Pharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc) (citation omitted, alteration
in original). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. “If. . . the specification contains a description of the claimed invention,
albeit not in ipsis verbis (in the identical words), then the examiner . . . , in
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Application 12/763,926
order to meet the burden of proof, must provide reasons why one of ordinary
skill in the art would not consider the description sufficient.” In re Alton, 76
F.3d 1168, 1175 (Fed. Cir. 1996)
Here, the Specification discloses a “method of treating a condition
associated with a chemosensory receptor by administering a composition
having at least one chemosensory receptor ligand to [] the duodenum,
jejunum, ileum or colon.” Spec. |13. The Specification identifies a variety
of diseases, including diabetes, as being “associated with a chemosensory
receptor.” Id. at |22. The Specification also provides protocols for testing
the efficacy of the composition in obese and healthy human subjects. See,
e.g., id. at || 453 459 (Examples 32—34).
The Examiner found that the claimed invention did not satisfy the
written description requirement because the Specification “provides no
actual working examples of even a single embodiment of the claimed
method,” and provides “no evidence that... the administration of sucralose
to an individual afflicted with diabetes produced any effect whatever on the
blood glucose level of that individual irrespective of how that sucralose was
administered.” Final Act. 3.3 The Examiner cited Mezitis,4 Grotz,5 Fujita6
3 Office Action mailed March 10, 2014 (“Final Act.”).
4 Nicholas H. E. Mezitis et al, Glycemic Effect of a Single High Oral Dose of
the Novel Sweetener Sucralose in Patients with Diabetes, 19(9) Diabetes
Care 1004 (1996) (“Mezitis”).
5 V. Lee Grotz et al., Lack of Effect of Sucralose on Glucose Homeostasis in
Subjects with Type 2 Diabetes, 103 Journal of the American Dietetic
Association, 1607-1612 (2003) (“Grotz”).
6 Yukihiaro Fujita et al., Incretin Release from Gut is Acutely Enhanced by
Sugar but not by Sweeteners in Vivo, 296 Am. J. Physiol. Endocrinol.
Metab, E473-E479 (2008) (“Fujita”).
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Application 12/763,926
and Ma7 to support the position that “at the time that the instant application
was filed, there was overwhelming evidence that the administration of
sucralose, by any means, had no measurable effect upon blood glucose
levels.” Id. at 4. The Examiner also found that FDA8 taught that sucralose
was “well known to pass, unmetabolized, through the digestive system of
mammals,” and concluded that this would result in “exposure of the entire
digestive system of that mammal, including the region beyond the stomach,
to sucralose.” Id.', Ans. 5—6. Based upon the absence of working examples,
and the teachings in the art that sucralose had no effect on blood glucose
levels, the Examiner concludes that the Specification did not convey that the
inventors were in possession of the claimed method. Final Act. 2—7.
We begin by construing the claims. We construe the phrase
“formulated to release the sweet receptor ligand beyond the stomach” as
used in claim 1 to require that the sweet receptor ligand not be released from
the composition in which it was administered until after it has cleared the
stomach. This is consistent with how the Specification describes the
formulation of the claimed compositions. See, Spec. 21 (“The
compositions described herein can be formulated with an enteric coating”),
see also, Tflf 14—17 (disclosing that compositions can be formulated such that
the ligand is released at set times subsequent to administration that are
consistent with the time required to clear the stomach and at pHs consistent
7 Jing Ma et al., Effect of the Artificial Sweetener, Sucralose, on Gastric
Emptying and Incretin Hormone Release in Healthy Subjects, 296 Am. J.
PHYSIOL. GASTROINTEST. LIVER PHYSIOL. G735-739 (2009) (“Ma”).
8 United States Food and Drug Administration, Food Additives Permitted for
Direct Addition to Food for Human Consumption; Sucralose, 63(64) Federal
Register 16417-16433 (1998) (“FDA”).
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Application 12/763,926
with those found in the intestine). It is also consistent with the ordinary
meaning of the term “release” — “to free from confinement, bondage,
obligation, pain, etc.” or “to free from anything that restrains.”
www.dictionary.com/browse/release, accessed July 12, 2017.
Appellants argue, inter alia, that “none of the cited references
[Mezitis, Grotz, Fujita, Ma, and FDA] are on point at least because none of
the references describe delivery of the non-metabolizable sweetener beyond
the stomach.” Reply. Br. 3. According to the Appellants, the Examiner has
“merely provided evidence that sucralose administered orally and/or directly
into the stomach, as opposed to beyond the stomach as recited in the instant
claims, does not affect metabolic hormone profiles.” App. Br. 8—9.
Appellants argue that “such evidence has little or no bearing on the
operability of the instant methods involving administration of sweet receptor
ligands beyond the stomach.” Id. at 9. Appellants have persuaded us that
the Examiner has not provided sufficient reason “why one of ordinary skill
in the art would not consider the description sufficient.” In re Alton, 76 F.3d
1168, 1175 (Fed. Cir. 1996).
Appellants’ arguments are implicitly premised on construing the
phrase “formulated to release the sweet receptor ligand beyond the stomach”
in claim 1 to require that the ligand be released only after it has passed
through the stomach. In light of our claim construction, we agree with
Appellants and find that the evidence relied upon by the Examiner as
providing reason “why one of ordinary skill in the art would not consider the
description sufficient” is not persuasive. Although the Examiner is correct
that each of Mezitis, Grotz, Fujita, and Ma provides evidence that the
administration of sucralose has no effect on blood glucose levels, none of
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these references speak to the situation claimed, in which sucralose (or
another sweet receptor ligand) is not released until after it clears the
stomach. See, Mezitis 1004 (reflecting testing in which a test subject
“consum[ed] the test substance, which consisted of 1,000 mg sucralose or
cellulose placebo that was contained in three opaque capsules.”); Grotz 1608
(“Subjects received two capsules per day of either placebo or sucralose . . .
to be taken at breakfast and dinnertime for the next 13 weeks.”); Fujita
E474—E475 (describing testing of sweeteners administered orally and using
a “stainless steel gavage tube”); Ma G476 (testing involved intragastric
infusion of formulations including, inter alia, sucralose). As explained in
the Fineman Declaration,9 “delivering chemosensory receptor ligands to the
stomach may produce confounding signals that blunt the hormone signals
achieved when the same ligands are delivered beyond the stomach.”
Fineman Decl. 110. As the Examiner has not carried the burden of
providing a sufficient reason why one of ordinary skill in the art would not
consider the Specification adequate to satisfy 35U.S.C. § 112, first
paragraph’s written description requirement, we reverse the Examiner’s
rejection of claims 1—4, 9—14, 17, and 18 for failing to meet the written
description requirement.
ENABLEMENT
A description adequate to satisfy the enablement requirement of
35 U.S.C. § 112(a) requires, inter alia, that the specification enable the
person of ordinary skill in the art to make and use the claimed invention.
“Although the statute does not say so, enablement requires that the
9 Declaration of Mark Fineman Pursuant to 37 C.F.R. § 1.132, signed
September 23, 2013 (“Fineman Declaration”).
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specification teach those in the art to make and use the invention without
‘undue experimentation. ’ . . . That some experimentation may be required is
not fatal; the issue is whether the amount of experimentation required is
‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (internal citation
omitted). The Examiner bears the burden of explaining why the scope of
protection claimed is not adequately enabled by the description of the
invention provided in the specification including, “providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561—62 (Fed. Cir. 1993).
The Examiner found that the claims did not comply with the
enablement requirement for reasons similar to those underlying the
Examiner’s written description rejection. In particular, the Examiner relied
upon absence of “actual working examples” and the “overwhelming
evidence that the administration of sucralose, by any means, had no
measurable effect upon blood glucose levels.” Final Act. 3^4. The
Examiner concluded that the Specification “fail[ed] to supply the guidance
that would be needed by a routine practitioner to successfully practice that
method with any reasonable expectation of producing a beneficial result.”
Ans. 3.
As discussed above, Mezitis, Grotz, Fujita, and Ma do not provide
sufficient evidence to counter the teaching of the Specification that “a
condition associated with a chemosensory receptor” can be treated “by
administering a composition having at least one chemosensory receptor
ligand to [] the duodenum, jejunum, ileum or colon.” Spec. 113. None of
these references provides “sufficient reasons for doubting any assertions in
the specification as to the scope of enablement.” In re Wright, 999 F.2d at
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1561—62. Moreover, we agree with Appellants that “[o]ne of ordinary skill
in the art would understand how to formulate a composition to release an
active ingredient to particular regions of the gastrointestinal tract based on
time or pH as recited in the present claims at the time of filing.” Reply Br.
5; see also, Spec. 1164 (“the methods and compositions directed to
chemosensory receptor ligand(s) are provided in the form of controlled,
sustained, or extended release formulations, known collectively as ‘modified
release’ formulations [which] can be administered by modified release
means or by delivery devices that are well known to those of ordinary skill
in the art.”). As the Examiner has not provided sufficient reason to doubt
the assertions made in the Specification, we reverse the Examiner’s rejection
of claims 1—4, 9—14, 17, and 18 under 35 U.S.C. § 112, first paragraph for
failure to comply with the enablement requirement.
UTILITY
Section 101 requires a utility that is both “substantial” and “specific.”
A substantial utility requires:
showing] that an invention is useful to the public as
disclosed in its current form, not that it may prove useful
at some future date after further research. Simply put, to
satisfy the “substantial” utility requirement, an asserted
use must show that that claimed invention has a
significant and presently available benefit to the public.
In re Fisher, 421 F.3d 1365, 1371 (Fed. Cir. 2005). A specific utility is “a
use which is not so vague as to be meaningless.” Id. In other words, “in
addition to providing a ‘substantial’ utility, an asserted use must also show
that that claimed invention can be used to provide a well-defined and
particular benefit to the public.” Id. “[T]he PTO has the initial burden of
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challenging a presumptively correct assertion of utility in the disclosure.” In
re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995). “Only after the PTO
provides evidence showing that one of ordinary skill in the art would
reasonably doubt the asserted utility does the burden shift to the applicant to
provide rebuttal evidence sufficient to convince such a person of the
invention’s asserted utility.” Id.
Here, the Specification identifies a substantial and specific utility for
the claimed method — treating conditions associated with a chemosensory
receptor. See, e.g., Spec. H 13 and 22. As with the written description and
enablement rejections, the Examiner relies principally on “the overwhelming
experimental evidence of record that was available at the time that the
instant application was filed indicates that the administration of sucralose to
a diabetic, or any other mammal in vivo, had no demonstrable effect.” Ans.
11. For the reasons discussed above, the evidence relied upon be the
Examiner — i.e., Mezitis, Grotz, Fujita, and Ma — does not provide sufficient
reason to doubt the asserted utility of administering a sweet receptor ligand
beyond the stomach. Moreover, the Fineman Declaration reflects that
“administration of chemosensory receptor ligands beyond the stomach is
able to augment meal induced secretion of GLP-1 and/or PYY, the
upregulation of which is associated with beneficial effects for the treatment
of diabetes and on weight loss in diabetic and non-diabetic populations.”
Fineman Deck 122. Accordingly, we reverse the Examiner’s rejection of
claims 1—4, 9—14, 17, and 18 for failing to comply with the utility
requirement.
SUMMARY
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For the reasons discussed herein, we reverse the Examiner’s decision
to reject claims 1—4, 9—14, 17, and 18 for failing to comply with the written
description requirement, the enablement requirement, and the utility
requirement.
REVERSED
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