Ex Parte Puschett et al

Patent Trials and Appeals Board

Jun 20, 2019

14169365 - (D) (P.T.A.B. Jun. 20, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/169,365 01/31/2014
32425 7590 06/24/2019
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
FIRST NAMED INVENTOR
Jules B. Puschett
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.
JBPU.P0002US.Cl 4268
EXAMINER
PAGONAKIS, ANNA
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/24/2019 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):
aoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JULES B. PUSCHETT and LEE SHAPIR0 1
Appeal 2018-003945
Application 14/169,365
Technology Center 1600
Before ULRIKE W. JENKS, ELIZABETH A. LA VIER,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134(a) involving claims to a
method for treating brain injuries which have been rejected for failing to
satisfy the written description requirement, for lack of enablement and for
non-statutory obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Dr. Jules Puschett. Br. 3.
2 We have considered and herein refer to the Specification of Jan. 31, 2014
("Spec."); Final Office Action of Dec. 7, 2016 ("Final Act."); Appeal Brief
of Aug. 7, 2017 ("Br."); and Examiner's Answer of Dec. 13, 2017 ("Ans.").
Appeal 2018-003945
Application 14/169,365
STATEMENT OF THE CASE
Appellants' Specification discloses that:
It has long been known that traumatic brain injuries can result
in temporary problems, permanent problems, and in some
instances, death. It has, more recently, been recognized that
such brain injuries may not, initially, produce symptoms which
cause the patient, others, or even medically-skilled individuals
to be concerned even though, within a day or two, very serious
consequences may result.
Spec. ,-J 2. Present diagnostic techniques are not totally effective in
identifying traumatic brain injuries. Id. ,-i 4. The Specification describes
methods for diagnosing and treating traumatic brain injuries. Id. ,-i 8.
Claims 1, 2, 11, 12, and 16 are on appeal. Claim 1 is representative
and reads as follows:
1. A method of treating a patient comprising administering a
therapeutically effective dose of a MBG antagonist to the
patient that has experienced an indirect or direct shock to the
head, and has MBG levels 30% higher than a subject that has
not experienced an indirect or direct shock to the head.
The claims stand rejected as follows:
Claims 1, 2, 11, 12, and 16 have been rejected under 35 U.S.C. § 112,
first paragraph for failing to comply with the written description
requirement.
Claims 1, 2, 11, 12, and 16 have been rejected under 35 U.S.C. § 112,
first paragraph for lack of enablement.
Claims 1, 2, 11, 12, and 16 have been rejected for non-statutory
obviousness-type double patenting over claims 1-8 of US 8,642,568 B2.
2
Appeal 2018-003945
Application 14/169,365
WRITTEN DESCRIPTION
Issue
The issue with respect to this rejection is whether the Examiner has
properly determined that the present Specification does not satisfy the
written description requirement.
The Examiner finds that the Specification does not provide an
adequate written description of the limitations "a therapeutically effective
dose of a MBG [ marinobufagenin] antagonist" and "a marinobufagenin level
at least 30 percent higher than a subject [who] has not experienced an
indirect or direct shock to the head." Final Act. 3. The Examiner finds that
only the preferred embodiment in the Specification teaches that a traumatic
brain injury exists if the elevation of MBG is at least 30 percent over that of
a normal patient. Id. The Examiner also finds that the Specification is silent
as to the genus of MBG antagonists as the Specification only identifies one
MBG antagonist, resibufogenin ("RBG"). Id. The Examiner concludes that
the claims lack sufficient written support.
Appellants contend that the Specification describes the claimed
invention in sufficient detail such that one skilled in the art could reasonably
conclude that the inventor had the claimed invention in their possession. Br.
4.
With respect to the limitation "a therapeutically effective dose of a
MBG antagonist," Appellants contend that the limitation is used consistently
throughout the Specification and gives an example of what is meant by the
term. Appellants point to paragraph 27 of the Specification where it teaches
that 120 µg of resibufogenin was administered to 10 rats to prevent brain
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Appeal 2018-003945
Application 14/169,365
mJury. Br. 6. Appellants also point to paragraph 3 8 of the Specification
where it teaches that an effective amount of RBG is an amount sufficient to
prevent the formation of a glial scar. 3 Br. 5.
Appellants argue that the limitation "a marinobufagenin level at least
30 percent higher than a subject that has not experienced an indirect or direct
shock to the head" is supported by the Specification. Br. 6. Appellants cite
to paragraph 35 of the Specification where it states "[i]n a preferred
embodiment of the present invention, it is determined that a traumatic brain
injury exists if the elevation ofmarinobufagenin is at least about 30
percent over that of a normal patient." Id. ( emphasis added in brief
( quoting Spec. ,i 3 5) ). Appellants contend that just because the level of
MBG is disclosed in a preferred embodiment does not detract from the
disclosure supporting the limitation in the claims. Id. at 7.
Appellants argue that the genus of MBG antagonists is also supported.
Id. at 8. Appellants contend that the Specification discloses a well-known
MBG antagonist and its use in treating a head injury. Id. Appellants
contend that one skilled in the art could readily substitute any other MBG
antagonist and achieve the same result without undue experimentation. Id.
Appellants contend that one skilled in the art would understand that
Appellants clearly possessed the claimed invention. Id.
3 The Specification teaches that the formation of a glial scar is an indicator
of brain injury. See Spec. ,i 38.
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Appeal 2018-003945
Application 14/169,365
Principles of Law
"In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue." Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
"Put another way, one skilled in the art, reading the original
disclosure, must immediately discern the limitation at issue in the claims."
Id. at 1323.
The Federal Circuit explained that:
Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor
cannot lay claim to that subject matter unless he can provide a
description of the compound sufficient to distinguish infringing
compounds from non-infringing compounds, or infringing
methods from non-infringing methods.
University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 926 (Fed. Cir.
2004).
In Ariad, the court explained:
sufficient description of a genus instead requires the disclosure
of either a representative number of species falling within the
scope of the genus or structural features common to the
members of the genus so that one of skill in the art can
"visualize or recognize" the members of the genus.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010)
(en bane).
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Appeal 2018-003945
Application 14/169,365
Analysis
We have considered the arguments presented by Appellants and the
Examiner and find that, with respect to claims 1, 2, and 11, the Examiner's
finding of a lack of written description is correct. With respect to claims 12
and 16, we find the rejection is erroneous.
The Examiner found that the limitation referring to MBG levels 30%
higher than a subject that has not experienced an indirect or direct shock to
the head was not supported by the Specification. We do not agree. The
Specification teaches "[i]n a preferred embodiment of the present invention,
it is determined that a traumatic brain injury exists if the elevation of
marinobufagenin is at least about 30 percent over that of a normal patient."
Spec. ,-J 35. We agree with Appellants that this passage, in the context of the
Specification as a whole, provides support for the recited limitation.
The limitation in claim 1 calling for a therapeutically effective amount
of MBG antagonist, however, is not supported by the Specification. As the
Examiner points out, the Specification lists only one MBG antagonist, RBG.
The disclosure of only one member of the genus, absent any disclosure of
structural features common to the genus does not allow one skilled in the art
to visualize or recognize the members of the genus. See Ari ad, 598 F .3d at
1350.
Appellants contend that following the teachings of the Specification,
one skilled in the art can readily identify other MBG antagonists without
undue experimentation. Br. 8. While this is true, whether undue
experimentation is needed is a question of enablement, not written
description. The written description requirement is separate from the
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Appeal 2018-003945
Application 14/169,365
enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563
(Fed. Cir. 1991 ). When claiming a genus, the Specification must disclose
"either a representative number of species falling within the scope of the
genus or structural features common to the members of the genus so that one
of skill in the art can 'visualize or recognize' the members of the genus."
Ariad, 598 F.3d at 1350. That one skilled in the art might be able to later
identify additional members of the genus is insufficient. "One needs to
show that one has truly invented the genus, i.e., that one has conceived and
described sufficient representative species encompassing the breadth of the
genus. Otherwise, one has only a research plan, leaving it to others to
explore the unknown contours of the claimed genus." AbbVie Deutschland
GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014).
Claims 12 and 16 specifically claim the use of RBG, which is
disclosed in the Specification. Br. 13 (Claims App'x); Spec. ,-J 37. We find
that claims 12 and 16 are sufficiently supported by the Specification.
Conclusion of Law
We conclude that the written description requirement has not been
met for claims 1, 2, and 11 but that it has been met for claims 12 and 16.
Accordingly, we affirm the writing description rejection as to claims 1, 2,
and 11, but reverse it as to claims 12 and 16.
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Application 14/169,365
ENABLEMENT
Issue
The issue with respect to this rejection is whether the Examiner has
properly determined that the claims are not enabled by the present
Specification.
The Examiner finds that while the Specification is enabling for
inhibiting glial scar formation associated with traumatic brain injury, the
Specification is not enabling for treating a patient with traumatic brain
injury. Final Act. 4-5. The Examiner finds "[t]he instant specification as
originally filed lacks adequate guidance, direction or discussion to apprise
the skilled artisan how the claimed may be used to achieve a method of
reducing the risk to brain tissue." Id. at 6. The Examiner finds that the
Specification does not set forth any examples of treating traumatic brain
injury. Id. The Examiner contends that while the absence of working
examples cannot be the sole factor in determining enablement, the absence
of a working example provides additional weight to the Examiner's
conclusion that the claims are not enabled. Id. at 7.
The Examiner finds the Specification is devoid of any correlation
between the claimed method and its efficacy in treating the disclosed
conditions. Id. The Examiner finds that the Specification
fails to provide any guidance or direction in support of the
reasonable expectation of success in actually effecting the
treatment of the disclosed disorders using the instantly claimed
compound in the absence of any evidence supporting the
allegation that the elected compound is, in fact, effective to
achieve such a therapeutic objective, either by reduction to
practice or at least by elucidating the mechanism by which the
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Application 14/169,365
claimed compound works and correlating such activity to
therapeutic improvement of the disclosed disorders or diseases.
Id. at 7-8.
The Examiner concludes
As the cited art and discussion of the above factors
establish, practicing the claimed method in the manner
disclosed by Applicant would not imbue the skilled artisan with
a reasonable expectation or ability to make and use the full
scope of the invention as instantly claimed, given the disclosure
and supporting examples provided in the present specification
and the state of the art at the time of the invention. In order to
actually achieve the claimed invention, it is clear from the
discussion above that the skilled artisan could not rely upon
Applicant's disclosure as required by 35 U.S.C. 112, first
paragraph, and would have no alternative recourse but the
impermissible burden of undue experimentation in order to
practice the full scope of the embodiments presently claimed.
Id. at 8-9.
Appellants contend that the Specification describes the effects of brain
injury and shows that glial scar formation is an indicator of brain injury. Br.
9-10. Appellants contend that one skilled in the art would accept
amelioration of glial scar formation as an indicator that the claimed method
is an effective treatment for brain injury. Id.
Appellants also contend that
It is clear the current application provides one of skill
sufficient description to enable one of skill to make and use the
claimed invention without undue experimentation. Based on
the guidance provided by the current specification in
combination with what is known in the art one of skill would
recognize (1) elevated levels of MBG are pathogenic, (2)
traumatic brain injuries are associated with an elevation in
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Application 14/169,365
MBG, and (3) the pathogenic consequences of elevated MBG
can be treated by administering a MBG antagonist, such as
resibufogenin (RBG).
Id. at 11.
Principles of Law
The Federal Circuit explained that:
Section 112 requires that the patent specification enable those
skilled in the art to make and use the full scope of the claimed
invention without undue experimentation .... [ S]ee also In re
Goodman, 11 F.3d 1046, 1050 (Fed. Cir. 1993) ("[T]he
specification must teach those of skill in the art how to make
and how to use the invention as broadly as it is claimed.").
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070-71 (Fed. Cir.
2005) (internal quotes omitted).
"[ A ]n invention may be enabled even though it has not been
described." University of Rochester v. G.D. Searle & Co., 358 F.3d 916,
921 (Fed. Cir. 2004).
The court in Amgen explained that:
[t]he enablement requirement is often more indulgent than the
written description requirement. The specification need not
explicitly teach those in the art to make and use the invention;
the requirement is satisfied if, given what they already know,
the specification teaches those in the art enough that they can
make and use the invention without "undue experimentation."
Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1334 (Fed. Cir.
2003) ( citation omitted).
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Application 14/169,365
Analysis
We have considered the positions advanced by the Examiner and
Appellants and find that Appellants have the better position.
The Specification teaches that traumatic brain injury can result in the
formation of glial scars, a loss of GP AP-labeled astrocytes and the
appearance of hypertrophied astrocytes. Spec. ,-J 27. The Specification also
teaches that the administration of RPG prevents the formation of glial scars
and ameliorates the other effect of brain injury. Id.
The Specification teaches how to determine whether a patient has
suffered a brain injury. Specifically, the Specification teaches how to
measure MBG levels and that MBG levels that are 30 percent higher than
normal indicate the brain injury has occurred. Id. ,-i,-i 33-35.
Finally, the Specification provides a working example where rats were
subject to traumatic brain injury by impact and a group of the rats were
treated with 120 µg of RBG 90 minutes after imposition of brain trauma. Id.
,-J 27. The group of rats treated with RBG exhibited no glial scars, and, when
compared to the untreated rats, exhibited a reduction in the decrease in
GP AP immunoreactivity and a greater portion of the astrocytes had a normal
appearance. Id. ,-i 38. Therefore, we agree with Appellants (see Br. 10) that
extension of this study to human subject experiencing head trauma would be
routine and would not involve undue experimentation.
Conclusion of Law
We conclude that the Examiner has not demonstrated that the claims
are not enabled. Accordingly, we reverse the enablement rejection.
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Application 14/169,365
OBVIOUSNESS-TYPE DOUBLE PATENTING
Appellants have offered no substantive argument with respect to this
rejection, other than to off er to file a terminal disclaimer upon allowance of
the present claims. Br. 11. Therefore, we summarily affirm this rejection.
See 37 C.F.R. § 421.37(c)(iv).
SUMMARY
We affirm the rejection of claims 1, 2, and 11 under 35 U.S.C. § 112,
first paragraph for lack of written description.
We reverse the rejection of claims 12 and 16 under 35 U.S.C. § 112,
first paragraph for lack of written description.
We reverse the rejection of claims 1, 2, 11, 12, and 16 under 35
U.S.C. § 112, first paragraph for lack of enablement.
We affirm the rejection of claims 1, 2, 11, 12, and 16 for non-statutory
obviousness-type double patenting.
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. § l .136(a).
AFFIRMED
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