Ex Parte Katz

Patent Trial and Appeal Board

Jul 28, 2016

12306552 (P.T.A.B. Jul. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/306,552 10/16/2009 David M. Katz
68705 7590 08/01/2016
TAROLLI, SUNDHEIM, COVELL & TUMMINO, LLP
1300 EAST NINTH STREET
SUITE 1700
CLEVELAND, OH 44114
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.
CWR-8170US PCT 4810
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
08/01/2016 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):
rkline@tarolli.com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID M. KA TZ 1
Appeal2014-005663
Application 12/306,552
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving a claims to a
method of treating non-neurodegenerative pathologies or respiratory
disorders. We have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 According to Appellant, the real party in interest is Case W estem Reserve
University. (Br. 2.)
Appeal2014-005663
Application 12/306,552
STATEMENT OF THE CASE
Claims on Appeal
Claims 1 and 3-19 are on appeal.2 (Claims Appendix, Br. 29-39.)
Claims 1 and 8 are illustrative and read as follows:
1. A method of treating non-neurodegenerative pathologies associated
with derangement in brain-derived neurotrophic factor signaling in the brain
stem of a subject comprising:
administering to the subject an amount of at least one ampakine
effective to increase brain-derived neurotrophic factor expression in at least
one of brain stem neurons and nodose sensory neurons of the subject.
(Id. at 29.)
8. A method of treating respiratory disorders in a subject caused by loss-
of-function mutations of the gene encoding methyl-CpG binding protein 2
(MeCP2), comprising:
administering to the subject an amount of at least one ampakine
effective to increase brain-derived neurotrophic factor expression in brain
stem neurons and nodose sensory neurons and improve respiratory function
of the subject.
(Id. at 32-33.)
Examiner's Rejections
1. Claims 1and3-7 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Gall, 3 as evidenced by Zoghbi. 4 (Final Act. 2.)5
2 Appellant elected the ampakine species 1-(1,4-benzodioxan-6-
ylcarbonyl)piperidine, also known as GR87. (Response to Election
Requirement dated Mar. 30, 2012. See also Final Act. 2.)
3 Gall et al., US 6,030,968, issued Feb. 29, 2000 ("Gall").
4 Zoghbi et al., US 6, 7 09 ,817 B 1, issued Mar. 23, 2004 ("Zoghbi").
5 Office Action dated Mar. 13, 2013.
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2. Claims 8-19 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Zoghbi and Gall. (Id. at 5.)
FINDINGS OF FACT
We adopt as our own the Examiner's findings and analysis concerning
the scope and content of the prior art. The following findings are included
for emphasis and reference convenience.
FF 1. The Specification states that "[b ]y non-neurodegenerative
pathology, it is means [sic] diseases and disorders that are not associated
with neuronal injury or neuronal death .... These non-neurodegenerative
pathologies can include pervasive development disorders, such as Rett
Syndrome and autism." (Spec. i-f 44.)
FF 2. Gall teaches "[m]ethods for increasing the level of neurotrophic
factors and neurotrophic factor receptors in the brain of a mammal ...
comprising administering to a mammal an effective amount of an allosteric
upmodulator of ... (AMPA) receptors" (e.g., an ampakine). (Gall Abstract.)
FF 3. Gall teaches that pathologies that would benefit from its
invention (administration of ampakines) include Rett syndrome. (Gall col.
6, 11. 21-23 and 37.)
FF 4. Gall teaches brain derived neurotrophic factor (BDNF) mRNA
levels were significantly increased by treatment with ampakine GR87. (Gall
col. 14, 11. 6-45.)
FF 5. Gall teaches that "[t]ypical dosages for systemic administration
range from 0.1 to 50 milligrams per kg weight of subject per
administration." (Gall col. 10, 11. 38--40.)
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FF 6. Zoghbi teaches that Rett syndrome (RTT) patients exhibited a
"positive correlation ... between truncating mutations and ... breathing
abnormalities." (Zoghbi col. 11, 11. 60-66.)
FF 7. The Examiner finds that Gall teaches the treatment of Rett
syndrome (R TT) by administration of GR87 with the same therapeutic
amounts as claimed by Appellant, and that treatment of "non-
neurodegenerative pathologies" (including associated respiratory
abnormalities) is inherent upon treatment of the same disorder (R TT) by
administration of the same active agent (GR87) to RTT patients. (Final Act.
3.)
FF 8. Zoghbi teaches that "defects in MECP2 are related to Rett
syndrome" and that "MECP2 is clearly involved in Rett syndrome and its
related features."6 (Zoghbi col. 13, 1. 15-20.)
ISSUES
Whether a preponderance of evidence of record supports the
Examiner's (1) finding of anticipation under 35 U.S.C. § 102(b), and (2)
conclusion of obviousness under 35 U.S.C. § 103(a).
DISCUSSION
Principles of Law
Claims under examination are given their broadest reasonable
interpretation consistent with the specification, as interpreted by one of
ordinary skill in the art. In re Am. Academy of Sci. Tech Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004).
6 MECP2 refers to methyl-CpG-binding protein 2. (Zoghbi col. 8, 11. 52-
53.)
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A claim is anticipated if a prior art reference discloses every limitation
of the claimed invention, either explicitly or inherently. In re Schreiber, 128
F.3d 1473, 1477 (Fed. Cir. 1997). In considering the disclosure ofa
reference for anticipation, it is proper to take into account not only specific
teachings of the reference but also the inferences that one skilled in the art
would reasonably be expected to draw therefrom. In re Preda, 401 F .2d
825, 826 (CCP A 1968).
"It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable." In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citing cases).
When the examiner has required the applicant to elect single chemical
species for examination, the issue on appeal is the patentability of the single
elected species. It is appropriate to limit discussion to that single issue and
take no position respecting the patentability of the broader generic claims,
including the remaining, non-elected species. See Ex parte Ohsaka, 2
USPQ2d 1461 (Bd. Pat. App. Int. 1987). We limit discussion and
consideration to the elected species, and take no position respecting the
patentability of the broader generic claims, including the remaining, non-
elected species.
Rejection No. I-Anticipation
Claim 1
Analysis
We agree with the Examiner's finding that claim 1 is anticipated by
Gall, as evidenced by Zoghbi. (FF 1-7.) Appellant challenges that finding
with several arguments.
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Appellant asserts that Gall does not "disclose treating non-
neurodegenerative pathologies with ampakine in any amount. (Br. 7.) We
are not persuaded. Non-neurodegenerative pathologies, as recited in claim
1, includes Rett syndrome. (FF 1.) Moreover, Gall discloses treatment of
that pathology (RTT) with a specified amount of ampakine (GR87). (FF 3-
5.)
Appellant argues that Gall does not specifically disclose or inherently
teach the limitations of claim 1. (Br. 7-8.) We understand this argument to
refer to the recited increase in BDNF expression in brain stem neurons or
nodose sensory neurons, and that "the outcome of the step" taught by Gall
"provides a result that was not prior known, and thus not inherently
anticipated." (Id. at 8-9.) We are not persuaded. Gall discloses a method of
increasing BDNF expression in the brain by administration of an ampakine
(FF 2--4), and the mere discovery or claiming of a new benefit or outcome
(treating non-neurodegenerative pathologies) of that method does not render
Appellant's process patentable. See Woodruff, 919 F.2d at 1578. Moreover,
inherent anticipation may correspond to a claimed new benefit, or a
scientific explanation for the prior art's function, but the new realization
alone does not render the old invention patentable. Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (citing cases).
Accordingly, we find no error in the Examiner's finding of and reliance on
inherent anticipation. 7
7 Appellant's reference to "improper hindsight" (Br. 9) is inapt since that
concept applies, if at all, in the context of obviousness, not anticipation.
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Appellant argues that Gall, as evidenced by Zoghbi, "do not enable a
person skilled in the art to practice the claimed method." (Br. 10.) In
support of that argument, Appellant focuses on alleged deficiencies in Gall.
(Id.) Because Gall is presumptively enabled, and teaches the claimed
method of increasing BDNF, the burden shifts to Appellant to rebut that
presumption. See In re Antor Media Corp., 689 F.3d 1282, 1287-88 (Fed.
Cir. 2012) (citing cases). We find that Appellant has not persuasively
rebutted the presumption of enablement that applies to Gall.
Gall need only enable the portions of its disclosure alleged to
anticipate. Id. at 1290. Moreover, proof of efficacy is not required for Gall
to be enabling for purposes of anticipation; rather, the proper issue is
whether Gall "describes the claimed invention sufficiently to enable a person
of ordinary skill in the art to carry out the invention." See Impax Labs., Inc.
v. Aventis Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006). Here, Gall
describes experiments wherein BDNF was increased by administration of
the elected ampakine (GR87), and expressly states that Rett syndrome is a
pathology (a non-neurodegenerative pathology according to Appellant) that
would benefit from administration (in a dosage range) of the invention. (FF
2-5.) Accordingly, we conclude that Gall is enabled because it sufficiently
describes the claimed invention to enable a person of ordinary skill in the art
to carry it out.
Claims 3-6
Appellant states that claims 3---6 depend directly or indirectly from
claim 1 and are allowable because of the "deficiencies in the rejection with
respect to claim 1 and the specific limitations recited in claims 3-6." (Br.
16.) Claims 3-6 are thus anticipated for the reasons set forth above, and for
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failing to assert any additional arguments beyond those presented in
response to the rejection of claim 1. See 37 C.F.R. § 41.37(c)(l)(iv); Hyatt
v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008).
Claim 7
Appellant argues that "the range of ampakine administered to the
subject in Gall [] is not described with sufficient specificity to be
anticipatory of the range recited in claim 7." (Br. 17.) We are not
persuaded. Claim 7 recites a range of "about 10 mg/kg per day to about 50
mg/kg per day." (Br. 32.) The term "about" in defining the claimed range is
one of degree, and is given its broadest reasonable interpretation consistent
with the specification, as interpreted by one of ordinary skill in the art. See
Am. Academy of Sci. Tech Ctr., 367 F.3d at 1364. The Specification states
that "[t]he quantity of active component in a unit dose preparation may be
varied or adjusted from 0.1 mg/kg per day to about 100 mg/kg per day, for
example, ranging from 10 mg/kg per day to about 50 mg/kg per day
according to the particular application and the potency of the active
component." (Spec. i-f 84.) Accordingly, for purposes of our analysis herein,
we conclude that a person of ordinary skill in the art would interpret "about
50 mg/kg per day" in claim 7 as including (at least) "49.9 mg/kg per day."
Based on the foregoing construction, Gall's teaching of0.1to50
milligrams per kg (FF 5) discloses a range that overlaps and is broader than
the claimed range. Moreover, because Appellant does not establish the
criticality of its claimed range, Gall anticipates claim 7. See Ineos USA LLC
v. Berry Plastics Corp., 783 F.3d 865, 869-70 (Fed. Cir. 2015).
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Rejection No. 2--0bviousness
The Examiner concluded that it would have been obvious to a person
of ordinary skill in the art, based on the teachings of Zoghbi and Gall, to use
ampakines (including GR87) for the treatment of R TT patients (e.g., with
breathing abnormalities per Zoghbi) because Gall teaches that GR87 is
useful for treatment of RTT. (Final Act. 6.) Furthermore, one of skill in the
art would have been motivated to do so in order to achieve an expected
benefit of ampakines (GR87) in the treatment of RTT as taught by Gall.
(Id.) In addition, the Examiner found a reasonable expectation of success in
the treatment of R TT with GR87 because Gall teaches that GR87 has
therapeutic benefit in the treatment of RTT. (Id.) The Examiner also found
that improving breathing problems in patients suffering from R TT is an
obvious result upon the treatment of R TT which causes the symptoms of
breathing difficulties. (Id.)
We find that the Examiner has satisfied the burden of showing "some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007). Moreover, the Examiner has established a prima facie case of
obviousness and, as discussed below, Appellant has not overcome that prima
facie case.
We note at the outset that the test for obviousness is what the
combined teachings of Zoghbi and Gall would have suggested to one of
ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981)
(citing cases). Furthermore, "'a reference must be considered not only for
what it expressly teaches, but also for what it fairly suggests.'" In re Baird,
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16 F.3d 380, 383 (Fed. Cir. 1994) (quoting Jn re Burckel, 592 F.2d 1175,
1179 (CCPA 1979)).
Claim 8
Appellant repeats many of the arguments set forth above in
connection with claim 1, and they are unpersuasive for the reasons set forth
above. Appellant also argues that Zoghbi teaches that "only some of the
features of Rett syndrome may be accounted for by the loss of MeCP2
function." (Br. 20.) However, given that Zoghbi specifically correlates RTT
with breathing abnormalities (FF 6) and with loss of MeCP2 function (FF 8),
we find that Zoghbi "fairly suggests" a correlation between breathing
abnormalities and loss of MeCP2 function. See Baird, 16 F.3d at 383.
Appellant also argues that there was "uncertainty in the art regarding
the effects of MeCP2 on BDNF expression" and that "the outcome of a
method of Gall ... would not be inherent." (Br. 21-23.) We understand
this argument to essentially be that the mechanism of action of MeCP2 and
BDNF expression, particularly as it relates to respiratory disorders, was
unclear or unknown prior to the present invention. But even if that were so,
because Gall discloses the same administration step as recited in claim 8, the
particular benefits (e.g., improved respiratory function) "must naturally
flow" from that method even if not recognized at the time of Gall's
disclosure. See Perricone, 432 F.3d at 1378. While Perricone involved
anticipation based on inherency, 8 the Examiner's obviousness conclusion is
8
.... 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 ... In re Best, 562 F.2d 1252, 1255 (CCPA
1977) (emphasis added.)
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based on an actual recognition in the art; namely, Zoghbi's teaching and
suggestion of the benefit (improved respiratory function) that Appellant
asserts is new. (FF 6, 8.)
Appellant also argues that one skilled in the art would not have had a
reasonable expectation of success. (Br. 23-24.) A reasonable expectation of
success "refers to the likelihood of success in combining references to meet
the limitations of the claimed invention." Intelligent Bio-Systems, Inc. v.
Illumina Cambridge Ltd., 821F.3d1359, 1367 (Fed. Cir. 2016). Here,
given the teachings of Gall and Zoghbi (FF 2-8), we agree with the
Examiner's finding that a person of ordinary skill in the art would have had
a reasonable expectation of success in combining the references to meet the
limitations of claim 8. (Final Act. 6.) See also KSR, 550 U.S. at 421 ("A
person of ordinary skill is also a person of ordinary creativity, not an
automaton."); In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (skill is
presumed on the part of one of ordinary skill in the art). Appellant provides
no rebuttal evidence to support a finding of a lack of a reasonable
expectation of success on the part of one of ordinary skill in the art familiar
with the disclosures of Gall and Zoghbi. Appellant bears burden of
providing factual evidence of nonobviousness to rebut prima facie case. Ex
parte Phillips, 28 USPQ2d 1302 (Bd. Pat. App. Int. 1993).
Claims 9-13
Appellant states that claims 9-12 depend directly or indirectly from
claim 8 and are allowable because of the "deficiencies in the rejection with
respect to claim 1 [sic, 8] and the specific limitations recited in claims 9-
12." (Br. 24.) Appellant also states that "[c]laim 13 recites similar
limitations as claims 7 and 8 and is therefore allowable because of the
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aforementioned deficiencies in the rejection with respect to claims 7 and 8."
(Id.) Claims 9-13 are thus obvious for the reasons set forth above, and for
failing to assert any additional arguments beyond those previously
presented. See 37 C.F.R. § 41.37(c)(l)(iv).
Claim 14
Appellant asserts essentially the same arguments set forth above in
connection with claims 1 and 8, and they are unpersuasive for the reasons set
forth above. In addition, Appellant argues that the Examiner has engaged
"improper hindsight" in the rejection of claim 14 based on the combination
of Zoghbi and Gall. (Br. 25-26.) However, rather than using hindsight, the
Examiner points to specific disclosures in the prior art that describe the
limitations of Appellant's claimed method. (Final Act 5----6.) \Ne therefore
find that the Examiner's obviousness conclusion is based on sufficiently
articulated reasoning that overcomes any co11cen1s about hindsight bias. See
KSR, 550 U.S. at 418.
Claims 15-19
Appellant states that claims 15-18 depend directly or indirectly from
claim 14 and are allowable because of the "deficiencies in the rejection with
respect to claim 1 [sic, 14] and the specific limitations recited in claims 15-
18." (Br. 27.) Appellant also states that "[c]laim 19 recites similar
limitations as claims 7 and 14 and is therefore allowable because of the
aforementioned deficiencies in the rejection with respect to claims 7 and
14." (Id.) Claims 15-19 are thus obvious for the reasons set forth above,
and for failing to assert any additional arguments beyond those previously
presented. See 37 C.F.R. § 41.37(c)(l)(iv).
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Conclusion
A preponderance of evidence of record supports the Examiner's
finding that claims 1 and 7 are anticipated under 35 U.S.C. § 102(b). Claims
3---6 were not argued separately and fall with claim 1.
A preponderance of evidence of record supports the Examiner's
conclusion that claims 8 and 14 are obvious under 35 U.S.C. § 103(a).
Claims 9-13 were not argued separately and fall with claim 8 and
claims 15-19 were not argued separately and fall with claim 14.
We limit this decision to the elected species, and take no position
respecting the patentability of the broader generic claims, including the
remaining, non-elected species.
SUMMARY
We affirm the rejections of all claims on appeal.
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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