Ex Parte Mulugeta et al

Patent Trial and Appeal Board

May 18, 2018

11766012 (P.T.A.B. May. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111766,012 0612012007
7590
RIVERSIDE LAW LLP
05/18/2018
300 Four Falls Corporate Center, Suite 710
300 Conshohocken State Road
West Conshohocken, PA 19428
FIRST NAMED INVENTOR
Million Mulugeta
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.
7158-72785-03 8593
EXAMINER
NIEBAUER, RONALD T
ART UNIT PAPER NUMBER
1676
MAILDATE DELIVERY MODE
05/18/2018 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 MILLION MULUGETA, LIXIN WANG, YVETTE TACHE, and
JEAN RIVIER 1
Appeal 2017-003111
Application 11/766,012
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for promoting hair growth or preventing hair loss in a subject. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 According to Appellants, the real parties in interest are (1) The Regents of
the University of California, (2) the U.S. Government represented by the
Department of Veterans Affairs, and (3) Salk Institute for Biological
Studies. (Appeal Br. 3.)
Appeal2017-003111
Application 11/766,012
STATEMENT OF THE CASE
Claims on Appeal
Claims 1, 8-13, 15-19, 21-24, and 26-28 are on appeal. 2 (Claims
Appendix, Appeal Br. 21-23.) Claims 1and27 are the only independent
claims on appeal and read as follows (emphases added):
1. A method for promoting hair growth in a subject,
compnsmg:
administering to a subject having a decrease in the number
of hair follicles in the anagen phase an effective amount of a
cyclic peptide non-selective antagonist of corticotrophin release
factor (CRF) receptors 1and2 that increases the number of hair
follicles in the anagen phase, wherein the antagonist is astressin
B and administration is by subcutaneous, intraperitoneal, topical
or transdermal delivery;
increasing the number of hair follicles in the anagen phase;
and
promoting hair growth in the subject.
27. A method of preventing hair loss in a subject, comprising:
administering to a subject susceptible to hair loss a
therapeutically effective amount of a cyclic peptide non-selective
antagonist of corticotrophin release factor (CRF) receptors 1
and 2 that prevents hair loss, wherein the antagonist is astressin
B and administration is by subcutaneous, intraperitoneal, topical
or transdermal delivery;
assessing hair growth in the subject; and
preventing hair loss in the subject.
2 Appellants elected astressin B as the species of cyclic CRF antagonist
peptide. (Final Action dated March 7, 2016 ("Final Act."), 2.) We limit
discussion and consideration to the elected species, and take no position
respecting the patentability of broader generic claims, including any
remaining, non-elected species. See Ex parte Ohsaka, 2 USPQ2d 1460,
1461 (Bd. Pat. App. Int. 1987).
2
Appeal2017-003111
Application 11/766,012
Examiner's Rejections
1. Claims 1, 8-13, 15, 16, 21-24, and 26-28 stand rejected under pre-
AIA 35 U.S.C. § 103(a) as unpatentable over Ikeda3 and Rivier. 4 (Final Act.
4--7.)
2. Claims 1, 8-13, 15-19, 21-24, and 26-28 stand rejected under pre-
AIA 35 U.S.C. § 103(a) as unpatentable over Ikeda, Rivier, Nielsen, 5 and
Rasmussen. 6 (Id. at 7-8.)
DISCUSSION
Issue
Whether a preponderance of evidence of record supports the
Examiner's rejections under pre-AIA 35 U.S.C. § 103(a).
Examiner's Position
In rejecting claims 1 and 27, the Examiner finds that "Ikeda teach[ es]
hair growth stimulants containing corticotrophin release factor ( CRF 1)
receptor antagonists," but "does not expressly teach a cyclic peptide as the
antagonist." (Final Act. 4.) According to the Examiner, "one would be
motivated to use known corticotrophin release factor antagonists,
particularly those with desirable properties. Rivier teach[ es] constrained
corticotrophin releasing factor antagonists with long duration of action,"
including astressin B. (Id.) The Examiner concludes that "[t]he claims
3 Ikeda et al., WO 02/19975 Al, pub. March 14, 2002 ("Ikeda").
4 J.E. Rivier et al., Constrained Corticotropin Releasing Factor Antagonists
(Astressin Analogues) with Long Duration of Action in the Rat, J. MED.
CHEM. 42, 3175-82 (1999) ("Rivier").
5 Nielsen et al., US 5,767,152, issued June 16, 1998.
6 Rasmussen et al., US 2003/0086903 Al, pub. May 8, 2003.
3
Appeal2017-003111
Application 11/766,012
would have been obvious because the substitution of one known element
(CRF antagonist of Rivier) for another (CRF antagonist of Ikeda) would
have yielded predictable results to one of ordinary skill in the art at the time
of invention." (Id. at 7.)
Appellants' Position
Appellants argue that one of skill in the art would have had no
motivation to substitute astressin B, a non-specific CRF 1 and 2 antagonist,
in place of the CRFl antagonist of Ikeda. (Appeal Br. 12-14.) Appellants
further argue that Rivier does not refer to hair growth, and "the Examiner
offers no prior art support for the usefulness of non-selective CRF 1/2
receptors antagonists in hair growth stimulation." (Id. at 12.)
Appellants support their argument with the Slominski Declaration. 7
(Id. at 14.) The Slominski Declaration states in part that:
CRF 1 and CRF2 receptors family members differ in their tissue
distribution, pharmacology and regulation. [citing Hauger ]8
Depending on the cell types and context, the two receptors at
times mediate opposite effects. [citing Bale & Vale] 9 Thus for
one skilled in the field it is not obvious that a non selective
antagonist to have effect on what is taught to be mainly a CRFl
receptor blockade response. Thus the statements of Ikeda et al.
and Rivier et al. do not make it obvious to use the non selective
antagonist astressin B for hair growth.
(Slominski Deel. i-f 6.)
7 Declaration under 37 C.F.R. § 1.132 of Andrej T. Slominski, M.D., Ph.D.,
dated Aug. 29, 2012 ("Slominski Declaration" or "Slominski Deel.").
8 R.L. Hauger et al., Corticotropin Releasing Factor (CRF) Receptor
Signaling in the Central Nervous System: New Molecular Targets, CNS
NEUROL. DISORD. DRUG TARGETS 5(4), 453-79 (2006).
9 T.L. Bale et al., CRF and CRF Receptors: Role in Stress Responsivity and
Other Behaviors, ANNU. REV. PHARMACOL. TOXICOL. 44, 525-57 (2004).
4
Appeal2017-003111
Application 11/766,012
Appellants further argue that the state of the art does not support
replacing a CRF 1 antagonist with a non-selective CRF 1/2 antagonist.
(Appeal Br. 14.) Appellants point to articles by Martinez, 10 Nozu 2013, 11
and Nozu 2014 12 as support for the argument that "replacing a CRF 1
antagonist with a non-selective CRF 1/2 antagonist is not an obvious and
predictable to work replacement." (Id.) Martinez, Nozu 2013, and Nozu
2014 are also cited in the Mulugeta Declaration 13 as support for the
statements that "[ m Jost literature data outside the hair growth stimulation
area of research, show that in general, selective CRF 1 or CRF2 receptor
antagonists have different biological effects than non-selective CRF receptor
antagonist," and "[t]he data shows that the biological effects of blocking the
two CRF receptors is not necessarily the same as blocking just one of the
two receptors." (Mulugeta Deel. i-f 9.) For example, the Mulugeta
Declaration states that Martinez "showed that CRF-induced delayed gastric
emptying in rats is prevented by the non-selective CRF1/CRF2 receptor
antagonist astressin, but not by a selective CRF 1 receptor antagonist,
10 V. Martinez et al., Central CRF inhibits gastric emptying of a nutrient
solid meal in rats: the role of CRF2 receptors, AM. J. PHYSIOL. 274, 965-70
(1998) ("Martinez").
11 T. Nozu et al., Peripheral corticotropin-releasingfactor (CRF) induces
stimulation of gastric contractions in freely moving conscious rats: role of
CRF receptor types 1and2, NEUROGASTROENTEROL MOTIL 25, 190-97
(2013) ("Nozu 2013").
12 T. Nozu et al., A Balance Theory of Peripheral Corticotropin-Releasing
Factor Receptor Type 1 and Type 2 Signaling to Induce Colonic
Contractions and Visceral Hyperalgesia in Rats, ENDOCRINOLOGY, 1-10
(2014) ("Nozu 2014").
13 Declaration of Million Mulugeta et al. Pursuant to 37 C.F.R. § 1.132,
dated Nov. 13, 2014 ("Mulugeta Declaration" or "Mulugeta Deel.").
5
Appeal2017-003111
Application 11/766,012
NBI27914." (Id.) The Mulugeta Declaration also provides test data
indicating that the CRFl receptor antagonist NBI 27914 did not result in hair
growth in mice. (Id. i-f 6.)
Analysis
The issue in this case turns on the substitution of astressin B, a cyclic
peptide non-selective antagonist of CRF receptors 1 and 2, in place of the
CRF 1 antagonist of Ikeda for promoting hair growth or preventing hair loss.
On this record, and in view of the arguments and evidence of Appellants, we
find that a preponderance of the evidence supports the Appellants' position
that it would not have been obvious to substitute astressin B for the CRF 1
antagonist of Ikeda. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
("patentability is determined on the totality of the record, by a
preponderance of evidence with due consideration to persuasiveness of
argument.").
In addressing Appellants' lack of motivation argument, the Examiner
focuses on Ikeda' s statement that "[h Jere, we have included all compounds
having antagonistic activity to the CRF 1 receptor as the CRF 1 receptor
antagonist" (Ikeda 13). (Ans. 10-12.) We understand that the Examiner
interprets that statement to mean that Ikeda teaches the use of all compounds
having antagonistic activity to CRF 1, including CRF 1 receptor antagonists
and CRF 1 and 2 receptor antagonists. (See id.) Appellants contend that
Ikeda's statement "[h Jere, we have included all compounds ... "means that
"there are no others as far as Ikeda is concerned." (Appeal Br. 14.) In this
regard, we note that Ikeda specifically discusses CRF 2 receptors (see Ikeda
12), but makes no mention of the use of CRF 2 receptor antagonists or
blocking both CRF receptors 1 and 2 for promoting hair growth. We thus
6
Appeal2017-003111
Application 11/766,012
interpret that quoted statement in Ikeda as teaching all compounds within the
category of CRF 1 receptor antagonists, but not necessarily including
compounds within the category of CRF 1 and 2 receptor antagonists.
The Examiner responds to the Slominski Declaration by again quoting
the statement in Ikeda regarding "all compounds having antagonistic activity
to the CRFl receptor," and further stating that "[t]he plain meaning of CRFl
receptor antagonist relates to the ability of a compound to antagonize the
CRFl receptor" and "[i]mportantly, in the instant case a CRFl antagonist is
a CRF 1 antagonist whether or not it has additional effects such as interaction
with CRF2." (Ans. 12.) The Examiner does not support those statements
with evidence or any persuasive teaching or suggestion in the prior art that a
CRF 1 and 2 receptor antagonist may be substituted in place of a CRF 1
antagonist yielding the predictable result of promoting hair growth or
preventing hair loss. 14 Moreover, those unsupported statements appear to
conflict with the evidence submitted by Appellants. (See Slominski
Declaration and Mulugeta Declaration.)
The Examiner dismisses Appellants' reliance on Martinez, N ozu
2013, and Nozu 2014 because such references do not relate to hair growth.
(Ans. 13.) But that position misses the point that, according to Appellants,
the state of the art of CRF antagonists does not support replacing a CRF 1
antagonist with a non-selective CRF 1/2 antagonist. (Appeal Br. 14--15.)
That is, contrary to the Examiner's position, the present case is not one
involving the mere substitution of one element for another, yielding
predictable results. (Reply Br. 3-5.)
14 For example, and as noted above, we are not persuaded that the scope of
Ikeda's teaching necessarily aligns with the Examiner's interpretation.
7
Appeal2017-003111
Application 11/766,012
In considering the totality of the record, including the quoted
statement in Ikeda and the Slominski and Mulugeta Declarations, we are
persuaded by Appellants that an antagonist to CRF receptors 1 and 2 would
not have been necessarily interchangeable with or equivalent to a CRF
receptor 1 antagonist. Accordingly, the rejection of independent claims 1
and 27 is reversed. The rejections of claims 8-13, 15-19, 21-24, 26, and 28
are reversed because all of those claims depend, directly or indirectly, from
claims 1 or 27. See In re Fine, 837 F.2d 1071, 1076 (Fed. Cir. 1988).
Conclusion of Law
A preponderance of evidence of record fails to support the Examiner's
rejections of claims 1, 8-13, 15-19, 21-24, and26-28 for obviousness.
SUMMARY
We reverse the rejections of all claims on appeal.
REVERSED
8