Ex Parte Ali et al

Patent Trial and Appeal Board

Feb 16, 2017

13120127 (P.T.A.B. Feb. 16, 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.
13/120,127 04/28/2011 Shoukath M. Ali JINA-30678/US-2/PCT 7260
72960 7590
Casimir Jones, S.C.
2275 DEMING WAY, SUITE 310
MIDDLETON, WI 53562
EXAMINER
KISHORE, GOLLAMUDI S
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
02/21/2017 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):
docketing @ c asimirj ones .com
pto.correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHOUKATH M. ALI, ATEEQ AHMAD, MOGHIS U. AHMAD,
SAIFUDDIN SHEIKH, and IMRAN AHMAD.1
Appeal 2015-007460
Application 13/120,127
Technology Center 1600
Before ERIC B. GRIMES, TIMOTHY G. MAJORS, and RACHEL H.
TOWNSEND, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
therapeutic composition, which have been rejected as indefinite and obvious.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
“Androgenic alopecia (AGA) is the most common form of hair loss.”
(Spec. 11.) “Minoxidil is effective when delivered topically a[t] a
1 Appellants identify the Real Party in Interest as Jina Pharmaceuticals, Inc.
(Appeal Br. 3.)
Appeal 2015-007460
Application 13/120,127
concentration of about 0.01% to about 5%.” (Id. 13.) “Finasteride . . . has
also been marketed orally in low dosage form.” (Id. 14.)
Claims 17—19, 21—23, and 25—30 are on appeal. Claim 17 is the only
independent claim and reads as follows:
17. A lipid composition comprising at least two active compounds
dissolved in a non-toxic solvent-water system, wherein the composition
comprises:
effective amounts of finasteride and minoxidil; and
a lipid or mixture of lipids
in a non-toxic solvent-water system, wherein the composition is a
clear lipidic solution obtainable by mixing dissolved active compound and a
lipid or mixture of lipids together in said non-toxic solvent-water system to
produce said clear lipid solution.
The claims stand rejected as follows:
Claims 18, 25, 29, and 30 under 35 U.S.C. § 112, second paragraph,
as indefinite (Ans. 3);
Claims 17—19, 21, 22, and 25—28 under 35 U.S.C. § 103(a) as obvious
based on any of Touitou,2 Uster,3 or Catalfo,4 combined with Naughton5
(Ans. 3);
Claims 17—19, 21—23, and 25—28 under 35 U.S.C. § 103(a) as obvious
based on any of Touitou, Uster, or Catalfo, combined with Naughton, and
Haas6 and/or Leigh7 and/or Tenzel8 (Ans. 4);
2 Touitou, US 5,540,934, issued July 30, 1996.
3 Uster et al., US 4,828,837, issued May 9, 1989.
4 Catalfo et al., US 6,596,266 B2, issued July 22, 2003.
5 Naughton, US 2007/0237750 Al, published Oct. 11, 2007.
6 Haas et al., US 2005/0232984 Al, published Oct. 20, 2005.
7 Leigh, US 5,053,217, issued Oct. 1, 1991.
8 Tenzel et al., US 5,000,887, issued Mar. 19, 1991.
2
Appeal 2015-007460
Application 13/120,127
Claims 17—19, 21—23, and 25—28 under 35 U.S.C. § 103(a) as obvious
based on Mahe,9 combined with Naughton, and Haas and/or Leigh and/or
Tenzel (Ans. 5);
Claims 21, 29, and 30 under 35 U.S.C. § 103(a) as obvious based on
any of Touitou, Uster, Catalfo, or Mahe, combined with Naughton, and Haas
and/or Leigh and/or Tenzel, and Kolter10 (Ans. 7).
I
The Examiner has rejected claims 18, 25, 29, and 30 under 35 U.S.C.
§ 112, second paragraph. The Examiner concludes that claims 18 and 25 are
indefinite because they use the terms “other,” “preferably,” “such as,” and
“and/or.” (Ans. 3.) Appellants state that these claims will be amended to
remove the offending language. (Appeal Br. 7.) We therefore affirm the
rejection of claims 18 and 25 under 35 U.S.C. § 112, second paragraph.
The Examiner has rejected claims 29 and 30 on the basis that “[cjlaim
29 which recites tacrolimus is inconsistent with claim 17 and the term,
‘tacrolimus’ has no antecedent basis in claim 17. Similar is the case with
claim 30 which recites amphotericin B.” (Ans. 3.)
We will reverse the rejection of claims 29 and 30. Claim 17, from
which claims 29 and 30 depend, uses the transition term “comprising,” and
is therefore open to ingredients other than those listed. Claims 29 and 30
add the limitation that the composition comprises tacrolimus or amphotericin
B, respectively, among other things. Thus, the most straightforward reading
of claims 29 and 30 is that they include tacrolimus or amphotericin B,
9 Mahe, US 6,001,812, issued Dec. 14, 1999.
10 Kolter et al., US 2008/0248117 Al, published Oct. 9, 2008.
3
Appeal 2015-007460
Application 13/120,127
respectively, in addition to, not instead of, the active agents recited in claim
17. The Examiner, in fact, relies on this interpretation in rejecting claims 29
and 30 over the prior art. (See Ans. 7.)
II
The Examiner has rejected claims 17—19, 21, 22, and 25—28 as
obvious based on any of Touitou, Uster, or Catalfo, combined with
Naughton. The Examiner has also rejected claims 17—19, 21—23, and 25—30
as obvious based on any of Touitou, Uster, or Catalfo, combined with
Naughton, and one or more of Haas, Leigh, Tenzel, and Kolter. The
Examiner has rejected claims 17—19, 21—23, and 25—28 as obvious based on
Mahe, combined with Naughton, and one or more of Haas, Leigh, or Tenzel.
The same issue is dispositive for all of these rejections.
The Examiner finds that each of Touitou, Uster, Catalfo, and Mahe
discloses compositions comprising minoxidil, lipids, and a solvent. (Ans. 3—
4, 6.) The Examiner finds that “Naughton while disclosing compositions for
promoting hair growth teaches that minoxidil could be used together with
hair promoting agent finasteride.” {Id. at 4.) The Examiner concludes that
“[t]he inclusion of additional hair promoting agents such as finasteride in the
minoxidil compositions of Touitou and Uster [or Catalfo or Mahe] would
have been obvious . . . since Naughton teaches the use of minoxidil and
finasteride in combination.” {Id. at 4, 6.)
Appellants argue that Naughton discloses a “three dimensional tissue
conditioned medium” as an alternative to minoxidil and finasteride for hair
loss. (Appeal Br. 10.) Appellants argue that Naughton teaches that the
“known minoxidil and/or finasteride drugs may be used as adjunct
treatments to the media/tissue preparations,” but “does not suggest[] mixing
4
Appeal 2015-007460
Application 13/120,127
either minoxidil or finasteride with the media/tissue preparation (e.g., for
injection), or mixing the two prior art compositions together.” (Id.)
We agree with Appellants that the Examiner has not pointed to
evidence showing that a composition comprising both minoxidil and
finasteride would have been obvious based on the cited references. Touitou
discloses a composition comprising minoxidil, soybean lecithin, a propylene
glycol/ethanol mixture, and water. (Touitou 4:46—50.) Touitou states that
its “ethosomal” compositions enhance skin permeation. (Id. at 2:8—9.)
Uster discloses that a “minoxidil composition can be entrapped in non­
crystalline form in both lipid emulsion particles and liposomes, providing
additional advantages for topical administration of the drug.” (Uster 7:8—
11.) Catalfo discloses minoxidil-containing compositions (Catalfo 2:8—12),
that are topically applied (id. at 4:22—25) and can contain liposomes or lipid-
emulsion particles (id. at 5:17—18) and an aqueous alcohol solvent (id. at
5:48—50). Mahe discloses topically applied compositions that can comprise
minoxidil and a mixed water/alcohol medium, and can be in the form of an
emulsion. (Mahe 5:24—36, 5:40-47, 6:3, 6:36-41.)
Naughton states that “[cjurrent pharmacological treatments for hair
loss include Minoxidil and Finasteride.” (Naughton | 5.) Naughton
discloses “compositions [that] comprise conditioned media made from a
three dimensional tissue in which the cultured tissue produces growth factors
that promote hair follicle development and hair growth.” (Id. 17.)
Naughton states that its composition “can be administered by injection or a
catheter. The methods comprise administering intradermally or
subcutaneously to a subject an effective amount of the compositions.” (Id.)
5
Appeal 2015-007460
Application 13/120,127
Naughton states that
[i]n various embodiments, the compositions may be used singly
or in combination with other agents affecting hair growth, such
as inducers of skin vascularization and inhibitors of
dihydrotestosterone synthesis. Exemplary agents for inducing
skin vascularization include Minoxidil and VEGF. Exemplary
agents for inhibiting dihydrotestosterone synthesis are
finasteride and dutasteride.
(Id. 1 8.)
As Appellants have pointed out (Appeal Br. 11), the Specification
states that minoxidil is marketed for topical use while finasteride is marketed
for oral administration, and “finasteride ... is not available topically as
approved product for the treatment of AGA [androgenic alopecia].” (Spec.
3—5.) The Examiner has not pointed to any evidence showing topical
administration of finasteride.
While Naughton discloses that its composition can be used “in
combination with other agents,” including minoxidil and finasteride, it also
discloses that its composition is administered by injection, not topically or
orally. Given the different routes of administration of Naughton’s
composition, minoxidil, and finasteride, we agree with Appellants that
Naughton’s suggestion of using the agents “in combination” is not a
sufficient basis for concluding that it would have been obvious to combine
minoxidil and finasteride in a single composition, as required by claim 17.
The Examiner relies on Haas, Leigh, and Tenzel only as evidence that
the composition that would result from combining any of Touitou, Uster, or
Catalfo, with Naughton, would be clear. (Ans. 4—5.) The Examiner relies
on Kolter as evidence showing that it would have been obvious to add either
tacrolimus or amphotericin B to a minoxidil/fmasteride mixture. (Id. at 7.)
6
Appeal 2015-007460
Application 13/120,127
Thus, the Examiner has not pointed to teachings in the other cited references
that would make up for the deficiency discussed above.
SUMMARY
We affirm the rejection of claims 18 and 25 under 35 U.S.C. § 112,
second paragraph.
We reverse the rejection of claims 29 and 30 under 35 U.S.C. § 112,
second paragraph.
We reverse all of the rejections under 35 U.S.C. § 103(a).
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-IN-PART
7