Ex Parte Maurer et al

Patent Trial and Appeal Board

Oct 26, 2018

12945808 (P.T.A.B. Oct. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/945,808 11/12/2010
34725 7590 10/26/2018
CHALKER FLORES, LLP
14951 North Dallas Parkway, Suite 400
DALLAS, TX 75254
FIRST NAMED INVENTOR
Barry James Maurer
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.
TECH:1086 8586
EXAMINER
PAGONAKIS, ANNA
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
10/26/2018 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 BARRY J. MAURER and CHARLES P. REYNOLDS
Appeal2017-009199
Application 12/945,808
Technology Center 1600
Before FRANCISCO C. PRATS, MICHAEL J. FITZPATRICK, and
SUSAN L. C. MITCHELL, Administrative Patent Judges.
FITZPATRICK, Administrative Patent Judge.
DECISION ON APPEAL
Barry J. Maurer and Charles P. Reynolds, ("Appellants") 1 appeal
under 35 U.S.C. § 134(a) from the Examiner's final decision rejecting
claims 2-3, 5-7, 11-13, and 15-18. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
1 The real party in interest is identified as Texas Tech University System.
Appeal Br. 2.
Appeal2017-009199
Application 12/945,808
STATEMENT OF THE CASE
The Specification
According to Appellants, the "invention relates to the combination of
novel sphingoid bases and their use in chemotherapy regimens for the
treatment ofhyperproliferative disorders [e.g., cancer]." Spec i-f2.
"Sphinganines constitute a group of related long-chain aliphatic 2-amino-
1,3-diols." Id. ,I4. "D-erythro-sphinganine (i.e, D-erythro-
dihydrosphingosine = (2S,3R)-2-aminooctadecanel,3-diol = D-erythro-2-
amino-1,3-octadecanediol = (2S,3R)-2-amino-l ,3-octadecanediol), an 18-
carbon length sphinganine, is the most frequent naturally-occurring
sphinganine in mammals." Id.
"Safingol is the artificial, L-threo-stereochemical ( diastereomer)
variant of native, 18-carbon chain length, D-erythro-sphinganine." Spec. i-f 5.
"Safingol is also variously named L-threo-sphinganine = L-threo-
sphinganine (2S, 3S) = L-threo-dihydrosphingosine = L-threo-2-amino-1,3-
octadecanediol = (2S,3S)-2-amino-1,3-octadecanediol." Id.
"The present invention relates to L-threo-sphinganine compositions of
non-18 carbon chain length (i.e. exclusive of safingol)." Id. i-fl3.
The Rejected Claims
Claims 2-3, 5-7, 11-13, and 15-18 stand rejected. Final Act. 1.
Claims 1, 9, and 10 been withdrawn from consideration. Id.
Claim 2 is representative and reproduced below.
2. A method of treating a hyperproliferative disorder
in a subject in need of such treatment, comprising administering
to said subject, in combination, a treatment effective amount of:
(a) a ceramide-increasing retinoid or a pharmaceutically
acceptable salt thereof; and
2
Appeal2017-009199
Application 12/945,808
(b) a non-18 carbon chain length L-threo-sphinganine( s ),
or pharmaceutically acceptable salt thereof selected from a
carbon chain length of 17 carbons, 19 carbons, or 20 carbons.
Appeal Br. 21.
The Appealed Rejections
The following rejections are before us for review:
1. claims 2-3, 5-7, 11-13, and 15-18 under 35 U.S.C. § 103 as
unpatentable over Maurer2 (Final Act. 3); and
2. claims 2-3, 5-7, 11-13, and 15-18 for non-statutory
obviousness-type double-patenting over claims 1-7 and 10-19 of Maurer
(Final Act. 5).
DISCUSSION
Rejection 1
The Examiner rejects claims 2-3, 5-7, 11-13, and 15-18 under
35 U.S.C. § 103 as unpatentable over Maurer. Final Act. 3.
Maurer has three named inventors, two of whom are applicants and
Appellants. Compare Maurer at [75], with Spec. (cover page); see also
Appeal Br. 13 ("Appellant(s) is/are fully aware of Maurer as it is our own
work.").
Maurer relates to "the treatment of hyperproliferative disorders, and
formulations useful for carrying out the same." Maurer 1:13-14.
Hyperproliferative disorders include tumors and cancers such as brain
cancer. Id. at 5:51-53.
2 US 6,352,884 Bl, issued Mar. 5, 2002 ("Maurer").
3
Appeal2017-009199
Application 12/945,808
The Examiner points out that Maurer discloses and claims methods of
treating hyperproliferative disorders comprising administering a) a
ceramide-generating retinoid, including fenretinide; and b) a ceramide-
degradation inhibitor, including safingol. Final Act. 3--4 ( citing Maurer at
[57], Fig. 4, claims 10-12). Appellants do not dispute this.
Safingol is identical in structure to compounds recited in the claimed
methods, except in regard to the length of the carbon chain. Whereas
safingol has a carbon chain length of 18 carbons, the claims recite using
non-18 carbon chain length L-threo-sphinganines. See, e.g., Appeal Br. 21
(claim 2 reciting "a non-18 carbon chain length L-threo-sphinganine(s), or
pharmaceutically acceptable salt thereof selected from a carbon chain length
of 17 carbons, 19 carbons, or 20 carbons.").
The Examiner reasons that, due to the structural homology between
the prior art compound and the claimed compounds and the known use of
the prior art compound in treating hyperproliferative disorders, the claimed
compounds would have been prima facie obvious for treating
hyperproliferative disorders. Final Act. 4. More specifically, the Examiner
reasons and concludes as follows:
Though Maurer et al. teaches the administration of an
identical chemical structure but for the fact the compound has a
difference in the carbon length of the compound of Maurer et al.
and therefore shares a significant structural homology to the
compound instantly claimed. The use, therefore, of a compound
with C 17, C 19 and C20 rather than C 18 in this position would
have been prima facie obvious at the time of the invention. Such
a person would have been motivated to do so with a reasonable
expectation of success in achieving the same, or substantially
similar therapeutic benefit to the patient, because the shared
structural similarities and, thus, homology between the
compounds, would have reasonably predicted that the
4
Appeal2017-009199
Application 12/945,808
compounds would have shared similar pharmacologic properties
due to their homologous chemical structures (i.e. in this case, the
compounds would have exhibited similar treatment of
hyperpro liferati ve disorders).
It has long been held in patent law that a prima facie case
of obviousness may be based upon the structural similarity, i.e.
an established structural relationship between a prior art
compound and the claimed compound, such as homology or
position isomerization. Please see In re Deuel, 34 USPQ2d at
1214. The necessary motivation to make a claimed compound
and, thus, the prima facie of obviousness, rises from the
reasonable expectation that compounds similar in structure will
have similar properties. Please see In re Gyurik, 596 F .2d 1012,
201 USPQ 552 (CCPA 1979) andinRe Grabiak, 226 USPQ 870.
Please also see MPEP 2144.09, which states that compounds that
are homologous (e.g., compounds differing regularly by the
successive addition of the same chemical group, e.g, by -CH2-
groups, such as in the present case) are generally of sufficiently
close structural[] similarity that there is presumed expectation
that such compounds possess similar pharmacologic properties.
Final Act. 4.
All of Appellants' arguments rest on the fact that the C 1 7, C 19 and
C20 chain length L-threo-sphinganines recited in the claims "are NOT
present in ANY living cell in humans" and the purported significance
Appellants place on that fact. Appeal Br. 13. In that regard, Appellants
argue: "As such compounds are not present in any living cell their there is
no reason to believe there is any activity associated with C 1 7, C 19 and C20
chain length L-threosphinganine(s)." Id.
We are not persuaded by Appellants' arguments. As a factual matter,
Appellants have not provided evidence that non-naturally occurring
compounds would have been presumed to be inactive by the person of
5
Appeal2017-009199
Application 12/945,808
ordinary skill in the art. 3 Indeed, as the Examiner points out, it was known
in the art that safingol, an artificial compound, was therapeutic. Ans. 8-9;
Spec. ,rs ("Safingol is the artificial, L-threo-stereochemical ( diastereomer)
variant of native, 18-carbon chain length, D-erythro-sphinganine.").
Under controlling law, there is a reasonable expectation that
compounds similar in structure will have similar properties. In re Gyurik,
596 F.2d 1012, 1018 (CCPA 1979) ("In obviousness rejections based on
close similarity in chemical structure, the necessary motivation to make a
claimed compound, and thus the prima facie case of obviousness, rises from
the expectation that compounds similar in structure will have similar
properties."). This law is applicable to the facts before us in which the prior
art teaches a safingol and its beneficial use in treating hyperproliferative
disorders and the claims recite compounds that are identical to safingol but
for the number of carbons in a carbon chain thereof.
We affirm Rejection 1.
Rejection 2
The Examiner rejects claims 2-3, 5-7, 11-13, and 15-18 fornon-
statutory obviousness-type double-patenting in view of Maurer claims 1-7
and 10-19. Final Act. 5. Although Rejection 2 is based on what Maurer
claims, and not merely on what Maurer discloses, it is virtually identical in
substance to Rejection 1. Id. at 5-7.
3 Appellants also argue that the prior art teaches away from the claimed
invention and further that the claimed invention provided unexpected results.
Appeal Br. 14--16. Both of these additional arguments likewise are based on
the unestablished premise that non-naturally occurring compounds are
presumed to be inactive by the person of ordinary skill in the art. Id.
6
Appeal2017-009199
Application 12/945,808
In particular, the Examiner finds that Maurer claims almost the same
method as, for example, claim 2, with the only difference being that claim 2
recites the administration of a C 17, C 19, or C20 L-threo-sphinganine instead
of C 18 L-threo-sphinganine (safingol). See id. at 6; Maurer claim 12. As
discussed above, a person of ordinary skill in the art would have been
motivated, with a reasonable expectation of success, to substitute the
structurally similar Cl 7, CI9, or C20 L-threo-sphinganine in lieu the prior
art taught C 18 L-threo-sphinganine.
We affirm Rejection 2.
SUMMARY
For the reasons discussed, we affirm the Examiner's rejections of
claims 2-3, 5-7, 11-13, and 15-18.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
7