Ex Parte Maurer et al

Patent Trial and Appeal Board

Oct 18, 2018

13856015 (P.T.A.B. Oct. 18, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/856,015 04/03/2013
34725 7590 10/18/2018
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: 1086DIV 4345
EXAMINER
PAGONAKIS, ANNA
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
10/18/2018 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 BARRY J. MAURER and CHARLES P. REYNOLDS
Appeal2017-009136
Application 13/856,015
Technology Center 1600
Before RICHARD M. LEBOVITZ, MICHAEL J. FITZPATRICK, and
JOHN G. NEW, 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 18-34 and 36. 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.
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Application 13/856,015
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. In contrast to D-erythro-sphinganine (which
has an 18-carbon backbone), "[ t ]he present invention relates to L-threo-
sphinganine compositions of non-18 carbon chain length." Id. ,II 3
( emphasis added).
The Rejected Claims
Claims 18-34 and 36 stand rejected. Final Act. 1. Claim 35 has been
withdrawn from consideration. Id.
Claims 18 and 19 are representative and reproduced below.
18. A L-threo-sphinganines composition comprising:
a L-threo-sphinganine having a carbon chain
length of 17, 19 or 20.
19. A L-threo-sphinganines composition comprising:
a L-threo-sphinganines having a carbon chain
length of 16 carbons, 15 carbons, or 21 carbons.
Appeal Br. 21.
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Application 13/856,015
The Appealed Rejections
The following rejections are before us for review:
1. claims 19 and 23 are rejected under 35 U.S.C. § 112(a) or 35
U.S.C. § 112 ,II (pre-AIA) as because the specification fails to contain a
written description of them (Final Act. 11 );
2. claims 18-34 and 36 under 35 U.S.C. § 103 as unpatentable
over Maurer2 (Final Act. 13); and
3. claims 18-34 and 36 for non-statutory obviousness-type
double-patenting in view of Maurer claims 1-7 and 10-19 (Final Act. 20).
DISCUSSION
Rejection 1
The Examiner rejects claims 19 and 23 under 35 U.S.C. § 112(a) or 35
U.S.C. § 112 ,II (pre-AIA) because the specification fails to contain a
written description of the subject matter of those claims. Final Act. 2-3.
Section 112(a) states the following:
The specification shall contain a written description of the
invention, and of the manner and process of making and using it,
in such full, clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same[.]
35 U.S.C. § 112(a); see also 35 U.S.C. § 112 ,II (pre-AIA) (stating the same).
The rejection is based on the written description, not the enablement,
requirement of§ 112(a). Final Act. 2-3. Specifically, the Examiner
determined that the specification, as filed, lacks written description of L-
2 US 6,352,884 Bl, issued Mar. 5, 2002 ("Maurer").
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Application 13/856,015
threo-sphinganines having a carbon chain length of 15 carbons, which are
recited in claims 19 and 23. Final Act. 3.
Whether the specification as filed contains a written description of
claims 19 and 23 is a question of fact. Lilly Ariad Pharm., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010). Specifically, the question of fact
asks "whether the disclosure of the application relied upon reasonably
conveys to those skilled in the art that the inventor had possession of the
claimed subject matter as of the filing date." Ariad Pharm., 598 F.3d at
1351.
Appellants cannot point to an in haec verba disclosure of an L-threo-
sphinganine having a carbon chain length of 15 carbons. However, such
support is not necessary. Ariad Pharm., 598 F.3d at 1352.
Appellants point out that specification discloses a genus of L-threo-
sphinganines having a carbon chain length from 10 to 30 carbons. Appeal
Br. 11 ( citing Spec. ,II 9). Appellants argue that the explicit disclosure of
this genus adequately discloses the species within it. We agree with
Appellants. As held in In re Wertheim, 541 F.2d 257, 264---65 (CCPA 1976),
a disclosure of broader range can provide written description support for
narrower ranges and values within that disclosed range.
We reverse Rejection 1.
Rejection 2
The Examiner rejects claims 18-34 and 36 under 35 U.S.C. § 103 as
unpatentable over Maurer. Final Act. 13.
Maurer has three named inventors, two of whom are applicants and
Appellants. Compare Maurer at [7 5], with Spec. ( cover page).
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Application 13/856,015
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.
The Examiner points out that Maurer discloses and claims the use of
safingol, C18-L-threo-dihydrosphingosine. Final Act. 5; Maurer at [57]
( disclosing "L-threo-dihydrosphingosine"), 11 :34--36 ("Most preferred is L-
threo-dihydrosphingosine, also known as (2S,3S)-2-amino-l,3-
octadecanediol or safingol."), 26: 12-14 ( claim 12 reciting "L-threo-
dihydrosphingosine or a pharmaceutically acceptable salt thereof.").
"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." Spec. i-f4.
Safingol is identical in structure to compounds within the scope of the
claims, except in regard to the length of its carbon chain. Whereas safingol
has a carbon chain length of 18 carbons, the claims recite different carbon
chain lengths. See, e.g., Appeal Br. 21 ( claim 19 reciting "a L-threo-
sphinganine having a carbon chain length of 17, 19 or 20.").
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. Final Act. 5---6. The
Examiner concludes that the claimed compounds would have been obvious,
stating that a person of ordinary skill in the art:
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
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Application 13/856,015
structural similarities and, thus, homology between the
compounds, would have reasonably predicted that the
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 hyperproliferative 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) and In Re 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 structurally similarity that there
is presumed expectation that such compounds possess similar
pharmacologic properties.
Final Act. 6.
Appellants argue that the claimed, non-18 carbon chain length L-
threo-sphinganines, "are NOT present in ANY living cell in humans" and,
thus, "there is no reason to believe there is any activity associated with them
and/or any possible activity would be wildly unpredictable." Appeal Br. 14.
Appellants further argue that "the skilled artisan would instantly recognize
that [the non-C18] chain length L-threo-sphinganine(s) are not natural and
would instantly reason that they were inactive or would have no idea of the
activity." Id.
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We are not persuaded by these arguments. As a factual matter,
Appellants have not provided evidence that non-naturally occurring
compounds are presumed to be inactive by the person of ordinary skill in the
art. 3 Further, 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 compound (safingol) and its beneficial use in treating
hyperproliferative disorders and the claims recite compounds that are
identical to the prior art compound but for the number of carbons in a carbon
chain.
We affirm Rejection 2.
Rejection 3
The Examiner rejects claims 18-34 and 36 for non-statutory
obviousness-type double-patenting in view of Maurer claims 1-7 and 10-19.
Final Act. 20. Although Rejection 3 is based on what Maurer claims, and
not merely on what Maurer discloses, it is virtually identical in substance to
Rejection 2.
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. 16-17. 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.
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Appellants do not argue the merits of Rejection 3. Appeal Br. 20. We
therefore summarily affirm Rejection 3. See 37 C.F.R. § 4I.37(c)(iv)
("[ A ]ny arguments or authorities not included in the appeal brief will be
refused consideration by the Board").
SUMMARY
For the reasons discussed, we reverse the rejection of claims 19 and
23 under 35 U.S.C. § 112, but affirm the rejections of claims 18-34 and 36
under 35 U.S.C. § 103 and for non-statutory double-patenting.
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
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