Ex Parte KESHET et al

Patent Trial and Appeal Board

Mar 16, 2017

14304948 (P.T.A.B. Mar. 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.
14/304,948 06/15/2014 Eli KESHET 59230 4574
67801 7590 03/20/2017
MARTIN D. MOYNIHAN d/b/a PRTSI, INC.
P.O. BOX 16446
ARLINGTON, VA 22215
EXAMINER
SAOUD, CHRISTINE J
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
03/20/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ELI KESHET, SHAY SELA,
AHUVAITIN, and SIMCHA YAGEL1
Appeal 2016-001273
Application 14/304,948
Technology Center 1600
Before JEFFREY N. FREDMAN, ELIZABETH A. LaVIER,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
composition-of-matter for detection of sFlt-14, which have been rejected as
unpatentable under 35 U.S.C. § 101. We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
1 Appellants identify the Real Parties in Interest as Yissum Research
Development Company of the Hebrew University of Jerusalem Ltd. and
Hadasit Medical Research Services and Development Ltd. (App. Br. 2.)
Appeal 2016-001273
Application 14/304,948
STATEMENT OF THE CASE
Background
Appellants’ invention “relates to isolated polypeptides and
polynucleotides encoding [the] same for the diagnosis and treatment of
VEGF [vascular endothelial growth factorj-associated medical conditions.”
(Spec. 1:28—30.) According to the Specification, “VEGF plays an important
regulatory function in the formation of new blood vessels during embryonic
vasculogenesis” and “activities of VEGF are mediated primarily by its
interaction with two high-affinity receptor tyrosine kinases: fms-like
tyrosine kinase-1 (Fit-1/ VEGFR-1) and kinase-insert domain region
(KDR/Flk-1/VEGFR-2).” {Id. at 1:32—37.) The Specification discloses
“[alternative splicing of Fit-1 results in the production of an endogenously
secreted protein referred to as soluble Fltl (sFltl). . . [, which] can
antagonize circulating VEGF by binding it and preventing interaction [] with
its endogenous receptors.” {Id. at 2:1—6.) The Specification further
discloses that “sFltl also binds and antagonizes placental growth factor
(P1GF). . . , which is produced predominantly in the placenta.” {Id. at 2:6—
8.)
According to the Specification, “[p]reeclampsia, the most common,
dangerous, unpredictable complication of pregnancy is a major cause of
maternal, fetal, and neonatal mortality worldwide.” {Id. at 2:15—16.) The
Specification explains that “[t]he soluble VEGF receptor sFlt-1, which
specifically binds and antagonizes circulating VEGF and P1GF, has been
previously contemplated as the leading cause of preeclampsia.” {Id. at
10:31—32.) The Specification discloses, however, that “the present inventors
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Application 14/304,948
have identified a novel VEGF receptor variant. . . [and] show that it is the
sFlt-14 [variant] rather than sFlt-1 (supra) that is highly expressed in
preeclampsia.” {Id. at 11:4—10.) Thus, according to the Specification, “sFlt-
14 provides a valuable indicator of preeclampsia or predisposition thereof.”
{Id. at 11:19-20.) The Specification discloses, among other things, “the
unique cDNA sequence of the novel sFlt-14 isoform” and the “sequences of
peptides synthesized in order to create specific polyclonal antibodies which
distinguish between sFlt-1 and sFlt-14.” {Id. at 8:17—18, 32—33.)
The Claims
Claims 1—6 are on appeal. Claim 1 is the only independent claim
before us and reads as follows:
1. A composition-of-matter for detection of sFlt-14
comprising a biological sample of a pregnant female human
subject comprising an antibody capable of binding said sFlt-14
or portion of said sFlt-14 as set forth in SEQ ID NO: 2 or 4 and
not sFlt-1 as set forth in SEQ ID NO: 10.
(App. Br. 9 (Claims App’x).)
The Rejection
Claims 1—6 stand rejected as unpatentable under 35 U.S.C. § 101 for
lack of utility. (Final Act. 3—4.)
DISCUSSION
The courts “have required a claimed invention to have a specific and
substantial utility to satisfy § 101.” In re Fisher, 421 F.3d 1365, 1371 (Fed.
Cir. 2005). A substantial utility requires “showing] that an invention is
useful to the public as disclosed in its current form, not that it may prove
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useful at some future date after further research. Simply put, to satisfy the
‘substantial’ utility requirement, an asserted use must show that that claimed
invention has a significant and presently available benefit to the public.” Id.
A specific utility is “a use which is not so vague as to be meaningless.” Id.
The Examiner rejected claims 1—6 “because the claimed invention
lacks patentable utility.” (Final Act. 3.) According to the Examiner, “the
instant specification fails to teach a specific and substantial use ... for a
composition of matter as claimed, absent evidence to the contrary.” {Id. at
3—4.) More specifically, the Examiner finds that the Specification
clearly teaches uses for the antibody recited in the claims such as
in a method of diagnosis but because the specification does not
indicate a composition of matter as currently claimed as part of
the intended invention, there is no disclosure of how this
composition of matter is to be used in a specific and substantial
way. Furthermore, the composition which is the antibody bound
to sFlt-14 in a sample is not useful for detection because the
antibody is already bound to the sFlt-14.
{Id. at 4.) According to the Examiner, “[t]he intermediate product is not
what is useful for detection of sFlt-14; it is the antibody and then any
detection means used for then detecting the complex.” {Id. at 5.)
We are not persuaded the Examiner established by a preponderance of
the evidence that the claims lack utility under Section 101. To the contrary,
we agree with Appellants that “the skilled artisan would immediately
recognize that the claimed composition is useful in a protein assay such as
an ELISA assay.” (App. Br. 6.) The portion of the Specification cited by
Appellants in support teaches
the antibodies may be contacted with the biological sample so
a[s] to form an immunocomplex. Detection of the level and
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presence of the complex may be effected using methods which
are well known in the art. Examples of such methods include,
but are not limited to, Western blot, Radio-immunoassay (RIA),
Fluorescence activated cell sorting (FACS), and
Immunohistochemical analysis.
(Spec. 28:5—9.) As Appellants persuasively argue, “[t]he assay will
be uninformative in the absence of the serum (which may contain the
sFlt-14 indicative of preeclampsia) or the antibody, both constituting
the claimed composition.” (App. Br. 6—7; see also Reply Br. 2—3.)
Thus, contrary to the Examiner’s findings, we agree with
Appellants that the Specification provides a specific and substantial
utility for the claimed composition comprising a biological sample
and the antibody2 targeted to sFlt-14, but not sFlt-1. The
Specification shows that such a composition is useful, at minimum,
for detecting levels of sFlt-14 and the risk of preeclampsia. (See, e.g.,
Spec. 6:19—23, 7:1—8, 28:5—9; see also supra Background.) The
Examiner has provided insufficient evidence or scientific reasoning to
call into doubt these teachings in the Specification. In re Langer, 503
2 We interpret the antibody as one that is designed, and not endogenous to
humans. (See, e.g., Spec. 49 (Example 2); see also Reply Br. 3 (“the
claimed composition [] is non-natural. . . Examiner actually contests the
validity of patents to synthetic antibodies which can be used for
diagnostics.”) We note that the Examiner has provided no evidence that
antibodies with the specificity required by the claims are necessarily
naturally present in the patients at issue. “Inherency . . . may not be
established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient.”
MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).
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Application 14/304,948
F.2d 1380, 1391 (CCPA 1974) (“[A] specification which contains a
disclosure of utility which corresponds in scope to the subject matter
sought to be patented must be taken as sufficient. . . unless there is
reason for one skilled in the art to question the objective truth of the
statement of utility or its scope.”). Given the dangers posed by
preeclampsia, we are also persuaded Appellants’ invention would be
useful for skilled persons and the public. (Spec. 2:15—16.)
We also recognize, but are unpersuaded by, the Examiner’s
assertion that the cited utility is nonstatutory subject matter. In the
Response to Argument portion of the Answer, the Examiner states
In so far as Appellant is asserting a use of the claimed
composition for diagnosis of preeclampsia by measuring
the levels of sFlt-14 and correlating those levels to a
disease state, this asserted use would not be statutory . . .
because such a method would be directed to a judicial
exception without significantly more.
(Ans. 4—5.) We are, however, unaware of authority holding that the
utility to which a claimed tangible and non-naturally occurring
composition may be put must itself be statutory and otherwise not
covered by any judicial exception (e.g., laws of nature, natural
phenomena, etc.).3 And we do not decide issues that are not presently
before us, such as whether a hypothetical method claim directed to the
utility (as characterized by the Examiner) would be patent eligible.
3 The utility of a newly-designed drug may, for example, be the inhibition of
biochemical processes that cause or contribute to a disease state, and thus
involve natural phenomena. That would not, however, mean that the drug
lacks utility under Section 101.
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For the reasons above, we are not persuaded that claims 1—6 are
unpatentable for lack of utility.
SUMMARY
We reverse the rejection of claims 1—6 under 35 U.S.C. § 101.
REVERSED
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