Ex Parte Soderlund et al

Patent Trial and Appeal Board

Mar 8, 2016

10451640 (P.T.A.B. Mar. 8, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/451,640 07/10/2003 Hans Soderlund
4372 7590 03/10/2016
ARENT FOX LLP
1717 K Street, NW
WASHINGTON, DC 20006-5344
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.
108306-00019 3211
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
03/10/2016 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):
DCIPDocket@arentfox.com
IPMatters@arentfox.com
Patent_Mail@arentfox.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANS SODUERLUND, KARI KA TAJA,
MARJA P ALOHEIMO, MARJA ILMEN, and KRISTIINA TAKKINEN 1
Appeal2013-009322
Application 10/451,640
Technology Center 1600
Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an analyte
quantification method. The Examiner has rejected the claims as lacking
enablement and utility. We have jurisdiction under 35 U.S.C. § 6(b). We
reverse.
1 Appellants identify the real party in interest as Valtion Teknillinen
Tutkimuskeskus (Br. 2).
Appeal2013-009322
Application 10/ 451, 640
STATEMENT OF THE CASE
Claims 1, 3, 8-11, 14--17, 39, and 54--63 are pending and on appeal
(Br.2 4). Claim 1 is illustrative and is set forth in Appendix I to Appellants'
Brief (id. at 39--40).
Claims 1, 3, 8-11, 14--17, 39, and 54--63 stand rejected under 35
U.S.C. § 112(a) or§ 112, first paragraph, as failing to comply with the
enablement requirement (Ans. 3 5).
Claims 1, 3, 8-11, 14--17, 39, and 54--63 also stand rejected under 35
U.S.C. § 101 for lacking utility (id. at 20).
ENABLEMENT
The Examiner finds that the "'analyte polynucleotides' that are to be
quantified can be derived from virtually any and all manner of life forms, be
it known and characterized, known and uncharacterized as well as yet to be
discovered" (Ans. 7). However, the Examiner finds that "the pools of
probes required ... to practice the claimed methods are not disclosed" (id. at
7-8). In addition, the Examiner finds that the "conditions of hybridization,
e.g., stringency, specificity, etc., are not defined" (id. at 11 (emphasis
omitted)).
Principles of Law
"[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without 'undue experimentation."' In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
2 "Br." refers to the Brief on Appeal dated April 23, 2012.
3 "Ans." refers to the substitute Examiner's Answer dated April 25, 2013.
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Application 10/ 451, 640
Even if some of the claimed combinations were inoperative, the
claims are not necessarily invalid. "It is not a function of the
claims to specifically exclude possible inoperative
substances .... " ... Of course, if the number of inoperative
combinations becomes significant, and in effect forces one of
ordinary skill in the art to experiment unduly in order to practice
the claimed invention, the claims might indeed be invalid.
Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1576-
77 (Fed. Cir. 1984) (quoting In re Dinh-Nguyen, 492 F.2d 856, 858-59
(CCP A 1974) (emphasis omitted)).
When rejecting a claim under the enablement requirement of
section 112, the PTO bears an initial burden of setting forth a
reasonable explanation as to why it believes that the scope of
protection provided by that claim is not adequately enabled by
the description of the invention provided in the specification of
the application; this includes, of course, providing sufficient
reasons for doubting any assertions in the specification as to the
scope of enablement.
In re TVright, 999 F.2d at 1561---62.
Analysis
Appellants argue that, "[b ]ecause the user knows the targets he wants
to quantify, he also knows the best probes for said targets" (Br. 25). In
particular, Appellants argue "that a person of ordinary skill in the art ...
knows what kinds of probes can be used together in the same pool in order
to obtain the desired results using the presently-claimed methods" (id.).
Appellants also argue that "[d]etermining [hybridization] conditions does
not present an undue burden to the person of ordinary skill in the art who
wants to quantify a plurality of known target polynucleotides" (id. at 34). In
support of their positions, Appellants point to the Declarations of Ann-
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Application 10/ 451, 640
Christine Syvanen4 and Jari Vehmaanpera5 (id. at 26 & 34). We conclude
that the Examiner has not adequately explained why selecting probes and
hybridization conditions for the claimed methods would not have been
within the skill of the art.
The Examiner takes issue with Dr. Syvanen's Declaration because it
states that "I have selected probes that specifically recognize the sequences I
want to determine" (Ans. 37 (emphasis omitted)). The Examiner raises a
similar issue with regard to Dr. Vehmaanpera's Declaration (id. at 38-39).
While we acknowledge that it may not be possible to utilize the claimed
methods if one has no idea what he or she is looking for, we do not agree
with the Examiner that this demonstrates that the claims are not enabled.
We also acknowledge the Examiner's concern "that the claimed
method does not require the probe to be specific for their target" or "to
utilize those hybridization conditions that result in specific hybridization
(i.e., the probe binds only to the intended target)" (id. at 37). In addition, we
understand that certain selections may render the methods inoperable (id. at
10-13). However, we do not agree with the Examiner that the failure to
include every aspect of the selection process in the claims renders them non-
enabled. The issues regarding probes and hybridization conditions goes to
the quality of the quantification data, but does not implicate any concern as
to whether probes, appropriately chosen by the person of ordinary skill,
4 Declaration under 37 C.F.R 1.132 of Dr. Ann-Christine Syvanen dated
June 4, 2007 (filed July 12, 2007).
5 Declaration under 37 C.F.R 1.132 of Dr. Jari Vehmaanpera dated June 8,
2007 (filed July 12, 2007).
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Application 10/ 451, 640
would specifically hybridize and yield interpretable data under appropriately
selected conditions. See, e.g., Syvanen's Deel. 4.
The Examiner also finds:
The claims require neither the plurality of analyte
polynucleotides nor the numerical values obtained be associated
or otherwise correlated with any state, condition, precondition,
disease, etc. The disclosure has not been found to teach how one
is to use the resulting numerical information about any analyte
polynucleotide in any method ... when, as appellant admits, the
analyte polynucleotides can be from a wholly uncharacterized
genome.
(Ans. 9.) We are not persuaded. While we recognize that the claims broadly
recite methods for quantifying multiple analyte polynucleotides and,
therefore, do not specify the particular use of any given method, we do not
agree with the Examiner that this render the claims non-enabled.
Conclusion
The Examiner has not set forth a prima facie case that the claims are
not enabled. We, therefore, reverse the enablement rejection.
UTILITY
The Examiner finds that "the disclosed invention is inoperative and
therefore lacks utility" (Ans. 20). In addition, the Examiner finds:
Assuming arguendo, that the claims were directed to an operable
method, a point the Office does not concede, the method must
result in a product that has either a specific, substantial, and
credible asserted utility or a well-established utility. The present
claims all result in the quantification of an undefined analyte
nucleic acid. The number, or quantity, of molecules of a given
analyte polynucleotides is an intangible property that, while
arguably a credible and specific utility, it not deemed to
constitute a substantial utility.
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(Id. at 24.)
Principles of Law
Section 101 requires a utility that is both substantial and specific. A
substantial utility requires:
show[ing] that an invention is useful to the public as disclosed in
its current form, not that it may prove 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.
In re Fisher, 421F.3d1365, 1371 (Fed. Cir. 2005). A specific utility is "a
use which is not so vague as to be meaningless." Id. In other words, "in
addition to providing a 'substantial' utility, an asserted use must also show
that [the] claimed invention can be used to provide a well-defined and
particular benefit to the public." Id.
"An inoperative invention, of course, does not satisfy the requirement
of 35 U.S.C. 101 that an invention be useful." In re Harwood, 390 F.2d 985,
989 (CCPA 1968). However, "[t]o violate 101 the claimed device must be
totally incapable of achieving a useful result." Brooktree Corp. v. Advanced
Micro Devices, Inc., 977 F.2d 1555, 1571 (Fed. Cir. 1992).
[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 to satisfy the utility requirement of
§ 101 for the entire claimed subject matter unless there is reason
for one skilled in the art to question the objective truth of the
statement of utility or its scope.
In re Langer, 503 F.2d 1380, 1391(CCPA1974).
[T]he PTO has the initial burden of challenging a presumptively
correct assertion of utility in the disclosure. Only after the PTO
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Application 10/ 451, 640
provides evidence showing that one of ordinary skill in the art
would reasonably doubt the asserted utility does the burden shift
to the applicant to provide rebuttal evidence sufficient to
convince such a person of the invention's asserted utility.
In re Brana, 51F.3d1560, 1566 (Fed. Cir. 1995) (citation omitted).
Analysis
Appellants argue that "the Examiner has failed to make the required
prima facie showing that the claimed invention lacks utility" (Br. 3 6). We
agree.
The Specification discloses:
The method of the present invention is useful for quantitative and
comparative assessment of variations in the quantity or quality
of different characterized, partially characterized or
uncharacterized polynucleotides in targeted cell or tissue
samples due to inherent changes or as a response to external or
internal stimuli. The method ... can be used for evaluating the
effect of treatment modalities, epidemiologic situations, hygienic
rl" . . i,.· 1 1 .
COilultlOilS, illlCfOula_t popU_iatlOilS.
(Spec. 20.) The Examiner acknowledges this assertion of utility, but states
that "none of the claims is drawn to such 'evaluation' and ... limitations
found in the disclosure are not being read into the claims when such are a
lynchpin to patentability" (Ans. 10).
As discussed above, we understand that certain selections of probes
and hybridization conditions may render the methods inoperable. However,
it "is not a function of the claims to specifically exclude ... possible
inoperative [embodiments]." In re Dinh-Nguyen, 492 F.2d at 858-59. Thus,
we do not agree with the Examiner that the fact that the claims may include
inoperative embodiments is sufficient to demonstrate that they lack utility.
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With regard to the Examiner's allegation that Appellants have not set
forth a substantial utility, we conclude that the Examiner does not
adequately explain why "quantitative and comparative assessment of
variations in the quantity or quality of different ... polynucleotides in
targeted cell or tissue samples" and, more specifically, "evaluating the effect
of treatment modalities, epidemiologic situations, hygienic conditions,
[and/or] microbial populations" (Spec. 20) would not be considered
substantial.
The Examiner states that the "present claims all result in the
quantification of an undefined analyte nucleic acid" (Ans. 24). Thus, the
Examiner's concern may be that the claims read on situations where one has
no idea what is in a sample and, therefore, cannot even design appropriate
probes for use in the method (see id. at 7-8). However, we do not agree
with the Examiner that this potential issue is sufficient to support a utility
rejection.
Conclusion
The Examiner has not set forth a prima facie case that the claims lack
utility. We, therefore, reverse the utility rejection.
REVERSED
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