DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I and certain species in the reply filed on 11/17/2025 is acknowledged.
Claims 4-6, 13-16, 18, 20-22, 24, 30, 33-57 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 11, 12, 17-19, 25-29, 31, 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Green et al (Cell, 2014, of record).
Green et al teach an detection assay comprising an RNA that binds (detects) a complementary sequence (an analyte), a ribosome binding site and a sequence encoding a repressed reporter gene (initiator protein domain) that, upon expression produces a signal (a signal amplification component). In the presence of analyte, the reporter protein (GFP, an enzyme) is expressed and thus activated. A hairpin in the RNA is disrupted upon analyte binding. See Fig. 1 B and D. Claim 12 does not remove the fluorescent protein limitation of claim 11 from the claimed scope. The compositions comprised cell nutrients and PBS buffer (p.937-938). The concentration of an RNA analyte could be estimated (Fig. 4 D,E).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 7-12, 17-19, 23, 25-29, 31 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims encompass compositions for analyte detection comprising an RNA with “an analyte recognition domain”, an “initiator protein domain” and a “signal amplification component” which must function together to activate the signal, e.g. as recited in claim 1.
However, applicant was not in possession of the claimed genera of RNAs with “an analyte recognition domain”, an “initiator protein domain” or a “signal amplification component” with the ability to detect any analyte as elements of the claimed products in the absence of providing sufficient structural and functional characteristics of the genera of each of these elements broadly encompassed by the instant claim language.
However, the instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genera of “analyte recognition domain”, an “initiator protein domain” and a “signal amplification component” that are functional for analyte detection.
"It is not sufficient to define the recombinant molecule by its principal biological activity, e.g. having protein A activity, because an alleged conception having no more specificity than that is simply a wish to know the identity of any material with that biological property." Colbert v. Lofdahl, 21 USPQ2d, 1068, 1071 (BPAI 1992). Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required
The claims do not recited sufficient written description of the structural and functional characteristics coupled with a known or disclosed correlation between function and structure, since the disclosure fails to describe the common attributes or characteristics that identify each member of the genera of “analyte recognition domain”, an “initiator protein domain” and a “signal amplification component” that are functional for analyte detection.
Therefore, there is insufficient written description of the claimed genera of compositions of an “analyte recognition domain”, an “initiator protein domain” and a “signal amplification component” in the absence of defining the relevant identifying characteristics such as the structure or other physical and/or chemical characteristics of the claimed genera.
Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
The Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement make clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus.
It is not sufficient to define a genus without sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics.
In the absence of sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, the claimed invention is not described in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
With respect to reliance upon screening for structural and/or functional equivalents,
the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Applicant is relying upon certain biological activities and the disclosure of a limited number of species (RNA molecules that can detect an RNA analyte, GFP as a signal amplification component) to support entire genera.
The problem here is that the instant specification fails to provide a sufficient disclosure of
each of the compositions of an “analyte recognition domain”, an “initiator protein domain” and a “signal amplification component” in order for the them to retain the appropriate structural and functional requirements for analyte detection, as broadly encompassed by the claimed invention.
A skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genera that exhibit the appropriate structural and functional elements for analyte detection.
Therefore, there is insufficient written description for genera of compositions of an “analyte recognition domain”, an “initiator protein domain” and a “signal amplification component”, broadly encompassed by the claimed invention at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 USC 112, first paragraph.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638