DETAILED ACTION
Notice of AIA Status
The present application, filed on 5/12/23, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-4, 6-7, 9-11 and 13-14 are rejected.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 6-7, 9-11 and 14 in the reply filed on 01/12/26 is acknowledged.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: amplification module in claim 1. The corresponding structure described in the specification as performing the claimed function is a masked nucleic acid in some embodiments and an unmasked nucleic acid in some embodiments as described in [0024] of US20240018607A1 publication of the instant application.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) the limitation is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 6-7, 9-11 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/866,858 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of claim 1 encompasses the subject matter of instant claims 1-4, 6-7, 9-11 and 14.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fu (US20190292580), teaches a system (sensor in claim 1) comprising:
a translation module (trigger module in claim 1) comprising:
a first nucleic acid (first nucleic acid molecule in claim 1) comprising a first polynucleotide (a nucleic acid inherently comprises one or more polynucleotide chains. Nucleic acids (DNA and RNA) are biopolymers composed of nucleotide monomers covalently linked into long strands, which are referred to as polynucleotides. DNA consists of two such chains, and RNA has a single polynucleotide chain) (see claim 1, which recites “a first nucleic acid molecule, comprising a first portion specific for a target, a second portion, and a third portion”), and
a second nucleic acid (second nucleic acid molecule in claim 1) comprising a second polynucleotide (a nucleic acid comprises one or more polynucleotide chains. Nucleic acids (DNA and RNA) are biopolymers composed of nucleotide monomers covalently linked into long strands, which are referred to as polynucleotides. DNA consists of two such chains, and RNA has a single polynucleotide chain), wherein the second polynucleotide is configured to reversibly hybridize the first polynucleotide (see claim 1, which recites “the third stem portion is complementary to the second portion of the first nucleic acid molecule, thereby resulting in hybridization between the third stem portion and the second portion of the first nucleic acid molecule”); and
wherein the translation module (trigger module) is configured to accept one or more input signals (target in claim 1), wherein the one or more input signals (target agents in [0003], which recites “the sensors permit detection of a broad array of target agents”) comprise one or more target nucleic acids (nucleic acids in see [0003], which recites “the sensors permit detection of a broad array of target agents, such as nucleic acids”),
wherein the one or more target nucleic acids (nucleic acids) comprise a target polynucleotide (see [0185], which recites “target molecule is a nucleic acid molecule”) (a nucleic acid inherently comprises one or more polynucleotide chains. Nucleic acids (DNA and RNA) are biopolymers composed of nucleotide monomers covalently linked into long strands, which are referred to as polynucleotides. DNA consists of two such chains, and RNA has a single polynucleotide chain),
wherein the first polynucleotide (first nucleic acid molecule) is configured to hybridize the target polynucleotide (nucleic acids) (see [0185], which recites “target molecule is a nucleic acid molecule, the sample to be tested can be treated with agents that permit disruption of the cells or pathogen. The nucleic acid molecules can be extracted or isolated, and then exposed to a sensor disclosed herein containing a sequence that is complementary to the target DNA or RNA sequence, such that the complementary nucleic acid sequence can hybridize to the target nucleic acid, thereby permitting detection of the target nucleic acid”), and
wherein the second polynucleotide (second nucleic acid molecule) is configured to dissociate from the first polynucleotide (first nucleic acid molecule) (see claim 15, which recites “contacting a sample with the sensor of claim 1, under conditions that permit the target agent to bind to the first nucleic acid portion specific for the target of the first nucleic acid molecule, thereby displacing the first nucleic acid molecule from the second nucleic acid molecule”) to provide a translator output (conformational change of the trigger molecule in [0143], which recites “contacting the disclosed sensors (both the trigger module and the sensory module, e.g., 110 and 120 of FIG. 1A or 210 and 220 of FIG. 1B) with a sample, under conditions that allow a target in the sample to bind to the first portion of the first nucleic acid molecule that is specific for the target (e.g., 132 of FIG. 1D or 232 of FIG. 1G), thereby displacing the first nucleic acid molecule (e.g., 130 of FIG. 1A or 230 of FIG. 1B) from the second nucleic acid molecule (e.g., 140 of FIG. 1A or 240 of FIG. 1B). This results in a conformational change of the trigger molecule, which allows or permits the nucleic acid molecule of the sensory module (e.g., 170 of FIG. 1A or 270 of FIG. 1B) to hybridize to the first and second stem portion (e.g., 144 of FIG. 1D) of the second nucleic acid molecule (e.g., due to complementarity between the two nucleic acid molecules)”);
an amplification module (sensory module in claim 1) comprising one or more sensing modalities (fourth nucleic acid in claim 15),
wherein the amplification module (sensory module) is configured to accept the translator output (conformational change of the trigger molecule) (see [0143], which recites “this results in a conformational change of the trigger molecule, which allows or permits the nucleic acid molecule of the sensory module (e.g., 170 of FIG. 1A or 270 of FIG. 1B) to hybridize to the first and second stem portion (e.g., 144 of FIG. 1D) of the second nucleic acid molecule (e.g., due to complementarity between the two nucleic acid molecules)”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN BORTOLI whose telephone number is (571)270-3179. The examiner can normally be reached 9 AM till 6 PM EST Monday through Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797