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 .
DETAILED ACTION
1. The Applicant’s response to the office action filed on October 22, 2025 is acknowledged.
Status of the Application
2. Claims 1-4, 6-11, 22-23, 26 are pending under examination. Claims 27-28, 48-52 and 60-64 were previously withdrawn from further consideration as being drawn to non-elected group. Claims 5, 12-21, 24-25, 29-47 and 53-59 were cancelled. The Applicant’s arguments have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-Withdrawn
3. The objection to the specification has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112-maintained
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 2 recites ‘oligonucleotide base pairs of the aptamer’. The metes and bounds of the claim are unclear and indefinite because it is not clear if the aptamer is an oligonucleotide
aptamer comprising oligonucleotide sequence or not.
Response to Arguments:
With reference to the rejection of claim 2 under 35 USC 112(b), the Applicant’s arguments have been considered and found unpersuasive. With reference to the arguments drawn to aptamer comprising oligonucleotide citing a paragraph from the specification to support the arguments, the arguments have been fully considered and found unpersuasive. As noted in MPEP 2111, although the claims are given broadest reasonable interpretation, the limitations of the specification cannot be read into the claims and the claim 1 upon which the claim 2 depends, lack support for an aptamer comprising oligonucleotide and it is unclear what the limitations in claim 2 is referring to.
Claim Rejections - 35 USC § 102-withdrawn
5. The rejection of claims under 35 USC 102(1) as being anticipated by Margulies et al., has been withdrawn in view of the amendment.
6. The rejection of claims 1-4, 6-11, 22-23 and 26 under 35 U.S.C. 102(a)(1) as being anticipated by Miyahara et al. (US 2014/0124383) has been withdrawn in view of the amendment and persuasive arguments.
Double Patenting
7. 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, 6-11, 22-23 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 9-11, 13-15, 19-22, 24, 29-33, 35, 46, 50-51, 54, 57, 66, 69 of co-pending Application No. 17/908,809. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1-4, 6-11, 22-23 and 26 are entirely within the scope of the claims in the co-pending application. Specifically, the method steps of the 1-4, 6-11, 22-23 and 26 claims comprising a method of detecting the presence of a target analyte comprising contacting target analyte with an aptamer comprising a detectable marker situated at an internal location within the aptamer, wherein the detectable marker is situated at a position that is x nucleotides from a terminus of the aptamer, wherein x is an integer that is 1, n/2 or any integer between 1 and n/2, wherein n is the length of the aptamer and an even or odd number, wherein target analyte binding to the aptamer results in restriction of internal rotation of the marker, resulting in a detectable change in the marker are within the scope of the claims in the co-pending application, specifically claim 1 is within the scope of the claim 1 in combination with claims 19-20 of the co-pending application. The claims 1-4, 6-11, 22-23 and 26 differ from the claims in the co-pending application in reciting an aptamer which is considered obvious over the spherical nucleic acid of the claims in the co-pending application and considered co-extensive in scope. Thus, the instant claims 1-4, 6-11, 22-23 and 26 are obvious over the claims in the co-pending application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-11, 22-23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Margulies et al. (US 2017/0307625) in view of Christensen et al. (US 2006/0014144).
Margulies et al. teach a method of claim 1, detecting the presence of a target analyte comprising the step of contacting the target analyte with an aptamer (molecular sensor, DNA probe or selective protein binder) comprising a detectable marker (intercalator (thiazole orange), cyanine dye or fluorophore) situated at an internal location within the aptamer, wherein the contacting results in binding of the target analyte to the aptamer, wherein target analyte binding to the aptamer results in restriction of internal rotation of the marker, resulting in a detectable change in the marker (para 0103-0104, 0032-0039, 0051-0052, 0084-0091).
With reference to claim 2, Margulies et al. teach that target analyte binding to the aptamer results in forced intercalation (FIT) of the marker between oligonucleotide base pairs of the aptamer (para 0103-0104, 0051-0052, 0263).
With reference to claims 7-9, Margulies et al. teach that the detectable marker is a marker with internal rotation-dependent fluorescence or a viscosity-sensitive marker, wherein the detectable marker is thiazole orange (TO), quinoline blue, quinoline violet, thiazole red, a derivative thereof, or a cyanine derivative (para 0103-0104, 0084-0091).
With reference to claim 10, Margulies et al. teach that the change in the detectable marker is proportional to concentration of the target analyte (para 0016, 0096).
With reference to claim 11, Margulies et al. teach that the target analyte is a protein, an ion, a small molecule, a lipid, a carbohydrate, an oligosaccharide, a cell, or a combination thereof (para 0103-0104, 0084-0090).
With reference to claim 22, Margulies et al. teach that wherein the aptamer comprises a spacer (linker) (para 0018, 0091).
However, Margulies et al. did not specifically teach the position of the detectable marker in the aptamer.
Christensen et al. teach a method of 1-4, 6-11, 22-23, 26, for detecting the presence of an analyte (nuclear extracts, or nucleic acid) comprising hybridizing the target nucleic acid with an oligonucleotide (aptamer) comprising intercalating pseudonucleotide oligonucleotide (INA oligo), wherein the intercalator (marker) is positioned at a position internal from the terminus of the oligonucleotide (aptamer), wherein the intercalator is positioned any integer between 1 and n/2, anywhere within n nucleotides, wherein n is the length of the aptamer comprising even or odd number of nucleotides, resulting conformationally restricted rotation (para 0405-0409, 0432-0467, 0190-0192, 0385, 0178-0179, 0963-0966, 0975-0976, 0218-0219, Fig. 25), wherein the method comprises an additional oligonucleotide aptamer (para 0104-0107, 0433-0467: indicating a pair of oligonucleotides).
It would be prima facie obvious to an ordinary person skilled in the art before the effective filing date of the invention to modify the method of Margulies et al. with the oligonucleotide comprising pseudonucleotide intercalator as taught by Christensen et al. to develop an improved method for detecting a target analyte. The ordinary person skilled in the art would have motivated to combine the method of Margulies et al. with an INA oligonucleotide as taught by Christensen et al. and have a reasonable expectation of success that the combination would improve the specificity of the method because Christensen et al. explicitly taught use of aptamer (oligonucleotide) comprising internally positioned intercalator that would conformationally restrict rotation of the intercalator and improve the specificity of binding to the target analyte (para 0178, 0218, 0975) and such a modification is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681