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 .
Status of the Application
The Reply filed December 22, 2025 is acknowledged.
Claims 1-12 are pending and are being examined on the merits.
Response to Arguments
All of the previously made objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the claims and specification.
Comments regarding priority claim
The instant application is a child application of US Serial No. 17/899,851, which has issued into US Patent No. 11,970,736. A Restriction Requirement was issued in the ‘851 application on June 29, 2023, requiring restriction between Group I claims, directed to a method for detection of target nucleotide sequences, and Group II claims, directed to a kit comprising various oligonucleotides. Applicant elected the Group I claims, and the Group II claims were ultimately canceled. The Restriction Requirement was not withdrawn. The instant case is directed to the Group II claims from the ‘851 application. However, Applicant filed the instant application as a Continuation of the ‘851 application, not a Divisional. This is reflected both in the instant Application Data Sheet (ADS) and the instant Filing Receipt. Since the instant case was not filed as a Divisional, the provisions of 35 USC 121 are not applicable. Thus, the instant claims have been re-considered and a double-patenting rejection has been added below. Applicant may either submit a corrected ADS designating the application as a Divisional, or substantively address the double-patenting rejection, perhaps by submitting a Terminal Disclaimer.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 recites that the “plurality of samples includes a blood …, saliva …, urine …, or …
feces sample”. Claim 7 depends from claim 1, which is directed to a kit of parts for detecting target nucleotides in samples. Thus, the claim 7 limitations reciting various types of samples is a statement of intended use (as is the “for the … detection” recitation in claim 1). The instant specification does not describe embodiments of the claim 1 kit that have modifications based on the type of sample comprising the target nucleotides. Thus, since the type of sample in claim 7 does not result in a structural difference for the components of the claim 1 kit, then the claim 7 statement of intended use is not further limiting (MPEP 2110.2 (I)), and claim 7 is in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,970,736 (hereinafter, the ‘736 patent) in view of Ahern (Biochemical, Reagents Kits Offer Scientists Good Return on Investment, The Scientist, July 1995).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of the ‘736 patent teach all of the embodiments of the oligonucleotides recited in instant claims 1-12. In addition, regarding the “kit” limitations, Ahern teaches that it is useful to organize nucleic acid assay reagents into kits (p. 4, para. 4).
It would have been prima facie obvious to modify the ‘736 patent oligonucleotides by incorporating them into a kit, as taught by Ahern. The ordinary artisan would have been motivated to do so in order to achieve the expected advantage of a less expensive and more efficient method of storing and transporting assay reagents and components. The ordinary artisan would have had an expectation of success as assembling assay components into kits is well-known in the art.
Prior Art
The subject matter of independent claim 1 is free of the art, and consequently dependent claims 2-12 are also free of the art.
The closest prior art is Tamminen1 (WO 2019/038372), which is directed to methods for accurate and massively parallel quantification of one or more nucleic acid targets and to the oligonucleotides corresponding to such methods (e.g., abstract). In, e.g., Fig. 2A, Tamminen teaches each of the oligonucleotide components of instant claim 1, except for the instant barcode loop oligo. In, e.g., claim 1, Tamminen also teaches various capabilities of the oligonucleotides, including annealing the various oligonucleotides together to form ligation complexes and contacting those ligation complexes with the target nucleotide sequences to form hybridization complexes, and then pooling and amplifying the hybridization complexes and sequencing the amplification products.
Regarding the limitations relating to the instant barcode loop oligo, other prior art references teach similar structures with barcodes. For example, Church2 (US Patent App. Pub. No. 2008/0269068) teaches a padlock probe/molecular inversion probe with a barcode sequence which can be used for multiplex sequencing reactions (e.g., Fig. 2A, para. 7).
However, there does not appear to be any reason for the ordinary artisan to modify the Tamminen ligation complex oligonucleotides with an additional oligonucleotide that comprises a barcode, nor is there any reason for the ordinary artisan to design such an additional oligonucleotide according the structure of instant barcode loop oligo with, e.g., regions that hybridize in part to the bridge oligo. Therefore, the prior art does not reasonably teach or suggest, at least, the instant barcode loop oligo, and thus the instant claim 1 and dependent claims 2-12 are free of the art.
Conclusion
Claims 1-12 are being examined and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Tamminen was cited in the Information Disclosure Statement submitted September 23, 2024.
2 Church was cited in the Information Disclosure Statement submitted September 23, 2024.