Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTION
2. The specification is objected to because of the following informality: the continuation information must be updated to indicate the issue of the parent ‘482 application as U.S. 11,788,138.
NON-PRIOR ART REJECTIONS
3. 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.
Claims 21, 25-27, and 29 are 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.
A) Claims 21 and 25-26 (and indirectly claim 27) are indefinite because they depend from claim 19, whereas according to the presentation and organization of the independent claims, it would appear that the intention is for dependency from claim 20. Correction or clarification is required.
B) Claim 29 is indefinite because ‘reversible blocking group’ lacks proper antecedent basis in independent claim 28. For consistency, it is suggested that ‘cleavable blocking group’ be used in an amended claim. Correction is required.
4. 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.
5. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,851,410. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim and the pending claim are related as genus-explicitly recited species. That is, the pending claim recites the species ‘antibody that binds to the nucleobase and the reversible blocking group’, which is a species within the genus recited in the patented claim, ‘affinity reagent binds to the nucleobase, the cleavable blocking group, or both.’
6. Claims 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 10,851,410. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim and the pending claim are related as genus-obvious species. That is, the patented claim recites the genus ‘affinity reagents’ and the pending claims recite the species ‘antibodies’. One of ordinary skill in the art would have been motivated to select an antibody as the affinity reagent for use in the patented kit because this would have merely followed from straightforward, logical scientific reasoning, because antibodies were unarguably conventional affinity reagents in the prior art. It would have been prima facie obvious to one of ordinary skill in the art considering the patented kit to make and use the pending kit.
7. Claims 2-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 10,851,410. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending kits, comprising 2, 3, or 4 antibody affinity reagents which bind to NLRT nucleotides incorporated into primer extension products for sequencing, have no use or purpose other than for use in the patented method. Thus, the claims are not drawn to patentably-distinct inventions.
8. Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,788,138. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim and the pending claim are related as genus-explicitly recited species. That is, the pending claim recites the species ‘antibody that binds to the nucleobase and the reversible blocking group’, which is a species within the genus recited in the patented claim, ‘affinity reagent binds to the nucleobase, the cleavable blocking group, or both.’
9. Claim 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 of U.S. Patent No. 11,788,138. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim and the pending claim are related as genus-explicitly recited species. That is, the pending kit recites the species ‘antibodies’, which is a species within the genus recited in the patented kit, ‘affinity reagent is an antibody or aptamer.’
10. Claim 2-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 32-47 of U.S. Patent No. 11,788,138. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims and the pending claims are related as genus-explicitly recited species. That is, the pending kit recites the species ‘antibodies’, which is a species within the genus recited in the patented kit, ‘affinity reagent is an antibody or aptamer.’
ALLOWABLE SUBJECT MATTER
11. As determined during prosecution of the parent ‘566 application, the closest prior art includes WO 2013/044018, WO 2016/065248, and US 2014/0242579, which disclose sequencing methods in which detection is based on binding of affinity reagents to affinity moieties which have been conjugated or attached to nucleotides or cleavable blocking groups for the purpose of facilitating affinity binding, as opposed to the claimed invention in which affinity reagents bind directly to a nucleotide (or portion thereof) or cleavable blocking group itself. This is consistent with the broadest reasonable interpretation of the claims in view of the specification as a whole, which excludes the teachings of the prior art regarding modifying a nucleotide to provide an affinity moiety, and then targeting that added affinity moiety with an antibody as a means of detection.
CONCLUSION
12. No claims are allowable.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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04/23/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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