DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
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 57-59 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.
Each of these claims depends from a cancelled claim.
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 2, 3, 5-7, 9, 24, 144-147 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 10, 19, 22 and 27 of U.S. Patent No. 11,697,840 in view of Landegren (US 9,551,032). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘840 claims disclose:
Regarding claim 2:
A method of detecting an analyte of interest in a sample comprising:
‘840 claim 1: “A method of detecting an analyte of interest in a sample comprising:”
a. contacting a complex on a surface comprising the analyte, a binding reagent for the analyte, a first detection reagent for the analyte comprising a first proximity probe, and a second detection reagent for the analyte comprising a second proximity probe
‘840 claim 1: “a. contacting the sample with a surface comprising (i) a binding reagent for the analyte…and binding the analyte to the binding reagent to form a surface-bound complex; b. contacting the surface-bound complex with a first detection reagent for the analyte comprising a first proximity probe and a second detection reagent for the analyte comprising a second proximity probe to form a detection complex comprising the binding reagent, the analyte, and the first and second detection reagents”
with one or more connector oligonucleotides comprising:
a first circularization probe complementary to a first region of the first proximity probe and a first region on the second proximity probe,
and a second circularization probe complementary to a second non-overlapping region of the first proximity probe and a second non-overlapping region of the second proximity probe,
‘840 claim 1: “c. contacting the detection complex formed in (b) with one or more connector oligonucleotides comprising: (i) a first connector probe complementary to a first region of the first proximity probe and a first region of the second proximity probe, and (ii) a second connector probe complementary to a second non-overlapping region of the first proximity probe and a second non-overlapping region of the second proximity probe, and ligating the first and second connector probes to form a target oligonucleotide”
and wherein the surface further comprises an anchoring reagent comprising an anchoring sequence;
‘840 claim 1: “surface comprising…an anchoring reagent comprising an anchoring oligonucleotide”
b. amplifying the circular DNA template to generate an amplicon comprising a plurality of detection sequences and an anchoring sequence complement;
‘840 claim 1: “amplifying the target oligonucleotide to generate an amplicon comprising (i) a plurality of detection oligonucleotides and (ii) an anchoring oligonucleotide complement, wherein the anchoring oligonucleotide complement is complementary to the anchoring oligonucleotide”
‘840 claim 4: “wherein the amplifying comprises rolling circle amplification (RCA)”
c. hybridizing the anchoring sequence to the anchoring sequence complement;
‘840 claim 1: “hybridizing the anchoring oligonucleotide to the anchoring oligonucleotide complement”
d. hybridizing a plurality of detection probes to the plurality of detection sequences;
‘840 claim 1: “hybridizing a plurality of detection probes to the plurality of detection oligonucleotides”
and e. measuring the amount of analyte bound to the surface.
‘840 claim 1: “measuring the amount of detection probes bound to the surface, thereby detecting the analyte”.
Regarding claim 3: ‘840 claim 2 discloses the first and second detection reagents are antibodies. Something recognized by an antibody is, by definition, an antigen.
Regarding claims 5-7: ‘840 claim 7 discloses measuring by ECL using an ECL label.
Regarding claim 9: ‘840 claim 19 discloses a surface with discrete binding domains, each comprising a binding reagent and anchoring reagent bound thereto.
Regarding claim 24: ‘840 claims 19 and 22 disclose the same features as discussed for claim 2 above and bring in the aspect of detecting “a plurality” of analytes.
Regarding claim 144: ‘840 claim 1 performs the steps in the recited order.
Regarding claim 145: ‘840 claim 10 recites essentially the same method as ‘840 claim 1, except with the order of steps recited in claim 145.
Regarding claims 146-147: ‘840 claim 27 discloses the surface as a multi-well plate; it would have been obvious to use the standard well-number plates recited in claim 147.
The ‘840 claims do not refer to the connectors as “circularization probes”, and do not disclose wherein the contacting is performed under conditions sufficient for the first circularization probe and the second circularization probe to form a circular DNA template. That is, the ‘840 claims do not specifically indicate that the ligation of the first and second connector probes forms a circular target molecule.
However, one of ordinary skill in the art knows that RCA (rolling circle amplification, as recited in ‘840 claims 4 and 22) utilizes a circular template molecule.
In addition, Landegren demonstrated how two proximity probes could be used as scaffolds to ligate two single-stranded “circularization probes” into a circle to be used as a template for rolling circle amplification; see figure 6, last two panels.
Therefore, it would have been obvious to ligate the connector probes into a circle when practicing the methods of the ‘840 claims involving RCA.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 10, 19, 22 and 27 of U.S. Patent No. 11,697,840 in view of Landegren (US 9,551,032) as applied to claims 2, 3, 5-7, 9, 24, 144-147 above, and further in view of Glezer (WO 2010/118411 A2).
The disclosures of the ‘840 claims and Landegren have been discussed. The ‘840 claims, though disclosing a binding assay on a surface using ECL labels to measure the amount of analyte as discussed above, did not disclose the surface was an electrode, or applying a waveform to the electrode to generate ECL.
Glezer disclosed this feature; see claims 86, 87, for example.
It would have been obvious to use an electrode as the surface and apply a waveform to generate ECL when practicing the method suggested by the combined disclosures of the ‘840 claims and Landegren, since Glezer had already disclosed this technique.
Claim 56 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 10, 19, 22 and 27 of U.S. Patent No. 11,697,840 in view of Landegren (US 9,551,032) as applied to claims 2, 3, 5-7, 9, 24, 144-147 above, and further in view of Polansky (US 2004/0023207).
The disclosures of the ‘840 claims and Landegren have been discussed.
Polansky taught (paragraph [0919]): “Well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures.”
It would have been obvious to one of ordinary skill in the art to put the materials for practicing the method suggested by the combined disclosures of the ‘840 claims and Landegren into a kit to obtain the advantages disclosed by Polansky.
Conclusion
Claims 4, 10, 31 and 39 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681