DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment filed 07/02/2026 has been fully considered. Regarding the Office action mailed 01/09/2026:
The rejection of claims 57-59 under 35 USC 112(b) is withdrawn in view of the amendment correcting claim dependency.
The nonstatutory double patenting rejection based on U.S. Patent 11,697,840 is withdrawn in view of Applicant’s arguments that double patenting is barred due to a restriction made in U.S. Patent application 16/136,498, which issued as the ‘840 patent. After careful review, the examiner agrees that the restriction bars this double patenting rejection.
However, further review indicates that there are grounds for nonstatutory double patenting over U.S. Patent 10,114,015. This rejection is set forth below, and this Office action is NON-FINAL.
Claim Objections
Claims 24, 31, 39, 56-59 and 145 are objected to because of the following informalities:
In claim 24, line 5, the claim should read: “…a first detection reagent for the analyte…”. Claims 31 and 39 depend from claim 24 and are objected to for the same reason.
In claim 32, line 3, the claim should read: “…plurality of analytes is immobilized…”.
In claim 56, section iii, the language "one or more detection probes having a sequence capable of hybridizing to the detection sequence" would be more favorably considered. This is because, as described in the specification, once the circularized probes are subjected to amplification, the resulting amplicon would contain the “detection sequence” (corresponding to the “detection sequence complement” in the circularized probe). The detection probe, then, should hybridize to this “detection sequence” in the amplicon, i.e. the detection probe would be complementary to the “detection sequence”, not to the “detection sequence complement”. Claims 57-59 depend from claim 56 and are objected to for the same reason.
In claim 145, line 3, there is an extra “and” that should be removed.
Appropriate correction is required.
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.
Prosecution History
The instant application is related to two prior applications as follows:
14/208,040 issued as U.S. Patent 10,114,015 grandparent
16/136,498 issued as U.S. Patent 11,697,840 parent
18/320,411 instant application
In the ‘040 application, a restriction was made1 into four groups:
I claims 23, 25-30, 31-51 method
II claims 24, 25-30, 144-147 method (circularization)
III claims 52-55 kit
IV claims 56-63 kit (circularization)
The distinction between groups I and II was: “The method of Invention I requires amplifying a plurality of target sequence, whereas the method of Invention II requires amplifying a plurality of circular DNA templates.”
Similarly, the distinction between groups III and IV was: “The kit of Invention III requires connector probes, whereas the kit of Invention IV requires circularization probes.”
Note that in original claims 52 and 56 of the ‘040 application, the “connector probes” and the “circularization probes” were described similarly as far as their complementarity to the proximity probes (note the only differences between the claims are highlighted):
52. (Original) A kit for the measurement of an analyte of interest in a sample, the kit comprising:
a. A surface comprising a binding reagent for the analyte and an anchoring reagent comprising an anchoring sequence complementary to an amplicon sequence; and
b. In one or more containers, compartments, or vessels:
i. Two detection reagents for the analyte, wherein the two detection reagents comprise a first proximity probe and a second proximity probe, respectively;
ii. one or more connector oligonucleotides including a first connector probe complementary to a first region of the first proximity probe and a first region on the second proximity probe, and 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
iii. One or more detection probes complementary to the detection probe sequence.
56. (Original) A kit for the measurement of an analyte of interest in a sample, the kit comprising:
a. A surface comprising a binding reagent for the analyte and an anchoring reagent comprising an anchoring sequence complementary to an amplicon sequence; and
b. In one or more containers, compartments, or vessels:
i. Two detection reagents for the analyte, wherein the two detection reagents comprise a first proximity probe and a second proximity probe, respectively;
ii. One or more connector oligonucleotides including 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; and
iii. One or more detection probes complementary to the detection probe sequence.
The specification of the ‘040 application does not specifically define either “connector probe” or “circularization probe” as to indicate any structural difference between these components, although the term “circularization” implies the forming of a circle. However, this difference in terminology was the basis for the restriction.
Applicant elected group III (the “connector probe”). The claims of the instant application are directed to the “circularization probe”. However, during prosecution of the ‘040 application, an amendment was filed 04/16/2018 to amend claim 52 to insert the following language:
“…wherein hybridization of the one or more connector oligonucleotides to the first and second proximity probe sequences via the complementary sequences allows ligation of the one or more connector oligonucleotides to form a circular oligonucleotide that serves as a template for producing an amplicon…”.
That amendment is reflected in the claim ultimately issued in U.S. Patent 10,114,015. This language can reasonably be considered to qualify the “connector probe” as a “circularization probe”. The amendment thereby crossed the line of demarcation in the original restriction of the ‘040 application. As such, consideration for double patenting is no longer barred; see MPEP 804.01:
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
See also MPEP 804.02:
A nonstatutory double patenting rejection may also be avoided if consonance between the originally restricted inventions is maintained in a divisional application. "Section 121 shields claims against a double patenting challenge if consonance exists between the divided groups of claims and an earlier restriction requirement." Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1381, 68 USPQ2d 1865, 1871 (Fed. Cir. 2003). "Consonance requires that the line of demarcation between the ‘independent and distinct inventions’ that prompted the restriction requirement be maintained ... Where that line is crossed the prohibition of the third sentence of Section 121 does not apply." Symbol Techs, Inc. v. Opticon, Inc., 935 F.2d 1569, 1579, 19 USPQ2d 1241, 1249 (Fed. Cir. 1991) (quoting Gerber Garment Technology Inc. v. Lectra Systems Inc., 916 F.2d 683, 688, 16 USPQ2d 1436, 1440 (Fed. Cir. 1990)). "However, even if such consonance is lost, double patenting does not follow if the requirements of Section 121 are met or if the claims are in fact patentably distinct … The purpose of Section 121 is to accommodate administrative convenience and to protect the patentee from technical flaws based on this unappealable examination practice." Applied Materials Inc. v. Advanced Semiconductor Materials, 98 F.3d 1563, 1568, 40 USPQ2d 1481, 1484 (Fed. Cir. 1996).
Claims 56-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 10,114,015. Although the claims at issue are not identical, they are not patentably distinct from each other because while the instant claims refer to a “circularization probe”, but does not indicate that these probes actually form a circle during use, and the ‘015 claims do not use the term “circularization probe”, the ‘015 claims nevertheless describe the formation of a circle by the “connector oligonucleotides” during use, which would reasonably qualify them as a type of “circularization probe”.
Regarding instant claim 56, the ‘015 claims disclose or suggest:2
A kit for the measurement of an analyte of interest in a sample, the kit comprising:
“A kit for the measurement of an analyte of interest in a sample, the kit comprising:”
a. a surface comprising a binding reagent for the analyte and an anchoring reagent comprising an anchoring sequence; and
“a. a surface comprising at least one binding domain to which are bound a binding reagent for the analyte and an anchoring reagent comprising an anchoring sequence complementary to a first region of an amplicon sequence; and”
b. in one or more containers, compartments, or vessels:
“b. in one or more containers, compartments, or vessels:”
i. a first detection reagent for the analyte and a second detection reagent for the analyte, wherein the first and second detection reagents comprise a first proximity probe and a second proximity probe, respectively;
“i. two detection reagents for the analyte, wherein the two detection reagents comprise a first proximity probe sequence and a second proximity probe sequence, respectively;”
ii. one or more connector oligonucleotides comprising:
“ii. one or more connector oligonucleotides that comprise”
a first circularization probe complementary to a first region of the first proximity probe and a first region on the second proximity probe,
“a first connector probe sequence complementary to a first region of the first proximity probe sequence and a first region of the second proximity probe sequence,”
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,
“and a second connector probe sequence complementary to a second non-overlapping region of the first proximity probe sequence and a second non-overlapping region of the second proximity probe sequence, wherein hybridization of the one or more connector oligonucleotides to the first and second proximity probe sequences via the complementary sequences allows ligation of the one or more connector oligonucleotides to form a circular oligonucleotide that serves as a template for producing an amplicon comprising a first region complementary to the anchoring sequence;” Therefore, the “connector probes” of the ‘015 claims can be reasonably considered “circularization probes”.
and iii. one or more detection probes complementary to the detection sequence complement.
“and iii. one or more detection probes comprising a sequence complementary to a second region of the amplicon sequence, wherein each of the one or more detection probes comprise a detectable label.”
Regarding the limitation wherein the one or more connector oligonucleotides further comprises a detection sequence complement, this follows from the fact that the ‘015 claims indicate that the “connector oligonucleotides” are ligated to form a circular template, which serves as a template to produce an amplicon, and that the detection probes comprise a sequence complementary to the amplicon. Because the amplicon represents the complement of the template, it follows that one of the “connector oligonucleotides” used to form the circular template must contain a sequence (a “detection sequence complement”) that corresponds to the “detection sequence” in the amplicon to which the detection probes are complementary.
Regarding instant claim 57, ‘015 claim 2 discloses a DNA polymerase.
Regarding instant claims 58 and 59, ‘015 claim 3 discloses an ECL label and an ECL co-reactant.
Conclusion
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
1 See Office action mailed 07/06/2015 in the ‘040 application.
2 Italics indicate instant claim language, normal type is from the ‘015 claims.
Prosecution Insights