DETAILED ACTION
Claims 1-15 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 09/27/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1.Claim(s) 1-9 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyce et al., WO2022/047085A1 (IDS filed on 09/27/2026).
Instant claim 1 recites “A method for analyzing a biological sample with at least one target analyte, the method comprising: adding to the biological sample at least a first marker and a second marker, wherein the first marker is configured to bind specifically to a first part of the at least one target analyte, and the second marker is configured to bind specifically to a second part of the at least one target analyte, and determining a presence of the target analyte in the biological sample based on detecting the first marker and the second marker in the biological sample.”
Boyce teaches a method and system (see whole document, see claim 13 of Boyce) for analysing a biological sample with at least one target analyte (see claim 1 of Boyce), the method comprising:
adding to the biological sample at least a first marker and a second marker, wherein the first marker is configured to bind specifically to a first part of the at least one target analyte, and the second marker is configured to bind specifically to a second part of the at least one target analyte (see claim 1 of Boyce, see [0047], see figure 14E), and
determining a presence of the target analyte in the biological sample based on detecting the first marker and the second marker in the biological sample (see [0029], see [00213]) (instant claims 1 and 15).
Boyce teaches prior to adding the first and second marker, fixing the biological sample in place (see [0030] teaching the sample being applied to the sensor) (instant claim 2), and the first and second marker are added simultaneously or subsequently (see claim 1 of Boyce, see [00263], see [00128]) (instant claim 3). Boyce teaches washing the first marker before adding the second marker (see [00249] teaching washing between each step) (instant claim 4). Boyce teaches optical readouts for the biological sample with the first and/or second marker are generated by a microscope (see [0054], see [0031], see [00106], see [00136]) (instants claim 5 and 14). Boyce teaches the presence of the target analyte in a biological sample is determined based on frequency and/or duration of light emitted by the first and second marker over time (see figure 22, see [0055], see figure 23) (instant claims 6-7). Boyce teaches determining equilibrium constants of association and dissociation of first and second markers with the target analyte and the presence of the target analyte is determined based on equilibrium constants (see [00206] teaching the use of the SELEX method to determine candidates with high affinity binding, it is known in the art that the SELEX method depends on and include the determination of equilibrium constants) (instant claim 8).
Boyce teaches setting environmental conditions that the biological sample is based at least on one physiochemical parameter of the first and/or second marker (see [00252], see [00119]) (instant claim 9). Boyce teaches where each of the first and/or second marker comprises an affinity reagent configured to specifically bind to the respective part of the target analyte, and the affinity reagent is an aptamer or antibody fragment (see [0023], see [0085], see [0095]) (instant claim 11). Boyce teaches the first and second marker comprises optically detectable labels that are distinguishable from each other (see [0008], see [00113]), see [00136]) (instant claim 12). Boyce teaches adding a further marker to the biological sample (see claim 13 of Boyce, see [00151], see [0097] teaching the use of a third nanostructure that contains an antibody (marker), thus resulting in the use of three markers) (instant claim 13).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
2.Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Boyce as applied to claims 1-9 and 11-15 as applied above.
The teachings of Boyce as it pertains to claims 1-9 and 11-15 are discussed in the 35 USC 102 rejection above.
While Boyce does not explicitly state that the environmental conditions are set such that the first and/or second marker are only transiently binding to the target analyte, Boyce teaches changing the pH or temperature (see [00252], see [00119]). It is known in the art that changing pH or temperature would result in transient binding (instant claim 10). Further, it would have been obvious to one of ordinary skill in the art at the time of the instant application to perform routine optimization for determining the environmental change that is needed for transient binding. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of the environmental change needed for transient binding would have been obvious at the time of the invention.
As noted in In re Aller, 105 USPQ 233 at 235, More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Routine optimization is not considered inventive, and no evidence has been presented that determining the environmental changes needed for transient binding was other than routine, and should be considered unexpected in any way as compared to the closest prior art.
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.
3.Claims 1, 5 and 12-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-15 and 18 of copending Application No. 18638714 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘714 teaches a method for analysing a biological sample with at least one target analyte, the method comprising: adding to the biological sample at least a first marker and a second marker, wherein the first marker is configured to bind specifically to a first part of the at least one target analyte, and the second marker is configured to bind specifically to a second part of the at least one target analyte, and determining a presence of the target analyte in the biological sample based on detecting the first marker and the second marker in the biological sample (see claims 13 and 14 of ‘714).
Regarding instant claim 5, ‘714 teaches wherein at least one optical readout of the biological sample with the first marker and/or the second marker is generated (see claim 13 of ‘714).
Regarding instant claim 12, ‘714 teaches wherein each of the first marker and the second marker comprises an optically detectable label, and the optically detectable labels of the first marker and the second marker are optically distinguishable from each other (see claims 13-15 of ‘714).
Regarding instant claim 13, ‘714 teaches further comprising adding at least a further marker to the biological sample (see claim 18 of ‘714).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4.Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18452628 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘628 teaches a method for analysing a biological sample with at least one target analyte, the method comprising: adding to the biological sample at least a first marker and a second marker, wherein the first marker is configured to bind specifically to a first part of the at least one target analyte, and the second marker is configured to bind specifically to a second part of the at least one target analyte, and determining a presence of the target analyte in the biological sample based on detecting the first marker and the second marker in the biological sample (see claim 12 of ‘628).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5.Claims 1, 5, and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9-10, and 12 of copending Application No. 18733881 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘881 teaches a method for analysing a biological sample with at least one target analyte, the method comprising: adding to the biological sample at least a first marker and a second marker, wherein the first marker is configured to bind specifically to a first part of the at least one target analyte, and the second marker is configured to bind specifically to a second part of the at least one target analyte, and determining a presence of the target analyte in the biological sample based on detecting the first marker and the second marker in the biological sample (see claim 1 of ‘881).
Regarding instant claim 5, ‘881 teaches wherein at least one optical readout of the biological sample with the first marker and/or the second marker is generated (see claim 1 of ‘881).
Regarding instant claim 11, ‘881 teaches wherein each of the first marker and the second marker comprises an affinity reagent configured to specifically bind to the respective part of the target analyte, and the affinity reagent is an aptamer or an antibody fragment (see claims 1 and 4).
Regarding instant claim 12, ‘881 teaches wherein each of the first marker and the second marker comprises an optically detectable label, and the optically detectable labels of the first marker and the second marker are optically distinguishable from each other (see claims 9-10 of ‘881).
Regarding instant claim 13, ‘881 teaches further comprising adding at least a further marker to the biological sample (see claim 12 of ‘881).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
