DETAILED ACTION
Claims 1-13 and 15 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 07/18/2024, 03/04/2025, and 08/27/2025 have 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.Claims 1-5, 7-10, 12 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aghvanyan et al., (WO 2015175856 A1) (IDS filed on 07/18/2024).
Aghvanyan teaches a method, kit, and device for determining an analyte suspected to be present in a sample (see claims 1 and 51 of Aghvanyan) comprising:
(a)contacting said sample with a sensor element (see page 100 “i) that involve the use of multiple sensors”, see page 16 “the measuring step can include binding the amplicon to a detection probe having a detectable label, measuring the detectable label and correlating the measurement to the amount of analyte in the sample, wherein the detection probe comprising a nucleic acid sequence that is complementary to a region of the amplicon”) comprising:
(i) an anchor layer which is present on a solid support (see claim 1 of Aghvanyan, see page 67 “capture reagent linked to a targeting agent and a solid phase supporting an immobilized targeting agent complement are provided as separate components.”);
(ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label (see claim 1 of Aghvanyan); and
(iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support (see claim 1 of Aghvanyan);
for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent (see page 50 “(a) concentrating the sample under conditions sufficient to form an analyte complex comprising the analyte bound to a first detection reagent”); and
(b) detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined (see page 13 “thereby forming a detection complex on the surface comprising the capture reagent, the analyte and the first and second detection reagents”, see page 71 “the invention includes methods for detecting and counting individual detection complexes. In a specific embodiment, the surface can comprise a plurality of capture reagents for one or more analyte molecules that are present in a sample and the plurality of capture reagents are distributed across a plurality of resolvable binding regions positioned on the surface”) (instant claims 1, 13, and 15).
Aghvanyan teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one detectable label (see page 1 “The methods are designed to amplify signals in immunoassays and anchor immunoassay complexes employed therein”, see page 54 “(ii) amplifying the signal from labeled detection complexes”, see page 90 “the limit of detection for the assay is that concentration that gives a signal that is at least 2.5 standard deviations above the background signal”) (instant claim 2). Aghvanyan teaches wherein said signal can be detected for a predetermined characteristic time period (see page 100 lines 9-18) (instant claim 3). Aghvanyan teaches the anchor layer is a lipid layer (see page 83 lines 20-23 “In order to probe internal target molecules, (cargo proteins, lipids or RNA molecules) the exosomes can be fixed and permeablized either prior to or after capture but before adding detection reagents”, see page 82 “ Exosomes have been shown to contain a wide variety of signaling molecules including but not limited to surface- bound and cytosolic proteins, lipids, mRNA, and miRNA, and it has been suggested that the identity and concentration of these species in each exosome can be used to deduce its cellular origin and function”) (instant claim 4). Aghvanyan teaches wherein said first binding agent is anchored in the anchor layer via an anchoring molecule (see claim 1 of Aghvanyan) (instant claim 5). Aghvanyan teaches the first and second binding agents being selected from the group consisting of an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claims 3-4 of Aghvanyan) (instant claims 7-8). Aghvanyan teaches wherein said determining an analyte comprises determining the presence, absence or amount of said analyte (see claims 1 and 28 of Aghvanyan, see page 21 “determining the presence or absence of an analyte molecule in each binding region”) (instant claim 9). Aghvanyan teaches wherein said detectable label is selected from the group consisting of: fluorescent labels, chemiluminescent label, radioactive labels, magnetic labels, and electrochemical labels (see page 5 “The detectable label can be measured by a measurement of light scattering, optical absorbance, fluorescence, chemiluminescence, electrochemiluminescence, bioluminescence, phosphorescence, radioactivity, magnetic field, or combinations thereof”) (instant claim 10).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Aghvanyan as applied to claims 1-5, 7-10, 12 and 15 above.
Aghvanyan teaches the use of a first binding agent and a second binding agent (see claim 1 of Aghvanyan). Aghvanyan teaches the first binding reagent binds to the analyte and the second binding reagent binds to the solid phase (see page 77 lines 27-32).
Aghvanyan does not explicitly teach the first binding agent exceeds the amount of said second binding agent by a factor between 10 and 100, between 20 and 80, between 30 and 70, or between 40 and 60.
However, it would have been obvious to one of ordinary skill in the art to routinely optimize the amount of first and second binding agents, as taught by Aghvanyan. It would have been obvious to one of ordinary skill in the art to perform routine optimization for determining the proper amount of first and second binding agents that are needed for the immunosensor. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of the amount of first and second binding agents would have been obvious at the time of the invention (instant claim 6).
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 concentrations of the activator and sensitizer was other than routine, that the concentrations resulting from the optimization have any unexpected properties, or that the result should be considered unexpected in any way as compared to the closest prior art.
3.Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Aghvanyan as applied to claims 1-5, 7-10, 12 and 15 above and in view of Sharafeldin et al., 3D-Printed Immunosensor Arrays for Cancer Diagnostics. Sensors (Basel). 2020 Aug 12;20(16):4514. doi: 10.3390/s20164514. PMID: 32806676; PMCID: PMC7472114.
The teachings of Aghvanyan et al., as it pertains to claims 1-5, 7-10, 12, and 15 are discussed in the 35 USC 102 rejection above.
Aghvanyan teaches said detector being capable of selectively detecting a signal in direct proximity to said second binding element (see page 100 lines 9-18 teaching the use of multiple sensors that use discrete assay domains on the surface that are distinguishable based on location on the surface and the use of reagents coated on particles that are distinguishable based on a particle property. See page 96 lines 31-33 and page 97 lines 1-10 teaching the use of labels that have the ability to independently detect an analyte of interest when the labels are in proximity to each other) (instant claim 11).
Aghvanyan does not teach the detector being positioned below the solid support.
Sharafeldin teaches the sensor element comprises a detector for detecting a signal elicited by the detectable label and the detector being placed below the solid support (see figure 7 showing the detector being placed below the support, see figure 8) (instant claims 11 and 13).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the methods and device of detecting an analyte of interest taught by Aghvanyan with the teaching of placing the detector below the solid support taught by Sharafeldin. Sharafeldin provides motivation by teaching that the use of transparent/semi-transparent devices with detectors/sensors beneath allowed for increased sensitivity (see pages 11-12). Further, it is known in the art that the location of the detectors is an obvious matter of choice depending on the assay being run and what is being measured. The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
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.
4.Claims 1-5, 7-8, 12, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-9, 13, and 15 of copending Application No. 18541708 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘708 teaches a method for determining an analyte suspected to be present in a sample comprising:(a) contacting said sample with a sensor element comprising: (i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label; and (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support; for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent; and (b) detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined (see claim 1 of ‘708).
Regarding instant claim 2, ‘708 teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one detectable label (see claim 2 of ‘708).
Regarding instant claim 3, ‘708 teaches wherein said signal can be detected for a predetermined characteristic time period (see claim 3 of ‘708).
Regarding instant claim 4, ‘708 teaches wherein said anchor layer is a lipid layer or lipid bi-layer (see claim 7 of ‘708).
Regarding instant claim 5, ‘708 teaches wherein said first binding agent is anchored in the anchor layer via an anchoring molecule (see claim 7 of ‘708).
Regarding instant claim 7, ‘708 teaches wherein said first binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 8 of ‘708).
Regarding instant claim 8, ‘708 teaches wherein said second binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 9 of ‘708).
Regarding instant claim 12, ‘708 teaches a device for determining an analyte suspected to be present in a sample comprising a sensor element comprising:(i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label; and (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support (see claim 13 of ‘708).
Regarding instant claim 15, ‘708 teaches A kit for determining an analyte suspected to be present in a sample comprising the device of claim 12 (see claim 15 of ‘708).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5.Claims 1-10, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-10, 13, and 15 of copending Application No. 18541875 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1, ‘875 teaches a method for determining an analyte suspected to be present in a sample comprising:(a) contacting said sample with a sensor element comprising: (i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label; and (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support; for a time and under conditions which allow for specific binding of the analyte suspected to be present in the sample to the first binding agent and specific binding of the second binding agent to the analyte bound to the first binding agent; and (b) detecting the formation of the complex of first binding agent, analyte and second binding agent whereby the analyte is determined (see claim 1 of ‘875).
Regarding instant claim 2, ‘875 teaches wherein said formation of the complex of first binding agent, analyte and second binding agent is detected by measuring the strength and/or duration of a signal elicited by the at least one detectable label (see claim 2 of ‘875).
Regarding instant claim 3, ‘875 teaches wherein said signal can be detected for a predetermined characteristic time period (see claim 3 of ‘875).
Regarding instant claim 4, ‘875 teaches wherein said anchor layer is a lipid layer or lipid bi-layer (see claim 4 of ‘875).
Regarding instant claim 5, ‘875 teaches wherein said first binding agent is anchored in the anchor layer via an anchoring molecule (see claim 5 of ‘875).
Regarding instant claim 6, ‘875 teaches wherein the amount of said first binding agent exceeds the amount of said second binding agent by a factor between 10 and 100, between 20 and 80, between 30 and 70 or between 40 and 60 (see claim 9 of ‘875).
Regarding instant claim 7, ‘875 teaches wherein said first binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 7 of ‘875).
Regarding instant claim 8, ‘875 teaches wherein said second binding agent is selected from the group consisting of: an antibody or fragment thereof, an aptamer, a receptor molecule or fragment thereof, and a ligand molecule or fragment thereof (see claim 8 of ‘875).
Regarding instant claim 9, ‘875 teaches wherein said determining an analyte comprises determining the presence, absence or amount of said analyte (see claims 1 and 10 of ‘875).
Regarding instant claim 10, ‘875 teaches wherein said detectable label is selected from the group consisting of: fluorescent labels, chemiluminescent label, radioactive labels, magnetic labels, and electrochemical labels (see claims 1-2 of ‘875).
Regarding instant claim 12, ‘875 teaches a device for determining an analyte suspected to be present in a sample comprising a sensor element comprising:(i) an anchor layer which is present on a solid support; (ii) a first binding agent which is capable of specifically binding to the analyte, which is anchored in the anchor layer and which comprises at least one detectable label; and (iii) a second binding agent which is capable of specifically binding to the analyte when bound to the first binding agent and which is immobilized on the solid support (see claim 13 of ‘875).
Regarding instant claim 15, ‘875 teaches a kit for determining an analyte suspected to be present in a sample comprising the device of claim 12 (see claim 15 of ‘875).
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
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