DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/26 has been entered.
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 1, 7, 8, 10-19 and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,392,771 in view of Urdea et al. (US 2010/0075436).
Regarding claims 1, 7, 11, 12, 17-19 and 25 – Claims 1-18 of the ‘771 Patent recite a method that includes the steps of: contacting one or more single cells with a first plurality of capturing synthetic particles, wherein the one or more single cells are capable of secreting a plurality of secreted factors, wherein each capturing synthetic particle comprises a plurality of capture probes capable of specifically binding to at least one of the plurality of secreted factors secreted by a single cell, wherein contacting one or more single cells with a first plurality of capturing synthetic particles comprises partitioning the one or more single cells and the first plurality of capturing synthetic particles to a plurality of first partitions, wherein a first partition of the plurality of first partitions comprises a single cell of the one or more single cells and a single capturing synthetic particle of the first plurality of capturing synthetic particles; pooling the single capturing synthetic particles from each first partition of the plurality of first partitions to generate a second plurality of capturing synthetic particles; contacting the second plurality of capturing synthetic particles with a plurality of secreted factor-binding reagents each capable of specifically binding to a secreted factor bound by a capture probe, wherein each of the plurality of secreted factor-binding reagents comprises a secreted factor-binding reagent specific oligonucleotide comprising a unique factor identifier sequence for the secreted factor-binding reagent; hybridizing a plurality of oligonucleotide barcodes with the secreted factor-binding reagent specific oligonucleotides, wherein the oligonucleotide barcodes each comprise a first molecular label; extending the plurality of oligonucleotide barcodes hybridized to the secreted factor-binding reagent specific oligonucleotides to generate a plurality of barcoded secreted factor-binding reagent specific oligonucleotides each comprising a sequence complementary to the unique factor identifier sequence and the first molecular label; and obtaining sequencing data of the plurality of barcoded secreted factor-binding reagent specific oligonucleotides to determine the number of copies of the at least one secreted factor secreted by at least one of the one or more single cells. Claims 1-18 of the ‘771 Patent do not recite measuring emissions of a synthetic particle to determine the secretion level of at least one secreted factor secreted by the one or more cells.
Urdea teaches using nanoreactor technology for sample analysis in microfluidic systems. The embodiments of the device and method most relevant to the instant claims are shown in Figures 1-5 and described in Paragraphs 0031-0128. Urdea teaches a plurality of synthetic particles (particles including magnetic beads, see Paragraphs 0039-0040 of Urdea) comprising capture probes (reagents including peptides, nucleic acids, antibodies, proteins, etc., see Paragraphs 0041-0042) each capable of specifically binding to at least one of a plurality of secreted factors secreted by a single cell, and a plurality of secreted factor-binding reagents comprised of a detectable moiety (reporters including quantum dots, see Paragraphs 0043-0044), the factor binding reagents comprising different reagents and different detectable moieties. With respect to the method claims, Urdea recites a method in the claims that includes the steps of contacting a first plurality of beads with a cell sample, partitioning the first beads and contacted cells, then pooling the plurality of partitioned first beads and cells for additional analysis which includes measuring emissions from the detectable moieties using cell sorting equipment. See the claims, especially claims 12-22; the Examples, and Paragraphs 0049-0083. Claims 1-18 of the ‘771 Patent recite obtaining sequencing data of the plurality of barcoded secreted factor-binding reagent specific oligonucleotides to determine the number of copies of the at least one secreted factor secreted by at least one of the one or more single cells, but do not specifically recite measuring emissions from the first particle or barcode oligonucleotide. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the fluorescence cell sorting equipment and particles from Urdea with the method recited in claims 1-18 of the ‘771 Patent. One of ordinary skill in the art would add the fluorescence cell sorting equipment and particles in order to perform optical assays as taught by Urdea.
Regarding claims 8, 10 and 21 - Urdea teaches the use of fluorescence cell sorting equipment in Paragraphs 0126-0127 and quantum dots as the detectable moiety in Paragraphs 0040, 0043 and 0055-0056.
Regarding claims 14 and 16 - Urdea recites identifying proteins or sugars as a part of the cell that may be identified in Paragraphs 0043-0044.
Regarding claim 15 - Urdea discloses use of antibodies as the capture of anchor probe in Paragraph 0042.
Regarding claims 13, 22 and 25 – Claim 9 of the ‘771 Patent recites at least one secreted factor comprising a cytokine.
Regarding claims 23 and 24 – Urdea teaches synthetic particles comprised of magnetic beads in Paragraph 0039-0040.
Claims 5 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,392,771 in view of Urdea et al. (US 2010/0075436), and further in view of Fan et al. (2017/0138942) . Claims 1-18 of the ‘771 Patent and Urdea as combined above in Paragraphs 4-11 recite every element of claims 5 and 6 except for the recited microplate dimensions. Fan teaches an array for detecting at least one target in a sample, and in particular a plurality of targets in a sample is disclosed. The array comprises, at least one capture agent or component thereof attached to a substrate, the at least one capture agent capable of specifically binding the at least one target to form a capture agent target binding complex. In Paragraphs 0240-0265, Fan teaches a microplate which may be used for their high throughput method. Fan teaches a microwell array of at least 10-1,000,000 wells in Paragraph 0153. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the microplate from Fan with the combined method recited in the ‘771 Patent and Urdea. One of ordinary skill in the art would add the microplate to the ‘771 Patent and Urdea in order to recite a have an array of containers for performing the method as taught by Fan.
Regarding claim 6 – Fan teaches every element of claim 6 except for the specific combination of well dimensions as recited in claim 6. Fan teaches a microarray of at least 100 microwells and also various dimensions of the wells including aspect ratio and volume in Paragraphs 0148-0167, but does not specifically recite the combination of features recited in claim 6. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time to determine the optimal combination of well dimensions including the number of wells, average diameter, volume and aspect ratio through routine experimentation. See MPEP 2144.05, Section II, A - Routine Optimization.
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.
Claims 1, 7, 8, 10-16, 19 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Urdea et al (US 2010/0075436). This rejection was applied to claims 1, 5, 7, 8, 10-16 and 19-24 in Paragraphs 8-14 of the Final Rejection mailed 10/24/26. The rejection has been removed for claim 5, but remains in effect for the other listed claims and also applies to new claim 25. Claim 5 has been added to the rejection under 35 U.S.C. 103 below. Please also see Response to Arguments below for a discussion of rejected claims 1 and 19.
Inventorship
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 5, 6, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Urdea et al. (US 2010/075436) in view of Fan et al. (2017/0138942). Urdea, as described in Paragraphs 4-10 of the Non-Final Rejection mailed 03/28/25, teaches every element of claims 5 and 6 except for the microplate having well dimensions as recited in claims 5 and 6 and the oligonucleotide barcodes recited in claims 17 and 18. Urdea shows containers for contacting the cell, synthetic particles and reagents, but does not specify a microplate.
Regarding claims 5 and 6 – Urdea teaches use of partitions in Figures 1-5 but does not recite a microplate. Fan teaches an array for detecting at least one target in a sample, and in particular a plurality of targets in a sample is disclosed. The array comprises, at least one capture agent or component thereof attached to a substrate, the at least one capture agent capable of specifically binding the at least one target to form a capture agent target binding complex. In Paragraphs 0240-0265, Fan teaches a microplate which may be used for their high throughput method. Fan teaches a microwell array of at least 10-1,000,000 wells in Paragraph 0153. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the microplate from Fan with the method of Urdea. One of ordinary skill in the art would add the microplate to Urdea in order to have a have an array of containers for performing the method as taught by Fan.
Regarding claim 6 – Fan teaches every element of claim 6 except for the specific combination of well dimensions as recited in claim 6. Fan teaches a microarray of at least 100 microwells and also various dimensions of the wells including aspect ratio and volume in Paragraphs 0148-0167, but does not specifically recite the combination of features recited in claim 6. The Examiner submits it would have been obvious to one of ordinary skill in the art at the time to determine the optimal combination of well dimensions including the number of wells, average diameter, volume and aspect ratio through routine experimentation. See MPEP 2144.05, Section II, A - Routine Optimization.
Regarding claims 17 and 18 - Fan teaches an array for detecting at least one target in a sample, and in particular a plurality of targets in a sample is disclosed. The array comprises, at least one capture agent or component thereof attached to a substrate, the at least one capture agent capable of specifically binding the at least one target to form a capture agent target binding complex. In the array, the at least one capture agent or component thereof arranged on the array so that capture agent target
Response to Arguments
Applicant’s arguments, filed 01/26/26, with respect to the rejection(s) of claims under U.S.C. 102(a)(1) as being anticipated by Urdea et al (US 2010/0075436) have been fully considered but they are not persuasive.
Applicant has argued that Urdea does not teach “partitioning the one or more single cells and the first plurality of first synthetic particles to a plurality of partitions, wherein a partition of the plurality of partitions comprises a single cell of the one or more single cells and a single first synthetic particle of the first plurality of first synthetic particles” as recited in claim 1 because Urdea does not teach compartmentalizing a cell with the first synthetic particle and instead teaches binding compounds such as proteins, acides, carbohydrates and lipids. Applicant has also argued that Urdea does not teach “wherein the first synthetic particle further comprises a plurality of anchor probes, and wherein each of the plurality of anchor probes is capable of specifically binding to a surface cellular target of a cell” as recited in claim 19. See pages 12-13 of Applicant’s Remarks.
The Examiner respectfully disagrees with Applicant with respect to both claims and directs Applicant to Paragraphs 0039-0045 of Urdea which teach a synthetic particle having a reporter molecule for binding with a cell. See esp. Paras 0043 and 0045. The Examiner submits Urdea teaches a synthetic particle that binds with a cell in addition to the other possible analytes cited by Applicant from Paragraph 0034 of Urdea.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 June 27, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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