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 .
The Track One Request, filed March 17, 2025, was granted April 21, 2025. Therefore,
this application is accorded special status.
Applicant cancels claims 1-14. Applicant newly adds claims 15-37. Claims 15-37, directed to a composition, are currently pending and under examination.
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on July 03, 2025 is acknowledged. However the election in moot in view of cancellation of claims 1-14. Therefore, due to the cancellation of claims 1-14 the restriction requirement is withdrawn.
Information Disclosure Statement
The information Disclosure Statements filed July 07, 2025 (2), 2025 have
been considered.
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.
Claims 15-19, 22-27, 31 and 34-37 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Samuels et al. (United States Patent No. US 9,150,852 B2, published October 06, 2015, effectively filed February 16, 2012).
Regarding claim 15, Samuels teaches a composition comprising a partition comprising a plurality of barcode molecules (Column 1, Lines 49-65). Samuels teaches the plurality of barcode molecules comprising a first barcode molecule comprising a nucleic acid barcode sequence (Column 6, Lines 33-47, Column 44, Lines 40-45, Column 49, Line 52—Column 50, Line 5 and Claims 1 and 12). Samuels teaches the first barcode molecule is hybridized to a first analyte, wherein the first analyte is not messenger ribonucleic acid (mRNA) and is not hybridized to the first barcode molecule via a poly- thymine (poly-T) sequence (Column 1, Lines 49-65, Column 3, Lines 12-27, Column 4, Line 65—Column 5, Line 10, Column 26, Lines 32-57, column 30, Lines 41-58 and Column 32, Lines 1-15). Samuels teaches a second barcode molecule comprising the nucleic acid barcode sequence and the second barcode molecule is hybridized to a second analyte as well as the second analyte is mRNA and is hybridized to the second barcode molecule via a poly-T sequence (Column 41, Lines 2-14).
Regarding claim 16, Samuels teaches the first analyte is a nucleic acid molecule (Abstract, Column 1, Lines 49-65 and Claim 1).
Regarding claim 17, Samuels teaches the first analyte comprises a deoxyribonucleic acid (DNA) oligonucleotide conjugated to an antibody (Column 52, Lines 61-63 and Column 53, Lines 43-51).
Regarding claim 18, Samuels teaches the DNA oligonucleotide comprises a barcode sequence (Column 34, Lines 54-60).
Regarding claim 19, Samuels teaches the plurality of barcode molecules is attached to a bead (Column 1, Lines 49-65 and Fig. 39).
Regarding claim 22, Samuels teaches barcode molecules of the plurality of barcode molecules are releasably attached to the bead (Column 39, Lines 61-66).
Regarding claim 23, Samuels teaches the partition is a partition among a plurality of partitions (Column 6, Lines 1-6, Column 19, Lines 29-30 and Fig. 41).
Regarding claim 24, Samuels teaches the plurality of partitions comprises at least about 1,000; 5,000; 10,000; 50,000; 100,000; 500,000; 1,000,000; 5,000,000; 10,000,000;50,000,000; 100,000,000; 500,000,000; or 1,000,000,000 partitions (Column 18, Lines 7-39 and Column 28, Line 47—Column 28, Line 38).
Regarding claim 25, Samuels teaches the partition is a droplet, and the plurality of partitions is a plurality of droplets (Column 1, Lines 49-65).
Regarding claim 26, Samuels teaches the partition is a well, and the plurality of partitions is a plurality of wells (Column 35, Lines 12-14, Column 36, Lines 32-36 and Column 54, Lines 25-32).
Regarding claim 27, Samuels teaches the first barcode molecule and the second barcode molecule further comprise a random N-mer sequence (Column 3, Lines 12-27 and Column 5, Lines 28-43).
Regarding claim 31, Samuels teaches a partition comprising a bead having a plurality of barcode molecules attached thereto (Column 1, Lines 49-65 and Fig. 39). Samuels teaches the plurality of barcode molecules comprises a first population of barcode molecules each hybridized to mRNA via a poly-T sequence, and the first population of barcode molecules each comprise a barcode sequence and a random sequence (Column 41, Lines 2-14). Samuels teaches a second population of barcode molecules each hybridized to a DNA-antibody conjugate via a sequence that is not poly-T (Column 1, Lines 49-65, Column 3, Lines 12-27, Column 4, Line 65—Column 5, Line 10, Column 26, Lines 32-57, column 30, Lines 41-58 and Column 32, Lines 1-15). Samuels teaches the second population of barcode molecules each comprise a barcode sequence and a random sequence (Column 3, Lines 12-27 and Column 5, Lines 28-43). Samuels teaches the barcode sequences are constant among the plurality of barcode molecules and the random sequences vary among the plurality of barcode molecules (Column 6, Line 64—Column 7, Line 7).
Regarding claim 34, Samuels teaches the partition is a partition among a plurality of partitions (Column 6, Lines 1-6, Column 19, Lines 29-30 and Fig. 41).
Regarding claim 35, Samuels teaches the plurality of partitions comprises at least about 1,000; 5,000; 10,000; 50,000; 100,000; 500,000; 1,000,000; 5,000,000;10,000,000;50,000,000; 100,000,000; 500,000,000; or 1,000,000,000 partitions (Column 18, Lines 7-39 and Column 28, Line 47—Column 28, Line 38).
Regarding claim 36, Samuels teaches the partition is a droplet, and the plurality of partitions is a plurality of droplets (Column 1, Lines 49-65).
Regarding claim 37, Samuels teaches the partition is a well, and the plurality of partitions is a plurality of wells (Column 35, Lines 12-14, Column 36, Lines 32-36 and Column 54, Lines 25-32).
Samuels teaches each and every limitation of claims 15-19, 22-27, 31 and 34-37, and therefore, Samuels anticipates claims 15-19, 22-27, 31 and 34-37.
Claim Rejections - 35 USC § 103
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.
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.
Claims 20-21, 28-30, and 32-33 are rejected under 35 U.S.C. 103 as being
unpatentable over Samuels et al. (United States Patent No. US 9,150,852 B2, published October 06, 2015, effectively filed February 16, 2012) cited on the IDS filed July 07, 2025, in view of Xu (U.S. Patent Application Publication US 2006/0084101 A1, published April 20, 2006).
Regarding claim 20-21, Samuel teaches a bead as discussed above.
Regarding claim 28, Samuels teaches a composition a plurality of droplets and the plurality of droplets comprises a bead having a plurality of barcode molecules attached thereto (Column 1, Lines 49-65 and Fig. 39). Samuels teaches the plurality of barcode molecules comprises a first barcode molecule comprising a nucleic acid barcode sequence (Column 6, Lines 33-47, Column 44, Lines 40-45, Column 49, Line 52—Column 50, Line 5 and Claims 1 and 12). Samuels teaches the first barcode molecule is hybridized to a first analyte and the first analyte is not mRNA and is not hybridized to the first barcode molecule via a poly-T sequence (Column 1, Lines 49-65, Column 3, Lines 12-27, Column 4, Line 65—Column 5, Line 10, Column 26, Lines 32-57, column 30, Lines 41-58 and Column 32, Lines 1-15). Samuels teaches a second barcode molecule comprising the nucleic acid barcode sequence and the second barcode molecule is hybridized to a second analyte as well as the second analyte is mRNA and is hybridized to the second barcode molecule via a poly-T sequence (Column 41, Lines 2-14). Samuels teaches the first barcode molecule and the second molecule further comprise a random N-mer sequence (Column 3, Lines 12-27 and Column 5, Lines 28-43. Samuels teaches detecting and labeling multiple targets (Column 1, Lines 37-43 and Column 69, Lines 41-42).
Regarding claim 29, Samuels teaches the first analyte is a nucleic acid molecule (Abstract, Column 1, Lines 49-65 and Claim 1).
Regarding claim 30, Samuels teaches the first analyte comprises a DNA oligonucleotide conjugated to an antibody and the DNA oligonucleotide comprises a barcode sequence (Column 52, Lines 61-63 and Column 53, Lines 43-51 and Column 34, Lines 54-60).
Regarding claims 32-33, Samuel teaches a bead as discussed above.
Samuels does not teach or suggest that the bead is a gel bead or that the bead comprises polyacrylamide.
Xu teaches detecting and labeling at least two different target molecules (Page 1, [0003] and Page 1, [0007]-[0009]). Xu teaches a first and second tagged molecule as well as a first and second probed target molecule bound to a solid support (i.e., barcoded, Page 1, [0007]-[0009]). Xu teaches the solid support may be a gel bead as well as the bead may comprise polyacrylamide (Page 7, [0067] and Page 3, [0035]). Xu teaches the sample and or target may be mRNA or DNA (Page 4, [0040] and Page 3, [0031]). Xu teaches DNA conjugated to an antibody (Page 3, [0031]). Xu teaches that the methods disclosed allow for advantageous simultaneous detection of multiple target molecules in a single assay (Page 2, [0017]).
As a common field of endeavor, both Samuels and Xu teach multiple target labeling and detection using beads and tagged/barcoded probes. It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Samuels by substituting the gel beads comprising polyacrylamide as taught by Xu because it has been held that the simple substitution of one known element for another to obtain predictable results is obvious. In re Fout, 213 USPQ 532 (CCPA 1982), In re O'Farrell, 7 USPQ2d 1673 (Fed. Cir. 1988). Simply substituting the beads of Samuels with the beads of Xu would obtain predictable results because both Samuels and Xu teach multiple target labeling and detection using beads and tagged/barcoded probes.
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 15-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 11, 18, 27, 39, 44, and 56 of U.S. Patent No. 9,951,386. Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for single cell processing or analysis or create a composition comprising droplets, beads and barcoding for single cell analysis using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Claims 15-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 24-25, 27-28 and 30-31 of U.S. Patent No. 12,312,640. Although the claims at issue are not identical, they are not patentably distinct from each other because while the preambles are slightly different, it appears that the steps of the claims are identical, so it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform a method for single cell analysis or create a composition comprising droplets, beads and barcoding for single cell analysis using those same steps. Therefore, the claims are not deemed to be patentably distinct.
Conclusion
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/JESSICA D PARISI/Examiner, Art Unit 1684
/NANCY J LEITH/Primary Examiner, Art Unit 1636