Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 09/02/26 has been entered.
NEW GROUNDS OF REJECTION NECESSITATED BY THE IDS FILED 09/02/26
3. 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.
4. 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 36-37, 40-45, 50-52, 54-55, 58-61, 63, and 65-86 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yellen et al. (WO 2019/079399).
Regarding independent claims 36 and 54, Yellen discloses a method comprising: introducing a plurality of live cells into a fluidic device such that first and second live cells are located in first and second different discrete areas of the device, wherein the first and second cells are in a biological communication; performing a functional assay on the first cell in the first discrete area; and in the first discrete area releasing nucleic acids from the first cell such that the nucleic acids are captured on a planar surface within the first discrete area. Further regarding independent claim 54, Yellen discloses sequencing nucleic acids in the first discrete area. See paragraphs 3-4, 10, 43-50, 59, 78, 104, 109-111, 114-134, and 168-169. The claimed methods cannot be distinguished from the methods of Yellen.
Regarding claims 37 and 55, Yellen discloses imaging the cell.
Regarding claims 40, 58, and 83, Yellen discloses detecting a protein secreted by the cell.
Regarding claims 41 and 59, Yellen discloses detecting the protein via a capture antibody.
Regarding claims 42 and 60, Yellen discloses locating an antibody on a bead.
Regarding claims 43 and 61, Yellen discloses detecting a cytokine.
Regarding claim 44, Yellen discloses capture of a nucleic acid from the cell using a capture oligonucleotide in the discrete area.
Regarding claim 45, Yellen discloses the use of barcodes.
Regarding claim 50, Yellen discloses detection of mRNA via production of cDNA.
Regarding claim 51, Yellen discloses lysing cells.
Regarding claims 52 and 63, Yellen discloses assessing a response of the cell to a drug.
Regarding claims 65-70, Yellen discloses trapping a cell in a discrete area.
Regarding claims 71-75 and 79-83, Yellen discloses assessing a biological communication based on a molecule produced by a cell, such as a protein, cytokine, or chemokine.
Regarding claims 76-77 and 84-85, Yellen discloses that the biological communication is during the functional assay step or the releasing nucleic acids step.
Regarding claims 78 and 86, Yellen discloses the use of different types of first and second cells.
5. 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.
6. 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.
7. 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.
8. Claims 38-39, 46-49, 53, 56-57, 62, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Yellen.
The teachings of Yellen are discussed above.
Regarding claims 38 and 56, Yellen does not disclose assessing cell morphology.
Regarding claim 39 and 57, Yellen does not disclose assessing cell motility.
Regarding claim 46-49, Yellen does not disclose the use of a capture oligonucleotide comprising a sequencing primer.
Regarding claims 53 and 64, Yellen does not disclose assessing a surface protein of the cell.
Regarding claim 62, Yellen does not disclose sequencing by in-situ hybridization.
One of ordinary skill in the art would have been motivated to modify the method of Yellen in the manner of these dependent claims because doing so would have merely involved straightforward, logical scientific reasoning, which as well established in U.S. patent practice does not support unobviousness. That is, cell morphology and cell motility were phenotypic characteristics of cells known to be important and for which it was conventional to assess. The use of capture oligonucleotides having sequencing primers was conventional for facilitating sequencing of captured nucleic acids. Assessing surface proteins of cells was conventional and of known importance. Performing sequencing of nucleic acids in numerous ways including by in-situ hybridization was also conventional. Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed methods.
CONCLUSION
9. No claims are free of the prior art.
10. Yellen et al. (US 2021/0114029) is made of record by the Office as a reference of interest.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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09/09/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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