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 .
NEW GROUNDS OF REJECTION NECESSITATED BY THE IDS FILED 08/24/26
2. 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.
3. 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 1-2, 5-10, 12-17, 19, 32-35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yellen et al. (WO 2019/079399).
Regarding independent claim 1, Yellen discloses a method comprising: introducing a plurality of live cells into a fluidic device such that an individual live cell is located in a discrete area of the device; assessing a characteristic of the cell in the discrete area including interaction with another cell, protein secretion by the cell, and response of the cell to a drug; and in the discrete area releasing nucleic acids from the cell. See paragraphs 3-4, 10, 43-50, 59, 104, 109-111, 114-134, and 168-169. The claimed methods cannot be distinguished from the methods of Yellen.
Regarding claim 2, Yellen discloses imaging the cells.
Regarding claim 5, Yellen discloses detecting a protein secreted by the cell.
Regarding claim 6, Yellen discloses detecting the protein via a capture antibody.
Regarding claim 7, Yellen discloses locating an antibody on a bead.
Regarding claim 8, Yellen discloses detecting a cytokine.
Regarding claim 9, Yellen discloses capture of a nucleic acid from the cell using a capture oligonucleotide in the discrete area.
Regarding claim 10, Yellen discloses the use of barcodes.
Regarding claims 12-14, Yellen discloses sequencing nucleic acids within the discrete area.
Regarding claim 15, Yellen discloses detection of mRNA via production of cDNA.
Regarding claim 16, Yellen discloses lysing cells.
Regarding claim 17, Yellen discloses assessing a response of the cell to a drug.
Regarding claim 19, Yellen discloses the use of human cells and assessing a health status.
Regarding claims 32-35, Yellen discloses assessing an interaction between cells, based on production of a molecule, such as a cytokine.
Regarding claim 38, Yellen discloses assessing interaction between cells, cell protein secretion, and response of a cell to a drug.
4. 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.
5. 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.
6. 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.
7. Claims 3-4, 11, 18, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Yellen.
The teachings of Yellen are discussed above.
Regarding claim 3, Yellen does not disclose assessing cell morphology.
Regarding claim 4, Yellen does not disclose assessing cell motility.
Regarding claim 11, Yellen does not disclose the use of a capture oligonucleotide comprising a sequencing primer.
Regarding claim 18, Yellen does not disclose assessing a surface protein of the cell.
Regarding claims 36-37, Yellen does not disclose assessing a cell response to a physiological condition, such as temperature or mechanical stimulus.
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. Assessing cell response to various surrounding physiological conditions was also conventional and of known importance. 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
8. No claims are free of the prior art.
9. Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 08/24/26 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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09/02/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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