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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 5/26/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 2/25/2026 of Group I, claims 1 and 87-103 is acknowledged.
Applicant has elected in the Reply filed on 5/26/2026 the following species:
A. RNA is sequenced in the first sequencing (claim 1)
B. RNA is sequenced in the second sequencing (claim 1)
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 1 and 87-103 are pending.
Claims 1 and 87-103 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 - (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of the second paragraph of 35 U.S.C. 112 (pre-AIA ):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 87 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 87 lacks clear antecedent basis in the recitation of "claim 0". Correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 87-103 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea (mental processes) without significantly more. Claims 87-103 depend directly or indirectly from claim 1.
The claim 1 limitations directed to an abstract idea (mental processes) are (g) determining a level of a barcode sequenced in the first sequencing, second sequencing, and/or third sequencing.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are (a) obtaining a plurality of barcoded cells, wherein each barcoded cell comprises a single, unique barcode or a unique combination of barcodes; (b) performing a first sequencing of RNA on a subset of the plurality of barcoded cells; (c) culturing the plurality of barcoded cells in the presence of a selection pressure for a first period of time, thereby forming a first plurality of cells; (d) performing a second sequencing of RNA on a subset of the first plurality of cells; (e) culturing the first plurality of cells in the presence of the selection pressure for a second period of time, thereby forming a second plurality of cells; and (f) performing a third sequencing of RNA on at least a subset of the second plurality of cells (see entire document especially Figure 1, Figure 5 and pages 444 to 447).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
Claim Rejections - 35 USC § 102
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 and 87-103 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhang et al. (2015) Nature Medicine volume 21 pages 440 to 448 cited in the 6/3/2024 IDS (hereinafter known as "Bhang").
With regards to claims 1 and 87-103, Bhang teaches:
a) as in claims 1 and 87-103, a method for screening cells for a trait, the method comprising: (a) obtaining a plurality of barcoded cells, wherein each barcoded cell comprises a single, unique barcode or a unique combination of barcodes; (b) performing a first sequencing of RNA on a subset of the plurality of barcoded cells; (c) culturing the plurality of barcoded cells in the presence of a selection pressure for a first period of time, thereby forming a first plurality of cells; (d) performing a second sequencing of RNA on a subset of the first plurality of cells; (e) culturing the first plurality of cells in the presence of the selection pressure for a second period of time, thereby forming a second plurality of cells; (f) performing a third sequencing of RNA on at least a subset of the second plurality of cells; and (g) determining a level of a barcode sequenced in the first sequencing, second sequencing, and/or third sequencing; wherein the plurality of barcoded cells had been expanded in culture prior to step (a); wherein: (i) steps (e) and (f) are repeated for one or more iterations thereby forming one or more subsequent pluralities of cells and thereby performing one or more subsequent sequencings on a subset of said pluralities of cells and/or (ii) step (g) further comprises determining levels of barcodes sequenced in the one or more subsequent sequencings; wherein the plurality of barcoded cells comprises a plurality of clonal populations, wherein each cell within a single clonal population comprises the same single, unique barcode; wherein the relative abundance of cells in each clonal population is (i) approximately equal to the number of cells in each other clonal population in step (a); wherein a level of two or more barcodes sequenced in the first sequencing are determined; wherein the barcode(s) is enriched compared to: (i) one or more other barcodes in the first plurality of cells and/or the second plurality of cells; further comprising identifying one or more genes having higher levels of expression in cells comprising the enriched barcode(s); wherein the identifying the one or more genes comprises: (i) determining that the level of expression of at least one gene is higher in the first sequencing; further comprising: (h) identifying a barcode(s) that is enriched in the first plurality of cells; and (i) identifying from the first sequencing a first gene having a higher level of expression in cells comprising the enriched barcode(s) than in cells comprising a barcode(s) that is not enriched in the first plurality of cells; wherein the expression of the third gene is not higher in cells comprising a barcode(s) that is not enriched in the first plurality of cells; further comprising: (j) identifying a barcode(s) that is enriched in the first plurality of cells; and (k) identifying from the second sequencing a fourth gene having a lower level of expression in cells comprising the enriched barcode(s) than in cells comprising a barcode(s) that is not enriched in the first plurality of cells, such that the lower expression of the fourth gene indicates that the first gene is a candidate adaptive trait for resistance; wherein the expression of the fourth gene is not lower in cells comprising a barcode(s) that is not enriched in the first plurality of cells; wherein the one or more genes comprises a gene set; wherein the unique barcode is integrated into the genome of the barcoded cell; wherein the first sequencing, second sequencing, and the third sequencing is performed using RNA-seq; wherein the selection pressure is treatment with a therapeutic agent; wherein the first period of time is between about 30 minutes and about 1 month (see entire document especially Figure 1, Figure 5 and pages 444 to 447).
Thus, Bhang anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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