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 12/12/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 12/12/2025 of Group I, Claim(s) 1, 3-4, 7, 11, 14, 17-18 and 46-48 is acknowledged.
Applicant has elected without traverse in the Reply filed on 12/12/2025 the following species:
A. the antigen is a polypeptide with the sequence according to one of SEQ ID NOs 1-3092 encoded for by a nucleic acid molecule (claim 7)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 1, 3-4, 7, 11, 14, 17-21, 24, 26, 30, 33, 35, 38, 40, 43-44 and 46-48 are pending.
Claims 19-21, 24, 26, 30, 33, 35, 38, 40 and 43-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 12/12/2025.
Claims 1, 3-4, 7, 11, 14, 17-18 and 46-48 are under examination in this Office Action.
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, 3-4, 7, 11, 14, 17-18 and 46-48 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 3-4, 7, 11, 14, 17-18 and 46-48 depend directly or indirectly from claim 1.
The claim 1 limitations directed to an abstract idea (mental processes) are (d) identifying the barcoded nucleic acid molecule, thereby identifying the encoded target protein of interest as an antigen for binding by at least one antibody in the sample.
This judicial exception is not integrated into a practical application because the data gathering steps required to use the identifying do not add a meaningful limitation to the method as they are insignificant extra-solution activity
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 1 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are (a) contacting a library of display cells or particles with a sample comprising at least one antibody, wherein the library comprises a plurality of cells or particles wherein together the plurality of cells or particles comprises nucleic acid molecules for expression of a plurality of target proteins, wherein each target protein comprises an ectodomain of an extracellular protein; wherein each cell or particle of the plurality of cells or particles comprises a barcoded nucleic acid molecule, wherein each nucleic acid molecule comprises i) a nucleotide sequence encoding a target protein of interest for display on the surface of the cell or particle; and ii) a unique nucleotide barcode sequence; (b) isolating one or more antibody-bound cell or particle; (c) isolating at least one barcoded nucleic acid molecule from at least one cell or particle of step (b).
Federowicz et al. (10/24/2019) US Patent Application Publication 2019/0323001 A1 cited in the 5/22/2025 IDS (hereinafter referred to as "Federowicz") teaches (a) contacting a library of display cells or particles with a sample comprising at least one antibody, wherein the library comprises a plurality of cells or particles wherein together the plurality of cells or particles comprises nucleic acid molecules for expression of a plurality of target proteins, wherein each target protein comprises an ectodomain of an extracellular protein; wherein each cell or particle of the plurality of cells or particles comprises a barcoded nucleic acid molecule, wherein each nucleic acid molecule comprises i) a nucleotide sequence encoding a target protein of interest for display on the surface of the cell or particle; and ii) a unique nucleotide barcode sequence; (b) isolating one or more antibody-bound cell or particle; (c) isolating at least one barcoded nucleic acid molecule from at least one cell or particle of step (b) (see [0005] to [0140]).
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, 3-4, 14, 17-18 and 46-48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Federowicz et al. (10/24/2019) US Patent Application Publication 2019/0323001 A1 cited in the 5/22/2025 IDS (hereinafter referred to as "Federowicz").
With regards to claims 1, 3-4, 14, 17-18 and 46-48, Federowicz teaches:
a) as in claims 1, 3-4, 14, 17-18 and 46-48, a method of identifying at least one polypeptide which binds to at least one antibody, wherein the method comprises: (a) contacting a library of display cells or particles with a sample comprising at least one antibody, wherein the library comprises a plurality of cells or particles wherein together the plurality of cells or particles comprises nucleic acid molecules for expression of a plurality of target proteins, wherein each target protein comprises an ectodomain of an extracellular protein; wherein each cell or particle of the plurality of cells or particles comprises a barcoded nucleic acid molecule, wherein each nucleic acid molecule comprises i) a nucleotide sequence encoding a target protein of interest for display on the surface of the cell or particle; and ii) a unique nucleotide barcode sequence; (b) isolating one or more antibody-bound cell or particle; (c) isolating at least one barcoded nucleic acid molecule from at least one cell or particle of step (b); and (d) identifying the barcoded nucleic acid molecule, thereby identifying the encoded target protein of interest as an antigen for binding by at least one antibody in the sample; wherein the method further comprises the step of: (b′) expanding the one or more isolated antibody-bound cell; wherein identifying the barcoded nucleic acid molecule comprises amplifying the barcoded nucleic acid molecule; wherein the sample comprises at least one antibody purified from blood; wherein the antibody is an autoantibody; wherein the antibody is associated with an autoimmune disease; wherein the target protein is an extracellular protein; wherein the extracellular protein is a full-length protein; wherein the one or more ectodomains are full-length ectodomains or the target protein comprises a properly folded tertiary structure of secreted or ectodomain antigen (see [0005] to [0140]).
Thus, Federowicz 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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