DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on November 4, 2025 has been entered. The claims pending in this application are claims 21-36. The objections and rejection not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on November 4, 2025. Claims 21-36 will be examined.
Claim Objections
Claim 21 is objected to because of the following informality: “repertoire of bait particles” in line 5 should be “the repertoire of bait particles”.
Claim 24 is objected to because of the following informality: “a cell surface” should be “its cell surface”.
Claim 31 or 33 is objected to because of the following informality: “influenza” should be “the influenza virus”.
Claim 32 is objected to because of the following informality: “another bait particle” should be “other bait particle”.
Claim 34 is objected to because of the following informality: “another oligonucleotide” should be “other oligonucleotide”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
This rejection is different from the rejection under 35 U.S.C. 112(a) mailed on May 5, 2025.
Claims 21-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for mixing a repertoire of bait particles with a repertoire of target cells, does not reasonably provide enablement for isolating any kind of target cell of interest using the methods recited in claims 21-36. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a method of isolating a target cell of interest. The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 21-36 encompass a method of isolating any kind of target cell of interest, wherein the target cell comprises an antibody encoded by a plurality of nucleic acids, and wherein the antibody is expressed from the plurality of nucleic acids and the antibody is displayed on the surface of the target cell, comprising the steps of: mixing a repertoire of bait particles with a repertoire of target cells, wherein repertoire of bait particles comprises a repertoire of antigens, wherein a bait particle in the repertoire of bait particles comprises an antigen of interest and an oligonucleotide, wherein the oligonucleotide comprises a barcode that is specific for the antigen of interest; isolating a bait particle with the target cell of interest bound to the antigen of interest, wherein the antibody displayed on the surface of the target cell of interest binds to the antigen of interest; sequencing the barcode from the isolated bait particle with the target cell of interest to identify the antigen of interest; lysing the target cell; and sequencing the plurality of nucleic acids that encode the antibody in the target cell of interest, whereby a target cell of interest is isolated and identified.
Working Examples
Although the specification provides 49 working examples (see pages 27-34 of US 2023/0280332 A1, which is US publication of this instant case), the specification provides no working example for isolating any kind of target cell of interest using the methods recited in claims 21-36.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides 49 working examples (see pages 27-34 of US 2023/0280332 A1, which is US publication of this instant case). However, the specification provides no working example for isolating any kind of target cell of interest using the methods recited in claims 21-36. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the examiner has not found any prior art which is related to isolate any kind of target cell of interest using the methods recited in claims 21-36.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether any kind of target cell of interest can be isolated using the methods recited in claims 21-36.
Although the specification teaches that “B-cells (or cells with antibody display technologies) having surface bound antibodies are incubated with the barcoded antigen beads” (see paragraph [0249] of US 2023/0280332 A1, which is US publication of this instant case) and it is known that only B cells produce antibody molecules which may be either secreted or inserted into the plasma membrane where they serve as a part of B-cell receptors (see page 1 of “B cell” from Wikipedia), since the specification and available arts do not teach that, besides B cells, other types of cells also can insert antibody molecules into their plasma membranes and claim 21 does not require that the target cell of interest is a B cell, if the target cell of interest is not a B cell, it is unpredictable how the antibody can be displayed on the surface of the target cell such that a bait particle with the target cell of interest bound to the antigen of interest cannot be isolated and the target cell of interest cannot be isolated using the methods recited in claims 21-23 and 25-36. Furthermore, since claim 21 requires lysing the target cells, after the target cells are lysed, it is unpredictable how the target cell of interest can be isolated using the methods recited in claims 21-36.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. The undue experimentation at least includes to test whether any kind of target cell of interest can be isolated using the methods recited in claims 21-36.
Response to Arguments
Applicant’s arguments with respect to claims 21-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
November 24, 2025