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
Status of Claims
Claims 1-20 are pending. Claims 8-15 have been withdrawn as drawn to non-elected inventions. Claims 16-20 have been added. Claims 1-7 and 16-20 have been examined.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1-7 and 16-20, in the reply filed on 05/29/2026 is acknowledged.
Priority
This application, Serial No. 18/560,106 (PGPub: US2024/0302264) was filed 11/10/2023. This application is a 371 of PCT/US2022/027927 filed 05/05/2022 which claims benefit of 63/186,713 filed 05/10/2021.
Information Disclosure Statements
The Information Disclosure Statements filed 11/10/2023 and 12/05/2023 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 1-7 and 16-20 are 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “detecting one or more target shaped particles having respective cells loaded therein” and it is unclear if the “target” is referencing the particles with cells loaded therein or if a target shaped particle has an additional “target” entity being detected that distinguishes them from the other particles with cells loaded therein.
Claims 1-7 and 16-20 recite the term “shaped”, which is a relative term which renders the claim indefinite. The term “shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonable apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1, 4-6 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Carlo et al. (WO 2020/037214, Pub Date: 02/20/2020, hereinafter “Di Carlo”).
Regarding claim 1, Di Carlo teaches throughout the publication a method of analyzing shaped particles using a flow cytometer or a fluorescence activated cell sorter (FACS) comprising: providing a population of shaped particles with at least some of the population of shaped particles having cells loaded therein; flowing the population of shaped particles through the flow cytometer or FACS; optically interrogating the shaped particles in the flow cytometer or FACS to measure scattered light for each shaped particle; and detecting one or more target shaped particles having respective cells loaded therein based at least in part on a measurement of forward scattered light, a measurement of side scattered light, and/or a measurement of back scattered light (paragraphs 0045, 0078, 0180-0181 and see claim 37).
Regarding claim 4, Di Carlo teaches the method wherein the one or more target shaped particles is detected based on a gating of two or more of measured forward scattered light and measured side scattered light (paragraph 0045).
Regarding claim 5, Di Carlo teaches the method wherein the shaped particles are optically interrogated for a fluorescence signal and the one or more target shaped particles are further detected at least in part on a measured fluorescence signal level and wherein the one or more target shaped particles having respective cells loaded therein are sorted based on the measured fluorescence signal level (paragraphs 0044-0045 and claim 37).
Regarding claim 6, Di Carlo teaches the method wherein a longest dimension of the shaped particles is between 30-60 pm (paragraph 0047).
Regarding claim 16, Di Carlo teaches the method wherein the fluorescence signal is emitted by a fluorescent reporter that has an affinity to secreted or released biomolecules from the cells loaded in the one or more target shaped particles (paragraph 0178).
Regarding claim 17, Di Carlo teaches the method wherein the fluorescence signal is emitted by a fluorescent reporter that has an affinity to the respective cells loaded in the one or more target shaped particles (paragraph 0178).
Regarding claim 18, Di Carlo teaches the method wherein the cells are loaded into cavities or voids contained in the population of shaped particles (paragraph 0007).
Regarding claim 19, Di Carlo teaches the method wherein the shaped particles have a diameter within the range of about 35 µm and about 85 µm (paragraph 0047).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Di Carlo et al. (WO 2020/037214, Pub Date: 02/20/2020, hereinafter “Di Carlo”).
Regarding claim 2, Di Carlo teaches that sorting the particles is based on a threshold intensity or color measured with the flow cytometer (see claim 37), sorting can be conducted using forward and side scatter signals (paragraph 0181) and more specifically that sorting of desired particles can be based off signal events above a specified threshold (paragraph 0045). While Di Carlo does not explicitly teach that the sorting of target particles is based on the measurement of forward scattered light being above a threshold level and the measurement of side scattered light being above a threshold level, it would be obvious given the teachings described above that since both forward and side scatter signals are analyzed in the particles, that both forward and side scatter signals would need to be above a desired threshold for distinguishing desired properties.
Regarding claim 3, Di Carlo teaches the method wherein the particles can be provided within droplets (paragraphs 0047-0048) and isolating desired drops (paragraph 0092). While Di Carlo does not explicitly teach deflecting the droplets with the one or more target shaped particles contained therein and at least two adjacent droplets from the stream of droplets, it would be obvious to modify the isolation of desired droplets process as an obvious matter of design choice to arrive at the same isolation of desired droplets. Additionally the number of adjacent drops would be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the particle sorting art.
Regarding claim 7, although Di Carlo does not specifically teach the method wherein the shaped particles are analyzed at a rate of > 400 events / second, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 7 are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the particle sorting art.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Di Carlo et al. (WO 2020/037214, Pub Date: 02/20/2020, hereinafter “Di Carlo”), as applied to claims 1 and 5 above, and further in view of Birnbaum et al. (US 2018/0058987, hereinafter “Birnbaum”).
Regarding claim 20, Di Carlo teaches the method using flow cytometry for flow sorting (see claim 37). While the reference does not teach adjusting one or more of a drop delay or a sorting mask configuration to maximize sort efficiency or purity of the shaped particles, Birnbaum teaches the sorting of cells (abstract) and more specifically teaches a custom sorting mask was creating for efficiency (paragraphs 0047 and 0075).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the sorting of Di Carlo to include a sorting mask as taught by Birnbaum because it would have been desirable to ensure that only the desired cells are manipulated at the desired time thereby maximizing sorting efficiency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 4-5 and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-35, 37 and 43 of copending Application No. 17/996,927 (reference application – Notice of Allowance mailed 05/01/2026).
Although the claims at issue are not identical, they are not patentably distinct from each other because, regarding instant claims 1, 4-5 and 18-19, application 927 claims a method of performing a cell secretion assay using shaped particles, the method comprising: (a) providing a plurality of shaped particles, wherein each shaped particle of the plurality of shaped particles has a diameter of less than 70 pm, a void or cavity formed therein, is three-dimensional, and comprises one of: crescent shaped, bowl shaped, or moon shaped; (b) loading at least one cell into a void or cavity of at least one shaped particle of the plurality of shaped particles; (c) adding an affinity capture agent to the at least one shaped particle specific to a cell secretion; (d) incubating the at least one shaped particle with the at least one cell loaded therein for a period of time such that a cell secretion is secreted from the at least one cell and binds to the affinity capture agent; (e) adding a stain, dye, label, or other secondary affinity capture agent specific to the cell secretion on or in the at least one shaped particle; (f) detecting a signal formed or property generated by the stain, dye, label, or other secondary affinity capture agent upon interaction with the cell secretion; and (g) analyzing or sorting the at least one shaped particle of (e) based on the signal formed or property generated by the stain, dye, label, or other secondary affinity capture agent; wherein the analyzing or sorting of (g) comprises flowing the at least one shaped particle through a flow cytometer, fluorescence activated cell sorter, or other single-cell analysis instrument; further comprising sorting the at least one shaped particle based on a threshold or gate in fluorescence intensity, scatter intensity, or other signal measured with the flow cytometer, fluorescence activated cell sorter, or other single-cell analysis instrument (see reference claims 33-35, 37 and 43).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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