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 .
Applicant’s election without traverse of Group II. in the reply filed on 12/2/2025 is acknowledged.
In that all non-elected claims have been cancelled. No claims are withdrawn at this time.
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 33-43 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.
Regarding claims 33-42, the term “shaped” in claims 33-42 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 reasonably apprised of the scope of the invention. Unlike claim 43 which defines what is meant/intended by the expression “shaped”, the utilization of “shaped” in setting forth the particles of these claims without further recitation as to their external form, contours or outline renders these claims confusing as to intent because it can not be determined what degree of limitation, if any, is intended by the recited term “shaped” without further identification of external form, contours or outline by the claims. Recitations as to any internally situated void or cavity formed therein do not resolve the ambiguity concerning use of the term “shaped” as these recitations do not address the ambiguity concerning what, if any, meaning or limitation is intended to be imparted to the external form, contours or outline of the particles defined by the claims.
Appropriate correction is required.
Regarding claims 33-42, recitation of the language “of interest” in association with “a cell secretion” is confusing as to intent because it can not be determined how this term is intended to be further defining of the affinity capture agent that this language appears to be further defining.
Further regarding claims 33-42, claim 33 recites the limitation "the cell secretion of interest" in line 13. There is insufficient antecedent basis for this limitation in the claim. Though claim 33 previously recites selection of “an affinity capture agent” (that is) “specific to a cell secretion of interest”, there is no previous recitation and/or identification of a cell secretion of interest in the cell(s) of the claim that is/are to be secreted in step (d) of the claims.
Appropriate correction is required.
Claims 33-42 are further confusing as to intent because it can not be definitively ascertained what “signal” or “property” is intended to be included or excluded by the analyzing or sorting operation set forth by these claims without the means for detecting said “signal” and/or “property” being set forth by the claims.
Appropriate correction is required.
Similarly, claim 43 is confusing as to intent because it can not be definitively ascertained what “fluorescence signal” and/or “scatter signal” is intended to be included or excluded by the analyzing operation set forth by this claim without the means or parameters used to detect said “signal” being set forth by the claims.
Appropriate correction is required.
Claim 41 is separately confusing as to intent because the relevance or intended meaning of the range of ratio values set forth by this claim can not be definitively ascertained without the specifically intended “characteristic” associated with the “dimension of the at least one cell” critical to determination of the ratio of the claims being identified by the claims.
Appropriate correction is required.
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 33-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 9, 11 and 13-34 of copending Application No. 18/560,103 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they differ in specifics of processing, analyzing and/or sorting operations, along with provided particle size requirements in a manner which would have been obvious to one having ordinary skill in the art with the expectation of success in the absence of a showing of new or unexpected results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: To the degree that the intended limitations of the claims can be ascertained in li8ght of the above rejections under 35USC112, the prior art, including WO 2020/037214 and Rutte et al.(BioRxiv Document), taken either alone or in combination with other prior art, are insufficient in their teaching or fair suggestion of methods of performing cell secretion assays and/or analyzing or sorting cells adhered to shaped particles with a flow cytometer as defined by the claims through utilization of shaped particles as defined by the claims having diameters as defined by the claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ellinger et al. is cited for its disclosure of relevant processes for employment of particles in analyzing, detecting, quantitating and analyzing materials in the related arts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John Cooney whose telephone number is 571-272-1070. The examiner can normally be reached on M-F from 9 to 6. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Heidi Riviere Kelley, can be reached on 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN M COONEY/ Primary Examiner, Art Unit 1765