DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-9 in the reply filed on April 29, 2026 is acknowledged. The traversal is on the ground(s) that applicant has amended claims 42-49 of Group III to depend from claim 1 of Group I. This is found persuasive.
Information Disclosure Statement
The information disclosure statement filed October 28, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
No copy of NPL document #040 has been found.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the term “and/or” minimally only requires “or”. Therefore, the phrase “genomic, transcriptomic, and/or proteomic assay” provides for a list of 3 alternative assays. However, it is noted that there is no clear distinct for in the claim of functional, genomic, transcriptomic, and proteomic assay because none of such are defined in the claim by requiring any actual specific, distinct steps that required to be done to the single cell. Any assay can be subjectively considered as “functional”.
It is noted that claim 46 is also directed to a list of alternatives, options that only requires 1.
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 1-9 and 42-49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The preamble of the claim 1 and step (c) recite a method/step of linking functional single cell information with genomic, transcriptomic, and/or proteomic single cell information (and further in (c)) by associating the first barcode or first label with the second barcode or second label. . The “associating” of the first barcode or label with the second barcode or label is an evaluation and therefore an abstract idea. It is also not specified what is meant, required to be done to constitute “linking” the prior mentioned information with “genomic, transcriptomic, and/or proteomic single cell information” (also not structure and not specifically defined in the claim…”linking” of information can be done mentally, in one's mind (brain). The “linking” and “associating” information with information and a barcode or label falls within the “Mental Processes” grouping of abstract ideas. Additionally, the MPEP states that collecting information, analyzing the information, and displaying results is an abstract idea when the analysis steps are recited at a high level of generality such that they could be performed in the human mind (MPEP 2106.04(a)(2) III A). The encompasses “linking” and “associating” information. Therefore, the claim is directed to an abstract idea.
This judicial exception is not integrated into a practical application because once the linking is done there is no application much less a particular practical application. Each other elements are performing assays and would be considered data gathering and an insignificant extra solution activity MPEP2106.05(g). Therefore there is no application much less a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because performing the broad functional assay and genomic, transcriptomic, and/or proteomic assay are insignificant extra solution activity (MPEP 2106.05(d)) and further previously known in the art to be well understood, routine and conventional broad assay procedures. Therefore, the claim is not patent eligible.
The dependent claims 2-9 and 42-49 do not solve the issues of above.
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 1-9 and 42-49 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.
As to claim 1, it is unclear what is considered as “functional single cell information” and “genomic, transcriptomic, and/or proteomic single cell information” because are not defined in the claim. However, it is noted that “information” (data) is not structure. One can name any “information” as one desires.
Furthermore, it is unclear what is meant, required to be done that is considered as “linking” the information because such is not clearly defined in the claim. One can mentally “link” any information with each other or anything else as desired, including “mentally”.
Furthermore, it is unclear what is required to be done by who, what to provide for performing a “functional” assay on a single cell located in the cavity of a nanovial, wherein the functional assay is associated with a first barcode or a first label; (b) and performing a genomic, transcriptomic, and/or proteomic assay on the single cell in the nanovial, wherein the genomic, transcriptomic, and/or proteomic assay is associated with a second barcode or a second label because both “a functional assay on a single cell located in the cavity of a nanovial” and “a genomic, transcriptomic, and/or proteomic assay on the single cell in the nanovial” are not defined in the claim by any specific steps. There is no distinction between what constitutes performing the “assays”. The assays are not mutually exclusive. The latter genomic, transcriptomic, and/or proteomic assay are not precluded from being considered as “functional” assays.
As to claims 1, 7, and 42, it is unclear what is meant by, required by the phrases/term, “associated with” and “associating” because such are vague, ambiguous and are not defined in the claims. One can subjectively assert that any 2 or more things (tangible or intangible information, data) are “associated with” each other and mentally perform “associating” things with each other. Therefore, it is unclear what is required of an undefined assay, cell, and information to be considered as being associated with a first barcode and a first (broad) label.
Claim 1 recites the limitation "the cavity" in (a). There is insufficient antecedent basis for this limitation in the claim.
Claims 2-9 and 42-49 are rejected via dependency upon rejected claim 1.
As to claim 2, it is unclear what is required to be done by who, what, etc. that is considered as “sorting the nanovial based on a signal generated by the functional assay” because the claim does not clearly provide for such. It is unclear what the nanovial is required to be sorted from. Furthermore, it is unclear what is considered as a “signal” (not specified, defined in the claim) and what is required to be done…for such sorting to be considered as being “based on” such signal because the claim does not recite such. One can mentally “sort” a nanovial (during, after… an assay has been performed) “based on” any “signal” (physical, chemical, visual, smell, sound, etc.) as one desires. Also applicable to claim “one or more signals” in claim 42. It is unclear what is required of signals to be “related to” anything because of the same reasons given above directed to “associated with”.
As to claims 3-5, it is unclear what is further required by the claims because the claims do not provide for any additional steps to that of claim 1 nor further limit any prior step of claim 1. Claims 3-5 only rename the functional assay of claim 1, but do not provide for what is required to be done (steps) by who, what to define such respective assays. There is no distinction between each of such assays and the prior assays recited in claim 1. See prior rejection of 1.
As to claim 6, it is unclear what is further required by the claim because the claim does not provide for any additional step to that of claim 1 nor further limit any prior step of claim 1. Furthermore, it is noted that the claim is directed to the alternative “genomic” assay of claim 1. Such alternative assay has not been required to be performed. Therefore, the claim is conditional based upon such alternative being selected. The method of claim 1, is not limited to a genomic assay. Furthermore, the claim only renames that the genomic assay (not defined by any specific steps…see above), but does not provide for what is required to be done (steps) by who, what to define such single cell RNA sequencing assay.
The term “unique” in claims 7-8 is a relative term which renders the claims indefinite. The term “unique” 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. What may be considered as “unique” to one person may not be considered as such by another and vice versa.
As to claim 7, it is unclear what is required of the nanovial to be “associated with“ a oligonucleotide tag or anything else. See prior rejection above. The phrase “associated with” does not provide for any clear definitive relationship, structural or otherwise.
As to claim 8-9, it is unclear what is required to define each of the respective “regions” recited in claims 8-9 because such are not defined in the claims. There is no indication in the (of a oligonucleotide tag, barcode, and label) claims what defines such regions because such are not defined by any definitive structural boundaries, dimensions so as distinguish the respective regions from any other “region”.
As to claim 42, it is unclear what is the nexus of the “a nanovial” and “a cavity” recited in (a) to the prior “a nanovial” and “the cavity” recited in (a) of claim 1, if such are respectively the same or different because the claim does not clearly indicate such It is noted that such are not required to be the same. Therefore, it is unclear which/what nanovial and cavity are being referenced by the later recited phrases “the cavity” and “the nanovial” recited in claim 42-43 and 48.
As to claims 42-44, it is unclear what the pronouns “therein” and “thereto”. In (i) of claim 1 it is presumed that “therein” refers to the nanovial. If so, the claim should clearly recite such and each occurrence of the terms throughout the claims should be amended to specify what such reference.
It is noted that the “affinity agent”, “antibody-producing cell” (see also further cells recited in the claim and further claims), “one or more antibody” “detection agent”, and “antigen” (see also “cell capture agents” in claims 43) are each not specified as being any specific “agent” (material, substance, chemical, etc.), cell, nor antibody.
Furthermore, it is noted that it is not stated who, what are required to perform each of the steps recited in claims 42 and 49. It is noted that steps such as “linking”, “associating”, and “identifying” can performed mentally, visually by using one’s brain eye’s and other senses.
As to claim 42 (vii) it is unclear what is required to be done to be considered as performing “associating” for the same previously stated above relative to “linking” and “associating”.
Claim 42 recites the limitation "the antigen of interest" in (vii). There is insufficient antecedent basis for this limitation in the claim. See also the applicable rejection above directed to “based on”.
As to claim 45, it is unclear what is required to be considered as a “detectable label” because such is noted defined in the claim. Furthermore, a “label” can be “detectable” by any means desired including mentally, and via one’s natural senses.
As to claim 49, it is unclear what is meant by “prior to (c)” because there is no indication as to what is “(c)”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Heroux; Jeffrey A. et al.; STERN; David et al.; AKSEL; Tural et al.; AKSEL; Tural et al.; Aksel; Tural et al.; Aksel; Tural et al.; BUES; Johannes et al.; SCHNALL-LEVIN; Michael et al.; Stadnisky; Michael et al.; Fan; Christina et al.; GAUBLOMME; Jellert et al.; Jendrisak; Jerome et al.; Marrache; Sean et al.; MILLER; Ben et al.; VITALIANO; FRANCO et al.; CHEE; Mark S. et al.; Huff; Jeffrey B. et al.; Huff; Jeffrey B. et al.; MA; Philip et al.; and Levin; Andrew E. disclose assay devices and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. 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.
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
Prosecution Insights