Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
OBJECTION
2. The specification is objected to because of the following informality: the continuation information must be updated to indicate the current status of the parent applications.
NON-PRIOR ART REJECTION
3. 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 1-28 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.
Claims 1-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: forming chambers or enclosures using a polymer prescursor that is polymerized to enclose cells on a surface of a microfluidic device. Lacking this critical step, it cannot be understood how steps (a) – (c) of independent claim 1 function together so as to accomplish a method of cellular analysis. For example, there is no nexus between cells disposed adjacent to a surface comprising capture sites comprising capture oligonucleotides in step (a), and nucleic acids released and captured in steps (b) and (c). In other words, there is no connection or relation between any given cell and any given capture site, so it cannot be determined how a functional analysis is to be accomplished. Clarification is required.
4. 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.
Claims 1-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 recites steps of disposing a plurality of cells adjacent to a surface, releasing nucleic acids from cells, and capturing nucleic acids with capture oligonucleotides. The Office does not find support in the specification for a method which is this broad, such as would support that the inventors contemplated and were in possession of the method as now claimed. Thus, the claims comprise new matter. All of the methods described in the specification are in the context of enclosing cells in chambers or enclosures within a microfluidic device using a polymer precursor that is polymerized. If this rejection is traversed, it is requested that support be pointed to in the specification with particularity, as in page, paragraph, or line numbers.
CONCLUSION
5. Due to the above indefiniteness issue, a complete search and analysis of the relevant prior art was not possible. Based on the disclosed invention, the Office cites Varadarajan et al. (US 2021/0018503) and Pishko et al. (US 2003/0175824) as the closest prior art.
6. No claims are allowable.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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09/28/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
