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 without traverse of group I (claims 1-7) in the reply filed on Nov. 14, 2025 is acknowledged.
Claims 8 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-7 from the claim set dated April 20, 2023 are examined below.
Priority
The instant application claims foreign priority 35 U.S.C. 119(a)-(d) to Japanese Patent Application No. 2020-178448 filed on Oct. 23, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is Oct. 23, 2020.
Information Disclosure Statement
The information disclosure statements filed Apr. 20, 2023 and Nov. 13, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs 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 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 “a plurality of upper cell culture chamber and lower cell culture chambers…”. This phrase is indefinite because, while it is clear that there is a plurality of pairs, specifically what is paired is unclear, as the claim could be interpreted as the pairs being (1) upper chamber paired with lower chamber or (2) upper chamber paired with upper chamber to create a pair and lower chamber paired with lower chamber to create a pair. While the drawings and the specification appear to support the (1) interpretation, the language of the claim requires clarification. It is recommended that the claim be amended to recite “…a plurality of cell culture chambers, each of the plurality comprising a pair consisting of an upper cell culture chamber and a lower cell culture chamber…” and the rest of the claim being amended to be consistent with this recitation.
Claim 1 further recites that the upper cell culture chambers are “coupled and integrated” and the lower cell culture chambers are “coupled and integrated”. This term is indefinite as it is unclear what the culture chambers are coupled and integrated with. If the cell culture chambers are coupled and integrated with one another, that should be recited.
Claims 2-7 do not correct this indefiniteness and are rejected on that basis.
Claims 2 and 3 are further rejected as each recites “…through-holes each being the inner wall” (through-holes (33d), (35c), (29e)). This is indefinite because it can be interpreted as the through-holes = the inner wall, which is impossible. Further, it is unclear if what is intended is that the cell culture plate (33) or the bottom board (35a) (claim 2) or the cell culture plate (29) is the inner wall OR if the intention is for the through-holes to be in the inner wall (“through-holes being in the inner wall”).
For the purposes of examination, prior art is being applied that will account for any of these limitation interpretations.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Crespi et al. (U.S. Patent App. No. 2007/0269850, cited on IDS filed on April 20, 2023) in view of Mussi (U.S. Patent No. 5,665,596, cited on IDS filed on April 20, 2023).
Crespi et al. teach a cell culture device for seeding cells on a filter that extends over a well of an analysis device, the device having an elastomer body that has first and second surfaces separated from one another by a flow passage. The flow passage penetrates the first and second surfaces and extends between them, and is detachably engaged to the outside surface of the well in a sealed state and a filter is formed so as to be at least partially surrounded by the flow passage. The filter may include holes with various dimensions and configurations. The device is useful for growing cells on an outer or inner surface of one of more than one filters. (paras. [0011], [0012], [0016], figs. 4-6, claim 1).
Crespi et al. do not teach a cell culture chamber cover.
Mussi teach an adaptor that is used with a cell culture insert, indicating that a cover is placed on top of the assembly so as to prevent contamination when culturing cells in a receptacle formed by placing the adaptor on a second end of the cell culture insert (col. 4, l. 50 – col. l. 19; fig. 2).
It would have been obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the device taught by Crespi et al. to incorporate including a cell culture chamber cover (as taught by Mussi) because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because both references are directed to devices for enabling sophisticated, multiple cell type and layers cell culture devices and, as Mussi teaches covering the cell culture device to prevent contamination, including a cover in the device taught by Crespi et al. would have been an obvious choice when employing the device in a cell culture context.
With respect to claim 3, as Crespi et al. teach that the filter may have holes with various dimensions and placement, a person of ordinary skill would have further taken the step of covering the lower part of the analysis device (Fig. 4 of Crespi) to prevent leakage of culture solution from the through holes.
Conclusion
Claims 2, and 4-7 are free of prior art and should be allowable when the indefiniteness rejections are overcome.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634