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 of Group I in the reply filed on 2/3/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 16, 18, 22, 23, 26, 30, 31, 34-37, 40, 41, 43, 44, 49-52, 58, 59, 64 and 65 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
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) 1-8, 11, 13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2018/0298320, hereinafter Nelson.
Regarding claim 1, Nelson teaches a device for use with a tissue culture plate comprising a plurality of tissue culture wells (abstract), the device comprising a cylindrical well insert (item 53) configured to be inserted into said tissue culture wells (paragraph [0027]), wherein said well insert comprises a rim section (the upper flat section of item 42) on one end of the insert (figure 2A) and one or more carrier or platform (item 98) sections on an opposite end of the insert (figure 2A), wherein said carrier or platform section or sections is disposed around a perimeter of said opposite end (figure 2A), and said carrier or platform section or sections is positionable in said tissue culture wells so as to be suspended off the bottom of said tissue culture wells (figure 5).
Regarding claim 2, the tissue culture plate is not positively claimed and therefore any limitation on the tissue culture plate has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Nelson.
Regarding claim 3, the tissue culture plate is not positively claimed and therefore any limitation on the tissue culture plate has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Nelson. The examiner notes that as the tissue culture plate is not positively recited and the distance between the rim section and the carrier or platform section being less than the depth of the tissue culture wells would be possible depending upon the depth of the tissue culture wells which are not claimed and is therefore taught by Nelson.
Regarding claim 4, the tissue culture plate is not positively claimed and therefore any limitation on the tissue culture plate has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Nelson. The examiner notes that as the tissue culture plate is not positively recited and the carrier or platform is suspended off the bottom of the tissue culture wells by about 1 mm would be possible depending upon the depth of the tissue culture wells which are not claimed and is therefore taught by Nelson.
Regarding claim 5, the tissue culture plate is not positively claimed and therefore any limitation on the tissue culture plate has minimal patentable weight (MPEP § 2115). The claim is therefore taught by Nelson. The examiner notes that as the tissue culture plate is not positively recited and the rim section has a diameter slightly larger than a diameter of the tissue culture wells would be possible depending upon the diameter of the tissue culture wells which are not claimed and is therefore taught by Nelson.
Regarding claim 6, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Nelson and the apparatus of Nelson is capable of accommodating a cell complex. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nelson (see MPEP §2114).
Regarding claim 7, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Nelson and the apparatus of Nelson is capable of positioning a cell complex not in a central region of the tissue culture wells. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nelson (see MPEP §2114).
Regarding claim 8, Nelson teaches wherein said carrier or platform section comprises one or more annular carriers or platforms (paragraph [0041]).
Regarding claim 11, Nelson teaches wherein said carrier or platform section comprises micropores (paragraph [0041]) and short vertical walls (paragraph [0041]) to keep said cell complex in place (intended use MPEP § 2114 (II)).
Regarding claim 13, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Nelson and the apparatus of Nelson is capable of having the cell complex comprising a hydrogel. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nelson (see MPEP §2114).
Regarding claim 15, Nelson teaches wherein said well insert comprises a wall that comprises open lattice or does not comprise any open space (paragraph [0041]).
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.
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) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson.
Regarding claim 12, Nelson teaches all limitations of claim 8; however, Nelson fails to teach each of said micropores have a size of about 100 microns to about 1,000 microns.
Nelson further teaches that the microporous matrix is of a sufficient porosity to allow the passage of macromolecules, proteins, ions, and nutrients from culture medium to cross the microporous matrix and contact cells or tissues deposited on a surface (culture surface) of the microporous matrix, while preventing direct cell to cell contact between cells or tissues cultured on the microporous matrix in the culture insert with cells cultured in the corresponding well of a multiwell plate containing culture medium (paragraph [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum pore size to a range of 100 to 1,000 microns which would allow the passage of macromolecules, proteins, ions, and nutrients from culture medium to cross the microporous matrix while preventing direct cell to cell contact between cells or tissues (paragraph [0042]) (MPEP § 2144.05 (II)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796