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 .
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.
Claim 70 is 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 claim 70, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 70 contains the trademark/trade names Matrigel, Cultrex BME, CELLLINK GelXA, CELLLINK LAMININK 111. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a basement membrane and, accordingly, the identification/description is indefinite.
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) 1-6, 8, 11, 13, 15, 66, 67, 69 and 70 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 at a top (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, bottom end of the insert (figure 2A), wherein said carrier or platform section or sections is disposed around a perimeter of said bottom end (figure 2A) and not occupying or obstruction the central region of said tissue culture well when inserted therein (item 98 is on the bottom of the cylindrical well insert and the central region in a vertical and horizontal direction is not occupied by item 98 when item 53 is fully inserted into the well), 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 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]).
Regarding claim 66, Nelson teaches wherein the carrier or platform comprises an active cell complex (paragraph [0033]).
Regarding claim 67, Nelson teaches wherein the active cell complex comprises cells that can metabolize one or more candidate therapeutic agents (paragraph [0003], the cells/tissues would be able to metabolize therapeutic agents).
Regarding claim 69, Nelson teaches wherein the active cell complex comprises a hydrogel (paragraph [0042]).
Regarding claim 70, Nelson teaches wherein said active cell complex comprises a hydrogel such as collagen or gelatin (paragraph [0042]).
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)).
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nelson in view of United States Application Publication No. 2020/0318048, hereinafter Sandoz.
Regarding claim 68, Nelson teaches all limitations of claim 66; however, Nelson fails to teach the active cell complex comprises liver cells.
Sandoz teaches a cell culture device in which liver cells are cultured and that the liver cells would allow for testing of the liver cells against pharmacological effect assessment, carcinogenicity assessment, drug/agent interaction assessment, dose assessment, adsorption assessment, disposition assessment, metabolism assessment, elimination studies and the like (Sandoz, paragraph [0141]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized liver cells as the active cell complex because it would allow for testing of the liver cells against pharmacological effect assessment, carcinogenicity assessment, drug/agent interaction assessment, dose assessment, adsorption assessment, disposition assessment, metabolism assessment, elimination studies and the like (Sandoz, paragraph [0141]).
Response to Arguments
Applicant's arguments filed 7/13/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument that the claim requires a platform or section not in the central region of the tissue culture well and Nelson has a structure in the central region is not found persuasive. The claim has not identified what is meant by the central region of the tissue culture well and the central region which is located both vertically and horizontally in the middle of the tissue culture well is considered to be the central region. With the interpretation, there is no structure of Nelson which is present in the central region of the tissue culture well and therefore Nelson anticipates the instant claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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