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 .
Applicant’s filing of claims 1-20 on 8/8/23 is acknowledged. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/8/23 was acknowledged. Accordingly, the information disclosure statement is being 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 4-5 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 4 contains the trademark/trade name Matrigel. 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 the matrix 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.
Claims 1, 3-4, 6-9, 12-15 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nam et al. (“Nam,” US Pub. No. 2015/0101070, cited in IDS).
As to claims 1 and 12, Nam teaches a method of performing cancer-immune cell co-culture (e.g., [0018] et seq.), comprising: applying an anchoring layer to a micropillar chip (Each 60 nl of 0.01% poly-L-lysine (Sigma-Aldrich, US) was discharged onto the ends of the micropillar using a microarray spotter, [0062] et seq.); preparing a composition including a plurality of cancer cells (cancer cells isolated from tumor tissues of a brain glioblastoma patient were mixed into hydrogel, [0030] et seq.); spotting an amount of the composition on the anchoring layer of a plurality of micropillars on the micropillar chip (and then subjected to three-dimensional culture onto a micropillar, [0030] et seq.); and incubating the composition on the micropillar chip (three-dimensional cultured cancer cells, [0030] et seq.), wherein the plurality of cancer cells is from a cancer cell line, primary cells from a tumor, or combinations thereof (e.g., [0030] et seq.); applying growth medium to a plurality of microwells of a microwell chip, wherein the plurality of micropillars are configured to fit within the plurality of microwells (e.g., [0065] et seq.); immersing the spheroids in the growth medium; applying one or more treatments against the plurality of cancer cells to the microwells (e.g., [0069] et seq.); and identifying the effect of the one or more treatments on the plurality of cells, wherein the anchoring layer includes polydopamine, polylysine, fibronectin, laminin, collagen, or combinations thereof, and wherein the plurality of cancer cells is from a cancer cell line, primary cells from a tumor, or combinations thereof (e.g., [0061] et seq.).
As to claim 3, see e.g., [0030] et seq.
As to claim 4, see e.g., [0039] et seq.
As to claim 6, see e.g., [0062] et seq.
As to claims 7 and 8, see e.g., [0021] et seq.
As to claim 9, see e.g., [0061] et seq.
As to claims 13-15, see e.g., [0030] et seq.
As to claims 17 and 18, see e.g., [0021] et seq.
As to claim 19, Nam teaches a chip system comprising: a micropillar chip and a microwell chip, the micropillar chip including a plurality of micropillars configured to fit within corresponding microwells on the microwell chip; an anchoring layer on at least a portion of the micropillars; an amount of a hydrogel composition on the anchoring layer, the hydrogel composition including: a matrix including Matrigel, alginate, collagen, peptides, or combinations thereof, and a concentration of cells between about 1×10.sup.5 cells/mL and about 1×10.sup.9 cells/mL composition, wherein the amount of the hydrogel composition is between about 60 nL and about 500 nL, wherein the anchoring layer includes polydopamine, polylysine, fibronectin, laminin, collagen, or combinations thereof, and wherein the cells are from a cancer cell line, primary cells from a tumor, or combinations thereof.
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.
Claims 2, 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Orr et al. (“Orr,” US Pub. No. 2015/0247112, cited in IDS).
See Nam above.
As to claim 2, while Nam teaches applying a medium to microwells of a microwell chip; immersing the plurality of micropillars in the medium on the microwell chip to facilitate co-culture of the cancer cells and the immune cells; and identifying a cytotoxic effect of the medium on the cancer cells (e.g., [0065] et seq.), Nam does not specifically teach a cell culture including a concentration of immune cells. Orr teaches a cell culture including a concentration of immune cells in e.g., [0009] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include a cell culture including a concentration of immune cells because it would be desirable to include components that would allow for continuous monitoring and measurement of the growth of a cell culture (e.g., [0044] et seq. of Orr).
As to claim 10, Nam does not specifically teach the immune cells include lymphocytes, monocytes, macrophages, peripheral blood mononuclear cells, dendritic cells. Orr teaches a three-dimensional environment containing one or more non-cancer cell types such epithelial cells, fibroblast, adipocytes, endothelial cells, macrophages, T-cells, B-cells in e.g., [0009] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include immune cells include lymphocytes, monocytes, macrophages, peripheral blood mononuclear cells, dendritic cells because having such cell types would enhance the method of assessing responsiveness to therapeutic agents (e.g., [0009] of Orr).
As to claim 11, Nam teaches the medium further includes one or more treatments, the treatments including a concentration of antibodies, a concentration of therapeutic small molecules in e.g., [0065] et seq.
Claims 5, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nam in view of Lee et al. (“Lee,” US Pub. No. 2013/0184182, cited in IDS).
See Nam above.
As to claims 5, 16 and 20, Nam does not specifically teach one or more extracellular matrix proteins including fibronectin, laminin. Lee teaches fixing material 120 is not particularly limited but may include, for example, polyethyleneimine, polylysine, polyvinylamine, polyarylamine, fibronectin, gelatin, collagen, elastine, laminin, or the like in e.g., [0038] et seq. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include one or more extracellular matrix proteins including fibronectin because such fixing materials may be formed on the protruded surfaces of the micro-pillars in order to fix the biomaterials to the protruded surfaces (e.g., [0038] of Lee).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to 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, Lyle Alexander can be reached at 571-272-1254.
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.
/LORE R JARRETT/Primary Examiner, Art Unit 1797
3/7/2026