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 .
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.
Claim Status
Applicant’s arguments and amendments dated 3/19/26 have been received and entered in the application.
Claims 1-2, 4-7, 9-12, 14-15 are currently pending and examined on the merits.
Claims 1, 4-7, 9, 11, 14-15 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
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 1-2, 4-12, 14-15 is/are rejected under 35 U.S.C. 103 as being obvious over Hiroshi et al., EP 3187580 A1 (cited on IDS dated 8/30/23, hereinafter Hiroshi) in view of R. Ian Freshney, “Culture of Tumor Cells.” In: Culture of Animal Cell: A Manual of Basic Technique and Specialized Applications. (Hoboken, NJ, John Wiley & Sons, Inc., 2010), pp. 463-479. QH585.2.F74 2010 (cited on IDS dated 8/30/23, hereinafter Freshney).
Regarding claims 1, 4, 8, 14, Hiroshi discloses methods of constructing an artificial peritoneal tissue useful for investigating peritoneal metastasis ([0005]-[0007]). The artificial peritoneal tissue construct is composed of an extracellular matrix (ECM), vascular endothelial cells, lymphatic endothelial cells, and fibroblasts ([0012]-[0014]). The construct may further contain a mesothelial cell layer deposited on an upper surface of the construct ([0025], [0040]-[0042]). In some embodiments, the construct contains additional cell types ([0022]). Hiroshi discloses that each of the cell types may be derived from a primary cultured cell, a passaged cell, or a cell line ([0025]-[0026], [0028], [0068]). In some embodiments, the construct may be used for evaluating behavior of a cancer cell in the peritoneal tissue ([0031]). Cancer cells may be placed on the construct and cultured ([0043]-[0047]).
The ECM may be composed of multiple extracellular matrix components, including fibronectin and heparin ([0024], [0061]; consistent with applicant’s specification at [0068] heparin is interpreted as a strong polyelectrolyte is interpreted as a cationic buffer solution). Fibronectin is preferably prepared as a liquid in a Tris-hydrochloride buffer ([0063]-[0067] ; consistent with applicant’s specification at [0068] Tris-hydrochloride buffer is interpreted as a cationic buffer solution).
In one embodiment, Hiroshi discloses alternately seeding ECM coated human dermal fibroblasts (hDFs) and ECM coated human umbilical vein endothelial cells (HUVECs) on a porous polyester membrane culture insert in a 24 well plate to form a layered cell construct ([0037], [0053]-[0061], [0068]).
Regarding claims 5, 15, Hiroshi discloses that the HUVECs cells form a lumen similar in structure to that of a blood vessel in native tissues ([0016]-[0017]). The lymphatic endothelial cells likewise form a lumen similar in structure to that of lymphatic vessels in native tissues ([0018).
Regarding claim 6, Hiroshi discloses that the resultant construct may have a thickness of 45 µm ([0079]).
Regarding claims 7 and 11, Hiroshi does not disclose that the cell structure may have a thickness of 150 µm or more.
However, changes in size or proportion are considered routine expedients requiring only ordinary skill in the art. See MPEP § 2144.04. Therefore, it would be obvious to one of ordinary skill in the art that the thickness of the construct could be increased.
Hiroshi does not explicitly disclose that the second cells are primary cells recovered from a tissue collected from a living body. Regarding claim 10, Hiroshi also does not disclose that the isolated second cells are sorted using certain methodologies, and seeding on the construct.
Freshney discloses methods for the culture of tumor cells (Chp 24). Freshney explains that known methods for the isolation and culture include obtaining a tumor biopsy from a primary tissue, fractionating, enzymatically digesting, and density gradient (Section 24.8). Freshney further states that protocols for the isolation and culture may be determined by one of ordinary skill in the art (Section 24.8).
As Hiroshi discloses that cancer cells may be utilized in the construct for evaluating behavior of a cancer cell in the peritoneal tissue ([0031], [0043]-[0047]), it would be obvious to one of ordinary skill in the art that known methods for preparation of the cancer cells could be utilized as disclosed in Freshney. A skilled artisan would be motivated to use the methods disclosed by Freshney as they are well known, and would lead to a reasonable expectation of successfully isolating cancer cells from a primary tissue.
Response to Arguments
Applicant's arguments dated 3/19/26 have been fully considered are moot in view of the new grounds of rejection necessitated by applicant’s amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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