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
Claims 1-16 are currently pending and examined on the merits.
Claim Objections
Claims 1, 3, 14-16 are objected to because of the following informalities. Appropriate correction is required.
Claim 1 appears to be missing a comma between “the stroma” and “or two or more”.
Claim 1 appears to be missing a “from” between “cells recovered” and “a tissue collected”.
Claim 3 appears to contain a typographical error and should read includes”.
Applicant is advised that should claim 4 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 5 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 8 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-10, 14-16 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
Claim 1 recites the limitation "the stroma". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the thickness". There is insufficient antecedent basis for this limitation in the claim.
Claim 1 contains the limitation “forming a cell structure being composed of a single layer of first cells constituting the stroma or two or more cell layers of the first cells laminated in the thickness direction, which comprises”. It is unclear whether this limitation is indicating that the following steps are used to produce the cell structure if two or more cell layers are utilized, or if the following steps are used to produce the cell structure if wither a single layer or two or more cell layers are utilized. For examination purposes this limitation is interpreted as comprising “forming a cell structure , a wherein the forming comprises:”
Claim 1 contains the limitations “being composed of a single layer of first cells” and “in which first cells are laminated in multiple layers”. It is unclear how the first cells may be present in both a “single layer” and “multiple layers”. For examination purposes claim 1 is interpreted as comprising “obtaining the cell structure in the cell culture vessel, wherein the cell structure comprises a single layer of the first cells, or multiple layers of the the thickness direction
Claim 3 contains the limitation “wherein the cell structure include one or more members selected from the group consisting of fibroblasts, pericytes, endothelial cells, and immune cells as the second cells”. Claim 3 depends from claim 1, which indicates that the second cells are seeded on top of the cell structure. It is unclear how the second cells are both a part of the cell structure and seeded on top of the cell structure.
Claim 6 recites the limitation "the thickness". There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the thickness". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 contains the limitation “wherein the cell structure include one or more members selected from the group consisting of fibroblasts, pericytes, endothelial cells, and immune cells as the second cells”. Claim 13 depends from claim 11, which indicates that the second cells are seeded on top of the cell structure. It is unclear how the second cells are both a part of the cell structure and seeded on top of the cell structure.
Claim Rejections - 35 USC § 102
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, 3-6, 8, 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hiroshi et al., EP 3187580 A1 (cited on IDS dated 8/30/23, hereinafter Hiroshi).
Regarding claims 1, 3-4, 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 tissue, a passaged cell, or a cell line ([0025]-[0026], [0028], [0068]).
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 8, 16, 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]).
Therefore, every limitation of claims 1, 3-6, 8, 14-16 is present in Hiroshi, and the subject matter is anticipated.
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 7, 11, 13 is/are rejected under 35 U.S.C. 103 as being obvious over Hiroshi as applied to claims 1, 3-6, 8, 14-16 above.
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.
Claims 2, 9-10, 12 is/are rejected under 35 U.S.C. 103 as being obvious over Hiroshi as applied to claims 1, 3-8, 11, 13-16 above, and in further 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 2, 9, 12, Hiroshi does not disclose that the second cells are isolated from either a fragmented material of the tumor tissue or an enzymatically-digested product of the tumor tissue.
Regarding claim 10, Hiroshi 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, 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 each of the cell types, including cancer cells, may be derived from a primary tissue ([0025]-[0026], [0029]), 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.
Conclusion
No claims are allowed.
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.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632