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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The instant application is a national stage entry under 35 U.S.C. § 371 of PCT/JP2022/045961, filed 14 December 2022, which claims priority to JP 2021-204143, filed 16 December 2021.
Claim Status
The Examiner initiated an interview with Applicant’s representative, Paul Rauch, on 15 September 2026 regarding the claim status. Paul Rauch indicated the claims to be examined are the claims of the preliminary amendment filed 12 June 2024, new claims 9-27. Paul Rauch stated the claims filed 13 December 2024 were the original claims and were included in error.
Claims 1-8 have been canceled, claims 9-27 are new, and claims 9-27 have been considered on their merits.
Claim Interpretation
Claim 9 recites the steps, the mesenchymal stem cell line having been produced by a production method comprising steps (A) and (B). These steps, to include the steps of (A) and (B) read as product-by-process limitations. Product-by-process limitations are considered only in as far as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e., is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP 2113. Thus, any mesenchymal stem cell line derived from an adipose tissue reads on the cells to be administered, absent evidence to the contrary.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lam et al. (Transplantation Direct 2017;3: e160, published online 11 May 2017, IDS ref.).
Regarding claim 9, Lam teaches topical application (administration) of adipose-derived mesenchymal stromal cells (ADMSCs) ameliorated liver parenchyma damage after ischemia-reperfusion injury in a Sprague-Dawley rat model (Abstract and p. 2, Materials and Methods). The method of Lam reads as a method for treating a hepatic disorder. Based on the claim interpretation above, Lam anticipates the limitations of claim 9.
Regarding claims 10-12, these claims are all directed to the product-by-process steps of claim 9, thus are not considered limiting. Therefore, the claims are interpreted the same as claim 9 and are rejected for the same reasons.
Regarding claims 13-18, these claims are all directed to the product-by-process steps of claim 9, thus are not considered limiting. Therefore, the claims are interpreted the same as claim 9 and are rejected for the same reasons. However, if these steps were considered limiting,
Lam teaches the adipose tissue was washed with sterile phosphate-buffered saline and treated with collagenase in PBS, followed by filtration through a 100-µm mesh filter, the filtrate washed three times and suspended in DMEM with FBS, antibiotics, and L-glutamine (p. 2, Adipose-Derived MSCs).
Regarding claims 19-21, Lam teaches the ADMSCs were grown for 3 to 5 passages, then harvested with trypsin/ethylenediaminetetraacetic acid and characterized by FACS (p. 2, Cell Phenotyping). Lam teaches the ADMSCs were cultured in adipogenic differentiation culture media and the differentiated adipocytes were stained with Oil-Red-O (p. 2, Adipogenic, Chondrogenic, and Osteogenic Differentiation Potential). Lam teaches the ADMSCs were labeled with antibodies against CD29, CD45, and CD90 (p. 2, Cell Phenotyping). Lam teaches flow cytometry analysis showed the ADMSCs strongly expressed CD29 and CD90 but was negative for CD45 (p. 3, Results and Figure 1A).
Regarding claims 22-24, Lam teaches topical application of adipose-derived mesenchymal stromal cells (ADMSCs) ameliorated liver parenchyma damage after ischemia-reperfusion injury in an animal model (Abstract).
Thus, the reference anticipates the subject matter of claims 9-24.
Claim Rejections - 35 USC § 103
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 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 9-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lam et al. (Transplantation Direct 2017;3: e160, published online 11 May 2017, IDS ref.) as applied to claims 9-24 above, and further in view of Matsubara et al. (US 2020/0190474 A1, published 18 June 2020, IDS ref.).
Lam anticipates the subject matter of claims 9-24, and thus, also renders them obvious.
Regarding claims 25-27, Lam does not teach wherein the vertebrate animal is a human.
However, Matsubara teaches a method for producing a mesenchymal cell line derived from a vertebrate adipose tissue wherein, the method comprises: (A) inducing differentiation of one or more cells selected from a stromal vascular fraction comprising a mesenchymal stem cell, an adipose progenitor cell, and a stromal cell of a vertebrate adipose tissue into a mature adipocyte; and (B) inducing dedifferentiation of the mature adipocyte obtained in step (A) to obtain a mesenchymal cell line derived from the vertebrate adipose tissue (Abstract). Matsubara teaches in step (4) of the method for producing mesenchymal cell line derived from a vertebrate adipose tissue, wherein the step of inducing differentiation of one or more cells into mature adipocytes in step (A) of culturing cells in a basal medium for mesenchymal cell culture comprising one or more adipose cell differentiation inducing substances selected from the group consisting of dexamethasone, isobutylmethylxanthine, insulin, and serum (para. [0020]). Matsubara teaches in step (5) the method for producing a mesenchymal cell line derived from a vertebrate adipose tissue, wherein inducing dedifferentiation of the mature adipocyte in step (B) is to perform ceiling culture of the mature adipocyte (para. [0020]). Matsubara teaches the cell was obtained by treating the vertebrate adipose tissue with an enzyme capable of dispersing the adipose tissue cells, wherein the enzyme capable of dispersing the vertebrate adipose tissue cells is one or more enzymes selected from the group consisting of collagenase, trypsin, caseinase, clostripain, trypsin-EDTA, dispase, thermolysin, pronase, hyaluronidase, pancreatin, elastase, and papain (para. [0020]). Matsubara teaches the cells express one more surface marker of mesenchymal cells: CD13, CD29, CD44, CD71, CD73, CD90, CD105, CD166, HLA-ABC; and do not express one or more surface marker group of blood cells: CD11b, CD14, CD19, CD34, CD41, CD42b, CD45, CD56, HLA-DR (para. [0021]).
Matsubara teaches the species from which the adipose tissue is derived is not particularly limited as long as a species is a vertebrate, and teaches examples include both rat and human (para. [0036] and Figs. 1-7).
Therefore, it would have been obvious to one of ordinary skill in the art to apply the method of Lam to a human with a reasonable expectation of success because it is well known in the art that the Sprague-Dawley rat model is widely used as a liver disease model for humans. One would have been motivated to apply the method of Lam to a human because both Lam and Matsubara teach ADMSCs with the same surface markers, which strongly expressed CD29 and CD90 but were negative for CD45 and Matsubara teaches the species from which the adipose tissue is derived is not particularly limited as long as a species is a vertebrate, and teaches examples include both rat and human.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Relevant prior art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Figiel-Dabrowska et al. (Cells, 2021, 10, 1475, published 11 June 2021)
Figiel-Dabrowska teaches following adipose tissue isolation and collagenase digestion, the stromal vascular fraction (SVF) can be obtained and following plating the cells and cultivation, adipose-derived stem/stromal cells are obtained. Figiel-Dabrowska teaches nearly 500 clinical trials worldwide (including: SVF-stromal-vascular fraction, ASC-adipose-derived stem/stromal cells) are assessing the therapeutic properties of adipose-derived regenerative cells in various diseases.
Conclusion
No claims are allowed.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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