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 .
Claims 14-15, 17-18,30-31 are under examination.
RCE
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 2, 2026 has been entered.
Response to Applicants Arguments/Amendments
Applicants have recently amended the instant set of claims. Because of the recent claim amendments, the former art and 112(b) rejections are withdrawn and new rejections put forward.
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 14-15,17-18,30-31 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. Applicants argue that the cells are in a matrix which is not considered a type of scaffolding. This is problematic because a cell matrix is a type of 3D scaffolding as discussed in the reference, “What is scaffold-based 3D culture.” Although the specification states that the cells are not in a scaffolding, a 3D matrix that surrounds cells is considered scaffolding in the art. The matrix material recited in the clams is able to provide physical support to cells, allowing cells to aggregate and proliferate which is exactly what a scaffold does (What is scaffold-based 3D culture). It would be preferable to describe what the matrix is rather than stating that it is not a scaffold.
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 14-15, 17-18, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Miyagawa (WO 2016167332) in view of Herickhoff (US 20150037783) and Swioklo “Alginate Encapsulation for the Improvement Hypothermic Preservation of Human Adipose-Derived Stem Cells” Stem Cells Translation Medicine 2016; 5:339-349. Miyagawa (US 20180042220) is serving as an English translation for WO 2016167332 and will be referred to in this rejection.
Miyagawa teaches a method of producing a cryopreserved material obtained by freezing cells, the method comprising the following steps (a) and (c), the step (c) being carried out after the step (a): (a) immersing the cells in a cryopreservation medium (Paragraphs 11 and 81 of Miyagawa);
(c) freezing the cells in the cryopreservation medium (Paragraph 14 of Miyagawa),
the method further comprising step (b) of reducing an amount, relative to the cells, of the cryopreservation medium in which the cells are immersed, the step (b) being carried out after the step (a) (Paragraph 12 of Miyagawa), the cells which have been subjected to the step (b) being frozen in the step (c) (Paragraph 14 of Miyagawa),
the cells being mesenchymal stem cells in the form of a three-dimensional cell mass, wherein the three-dimensional cell mass is a three- dimensionally extending object (i) in which a matrix that has been produced by the mesenchymal stem cells is disposed of three-dimensionally, (ii) in which cells are arranged three-dimensionally, and (iii) which contains cells that maintain bonds between them and the orientations thereof (Abstract and Paragraph 69),
the cryopreservation medium containing no cytokine (Paragraphs 91-93 of Miyagawa---cytokines are not required) as in instant Claims 14 and 15.
Miyagawa teaches a cryopreservation medium in paragraphs 91-92. Miyagawa does not teach that the cryopreservation medium includes fatty acids. Herickhoff teaches that fatty acids such as phosphatidic acid can be used in a cryopreservation medium (Paragraphs 51 and 53 of Herickhoff). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have included in the phosphatidic acid of Herickhoff with the cryopreservation medium taught by Miyagawa. An artisan would have been motivated to have used phosphatidic acid (a fatty acid) in Miyagawa’s cryopreservation medium because it is a cryoprotectant that can be used to aide in the cryopreservation process as taught by Herickhoff paragraphs 51 and 53). Furthermore, phosphatidic acid can protect cryopreservation samples from damage that occurs during freezing (Paragraphs 8-13 of Herickhoff) Because the Herickhoff reference teaches that such an agent can be used to promote cryopreservation and protect the viable cells thus preserved, there would have been a high expectation for success (Paragraphs 51 and 53 of Herickhoff) as in instant Claims 14-15.
Miyagawa fails to teach that the cells can be in a 3D matrix that comprises a polysaccharide. Swioklo teaches that cells can be placed in a 3D matrix such as alginate (a polysaccharide) (Abstract of Swioklo). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the encapsulation method taught by Swioklo. An artisan would have been motivated to have encapsulated the cells in alginate because it provides improved viable cell recovery (Abstract of Swioklo). Because encapsulation within alginate (a polysaccharide) can improve cell viability, an artisan would have been motivated to have used alginate to further protect cells from decreases in temperatures (Abstract of Swioklo). Encapsulating the cells in alginate would allow the cells to be arranged in a 3D format, maintain bonds between the cells, and maintain orientation between the cells as in instant Claims 14 and 15.
Dependent Claims taught by Miyagawa
Miyagawa teaches that step (b) includes bringing the cells into a state in which the cells are not immersed in the cryopreservation medium (Paragraphs 12 and 28 of Miyagawa) as in instant Claims 17 and 30.
Miyagawa teaches that step (c) includes freezing the cells at -80°C or below (Paragraph 90 of Miyagawa) as in instant Claims 18 and 31.
Miyagawa teaches a method of cryopreservation that includes exposing cells in a matrix (a cell sheet) to a cryopreservation agent/medium, then decreasing the amount of cryopreservation agent/cryopreservation medium before cryopreserving the cells. Miyagawa does not teach including a fatty acid within the cryopreservation medium. However, a skilled artisan would have been motivated to have included a fatty acid such as phosphatic acid because it can assist with the cryopreservation of cells as taught by Herickhoff. Miyagawa fails to further teach encapsuling the cells in alginate. However, an artisan of ordinary skill in the art would have been motivated to have encapsulated the cells in alginate because it provides further protection from decreases in temperature. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and cryopreservation. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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