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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/21/2025 and 3/17/2025 have been considered by the examiner.
Interview Summary
On 8/21/2026, an interview to better understand the claimed invention and potentially identify allowable subject matter was had with Applicant’s representative, Dan Morath, and inventors, Anna Gooch and Christof Westenfelder. Applicants agreed to amend independent claims to require 1-13 ng/mL for each of bFGF, PDGF-BB and EGF to move the claimed invention to allowance as this aligned with the outcomes presented in the Figures and Tables. However, upon further search the Examiner identified a relevant reference (see below) which necessitated a rejection.
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.
Claims 1-13, 16-26, 30, 31, 33 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raviv et al. (US 2021/0115395) in view of Yoshimura et al. (US 2008/0317718).
Raviv is directed to media for culturing stromal cells, such as human mesnenchymal stromal cells (i.e. mesenchymal stem cells) and adipose stromal cells (see [0020]; see instant claims 10-12). The cultured cells may be allogenic (see [0141]; see instant claim 34). The media comprises a basal medium (see [0032, 0041]; see instant claim 1) together with various additives to promote cellular expansion such as the growth factors EGF, PDGF-BB and bFGF (see [0041, 0053] and claims 4 and 11), glucocorticoids such as hydrocortisone (see [0048] and claim 7), proteins such as insulin and transferrin (see [0041, 0049] and claim 11), amino acids such as L-glutamine and L-alanine (see [0035, 0041, 0064]), antioxidants such as ascorbate (see [0065]) and buffering agents such as HEPES and sodium bicarbonate (see [0035]; see instant claim 1). The media may be supplemented with species specific serum in an amount of 5%, 10%, etc. (see [0021-0028, 0031]; see instant claims 2-4). Raviv teaches that the proteins, growth factors, cytokines, etc. are to be functional on the target cell culture and perform as a homologue from the same species of the target cells thus obviating using native proteins, growth factors of the cell type being culture.
Methods of making the cell culture media are described wherein the basal medium is modified with the growth factors and proteins so as to produce the final culture media (see [0225-0235]/Examples; see instant claims 16-19).
Methods of culturing cells are also contemplated wherein cells are cultured on the prepared cell culture media (see [0225-0235]/Examples and claim 1; see instant claims 21, 22, 25 and 26).
Methods of using the cell culture media to prepare and isolate exosomes are also contemplated (see [0175, 0192, 0208]; see instant claims 30 and 31). Methods of collecting the exosomes for use in therapeutic methods are contemplated (see [0214]; see instant claims 33 and 34).
Raviv fails to teach the cells as belonging to the canine species.
Yoshimura is directed to the use of cell culture media for the differentiation of adipose-derived precursor cells. The cell culture medium is con contain at least one ingredient selected from adrenocortical steroids, growth factors, insulin, glucose, ascorbic acid/derivatives thereof, progesterone, transferrin, buffering agents, serum, and so on (see [0016, 0068, 0121]). Yoshimura teaches that ascorbic acid and progesterone are included in the cell medium as a differentiation promoting agent (see [0120]). It is also taught that ascorbate-2-phosphate is a suitable alternative to ascorbic acid (see [0120, 1021]) and would thus be considered an obvious variant of the ascorbic acid used by Raviv. See MPEP 2144.06.
Yoshimura teaches that their cell culture media can be used for growing various stem cell populations, e.g. pancreatic, liver and so on (see [0051]) of myriad species such as humans and dogs (i.e. canine) (see [0090]; see instant claims 6-9, 13, 20, 23, 24). See MPEP 2143(I)(A).
In all, the combination of Raviv and Yoshimura suggests a cell culture media and its method of making/using, the media comprising a basal medium, sodium bicarbonate and HEPES (as buffering agents), alanine and glutamine as amino acids, insulin as a protein, hydrocortisone as a glucocorticoid, progesterone as a differentiating agent, ascorbic-2-phosphate (Asc-2-p) as an antioxidant/differentiating agent, and species specific bFGF, PDGF-BB, EGF and serum.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 14, 15, 27-29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Raviv et al. (US 2021/0115395) in view of Yoshimura et al. (US 2008/0317718) as applied to claims 1-13, 16-26, 30, 31, 33 and 34 above, and further in view of Yoon (US 2002/0187551).
Raviv and Yoshimura fail to teach the culture cells as being islet cells.
Yoon teaches compositions and methods for culturing islet cells and their stem cell progenitors (see [0014, 0072] and claim 1) by culturing the cells in a serum-modified medium comprising a basal medium supplemented with various growth supporting agents such as EGF, PDGF, hydrocortisone, progesterone and so on (see [0060] and claim 1). It would have been obvious to modify Raviv and Yoshimura such that the cell culture medium was used to grow islet cells (human, canine, etc.) with a reasonable expectation for success given the overlap in culture medium compositions of the prior art references. See MPEP 2143(I)(a, g).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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