DETAILED ACTIONNotice 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
This application is a national stage entry of 35 U.S.C. 371 of PCT/CZ2023/050017 (filed on 04/06/2023), which claims priority to CZECHIA PV 2022-148 (filed on 04/08/2022).
Drawings
The drawings filed on 09/27/2024 are objected to because they contain color images, but there is no granted petition for color drawings. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claims Status
Claims 1-9 are pending and have been examined on the merits.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1 recites, …molecular weight of from ….g/mol , …at concentration of from …%(w/v), and …concentration of from …% (v/v).
The claim should recite “is from” for clarity. Claims 2-7 are dependent on claim 1 and inherent the deficiencies.
Appropriate correction is required.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nevi et al (Scientific Reports, 2017; as cited in IDS filed on 05/26/2026), in view of Millipore Sigma Product catalogue (https://www.sigmaaldrich.com/US/en/search/9067-32-7?focus=products&page=1&perpage=30&sort=relevance&term=9067-32-7&type=cas_number) and Gilfanova et al (Cytotherapy, 2021)).
Regarding claims 1-3 and 5, Nevi et al teaches cryopreservation medium comprising DMSO and sodium hyaluronate for cryopreserving human stem progenitor cells (See, abstract). This reads on, a cryopreservation medium for cryopreservation of stem cells, cell lines and tissues from living cells, the cryopreservation medium comprising hyaluronic acid… and DMSO.
Nevi et al teaches three different cryopreservation media with varying concentrations of hyaluronic acid (HA). The cryopreservation medium were prepared in 10mL batches consisting of Kubota’s Medium (KM), which contains RPMI 1640,supplemented with 10% DMSO (1 mL), and concentrations of HA at 0.1% (0.1mL) and 0.05% (0.005mL). This reads on, wherein the hyaluronic acid… is present in the cryopreservation medium at a concentration of from 0.08-0.2% (w/v).
The HA was prepared by mixing 200mg sodium hyaluronate in 30mL of KM; the HA was sourced from SIGMA (#SO7080000). (See, p11 Methods and Buffers for Cryopreservation). The HA does not have a molecular weight listed on the SIGMA site but the CAS number 9067-32-7 associated with the sodium hyaluronate has various molecular weights available ranging from 1,200 to 2,400,000 g/mol (See, Millipore Sigma Product catalogue). There is one product (#63357) with sodium hyaluronate at molecular weight 1,500,000 -1,750,000 g/mol. This reads on, wherein the hyaluronic acid and/or sodium salt thereof has a weight molecular weight from 1,000,000 to 2,200,000 g/mol of claim 1, wherein .. from 1,000,000 to 1,750,000 g/mol of claim 2, and wherein.. thereof is 1,500,000 g/mol of claim 3.
While Nevi is silent on the molecular weight of the HA, the molecular weight of the HA is considered prima facie obvious. It would have been prima facie obvious to have substituted the sodium hyaluronate/ HA to the HA of Millipore #63357 with MW of 1,500,000-1,750,000 g/mol, which is within the claimed range. Both HA formulations share a CAS number (9067-32-7) indicating they are the share the same chemical structure, therefore there would be have been a reasonable expectation of success as substitution of one element for another known in the field, wherein the result of the substitution would have been predictable, is considered obvious.
This rationale aligns with the principle of KSR for simple substitution of one known element for another to obtain predictable results (See, MPEP 2143).
Nevi et al provides a DMSO concentration to be 10% in the cryopreservation medium. DMSO is a known cryoprotectant in the art.
Gilfanova et al teaches the cryopreservation of hematopoietic stem cells (HSCs) in DMSO at concentrations 5%, 7.5%, and 10%. Gilfanova et al teach that DMSO toxicity effects on normal function of cryopreserved cells are of concern (See, Abstract).
Gilfanova et al teaches the cells cryopreserved in 5%, 7.5% and 10% DMSO have no statistical difference in live cells and colonies formed after thawing or in live cells or expansion of subpopulations after thaw (See, p1055 col 1 paragraph 3 and Figure 1). Therefore, Gilfanova et al concluded that human HSCs are effectively cryopreserved in DMSO concentrations as low as 5%.
Therefore, Gilfanova et al provides motivations to optimize the DMSO concentration for the cryopreservation to achieve preservation such that when thawed cells are functional and illustrates that such optimization would have been a matter of routine experimentation. Thus, one of ordinary skill in the art would have been able to optimize the DMSO concentration of the method to 5% of DMSO within the cryopreservation medium. In this case of result effective variable, the discovery of optimum concentration would be routinely optimized by one having ordinary skill in the art based on the specifics of the cells being cryopreserved. As such, the concentration of the DMSO would have been a matter of routine optimization (See, MPEP 2144.05).
Regarding claim 4, following the discussion above, Nevi et al teaches that solution 2A of the cryopreservation medium has a concentration of HA 0.1%. This reads on, wherein the hyaluronic acid and/or sodium salt thereof is present at a concentration of 0.1% (w/v).
Regarding claims 6-7, following the discussion above, Nevi et al teaches that the cryopreservation medium were prepared in 10mL batches consisting of Kubota’s Medium (KM), which contains RPMI 1640 (See, p10-11). The HA was prepared by mixing 200mg sodium hyaluronate in 30mL of KM. This reads on, wherein the hyaluronic acid and/or sodium salt thereof is present in the cryopreservation medium dissolved in a standard medium comprising RPMI 1640 of claim 6 and 7.
Regarding claim 8, following the discussion above, Nevi et al teaches the cryopreservation of human biliary tree stem cells (hBTSCs) with the three solutions for cryopreservation, including solution with HA at 0.1% concentration (See, p2 paragraph 2). This reads on, a method of cryoprotecting samples for cryopreservation comprising providing a sample of stem cells and adding the sample the cryopreservation medium of claim 1.
Regarding claim 9, following the discussion above, Nevi et al teaches a method of cryopreservation comprising putting cells for cryopreservation on a vial with 1 mL of the prepared 10mL of cryopreservation medium. Then the vials are put into Cryo-container that allows for the vials to lower temperature at 1°C per minute to -80°C over 24 hours in a freezer, then placed in liquid nitrogen at -196°C (See, p11 Methods and Buffers for cryopreservation). This reads on, a method of cryopreserving stem cells….comprising: a) adding the cryopreservation medium of claim 1 to stem cell cultures, cell lines…; and b) slow freezing the cell cultures, cell lines…in the cryopreservation medium for subsequent preservation at a temperature of from -80°C to -196°C of claim 9.
Therefore, claims 1-9 are rendered obvious by Nevi et al, in view of Gilfanova et al (Cytotherapy, 2021) and Millipore Sigma.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Caroline M Lara whose telephone number is (571)272-4262. The examiner can normally be reached 7:00 to 4:30pm M-Th.
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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