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 .
Election/Restriction
Applicant’s election without traverse of Group I in the reply filed on 2/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The requirement is still deemed proper and therefore made FINAL.
Claims 1, 2, 4, 6, 7, 10, 13, 15, 18-21, 23, 24, 26, 28, 29, 31, 33, and 34 are pending of which claims 18-21, 23, 24, 26, 28, 29, 31, 33, and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pending claims 1, 2, 4, 6, 7, 10, 13, and 15 have been examined on the merits.
Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 2, 4, 6, 7, 10, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Han et al (WO 2020/047369 A2).
The instant claims are drawn to a composition for the intended use of cryopreservation medium, comprising (claims 1+) amounts of:
a 1st and crypoprotective particle or molecule, optionally:
in an amount of 10-50% w/v (claim 2), or
comprising a spherical, globular, or polymerized material (see e.g. among the species in claims 10, 13)
a 2nd crypoprotective particle or molecule, optionally:
in an amount of 1-15% w/v (claim 4), or
comprising a glycosaminoglycan, a modified glycosaminoglycan, chondroitin sulfate A, chondroitin sulfate C, chondroitin sulfate D, dermatan sulfate, a salt thereof, or a combination thereof (see claim 15).
an aqueous liquid; and
optionally, no (claim 6) or less than 5% w/v (claim 7) of a cell permeating cryoprotectant, optionally comprising dimethyl sulfoxide, glycerol, ethylene glycol, propanediol, or a combination thereof (claim 7).
Han et al (WO ‘369), however teaches (see entire document, e.g. paragraphs [0038-0048] and claim 29) a composition comprising “a freezable medium comprises a hydrophilic and non-toxic macromolecule and an aqueous liquid” which may comprise “a cryoprotectant” [0038] (cryopreservation medium, cryoprotective molecule/particle as required of instant claim 1). The composition may optionally further contain “cryoprotectant [which] comprises dimethyl sulphoxide (DMSO), glycerol, ethylene glycol, propanediol,…and other” materials [0039] (broadly the presence or absence of cell permeating cryoprotectant, as required of instant claims 6,7), “polysaccharides, polyvinylpyrrolidone and polyethylene glycol and other polymers, other non-permeating cryoprotectants including…chondroitin sulfate and lactobionates, or any combination thereof” [0039] (broadly a 2nd cryoprotective particle/molecule, as required of instant claims 1,15), and/or a polymer selected from the group consisting of “hydrophilic polysaccharides, polymerized cyclodextrin or saccharides, globular proteins or spheroproteins, spherical glycoproteins formed by attaching oligosaccharide chains of globular proteins, other derivatives of globular proteins, and combinations thereof” [0048] (broadly a 1st cryoprotective particle/molecule, as required of instant claims 1,10).
The cited reference discloses a composition and combinations comprising component materials (i)-(iv) as above, which appear to be identical to the presently claimed composition since the component materials provided include the same species instantly identified as suitable therefore and having the requisite preferred functioning as instantly claimed. Consequently, the claimed composition appears to be anticipated by the reference.
In the alternative, even if the composition (with respect to amounts (including concentrations/dilutions/proportions thereamong) is not identical to the referenced composition, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of the claimed composition, particularly in view of the similar characteristics which they have been shown to share (e.g. the same/similar suitability for cryopreservation). Thus, the claimed composition would have been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655