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 .
This action is in response to the papers filed September 14, 2026.
Claims 1-15 are pending in the application as set forth in the claim set filed 09/23/2024.
Applicant’s election without traverse of Group II (5-8 and 13-15) in the reply filed on 09/14/2026 is acknowledged.
Claims 1-4 and 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/14/2026. The requirement is still deemed proper and is therefore made FINAL.
Therefore, claims 5-8 and 13-15 are examined on the merits.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/FR2022/050530 filed March 22, 2022.
Thus, the earliest possible priority for the instant application is March 22, 2022.
Claim objection
Claims 7 and 13 are objected to because improperly state their intended Markush groups; the proper format requires the use of the phrase “selected from the group consisting of”. Appropriate correction is requested.
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 5-8 and 13-15 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.
Claim 5 recites “selected from” and then only provides one option as a group of “albumins.” This does not demonstrate the metes and bounds of the invention as it is unclear what albumins are being selected.
Claim 5 recites the term “conditioning,” however there is not an example or definition of the term within the specification to know what a “conditioning” step would encompass.
Claim 5 reictes the term “optionally” which is an alternative format which is indefinite and ambiguous whether conditioning is part of the method steps.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “between -79°C and -197°C” , and the claim also recites “approximately -80°C” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is interpreted that the narrower limitation is exemplary and not required.
Claim 5 recites “the mixture” however, there is no previous mention of “a mixture” in the claim and therefore, the term lacks antecedent basis.
Claim 9 is indefinite in its recitation of “suspending the cells from the centrifugation supernatant” in line 5, step iii. The practitioner in the art would readily understand that cells are resuspended from a precipitate and not a supernatant after centrifugation. As such the metes and bounds of the claims are indefinite.
For the sake of compact prosecution, it is interpreted that this is a typographical error as the Examples and protocols all use cells from the pellet and not cells from the supernatant which are put in proline (para. 0042 of the instant specification).
The claims which depend on claim 5 are additionally rejected as being indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 5-7 and 13 are rejected under 35 U.S.C. 102(a) as being anticipated by Arav (2012, Biopreservation and Biobanking 10(4): 386-394)
Regarding claim 5 step a, Arav teaches a method of preserving red blood cells (i.e. non-adherent cells) by cryopreservation (i.e. freezing) in a 10% human serum albumin (HSA) by weight/volume (i.e. non-toxic cryoprotectant) freezing solution dissolved in PBS (i.e. isotonic, aqueous solution) (Abstract, p. 387, Freezing solutions).
Regarding claim 5 step b, this is an optional step and as addressed in the above 112b rejection, there is no definition of “conditioning the mixture” only a disclosure that an artisan may do so at some point in the cryopreservation process.
Regarding claim 5 step c, Arav teaches directional freezing of the RBC with freezing solution sample (p. 387-388, bridging section).
Regarding claim 5 step d, Arav teaches the solution is preserved at a gradient of -120°C and -130°C (p. 388, 2nd full paragraph).
Regarding claim 6, Arav teaches the cryoprotectant is 10% HSA (p. 387, Freezing solutions).
Regarding claims 7 and 13, Arav teaches the solution comprises trehalose (p. 387, Freezing solutions).
Therefore, the invention is anticipated by Arav.
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 8, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Arav (2012, Biopreservation and Biobanking 10(4): 386-394) in view of Lagerberg (TRANSFUSION 2007;47:2242-2249) and Liu (Journal of Nanomaterials, 2021, 9990709, 14 pages)
As discussed above in the 102 rejection and incorporated herein in its entirety, Arav reads on the limitations of claims 5-7, as a method of preserving non-adherent cells by freezing RBCs in a solution of 10% human serum albumin and trehalose which is directionally freezed at -120°C and -130°C.
Regarding claim 8, 14 and 15, Arav teaches that the cells are contacted with the water’s surface at 37°C in order to thaw the frozen cells (p. 388, Thawing). However, Arav does not teach a step of centrifugation and a step of suspending the mixture in saline with 1 and 10% proline. While step iii) states that the “cells from the centrifugation supernatant” are put in a saline solution with proline, it is interpreted that this is a typographical error as the Examples and protocols all use cells from the pellet and not cells from the supernatant which are put in proline (para. 0042 of the instant specification).
Lagerberg teaches a method of cryopreservation in which cells are cryopreserved and then centrifuged to remove cryoprotectant before being re-suspended in a resuspension media for storage which comprise saline (p. 2243, 2nd column; p. 2245, 2nd column). Lagerberg teaches that differences in the resuspended storage media osmolarity results in water influx, cell swelling, and eventually hemolysis (p. 2247, bridging paragraph).
Liu teaches that proline can be utilized at concentrations such as 4, 6, 8 or 10% in methods of cryopreservation (Table 3). Proline is non-toxic, counteracts osmotic injury, and reduces injury from ice crystallization to the cells (p. 5, 1st column).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to centrifuge the thawed cells of Arav and resuspend the pellet in a solution for storage comprising saline and 4 to 10% proline with a reasonable expectation of success. An artisan would have been motivated to centrifuge the sample as it is a known method of removing the cryoprotectant as taught by Lagerberg and then resuspend the pellet in a storage media comprising saline and proline as Liu teaches that proline counteracts osmotic injury.
Therefore, the invention would have been obvious to one of ordinary skill in the art at the time of the effective filing date
Relevant prior art
Quan et al. CryoLetters 28(2), 95-108 (2007)
Conclusion
No claims are allowed.
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/ALEXANDRA F CONNORS/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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