DETAILED ACTION
Applicant's amendment and remarks filed on April 15, 2026 has been entered. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
All prior art rejections over Ditommaso et al. (US 2019/0017072 A1, “Ditommaso”) in view of McGann et al. (US 2006/0063141 A1, “McGann”) and Crowe et al. (US 2002/0114791 A1, “Crowe”) are withdrawn upon further consideration. Applicant’s arguments filed April 15, 2026 have been considered. Applicant’s arguments regarding the Crowe reference has been found persuasive and is acknowledged below. Ditommaso’s cells have been constricted and perturbed such that an antigen/adjuvant complex enters the pores of the cells (see paragraph [0031]). McGann suggests cryopreservation of any kind of cell, however, Ditommaso’s cells have been perturbed, thus their integrity and how they are impacted by cryopreservation and DMSO is not so predictable that one would have had a reasonable expectation of success of the claimed yield of intact cells post-thaw. Crowe’s teachings are directed to lyophilized cells, in contrast to Ditommaso’s cells that are not lyophilized. Therefore, the rejections over Ditommaso, McGann and Crowe are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New Rejection) Claims 1, 10, 16, 20, 22, 23, 30, 32, 35, 39, 42 and 47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 1 and 10 recite, “hypoosmotic conditions” and “hyperosmotic conditions”. Paragraph [0169] of the published application (US 20220233676) provides support for “hypotonic” and “hypertonic”, but not “hypoosmotic conditions” and “hyperosmotic conditions”. Paragraph [0169] also discloses maintaining osmolarity, but that is not support for the embodiment of the absence of “hypoosmotic conditions” and “hyperosmotic conditions” since the starting osmolarity is not stated.
Conclusion
Claims 60-62, 66 and 75 are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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