DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-2, 20, 24, 39, 48, 142, 143 and 145-165 are pending upon entry of amendment filed on 4/23/26.
Claim 1-2, 20, 24, 39, 48, 142, 143 and 145-165 are under consideration in the instant application.
3. Applicant’s submission of IDS filed on 4/23/26 has been acknowledged.
4. The following rejection remains.
5. 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 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.
6. 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 of this title, 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 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.
7. Claims 1, 2, 20, 24, 39, 48, 142, 143 and 145-165 are rejected under 35 U.S.C. 103(a) as being unpatentable over Alsuliman et al. (Cytotherapy, 2016, vol. 18, pp.1312-1324, IDS reference, of record) in view of U.S.Pub 2006/0121005 (of record) for the reasons set forth in the office action mailed on 10/24/25.
Alsuliman et al. teach cryopreservation of CD4+/CD25+ Tregs after enrichment using CliniMacs in the presence of DMSO under liquid nitrogen (p. 1313-1314). Given that nitrogen is liquid around -200oC,the storage under liquid nitrogen inherently has the temperature around -200oC and claim 152 is included in this rejection. The PBMC was enriched with CD8+, expanded and cryopreserved, the inflammatory cytokine production was suppressed (p.1313) and the leukaphresis products was obtained from amyotrophic lateral sclerosis (ALS) (p. 1313). The use of healthy controls (p. 1319) reads on establishing baseline and meets the limitation of claim 1.
In addition, Alsuliman et al. teach addition of rapamycin to stimulate CD4+CD25+, 6 days later IL-2 added every 2-3 days and after 25 days of culture cells were harvested and characterized (p. 1314). The suppression of proinflammatory cytokines is shown by reduction of TNFa and IFN- (p. 1319). Further in Fig 5 (p. 1320), the suppression activity of TNFa and INF-g of is shown as well as at least 70% of expanded Tregs; more than 1.2x10 9 Tregs were expanded (p. 1321). IN Fig7, Alsuliman et al. disclose the overall process of selection and freezing of Tregs from ALS patient by leukopherisis in closed system, stimulation and restimulation in 25 days after freezing and thawing, it meets the limitation of claim 153.
The disclosure of the Alsuliman differs from the instant claimed invention in that it does not teach freezing temperature of 1oC min to -40oC or expanding as in claim 150 and enriching within 30min as in claim 1 of the instant application.
The ‘005 publication teaches freezing cells to -80oC at a rate of 1oC per minute and expanding and enriching within 30 min ([0101-0107]]) to maintain viability of cells.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize freezing methods and cell manipulation methods as characterized in the ‘005 publications into the Tregs expansion from ALS taught by the Alsuliman.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the expansion, enriching and freezing conditions generally known for T cells would be applicable to Tregs especially IL-2/rapamycin treatment and CD4/CD25 is involved and the known expansion, enriching and freezing improves viability of cells.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant’s response filed on 4/23/26 has been fully considered but they were not persuasive.
Applicant has asserted combination of the references do not teach or suggest the claimed method; the ‘005 publication does not teach obtaining cell samples within 30 minutes before initiation step and the ‘005 publication describes enrichment of T cells from 30 min to 36 hours in order to preferentially select populations of T cells but it is silent on initiation of cell selection within 30mins. Further, the ‘005 publication fails to teach a method compositing the stepwise protocol for cryopreservation of expanded T cells.
However, upon closer review of the ‘005 publication, the ‘005 publication discloses collecting T cells from a patient directly following the treatment or shortly after treatment period ([0110]). The ‘005 publication adds the ex vivo expansion, enhanced engraftment and in vivo expansion would perform within the time window after the therapy. As such, although the specific time of within 30 minutes are not taught, the expansion or enrichment step must contemplate immediately that reads on within 30 minutes. As such, “directly” after treatment the T cell may be obtained and quality and ability to be expand and T cell isolation may be done in 30 minutes ([0101]). Note that the preparation of the selection of Tregs may be done after leukapheresis (p. 1313 of Alsuliman). As such, the combination of the references remains obvious and the rejection is maintained. Applicant is advised to recite specific condition that can be used in sample collection and/or enriching steps that may obviate the rejection.
8. No claims are allowed.
9. THIS ACTION IS MADE FINAL. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 8, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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