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 .
Claim 2 has been canceled. Claims 74 and 75 have been added. Claims 1, 4, 5, 26, 30, 59-65, 67-75 are pending and under consideration.
The objections to the disclosure are withdrawn in light of applicant’s amendments.
The rejection of claim 60 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s amendment.
The rejection of claims 4, 26 and 30 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The rejection of claims 1, 4, 26, 30 and 63 under 35 U.S.C. 102(a)(1) as being anticipated by the abstract of Solders et al (European Journal of Immunology, August 2016, Vol. 46, suppl. 1, page 50, abstract no. 4101) as evidenced by Dusseaux et al (Blood, 2011, Vol. 117, pp. 1250-1259);
the rejection of claims 1, 4, 26, 30, 63-65, 67-72 under 35 U.S.C. 103 as being unpatentable over Leeansyah et al (Trends in Microbiology, 2020, Vol. 29, pp. 504-516) in view of the abstract of Solders et al (European Journal of Immunology, August 2016, Vol. 46, suppl. 1, page 50, abstract no. 4101) as evidenced by Dusseaux et al (Blood, 2011, Vol. 117, pp. 1250-1259);
the rejection of claims 1, 4, 26, 30, 59-65, 67-73 under 35 U.S.C. 103 as being unpatentable over Leeansyah et al in view of the abstract of Solders et al and Dusseaux et al as applied to claims 1, 2, 4, 26, 30, 63-85, 67-72 above, and further in view of Olivera et al (Frontiers in Immunology, March 21, 2023, Vol.4, 27 pages); and
the rejection of claims 1, 4, 5, 26, 30, 63-65, 67-72 under 35 U.S.C. 103 as being unpatentable over Leeansyah et al in view of the abstract of Solders et al and Dusseaux et al as applied to claims 1, 2, 4, 26, 30, 63-65, 67-72 above, and further in view of Chua et al, (Infection and Immunity, 2012, Vol. 80, pp. 3256-3267), Motohashi et al (Clinical Cancer Research, 2006, Vol. 6079-6086) as evidenced by Shin et al (Journal of Korean Oriental Medicine, 2010, Vol. 3 pp. 1-7) and Touret et al (Journal of the Immunotherapy of Cancer, 2021, Vol. 9, article e003123)
is withdrawn in light of applicant’s amendments.
New Grounds of Rejection
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.
Claim 59-62, and 74 are 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.
The recitation of “non-engineered MAIT cells” in claims 59, 62 and 74 is unclear, because “MAIT cells” encompass MAIT cells from various locations, such as peripheral blood, cord blood in addition to IVB.
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.
Claims 59-62, 74, and 75 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.
It is noted that claims 59-62 in the amended claim set filed on 9/18/2025 is the first instance of describing that the exogenous cytokine referred to in the specification is provided by the recombinant expression of the exogenous cytokine. The originally filed specification and the provisional application do not describe the origin of the cytokine as being expressed by the recombinant IVB MAIT cell. The originally filed drawings provide data regarding perforin and granzyme B expression which contrast between IVB, cord blood and peripheral blood MAIT cells after stimulation with “T cell activators” (Figures 14A and 14B, and page 19, paragraph [0074]). This fails to provide support for instant amended claim 59 requiring that exogenous Il-12 and Il-18 is provided by the recombinant MAIT cell; and the co-expression of both of Il-12 and Il-18 by the IVB MAIT cells provide for increased cytotoxic activity relative to MAIT cells not expressing the IL-12 and Il-18. Further, neither the originally filed specification, the originally filed drawings nor the claim set of 9/18/2025 provide support for instant amended claim 62 requiring that the expression of Il-12 and Il-18 by the recombinant IVB MAIT cells provides for enhanced Granzyme B and/or perforin activity relative to non-engineered MAIT cells.
New claim 74 is drawn to a cell composition comprising a MAIT cells from IVB, wherein MAIT cells are engineered to express at least one of Il-12 or Il-18, wherein the expression results in enhanced granzyme B and/or perforin activity relative to non-engineered MAIT cells. Thus, while the claim set of 9/18/2025 provides support for the expression of IL-12 or Il-18 by the recombinant IVB MAIT cells, it fails to provide support for enhanced granzyme B and/or perforin activity relative to non-recombinant MAIT cells.
New claim 75 is drawn to a cell composition comprising MAIT cells derived from placental tissue, wherein said MAIT cells are engineered to express at least one exogenous cytokine which is secreted or expressed in membrane bound form, and wherein the MAIT cells express a cytokine receptor responsive to said exogenous cytokine. Claims 59-62 of the amended claim set of 9/18/2025 provides support for MAIT cells engineered to express at least one exogenous cytokine, wherein the cytokine is secreted or in a membrane bound form. Neither the amended clam set of 9/18/2026, or the originally filed specification provide support for “wherein said MAIT cells express a cytokine receptor responsive to said exogenous cytokine”.
One of skill in the art would reasonably conclude that applicant was not in possession of the clamed invention at the time of filing the provisional application, or at the time of filing the instant application on 9/18/2025.
Allowable Subject Matter
Claims 1, 4, 5, 26, 30, 63-65 and 67-73 are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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