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 .
Claims 26, 31 and 34 have been canceled. Claims 1, 27-30, 32-33 and 35 have been amended. Claim 64 has been added. Claims 1, 4-8, 20-25, 27-30, 32-35, 59, 60 and 62-64 are pending and under consideration.
The rejection of claims 26-35 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of the cancelation of claims 26, 31 and 34 and the amendment of claims 27-30, 32-33 and 35.
The rejection of Claim 1, 5-8, 20-35, 59, 60, 62 and 63 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendment of claim 1.
The rejection of claims 1, 4-6, 8, 20-25, 27-29, 34, 59, 60, 62, and 63 under 35 U.S.C. 103 as being unpatentable over Hariri et al (WO2020/113234) in view of the abstract of Solders et al (European Journal of Immunology, 2016, Vol. 46, suppl. 1, page 50, abstract no. 4101), Anak et al (WO2018/023025) Dusseaux et al (Blood, 2011, Vol. 117, pp. 1250-1259) and Xu et al (WO2022/223975), and
the rejection of claims 1, 4-8, 20-25, 27-29, 34, 59, 60, 62, and 63 under 35 U.S.C. 103 as being unpatentable over Hariri et al, the abstract of Solders et al, , Anak et al, Dusseaux et al and Xu et al as applied to claims 1, 4-6, 8, 20-25, 27-29, 34, 59, 60, 62, and 63 above, and further in view of Klampatsa and Albelda (Journal of Cellular Immunology, 2020, Vol. 2, pp. 192-200) is withdrawn in light of applicant’s amendments.
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 28-30, 32, 33, 64 is 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 28 is vague and indefinite in the recitation of “wherein following stimulation with PMA and Ionomycin at least 30% of said selected placental MAIT cells express Granzyme B. It is unclear if applicant is intending that at least 30% the cells of the composition actually have been stimulated with PMA and Ionomycin, or if the 30% of the cells of the composition have the ability to express Granzyme B after stimulation with PMA and Ionomycin.
Claim 29 is vague and indefinite I the recitation of “wherein following stimulation with PMA and Ionomycin at least 70% of said selected placental MAIT cells express Perforin. It is unclear if applicant is intending that at least 70% the cells of the composition actually have been stimulated with PMA and Ionomycin, or if the 70% of the cells of the composition have the ability to express Perforin after stimulation with PMA and Ionomycin.
Claim 30 is vague and indefinite I the recitation of “wherein following stimulation at least 30% of said selected placental MAIT cells co- express Perforin and/or granzyme B. (i)Firstly, it is unclear if applicant is intending that at least 30% the cells of the composition actually have been “stimulated” with any agent, or if the 30% of the cells of the composition have the ability to co-express Perforin after any stimulation. (ii)Secondly, it is unclear how a co-expression is to be attained if Granzyme B is an alternative to Perforin rather than required to br co-expressed with perforin. Amendment of the claim to substitute “and” in place of “and/or” would overcome this portion of the rejection.
Claim 32 is vague and indefinite I the recitation of “wherein following stimulation with PMA and Ionomycin at least 70% of said selected placental MAIT cells express TNFα.. It is unclear if applicant is intending that at least 70% the cells of the composition actually have been stimulated with PMA and Ionomycin, or if the 70% of the cells of the composition have the ability to express TNFα after stimulation with PMA and Ionomycin.
Claim 33 is vague and indefinite I the recitation of “wherein following stimulation with PMA and Ionomycin at least 70% of said selected placental MAIT cells co-express IFNγ and TNFα. It is unclear if applicant is intending that at least 70% the cells of the composition actually have been stimulated with PMA and Ionomycin, or if the 70% of the cells of the composition have the ability to co-express IFNγ and TNFα after stimulation with PMA and Ionomycin.
Claim 64 is vague and indefinite n the recitation of “wherein following stimulation with PMA and Ionomycin at least 70% of said selected placental MAIT cells express TNFα. It is unclear if applicant is intending that at least 70% the cells of the composition actually have been stimulated with PMA and Ionomycin, or if the 70% of the cells of the composition have the ability to express TNFα after stimulation with PMA and Ionomycin.
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 1, 4-8, 20-25, 27-30, 32-35, 59, 60, 62 and 63 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.
Part 1
Claim 1 has been amended to specify that at least 30% of said selected placental MAIT cells exhibit a CD45RA-/CD62L- effector phenotype.
Claim 27 has been amended to specify that at least 30% of said selected placental MAIT cells co-express CCR5 and CCR6 and less than 50% express CXCR4.
Claim 28 has been amended to specify that following stimulation with PMA/ionomycin at least 30% of the selected placental MAIT cells express Granzyme B.
Claim 30 has been amended to state that following stimulation at least 30% of said selected placental MAIT cells co-express Perforin and/or Granzyme B.
Claim 35 has been amended to specify that at least 30% of said selected placental MAIT cells express CD8a+/CDβ-.
The originally filed specification fails to provide a written description for “at least 30%” of the above properties attributed to the selected placental MAIT cells. It is noted that the specification states:
the term “population”, when used in conjunction with a particular cell attribute or attributes, may encompass a collection of cells, at least 70% of which exhibit the mentioned attribute or attributes. In other embodiments, at least 80%, at least 85%, at least 90%, at least 92%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of the cells in the collection exhibit the mentioned attribute or attributes.
However, the specification makes no mention of the above cellular attributes for at least 30% of the selected placental MAIT cells. One of skill in the art would reasonably conclude that applicant was no in possession of the claimed invention at the time of filing.
Part 2
Claim 35 has been amended to replace CD8αα+ with CD8α+β-. This is not commensurate with CD8αα+ which indicates two alpha chains. The originally filed disclosure fails to support this amendment. One of skill in the art would reasonably conclude that applicant was no in possession of the claimed invention at the time of filing.
All claims are rejected.
Conclusion
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