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 1, 4, 12, 16, 26, 30 and 31 have been amended. Claims 1, 3-5, 8, 10, 12-14, 16, 18, 22, 24, 26, 27, 28, 30 and 31 are pending are pending and under consideration.
Claim s 1 and 31 are objected to because of the following informalities: the meaning of the acronym, TABi, should be spelled out in the first instance of use, followed immediately by (TABi). Appropriate correction is required.
The objection to claim 4 for stating “cTL” versus “CTL” is withdrawn in light of applicant’s amendment.
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 1, 3-5, 8, 10, 12-14, 16, 18, 22, 24, 26, 27, 28, 30 and 31 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.
(A)Claims 16 and 31 have been amended to state that the TABis are obtained in less than 2 hours from collecting the apoptotic bodies. It is unclear if this collection refers to the first collection by low speed centrifugation, or if this collection is the final collection after high speed centrifugation.
(B)Claim 12 lists vindesine and vinorelbine. It is unclear if the selected drug must include both of vindesine and vinorelbine.
(E)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 12 recites the broad recitation aziridines, and the claim also recites thiotepa, which is the narrower statement of the range/limitation;
claim 12 recites the broad recitation nitrosoureas, and the claim also recites carmustine, lomustine, semustine which is the narrower statement of the range/limitation;
claim 12 recites the broad recitation triazines, and the claim also recites dacabazine and temozolomide which is the narrower statement of the range/limitation
claim 12 recites the broad recitation platinum derivatives, and the claim also recites cisplatin, oxaliplatin, carboplatin and satraplatin 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.
(F)The terms “low” and “high” in claims 1, 16 and 31 are relative terms which render the claims indefinite. The terms “low” and “high” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Section 2173 of the M.P.E.P. states
Claims Must Particularly Point Out and Distinctly Claim the Invention
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent..
In the instant case, the specification does not provide a limiting definition for “low” speed centrifugation which would provide a boundary between that which is “low” speed versus that which is not low speed, nor does the specification does not provide a limiting definition for “high” speed centrifugation which would provide a boundary between that which is “high” speed versus that which is not high speed. Thus, a potential infringer would not be able to ascertain when a centrifugation speed was large enough not to be considered low, or low enough not to be considered high and therefore outside the scope of the claims. Further, it is unclear what applicant intends as the speeds of the low-speed and high-speed centrifugation
Applicant argues that the dependent claims clearly and unequivocally define boundaries for high and low speed centrifugation. Applicant further argues that paragraph [0024] of the specification define amounts which may vary from a stated value by at least , 1, 2, 3, 4, 5, 6, 7, 10, 12 or 15%. This has been considered but not found persuasive. Firstly paragraph [0024] states:
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which has nothing to do with centrifugation speeds or “amounts”. Secondly, the dependent clams cannot be used to establish the metes and bounds of the claims on which they depend.
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, 3-5, 8, 10, 12-14, 16, 18, 22, 24, 26, 27, 28, 30 and 31 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.
Claim 1 has been amended to require a method of preparing apoptotic bodies with reduced fragmentation, wherein the apoptotic bodies recovered in the final step have “reduced fragmentation”. Claim 16 has been amended to require an immunogenic tumor apoptotic body immunization composition with reduced fragmentation , wherein the apoptotic bodies recovered in the final step have “reduced fragmentation” relative to the TABI obtained from a single centrifugation step. Claim 31 has been amended to require a method of preparing apoptotic bodies with reduced fragmentation, wherein the apoptotic bodies recovered in the final step have “reduced fragmentation”.
The originally filed disclosure fails to support the requirement of “reduced fragmentation”. The specification teaches that the apoptotic bodies per se are formed from fragmentation of apoptotic cells into membrane enclosed vesicles (paragraph [0030]). The specification makes no mention of “reduced fragmentation” of the TABis or avoiding further breakage of the TABis into smaller fragments. One of skill in the art would reasonably conclude that applicant was not in possession of the claimed invention at the time of filing.
The rejection of claims 1, 3, 5, 8, 12, 13, 14, 16, 18, 19, 22, 26, 27, 28 and 31 under 35 U.S.C. 103 as being unpatentable over in view of Gregoire et al (WO99/58645, reference of the IDS submitted 9/13/2022) in view of Jiang et al (Nature Protocols, 2016, Vol. 11, pp. 655-663), Mor (WO2005/054814), Griffith et al (U.S. 6,355,810), and Goldrick et al (WO2011/100458); and
the rejection of claims 1, 3, 5, 8, 12, 13, 14, 16, 18, 19, 22, 26, 27, 28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Gregoire et al, Jiang et al, Mor, Griffith et al and Goldrik et al as applied to claims 1, 3-5, 8, 12-14, 16, 18, 19, 22, 26, 27, 28, 30 and 31 above, and further in view of Palma et al (Cancer Immunol Immunother, 2012, Vol. 61, pp. 865-879) and Durai et al (Cancer Immunol Immunother, 2009, Vol. 58, pp. 209-220)
is withdrawn in light of applicant’s arguments.
Applicant argues that it is counterintuitive that the combination of a first low speed centrifugation of less than 100G separates the apoptotic bodies from cellular debris without damaging the apoptotic bodies and that the second high speed centrifugation at greater than 1500G did not damage the apoptotic bodies but served to separate them from cellular ad organelle debris to yield a high purity of apoptotic bodies. This has been considered and found persuasive. Therefore, the instant methods provide unexpected results.
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
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