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 2, 3, 10, 17, and 21 have been canceled. Claims 1, 4-7, 11, 14-16, 19, 20, 22 and 23 have been amended. Claims 1, 4-9, 11-16, 18-20, 22 and 23 are pending and under consideration.
Claim 15 objected to because of the following informalities: the absence of the word “from” between “selected” and “stroke”. . Appropriate correction is required.
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 19, 20, 22 and 23 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)The recitation of “the n=20-100” in claim 20 lacks antecedent basis within the claim which does not refer to an “n” index number. Claim 22 is included in this rejection for dependency on claim 20.
(B)Claim 19 is vague and indefinite in the recitation of “in preparation of a living cell drug, wherein the living cell drug is a living cell modified with a nano-drug on the surface. The claim directs the administration of the membrane anchoring molecule of claim 16. When given the broadest reasonable interpretation, the administration of the molecule of claim 16 is without anchorage to a cell. It is unclear if the preparation of the living cell drug is to be accomplished in vivo.
(C)Claim 23 is vague and indefinite in the recitation of “in preparation of a living cell drug, wherein the living cell drug is a living cell modified with a nano-drug on the surface. The claim directs the administration of the membrane anchoring molecule of claim 20. When given the broadest reasonable interpretation the administration of the molecule of claim 20 is without attachment to a nano-drug. It is unclear if the preparation of the living cell drug is to be accomplished in vivo.
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, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 19 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for nano-drugs which are liposomes, nanovesicles and solid lipid nanoparticles, does not reasonably provide enablement for nano drugs lacking lipid moieties.. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re wands, 858 F.2d 731, 737.8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The method of claim 1 requires the cell membrane anchoring molecule of I, having at one end, a moiety for a click reaction and at the other end a common lipid, or a long-chain alkane, wherein the cell membrane anchoring moiety anchors to a cell surface. Claim 1 requires modifying the surface of a “nano-drug” with a corresponding reactive group in order to carry out a orthogonal click reaction between the moiety on the cell membrane anchoring molecule and the corresponding click moiety on the surface of the nano drug. Claim 1 also requires that the corresponding reactive group modifier for modifying the surface of the nan drug has the general formula provided, having at one end a moiety to react with the moiety of the cell membrane anchoring molecule, and at the other end a common lipid or a long-chain alkane. As such, in order for the corresponding reactive group modifier to actually modify the nano-drug, the nano drug must have a surface chemistry that would allow for attachment of the R2 group which is a common lipid or a long-chain alkane, such as a liposome, a solid lipid nanoparticle or nanovesicles. The art teaches many different surface chemistries for nano-drugs, such as self-assembled nanopeptides (abstract of Zhao et al, Advances in Polymer Science, 2006, Vol. 203, pp. 145-170), self-assembled pH-sensitive nanoparticles comprising pullulan acetate and loaded with 5-FU (Liu et al, Chinese Journal of Chemical engineering, 2006, Vol. 14, pp. 377-382); 3 layered nanoparticles comprising a core of polycaprolactone, a PDEA layer, and a polyethylene glycol outer layer (Shen et al, AIChE Journal, 2008, Vol. 54, pp. 2979-2989); micellar nanoparticles comprising silk sericin (Mandal et al, Nanotechnology, 2009, Vol. 20, No. 35, article 355101); or self-assembled cationic oligopeptide (abstract of Wiradharma et al, Polymer Preprints, ACS, 2009, Vol. 50); folic acid decorated, PEG functionalized nanographene oxide (Zhuang et al, ACS Omega, 2018, Vol. 3, pp. 2396-2405); co-polymer -encapsulated Fe3O4 (Ge et al, ACS applied materials & interfaces, 2018, Vol.10, pp. 20342-20355) and nanoparticulate dispersions of a liquid crystal (Gong et al, ACS Applied Materials & Interfaces, 2011, Vol. 3, pp. 1552-1561). It is clear that not all nano-drugs would have a surface chemistry amenable to a strong interaction with the R2 of the “corresponding reactive group modifier” such that after the click ligation with the cell membrane anchoring molecule, anchored on the cell surface, a stable conjugate with the nano-drug will result. The specification provides no teachings or guidance for the use of “nano-drugs” other than liposomes, membrane vesicles or solid lipid nanoparticles, all of which could be used as drug carriers and all of which would form a strong association with the R2 group of the corresponding reactive group modifier. It is noted that the specification also contemplate “micelles” as a preferred embodiment of a nano-carrier. However, the art (Mandal et al, above) ,demonstrates that not all nano-scaled micelles have a lipid outer layer. Thus, one of skill in the art would be subject to undue experimentation without reasonable expectation of success in order to carry out the broadly claimed method of anchoring and modifying a nano-drug on he surface of a cell by using nano-drugs which were not nano-drug carriers other than liposomes, membrane vesicles or solid lipid nanoparticles.
Claims 19 and 23 are included with this rejection because it is unclear what applicant is trying to claim.
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The rejection of claims 1, 11-15 under 35 U.S.C. 103 as being unpatentable over Feldborg et al (Bioconjugate Chemistry, 2012, Vol. 23 pp. 2444-2450) in view of Vabbilisetty et al (ACS Omega, 2018, Vol. 3, pp. 1589-1599) and Li et al (ACS Nano, 2011, Vol. 5, pp. 7462-7470, reference of the IDS filed 4/29/2022) is withdrawn in light of applicant’s amendment.
All other rejections and/or objections as set forth in the prior Office action are withdrawn.
Allowable Subject Matter
Claims 16 and 18 are allowed.
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.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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