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 .
DETAILED ACTION
SPECIFICATION OBJECTION
A subsection, “BRIEF DESCRIPTION OF DRAWING”, is missing from the specification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the recited “Use of” is not one of the four categories of patent eligible subject.
The examiner suggests “A method of using” instead.
Claim Rejections - 35 USC § 112
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 4, 12, 13 and 15 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 recited expression of a range within a range, preferably and especially preferred of claim 4, preferably of claim 12, preferably of claim 13 and preferably, very preferred and most preferred of claim 15) would be indefinite. Separate dependent claims reciting the preferred/narrow range are suggested.
Claim Rejections - 35 USC § 103
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, 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.
Claims 1, 3-5, 7, 8 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Englert et al. (Enhancing the Biocompatibility and Biodegradability of Linear Poly(ethylene imine) through Controlled Oxidation), Macromolecules, 48(20), 7420-7427 (or pages A to H)
Englert et al. teach a structure of LPEI in Figure 1 in a left column of page C. Englert et al. teach that the LPEI with a degree of oxidation of about 67% obtained by acidic hydrolysis of poly(2-oxazoline) containing up to 5% of 2-ethyl-2-oxazoline units (See a lower portion of a right column at page B).
The recited about 67% obtained by acidic hydrolysis of poly(2-oxazoline) containing up to 5% of 2-ethyl-2-oxazoline units of the LPEI would encompass the recited mol % of structural units of the formulae (I), (II) and (III) of the instant claim 1.
Thus, it would have been obvious to one skilled in the art before the effective filing date of invention to utilize the LPEI having the recited mol % of the structural units of the formulae (I), (II) and (III) of the instant claim 1 from Englert et al. since the “up to 5% of 2-ethyl-2-oxazoline units” taught by Englert et al. would encompass the instant lower limit of 5 mol % absent showing otherwise.
Regarding claims 3 and 4, a unit of -N(COCHeCh3) of the LPEI of the Figure 1 would meet the claims 3 and 4.
Regarding claim 5, the recited R2 of claim 1 reciting n and p would be optional when the claim 5 is combined with the claim 1.
Regarding claim 7, a reaction taught in “results and Discussion” at pages B and C would meet the claim 7.
Regarding claim 8, Englert et al. teach utilization H2O2 in Figure 2 meeting the recited hydroperoxide of claim 8.
Regarding claim 10, Englert et al. teach that the PEI can electrostatically interact with the DNA/RNA phosphate groups and form so called polyplexes in “Introduction” at page A meeting claim 10.
Regarding claims 11-12, the polyplexes are inherently nanoparticles meeting claims 11-12. phosphate groups
Regarding claim 13, the phosphate groups are anionic meeting claim 13.
Regarding claim 14, the polyplexes would meet claim 14.
Regarding claim 15, the recited copolymer comprising the structural units of the formulae (I), (II) and (III) taught by Englert et al. would make the instant copolymer obvious as discussed above and thus the polyplexes comprising the PEI interact with the DNA/RNA phosphate groups would make the recited claim 15 obvious.
Regarding claim 16, the DNA/RNA of the polyplexes would meet claim 16.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-12 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/253,693 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the recited “0 to 20 mol % of structural units of the formula (III) and “0 to 20 mol % of structural units of the formula (VI)” of claim 1 of the copending Application would overlap the instantly recited “20 to 90 mol % of structural units of the formula (III) and “20 to 90 mol % of structural units of the formula (VI)” of the instant claim 1
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CLAIM OBJECTION
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims since Englert et al. fail to teach or suggest the mol % of the claim 2.
EXAMINER’S COMMENT
EP 2800773 B1 (Dec. 13, 2017) equivalent to submitted CN 104024306 A (Sep. 3, 2014) is enclosed.
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/TAE H YOON/ Primary Examiner, Art Unit 1762