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 Objections
The claims are objected to because of the following informalities:
The images used to represent the formula in the claims are illegible. For example, in claim 1, formula (I), it is unclear the subscripts for the R groups and most of the L groups. Appropriate correction is required, such as using a higher resolution image. For purposes of examination, Examiner will rely on the formula in the specification, which are fuzzy as well, but not as bad.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-16, and 19-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Borros Gomez et al (US 2020/147237, hereinafter Borros Gomez ‘237).
Borros Gomez ‘237 discloses modified poly(beta-amino ester)s (pBAEs) as vectors for the delivery of virus-based therapeutic agents in therapy (claims 1-29; [0001]). It discloses the preparation of a representative pBAE derived from 5-amino-1- pentanol, hexylamine, and/or mPEG, and 1,4-butanediol diacrylate, identical to the present invention ([0244]-[0249]; examples 1, 2), further end-modified with oligopeptides, having an amine or a thiol group ([0250]-[0319]; examples 3-7; tables 1, 2), providing a library of conjugates of the general formula as follows:
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192
922
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falling within the scope of the present application. D1 further discloses a list of equivalent alternatives comprising the oligopeptide being derived from Formula IV as follows
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227
450
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further specifying that Ra is HO₂C(CH₂)₂- or HO₂C-CH₂- with p = 2-19 ([0063, [0066]), which results in a zwitterionic polymer falling within the scope of the present application, in particular R₃ with r = 0. It further discloses nanoparticles, or vehicles comprising a pharmaceutically acceptable diluent or an excipient, or a delivery system based on the said conjugates ([0164], [0187]- [0211], [0242]; examples 8-20; figure 21).
Examiner notes a genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See MPEP 2131.02.
Claims 1-3, 6-16, and 19-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Borros Gomez et al (2018/250410, hereinafter Borros Gomez ‘410).
Borros Gomez ‘410 discloses polymers suitable for use in delivery of active agents and also pertains to nanoparticles comprising these polymers and methods for their production (claims 1-23; [0002]). It discloses a similar library of pBAE conjugated to oligopeptides/DNA complexes and their use ([0146]-[0182]; examples 1-3, 5-13; table 1; figure 8), as disclosed in Borros Gomez ‘237 discussed above. Borros Gomez ‘410 also discloses the list of equivalent alternatives of the oligopeptide acc. to Formula IV ([0020], [0023]), identical to Borros Gomez ‘237.
Examiner notes a genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See MPEP 2131.02.
Claims 1-3, 6-16, and 19-22 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Oh et al (US 2018/000968).
Oh et al discloses nanoparticles that are suitable for use in delivery of active agents comprising PBAEs and additives that are sugars or sugar derivatives (claims 1-26; [0001]). D3 again discloses a similar library of pBAE conjugated to oligopeptides/DNA complexes and their use ([0201]-[0274]; examples 1-20; table 1), as disclosed in Borros Gomez ‘237 and ‘410. Oh et al also discloses the list of equivalent alternatives of the oligopeptide acc. to Formula IV ([0033], [0035]), identical to Borros Gomez ‘237 and ‘410.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Borros Gomez et al (2018/250410, hereinafter Borros Gomez ‘410).
Borros Gomez ‘410 is discussed above but requires the selection from a limited list of compounds. If this is more than permitted for anticipation, then selection would have been obvious where the polymers and nanoparticles are disclosed in the prior art and selection would have been obvious. Further, it would have been obvious to vary R4 and R9 based on the teaching of the reference.
Claims 1-16 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Borros Gomez et al (2020/147237, hereinafter Borros Gomez ‘237).
Borros Gomez ‘237 is discussed above but requires the selection from a limited list of compounds. If this is more than permitted for anticipation, then selection would have been obvious where the polymers and nanoparticles are disclosed in the prior art and selection would have been obvious. Further, it would have been obvious to vary R4 and R9 based on the teaching of the reference.
Claims 1-16 and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Borros Oh et al (US 2018/000968).
Oh et al is discussed above but requires the selection from a limited list of compounds. If this is more than permitted for anticipation, then selection would have been obvious where the polymers and nanoparticles are disclosed in the prior art and selection would have been obvious. Further, it would have been obvious to vary R4 and R9 based on the teaching of the reference.
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 1-16 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/292157 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘157 claims what appears to be the same compounds instantly claimed using different language, such as the independent claim directed to functional language instead of structural. The formula of ‘157 appears to be a narrower form of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 15/908,112 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘112 claims what appears to be overlapping polymers instantly claimed using different constituent groups.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-16 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 16/615,642 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘642 claims what appears to be overlapping polymers instantly claimed using different constituent groups.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612