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 .
Response Election/Restrictions
Applicant’s election without traverse of cyclic di-GMP as the STING agonist and PE as the disclosed lipid in the reply filed on 12/10/2025 is acknowledged.
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.
Claim 3 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 3 recites the lipid nanodisc comprises (i)-(iv), but item (iv) is “a combination of (i)-(iii).” Where items (i)-(iii) are already required, it is unclear what item (iv) is claiming. It is also unclear if the intent was for the list to be modified by “or” instead of “and”, or if the preamble is missing Markush language.
Claim Rejections - 35 USC § 103
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 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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Irvine et al (US2018/0015174).
Irvine et al teaches lipid nanodiscs comprising PEG, HSPC, and DSPE (¶ 225). The cyclic dinucleotides actives include STING agonists, such as cdGMP complexes (¶ 41). The nanoparticles may be disk-like micelles and have diameters from 10nm to about 100nm (¶ 46). The polymers used may include conjugated PEG (¶ 95) present between 1 to about 100 units (¶ 96), as well as phosphate lipids (¶ 146).
Irvine et al does not disclose a nanodisc with cdGMP complexes as the actives or the specific liposomal components instantly claimed.
It would have been obvious to one of ordinary skill in the art to select from among the actives, and then to formulate a nanodisc using the liposome components taught by the reference.
With regards to instant claims 3-6, the ranges instantly claimed are both obvious as overlapping the ranges of the prior art and they would have been obvious where the prior art range is used as a starting point for optimization based on the size of the active for delivery. See MPEP 2144.05.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lioux et al (EP 3505188), in view of Ablasser et al (EP 3502102), Gindy et al (EP 3556353), Zetterberg et al (J of Colloid and Interface Science, v 484, 2016, pp 86-96).
Lioux et al teaches conjugates comprising CDN's (i.e. STING agonists) covalently linked to Biologically Active Molecule unit (see claims 1 and 11, see also claims 2-10). Lioux et al further teaches that the Biologically Active Molecule unit comprises a lipid to form liposomal structure with CDN or a nanoparticle to protect and to increase the uptake of CDN (see paragraph [0053], see also claim 13). The conjugate may comprise a spacer, wherein the spacer may be PEG or a polyamine (see claims 12 and 14).
Lioux et al does not disclose that the elected STING agonist, lipid is a diacyl lipid, PE as the polymer-modified lipid, or that the CDN-lipid conjugates are in the form of lipid nanodiscs.
Ablasser et al teaches cyclic di-GMP was a known STING activator (pg 19 line 35).
Gindy et al teaches the incorporation of phosphatidylethanolamine (claim 11) in conjunction with STING agonists (claim 16) as conjugates (claim 20).
Zetterberg et al teaches DSPE-PEG nanosized lipodisks were known in the art and their importance as delivery systems. It teaches the incorporation of increased amounts of ligand-linked PEG-lipids. This general method is exemplified with the use of DSPE- PEG₃₄₀₀⁻EGF (see whole document and in particular section "4. Conclusions").
It would have been obvious to one of ordinary skill in the art to use known STING agonists in the liposomes of the primary reference, such as disclosed by Ablasser et al, and then to conjugate them based on the teaching of Gindy et al.
It would have been obvious to one of skill in the art to modify the lipids of the primary reference using alternative CDN-lipid compositions would have found in Zetterberg et al, resulting in DSPE-PEG nanosized lipodisks and ligand-linked PEG-lipids.
With regards to instant claims 3-6, where the motivation by Zetterberg et al is to formulate nanosized lipodisks, it appears the ranges would be obvious and/or overlap those suggested. As such, the ranges are both obvious as overlapping and they would have been obvious based on the motivation to optimize the size based on the active material in the liposome and the delivery method. See MPEP 2144.05.
Nonstatutory 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,300,145. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘145 in view of Irvine et al (US2018/0015174). ‘145 claims a nanoparticle comprising a peptide nucleic acid, lipids, polymer, and cyclic dinucleotide (claim 1). The particles may be disc-like micelles (claim 11). ‘145 requires the selection of the shape and size of the particles to read on the instant claims. As discussed above, Irvine et al provides teaching and motivation to select disc-like micelles and to optimize their size. Further, the various components instantly claimed are disclosed, so when the skilled artisan is formulating the nano-discs of ‘145, it would have been obvious to use the disclosed components which are species within the claimed genus.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,207,418. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘418 in view of Irvine et al (US2018/0015174). ‘145 claims a nanoparticle comprising a PNA-amphiphile conjugates, lipids, polymer, and cyclic dinucleotide (claim 1). The particles may be disc-like micelles (claim 9). ‘418 requires the selection of the shape and size of the particles to read on the instant claims. As discussed above, Irvine et al provides teaching and motivation to select disc-like micelles and to optimize their size. Further, the various components instantly claimed are disclosed, so when the skilled artisan is formulating the nano-discs of ‘418, it would have been obvious to use the disclosed components which are species within the claimed genus.
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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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612