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, 5, 8, 14, 21-25, 30, 31, and 33-47 remain pending.
Claims 5, 21-25, 30, 31, 35-39, and 44 remain withdrawn as being drawn to non-elected groups or species.
No claims are currently amended.
Claims 1, 8, 14, 33, 34, 40-43 and 45-47 are currently under consideration to the extent that it reads upon the species under consideration, namely, sebacic acid and N-methylmorpholine.
Rejections Maintained
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.
Claim(s) 1, 8, 14, 34, 41-43, and 45-47 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wellings (WO 2012/143508)(IDS Reference).
Wellings exemplifies a microparticle composition comprising N-methylmorpholine and sebacic acid (see entire document, for instance, page 23, lines 16-17, Example 11). The molar ratio of the sebacic acid to N-methylmorpholine is taught as being to 1:1 (see entire document, for instance, page 23, lines 16-17, example 11). It is noted that the instant specification on page 6, lines 15-19 indicates that,
By selecting more than one acid for example in which the acids have different n values, the size of the microparticle may be tailored. A longer hydrophobic portion connecting the acid groups suitably provides a larger microparticle. For example where n is 8, sebacic acid, a particle of size 2,6 microns may be obtained and where n is 11, brassylic acid, a particle of size 3,0 microns may be obtained.
Therefore, since the Wellings teaches the same components in the same orientation with the sebacic acid, the particle size of the microparticles of Wellings would be 2.6 microns.
With regard to claim 47 that Applicant is reminded that the intended use of a product claim carries no patentable weight unless it imparts a structural limitation. See MPEP 2111.02. Therefore, since the intended use of the composition as a peptide or oligonucleotide support is merely identifying that the composition could be used in said manner, and not imparting a structural limitation, it is the Examiner's position that the composition is capable of performing the intended use. It is noted that if these limitations did include structural limitations they would have been withdrawn since they did not fall within the elected species, however, since there is not structural element, the claim is not withdrawn.
Response to Arguments
Applicant argues in the Remarks filed 02/09/2026 that the Examiner has overlooked the fact that the reactants in Wellings include EDCI, a promotor of polymerization. Applicant therefore asserts that the prior art composition would crosslink and would not read on the instant claims. Applicant’s argument is not found persuasive. It is noted that the first step in example 5 of Wellings is the combination of the poly epsilon lysine and sebacic acid, wherein absent evidence to the contrary, self-assembly would necessarily occur. Applicant’s attention is drawn to the fact that EDCI is not added until a later step in the process of example 5. As such, the composition prior to the EDCI inclusion step would necessarily form the instantly claimed composition, absent Applicant having excluded essential subject matter.
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, 8, 14, 33, 34, 40-43 and 45-47 (all claims currently under consideration) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,500,140. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite self-assembled microparticles having a particle size of 0.5 to 10 microns which comprises an acid having two or more acid groups comprising one or more of brassylic acid, sebacic acid and/or azelaic acid and an organic base comprising one or more of N-methylmorpholine,N,N-dimethylaminoethanol, 4-dimethylaminopyridine, imidazole, 1-methylamidazole poly(diallyldimethylammonium chloride) (PDAC), didecyldimethylammonium chloride (DDAC), dodecyldipropylenetriamine (DDPT) and poly epsilon lysine (see claim 1). The microparticle comprises acid groups and basic groups in a molar ratio from 0.7 to 1.3:1 (see claim 4).
Response to Arguments
Applicant requests in the Remarks filed 02/09/2026 that the rejection be held in abeyance. Applicant’s argument is not found persuasive and the rejection is therefore maintained.
Claims 1, 8, 14, 33, 34, 40-43 and 45-47 (all claims currently under consideration) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,471,130. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite self-assembled multi-lamellar microparticles having a particle size of 0.5 to 10 microns which comprises an acid having two or more acid groups comprising one or more of brassylic acid, sebacic acid and/or azelaic acid and an organic base comprising one or more of N-methylmorpholine,N,N-dimethylaminoethanol, 4-dimethylaminopyridine, imidazole, 1-methylamidazole poly(diallyldimethylammonium chloride) (PDAC), didecyldimethylammonium chloride (DDAC), dodecyldipropylenetriamine (DDPT) and poly epsilon lysine (see claims 1, 3, and 6). The microparticle comprises acid groups and basic groups in a molar ratio from 0.7 to 1.3:1 (see claim 5).
Response to Arguments
Applicant requests in the Remarks filed 02/09/2026 that the rejection be held in abeyance. Applicant’s argument is not found persuasive and the rejection is therefore maintained.
Claims 1, 8, 14, 33, 34, 40-43 and 45-47 (all claims currently under consideration) are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,273,207. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims recite self-assembled multi-lamellar microparticles having a particle size of 0.5 to 10 microns which comprises an acid having two or more acid groups comprising one or more of brassylic acid, sebacic acid and/or azelaic acid and an organic base comprising one or more of N-methylmorpholine, N,N-dimethylaminoethanol, 4-dimethylaminopyridine, imidazole, 1-methylamidazole poly(diallyldimethylammonium chloride) (PDAC), didecyldimethylammonium chloride (DDAC), dodecyldipropylenetriamine (DDPT) and poly epsilon lysine (see claims 1, 3, and 6). The microparticle comprises acid groups and basic groups in a molar ratio from 0.7 to 1.3:1 (see claim 4).
Response to Arguments
Applicant requests in the Remarks filed 02/09/2026 that the rejection be held in abeyance. Applicant’s argument is not found persuasive and the rejection is therefore maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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