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 .
112 Rejections Withdrawn
The rejections of claims 1-20 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, have been overcome by inventor’s amendment. With respect to claim 17, the amendment cancels the claim. With respect to claims 1-4, 7, 12-18 and 20, the amendment clarifies the claims as appropriate. With respect to the remaining claims (indefinite from indefinite), the rejection is moot.
Claim Rejections - 35 USC § 112, NEW
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 12 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.
It is unclear why, in the third text line of the claim, the phase liposomal composition is tandemly repeated (“…an otherwise identical liposomal composition liposomal composition…”).
The examiner respectfully suggests deleting the second instance of the phase.
Double Patenting, MAINTAINED and NEW
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.
Claim 11 remains provisionally rejected, and claim 12 is also now rejected, on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/908,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a liposomal composition for sustained release of an active comprising a first liposomal core comprising PC, PE and PS and the active dispersed within the this first core, and a second core surrounding the first core comprising one or more peptide and at least one polysaccharide, where the composition further comprises a coating of ethyl cellulose (claim 11). Dependent claim 12 (from claim 11) teaches that the coated liposomal composition exhibits a sustained release of the active relative to an uncoated liposomal composition.
As stated in the previous Office Action, the reference application teaches a composition for sustained release of an active comprising a plurality of liposomal beadlets wherein each beadlet comprises a liposomal core comprising PC, PE and PS and the active dispersed within the this first core, and a second core surrounding the first core comprising one or more peptide and a polysaccharide, and a polymer beadlet shell surrounding the second core (claim 1). The definition of the term beadlet in the reference specification is simply: a liposomal core comprising PC, PE and PS and the active dispersed within the this first core, and a second core surrounding the first core comprising one or more peptide and a polysaccharide, and a polymer beadlet shell surrounding the second core (page 1, [0003]). The term shell is explicitly defined as inter alia ethyl cellulose (page 1, [003]).
As is clear from the outlines above, the instant composition intrinsically comprises the subject matter of the reference claim. The reference application beadlets are simply the liposomes of the instant claim. In sum, the two claims are simply two ways of saying the same thing. Dependent claim 12 is included in this rejection because its limitation (the exhibition of an increase in sustained release) is intrinsic to the fact that the composition is coated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The examiner notes that inventor has submitted a Terminal Disclaimer. However, this Terminal Disclaimer has been disapproved due to the use of an incorrect form. Resubmission on form PTO/AIA /25 (04-13) for a pending reference, and/or form PTO/AIA /26 (04-14) for a prior patent, is required. No additional fee is required for the resubmission.
Allowable Subject Matter
Claims 1-10, 13-16 and 18-20 are allowed for reasons of record (1/30/2026).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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, Ali Soroush, can be reached at 571-272-9925 The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 4/5/2026
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