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 .
Restriction/Election
Applicant’s election without traverse of Group I, claims 1-5, 8, 9, 17, 18, 20, 22-24, 30, 31, 35 and 36 in the reply filed on 05/12/25 is acknowledged.
Claims 37 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/12/25.
Status of Claims/Rejections
Applicants’ remarks regarding the amended claims, drawn to a methionine residue being oxidized in the form of sulfoxide were effective in overcoming the 103(A) rejection of record. No further art was found, rendering the claims novel and unobvious. However, the terminal disclaimed filed on 12/04/25 was not approved because applicants are required to establish the proper chain of title for the power of attorney to be accepted and the terminal disclaimer to be filed and approved. As such, the previous double patenting rejection is upheld, pending a new terminal disclaimer filing and approval.
Claims 1-3, 5, 8, 9, 14, 17, 18, 20, 22-24, 30, 31, 35 and 36 are currently under examination.
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, 5, 8, 9, 14, 17, 18, 20, 22-24, 30, 31, 35 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 14, 16, 17, 19, 21, 22, 24-27, 32, 38 and 39 of copending Application No. 17/638,995 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘995 are drawn to the following:
A liposome comprising a modified peptide having the structure:
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wherein R1 and R2 are each the same or different and are an alkyl chain having between 13 and 19 carbon atoms, R3 is a peptide having a sequence according to SEQ ID NO: 1, and wherein R4 is a linker having the structure R6-R5-R7, wherein R6 and R7 are each independently a bond or a carbonyl group; and R.sub.5 is selected from the group consisting of: C1-20 straight alkyl, C3-20 branched alkyl, C3-20 cyclic alkyl, and C6-20 arylalkyl; and at least one cannabinoid.
2. The liposome according to claim 1 wherein R1 and R2 are a linear alkyl chain having 15 carbon atoms.
3. The liposome according to claim 1 wherein the peptide is attached to the succinate moiety at the N-terminus of the peptide.
4. The liposome according to claim 1 wherein R3 comprises the peptide having a sequence according to SEQ ID NO:1 wherein the methionine residue is oxidized in the form of sulfoxide.
5. The liposome according to claim 1 wherein R6 and R7 are each a carbonyl group.
8. The liposome according to claim 1 wherein R.sub.5 is a C1-6 straight alkyl or a C3-6 branched alkyl.
9. The liposome according to claim 1 wherein R5 is a C2 straight alkyl.
14. The liposome according to claim 1, further comprising a phospholipid and a cholesterol.
16. The liposome according to claim 14 wherein the phospholipid is 1,2-distearoyl-sn-glycero-3-phosphocholine.
17. The liposome according to claim 16 wherein the molar ratio of phospholipid to cholesterol is between 3:1 and 1:1.
19. The liposome according to claim 14 wherein the modified peptide is present in a molar percentage of 0.05% to 5%, relative to the combined amount of cholesterol and phospholipid.
21. The liposome according to any claim 14, and free of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC).
22. The liposome according to claim 14, and free of 1,2-palmitoyl-phosphatidic acid (DPPA).
23. (canceled)
24. The liposome according to claim 1 wherein the cannabinoid is CBD, CBN, or THC.
26. The liposome according to claim 1 wherein the cannabinoid is in the form of plant extract.
27. A plurality of liposomes according to claim 1 wherein the mean diameter is between 50 nm and 300 nm.
32. The plurality of liposomes according to claim 27 wherein the zeta potential of a liposome is from −10 mV to −120 mV or from +10 mV to +120 mV.
38. The liposome according to claim 1 wherein the molar percentage of cannabinoid in the liposome is between 1-20% of the composition.
39. The liposome according to any claim 1 wherein the cannabinoid is encapsulated within the liposome.
This meets the limitations of instant claims 1-3, 5, 8 and 9 by teaching the same peptide-liposome structure, (claims 1-5, 8 and 9 of ‘995), a linear alkyl (claim 2 of ‘995), N-terminal conjugation (Claim 3 of ‘995), oxidized methionine (Claim 4 of ‘995). Instant claims 14, 17, 18, and 20 are met by claims 14 and 16-19 of ‘995, which teach the same cholesterol/phospholipid/peptide liposomes. Instant claims 22 and 23 are met by claims 21 and 22, which teach the same exclusion of DOPC and DPPA. Instant claims 30, 31, 35 and 36 are met by claims 26, 37 and 32, which teach the same plurality of liposomes with the same average diameter and zeta potential ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. 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 JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654