DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant’s election of Group I (claims 1-11) and the species of active ingredient (sphingolipid) in the reply filed on 26 January 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
There are no figures or drawings filed in the application. However, figures are discussed in the specification (section starting at the end of page 7). Appropriate correction is required.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over PCT Patent Application Publication WO 2020/079302 in view of Unger et al. (US Patent Application Publication 2005/0019266). The above PCT publication is not in English. As such, Tallo Dominguez et al. (US Patent Application Publication 2021/0361569) will be referred to for supporting the rationale of this rejection.
Tallo Dominguez et al. discloses nanostructured lipid gel formed from phospholipids, fatty acids, and a high water content (abstract and claim 1). The lipid gel has alternating layers and vesicles (abstract & figure3B). There is between 3% and 30% of the lipids formed from a mixture of the phospholipids and the fatty acids (claim 1), and between 70 and 97% water (id.). As for the lipids, the phospholipid can be hydrogenated soy phosphatidylcholine (claim 4), which is a zwitterionic lipid. Tallo Dominguez et al. expressly states that lipid gel also does not have polymers or surfactants (claim 1), and Tallo Dominguez et al. does not suggest fatty alcohols in the lipid gel.
Independent instant claim 1 recites that the lipid gel has no fatty acids, while Tallo Dominguez et al. does state the presence of fatty acids. However, the scope of the term in the instant claim is narrower than that disclosed by Tallo Dominguez et al. The instant specification defines “fatty acid” to “a monocarboxylic acid with a linear hydrocarbon chain with a minimum of 4 carbons, and it can be saturated or unsaturated” (page 4, lines 5-6). Tallo Dominguez et al. states that the fatty acid can be a saturated or unsaturated fatty acid with a chain length between 10 and 24 C atoms, with one or more double links (paragraph [26]). While the seven specific acids stated are all linear, there is no requirement that linear fatty acids must be used.
And the use of branched fatty acids as lipids in vesicles is known, as demonstrated by Unger et al. This reference discloses vesicle preparations (claim 1), and that the lipids include fatty acids (paragraph [104]). And useful; fatty acids include isostearic acid (paragraph [120]), which is a branched (not linear) fatty acid. Further, negatively charged lipids, such as fatty acids, are taught by Unger et al. to enhance the stability of the vesicle when incorporated in amounts of 1 to 10 mol% of the total lipids employed (paragraph [104]). This branched fatty acid is not excluded from the scope of instant claim 1.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included isostearic acid as the fatty acid in the lipid gel taught by Tallo Dominguez et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Further, the inclusion of isostearic acid would help to enhance the stability of the vesicle.
Instant claims 2 and 3 further limit the zwitterionic phospholipid, and the hydrogenated soy phosphatidylcholine taught by Tallo Dominguez et al. reads upon these limitations.
Instant claims 4-8 further recite the inclusion of a lipid such as an anionic lipid, as well as limitations to the relative amount. The inclusion of the anionic fatty acid lipid taught by Unger et al. in the amount taught by Unger et al. reads upon the limitations of instant claims 4-5 and 7-8.
As for instant claim 6, the range taught by Unger et al. does not read upon the amount recited by instant claim 6. But it does overlap. And in cases involving overlapping ranges, where the instantly claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05.
Instant claims 9-10 recite the further inclusion of active ingredients such as sphingolipids and proteins, and such actives are suggested by Tallo Dominguez et al. (claim 9).
Instant claim 11 further limits the relative amounts of the lipid and the water, and the ranges taught by Tallo Dominguez et al. overlap this range.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-9 of U.S. Patent No. 12,208,163 in view of Unger et al. (US Patent Application Publication 2005/0019266).
The issued claims recite all of the limitations recited by the instant claims (including zwitterionic lipids in claim 2) except for the fatty acid limitation. Independent instant claim 1 recites that the lipid gel has no fatty acids, while the issued claims state the presence of fatty acid. However, the scope of the term in the instant claim is narrower than that of the issued claims. The instant specification defines “fatty acid” to “a monocarboxylic acid with a linear hydrocarbon chain with a minimum of 4 carbons, and it can be saturated or unsaturated” (page 4, lines 5-6). No such limitation with respect to linear fatty acids is recited by the issued claims (or defined in the specification).
And the use of branched fatty acids as lipids in vesicles is known, as demonstrated by Unger et al. This reference discloses vesicle preparations (claim 1), and that the lipids include fatty acids (paragraph [104]). And useful; fatty acids include isostearic acid (paragraph [120]), which is a branched (not linear) fatty acid. Further, negatively charged lipids, such as fatty acids, are taught by Unger et al. to enhance the stability of the vesicle when incorporated in amounts of 1 to 10 mol% of the total lipids employed (paragraph [104]). Thus, this fatty acid is not excluded from the scope of instant claim 1.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have included isostearic acid as the fatty acid in the lipid gel recited by the instant claims. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Further, the inclusion of isostearic acid would help to enhance the stability of the vesicle.
Conclusion
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/Brian Gulledge/Primary Examiner, Art Unit 1699