DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments and arguments/remarks filed 5/4/2026 is acknowledged.
Newly submitted claims 32 -34 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: These claims recite a transdermal delivery system which is the system of withdrawn claim 28.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 32-34 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
4. 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 1-5, 11 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Tu et al. (US 2022/0265566) and Lepine (US 20220409682).
Kuar et al. (US 2022/0151945) (hereinafter Kuar et al.) disclose solid lipid nanoparticles with lipid matrix comprising at least one biocompatible lipid forming a generally spherical particle containing curcumin. The particles have a coat of surfactant (para 0222). The particle sizes are 20-80 nm (abstract). The lipid matrix comprises at least two distinct biocompatible lipids which include glycerides and fatty acids (para 0027).
Kuar et al. disclose natural surfactants such as soy lecithin (paras 0078, 0079, 108, claims 10-11). Tu et al. (US 2022/0265566) disclose solid lipid nanoparticles and natural surfactants avoid bio toxicity problems and are generally recognized as safe (para 0002). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use natural surfactants in the compositions of Kuar et al. One would have been motivated to do so because it would avoid toxicity problems.
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose C-phycocyanin.
Lepine (US 20220409682) (hereinafter Lepine) discloses c-phycocyanin has antioxidant activity (para 0018-1009). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include C-phytocyanin in the compositions of Kuar et al. in order to improve antioxidant properties. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
5. Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Tu et al. (US 2022/0265566) and Lepine (US 20220409682) as applied to claims1-5, 11 and 31 and further in view of Fresu (US 20170368115).
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose spirulina (algae-derived material).
Fresu (US 20170368115) (hereinafter Fresu) discloses spirulina improve the bioavailability of orally administered curcumin and preparations including spirulina containing curcumin have improved bioavailability (abstract). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate spirulina into the compositions of Kuar et al. One would have been motivated to do so in order to improve bioavailability.
6. Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Tu et al. (US 2022/0265566) and Lepine (US 20220409682) as applied to claims 1-5, 11 and 31 and further in view of Chadeayne (US 20190142851).
Kuar et al. has been discussed supra and disclose curcumin and the compositions have antioxidant properties but does not disclose psilocybin. Chadeayne (US 20190142851) (hereinafter Chadeayne) disclose that psilocybin has antioxidant properties (para 0348). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include psilocybin in the compositions of Kuar et al. in order to improve antioxidant properties. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
7. Claims 1 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Kuar et al. (US 2022/0151945) in view of Tu et al. (US 2022/0265566) and Lepine (US 20220409682) as applied to claims 1-5, 11 and 31 and further in view of Pautu et al. “pH-Responsive Lipid Nanocapsules: A Promising Strategy for Improved Resistant Melanoma Cell Internalization”.
Kuar et al. has been discussed supra and does not disclose pH responsive coatings. Pautu et al. disclose that pH-responsive copolymer bearing a lipophilic chain end has been used providing the lipid nanoparticles (LNC) a stealth behavior in physiological conditions and responsiveness to the acid tumor environment (conclusions). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to coat the lipid nanoparticle of Kuar et al. with pH responsive coatings. One would have been motivated to do so because it would provide stealth behavior in physiological conditions and responsiveness to tumor environments.
RESPONSE TO ARGUMENTS
8. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicants argue that Lepine does not teach C-PCs antioxidant properties or formulating into solid lipid nanoparticles or incorporation within a lipid matrix as claimed. Lepine does not address the formulation challenges associated with incorporating C-PC into a SLN system.
Applicants are arguing the references individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicants argue that the instant specification demonstrates that the C-PC exhibited far more than merely another oxidant to Kuar’s system. Neither Kaur or Lepine recognizes or proposes the multifaceted solution.
In response, the Examiner respectfully submits that this argument is not found persuasive because the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
CONCLUSION
9. 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.
CORRESPONDENCE
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
Prosecution Insights