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 .
Applicant’s amendment and reply filed August 25, 2025 have been received and entered into the case. Claims 2, 14 and 16 are canceled; claims 1, 3 – 13, 15 and 17 – 20 are pending; claims 19 – 20 are withdrawn; claims 1, 3 – 13, 15 and 17 – 18 have been considered on the merits. All arguments have been fully considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 25, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Previous rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn due to amendments reciting a specific amount, deleting improper Markush language and clarifying specific parameters in claims 9, 13 and 15.
Claim Rejections - 35 USC § 102
Previous rejections under 35 U.S.C. 102a1 and 102a2 as being anticipated by Zimmerman et al. (US 2008/0081082) as evidenced by N’Guyen et al. (US 5516507) and Katinger et al. (US 5942245) are withdrawn due to the amendment requiring deoxygenated water and liposome as the carrier in the composition.
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.
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, 3 – 7, 12 – 13, 15 and 17 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmerman et al. (US 2008/0081082) as evidenced by N’Guyen et al. (US 5516507) and in view of Perry (US 9468597).
Regarding claim 1, Zimmerman teaches topical compositions (abstract) comprising 0.0001 – 5% superoxide dismutase (SOD) (0007, 0023 – 0024, 0039) with a stabilizing carrier (0023-0024,0069 – 0070) such as liposomal capsule (or a liposome) (0037) for topical application (abstract, examples 6-11).
Zimmerman does not teach the composition wherein the carrier comprises deoxygenated water. However, the reference teaches the compositions may include water or deionized water (0081, examples) and include cosmetically and pharmaceutically acceptable carriers that are known or conventional in the art and do not have detrimental effects on the composition (0037, 0069 - 0071). At the time the claims were filed, deoxygenated water was a known and conventional carrier for topical antioxidant compositions. In support, Perry teaches stabilized, topical antioxidant compositions (abstract) wherein the carrier is deoxygenated water (example 1, col.7 line 55-68, col.9 line 5-15, claim 13). Perry teaches the removal of oxygen from water allows for long shelf life and stability of the antioxidant compositions (col.9 line 35-41). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated to use deoxygenated water as the carrier for Zimmerman’s composition, since was a well-known topical carrier in the art and having the advantage for longer shelf life in antioxidant compositions.
Regarding claim 3, the combined references do not indicate a ppm of oxygen in the deoxygenated water. However, Perry teaches oxygen is removed and replaced with nitrogen (col.7,9) indicating that no oxygen remains and that the intent is to remove all oxygen. In this regard, the deoxygenated water disclosed by Perry would have less than the parts per million as claimed. Notwithstanding, based on the teaching of Perry, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to reduce, or optimize, the amounts of remaining oxygen as a matter of routine experimentation and as directed by Perry.
Regarding claims 4 – 6, the composition further includes preservatives and/or emollients (0069-0074), adjuvants (0087) fatty acids (0089), lecithin (phospholipids) (examples).
Regarding claim 7, the compositions may include other active agents such as sunscreen (0075).
Regarding claim 12, Zimmerman does not teach the composition with the claimed pH. Generally, differences in parameters such as pH will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (2144.05 IIA).
Regarding claim 13, the composition can be as a solution, emulsion, gel, cream, ointment (0069).
Regarding claim 15, although Zimmerman does not indicate the claimed intended properties of the composition, the claimed properties are conditional to the amount of SOD in the composition. Further, the claimed conditions do not further limit the composition itself beyond having 0.2% SOD and a stabilizing carrier. In this regard, Zimmerman teaches the amount of SOD and must therefore also teach the conditional properties.
Regarding claim 17, the compositions do not required the claimed components and are substantially free of ethanol and capsaicin.
Regarding claim 18, Zimmerman teaches SODs that may be used in the topical compositions are those taught by US 5516507, which is incorporated therein (0039). Turning to this reference, example SODs include Cu-Zn type SOD, or SOD1 and SOD3, per applicant’s specification, page 14.
Thus, the combination of references renders the claims prima facie obvious.
Claims 1, 7 – 11 are rejected under 35 U.S.C. 103 as being unpatentable over Katinger et al. (US 5942245) in view of Perry (US 9468597); and further in view of Widgerow (US 2012/0058167).
Regarding claim 1, Katinger teaches topical compositions comprising 0.01 – 5% superoxide dismutase (SOD) in liposomes mixed with physiological carriers (abstract, claims).
Katinger does not teach the composition wherein the carrier comprises deoxygenated water. At the time the claims were filed, deoxygenated water was a known and conventional carrier for topical antioxidant compositions. In support, Perry teaches stabilized, topical antioxidant compositions (abstract) wherein the carrier is deoxygenated water (example 1, col.7 line 55-68, col.9 line 5-15, claim 13). Perry teaches the removal of oxygen from water allows for long shelf life and stability of the antioxidant compositions (col.9 line 35-41). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated to use deoxygenated water as the carrier in Katinger’s composition, since was a well-known topical carrier in the art and having the advantage for longer shelf life in antioxidant compositions.
Regarding claim 7, the compositions may include additional active agents, such as hyaluronic acid (col.2 line 44-56) or other active agents (col.14 21-36).
Regarding claims 8 – 11, Katinger does not teach the composition further comprising anesthetics such as lidocaine. However, Katinger does teach the compositions are formulated to heal burns, skin lesions (abstract), inflammation and scalds (examples). Widgerow teaches topical compositions for treating scars wherein the compositions include SOD (0042) and may further include analgesic such as lidocaine, when used to treat burns, wounds or inflammation (0071). At the time the claims were filed, it would have been obvious to one of ordinary skill in the art to combine the instant ingredients for their known benefit in treating burns, wounds and inflammation, as disclosed by the cited references above, since each is well known in the art for the same purpose. It would have been further obvious to one of ordinary skill in the art to optimize the amount of lidocaine as a matter of routine experimentation since it was a recognized active agent and therefore a recognized result effective variable. The idea for combining them flows logically from their having been used individually in the prior art.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
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 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7, 10 – 26 of copending Application No. 17/978 019 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because each of the claim sets are drawn to the same topical compositions comprising SOD, a stabilizing carrier (deoxygenated water), preservatives (vitamins, antioxidants), stabilizing agents and lidocaine; have the same pH and forms; and wherein they have the same stability properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the prior art fails to teach the claimed composition which requires a specific amount of SOD, deoxygenated water and liposome; and that the combination of deoxygenated water and liposome results in a composition with improved SOD stability and activity which demonstrates surprising results of superior therapeutic effects in a variety of conditions demonstrated by the examples of the specification. Applicant further argues that the copending applications fail to teach the claimed composition which requires a specific amount of SOD, deoxygenated water and liposome.
However, these arguments fail to persuade. Both Zimmerman and Katinger teach topical SOD compositions disclosing the claimed amount of SOD with liposomes as a carrier. The combinations of these references with Perry demonstrate that deoxygenated water was a well known and routinely used carrier for such compositions, rendering the use thereof as a routine practice at the time the claims were filed.
Regarding applicant’s assertions of surprising results, the examples relied upon fail to demonstrate any unexpected result or benefit to the claimed composition. Rather, the examples show that the composition works for some subjects and not others, which alone, is insufficient to demonstrate surprising results.
Regarding the argument that the copending applications fail to teach the claimed composition which requires a specific amount of SOD, deoxygenated water and liposome, this is persuasive to application 17/980 387 and has been withdrawn.
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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, Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699