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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1 – 26 in the reply filed on August 27, 2025 is acknowledged. The traversal is on the grounds that the inventions are related, not independent, not distinct, have an overlapping search with the terms “SOD” and “topical composition,” and that there is no serious burden on examiner to examine all groups together. Applicant additionally requests rejoinder of non-elected groups and evidence of distinctness between the inventions.
This is not found persuasive because as indicated in the election restriction requirement, the inventions are both independent and distinct because the groups are related as product and process of use. The inventions were shown to be distinct with a two-way demonstration. Specifically, (1) the process for using the product as claimed can be practiced with another materially different product AND (2) the product as claimed can be used in a materially different process of using that product.
With regard to the literature, it is agreed that the searches for both groups may overlap. However, an overlapping search is not a coextensive search, creating a serious burden to examine all groups together.
The requirement is still deemed proper and is therefore made FINAL.
Applicant is reminded that non-elected claims may be considered for rejoinder when all claims directed to the elected invention are in condition for allowance. In order to be eligible for rejoinder, a claim to a nonelected invention must depend from or otherwise require all the limitations of an allowable claim. In order to retain the right to rejoinder, applicant is advised that the claims to the nonelected invention(s) should be amended during prosecution to require the limitations of the elected invention. Failure to do so may result in a loss of the right to rejoinder. MPEP 821.04
Claims 1 – 33 are pending; claims 27 – 33 are withdrawn as non elected subject matter; claims 1 – 26 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 27, 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
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.
Claims 1 – 21 and 23 – 26 are 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.
Claim 1 and its dependents are drawn to a topical composition, however are rendered vague and indefinite for reciting “therapeutically effective amount”. Although on its face the phrase is not indefinite, the claims fail to state the function which is to be achieved and more than one effect is implied by the specification (specification pp.7, 45 - 47, MPEP 2173.05(c) III). For purposes of examination the claim is interpreted to encompass topical compositions comprising any amount of superoxide dismutase (SOD).
In claims 6 and 7, it is unclear if the recited components are intended to be a Markush group in the alternative as proper Markush language is not recited. It is further unclear if “a combination thereof” indicates all must be included or various combinations may be included. Clarification is required.
In claims 8 and 10, “consisting essentially of” is improper Markush language and is considered open ended language from which to choose stabilizing agents. Correction and clarification are required.
In claim 12, “active agent” is not adequately defined by the claim language or specification.
In claim 15, the term “member” is confusing as it is unclear how the term limits the scope of the claim. Applicant may overcome this rejection by deleting “a member” from the claim.
Claim 17 is indefinite because it appears to change the scope of rather than further define the claim on which it depends by reciting “or a different.” Clarification is required.
Claim 20 is rendered indefinite for reciting a viscosity of the composition without also setting forth the conditions at which the viscosity must occur, e.g., temperature, pressure and shear rate.
In claim 21, the phrase “is formulated as” renders the claim indefinite as it is unclear whether the phrase is intended to indicate a product by process step, or an active step that must be carried out to meet the limitation of the claim. For purposes of examination the limitation will be interpreted to mean the composition is in the form of one of those listed.
In claim 21, it is unclear how a single composition can be a combination of the recited forms, e.g., solution, hydrogel, cream, paste and patch.
In claim 23, the recitations of “or” render the claim indefinite as it is unclear which parameters are recited in the alternative. Specifically, it is unclear if the concentration of SOD is required to be 0.02% and also have one of the following characteristics, or if the recited concentration is an alternative to the following characteristics.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claim appears to change the scope of claims 1 and 12, which require a composition to include SOD and an active agent in the same composition, to include multiple compositions containing different components (e.g., the SOD and active agent).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4 – 13, 17 – 18, 20 – 23, 25 – 26 are rejected 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).
Regarding claim 1, Zimmerman teaches topical compositions (abstract) comprising therapeutically effective amounts of superoxide dismutase (SOD) (0007, 0023 - 0024) with a stabilizing carrier (0023-0024,0069 – 0070) for topical application (abstract, examples 6-11).
Regarding claims 4 – 8 and 10 - 11, the composition further includes preservatives and/or emollients (0069-0074), adjuvants (0087) fatty acids (0089), lecithin (phospholipids) (examples), liposomal capsules (encapsulating agent) (0037), starch (0072).
Regarding claim 9, the liposomal capsule acts to stabilize the SOD, effectively forming a complex with the SOD (0037).
Regarding claims 12 – 13 and 17 - 18, the compositions may include other active agents such as various antioxidants, vitamins and sunscreens (e.g., bioflavonoid, tocopherol, green tea extract) (0007, 0024, examples) in amounts of 0.1 – 7% (examples 9 – 12).
Regarding claims 20 - 21, the composition can be as a solution, emulsion, gel, cream, ointment (0069), indicating they would fall into the claimed viscosity upon use thereof.
Regarding claim 22, the SOD is present at 0.0001 – 5% (0039).
Regarding claim 23, 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 25, the compositions do not require the claimed components and are substantially free of ethanol and capsaicin.
Regarding claim 26, 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.
The reference anticipates the claimed subject matter.
Claims 1, 4 – 7, 9 – 12, 17, 19 – 23, 25 – 26 are rejected under 35 U.S.C. 102a1 and 102a2 as being anticipated by Katinger et al. (US 5942245).
Regarding claim 1, Katinger teaches topical compositions comprising therapeutically effective amounts of superoxide dismutase (SOD) and carriers (abstract).
Regarding claims 4 – 7 and 9 – 11, the composition may further include liposome (phospholipid) as a stabilizing agent (col.2 line 18-31).
Regarding claims 12 and 17, 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 claim 19, the formulations are adjusted to ph 7.5 (example 1), or about 7.4.
Regarding claims 20 - 21, the compositions are formed as ointment, gels, creams, liquid (col.7 line 19-26), or hydrogel (col.6 line 42-50), indicating they fall within the claimed viscosity upon application.
Regarding claim 22, the SOD is present at 0.01 – 5% (col.7 line 38-50).
Regarding claim 23, although Katinger 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, Katinger teaches the amount of SOD and must therefore also teach the conditional properties.
Regarding claim 25, the compositions do not required the claimed components and are substantially free of ethanol and capsaicin.
Regarding claim 26, Katinger teaches SODs that may be used in the topical compositions include Cu-Zn type SOD, or SOD1 and SOD3, and Mn-SOD, or SOD2, per applicant’s specification, page 14.
The reference anticipates the claimed subject matter.
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 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zimmerman et al (US 2008/0081082) in view of Perry (US 9468597).
Regarding claim 1, Zimmerman teaches topical compositions (abstract) comprising therapeutically effective amounts of superoxide dismutase (SOD) (0007, 0023 - 0024) with a stabilizing carrier (0023-0024,0069 – 0070) for topical application (abstract, examples 6-11).
Regarding claim 2, Zimmerman does not teach the composition wherein the carrier is deoxygenated water. However, Zimmerman teaches the topical antioxidant compositions include deionized water (examples) and cosmetically/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). 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 claim 24, the combined teachings of Zimmerman and Perry do not materially change the basic and essential characteristics of the antioxidant composition. In this regard, the combination of references is deemed to meet the “consisting essentially of” language.
Thus, the combination of references renders the claims prima facie obvious.
Claims 1, 12 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Katinger et al. (US 5942245) in view of Widgerow (US 2012/0058167).
Regarding claim 1, Katinger teaches topical compositions comprising therapeutically effective amounts of superoxide dismutase (SOD) and carriers (abstract).
Regarding claim 12, 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 13 - 16, 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 – 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims:
1, 3 – 13, 15, 17 – 18 of copending Application No. 18/396 458; and
1, 6, 9, 12 - 17, 20 - 21 of copending Application No. 17/980 387 (reference applications).
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.
No claims are allowed.
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).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 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