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 the method of Claims 11-16 in the reply filed on 11 May 2026 is acknowledged. The traversal is on the ground(s) that unity of invention exists and the Examiner improperly applied art to demonstrate the absence of unity of invention. This is not found persuasive because as the record demonstrates, and applicants admit, the technical feature shared by the claims, a composition containing each of selenium and an antioxidant was, in fact, known in the art prior to applicants having filed the instant application. The prior art, considered as a whole, discloses this combination, as applicants acknowledge. See Applicants response 11 May 2026, Section II.B. (stating “Loscalzo…broadly describes compositions combining a selenium compound with an antioxidant.”). The technical feature shared by the instant claims is precisely this. Applicants acknowledgement that the shared technical feature of the instant claims being known in the art, in accord with the Examiner’s analysis, is sufficient to establish a lack of unity of invention. As search burden is immaterial to restriction in the context of a National Stage entry of an International application per U.S. practice, applicants remaining arguments are unpersuasive as irrelevant to the proper question being addressed.
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 1-5 and 11-16 are pending.
Claims 1-5 are withdrawn from consideration as directed to a non-elected invention.
Claims 11-16 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application is a National Stage entry of International application PCT/KR2022/013994 filed 19 September 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to Korean national applications 10-2021-01258067 filed 17 September 2021, and 10-2022-0117850 filed 19 September 2022.
Claim Interpretation
Applicants claims are directed to methods of treating osteoarthritis by the administration of a composition combining selenium and an antioxidant. Dependent claims 12 and 13 narrow the identity of the selenium containing compound and the antioxidant compound, respectively. Claims 14 and 15 narrow the amount of selenium material and antioxidant, respectively. Claim 16 further narrows the identity and amount of the antioxidant to be present in the composition administered in the method claimed.
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.
Claims 11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill (J. Hill & H.A. Bird, Failure of Selenium-ACE to Improve Osteoarthritis, 29 Br. J Rheumatol. 211 (1990)) as evidenced by “Selenium ACE+D” (Wassen International, available at https://wassen.com/products/selenium-ace-d?variant=43214520910048, Retrieved 29 June 2026).
Hill describes the treatment of osteoarthritis patients by the oral administration of SELENIUM-ACE, a product of Wassen International. (Pg.211-12). The product information obtained by Wassen International, the manufacturer of SELENIUM-ACE indicates that selenium is present in the amount of 96µg, which converts to 1.21µM (using the molar mass of selenium of 78.96g/M), and 80mg of vitamin C, also known as ascorbic acid, which is present in the amount of 80mg, or 0.45mM applying the molecular weight of ascorbic acid of 176.12g/M. These values fall within, and therefore anticipate, the limitations of Claims 11 and 13-15.
Claim Rejections - 35 USC § 103
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 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 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Loscalzo (WO2008/027547) in view of Pera (IT LI20070008)(machine translation and copy of U.S. application 11/277,954 specification provided as translation; all references are to the U.S. Specification).
Loscalzo describes antioxidant combination compositions used to address oxidant stress in cells. (Pg.2). Loscalzo indicates these compositions may be used in the treatment of inflammatory and autoimmune disorders including, among others, arthritis. (Pg.3, 7). These compositions are taught to include antioxidants such as selenium compounds as well as vitamin C and glutathione, among others. (Pg.5). Suitable sources of selenium for use in these compositions and methods include the selenite and selenomethionine recited by Claim 12, provided in an amount effective to treat the condition in the subject to which they are administered. (Pg.10). While not reciting the concentrations of Claim 14, by indicating that the amount of selenium compound is to be used “in an amount effective to treat the condition,” Loscalzo establishes the selenium content of such compositions is a result effective variable suitable for optimization through little more than routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
Loscalzo establishes that combinations of antioxidants, including but not being limited to any or all of selenium via selenite or selenomethionine, vitamin C, and glutathione may be used in the treatment of inflammatory or autoimmune disorders including arthritis. However, the treatment of osteoarthritis in particular, or any useful concentrations of each of vitamin C, glutathione, or the N-acetylcysteine recited by Claims 13, 15, and 16 is not specifically identified by Loscalzo.
This is cured by the teachings of Pera, which also describes compositions containing antioxidants to be used in the treatment of redox-sensitive diseases and disorders. (Pg.1, 11, 12). Pera indicates that free radical scavengers including glutathione peroxidase, vitamin C, and selenium are known to act as antioxidants in the body. (Pg.12). Pera indicates that arthritis, and more specifically osteoarthritis, represent such a redox-sensitive inflammatory disease. (Pg.11, 16). Pera teaches that supplemental N-acetylcysteine (NAC) of Claims 13 and 16 is converted by the body into glutathione which, when combined with selenium is converted into the antioxidant enzyme superoxide dismutase. (Pg.28). Pera teaches that NAC works best when combined with Vitamin C, providing the skilled artisan a motivation to combine NAC, glutathione, and Vitamin C to generate optimal antioxidant status. Id. In addition, Pera indicates that supplements combining glutathione, selenium, and NAC can not only immediately supplement glutathione, but will also serve to increase the body’s production of endogenous glutathione and thereafter glutathione peroxidase to neutralize hydrogen peroxides. (Pg.47). Pera indicates the recommended intake of selenium is 50-200 micrograms, defining a range of 0.63-2.5µM selenium to be used in the compositions, rendering the limitations of Claim 14 prima facie obvious. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Pera describes a number of exemplary embodiments of such compositions, including one labeled “Formula 8 for medical treatment” which combines 200mg glutathione, 500mg Vitamin C, 100mg NAC, and 50 mcg of selenomethionine. (Pg.51). Considering the molecular weights of each of glutathione (307 g/mol), NAC (163 g/mol), vitamin C (176 g/mol), and selenomethionine (196 g/mol), this exemplary embodiment contains 0.65mM glutathione, 0.61mM NAC, 2.84mM Ascorbic acid, and 0.255mM selenomethionine, addressing the selenium containing material limitations of Claim 14 and the NAC limitations of Claim 16, and rendering obvious the glutathione and Vitamin C limitations of Claim 16. (Pg.61), see Aller, supra.(Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation).
Loscalzo therefore teaches the use of combinations of antioxidants including selenium via selenite or selenomethionine, vitamin C, and glutathione for the treatment of inflammatory or autoimmune disorders including arthritis. Pera indicates that antioxidant combinations incorporating the claimed amounts of each of glutathione, NAC, ascorbic acid, and selenomethionine may be used in the treatment of inflammatory disorders including osteoarthritis. It therefore would have been prima facie obvious to have used the claimed combination of glutathione, NAC, ascorbic acid, and selenomethionine in the treatment of osteoarthritis. This is because the art teaches the claimed combination of antioxidants would provide antioxidant supplementation and that such supplementation would be expected to result in the treatment of inflammatory and redox-mediated disorders including the osteoarthritis of the present claims.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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