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 .
Detailed Action
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 June 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner except where lined through. The lined through document was not provided. See attached copy of PTO-1449.
Status of Application
2. Applicant’s arguments/remarks filed 26 August 2025 are acknowledged. Claims 1, 5, 12, 16, 30-31, 35-37, and 74-84 are currently pending. Claims 2-4, 6-11, 13-15, 17-29, 32-34, and 38-73 are cancelled. Claims 74-84 are newly added. Claims 1, 16, 30 and 35 are amended. Claims 1, 5, 12, 16, 30-31, 35-37, and 74-84 are examined on the merits within.
Withdrawn Rejections
3. Applicant’s arguments, filed 26 August 2025, with respect to the 35 U.S.C. 112(b) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejections of claims 16, 30-31, and 35-37 have been withdrawn. The 35 U.S.C. 102(a)(1) Rejections of Kirnon and Bland are withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejections of Kirnon et al. in view of Greenberg et al. have been withdrawn in view of the amendments and arguments.
Claim Rejections – 35 U.S.C. 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.
5. Claim(s) 1, 5, 12, 74, 80 and 82 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bland (U.S. Patent No. 5,629,023) in view of Schmidl (U.S. Patent No. 4,414,238).
Bland teaches a medical food comprising a buffering agent and N-acetylcysteine. See abstract. Buffering agents including dipotassium phosphate, ammonium acetate, and potassium acetate. See column 4, lines 53-61. The dietary composition is a powder-like mixture which is administered to patients mixed with water or fruit juice. See column 6, lines 60-67. The composition additionally comprises vitamins. See claim 1.
Bland does not teach a pH between 3.5 and 6.7.
Schmidl teaches a ready to use liquid elemental diet comprising a nutritionally acceptable combination of carbohydrate, amino acid and lipid components having a pH ranging from about 3.0 to 4.4. See abstract. The pH allows for stability over prolonged periods. See column 2, lines 5-25. Amino acids include cysteine and glycine. See Table II. The composition may also include dipotassium phosphate. See Table III.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the pH of the formulation of Bland to increase the stability of the ingredients. One would have been motivated, with a reasonable expectation of success, to prolong storage of the formulation. Since Bland teaches the addition of fruit juice, it would have been obvious to substitute one flavoring agent for another to yield predictable results while achieving a desired taste.
6. Claim(s) 16 and 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bland (U.S. Patent No. 5,629,023) in view of Schmidl (U.S. Patent No. 4,414,238) as applied to claims 1, 5, 12, 74, 80 and 82 above and further in view of Kirnon et al. (U.S. Patent Application Publication No. 2018/0161297).
Bland and Schmidl do not teach the claimed glycine derivatives.
Kirnon et al. teach compositions comprising glycine and N-acetylcysteine. See abstract. The composition also comprises pH buffering agents such as sodium acetate, sorbitan monolaurate or triethanolamine oleate. See paragraph [0068]. The composition also includes a diluent such as dicalcium phosphate (i.e., provides buffer function). See paragraph [0065]. The active compounds may be formulated as a liquid composition by dissolving or dispersing in a carrier. See paragraph [0067]. The composition may be in the form of an emulsion, suspension, solution, etc. See paragraph [0062]. The glycine derivative is selected from the group consisting of D-Allylglycine; N-[Bis(methylthio)methylene]glycine methyl ester; Boc-allyl-Gly-OH (dicyclohexylammonium) salt; Boc-D-Chg-OH; Boc-Chg-OH; (R)—N-Boc-(2′-chlorophenyl)glycine; Boc-L-cyclopropylglycine; Boc-L-cyclopropylglycine; (R)—N-Boc-4-fluorophenylglycine; Boc-D-propargylglycine; Boc-(S)-3-thienylglycine; Boc-(R)-3-thienylglycine; D-α-Cyclohexylglycine; L-α-Cyclopropylglycine; N-(2-fluorophenyl)-N-(methylsulfonyl) glycine; N-(4-fluorophenyl)-N-(methylsulfonyl)glycine; Fmoc-N-(2,4-dimethoxybenzyl)-Gly-OH; N-(2-Furoyl)glycine; L-α-Neopentylglycine; D-Propargylglycine; sarcosine; Z-α-Phosphonoglycine trimethyl ester, and a mixture thereof. The glycine and N-acetylcysteine may be comprised in a dipeptide, such as N-acetylcysteinylglycine or cysteinylglycine. See paragraph [0038].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one glycine compound for another to yield predictable results because both Bland and Kirnon et al. are directed to similar formulations comprising N-acetyl cysteine, glycine, and buffering components.
7. Claim(s) 76-78 and 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bland (U.S. Patent No. 5,629,023) in view of Schmidl (U.S. Patent No. 4,414,238) as applied to claims 1, 5, 12, 74, 80 and 82 above and further in view of De Angelis (WO2015/087213).
Bland and Schmidl do not teach sodium carbonate or potassium carbonate.
De Angelis teaches a food supplement comprising D-mannose, Morinda citrifolia freeze dried juice and N-acetylcysteine. See abstract. The formulation also comprises an acidity adjusting agent selected from sodium carbonate and potassium carbonate. See claim 5. De Angelis teaches N-acetylcysteine in amounts of 0.1 to 6% weight/weight. See claim 1.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use sodium carbonate and/or potassium carbonate to adjust the pH of the formulation because De Angelis teaches these agents as effective acidity adjusting agents in food supplements comprising N-acetylcysteine. It would have been obvious to modify the ratio of acidity adjusting agents dependent on the desired pH of the formulation.
8. Claim(s) 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bland (U.S. Patent No. 5,629,023) in view of Schmidl (U.S. Patent No. 4,414,238) as applied to claims 1, 5, 12, 74, 80 and 82 above and further in view of Truong-Le et al. (U.S. Patent Application Publication No. 2003/0215515).
Bland and Schmidl do not teach sodium hydroxide or potassium hydroxide.
Truong-Le et al. teach compositions to preserve bioactive materials. See abstract. Formulations may comprise 10 mM N-acetylcysteine. The pH can be adjusted with either potassium hydroxide or sodium hydroxide. See paragraph [0156].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute one buffering agent for another to yield predictable results because Truong-Le et al. teach sodium and potassium hydroxide effectively modify the pH of formulations comprising N-acetylcysteine.
9. Claim(s) 30-31, 35-37, and 83-84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirnon et al. (U.S. Patent Application Publication No. 2018/0161297) in view of Schmidl (U.S. Patent No. 4,414,238).
Kirnon et al. teach compositions comprising glycine and N-acetylcysteine. See abstract. The composition also comprises pH buffering agents such as sodium acetate, sorbitan monolaurate or triethanolamine oleate. See paragraph [0068]. The composition also includes a diluent such as dicalcium phosphate (i.e., provides buffer function). See paragraph [0065]. The active compounds may be formulated as a liquid composition by dissolving or dispersing in a carrier. See paragraph [0067]. The composition may be in the form of an emulsion, suspension, solution, etc. See paragraph [0062]. The glycine derivative is selected from the group consisting of D-Allylglycine; N-[Bis(methylthio)methylene]glycine methyl ester; Boc-allyl-Gly-OH (dicyclohexylammonium) salt; (R)—N-Boc-(2′-chlorophenyl)glycine; Boc-L-cyclopropylglycine; Boc-L-cyclopropylglycine; (R)—N-Boc-4-fluorophenylglycine; Boc-D-propargylglycine; Boc-(S)-3-thienylglycine; Boc-(R)-3-thienylglycine; D-α-Cyclohexylglycine; L-α-Cyclopropylglycine; N-(2-fluorophenyl)-N-(methylsulfonyl) glycine; N-(4-fluorophenyl)-N-(methylsulfonyl)glycine; Fmoc-N-(2,4-dimethoxybenzyl)-Gly-OH; N-(2-Furoyl)glycine; L-α-Neopentylglycine; D-Propargylglycine; sarcosine; Z-α-Phosphonoglycine trimethyl ester, and a mixture thereof. The glycine and N-acetylcysteine may be comprised in a dipeptide, such as N-acetylcysteinylglycine or cysteinylglycine. See paragraph [0038].
Kirnon et al. teach administering the composition for medical conditions related to insufficient levels of glutathione including treatment of metabolic syndrome. See paragraph [0010]. The composition may be provided orally to the individual. See paragraph [0037]. Kirnon et al. teach administering the formulation to treat sarcopenia, sarcopenic obesity, and muscle wasting in elderly. See Examples 1 and 2.
Kirnon et al. do not teach adjusting the pH to between 3.7 and 6.5.
Schmidl teaches a ready to use liquid elemental diet comprising a nutritionally acceptable combination of carbohydrate, amino acid and lipid components having a pH ranging from about 3.0 to 4.4. See abstract. The pH allows for stability over prolonged periods. See column 2, lines 5-25. Amino acids include cysteine and glycine. See Table II. The composition may also include dipotassium phosphate. See Table III.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the pH of the formulation of Kirnon et al. to increase the stability of the ingredients. One would have been motivated, with a reasonable expectation of success, to prolong storage of the formulation.
Conclusion
10. 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
11. No claims are allowed at this time.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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, Robert Wax can be reached at 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WORSHAM/Primary Examiner, Art Unit 1615