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 .
Claim Status
Claims 1, 3, 5, 6, and 9-16 were amended and claims 2 and 4 were canceled in the response filed 2/17/2026. Claims 1, 3, and 5-31 are pending, claims 17-31 stand withdrawn, and claims 1, 3, and 5-16 are under examination.
Priority
The instant application was filed on 5/30/2024.
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See filing receipt dated 6/14/2024.
Claims 1, 3, and 5-16 only appear to be able to claim the benefit of the instant filing date (5/30/2024). None of the prior applications disclose a method for treating a disease or condition in an animal or human in need thereof comprising identifying that a subject has a disease or condition caused by oxidative stress and providing an effective amount of an N-acetylcysteine amide (NACA).
Withdrawn Objections
The amendments filed on 2/17/2026 are persuasive to overcome the objections to the specification, drawings, and claims of record on p. 3-5 of the OA dated 11/17/2025. Therefore, the objections are withdrawn.
Claim Interpretation
Impurities B1 and B2 are defined in [0196] of the specification as filed:
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Regarding claims 15 and 16, the term “diNACA” is defined as disulfide of N-acetyl-L-cysteine amide in [0005] of the specification as filed.
New Claim Objections
Claim 1 is objected to because of the following informalities:
The Applicant amended claim 1, lines 5-6 to recite the following:
“providing an effective amount of comprising an N-acetylcysteine amide (NACA) composition in the animal or human sufficient to increase a concentration of NACA, and at least one of impurities B1 and B2”
There are two issues with the limitation. First, the underlined phrase “of comprising” does not make sense in the first line above. Presumably the Applicant is intending to claim a composition comprising an effective amount of NACA and at least one of impurities B1 and B2, but the way it is written does not make sense.
The second issue is the phrase “in the animal or human” in the second line above. One can provide an effective amount of NACA to the human or animal or raise the concentration of NACA in a human or animal. The word “in” does not make sense in the context in which it is used in the claim. Presumably, the Applicant is intending to claim providing a composition comprising an effective amount of NACA and at least on of impurities B1 and B2 to the animal or human sufficient to increase a concentration of NACA in the animal or human, wherein impurity B1… However, the way it is written does not make sense.
Appropriate correction is required.
Withdrawn Claim Rejections - 35 USC § 112
Applicant canceled claim 4, therefore the 35 USC 112(b) rejection of record on p. 5-6 of the OA dated 11/17/2025 is withdrawn.
New Claim Rejections - 35 USC § 112(d)-Necessitated by Amendment
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 3 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.
Independent claim 1 was amended to include the range of “wherein impurity B1 is at a level greater than zero but less than 5% peak area percent (PA%) and impurity B2 is at a level greater than zero but less than 7 PA% as determined by HPLC peak area analysis”. This is identical to the third option in claim 3. Therefore, when this embodiment is present, it fails to further limit claim 1.
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.
Maintained Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. See p. 6-10 of the OA dated 11/17/2025 regarding the rejection of record.
Claim(s) 1, 3, and 5-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wall (US 10590073B2, published 3/17/2020, of record) in combination with Goldstein (US2009/0234011, published on 9/17/2009, of record).
Applicant Claims
Applicant claims a method for treating a disease or condition in an animal or human in need thereof comprising:
identifying that the animal or human has a disease or condition caused by oxidative stress;
providing a composition comprising an effective amount of N-acetylcysteine amide (NACA) and at least one of impurities B1 and B2 to the animal or human sufficient to increase a concentration of NACA in the animal or human, wherein impurity B1 is at a level greater than zero but less than 5% peak area percent (PA%) and impurity B2 is at a level greater than zero but less than 7 PA% as determined by HPLC peak area analysis.; and
treating the disease or condition with NACA that comprises at least one of impurities B1 or B2.
Determining the Scope and Content of the Prior Art (MPEP §2141.01)
Wall discloses a process for preparing NACA. See claim 1. Wall further discloses that the NACA produced from said process contains impurities B1 and B2, though they are not fully characterized. Wall also explicitly teaches that B1 and B2 are detectable by HPLC and provides a chromatogram in Figure 13. See Fig. 13 and col. 16, line 62-col. 17, line 17. As the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of Wall is identical, or substantially identical, to those of instant claims 1 and 3. See MPEP 2112 and example 4 in [0202-0204] of the specification as filed. Wall further teaches that the disclosed process for preparing NACA can be used as an efficient method for the effective, large-scale synthesis of NACA that provides the product in high chemical yields, and high chemical and enantiomeric purity, without the need for chromatography. See col. 1, lines 45-50 and col. 5, lines 33-40.
Goldstein teaches methods and compositions comprising N-acetylcysteine amide (NACA/NAC amide) which are used in treatments and therapies for human and non-human mammalian disease, disorder, conditions, and pathologies. The compositions, alone or in combination with other suitable agents, are used to treated conditions and diseases caused by oxidative stress. See abstract and claims. Goldstein further teaches that the humans and non-human mammals in need of treatment are detected (identified) by means of physical examination, laboratory, or instrumental methods. See [0037-0042]. Goldstein teaches that the NACA compositions are provided in a therapeutically effective amount to treat the diseases and conditions caused by oxidative stress, including but not limited to traumatic brain injury (claim 8) and Alzheimer’s (claim 7). See [0152]. The examples of Goldstein teach that administration of NACA to a subject increases the concentration of NACA in said subject, in order to treat the diseases and conditions caused by oxidative stress. See [0195-0254].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02-03)
Wall does not explicitly teach using NACA to treat a disease or condition caused by oxidative stress. Goldstein does not explicitly teach NACA comprising impurities B1 and B2.
Finding of Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of Wall and Goldstein to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to combine the production process of Wall, which will necessarily produce NACA comprising B1 and B2 because it is identical to that claimed, with the treatment methods of Goldstein in order to predictably arrive at a method for effectively and efficiently producing NACA in high yield, chemical and enantiomeric purity for use in the treatment of diseases and conditions caused by oxidative stress in humans and non-human mammals. Also see MPEP 2143(I)(A).
Regarding claims 5, 6, and 9-13, Goldstein teaches that the NACA can be administered by several routes, including but not limited to oral, intramuscular, and topical administration. Goldstein teaches that the NACA can also be administered by injection or in the form of a topically administered gel, ointment, cream, suppository, lotion, drops, liquids, sprays and powders. See [0115-0117]. Goldstein also teaches that topical administration includes solutions of NACA. See [0117]. Goldstein teaches that dosages are depending upon the concentration of NACA, the mode of administration, and the condition or disease to be treated. See [0121], which recites: “as is appreciated by the skilled practitioner in the art, dosing is dependent on the severity and responsiveness of the condition to be treated, but will normally be one or more doses per day, with course of treatment lasting from several days to several months, or until a cure is effected or a diminution of disease state is achieved. Persons ordinarily skilled in the art can easily determine optimum dosages, dosing methodologies, and repetition rates”. In the same paragraph Goldstein further recites an exemplary oral dosage of at least 25-500 mg per dose, which overlaps with several of the claimed ranges. Also see MPEP 2144.05 regarding the obviousness of ranges and routine optimization.
Regarding claim 14, though this is a product-by-process type limitation to define the NACA composition and the process limitations are not accorded patentable weight, Wall does explicitly teach that the NACA can be purified by crystallization and that no chromatography is required. See col. 9, lines 33-40 and col. 1, lines 45-50.
Regarding claims 15 and 16, diNACA, or di-N-acetylcystine amide, is the immediate precursor to NACA in the process of Wall. As the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of Wall is identical, or substantially identical, to those claimed. See MPEP 2112. Further, Wall explicitly teaches that the NACA has a purity of ≥ 98.0%, which encompasses the ranges of impurities in the claim. See col. 9, lines 37-40 and col. 15, lines 5-16.
Response to Applicant Arguments on p. 13-15 of the response filed 2/17/2026
The Applicant argues that Wall (US 10590073B2) does not qualify as prior art against the present invention as this application claims priority to US App. No. 16/137262 (The app. no. of US 10590073B2). On p. 13 of the response (see Priority Objection section), the Applicant argues that none of the prior applications (in the parent family of the instant invention) disclose a method for treating a disease or condition in an animal or human in need thereof comprising identifying that a subject has a disease or condition caused by oxidative stress and providing an effective amount of an N-acetylcysteine amide (NACA). Applicants traverse the priority objection, as this application and the NACA composition claim priority to, at least, U.S. Application Serial No. 16/137,262, thus disqualifying Wall as prior art. Applicant additionally includes a “Statement of Joint Ownership”, which appears to refer to pre-AIA case law to support the argument.
Applicant further argues that the claims have been amended to clarify that what is claimed is a NACA composition that includes NACA and impurities B1 and B2 at the listed levels. Thus, the impurities are part of the composition and directly claim the product. As such, the limitation is not a product-by-process limitation. Nothing in the art of Wall or Goldstein teaches NACA composition that includes NACA and impurities B1 and B2 at the listed levels for the treatment claimed.
The Applicant’s arguments have been fully considered but are not persuasive. Regarding the applicability of Wall as prior art, as discussed in the “Priority” section of the previous (p. 2-3) and instant office action, “none of the prior applications disclose a method for treating a disease or condition in an animal or human in need thereof comprising identifying that a subject has a disease or condition caused by oxidative stress and providing an effective amount of an N-acetylcysteine amide (NACA)”. The Applicant’s comments in the response appear to confirm this determination.
As shown by filing receipt dated 6/14/2024, the instant application is the fourth CIP of US app. no. 16/137262 (Wall):
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. As taught by MPEP 210.8: “A continuation-in-part is an application filed during the lifetime of a prior-filed nonprovisional application, international application designating the United States, or international design application designating the United States repeating some substantial portion or all of the prior-filed application and adding matter not disclosed in the prior-filed application (emphasis added)”.
MPEP 211.05(I) discusses the disclosure requirement that must be met in order to successfully claim the benefit of priority to an early application:
“To be entitled to the benefit of the filing date of an earlier-filed application, the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or earlier-filed nonprovisional application or provisional application for which benefit is claimed); the disclosure of the invention in the prior application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) except for the best mode requirement. See Transco Prods., Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). Accordingly, the disclosure of the prior-filed application must provide adequate support and enablement for the claimed subject matter of the later-filed application in compliance with the requirements of 35 U.S.C. 112(a) (emphasis added) except for the best mode requirement.”
With respect to continuation-in-part applications MPEP 211.05(B) recites:
“A continuation-in-part application may include matter not disclosed in the prior-filed application. See MPEP § 201.08. Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application (emphasis added). If there is a continuous chain of co-pending nonprovisional applications, each co-pending application must disclose the claimed invention of the later-filed application in the manner provided by 35 U.S.C. 112(a) in order for the later-filed application to be entitled to the benefit of the earliest filing date. See Regents of the University of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 1358, 1360, 2023 USPQ2d 269”.
Accordingly, as the Applicant appears to admit that none of the priority applications disclose all of the claimed features of the independent claim 1, then the claims are only entitled to the benefit of the instant filing date (5/30/2024) because a claim can only have a single filing date. Therefore, though the instant application claims the benefit of priority to US app. no. 16/137262 (Wall), the claims of the instant application are not entitled to the benefit of that priority. Wall (US 10590073B2) was published on 3/17/2020, and thus qualifies as prior art under 35 USC 102(a)(1).
Regarding the “Statement of Joint Ownership”, the case law cited by the Applicant refers to pre-AIA . The instant application was filed in 2024, and the earliest priority claim is to an application filed in 2017. Thus, the instant application is subject to AIA , not pre-AIA , under any possible priority dates.
Regarding the levels of B1 and B2 in the NACA, example 4 in [0202-0204] of the specification as filed explicitly teaches that NACA used in the characterization experiment was prepared and quantified using methods described in Wall:
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. Therefore, the claimed levels of B1 and B2 are inherent to the Wall publication. Also see MPEP 2112.
For these reasons, the rejection of record is maintained.
Withdrawn Statutory Double Patenting Rejection
The amendments to the instant claims and those of 18/770850 (‘850) are sufficient to overcome the rejection of record on p. 11-12 of the OA dated 11/17/2025; therefore, the rejection is withdrawn.
Modified Non-Statutory Double Patenting Rejection-Necessitated by Amendment
See p. 12-20 of the OA dated 11/17/2025 regarding the rejections of record.
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, 3, and 5-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of co-pending Application No. 18/770850 (reference application).
The claims of ‘850 are directed to a product with the same intended use as that claimed and is made by an identical process to that claimed, which inherently produces impurities B1 and B2 in the claimed levels. Therefore, the claims of ‘850 anticipate the claimed process. This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10590073 (Wall in the 35 USC 103 rejection) in view of Goldstein (US2009/0234011, published on 9/17/2009).
The teachings of ‘073/Wall and Goldstein were disclosed in the 35 USC 103 rejection above and are incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of ‘073 and Goldstein to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to combine the production process of ‘073, which will necessarily produce NACA comprising B1 and B2 because it is identical to that claimed, with the treatment methods of Goldstein in order to predictably arrive at a method for effectively and efficiently producing NACA in high yield, chemical and enantiomeric purity for use in the treatment of diseases and conditions caused by oxidative stress in humans and non-human mammals. Also see MPEP 2143(I)(A).
Regarding claims 5, 6, and 9-13, Goldstein teaches that the NACA can be administered by several routes, including but not limited to oral, intramuscular, and topical administration. Goldstein teaches that the NACA can also be administered by injection or in the form of a topically administered gel, ointment, cream, suppository, lotion, drops, liquids, sprays and powders. See [0115-0117]. Goldstein also teaches that topical administration includes solutions of NACA. See [0117]. Goldstein teaches that dosages are depending upon the concentration of NACA, the mode of administration, and the condition or disease to be treated. See [0121], which recites: “as is appreciated by the skilled practitioner in the art, dosing is dependent on the severity and responsiveness of the condition to be treated, but will normally be one or more doses per day, with course of treatment lasting from several days to several months, or until a cure is effected or a diminution of disease state is achieved. Persons ordinarily skilled in the art can easily determine optimum dosages, dosing methodologies, and repetition rates”. In the same paragraph Goldstein further recites an exemplary oral dosage of at least 25-500 mg per dose, which overlaps with several of the claimed ranges. Also see MPEP 2144.05 regarding the obviousness of ranges and routine optimization. Regarding claims 14-16, as the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of ‘073 is identical, or substantially identical, to those claimed. See MPEP 2112.
Claims 1, 3, and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11091433 (‘433) in view of Goldstein (US2009/0234011, published on 9/17/2009).
The teachings of Goldstein were disclosed in the 35 USC 103 rejection above and are incorporated herein.
Claims 1 and 28 of ‘433 teach species of the process in instant claim 1 for producing NACA. ‘433 does not explicitly teach NACA comprising impurities B1 and B2.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of ‘433 and Goldstein to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to combine the production process of ‘433, which will necessarily produce NACA comprising B1 and B2 because it is identical to that claimed, with the treatment methods of Goldstein in order to predictably arrive at a method for effectively and efficiently producing NACA in high yield, chemical and enantiomeric purity for use in the treatment of diseases and conditions caused by oxidative stress in humans and non-human mammals. Also see MPEP 2143(I)(A).
Regarding claims 5, 6, and 9-13, Goldstein teaches that the NACA can be administered by several routes, including but not limited to oral, intramuscular, and topical administration. Goldstein teaches that the NACA can also be administered by injection or in the form of a topically administered gel, ointment, cream, suppository, lotion, drops, liquids, sprays and powders. See [0115-0117]. Goldstein also teaches that topical administration includes solutions of NACA. See [0117]. Goldstein teaches that dosages are depending upon the concentration of NACA, the mode of administration, and the condition or disease to be treated. See [0121], which recites: “as is appreciated by the skilled practitioner in the art, dosing is dependent on the severity and responsiveness of the condition to be treated, but will normally be one or more doses per day, with course of treatment lasting from several days to several months, or until a cure is effected or a diminution of disease state is achieved. Persons ordinarily skilled in the art can easily determine optimum dosages, dosing methodologies, and repetition rates”. In the same paragraph Goldstein further recites an exemplary oral dosage of at least 25-500 mg per dose, which overlaps with several of the claimed ranges. Also see MPEP 2144.05 regarding the obviousness of ranges and routine optimization. Regarding claims 14-16, as the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of ‘433 is identical, or substantially identical, to those claimed. See MPEP 2112.
Claims 1, 3, and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11548851 (‘851) in view of U.S. Patent No. 10590073 (‘073, published 3/17/2020) and Goldstein (US2009/0234011, published on 9/17/2009).
The teachings of Goldstein were disclosed in the 35 USC 103 rejection above and are incorporated herein.
Claims 1-17 of ‘851 teach the production of diNACA (di-N-acetylcystine dimethylester) using the same steps as those for producing NACA in instant claim 1. ‘851 does not explicitly teach NACA comprising impurities B1 and B2.
‘073 teaches that the diNACA produced in ‘073 can be used to produce NACA comprising impurities B1 and B2. See claims.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of ‘851, ‘073, and Goldstein to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to combine the production process of ‘851, with that of ‘073 in order to produce NACA comprising B1 and B2 using an identical process to that claimed, wherein Goldstein teaches that NACA can be used to treat diseases and conditions associated with oxidative stress. Thus, Goldstein provides a motive to combine the process of ‘851 with that of ‘073 to obtain the pharmaceutical NACA. It would have been further prima facie obvious to combine the process of ‘851/’073 for producing NACA with the treatment methods of Goldstein in order to predictably arrive at a method for effectively and efficiently producing NACA in high yield, chemical and enantiomeric purity for use in the treatment of diseases and conditions caused by oxidative stress in humans and non-human mammals. Also see MPEP 2143(I)(A).
Regarding claims 5, 6, and 9-13, Goldstein teaches that the NACA can be administered by several routes, including but not limited to oral, intramuscular, and topical administration. Goldstein teaches that the NACA can also be administered by injection or in the form of a topically administered gel, ointment, cream, suppository, lotion, drops, liquids, sprays and powders. See [0115-0117]. Goldstein also teaches that topical administration includes solutions of NACA. See [0117]. Goldstein teaches that dosages are depending upon the concentration of NACA, the mode of administration, and the condition or disease to be treated. See [0121], which recites: “as is appreciated by the skilled practitioner in the art, dosing is dependent on the severity and responsiveness of the condition to be treated, but will normally be one or more doses per day, with course of treatment lasting from several days to several months, or until a cure is effected or a diminution of disease state is achieved. Persons ordinarily skilled in the art can easily determine optimum dosages, dosing methodologies, and repetition rates”. In the same paragraph Goldstein further recites an exemplary oral dosage of at least 25-500 mg per dose, which overlaps with several of the claimed ranges. Also see MPEP 2144.05 regarding the obviousness of ranges and routine optimization. Regarding claims 14-16, as the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of ‘851/’073 is identical, or substantially identical, to those claimed. See MPEP 2112.
Claims 1, 3, and 5-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18-22 of co-pending U.S. App. No. 18/094459 (‘459) in view of U.S. Patent No. 10590073 (‘073, published 3/17/2020) and Goldstein (US2009/0234011, published on 9/17/2009).
The teachings of Goldstein were disclosed in the 35 USC 103 rejection above and are incorporated herein.
The claims of of ‘459 teach the production of diNACA (di-N-acetylcystine dimethylester) using the same steps as those for producing NACA in instant claim 1. ‘459 does not explicitly teach NACA comprising impurities B1 and B2.
‘073 teaches that the diNACA produced in ‘073 can be used to produce NACA comprising impurities B1 and B2. See claims.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of ‘459, ‘073, and Goldstein to arrive at the instantly claimed process with a reasonable expectation of success before the effective filing date of the claimed invention. A person of ordinary skill would have been motivated to combine the production process of ‘459, with that of ‘073 in order to produce NACA comprising B1 and B2 using an identical process to that claimed, wherein Goldstein teaches that NACA can be used to treat diseases and conditions associated with oxidative stress. Thus, Goldstein provides a motive to combine the process of ‘459 with that of ‘073 to obtain the pharmaceutical NACA. It would have been further prima facie obvious to combine the process of ‘459/’073 for producing NACA with the treatment methods of Goldstein in order to predictably arrive at a method for effectively and efficiently producing NACA in high yield, chemical and enantiomeric purity for use in the treatment of diseases and conditions caused by oxidative stress in humans and non-human mammals. Also see MPEP 2143(I)(A).
Regarding claims 5, 6, and 9-13, Goldstein teaches that the NACA can be administered by several routes, including but not limited to oral, intramuscular, and topical administration. Goldstein teaches that the NACA can also be administered by injection or in the form of a topically administered gel, ointment, cream, suppository, lotion, drops, liquids, sprays and powders. See [0115-0117]. Goldstein also teaches that topical administration includes solutions of NACA. See [0117]. Goldstein teaches that dosages are depending upon the concentration of NACA, the mode of administration, and the condition or disease to be treated. See [0121], which recites: “as is appreciated by the skilled practitioner in the art, dosing is dependent on the severity and responsiveness of the condition to be treated, but will normally be one or more doses per day, with course of treatment lasting from several days to several months, or until a cure is effected or a diminution of disease state is achieved. Persons ordinarily skilled in the art can easily determine optimum dosages, dosing methodologies, and repetition rates”. In the same paragraph Goldstein further recites an exemplary oral dosage of at least 25-500 mg per dose, which overlaps with several of the claimed ranges. Also see MPEP 2144.05 regarding the obviousness of ranges and routine optimization. Regarding claims 14-16, as the NACA comprising B1 and B2 in Wall is produced by an identical process to that claimed, it is presumed that the NACA, B1, and B2 composition of ‘851/’073 is identical, or substantially identical, to those claimed. See MPEP 2112. This is a provisional nonstatutory double patenting rejection.
The Applicant requests that all non-statutory double patenting rejections be held in abeyance on p. 15 of the 2/17/2026 response. Therefore, they are maintained for the reasons set forth above.
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 AMY C BONAPARTE whose telephone number is (571)272-7307. The examiner can normally be reached 11-7.
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/AMY C BONAPARTE/ Primary Examiner, Art Unit 1692