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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/11/2026 has been entered.
Claim Status
Claims 1 and 3 were amended and claims 7 and 8 were canceled in the after-final response filed on 5/11/2026. The claim set filed on 6/11/2026 appears to be identical to that filed on 5/11/2026. Claims 1, 3, 5, 6, and 9-31 are pending. Claims 17-31 stand withdrawn and claims 1, 3, 5, 6, and 9-16 are under examination.
Withdrawn Claim Objections/Rejections
The amendments filed on 5/11/2026 were persuasive to overcome the claim objection of record on p. 3-4 of the OA dated 3/11/2026 and the 35 USC 112(d) rejection of record on p. 4-5 of the OA dated 3/11/2026. Both were withdrawn in the advisory action dated 5/19/2026.
The terminal disclaimer filed on 6/11/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending app. no. 18/770850 and 18/094459 and US patent no. 10590073, 11091433, and 11548851 has been reviewed and is accepted. The terminal disclaimer has been recorded. Therefore, the non-statutory double patenting rejections of record on p. 14-22 of the OA dated 3/11/2026 are withdrawn.
Priority
The instant application was filed on 5/30/2024 and claims the benefit of priority to:
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See filing receipt dated 6/14/2024.
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 original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications, Application Nos. 18/094459; 17/366913; 16/818416; 16/137262; and 62/561129, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claims 1, 3, 5, 6, and 9-16 only appear to be able to claim the benefit of the instant filing date (5/30/2024). The priority applications provide support for the production of NACA having the claimed impurities and being produced by the product-by-process limitations of claims 17, 26, and 29. However, 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 priority applications appear to be totally silent regarding any methods of treatment.
The Examiner invites the Applicant to point out where ALL of the limitations in claims 1, 3, 5, 6, and 9-16 can be found in the applications in the claimed priority chain to provide the Applicant with the priority date of one of the earlier filed applications.
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.
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. 5-13 of the OA dated 3/11/2026 regarding the rejection of record.
Claim(s) 1, 3, 5, 6, and 9-16 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 an effective amount of an N-acetylcysteine amide (NACA) composition to the animal or human sufficient to increase a concentration of NACA, and at least one of impurities B1 and B2, 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, wherein the disease or condition is selected from retinitis pigmentosa, retinitis pigmentosa associated with Usher syndrome, age-related macular degeneration, cystinosis, corneal endothelial loss, amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, a liposomal storage disease, a gain of function mutation in ACOX1, or Hereditary cystatin C amyloid angiopathy (previously claim 7).
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 and Alzheimer’s. 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, 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. 10-11 of the response filed 6/11/2026 regarding Priority and the Claim Rejections under 35 U.S.C. §103
The Applicant argues that Wall (US 10590073B2) does not qualify as prior art against the present invention as the instant application claims priority to US App. No. 16/137262 (the app. no. of US 10590073B2) as evidenced by the ADS filed with the instant application. However, the Applicant also 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).
The Applicant traverses the 35 USC 103 rejection of record over Wall (US 10590073B2) because “the application claims priority to Wall, Application Serial No. 16/137,262, now issued patent No. 10,590,073 are assigned to Nacuity Pharmaceuticals, Inc. Because the present application claims priority to Application Serial No. 16/137,262, now issued patent No. 10,590,073, it is not applicable prior art, and the subject matter claimed finds support in that application. The prior art to which this application claims priority cannot be cited against the present invention for the subject matter to which it claims priority. Stated another way, the prior art cannot both teach that which is against the Applicant (treating a subject with NACA having certain impurities), but then not allow the Applicant to claim priority to what is taught therein. Wall teaches the impurities as claimed herein and to which the present application claims priority. As such, Wall is not applicable prior art.
Goldstein fails to provide that which is missing from Wall, that is nothing in Goldstein teaches the treatment of any disease or condition with a NACA having the claimed impurities. Without demur and solely to move prosecution forward without disclaimer or prejudice, claim 1 has been amended to include the limitations of canceled claim 7. Nothing in the combination of Wall and Goldstein teaches the invention as claimed.”
The Applicant’s arguments have been fully considered but are not persuasive. Regarding the applicability of Wall as prior art, as discussed on p. 2-3 of the OA dated 11/17/2025; on p. 2 and 9-13 of the OA dated 3/11/2026; the advisory action dated 5/19/2026; and in the “Priority” section of the 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 priority applications appear to be totally silent regarding any methods of treatment. The Applicant’s comments in the response appear to confirm this determination.
The priority applications provide support for the production of NACA having the claimed impurities and being produced by the product-by-process limitations of claims 17, 26, and 29. Therefore, if the claims were limited to this supported scope, then the Applicant could be entitled to claim the benefit of priority of the filing date of one of the earlier applications in the priority chain and potentially disqualify Wall as prior art (assuming the disclosures of the earlier priority applications provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the entire claimed invention).
However, independent claim 1 is directed to:
“a method for treating a disease or condition in an animal or human in need thereof, the method comprising:
identifying that the animal or human has a disease or condition caused by oxidative stress;
providing an effective amount of an NACA composition to the animal or human sufficient to increase a concentration of NACA… and
treating the disease or condition with NACA…wherein the disease or condition is…”.
As described above, none of these limitations appear to be adequately described in any of the priority documents cited on the ADS in the instant application to meet with the requirements under 35 USC 112(a) in order for the instant claims to be accorded the earliest priority claimed by Applicant. Priority is not automatically accorded because Applicant claims it on the ADS. The Examiner invites the Applicant to point out where ALL of the limitations in independent claims 1, 3, 5, 6, and 9-16 can be found in the applications in the claimed priority chain to provide the Applicant with the priority date of one of the earlier filed applications.
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”.
With respect to “Typical Circumstance Where Adequate Written Description Issues Arises” see MPEP 2163.03 (II) and (III):
II. RELIANCE ON FILING DATE OF PARENT APPLICATION UNDER 35 U.S.C. 120
Under 35 U.S.C. 120, the claims in a U.S. application are entitled to the benefit of the filing date of an earlier filed U.S. application if the subject matter of the claim is disclosed in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph in the earlier filed application (emphasis added). See, e.g., Tronzo v. Biomet, Inc., 156 F.3d 1154, 47 USPQ2d 1829 (Fed. Cir. 1998); In re Scheiber, 587 F.2d 59, 199 USPQ 782 (CCPA 1978). See also Regents of the Univ. of Minnesota v. Gilead Scis., Inc., 61 F.4th 1350, 2023 USPQ2d 269 (Fed. Cir. 2023).
III. RELIANCE ON PRIORITY UNDER 35 U.S.C. 119 [AltContent: rect]
Under 35 U.S.C. 119(a) or (e), the claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph (emphasis added). Purdue Pharma LP v. Iancu, 767 Fed. Appx. 918, 923-24, 2019 USPQ2d 136363 (Fed. Cir. 2019); In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawai v. Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
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 because they lack sufficient support under 35 USC 112(a). In other words, priority is not automatically accorded to a previous application because Applicant claims it properly on an ADS, the claim must also be fully supported by the cited priority application according to the provisions of 35 USC 112(a). The Examiner invites the Applicant to point out where ALL of the limitations in independent claims 1, 3, 5, 6, and 9-16 can be found in the applications in the claimed priority chain to provide the Applicant with the priority date of one of the earlier filed applications.
Therefore, Wall (US 10590073B2) published on 3/17/2020, qualifies as prior art under 35 USC 102(a)(1).
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.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY C BONAPARTE/Primary Examiner, Art Unit 1692
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