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 1-30 were previously pending.
Applicant filed a Response to Notice to File Missing Parts on 02 May 2025.
In their Response, Applicant cancelled claims 1-30 and added claims 31-50.
Therefore, claims 31-50 are now pending and currently under examination.
Priority
Examiner acknowledges Applicant’s claim to the following priority:
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Information Disclosure Statement (IDS)
The IDSs (2) filed on 01 July 2025 and 11 August 2026 have been considered by the examiner. Signed copies are enclosed.
Claim Objection - Warning
Applicant is advised that should claim 31 be found allowable, claim 35 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
Claim 49 is objected to for the following reasons: Claim 49 recites “liquid form” twice. This is assumed to be a typographical error. While the duplicate recitation does not presently render the scope of the claim indefinite, amendment is suggested to reduce redundancy.
Claim Rejections - 35 USC § 112(b)
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 39 and 48 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 39 is rejected under 35 USC 112(b) for the following reasons:
Claim 39 recites, “[t]he foodstuff composition of claim 38, wherein said suitable form comprises…a non-slow- or non-sustained-release from.” The context suggests Applicant may have intended ‘form’ instead of ‘from,’ but may also suggest Applicant intended an additional limitation after ‘from.’ The specification also reiterates this phrase (see [0077]), so it is unclear what Applicant is intending and one of ordinary skill in the art could not determine with reasonable certainty the metes and bounds of claim 39.
Claim 35, from which claim 39 ultimately depends, recites “a prodrug of N-acetyl L-cysteine in a suitable form,” and claim 38 subsequently defines “said suitable form” as a liquid, gel, semi-liquid, semi-solid, or solid form. Thus, by antecedent basis, the “suitable form” recited in claim 39 appears to refer to the form of the recited NAC prodrug.
Claim 39, however, further recites that “said suitable form comprises a tablet form, a capsule form, an oral gel form, a food form, a chewable form, a non-chewable form, a slow- or sustained-release form, or a non-slow- or non-sustained-release from [sic].” It is unclear whether the recited ‘suitable forms’ are intended to characterize the NAC prodrug itself or the overall foodstuff composition of claim 35. For example, a tablet or capsule ordinarily describes dosage form of an overall composition rather than the physical form of an individual active ingredient. Likewise, the recitation of ‘a food form’ creates further ambiguity because claim 35 separately requires the overall claimed composition to be a foodstuff composition comprising a food carrier.
Accordingly, one of ordinary skill could not determine the metes and bounds of claim 39 with reasonable certainty because it is unclear whether the recited forms characterize the prodrug, the food carrier, or the overall foodstuff composition.
Claim 48 is rejected under 35 USC 112(b) for the following reason:
Claim 48 depends from claim 47, in which the composition of claim 42 further comprises one or more pharmaceutically acceptable excipients which include a binder, disintegrant, lubricant, filler, etc. Claim 48 then recites, “[t]he composition of claim 47, wherein one or more pharmaceutically acceptable excipients further comprise magnesium stearate, and/or silicon dioxide.” It is unclear if this claim intends for magnesium stearate and silicon dioxide as a species of the pharmaceutically acceptable excipients recited in claim 47 or if claim 48 requires magnesium stearate and silicon dioxide in addition to the pharmaceutically acceptable excipients of claim 47. Accordingly, one of ordinary skill could not determine the metes and bounds of claim 48 with reasonable certainty because the scope of the claim is ambiguous.
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.
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.
Claims 31-41 are rejected under 35 U.S.C. 103 as being unpatentable over Giustarini (cited in Applicant’s 11 August 2026 IDS as: “N-Acetylcysteine ethyl ester (NACET): A novel lipophilic cell-permeable cysteine derivative with an unusual pharmacokinetic feature and remarkable antioxidant potential,” published 19 September 2012) and in further view of Leal (US Pat. No. 10,299,503 B2, date of patent 28 May 2019) and NOW (NAC 600 mg, label version entered 12 February 2021).
Regarding claim 31 –
Giustarini teaches large clinical trials have failed to confirm the supposed beneficial effects of N-acetylcysteine (NAC) in preventing oxidative stress-related diseases that may be due to NACs low bioavailability (abstract). Giustarini hypothesized the esterification of the carboxyl group of NAC to produce N-acetylcysteine ethyl ester (NACET) would drastically increase the lipophilicity of NAC and thus, greatly improve its pharmacokinetics (abstract). Giustarini teaches oral treatment of NAC and NACET, finding that NACET, but not NAC, was able to significantly increase the glutathione content of tissues (abstract, p. 1523). Guistarini further teaches the unique feature of NACET to accumulate in human erythrocytes where it behaves as a potent protector against hydroperoxide-induced oxidative damage (abstract, p. 1529). Thus, Guistarini teaches the claimed NACET prodrug and its glutathione-modulating capability.
While Giustarini does not expressly characterize the taught NACET composition as a food composition comprising a food carrier, this limitation is made obvious in view of Leal.
Leal teaches NAC compositions formulated for oral consumption and expressly teaches combining such compositions with food and beverages, including chicken soup and flavored drinks (abstract and col. 2, lines 52-56).
Regarding claim 32 –
Leal expressly teaches incorporating NAC compositions into food and beverages (col. 9, lines 29-32). Accordingly, packaging the modified NACET composition as a beverage or semi-solid food (e.g., soup) would have been an obvious use of the known food delivery forms.
Regarding claim 33 –
Giustarini expressly teaches NACET.
Regarding claim 34 –
NOW teaches an oral dietary supplement comprising selenium, molybdenum, and NAC (p. 3). Furthermore, NOW teaches selenium and molybdenum are essential trace minerals that facilitate production of glutathione enzymes (p. 4).
Regarding claim 35 –
As discussed above, Giustarini teaches NACET; Leal teaches combining NAC compositions with conventional food carriers; and NOW teaches oral compositions of NAC include selenium and molybdenum, which facilitate important enzymes related to glutathione and NAC.
Regarding claim 36 –
NOW expressly teaches an orally administered dietary supplement containing 600 mg of the NAC prodrug (p. 2).
Regarding claim 37 –
Leal expressly teaches dispersing an NAC formulation in tomato juice and adding such compositions to other consumable food or beverage products (col. 13, lines 7-21).
Regarding claims 38 and 39 –
Giustarini teaches a liquid dosage form of NACET (p. 1523).
Regarding claim 40 –
Giustarini expressly teaches NACET.
Regarding claim 41 –
As discussed above, Giustarini teaches that orally administered NACET significantly increases glutathione in tissues and accumulates in erythrocytes. Accordingly, the recited glutathione-modulating function is an expected property of an effective amount of NACET. Therefore, claim 41 would have been obvious.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the NAC of Leal and NOW with the NACET taught by Giustarini. Giustarini expressly teaches that NACET is an orally active NAC-derivative having improved cellular penetration and pharmacokinetic properties. Giustarini further teaches that NACET is a potential substitute for NAC as a GSH-related antioxidant. The substitution would have been motivated by the known advantages of NACET compared to NAC, expressly taught by Giustarini, with a reasonable expectation the NACET would retained its glutathione-related activity.
The limitation requiring NACET in an amount effective to modulate red blood cell, plasma, serum, or organ glutathione levels does not patentably distinguish the claimed composition from the prior art. Giustarini expressly teaches that oral administration of NACET significantly increases glutathione in tissues and accumulates in erythrocytes. Thus, Giustarini does not merely disclose the same chemical compound for an unrelated purpose; it teaches administration of NACET for the same glutathione-related biological effect recited in the claims.
Claims 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over Giustarini (previously cited above) and in further view of NOW (previously cited above), and Kumar (“Supplementing Glycine and N-Acetylcysteine (GLYNAC) in Older Adults Improves Glutathione Deficiency, Oxidative Stress, Mitochondrial Dysfunction, Inflammation, Physical Function, and Aging Hallmarks: A Randomized Clinical Trial,” published 17 August 2022).
Regarding claim 42 –
Giustarini teaches NACET as an orally-active NAC derivative that enters cells, generates NAC and cysteine, increases glutathione, and has potential to substitute for NAC as a GSH-related antioxidant.
While Giustarini does not expressly teach a composition comprising NACET and glycine, selenium, or molybdenum, this limitation is made obvious over Kumar or NOW.
Kumar teaches combining NAC with glycine for glutathione supplementation and reports correction of RBC glutathione deficiency following GlyNAC supplementation (abstract, p. 79).
NOW independently teaches a dietary supplement comprising NAC together with selenium and molybdenum.
Therefore, it would have been obvious to substitute NAC with NACET in either of the known compositions of Kumar and NOW to obtain the known pharmacokinetic and cellular delivery advantages of NACET.
Regarding claim 43 –
NOW expressly teaches 600 mg NAC per capsule, which falls within the instantly claimed 10 to 1,000 mg range.
Regarding claim 44 –
Giustarini expressly teaches NACET.
Regarding claim 45 –
NOW expressly teaches 25 mcg selenium and 50 mcg molybdenum, both within the claimed ranges.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the NAC of Kumar and NOW with the NACET taught by Giustarini. Giustarini expressly teaches that NACET is an orally active NAC-derivative having improved cellular penetration and pharmacokinetic properties. Giustarini further teaches that NACET is a potential substitute for NAC as a GSH-related antioxidant. The substitution would have been motivated by the known advantages of NACET compared to NAC, expressly taught by Giustarini, with a reasonable expectation the NACET would retained its glutathione-related activity.
The limitation requiring NACET in an amount effective to modulate red blood cell, plasma, serum, or organ glutathione levels does not patentably distinguish the claimed composition from the prior art. Giustarini expressly teaches that oral administration of NACET significantly increases glutathione in tissues and accumulates in erythrocytes. Kumar further teaches modulation of GSH in red blood cells. Thus, Giustarini does not merely disclose the same chemical compound for an unrelated purpose; it teaches administration of NACET for the same glutathione-related biological effect recited in the claims.
Claims 46-50 are rejected under 35 U.S.C. 103 as being unpatentable over Giustarini (previously cited above), NOW (previously cited above), and Kumar (previously cited above) as applied to claims 42-45 above, and further in view of Gemili (US 2022/0016062 A1, published 20 January 2022).
The teachings of Giustarini, Kumar, and NOW are discussed above. While the combination of Guistarini, NOW, and/or Kumar teach a composition comprising NACET and glycine, selenium, and/or molybdenum, neither reference expressly teaches the limitation of claim 46. However, this limitation is made obvious over Gemili.
Regarding claim 46 –
Gemili teaches nutritional compositions comprising NAC and glycine ([0084]). Specifically, Gemili teaches a unit dosage form comprising 600 mg NAC and 600 mg glycine ([0090]). Gemili further teaches that glutathione is synthesized from glutamate, cysteine, and glycine and describes NAC/glycine nutritional products for conditions associated with reduced glutathione ([0011]). Gemili also teaches inclusion of minerals in the NAC/glycine composition selected from selenium and molybdenum among others ([0086]).
Regarding claim 47 –
Gemili expressly teaches oral preparations may comprise additional additives which can be used in accordance with the desired final dosage form such as binders, disintegrants, or lubricants ([0134]).
Regarding claim 48 –
Gemili expressly teaches the additional additives discussed above may comprise lubricants such as magnesium stearate ([0134]).
Regarding claim 49 –
Gemili expressly teaches oral preparations in tablet form ([0134]) or liquid form ([0095]).
Regarding claim 50 –
As previously discussed, Giustarini expressly teaches that orally administered NACET significantly increases glutathione content in multiple tissues and further teaches that NACET accumulates in human erythrocytes. Giustarini explains that NACET enters cells and is converted to NAC and cysteine and concludes NACET is a more effective glutathione precursor compared to NAC. Finally, Giustarini teaches NACET is a potential substitute for NAC as a GSH-related antioxidant.
Thus, Giustarini does not merely disclose NACET for an unrelated purpose, but expressly teaches the same glutathione-modulating capability recited in claim 50. Moreover, when the composition of Giustarini is administered in an amount demonstrated to produce the recited glutathione effect, the claimed functional limitation describes a capability possessed by the prior art composition rather than a structural distinction over that composition.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include glycine in the composition of Giustarini/Kumar/NOW that would result in a composition comprising NCET, glycine, selenium, and molybdenum. One of ordinary skill would be motivated to do so because Gemili expressly contemplates nutritional compositions comprising NAC, glycine, and minerals, and identifies both selenium and molybdenum among suitable minerals. Thus, inclusion of the NOW-disclosed amounts of selenium and molybdenum in Gemili’s NAC/glycine nutritional composition would have represented the predictable use of known nutritional components in amounts already known in the art as suitable for coadministration with NAC.
It would have further been obvious to substitute NACET, as taught by Giustarini/Kumar/NOW, for the NAC of the modified Gemili/NOW composition. Giustarini expressly teaches NACET possesses improved pharmacokinetic properties relative to NAC, increases glutathione, is converted intracellularly to NAC and cysteine, and is a suitable glutathione-related antioxidant substitute for NAC. Thus, one of ordinary skill would have had an express reason to substitute NAC with NACET in the known nutritional composition of Gemili/NOW to obtain the known improved pharmacokinetic properties of NACET while retaining the glutathione-related function of NAC.
Conclusion
Claim 49 is objected to. Claims 31-50 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. 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.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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