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 .
Response to Election/Restriction filed on 11/03/2025 is acknowledged.
Claims 1-4, 7, 11-16, 19-25 and 132-133 are pending in this application.
Restriction
Applicant’s election of the following species:
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70
494
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36
426
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38
470
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40
528
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36
414
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in the reply filed on November 3, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 25 is withdrawn from further consideration as being drawn to nonelected species. During the search, a prior art was found for the species wound. Claims 1-4, 7, 11-16, 19-24 and 132-133 are examined on the merits in this office action.
Objections
5. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present disclosure is drawn to a method of treating...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). Applicant is recommended to amend the abstract to recite, “A method of treating…is described.”
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 112
6. 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.
7. Claim 22 is 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.
8. Regarding claim 22, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
U.S.C. 112(d)
9. 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.
10. 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. 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.
11. Claim 3 recites, “The method of claim 2, wherein the skin condition is selected from the group consisting of” psoriasis…mouth pain…and keratosis pilaris.” Claim 3 depends from claim 2. Claim 2 recites, “condition is a skin condition”. The recitation of “mouth pain” is not a skin condition. Claim 3 is broader than claim 2. Therefore, claim 3 does not further limit instant claim 2.
Improper Markush
12. Claim 22 is rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature and a common use. For example, an antioxidant, an antibiotic, an antiviral, an antitoxin…a cytokine, an amino acid, a protein, a vaccine, a hormone, a vitamin, oleuropein do not share a common core structure and a common use.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
U.S.C. 102
13. 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.
14. 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.
15. Claim(s) 1-4, 7, 11-13, 19, 22 and 132-133 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watanabe et al (Clinical, Cosmetic and Investigational Dermatology, 2014, 7: 267-274).
16. Watanabe et al teach a reduced glutathione (GSH) and the skin-whitening effect in humans (see abstract). Watanabe et al teach that topical whitens skin and improves skin condition in healthy women (see abstract). Watanabe et al teach that the GSSG is readily reduced to GSH in the body by glutathione reductase (see p. 272, right column). Watanabe et al teach that oral administration of GSH in humans reduces melanin production in the skin (see p. 268, left column). Watanabe et al teach a formulation of test lotions comprising oxidized glutathione (GSSG) with other ingredients, such as Polyethylene glycol monostearate (see Table 1, p. 269), meeting the limitation of instant claim 13. Watanabe et al teach that “other skin-whitening agents that have antioxidant activity and melanogenesis-inhibitory effects include L-ascorbic acid and its derivatives (see for example, p. 273, left column), meeting the limitation of instant claims 19 and 22.
Watanabe et al teach that “defective wound healing in patients with diabetes results from dysfunction of skin fibroblasts and epidermal keratinocytes; this dysfunction is related to the disruption of intracellular GSH homeostasis…GSH enhances collagen contraction in human dermal fibroblasts and protects the keratinocytes from apoptosis under hyperglycemic conditions (see p. 273, bottom of left column to top of right column). Watanabe et al teach that “…oral intake of GSH enhances skin whitening in human subjects…healthy medical students who took 250 mg of GSH orally twice daily for 4 weeks had significantly lower melanin index values than those who received placebo…” (see p. 273, left column, 1st full paragraph), meeting the limitation of instant claims 4 and 7. In regards to claims 132-133, the claims recite an end results. With respect to “wherein the symptoms of the condition are reduced by at least about 10% since commencement of the treatment (claim 11); wherein more than about 80% of the rGSH remains in a reduced form upon administration to the subject (claims 132); wherein more than about 50% of the rGSH remains in a reduced form upon reaching a situs of action in the subject (claim 133)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Watanabe et al teach ALL of the active method steps in regards to rGSH, since Watanabe et al teach that the skin whitening effect of reduce glutathione is known. Additional function of rGSH is also known (e.g., functions as a major antioxidant) (see abstract). The MPEP states the following: When the compound is not specifically named, but instead it is necessary to select potions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated (See MPEP 2105). Therefore, the method of treating a skin condition with a rGSH is at once envisaged from the teachings of Watanabe et al.
Since Watanabe et al teach all of the active method steps, Watanabe et al anticipates instant claims 1-4, 7, 11-13, 19, 22 and 132-133.
17. Claims 1-3, 12 and 132-133 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greener patent (US Patent No. 8506945).
18. Greener patent teaches a gel material with the ability to reduce glutathione dimer (GS-SG) to glutathione monomer (GSH) for therapeutic benefit in topical, for example wound, and internal, for example atherosclerotic, applications (see for example, Example 48, column 27, lines 9-13), meeting the limitation of instant claims 1-3 and 11-12. In regards to claims 132-133, the claims recite an end results. With respect to “wherein the symptoms of the condition are reduced by at least about 10% since commencement of the treatment (claim 11); wherein more than about 80% of the rGSH remains in a reduced form upon administration to the subject (claims 132); wherein more than about 50% of the rGSH remains in a reduced form upon reaching a situs of action in the subject (claim 133)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Since the Greener patent teaches all of the active method steps, the Greener patent anticipates instant claims 1-3, 12 and 132-133.
19. Claims 1 and 132-133 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demopoulos et al (US 2002/0136763, filed with IDS).
20. Demopoulos et al teach a method of treating a subject having a condition responsive to treatment with reduced glutathione (rGSH) (see paragraph [0115]), meeting the limitation of instant claim 1. Demopoulos et al teach that glutathione may also be used, alone or in combination with other therapies for the treatment of free radical associated neurological conditions, comprising administering a therapeutically amount of substantially alpha-D-glucopyranoside-free (composition without added alpha-D-glucopyranoside) (see paragraph [0169], for example) and administering a stabilized rGSH composition to the subject (see abstract). Demopoulos et al teach the dosage form of glutathione formulation is preferably stabilized with reducing agent (antioxidant)…the preferred dosage form in a capsule, e.g., a two-part gelatin capsule, which protects the glutathione from air and moisture, while dissolving quickly in the stomach (see paragraph [0122]), meeting the limitation of instant claim 7. In regards to claims 11 and 132-133, the claims recite an end results. With respect to “wherein more than about 80% of the rGSH remains in a reduced form upon administration to the subject (claims 132); wherein more than about 50% of the rGSH remains in a reduced form upon reaching a situs of action in the subject (claim 133)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Since the Demopoulos et al all of the active method steps, the Greener patent anticipates instant claims 1 and 132-133.
U.S.C. 103
21. 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.
22. 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.
23. 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.
24. 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.
25. Claim(s) 1-4, 7, 11-16, 19-24 and 132-133 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al (Clinical, Cosmetic and Investigational Dermatology, 2014, 7: 267-274) in view of Olejnik patent (US Patent No. 4645768), Hou et al (US 2017/0065552), Guilford et al (US 2015/0374626) and Hussein et al (Int. J. Curr. Microbiol. App. Sci., 2016, 5(9): 400-404).
26. Watanabe et al teach a reduced glutathione (GSH) and the skin-whitening effect in humans (see abstract). Watanabe et al teach that topical whitens skin and improves skin condition in healthy women (see abstract). Watanabe et al teach that the GSSG is readily reduced to GSH in the body by glutathione reductase (see p. 272, right column). Watanabe et al teach that oral administration of GSH in humans reduces melanin production in the skin (see p. 268, left column). Watanabe et al teach a formulation of test lotions comprising oxidized glutathione (GSSG) with other ingredients, such as Polyethylene glycol monostearate (see Table 1, p. 269), meeting the limitation of instant claim 13. Watanabe et al teach that “other skin-whitening agents that have antioxidant activity and melanogenesis-inhibitory effects include L-ascorbic acid and its derivatives (see for example, p. 273, left column), meeting the limitation of instant claims 19 and 22.
Watanabe et al teach that “defective wound healing in patients with diabetes results from dysfunction of skin fibroblasts and epidermal keratinocytes; this dysfunction is related to the disruption of intracellular GSH homeostasis…GSH enhances collagen contraction in human dermal fibroblasts and protects the keratinocytes from apoptosis under hyperglycemic conditions (see p. 273, bottom of left column to top of right column). Watanabe et al teach that “…oral intake of GSH enhances skin whitening in human subjects…healthy medical students who took 250 mg of GSH orally twice daily for 4 weeks had significantly lower melanin index values than those who received placebo…” (see p. 273, left column, 1st full paragraph), meeting the limitation of instant claims 4 and 7. In regards to claims 132-133, the claims recite an end results. With respect to “wherein the symptoms of the condition are reduced by at least about 10% since commencement of the treatment (claim 11); wherein more than about 80% of the rGSH remains in a reduced form upon administration to the subject (claims 132); wherein more than about 50% of the rGSH remains in a reduced form upon reaching a situs of action in the subject (claim 133)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Watanabe et al teach ALL of the active method steps in regards to rGSH, since Watanabe et al teach that the skin whitening effect of reduce glutathione is known. Additional function of rGSH is also known (e.g., functions as a major antioxidant) (see abstract). The MPEP states the following: When the compound is not specifically named, but instead it is necessary to select potions of teachings within a reference and combine them, e.g., select various substituents from a list of alternatives given for placement at specific sites on a generic chemical formula to arrive at a specific composition, anticipation can only be found if the classes of substituents are sufficiently limited or well delineated. Ex parte A, 17 USPQ2d1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able to "at once envisage" the specific compound within the generic chemical formula, the compound is anticipated (See MPEP 2105). Therefore, the method of treating a skin condition with a rGSH is at once envisaged from the teachings of Watanabe et al.
Since Watanabe et al teach all of the active method steps, Watanabe et al anticipates instant claims 1-4, 7, 11-13, 19, 22 and 132-133.
The differences between the reference and instant claims are that Watanabe et al do not teach a stabilizing carrier comprises deoxygenated water, a suspension, a solution, co-administration with an active agent, the active agent is an antibiotic and the condition is a burn.
27. However, Olejnik patent teaches that ingredient and any excipients can be dissolved in water, preferably deoxygenated water…evaporating (freeze drying)…the solid mixture may be reconstituted with deoxygenated water or water for injection (see for example, column 2, lines 52-62).
28. Additionally, Hou et al teach that combining an active ingredient with an aqueous medium with a reduced level of dissolved oxygen relative to saturation level (i.e., a deoxygenated aqueous medium) formed a more stable formulation than by first forming the formulation followed by removing dissolved oxygen therefrom (see paragraph [0018], for example).
29. Further, Guilford et al teach the simultaneous administration of the liposomal reduced glutathione in combination with antibiotics known to have an effect on non-resistant forms of Klebsiella in order to improve the efficacy of the antibiotic…The ability of the administration of liposomal reduced glutathione in combination with antibiotic will increase the susceptibility of a range of organisms known to be resistant to antibiotics and will include but not limited to (1) Klebsiella pneumoniae, (2)…and (7) Klebsiella ornithinolytica (see paragraph [0039]).
30. Hussein et al teach that Klebsiella pneumoniae is a Gram-negative nonmotile, encapsulated, lactose-fermenting, facultative anaerobic, rod-shaped bacterium (see p. 400, Introduction). Hussein et al teach that Klebsiella pneumoniae is isolated from burn infections; collected from infected burn wounds at burn center (see abstract). Hussein et al teach that the type and quantity of microorganisms that colonize the burn wound may influence the risk of invasive wound infection.
31. Therefore, it would have been obvious to combine the teachings of Watanabe et al, Olejnik patent, Hou et al, Guilford et al and Hussein et al to treat skin conditions, such as burns and wounds with reduced GSH in combination with antibiotics in a stabilizing carrier that is deoxygenated water. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Olejnik patent teaches formulations in deoxygenated water, and Hou et al teach that combining an active ingredient with an aqueous medium with a reduced level of dissolved oxygen relative to saturation level (i.e., a deoxygenated aqueous medium) formed a more stable formulation than by first forming the formulation followed by removing dissolved oxygen therefrom, and Guilford et al teach the combination of GSH and antibiotic improved the efficacy of the antibiotic. Hussein et al teach that wounds and burns produce Klebsiella pneumoniae infections, and Guilford et al teach the combination of rGSH and antibiotic increase the susceptibility of a range of organisms known to be resistant to antibiotics, and one of the organism is Klebsiella pneumoniae. Therefore, one of ordinary skill in the art would be motivated to combine the teachings with a reasonable expectation of success.
Therefore, the combined arts is prima facie obvious over instant claims 1-4, 7, 11-16, 19-24 and 132-133.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/25/2026