Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-19 are pending and are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDS) dated 8/29/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Priority
This application is a divisional of 17/582,286 filed on January 24, 2022, which is a divisional of 15/523,657 filed on May 1, 2017, now U.S. Patent No. 11,268,964 issued March 8, 2022, which is a U.S. 371 National Phase Application from PCT No. PCT/US2015/060172 international filing date of November 11, 2015, title Biomarkers Useful in the Treatment of Subjects Having Disease of the Eye, and claims benefit of U.S. Provisional Serial No. 62/078,138, filed on November 11, 2014 and U.S. Provisional Serial No. 62/188,377, filed on July 2, 2015.
It is noted that the divisional applies only to claims 1-9 of the instant applications as these were the claims which were restricted and cancelled from the parent application 17/582,286. Claims 10-19 are similar to those claims allowed in the parent applications 17/582,286 and 15/523657 and are therefore considered as continuation of those parent applications.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-6 and 8-9 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Pincemail et al. (US 2005/0112572) reference cited in IDS 8/29/2024).
Instant claims 1-9 are drawn to a kit for determining, oxidative stress in the eye comprising:
a first container for a biological sample from the subject.
b) a second container for a control biological sample;
c)one or more vials that comprise reagents to determine: cupric reducing
antioxidant capacity, GSH/GSSG ratio, and carbonyl adduct level in the sample of a) and b); and
d) instructions for comparing the one or more measurements of c) in the samplefrom the subject to the control sample, wherein an increase in carbonyl adduct level, a ratio of GSH to GSSG is reduced, and/or a reduction in cupric antioxidant capacity is indicative of oxidative stress.
Pincemail disclose a process for detecting oxidative stress in a sample and to a kit for this implementation.(abstract). They disclose that the test kit suitable for performing the method according to the present invention comprises reagents capable of determining the amount of at least 2 oxidative stress markers. Preferably, the reagent capable of determining the amount of said oxidative stress marker is specific to said oxidative stress marker[0129]. They disclose the method for quantifying or staging the severity of an eye disease associated with oxidative stress (para [0083] .Said method for the detection of oxidative stress in an individual further comprises the step of evaluating the result in the context of said risk factor'; [0100] 'Preferably, the diseases are selected from...cataracts, retinopathy, retinal degeneration'), comprising:
a) obtaining a biological sample from the subject (claims 1,2);
b) providing a control biological sample (claims 1,2);
c) measuring GSH/GSSG ratio in the sample of a) and b) (claims 1, 2, 22);
d) comparing the one or more measurements of c) in the sample from the subject to the control sample (claims 1,2, 22, 23); and
e) quantifying or staging the severity of disease in the subject as progressing in stage, or increasing in severity, if the GSH/GSSG ratio is reduced relative to the control sample (claims 1, 2, 22, para [UU84J' I he present invention allows for the risk factor-specific testing of individuals which enables a fine-tuning of diagnosis...of the underlying oxidative stress syndrome in the physiological and/or pathological condition'). Pincemail teaches the sample is from the blood of the subject (para [0001], [0133]). Pincemail teaches the levels of protein carbonyl levels are determined by EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, noncompetitive immunoassay, sandwich immunoassay, agglutination assay, Western blot assay, or immunochips (para [0125]-[0128]). Pincemail teach the oxidative stress is indicative of an eye disorder (para [0020]. Pathologies Associated with Increased Oxidative Stress. [0030] 'Eyes: cataract, retinopathy (newborn), retinal degeneration'; [0100] 'the diseases are selected from...cataracts, retinopathy, retinal degeneration'). Pincemail teach the eye disease is selected from cataract, retinopathy, and retinal degeneration (para [0020] Pathologies Associated with Increased Oxidative Stress. [0030] 'Eyes: cataract, retinopathy (newborn), retinal degeneration'; [0100] 'the diseases are selected from...cataracts, retinopathy, retinal degeneration'). Pincemail teaches that when oxidative stress largely overwhelms the natural defense systems, recourse to antioxidant therapy is necessary so as to limit the harmful action of AOS and exemplifies N-acetylcysteine (NAC), which increases the intracellular GSH concentration, and certain metals acting as cofactors [0037-0040]. PIncemail et al. teaches Carbonyl assay and that Oxidative modifications of intracellular proteins have been suggested to play a key role in the causation of senescence-associated losses in physiological functions because oxidized proteins often lose catalytic function and undergo selective degradation. Addition of carbonyl-containing adduct to the side chains of amino-acid residues (lysine, arginine, . . . ) is arguably the most well characterized, age-associated, post-translation structural alteration in proteins [0062]. They further teach the degree of protein oxidation was monitored by the method, which uses the reaction of 2,4-dinitrophenylhydrazine (DNPH) with the carbonyl groups of oxidized proteins. Protein carbonyls were then read at 370 nm and evaluated using a molar absorption coefficient of 22,000 M.sup.-1cm.sup.-1 [0192]. Pincemail teaches the sample is from the blood of the subject (para [0001], [0133]).
Therefore the Kit disclosed by Pincemail et al. fully anticipates instant claims 1 and 3-9.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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.
Claims 1, 3-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pincemail et al. (US 2005/0112572) in view of Grinberg et al. (Free Radical biology and Medicine 38 (2005)136-145) (references cited in IDS 8/29/2024).
Instant claims 1-9 are drawn to a kit for determining, oxidative stress in the eye comprising:
a first container for a biological sample from the subject;
b)a second container for a control biological sample;
c)one or more vials that comprise reagents to determine: cupric reducing
antioxidant capacity, GSH/GSSG ratio, and carbonyl adduct level in the sample of a) and b); and
d) instructions for comparing the one or more measurements of c) in the samplefrom the subject to the control sample, wherein an increase in carbonyl adduct level, a ratio of GSH to GSSG is reduced, and/or a reduction in cupric antioxidant capacity is indicative of oxidative stress.
Claims 10-11 are drawn to a method for treating a subject having a disease selected from retinitis pigmentosa comprising: obtaining a biological sample from the subject; providing a control biological sample; measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, carbonyl adduct level in the sample of a) and b); comparing the one or more measurements of c) in the sample from the subject to the control sample; quantifying or staging the severity of the disease in the subject as progressing in stage, or increasing in severity, if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control sample, and/or if the levels of carbonyl adduct level is elevated relative to the control sample; and selecting a course of treatment for the disease in the subject which is based on the stage or severity of disease indicated in e).
Claims 12-13 are drawn to a method for monitoring the treatment of a subject having retinitis pigmentosa comprising: obtaining a biological sample from the subject; providing a control biological sample; measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, carbonyl adduct level, in the sample of a) and b); comparing the one or more measurements of c) in the sample from the subject to the control sample; determining the stage or the severity of disease in the subject, wherein if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control sample, and/or if the levels of carbonyl adduct level is elevated relative to the control sample then the disease is identified as progressing in stage, or increasing in severity, or if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is elevated relative to the control sample and/or if the levels of carbonyl adduct level is reduced relative to the control sample then the disease is identified as reducing in stage, or decreasing in severity of the retinitis pigmentosa; selecting a course of treatment for the disease in the subject which is based on the stage or severity of disease indicated in e); and after administration of the course of treatment to the subject, repeating steps one or more times.
Claims 14-19 are drawn to a method for quantifying and treating oxidative stress in an eye of a subject with the kit of claim 1, comprising: obtaining a biological sample from the eye of the subject; providing a control biological sample; ratio, and carbonyl adduct level in the sample of a) and b); and comparing the one or more measurements of c) in the sample from the subject to the control sample, wherein an increase in carbonyl adduct level, a ratio of GSH to GSSG is reduced, and/or a reduction in cupric antioxidant capacity is indicative of oxidative stress, wherein the levels of protein carbonyl levels are determined by EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, agglutination assay, Western blot assay, slot blot assay, fluorescence polarization, latex agglutination, lateral flow assay, immunochromatographic assay, immunochips, dip stick immunotesting, or bead-based technology; and administering an effective treatment to the subject having oxidative stress in the eye, wherein the effective treatment comprises N-Acetylcysteine Amide (NACA).
Pincemail teaches a method for quantifying or staging the severity of an eye disease associated with oxidative stress (para [0083] These findings have important impacts on the diagnosis and possible therapy of diseases based on oxidative stress': [0098] 'said method tor the detection of oxidative stress in an individual further comprises the step of evaluating the result in the context of said risk factor'; [0100] 'Preferably, the diseases are selected from...cataracts, retinopathy, retinal degeneration'), comprising:
a) obtaining a biological sample from the subject (claims 1,2);
b) providing a control biological sample (claims 1,2);
c) measuring GSH/GSSG ratio in the sample of a) and b) (claims 1, 2, 22);
d) comparing the one or more measurements of c) in the sample from the subject to the control sample (claims 1,2, 22, 23); and
e) quantifying or staging the severity of disease in the subject as progressing in stage, or increasing in severity, if the GSH/GSSG ratio is reduced relative to the control sample (claims 1, 2, 22, para [UU84J' I he present invention allows for the risk factor-specific testing of individuals which enables a fine-tuning of diagnosis...of the underlying oxidative stress syndrome in the physiological and/or pathological condition'). Pincemail teaches the sample is from the blood of the subject (para [0001], [0133]). Pincemail teaches the levels of protein carbonyl levels are determined by EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, noncompetitive immunoassay, sandwich immunoassay, agglutination assay, Western blot assay, or immunochips (para [0125]-[0128]). Pincemail teach the oxidative stress is indicative of an eye disorder (para [0020]–Pathologies Associated with Increased Oxidative Stress. [0030] 'Eyes: cataract, retinopathy (newborn), retinal degeneration'; [0100] 'the diseases are selected from...cataracts, retinopathy, retinal degeneration'). Pincemail teach the eye disease is selected from cataract, retinopathy, and retinal degeneration (para [0020]–Pathologies Associated with Increased Oxidative Stress. [0030] 'Eyes: cataract, retinopathy (newborn), retinal degeneration'; [0100] 'the diseases are selected from...cataracts, retinopathy, retinal degeneration'). Pincemail teaches that when oxidative stress largely overwhelms the natural defense systems, recourse to antioxidant therapy is necessary so as to limit the harmful action of AOS and exemplifies N-acetylcysteine (NAC), which increases the intracellular GSH concentration, and certain metals acting as cofactors [0037-0040]. PIncemail et al. teaches Carbonyl assay and that Oxidative modifications of intracellular proteins have been suggested to play a key role in the causation of senescence-associated losses in physiological functions because oxidized proteins often lose catalytic function and undergo selective degradation. Addition of carbonyl-containing adduct to the side chains of amino-acid residues (lysine, arginine, . . .) is arguably the most well characterized, age-associated, post-translation structural alteration in proteins [0062]. They further teach The degree of protein oxidation was monitored by the method, which uses the reaction of 2,4-dinitrophenylhydrazine (DNPH) with the carbonyl groups of oxidized proteins. Protein carbonyls were then read at 370 nm and evaluated using a molar absorption coefficient of 22,000 M.sup.-1cm.sup.-1 [0192]. Pincemail teaches the sample is from the blood of the subject (para [0001], [0133]).
While Pincemail et al. teaches treatment with NAC is a non-targeted antioxidant, they do not teach treatment with NACA.
However, Grinberg et al. discloses that N-acetylcysteine amide (AD4 or NACA), the amide form of N-acetylcysteine (NAC) and a copper chelator (abstract). They teach that In NAC, the carboxyl group is negatively charged at physiological pH, limiting the drug’s ability to cross cell membranes. A newly designed amide form of NAC, N-acetylcysteineamide (AD4 or NACA), in which the carboxylic group is neutralized, is expected to be more lipophilic and cell-permeating and this compound was recently shown to cross the blood– brain barrier, scavenge free radicals and chelate copper ions (Cu2+). They teach that In a metabolically competent cell, the high reducing potential of the GSH/GSSG system provides sufficient antioxidant protection (page 144, col.1, under RBC metabolism and thiol-induced protection). Their study demonstrated that that AD4-supplemented RBCs maintained their normal thiol level and resisted intracellular oxidation. The further teach that the antioxidative effects of AD4 (NACA) illustrate the benefits of a membrane-crossing reagent that tilts the delicate intracellular redox state and supports an earlier proposal for the use of esterified cysteine derivatives in various diseases and disorders associated with oxidative stress (page 144, under significance).
Accordingly, the instantly claimed Kit and methods would be prima facia obvious over the teachings of Pincemail et al. and Grinberg et al. Substituting NACA for NAC in the method of Pincemail et al, would be obvious motivated by the teachings of Grinberg et al. that this derivative of NAC has more lipophilic and cell permeating properties and functions successfully as an antioxidant. Pincemail et al. explicitly teaches the kit and the method of determining the oxidative stress level in a subject having eye disease, by following the instantly recited steps of obtaining the biological sample which is blood, providing a control sample, measuring the GSH/GSSG ratio, comparing the measurements and quantifying or staging the severity of the disease and finally selecting a course of treatment of the disease in the subject which includes NAC. A person of ordinary skill in the art would be imbued with confidence that substitution of NAC with NACA would provide for a better treatment option as it has better bioavailability.
Claims 2 and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Pincemail et al. (US 2005/0112572) and Grinberg et al. (Free Radical biology and Medicine 38 (2005)136-145 as applied to claims 1,3 and 11,13 above, and further in view of Riley et al ( Investigative ophthalmology and visual science, 19.1; 1980, 94-96, reference already of record)
While Pincemail et al. teaches that oxidative stress is indicative of an eye disorder (para [0020]–Pathologies Associated with Increased Oxidative Stress. [0030] 'Eyes: cataract, retinopathy (newborn), retinal degeneration'; [0100] 'the diseases are selected from...cataracts, retinopathy, retinopathy, retinopathy, retinal degeneration they do not explicitly teach where the sample is from the aqueous humor of the eye of the subject
However, Riley teaches a method of measuring a ratio of GSH to GSSG in a sample is from the aqueous humor of the eye of a subject (abstract 'Glutathione was measured in the aqueous humor of rabbit, dog, monkey, baboon, and man'; p. 94, col. 2, para 1 'The present study employs the sensitive and specific method of Tietzel 0 and demonstrates that glutathione is present in the aqueous of all five mammalian species examined. Moreover, it shows that the redox state of the oxidized: reduced glutathione (GSSG:GSH) couple is well toward the reduced end, indicating a potent ability for scavenging of oxidizing radicals').
It would have been obvious to one of ordinary skill in the art to have performed the methods taught by Pincemail wherein the sample is from the aqueous humor of the eye of the subject, in order to detect the marker of oxidative stress in the subject (a ratio of GSH to GSSG) in a region localized to the associated eye disorder.
Double Patenting
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US 11,268,964 (964)
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other.
Instant claims 14-19 are drawn to a method for quantifying and treating oxidative stress in an eye of a subject with the kit of claim 1, comprising: obtaining a biological sample from the eye of the subject; providing a control biological sample; ratio, and carbonyl adduct level in the sample of a) and b); and comparing the one or more measurements of c) in the sample from the subject to the control sample, wherein an increase in carbonyl adduct level, a ratio of GSH to GSSG is reduced, and/or a reduction in cupric antioxidant capacity is indicative of oxidative stress, wherein the levels of protein carbonyl levels are determined by EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, agglutination assay, Western blot assay, slot blot assay, fluorescence polarization, latex agglutination, lateral flow assay, immunochromatographic assay, immunochips, dip stick immunotesting, or bead-based technology; and administering an effective treatment to the subject having oxidative stress in the eye, wherein the effective treatment comprises N-Acetylcysteine Amide (NACA).
Claims 1-6 of ‘964 are drawn to a method for determining and treating oxidative stress in the eye comprising: a) obtaining a sample from a subject; b) providing a control sample; c) measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, and carbonyl adduct level in the sample of a) and b); d) comparing the one or more measurements of c) in the sample from the subject to the control serum sample; e) quantifying the oxidative stress in the eye, if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control serum sample, and/or if the levels of carbonyl adduct level is elevated relative to the control serum sample, wherein the levels of protein carbonyl levels are determined by EIA (enzyme immunoassay), ELISA (enzyme linked immunosorbent assay), RIA (radioimmunoassay), indirect competitive immunoassay, direct competitive immunoassay, non-competitive immunoassay, sandwich immunoassay, agglutination assay, Western blot assay, slot blot assay, fluorescence polarization, latex agglutination, lateral flow assay, immunochromatographic assay, immunochips, dip stick immunotesting, or bead-based technology; and f) administering an effective treatment to the subject having oxidative stress in the eye, wherein the effective treatment comprises N-Acetylcysteine Amide (NACA).
It would have been obvious to a person having ordinary skill in the art to utilize the method disclosed in co-pending ‘964 in the method of method for quantifying and treating oxidative stress in an eye of a subject, thus arriving at the instant claims.
Claims 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of US 12,078,641 (‘641)
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other.
Claims 10-11 are drawn to a method for treating a subject having a disease selected from retinitis pigmentosa comprising: obtaining a biological sample from the subject; providing a control biological sample; measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, carbonyl adduct level in the sample of a) and b); comparing the one or more measurements of c) in the sample from the subject to the control sample; quantifying or staging the severity of the disease in the subject as progressing in stage, or increasing in severity, if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control sample, and/or if the levels of carbonyl adduct level is elevated relative to the control sample; and selecting a course of treatment for the disease in the subject which is based on the stage or severity of disease indicated in e).
Claims 12-13 are drawn to a method for monitoring the treatment of a subject having retinitis pigmentosa comprising: obtaining a biological sample from the subject; providing a control biological sample; measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, carbonyl adduct level, in the sample of a) and b); comparing the one or more measurements of c) in the sample from the subject to the control sample; determining the stage or the severity of disease in the subject, wherein if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control sample, and/or if the levels of carbonyl adduct level is elevated relative to the control sample then the disease is identified as progressing in stage, or increasing in severity, or if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is elevated relative to the control sample and/or if the levels of carbonyl adduct level is reduced relative to the control sample then the disease is identified as reducing in stage, or decreasing in severity of the retinitis pigmentosa; selecting a course of treatment for the disease in the subject which is based on the stage or severity of disease indicated in e); and after administration of the course of treatment to the subject, repeating steps one or more times.
Claims 1-6 of ‘641 are drawn to a method for treating a subject having retinitis pigmentosa comprising: a) obtaining a biological sample from the subject; b) providing a control biological sample; c) measuring one or more of the following: cupric reducing antioxidant capacity, GSH/GSSG ratio, carbonyl adduct level in the sample of a) and b); d) comparing the one or more measurements of c) in the sample from the subject to the control sample; e) quantifying or staging the severity of the disease in the subject as progressing in stage, or increasing in severity, if the levels of cupric reducing antioxidant capacity and/or GSH/GSSG ratio is reduced relative to the control sample, and/or if the levels of carbonyl adduct level is elevated relative to the control sample; and f) selecting a course of treatment for the disease in the subject which is based on the stage or severity of disease indicated in e), wherein the treatment includes administering an effective treatment to the subject having retinitis pigmentosa, wherein the effective treatment comprises N-Acetylcysteine Amide (NACA).it would have been obvious to a person having ordinary skill in the art to utilize the method disclosed in co-pending ‘964 in the method of method for quantifying and treating oxidative stress in an eye of a subject.
Therefore, It would have been obvious to a person having ordinary skill in the art to utilize the method disclosed in co-pending ‘641 in the method for treating a subject having retinitis pigmentosa arriving at the instant claims.
Conclusion
Claims 1-19 are rejected. No claims are allowed
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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