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 .
Information Disclosure Statement
Two information disclosure statements (IDS) submitted: one on 05/31/2024 and one on 11/19/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, or included in the IDS, they have not been considered.
Status of the Claims
Claims 1-13 are pending in this application.
Claim Objections
Claims 4-5 objected to because of the following informalities:
Claim 4 is missing commas “,” – claim should read: “…24 or more, 26 or more, 28 or more, 30 or more, 42 or less, 40 or less, or 38 or less carbon atoms, containing 3 or more, 4 or more, or 6 or less double bonds, and containing 0 or more, 1 or less, 2 or less, or 3 or less hydroxy groups.” (see 112(b)).
Claim 5 is missing a comma “,” – “8 to 18 or 10 to 18” should read “8 to 18, or 10 to 18” (see 112(b)).
Appropriate correction is required.
Claim Interpretation
The specification defines “oxidative stress-related disorders” as follows:
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The term “pharmaceutically functional derivative is defined in [0085] of the spec. “This term includes esters, ethers, amides and prodrugs of the very-long-chain polyunsaturated fatty acid.”
With regards to fatty acid notation – refer to [0091] of the spec.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of some oxidative stress-related diseases, does not reasonably provide enablement for treatment of Down Syndrome, Alzheimer’s Disease (AD), Parkinson’s disease (PD), psychological aging, photoaging of skin, etc.; or for prevention of Down Syndrome, Alzheimer’s Disease (AD), Parkinson’s disease (PD), psychological aging, photoaging of skin, all cancers, all neurological disorders, etc. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make use of the invention commensurate in scope with these claims.
The applicant’s attention is drawn to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998), where the court set forth eight factors to considers when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the examples; and (8) the quantity of experimentation necessary.
Breadth of Claims
Claim 1 broadly encompasses a method of treating or preventing any disorder associated with oxidative stress (any cancer, any neurological disorder, Down Syndrome etc., as defined in [0003] of the spec. – also see claims 9-11), in any subject in need thereof, comprising administration of any very-long chain polyunsaturated fatty acid (VLC-PUFA). Claims 9-11 narrow the scope of the diseases somewhat, however, Applicant provides no evidence to support treatment or prevention of a number of the diseases claimed, including, for example, Down Syndrome, Alzheimer’s Disease (AD), Parkinson’s disease (PD), psychological aging, photoaging of skin, etc.
The term “subject” was not defined in the specification. Accordingly, the broadest reasonable interpretation of the term “subject” is taken to be any animal (humans, other primates, dogs, cats, squid, etc.).
The term “prevention” is not defined in the specification. The Oxford English Dictionary (2024) defines “prevent” as to “preclude the occurrence” and thus claim 1 encompasses embodiments in which the claimed compounds can preclude the many diseases mediated by oxidative stress. See definition II.9.a. Obtained from oed.com [retrieved on 2025-03-05] URL:httos://www.oed.convdictionary/prevent_y?t=true).
Nature of the invention/ State of the Prior Art/ Predictability in the Art
The art provides no successful method of prevention for all cancers, as taught by Gu et al. (J. Cancer Prev. 25(3): 127-135, 2020) beyond: (i) eliminating or mitigating risk factors by adopting healthy behaviors and lifestyles, such as avoiding tobacco, alcohol, and UV radiation; (ii) screening to identify precancerous lesions and taking intervention measures to prevent disease progression to malignancy; or (iii) controlling the symptoms or morbidity caused by cancer therapy. Gu also recommends that high-risk populations take chemo-preventive agents such as selective estrogen receptor modulators for breast cancer, and non-steroidal anti-inflammatory drugs (aspirin) for colorectal cancer prevention etc. There is not one single drug that works for the prevention of all cancers.
The NHS discloses no known methods for Alzheimer’s prevention, and teaches only ways of reducing risks, which include lowering risk of cardiovascular disease by stopping smoking, keeping alcohol to a minimum, eating a healthy diet, exercise, etc. (Obtained from nhs.uk [retrieved on 04/24/2026]<URL: https://www.nhs.uk/conditions/alzheimers-disease/prevention/>) – Pub. Date: 04 July 2024.
The Mayo Clinic teaches there is no way to prevent Down Syndrome. Obtained from mayoclinic.org [retrieved on 04/24/2026]<URL: https://www.mayoclinic.org/diseases-conditions/down-syndrome/symptoms-causes/syc-20355977>) – Pub. Date: Nov. 12, 2024.
The World Health Organization discloses that prevention of mental health deterioration in older adults focuses on supporting healthy aging by creating physical and social environments that support well-being an enable people to do what they enjoy despite losses in capacity. There are no drugs to prevent or treat psychological aging, though the WHO suggests health, social, and financial programs to ensure the needs of the subject are met, to reduce unnecessary stress and support healthy living. Obtained from who.int [retrieved on 04/25/2026]<URL: https://www.who.int/news-room/fact-sheets/detail/mental-health-of-older-adults>) – Pub Date: 8 October 2025.
The Cleveland Clinic discloses ways to prevent photoaging of skin include wearing sunscreen daily, hats, avoiding peak UV hours, and avoid tanning. There are no prophylactics to prevent aging. Obtained from Clevelandclinic.org [retrieved on 04/26/2026]<URL: https://my.clevelandclinic.org/health/diseases/5240-sun-damage-protecting-yourself>) – Pub Date: 10/28/2022.
Duarte-Jurado et al. (Antioxidants 2021, 10(3), 453) teaches that “Although preclinical studies have demonstrated the efficacy of these compounds to maintain neuronal survival and activity in PD models, these results have not been reflected in clinical trials, antioxidants have not been able to act as disease modifiers in terms of clinical symptoms.” (abstract).
Calder et al. (Am. J. Clin. Nutr. 2006; 83:1505S–1519S) specifically teaches that α – linoleic acid, shown below, does not appear to exert anti-inflammatory effects at achievable intakes (abstract) – thus demonstrating that not all VLC-PUFAs (as encompassed by claim 1) share the same functional limitations.
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Finally, the medical arts are also generally considered to be unpredictable making the goal of achieving prevention in this case even less likely. See Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970) (“In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involve.”).
Level of One of Ordinary Skill
The level of one of ordinary skill in the art would be high, likely an M.D. or Ph.D. in the medical arts (e.g., studying treatment of cancers and neurological conditions, etc.). See Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376 at 1381–82 (Fed. Cir. 1983) (Factors that may be considered in determining level of ordinary skill in the art include: … type of problems encountered in the art …”).
Guidance/Working Examples
Example 1 of the specification [0135] discloses a study of relative ROS production in vitro with human alveolar epithelial cells after treatment with hydrogen peroxide (results shown in Figure 1). Example 2 [0137] evaluates the effects of treating cells with a fatty acid ethyl ester prior to hydrogen peroxide administration – Figure 2 summarizes the results of protection. Examples 3-4 [0141]-[0146] show the effects of protection from oxidative stress in human retinal pigment epithelial cells, pretreated with fatty acid ethyl ester before administration of H2O2 (see Figures 3-4). No specific examples demonstrate treatment or prevention of any of the diseases claimed.
Degree of Experimentation
To practice the invention as claimed, the skilled artisan would have to screen every “very-long chain polyunsaturated fatty acid (VLC-PUFA)” in order to determine whether the compounds meet the functional limitations of the claim for the treatment and prevention of any disorder associated with oxidative stress (including cancers, neurological conditions, and Down Syndrome) – which the art suggests they do not – see Calder et al. cited herein. In addition, the skilled artisan would need to determine which subjects would benefit from treatment and prevention of these diseases (humans, other primates, cats, dogs, squid, etc.) by administering the instantly claimed compounds to a statistically significant pool of subjects from each species. Prevention the aforementioned conditions would require long-term monitoring of each patient for appearance of any new cancers, neurological conditions, and Down Syndrome, psychological aging, photoaging of skin, etc. Thus, the quantity of experimentation in this area would be extremely large, since there are a significant number of parameters that would have to be studied beyond the preliminary in vitro studies provided on the protection of cells by PUFAs from H2O2. Furthermore, the ultimate outcome of such experimentation is completely unpredictable.
In sum, taking into consideration the Wands factors outlined above, an undue amount of experimentation would be required here to make and use the full scope of the claimed invention.
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 4-5 and 11 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claim 4 recites the broad recitations “28 or more… and 42 or less” or “3 or more… and 6 or less”, and the claim also recites “or 30 or more and 42 or less” or “4 or more and 6 or less” which are the narrower statements of the range/limitations. See claim objection for how to resolve this issue.
Claim 5 recites the broad recitations “8 to 18”, and the claim also recites “10 to 18” which are the narrower statements of the range/limitations (see claim objection also – comma should resolve this issue by making the full list a list of alternatives).
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Furthermore, claim 4, as worded, is unclear because a fatty acid cannot be, for instance, 28 and 42 carbons long at the same time (as suggested by the recitation “28 or more or 30 or more and 42 or less”). For the purposes of applying art, claim 4 will be interpreted as reading: “…24 or more, 26 or more, 28 or more, 30 or more, 42 or less, 40 or less, or 38 or less carbon atoms, containing 3 or more, 4 or more, or 6 or less double bonds, and containing 0 or more, 1 or less, 2 or less, or 3 or less hydroxy groups.” (see claim objection).
Regarding claim 11, the phrase "(for example, ischemia)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Examiner suggests removing parentheses and information therein.
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 1-11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1 and 9-11, Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) – thus anticipating the instant claim (see [0097] and Raman’s claims 136-137).
Regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
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.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”), as applied to claims 1-11; in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of Raman are disclosed in the 102-section above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Raman’s VLC-PUFAs for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Raman discloses their VLC-PUFA compounds as antioxidants, and discloses pharmaceutical compositions thereof and methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
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 conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,193,085 B2 (US ‘085); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, US ‘085 claims a free PUFA composition comprising 80% or more fatty acid, wherein the fatty acid can be arachidonic acid (one of the PUFAs listed in claim 5, when m3 = 1). US ‘085 claims their composition comprising an iron content of 0.1 ppm or less (reading on 0 ppm iron in the composition).
While US ‘085 does not teach their PUFA compositions for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137). Raman discloses arachidonic acid as a PUFA ([0057]).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer US ‘085’s PUFA composition to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘085 discloses their PUFA composition; further because Raman teaches VLC-PUFAs are effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
Claims 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,193,085 B2 (US ‘085); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of US ‘085 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While US ‘085 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer US ‘085’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘085 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,976,254 B2 (US ‘254); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, US ‘254 claims a method of manufacturing a composition comprising eicosapentaenoic acid (a PUFA) (US ‘254’s claims 1-3). US ‘254 further claims the method for the preparation of eicosapentaenoic alkyl ester (reading on instant claims 2 and 8).
While US ‘254 does not teach their prepared composition comprising eicosapentaenoic acid (a PUFA) for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137). Raman discloses eicosapentaenoic acid as a PUFA ([0057]).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer US ‘254’s PUFA composition to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘254 discloses their PUFA composition; further because Raman teaches VLC-PUFAs are effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
Claims 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,976,254 B2 (US ‘254); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of US ‘254 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While US ‘254 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer US ‘254’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘254 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 12 of U.S. Patent No. 12,110,473 B2 (US ‘473); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, US ‘473 claims a method of manufacturing a composition comprising a PUFA, such as eicosapentaenoic acid (US ‘473’s claims 1, 3, and 12).
While US ‘473 does not teach their prepared composition comprising their PUFAs for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137). Raman discloses eicosapentaenoic acid as a PUFA ([0057]).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer US ‘473’s PUFA composition to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘473 discloses their PUFA composition; further because Raman teaches VLC-PUFAs are effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
Claims 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 12 of U.S. Patent No. 12,110,473 B2 (US ‘473); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of US ‘473 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While US ‘473 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer US ‘473’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘473 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,590,266 B2 (US ‘266); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, US ‘266 claims a method of manufacturing a composition comprising a PUFA (US ‘266’s claim 1).
While US ‘266 does not teach their prepared composition comprising their PUFAs for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer US ‘266’s PUFA composition to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘266 discloses their PUFA composition; further because Raman teaches VLC-PUFAs are effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
Claims 12-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,590,266 B2 (US ‘266); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of US ‘266 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While US ‘266 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer US ‘266’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because US ‘266 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of copending Application No. 18/881,578 (Copending ‘578). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-13, Copending ‘578 claims a method of treating age-related macular degradation in a subject in need thereof comprising administration of a 24-40 VLC-PUFA, anticipating all the instant claims (Copending ‘578’s claims 1-32).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-79 of copending Application No. 18/879,399 (Copending ‘399); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, Copending ‘399 claims a method of manufacturing a PUFA with more than 19 carbons and up to 7 double bonds, wherein the PUFA can be a free acid or alkyl ester (Copending ‘399’s claims 46 and 78).
While Copending ‘399 does not teach their prepared PUFAs for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer Copending ‘399’s PUFAs to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘399 discloses methods of making PUFAs; further because Raman teaches VLC-PUFAs and pharmaceutical compositions thereof as effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claims 2 and 8, Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
This is a provisional nonstatutory double patenting rejection.
Claims 12-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-79 of copending Application No. 18/879,399 (Copending ‘399); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of Copending ‘399 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While Copending ‘399 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Copending ‘399’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘399 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
This is a provisional nonstatutory double patenting rejection.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/495,452 (Copending ‘452); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, Copending ‘452 claims a method of manufacturing a PUFA ester composition (Copending ‘452’s claims 1).
While Copending ‘452 does not teach their prepared PUFA composition for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137). Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer Copending ‘452’s PUFA ester compositions to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘452 discloses methods of making PUFA ester compositions; further because Raman teaches VLC-PUFAs can be administered as acids or esters, and discloses pharmaceutical compositions thereof as effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
This is a provisional nonstatutory double patenting rejection.
Claims 12-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/495,452 (Copending ‘452); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of Copending ‘452 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While Copending ‘452 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Copending ‘452’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘452 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
This is a provisional nonstatutory double patenting rejection.
Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 19/497,654 (Copending ‘654); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”).
Regarding instant claims 1-11, Copending ‘654 claims a method of manufacturing a PUFA acid and ester compositions (Copending ‘654’s claims 1).
While Copending ‘654 does not teach their prepared PUFA composition for the treatment of oxidative stress-related diseases; the teachings of Raman are relied upon for these disclosures.
Raman discloses an embodiment to reduce at least one symptom of inflammation or neurodegeneration or retinal degeneration or macular degeneration (anticipating eye disease (claim 9), and macular degeneration (claim 10), and retinal degeneration (claim 11)) in an individual in need thereof comprising administration of their VLC-PUFAs (all of which are known in the art to be oxidative stress-related disorders) (see [0097] and Raman’s claims 136-137). Raman discloses their VLC-PUFAs may be provided as ethyl or methyl esters (anticipating ester, and specifically ethyl ester – claim 8) [0097].
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the instant application to administer Copending ‘654’s PUFA acid or ester compositions to a subject suffering from an oxidative stress-related disease such as retinal degeneration or macular degeneration. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘654 discloses methods of making PUFA compositions; further because Raman teaches VLC-PUFAs can be administered as acids or esters, and discloses pharmaceutical compositions thereof as effective for the treatment of oxidative stress-related diseases of the eye, such as retinal degeneration or macular degeneration.
Further regarding claim 3, Raman teaches if their VLC-PUFA compound is an acid then it may be prepared as an inorganic salt or an organic base salt (see [0144]).
Further regarding claims 4-5, Raman discloses (for instance) the VLC-PUFA below (page 24, bottom), which anticipates the instant compounds when: (for claim 4) 28 carbons, 6 double bonds, and 0 hydroxy groups; (claim 5) m2 = 9.
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Regarding claims 6-7, Raman claims their method of dietary management of oxidative-stress related conditions (specifically mentioning macular eye degeneration) comprising administration of a C34:5n3 VLC-PUFA – thus anticipating instant claims 6-7 (Raman’s claims 136-137 and 145).
This is a provisional nonstatutory double patenting rejection.
Claims 12-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of copending Application No. 19/497,654 (Copending ‘654); in view of Raman et al. (US 2013/0190399 A1 – cited in IDS) (“Raman”); as applied to claims 1-11; further in view of Suresh et al. (Research J. Pharm. and Tech. 7, 2014, 1330-1344) (“Suresh”).
The teachings of Copending ‘654 and Raman are disclosed above and incorporated herein.
Raman teaches PUFAs have antioxidant activity [0095].
While Copending ‘654 and Raman doesn’t specifically teach their diseases being caused by reactive oxygen species, the teachings of Suresh are relied upon for these disclosures.
Suresh teaches, in macular degeneration, the main cause of generation of reactive oxygen species is when UV and visible light radiation passes from retina to the photoreceptor (rod and cones) and pigmented epithelial cell (PE). The transformation of light into the nerve impulse through the photoreceptors develops free radicals. These free radicals include reactive oxygen species like hydrogen peroxide, superoxide and hydroxyl radicals (last para., page 6). Suresh specifically teaches the eye is an organ with intense reactive oxygen species (ROS) activity, and it requires high levels of antioxidants to protect its natural unsaturated fatty acids (para. 1, page 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to administer Copending ‘654’s and Raman’s PUFAs composition and method for the treatment of oxidative-stress related disorders that are caused by free radicals and reactive oxygen species, like superoxides, such as macular degeneration, in view of Suresh. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Copending ‘654 and Raman disclose their VLC-PUFA compositions and compounds as antioxidants, and disclose methods of treating macular degeneration comprising administration of their compounds; further because Suresh teaches reactive oxygen species, such as superoxide and hydroxy radicals (last para., page 6) are involved in macular degeneration.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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