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
The office acknowledges Applicants filing of the claim amendments and arguments on 6/11/2025 in response to the office action dated 3/13/2025. Claims 4-5 have been cancelled. Claims 1-3, 6 have been amended and claims 7-14 have been added new. Applicants arguments have been fully considered but are moot in view of the new rejections necessitated by the claim amendments. The pending claims 1-3, 6-14 are examined based on the merits herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-3, 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Platt (Blood, 59, 5, 1982, p 1055-1060) in view of Ruiz-Nunez (Free Radicals and Antioxidants, 3 (2013) S22-29).
Ruiz-Nunez teach that supplementation of patients with sickle cell disease (SCD) with astaxanthin increases plasma- and erythrocyte-astaxanthin and may improve the hemolytic component of the disease (See Title). The open label pilot study showed that oral astaxanthin supplementation (8-12 mg, daily oral dose, oft gel gelatin capsules containing an astaxanthin extract from the algaH. pluvialis; Cyanotech, see 2.2 Astaxanthin Supplementation) increases astaxanthin concentrations in both plasma and RBC of SCD patients without any observed adverse reactions (see 5. Conclusions, col. 1, page S28). Astaxanthin incorporates into SCD RBC and may favorably affect the hemolytic component (See p s22, Conclusion, Table 1 for data after supplementation, also see 4.2 of page S27). Ruiz-Nunez teach that homozygous sickle cell anemia (SS disease) is a chronic hemolytic anemia characterized by reticulocytosis, marrow hyperplasia, indirect hyperbilinubinemia, decreased erythrocyte survival, and increased carbon monoxide excretion (See p 1055, para 1).
Ruiz-Nunez is not explicit in teaching that administration of astaxanthin suppressed exercise-Induced hemolysis or exercise induced hemolytic anemia in subjects.
Platt teach regarding exercise-Induced hemolysis in sickle cell anemia based on shear sensitivity and erythrocyte dehydration (See title). It is taught that in individuals with normal erythrocytes, exercise-induced hemolysis is associated with exposure of the cells to the tremendous mechanical forces generated during traumatic activities such as prolonged marching or jogging on pavement, karate exercising (See Discussion, p 1058, para 1, lines 1-5). Platt further teach that the exercise-induced hemolysis in sickle cell anemia patients is related to the lysis of dehydrated, shear-sensitive cells (abstract). The clinical characteristics and results of exercise testing are shown in Table 1. These studies show that individuals with SS disease have dense, dehydrated shear-sensitive erythrocytes and exercise-induced intravascular hemolysis (See p 1059, col, 2, last para).
From the teachings of the prior art a skilled person before the effective filing date of the invention would have found it obvious to arrive at the claimed methods because (i) Ruiz-Nunez teach administration of astaxanthin supplement (gel capsule pharmaceutical composition) to SCD subjects increases astaxanthin concentrations in both plasma and RBC of SCD patients without any observed adverse reactions;. astaxanthin incorporates into SCD RBC and may favorably affect the hemolytic component (ii) Platt teach that exercise-induced hemolysis is associated with exposure of the cells to the tremendous mechanical forces generated during traumatic activities such as prolonged marching or jogging on pavement, karate exercising. A person skilled in the art would have found it obvious to administer astaxanthin gel capsule composition to SCD subjects who does prolonged marching or jogging on pavement, karate exercising to improve the hemolytic component. A person skilled in the art would have been motivated to do so is to achieve therapeutic benefits and treat exercise-induced hemolysis or hemolytic anemia. It is noted that hemolysis or hemolytic anemia is the destruction of red blood cells. Anemia is a condition in which the hemoglobin concentration in the blood unit volume decreases below the normal range due to hemolysis (See [0002] of instant specification for definition). Further it is noted that administration of astaxanthin to subjects with sickle cell anemia who does traumatic activities, e.g. jogging on pavement would result in the same pharmacological effects including suppressed exercise-Induced hemolysis or hemolytic anemia in SCD subjects. As to the effective amount, the reference teach astaxanthin supplement effective to improve the hemolytic component of the disease. Thus claims 1-3, 6-8 would have been obvious over the combined prior art teachings. As to claims 9-14, in regards to further increasing hemoglobin content or number of erythrocytes in the subject, administration of the same agent herein astaxanthin composition to SCD subjects who does traumatic activities like jogging on the pavement from the prior art teachings would result in substantially same pharmacological effects.
Claim Objections
Claims 9-14 are objected to because of the following informalities:
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It is noted in the claims, the method cannot comprise increasing number of erythrocytes or hemoglobin as claimed. In other words they are the effects of administration of astaxanthin to the subject population as claimed. It is suggested that the claims be amended to, for example, ‘The method according to claim 7, wherein improving exercise-induced hemolytic anemia results in increasing the number of erythrocytes’. Appropriate correction is required.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627