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
Applicant’s response, dated 08/05/2026, is acknowledged. Claims 41, 45, 49, 55-57, 59-61, 112, 120-121, 123-124 are canceled. Claims 31-32, 50, 54, 70-73, 92, 118, 135-138, 143 and 160 are pending and now evaluated on its merit.
Priority
This application claims foreign benefit to GB2014160.2, dated 09/09/2020.
Response to Arguments
Applicant's arguments filed 08/05/2026 have been fully considered but they are not persuasive.
Applicant argues (pages 4-5) in reference to the 103 rejections of claims 31, 92 and 135-138 over Fowler, “it is clear that the main focus of Fowler is the use of hydroxytyrosol” and Fowler teaches the synergy of the combination of hydroxytyrosol with caffeine or L-carnithine. Additionally present application does not mention hydroxytyrosol and Fowler shows no support of hydroxytyrosol being synergistic with claimed agents of resveratrol, niacinamide, alpha lipoic acid, quercetin and EGCG.
It is noted from claim 31, claimed language of “comprising” may further includes other agents to be added to the composition additionally although Fowler does not teach the claimed agents in a specific example Fowler does not have to teach each and every embodiment to be of prior art as per MPEP 2123: A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989), Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Therefore, the rejection of claims 31, 92 and 135-138 are maintained.
Applicant argues (page 6) in reference to the 103 rejections of claims 32, 59, 60 and 123-124, claim 32 of claimed invention does not define a composition combining apigenin and navitoclax. It is noted from claim 32, claimed language of “comprising” may further include other agents to be added to the composition, additionally navitoclax is an agent used in senescence-associated disease. Therefore, the rejection of claims 32, 59, 60 and 123-124 are maintained.
Applicant argues (page 7) in reference to claims 50, 54, 118 and 143, Gupta makes no mention of senescence or senolytic activity but directed towards treatment of ageing related problems due to mitochondrial dysfunction. Applicant additionally argues claim 32 is dependent on claim 31, while examiner makes no mention of claim 32 and claim 143 depends on claim 92 which does not require magnolol or honokiol. It is noted claim 32 has no merit in claims 50, 54, 118 and 143, as the claims are dependent on claim 31 and not 32. In terms of the teachings of Gupta, the treatment of dermatological disorders reads to senescence disease or disorder, additionally Gupta teaches the agents of claimed invention as well as claimed language of comprising may further include other senescence agents. Applicant is picking and choosing specific teachings from Gupta instead of evaluating the teaching as a whole. Therefore, the rejection of claims 50, 54, 118 and 143 are maintained.
Applicant argues (page 8) in reference to claim 160, the claim is dependent on claim 92 in which neither claim 92 nor 160 makes mention of metformin or niclosamide. It is noted from claim 92, claimed language of “comprising” may further include other agents to be added to the composition, in which metformin or niclosamide are agents used to treat a senescence disease or disorder. Additionally claim 160 is dependent on claim 37 which recites a list of senescence diseases or disorders of which consist of arthritis. Thus, claim 160 merely further limits the type of arthritis but does not claim the senescence disease of claim 92 is osteoarthritis.
Applicant have overcome the 112a rejection of claims 41, 57 and 121 and the 112b rejection of claims 32 and 70-72. However, the 112b rejection of claim 73 is maintained as applicant have not amended the claim to exclude ageing as proclaimed in applicants remarks on 08/05/2026.
Claim Interpretation
Claim 160 recites the method of claim 137 wherein the senescence-associated effects of ageing osteoarthritis, examiner is interpreting this limitation as further limiting the arthritis of claim 137 and not as the senescence-associated effects of ageing is osteoarthritis from the method of claim 92.
Claim Rejections - 35 USC § 112
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.
Claim 73 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 73 recites the limitation "a composition according to claim 31 wherein the senescence-associated effects of ageing" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 73 depends on claim 31, in which the claim’s language fails to recite the limitation of “ageing”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 31, 70-73, 92, 135-138 and 160 are rejected under 35 U.S.C. 103 as being unpatentable over Fowler et al. (US 20120225840 A1).
Regarding claims 31, 70-73, 92, 135-138 and 160, Fowler teaches a method to maintain or increase mitochondrial biogenesis in cardiac muscle, skeletal muscles, and liver tissue comprising administration of hydroxytyrosol in combination with at least one of the compounds selected from the group consisting of resveratrol, niacinamide, alpha-lipoic acid, quercetin and EGCG (relevant to claim 31) (abstract). As taught by Fowler mitochondrial function, thus available energy, decreases with aging (relevant to claim 92) (para. 0079). The administration of the above composition protects the mitochondria against infections, inflammation, exposure to environmental pollution and chronic degenerative diseases (para. 0056). The composition improves skeletal muscle mass by stimulating anabolic pathways, inhibiting catabolic pathways and accelerating muscle regeneration when damaged (relevant to claims 72-73 and 136-137) and maintaining tissue/organ function and prevent tissue/organ failure triggered by mitochondrial dysfunction (para. 0068)
Another aspect of the composition is of a cosmetic dermatological skin care composition which promotes mitochondria well-being, and which encourages optimal mitochondrial function in the skin, and thus which boosts the energy metabolism of the skin (relevant to claims 70-71, 135 and 138) (para. 0106-0108).
In terms of claim 160, the senescence-associated effects of ageing of osteoarthritis merely limits the type of arthritis of claim 137. The claim is dependent on claim 137 which recites a list of senescence diseases or disorders which consist of arthritis and claim 160 recites the type of arthritis.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have combined the agents of resveratrol, niacinamide, alpha-lipoic acid, quercetin and EGCG to treat or alleviate a senescence-associated disease, disorder or effect from the teachings of Fowler. One would have been motivated to do so from the teachings of Fowler of a composition comprising one or more agents from a list which consist of resveratrol, niacinamide, alpha-lipoic acid, quercetin and EGCG to improve skeletal muscle mass. There is a reasonable expectation of combining the agents of resveratrol, niacinamide, alpha-lipoic acid, quercetin and EGCG to treat or alleviate a senescence-associated disease, disorder or effect from the teachings of Fowler.
Claims 32, 50, 54, 118 and 143 is rejected under 35 U.S.C. 103 as being unpatentable over Fowler et al. (US 20120225840 A1) in view of Gupta et al. (US Patent No. 8211873).
The teachings of Fowler for the above 103 rejection of claims 31, 70-73, 92, 135-138 and 160 are incorporated herein by reference.
Fowler fails to teach the composition further comprising Magnolol and Honokiol.
Gupta teaches treatment of dermatological disorders that include challenged skin from cancer, diabetes, radiation treatments, chemotherapy, and sun-burn; mitochondrial dysfunction; age spots; acne, loss of cellular antioxidants; skin changes associated with aging including collagen loss, loss of skin pliability, loss of skin suppleness, skin wrinkles and fine lines, oxidation, damage from radiation, damage from free radicals, and damage from UV; dry skin; xerosis; ichthyosis; dandruff; brownish spots; keratoses; melasma; lentigines; liver spots; skin pigmentation including pigmented spots, dark circles under the eyes, darkened skin, and blemishes; oily skin; warts; eczema; pruritic skin; psoriasis; inflammatory dermatoses; topical inflammation; disturbed keratinization; scalp dryness; skin depigmentation, and combinations thereof comprising a chiral-correct mitoprotectant agent, and (ii) an Intra-cellular antioxidant or free-radical neutralizing agent, and (iii) an anti-inflammatory agent, and (iv) a collagen or fibrin boosting agent (relevant to claim 143)(Page 2, 1st para.).
Gupta teaches the anti-inflammatory transparent gel of Example 13, which includes a combination of Magnolol and Honokiol (relevant to claims 32, 50, 54 and 118), antioxidants selected from a list which includes Resveratrol and Quercetin and collagen and fiber boosting agent selected from a list which consist of niacinamide.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have combined Magnolol and Honokiol to the combination composition taught by Fowler to treat or alleviate a senescence-associated disease, disorder or effect. One would be motivated to do so from the teachings of Gupta and Dischler for the same treatment of a skin condition comprising the same ingredients of quercetin, resveratrol and niacinamide. Thus, the addition of agents of Magnolol and Honokiol would increase the effectiveness of the composition. There is a reasonable expectation of combining Magnolol and Honokiol to the combination composition taught by Fowler to treat or alleviate a senescence-associated disease, disorder or effect.
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
