DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 24 February 2026 in which claims 21, 24, 28 and 31 were amended to change the scope and breadth of the claims, and 32-34 were newly added.
Claims 21-34 are pending in the current application and are examined on the merits herein.
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 .
Claim Interpretation
The recitation “(i) rutin or (ii) rutin and curcumin, and hydroxytyrosol” in the independent claims is broadly and reasonably interpreted to mean two combinations “rutin and hydroxytyrosol”, and “rutin, curcumin, and hydroxytyrosol”.
Withdrawn Rejections
Applicant’s amendment, filed 24 February 2026, with respect to the rejection of claims 21-31 under 35 U.S.C. § 102(a)(1)/(a)(2), as being anticipated by Darland et al., has been fully considered and is persuasive, because claim 21 has been amended to require “rutin…and hydroxytyrosol” or “rutin and curcumin, and hydroxytyrosol”. Darland et al. do not expressly disclose hydroxytyrosol. The rejection is hereby withdrawn.
Applicant’s amendment, filed 24 February 2026, with respect to the rejection of claims 21-23, 25, 28 and 31 under 35 U.S.C. § 102(a)(1), as being anticipated by Umar et al., has been fully considered and is persuasive, because claim 21 has been amended to require “rutin…and hydroxytyrosol” or “rutin and curcumin, and hydroxytyrosol”. Umar et al. do not expressly disclose hydroxytyrosol. The rejection is hereby withdrawn.
New & Modified Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 24 February 2026, where the limitations in pending claims 21, 24, 28 and 31 as amended now have been changed and claims 32-34 have been newly added. Therefore, rejections from the previous Office Action, dated 24 November 2025, have been modified and are listed below.
Response to Arguments
Applicant's arguments filed 24 February 2026 have been fully considered but they are not persuasive.
Applicant contends the present claims have unexpected results as detailed in Figures 1B, 2B and 3B.
Figure 1B is insufficient to show the claimed invention has unexpected results, because the combination of ingredients shown at the far end are a result of combining hydroxytyrosol, quercetin and curcumin in 1:1:1 ratios. The present claims, however, do not require quercetin. Instead, they are directed towards rutin and hydroxytyrosol, or rutin, curcumin and hydroxytyrosol.
Figure 2B is directed towards a specific mixture of hydroxytyrosol, quercetin and curcumin in 1:1:1 ratios. The present claims, however, do not require quercetin. Instead, they are directed towards rutin and hydroxytyrosol, or rutin, curcumin and hydroxytyrosol.
Figure 3B is directed towards a specific mixture of hydroxytyrosol, quercetin and curcumin in 1:1:1 ratios. The present claims, however, do not require quercetin. Instead, they are directed towards rutin and hydroxytyrosol, or rutin, curcumin and hydroxytyrosol.
Thus, the results do not appear to be commensurate in scope with the present claims.
The rejections are hereby maintained.
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.
Claim(s) 21-34 are rejected under 35 U.S.C. 103 as being unpatentable over Dinh (US Patent Application Publication No. 2017/0079989, cited in previous Office Action) in view of Darland et al. (US Patent No. 6,210,701, cited in previous Office Action) and further in view of Takeda et al. (Phytomedicine, July 2013, vol. 20, pp. 861-864, cited in PTO-892).
Dinh teaches a method for treating osteoarthritis in a joint having an intra-articular space and tissue near the intra-articular space, the method comprising delivering a therapeutically effective amount of an anti-inflammatory agent (AA) and a therapeutically effective amount of an angiogenesis inhibitor (AI) into the intra-articular space (claim 1). The composition can further comprise an anti-inflammatory agent sensitizer (AAS) that increases the effectiveness of the AI by at least four times, and/or an angiogenesis inhibitor sensitizer that increases the effectiveness of the AI by at least four times (para [0044]). The AA or the AI is an mTor inhibitor (claim 12). Dinh exemplifies a curcumin containing preparation (example 2). Curcumin can function as an AA, AI, AIS or AAS (para [0039]). Curcumin is also described as a suitable mTor inhibitor (para [0026]). Dinh teaches the angiogenesis inhibitor includes small amounts of vitamin D (para [0078]). Dinh teaches the composition is designed to deliver the AA and AI in therapeutically significant amounts over at least about 1 week, 2 weeks, 1 month or 2 months (para [0045]).
Dinh teaches in addition to cartilage, the subchondral bone and synovium are believed to be involved in the initiation and progression of OA (para [0004]). Since articular cartilage is essentially avascular, it requires adjacent highly vascularized structures for metabolic support that is mediated by the subchondral bone and synovium. “Recently, the role of inflammation in the degradative process in osteoarthritis is increasingly recognized. Histologically, chronic synovitis is observed in patients undergoing joint replacements. Macrophage infiltration, endothelial proliferation and increased angiogenesis in the synovium apparently contribute to the disease progression” (para [0007]). Dinh teaches matrix metalloproteinases (MMPs) are secreted in the synovial fluid of the joint by the synovial lining cells in response to stimulation by various proinflammatory cytokines (para [0011]. The MMPs in turn destroy the cartilage, thereby perpetuating inflammatory reactions. “Increased vascular turnover in the osteoarthritic synovium reflects a change in the balance between angiogenic and anti-angiogenic factors…synovial neovascularization may be largely driven by synovitis” (para [0016]).
Dinh teaches a method for treating the underlying cellular processes that cause pain and tissue destruction associated with OA. Thus, in one embodiment, the method comprises administering to the affected synovial tissue an effective amount of a pharmaceutical ingredient that lower MMP levels, and lower cartilage destruction and pain (para [0025]; [0068]).
Dinh does not expressly disclose administering rutin for treating or preventing synovitis (present claim 21). Dinh does not expressly disclose administering the composition daily for at least two to three months (present claims 32 and 33).
Darland et al. teach a medical food for ameliorating inflammation-released disease comprising rosemary, curcumin, at least one macronutrient, and at least one member of the group consisting of quercetin and rutin (claim 1). The medical food is formulated to provide a daily dosage of 360 to 440 mg curcumin based on a serving size of about 45-60 g of said medical food taken up to twice a day. The medical food is formulated to provide a daily dosage of rutin in an amount from 360-440 mg based on said serving size taken up to twice a day (claim 10). The medical food is formulated to provide a daily dosage of quercetin in an amount from 360-440 mg based on said serving size taken up to twice a day (claim 9). Darland et al. teach composition 1 comprising 400 mg curcumin and 400 mg rutin (table 3). The composition further comprises a carbohydrate, protein and fat (Table 3 and claim 1). The composition further comprises 200 IU vitamin D. The composition does not comprise vitamin K. Darland et al. teach the curcumin is utilized as a turmeric extract in powder form; quercetin is utilized as either pure quercetin or as a quercetin glycoside (e.g., rutin), (col.6:27-41). Quercetin functions as an antioxidant, and possesses synergistic antioxidant activity when combined with the other dietary components of the dietary supplement and medical food described above (example 2).
The composition is in the form of a dietary supplement or medical food, for treating inflammation-related diseases including arthritis (col.4:24-29). Arthritis includes osteoarthritis and rheumatoid arthritis (col.6:22-27). Typical treatment continues for four to eight weeks (i.e. daily for at least a month), (col.7:5-23). Patients with rheumatoid arthritis and psoriatic arthritis were administered “Composition 1” for 3-9 weeks. The patients varied in age from 16 to 55 years, with an average age of 43 ± 11 years (i.e. an aging human), (Example 1: col.7:49-54). Darland et al. teach “the majority of subjects reported improvement in the physical parameters of MOS SF-36, as shown by the increase in scores in the Physical Functioning, Role Physical, Bodily Pain, and General Health Sections” (col. 10:8-18).
Takeda et al. teach hydroxytyrosol (HT) was effective in alleviate pain in patients with gonarthrosis, i.e. osteoarthritis of the knee (abstract). The patient population was treated with 50.1 mg/day olive extract, having 10.04 mg hydroxytyrosol (HT), for four weeks (p.862, Study Design). Takeda et al. teach HT functions as an anti-oxidant and an anti-inflammatory agent (p.863, Discussion).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising rutin, curcumin and hydroxytyrosol to a subject suffering from synovitis.
Starting from Dinh, one having ordinary skill in the art would have looked to the teaching of Darland and Takeda, because they are all concerned with alleviating symptoms in patients suffering from arthritis, including osteoarthritis. The ordinary artisan would have been motivated to administer curcumin to treat or prevent synovitis in a subject suffering from osteoarthritis, because Dinh expressly teaches a method for administering therapeutically active agents into the osteoarthritic synovium to reduce cartilage destruction, wherein curcumin is described as one of two agents that can serve more than one function. These functions include AA, AI, AIS or AAS. Thus, Dinh clearly prefers curcumin as an active agent for administration to a subject having OA to treat or prevent synovitis in subjects having OA.
The ordinary artisan would have been motivated to include additional active agents, because Dinh clearly teaches administering combinations of therapeutically active agents, including anti-inflammatory agents and anti-inflammatory agent sensitizers which increases the effectiveness of the anti-inflammatory agent. The ordinary artisan would have been motivated to administer rutin in combination with curcumin, because the combination of curcumin and rutin have been taught by Darland for treating inflammatory conditions associated with arthritis, including osteoarthritis.
The skilled artisan would have also been motivated to administer hydroxytyrosol, because Takeda et al. found it was affective in alleviating pain in patients with osteoarthritis of the knee. It is also recognized as an anti-inflammatory agent and anti-oxidant, wherein Dinh teaches administering combinations of therapeutically active agents, including anti-inflammatory agents and anti-inflammatory agent sensitizers which increases the effectiveness of the anti-inflammatory agent.
The ordinary artisan would have had a reasonable expectation of success because Darland found the combination of curcumin and rutin were effective in improving the overall quality of life in patients suffering from chronic arthritis. Furthermore, Darland teach rutin is a glycoside form of quercetin, it can function as a substitute for quercetin, and found quercetin possessed synergistic antioxidant activity when it was combined with the curcumin-containing dietary supplement and medical food.
While the prior art teach administering the compositions for 2 months, one having ordinary skill in the art would have been motivated to administer the composition for more than 2-3 months, because individuals have different degrees of arthritis and/or articular damage, and may be in need of a longer treatment duration.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 21-34 are rejected under 35 U.S.C. 103 as being unpatentable over Dinh and Darland et al. as applied to claims 21-34 above, and further in view of Umar et al. (Indian Journal of Rheumatology, 2012, vol. 7, issue 4, pp. 191-198, cited in previous Office Action) and Takeda et al. (Phytomedicine, July 2013, vol. 20, pp. 861-864, cited in PTO-892).
Dinh teaches as discussed above.
Dinh does not expressly disclose administering rutin to treat or prevent synovitis (present claims 21, 28 and 31).
Darland et al. teach as discussed above.
Umar et al. teach joint cartilage destruction is caused by free radicals released by activated neutrophils, and rutin alleviates the effects of arthritis because of its antioxidant and anti-inflammatory activity (abstract). Rheumatoid arthritis is characterized by cellular infiltration and proliferation of synovium, leading to progressive destruction of the joints through the interaction between infiltrating cells and mediators they produce (p.1, first para). Umar et al. found articular elastase levels in the articular joints were evaluated (p.3, second para). Articular elastase activity is a marker for joint inflammation (p.6, second para). Its activity is directly proportional to inflamed tissue, and articular cartilage degradation (p.6, second, third, and fourth para). Umar et al. found rutin significantly attenuated ELA levels in an RA animal model (p.4, Effect of rutin on cartilage elastase activity). Administration of rutin was found to reduce the levels of free radicals, as evidenced by normalized levels of GSH and SOD (p.6, third para). Furthermore, Umar et al. found treatment with rutin significantly decreased nitric oxide levels, which are known to be elevated in the synovial fluid of patients with rheumatoid arthritis. Treatment with rutin decreased the number of infiltrating cells, attenuated bone degradation and synovial hyperplasia in the RA-animal model (p.6, right col.).
Takeda et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising rutin, curcumin and hydroxytyrosol to a subject suffering from synovitis.
In addition to the reasons discussed above, the ordinary artisan would have been motivated to administer rutin (in combination with curcumin and hydroxytyrosol) to treat or prevent articular cartilage degradation subsequent to synovitis because Umar et al. found treatment with rutin decreased the number of infiltrating cells, attenuated bone degradation and synovial hyperplasia in the RA-animal model. Like Darland et al., Umar et al. found rutin functions as an antioxidant and anti-inflammatory agent for the treatment of arthritis. Umar et al. went further and measured markers of synovial and joint inflammation and cartilage degradation, and found rutin was effective in attenuating disease progression. Thus, the ordinary artisan would have been motivated to administer rutin and hydroxytyrosol, or a combination of rutin, curcumin and HT to a subject suffering from synovitis to treat or prevent articular cartilage degradation with a reasonable expectation of success, because rutin and HT were both effective in an arthritis model, both function as anti-oxidants and anti-inflammatory agents, and rutin improved synovial inflammation and attenuated disease progression.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
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