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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission dated 10/14/2025 has been entered pursuant to RCE filed on 10/14/2025.
Pursuant to the amendment dated 10/14/2025, claims 1-87 and 91-99 are cancelled and claims 88-90 and 100-101 are amended. Claims 1, 3, 10, 11, 15, and 20-31 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a CON of 14/853,063 filed on 09/14/2015, which is a CON of 14/305,839 filed on 06/16/2014, which claims domestic benefit to 61/836,113 filed on 06/17/2013 and 61/895,234 filed on 10/24/2013.
Withdrawn Rejections
Applicant’s amendment, filed on 10/14/2025, with respect to the rejection of claims 88-90 and 100-101 under 35 U.S.C. 103 as being unpatentable over Mobasheri et al. (Int. J. Mol. Sci., 2012) in view of Hosek et al. (Journal of Natural Products, 2011) has been fully considered and is persuasive. Applicant has amended claims 88-90 and 100-101 to add the additional limitation wherein the ratio of Morus alba extract to Curcuma longa extract is 4:1, 2:1, or 1:1 which is not taught by either Mobasheri or Hosek. The rejection is hereby withdrawn.
Maintained Objection to the Abstract of the Disclosure
Applicant is reminded of the proper language and format for an abstract of the disclosure. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The present disclosure,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Response to Arguments
Applicant's arguments filed 10/14/2025 do not address the objection to the abstract. Thus, the objection is maintained.
New Rejections
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 88 is rejected under 35 U.S.C. 103 as being unpatentable over Chitre et al. (US 2010/0150865 A1, published 06/17/2010, see PTO-892), Chung et al. (J. of Pharmacy and Pharmacology, published 08/06/2003, see PTO-892), Roh et al. (J. of Health Sci., published 01/05/2011, see PTO-892) and Shrivastava et al. (J Physiol Biochem, published 10/31/2012, see PTO-892).
Chitre is drawn to the study of formulations to inhibit cyclooxygenase (COX) and pro-inflammatory cytokine mediated diseases (title). Chitre teaches a method for alleviating one or more symptoms associated with a medical condition mediated by one or more of a cyclooxygenase, a pro-inflammatory cytokine, and a pro-inflammatory enzyme. The method includes administering an effective amount of a composition to a person suffering from the medical condition wherein the composition comprises an extract of Curcuma Longa (claim 1). The medical condition may be rheumatoid arthritis (claim 12). Chitre teaches that the extract of Curcuma longa includes 20-50% curcuminoids on a dry basis. The pharmacological activity and efficacy of the extract of Curcuma longa present in the composition towards alleviating the one or more symptoms associated with the medical condition is attributed to the amount of the curcuminoid present in the extract of Curcuma longa (paragraph 0044). Chitre showed that a formulation comprising Curcuma longa reduced inflammation in carrageenan-
induced paw edema in rats (Figure 1). Chitre showed that in a model wherein arthritis or inflammation in the joint was induced by injection of Complete Freund’s Adjuvant (CFA_ in to the left hind footpad of rats, the formulation comprising Curcuma Longa (paragraph 0070) showed a dose dependent inhibition of TNF-α production (Figure 7) and an inhibition of NO (Figure 8). Chitre teaches that the composition may be in capsule form and contain 5-50mg of the extract of Curcuma longa (paragraph 0041). The composition can also be used as combination therapy with any other known anti-inflammatory agents (abstract). Chung teaches administering to the person the effective amount of the composition comprising Curcuma longa and an effective amount of one or more drugs to alleviate one or more symptoms associated with the medical condition. The one or more drugs may include a cyclooxygenase (COX) inhibitor and the one or more drugs may be obtained from a natural source (paragraph 0047).
Regarding the limitation of the Curcuma longa extract being enriched for one or more curcuminoids, Chitre teaches that the extract of Curcuma longa was found to contain not less than 27% of curcuminoids (paragraph 0062). The instant specification showed the total percentage of curcuminoids from the Curcuma Longa extract of the instant invention to be between 26.53-30.04% (instant specification page 111). Therefore, the Curcuma longa extract taught by Chitre would meet the limitations of being enriched with one or more curcuminoids as it has the same amount of curcuminoid as the Curcuma longa extract of the instant invention.
Chitre does not directly teach that the administration of the composition would support a normal and comfortable range of motion and/or flexibility in a mammal. Chitre does not directly teach the addition of a Morus alba extract enriched for one or more prenylated flavonoids.
Chung is draw to the in-vitro and in-vivo anti-inflammatory effect of oxyresveratrol from Morus alba (title). Chung teaches that mulberroside A is one of the components of Mori Cortex, which is the dried root of Morus alba and that mulberroside A expresses its pharmacological effects after being converted to oxyresveratrol in the body (page 1695). Chung isolated mulberroside A from the water extract of Mori Cortex (page 1696). Chung exemplified administering 37.5-50 mg/kg body weight of mulberroside A or 7.5-10 mg/kg body weight of oxyresveratrol to carrageenin-induced paw edema in rats (page 1697-1698). Both mulberroside A and oxyresveratrol inhibited the edema induced by carrageenin in a dose-dependent manner. Chung teaches that oxyresveratrol significantly inhibited COX-2 activity invitro.
Roh is drawn to the preventative and therapeutic effects of extract of Ramulus Mori (ERM) on collagen-induced arthritic in Mice via suppression of inflammatory T cells (title). Ramulus Mori (RM) is the dried young branch of Morus alba. Roh teaches that the constituents of RM include oxyresveratrol (page 142). Roh teaches that rheumatoid arthritis (RA) causes edema and joint pain during the early period of disease. Roh investigated the anti-RA effects of RM using a collagen-induced arthritic mice model (page 148). Roh found that ERM reduced the levels of TNF-α in macrophages and improved inflammation of paw joints (PJs). ERM notably decreased the induction of RA in the CIA model by reducing the levels of inflammatory cytokines and rheumatoid factor in the sera and suppressing the number of immunocytes amount peripheral blood mononuclear cells (PBMCs) and PJs (abstract).
Shrivastava is drawn to the study of inflammation and rheumatoid arthritis (title). Shrivastava teaches that biologic agents that specifically inhibit the effects of TNF-α and IL-6 are effective in the treatment of RA patients. This in turn improves the patient’s quality of life by improving their mobility and function (page 344).
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Chitre, Chung, Roh and Shrivastava before the effective filing date of the claimed invention by adding an extract of Morus alba enriched for one or more prenylated flavonoids such as mulberroside A and oxyresveratrol as taught by Chung and oxyresveratrol as taught by Roh to the composition comprising a Curcuma longa extract enriching for one or more curcuminoids that reduces TNF-α and treats RA as taught by Chitre and would lead to the improvement of mobility as taught by Shrivastava to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the composition comprising a curcuma longa extract for treating RA as taught by Chitre by adding an extract of Morus alba because Chitre teaches that a COX inhibitor may be added to the treatment, Roh teaches that the extract of Morus alba comprises oxyresveratrol and can be used to treat RA and Chung teaches that oxyresveratrol is a COX inhibitor. One of ordinary skill in the art would have a reasonable expectation of success because Chitre teaches a composition administered to a person to treat rheumatoid arthritis and reduces TNF-α comprising Curcuma longa and that additional components such as a COX inhibiter may be also administered, Chung teaches that oxyresveratrol acts as a COX inhibitor, and Shrivastava teaches that reducing TNF-α is an effective treatment for RA and improves mobility.
It would have been prima facie obvious for one of ordinary skill to combine the teachings of Chitre, Chung, Roh, and Shrivastava before the effective filing date of the claimed invention to optimize the ratio of Morus alba extract to Curcuma longa extract to be 4:1, 2:1, or 1:1 to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the ratio of the two extracts because Chitre teaches the administration of 5-50 mg Curcuma Longa extract and Chung teaches the administration of 37.5-50 mg/kg body weight of mulberroside A or 7.5-10 mg/kg body weight of oxyresveratrol. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claims 89-90 and 100-101 are rejected under 35 U.S.C. 103 as being unpatentable over Chitre et al. (US 2010/0150865 A1, published 06/17/2010, see PTO-892), Chung et al. (J. of Pharmacy and Pharmacology, published 08/06/2003, see PTO-892), and Roh et al. (J. of Health Sci., published 01/05/2011, see PTO-892).
The teachings of Chitre are discussed above
Chitre does not directly teach the addition of a Morus alba extract enriched for one or more prenylated flavonoids.
The teachings of Chung are discussed above.
The teachings of Roh are discussed above.
It would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Chitre, Chung, and Roh before the effective filing date of the claimed invention by adding an extract of Morus alba enriched for one or more prenylated flavonoids such as mulberroside A and oxyresveratrol as taught by Chung and oxyresveratrol as taught by Roh to the composition comprising a Curcuma longa extract enriching for one or more curcuminoids for the treatment of rheumatoid arthritis as taught by Chitre to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the composition comprising a curcuma longa extract for treating RA as taught by Chitre by adding an extract of Morus alba because Chitre teaches that a COX inhibitor may be added to the treatment, Roh teaches that the extract of Morus alba comprises oxyresveratrol and can be used to treat RA and Chung teaches that oxyresveratrol is a COX inhibitor. One of ordinary skill in the art would have a reasonable expectation of success because Chitre teaches a composition administered to a person to treat rheumatoid arthritis comprising Curcuma longa and that additional components such as a COX inhibiter may be also administered, and Chung teaches that oxyresveratrol acts as a COX inhibitor.
It would have been prima facie obvious for one of ordinary skill to combine the teachings of Chitre, Chung, and Roh before the effective filing date of the claimed invention to optimize the ratio of Morus alba extract to Curcuma longa extract to be 4:1, 2:1, or 1:1 to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the ratio of the two extracts because Chitre teaches the administration of 5-50 mg Curcuma Longa extract and Chung teaches the administration of 37.5-50 mg/kg body weight of mulberroside A or 7.5-10 mg/kg body weight of oxyresveratrol. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 88-90 and 100-101 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that there is a significant and unexpected synergistic result by combining the two extracts that could not be understood or appreciated by one of ordinary skill in the art. Applicant argues that Examples 33 and 34 and 50 to 53 present the individual components, the theoretical result of the combination, and the actual results of the combination of components. Applicant argues that the results of those examples shows that the combination has an unexpected and greater effect that the individual components alone or the theoretical combination. The argument is not persuasive. The results indicated in Examples 33 and 34 are shown below in Table 18 (instant specification page 123-124). There is no statistical data provided for one of ordinary skill in the art to determine if the difference between the theoretical value and the experimental results is significant. For example, in the 1C:1M examples, there is no indication that the theoretical value of 53% inhibition is statistically different than the experimental result of 57.5% inhibition. Without statistical differences, it appears that the 1C:1M composition has an expected additive inhibition effect rather than a synergistic effect. MPEP 716.02(b) states that the evidence relied upon should establish that the differences in results are in fact unexpected and unobvious and are of both statistical and practical significance. Further, no data outside of the claimed range was provided. MPEP 716.02(d) states that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
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Conclusion
No claims are allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693