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 .
Acknowledgement of Receipt
Applicant's response filed on 02/04/2026 to the Office Action mailed on 11/05/2025 is acknowledged.
Claim Status
Claims 1-17 are pending.
Claims 1-3 are withdrawn as being directed to a non-elected invention.
Claims 4-17 have been examined.
Claims 4-17 are rejected.
Priority
Priority to 371 PCT/US21/59830 filed on 11/18/2021, which claims priority to application 63/115146 filed on 11/18/2020 is acknowledged.
Drawings
The drawings filed on 11/05/2025 are accepted.
Withdrawn Claim Rejections - 35 USC § 102
Response to Applicant’s Arguments
The rejection of claims 4 and 6-15 under 35 U.S.C. 102(a)(1) as being anticipated by CN 104069465 to Zheng Jiayuan (Zheng) (abstract cited on IDS dated 5/18/25- full translation attached herewith), as evidenced by Zeinali et al (Zeinali; 11/22/2019) is withdrawn in view of the amendments to the claims.
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.
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 rejection is reiterated from the previous Office Action.
Claim(s) 4-17 are rejected under 35 U.S.C. 103 as being unpatentable over WO2018101398A1 to Takashi et al (abstract cited on IDS dated 5/18/25. full translation submitted herewith) in view of Zeinali et al (Zeinali; 11/22/2019).
Takashi teaches a pharmaceutical composition for use in the treatment or prevention of inflammatory bowel disease (IBD), the pharmaceutical composition comprising apelin or an apelin receptor agonist (abstract, page 1). For the IBD, Takashi teaches treating ulcerative colitis and Crohn’s disease (page 8, 1st paragraph).
Page 7 of Takashi refers to WO2013/146891 that states that saffron, crocetin are the main components of saffron extract. Page 8 of Takashi teaches that apelin receptor agonists include saffron extract (further on page 10, last para). In particular, page 11, 1st full para describes apelin receptor agonist including saffron extract for treating IBD. For the claimed administration, Takashi teaches various methods including oral administration (p 9, para 1), including food composition (paragraphs bridging pages 11-12 & page 12, 1st para). For the claimed dosage, Takashi teaches apelin dose of 100 to 1,000,000 nmol/per day and 1-100 times per month (p 10, 3rd para). Example 4 of the reference teaches effect of apelin receptor agonist on inflammatory macrophages and shows reduction of chemokine cytokines. Example 5 shows the effect of apelin receptor agonist in IBD model animal, and the survival rate of the control group mice at 8 weeks after the transfer was about 60%, compared with about 90% in the apelin-administered group (FIG. 4- paragraphs on p 15-16).
Takashi suggests saffron extract as a suitable apelin receptor agonist for treating IBD, but does not exemplify or explicitly state an embodiment composition comprising saffron extract.
In this regard, Zeinali teaches Crocus sativus (Saffron) for immunoregulatory and anti-inflammatory properties. Zeinali teaches that the chemical components of Saffron extracts include the claimed crocin, safranal and picrocrocin (see col. 1 on page 334 & fig. 1). Further, Zeinali teaches the beneficial effects of saffron on inhibition of serum levels of NF-ĸB, TNF-alpha, interferon gamma and interleukin levels such as IL-1beta, IL-6 etc (abstract, Table 1 and page 337- col. 2). Zeinali suggests saffron dosages of 100 mg, 200 or 400 mg/day for 7 days) with safe doses up to 1.5g/day (col. 1, p 337).
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to prepare an oral composition with an effective amount of saffron extract as an apelin receptor agonist, and employ the composition for the treatment of IBD because while Takashi clearly suggests saffron extract as a suitable apelin receptor agonist in treating IBD. Hence, one of an ordinary skill in the art would have expected that the oral or food composition of Takashi comprising saffron extract (that includes safranal, crocin and picrocrocin) would provide an effective treatment for treating inflammation, including IBD, by reducing the levels of pro-inflammatory cytokines, and further meet the functional limitations of claims 10-15. One of an ordinary skill in the art would have further employed saffron at a suitable dose such as the claimed dose i.e., 100 mg because Zeinali suggests that a dose of up to 1.5g/day can be administered safely, and hence one of an ordinary skill in the art would have expected an effective treatment of IBD with a suitable amount of saffron extract.
Response to Applicant’s Arguments
Applicant argues that Takashi does not teach or suggest the claimed dosage of saffron for treating IBD. Applicant’s argument has been fully considered but found not to be persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant also argues that Zeinali et al. does not relate to the treatment of IBD. Applicant’s argument has been fully considered but found not to be persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant finally argues that the instant claims are not obvious over the combination of Takashi and Zeinali et al. Applicant’s argument has been fully considered but found not to be persuasive. Takashi teach using saffron extract for the purpose of treating IBD. Zeinali et al. teach a dosage of saffron extract for the purpose of having anti-inflammatory properties. Since, IBD is an inflammatory disease, it would be expected that the dosage of saffron extract taught by Zeinali et al. would be effective in treating IBD inflammation.
With regard to the amended claim 16 dosage amount, one of ordinary skill in the art at the time of the filing of the application, would have been obvious through routine optimization. Generally, 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).
Therefore, the rejection is maintained.
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.
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/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614