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 .
Claim Status
Applicant’s remarks and amendments, filed 30 December 2025 in response to the non-final rejection mailed 30 September 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 30 December 2025 replaces all prior versions and listings of the claims.
Claims 1, 3, 5, and 11 are pending. Claim 4 is canceled by Applicant’s amendment. Claims 1 and 11 are amended. Claims 1, 3, 5, and 11 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments, on page 4 of the reply filed 30 December 2025 with respect to the rejection of Claims 1, 3-5, and 11 under 35 USC § 103 have been fully considered. The rejections of Claim 4 is withdrawn due to cancellation of the claim.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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.
Claims 1, 3, 5, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al. (KR 20110031599 A, translation, 47 pages) in view of Park et al. (J Nutri, 2011, 1931-1937) and Kwon et al. (Inflammation, 2011, pages 535-544) as evidenced by Lee et al. (Cell Metab, 2014, 484-497), Arpitha et al. (Int J Sci Tech Eng, 2017, 6 pages), Wu et al. (Chem Nat Compd, 2019, 324-326), Elkhateeb et al. (Phytochem, 2005, 2577-2580), Jahan (Brac Uni, Feb 2020, 38 pages), Ito et al. (Phytochem, 2002, 171-174), and Garg et al. (Int J Pharm Pharm Sci, 2013, 3-8).
The instant claims are as of record, drawn to a method for treating and a method for improving cardiovascular and metabolic diseases including dyslipidemia, hyperlipidemia, and arteriosclerosis, comprising administration of a composition comprising an extract or fraction isolated from Elaeocarpus petiolatus as an active ingredient wherein the composition inhibits binding of Resistin-CAP1.
Oh et al. teach a composition comprising Elaeocarpus petiolatus extract for the prevention and treatment of inflammatory disease (Oh et al., Claim 1, page 37; as required for instant Claims 1 and 11) that is administered (Oh et al., [0046], page 19; as required for instant Claims and 11) via oral and parenteral formulations. The leaves, stems, or roots of Elaeocarpus petiolatus (Oh et al., [0034], page 15; as required for instant Claim 3) can be extracted using methanol (alcohol having 1 to 4 carbon atoms), water, or a mixture thereof (fraction is fractioned with; Oh et al., Claims 3 and, page 37; as required for instant Claims 5). Additionally, the composition can also be administered as a health food (food composition; Oh et al., Claim 9, page 39; as required for instant Claim 11).
Oh et al. do not teach wherein the extract or fraction improves or treats cardiovascular and metabolic diseases including dyslipidemia, hyperlipidemia, and arteriosclerosis, an aqueous ethanolic extract, or that the composition inhibits binding of Resistin-CAP1.
Park et al., however, teach that ellagic acid (extract or fraction of Elaeocarpus petiolatus, instant specification, pages 23-24) blocks internalization of LDL and prevents cholesterol efflux, thereby providing a potential treatment to interrupt development of atherosclerosis (arteriosclerosis; Park et al., Abstract, page 1931 and Discussion, page 1934; as required for instant Claims 1 and 11). While Park et al. do not explicitly teach that the ellagic acid is from Elaeocarpus petiolatus, it is known in the art that ellagic acid is present in the Elaeocarpus genus as a whole (Wu et al., para. 1, lines 4-6), and additional studies have confirmed its presence in specific species as summarized in the table below:
Publications showing Elaeocarpus spp. Comprises ellagic acid
Author
Year
Species
Location
Synonyms
Ito et al.
2002
E. mastersii
Title, Abstract
Elkhateeb et al.
2005
E. parvifolius
Title, Abstract
Jahan
2020
E. sphaericus
1.1., page 3
E. ganitrus
Jahan
2020
E. floribundus
1.4., page 9
E. grossus; E. lobbianus; E. ramosii; E. rigidus
Arpitha et al.
2017
E. ganitrus
Abstract
E. sphericus; E. augustifolius
Garg et al.
2013
E. sphaericus
Abstract
E. ganitrus
Wu et al.
2019
E. sylvestris
p. 324, para. 2
E. henryi; E. kwangtungensis; E. omeiensis
Kwon et al. teach that an extract of Elaeocarpus petiolatus bark extracted with ethanol (aqueous ethanolic extract; as required for instant Claims 1 and 11) suppresses (inhibits) NF-κB translocation (inhibits the binding of Resistin-CAP1; Kwon et al., Abstract, page 535; as required for instant Claims 7 and 9). While Kwon et al. does not explicitly teach inhibition of Resistin-CAP1 binding, Lee et al. teach that Resistin-CAP1 upregulates NF-κB transcription (Lee et al., Abstract, page 484) as part of its inherent mechanism of action, and thus the known inhibition of NF-κB by Elaeocarpus petiolatus extract inherently teaches the inhibition of Resistin-CAP1.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Oh et al., Park et al., and Kwon et al. in order to arrive at the instantly claimed invention. A skilled artisan would understand that because ellagic acid is effective for the treatment of ellagic acid and that because ellagic acid is found in Elaeocarpus sp., extracts of Elaeocarpus petiolatus would also be effective for treating arteriosclerosis. This could readily be combined with the method of Oh et al. in order to provide the composition to a patient in need thereof and a skilled artisan could expect to do so with a reasonable expectation of success, as well as that administering composition would inherently inhibit binding of Resistin-CAP1 because it has been shown to inhibit NF-κB translocation as an inherent part of its mechanism of action. Ultimately, it would be obvious to a skilled artisan to use a different species within a genus of plant shown to comprise ellagic acid for the instantly claimed method and achieve effects (e.g., treating arteriosclerosis, inhibition of Resistin-CAP1) that are well known within the art.
Prior Art Made of Record but not Relied Upon
Jain et al. (Asian J Pharm Clin Res, 2017, 5 pages) teaches that Elaeocarpus ganitrus extract given to rabbits at a dose of 250-500 mg/kg of body weight has anti-atherosclerotic and antioxidant activity.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
The applicant argues that ellagic acid was not identified in their 95% ethanolic extract of E. ganitrus and therefore one of ordinary skill in the art would not know that plants in the genus Elaeocarpus comprise ellagic acid, which has been shown to be effective for treating arteriosclerosis. The Examiner, however, disagrees because a skilled artisan consulting the art prior to the effective filing date of the instant application would encounter the evidentiary art of Lee et al. (Cell Metab, 2014, 484-497), Arpitha et al. (Int J Sci Tech Eng, 2017, 6 pages), Wu et al. (Chem Nat Compd, 2019, 324-326), Elkhateeb et al. (Phytochem, 2005, 2577-2580), Jahan (Brac Uni, Feb 2020, 38 pages), Ito et al. (Phytochem, 2002, 171-174), and Garg et al. (Int J Pharm Pharm Sci, 2013, 3-8), all of which teach the presence of ellagic acid in various Elaeocarpus species, including E. ganitrus. A skilled artisan would therefore expect to find ellagic acid in these plants and therefore would reasonably expect efficacy against arteriosclerosis.
The applicant additionally argues that because their ellagic-acid free extract of E. ganitrus does not have a concentration-dependent inhibition of resistin-induced TNF-α production in THP-1 cells as presented in Example 8, this embodiment demonstrates synergism and that a skilled artisan would not be able to predict the effect. Firstly, it is noted that the features upon which applicant relies (i.e., concentration-dependent inhibition of resistin-induced TNF-α production in THP-1 cells; synergism) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is additionally noted that the E. ganitrus also has concentration-dependent inhibitory effect against TNF-α production and its effect at lower concentrations is similar to that of E. petiolatus total extract at a higher concentration when compared to the treated control group (see e.g., Figure 7B of the instant disclosure).
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655