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 .
Response to Amendment
Applicant's amendment and argument filed May 19, 2025, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 6-13, 15-20, 22, and 23 are pending and have been examined on the merits.
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 1, 6-13, 15-20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa (Chem. and Biodiver., June 2009, 6(6), pp. 903-915 ; IDS).
The instant claims are as of record, drawn to a method of administering a Chinese green tea plant (Camellia sinensis) flower extract.
Yoshikawa, however teaches (and entitled “Acylated Oleanane- Type Triterpene Saponins with Acceleration of Gastrointestinal Transit and Inhibitory Effect on Pancreatic Lipase from Flower Buds of Chinese Tea Plant (Camellia sinensis)”) teaches extracts from the flower buds of tea plant accelerates GI transit time and inhibits pancreatic lipase (e.g. at abstract), and further shows inhibition results of pancreatic lipase including up to 100% inhibition (at page 905, Table 2). The extracts show an anti-obese effects (page 910 last paragraph) and the compounds may be useful the prevention of obesity (page 911 first paragraph).
The claims differ from Yoshikawa in that they include additional functional features such as inhibiting amylase, lipid peroxidation, radical scavenging, and various types of formulations.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to administer green tea flower extract to reduce body weight as taught by Yoshikawa and to also inhibit various enzymes because the extract inherently performs those functions. Antioxidant effects of green tea in general are well known. Regarding additional components as listed in the claims (clm. 17), diet formulations and foods in general commonly include such components. Regarding formulations listed in claims 16 and 18, all are conventional formulations and green tea has long been included in many such formulations as a food additive or seasoning. Further, all the claimed additives and formulations read on a cup of green tea with sugar or milk added.
It is the examiner's position that on page 910, Yoshikawa teaches in the second full paragraph, in the present study, the MeOH extract from the flower buds of C. sinensis was found to exhibit accelerating effect on gastrointestinal transit in mice, see Table 5. This would appear to show the extract was administered. The pancreatic lipase inhibitory effect is discussed throughout the article, see Table 2. At a minimum, the article is an invitation to try regarding treating obesity. The present claims are not directed to a mechanism for regulating obesity, however as evidenced by the instant and preceding Applications’ disclosures, the polar (hydro and/or alcoholic) extracts so provide the PPARg and C/EBPa activity, and in view thereof the prior art extracts if not expressly reciting are considered to differ in degree of activity (extraction of the same materials though differing in mere amounts and proportions thereof).
Yoshikawa is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided by this reference with respect to providing green tea flower extract therapeutic compositions/extracts and in the manner disclosed therein, as well as the ordinary skill and knowledge of one in the art, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ranges in which to perform such a (broad) “promoting” of healthy body weight), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant has argued that the prior art is distinguished in that the flower buds in light of Kent et al are not necessarily the same phenotype or having the same properties as the flower per se. Applicant’s arguments have been fully considered are found to be not persuasive. The evidence provided with respect to the analogous rose bud is considered by the Examiner to demonstrate the same compounds are/remain present in both the bud and matured flowers, albeit in differing amounts and proportions. Accordingly the qualitative effect, but not necessarily the quantitative effects are still expected regardless of the flower bud or flower extract source. Consequently the qualitative claims (those rejected herein) are/stand as rejected and those drawn to the quantitative properties considered distinguishing in the (mature) flower (i.e. claims 2, 3, and 5) are presently not included in the instant, amended ground of rejection.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 5-13, 15-20, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,642,389 (claims 1-21; reference patent).
Although not identical the claims are not patentably distinguished, because each of the instant and reference inventions as claimed are drawn to processes comprising green tea C. sinensis flower extract to a subject for healthy weight promoting (see each at claims 1), including IC50 values (compare instant claims 2-3 vs. reference claim 2-3), and each of the dependent claims are so nearly phrased as to embrace the same subject matter (compare instant claims 5-13 and 15-20, 22, and 23 vs. reference claims 3-12 and 14-21, respectively), including, as presently amended, the recited activities of PPARg and C/EBPa in the respective green tea flower extracts (see also e.g. [0012] of the instant disclosure).
Response to Arguments
Applicant has argued that the nonstatutory obviousness-type double patenting rejection be held in abeyance. However, this is not persuasive as the MPEP does not provide for holding the rejection in abeyance. The rejection is still deemed proper and stands, including for the reasons of record.
Conclusion
No claims are presently 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 AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/
Primary Examiner, Art Unit 1655