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 .
Priority
Instant application 18/192,624 filed on 03/29/2023 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1 and 21-38 are pending.
The amendment filled on 02/26/2026 have been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/20/2025 and 11/08/2023 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 02/26/2026 is acknowledged. The traversal is on the ground(s) that it would not create an undue burden on the Office to simultaneously search subject matter of Groups I and II. This is not found persuasive because search for each of the inventions is not co-extensive particularly regarding the literature search. Group I does not necessarily read on the prior art applicable to Group II because the method claims require a distinct patient population that is not required by the product claims. Burden consists not only of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement and double patenting issues. The requirement is still deemed proper and is therefore made FINAL.
Claims 37 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/26/2026.
Regarding species election, in an office action mailed on 02/03/2026 examiner requested:
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It should be noted that Applicant did not elect any species.
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 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 and 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Monks (Monks, N. R., Ferraz, A., Bordignon, S., Machado, K. R., Lima, M. F. S., Rocha, A. B., & Schwartsmann, G. (2002). In vitro Cytotoxicity of Extracts from Brazilian Asteraceae. Pharmaceutical Biology, 40(7), 494–500) in view of Pandey (Amita Pandey, Shalini Tripath., Journal of Pharmacognosy and Phytochemistry 2014; 2 (5): 115-119).
Monks teaches that ethanol extracts from Baccharis coridifolia have anti-proliferative activity (see abstract).
Further, Monks teaches the extracts have been tested using three cell lines: HT29, NCI-H460 and U373 (see abstract and Table 2):
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Monks teaches “Baccharis coridifolia was found to be the most potent species tested. Both the organic and aqueous extracts from leaves and stems resulted in IC50 concentrations below 5 mg/ml” (see page 498, last paragraph).
Monks teaches compositions comprising monohydric alcohol (ethanol) (see Methodology, page 495).
Regarding claim 28, Monks teaches ethanol extracts (organic) (see page 495, Collection and extraction of plant materials).
Regarding claim 30, Monks teaches the plant material comprises leaves (see page 498, last paragraph).
Regarding claim 34, Monks teaches purifying the macerate by filtration (see page 495, Collection and extraction of plant materials):
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Regarding claim 36, Monks teaches the extract have been tested on NCI-H460 human large cell lung carcinoma cell lines:
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Therefore, one of ordinary skill in the art would understand that Monks’s ethanol extracts from Baccharis coridifolia are intended for treatments of cancers, including carcinoma in an individual in need
Monks does not explicitly teach the extraction steps recited in the instant claims.
It should be noted that the instant claims recite a pharmaceutical composition which is prepared by a method comprising steps (a) and (b). The instant claims require incubating the macerate for a period of at least 21 days whereas Monks teaches maceration for 48 hours.
Regarding instant claims 21-24, Monks is silent about the ratio of the plant material to the solvent.
Regarding claims 26 and 27, Monks is silent about the concentration of alcohol.
However, since Monks teaches ethanol extracts from Baccharis coridifolia comprising one or more anti-oncogenic phytochemicals, a person of ordinary skill before the effective filing date of the instant application would have been capable to adjust extraction parameters by routine experimentations. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
In addition, Pandey teaches:
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Regarding instant claim 21, it should be noted that Pandey teaches plant material to the solvent of 10:100 (solvent to sample 100:10 (v/w)) (see page 116, “Variation in extraction methods usually depends upon”).
During extraction, solvents diffuse into the solid plant material and solubilize compounds with similar polarity (see abstract of Pandey). Knowing that ethanol extracts from Baccharis coridifolia have anti-proliferative activity, one of ordinary skill in the art would have been motivated to optimize the incubating time and the solvent concentration needed to solubilize the plant material.
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 and 21-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No.11918553 in view of Monks (Monks, N. R., Ferraz, A., Bordignon, S., Machado, K. R., Lima, M. F. S., Rocha, A. B., & Schwartsmann, G. (2002). In vitro Cytotoxicity of Extracts from Brazilian Asteraceae. Pharmaceutical Biology, 40(7), 494–500).
The claims of U.S. Patent No.11918553 recite:
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It should be noted that the claims of U.S. Patent No.11918553 recite the same pharmaceutical composition as recited in the instant claims.
The claims of U.S. Patent No.11918553 do not recite using the recited composition for treatments of cancer.
However, Monks teaches that ethanol extracts from Baccharis coridifolia have anti-proliferative activity (see abstract).
Further, Monks teaches the extracts have been tested using three cell lines: HT29, NCI-H460 and U373 (see Table 2):
Regarding instant claim 36, Monks teaches carcinoma (see page 495, right column, first paragraph):
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Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition recited by claims of U.S. Patent No.11918553 for treatment of cancer because Monks teaches that ethanol extracts from Baccharis coridifolia have anti-proliferative activity.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621