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 .
Election/Restrictions
Applicant’s election without traverse of species from claims 14, 18, 16 and 19, and 21 and 22 in the reply filed on November 14, 2023 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).The requirement is still deemed proper and is therefore made FINAL.
Claim 23 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 13th, 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 13-23 are pending and claims 13-22 are examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR 10-2021-0113855, filed on November 14, 2023. The priority date is August 27th, 2021.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 14th, 2023 and May 9th, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The IDS contains references in a foreign language which have been considered to the
extent presented in the English language; as presented and accompanied by reference document
which is an English language equivalent or translation, to the extent cited in the instant
Application' s disclosure, or as cited by the Examiner in a PTO-892. Additional references which
have been considered have been initialed (fully considered) or also annotated in the IDS (to
indicate the extent considered). References which have not been considered have been lined
through. An initialed copy of the IDS has been placed in the instant Application file.
Drawings
The drawings were received on November 14th, 2023. These drawings are acceptable.
Specification
The use of the terms Witepsol and Tween, which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following each term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Foods 2020, 9 (11), 1590).
Kim et al. recites: “Recent advances in immuno-oncology (I-O) therapy demonstrated the promising clinical evidences of immune checkpoint inhibitors for multiple types of cancers [1]. The programmed cell death protein 1 receptor (PD-1), and its ligand programmed death ligand 1 (PD-L1), are one of most extensively studied immune checkpoints” (Kim et al. Introduction; instant claims 13 and 15-19). Kim et al. recite the results of a competitive ELISA (enzyme-linked immunosorbent assay) procedure: “The results confirmed that RCE [Rubus coreanus extract] dose-dependently interfered the binding of PD-1 and PD-L1 at an indicated concentration in rage from 25 to 800 μg/mL” (Kim et al. subheading 3.1; instant claims 13 and 15). Kim et al. recite the unripe berries of Rubus coreanus extracted with distilled water (Kim et al. subheading 2.2; instant claim 14). Kim et al. also performed tests demonstrating in vivo anti-tumor efficacy of Rubus coreanus extract (RCE): “To examine the anti-tumor efficacy of RCE, hPD-L1 knock-in MC38 tumor cells were injected subcutaneously (s.c.) into humanized PD-1 mice and RCE and anti-PD-1 were treated orally or intraperitoneally (i.p.)”, where the MC38 cell line is colorectal cancer (Kim et al. Supplementary Materials subheading S.2.1; instant claims 16 and 19). Kim et al. recited the following summary of their results: “Collectively, the present results suggest that the oral administration of RCE effectively attenuates tumor growth in humanized PD-1 mice, indicating that RCE could be utilized as a potential candidate agent for cancer therapeutics targeting PD-1 and PD-L1” (Kim et al. subheading 3.2; instant claims 13 and 15-19). Kim et al. also recite a method of cancer treatment by blocking an immune checkpoint: “Based on our results, RCE can be applied to the diet on cancer patient to enhance anti-cancer immunity via blocking PD-1/PD-L1 interaction” (Kim et al., Discussion, paragraph 4; instant claims 13 and 15-19).
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 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Foods 2020, 9 (11), 1590) as applied to claims 13-19 above, and further in view of Alcindor and Beauger (Current Oncology 2011, 18 (1), 18-25).
Independent claim 17 is drawn to a method for treating a disorder relating to an immune checkpoint inhibition, the method comprising administering to a subject in need thereof a composition comprising a Rubus coreanus extract as an effective component.
Dependent claim 20 recites: “The method of claim 17, wherein the composition further comprises an anti-cancer active agent”. Dependent claim 21 recites: “The method of claim 20, wherein the anti-cancer active agent is an anti-cancer agent or an immune checkpoint inhibitor”. The applicant has elected “anti-cancer agent” for claim 21 (included Response to Restriction Requirement). Dependent claim 22 recites: “The method of claim 20, wherein the anti-cancer active agent is an anti-cancer agent selected from the group consisting of actinomycin D, …, oxaliplatin, …, and a combination thereof. The applicant has elected oxaliplatin (included Response to Restriction Requirement).
As demonstrated above, the method of claim 17 is anticipated by Kim et al., where the disorder related to immune checkpoint inhibition is cancer, treated through targeting the immune checkpoint of PD-1 and PD-L1. Considering the utility of the method of claim 17 for treating cancer, it would be obvious to combine the administered composition of claim 17 with an anti-cancer active agent, such as an anti-cancer agent (instant claims 20 and 21). Oxaliplatin is an anti-cancer agent with known activity against colorectal cancer (Alcindor and Beauger, subheading 6.2), like the composition comprising Rubus coreanus extract recited by Kim et al. used to treat colorectal cancer (Kim et al. subheading 3.2 and Supplementary Materials subheading S.2.1). Therefore, it would have been obvious to combine oxaliplatin with Rubus coreanus extract, to one of ordinary skill in the art before the effective filing date of the claimed invention (instant claim 22).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: all of the components of the composition administered in the claimed method for treating a disorder relating to an immune checkpoint inhibition are individually thought to possess anti-colorectal cancer activities. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art”.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655