DETAILED ACTION
The present application is a national stage entry of PCT/KR2022/018180, filed 17 November 2022, which claims foreign priority to KR1020210160623, filed 19 November 2021.
The preliminary amendment filed 08 July 2024 is acknowledged. Claims 1-9 are pending in the current application and are examined on the merits herein.
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 .
Title and Abstract Objection
The abstract and title of the disclosure is objected to because the word “novel” should not be included per 37 CFR 1.72(a), also see MPEP 606. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 8 are objected to because of the following informalities: the use of parentheses marks in claim 1 “(where…alkyl)” is unnecessary, and should be removed. Appropriate correction is required.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Huang et al. (WO 2005/034963, cited in IDS submitted 03 July 2024).
Huang et al. disclose a method for preventing cancer in humans or other animals, the method comprising administering an effective amount of Rh2 ginsenoside (claim 1). The structure of ginsenoside-Rh2 is as follows:
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(p.7). Ginsenoside-Rh2 is identical to the compound of Formula 2 recited in claim 5. Huang et al. disclose the method is used to prevent multiple myeloma (claim 7).
Ginsenoside Rh2 reads on the compound of Formula 1, wherein A1 is a C1 alkyl substituted with hydroxy (i.e. hydroxymethyl), A2 to A4 are each hydrogen, R2-R6 are each methyl (i.e. C1 alkyl), R7 is hydrogen, and n is 2.
Thus, the disclosure of Huang et al. anticipates claims 1-6 of the present application.
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.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (“Discovery of selective anti-cancer ginsenosides targeting polo-like kinases, cited in IDS submitted 03 July 2024; full google machine translation cited in PTO-892) in view of Armoiry et al. (Journal of Clinical Pharmacy and Therapeutics, 2008, vol. 33, pp. 219-226, cited in IDS submitted 07 October 2025).
Kim et al. teach testing the activity of multiple ginsenosides against multiple myeloma cell lines, including testing the combination of ginsenoside with lenalidomide, immunoadjuvant (p.4). Ginsenoside-Rh2 and compound K were particularly effective at inhibiting cell proliferation in ARH77 multiple myeloma cell line (p.5, figure 1). To investigate the combination and synergistic effects of lenalidomide and ginsenoside components, mice were treated with lenalidomide monotherapy and combination therapy with ginsenoside compound K (p.9). Kim et al. teach Rh2 and compound K inhibited MM cells in a dose-dependent manner (p.9, Results). They showed minimal cytotoxicity towards primary healthy peripheral blood-derived stem cells and mesenchymal stem cells.
Kim et al. do not expressly disclose the co-administration of Rh2 with lenalidomide (present claim 8).
Armoiry et al. teach lenalidomide is an immunomodulatory drug derived from thalidomide, with improved anti-inflammatory and anti-neoplastic properties, yet less cytotoxic (abstract). In relapsed or refractory multiple myeloma (MM), lenalidomide, combined with standard dose dexamethasone, is superior to dexamethasone in terms of time to progression, response rate and overall survival (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer ginsenoside Rh2 with lenalidomide to treat multiple myeloma.
According to MPEP 2144.06: “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 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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, ginsenoside-Rh2 was observed to have a positive effect on inhibiting cell proliferation in ARH77 multiple myeloma while lenalidomide functions as an immunoadjuvant and anti-neoplastic agent. Thus, the skilled artisan would have been motivated to combine the two drugs wherein they each produce different effects for the treatment of multiple myeloma.
Additional motivation lies in the express teaching where Kim et al. discuss testing the combination of ginsenoside with lenalidomide as an immunoadjuvant. Kim et al. teach treating mice with lenalidomide monotherapy and combination therapy with ginsenoside compound K to investigate the combination and synergistic effects of lenalidomide and ginsenoside components. Kim et al. found ginsenoside Rh2 and compound K were both highly bioactive towards multiple myeloma cell lines. Thus, the ordinary artisan would have been motivated to also substitute ginsenoside compound K with ginsenoside Rh2, since they are art-recognized alternatives, and combine it with lenalidomide with a reasonable expectation of success for treating multiple myeloma.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. and Armoiry et al. as applied to claims 1-9 above, and further in view of Huang et al (cited above).
Kim et al. teach as discussed above.
Kim et al. do not expressly disclose the co-administration of Rh2 with lenalidomide (present claim 8).
Armoiry et al. teach as discussed above.
Huang et al. teach as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer ginsenoside Rh2 with lenalidomide to treat or prevent multiple myeloma.
According to MPEP 2144.06: “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 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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combining known therapies into a single therapy is a commonly applied method for identifying improved therapeutic outcomes with minimal adverse effect for the patient because each monotherapy is already known to be effective. Here, ginsenoside-Rh2 was observed to have a positive effect on inhibiting cell proliferation in ARH77 multiple myeloma, and for preventing multiple myeloma, while lenalidomide functions as an immunoadjuvant and anti-neoplastic agent. Thus, the skilled artisan would have been motivated to combine the two drugs wherein they each produce different effects for treating or preventing multiple myeloma.
Additional motivation lies in the express teaching where Kim et al. discuss testing the combination of ginsenoside with lenalidomide as an immunoadjuvant. Kim et al. teach treating mice with lenalidomide monotherapy and combination therapy with ginsenoside compound K to investigate the combination and synergistic effects of lenalidomide and ginsenoside components. Kim et al. found ginsenoside Rh2 and compound K were both highly bioactive towards multiple myeloma cell lines. Thus, the ordinary artisan would have been motivated to also substitute ginsenoside compound K with ginsenoside Rh2, since they are art-recognized alternatives, and combine it with lenalidomide with a reasonable expectation of success for treating or preventing multiple myeloma.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699
