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 Group I (claims 1-12) in the reply filed on 17 September 2026 is acknowledged.
Claim 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 17 September 2026.
Claims 1-12 are under current consideration.
Drawings
The drawings are objected to because: the view numbers are not preceded by the abbreviation “FIG.” per 37 CFR 1.84(u)(1); Figure 1 is split into partial views on two separate pages but the partial views are not identified by the same number followed by a capital letter (e.g., FIG. 1A, FIG. 1B, etc.) per 37 CFR 1.84(u)(1); Figure 2 is split into partial views on two separate pages but the partial views are not identified by the same number followed by a capital letter (e.g., FIG. 2A, FIG. 2B, etc.) per 37 CFR 1.84(u)(1); and FIGS. 5-9 contain illegible characters/letters/numbers per 37 CFR 1.84(p)(1) that do not measure at least .32 cm (1/8 inch) in height per 37 CFR 1.84(p)(3). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a formulation but then recites “the use of sodium pentaborate pentahydrate, curcumin and piperidine in combination as active substance”, thereby claiming a product as well as a method step, which renders the claim indefinite per MPEP 2173.05(p)(II). It is noted that the recitation “for use in treatment of liver cancer” is acceptable as it merely recites an intended use of the formulation rather than a method step. Claims 2-12 are rejected as depending upon claim 1 without remedying such deficiency.
Claim 2 recites a formulation but then recites “it is used in the treatment of non-viral liver cancer or viral liver cancer”, thereby claiming a product as well as a method step, which renders the claim indefinite per MPEP 2173.05(p)(II). Claim 3 is rejected as depending upon claim 2 without remedying such deficiency.
Regarding claims 6-8, the term "preferably" renders the claims indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the route of administration" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the route of administration" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the dosage form" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahin et al. '447 (WO 2014/200447 A1; published 18 December 2014; of record) in view of Sahin et al. '125 (WO 2020/214125 A1; published 22 October 2020; of record).
Sahin et al. '447 discloses an angiogenesis inhibitor preferably comprising sodium pentaborate pentahydrate in its composition (claim 5) wherein such boron derivative is at a therapeutically effective amount (claim 6) wherein the composition is effective in the treatment of hepatoma (i.e., hepatocellular carcinoma, liver cancer) (claim 12) wherein concentration of sodium pentaborate pentahydrate is between 20 µg/ml and 10 mg/ml (page 7 lines 19-20).
Although Sahin et al. '447 does not disclose that the composition also comprises curcumin and piperine as claimed, Sahin et al. '125 discloses pharmaceutical formulations comprising piperine and curcumin (claim 1) wherein the formulation is in water (i.e., a pharmaceutically acceptable excipient, liquid form) (claim 10) wherein the formulation is used for treating liver cancer or hepatoma (i.e., hepatocellular carcinoma) (claim 15) wherein curcumin has anti-cancer properties (page 1 lines 9-15) and piperine increases the solubility and bioavailability of curcumin (page 1 lines 21-24).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Sahin et al. '447 and Sahin et al. '125 by combining the compositions of Sahin et al. '447 and Sahin et al. '125, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to make a composition effective at treating liver cancer, given that both compositions are disclosed as treating liver cancer, and given 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 to be used for the very same purpose, per MPEP 2144.06(I).
Further regarding claim 1, the recitation of “for use in treatment of liver cancer” is merely a statement of intended use that imposes no additional structure/limitation other than that already recited in the claim. Nevertheless, both Sahin et al. '447 and Sahin et al. '125 teach treatment of hepatoma (i.e., hepatocellular carcinoma, liver cancer).
Further regarding claim 2, the recitation therein is merely a statement of intended use that imposes no additional structure/limitation other than that already recited in the claim. Nevertheless, both Sahin et al. '447 and Sahin et al. '125 teach treatment of hepatoma (i.e., hepatocellular carcinoma, liver cancer), which necessarily must be either non-viral or viral liver cancer.
Further regarding claim 3, the recitation therein is merely a statement of intended use that imposes no additional structure/limitation other than that already recited in the claim. Nevertheless, both Sahin et al. '447 and Sahin et al. '125 teach treatment of hepatoma (i.e., hepatocellular carcinoma, liver cancer).
Further regarding claims 4 and 7-9, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize treatment efficacy of hepatoma using the composition of Sahin et al. '447 in view of Sahin et al. '125 as discussed above by varying the amounts of curcumin and piperine therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because curcumin was known as an active agent to treat hepatoma and piperine was known to increase the solubility and bioavailability of curcumin per Sahin et al. '125, and thus both were known result effective variables. Moreover, active agent concentration is a known result effective variable the determination of which is a matter of routine experimentation. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Further regarding claims 6 and 9, Sahin et al. '447 discloses concentration of sodium pentaborate pentahydrate between 20 µg/ml and 10 mg/ml, which given the molar mass of sodium pentaborate pentahydrate of 295.12 g/mol, results in a concentration range of about 68-68,000 µM, which overlaps the claimed concentrations of 1700-8500 µM, and 1700 µM, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 244.05(I). Alternatively, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize treatment efficacy of hepatoma using the composition of Sahin et al. '447 in view of Sahin et al. '125 as discussed above by varying the amount of sodium pentaborate pentahydrate therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because sodium pentaborate pentahydrate was known as an active agent to treat hepatoma per Sahin et al. '447, and thus was a known result effective variable. Moreover, active agent concentration is a known result effective variable the determination of which is a matter of routine experimentation, as discussed above.
Further regarding claim 10, the recitation therein is merely a statement of intended use that imposes no additional structure/limitation other than that already recited in the claim, and moreover any administration necessarily must be either systemic or local.
Further regarding claim 11, the recitation therein is merely a statement of intended use that imposes no additional structure/limitation other than that already recited in the claim.
Further regarding claim 12, the composition of Sahin et al. '447 in view of Sahin et al. '125 as discussed above is liquid form, as Sahin et al. '125 teaches that the formulation is in water as discussed above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
