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 .
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.
This office action is a response to applicant’s communication submitted July 12, 2024, wherein claims 1, 3, 7, 11, 17, and 24-25 were preliminarily amended, and claims 4-6, 12-16, 18-19, and 22-23 were canceled.
Claims 1-3, 7-11, 17, 20-21, and 24-25 are pending in this application.
Priority
This application is a 371 of PCT/KR2020/019368 filed 12/30/2020 and claims foreign priority to KR10-2019-0177439 filed 12/30/2019. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Claim Interpretation
With respect to instant claims 1 and 17, which are directed to a pharmaceutical composition and food composition respectively and recite the phrase “for preventing or treating cancer” and “for preventing or ameliorating cancer” respectively. The Examiner notes that it is well settled that “intended use” of a composition or product, e.g., “for preventing or treating”, will not further limit claims drawn to a composition, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed (See MPEP 2111.02 (II)).
Drawings
The drawings are objected to because:
Figures 2c, 3c, 6b, 7b 8b use the term “uM” to denote micromolar, when the term “µM” should be used.
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 Objections
Claims 3, 10, 21, and 25 are objected to because of the following informalities:
In claim 3, the phrase “glucose cotransporter-2 inhibitor” should read “sodium-glucose cotransporter-2 inhibitor”.
In claims 10 and 21, there should be an “or” before the phrase “killing the cells” as the alternatives are part of a list and to be consistent with the rest of the claim. See 112(b) issues described below.
Claim 25 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 11. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). The Examiner notes that claim 25 is directed towards a method, but it is dependent on claim 1, and recites the same claim language other than the word “method”, as claim 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 7-9, 17, 20, and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The specification, while being enabling for the amelioration or treatment of cancer, does not reasonably provide enablement for the prevention of the same. The specification does not enable any person skilled in the art to which is pertains, or with which it is most clear connected, to make and use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)).
These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4)
relative skill in the art; (5) amount of direction provided by the inventor; (6) the level of
predictability in the art; (7) the existence of working examples; and (8) quantity of
experimentation needed to make or use the invention based on the content of the disclosure. All
of the factors have been considered with regard to the claim, with the most relevant factors
discussed below:
(1& 2) The breadth of the claims and nature of the invention: The claims are directed towards compositions comprising gossypol, a biguanide-based compound, and a sodium-glucose cotransporter-2 inhibitor for the prevention or treatment/amelioration of cancer
(3) The state of the prior art: While there are publications that describe methods of treating some cancer with gossypol, a biguanide-based compound, and a sodium-glucose cotransporter-2 inhibitor, there is no evidence in the prior art that the claimed composition would prevent cancer as claimed. For example, Villani (Molecular metabolism, 2016, IDS filed March 12, 2026) teaches SGLT2 inhibitor, such as canaglifozin, reduces cancer cell proliferation of inhibiting mitochondrial complex-I supported respiration (abstract, title). Lu (Medicine Reports, 2017, IDS filed March 12, 2026) teaches gossypol induces cell death by activating apoptosis and autophagy in HT-29 cells ang suggests its use as an antitumor agent (abstract). Jackson (Oncotarget, 2017, IDS filed March 12, 2026) teaches phenformin, a biguanide, has antitumorigenic effects in human ovarian cancer cells (abstract) Thus, in short, the art recognizes administering therapeutic compositions containing gossypol, a biguanide-based compound, or a sodium-glucose cotransporter-2 inhibitor can treat cancer, but not in the absolute prevention of cancer.
(4) The level of skill in the art: The level of skill in the art would be high, mostly likely at
the Ph.D. /MD level.
(5 & 7) The amount of direction provided by the inventor and the existence of working
examples: Applicant has not provided examples that demonstrate that the composition claimed
is effective at preventing cancer. The instant specification has demonstrated that the SGLT-2 inhibitor, gossypol, and phenformin can effectively inhibit the proliferation and metastasis of brain cancer stem cells (pg. 41-42, para. 00158).. Applicant has not demonstrated that when the composition is administered to a subject, it would prevent said cancer from occurring.
(6) The level of predictability in the art: The prior art does not teach a method of preventing cancer by administering a therapeutic composition. Although some methods may ameliorate or treat cancer, there is nothing in the prior art that indicates that prevention is possible.
(8) The quantity of experimentation necessary: Neither the instant specification nor the state of the art have demonstrated how therapeutic compositions, such as the composition claimed, can prevent cancer from occurring. An undetermined number of experimental factors utilizing a composition and its method for preventing would have to be resolved by the practitioner and/or the patient for the following reasons: the factors are not sufficiently discussed in the specification to provide guidance to utilize the invention as claimed.
Therefore, other than proposing an initial hypothesis, the entire burden of research
involved in utilizing the compositions claimed to prevent cancer would fall on the shoulders of the skilled artisan attempting to practice the claimed invention, presenting an undue burden of unpredictable experimentation.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a
reward for search, but compensation for its successful conclusion.” And “patent protection is
granted in return for an enabling disclosure of an invention, not for vague intimations of general
ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the state of the art and the lack of guidance or working examples, Applicant fails to provide information sufficient to practice the claimed invention without undue experimentation.
It is noted that the term “prevent” does not necessarily mean that something is kept
from ever occurring, but such is an interpretation available to the Examiner that falls under
the “broad and reasonable” standard for claim term interpretation as set forth in the MPEP at §
2111 and thus is proper.
It is suggested to remove the phrase “preventing” from the claims to overcome the rejection.
Claim Rejections - 35 USC § 112 (b)
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 11, 21, and 25 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.
Regarding claims 11 and 21: The phrase “the cells” renders the claim indefinite, because it is unclear whether this in reference to cancer cells, cancer stem cells which were also previously recited within the claim, or cells in general.
Regarding claim 25: Claim 25 recites “the method for preventing or treating cancer of claim 1, wherein the treating comprises”. However, claim 1 is directed to a pharmaceutical composition. The claims being directed to separate classes of invention leads to a lack of clarity, thus claim 25 is rendered indefinite. The Examiner suggests amending claim 25 to be dependent on claim 24, which is directed to a method.
Claim Rejections - 35 USC § 103
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 1-3, 7-11, 17, 20-21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cheong (KR 20180045883, English translation relied upon provided on PTO-892, IDS filed IDS filed March 12, 2026) in view of Villani (Molecular Metabolism, 2016, IDS filed March 12, 2026).
Regarding claims 1-3, 7-11, 17, 20-21, and 24-25: Cheong teaches a pharmaceutical composition for treating cancer comprising a polyphenol compound, a biguanide compound, and an anticancer agent which can inhibit the growth of cancer cells (English translation, abstract). The pharmaceutical composition is highly effective for treatment of cancer tissues comprising a large amount of cancer stem cells or low grade cancers (abstract). The compositions can be used for the treatment of cancer including cancer stem cells or inhibition of metastasis of cancer (English translation, pg. 4, para. 5) Cheong teaches a composition comprising gossypol, phenformin and irinotecan for the inhibition of gastric cancer cells (English translation, pg. 6, example 3-1). Cheong teaches that the present invention can be classified into a prostate cancer, chronic leukemia, acute leukemia, lymphocytic lymphoma, renal cancer, ureter cancer, renal cell carcinoma, renal pelvic carcinoma, central nervous system tumor, primary central nervous system lymphoma, spinal cord tumor (English translation, pg. 2, para. 8). Cheong teaches the composition can be administered orally (English translation, pg. 4, para. 6). According to the instant specification, the phrase “food composition" refers to a composition that is used in various ways to prevent or ameliorate the indications targeted by the present invention (pg. 16, para. 0046). Thus, wherein the composition of Cheong treats cancer and can be administered orally, it is encompassed by the phrase “food composition” based on the instant specification.
Cheong does not teach wherein the composition includes a sodium-glucose cotransporter-2 inhibitor, such as canagliflozin or dapagliflozin.
However, Villani teaches that like the biguanide metformin, Canagliflozin not only lowers blood glucose but also inhibits complex-I supported respiration and cellular proliferation in prostate and lung cancer cells (abstract). Villani teaches recent studies indicated that the SGLT2 inhibitors Canagliflozin and Dapagliflozin may inhibit the growth of pancreatic and colon cancer cells, potentially through inhibition of SGLT2-mediated glucose uptake (pg. 1049, col. 1, para.1). Villani concludes that biguanides, Canagliflozin inhibits mitochondrial respiration and cellular proliferation, suggesting that this type 2 diabetes medication may also have utility in treating cancer (pg. 1049, col. 1, para. 1)
Taken together, it would have been prima facie obvious to modify the composition of Cheong by including canagliflozin in the composition as taught by Villani. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as combination therapies for the treatment of cancer is a known technique in the art and the art recognizes the anticancer ability of canagliflozin, for the purpose of treating the cancer more effectively via separate mechanisms. 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.... The idea of combining them flows logically from their having been individually taught in the prior art (See MPEP 2144.06 (I)).
Claims 17 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cheong (KR 20180045883, English translation relied upon provided on PTO-892, IDS filed IDS filed March 12, 2026) and Villani (Molecular Metabolism, 2016, IDS filed March 12, 2026) as applied to claims 1-3, 7-11, 17, 20-21, and 24-25 above in view of Kim (KR 20180097161, IDS filed IDS filed March 12, 2026, English translation relied upon provided on PTO-892).
Regarding claims 17 and 20-21: Even if assuming for the sake of argument the claims directed to a food composition were interpreted in such a way as to not be rendered obvious over Cheong and Villani, claims 17 and 20-21 would have been rendered obvious further in view of Kim.
As discussed above, Cheong and Villani render obvious the composition above administered orally.
They do not teach wherein the composition is a food composition.
However, Kim teaches a pharmaceutical composition comprising gossypol and phenformin, which can exhibit a synergistic effect in the treatment of pancreatic cancer (abstract). Kim teaches examples of the formulations for oral administration include tablets, pills, light / soft capsules, liquids, suspensions, emulsions, syrups, granules and elixirs (English translation, pg. 7, para. 5). According to the instant specification, the food composition containing the composition of the present invention as an active ingredient may be prepared as various foods, for example, beverages, gums, teas, vitamin complexes, powders, granules, tablets, capsules, confectionery, cakes, bread, and the like (pg. 16, para. 0046). Thus wherein Kim teaches tablets, capsules, these constitute foods based on the instant specification.
Taken together it would have been prima facie obvious to a person of ordinary skill in the art to formulate the composition of Cheong and Villani as a tablet or capsule as taught by Kim. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as oral formulations in tablet/capsule form is a routine practice in the art of treating cancer, for the purpose of a facile way to administer the composition.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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