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 November 2, 2023. Claims 1-8 are pending in this application . Priority This application is a 371 of PCT/CN2020/094830 filed 06/08/2020 and claims foreign priority to C N 201910494758.8 filed 06/10/2019 . Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received. Drawings The drawings are objected to because: Figure 1 has blurry drawings which render them illegible. There are overlaps between subscripts and atoms: . Additionally subscripts are blurry and unclear in the structures shown. 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. Specification The disclosure is objected to because of the following informalities: The instant specification contains the same structure issues as described above. Additionally on page 48, it is unclear whether the last paragraph is part of para. 197 or is meant to be para. 198. Appropriate correction is required. Claim Objections Claim 1 objected to because of the following informalities: Claim 1 recites “formula I” twice, which is redundant. Claim 1 recites “formula I” twice, which is redundant. In claim 1 there is overlap between subscript b and an oxygen atom in the following structure: . Claim 1 recites two sentences, however individual claims should be limited to one sentence. In claim “and a pharmaceutically acceptable salt,” should read “or a pharmaceutically acceptable salt,” to clarify that the claim is directed towards a compound and not a composition. Appropriate correction is required. Claim 3 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. Claims 4-8 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claim s 3-8 have not been further treated on the merits. The Examiner notes that claims 5-8 as written would be rejected as they present additional issues such as: Claims 7 -8 would be rejected under 35 U.S.C. 101 because: T he claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims. one cannot claim a new use per se, because it is not among the categories of patentable inventions (process, machine, manufacture, or composition of matter) specified in 35 U.S.C. § 101 . Claims 5-8 would be 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. The claims are unclear as to whether they are directed towards an improper use claim, a method claim for treating, a method claim for preparing, or a composition of matter. Claim Interpretation Claim 1 recites “The derivative of the present disclosure has an efficient and broad-spectrum anti-cancer activity.”. The Examiner notes that a compounds properties cannot be separated from the compound itself. Thus if a prior art anticipates a claimed compound, that compound necessarily possesses the activity. Claim Rejections - 35 USC § 112 (a) Written Description 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 1-2 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated: “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers , 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe , 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute s a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli , the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli , 872, F.2d at 1012, 10 USPQ2d at 1618. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below. The claims herein are drawn a compound which is a flavone derivative possessing R1 and R4 groups that can be amino . However the instant specification does not demonstrate the preparation of any compounds with this substitution, other than stating it is a possible substitution. The claims herein are drawn to a compound which is a flavone derivative possessing R4 groups that can be , wherein R5 is a monosaccharide residue or an oligosaccharide, and L is selected from the group consisting of a polypeptide, C ₁ -C ₂₀ linear alkyl or a derivative thereof, a derivative of C ₁ -C ₂₀ linear or branched acyl, C ₁ -C ₂₀ glycol or a derivative thereof, N 0 0-100, d is an integer from 0-100, e is an integer from 1-100 . The specification does not limit the structure of the monosaccharide residue, oligosaccharide residues, or polypeptides , how or where th ey are incorporated , or how the y are attached at R 5 and L, except for the compounds specifically made as recited by claim 4 . Monosaccharide residue, oligosaccharide residues, or polypeptides can vary significantly in structure, function, and size. Thus, the claim encompasses to a broad genus of any flavone derivatives compounds containing a monosaccharide, oligosaccharide, polypeptide somehow linked to one another and a lso flavone derivatives with a O-NH2 group with no means of preparation. The specification provides support for compounds where the R4 groups and monosaccharides ha ve the structures defined in claim 4 (also see specification page 5) . The specification as originally filed does not provide adequate support for the generic claims herein. The specification merely describes compounds (page 5 ) which contain the monosaccharides and structures as shown in claim 4 . Other than those compounds, the claims are extremely broad and encompass an infinite number of possible compounds, the vast majority of which are not described in the specification. The skilled artisan would also understand that, within that large number of compounds, are a large number of embodiments of immense structural variation, which is not described. The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. The genus in this instance contains an infinite number of compounds, and the disclosed compounds are only those where the monosaccharides and R4 group ha ve the structures shown in claim 4 . The specification lacks sufficient variety of species to reflect the breadth of the infinite genus in claim 1. While having written description of the compounds containing the R 1- 4 groups and monosaccharides shown in claim 4 , the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims. Claim Rejections - 35 USC § 112 (a) Enablement 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 1-2 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 compounds claimed or salts thereof, does not reasonably provide enablement for solvates or hydrates thereof as claimed. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. 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 compounds, salts, solvates, or hydrates thereof, which are flavone derivatives useful for the treatment of tumors. (3) The state of the prior art: There is prior art that teaches pharmaceutical compounds can be made into salts, solvates, polymorphs, co-crystals, and hydrates. For example, Healy et al (Advanced Drug Delivery Reviews, 2017 , cited on PTO-892 ) teaches active pharmaceutical ingredients (APIs) may exist in various solid forms and differences in solid forms often lead to differences in thermodynamic parameters and physicochemical properties for example solubility, dissolution rate, stability and mechanical properties of APIs (abstract). The fundamental characteristics and trends observed for pharmaceutical hydrates, solvates and amorphous forms are presented, with special emphasis, due to their relative abundance, on pharmaceutical hydrates with single and two-component (i.e. cocrystal) host molecules (abstract). However, Healy teaches that there are various means by which solvent can be associated with crystalline solids: adsorption on a solid surface, adsorption and absorption into disordered regions and crystal defects, the physical inclusion of liquid during crystal growth, and solvent associated as part of crystal packing (pg. 27, section 2.1). Pharmaceutical APIs, and their mixtures/formulations can be processed by different techniques, including solvent-based and fusion-based methods (pg. 39, section 3.3). Different manufacturing methods can lead to different solid forms of single and multicomponent systems (pg. 39, section 3.3). The characterization of different solid-state forms of APIs - solvates, hydrates, and amorphous forms - is pivotal in early-stage solid form screening during drug product development, not just for single component systems, but also for two component systems (pg. 42, section 5). Additionally, Shin (J. Therm. Anal. Calorim., 2014, cited on PTO-892) teaches a specific example of flavonoid can form both hydrates and solvates (abstract). Shin also teaches that 80-90% of organic compounds are capable of existing in polymorphic forms (pg. 2457, col 2, para. 4). Thus, in short, the art recognizes hydrates, polymorphs, co-crystals and solvates of compounds can be made and can take on different forms with different properties, requiring extensive characterization , but also not all compounds can exist in polymorphic forms . (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 demonstrated the claimed compounds in hydrate or solvate form. The instant specification has demonstrated the characterization of these compounds (pg. 29 , for example). Applicant has not demonstrated synthesis or characterization of these compounds as hydrates or solvates. (6) The level of predictability in the art: There are not any clear, routine teachings in the art that would enable the compounds to be prepared as hydrates or solvates. (8) The quantity of experimentation necessary: Neither the instant specification nor the state of the art have demonstrated how the compounds can be made into hydrates or solvates. In order to translate the compounds in Applicant’s disclosure into a hydrates or solvates, one skilled in the art would have to develop a crystallization method and use advanced analytical techniques to characterize the properties of the compounds as a hydrate or solvate. As discussed with Healy, differences in solid forms often lead to differences in thermodynamic parameters and physicochemical properties for example solubility, dissolution rate, stability and mechanical properties of APIs. Genentech, 108 F.3d at 1366, s t ates 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. 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 appl icant regards as his invention. Claim 2 is 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 claim 2: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation the monosaccharide residue and the oligosaccharide residue , and the claim also recites “preferably the following monosaccharide residues 1-24:” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim Rejections - 35 USC § 102 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 1 is rejected under 35 U.S.C. 102 FILLIN "Insert either \“(a)(1)\” or \“(a)(2)\” or both. If paragraph (a)(2) of 35 U.S.C. 102 is applicable, use form paragraph 7.15.01.aia, 7.15.02.aia or 7.15.03.aia where applicable." \d "[ 2 ]" (a)(1) as being anticipated by Li (CN101591318, cited on PTO-892) . The English translation has been provided by the Examiner. Regarding claim 1: Li teaches antitumor flavone derivatives, preparation thereof, and compositions thereof ( English translation, abstract). Li teaches (Original document, pg. 12, top of page). Conclusion No claims are allowed in this action. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Guo (CN 109369748, cited on PTO-892, English translation has been provided by the Examiner) teaches icariside I class compounds and derivatives thereof of the following formula (English translation, abstract, original document, abstract). Slamova ( Int. J. Mol. Sci. , 2018, cited on PTO-892) teaches glycosylation of flavonoids enhance water solubility (abstract). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SAMUEL L GALSTER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-0933 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:00 AM - 5:00 PM . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Scarlett Y Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5241 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /S.L.G./ Examiner, Art Unit 1693 /ANDREA OLSON/ Primary Examiner, Art Unit 1693