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. Status of Claims Claims 1-15 were originally filed on December 21, 2022. The amendment received on December 21, 2022, amended claims 3, 5-6, 8-10, and 12-15; and added new claims 16-20 . The amendment received on August 14, 2025, amended claims 1-2, 5, 7, and 14. Claims 1- 2 0 are currently pending and under consideration. Priority The present application claims status as a 371 (National Stage) of PCT/CN2021/101405 filed June 22, 2021, and claims priority under 119(a)-(d) to Chinese Application No. 202010571978.9 filed on June 22, 2020. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Chinese Application No. 202010571978.9, which papers have been placed of record in the file. Please note that the Chinese application is not in English and therefore cannot be verified. Information Disclosure Statement The information disclosure statement (IDS) submitted on December 2 1 , 20 2 2 is being considered by the examiner. Sequence /Claim Interpretation For claim s 1 , 3, and 13 , please note that the Examiner is interpreting the scope as closed-ended (i.e., in light of “is”, which is construed as closed-ended) requiring 100% identity and the same length to SEQ ID NO: 1. For claim 2, please note that the Examiner is interpreting the scope as closed-ended (i.e., in light of “is”, which is construed as closed-ended) requiring 100% identity and the same length to any of SEQ ID NOs: 3-9. Moreover, regarding interpretation of “a polypeptide fragment containing any of the following amino acid arrangements :”, p ursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the " broadest reasonable interpretation " standard: The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1) . Given that the instant specification only utilizes a single polypeptide sequence as depicted in Tables 1-2 and in Experiments 1-10, the Examiner is interpreting that the polypeptide fragment contains any one of the following whole amino acid sequences in order to advance prosecution. However, the broadest reasonable interpretation of “ a polypeptide fragment of any of the following” encompasses a fragment, i.e., any dipeptide, of one or more of the following amino acid sequences as further articulated in the 112( b ) rejection below. For claim 3, please note that the Examiner is interpreting that the polypeptide complex requires a polypeptide sequence of SEQ ID NO: 1 as recited in instant claim 1 thereby limiting the polypeptide to 100% identity and same length of SEQ ID NO: 1 and any macromolecular material. It is noted that a macromolecular material is defined as any class of natural or synthetic substances composed of very large molecules that are multiples of simpler chemical units called monomers (See Britannica, “Polymer”, available online at https://www.britannica.com/science/macromolecule , 6 pages (accessed on 11/24/25) at pg. 1, 1 st paragraph) (hereinafter “Britannica 1”). Macromolecules are very large molecules, usually with a diameter ranging from about 100 to 10,000 angstroms (See Britannica, “Macromolecule”, available online at https://www.britannica.com/science/macromolecule , 1 page (accessed on 11/24/25) at pg. 1, 1 st paragraph) (hereinafter “Britannica 2”). As such, an ordinary skilled artisan would be well-aware of what constitutes a macromolecular material. For claim 5, please note that the Examiner is interpreting the scope of claim 5 as closed-ended requiring 100% identity and same length to one of SEQ ID NOs: 7 or 8. For claim 16, please note that since the instant specification does not define what constitutes a “high polymer”, the plain and ordinary meaning of the term applies. See MPEP 2111.01. Britannica 1 teaches that when the number of monomers is very large, the compound is sometimes called a high polymer (See Britannica 1, pg. 1, 3 paragraph). As such, an ordinary skilled artisan would be well-aware of what constitutes a high polymer. Claim Objections Claims 1-2 and 14 are objected to because of the following informalities: the claims recite, “amino acid arrangements ” . It is respectfully requested that the claims refer to “amino acid sequence” or “amino acid sequences” given that MPEP 2422 refers to “sequences” as opposed to “arrangements”. Appropriate correction is required. Claim 1 is objected to because of the following informalities: the claim 1 recites, “ [a] polypeptide specifically binding to CD123 protein, …X 3 is I or D; X 4 is C or N; X 5 is absent,…” It is respectfully requested that claim 1 recites, “ [a] polypeptide specifically binding to a CD123 protein, …X 3 is I or D; X 4 is C or N; and X 5 is absent,…” in order to be grammatically correct. Appropriate correction is required. Claim 2 is objected to because of the following informalities: claim 2 recites, “….any of the following amino acid arrangements:” with each sequence listed. It is respectfully requested that “or” is added after SEQ ID NO: 8 and before SEQ ID NO: 9 in order to be grammatically correct. Appropriate correction is required. Claim 3 is objected to because of the following informalities: the claim 3 recites, “[a] polypeptide complex specifically binding to CD123 protein,.…” It is respectfully requested that claim 3 recites, “[a] polypeptide complex specifically binding to a CD123 protein,.…” in order to be grammatically correct. Appropriate correction is required. Claims 5 is objected to because of the following informalities: the claim 5 recites , “…wherein the polypeptide is selected from SEQ ID NO: 7 or SEQ ID NO: 8." It is respectfully requested that claim 5 recites, “…wherein the polypeptide is selected from SEQ ID NO: 7 and SEQ ID NO: 8." See MPEP § 2173.05(h). A ppropriate correction is required. Claims 6 is objected to because of the following informalities: the claim 6 recites, “wherein the macromolecular material is selected from one of more of the following substances:…. polyoxyethylene polyoxypropylene ether block copolymer (molecular weight ratio of polyoxyethylene and polyoxypropylene is 80:20) and polylactic acid – glycolic acid copolymer…” It is respectfully requested that claim 6 recites, “wherein the macromolecular material is selected from one of more of the following substances:…. polyoxyethylene polyoxypropylene ether block copolymer (molecular weight ratio of polyoxyethylene and polyoxypropylene is 80:20), and polylactic acid – glycolic acid copolymer…” with a comma between … 80:20) and polylactic acid. See MPEP § 2173.05(h). Appropriate correction is required. Claims 10 is objected to because of the following informalities: the claim 10 recites, “…wherein the chemotherapy drug is selected from one or more of vinecristine , doxorubicin hydrochloride, camptothecin , cyclophosphamide." It is respectfully requested that claim 10 recites, “…wherein the chemotherapy drug is selected from one or more of vinecristine , doxorubicin hydrochloride, camptothecin , and cyclophosphamide." See MPEP § 2173.05(h). Appropriate correction is required. Claim 10 is objected to because of the following informalities: the claim 1 recites, “[a] co-delivery system specifically binding to CD123 protein,.…” It is respectfully requested that claim 10 recites, “[a] polypeptide specifically binding to a CD123 protein,….” in order to be grammatically correct. Appropriate correction is required. Claim 11 is objected to because of the following informalities: the claim 11 recites, “wherein the mass ratio of the chemotherapy drug to the polypeptide complex is 1: (10-80)”. It is respectfully requested that claim 11 recites, “wherein the mass ratio of the chemotherapy drug to the polypeptide complex is 1:10-80” in order to be grammatically correct. Appropriate correction is required. Claim 13 is objected to because of the following informalities: the claim 13 recites, “…a co-delivery system , wherein the method…and filtering (for example, using a hydrophilic PES membrane filter) to remove free chemotherapy drug, to obtain the co-delivery system.” It is respectfully requested that claim 13 recites, “…a co-delivery system, wherein the method… and filtering (for example, using a hydrophilic PES membrane filter) to remove free chemotherapy drug to obtain the co-delivery system” in order to be grammatically correct (i.e., remove space after “system” and remove the last comma). Appropriate correction is required. Claim 14 is objected to because of the following informalities: the claim 14 recites, “…X 3 is I or D; X 4 is C or N; X 5 is absent,…” It is respectfully requested that claim 14 recites, “…X 3 is I or D; X 4 is C or N; and X 5 is absent,…” in order to be grammatically correct. Appropriate correction is required. Claim 14 is objected to because of the following informalities: the claim 14 recites, “…the general formula of amino acid…, the polypeptide complex,…the co-delivery system is prepared ” . It is respectfully requested that claim 14 recites, “…the general formula of amino acid…, the polypeptide complex,… and the co-delivery system is prepared” in order to be grammatically correct. Appropriate correction is required. Claim 14 is objected to because of the following informalities: the claim 14 recites, “…wherein the chemotherapy drug is selected from one or more of vinecristine , doxorubicin hydrochloride, camptothecin , cyclophosphamide." It is respectfully requested that claim 14 recites, “…wherein the chemotherapy drug is selected from one or more of vinecristine , doxorubicin hydrochloride, camptothecin , and cyclophosphamide." It is respectfully requested that claim 10 recites, See MPEP § 2173.05(h). Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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 1-4, 6, and 8-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling : for a polypeptide to specifically bind a CD123 protein where the general formula of an amino acid sequence of the polypeptide is SEQ ID NO: 7 or 8; for a polypeptide complex to specifically bind a CD123 protein comprising the polypeptide and a macromolecular material where the polypeptide complex is prepared from raw materials including 1 part by weight of the polypeptide and 1-50 parts by weight of the macromolecular material; and for a co-delivery system to specifically bind a CD123 protein comprising the polypeptide complex and a chemotherapy drug such as vincristine, doxorubicin HCl, camptothecin , or cyclophosphamide where the co-delivery system is prepared by mixing the polypeptide complex and the chemotherapy drug; and for treating leukemia associated with CD123 expression in a patient by administering an effective amount of a polypeptide complex or a co-delivery system to the patient where t he polypeptide complex is according to claim 4 (i.e., the polypeptide is SEQ ID NO: 7 or 8) , and the co-delivery system is according to claim 10 where the polypeptide in the polypeptide complex is SEQ ID NO: 7 or 8 , but does not reasonably provide enablemen t : for a polypeptide to specifically bind a CD123 protein where the general formula of an amino acid sequence of the polypeptide is SEQ ID NO: 1 other than SEQ ID NO: 7 or 8; for a polypeptide complex to specifically bind a CD123 protein comprising SEQ ID NO: 1 other than SEQ ID NO: 7 or 8 and a macromolecular material where the polypeptide complex is prepared from raw materials including 1 part by weight of the polypeptide and 1-50 parts by weight of the macromolecular material; and for a co-delivery system to specifically bind a CD123 protein comprising the polypeptide complex with SEQ ID NO: 1 other than SEQ ID NO: 7 or 8 and a chemotherapy drug such as vincristine, doxorubicin HCl, camptothecin , or cyclophosphamide where the co-delivery system is prepared by mixing the polypeptide complex and the chemotherapy drug; and for treating leukemia NOT associated with CD123 expression in a patient by administering an effective amount of a polypeptide, a polypeptide complex, or a co-delivery system to the patient where the polypeptide , whether alone or in a polypeptide complex or a co-delivery system , has an y amino acid sequence including SEQ ID NO: 7 or 8 ; for treating leukemia associated with CD123 expression in a patient by administering an effective amount of a polypeptide complex, or a co-delivery system to the patient where the polypeptide is SEQ ID NO: 1 other than SEQ ID NO: 7 or 8 ; and for treating leukemia associated with CD123 expression in a patient by administering an effective amount of a polypeptide where the polypeptide is any one of SEQ ID NO: 1 and 3-9. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. As stated in MPEP §2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’.” These factors include, but are not limited to: 1. The breadth of the claims; 2. The nature of the invention; 3. The state of the prior art; 4. The level of skill in the art; 5. The level of predictability in the art; 6. The amount of direction provided by the inventor; 7. The presence or absence of working examples; 8. The quantity of experimentation necessary needed to make or use the invention based on the disclosure. See In re Wands USPQ 2d 1400 (CAFC 1988). The eight In re Wands factors are applied to Claims 1-4, 6, and 8-20 as follows: The Breadth of the Claims and The Nature of the Invention For claims 1-4, 6, and 8-20, although addressing that the polypeptide specifically binds to a CD123 protein by utilizing an amino acid sequence of SEQ ID NO: 1, the amino acid variability encompassed in SEQ ID NO: 1 is insufficient for an ordinary skilled artisan to extrapolate the efficac y demonstrated in the specification for SEQ ID NOs: 7 and 8 to extend to the full scope of the claimed genus of polypeptide sequences; especially given that even SEQ ID NOs: 7 and 8 when either complexed with a macromolecular material or alone failed to reduce leukemic cell viability (See instant, Figure 11), but was able to prolong mouse survival when complexed with a macromolecular material (See instant Figure 13). Without a core structure or sequence shared among the polypeptide sequences shown as necessary for CD123 protein binding or without a representative number of species exhibiting the function of CD123 protein binding that can be extrapolated to extend to the scope of the claimed genus, an ordinary skilled artisan would be unduly burdened to test each sequence. Although not every species is required to be demonstrated to evidence the intended result, given that SEQ ID NOs: 7 and 8 failed to reduce leukemic cell viability in any tested cell line and given that SEQ ID NOs: 7 and 8 do not constitute a core sequence that can be extended to the broader genus, two species demonstrating the property of CD123 protein binding would not support that other peptides without a common core structure or sequence would similarly function thereby treating any form of leukemia including leukemia associated with CD123 protein expression. Accordingly, claims 1-4, 6, and 8-20 are unduly broad with respect to the polypeptides that specifically bind to a CD123 protein where such binding results in the treat ment of leukemia in a patient . For claims 14-15, a lthough addressing that the patient is suffering from leukemia and where the patient can be treated by administering a polypeptide with an amino acid sequence of SEQ ID NO: 1 , a polypeptide complex comprising the polypeptide and a macromolecular material where the polypeptide complex is prepared from raw materials including 1 part by weight of the polypeptide and 1-50 parts by weight of the macromolecular material , or a co-delivery system comprising the polypeptide complex and a chemotherapy drug such as vincristine, doxorubicin HCl, camptothecin , or cyclophosphamide where the co-delivery system is prepared by mixing the polypeptide complex and the chemotherapy drug ( See claim 14 ), the forms of leukemia to be treated include all leukemia forms including forms that do not express a CD123 protein . Patnaik et al. teaches in a number of leukemia types including acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), blastic plasmacytoid dendritic cell neoplasm (BPDCN), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), chronic myelomonocytic leukemia (CMML), hairy cell leukemia (HCL), variant hair cell leukemia ( HCLv ), and myelodysplastic syndrome (MDS) (See Patnaik et al., Leukemia & Lymphoma 62 :2568-2586 (2021) at Table 1). CD123 expression rates vary dramatically depending on the form of leukemia; for example, 55-97% of AML patients exhibit CD123 expression on leukemia cells whereas 4-10% of CLL patients exhibit CD123 expression on leukemia cells (See Patnaik article, Table 1). Thus, the scope of the treatment method encompasses treatment of any leukemia irrespective of the CD123 expression level. Accordingly, claims 14-15 are unduly broad with respect to the scope of leukemias to be treated. The State of the Prior Art The prior art does not demonstrate that a polypeptide with the amino acid sequence of SEQ ID NO: 1 thereby encompassing SEQ ID NOs: 3-9 specifically bind to a CD123 protein. Furthermore, the prior art does not demonstrate that this polypeptide, whether alone or complexed with a macromolecular material , treats any form of leukemia in a patient. However, as discussed supra , Patnaik et al. demonstrates in Table 1 that CD123 expression is present in a number of hematological malignancies including different forms of leukemia (See Patnaik, Table 1) ( See also : Testa et al., Cancers 11 :31 pages (2019) at abstract: teaching that CD123 is widely overexpressed in various hematological malignancies including AML, B-cell ALL, HCL, and BPDCN) . But, the percent of CD123 expression for each form of leukemia varies greatly. BPDCN and HCL exhibit the highest CD123 expression ranging from 75-100% and 86-100%, respectively, whereas CLL exhibits the lowest CD123 expression ranging from 4-10% (See Patnaik, Table 1). As such, Patnaik et al. demonstrates that treatment of a leukemia by administering an agent that binds to CD123 would be dependent upon whet h er the leukemic cells express CD123. Therefore, the level of predictability in the art is dependent on many factors including whether the leukemia cells express CD123 , whether the polypeptides specifically bind to CD123 whereby such binding would result in treatment of leukemia associated with CD123 expression, and whether the polypeptide alone, even if it can specifically bind to CD123, can effectively treat any leukemia . The Level of Skill in the Art Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art for treatment of leukemia in a patient by administering a polypeptide of SEQ ID NO: 1, a polypeptide complex comprising SEQ ID NO: 1, or a co-delivery system comprising the polypeptide complex and a chemotherapeutic drug, and where such treatment is due to the polypeptide specifically binding to a CD123 protein expressed on the leukemic cells . The Level of Predictability in the Art The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., administering an effective amount of a polypeptide of SEQ ID NO: 1, a polypeptide complex comprising SEQ ID NO: 1 and a macromolecular material, or a co-delivery system comprising the polypeptide complex and a chemotherapeutic drug to a patient in order to treat leukemia such that the polypeptide specifically binds to a CD123 protein ), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher , 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work. In the instant case, Applicants only demonstrate that SEQ ID NOs: 7 and 8 as a polypeptide when complexed with mPEG2000-PCL2000 as a macromolecular material can extend the survival rate of mice suffering from AML (See instant specification, Experiment 10, Figure 13 ) , only SEQ ID NOs: 7 and 8 can specifically bind to AML cells that exhibit CD123 at a concentration of at least 5 µM (See instant specification, Experiment 2 , Figures 2-3 ) , and AML leukemic cell viability is statistically reduced only when doxorubicin HCl is combined with SEQ ID NO: 7 or a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 (See instant specification, Experiment 8, Figure 11 ) , but fails to demonstrate (1) that any polypeptide other than SEQ ID NOs: 7 and 8 can specifically bind to a CD123 protein, (2) that any polypeptide of SEQ ID NO: 1 alone can treat any form of leukemia including CD123+ leukemic cells, and (3) that leukemia that does not express a CD123 protein can be treated by any polypeptide of SEQ ID NO: 1 or complex comprising any polypeptide of SEQ ID NO: 1 and a macromolecular material. Regarding the polypeptide specifically binding to a CD123 protein, it appears that Applicants rely on the assumption that by providing evidence that SEQ ID NOs: 7 and 8 bind to CD123 would support every polypeptide sequence of SEQ ID NO: 1 binding to CD123. However, such an assumption cannot be made. W hen comparing instant SEQ ID NOs: 7 and 8, it is noted that the core sequence shared between both is: DDDYDTRAQGTDIG[C/N]DFRRISDDD. Although SEQ ID NO: 8 contains GG added at the N-terminus, neither sequence demonstrates the variability at the X1 (i.e., absent or D), X2 (i.e., R), X3 (i.e., D), and X5 (i.e., absent, D, or DRR) of instant SEQ ID NO: 1. Furthermore, although the specification provides a conclusory statement that the other polypeptides in Table 1, i.e., SEQ ID NOs: 3-6 and 9, provide results consistent with SEQ ID NOs: 7 and 8, the data has not been provided. Given that the charge of the polypeptide can vary depending on the encompassed variability, e.g., C-terminus being DRR vs DDD , X2 being R instead of A, and/or X2 being D instead of I , and given that the substitutions at positions X2 and X3 are not conservative substitutions, there is no indication that similar positive results for SEQ ID NOs: 7 and 8 can be expected to extend to other sequences of SEQ ID NO: 1. Applicants are invited to provide the statistically significant data demonstrating that SEQ ID NOs: 3-6 and 9 exhibit similar binding capability to CD123 as SEQ ID NOs: 7 and 8. Without such data, the level of unpredictability is high thereby requiring more experimentation demonstrating that a representative number of polypeptides for SEQ ID NO: 1 specifically bind to a CD123 protein. Therefore, it is unpredictable that a polypeptide of SEQ ID NO: 1 other than SEQ ID NOs: 7 and 8 specifically bind to a CD123 protein. Regarding leukemia treatment, it appears that Applicants rely on the assumption that by providing evidence that a complex comprising SEQ ID NO: 7 or 8 complexed with mPEG2000-PCL2000 as a macromolecular material extends the survival rate of mice suffering from AML or that SEQ ID NO: 7 or 8, whether alone or complexed with a macromolecular material, treats AML expressing a CD123 protein when combined with a chemotherapeutic drug would exhibit similar intended results for treatment of any leukemia irrespective of CD123 expression and for treatment of any leukemia including those exhibiting CD123 expression by administration of any polypeptide of SEQ ID NO: 1 alone. However, such an assumption cannot be made because there is no indication that administration of any polypeptide of SEQ ID NO: 1, whether alone or complexed with a macromolecular material, can treat a leukemia that does not express a CD123 protein, and/or there is no indication that administration of any polypeptide of SEQ ID NO: 1 alone can treat any leukemia including those that express CD123. In fact, the instant specification demonstrates that the CML K562 cell line does not express CD123 (See instant specification, Experiment 1 ) . Plus, Figure 11 demonstrates that SEQ ID NO: 7 and a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 does not reduce AML leukemic cell viability without combining the polypeptide or complex with doxorubicin HCl (See instant specification, Figure 11). Moreover, Figure 13 only demonstrates that a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 extends the survival rate of mice suffering from AML, but does not demonstrate that the polypeptide alone can extend the survival rate. Since the polypeptide is complexed with mPEG2000-PCL2000, the in vivo half-life of the polypeptide would be expected to be increased thereby improving efficacy of the polypeptide. As such, without more experimentation demonstrating the efficacy of the polypeptide alone for treatment of any leukemia including those expressing CD123, and demonstrating the efficacy of the polypeptide, whether alone or complexed with a macromolecular material, for treatment of any a leukemia not expressing a CD123 protein, the level of unpredictability remains high. Therefore, it is unpredictable that administration of a polypeptide of SEQ ID NO: 1 including SEQ ID NOs: 7 and 8 alone can treat any leukemia irrespective of CD123 expression, or that administration of a polypeptide including those complexed with a macromolecular material can treat a leukemia that does not express a CD123 protein. The Amount of Direction Provided by the Inventor, The Presence or Absence of Working Examples, and The Quantity of Experimentation Necessary In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to practice the presently claimed invention would be unable to do so without engaging in undue experimentation. One wishing to practice the presently claimed invention would have to produce additional data and experimentation to determine whether (1) a representative number of polypeptide species within the claimed subgenus of SEQ ID NO: 1 specifically binds to a CD123 protein, or there is a core structure or sequence shared among the species that is necessary for the polypeptide to bind to a CD123 protein, and (2) administering an effective amount of a polypeptide of SEQ ID NO: 1, a polypeptide complex comprising SEQ ID NO: 1 and a macromolecular material, or a co-delivery system comprising the polypeptide complex and a chemotherapeutic drug to a patient treat s leukemia . The Specification discloses experiments demonstrating that SEQ ID NOs: 7 and 8 bind to leukemic cells expressing CD123 but not to leukemic cells not expressing CD123 (See instant specification, Experiment 2; Figures 2-3); demonstrating that a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 bind to leukemic cells expressing CD123 but not to leukemic cells not expressing CD123 (See instant specification, Experiments 4-7; Figures 6-10); demonstrating that SEQ ID NO: 7 or a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 when combined with doxorubicin HCl reduce AML leukemic cell viability (See instant specification, Experiment 8; Figure 11); and demonstrating that a complex containing SEQ ID NO: 7 and mPEG2000-PCL2000 extends the survival rate of mice suffering from AML (See instant specification, Experiment 10; Figure 13). However, the specification demonstrates that SEQ ID NO: 7 or a complex of SEQ ID NO: 7 and mPEG2000-PCL2000 do not reduce AML leukemic cell viability (See instant specification, Figure 11), and only this complex extends the survival rate of mice suffering from AML (See instant specification, Figure 13). As such, the specification provides limited specific guidance or direction on the full scope of a polypeptide of SEQ ID NO: 1 binding to a CD123 protein, treatment of leukemia not associated with CD123 expression, and treatment of leukemia by a polypeptide of SEQ ID NO: 1 alone or complexed with a macromolecular material other than SEQ ID NOs: 7 or 8. Additionally, the Specification expressly demonstrates that the polypeptides would not treat leukemia unless the leukemia is associated with CD123 expression (See instant , Experiment 2; Figures 2-3 ). Although the specification provides conclusory statements that the other polypeptides in Table 1, i.e., SEQ ID NOs: 3-6 and 9, provide results consistent with SEQ ID NOs: 7 and 8, the data has not been provided. In the absence of such information, a person of ordinary skill in the art would reasonably require an undue quantity of experimentation to determine (1) a core structure or sequence shared among each polypeptide species that is necessary for binding to a CD123 protein, (2) the efficacy of a polypeptide of SEQ ID NO: 1 alone for the treatment of leukemia irrespective of whether the leukemia is associated with CD123 expression, and (3) the efficacy of a polypeptide of SEQ ID NO: 1 other than SEQ ID NOs: 7 and 8 when complexed with a macromolecular material for treatment of leukemia associated with CD123 expression . Conclusion of 35 U.S.C. 112(a) (Enablement) Analysis MPEP §2164.01(a), 4 th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright , 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Genentech Inc. v. Novo Nordisk A/S , 42 USPQ2d 1001, 1005 (CA FC), states that, “[p] atent 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,” citing Brenner v. Manson , 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005. After applying the Wands factors and analysis to claims 1-4, 6, and 8-20 , in view of the applicant’s entire disclosure, and considering the In re Wright , In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 1-4, 6, and 8-20 would not be enabled by the written disclosure excluding that of SEQ ID NOs: 7 and 8 specifically binding to a CD123 protein , being administer ed alone or when complexed with a macromolecular material in combination with a chemotherapeutic drug to a patient in order to treat leukemia associated with CD123 expression , and administering a complex comprising SEQ ID NOs: 7 or 8 and a macromolecular material without being combin ed with a chemotherapeutic drug to a patient in order to treat leukemia associated with CD123 expression . Therefore, claims 1-4, 6, and 8-20 , are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to utilize a polypeptide of SEQ ID NO: 1 other than SEQ ID NOs: 7 and 8 to specifically bind to a CD123 protein , to administer this polypeptide, whether alone or complexed to a macromolecular materia l, to a patient in order to treat leukemia not associated with CD123 expression , and to administer SEQ ID NO :1 including SEQ ID NOs: 7 and 8 alone to a patient in order to treat any leukemia irrespective of CD123 expression . 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 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. Claim 2 is directed where the polypeptide is a polypeptide fragment containing any of the following amino acid sequences: SEQ ID NOs: 3-9. However, claim 2 is dependent upon claim 1, which is directed to a single polypeptide of SEQ ID NO: 1 . There are two separate clarity issues with “polypeptide fragment”. First, it is noted that SEQ ID NOs: 3 to 9 are not fragments of SEQ ID NO: 1. Rather, SEQ ID NOs: 3 to 9 are species that fall within the general formula of SEQ ID NO: 1. As such, it is unclear if a polypeptide fragment of claim 2 is a fragment of SEQ ID NOs: 3 or 9, or whether the polypeptide fragment is intended to be the full length of any of SEQ ID NOs: 3 to 9. The former would broaden the scope of claim 1 since claim 1 does not encompass fragments of SEQ ID NO: 1, and the latter would render the claim language inconsistent with the plain and ordinary meaning of the word “fragment”, which would imply the polypeptide is less than the whole of one of SEQ ID NOs: 3-9 . Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to what constitutes a polypeptide fragment. Second, it is noted that a polypeptide fragment containing any of the following amino acid sequences encompasses multiple interpretations. First, the polypeptide fragment encompasses the interpretation where the fragment contains any one of SEQ ID NOs: 3-9. Alternatively, the polypeptide fragment encompasses the interpretation where the fragment contains one or more of SEQ ID NOs: 3-9. The latter interpretation would broaden the scope of claim 1 since claim 1 does not encompass more than one polypeptide. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to the number of amino acid sequences that constitute a polypeptide fragment. As stated in the “Sequence Interpretation” section supra , the Examiner is interpreting the scope of claim 2 in light of the specification such that wherein the polypeptide contain s any one of SEQ ID NOs: 3-9 in order to advance prosecution. Claims 6-7 and 17 contains the trademark/trade name, Soluplus ®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a species of macromolecular material containing polyvinyl caprolactam, polyvinyl acetate, and polyethylene glycol in a molecular weight ratio of 57:30:13, and, accordingly, the identification/description is indefinite. Claim 6-7 and 17 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. The use of parenthetical phrases render the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). More specifically, for claim 6, the molecular weight ratios of polyoxyethylene / polyoxyproylene and PLGA are provided in parentheses. For claims 7 and 17, the molecular weight ratio of polyvinyl caprolactam, polyvinyl acetate, and polyethylene glycol is 57:30:13 is provided in parentheses. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to whether the subject matter within the parentheses are part of the claimed invention. Please note that the Examiner is interpreting the scope of claims 6-7 and 17 such that the subject matter within the parentheses are not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter within the parentheses can be recited in a new dependent claim. Claims 8-9 and 18 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 8 recites the limitations "the macromolecular material" and “the polypeptide” in line 3 . There is insufficient antecedent basis for this limitation in the claim. Although it is recognized that the method of claim 8 is to prepare the polypeptide complex of claim 3, the body of the claim does not encompass the limitations recited in claim 3 as it does not depend upon claim 3. In order to advance prosecution, the Examiner is interpreting the scope of claim 8 such that the polypeptide that is dissolved in PBS solution is the polypeptide recited in claim 3. It is further noted that the macromolecular material in claim 3 is not limited, and thus, “a macromolecular material” in claim 8 would similarly not be limited. Additionally, claims 9 and 18 are rejected by virtue of the their dependency. Claims 8-9 and 18 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 claim 8, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Please note that the Examiner is interpreting the scope of claims 8-9 and 18 such that the subject matter following “for example” is not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter following “for example” can be recited in a new dependent claim. Claim 8-9 and 18 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. The use of parenthetical phrases render the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). More specifically, for claim 8, using a hydrophilic polyethersulfone (PES) membrane filter is provided in parentheses. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to whether the subject matter within the parentheses are part of the claimed invention. Please note that the Examiner is interpreting the scope of claim 8 such that the subject matter within the parentheses is not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter within the parentheses can be recited in a new dependent claim. Claims 12 and 20 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. The use of parenthetical phrases render the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). More specifically, for claim 12, the encapsulation rate is provided in parentheses. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to whether the subject matter within the parentheses are part of the claimed invention. Please note that the Examiner is interpreting the scope of claim 12 such that the subject matter within the parentheses is not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter within the parentheses can be recited in a new dependent claim. Additionally, claim 20 is rejected by virtue of the their dependency. Claim 13 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. Claim 13 recites the limitations "the chemotherapy drug” in line 3. There is insufficient antecedent basis for this limitation in the claim. In order to advance prosecution, the Examiner is interpreting the scope of claim 13 such that the polypeptide that is dissolved in PBS solution is the polypeptide recited in claim 3. It is further noted that the macromolecular material in claim 3 is not limited, and thus, “a macromolecular material” in claim 8 would similarly not be limited. Claim 13 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 13, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Please note that the Examiner is interpreting the scope of claims 13 such that the subject matter following “for example” is not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter following “for example” can be recited in a new dependent claim. Claims 13 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. The use of parenthetical phrases render the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). More specifically, for claim 13, using a hydrophilic PES membrane filter is provided in parentheses. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to whether the subject matter within the parentheses are part of the claimed invention. Please note that the Examiner is interpreting the scope of claim 13 such that the subject matter within the parentheses is not part of the claim invention in order to advance prosecution. The Examiner suggests that the subject matter within the parentheses can be recited in a new dependent claim. Claims 15 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. The phrase "but is not limited to" render s the claims indefinite because it is unclear whether the limitations following the phrases or in parentheses are part of the claimed invention. See MPEP § 2173.05(d). As such, it is unclear which leukemias are encompassed by the scope of claim 15. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to which leukemias are encompassed. Please note that the Examiner is interpreting the scope of claim 15 such that the leukemia is one or more of the three species of leukemia recited in order to advance prosecution. Allowable Subject Matter Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that when the polypeptide sequence in the polypeptide complex is SEQ ID NO: 7 or 8, the polypeptide is enabled to bind to a CD123 protein as indicated in the 112(a) rejection supra . Furthermore, there is no teaching or suggestion in the art to arrive at the amino acid sequences of SEQ ID NOs: 7 or 8. Thus, claim 5 is free of the prior art. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT THEA D' AMBROSIO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1216 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 11:00 to 8:00 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. 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