DETAILED ACTION The present application is a national stage entry of PCT/IN2020/051027, filed 13 December 2020, which claims foreign priority to IN201911051914, filed 14 December 2019. Claims 1-10 are pending in the current application and are examined on the merits herein. Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions Applicant's election with traverse of L-arginine as the Second species of cationic compound, and Dextran-40 as the Third species of macromolecular scaffold in the reply filed on 19 January 2026 is acknowledged. During a telephone conversation with Daniel Swirsky on 30 March 2026 , a provisional election was made with traverse to prosecute the species of polymyxin B as a First species of polybasic/cationic drug, claims 1 and 5. The traversal is on the ground(s) that renal toxicity and other systemic toxicities are well-recognized class effects of polymyxins and aminoglycosides . Applicant argues the present invention addresses this common technical problem through a single, unified technical solution. The elected species have been searched, and found to be free of the prior art. The species of polybasic/cationic drug was expanded to include aminoglycosides. The species of cationic compound was expanded to the other amino acids recited in claim 1. And the species of macromolecule for scaffold base was expanded to include those other polysaccharides recited in claim 1. The combination of species is free of the art. The election of species requirement is withdrawn. Claim Objections Claim s 1 -10 are objected to because of the following informalities: “1-arginine” and “1-lysine” appears to be an obvious error, and should say “L-arginine” and “L-lysine”, respectively. Appropriate correction is required. Claims 1-10 recite “ the said” multiple times, e.g. “ the said complex”. This is redundant, and only “the” or “said” is needed. 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 1-10 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 complex formed from aminoglycoside s or polymyxin antibiotic s with an amino acid selected from L-arginine, L-lysine and histidine, and a macromolecule as claimed, does not reasonably provide enablement for a complex formed from aminoglycoside s or polymyxin antibiotic s with ethoxylated amines or quaternary ammonium compounds , and a macromolecule as claimed. 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. The Applicant’s attention is drawn to In re Wands , 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman , 230 USPQ 546 ( BdApls 1986) at 547 the court recited eight factors: (1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. The nature of the invention : The nature of the invention is directed towards reducing the nephrotoxicity of aminoglycoside antibiotics or polymyxin, by forming a supramolecular cationic complex with a cationic compound, and a macromolecular scaffold. The state of the prior art / The predictability or unpredictability of the art: Bashan et al. ( Indian Journal of Pharmacology , 2014, vol. 46, no. 6, pp. 608-612, cited in PTO-892), teach L-arginine has a protective effect on gentamicin (aminoglycoside antibiotic)-induced nephrotoxicity (abstract). Williams et al. ( The Journal of Pharmacology and Experimental Therapeutics , 1986, vol. 237, no. 3, pp. 919-925, cited in PTO-892) found polyamino acids like polylysine inhibited nephrotoxicity induced by gentamicin, when coadministered with aminoglycoside antibiotics (abstract). However, they found monoamino acids like lysine and arginine were without effect at 10 times the molar concentration of gentamicin, while polyamino acids inhibited gentamicin binding irrespective of ionic charge (p.1986, Results). Williams et al. teach also found only two of the 13 tested polyamines were able to bind with gentamicin (Table 1). Bashan et al. and Williams et al. as a whole, are concerned with mitigating the nephrotoxicity caused by aminoglycoside antibiotics and polymyxin. While Bashan et al. found L-arginine had a protective effect on gentamicin-induced nephrotoxicity, Williams et al. found the monoamino acids and polyamines were not effective in binding with gentamicin. Thus, the art of using the claimed amino acids and amines in combination with the claimed Markush of polybasic/cationic drugs, appears to be unpredictable. The relative skill of those in the art : The relative skill of those in the art is low, since forming electrostatic complexes with aminoglycoside antibiotics or polymyxin to reduce nephrotoxicity caused by said antibiotics was not well known before the effective filing date of the claimed invention . The breadth of the claims : The breadth of the claims includes a broad class of ethoxylated amines and quaternary ammonium compounds , which can have other functional and chemical groups that would prevent them from forming a supramolecular complex. The amount of direction or guidance presented / Th e presence or absence of working examples : The only cationic compounds tested were Arginine, and Lysine. The quantity of experimentation necessary : In order to practice the invention with the full range of all possible ethoxylated amines and quaternary ammonium compounds, one skilled in the art would undertake a novel and extensive research program to show that supramolecular complexes can be formed with any ethoxylated amine or quaternary ammonium compound , regardless of the presence of other functional groups . In order to determine the efficacy of the claimed combinations, various in vitro tests would have to be performed (e.g. total equivalent antioxidant capacity (TEAC) assay; superoxide radical scavenging assay; scavenging hydrogen peroxide oxidative stress; reducing power assay). These trials would need to be run separately and repeatedly for each possible combination. The experimentation involved would therefore be significant, undue and unpredictable. 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 breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for a complex formed from aminoglycoside s or polymyxin antibiotic s with ethoxylated amines or quaternary ammonium compounds , and a macromolecule as claimed. 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. Claims 1-10 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 recitation “Compositions and formulations made of polybasic drugs…by forming supramolecular cationic complex…wherein such complexes comprise of” in claim 1 renders the claim herein indefinite. Since the claim recites the active form of form “by forming”, it appears the claim is directed to a process of making. The term “such complexes” suggests the claim is not necessarily limited to a supramolecular cationic complex. The claim would be clearer if “such” was replaced with “said”. The claim c ould also be amended to either recite product-by-process language rather than “by forming” , e.g. “Compositions for reducing multi-organ toxicities in mammals, said composition is a supramolecular cationic complex prepared without chemical cross-linking, said complex comprises:” Additionally, the product claim recites a method of using step. The recitation “(d) wherein the said complex is administered to a subject in need by parenteral route” in claim 1, renders the claim herein indefinite. Claim 1 is a product claim, and not a method of use claim. The limitation of step (d) is interpreted as an intended use limitation , since a product claim is distinct statutory category of invention from a method of use. This rejection could be overcome if this limitation were deleted. Regarding claim 1, the phrase "such as" in “ said macromolecule is selected from a group of natural polysaccharide such as…” renders the claim and dependent claims 2-10 herein indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, the Markush-type language in claim 1 “selected from a group of ” should be amended to recite “selected from the group consisting of”. Each Markush-type limitation should clearly recite “and/or” before the last alternative, so that it is clear the list of alternatives for that particular member is complete. For example, “selected from 1-arginine, 1-lysine, histi di ne” could be clearer if it said “selected from 1-arginine, 1-lysine, or histidine” , or “selected from the group consisting of 1-arginine, 1-lysine, and histidine” . The recitation “(c) a macromolecule for scaffold base; wherein the said macromolecule is selected from a group of natural polysaccharide such as dextran, polysialic acid, pullulans, dextrin, hyaluronic acid, chitosan and heparin, wherein the said macromolecule is a low molecular weight dextran without chemical modification ” in claim 1 renders the claim herein indefinite. As noted above, the use of the term “such as” renders the claim indefinite. However, assuming this term were deleted, it appears Applicant is first defining a list of alternative members of a macromolecule for scaffold base. Yet, the claim then said “wherein the said macromolecule is a low molecular weight dextran without chemical modification”, which now limits the scaffold to only a “low molecular weight dextran without chemical modification”. It is not clear if this was the intention, or if Applicant meant to say “wherein the dextran is a low molecular weight dextran without chemical modification”. Currently, the claim appears to be limited to a “low molecular weight dextran without chemical modification”. The recitation “low molecular weight dextran D40” in claims 5-8 lack antecedent basis from claim 1. While claim 3 specifies the low molecular weight dextran “is dextran 40 KDa ”, claim 1 does not. Additionally, the use of the abbreviation “D40” is nowhere previously recited. Thus, it is not clear this limitation is in reference to the molecular weight. The recitation “wherein the ratio of cationic amino acid to macromolecule in supramolecular cationic complex formation of polymyxin polybasic drugs is between 7.5:1 to 2.5:1” in claim 10 renders the claim herein indefinite, because it appears to lack antecedent basis from the range in present claim 1. Claim 1 recites a range of drug to amino acid to macromolecule of “1: 0.1:0.1 to 1: 3:1 ”. The range recited in claim 10 does not seem to include compositions having more than 3:1 cationic amino acid to macromolecule”. The recitation “wherein the said supramolecular complex is formed by cation-π interaction” in claim 10 renders the claim herein indefinite, because it is not clear which of the three components making up the complex form this interaction as claimed. According to the Specification (see para [0104] of the published application), this interaction refers to the polybasic/cationic drug and the cationic amino acid. However, claim 10 then further defines the ratio of the cationic amino acid and the macromolecule. Thus, it is unclear if the “cation-π interaction” is the interaction between the polybasic/cationic drug and the cationic amino acid, or between the cationic amino acid and macromolecule. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.— Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph , as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The recitation “wherein the ratio of cationic amino acid to macromolecule in supramolecular cationic complex formation of polymyxin polybasic drugs is between 7.5:1 to 2.5:1” in claim 10, fails to further limit the subject matter of the claim upon which it depends. Claim 1 recites a range of drug to amino acid to macromolecule of “1: 0.1:0.1 to 1: 3:1 ”. The range recited in claim 10 requires a range outside the range of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Closest Prior Art The following references are the closest prior art: Andremont et al. ( WO2010 /103119 , cited in PTO-892), Bashan et al. ( In dian Journal of Pharmacology , 2014, vol. 46, no. 6, pp. 608-612, cited in PTO-892) , Williams et al. ( The Journal of Pharmacology and Experimental Therapeutics , 1986, vol. 237, no. 3, pp. 919-925, cited in PTO-892) and Shurshina et al. ( Russian Journal of Physical Chemistry B. , 2018, vol. 12, no. 1, pp. 135-141, cited in PTO-892). Andremont et al. describe formulations comprising a macrolide or aminoglycoside, or quinolone antibacterial and an anti-Gram-negative lipopeptide (polymyxin) antibacterial agent or other peptide antibacterials effective against Gram-negative bacteria (abstract). Polymyxin B is a preferable bacteria (p.24:4-10). A n dremont et al. teach the use of a polymer to deliver the drugs to the gastrointestinal tract (p.27: 16-29). In some embodiments, the active agents are encapsulated in inactive toxic layers (for example polymer layers), which let them reach the lower part of the ileum, the caecum, and/or the colon (p.31:3-9). Certain polysaccharides can be used to formulate colon-targeted drug delivery systems, including chitosan and dextran (p.28-29, bridging para). Andremont et al. teach aminoglycosides and polymyxin can cause nephrotoxicity (p.21; and p.23-25). Bashan et al. teach L-arginine has a protective effect on gentamicin (aminoglycoside antibiotic)-induced nephrotoxicity (abstract). Williams et al. teach polyamino acids like polylysine inhibited nephrotoxicity when coadministered with aminoglycoside antibiotics (abstract). Williams et al. teach monoamino acids like lysine and arginine were without effect at 10 times the molar concentration of gentamicin, while polyamino acids inhibited gentamicin binding irrespective of ionic charge (p.1986, Results). Shurshina et al. teach chitosan encapsulates aminoglycoside antibiotics via hydrogen bonds between the amino groups of chitosan and amino groups of amikacin and gentamicin (Table 1; conclusion). Bashan et al. and Williams et al. as a whole, are concerned with mitigating the nephrotoxicity caused by aminoglycoside antibiotics and polymyxin. While Bashan et al. found L-arginine had a protective effect on gentamicin-induced nephrotoxicity, Williams et al. found the monoamino acids like arginine were not effective in binding with gentamicin , even at ten times the molar concentration of gentamicin . Furthermore, while the use of polysaccharides like dextran and chitosan were known for encapsulating the claimed antibiotics via hydrogen bonds, there is no prior art teaching the combination of elements as claimed. Thus, the art of using the claimed amino acids in combination with the claimed Markush of polybasic/cationic drugs and macromolecule, at the claimed ratio, is unpredictable. The claims would be allowable upon overcoming the objections and rejections under 35 U.S.C. §112 (a)( b) and (d) . Conclusion In view of the rejections to the pending claims set forth above, no claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BAHAR A CRAIGO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-1326 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: Noon-8pm ET . 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 Fereydoun Sajjadi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-3311 . 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