DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions Applicant's election with traverse of the composition of Claims 1-19 in the reply filed on 20 January 2026 is acknowledged. The traversal is on the ground that searching multiple independent and distinct inventions simultaneously would not place on the examiner an undue search burden as subject matter of these inventions would be encountered by the searches for the elected invention. This is not found persuasive because applicants offer no evidence to support this position, which represents attorney argument where evidence is required. In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required”). The requirement is still deemed proper and is therefore made FINAL. Status of the Claims Claims 1-24 are pending. Claims 20-24 are withdrawn from consideration as directed to non-elected inventions. Claim 1-19 are presented for examination and rejected as set forth below. Priority The instant application is a Continuation of earlier application 17/049,152 filed 20 October 2020, which is a National Stage entry of International application PCT/US2019/028418 filed 20 April 2019, which claims the benefit of Provisional U.S. application 62/660,515 filed 20 April 2018. Claim Interpretation Applicants Claims are directed to compositions combining a plurality of polymers having a hydrophobic backbone having a first set of pendant groups containing at least one cationic group bound thereto, and a second set of pendant groups attached thereto being at least one hydrophilic polymer, combined with at least two therapeutic agents, different from one another, with at least one containing a nucleic acid. Dependent claims narrow the identity of the therapeutic compounds, or indicate that the pendant groups are to be attached to the hydrophobic polymer backbone via linking groups containing defined elements. The examiner notes that the functional language concerning pi-pi stacking is addressed, per applicants own specification, by substituents having planar ring systems. Aromatic, and more specifically benzyl groups, are claimed as suitable moieties to provide the claimed pi-pi stacking. Claims 13-15 specify that the polymer backbone is to be obtained by particular synthetic methods: “ [E] ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. ” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) . Claim 19 indicates that the hydrophilic pendant groups are to be attached to the hydrophobic backbone via a labile moiety. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim s 1, 2, 4, 13-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mayes (U.S. 6,399,700) . Mayes describes drug delivery devices comprising comb copolymers having hydrophobic backbones and hydrophilic side chains which can be end-capped with various ligands. (Abs.). Mayes indicates that biodegradable backbones are preferred for drug delivery applications. (Col.3, L.55-67; Col.8, L.37-59)). In certain embodiments, the comb copolymers of Mayes are configured to adhere to the surfaces to which they are applied. (Col.5, L.30-35). Biodegradable polyethylene glycols, which are hydrophilic polymer chains and address the labile linking moiety limitation of Claim 19, represent one embodiment of the hydrophilic side chains of the copolymers of Mayes, and may be equipped with an amine end-capping group, addressing the limitations of Claims 16 and 17. (Col.9, L.16-50). Mayes indicates that ionic side chains may be incorporated as the side groups on the hydrophobic polymer backbone when used as drug delivery devices. (Col.17, L.34-37). Synthetic organic compounds, as well as polynucleic acids represent therapeutic or prophylactic agents which may be combined with the polymers when used as drug delivery devices. The specific combination of features claimed is disclosed within the broad teachings of the reference , but such “picking and choosing” within several variables does not necessarily give rise to anticipation . Corning Glass Works v. Sumitomo Elec. , 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a hydrophobic polymer backbone bearing a combination of biodegradable hydrophilic polyethylene glycol and ionic amine containing pendant groups which contain combinations of synthetic organic molecules and polynucleic acids as active drug agents , anticipation cannot be found. That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement , the combination is obvious.” KSR v. Teleflex , 127 S.Ct . 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro , 425 U.S. 273, 282 (1976)) . “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions .” ( Id. ). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of a hydrophobic polymer backbone bearing a combination of biodegradable hydrophilic polyethylene glycol and ionic amine containing pendant groups which contain combinations of synthetic organic molecules and polynucleic acids as active drug agents from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.” Claim s 1- 4, 6- 17 , and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mayes as applied to claim s 1, 2, 4, 13-16, and 19 above, and further in view of Gao ( WO 2014/ 0 093631) . Mayes, discussed in greater detail above, suggests compositions containing a hydrophobic polymer backbone bearing a combination of biodegradable hydrophilic polyethylene glycol and ionic amine containing pendant groups which contain combinations of synthetic organic molecules and polynucleic acids as active drug agents. However, Mayes does not describe a small molecule active agent having a molecular weight of less than 1kDa such as a chemotherapeutic agent , or linkers containing moieties interactive via pi-pi stacking such as aromatic groups or benzyl groups . This is cured by the teachings of Gao, which also teaches drug delivery constructs bearing hydrophilic and hydrophobic domains, bearing what Gao refers to as a “compound interactive domain” located between the hydrophilic and hydrophobic domains. (Abs.). Gao indicates that incorporating these compound interactive domains increases the loading capacity of the carrier system. [13]. Gao indicates that in preferred embodiments, the compound interactive domain is one which interacts with the compound via pi-pi stacking. [10]. Gao specifically indicates that paclitaxel, a chemotherapeutic agent having a molecular mass of 854 g/mol, may be combined with polymers having a hydrophilic polyethylene glycol domain linked to a hydrophobic backbone by a fluorenylmethyloxycarbonyl group. [ 09; 15-16]. It would have been prima facie obvious to have incorporated a compound interactive domain such as a fluorenylmethyloxycarbonyl as the linking group between the hydrophilic and hydrophobic domains of the comb polymer of Mayes, and used this to increase the drug loading capacities of the polymers suggested therein. One of ordinary skill would have considered the increase in drug loading achieved thereby a benefit to be obtained from such a modification, and prima facie obvious thereby. S ee In re Sernaker , 702 F.2d 989, 994-95 (Fed. Cir. 1983) (“ The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination .”). In a similar manner, it would have been prima facie obvious to have incorporated a synthetic organic molecule such as paclitaxel into such polymer carriers, owing to the art’s having taught such an agent as suitably being combined with polymers bearing both hydrophobic and hydrophilic regions linked by a compound interactive domain. Claims 1-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mayes and Gao as applied to Claims 1-4, 6-17, and 19 above, and further in view of Nielsen (Loretta Nielsen, et al, Adenovirus-mediated p53 Gene Therapy and Paclitaxel Have Synergistic Efficacy in Models of Human Head and Neck, Ovarian, Prostate, and Breast Cancer , 4 Clin. Cancer Res . 835 (1998)) . Mayes and Gao, discussed in greater detail above, suggests compositions containing a hydrophobic polymer backbone bearing a combination of biodegradable hydrophilic polyethylene glycol and ionic amine containing pendant groups linked to the hydrophobic backbone by a fluorenylmethyloxycarbonyl group capable of pi-pi stacking which contain combinations of synthetic organic molecules such as paclitaxel and polynucleic acids as active drug agents . However, neither Mayes nor Gao specify that the active agents should be a combination of a small organic molecule such as paclitaxel and either a gene or a siRNA molecule as the polynucleic acid. This is cured by the teachings of Nielsen, which teaches that combinations of p53 gene therapy and paclitaxel demonstrates synergistic treatment response in a variety of cancers. It therefore would have been prima facie obvious to one of ordinary skill in the art to have combined a small molecule chemotherapeutic such as paclitaxel with a gene such as p53 in the sustained release compositions suggested by Mayes and Gao, owing to the expectation that some advantage or expected beneficial result would have been produced by their combination. S ee In re Sernaker , supra . Double Patenting - Statutory A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 10-12 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 7, and 8 of prior U.S. Patent No. 11,857,634 . This is a statutory double patenting rejection. Double Patenting – Nonstatutory The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claims 1-19 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-18 of U.S. Patent No. 11,857,634 . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘634 patent represent a subgenus of the instant claims, either anticipating or rendering them prima facie obvious . Conclusion No Claims are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SEAN M BASQUILL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5862 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday through Thursday, 5:30 AM to 4 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 Ali Soroush can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-9925 . 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. /SEAN M BASQUILL/ Primary Examiner, Art Unit 1614