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. DETAILED ACTION Status of the Application Claims 1-20 are pending and are currently under examination. Drawings Color photographs and color drawings filed on 10/27/2023 are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color (Fig. 5B). Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). 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 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claims 1- 4, 6-9, 11 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ullah et al. " ( Nanoparticles ‐ assisted delivery of antiviral ‐ siRNA as inhalable treatment for human respiratory viruses: a candidate approach against SARS ‐ COV ‐ 2." Nano Select 1.6 (2020): 612-621 ) and Zhang et al. (US 20130302252) and Amin et al. ( "Protease targeted COVID-19 drug discovery and its challenges: Insight into viral main protease ( Mpro ) and papain-like protease ( PLpro ) inhibitors." Bioorganic & medicinal chemistry 29 (2021): 115860 ) . Claim interpretation: The limitation s o f si UTR, siLPro and siMPro are not defined in the specification and are interpreted as the siRNA that target 5 ′-untranslated region (UTR) , protease ( Mpro ) and papain-like protease ( PLpro ) in view of Amin et al cited above. Ullah et al. teach a SARS-CoV-2 targeted siRNA therapy for COVID-19 is emerging as an efficient therapy (see page 614 ). Ullah et al. teach siRNA are negatively charged and unstable and the in vivo delivery of siRNA is still a major obstacle in therapeutic applications . Ullah et al. teach adenoviruses have been used as a siRNA carrier to ensure siRNA protection and the retention of their biological activity. But a major problem associated with viral based delivery has been immuno-response against the administered virus and, in some viral vector-like lentivirus, random insertion in chromosomes leading to gene dysfunctions. Therefore, efficient, non-toxic, biocompatible and targeted delivery methods remain an urgent goal (see page 614 section 4). Ullah et al. teach nanoencapsulation of the antiviral siRNA are becoming successful as delivery methods which address the current challenges of stability and fragile nature of siRNA (see page 616). Ullah et al. teach siRNA as nanoparticles can be used to develop inhalable treatments for SARs (see abstract). Ullah et all do not specifically teach using a targeted coated nanoparticle. Zhang et al. teach t he success of nanovectors relies on the apt design and integration of coatings that ensure biocompatibility and ability in a biologic milieu and proper intracellular trafficking. To date, most nanovectors developed for gene delivery applications are coated with cationic synthetic polymers (e.g., polyethylenimine (PEI), poly amidoamines (PAMAM)) or lipids. A common characteristic among these carriers is their high cationic charge density at physiological pH, which contributes to both the complex formation with anionic siRNA and interaction with the negatively charged cell membrane. This interaction with cell membranes typically leads to the endocytosis of the nanovector , entrapping the nanovector within cellular endosomal vesicles. Within the cellular endosomes the amino groups of cationic polymers function as proton sponges causing the swelling and eventual rupture of the endosome releasing the nanovector into the cytoplasm, a process known as endosomal escape. However, the high cationic charge density of these synthetic polymers also renders them highly cytotoxic. ( see 0005). Zhang et al. further teach that de spite the advances in the development of siRNA carriers, a need exists for an siRNA carrier that is effective for intracellular delivery of siRNA and that provides a safer alternative to the highly cationic nanovectors and teach the use of Oleic acid -coated nanoparticles ( 0140) to efficiently delivery siRNA. Zhang et al teach methods of introducing cells using the nanovectors and methods of treating tissues (see claims). Amin et al. teach r ecent studies revealed that SARS- CoV 2 has a comparable genomic pattern to other corona viruses wherein they comprise a 5 ′-untranslated region (UTR), a replicase complex for encoding non-structural proteins ( nsps ), spike protein (S) gene, envelope protein (E), membrane protein (M) gene, nucleocapsid protein (N) gene, 3 ′-UTR, and numerous unknown non-structural parts which provide them support against the environmental factors. 22–24 Usually, these viruses harvest several polypeptides which promote proteolytic breakdown to produce 20 additional proteins during their lifecycle. Among them two crucial proteases such as main protease ( Mpro ) and papain-like protease ( PLpro ) are vital for virus replication. Amin further teach that a tremendous effort has been spent on studying these proteases in order to discover specific inhibitors against this noxious COVID-19 (see page 115860-115861). It would have been obvious to one of ordinary skill in the art to use the nanovector of Zhang et al.. to encapsulate the siRNA of Ullah to target SARS- CoV 2 to treat a COVID 19 infection in the nanovector to ensure efficient delivery and silencing. It would have further been obvious to target the UTR, ( Mpro ) and papain-like protease ( PLpro ) because they have be en found to be vital for virus replication. Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claim(s) 5, 10, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ullah et al. " ( Nanoparticles ‐ assisted delivery of antiviral ‐ siRNA as inhalable treatment for human respiratory viruses: a candidate approach against SARS ‐ COV ‐ 2." Nano Select 1.6 (2020): 612-621 ) and Zhang et al. (US 20130302252) , Amin et al. ( "Protease targeted COVID-19 drug discovery and its challenges: Insight into viral main protease ( Mpro ) and papain-like protease ( PLpro ) inhibitors." Bioorganic & medicinal chemistry 29 (2021): 115860 ) , Ciavarella et al. ( "Pharmacological (or synthetic) and nutritional agonists of PPAR-γ as candidates for cytokine storm modulation in COVID-19 disease." Molecules 25.9 (2020): 2076 ) and Rodríguez- Pascau , Laura, et al. ( "PPAR gamma agonist leriglitazone improves frataxin-loss impairments in cellular and animal models of Friedreich Ataxia." Neurobiology of Disease 148 (2021): 105162 ). Ullah et al., Zhang et al. and Amin et al. are relied upon as above but do not teach using a PPAR gamma agonist. Ciavarella et al. teach the cytokine storm is an abnormal production of inflammatory cytokines, due to the over-activation of the innate immune response. This mechanism has been recognized as a critical mediator of influenza-induced lung disease, and it could be pivotal for COVID-19 infections. Thus, an immunomodulatory approach targeting the over-production of cytokines could be proposed for viral aggressive pulmonary disease treatment. In this regard, the peroxisome proliferator-activated receptor (PPAR)-γ, a member of the PPAR transcription factor family, could represent a potential target. Beside the well-known regulatory role on lipid and glucose metabolism, PPAR-γ also represses the inflammatory process. Similarly, the PPAR-γ agonist thiazolidinediones (TZDs), like pioglitazone, are anti-inflammatory drugs with ameliorating effects on severe viral pneumonia (see abstract). Ciavarella et al. teach PPAR-γ could be a valid option to strengthen the immune system via natural methods in order to prevent cytokine storm occurrence in the case of infections due to coronavirus (see conclusion ). Pascau et al. teach Leriglitazone (5-[[4-[2-[5-(1-hydroxyethyl)pyridin-2-yl]ethoxy] phenyl]methyl]-1,3-thiazolidine-2,4-dione hydrochloride) is the hydrochloride salt of the active metabolite M4 (M-IV) of pioglitazone (Actos®, Takeda). Leriglitazone is a novel and orally bioavailable PPARγ agonist that engages the target receptor at the levels required for efficacy within the CNS (see page 105162). It would have been obvious to use a PPAR-γ agonist thiazolidinediones (TZDs) alone or in combination with a siRNA in methods of treating SARS given it was known to be pivotal for treatment of inflammatory cytokine storms in COVID infections. Given Leriglitazone is a novel and orally bioavailable PPARγ agonist and a hydrocholoride salt of pioglitazone , it would have been obvious to try this as an anti-inflammatory drug in COVID infections . Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. 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. Written Description Claims 1-20 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 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 or a joint inventor, or for pre-AIA 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. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc ., 935 F.2d at 1563-64, 19 USPQ2d at 1117. 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: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species by “…disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function al and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The claims are drawn to a genus of nanoparticles surface coated with any targeting moiety, a genus of PPAR gamma agonists and a genus of siRNA targeting conserved regions of the S AR CoV-2 virus with the function of treating, in combination, methods of a coronavirus infection. The specification describes a PPAR agonist, leriglitazone (LG), a siUTR and a nanoparticle with linoleic acid as a targeting moiety and teach prophetic method s of treatment of CoV2 infection. The claims do not indicate what distinguishing characteristics of the PPAR agonist, leriglitazone (LG) , the si UTR siRNA or the linoleic acid targeting moiety that are concisely shared by the members of the broad genes of each that would convey to one of skill in the art that these dsRNA represent the entire genus of a compositions that would treat a SARS CoV-2 infection . A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. The prior art cited above describes siRNA can be targeted to specific regions of the coronal virus and delivered to cells using a nanoparticle surface coated however, the species in the prior art does not present the entire genus as instantly claimed. The single species in the composition described in the specification does not have any functional attributes because it is prophetic and thus would not be sufficient to represent the claimed genera. Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant , one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed. "A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) ( emphasis added ). Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin , 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester , 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar , 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. ” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for 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 a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder , 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin [e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention. Double Patenting 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. See 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);and, 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp . Claims 1-20 are provisionally rejected under the judicially created doctrine of double patenting over claims 1 and 4-17 of copending Application No. 18,389,272 . This is a provisional double patenting rejection since the conflicting claims have not yet been patented. Although the conflicting claims are not identical, they are not patentably distinct from each other because the instant claims and the claims of the patent are drawn to patently indistinguishable subject matter. The instant claims and Application ‘272 are drawn to a nanosystem targeted to SARS and methods of treatment and thus are not patently distinct from each other. This is a provisional obviousness-type double patenting rejection. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kimberly Chong at FILLIN "Phone number" \* MERGEFORMAT (571)272-3111 . The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm . If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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