CTNF 18/852,335 CTNF 78176 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-25 have been presented for examination on the merits. Priority This Application is a 371 of PCT/US20230164065 filed on 03/27/2023 which claims priority to provisional Application No. 63/324,348 filed on 03/28/2022. Claim Rejections - 35 USC § 112 07-30-02 AIA 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 applicant regards as his invention. 07-34-01 Claims 1-25 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 1 is directed to a method, comprising “co-administering to a subject in need thereof”. The preamble is incomplete as it is not disclosed what the method is regarding. A claim should belong to one of 4 statutory classes of claims, and here this is not stated. Also, claim 1 is indefinite for reciting “co-administering to a subject in need thereof” as it is not clear what the subject is in need of. Claim 3 recites the limitation "the small molecule potentiator” in the method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite or support a small molecule potentiator. Claim 3 recites the limitation "the cell surface expression of RXFP1” in the method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite or support either cell surface expression or RXFP1. Claim 7 recites the limitation "the small molecule potentiator” in the method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite or support a small molecule potentiator. Claim 13 recites the limitation "the potentiator” in the method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite or support a potentiator. Claim 15 is indefinite for not ending with a period. Thus, it is not clear if the claim is complete or incomplete. Claim 16 recites the limitation "the small molecule potentiator” in the composition of claim 15. There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not recite or support a small molecule potentiator. Claim 17 is indefinite for not ending with a period. Thus, it is not clear if the claim is complete or incomplete. Claim 18 is indefinite for reciting a wherein clause containing clauses (i)-(iv) without the use of “and” or “or” before clause (iv). Thus, it is not clear if all clauses (i) –(iv) are required or one of them. For purposes of examination, the term “or” is adopted. Claim 18 recites the limitation "the small molecule potentiator” in the composition of claim 16. There is insufficient antecedent basis for this limitation in the claim. Claim 16 does not recite or support a small molecule potentiator. Claim 18 is indefinite for reciting the amount of 0.01 to 25% of the total mass without indicating what the said mass is related to. Is it the total mass of the composition, the carrier or else? Claim 20 recites the limitation "the small molecule potentiator” in the composition of claim 19. There is insufficient antecedent basis for this limitation in the claim. Claim 19 does not recite or support a small molecule potentiator. Claim 20 recites the limitation "the cell surface expression of RXFP1” in the composition of claim 19, which depends on claim 15. There is insufficient antecedent basis for this limitation in the claim. Claim 19 does not recite or support either cell surface expression or RXFP1 and neither does claim 15. Claim 24 recites the limitation "the small molecule potentiator” in the composition of claim 15. There is insufficient antecedent basis for this limitation in the claim. Claim 15 does not recite or support a small molecule potentiator. Claim 24 is indefinite for reciting “According to claim 15 claims 15-23,”. It is not clear what claim does claim 24 depend on. Remaining claims are rejected for including the rejected limitations. 07-30-03-h AIA Claim Interpretation The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Recitations/limitations of “small molecule that increases expression, concentration or cell surface density” and “the effect of the ligand is potentiated by administration of the small molecule” are properties and/or effects of the said compounds and do not materially define or change the scope of the compounds. Claim 1 is directed to a method comprising co-administering to a subject a small molecule and a ligand of a therapeutic target. Claim 5 recites that the ligand is a small molecule. Thus, claim 1 and claim include an embodiment wherein the small molecule and ligand are the same compound. Claims 4 and 21 recite that the ligand binds to and induces relaxin/RXFP1 signaling. This is a property or effect of the ligand and does not materially affect the scope of the claimed method. Claim 20 is directed to a composition wherein the small molecule [potentiator] increases the cell surface expression of RXFP1”. This is a property or effect of the small molecule and does not materially affect the scope of the claimed composition. Applicant’s claims Claim 1 is directed to a method, comprising: co-administering to a subject in need thereof a small molecule that increases expression, concentration, or cell surface density of a therapeutic target, and a ligand of the therapeutic target, wherein the therapeutic effect of the ligand is potentiated by administration of the small molecule. Claim 15 is directed to a composition comprising a small molecule that increases expression, concentration, or cell surface density of a therapeutic target, and a ligand of the therapeutic target, wherein the therapeutic effect of the ligand is potentiated by administration of the small molecule Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1-4, 7-10 and 13 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Royce et al (Combination therapy with relaxin and methylprednisolone augments the effects subepithelial fibrosis in an experimental model of allergic airways disease) . Royce et al teach that anti-fibrotic hormone RLN ( relaxin ) can reverse airway remodelling and AHR (airway hyper-responsiveness) in a murine model of AAD (allergic airways disease). Royce et al also compared the effects of RLN with a CS ( corticosteroids ) ( methylprednisolone ) on airway remodeling and AHR when administered independently or in combination in the mouse AAD model. Methylprednisolone was administered intraperitoneally on the same day as nebulization for 6 weeks, whereas recombinant human RLN-2 was administered via subcutaneously implanted osmotic mini-pumps from weeks 9–11. Combination therapy with CS and RLN more effectively reduced subepithelial collagen thickness than either therapy alone. These findings demonstrate that RLN can modulate a broader range of airway remodeling changes and AHR than methylprednisolone and the combination of both treatments offers enhanced control of subepithelial fibrosis (See abstract). Royce et al teach that the major circulating and stored form of RLN found in humans, H2 RLN (equivalent to RLN in rodents) mediates its effects via the LGR7 [LRR (leucine-rich repeat) containing GPCR (G protein-coupled receptor)7] that has been re-named RXFP 1 ( RLN family peptide receptor-1 ), to modulate a number of downstream signal transduction pathways (See Page 42, 1 st Col., last para). It is disclosed that in addition to its well-characterized interaction with RXFP-1 , RLN has also been observed to act as a GR ( glucocorticoid receptor ) agonist and to activate glucocorticoid downstream pathways (See Page, 42, 2 nd Col. lines 1-4). Regarding claims 1-4, 7-9, as stated above, Royce et al teach co-administration of relaxin and methylprednisolone together. Regarding claims 10 and 13, as stated above, Royce et al teach co-administration of relaxin and methylprednisolone, wherein methylprednisolone was administered intraperitoneally on the same day as nebulization for 6 weeks, whereas recombinant human RLN-2 was administered via subcutaneously the following weeks . 07-15 AIA Claim s 1-5, 7, 9 and 13 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Nazarian et al (US 20190282665) . Nazarian et al teach methods for treating a stiffened joint in a subject that comprise administering relaxin , e.g., a PEGylated relaxin-2 , to the subject. The relaxin may be administered intra-articularly as a sustained release formulation. The present invention also provides sustained release formulations in the form of a hydrogel for administering polypeptides that are covalently attached to a polymer, e.g., PEG (See abstract). Regarding claim 1-2, 4, 7, 9 and 13 , Nazarian et al teach that relaxin is administered into the joint by an intraarticular injection. Further, the said methods may be combined with other methods currently used to treat joint stiffness, e.g. treatment with anti-inflammatory agents that may be administered locally or systemically. In one embodiment, relaxin may be administered to a subject, e.g., a human, in combination with steroids (See [0010], [0137] and claim 7). Regarding claims 3 and 5 , Nazarian et al teach the term “relaxin analog” includes a relaxin receptor agonist , e.g., any agent, such as a small molecule , a polypeptide, a polynucleotide or a polysaccharide, that can bind to and activate a relaxin receptor , e.g., one or more of RXFP1 , RXFP2, RXFP3 and RXFP4 (See [0065]) . 07-15 AIA Claim s 1-5, 7, 9-21 and 24-25 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Grinstaff et al ( US 20210361745 ) . Grinstaff et al teach compositions and methods for the treatment of diseases and disorders, wherein the compositions and methods involve administration of a microparticle, or composition thereof that includes an antifibrotic (See abstract). Regarding claims 1-5 , Grinstaff et al teach methods for treating a stiffened joint in a subject in need thereof, the methods comprise of administering to the subject an effective amount of an agent or ligand of the relaxin family receptors , a relaxin-2 variant, relaxin-2 chemically conjugated to a targeting agent , including a peptide sequence, polynucleotide, or a small molecule . Also disclosed is formulations formulated for administration comprising the antifibrotic agent wherein the agent is an agonist of the receptor RXFP1 or the antifibrotic agent is human relaxin-2 or an analog or variant (See [0007]-[0009], [0026] and [0190]). The agent may be a small molecule (See [0054]. Regarding claim 7 , Grinstaff et al teach some embodiments comprising the method of cotherapy wherein the drug is steroids (See [0326]). Regarding claims 9-14 and 24-25 , Grinstaff et al teach that the said microparticle or agent can be used in combination with other known agents and therapies (i.e. cotherapies ) for a disease, condition, or disorder. Administered “in combination,” as used herein, means that two (or more) different treatments are delivered to the subject during the course of the subject's affliction with the disorder. For example, the delivery of one treatment is still occurring when the delivery of the second begins, so that there is overlap in terms of administration, i.e. “simultaneous” or “concurrent delivery”. The said agents and the at least one additional therapy can be administered simultaneously , in the same or in separate compositions , or sequentially . For sequential administration, the agent described herein can be administered first, and the additional agent can be administered second , or the order of administration can be reversed. The agent and/or other therapeutic agents, procedures or modalities can be administered during periods of active disorder, or during a period of remission or less active disease. The microparticle or agent of this disclosure can be administered before another treatment, concurrently with the treatment, post-treatment, or during remission of the disorder (See [0324]). In some embodiments, the cotherapy is a drug , such as steroids (See [0326]). Regarding claims 15-18 , Grinstaff et al teach a formulation comprising microparticles comprising an aliphatic polyester and an antifibrotic agent , wherein (i) said microparticles have a diameter of 1-100 μm ; (ii) the antifibrotic agent is relaxin and is present in an amount that is 0.01-33% of total mass; (iii) said aliphatic polyester is of molecular weight 10,000-200,000 Daltons ; or (iv) the microparticles further comprise a vinyl polymer (See [0007] and claim 1). Regarding small molecule, Grinstaff et al teach that “agent” as used herein means any compound or substance such as, a small molecule , nucleic acid, polypeptide, peptide, drug, ion, etc. The amount of antifibrotic agent is 0.005-5% of the total formulation mass (See [0018], [0053]-[0054], [0092], [0097]). Regarding claims 19-21 , Grinstaff et al teach that the said “relaxin” as used herein, refers to a polypeptide belonging to the relaxin family (e.g., relaxin-2), a relaxin analog (e.g., a polypeptide that binds to a relaxin receptor ), a relaxin receptor agonist , or a fragment (e.g., a bioactive fragment) or variant of any of the foregoing and/or any agent that is an agonist of an agent that binds the relaxin receptor family of proteins ( RXFP1 , RXFP2, RXFP3, RXFP4) (See [0088], [0093] and [0097]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Royce et al (Combination therapy with relaxin and methylprednisolone augments the effects subepithelial fibrosis in an experimental model of allergic airways disease) as applied to claim 1 and in further view of Kocan et al (ML 290 is a biased allosteric agonist at the relaxin receptor RXFP1) . Teachings of Royce et al are delineated above and incorporated herein. Royce et al is silent with regard to the ligand being a small molecule RXFP1 agonist or the compound of claim 6. This is well known in the art as shown by Kocan et al. Kocan et al teach that activation of the relaxin receptor RXFP1 has been associated with improved survival in acute heart failure. ML290 is a small molecule RXFP1 agonist with simple structure, long half-life and high stability . Here we demonstrate that ML290 is a biased agonist in human cells expressing RXFP1 with long-term beneficial actions on markers of fibrosis in human cardiac fibroblasts (HCFs). ML290 did not directly compete with orthosteric relaxin binding and did not affect binding kinetics, but did increase binding to RXFP1 . ML290 caused strong coupling of RXFP1 to Gαs and GαoB but weak coupling to Gαi3. ML290 exhibited signalling bias at RXFP1 possessing a signalling profile indicative of vasodilator and anti-fibrotic properties (See abstract). Regarding claims 5-6 , Kocan et al also disclose that ML290 is the first small molecule agonist selective for RXFP1 (See Page 3, 3 rd para). Kocan et al state that “Chemical structure of ML290 is 2-Isopropoxy-N-(2-(3-(tri fluoromethyl sulfonyl) phenyl carbamoyl) phenyl) benzamide ” (See Page 8, Fig. 7). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the teachings of Kocan et al with that of Royce et al to arrive at the claimed invention with a reasonable expectation of success. It would have been obvious to do so because both Royce et al and Kocan et al disclose the administration of a ligand such as relaxin or its analog including a relaxin receptor such as RXFP1 and a small molecule to a subject for improved treatment. Royce et al teach that the said ligand is a small molecule RXFP1 and teaches RLN’s interaction with RXFP-1, wherein RLN has also been observed to act as a GR (glucocorticoid receptor) agonist. Kocan et al disclose that ML290 is a small molecule agonist selective for RXFP1. Thus, it would have been obvious to one of ordinary skill in the art to have incorporated the small molecule agonist, ML 290, of Kocan et al into the treatment method of Royce et al with a reasonable expectation of success. The rationale to support a conclusion that the claim would have been obvious is that one of ordinary skill in the art would have recognized from the teachings of both references that the treatment can effectively include relaxin or an agonist thereof such as ML 290 with a reasonable expectation of success. From the combined teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, 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 made . 07-21-aia AIA Claim s 11-12, 14-17, 19-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Nazarian et al (US 20190282665) . Nazarian et al’s teachings are delineated above and incorporated herein. Nazarian et al do not expressly disclose the dosage regimen of claims 11-12, the composition and carriers of claims 14-17. The said claims would have been obvious from the teachings. Regarding claim 11-12, Nazarian et al teach that relaxin is administered into the joint by an intraarticular injection. Further, the said methods may be combined with other methods currently used to treat joint stiffness, e.g. treatment with anti-inflammatory agents that may be administered locally or systemically. In one embodiment, relaxin may be administered to a subject, e.g., a human, in combination with steroids (See [0010], [0137] and claim 7). That is, the teachings encompass the administration of the small molecule before the ligand and also wherein the small molecule and ligand are delivered by the same route, as the steroid can be systemically delivered by injection as well and wherein the compounds are in the same carrier/composition. Regarding claims 14-16 , Nazarian et al teach administration to a subject the small molecule and the ligand and wherein the treatments can be combined. Thus, Nazarian et al encompass wherein the steroid is in the same composition and carrier with the ligand. Regarding claims 14-17, Nazarian et al teach that the relaxin can be administered as a gel, a cream, an ointment, a lotion, a drop, a suppository, a spray, a liquid or a powder composition (See [0015], [0096]). Also, disclosed is the dosage form/ carrier hydrogel (See [0006], [0016], [0138]). Regarding claims 19-22 , Nazarian et al teach the term “relaxin analog” includes a relaxin receptor agonist , e.g., any agent, such as a small molecule , a polypeptide, a polynucleotide or a polysaccharide, that can bind to and activate a relaxin receptor , e.g., one or more of RXFP1 , RXFP2, RXFP3 and RXFP4 (See [0065]). It would have been prima facie obvious to a person of ordinary skilled in the art at the time the invention was made to have followed the teachings of teachings of Nazarian et al to arrive at the instant invention. It would have been obvious to do so because Nazarian et al teach different embodiments for the disclosed treatments and while they do not expressly disclose a composition comprising both compounds, they clearly imply it. Nazarian et al also encompasses various treatment regimens including administration of small molecule before or after the administration of the ligand or ligand composition and together or separately. The known work in the field of treatments with ligands and small molecules, Nazarian et al would have prompted variations of it for use in the same field based on design incentives or other market forces where the variations are predictable to one of ordinary skill in the art. See MPEP 2144.09.II. From the combined teaching of the reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, 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 made . 07-21-aia AIA Claim s 1-21, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Royce et al (Combination therapy with relaxin and methylprednisolone augments the effects subepithelial fibrosis in an experimental model of allergic airways disease) in view of Grinstaff et al ( US 20210361745 ) . Teachings of Royce et al are delineated above and incorporated herein. Royce et al is silent with regard to a composition comprising the small molecule and the ligand in the same carrier, specially a microparticle carrier. This is taught by Grinstaff et al. Grinstaff et al’s teachings are delineated above and incorporated herein It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the teachings of Grinstaff et al with that of Royce et al to arrive at the claimed invention with a reasonable expectation of success. It would have been obvious to do so because both Royce et al and Grinstaff et al disclose the administration of a ligand such as relaxin or its analog including a relaxin receptor such as RXFP1 and a small molecule to a subject for improved treatment. Royce et al teach that the said small molecule is methylprednisolone, and Grinstaff et al teach a composition in the form of a microparticle comprising the said combination including an antifibrotic agent. Thus, it would have been obvious to one of ordinary skill in the art to have incorporated the small molecule of Royce et al into the microparticles of Grinsatff et al with a reasonable expectation of success. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143. In this case, corticosteroid, methylprednisolone of Royce et al would have been a suitable substitution for the antifbrotic agent of Grinstaff et al as both are known to be effectively combined with relaxin for improved treatment of a subject. From the combined teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, 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 made . 07-21-aia AIA Claim s 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Royce et al (Combination therapy with relaxin and methylprednisolone augments the effects subepithelial fibrosis in an experimental model of allergic airways disease) in view of Grinstaff et al ( US 20210361745 ) as applied to claims 1 and 15 above and in further view of Kocan et al (ML 290 is a biased allosteric agonist at the relaxin receptor RXFP1) . The teachings of Royce et al, Grinstaff et al and Kocan et al are delineated above and incorporated herein. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the teachings of Kocan et al and Ginstaff et al with that of Royce et al to arrive at the claimed invention with a reasonable expectation of success. It would have been obvious to do so because Royce et al, Kocan et al and Grinstaff et al, all teach the administration of a ligand such as relaxin or its analog including a relaxin receptor such as RXFP1 and a small molecule to a subject for improved treatment. Royce et al teach that the said ligand is a small molecule RXFP1 and teaches RLN’s interaction with RXFP-1, wherein RLN has also been observed to act as a GR (glucocorticoid receptor) agonist. Kocan et al disclose that ML290 is a small molecule agonist selective for RXFP1. Grinstaff et al teach a composition in the form of a microparticle comprising the said combination including an antifibrotic agent. Thus, it would have been obvious to one of ordinary skill in the art to have incorporated the small molecule agonist, ML 290, of Kocan et al into the treatment method of Royce et al and Grinstaff et al with a reasonable expectation of success. The rationale to support a conclusion that the claim would have been obvious is that one of ordinary skill in the art would have recognized from the teachings of all references that the treatment can effectively include relaxin or an agonist thereof such as ML 290 with a reasonable expectation of success. From the combined teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, 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 made . Double Patenting 08-33 AIA 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. Before consideration can be given to the issue of double patenting , two or more patents or applications must have at least one common inventor , common applicant, and/or be commonly assigned/owned or non-commonly assigned/owned but subject to a joint research agreement as set forth in 35 U.S.C. 102(c) or in pre-AIA 35 U.S.C. 103(c)(2) and (3) . For purposes of a double patenting analysis, the application or patent and the subject matter disqualified under 35 U.S.C. 102(b)(2)(C) or pre-AIA 35 U.S.C. 103(c) will be treated as if commonly owned. See MPEP § 804.03. Since the doctrine of double patenting seeks to avoid unjustly extending patent rights at the expense of the public, the focus of any double patenting analysis necessarily is on the claims in the multiple patents or patent applications involved in the analysis. 08-36 AIA Claim s 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-3 and 11 of U.S. Patent No. 11,439,685 in view of Royce et al (Combination therapy with relaxin and methylprednisolone augments the effects subepithelial fibrosis in an experimental model of allergic airways disease) . The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Royce et al. The examined claims and reference claims are drawn to a composition including a microparticle comprising the ligand and a small molecule. The difference is that examined claims recite the presence of a small molecule such as a corticosteroid while the reference claims recite the presence of an antifibrotic agent. The substitution is obvious over the teachings of Royce et al which teach a treatment comprising the ligand relaxin and a small molecule wherein the small molecule including methylprednisolone. Thus, the examined claims would have been obvious over the reference claims in view of Royce et al. Claims 1-25 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST. 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, Sue X. Liu can be reached at 571-272-5539. 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. /Mina Haghighatian/ Mina Haghighatian Primary Examiner Art Unit 1616 Application/Control Number: 18/852,335 Page 2 Art Unit: 1616 Application/Control Number: 18/852,335 Page 3 Art Unit: 1616 Application/Control Number: 18/852,335 Page 4 Art Unit: 1616 Application/Control Number: 18/852,335 Page 5 Art Unit: 1616 Application/Control Number: 18/852,335 Page 6 Art Unit: 1616 Application/Control Number: 18/852,335 Page 7 Art Unit: 1616 Application/Control Number: 18/852,335 Page 8 Art Unit: 1616 Application/Control Number: 18/852,335 Page 9 Art Unit: 1616 Application/Control Number: 18/852,335 Page 10 Art Unit: 1616 Application/Control Number: 18/852,335 Page 11 Art Unit: 1616 Application/Control Number: 18/852,335 Page 12 Art Unit: 1616 Application/Control Number: 18/852,335 Page 13 Art Unit: 1616 Application/Control Number: 18/852,335 Page 14 Art Unit: 1616 Application/Control Number: 18/852,335 Page 15 Art Unit: 1616 Application/Control Number: 18/852,335 Page 16 Art Unit: 1616 Application/Control Number: 18/852,335 Page 17 Art Unit: 1616 Application/Control Number: 18/852,335 Page 18 Art Unit: 1616 Application/Control Number: 18/852,335 Page 19 Art Unit: 1616 Application/Control Number: 18/852,335 Page 20 Art Unit: 1616 Application/Control Number: 18/852,335 Page 21 Art Unit: 1616 Application/Control Number: 18/852,335 Page 22 Art Unit: 1616
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