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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 May 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. Receipt of the Request for Continued Examination (RCE) under 37 C.F.R. 1.114, the amendment and Applicants’ Arguments/Remarks, all filed 12 May 2026 are acknowledged.
Claims 1 and 22-42 are currently pending. Claims 2-21 have been cancelled. Claims 1, 30, and 40-41 have been amended. Claim 42 is newly added. Claims 1 and 22-42 are examined on the merits within.
Continued Examination Under 37 C.F.R. 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 May 2026 has been entered.
Terminal Disclaimer
4. The terminal disclaimer filed on 12 May 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,439,685 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
5. Applicants’ arguments, filed 12 May 2026, with respect to the 35 U.S.C. 112(b) Rejection have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejection of claim 24 has been withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejections of Sprogoe et al. in view of Nazarian et al. and Ticho et al. have now been modified to instead recite Ticho et al. in view of Nazarian et al. and further in view of Sprogoe et al.
New Rejections
Claim Rejections – 35 U.S.C. 103
6. 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.
7. Claim(s) 1 and 22-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ticho et al. (WO2017/201340) in view of Nazarian et al. (U.S. Patent Application Publication No. 2019/0282665) and Sprogoe et al. (U.S. Patent Application Publication No. 2016/0296600).
Ticho et al. teach mRNA therapy for treatment of fibrosis, wherein mRNA, when administered in vivo, encodes human relaxin and fusion proteins comprising relaxin preferably encapsulated in lipid nanoparticles. See abstract. The composition comprises a dose of up to 2 mg/kg in a human subject. See claim 10. The lipid nanoparticle includes 0.5-15% PEG-modified lipid. See page 3. In some embodiments the nanoparticles have a diameter of greater than 950 nm or greater than 1000 nm. See page 237. Relaxin has therapeutic benefits such as treating and preventing fibrosis e.g., renal fibrosis, cardiac fibrosis or pulmonary fibrosis and cardiovascular disease e.g., acute heart failure, coronary artery disease, microvascular disease, acute coronary syndrome with cardiac dysfunction, or ischemia reperfusion. See page 1. The composition may be administered by inhalation, intravenously, or intramuscularly. See pages 256-258.
Ticho does not teach 0.01-10% relaxin.
Nazarian et al. teach a method of treating a stiffened joint in a subject by administering relaxin. See abstract. Doses include 0.0015 mg/kg and 0.5 mg/kg. See paragraph [0174]. Example 1 is directed to evaluation of the glenohumeral joint. The sustained release formulation provides release of a therapeutic dose of relaxin during a period of at least about 4 weeks. See paragraph [0026]. As used herein, an “effective amount,” is intended to include the amount of relaxin or an analog, a fragment or a variant thereof, that, when administered to a subject having a stiffened joint, is sufficient to effect treatment of the stiffened joint (e.g., by diminishing, ameliorating or maintaining the stiffened joint or one or more symptoms of the stiffened joint). The “effective amount” may vary depending on the sequence of the relaxin, how the relaxin is administered, the severity of the joint stiffness and the history, age, weight, family history, genetic makeup, the types of preceding or concomitant treatments, if any, and other individual characteristics of the subject to be treated. See paragraph [0077].
Sprogoe et al. teach carrier-linked relaxin prodrug for treatment of diseases which can be treated with relaxin. See abstract. The carrier is a hydrogel in the form of microparticles with a size diameter of 1 to 1000 µm. See paragraph [0124]. The carrier can be polyesters. See paragraph [0112]. The composition is used to treat diseases such as fibrosis of the heart, lungs, kidney or liver. See paragraph [0764]. The disease is a stroke. See paragraph [0770]. The composition can be administered by intraarticular injection, intradermal injection, intramuscular injection, subcutaneous injection, etc. See paragraph [0798]. Sprogoe et al. teach the microparticles may be administered with an excipient such as water. See paragraph [0079]. Sprogoe et al. teach the composition may be lyophilized. See paragraph [0726]. Sprogoe et al. teach the composition can be a sustained release formulation. See paragraph [0079].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to substitute relaxin for mRNA encoding relaxin to yield predictable results because Sprogue et al. teach the effectiveness of administering relaxin in combination with polyesters. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the percentage of relaxin in the formulation to achieve the desired effect, wherein the amount to achieve the desired effect may vary depending on route of administration, severity of joint stiffness, age, family history, etc. as taught by Nazarian et al. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use the formulation to treat joint fibrotic diseases, such as the glenohumeral joint, and stroke, because Nazarian et al. teach the effectiveness of using relaxin to treat joint disease of the glenohumeral joint and Sprogue et al. teach the effectiveness of relaxin in treating stroke and lung disease. It would have been obvious to modify the formulation by lyophilizing, administering with a vehicle, and formulating as a sustained release composition because Sprogue et al. teach effectively lyophilizing a combination of relaxin and polyester, administering the microparticle with water, and the effectiveness in a sustained release form.
Response to Arguments
Applicants’ arguments filed 12 May 2026 have been fully considered but they are not persuasive.
8. Applicants argued, “Sprogoe is not directed to relaxin encapsulated within aliphatic polyester microparticles. The systems involve different formulation design considerations, different release mechanisms, and different compositional parameters. Nazarian’s sustained release system is a hydrogel system wherein PEG is covalently attached to relaxin. Ticho fails to overcome the deficiencies. The Office’s rejection is based on impermissible hindsight. The rejection does not merely require routine substitution of one known carrier for another. It requires changing the delivery platform and does not provide a reasonable expectation of success.”
In response to applicants’ arguments, the rejection has been modified. The primary reference is Ticho et al. whom teach mRNA therapy for treatment of fibrosis, wherein mRNA, when administered in vivo, encodes human relaxin and fusion proteins comprising relaxin preferably encapsulated in lipid nanoparticles. See abstract. The lipid nanoparticle includes 0.5-15% PEG-modified lipid. See page 3. In some embodiments the nanoparticles have a diameter of greater than 950 nm or greater than 1000 nm. See page 237. Thus Ticho et al. teach microparticles of PEG encapsulated mRNA encoding relaxin. Therefore the delivery platform is not changed, nor hindsight analysis used. The prior art of Nazarian is now used to make obvious modification of the amount of relaxin. The prior art of Sprogue is provided to make obvious the use of the formulation in treating various ailments not taught by Ticho et al. and Nazarian, and to make obvious substitution of relaxin for mRNA encoding relaxin.
Thus this rejection is maintained.
Correspondence
9. No claims are allowed at this time.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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