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 13 June 2025 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. Applicants’ arguments/remarks filed 13 November 2025 are acknowledged. Claims 1 and 22-41 are currently pending. Claims 2-21 are cancelled. Claim 41 is newly added. Claims 1, 22-23, 25-28, 30, 32-33 and 40 are amended. Claims 1 and 22-41 are examined on the merits within.
Withdrawn Objections/Rejections
3. Applicants’ arguments, filed 13 November 2025, with respect to the claim objections have been fully considered and are persuasive. The objections of claims 25-28 and 32-33 have been withdrawn. The 35 U.S.C. 112(a) Rejection of claims 22-29 and 40 is withdrawn in view of the claim amendments. The 35 U.S.C. 112(b) Rejections of claims 1, 23, 32 and 40 has been withdrawn in view of the claim amendments. The 35 U.S.C. 102 (a)(1) Rejection of claims 1 and 22-27 has been withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejections of Sprogoe et al. (U.S. Patent Application Publication No. 2016/0296600) in view of Ticho et al. (WO2017/201340) and Sprogoe et al. (U.S. Patent Application Publication No. 2016/0296600) in view of Nazarian et al. (U.S. Patent Application Publication No. 2019/0282665) have been modified to reject the claims over Sprogoe et al. (U.S. Patent Application Publication No. 2016/0296600) in view of Ticho et al. (WO2017/201340) and Nazarian et al. (U.S. Patent Application Publication No. 2019/0282665).
Maintained Rejections
Claim Rejections – 35 U.S.C. 112(b)
4. 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.
5. Claim 24 is 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.
6. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 24 recites the broad recitation “Spinal Muscular Atrophy”, and the claim also recites “ (Type I, II, III, or IV)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
New Rejections
Claim Rejections – 35 U.S.C. 103
7. 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.
8. Claim(s) 1 and 22-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sprogoe et al. (U.S. Patent Application Publication No. 2016/0296600) in view of Ticho et al. (WO2017/201340) and Nazarian et al. (U.S. Patent Application Publication No. 2019/0282665).
Regarding instant claim 1, 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].
Regarding instant claims 22 and 28, the composition is used to treat diseases such as fibrosis of the heart, lungs, kidney or liver. See paragraph [0764]. Thus it would have been obvious to try administering the composition for interstitial lung disease to yield predictable results since Sprogoe et al. teach the effectiveness against lung disease.
Regarding instant claims 23-27, 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].
Regarding instant claim 30, 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 composition can be administered by intraarticular injection, intradermal injection, intramuscular injection, subcutaneous injection, etc. See paragraph [0798].
Regarding instant claim 36, Sprogoe et al. teach the microparticles may be administered with an excipient such as water. See paragraph [0079].
Regarding instant claim 37, Sprogoe et al. teach the composition may be lyophilized. See paragraph [0726].
Regarding instant claims 38-39, Sprogoe et al. teach the composition can be a sustained release formulation. See paragraph [0079].
Sprogoe et al. do not teach the dose of 1-2000 µg/kg or a nucleic acid that encodes relaxin or 0.01-10% relaxin.
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.
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].
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 properties for administration while achieving 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 modify the amount of relaxin to achieve the desired effect based on known safe effective dosage ranges taught by Ticho et al. and Nazarian et al. It would have been obvious to substitute mRNA that encodes for relaxin, for relaxin, to achieve effective results because Ticho et al. teach that mRNA encoding relaxin effectively treats fibrotic diseases. 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 of Sprogoe et al. to treat joint fibrotic diseases, such as the glenohumeral joint, because Nazarian et al. teach the effectiveness of using relaxin to treat joint disease of the glenohumeral joint.
Double Patenting
9. 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.
10. Claims 1 and 22-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,439,685.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 11,439,685 are directed to a formulation comprising aliphatic polyester and an antifibrotic agent. The only difference lies in the fact that the instant claims are additionally directed to the method of treating with the formulation, as well as the amount of relaxin when present. The instant claims are directed to 1-10% relaxin whereas U.S. Patent No. 11,439,685 comprises a larger range of 0.01 to 33% of relaxin. Since the instant claims fall within this range, the two are not patentably distinct.
Response to Arguments
Applicants’ arguments filed 13 November 2025 have been fully considered but they are not persuasive.
11. Applicants argued, “Sprogoe does not teach a microparticle having a diameter of 1 to100 µm and antifibrotic agent at 0.01 to 10% of total formulation mass. Ticho and Nazarian fail to cure the deficiencies.”
In response to applicants’ arguments, 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]. Nazarian teaches 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]. 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 properties for administration while achieving 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.
Thus this rejection is maintained.
12. Applicants argued, “A terminal disclaimer has been filed to overcome the non-statutory double patenting rejection. The rejection is now moot.”
In response to applicants’ arguments, a terminal disclaimer has not been filed at this time. Thus the rejection is maintained.
Conclusion
13. Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
14. No claims are allowed at this time.
15. 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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