DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 12/04/2025, is acknowledged. Amendments to the specification have been entered.
Claims 1-4, 6-16, 20-22, 31-32 are pending in this action. Claim 5 has been canceled. Claims 17-19, 23-30 have been cancelled previously. Claims 1-4, 6-16, 20-22, 31-32 have been amended. Claims 1-4, 6-16, 20-22, 31-32 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application, filed October 21, 2022, is a 371 of PCT/GB2021/050992, filed Apryl 23, 2021, which claims benefit of foreign priority to GB2006081.0, filed Apryl 24, 2020.
Information Disclosure Statement
The information disclosure statement, filed 12/04/2025, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 10 are objected to because of the following informalities: Claim 10 comprises the typographic error “selected from the group short chain triglycerides or medium chain triglycerides” that needs to be corrected to “selected from the group consisting of short chain triglycerides and medium chain triglycerides” or clarified. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-4, 6-16, 20-22, 31-32 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 pre-AIA the applicant regards as the invention.
Newly amended claim 1 recites the limitation “pharmaceutical dosage form comprises a pharmaceutical composition in a form of a heterogeneous mixture comprising solid particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2- sulfonamide” that is not reasonably clear. To this point, it is noted that the instant specification teaches that “it is important to ensure that the mixture is homogeneous, not only at the outset, but also that this homogeneity is retained during the loading process to ensure dose homogeneity within a production batch” (specification, Page 14). Therefore, it is unclear what the limitation “heterogenous mixture” refers to. Clarification is required.
Newly amended claim 6 recites the limitation “the triglycerides comprise one or more fatty acids selected from the group” that is not reasonably clear. In the present case, it is not clear what is understood as “triglycerides”. Is it a mixture of compounds (i.e., comprising)? Similar is applied to claim 7. Clarification is required.
Newly amended claim 7 recites the limitation “the triglycerides comprise a naturally-occurring oil or fat” that is not reasonably clear, because the compounds (i.e., triglycerides) are defines as a phase/liquid/oil or fat. Clarification is required.
Newly amended claim 12 recites the limitation “essentially free of water” that is not reasonably clear. In the present case, it is noted that neither the claims nor the instant specification provide a clear definition for said term/limitation, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
In response to applicant’s argument that the instant specification teaches that disclosed compositions are essentially free of water, i.e., comprise no more that about 5%, or no more than about 2%, or no more than about 1%, or no more than about 0.5%, or about 0.1% water or less” (specification Page 11, Lns. 22-25), it is noted that in the present case, it is not reasonably clear how much water are included in the claimed composition. – less than 5%, or less than 2%, or less than 1%, or less than 0.5%. Further, it is noted that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.” See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the metes and bounds of the claim are not reasonably clear. Similar is applied to claim 13 regarding the term “about”. Therefore, the clarification is required.
Newly amended claim 13 recites the limitation “particles of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butyl-thiophene-2-sulfonamide or pharmaceutically-acceptable salt thereof have a volume-based mean diameter that is no more than about 50 µm” that is unclear and indefinite. In the present case, as stated previously, where a claimed value (i.e., particle diameter) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Further, it is unclear with what accuracy (identified by the term “about”) the particle mean diameter should be measured (see above). Without knowing these parameters, the metes and bounds of the claimed subject matter are not clear. Clarification is required.
Claims 2-4, 8-11, 14-16, 20-22, 31-32 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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. A nonstatutory obviousness-type 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); 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 1-4, 6-16, 20-22, 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-19 of U.S. Patent No. 11,819,494 B2; (2) claims 1-24 of U.S. Patent No. 12,128,029 B2; (3) claims 1-27 of U.S. Patent No. 12,213,961 B2; (4) claims 1, 17-19 of U.S. Patent No. 11,654,115 B2; (5) claims 1-16 of U.S. Patent No. 12,121,614, and (6) claims 1-28 of U.S. Patent No. 11,844,868.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A method and compositions for improving lung function in a patient having idiopathic pulmonary fibrosis by perorally administering to said patient a therapeutically-effective amount of a sodium salt of N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (C21) in the form of a powder mixture homogenously dispersed throughout a carrier material provided in a dosage form/capsule. The specifications of said prior patents teach that said dosage forms can be presented in a form of a heterogeneous mixture comprising solid particles of C21, or a pharmaceutically-acceptable salt thereof, suspended in a pharmaceutically-acceptable, hydrophobic, lipid-based carrier in which C21 or salt thereof is essentially insoluble. In the present case, the prior patent independent claims are merely broader than instant claims that include additional limitation (i.e., hydrophobic, lipid-based carrier) and therefore are more specific.
In response to the applicant’s argument that the prior patents do not require a dosage form as instantly claimed that are suitable for peroral administration, it is noted that the specifications of said prior patents teach the use of dosage forms as instantly claimed. In the present case, the prior patent independent claims are merely broader than instant claims that include additional limitations and therefore are more specific. Therefore, the examiner maintains the positions that the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Response to Arguments
Applicant's arguments, filed 12/04/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments have been added to the rejections to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the claim language, the structure of the claimed dosage forms and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art, to place the application in condition for allowance.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach a method of treatment of idiopathic pulmonary fibrosis by peroral administration to a patient in need thereof a dosage form comprising N-butyloxycarbonyl-3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (C21 as the active agent) or a pharmaceutically acceptable salt therefore, wherein said dosage form/capsule comprises a heterogeneous mixture comprising solid particles of C21, or a pharmaceutically-acceptable salt thereof that are suspended in a pharmaceutically-acceptable, hydrophobic, lipid-based carrier in which C21 or salt thereof is essentially insoluble. Applicant teaches that said approach allows increasing/improving stability of said active agent C21 during the storage.
Conclusion
No claim is allowed at this time.
Applicant's 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615