DETAILED ACTION
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 .
1. Claims 1-4 are currently pending and currently under examination.
Priority
2. Application is a continuation-in-part of Application 18352807 filed on 7/14/2023, which is a continuation-in-part of application 18173882 filed on 2/24/2023 which claims benefit and priority from foreign application GB2219591.1 filed on 12/22/2022. Priority has been granted to the foreign application and the effective filing date of 12/22/2022.
Claim Rejections - 35 USC § 112
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.
3. Claims 1-4 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 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: “administering to the patient”.
Claim 4 recites “an anxiolytic such as buspirone, clonazepam, desvenlafaxine, fluoxetine, gabapentin and/or lorazepam; or a proton pump inhibitor such as omeprazole, pantoprazole or rabeprazole.” The use of the words “such as” makes it unclear whether the claim is limited to the list of drugs following or if it is open to other anxiolytics or proton pump inhibitors.
Claim Rejections - 35 USC § 102
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 –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahlof (US2018/0078529 A1, as cited on IDS 5/31/2024).
Regarding claim 1, Dahlof discloses a method of treating a patient diagnosed with an interstitial lung disease (ILD), including idiopathic pulmonary fibrosis, comprising: administering a pharmaceutical drug for treating pulmonary fibrosis. (See Dahlof, pg. 2 [0012]).
Regarding claims 2-3, Dahlof discloses the pharmaceutical drug for treating pulmonary fibrosis is an angiotensin II type 2 receptor agonist (ATRAG), specifically N-butyloxycarbonyl- 3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (Compound 21 or 'C21'). (See Dahlof pg. 2 [0013]).
Regarding claim 4, Dahlof teaches that the pharmaceutical drug for treating pulmonary fibrosis can be pirfenidone or nintedanib. (See Dahlof, pg. 1 [0006]).
5. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Camber (US11844868 B2, effective filing date 4/24/2020).
Camber discloses a method of treating a patient diagnosed with an interstitial lung disease, idiopathic pulmonary fibrosis, by administering to the patient ATRAG, N-butyloxycarbonyl- 3-(4-imidazol-1-ylmethylphenyl)-5-iso-butylthiophene-2-sulfonamide (Compound 21 or 'C21'). (See Cambert, abstract).
6. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1)(a)(2) as being anticipated by Camber 2 (US11654115 B2, effective filing date 4/24/2020).
Camber 2 claims a method for treating a patient diagnosed with an interstitial lung disease, specifically idiopathic pulmonary fibrosis, by administration of the ATRAG, C21. (See Camber 2, abstract)
Claim Rejections - 35 USC § 103
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 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.
7. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Camber (US11844868 B2, effective filing date 4/24/2020) in view of Dahlof (US2018/0078529 A1, as cited on IDS 5/31/2024).
Camber discloses the limitations of claim 1 as disclosed above.
Camber does not disclose the method of treating pulmonary fibrosis by administering pirfenidone or nintedanib.
Dahlof teaches administering pirfenidone and nintedanib for treating patients diagnosed with idiopathic pulmonary fibrosis as discussed above.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the method of treatment for Cambert with the method of treatment of Dahlof. It would have been obvious because combination therapy is a known practice in medicine and both pharmaceutical agents treat the same disease, idiopathic pulmonary fibrosis. Therefore, it would have been obvious for a person of ordinary skill in the art prior to the effective filing date to combine the methods of treatment in Cambert and Dahlof with a reasonable expectation of success for producing the present claimed invention.
8. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Camber 2 (US11654115 B2, effective filing date 4/24/2020) in view of Dahlof (US2018/0078529 A1, as cited on IDS 5/31/2024). .
Camber 2 discloses the limitations of claim 1 as discussed above.
Camber 2 does not disclose the pharmaceutical drug for treating pulmonary fibrosis is selected from pirfenidone or nintedanib.
Dahlof teaches the use of pirfenidone and nintedanib for treating idiopathic pulmonary fibrosis as discussed above.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the method of treatment for Camber 2 with the method of treatment of Dahlof. It would have been obvious because combination therapy is a known practice in medicine and both pharmaceutical agents treat the same disease. Therefore, it would have been obvious for a person of ordinary skill in the art prior to the effective filing date to combine the methods of treatment in Camber 2 and Dahlof with a reasonable expectation of success for producing the present 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. 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.
9. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11654115 (Hereinafter referred to as Patent ‘115) in view of Dahlof (US2018/0078529 A1, as cited on IDS 5/31/2024).
Patent ‘115 claims a method for treating interstitial lung disease, specifically idiopathic pulmonary fibrosis, by administration of the ATRAG, C21.
Patent ‘115 does not claim the pharmaceutical drug for treating pulmonary fibrosis is selected from pirfenidone, or nintedanib.
Dahlof teaches the use of pirfenidone and nintedanib for treating pulmonary fibrosis as discussed above.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the method of treatment for Patent ‘115 with the method of treatment of Dahlof. It would have been obvious because combination therapy is a known practice in medicine and both pharmaceutical agents treat the same disease. Therefore, it would have been obvious for a person of ordinary skill in the art prior to the effective filing date to combine the methods of treatment in Patent ‘115 and Dahlof with a reasonable expectation of success for producing the present claimed invention.
10. Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11844868 (Hereinafter referred to as Patent ‘868) in view of Dahlof (US2018/0078529 A1, as cited on IDS 5/31/2024).
Patent ‘868 claims a method for treating interstitial lung disease, specifically idiopathic pulmonary fibrosis, by administration of the ATRAG, C21.
Patent ‘868 does not claim the pharmaceutical drug for treating pulmonary fibrosis is selected from pirfenidone, or nintedanib.
Dahlof teaches the use of pirfenidone and nintedanib for treating pulmonary fibrosis as discussed above.
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date to combine the method of treatment for Patent ‘868 with the method of treatment of Dahlof. It would have been obvious because combination therapy is a known practice in medicine and both pharmaceutical agents treat the same disease. Therefore, it would have been obvious for a person of ordinary skill in the art prior to the effective filing date to combine the methods of treatment in Patent ‘868 and Dahlof with a reasonable expectation of success for producing the present claimed invention.
Conclusion
11. Claims 1-4 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY DUNN whose telephone number is (571)272-5825. The examiner can normally be reached Monday-Friday 8-4:30.
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/LINDSAY DUNN/Examiner, Art Unit 1644
/Laura B Goddard/Primary Examiner, Art Unit 1642
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