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 .
Request for Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/26 has been entered.
Priority
This application is a 371 of PCT/US21/24760 (03/30/2021) and has PRO 63/002,511 (03/31/2020).
Status
Claims 1-6, 8-16, 19-23 are pending.
Claim Rejections - 35 USC § 103
Claims 1-6, 8-16, 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (J Med Virol. 2020 (17-Mar-2020);92:612–617) in view of Pavliv et al. (US10314824) and Pavliv et al. (US20170312255, “Pavliv-2017”).
Sun teaches COVID-19 infections showed symptoms of fever, cough, fatigue, etc. (p. 2: “98% of the patients in their study had fevers, of which 78% had a temperature higher than 38°C. They reported that 76% of the patients had coughs, 44% of patients experienced fatigue and muscle pain, and 55% of patients had dyspnea.”) which can lead to pulmonary fibrosis as a serious complication (p. 616: “These studies consistently suggest that pulmonary fibrosis will become one of the serious complications in patients with SARSCoV‐2 infection.”). Sun teaches “The prevention of pulmonary fibrosis in patients recovered from 2019‐nCoV infections is an issue that urgently needs to be addressed” (p. 3). Sun does not teach administration of ifetroban (“thromboxane A2 receptor antagonist” as per claim 3).
Pavliv teaches treating and preventing pulmonary fibrosis by administration of ifetroban (Claim 1: “A method of treating pulmonary fibrosis in a mammal in need of treatment thereof, comprising administering a therapeutically effective amount of [1S-(1α,2α,3α,4α)]-2-[[3-[4-[(Pentylamino)carbonyl]-2-oxazolyl]-7-oxabicyclo[2.2.1]hept-2-yl]methyl]-benzenepropanoic acid (ifetroban)”; claim 7 – sodium salt thereof; cols 5-6: “In certain preferred embodiments, the pharmaceutical composition described above, the therapeutically effective amount is from about 10 mg to about 1000 mg ifetroban per day.”, “administration of a therapeutically effective amount of a thromboxane A2 receptor antagonist to a subject(s) or patient(s) in need thereof can prevent and/or treat fibrosis”, “examples include: Pulmonary fibrosis (lungs)”; “Symptoms of pulmonary fibrosis include shortness of breath, cough, and diminished exercise tolerance”).
Pavliv-2017 teaches ifetroban improves pulmonary function (claim 14: “ifetroban improves pulmonary function”)
One of ordinary skill in the art following the teaching of Sun would have been motivated to prevent pulmonary fibrosis in a SARSCov-2 patient based on Sun’s specific teaching and would have looked to therapies known to prevent pulmonary fibrosis such as taught by Pavliv and Pavliv-2017. One of ordinary skill in the art would have had considered each of the references because they are in the same field of endeavor – i.e., preventing and treating disease related to pulmonary function. One of ordinary skill in the art would have had a reasonable expectation of success because Sun teaches the need to prevent pulmonary fibrosis and Pavliv specifically teaches ifetroban is effective for the same purpose.
Regarding claim 1’s language of “wherein the administering is performed due to the patient having COVID-19 and not due to the patient having pulmonary fibrosis”, one of ordinary skill in the art would have been motivated to prevent pulmonary fibrosis in a patient and not due to the patient having pulmonary fibrosis. Thus, the claim element is met. Therefore claims 1 and 3 are prima facie obvious.
Regarding claim 2, one of ordinary skill in the art would have considered applying the therapy to the patient in every setting, including inpatient.
Regarding claim 4, Pavliv teaches the sodium salt (claim 7).
Regarding claim 5, Pavliv teaches parenteral administration (col. 5, line 51: “ifetroban may be administered orally, intranasally, rectally, vaginally, sublingually, buccally, parenterally, or transdermally.”).
Regarding claim 6, Pavliv teaches prevention (Abstract).
Regarding claims 8-9, Pavliv teaches treating with “preferably from about 100 to about 500 mg per day (col 5, line 49).
Regarding claim 10, Pavliv teaches oral administration (col. 5, line 51: “ifetroban may be administered orally, intranasally, rectally, vaginally, sublingually, buccally, parenterally, or transdermally.”) and “preferably from about 100 to about 500 mg per day (col 5, line 49) which one of ordinary skill in the art would have considered and arrive at the claimed invention.
Regarding claims 11 and 13 as with claim 1, Sun teaches preventing pulmonary fibrosis and symptoms of cough and fatigue while Pavliv and Pavliv-2017 teach treating cough and improving pulmonary function.
Regarding claim 12, Pavliv teaches treating with “preferably from about 100 to about 500 mg per day (col 5, line 49).
Regarding claim 14, Pavliv teaches the sodium salt (claim 7).
Regarding claim 15, Pavliv teaches oral administration (col. 5, line 51: “ifetroban may be administered orally, intranasally, rectally, vaginally, sublingually, buccally, parenterally, or transdermally.”) and “preferably from about 100 to about 500 mg per day (col 5, line 49) which one of ordinary skill in the art would have considered and arrive at the claimed invention.
Regarding claims 16 and 19 to subtypes of pulmonary dysfunction, Pavliv describes these types of pulmonary dysfunction (col 1, lines 38, to col 2, line 6). One of ordinary skill in the art would have considered applying ifetroban to these subtypes because of the common pathology as described by Pavliv and arrive at the claimed invention.
Regarding claim 20, Pavliv teaches varying the treatment to account for age and condition (col 6: “depending upon the subject and disease condition being treated, the weight and age of the subject, the severity of the disease, condition, the manner of administration and the like, which can readily be determined by one of ordinary skill in the art.”), which was well-known results effective variable that one of ordinary skill in the art would consider and arrive at the claimed invention.
Regarding claims 21-23 as with claim 1, Sun teaches preventing pulmonary fibrosis and treating symptoms of cough and fatigue while Pavliv and Pavliv-2017 teach treating cough and improving pulmonary function.
With each of the above claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of teachings of the primary reference in with the secondary reference all of which are in the same field of endeavor. Through the combined teachings, one of ordinary skill in the art would have arrived at the invention as claimed with a reasonable expectation of success before the effective filing date of the claimed invention.
Response to Remarks - 35 USC § 103
Applicant argues that the claims as amended are not obvious because the prior art teaches administration of ifetroban to treat pulmonary fibrosis while the claims as amended are not. This is not persuasive because one of ordinary skill in the art following the teaching of the prior art and treating a COVID-19 patient would have known of the need to prevent pulmonary fibrosis and arrive at the claimed invention “and not due to the patient having pulmonary fibrosis”.
Applicant argues that none of the cited art suggests administering ifetroban for treating COVID-19. This argument is not persuasive because in view of Sun, one of ordinary skill in the art would have known of the need to prevent pulmonary fibrosis in a COVID-19 patient and would have administered ifetroban as taught by Pavliv to achieve prevention.
Applicant argues that independent claim 11 expressly excludes pulmonary fibrosis and requires chronic administration and thus is nonobvious. This argument is not persuasive because one of ordinary skill in the art would have administered ifetroban to prevent pulmonary fibrosis in the same patient and in the same manner, including a daily dose (Pavliv col 10, line 62 to col 11), and arrive at the claimed invention from the teaching of Sun in view of Pavliv.
Applicant argues that independent claim 22 requires administration prior to development of pulmonary fibrosis in the patient and thus is nonobvious over the cited art. This argument is not persuasive because, as detailed above, one of ordinary skill in the art would have known from Sun that COVID-19 patients requires prevention of pulmonary fibrosis and thus would have considered Pavliv’s teaching of using ifetroban for prevention of pulmonary fibrosis and arrived at the claimed invention with a reasonable expectation of success.
Conclusion
No claims allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626