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 .
Priority
This application is a CON of 18/063,196 (12/08/2022 ABN)
18/063,196 has PRO 63/287,641 (12/09/2021),
and claims foreign priority to EP 21218207.5 (12/29/2021)
EP 22177757.6 (06/08/2022).
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.
Claims 15 and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 15 and 20 use the language “dose regimen as authorized” which is not sufficiently defined in the specification and renders the claim indefinite. One of skill in the art would not know the metes and bounds of the claims in view of the exemplary meaning derived from the specification. See MPEP 2173.05(d) (“Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.”).
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.
Claims 14-15, 17-20, 22-33 are rejected under 35 U.S.C. 103 as being unpatentable over Herrmann et al. (WO2019081235A1) in view of over Pouzet et al. (WO2013026797).
Herrmann teaches that idiopathic pulmonary fibrosis (IPF) is a species of a progressive fibrosing interstitial lung disease (PF-ILD). Herrmann at page 2, paragraph 2. Hermann teaches that the standard treatments of idiopathic pulmonary fibrosis are either Pirfenidone or Nintedanib treatment. Herrmann at page 4, paragraph 3.
Herrmann teaches that both Pirfenidone and Nintedanib, can only reduce the decline in FVC (i.e., forced vital capacity, which is the amount of air that an individual is able to forcibly exhale from his / her lungs after taking the deepest breath they can), consistent with a slowing of disease progression, but both are not able to stop or even reverse or heal the symptoms of IPF. Herrmann at page 4, paragraph 4.
Herrmann teaches that the most prominent side effects associated with both Nintedanib and Pirfenidone are gastrointestinal events, which are usually managed either by treatment interruption, dose reduction or symptomatic treatment of the gastrointestinal side effects. Herrmann at page 4, paragraph 6-7. Hermann teaches that due to these "accumulative gastrointestinal side effects" the combination of Pirfenidone and Nintedanib, to treat idiopathic pulmonary fibrosis is not frequently used. Herrmann at page 4, paragraph 6-7.
Herrmann teaches a method of treating progressive fibrosing interstitial lung diseases (PF- ILDs) preferably idiopathic pulmonary fibrosis, comprising administering to a patient in need thereof a combination of a therapeutically effective amount of Nintedanib or a pharmaceutically acceptable salt thereof and a therapeutically effective amount of one of formulas I, II or III or a pharmaceutically acceptable salt thereof. Herrmann at page 14-16. Herrmann teaches that more preferably the second combination partner is a PDE4B -inhibitor of formula III .
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wherein S* is a sulphur atom that represents a chiral center. Herrmann at page 16.
Hermann further teaches that formula (III) may be administered in a dose that will lead to an estimated human free fraction of the compound between 1 nMol/L to 2000 nMol/L, more preferred between 1 nMol/L to 1000 nMol/L. Herrmann at page 16-17, last paragraph to page 16.
Herrmann teaches that the PF-ILD treatment/IPF treatment with combination of Nintedanib and a PDE4B-inhibitor of formula III shows an improved therapeutic efficacy in PF-ILD/IPF-treatment compared to treatment with each of them; the combination treatment also further shows an acceptable tolerability in PF-ILD-treatment. Herrmann at page 8.
Herrmann teaches that the PDE4B inhibitor of formula I can be administered simultaneously, concurrently, sequentially, successively, alternately or separately with Nintedanib or a pharmaceutically acceptable salt thereof. Herrmann at page 24, last paragraph, line 1-6.
Herrmann also teaches a composition comprising a PDE4B-inhibitor of formula I Nintedanib or pharmaceutically acceptable salts thereof. Herrmann at claim 31. Herrmann specifies the PDE4-B-inhibitor of formula I is the compound of formula III. Herrmann at claim 34.
Regarding claim 14, Hermann does not teaches administering orally 18 mg of formula III.
Pouzet also teaches a method of treating a disease which can be treated by the inhibition of the PDE4-enzyme comprising the step of administering one of formulas I, II or III to a patient in need thereof. Pouzet at page 12, 4th paragraph. Pouzet teaches formula III to treat idiopathic pulmonary fibrosis. Pouzet at pages 4, 12, 14.
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Pouzet further teaches it is particularly preferable if the compounds of formula I are administered orally, and it is also particularly preferable if they are administered once or twice a day. Pouzet at page 75, 2nd paragraph.
One of ordinary skill in the art following the teaching of Hermann and Pouzet would have considered Pouzet’s finding of 3 mg/kg in vivo results and implement for human use and arrive at a corresponding mg range for humans, including 18 mg twice daily. Based on the teaching of Pouzet and as is well known in the art pharmaceutical dosing is a result effective variable that is routinely optimized such that one of ordinary skill in the art would have considered optimization of the dosing of the drug shown to be effective. MPEP § 2144.05(II)(A) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”). One of ordinary skill in the art would have also considered combination of known therapies for the same purpose in the same manner as Hermann and combined Formula III with pirfenidone. Such a combination is prima facie obvious. MPEP 2144.06 (“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). Thus, one of ordinary skill in the art would have combined the therapies with optimized dosage and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 15, administering a dose and dose regimen would have been obvious to one of ordinary skill in the art. Regarding claims 17 and 18, the combined teaching of the art suggests oral administration twice daily separately and in combination simultaneously.
Regarding claims 19 and 20, as with claims 14 and 15 the combined teaching of the art suggests the claimed invention. Regarding claims 22 and 23, the combined teaching of the art suggests oral administration twice daily separately and in combination simultaneously.
Regarding claim 24, Herrmann teaches the combination of formula III with nintedanib (claim 6), but does not teach the specific oral dosage. As with claim 14, the combined teaching of the art reasonably suggested the claimed invention to one of ordinary skill in the art.
Regarding claims 25 and 26, Hermann teaches 100 or 150 mg nintendanib twice daily (p. 10). Regarding claims 27 and 28, the combined teaching of the art suggests oral administration twice daily separately and in combination simultaneously.
Regarding claim 24, Herrmann teaches treating IPF with the combination of formula III with nintedanib (claim 6), but does not teach the specific oral dosage. As with claim 14, the combined teaching of the art reasonably suggested the claimed invention to one of ordinary skill in the art.
Regarding claims 25 and 26, Hermann teaches 100 or 150 mg nintendanib twice daily (p. 10). Regarding claims 27 and 28, the combined teaching of the art suggests oral administration twice daily separately and in combination simultaneously.
Regarding claim 29, Herrmann teaches treating IPF with the combination of formula III with nintedanib (claim 6), but does not teach the specific oral dosage. As with claim 14, the combined teaching of the art reasonably suggested the claimed invention to one of ordinary skill in the art.
Regarding claims 30 and 31, Hermann teaches 100 or 150 mg nintendanib twice daily (p. 10). Regarding claims 32 and 33, the combined teaching of the art suggests oral administration twice daily separately and in combination simultaneously.
Claims 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Herrmann et al. (WO2019081235A1) in view of over Pouzet et al. (WO2013026797) as applied to claims 14-15, 17-20, 22-33 above and further in view of FDA-pirfenidone (FDA Label for Esbriet (pirfenidone), revised 07/2019, cited in IDS 11/7/2025).
Regarding claims 16 and 21, Herrmann and Pouzet do not teach the dosage of pirfenidone, however, FDA-pirfenidone teaches approved dosage within the scope of the instant claims that one of ordinary skill in the art would have considered and arrived at the claimed invention with a reasonable expectation of success.
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.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-10 of US 11406638 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) in combination with a second agent such that one of ordinary skill in the art would have reasonably considered the same combination and arrive at the claimed invention as detailed in the 35 USC 103 rejection above.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 11813266 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) in combination with a second agent such that one of ordinary skill in the art would have reasonably considered the same combination and arrive at the claimed invention as detailed in the 35 USC 103 rejection above.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-9 of U.S. Patent No. 11406638 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) in combination with a second agent such that one of ordinary skill in the art would have reasonably considered the same combination and arrive at the claimed invention as detailed in the 35 USC 103 rejection above.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9115142 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) when the claim genus is construed in view of the species of the specification such that one of ordinary skill in the art would have reasonably considered administering the same formulation.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9115142 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) when the claim genus is construed in view of the species of the specification such that one of ordinary skill in the art would have reasonably considered administering the same formulation.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-33 of U.S. Patent No. 8754073 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) when the claim genus is construed in view of the species of the specification such that one of ordinary skill in the art would have reasonably considered administering the same formulation.
Claims 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8604039 in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims treating the same disease with the same compound of formula (III) when the claim genus is construed in view of the species of the specification such that one of ordinary skill in the art would have reasonably considered administering the same formulation.
Claims 14-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 7-12 of copending Application No. 18585280 (reference application) in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application is to a method of treating the same disease with the same compound of formula (III) in combination with a second agent such that one of ordinary skill in the art would have reasonably considered the same combination and arrive at the claimed invention as detailed in the 35 USC 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 14-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18474419 (reference application) in view of Herrmann et.al. (WO2019081235), Pouzet et al. (WO2013026797), and FDA-pirfenidone. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application is to a method of treating the same disease with the same compound of formula (III) in combination with a second agent such that one of ordinary skill in the art would have reasonably considered the same combination and arrive at the claimed invention as detailed in the 35 USC 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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