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 18/063,190 (12/08/2022 ABN)
18/063,190 has PRO 63/287,642 (12/09/2021),
and claims foreign priority to EP 21218202.6 (12/29/2021)
EP 22177750.1 (06/08/2022).
Claim Interpretation
During examination, a claim must be given its broadest reasonable interpretation consistent with the specification as it would be interpreted by one of ordinary skill in the art. MPEP § 2173.01(I); § 2111.01. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. MPEP § 2173.01(I).
Claim 1 is as follows (emphasis added):
1. A method of treating a patient suffering from a progressive fibrosing interstitial lung disease (PF-ILD) comprising the step of administering to said patient twice daily 18 mg of the PDE4B-inhibitor of formula III
. . .
as the only active agent.
It is noted that the claim is a “method … comprising …” where comprising is a term of art that is open-ended as detailed in MPEP 2111.03:
The transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) (“The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps.”); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp.v.CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); …
Thus, the claim is interpreted using the BRI which includes a method comprising administering Formula III as the only active agent and also comprising the additional step of administering other agents. Such an interpretation is also consistent with the specification’s description of formula III in combination with other agents, i.e. Specification pages 15 and 19, formula III and a therapeutically effective dose of nintedanib and formula III and a therapeutically effective amount of pirfenidone.
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 1-2, 4-5, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pouzet et al. WO2013026797 (“Pouzet”).
The claims are directed to (per independent claim 1) a method of treating a patient suffering from a progressive fibrosing interstitial lung disease (PF-ILD) comprising the step of administering to said patient twice daily 18 mg of the PDE4B-inhibitor of formula III. Progressive fibrosing interstitial lung diseases (PF-ILD) consist of a diverse group of interstitial lung diseases (ILD) characterized by a similar clinical phenotype of accelerated respiratory failure, frequent disease exacerbation and earlier mortality. The instant specification states that idiopathic pulmonary fibrosis (IPF) is a type of PF-ILD (i.e., page 6, 11).
Pouzet 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 the aforementioned compounds according to at least one of formulas I, II or III to a patient in need thereof. Pouzet at page 12, 4th paragraph. Pouzet further teaches a method of treating a disease which is selected from the group consisting of COPD, chronic sinusitis, idiopathic pulmonary fibrosis, alpha 1 antitrypsin deficiency, asthma and chronic bronchitis, comprising the step of administering one of the aforementioned compounds according to at least one of formulas I, II or III to a patient in need thereof. Pouzet at page 14, 3rd paragraph.
Pouzet teaches compounds according of one of formula I, II or III (where formula III is a racemic mixture of the claimed compound), wherein the S* represents a sulphur atom, which represents a chiral center being in the R-configuration. Pouzet at page 4. Thus, Pouzet is considered to specifically teach administration of the following compound:
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to treat a disease which can be treated by the inhibition of the PDE4-enzyme, including the specific disease of idiopathic pulmonary fibrosis. Pouzet at page 4; Id. at page 12, 4th paragraph.
Pouzet teaches that the compound of formula III/Example 2 (as a racemic mixture) is a PDE4B inhibitor with an IC50 of 7.2 nM. Pouzet at page 44, Table C. Pouzet teaches that the compound of formula III/Example 2 has an in vivo ED50 of 0.1 mg/kg body weight for the inhibition of LPS-induced neutrophil influx into bronchoalveolar lavage fluid of male Wistar rats. Pouzet at page 45-47 and Table E. Pouzet teaches that rats take 30-fold ED50 dose of the compound of formula III/Example 2 (3 mg/kg, p.o.) do not show relevant gastrointestinal side effects. Pouzet at page 49-51. Pouzet teaches that the rats for study weights 130-160 g. Pouzet at page 49, last paragraph, line 3.
Pouzet further teaches the compound of formula III/Example 2 may be administered orally in the form of a tablet, as a powder, as a powder in a capsule. Pouzet at page 74, last paragraph, line 1-2. Pouzet teaches administration as a coated tablet and 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.
Pouzet therefore teaches each and every element of claim 1 except the claim 1 dosage of 18 mg.
One of ordinary skill in the art following the teaching of 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 and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 2 and 4, Pouzet teaches twice daily oral administration of a coated tablet (p. 75).
Regarding claim 5, as with claim 1, one of ordinary skill in the art following Pouzet would have considered treating PF-ILD in the same manner and arrive at the claimed invention.
Regarding claim 7, Pouzet teaches twice daily oral administration of a coated tablet (p. 75).
Regarding claim 8, as with claim 1, Pouzet teaches treating IPF and one of ordinary skill in the art following Pouzet would have considered treating IPF in the same manner and arrive at the claimed invention.
Regarding claims 9 and 10, Pouzet teaches twice daily oral administration of a coated tablet (p. 75).
Regarding claim 11, as with claim 1, Pouzet teaches treating IPF by administering the same compound twice daily and one of ordinary skill in the art following Pouzet would have considered treating IPF in the same manner with an optimized formulated amount and arrive at the claimed invention.
Regarding claim 12, Pouzet teaches oral administration of a coated tablet (p. 75).
With each of the 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 elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date 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 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-7 of U.S. Patent No. 11813266. 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 each of the therapeutics to be effective individually.
Claims 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-9 of U.S. Patent No. 11406638. 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 each of the therapeutics to be effective individually.
Claims 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9115142. 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 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9115142. 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 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 32-33 of U.S. Patent No. 8754073. 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 1-2, 4-5, 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8604039. 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 1-2, 4-5, 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-33 of copending Application No. 18589552 (reference application). 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 each of the therapeutics to be effective individually.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-5, 7-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18474419 (reference application). 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 each of the therapeutics to be effective individually.
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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