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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 30, 2025 has been entered.
Priority
This application is a continuation of U.S. Application No. 18/087,672, filed on December 22, 2022, now issued as U.S. Patent No. 11,975,005, which is a continuation of U.S. Application No. 16/917,581, filed on June 30, 2020, now issued as U.S. Patent No. 11,564,925, which is a continuation of U.S. Application No. 15/559,360, filed on September 18, 2017, now issued as U.S. Patent No. 10,722,513, which is a §371 national phase of International Application No. PCT/AU2016/050209, filed on March 23, 2016, which claims priority to foreign Application No. AU2015901032, filed on March 23, 2015.
eTerminal Disclaimers
Acknowledgement is made of the eTDs filed over U.S. Patent Nos. 11,564,925; 11,975,005; and 10,722,513 on January 21, 2025.
Status of Claims
Claims 39-49 are pending in instant application.
Response to Arguments
In light of amendments filed October 30, 2025, the rejection of claim 39 under 35 U.S.C. 103 as being unpatentable over US 2013/0115309 A1 and Hall et. al. is hereby withdrawn.
Applicant's arguments filed October 30, 2025 have been fully considered but they are not persuasive.
Applicant argues that the amended claims now read “glucocorticoid-resistant pulmonary fibrosis”, and that the specification supports the unexpected discovery of PF-670462 as a treatment (see 10/30/25 Remarks at p. 5). Applicant further states PF-670462 is superior to other casein kinase inhibitors (see 10/30/25 Remarks at p. 9 Table 1).
The Examiner disagrees. As mentioned in the previous Office Action (see Final at p. 3 ¶1-3), the CK1 activity of PF-670462 is not necessarily relevant since PF-670462 is obvious in light of structurally similar p38 inhibitor SB-39063 for treating pulmonary fibrosis. The data with respect to CK inhibitors is also not persuasive because Applicant has not compared the instant invention to the closest prior art, which would be comparing the p38 inhibitory activity of PF-670462 to SB-39063. Furthermore, the new teachings of Irusen et. al. shows that treatment with p38 inhibitors reverse glucocorticoid resistance (see Irusen at p. 656 right col. ¶3), providing a motivation for one skilled in the art to treat a glucocorticoid-resistant pulmonary fibrosis with a p38 inhibitor.
Absent unexpected results showing:
PF-670462 does not inhibit p38 and cannot be considered a p38 inhibitor, and/or
PF-670462 is superior to other p38 inhibitors (such as SB-39063) in enhancing glucocorticoid efficacy,
the instant invention cannot be considered novel.
Maintained/Modified Rejections
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.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Underwood et. al.1 in view of Walton et. al.2 and Irusen et. al.3
Regarding treating pulmonary fibrosis, Underwood teaches trans-1-(4-hydroxycyclohexyl)-4-(4-fluoro-phenyl)-5-(2-methoxypyridimidin-4-yl)imidazole, SB 39063 (CAS Registry No. 193551-21-2) as a p38 inhibitor that reduces pulmonary fibrosis (see Underwood at Title and p. L895 left col. lines 4-15).
Regarding instant CAS# 950980-98-0, Walton teaches the instantly claimed compound, PF-670462 (CAS Registry No. 950980-98-0) is a p38 inhibitor (see Walton at p. 433 Figure 1 and p. 434 Table 2).
Instant and Walton
PF-670462 (CAS# 950980-98-0)
Underwood
SB 39063 (CAS# 193551-21-2)
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The prior art differs from the instant claims as follows: While Underwood teaches CAS# 193551-21-2 as a p38 inhibitor for treating pulmonary fibrosis and Walton teaches instantly claimed CAS#950980-98-0 as a p38 inhibitor, the prior art does not teach CAS#950980-98-0 as a treatment for glucocorticoid-resistant pulmonary fibrosis or specify administration embodiments.
However,
Regarding pulmonary fibrosis, Underwood teaches p38 inhibitors treat pulmonary fibrosis (see Underwood at p. L900 “Discussion”).
Regarding glucocorticoid-resistance, Irusen teaches administering p38 inhibitor SB203580 to asthmatic subjects blocked the suppression response to dexamethasone (see Irusen at p. 656 left col. ¶3). Irusen teaches p38 inhibitors have potential in reversing glucocorticoid insensitivity and reestablishing the beneficial effects of glucocorticoids (see Irusen at p. 649 “Conclusion”), and that p38 inhibitors can act as anti-inflammatory agents in their right (see Irusen at p. 656 right col. ¶3).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. Substituting a structurally similar p38 inhibitor (instant CAS# 950980-98-0 taught by Walton) for another p38 inhibitor (Underwood’s CAS# 193551-21-2) for treating pulmonary fibrosis would have been obvious because the compounds were both known in the art to function as p38 inhibitors (as taught by Underwood and Walton), and p38 inhibitors are known in the art to treat pulmonary fibrosis (as taught by Underwood) (see MPEP § 2143(I)(B), (G), 2144.09(I)). In addition, treating a glucocorticoid-resistant disease such as glucocorticoid-resistant pulmonary fibrosis with a p38 inhibitor would have been obvious because the prior art teaches p38 inhibitors reverse glucocorticoid resistance (as taught by Irusen) (see MPEP§ 2143(I)(G)).
Furthermore, it is well-within the ordinary skill in art to substitute one known p38 inhibitor for another known, structurally similar, p38 inhibitor for use the same purpose as taught by the prior art (treating pulmonary fibrosis).
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims 39, 46, 48-49 are obvious over Underwood in view of Walton and Irusen.
Claims 40-42, 45 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood, Walton, and Irusen as applied to claims 39 above and in further view of LiPing et. al.4
Underwood, Walton, and Irusen differ from claims 40-42 and 45 as follows: While Underwood and Walton teach p38 inhibitors for treating glucocorticoid-resistant pulmonary fibrosis, Underwood, Walton, and Irusen do not teach additionally administrating a glucocorticoid.
However,
Regarding administrating a glucocorticoid to treat idiopathic pulmonary fibrosis, LiPing teaches administrating the glucocorticoid budesonide alone or in combination with prednisone to treat idiopathic pulmonary fibrosis (see LiPing at Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. In addition or in the alternative, per MPEP § 2144.06(I), 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. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to combine two known treatments for pulmonary fibrosis (a p38 inhibitor as taught by Underwood and Walton, a glucocorticoid as taught by LiPing) to treat pulmonary fibrosis.
Furthermore, it is well-within the ordinary skill in art utilize known administration routes of a structurally similar p38 inhibitor for another known p38 inhibitor.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims 40-42 and 45 are obvious over Underwood in view of Walton and Irusen in further view of LiPing.
Claims 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood, Walton, and Irusen as applied to claims 39 above and in further view of Wollin et. al.5
Underwood, Walton, and Irusen differ from claims as follows: While Underwood, Walton, and Irusen teach p38 inhibitors for treating glucocorticoid-resistant pulmonary fibrosis, Underwood, Walton, and Irusen do not teach additionally administrating an anti-fibrotic compound.
Regarding administrating an anti-fibrotic compound to treat pulmonary fibrosis, Wollin teaches the anti-fibrotic nintedanib is a treatment of idiopathic pulmonary fibrosis (see Wollin at Abstract).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. In addition or in the alternative, per MPEP § 2144.06(I), 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. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been obvious to combine two known treatments for pulmonary fibrosis (a p38 inhibitor as taught by Underwood and Walton, an anti-fibrotic as taught by Wollin) to treat pulmonary fibrosis.
Furthermore, it is well-within the ordinary skill in art utilize known administration routes of a structurally similar p38 inhibitor for another known p38 inhibitor.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims are obvious over Underwood in view of Walton and Irusen in further view of Wollin.
Claims 46, 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood, Walton, and Irusen as applied to claims 39 above and in further view of US 2002/0151491 A16
Underwood, Walton, and Irusen differ from claims 46, 48-49 as follows: While Underwood, Walton, and Irusen teach p38 inhibitors for treating glucocorticoid-resistant pulmonary fibrosis, Underwood, Walton, and Irusen do not teach routes of administration.
However,
Regarding claim 46 and inhalation and claims 48-49 and oral administration, US’491 teaches p38 inhibitor SB220025 CAS Registry No. 165806-53-1 with an amine pyrimidine substituent (see US’491 claim 4), with embodiments of treatment including COPD (see US’491 at p. 2 [0015]) and administering via inhalation, ear drops, transtympanically, intramuscularly, intravenously, and by mouth (see US’491 at claim 7).
Instant and Walton
PF-670462 (CAS# 950980-98-0)
US’491
SB220025
CAS# 165806-53-1
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Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. Since p38 inhibitors are known to treat pulmonary fibrosis (as taught by Underwood), it would have been obvious to one skilled in the art to use known administration routes of a structurally similar p38 inhibitor (as taught by US’491) when treating a patient with a p38 inhibitor (as taught by Walton).
Furthermore, it is well-within the ordinary skill in art utilize known administration routes of a structurally similar p38 inhibitor for another known p38 inhibitor.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claims 46, 48-49 are obvious over Underwood in view of Walton and Irusen in further view of US’491.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Underwood, Walton, and Irusen as applied to claims 39 above and in further view of WO 99/014527.
Underwood, Walton, and Irusen differ from claim 47 as follows: While Underwood, Walton, and Irusen teach p38 inhibitors for treating glucocorticoid-resistant pulmonary fibrosis, Underwood, Walton, and Irusen do not teach routes of administration.
However,
Regarding claim 47 and administration as an aerosol, WO’452 teaches cytokine suppressive anti-inflammatory CSMP/RK/p38 kinase inhibitors (see WO’452 at p. 5 lines 25-35) including CAS Registry No. 219831-11-5. WO’452 teaches aerosol formulation or metered inhaler administration of the disclosed compounds (see US’452 at p. 58 lines 2-4), used for treating CSMP/RK/p38 kinase mediate diseases.
Instant and Walton
PF-670462 (CAS# 950980-98-0)
WO’452
Example 12
CAS# 219831-11-5
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Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention or otherwise at the time the invention was made, to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
Per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. Since p38 inhibitors are known to treat pulmonary fibrosis (as taught by Underwood), it would have been obvious to one skilled in the art to use known administration routes of a structurally similar p38 inhibitor (as taught by WO’452) when treating a patient with a p38 inhibitor (as taught by Walton).
Furthermore, it is well-within the ordinary skill in art utilize known administration routes of a structurally similar p38 inhibitor for another known p38 inhibitor.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Accordingly, claim 47 is obvious over Underwood in view of Walton and Irusen in further view of WO’452.
Conclusion
Claims 39-49 are rejected.
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/S.R./Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Underwood et. al. "SB 239063, a p38 MAPK inhibitor, reduces neutrophilia, inflammatory cytokines, MMP-9, and fibrosis in lung" American Journal of Physiology-Lung Cellular and Molecular Physiology, 2000, 279, 5, L895-L902 DOI: 10.1152/ajplung.2000.279.5.L895. Hereinafter Underwood.
2 Walton et. al. "Selective Inhibition of Casein Kinase 1ϵ Minimally Alters Circadian Clock Period" The Journal of Pharmacology and Experimental Therapeutics 2009, 330, 2, 430-439. DOI: 10.1124/jpet.109.151415. Hereinafter Walton.
3 Irusen et. al. "p38 Mitogen-activated protein kinase–induced glucocorticoid receptor phosphorylation reduces its activity: Role in steroid-insensitive asthma" JACI, 2002, 109, 4, 649-657. DOI: 10.1067/mai.2002.122465. Hereinafter Irusen.
4 LiPing et. al. "Budesonide inhalation for patients with idiopathic pulmonary fibrosis: a systematic review" Progress in Modern Biomedicine, 2010, 10, 17, 3312-3315. Abstract Only. Hereinafter LiPing.
5 Wollin et. al. "Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis" European Respiratory Journal 2015, 45, 5 1434-1445. DOI: 10.1183/09031936.00174914. First published online March 5, 2015. Hereinafter Wollin.
6 Filed November 27, 2001 and published October 17, 2002. Hereinafter US’491.
7 Filed July 1, 1998 and published January 14, 1999. Hereinafter WO’452.