DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 04/20/2026 has been entered. Claims 1-30 are cancelled. Claims 31-53 are new, are pending, and are currently under examination.
Priority
This application is a CON of 19/327,711 filed on 09/12/2025, now PAT 12605380, which is a CON of 19/070,739 filed on 03/04/2025, now PAT 12447148, and claims benefit of US PRO 63/711,648 filed on 10/24/2024, US PRO 63/649,067 filed on 05/17/2024, and US PRO 63/561,444 filed on 03/05/2024.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/561,444 or 63/649,067, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 31-53 recite “the improvement in lung function comprises one or more of the following: a reduction in extent of fibrosis, wherein the reduction in extent of fibrosis is a decrease from baseline in percent quantitative interstitial lung disease (%QILD)”, “the improvement in lung function is continuous during the period (or maintained or persists after the period) in which the subject is administered taladegib”, “the decrease from baseline in %QILD is at least -0.5%... or at least -9.0%”, “non-IPF progressive pulmonary fibrosis (PPF)”, “a total daily dose of taladegib of about 10-200 mg”, “administered to the subject for at least 4 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 20 weeks, at least 24 weeks, or longer”, and/or “the tablet comprises in percentage weight between 5 and 25% of taladegib, between 20 and 50% HPMCAS-H, between 15 and 45% mannitol, between 15 and 45% microcrystalline cellulose, between 1 and 5% croscarmellose sodium, between 0.5 and 5% silicon dioxide, between 0.5 and 5% sodium stearyl fumarate, and between 1 and 10% film coating”, which are not disclosed or supported by the prior-filed Application No. 63/561,444. Claims 31-53 also recite “an increase in lung volume, as quantified by deep learning model analysis of HRCT images; a reduction in pulmonary vascular volume, as quantified by deep learning model analysis of HRCT images; or a reduction in extent of fibrosis, as quantified by deep learning model analysis of HRCT images”, “the extent of increase in lung volume is at least 142.28 mL compared to placebo”, “the reduction in pulmonary vascular volume is at least -0.05 percentage points, at least -0.10 percentage points, at least -0.15 percentage points, at least -0.20 percentage points, or at least -0.25 percentage points compared to placebo”, and/or “the reduction in extent of fibrosis is at least 1.32% compared to placebo”, which are not disclosed or supported by the prior-filed Application No. 63/561,444 or 63/649,067. Thus, the priority date of claims 31-53 is 10/24/2024.
Information Disclosure Statement
Two information disclosure statement (IDS) filed on 04/20/2026 and 07/27/2026 have been considered.
Claim Objections
Claim 31 is objected to because of the following informalities: In claim 31, spell out the first abbreviated “HRCT” (line 9) to “high resolution computed tomography (HRCT)”. Appropriate correction is required.
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.
Claims 31-53 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 pre-AIA the applicant regards as the invention. Claims 32-53 depend from claim 31.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation “a reduction in extent of fibrosis, as quantified by deep learning model analysis of HRCT images” (lines 12 to 13), and the claim also recites “more of the following: a reduction in extent of fibrosis, wherein the reduction in extent of fibrosis is a decrease from baseline in percent quantitative interstitial lung disease (%QILD)” (lines 5-7) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The “more of the following” (line 5) would require both above broad and narrow recitations because %QILD is also measured by HRCT according to the Goldin, J. et al., 2018 provided in the IDS filed on 04/20/2026. Applicant is advised to connect the first and fourth bullets with conjunction “or”; to delete the recitation “; or” at the end of the third bullet; and to insert the conjunction “and” at the end of the second bullet.
Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(I) Claims 31-35 and 42-53 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Maher et al. (Endeavor BioMedicines, Poster presentation, A1056, American Thoracic Society, May 2024, referred to as Maher ‘2024, also listed in IDS filed on 04/20/2026) as evidenced by de los Rios et al. (US 2022/0265650, Aug. 25 , 2022, Applicant: Endeavor Biomedicines, Inc., referred to as Rios ‘650, also listed in IDS filed on 04/20/2026).
With regard to structural limitations “a method comprising administering taladegib (or a total daily dose of about 10-200 mg, 100-200 mg, or about 200 mg; or unit dose of about 25 mg, about 50 mg, about 100 mg, or about 200 mg; or once a day; or for at least 4 weeks; or as a tablet) to a subject suffering from or diagnosed with pulmonary fibrosis (or idiopathic pulmonary fibrosis, IPF) according to a treatment regimen that improves lung function in the subject, wherein the improvement in lung function comprises one or more of the following: a reduction in extent of fibrosis, wherein the reduction in extent of fibrosis is a decrease from baseline in percent quantitative interstitial lung disease (%QILD; or at least -0.5%)” (claims 31-35 and 42-51), and “the tablet comprises in percentage weight between 5 and 25% of taladegib, between 20 and 50% hydroxypropylmethylcellulose acetate succinate (HPMCAS-H), between 15 and 45% mannitol, between 15 and 45% microcrystalline cellulose, between 1 and 5% croscarmellose sodium, between 0.5 and 5% silicon dioxide, between 0.5 and 5% sodium stearyl fumarate, and between 1 and 10% film coating” (claims 52 and 53):
Maher ‘2024 disclosed A Phase 2a Randomized, Double-blind, Multicenter, Placebo-controlled 12-week Trial in Patients with idiopathic pulmonary fibrosis (IPF):
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. Treatment with ENV-101 Increased Total Lung Capacity by HRCT. Treatment with ENV-101 led to an ~8% increase from baseline in total lung volume in 3 months ENV-101 Treatment Led to Reduction of Interstitial Lung Disease and Lung Fibrosis by HRCT at Week 12:
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(1-page poster). Rios ‘650 (cited here as evidence only for tablet formulation) disclosed a Phase 2, Multi-Center Study Evaluating the Safety and Efficacy of Taladegib in subjects with IPF. Patients diagnosed with IPF are randomized in to taladegib and placebo groups. Baseline results from lung function tests (FVC , FEV1 and DLco), HRCT , and the UCSD Shortness of Breath (SOB) questionnaire are obtained. Taladegib is administered daily for 12 weeks, starting at 200 mg/day (page 13/15, [0070]). In some embodiments, the herein disclosed compounds of can be formulated as tablets containing 50 or 100 mg of the compound and the common pharmaceutical ingredients. One particular embodiment contains 16.1% taladegib, 37.6% HPMCAS-H, 9.3% mannitol, 28.6% microcrystalline cellulose, 2.9% croscarmellose sodium, 1.0% silicon dioxide, 1.2% sodium stearyl fumarate, and 3.4% Opadry (Film Coating) (page 9/15, [0032]).
Thus, these teachings of Maher ‘2024 as evidenced by Rios ‘650 anticipate Applicant’s claims 31-35 and 42-53 because (a) the same determinations of lung function were carried out and the effective amount to improve lung function was disclosed, and (b) the same HRCT imaging was performed and the %QILD was measured. The required 15 to 45% mannitol is obvious to skilled artisan and is optimizable because Rios ‘650 disclosed mannitol is a common pharmaceutical ingredient or excipient. The method of Maher ‘2024 as evidenced by Rios ‘650 meets all structural limitation of claimed method, and thus would achieve the same intended results, including “the decrease from baseline in %QILD is at least -0.5%... or at least -9.0%”, required by claims 35.
(II) Claims 31 and 36-41 are rejected under 35 U.S.C. 103 as being unpatentable over Maher et al. (Endeavor BioMedicines, Poster presentation, A1056, American Thoracic Society, May 2024, referred to as Maher ‘2024, also listed in IDS filed on 04/20/2026) as evidenced by de los Rios et al. (US 2022/0265650, Aug. 25 , 2022, Applicant: Endeavor Biomedicines, Inc., referred to as Rios ‘650, also listed in IDS filed on 04/20/2026), as applied to claims 31-35 and 42-53 above, and further in view of Walsh et al. (Am J Respir Crit Care Med Vol 206, Iss 7, pp 883–891, Oct 1, 2022, hereinafter referred to as Walsh ‘2022). The above disclosures of Maher ‘2024 as evidenced by Rios ‘650 are incorporated in their entirety here.
Maher ‘2024 as evidenced by Rios ‘650 did not explicitly disclose the limitations “an increase in lung volume, as quantified by deep learning model analysis of HRCT images (or at least 142.28 mL compared to placebo)”, “a reduction in pulmonary vascular volume, as quantified by deep learning model analysis of HRCT images (or at least -0.05 percentage points compared to placebo), “a reduction in extent of fibrosis, as quantified by deep learning model analysis of HRCT images (or at least 1.32% compared to placebo)”, required by claims 31 and 36-41.
Walsh ‘2022 disclosed that reliable outcome prediction in patients with fibrotic lung disease using baseline high-resolution computed tomography (HRCT) data remains challenging. Deep learning–based UIP probability (SOFIA [Systematic Objective Fibrotic Imaging Analysis Algorithm], trained and validated in the identification of usual interstitial pneumonia (UIP)-like features) on HRCT provides enhanced outcome prediction in patients with progressive fibrotic lung disease when compared with expert radiologist evaluation or guideline-based histologic pattern. In principle, this tool may be useful in multidisciplinary characterization of fibrotic lung disease, including using total interstitial lung disease [ILD] extent on HRCT. Likewise, subtle vascular volume abnormalities and lung volume shrinkage may also be incorporated into SOFIA’s output predictions (page 883, Abstract; page 890, right col., para. 1),
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the subjective measurements of lung capacity and/or extent of fibrosis as taught by Maher ‘2024 evidenced by Rios ‘650 with deep-learning algorithm for measuring extent of fibrosis, lung volume, and/or vascular volume, further in view of Walsh ‘2022, to enhance outcome prediction in patients with progressive fibrotic lung disease when compared with expert radiologist evaluation or guideline-based histologic pattern, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the subjective measurements of lung capacity and/or extent of fibrosis as taught by Maher ‘2024 evidenced by Rios ‘650 with deep-learning algorithm for measuring extent of fibrosis, lung volume, and/or vascular volume, further in view of Walsh ‘2022, one would achieve Applicant’s claims 31 and 36-41. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
