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 .
DETAILED ACTION
This office action is in reply to Applicant’s Arguments/Remarks filed 11 May 2026 for application 18/583,392 filed on 21 February 2024 with PRO 63/486,086 filed on 21 February 2023. Claims 12 and 16 are amended. Currently, claims 1-19 are pending.
Election/Restrictions
Applicant’s election, without traverse, of the laforin inhibitor recited in claim 5, illustrated below, is acknowledged:
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Applicant’s election of Miglustat, recited in claim 9 and illustrated below, is acknowledged:
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Applicant’s election of the glycogen synthase inhibitor recited in claim 13, illustrated below, is acknowledged:
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Applicant’s election of the glycogen phosphorylase inhibitor recited in claim 16, illustrated below, is acknowledged:
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Claims 6-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention or species, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nakamura et al. (Therapeutic agent for fibrosis and inhibitor of nuclear translocation of phosphorylated Smad, US 2018/0008585 A1, 2018).
Nakamura discloses Miglustat for use as a therapeutic agent for fibrosis by inhibiting the nuclear translocation of phosphorylated Smad (para. 0028). Miglustat is a GAA inhibitor.
As such, claim 1 is anticipated by Nakamura.
Regarding the limitation of claim 8, wherein the compound is the GAA inhibitor, is met as Nakamura discloses GAA inhibitor Miglustat for treating idiopathic pulmonary fibrosis.
Concerning the limitation of claim 9, wherein the GAA inhibitor is selected from the group consisting of acarbose, miglitol, voglibose, castanospermine, miglustat, and 1-deoxynojirimycin, is met as Nakamura discloses GAA inhibitor Miglustat for treating idiopathic pulmonary fibrosis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 non-obviousness.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. (Therapeutic agent for fibrosis and inhibitor of nuclear translocation of phosphorylated Smad, US 2018/0008585 A1, 2018) in view of Zhang et al. (Small molecule inhibitors of protein tyrosine phosphatases and used thereof, US 2018/0170861 A1, 2018) and Downey et al. (Protein tyrosine phosphatase-alpha (PTPα) promotes profibrotic responses in lung fibroblasts, Eur. Respiratory J. 2017, 50: PA3474).
Nakamura discloses the use of Miglustat for treating idiopathic pulmonary fibrosis.
They do not, however, disclose a glycogen phosphatase inhibitor for the purpose of treating pulmonary fibrosis.
Zhang rectifies this deficiency as they disclose the compound L319-21-M50 as a protein tyrosine phosphatase inhibitor (pg. 44 – Table 2):
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Zhang does not, however, teach the use of L319-21-M50 in treating pulmonary fibrosis.
Downey teaches mice genetically deficient in protein tyrosine phosphatase-alpha (PTPα) were protected from pulmonary fibrosis in experimental models (abstract). It stands to reason then that the same effect can be achieved pharmacologically.
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of L319-21-M50 as disclosed by Zhang for the pharmacological treatment of pulmonary fibrosis based on the in vivo result taught by Downey.
Claims 1 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Hoover et al. (Use of glycogen phosphorylase inhibitor for reducing non-cardiac tissue damage resulting from ischemia, EP 0846464 A2, 1998).
Nakamura discloses the use of Miglustat for treating idiopathic pulmonary fibrosis.
They do not, however disclose a glycogen phosphatase inhibitor for the purpose of treating pulmonary fibrosis.
Hoover addresses this by disclosing 5-chloro-1H-indole-2-carboxylic acid [(1S)-((R)-hydroxy-dimethylcarbamoyl-methyl)-2-phenyl-ethyl]-amide as a glycogen phosphorylase (GP) inhibitor (pg. 52 – line 14) for the use of reducing non-cardiac tissue damage resulting from ischemia or hypoxia including lung tissue (pg. 15 – line 28):
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As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the use of 5-chloro-1H-indole-2-carboxylic acid [(1S)-((R)-hydroxy-dimethylcarbamoyl-methyl)-2-phenyl-ethyl]-amide in treating pulmonary fibrosis as it is purposed for reducing tissue damage from ischemia or hypoxia, of which lung tissue afflicted by pulmonary fibrosis experiences hypoxia due to poor gas exchange.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura in view of Lederer et al. (Idiopathic pulmonary fibrosis, NEJM 2018, 378, 1811-1823).
Nakamura discloses the use of Miglustat for treating idiopathic pulmonary fibrosis.
They do not, however, teach wherein the subject is identified as being at risk for PF.
Lederer overcomes this obstacle by teaching the clinical presentation of pulmonary fibrosis along with other interstitial lung diseases and means to characterize patients including spirometry, chest radiographs, and computed tomography (CT) scans (pgs. 1811-1812 – clinical presentation; pg. 1813 – table 1).
As such, it would be prima facie obvious, to a person of ordinary skill in the art, before the effective filing date, to consider the presentations and means to characterize patients suffering from pulmonary fibrosis or other interstitial lung diseases using the teachings of Lederer.
Regarding the limitation of claim 18, wherein the subject is identified as having PF, is met as Lederer describes characterizations of an individual with fibrosis including reticulation, short irregular, linear opacities on CT, or traction bronchiectasis, dilated bronchi on CT due to peripheral retraction resulting from lung fibrosis (pg. 1812 – glossary). They further specify considerations to be kept in mind after the history and physical examination suggest interstitial lung disease (pg. 1813 – diagnosis).
Concerning the limitation of claim 19, wherein the subject has a history of at least one of smoking and a family history of PF, is met as Lederer teaches non-genetic risk factors such as cigarette smoking and (pg. 1813) and genetic mutations associated with idiopathic PF including TERT, TERC, PARN, and RTEL1 (pg. 1812).
Allowable Subject Matter
Claims 10-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons For Allowance
The following is an examiner’s statement of reasons for allowance: the elected species of glycogen synthase inhibitor in claim 13 is reported in the prior art in 100% by Morgans et al. (Inhibitors of glycogen synthase 1 (GYS1) and methods of use thereof, WO 2022/198196 A1, 2022) who discloses compound 19 as a glycogen synthase 1 (GYS1) inhibitor (pg. 458 – Table T1):
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They do not, however, teach the use of compound 19 in treating pulmonary fibrosis. No apparent connection was found in the prior art relating the inhibition of GYS1 and the treatment of pulmonary fibrosis. Jeffers et al. (Glycogen synthase kinase-3β inhibition with 9-ING-41 attenuates the progression of pulmonary fibrosis, Scientific Reports 2019, 9, 18925) reports that inhibition of GSK-3β appears to be an efficacious method of treating pulmonary fibrosis by controlling fibroblast-myofibroblast differentiation. However, GSK-3β appears to control expression of GYS1, without evidence of the reverse being found. As such, no relationship between pharmacological inhibition of GYS1 and pulmonary fibrosis treatment was found or was obvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Summary
Claims 1 and 8-9 are rejected under 35 U.S.C. 102(a)(2). Claims 1-5 and 15-19 are rejected under 35 U.S.C. 103. Claims 6-7 are withdrawn. Claims 10-14 are objected to as being dependent upon a rejected claim basis.
Conclusion
Claims 1-9 and 15-19 are rejected. Claims 10-14 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allen Chao whose telephone number is (571)272-7001. The examiner can normally be reached Monday - Friday 0700-1300.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN CHAO/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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