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 .
Status of Claims
Claims 1 and 3-14 are pending as of the response and amendments filed on 7/21/25. Claims 2 and 15-17 have been canceled.
The rejection of claims 2-3 under 35 USC 112(b) is withdrawn in consideration of the amendments.
The rejection of claims 1, 4-9, and 11-17 under 102(a)(1) as being anticipated by Kaminski, WO 2015191841 as evidenced by Nguyen is withdrawn in consideration of the amendments.
The rejection of claim 15 under 35 USC 102(a)(1) as being anticipated by Schwartz, WO 03049685 is withdrawn as this claim has been canceled.
The rejection of claim 16 under 35 USC 103 as being unpatentable over Schwartz is withdrawn as this claim has been canceled. The rejection of claim 17 under 103 as being unpatentable over Schwartz in view of Zhang, CN 103800325 is withdrawn as this claim has been canceled.
The rejection under 102(a)(2) over Lian, WO 2018226604, is withdrawn in consideration of the amendments.
Applicants’ reasons for traversal with respect to the 103 rejection over Lian are summarized and addressed below.
Applicants have argued Lian fails to render the features of claim 1 obvious, arguing Lian is silent as to any of the listed TR beta-agonists listed in amended claim 1 and fails to provide any suggestion or motivation to use the TR beta-agonists listed in amended claim 1 to treat or ameliorate a fibrotic lung disease. Applicants have argued one of ordinary skill in the art would have understood Lian only hypothesized the TR beta-agonists could treat pulmonary fibrosis, and at most generally and broadly asserts the agonists could be used to treat fibrotic diseases in general. Applicants have argued pulmonary fibrosis is merely mentioned within a long and extensive laundry list of fibrotic conditions, and Lian fails to demonstrate treatment of any fibrotic disease, and thus there is no reasonable expectation a compound useful for treating one type of fibrotic disease would be useful for treating all types of fibrotic disease. Applicants have maintained Lian fails to provide an actual working example of treating any fibrotic lung disease with TR beta-agonists, as one of ordinary skill in the art would have understood Lian’s description of treating pulmonary fibrosis in guinea pigs as a prophetic example. Applicants have further submitted Lian’s example 2 merely describes administering the compounds “as appropriate for its formulation, daily or as appropriate, for 6-10 weeks” but doesn’t teach a specific and appropriate formulation, dosage, or route of administration to achieve the desired therapeutic effect.
Applicants’ arguments have been fully considered but they are not persuasive. As discussed in the previous office action, in addition to compounds 1-4 that are exemplified by Lian for treating pulmonary fibrosis, other suitable TR beta agonists include GC-1, which is recited in amended claim 1. Regarding Applicants’ assertion Example 2 is merely a prophetic example, the examiner maintains the 35 USC § 103 statute doesn’t require the prior art to show an actual reduction to practice the render the claims prima facie obvious. Lian exemplifies pulmonary fibrosis as a fibrotic disease to be treated with TR beta-agonists (Ex. 2, para [0090]), and includes GC-1 as one of the therapeutic TR beta agonists (p. 28, compound number 17). The examiner maintains that one of ordinary skill in the art, in consideration of Lian would have found it prima facie obvious to have arrived at the claimed method of treating a fibrotic lung disease comprising administering to the subject a therapeutically effective amount of the elected TR beta agonist, GC-1. The examiner is not persuaded by Applicants’ arguments Lian doesn’t teach a specific and appropriate formulation, dosage, or route of administration to achieve the desired therapeutic effect, as Lian clearly teaches a dose range of TR beta agonist, as well as administration regimen (para [0077], [0079]). Moreover, it is noted most of Applicants’ claims don’t recite a specific formulation, dosage, or route of administration-see claims 1, 3-8, and 13-14. The 103 rejection of record over Lian is maintained for the reasons just discussed as well as those of record. This rejection is modified slightly to account for the amended claims. Additionally, a new 103 rejection over Lian in view of von Nussbaum, US 20140045802 is made upon consideration of the claims, and as von Nussbaum was cited in the IDS filed on 5/7/25.
Claims 1-17 were previously rejected for nonstatutory double patenting over claims 1-22 of US 11660281 in view of Kaminski. The rejection over claims 2 and 15-17 is withdrawn as these claims have been canceled. In the response filed on 7/21/25, Applicants have requested this rejection be held in abeyance until the prior art rejections are resolved. The nonstatutory double patenting rejection is maintained for reasons of record and modified slightly to account for the amended claims.
Claims 1 and 3-14 were examined and are rejected.
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.
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.
Claim(s) 1, 3-8, 10-11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian et. al., WO 2018226604 A1, publ. 12/13/2018, international filing date 6/4/2018, provisional appl. 62515421 filing date of 6/5/2017 (provides support to claimed subject matter described below).
Lian discloses the treatment of fibrotic conditions by administration of thyroid receptor beta (TRβ) agonists (title & abstract; para [0001]). Lian further discloses treatment of pulmonary fibrosis in a guinea pig disease model by administration of a TRβ agonist selected from compounds 1-4, shown below, once daily in a formulation for 6-10 weeks decreased the fibrosis score (p. 27, para [0052]; p. 64, para [0090]):
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. As Lian doesn’t disclose administration of an additional agent to treat pulmonary fibrosis in para [0090], this meets the claim limitation of the TRβ agonist being the only pharmaceutically active agent administered to the subject as recited in claim 5. As Lian discloses administration of a TRβ agonist ameliorated symptoms of pulmonary fibrosis in the guinea pigs, this meets the limitation of administration of a therapeutically effective amount of a TRβ agonist, thereby meeting the limitations of instant claims 1 and 6. Lian further discloses administration of the TRβ agonist orally, intravenously, nasally, pulmonary, and topically (para [0015]). Additionally, Lian discloses treatment of idiopathic pulmonary fibrosis within a list of 7 conditions (para [0014]); as one of ordinary skill in the art would have immediately envisaged treatment of idiopathic pulmonary fibrosis by administering a TRβ agonist from this passage in Lian. Regarding instant claim 10, “wherein administration of the at least one TRβ agonist does not cause significant or undesirable cardiac stimulation, weight loss, or blood lipid decrease in the subject”, as Lian discloses treatment of the same patient population with the same active agent, it would have been reasonably expected that the effect of treatment would have been the same as recited in claim 10. See MPEP 2112.02 (II): “The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957).
Additionally, Lian teaches additional TRβ agonists to include the following compound (para [0053], in particular compound 17 on p. 28):
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. This compound is structurally identical to Applicants’ elected species, GC-1. Lian further teaches administration of a TRβ agonist in combination with one or more active drug compounds, including pirfenidone and nintedanib (para [0085]). Lian teaches a dose of active agent to be administered in unit dose to range from about 0.01 mg/kg to about 120 mg/kg or more of body weight (para [0077]), and that the composition comprising the TRβ agonist is administered from one to four times per day; from once, twice, or three times weekly, or by other regimens (para [0079]). Treatment of other mammals, e.g., humans, is taught (para [0026-0027]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated a fibrotic lung disease in a patient in need thereof, including a human patient, comprising administering a therapeutically effective amount of the elected TRβ agonist, GC-1, and have had a reasonable expectation of success.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lian et. al., WO 2018226604 A1 as applied to claims 1, 3-8, 10-11, and 13-14 above, and further in view of von Nussbaum, US 20140045802, publ. 2/13/2014, cited in the IDS filed on 5/7/25.
The teachings of Lian as discussed above are incorporated herein. Lian doesn’t exemplify the embodiments of claims 9 and 12.
Von Nussbaum teaches 4-(4-cyano-2-thioaryl)dihydropyrimidin-2-one derivatives for use alone or in combination therapy for the treatment of various diseases (title & abstract). Pulmonary fibrosis is included as an exemplary disease for treatment (para [0013], [0187]), with TR agonists exemplified in combination with the 4-(4-cyano-2-thioaryl)dihydropyrimidin-2-one derivatives (para [0197], [0217], [0219]). Von Nussbaum teaches the active agents can be administered by a variety of delivery routes, including via inhalation (para [0236]), and teaches a dosage range for parenteral administration between about 0.01-0.5 mg/kg (para [0239]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have administered the elected TR beta agonist of the instant claims, GC-1, via inhalation to treat pulmonary fibrosis in a subject in need thereof, at the dosage range between about 0.01-0.5 mg/kg, in view of Lian and von Nussbaum. Lian teaches treating fibrotic diseases such as pulmonary fibrosis by administering a TR beta agonist, with GC-1 included among a group of TR beta agonists, while von Nussbaum teaches TR agonists in combination therapy for treating pulmonary fibrosis, delivered by routes such as inhalational, at a dose between about 0.01-0.5 mg/kg. The dose taught by von Nussbaum of 0.01-0.5 mg/kg corresponds to 10 µg/kg to 500 µg/kg, which overlaps with the dose range recited by instant claim 9. Therefore, it would have been prima facie obvious to have administered GC-1 to a subject in need of treatment for pulmonary fibrosis, at the concentration range recited by instant claim 9, and have had a reasonable expectation of success, in the absence of unexpected results.
Claim Rejections-Nonstatutory 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 and 3-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11660281 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating or ameliorating a fibrotic lung disease in a subject in need thereof comprising administering to the subject a therapeutically effective amount of the TRβ agonist, GC-1. Furthermore, both sets of claims recite further administering an additional agent that treats or ameliorates fibrotic lung disease, wherein the additional agent is pirfenidone or nintedanib (see instant claims 7 & 8, and patented claims 5 & 6); have overlapping dose ranges of the TRβ agonist, with instant claim 9 reciting 10-40 µg/kg and patented claim 7 reciting a dose of about 1 µg to 10000 mg; wherein the TRβ agonist is administered at a frequency selected from about three times per day (see instant claim 11 & patented claim 9); oral routes of administration (instant claim 12 & patented claim 10); wherein the subject is a mammal (instant claim 13 & patented claim 21); wherein the subject is a human (instant claim 14 & patented claim 22). The instant and patented claims are therefore not patentably distinct.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 5/7/25 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Information Disclosure Statement
The IDS filed on 5/7/25 has been considered.
Correspondence
Claims 1 and 3-14 were examined and are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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