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
Applicant’s preliminary amendment of 14 June 2024, in which claims 3-11 have been amended, and claims 12-22 and 32-40 have been cancelled, is acknowledged.
Claims 1-11, 23-31 are pending in the instant application.
Claims 1-11, 23-31 are being examined herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/US2022/072789, filed on 7 June 2022, which claims priority from U.S. Provisional Patent Application No. 63/208,268, filed on 8 June 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7 December 2023 and 1 April 2025 are acknowledged and considered.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-11, 23-31 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 2019/0054178, published 21 February 2019, cited in PTO-892), in view of Compere et al. (US 2005/0014817, cited in PTO-892), in further view of Solun et al. (Medicine in Drug Discovery 2020, 7, 100052, cited in PTO-892).
Li (US 2019/0054178) teaches [0004] 5-[3-(4-benzyloxyphenylthio)-fur-2-yl]-imidazolidin-2,4-dione compounds of the invention
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as selective inhibitors of MMP-12 useful in the treatment of diseases or conditions mediated by MMP-12, such as asthma, or chronic obstructive pulmonary diseases (COPD).
Li teaches [0020] a method of administering a pharmaceutical composition containing a compound of the formula (I)
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and a cyclodextrin to an animal or human subject.
Li specifically teaches [0030] IVO: 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione as a compound of formula (I), which the very compound of the instant claims.
Li studies (Example 4) the effect of different cyclodextrins on the aqueous solubility of 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]-fur-2-yl}-imidazolidin-2,4-dione (IVO)
[0035].
Li prepares ([0037], Example 6, Table 6) a complex of compound IVO, which is the very compound of the instant claims (as in instant claims 8, 30), with hydroxypropyl beta-cyclodextrin HPBCD, as in instant claim 9, where the weight ratio of the compound to the cyclodextrin is 1:3 (IVO:HPBCD = 25 : 75 (w/w)), which is within the range in instant claim 10. The IVO/HPBCD complex is named IVO/HPBCD ASD-01 [0037].
Li prepares [0038] a unit dose comprising 150 mg IVO + 450 mg HPBCD, which is a composition comprising a cyclodextrin and 150 mg of the compound of the instant claims, where the amount of compound IVO in the unit dose is as in instant claims 2, 24, and is within the range in instant claims 4, 5, 26, 27.
Li teaches (Example 11) a method of orally administering to a subject (beagle dog) a pharmaceutical composition (suspension) comprising hydroxypropyl-β-cyclodextrin (HPBCD) and IVO (which is the compound of the instant claims), thus oral administration, as in instant claims 7, 29.
Li does not teach that 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione, alone, or in a composition comprising cyclodextrin, is effective to treat acute respiratory distress syndrome (ARDS), as in the instant claims.
Li does not teach the therapeutic dose of compound effective to treat ARDS, as in instant claims 2, 4-6, 24, 26-28, nor does he teach the frequency of administration of the compound in the method of treating ARDS, once or twice a day, as in instant claims 3, 25.
Li does not teach that ARDS is caused by coronavirus, as in instant claims 11, 31.
Compere (US 2005/0014817) teaches [0086] that selective MMP-12 inhibitors are useful in the treatment of respiratory pathologies such as acute respiratory distress syndrome (ARDS).
Solun et al. (Medicine in Drug Discovery 2020, 7, 100052, cited in PTO-892) teach (Abstract) that COVID-19 causes acute respiratory failure due to widespread lung inflammation which progresses to acute respiratory distress syndrome (ARDS). Solun teaches (page 2, right column, second paragraph) that proinflammatory cytokines induce MMP over-expression and increase their activity thereby participating in airway remodeling. MMP-12 (macrophage elastase) can regulate the extracellular matrix component elastin and is involved in the tissue remodeling process.
It would have been obvious to a person of ordinary skill in the art to use the teachings of Li and Compere to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to administer to a subject suffering from ARDS a pharmaceutical composition taught by Li containing 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione (IVO) and hydroxypropyl beta-cyclodextrin, to treat ARDS, because Li teaches that the active compound 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione is a selective MMP-12 inhibitor, effective to treat diseases that are responsive to inhibition of MMP-12, and Compere teaches that
selective MMP-12 inhibitors are useful in the treatment of respiratory pathologies such as acute respiratory distress syndrome (ARDS). Thus, the person of ordinary skill in the art would have administered selective MMP-12 inhibitor 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione, alone or in a composition with cyclodextrin taught by Li, to a subject suffering from ARDS, with the expectation that said MMP-12 inhibitor will be effective to treat ARDS.
Regarding claims 2, 4-6, 24, 26-28, the person of ordinary skill in the art would have determined the therapeutic dose in the method of treating ARDS, and the frequency of administration, as in instant claims 3, 25, because such an exploration of different doses of therapeutic agent and different frequency of administration (once or twice a day) in the method of treatment with the aim of optimizing therapeutic effect, is well within the skill of the artisan.
Regarding claims 11, 31, it would have been obvious to administer selective MMP-12 inhibitor compound 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione to treat a subtype of ARDS, namely ARDS caused by coronavirus, because Solun teaches that COVID-19 causes acute respiratory distress syndrome (ARDS), and Solun teaches the link between MMP-12 (macrophage elastase) and lung inflammation. Thus, the person of ordinary skill in the art would have administered selective MMP-12 inhibitor 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione, alone or in a composition with cyclodextrin taught by Li, to a subject suffering from ARDS caused by COVID-19, with the expectation that said MMP-12 inhibitor will be effective to treat ARDS.
As such, claims 1-11, 23-31 are rejected as prima facie obvious.
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 1-11, 23-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043 (published as US 20240277670, cited in PTO-892) in view of Compere et al. (US 2005/0014817, cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043 render obvious the instant claims.
Claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043
are drawn to a method of administering a compound of formula (I)
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to a human subject in need thereof, comprising orally administering to the subject a pharmaceutical composition comprising the compound of formula (I) and a cyclodextrin, wherein a total dosage of the compound of formula (I) or the pharmaceutically acceptable salt thereof administered is about 25 mg to about 600 mg per administration. Claim 22 of U.S. Patent Application No. 18/568,043 recite that the subject is in need of a treatment of a disease such as asthma, or COPD.
The Specification of U.S. Patent Application No. 18/568,043 teaches [0005] that the compound of the invention is a MMP-12 inhibitor.
Claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043 do not teach that the compound is effective to treat ARDS, as in the instant claims.
Compere (US 2005/0014817) teaches [0086] that selective MMP-12 inhibitors are useful in the treatment of respiratory pathologies such as acute respiratory distress syndrome (ARDS).
It would have been obvious to a person of ordinary skill in the art to use the teachings of claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043 and Compere to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to administer to a subject a pharmaceutical composition taught by claims 1-14, 17, 22, 28-31 of copending U.S. Patent Application No. 18/568,043 containing 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione and cyclodextrin, to treat ARDS, because the Specification of U.S. Patent Application No. 18/568,043 teaches that the compound of the invention is a MMP-12 inhibitor teaches that the active compound 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione is a selective MMP-12 inhibitor, effective to treat diseases that are responsive to inhibition of MMP-12, and Compere teaches that
selective MMP-12 inhibitors are useful in the treatment of respiratory pathologies such as acute respiratory distress syndrome (ARDS). Thus, the person of ordinary skill in the art would have administered selective MMP-12 inhibitor 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione, alone or in a composition with cyclodextrin taught by the claims of U.S. Patent Application No. 18/568,043, to a subject suffering from ARDS, with the expectation that said MMP-12 inhibitor will be effective to treat ARDS.
Regarding claims 2, 4-6, 24, 26-28, the person of ordinary skill in the art would have determined the therapeutic dose in the method of treating ARDS, and the frequency of administration, as in instant claims 3, 25, because such an exploration of different doses of therapeutic agent and different frequency of administration (once or twice a day) in the method of treatment with the aim of optimizing therapeutic effect, is well within the skill of the artisan.
This is a provisional nonstatutory double patenting rejection.
Claims 1-11, 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent 10,532,102 (cited in PTO-892), in view of Compere et al. (US 2005/0014817, cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 of U.S. Patent 10,532,102 render obvious the instant claims.
Claims 1-3 of U.S. Patent 10,532,102 are drawn to a pharmaceutical composition comprising a compound of 5-{3-[4-(3-Methyl-benzyloxy) phenylthio]fur-2-yl}imidazolidine-2,4-dione (IVO); and a cyclodextrin, wherein the cyclodextrin is hydroxypropyl beta-cyclodextrin (as in instant claim 9), which is the very composition in the instant claims. Claim 2 of U.S. Patent 10,532,102 recites that the weight ratio of the compound of formula (I) to the cyclodextrin is 1:3, which is within the range in instant claim 10.
The Specification of U.S. Patent 10,532,102 teaches (column 1, lines 35-50) that 5-{3-[4-(3-Methyl-benzyloxy) phenylthio]fur-2-yl}imidazolidine-2,4-dione is a selective MMP-12 inhibitor, effective to treat diseases that are responsive to inhibition of MMP-12.
Compere is as above.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of claims 1-3 of U.S. Patent 10,532,102, and Compere to arrive at the instantly claimed method. The person of ordinary skill in the art would have been motivated to administer to a subject a pharmaceutical composition taught by claims 1-3 of U.S. Patent 10,532,102 containing 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione and cyclodextrin, to treat ARDS, because the Specification of U.S. Patent 10,532,102 teaches that the compound of the invention is a selective MMP-12 inhibitor, effective to treat diseases that are responsive to inhibition of MMP-12, and Compere teaches that selective MMP-12 inhibitors are useful in the treatment of respiratory pathologies such as acute respiratory distress syndrome (ARDS). Thus, the person of ordinary skill in the art would have administered selective MMP-12 inhibitor 5-{3-[4-(3-Methyl-benzyloxy)phenylthio]fur-2-yl}imidazolidine-2,4-dione, alone or in a composition with cyclodextrin taught by the claims of U.S. Patent 10,532,102, to a subject suffering from ARDS, with the expectation that said MMP-12 inhibitor will be effective to treat ARDS.
Regarding claims 2, 4-6, 24, 26-28, the person of ordinary skill in the art would have determined the therapeutic dose in the method of treating ARDS, and the frequency of administration, as in instant claims 3, 25, because such an exploration of different doses of therapeutic agent and different frequency of administration (once or twice a day) in the method of treatment with the aim of optimizing therapeutic effect, is well within the skill of the artisan.
As such, claims 1-11, 23-31 are rejected as prima facie obvious.
For similar reasons, claims 1-11, 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent 11,013,810 (cited in PTO-892), in view of Compere et al. (US 2005/0014817, cited in PTO-892); and over claims 1-21 of U.S. Patent 11,628,220 (cited in PTO-892), in view of Compere et al. (US 2005/0014817, cited in PTO-892).
Conclusion
Claims 1-11, 23-31 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629