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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on October 5th, 2023; and March 14th, 2025 are being considered by the examiner.
Specification
The use of the terms TWEENTM, PLURONICSTM, etc. which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Status of the Claims
Claims 1-19, 21, and 25 are pending in this application. Claims 20, 22-24, and 26-27 have been cancelled by applicant.
Claim Rejections - 35 USC § 102
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 1-3 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”).
Regarding claims 1-3, Kuriyama discloses dotinurad as a novel URAT1 inhibitor indicated for patients with hyperuricemia/gout, who require the inhibition of URAT-1 to excrete excess uric acid (UA) via the kidney (abstract) – anticipating a pharmaceutical composition comprising a URATI inhibitor alone.
Further regarding claim 2, Applicant is advised that a recitation of the intended use of the claimed invention, such as the use of Kuriyama’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 25, Kuriyama discloses dotinurad as a novel URAT1 inhibitor indicated for patients with hyperuricemia/gout (abstract).
Claims 1-2, 18, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jalal et al. (AJKD, 77, 2021, 478-480 – Published Online February 7th, 2021) (“Jalal”).
Regarding claims 1-2, Jalal discloses verinurad as a URAT1 inhibitor to be administered in combination with a xanthine oxidase inhibitor (XO), such as febuxostat (FBX), to reduce uric acid (UA) production in the body (page 1, last para.) – anticipating a pharmaceutical composition comprising a URAT1 inhibitor alone.
Further regarding claim 2, Applicant is reminded that a recitation of the intended use of the claimed invention, such as the use of Jalal’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 18, Jalal teaches verinurad and FBX lowered serum urate, which reduced albuminuria in patients with type 2 diabetes (T2DM) and CKD; and that reduced albuminuria may result in slowing CKD progression (anticipating CKD treatment) (page 478, col. 1, para. 2-3).
Regarding claim 25, Jalal discloses verinurad as a URAT1 inhibitor, which can treat gout or asymptomatic hyperuricemia when administered with an XO inhibitor (page 479, col. 1, starting on 11th to last line of para. 1).
Claims 1-2 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al. (Biomedicine & Pharmacotherapy, 2019, 110, 844–849) (“Xu”).
Regarding claims 1-2, Xu discloses resveratrol (RES) as a URAT1 inhibitor (abstract) – anticipating a pharmaceutical composition comprising a URAT1 inhibitor alone.
Further regarding claim 2, Applicant is reminded that a recitation of the intended use of the claimed invention, such as the use of Xu’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 21, Xu discloses RES as a promising agent for the treatment of hyperuricemia-related NAFLD (abstract).
Claims 1-4, 9-11, and 25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Kobashi et al. (US 8,367,843 B2 – cited in IDS) (“US ‘843”).
Regarding claims 1-3, US ‘843 claims dotinurad as one of their compounds of Formula I, when X is -SO2-, R1-2 are halogen, and R3 is hydrogen (US ‘843’s claims 1 and 3; and Example 1, Table 1, col. 73). US ‘843 also claims a pharmaceutical composition comprising their compounds (US ‘843’s claims 4-5 and 12-13; and Formulation Example in col. 75, end).
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Further regarding claim 2, Applicant is advised that a recitation of the intended use of the claimed invention, such as the use of US ‘843’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 4 and 9-11, US ‘843 discloses a formulation example with dotinurad (Example 1), wherein a powder of dotinurad, lactose, corn starch, etc. is produced by wet granulation (thus forming an amorphous form). This powder is then compressed to obtain 5 mg of compound Example 1 (dotinurad) in each tablet – thus anticipating the instant oral dosage form in the form of a tablet, comprising 0.1-20 mg of dotinurad (col. 75-76).
Regarding claim 25, US ‘843 claims a method of treating hyperuricemia comprising administration of their compounds (US ‘843’s claims 10-11).
Claims 1-3, 5-10, and 25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Uda et al. (US 10,752,601 B2 – cited in IDS) (“US ‘601”).
Regarding claims 1-3 and 5-6, US ‘601 claims a type II crystal form of dotinurad with characteristic peaks at least around 15.1, 18.1, 22.8, 23.7, and 24.0 degrees in XRPD (US ‘601’s claim 1) and a pharmaceutical composition comprising this crystal form (US ‘601’s claim 3) – anticipating a composition comprising a URAT1 inhibitor alone. US ‘601 discloses a DSC peak around 212 °C (US ‘601’s claim 2).
Further regarding claim 2, Applicant is advised that a recitation of the intended use of the claimed invention, such as the use of US ‘843’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 7-8, US ‘601 discloses a type I crystal form of dotinurad with characteristic peaks at least around 11.5, 14.6, 18.2, 24.0, and 25.5 degrees in XRPD with a DSC peak around 191 °C (col. 1, last 3 points) - anticipating a composition comprising a URAT1 inhibitor alone.
Regarding claims 9-10, US ‘601 discloses their crystal forms of dotinurad can be administered in oral forms, including tablets.
Regarding claim 25, US ‘601 teaches their crystal forms are useful for the treatment of hyperuricemia (col. 5, line 39).
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.
Claims 1-2 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3 and 25.
The teachings of Kuriyama are disclosed in the 102-section above and incorporated herein.
Regarding claims 1-2, Kuriyama discloses that allopurinol (a xanthine oxidoreductase inhibitor (XOR)) and benzbromarone (BZB) (a URAT1 inhibitor) have been utilized for hyperuricemia/ gout treatment (page S2, col. 1, last para.).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a pharmaceutical composition comprising allopurinol and BZB (a XOR inhibitor and a URAT1 inhibitor, respectively) to treat hyperuricemia or gout. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kuriyama’s teaching that combination of these two medications has been known for decades for the treatment of hyperuricemia and gout.
Applicant is advised, with respect to a mixture of the two claimed reagents, the courts have found that “[i]t 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Further regarding claim 2, Applicant is reminded that a recitation of the intended use of the claimed invention, such as the use of Kuriyama’s composition for the treatment of chronic kidney disease (CKD) in the instant application, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore, Applicant is advised that products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 13 and 15, Kuriyama teaches allopurinol, febuxostat (FBX), and topiroxostat as XOR inhibitors (page S2, col. 1, last para.).
Regarding claim 14, Kuriyama teaches dotinurad was administered at doses of 1, 2, and 4 mg for 8 weeks (page S2, col. 2, para. 5) – reading on fixed doses in clinical trials.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3, 13-15 and 25; in view of Kobashi et al. (US 8,367,843 B2 – cited in IDS) (“US ‘843”).
The teachings of Kuriyama are disclosed in the 102- and 103-sections above and incorporated herein.
Kuriyama teaches dotinurad was administered at doses of 1, 2, and 4 mg for 8 weeks (page S2, col. 2, para. 5).
While Kuriyama does not specifically teach oral formulations of dotinurad in tablet form, comprising 0.1-20 mg of dotinurad; the teachings of US ‘843 are relied upon for these disclosures.
US ‘843 discloses a formulation example with dotinurad (Example 1), wherein a powder of dotinurad, lactose, corn starch, etc. is produced by wet granulation (thus forming an amorphous form). This powder is then compressed to obtain 5 mg of compound Example 1 (dotinurad) in each tablet – thus anticipating the instant oral dosage form in the form of a tablet, comprising 0.1-20 mg of dotinurad (col. 75-76).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing of the claimed invention to prepare a tablet formulation of dotinurad for oral administration for the treatment of hyperuricemia/ gout, as taught by Kuriyama in view of US ‘843. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kuriyama discloses administration of 1, 2, and 4 mg doses of dotinurad; and US ‘843 discloses a tablet form for oral administration comprising 5 mg of dotinurad.
Regarding the claimed range of dotinurad present in the formulation, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3, 13-15 and 25; in view of Seth et al. (Cochrane Database of Systematic Reviews, 2014, Article No.: CD006077) (“Seth”).
The teachings of Kuriyama are disclosed in the 102- and 103-sections above and incorporated herein.
Kuriyama discloses different clinical trials comprising dotinurad (a URAT1 inhibitor); and FBX (Table 1) with FBX being administered at 2 mg. Furthermore, Kuriyama discloses FBX administration at 40 mg per day for 14 days without detrimental effects (page S4, col. 1, para. 2).
While Kuriyama does not specifically teach effective amounts of allopurinol or FBX for a pharmaceutical composition; the teachings of Seth are relied upon for these disclosures.
Seth teaches there may be no difference in the incidence of acute gout attacks with allopurinol up to 300 mg daily versus febuxostat 80 mg daily over eight to 24 weeks (21% with allopurinol versus 23% with febuxostat); however more participants may achieve target serum urate levels with febuxostat 80 mg daily versus allopurinol 300 mg daily (38% with allopurinol versus 70% with febuxostat) (page 2, para. 2). Seth discloses administration of up to 600 mg of allopurinol (page 2, para. 3).
Therefore, regarding claims 16-17, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a composition comprising a URAT1 inhibitor, such as dotinurad – as taught by Kuriyama, with an XO inhibitor, such as allopurinol or FBX for the treatment of hyperuricemia or gout; with allopurinol being present in amounts ranging from 300-600 mg (as taught by Seth), and FBX in amounts ranging from 40 mg (as taught by Kuriyama) to 80 mg (as taught by Seth). One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kuriyama teaches administration of URAT1 inhibitors, such as dotinurad and BZB, in combination with XO inhibitors like allopurinol and FBX for the treatment of hyperuricemia and/ or gout; further because Seth discloses effective amounts of allopurinol and FBX administered in clinical trials.
Regarding the claimed ranges of allopurinol and FBX, as claimed in claims 16-17, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3, 13-15 and 25; in view of Jalal et al. (AJKD, 77, 2021, 478-480 – Published Online February 7th, 2021) (“Jalal”).
The teachings of Kuriyama are disclosed in the 102- and 103-sections above and incorporated herein.
While Kuriyama does not teach treatment of CKD with their URAT1 inhibitor composition, the teachings of Jalal are relied upon for these disclosures.
Jalal teaches that combination treatment with FBX and verinurad (a URAT1 inhibitor) resulted in lower serum urate levels; and that lowering serum urate reduced albuminuria in patients with type 2 diabetes (T2DM) and CKD. Jalal teaches that recent data suggests that reduced albuminuria over a short period of time may be an acceptable surrogate outcome to evaluate whether this treatment may result in slowing CKD progression (page 478, col. 1, para. 2-3). Jalal discloses that published reports suggest that urate lowering with XO inhibitor therapy alone may not yield measurable kidney benefit (page 478, col. 2, last para.). Furthermore, Jalal teaches that verinurad is not being pursued as monotherapy for the treatment of gout or asymptomatic hyperuricemia owing to the potential for adverse kidney outcomes. Specifically, verinurad (a URAT1 inhibitor), when given without a XO inhibitor, has been shown to cause a transient increase in serum creatinine (page 479, col. 1, starting on 11th to last line of para. 1).
Therefore, regarding claim 18, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer dotinurad (a URAT1 inhibitor) in combination with FBX or allopurinol (XO inhibitors) for the treatment of CKD. One of ordinary skill would have been motivated to do so because Kuriyama teaches administration of URAT1 inhibitors in combination with XO inhibitors for the treatment of hyperuricemia/ gout; and teaches that dotinurad is a novel drug for uric acid (UA) reabsorption inhibition; and that UA is a precipitating factor and the progression of diseases like CKD. One would have been further motivated with a reasonable expectation of success because of Kuriyama’s disclosure of dotinurad’s positive performance in clinical trials; further because Jalal teaches that FBX and verinurad (a URAT1 inhibitor) resulted in lower serum urate levels; and that lowering serum urate reduced albuminuria in patients with type 2 diabetes (T2DM) and CKD; and that reduced albuminuria may result in slowing CKD progression.
Regarding claim 19, Kuriyama teaches dotinurad as a URAT1 inhibitor.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3, 13-15, and 25; in view of Xu et al. (Biomedicine & Pharmacotherapy, 2019, 110, 844–849) (“Xu”).
The teachings of Kuriyama are disclosed in the 102- and 103-sections above and incorporated herein.
While Kuriyama does not teach treatment of non-alcoholic fatty liver disease (NAFLD); the teachings of Xu are relied upon for these disclosures.
Xu teaches Hyperuricemia is a recognized risk factor for the development of nonalcoholic fatty liver disease (NAFLD); and investigates the effects of resveratrol (RES – a URAT1 inhibitor) on the treatment of hyperuricemia-related NAFLD in rats (abstract).
Therefore, regarding claim 21, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Kuriyama’s dotinurad (a URAT1 inhibitor), accepted for the treatment of hyperuricemia/ gout, to treat NAFLD. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kuriyama’s disclosure of dotinurad for the treatment of hyperuricemia, and its positive performance in clinical trials; further in view of Xu’s teaching that hyperuricemia is a recognized risk fact for NAFLD, and their teaching that RES (a URAT1 inhibitor) is a promising agent for the treatment of hyperuricemia-related NAFLD.
An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Thus, substitution of RES (a URAT1 inhibitor) for dotinurad (another URAT1 inhibitor) for the treatment of NAFLD, is obvious.
Claims 1-3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kuriyama et al. (Clinical and Experimental Nephrology, 2020, 24 (Suppl 1):S1–S5) (“Kuriyama”); as applied to claims 1-3, 13-15, and 25; in view of Saha et al. (Int. J. Basic Clin. Pharmacol., 2020; 9, 962-965) (“Saha”).
The teachings of Kuriyama are disclosed in the 102- and 103-sections above and incorporated herein.
While Kuriyama does not teach administration of their URAT1 inhibitor in combination with a sodium-glucose transport protein 2 inhibitors (SGLT2); the teachings of Saha are relied upon for these disclosures.
Saha teaches that SGLT2 inhibitors are known to have a decremental effect on serum UA levels (abstract) in T2DM patients. Saha discloses canagliflozin and dapagliflozin as SGLT2 inhibitors (page 963, col. 2, para. 1).
Therefore, regarding claims 1-3 and 12, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising Kuriyama’s URAT1 inhibitor (dotirunad) in combination with Saha’s SGLT2 inhibitors canagliflozin or dapagliflozin. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because both drugs are known to reduce serum UA levels, and both are known to be safe for human administration.
Applicant is reminded that the courts have found that “[i]t 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.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents.
Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627