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 Application
The Amendments and Remarks filed on 05/01/26 are acknowledged.
Claims 4-6, 9-11, 13-15, 17-20, 23-25, 28-29, 32-34, 39, 41-43, 53-54, and 56-57 were previously cancelled.
Claims 44-49 were amended.
Claims 50 and 51 were previously withdrawn from consideration.
Claims 1-3, 7-8, 12, 16, 21-22, 26-27, 30-31, 35-38, 40, 44-52, and 55 are pending.
Claims 1-3, 7-8, 12, 16, 21-22, 26-27, 30-31, 35-38, 40, 44-49, 52, and 55 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 05/01/26 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Maintained Rejections
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 of this title, 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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, 7-8, 38, 40, 44-45, 47, 49, 52, and 55 are again rejected under 35 U.S.C. 103 as being unpatentable over Hadd et al. (US 2020/00289457 A1 – “Hadd”).
Instant claim 1 is drawn to a tablet formulation comprising bexagliflozin for administration to a companion animal, wherein in an in vitro dissolution test said formulation releases at least 85% of its bexagliflozin after 30 minutes in a solution of 0.1N HCl at 37 ± 0.5°C in a USP Apparatus 2 (a paddle apparatus) with a paddle speed of about 75 rpm.
Hadd teaches a tablet dosage form comprising 5 to 50 mg of Compound 1 (bexagliflozin) having the formula:
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([0149] and claim 19). The tablet is administered to a feline in need thereof (Examples 3 and 5, claims 2, 4, 8, 10, 19).
Hadd does not expressly teach an in vitro dissolution test said formulation releases at least 85% of its bexagliflozin after 30 minutes in a solution of 0.1N HCl at 37 ± 0.5°C in a USP Apparatus 2 (a paddle apparatus) with a paddle speed of about 75 rpm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a tablet comprising 5 to 50 mg of bexagliflozin, as taught by Hadd, in view of the sustained release over a longer period, also as taught by Hadd, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because the in vitro dissolution profile is associated with the tablet formulation and inseparable from it. Since the prior art teaches the same tablet containing the same active ingredient, bexagliflozin, the same in vitro dissolution profile would have been expected. Instant claim 1 does not recite any structural features that distinguish the claimed tablet from the tablet of the prior art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1, 47, 49, 52, and 55, the limitations of a tablet formulation comprising bexagliflozin for administration to a companion animal (instant claim 1) and the dosage of 15 mg of bexagliflozin per tablet (instant claims 47, 49, 52, and 55) would have been obvious over the tablet dosage form comprising an overlapping range of 5 to 50 mg of Compound 1 or bexagliflozin ([0149], Examples 3 and 5, claims 2, 4, 8, 10, 19), as taught by Hadd. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 1, 44, 45, 47, 49, 52, and 55, the limitations of the in vitro dissolution profile and the pharmacokinetic (PK) parameters of Cmax, Tmax, f2 values would have been obvious over the sustained release ([0134], [0137]-[0138], and [0140]) and the methods of managing feline diabetes ([0099], Abstract, claim 19), as taught by Hadd, unless there is evidence of criticality or unexpected results. The recited dissolution parameters and PK parameters are the effects and properties of the composition which is taught by the prior art. One of ordinary skill in the art would have found it obvious to prepare the composition based on the teaching of Hadd and test the composition for in vitro dissolution and for PK parameters in order to test the release and therapeutic efficacy of the composition.
Regarding instant claim 7, the limitation of the tablet further comprising one or more fillers, one or more glidants, one or more lubricants, and one or more binders would have been obvious over suitable excipients including fillers ([0139]), lubricating agents ([0140]-[0141]), and binders ([0141]), as taught by Hadd.
Regarding instant claim 8, the limitation of the tablet comprising about 4 to 20% by weight of bexagliflozin would have been obvious over the total daily dosage of 5 to 50 mg of bexagliflozin (Abstract, [0149]), as taught by Hadd. One of ordinary skill in the art would have found it obvious to add bexagliflozin to the tablet formulation in a % by weight that corresponds with a desired dosage within 5 to 50 mg as taught by Hadd. The claimed range of about 4 to 20% by weight of bexagliflozin would have been an obvious variant over the dosage of 5 to 50 mg of bexagliflozin as taught by Hadd unless there is evidence of criticality or unexpected results.
Regarding instant claim 38, the limitation of a cat would have been obvious over the action of bexagliflozin which is unusually potent and qualitatively superior in cats than in other organisms ([0058]) and the methods of managing feline diabetes ([0099], Abstract, claim 19), as taught by Hadd.
Regarding instant claim 40, the limitation of the formulation which can be delivered daily with fewer than 1 dosing rejection per 30 dosing events cat would have been obvious over the methods of managing feline diabetes ([0099], Abstract, claim 19), as taught by Hadd. Furthermore, the limitation of “can be delivered …” is a future intended use of the claimed composition which is not given patentable weight. The claimed limitation does not add any specific structural component or alter the arrangement of the claimed structural components to distinguish over the tablet composition of the prior art.
Response to Arguments
Applicant’s arguments (Pages 8-11, filed 05/01/26) with respect to the rejection of claims 1, 7-8, 38, 40, 44-45, 47, 49, 52, and 55 under 35 U.S.C. 103 as being unpatentable over Hadd have been fully considered but are not persuasive.
Applicant points to paragraphs [0016] and [0017] and Tables 41 and 43 of the instant Specification and argues that the claimed dissolution profile is tied to the immediate release formulations. Applicant argues that in contrast Hadd teaches sustained release, controlled release, extended-release, timed-release or delayed release formulations (Hadd – [0137]). Applicant argues that “A sustained release tablet designed to "delay disintegration and absorption" and "provide a sustained action over a longer period" would not be expected to release ~85% of bexagliflozin in 30 minutes. Rather, such a formulation would exhibit a slower dissolution profile-the opposite of the rapid immediate release profile claimed.” Applicant argues that Hadd expressly teaches sustained/extended release tablets, which by definition would not release ≥85% bexagliflozin in 30 minutes.
This is not persuasive because even though Hadd does not expressly teach an in vitro dissolution test said formulation releases at least 85% of its bexagliflozin after 30 minutes in a solution of 0.1N HCl at 37 ± 0.5°C in a USP Apparatus 2 (a paddle apparatus) with a paddle speed of about 75 rpm, Hadd teaches the tablet formulation which comprises bexagliflozin as recited in instant claim 1. Instant claim 1 does not recite any features regarding the components, the corresponding concentration of components, or the arrangement of the components in the composition that distinguish over the tablet formulation taught by Hadd. Instant claim 1 does not recite any concentration of bexagliflozin or other components that are different from Hadd’s tablet. Instant claim 1 recites the transitional phrase “comprising” which is considered open language and allows the inclusion of the components of Hadd’s tablet such as the extended release components. Please see MPEP 2111.03(I). As Applicant indicated, the tablet formulation is tied to the dissolution profile recited in instant claim 1, i.e., the specific components with their corresponding concentrations and arrangement of these components in the tablet formulation are tied to the dissolution profile. However, instant claim 1 does not recite any specific concentration of bexagliflozin or any other components and their corresponding concentrations or concentration ranges necessary to product the tablet which provides the claimed dissolution profile. For instance the tablet formulations in TABLE 42 of the instant Specification are used for dissolution testing, the results of which are presented in TABLE 43. As such, the evidence is not commensurate in scope with the claimed invention. Please see MPEP 2145. Furthermore, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Applicant notes that claims 52 and 55 are independent claims directed to “a batch of bexagliflozin veterinary tablets” with specific bioequivalence-type statistical requirements – not merely a single tablet composition.
This is not persuasive because the claimed limitations of batches of bexagliflozin veterinary tablets that include 15 mg of bexagliflozin per tablet are rendered obvious by the total daily dosage of 5 to 50 mg of bexagliflozin (Abstract, [0149]), as taught by Hadd. One of ordinary skill in the art would have found it obvious to add bexagliflozin to a batch of bexagliflozin tablets within 5 to 50 mg as taught by Hadd. As explained above, instant claims 52 and 55 do not recite any structural components, corresponding concentrations, or arrangement of components that distinguish over Hadd’s tablets. The statistical parameters are associated with the tablets, which are taught by Hadd.
Applicant argues that the Office’s position that these statistical parameters are merely “effects and properties” of the composition taught by Hadd is an oversimplification.
This is not persuasive because instant claims do not recite any specific structure, materials/components, corresponding concentrations, or arrangement of the components that accomplish the statistical parameters. Please see MPEP 2173.05(g) which states: “Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc).”
Therefore, the rejection of 02/25/26 is maintained.
Claim Rejections - 35 USC § 103
Claims 2, 3, and 12 are again rejected under 35 U.S.C. 103 as being unpatentable over Hadd et al. (US 2020/00289457 A1 – “Hadd”) in view of Daoudal (EP 0 320 320 A2 – English Espacenet Translation) and Davidson (US 2005/0136096 A1).
Instant claim 2 is drawn to the tablet formulation of claim 1, further comprising a palatant.
The teaching of Hadd is discussed above.
Hadd does not expressly teach a palatant.
Daoudal teaches a tablet for domestic animals such as cats (Abstract, claim 1). The tablet contains a protein substance as a palatable matrix ([0007]-[0008]). The protein substance is liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]).
Davidson teaches a medicament composition for the administration to pets wherein the composition contains a film, a medicament and a flavoring that renders the film palatable to a pet (Abstract, claim 1). The flavoring includes catnip, poultry, chicken, animal products, chicken meat, chicken fat, beef hide, beef meat, beef fat, bacon, liver, an extract of chicken, an extract of beef, an extract of a meat by-product, etc. (claim 2). The flavoring is present in any effective amount, including an amount ranging from about 0.5 to 40 wt.% ([0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a tablet comprising 5 to 50 mg of bexagliflozin, as taught by Hadd, in view of the sustained release over a longer period, also as taught by Hadd, the use of palatants such as liver powder, as taught by Daoudal, the use of palatant flavorings which include catnip, chicken, fish, salmon, tuna, beef, bacon, liver, etc., in an amount of about 0.5 to 40 wt.%, as taught by Davidson, and produce the instant invention.
One of ordinary skill in the art would have been motivated to add palatants taught by Daoudal and Davidson in the tablet composition comprising bexagliflozin of Hadd because Daoudal teaches the advantage of a protein substance as a palatable matrix ([0007]-[0008]), wherein the protein substance is liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]), and Davidson teaches that the flavoring renders the composition palatable to pets (Abstract and [0047]).
Regarding instant claims 2 and 3, the limitations of a palatant would have been obvious over the palatable matrix ([0007]-[0008]) including liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]), as taught by Daoudal, and the flavoring that renders the film palatable to a pet (Abstract, claim 1), including catnip, poultry, chicken, animal products, chicken meat, chicken fat, beef hide, beef meat, beef fat, bacon, liver, an extract of chicken, an extract of beef, an extract of a meat by-product, etc. (claim 2), as taught by Davidson.
Regarding instant claim 12, the limitation of about 2 to 25% by weight of palatant would have been obvious over the palatant flavoring present in any effective amount, including an amount in an overlapping range of from about 0.5 to 40 wt.% ([0047]), as taught by Davidson. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Response to Arguments
Applicant’s arguments (Pages 8-11, filed 05/01/26) with respect to the rejection of claims 2, 3, and 12 under 35 U.S.C. 103 as being unpatentable over Hadd in view of Daoudal and Davidson have been fully considered but are not persuasive.
Applicant argues that “… claim 1 is not obvious in view of Hadd at least because Hadd does not teach or suggest an immediate release tablet formulation which releases at least 85% of its bexagliflozin after 30 minutes. Neither Daoudal nor Davidson cure this deficiency. These references merely disclose palatants for animal formulations. Adding a palatant to Hadd's sustained release tablet would still result in a sustained release tablet that would not meet the claimed dissolution profile.”
This is not persuasive because, as explained above, the claimed limitations of the tablet formulation are rendered obvious by the tablet taught by Hadd. Instant claims do not recite any features related to the structural components, the corresponding concentrations, or arrangement of the components to distinguish over Hadd. The deficiency in Hadd regarding a palatant is cured by Daoudal and Davidson. One of ordinary skill in the art would have been motivated to add the palatants taught by Daoudal and Davidson in the tablet composition comprising bexagliflozin of Hadd because Daoudal teaches the advantage of a protein substance as a palatable matrix ([0007]-[0008]), wherein the protein substance is liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]), and Davidson teaches that the flavoring renders the composition palatable to pets (Abstract and [0047]).
Therefore, the rejection of 02/25/26 is maintained.
Claim Rejections - 35 USC § 103
Claims 16, 21-22, 26-27, 30-31, and 35-36 are again rejected under 35 U.S.C. 103 as being unpatentable over Hadd et al. (US 2020/00289457 A1 – “Hadd”) in view of Wang et al. (US 2022/0117898 A1 – “Wang”).
Instant claim 16 is drawn to the tablet formulation of claim 7, comprising about 20 to 60% by weight of one or more fillers.
The teaching of Hadd is discussed above.
Although Hadd teaches a filler or an inert solid diluent like microcrystalline cellulose ([0142]), Hadd does not expressly teach a tablet comprising about 20 to 60% by weight of one or more fillers.
Wang teaches a tablet comprising bexagliflozin (Abstract, claim 1). The tablet further comprises a filler ([0117] and claim 33). Fillers include 11-13% by weight lactose and/or 18-20% by weight microcrystalline cellulose (MCC) ([0128]). The calculated combined weight of the filler is 13% + 20% = 43%. Formulation A contains 15 mg bexagliflozin or 4.2% by weight, 20.8% wt of MCC ([0208]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a tablet comprising 5 to 50 mg of bexagliflozin, as taught by Hadd, in view of the sustained release over a longer period, also as taught by Hadd, the use of fillers including11-13% by weight lactose and/or 18-20% by weight MCC, as taught by Wang, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because both Hadd and Wang are drawn to tablet formulations comprising bexagliflozin and fillers. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to use the fillers of Wang in their corresponding amounts in the tablet formulation of Hadd and have a reasonable expectation of success in producing a functional tablet comprising bexagliflozin.
Regarding instant claim 16, the limitation of about 20 to 60% by weight of one or more fillers would have been obvious over the tablet further comprising a filler ([0117] and claim 33), wherein fillers include 11-13% by weight lactose and/or 18-20% by weight MCC ([0128]), for a calculated combined filler weight of 43%, and Formulation A which contains 20.8% wt of MCC ([0208]), as taught by Wang. According to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 21, the limitation of microcrystalline cellulose would have been obvious over the MCC ([0128], [0208]), as taught by Wang.
Regarding instant claims 22 and 26, the limitations of about 0.5 to about 8% by weight of one or more glidants (instant claim 22) and colloidal silicon dioxide (instant claim 26) would have been obvious over the glidants including 1.0-1.5% by weight of colloidal silicon dioxide ([0126]), as taught by Wang. Please see MPEP 2144.05.
Regarding instant claims 27 and 30, the limitations of about 0.1 to 4% by weight of a lubricant (instant claim 27) and magnesium stearate (instant claim 27) would have been obvious over the lubricants including 1.5-2.5% by weight of magnesium stearate ([0126]), as taught by Wang. Please see MPEP 2144.05.
Regarding instant claims 31 and 36, the limitations of about 30 to about 50% by weight of one or more binders (instant claim 31) and lactose monohydrate and pregelatinized starch (instant claim 36) would have been obvious over the fillers including starches, lactose, and celluloses, including 11-13% by weight lactose and/or 18-20% by weight MCC ([0128]), for a calculated combined filler weight of 43%, as taught by Wang. Please see MPEP 2144.05.
Regarding instant claim 35, the limitation of the ratio of a first binder to a second binder of about 5.5:1 would have been obvious over the fillers including starches, lactose, and celluloses, including 11-13% by weight lactose and/or 18-20% by weight MCC ([0128]), as taught by Wang. One of ordinary skill in the art would have found it obvious to modify the ratio of the first binder to the second binder based on the fillers taught by Wang and based on the desired therapeutic attributes of the tablet.
Response to Arguments
Applicant’s arguments (Pages 11-12, filed 05/01/26) with respect to the rejection of claims 16, 21-22, 26-27, 30-31, and 35-36 under 35 U.S.C. 103 as being unpatentable over Hadd in view of Wang have been fully considered but are not persuasive.
Applicant argues that: “Wang's Abstract states that the goal is to provide "a lower peak plasma concentration, Cmax" compared to immediate release formulations. See Wang, Abstract. Wang teaches a dissolution profile of "~17% of its bexagliflozin after 1 hour" and "~80% after 8 hours." Wang, paragraph [0017]. This is the opposite of the claimed ~85% at 30 minutes. Combining Hadd with Wang would lead a person of ordinary skill in the art away from the claimed immediate release formulation, not toward it. There is no motivation to combine these extended release human formulations to arrive at an immediate release veterinary tablet.”
This is not persuasive because, as explained above, the claimed limitations of the tablet formulation are rendered obvious by the tablet taught by Hadd. Instant claims do not recite any features related to the structural components, the corresponding concentrations, or arrangement of the components to distinguish over Hadd. The deficiency in Hadd regarding a tablet comprising about 20 to 60% by weight of one or more fillers is cured by Wang. The references are properly combined because both Hadd and Wang are drawn to tablet formulations comprising bexagliflozin and fillers. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to use the fillers of Wang in their corresponding amounts in the tablet formulation of Hadd and have a reasonable expectation of success in producing a functional tablet comprising bexagliflozin. The immediate release parameters argued by Applicant are related to specific tablet formulations, i.e., in TABLE 42 of the instant Specification, which are not recited in the instant claims. Please see MPEP 2145 and MPEP 716.02(d).
Therefore, the rejection of 02/25/26 is maintained.
Claim Rejections - 35 USC § 103
Claims 37, 46, and 48 are again rejected under 35 U.S.C. 103 as being unpatentable over Hadd et al. (US 2020/00289457 A1 – “Hadd”) in view of Wang et al. (US 2022/0117898 A1 – “Wang”), Daoudal (EP 0 320 320 A2 – English Espacenet Translation), and Davidson (US 2005/0136096 A1).
Instant claim 37 is drawn to the tablet formulation of claim 7, wherein said tablet comprises bexagliflozin, 15 mg; lactose monohydrate, between 110.0 - 160 mg; microcrystalline cellulose, between 117.0 - 185.4 mg; palatant, between 30 - 44.2 mg, pregelatinized starch, between 19.2 - 54 mg, colloidal silicon dioxide, between 6 - 13.5 mg; and magnesium stearate, between 3.0 - 3.5 mg.
The teachings of Hadd are discussed above.
Hadd does not expressly teach all the components and the corresponding amounts recited in instant claim 37.
The teachings of Wang, Daoudal, and Davidson are also discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a tablet comprising 5 to 50 mg of bexagliflozin, as taught by Hadd, in view of the sustained release over a longer period, also as taught by Hadd, the use of fillers including11-13% by weight lactose and/or 18-20% by weight MCC, as taught by Wang, the use of palatants such as liver powder, as taught by Daoudal, the use of palatant flavorings which include catnip, chicken, fish, salmon, tuna, beef, bacon, liver, etc., in an amount of about 0.5 to 40 wt.%, as taught by Davidson, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because both Hadd and Wang are drawn to tablet formulations comprising bexagliflozin and fillers. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to use the fillers of Wang in their corresponding amounts in the tablet formulation of Hadd and have a reasonable expectation of success in producing a functional tablet comprising bexagliflozin.
One of ordinary skill in the art would have been motivated to add palatants taught by Daoudal and Davidson in the tablet composition comprising bexagliflozin of Hadd because Daoudal teaches the advantage of a protein substance as a palatable matrix ([0007]-[0008]), wherein the protein substance is liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]), and Davidson teaches that the flavoring renders the composition palatable to pets (Abstract and [0047]).
Regarding instant claims 37 and 48, the limitations of 15 mg of bexagliflozin (instant claim 37) and between 10-20 mg bexagliflozin (instant claim 48) would have been obvious over Formulation A which contains 15 mg bexagliflozin ([0208]), as taught by Wang.
Regarding instant claims 37 and 48, the limitations of between 110.0-160 mg lactose monohydrate and 117-185.4 mg of MCC (instant claim 37) and between 17.5-27.5 mg of lactose monohydrate and 20.5-30.5 mg of MCC (instant claim 48) would have been obvious over the lactose monohydrate ([0128]), and the fillers including 11-13% by weight lactose and/or 18-20% by weight MCC ([0128]), for a calculated combined filler weight of 43% ([0208]), as taught by Wang. One of ordinary skill in the art would have found it obvious to include different fillers and adjust the level of each of the fillers based on the desired therapeutic attributes of the tablet. The recited ranges would have been obvious variants given the teaching of Wang unless there is evidence of criticality or unexpected results.
Regarding instant claims 37 and 48, the limitations of 30-44.2 mg of palatant (instant claim 37) and between 7.5-11 mg palatant (instant claim 48) would have been obvious over the liver powder ([0010], [0012], [0021], claim 3), as taught by Daoudal, and the palatant flavoring at 0.5 to 40 wt.% ([0047]), as taught by Davidson. One of ordinary skill in the art would have found it obvious to adjust the palatant level in the tablet based on the amount taught by Davidson in order to achieve the desired level of palatability or acceptability by the cats. The recited ranges would have been obvious variants absent evidence of criticality or unexpected results.
Regarding instant claims 37 and 48, the limitations of 19.2-54 mg of pregelatinized starch (instant claim 37) and between 3-5 mg pregelatinized starch (instant claim 48) would have been obvious over the binders ([0141]), pregelatinized starch ([0142]) taught by Hadd, and the fillers including 40-50 mg of ([0141]), as taught by Wang. One of ordinary skill in the art would have found it obvious to include different fillers and binders and adjust the level of each of the components based on the desired therapeutic attributes of the tablet. The recited ranges would have been obvious variants given the teaching of Wang unless there is evidence of criticality or unexpected results.
Regarding instant claims 37 and 48, the limitations of 6-13.5 mg of colloidal silicon dioxide (instant claim 37) and between 1.5-2.5 mg colloidal silicon dioxide (instant claim 48) would have been obvious over the 4-5 mg of colloidal silicon dioxide ([0141]), as taught by Wang. One of ordinary skill in the art would have found it obvious to include different glidants and adjust the level based on the desired therapeutic attributes of the tablet. The recited ranges would have been obvious variants given the teaching of Wang unless there is evidence of criticality or unexpected results.
Regarding instant claims 37 and 48, the limitations of 3-3.5 mg of magnesium stearate (instant claim 37) and between 0.75-1.25 mg magnesium stearate (instant claim 48) would have been obvious over the lubricant, including magnesium stearate, that is between 1-5% by weight ([0126]), as taught by Wang. One of ordinary skill in the art would have found it obvious to adjust the level of the lubricant magnesium stearate based on the desired therapeutic attributes of the tablet. The recited ranges would have been obvious variants given the teaching of Wang unless there is evidence of criticality or unexpected results.
Regarding instant claim 46, the limitations of the tablet hardness of 5 to 10 kp and/or a friability of ≤ 1% by weight would have been obvious over the tablet hardness of 20 to 100 N ([0135]), which is calculated to be 2 kp to 10 kp (overlaps claimed range), and a friability of ≤1% by weight ([0136]), as taught by Wang.
Response to Arguments
Applicant’s arguments (Pages 12-13, filed 05/01/26) with respect to the rejection of claims 37, 46, and 48 under 35 U.S.C. 103 as being unpatentable over Hadd in view of Wang, Daoudal, and Davidson have been fully considered but are not persuasive.
Applicant argues that claim 1 is not obvious in view of Hadd at least because Hadd does not teach or suggest an immediate release tablet formulation which releases 85% of its bexagliflozin after 30 minutes, and Wang does not remedy this deficiency. Applicant argues that neither Wang's extended-release excipients nor the palatants of Daoudal and Davidson would lead a skilled person to the claimed immediate release formulation with its rapid dissolution profile.
This is not persuasive because, as explained above, the limitations of the tablet formulation recited in claim 1 are rendered obvious by the tablet taught by Hadd. Instant claim 1 does not recite any features related to the structural components, the corresponding concentrations, or arrangement of the components to distinguish over Hadd.
Regarding instant claim 37, the deficiency in Hadd regarding all the components and the corresponding amounts recited in instant claim 37 are cured by Wang, Daoudal, and Davidson. The references are properly combined because both Hadd and Wang are drawn to tablet formulations comprising bexagliflozin and fillers. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have found it obvious to use the fillers of Wang in their corresponding amounts in the tablet formulation of Hadd and have a reasonable expectation of success in producing a functional tablet comprising bexagliflozin.
One of ordinary skill in the art would have been motivated to add palatants taught by Daoudal and Davidson in the tablet composition comprising bexagliflozin of Hadd because Daoudal teaches the advantage of a protein substance as a palatable matrix ([0007]-[0008]), wherein the protein substance is liver powder ([0010], [0012], [0021], claim 3), the taste of which is particularly appreciated by cats ([0010]), and allows for the easy administration of preventive or curative treatments ([0009]), and Davidson teaches that the flavoring renders the composition palatable to pets (Abstract and [0047]).
The immediate release parameters argued by Applicant are related to specific tablet formulations, i.e., in TABLE 42 of the instant Specification, which are not recited in the instant claims. Please see MPEP 2145 and MPEP 716.02(d).
Therefore, the rejection of 02/25/26 is maintained.
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, 7-8, 16, 21-22, 26-27, 30-31, 35-36, 40, 44-47, 49, 52, and 55 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 3-6, 8-10, and 12-18 of copending Application No. 19/076,433 (the ‘433 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a tablet comprising bexagliflozin, and therefore, encompass overlapping or coextensive subject matter.
One difference is that instant claim 1 recites the in vitro dissolution parameters whereas claim 1 of the ‘433 Application is silent regarding these limitations.
Another difference is that claim 1 of the ‘433 Application recites the Raman spectra associated with the crystalline form of Compound 1 (bexagliflozin).
However, both sets of claims recite the same form of the composition (tablet) with the same pharmaceutical active ingredient (bexagliflozin). Therefore, the same properties of the composition, i.e., the in vitro dissolution parameters and the properties of the active ingredient are recited.
Therefore, instant claims are obvious over claims of the ‘433 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 13, filed 05/01/26) with respect to the provisional rejection of claims 1, 7-8, 16, 21-22, 26-27, 30-31, 35-36, 40, 44-47, 49, 52, and 55 on the ground of nonstatutory obviousness-type double patenting (NSDP) as being unpatentable over claims 1, 3-6, 8-10, and 12-18 of copending Application No. 19/076,433 (the ‘433 Application) have been fully considered but are not persuasive.
Applicant argues that they will consider filing a terminal disclaimer (TD) upon an indication of allowable subject matter.
This is not persuasive because allowable subject matter has not yet been identified. Until such time that a TD is filed the provisional NSDP rejection of 02/25/26 is maintained for the reasons given above.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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