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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3, 7-8, 12, 16, 21-22, 26-27, 30-31, 35-38, 40, 44-49, 52, and 55) in the reply filed on 11/18/25 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 50 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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.
Priority
This Application claims foreign priority to PCT/CN2022/093377 (published as WO 2023/220930 A1) filed on 05/17/22. A copy of WO 2023/220930 A1 is attached with this Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 08/04/23 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.
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 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:
PNG
media_image1.png
212
460
media_image1.png
Greyscale
([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.
Claims 2, 3, and 12 are 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.”
Claims 16, 21-22, 26-27, 30-31, and 35-36 are 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.
Claims 37, 46, and 48 are 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.
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 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.
Conclusion
No claims are allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-6023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARADHANA SASAN/Primary Examiner, Art Unit 1615