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 .
CONTINUING DATA
FOREIGN APPLICATIONS
EP 22175413.8 05/25/2022
This office action is in response to Applicant’s amendment submitted January 20, 2026. Claims 1-2, 4-6, 14-32, and 34-38 are pending.
The rejection of claims 2, 5-7, 10, 14, 16-20, 22, and 24-38 under 35 U.S.C. 112(b) for broad limitations followed by narrow limitations, “such as” language, lack of and/or in claims28-29, and derivatives in claim 14 is withdrawn in view of Applicant’s amendment.
Specification
The amendment to the specification filed January 20, 2026 is acknowledged. The objection to the specification is withdrawn.
The rejection of claim(s) 1-2, 5-6, 8-9, 14, 22, 28, and 34-35, and 37 under 35 U.S.C. 102(a)(1) as being anticipated by Wallenius is withdrawn because Wallenius does not teach a velagliflozin composition and Wallenius’s composition contained organic solvents.
The rejection of claim(s) 1-2, 5, 8-9, 11-13, 22, 28-29, and 37 under 35 U.S.C. 102(a)(1) as being anticipated by CN112239440A is withdrawn because CN112239440A does not teach a velagliflozin composition and the CN112239440A composition contained ethanol.
The rejection of Claim(s) 1-2, 5, 7-10, 12-15, 22-23, 26, 28-29, and 37 under 35 U.S.C. 102(a)(1) as being anticipated by Laine is withdrawn because Laine does not teach a velagliflozin composition. The examiner has not included a 103 rejection over Laine because Laine’s composition which contained only dapagliflozin, water, and cyclodextrin was not used for therapy. It was only used to test solubility. The identity of propylene glycol as an organic solvent or not is in question, which will be explained in the 112(b) rejection below. The question of prior art which uses propylene glycol is better addressed using the Weiler reference, as will be explained in the rejection below.
The rejection of claim(s) 8-13 under 35 U.S.C. 103 as being unpatentable over Weiler is withdrawn because that rejection proposed the use of multiple organic solvents, including ethanol.
The rejection of claims 1-6, 8-17, 20-29, and 34-37 on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10220017 is withdrawn because the ‘017 patent requires two organic solvents.
Claim Interpretation
Claim 37 recites the composition of claim 1 and a package leaflet. MPEP 2111.05 states that if the printed matter is not functionally or structurally related to the associated physical substrate, the printed matter is owed no patentable weight. In a kit containing chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. The current instance is similar to the kit containing chemicals and instructions for using the chemicals, so the printed matter is not given patentable weight.
The following new rejections were necessitated by Applicant’s amendment, which creates new combinations of limitations and requires “free of any organic solvent,” which was previously recited in claim 7 as substantially free.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-6, 14-32, and 34-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 was amended to require a composition containing a solubilizing agent and which is “free of any organic solvent.” This identity of the solubilizing agent and organic solvent is unclear because several of the solubilizing agents which are specifically claimed in dependent claims are also organic solvents. For example, polyethylene glycols and propylene glycols are recited in dependent claims 14 and 28-29 are organic solvents. Benzyl alcohol is recited in claim 28 and is an organic solvent. PEG 200, PEG 300, and PEG 400 are recited in claim 31-32 and are organic solvents. Propylene glycol monolaurate is recited in claim 32 and is an organic solvent. The claims, including claim 1 and the rejected claims which depend from claim 1, appear to be in conflict with each other, so it is unclear exactly what is intended to be claimed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14, 28-29, and 31-32 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1 requires “free of any organic solvents.” Claims 14, 28-29, and 31-32 depend from claim 1 and explicitly require organic solvents, so claims 14, 28-29, and 31-32 fail to include all the limitations of claim 1. Polyethylene glycols and propylene glycols are recited in dependent claims 14 and 28-29 and are organic solvents. Benzyl alcohol is specifically recited in claim 28 and is an organic solvent. PEG 200, PEG 300, and PEG 400 are recited in claim 31-32 and are organic solvents. Propylene glycol monolaurate is recited in claim 32 and is an organic solvent. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 4-6, 14, 20-23, 27, 35-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiler (WO 2017/032799 A1, 2017, cited on IDS).
Weiler teaches the following compositions in Table 4 on page 14:
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Composition 7 contains velagliflozin, propylene glycol, water, disodium hydrogen phosphate dodecahydrate, and potassium hydrogen phosphate. Claim 1 states that the composition of free of any organic solvents, but claim 14 depends from claim 1 and explicitly includes propylene glycols. To the extent that propylene glycol is not considered to be a solvent excluded by claim 1, Composition 7 anticipates the claims. Composition 7 contains a phosphate buffer which is known to maintain a near-neutral pH. The compositions have an NTU value less than 3.0. See end of page 6. The compositions are suitable for direct administration and are sterile. Page 5, lines 29-30. The composition is for oral administration (page 8, lines 30-35), and is flavored with honey.
The compositions are used for treating metabolic disorders of animals such as an equine animal. Page 3.
A kit-of-parts containing the composition and a package leaflet is disclosed. Page 4.
The composition is prepared by mixing water and organic solvents, adding flavor, adding the velagliflozin, and filtering. Page 14.
In Table 7, Trial 1 contained honey flavor and a preservative, propyl-hydroxy-benzoate.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiler (WO 2017/032799 A1, 2017).
Weiler teaches as set forth above.
Weiler’s examples do not contain two or more of the solubilizing agents recited in current claim 17.
Weiler teaches that the compositions can contain solubilizing agents including SDS, Cremophor RH 40, polysorbate 20, Lutrol F 68, PEG 300, or propylene glycol monolaurate. It would have been obvious to one of ordinary skill in the art at the time the application was filed to include any one or more of these solubilizing agents in Weiler’s compositions because Weiler suggests it.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiler (WO 2017/032799 A1, 2017) in view of Vadlamudi (2107 IOP Conf. Ser: Mater. Sci. Eng. 263 022023).
Weiler teaches as set forth above, but does not teach povidone as a solubilizer. Weiler also teaches that SGLT-2 inhibitors are poorly soluble in water. Page 2, lines 12-16.
Vadlamudi teaches that povidone is an example of an excipient that improves solubility of poorly solvable compounds. Page 4, List of excipients.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute povidone for one of Weiler’s solubilizers or to add povidone to Weiler’s solubilizers. The Supreme Court in KSR reaffirmed the familiar framework for determining obviousness as set forth in Graham v. John Deere Co. (383 U.S. 1, 148 USPQ 459 (1966)), but stated that the Federal Circuit had erred by applying the teaching- suggestion-motivation (TSM) test in an overly rigid and formalistic way. KSR, 82 USPQ2d 1385. Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. Simple substitution of povidone for another solubilizer taught by Weiler would result in the claimed invention, and the results would have been predictable because povidone is a well-known solubilizer for pharmaceuticals.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiler (WO 2017/032799 A1, 2017) in view of Abdollahpour (J. Iran. Chem. Soc. Vol. 7, No. 2, June 2010, pp. 516-520).
Weiller teaches as set forth above, including compositions containing a preservative (propyl-hydroxy-benzoate) in Table 7 (pages 15-16).
Weiller does not teach sodium benzoate as the preservative.
Abdollahpour teaches that sodium benzoate and propylparaben (Weiller’s preservative) are usually used as preservatives in pharmaceuticals. Page 516, Introduction.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to add sodium benzoate to Weiller’s compositions because sodium benzoate is a commonly used preservative in pharmaceuticals. Weiller teaches that the preservative is not necessary (page 16), but the skilled artisan would have used a preservative in order to further reduce microorganisms.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiller in view of Abdollahpour as applied to claim 30 above, and further in view of Haznedaroglu (Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology Volume 96, Issue 3, September 2003, Pages 340-344).
Weiller teaches as set forth above, but does not teach that NaOH was present in the compositions. Several of Weiller’s compositions do contain a citric acid buffer.
Haznedaroglu teaches that citric acid buffer is prepared by addition of NaOH. Page 341, first paragraph.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Weiller’s compositions containing NaOH because Weiller’s compositions contain citrate buffer and citrate buffer may be prepared using NaOH. It would have been obvious to incorporate sodium benzoate as a preservative for the reasons set forth above.
Claim(s) 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weiller in view of Abdollahpour as applied to claim 30 above, and further in view of Haznedaroglu (Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology Volume 96, Issue 3, September 2003, Pages 340-344) and Mariotti (US 2012/0115958 A1, 2012).
Weiller, Abdollahpour, and Haznedaroglu teach as set forth above. Weiller teaches that the compositions may contain sweeteners, but does not teach compositions containing sorbitol and/or xylitol.
Mariotti teaches that glycerol, sorbitol, and xylitol are used as sweeteners in liquid pharmaceutical compositions [0011].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare Weiller’s compositions containing sorbitol and/or xylitol because Weiller’s compositions contain a sweetener and sorbitol/xylitol are used as sweeteners. It would have been obvious to incorporate sodium benzoate as a preservative and NaOH as part of a citrate buffer for the reasons set forth above.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare a composition of claim 33 such as composition 8, which contains velagliflozin, citric acid monohydrate, NaOH, SDS, sodium benzoate, sorbitol, honey flavor, and water because Weiller teaches compositions containing velagliflozin, buffer, honey flavor, water, solubilizing agents which include SDS, and a preservative. Abdollahpour suggests the use of sodium benzoate as a preservative, Haznedaroglu teaches that citrate buffer is made by combining citric acid and NaOH, and Mariotti teaches sorbitol as a sweetener. Following the suggestion of the prior art would result in a composition containing the same components as claimed Composition 8. The skilled artisan would have optimized the amounts of each component using routine experimentation.
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 1-2, 4-6, 14-17, 20-29 and 34-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10709683. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘683 patent claims an aqueous composition containing velagliflozin and one or more of ethanol, propylene glycol, or glycerol (claim 1). As was set forth above, there remains a question of whether propylene glycol is considered an organic solvent in the context of the claims. In the case that propylene glycol is not considered to be an organic solvent, this rejection is made over a composition which contains only propylene glycol as the organic solvent. The composition is buffered at pH 3 to 9 (claim 11). The composition contains solubilizing agents such as SDS, etc. (claim 14). The composition contains viscosity-enhancing agents such as cellulose derivatives (claim 16). The composition contains flavors or sweeteners such as honey (claim 17). NTU is less than 3.0 (claim 22). A kit-of-parts is claimed (claim 23). The process recited in ‘683 claim 24 meets the limitations of current claim 26. Methods of treating metabolic disorders in animals is claimed (claim 28). The minimum amount of organic solvent is as low as 10 g/100mL (claim 20).
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare the composition comprising any one or more of ethanol, propylene glycol, or glycerol. “One or more” solvents implies that any one of the solvents could be used alone, or two or more of the solvents could be used in combination. The skilled artisan would have used any one of the solvents or any combination of two, or all three because the ‘683 patent claims “one or more” of three solvents.
Claims 1-2, 4-6, 14-15, 20-29, and 34-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/594,627 in view of Weiler (WO 2017/032799 A1, 2017, cited on IDS).
The ‘627 application claims a liquid composition containing an SGLT-2 inhibitor and a solubilizer. See claims 6-7. Velagliflozin is the only SGLT-2 inhibitor in the composition (claim 9). The composition includes one or more solvent selected from ethanol, propylene glycol, and glycerol (claim 13). As was set forth above, there remains a question of whether propylene glycol is considered an organic solvent in the context of the claims. In the case that propylene glycol is not considered to be an organic solvent, this rejection is made over a composition which contains only propylene glycol as the organic solvent. A method of treating a metabolic disorder is claimed, and administration is oral (claim 18). Equine animals are treated (claim 21).
The ’627 application does not claim that the composition is aqueous.
Weiler teaches as set forth above, compositions containing SGLT-2 inhibitors for treating metabolic disorders in animals. The compositions are aqueous. In addition to compositions in Table 4 on page 14 (reproduced above), the compositions are suitable for direct administration and are sterile. Page 5, lines 29-30.
The compositions have an NTU value less than 3.0. See end of page 6.
The pH using citric acid buffer is 6.0. Page 8, first paragraph. Citric acid buffer contains citric acid as recited in current claim 25.
The composition is for oral administration (page 8, lines 30-35), and is flavored with honey.
The compositions are used for treating metabolic disorders of animals such as an equine animal. Page 3.
A kit-of-parts containing the composition and a package leaflet is disclosed. Page 4.
The composition is prepared by mixing water and organic solvents, adding flavor, adding the velagliflozin, and filtering. Page 14.
Aqueous compositions comprising velagliflozin, 20% propylene glycol, and solubilizing agents such as SDS, Cremophor RH 40, Lutrol F 68, and PEG 300 were also prepared. Page 16, Example 5. This composition meets the limitations of claim 8.
Compositions in Table 7 (pages 15-16) contained a preservative, propyl-hydroxy-benzoate.
The composition in Example 6, pages 16-17 contained hydroxyethyl cellulose as a viscosity-enhancing agent.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare the ‘627 as an aqueous composition because the ‘627 composition is a liquid containing an SGLT-2 inhibitor and an alcohol, used for treating metabolic disorders in animals. Weiler also teaches a liquid containing an SGLT-2 inhibitor and an alcohol, used for treating metabolic disorders in animals, and the liquid contains water. The skilled artisan would have added water and additional excipients taught by Weiler in order to obtain a composition suitable for administering to animals for treatment of metabolic disorders.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-2, 4-6, 14-32, and 34-37 are rejected. Claim 38 is allowed. The closest prior art for claim 38 is Weiler, which requires at least one of ethanol, propylene glycol, and glycerol. The prior art of record does not suggest replacing ethanol, propylene glycol, and glycerol with a different solubilizer to arrive an at aqueous composition comprising velagliflozin.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693