DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 07/21/2026 has been entered. Claims 1-21 are pending in this application. Claims 17-21 are withdrawn. Claims 1-16 are currently examined.
Priority
This is US Application No. is 18/594,627 filed on 03/04/2024 and claims foreign priority of EP 23160128.7 filed on 03/06/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. EP 23160128.7, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 4 and 12 recite “ is no greater than 3 mL, or no greater than 2 mL” and/or “in solved or suspended form”, which are not disclosed or supported by the prior-filed application, Application No. EP 23160128.7. Thus, the priority date of claims 4 and 12 is 03/04/2024.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1-16) and species (container, recited in claim 6, and adaptor, recited in amended claim 15 depending from claim 6) in the reply filed on 07/21/2026 is acknowledged. The traversal is on the ground(s) that “there is no undue burden on the Examiner to examine all pending claims” (p. 27, para. 2). This is not found persuasive because "Inventions I/II are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, Invention I is directed to a syringe apparatus suitable for administering, but not requiring, a liquid pharmaceutical composition, whereas Invention II is directed to a method of administering a dosage of a liquid pharmaceutical composition. Thus, they are not disclosed as capable of use together and they have different designs and modes of operation”, as set forth no pages 4 to 5 of the Restriction/Election Requirement mailed on 05/21/2026. Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-16 are currently under examination. The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Twelve information disclosure statements (IDS) filed on 03/04/2024, 10/30/2025, 03/06/2026, and 07/21/2026 with appropriate assertion under 37 CFR 1.98 have been considered.
Claim Objections
Claims 1, 5, 7, 12, and 15 are objected to because of the following informalities: In claim 1, insert the missing word “open” immediately before the recitation “barrel forward end” (lines 18, 22, and 26) to be consistent with the preceding “open barrel forward end”. In claim 5, insert the missing word “open” immediately before the recitation “barrel forward end” (line 6) and “barrel rear end” (line 7) to be consistent with “open barrel forward end” and “open barrel rear end” in the preceding claim. In claim 7, replace the incorrect recitation “represented by” (a total of 23 occurrences), which means one of many, with “having”; change the incorrect conjunction “and” (second line from the end of the paragraph (1) compound) because the “and” indicates a combination of all substituents; insert the phase “of the formula (14)” immediately after the recitation “wherein R” (line 3 in the (14) paragraph) to differentiate from the preceding “R” in formula (12); change the incorrect recitation “tert. butyl” (lines 3 to 4 in the (14) paragraph) to “tert-butyl”; insert the phrase “of the formula (15)” immediately after the recitation “R1” (line 4 in the (15) paragraph) to differentiate from the preceding “R1” in formula (1); insert the phrase “of the formula (18)” immediately after the recitation “R3” (line 4 in the (18) paragraph) to differentiate from the preceding “R3” in formula (1); change the incorrect conjunction “and” before the last substituent in the (18) paragraph to “or” because the “and” indicates a combination of all substituents; insert the missing phrase “having the following formula” immediately after the recitation “(21) Rongliflozin”; and change the incorrect structure “
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“, which is not Rongliflozin, in the (21) paragraph to “
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”. In claim 12, change the incorrect recitation “solved” (line 2) to “dissolved”. In claim 15, insert the missing word “open” immediately before the recitation “barrel forward end” (lines 3, 9, and 10) and insert the word “hollow” immediately before the recitation “connection member” (line 3) to be consistent with the preceding term. Appropriate correction is required.
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 2, 7-12, and 16 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. Claims 8-12 depend from claim 7.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2, 7, and 16 recites the broad recitation “a polymer material” (line 2 of claims 2 and 16), or “wherein R1 denotes… R2 denotes… R3 denotes… R3 of the formula (18) denotes” (in formula (1) and formula (18)), and the claims also recite “preferably” or “most preferably” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 5 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Pheng et al. (US 2022/0280389, published on Sep. 8, 2022 and filed on Jan. 10, 2022, hereinafter referred to as Pheng ‘389).
With regard to structural limitations “a system comprising a syringe, comprising: (a) a barrel (or formed of a polymer material or polyethylene) comprising a hollow elongated member including an open barrel forward end and an open barrel rear end, the hollow elongated member comprising: a first portion that extends from the open barrel forward end to a transition section disposed along the hollow elongated member, the first portion having a first cross-sectional dimension; and a second portion that extends from the transition section to the open barrel rear end, the second portion having a second cross-sectional dimension that is greater than the first cross-sectional dimension; and (b) a plunger comprising an elongated member including a plunger forward end and a plunger rear end; wherein: (i) the plunger and the barrel are dimensioned such that a portion of the plunger including the plunger forward end is insertable within the hollow elongated member of the barrel at the open barrel rear end, and the plunger is extendible within the barrel until the plunger forward end engages with an internal surface portion of the hollow elongated member at the open barrel forward end; (ii) receipt of liquid pharmaceutical composition within the barrel of the syringe via the open barrel forward end is limited to a volume defined within the first portion of the barrel, wherein the volume is adjustable by adjusting a displacement of the plunger forward end away from the open barrel forward end; and (iii) a surface wall section of the plunger includes indicia comprising a dosage scale (or comprising a plurality of marks aligned in a direction that corresponds with a lengthwise dimension of the plunger; and in operation, the volume of the liquid pharmaceutical composition received within the first portion of the barrel in response to displacement of the plunger forward end away from the open barrel forward end is indicated by alignment of a corresponding mark of the dosage scale with an exterior surface of the barrel at the open barrel rear end) that indicates the volume of the liquid pharmaceutical composition received within the first portion of the barrel based upon a corresponding displacement of the plunger forward end away from the open barrel forward end” (claims 1, 2, and 5):
Pheng ‘389 disclosed an apparatus for advancing accurate quantities of fluids within a syringe for more controlled administration or dosing of, more particularly oral dosing of viscous fluids.
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. User advances liquid within the syringe by rotating (or alternatively pushing) the end of the plunger. As the plunger 10 progresses, uniform force is transferred from the plunger tip 85 to the liquid within the barrel 15, causing this material to exit the distal end 90 of the syringe. Addition of a recessed button, pin hole, or similar retraction mechanism to disengage the receiving element 95 from the plunger 10, such that the plunger 10 may be withdrawn from the barrel 15 if needed. In another embodiment the modified plunger 10 profile allows for more swift administration of liquid within the barrel 15 by offering a set of tactile and auditory plunger stops or teeth 120 for each unit dose. A pin 100 moves over the profile peaks of the plunger 10 and then clicks within each valley 125. Force to the plunger 10 is transferred to the receiving element 95, causing the spring 105 to compress and allowing the pin 100 to follow the contour of the stop or tooth 120 until it is propelled into next valley 125, creating the noise and vibration to signal the administration of a unit dose. The components will be manufactured from durable autoclavable plastics such as polypropylene and polyethylene (page 15/21, [0005, 0015]; page 2/21, Fig. 1A; page 10/21, Fig.8B and Fig. 8C; page 18/21 to 19/21, [0093, 0099, 0100, 0109]).
Thus, these teachings of Pheng ‘389 anticipate Applicant’s claims 1, 2, and 5.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(I) Claims 1-6, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Folger et al. (US 2014/0224680, Aug. 14, 2014, hereinafter referred to as Folger ‘2014) in view of Jones (US 9,566,388, hereinafter referred to as Jones’388, also listed in IDS filed on 03/06/2026) and Pieroni et al. (WO 2007/100779, September 7, 2007, hereinafter referred to as Pieroni ‘779).
With regard to structural limitations “a system comprising a syringe, comprising: (a) a barrel (or formed of a polymer material or polyethylene) comprising a hollow elongated member including an open barrel forward end and an open barrel rear end, the hollow elongated member comprising: a first portion that extends from the open barrel forward end to a transition section disposed along the hollow elongated member, the first portion having a first cross-sectional dimension; and a second portion that extends from the transition section to the open barrel rear end, the second portion having a second cross-sectional dimension that is greater than the first cross-sectional dimension; and (b) a plunger (or formed of a polymer material or polystyrene) comprising an elongated member including a plunger forward end and a plunger rear end; wherein: (i) the plunger and the barrel are dimensioned such that a portion of the plunger including the plunger forward end is insertable within the hollow elongated member of the barrel at the open barrel rear end, and the plunger is extendible within the barrel until the plunger forward end engages with an internal surface portion of the hollow elongated member at the open barrel forward end; (ii) receipt of liquid pharmaceutical composition within the barrel of the syringe via the open barrel forward end is limited to a volume defined within the first portion of the barrel, wherein the volume is adjustable by adjusting a displacement of the plunger forward end away from the open barrel forward end; and (iii) a surface wall section of the plunger includes indicia comprising a dosage scale (or comprising a plurality of marks aligned in a direction that corresponds with a lengthwise dimension of the plunger; and in operation, the volume of the liquid pharmaceutical composition received within the first portion of the barrel in response to displacement of the plunger forward end away from the open barrel forward end is indicated by alignment of a corresponding mark of the dosage scale with an exterior surface of the barrel at the open barrel rear end) that indicates the volume of the liquid pharmaceutical composition received within the first portion of the barrel based upon a corresponding displacement of the plunger forward end away from the open barrel forward end” (claims 1, 2, and 5), and “further comprising: a container that contains a liquid pharmaceutical composition (or including ethanol; or further comprising: an adaptor connected with an opening in the container, the adaptor comprising a hollow connection member that facilitates coupling of the open barrel forward end with the hollow connection member to facilitate transfer of the liquid pharmaceutical composition to the first portion of the barrel, wherein a portion of the hollow connection member of the adaptor has an outer diameter that is substantially similar to an inner diameter at the opening in the container to establish a frictional and fluid tight connection between the adaptor and the container, and the hollow connection member of the adaptor has an inner diameter that is substantially similar to an outer diameter of the open barrel forward end to establish a frictional and fluid tight connection between the adaptor and the barrel in response to insertion of the open barrel forward end into the hollow connection member, wherein the adaptor is form of a low density polyethylene, and the container is formed of a high density polyethylene)” (claims 6, 13, 15, and 16):
Folger ‘2014 disclosed Fig. 4, a schematic side view of an exemplary embodiment of a dispenser 20, preferably syringe-like dispenser, and Fig. 7, a schematic side view of an exemplary container 10:
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. The syringe-like dispenser 20 includes a syringe barrel 30 having an elongated cylindrical body defining a chamber for retaining fluid, a plunger 25 in fluid-tight slidable engagement inside the barrel 30, an elongated plunger rod 27 extending in the longitudinal direction through the barrel 30, and a tip 35 having a tip passageway. The front surface of the dispenser 20 is preferably provided with a scale reading which facilitates to determine and adjust the dosage of the liquid dosage form. The labeling indicated on the dispenser 20 contains a number of marks which preferably correspond to the weight (in kg) of the patient/animal patient. In the exemplary embodiment the plunger 25 of the dispenser 20 has a protruding part 40 which extends in the direction of the tip 35 and fits within the tip passageway in such a manner to be able to press the liquid in the tip passage way practically completely out of the dispenser 20. The adapter 50, respectively, has an application arrangement piece 55 with a through-hole 57 to fit with a dispenser 20 to the container 10. On one hand, the form of the adapter 50 is adapted to the form of the opening 11 and mouthpiece of the container 10 so that the adapter 50 is a removable seal disposed on, and sealingly engaged with a part of the inner walls at the upper end 12 of container 10. On the other hand, the adapter 50, particularly the through-hole 57 of the application arrangement piece 55, is adapted to the form of the tip 35 of a dispenser 20 to be inserted. In the exemplary embodiments shown the adapter 50 is a stopper, preferably made of a plastic material. The sealing 15 may be used to close the container 10 again whereby the adapter 50 still remains on the container. The adapter preferably has an additional edge, preferably an edge protruding to the outside as a further contact surface to provide additional contact with the container, particularly with the upper side or rim of the mouthpiece, in order to provide a tighter fit and to improve the fitting accuracy with the container (page 4/30, Fig. 4; page 8/30, Fig. 7; pages 26/30 to 27/30, [0308-0311, 0316, 0321]; page 16/30, [0113]). It is preferred to add PVP and optionally talc in the form of a solution in an organic solvent like ethanol and/or acetone (page 21/30, [0198]). Liquid dosage forms in general offer the option of very flexible dosing by adjusting the administered volume. The oily suspensions (preferably flavored) containing one or multilayered particles or pellets, lead to the desired result: they are very well accepted by the patients (exemplified by cats) and are in the majority of cases ingested voluntarily (page 24/30, [0273]).
Folger ‘2014 did not explicitly disclose the limitations (a) a surface wall section of the plunger includes indicia comprising a dosage scale (or comprising a plurality of marks aligned in a direction that corresponds with a lengthwise dimension of the plunger; and in operation, the volume of the liquid pharmaceutical composition received within the first portion of the barrel in response to displacement of the plunger forward end away from the open barrel forward end is indicated by alignment of a corresponding mark of the dosage scale with an exterior surface of the barrel at the open barrel rear end) that indicates the volume of the liquid pharmaceutical composition received within the first portion of the barrel based upon a corresponding displacement of the plunger forward end away from the open barrel forward end, required by claims 1 and 5, (b) a barrel is formed of polyethylene, a plunger is formed of polystyrene, the adaptor is form of a low density polyethylene, and the container is formed of a high density polyethylene”, required by claims 2 and 16, and (c) the first portion of the barrel has a length to diameter (L/D) ratio from 5 to 20, or the first portion of the barrel defines a volume within the hollow elongated member that is no greater than 3 mL, required by claims 3 and 4.
With regard to the limitation (a) above, Jones’388 disclosed Fig. 1A (a side perspective view of a syringe 100 utilizing a patient-based measuring indicia):
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. Syringe 100 includes a barrel 120 having a top, open end 124 and a bottom, closed end 122. Syringe 100 also includes a cross style plunger 110 having a top end 114, a bottom end 112, and four blades 116 (all four blades not explicitly shown) that make up the “cross” of the plunger. Barrel 120 is marked with two measurement lines 126. Plunger 110 contains a set of patient-based numerical measuring indicia 118 that represents a range of weight in kilograms for an adult patient (page 2/14, Fig. 1A; page 11/14, col. 3, lines 30-40).
With regard to the limitation (b) above, Pieroni ‘779 disclosed an improved adapter assembly for connecting a medication bottle to a needleless syringe. The bottle may be made of glass, plastic, or any other suitable material. The adapter can be made from any suitable polymeric material including, but not limited to, polyamides, polyesters, polycarbonates, polyolefins, polystyrene, and polyvinyl chloride. For example, the adapter can be molded from high-density polyethylene (HDPE) or low-density polyethylene (LDPE) (page 7/30, [0025]; page 10/30, [0031]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the generic surface of a plunger and generic plastic material (for barrel, plunger, container, and adapter) as taught by Folger ‘2014 with the patient-based measuring indicia on the surface of the plunger and specific plastic material (including polystyrene, high-density polyethylene or low-density polyethylene), respectively, in view of Jones’388 and Pieroni ‘779, followed by optimizing the length to diameter (L/D) ratio or volume of the first portion of the barrel to prepare a syringe for dosing of medicament or oral composition because the patient-based measuring indicia on the surface of the plunger provides informed and accurate dosing and the suitability of plastic material, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the generic surface of a plunger and generic plastic material (for barrel, plunger, container, and adapter) as taught by Folger ‘2014 with the patient-based measuring indicia on the surface of the plunger and specific plastic material (including polystyrene, high-density polyethylene or low-density polyethylene), respectively, in view of Jones’388 and Pieroni ‘779, followed by optimizing the length to diameter (L/D) ratio or volume of the first portion of the barrel to prepare a syringe for dosing of medicament or oral composition, one would achieve Applicant’s claims 1-6, 13, 15, and 16. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
(I) Claims 7-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Folger et al. (US 2014/0224680, Aug. 14, 2014, hereinafter referred to as Folger ‘2014) in view of Jones (US 9,566,388, hereinafter referred to as Jones’388, also listed in IDS filed on 03/06/2026) and Pieroni et al. (WO 2007/100779, September 7, 2007, hereinafter referred to as Pieroni ‘779), as applied to claims 1-6, 13, 15, and 16, further in view of Hadd et al. (WO 2021/092341, published on May 14, 2021, hereinafter referred to as Hadd ‘341, also listed in IDS filed on 10/30/2025).
The above teachings of Folger ‘2014 in view of Jones’388 and Pieroni ‘779 are incorporated into their entirety here but did not explicitly disclose the limitations “the liquid pharmaceutical composition comprises one or more SGLT-2 inhibitor compound(s) (or a structural derivative of glucopyranosyl-substituted benzene; or Velagliflozin (
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), Dapagliflozin, Canagliflozin, Empagliflozin, Luseogliflozin, Tofogliflozin, Ipragliflozin, Ertugliflozin, Atigliflozin, Remogliflozin, Sotagliflozin, Sergliflozin, Bexagliflozin, or Janagliflozin; or from 0.1 to 20 mg/mL; or valagliflozin, the only SGLT-2 inhibitor of 1.2 mg/mL or 15 mg/mL; or in dissolved or suspended form; or an organic polar solvent comprising propylene glycol and at least one of ethanol and glycerol), required by claims 7-12 and 14.
Hadd ‘341 disclosed a method of using sodium-glucose linked transporter (SGLT) inhibitors in the management of hypertension, renal disease (e.g., chronic kidney disease) or heart failure in companion animals (in particular, felines and canines). SOLT inhibitors are atigliflozin, bexagliflozin, canagliflozin, dapagliflozin, empagliflozin, enavogliflozin, ertugliflozin, henagliflozin, ipragliflozin, janagliflozin, licogliflozin, luseogliflozin, mizagliflozin, remogliflozin, sergliflozin, sotagliflozin, tianagliflozin and tofogliflozin. In addition, velagliflozin is being developed for the management of animal forms of diabetes and related morbidities. The use of all conformational or optical isomers and other mixtures of such isomers, as well as solvates, hydrates, isomorphs, polymorphs, co-crystals and tautomers are within the scope. In some embodiments, the compound that inhibits an SOLT or the prodrug thereof has a structure selected from the group consisting of:
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(pages 27/97 to 28/97, [0114, 0116]; page 45/97 to 48/97, [0157, 0160]). Companion animals include domestic animals preferably including canines (dogs), felines (cats), equidae (horses). In some embodiments, the therapeutically effective amount administered to a canine is a total daily dosage of about 10-4,000 μg kg-1 of the compound that inhibits an SGLT or the prodrug thereof or a total daily dosage selected from the group consisting of about 50 μg kg-1, 100 μg kg-1, 200 μg kg-1, 400 μg kg-1, 800 μg kg-1, 1,000 μg kg-1. In some embodiments, the therapeutically effective amount is one-time daily. In some embodiments, the therapeutically effective amount is two-times (twice) daily. In some embodiments, the therapeutically effective amount is an oral liquid dosage form. Oral liquid dosage forms can be clear solutions, emulsions or suspensions, such as colloidal suspensions or coarse suspensions. They are often predominantly aqueous but may contain medically acceptable co-solvents such as ethanol, propylene glycol, glycerol or polyethylene glycols (pages 54/97 to 55/97, [0171, 0174, 0178]; pages 58/97 to 62/97, [0189, 0191, 0198, 0199, 0206]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the generic oral composition or therapeutic as taught by Folger ‘2014 in view of Jones’388 and Pieroni ‘779 with the liquid pharmaceutical composition comprising one or more SGLT-2 inhibitor compound(s) further in view of Hadd ‘341, followed by optimizing the volume and concentration of the one or more SGLT-2 inhibitor compound(s) to prepare a syringe for dosing of medicament or oral composition because the one or more SGLT-2 inhibitor compound(s) is effective for treating many diseases, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the generic oral composition or therapeutic as taught by Folger ‘2014 in view of Jones’388 and Pieroni ‘779 with the liquid pharmaceutical composition comprising one or more SGLT-2 inhibitor compound(s) further in view of Hadd ‘341, followed by optimizing the volume and concentration of the one or more SGLT-2 inhibitor compound(s) to prepare a syringe for dosing of medicament or oral composition, one would achieve Applicant’s claims 7-12 and 14. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 [R-01.2024] [II.A].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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