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 .
DETAILED ACTION
2. This Office Action is responsive to Applicant’s Amendment and Remarks, filed March 30, 2026. The amendment, filed March 30, 2026, is entered, wherein claims 1, 3, 8 – 10, 15 – 16, and 21 are amended.
Claims 1 – 21 are pending in this application and are currently examined.
Priority
This application is a national stage application of PCT/IB2021/057356, filed August 10, 2021, which claims benefit of foreign priority document IN202021034475, filed August 11, 2020.
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. IN202021034475, 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. The foreign priority IN202021034475 does not provide support for the limitation of “non-aqueous vehicle is in range from 200 – 1000 mg/mL” recited in claim 7, “Propylene glycol and polyethylene glycol is in range from 0.1 to 15 mL” recited in claims 8, 15, and 21. Thus, the priority date of claims 7 – 8, 15, and 21 is August 10, 2021.
Withdrawn Rejections
4. The rejection of claim 9 in the previous Office Action, mailed December 29, 2025, 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 has been considered and is withdrawn in view of the amended claim 9.
The rejection of claims 1 – 7 and 10 – 14 in the previous Office Action, mailed December 29, 2025, under 35 U.S.C. 103 as being unpatentable over Joshi-Hangal et al. in view of Kumar has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 8 and 15 in the previous Office Action, mailed December 29, 2025, under 35 U.S.C. 103 as being unpatentable over Joshi-Hangal et al. in view of Kumar as applied to claims 1 – 7 and 10 – 14 above, and further in view of Walker and Chemical Book has been considered and is withdrawn in view of the amended claim 1.
The rejection of claim 9 in the previous Office Action, mailed December 29, 2025, under 35 U.S.C. 103 as being unpatentable over Joshi-Hangal et al. in view of Kumar as applied to claims 1 – 7 and 10 – 14 above, and further in view of MacLeod et al. has been considered and is withdrawn in view of the amended claim 1.
The rejection of claims 16 – 21 in the previous Office Action, mailed December 29, 2025, under 35 U.S.C. 103 as being unpatentable over Joshi-Hangal et al., Kumar, Walker, and Chemical Book as applied to claims 1 – 8 and 10 – 15 above, and further in view of Leung has been considered and is withdrawn in view of the amended claim 1.
The following are new grounds of rejection necessitated by Applicant’s Amendment and Remarks, filed March 30, 2026, wherein claims 1, 3, 8 – 10, 15 – 16, and 21 are amended. Previously cited references have been used to establish the new grounds of rejection.
New 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. 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.
Claims 1 – 2, 4, 10, 12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US10159714B2, cited in the previous Office Action mailed July 22, 2025).
a. Regarding claims 1 – 2, 4, 10, 12, 16, and 18, Leung teaches formulations and methods for treating cancer in mammals (Col. 1, lines 19 – 22). In other aspects, a GLP-1 receptor agonist and/or a beneficial agent is provided in a suspension formulation comprising (a) the GLP-1 receptor agonist and/or beneficial agent; and (b) a vehicle formulation, wherein the particle formulation is dispersed in the vehicle. In one aspect, the suspension formulation may comprise one or more stabilizers, wherein the stabilizer is inorganic compound, wherein the inorganic compound is KH2PO4. The suspension formulation further comprises a non-aqueous, single-phase suspension vehicle (Col. 2, lines 56 – 67; Col. 3, lines 17 – 21). The beneficial agent is an anticancer agent (Col. 3, lines 45 – 46), wherein the anticancer agent may be decitabine or azacitidine (Col. 21, line 55). The route of administration may be parenteral, including subcutaneous, intravenous, intramedullary, intraarticular, intramuscular, or intraperitoneal injection (Col. 9, lines 13 – 15).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate decitabine or azacitidine as the beneficial anticancer agent in the non-aqueous injectable suspension as taught by Leung because Leung explicitly teaches that decitabine or azacitidine may be the anticancer agent to be formulated into the non-aqueous injectable suspension. One would have been motivated to formulate decitabine or azacitidine as the beneficial anticancer agent in the non-aqueous injectable suspension as taught by Leung because it is known in the art that decitabine or azacitidine may be incorporated into the formulation. One of ordinary skill in the art would have had a reasonable expectation of success to formulate decitabine or azacitidine as the beneficial anticancer agent in the non-aqueous injectable suspension as taught by Leung because Leung explicitly teaches that decitabine or azacitidine is the beneficial agent that may be formulated into the non-aqueous injectable suspension.
Claims 3, 5 – 7, 11, 13 – 14, 17, and 19 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US10159714B2, cited in the previous Office Action mailed July 22, 2025) as applied to claims 1 – 2, 4, 10, 12, 16, and 18 above, and further in view of Joshi-Hangal et al. (US2004/0259820A1, cited in the previous Office Action mailed July 22, 2025).
b. Regarding claims 3, 5 – 7, 11, 13 – 14, 17, and 19 – 20, Leung teaches the limitations discussed above. Leung teaches that the amount of beneficial agent may be about 100 μL to about 1000 μL in volume (Col. 19, lines 23 – 24). Leung teaches that the non-aqueous, single-phase suspension vehicle comprises one or more polymers (Col. 2, line 67; Col. 3, line 1). Leung further teaches that the drug particles are incorporated in a suspension vehicle that do not settle in less than about three months at delivery temperature. Generally, smaller particles tend to have a lower settling rate in viscous suspension vehicles than larger particles (Col. 12, lines 50 -54). The viscosity of the suspension vehicle is typically sufficient to prevent the particle formulation from settling during storage and use in a method of delivery (Col. 14, lines 56 – 58).
However, Leung does not teach that the anticancer agent, or in particular decitabine or azacitidine, is present in range from 1 to 500 mg/mL and the stabilizing agent is present in range from 0.01 to 200 mg. Leung does not teach the non-aqueous vehicle is propylene glycol, polyethylene glycol, glycerin, medium chain triglycerides, wherein the non-aqueous vehicle is in range from 200 – 1000 mg/mL.
Joshi-Hangal et al. teach pharmaceutical formulations, kits, and vessels for delivering decitabine to a patient suffering from a disease in need of treatment with decitabine. The pharmaceutical formulation comprises decitabine solvated in a non-aqueous solvent that comprises glycerin, propylene glycol, polyethylene glycol, or combinations (Abstract), wherein decitabine is in a range between 0.1 and 200 mg/mL (para. [0040]). The pharmaceutical formulation may further comprise an acidifying agent, wherein the acidifying agent is citric acid (para. [0020 – 0021]), wherein the acidifying agent is at a concentration of 0.01 – 0.2 mg/mL (para. [0022]). Joshi-Hangal et al. teach that the formulation is prepared by dissolving crystalline powder of ascorbic acid in glycerin, mixing thoroughly, and dissolving micronized decitabine (para. [0153]). Joshi-Hangal et al. further teach an example that glycerin is in 980 mg with the specific gravity of glycerin and the formulation of 1.25 (para. [0152]). Moreover, Joshi-Hangal et al. discloses that decitabine is commonly formulated together with buffering salt, such as potassium dihydrogen phosphate, The example further discloses that amount of KH2PO4 used is 6.8 mg (para. [0008]).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the non-aqueous injectable suspension formulation as taught by Leung to employ the non-aqueous vehicles, including glycerin, propylene glycol, polyethylene glycol, or combinations in view of Joshi-Hangal et al. because Joshi-Hangal et al. teach that such component are suitable for formulating cytidine analog anticancer agents, such as decitabine, in non-aqueous injectable compositions. One would have been motivated to incorporate the specific vehicles taught by Joshi-Hangal et al. into the formulation of Leung to provide a pharmaceutically acceptable non-aqueous injectable formulation as both references are directed to the same anticancer agent. The modification represents the use of known formulation components according to their established functions to achieve predictable results. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification because Leung teaches the use of decitabine in non-aqueous suspension formulations and Joshi-Hangal et al. provide examples and guidance for formulating such agent using the claimed vehicles.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to formulate azacitidine in non-aqueous injectable suspension as taught by Leung using the non-aqueous vehicles, including glycerin, propylene glycol, polyethylene glycol, or combinations in view of Joshi-Hangal et al. because azacitidine and decitabine are closely related cytidine analog anticancer agents and Leung identifies both as alternative anticancer beneficial agents for the disclosed suspension formulation. One of ordinary skill in the art would have had a reasonable expectation of success to formulate azacitidine in non-aqueous injectable suspension as taught by Leung using the non-aqueous vehicles, including glycerin, propylene glycol, polyethylene glycol, or combinations in view of Joshi-Hangal et al. because Joshi-Hangal et al. demonstrate that such non-aqueous vehicles are suitable for formulating decitabine and Leung teaches azacitidine as an alternative anticancer agent in non-aqueous suspension formulations. The substitution of one known cytidine analog anticancer agent for another would have involved routine formulation optimization and would have been expected to yield a pharmaceutically acceptable injectable suspension.
Regarding claims 7, the calculated amount based on the example is 1225 mg/mL of glycerin. One would have performed routine experimentation to discover the best amount of non-aqueous vehicle and stabilizing agent for the optimal formulation characteristics.
Claims 8, 15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US10159714B2, cited in the previous Office Action mailed July 22, 2025) and Joshi-Hangal et al. (US2004/0259820A1, cited in the previous Office Action mailed July 22, 2025) as applied to claims 1 – 7, 10 – 14, and 16 – 20 above, and further in view of Walker (Organic Analytical Services, 2008, Reference included with PTO-892) and Chemical Book (Chemicalbook.com, July 2020, cited in the previous Office Action).
c. Regarding claims 8, 15, and 21, the references teach the limitations discussed above. Leung further defines that “single-phase” refers to a liquid homogenous system and a “homogeneous suspension” refers to a particle that is insoluble in a suspension vehicle and is distributed uniformly in a suspension vehicle (Col. 6, lines 54 – 62). The selected excipients and stabilizers may produce homogenous dispersions in suspension (Col. 14, lines 11 – 17).
However, these references do not teach the formulation comprises triethanolamine together with potassium dihydrogen phosphate in a range of 0.01 to 50 mg/mL.
Walker teaches that triethanolamine is used as dispersion agent (page 2, 1.1.3 Workplace exposure).
Chemical Book teaches that triethanolamine (TEA) has been used in salt formation for injectable solutions (page 3, para. 6). The lethal human oral dose of TEA is estimated to be 5 – 15 g/kg body weight (page 4, para. 4).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date to further modify the non-aqueous injectable suspension formulation as taught by Leung and Joshi-Hangal et al. to include triethanolamine in view of Walker and Chemical Book because triethanolamine is known in the art as dispersion agent and as an excipient used in injectable pharmaceutical compositions. One would have been motivated to include a known dispersion agent, such as triethanolamine, in the non-aqueous injectable suspension because the addition of such component is known in the art to promote uniform distribution of drug particles in the suspension vehicle. For the non-aqueous vehicle, the calculated amount based on the example is 1225 mg/mL of glycerin. One would have performed routine experimentation to discover the best amount of non-aqueous vehicle and stabilizing agent for the optimal formulation characteristics. One would also have performed routine experimentation to discover the best non-aqueous vehicle, whether alone or in combination, used in the suspension for the optimal formulation characteristics. Therefore, one of the ordinary skill in the art would have had a reasonable expectation of success to further modify the non-aqueous injectable suspension formulation as taught by Leung and Joshi-Hangal et al. to include triethanolamine in view of Walker and Chemical Book because it is known in the art that TEA is used in injectable pharmaceuticals and it acts as a dispersion agent.
Claim 9 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US10159714B2, cited in the previous Office Action mailed July 22, 2025) in view of MacLeod et al. (US2010/0247666A1, cited in the previous Office Action mailed December 29, 2025).
d. Regarding claim 9, Leung teaches formulations and methods for treating cancer in mammals (Col. 1, lines 19 – 22). In other aspects, a GLP-1 receptor agonist and/or a beneficial agent is provided in a suspension formulation comprising (a) the GLP-1 receptor agonist and/or beneficial agent; and (b) a vehicle formulation, wherein the particle formulation is dispersed in the vehicle. In one aspect, the suspension formulation may comprise one or more stabilizers, wherein the stabilizer is inorganic compound, wherein the inorganic compound is KH2PO4. The suspension formulation further comprises a non-aqueous, single-phase suspension vehicle (Col. 2, lines 56 – 67; Col. 3, lines 17 – 21). The beneficial agent is an anticancer agent (Col. 3, lines 45 – 46), wherein the anticancer agent may be decitabine or azacitidine (Col. 21, line 55). The route of administration may be parenteral, including subcutaneous, intravenous, intramedullary, intraarticular, intramuscular, or intraperitoneal injection (Col. 9, lines 13 – 15).
However, Leung does not explicitly teach the specific process steps for preparing the non-aqueous injectable suspension of an anticancer agent as recited in claim 9.
MacLeod et al. teach the method for preparing a suspension, wherein the method comprises (a) adding a predetermined amount of a solvent into a vessel; (b) sequentially adding predetermined amount of one or more other desired ingredients other than the API into the vessel while mixing continues; (c) adding a desired amount of a carboxy-containing vinyl polymer into the vessel while mixing continues until the polymer is completely dissolved to produce a first solution; (d) adjusting pH of the first solution to a predetermined pH value; and (e) adding a predetermined amount of API into the first solution while mixing continues under conditions of high-shear mixing to produce the suspension (para. [0057]).
It would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the known preparation method of MacLeod et al. to the non-aqueous suspension formulation of Leung because MacLeod et al. teach a general and conventional process for preparing pharmaceutical suspension and Leung teaches the corresponding non-aqueous suspension composition comprising an anticancer agent, such as decitabine or azacitidine, stabilizers, and non-aqueous vehicle. The combination represents the use of a known technique to prepare a known composition for its intended purpose, yielding predictable results. One of ordinary skill in the art would have had a reasonable expectation of success to apply the known preparation method of MacLeod et al. to the non-aqueous suspension formulation of Leung because the preparation of pharmaceutical suspensions by sequential addition of vehicle, excipients, and active agent with mixing is a routine and well-understood practice in the art.
Responses to Applicant’s Remarks:
Applicant’s Remarks, filed March 30, 2026, have been fully considered. Applicant’s argument regarding the amendment of claim 1, which requires “present as a dispersed phase within a non-aqueous vehicle forming a suspension” is persuasive; therefore, the previous rejections are withdrawn. However, insofar as Applicant’s arguments are applied to the new rejection set forth above, which relies on Leung as the primary reference in view of Joshi-Hangal et al. for the limitations of claim 1, the arguments are not persuasive for the reasons discussed below.
Regarding Joshi-Hangal et al., Applicant argues that Joshi-Hangal et al. disclose a dissolved system, not a suspension system. A person of ordinary skill in the art would not have had a reasonable expectation of success in converting the solubilized system into a suspension of water-soluble drug in a non-aqueous medium because such conversion requires control over dissolution behavior, maintenance of a dispersed phase, and stability of the suspension system.
Regarding Kumar, Applicant argues that Kumar broadly teaches suspensions as a dosage form but does not address the formulation of water-soluble drugs in non-aqueous suspension systems.
However, these arguments are moot because the current rejection does not rely on Joshi-Hangal et al. in view of Kumar. The current rejection relies on Leung for teaching a non-aqueous injectable suspension formulation comprising a beneficial anticancer agent, including azacitidine or decitabine, dispersed in a non-aqueous vehicle and relies on Joshi-Hangal et al. for specific non-aqueous vehicles and concentration ranges. Thus, Applicant’s arguments do not address the current grounds of rejection. For Joshi-Hangal et al., Joshi-Hangal et al. is not relied upon as the primary teaching of the claimed suspension system. Leung provides the teachings of the suspension formulation, including homogenous suspension/dispersed particle formulations in non-aqueous vehicles. Joshi-Hangal et al. is relied upon for the known use of non-aqueous vehicles in formulating related cytidine analog anticancer agents. Therefore, the current combination provides both the claimed suspension framework and the specific formulation components. Moreover, the current rejection is not based on converting the solubilized system of Joshi-Hangal et al. into a suspension. Leung is relied upon for teaching the non-aqueous suspension system, including a particle formulation dispersed in a non-aqueous vehicle and homogenous suspension formulation. Joshi-Hangal et al. is relied upon for teaching known non-aqueous vehicles used with related cytidine analog anticancer agents. Thus, the proposed combination does not required one of ordinary skill in the art to convert the solubilized system into a suspension.
Regarding claims 8 and 15, Applicant argues that Walker and Chemical Book merely disclose TEA as a general dispersion agent or injectable excipient, and do not suggest a TEA combination in the claimed context. Applicant further argues that a person of ordinary skill in the art would not have had a reasonable expectation of success in converting the solubilized system into the claimed suspension system. However, the argument is not persuasive. The current rejection does not rely on Joshi-Hangal et al. as teaching the claimed suspension system. Leung is relied upon for teaching a non-aqueous suspension formulation in which the particle formulation is dispersed in a non-aqueous vehicle and may form a homogenous suspension. Leung further teaches that selected excipients and stabilizers may be used to produce homogeneous dispersions in suspension. Joshi-Hangal et al. is relied upon for known non-aqueous vehicles used with related cytidine analog anticancer agents. Walker and Chemical Book are relied upon for teaching TEA as a known dispersion agent/injectable excipient. Thus, one of ordinary skill in the art would have been motivated to incorporate TEA into Leung’s suspension system in order to improve or maintain homogeneous dispersion of the anticancer agent within the non-aqueous vehicle. The rejection is therefore not based on converting the solubilized system into a suspension. Instead, the rejection applies known TEA dispersion agent to Leung’s suspension system for dispersing the anticancer agent in the non-aqueous vehicle.
Regarding MacLeod et al., Applicant argues that MacLeod et al. do not teach claim 9 because MacLeod et al. disclose complex suspension preparation methods involving polymer systems and specific process conditions, whereas the claimed process involves a simpler sequence in a non-aqueous system. The argument is not persuasive. MacLeod et al. is not relied upon for the specific claimed formulation components, but for the known process technique of preparing a suspension by adding a solvent to vessel, adding formulation components while mixing, and adding the API with continued mixing to form a suspension. These steps correspond to the claimed process of adding the non-aqueous vehicle to a manufacturing vessel, adding stabilizing agent with mixing, and adding anticancer drug with mixing to form a homogenous dispersion. The fact that MacLeod et al. may disclose additional or more complex embodiments does not negate its teaching of the basic sequential addition and mixing process.
Regarding Leung, Applicant argues that Leung cannot be used to substitute decitabine with azacitidine because the claims are directed to a specific suspension system and not merely to the choice of active agent. Applicant further argues that Leung does not teach or suggest that azacitidine can be formulated in the same non-aqueous suspension system as claimed, and that the substitution is not a simple equivalent replacement. However, these arguments are not persuasive. Leung teaches that the beneficial anticancer agent in the suspension formulation may be decitabine or azacitidine. Therefore, Leung identifies azacitidine and decitabine as suitable alternative anticancer agents for the disclosed suspension formulation. Joshi-Hangal et al. is not relied upon to teach azacitidine specifically, but rather for known non-aqueous vehicles used with the closely related cytidine analog anticancer agent decitabine. One of ordinary skill in the art would have had a reasonable expectation of success in applying the non-aqueous vehicle system taught by Joshi-Hangal et al. to azacitidine in view of Leung’s teaching that azacitidine is a suitable anticancer agent for such suspension formulations. Thus, the proposed modification is not based on the choice of active agent, but on the combined teachings of Leung and Joshi-Hangal et al. for related cytidine analog anticancer agents.
Conclusion
No claim is found to be allowable.
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.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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