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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 April 2026 has been entered.
Priority
The instant application was filed 23 January 2023 and is the national stage entry of PCT/EP2021/070577 filed 22 July 2021. The Applicant claims priority to several foreign applications as well as provisional application 63/056,094 filed 24 July 2020. The effective filing date of the instant application if 24 July 2020.
Examiner’s Note
The Applicant's arguments and amendments filed 19 March 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections and are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response filed 19 March 2026, it is noted that claim 1 has been amended and claim 21 has been newly added.
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.
Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bittorf (US 2009/0247468 A1) and Friesen (Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview, Molecular Pharmaceuticals, 2008), as evidenced by engineeringtoolbox.com.
Bittorf teaches a method for spray drying a drug, such as a solid dispersion of the drug (entire teaching; para. 7). A drug is mixed with a suitable solvent or combination of solvents (para. 8), such as acetic acid, dichloromethane, (para. 16) and acetone (para. 128). The composition may become supersaturated as a result of the low pH (para. 165). Polymers, such as HPMCAS, may be included (para. 29). The solvents dissolve both the drug and polymer, which is interpreted as addressing the active agent not in solid form. The solid dispersion is described as physically and chemically stable (para. 105), thus far partially addressing claim 1 and addressing claims 2-7, 9, 12, 13, 15, and 20. The combination of solvents, such as with a non-volatile solvent like acetic acid and a volatile solvent, such as dichloromethane or acetone (para. 16), is interpreted as addressing the first and second solvents, addressing claims 10, 11, 16-18.
In regards to the viscosity limitation in claims 1 and 21, the viscosity becoming lower after the addition of solvents, such as acetic acid and acetone, is interpreted as necessarily and inherently occurring when mixing a higher viscous solvent (acetic acid, 1.155 cP, engineeringtoolbox.com, pg. 1) and a lower viscous solvent (acetone, 0.316 cP, engineeringtoolbox.com, pg. 1). Bittorf teaches adding acetic acid in an amount of 0.1-15% (para. 18) and acetone in an amount of 20-35% (para. 18). Therefore, considering acetic acid has a viscosity that is three times higher than acetone and incorporating acetone in a higher amount than acetic acid, a skilled artisan would have been led to believe that the resulting supersaturated solution would have a lower viscosity than the first solvent.
Furthermore, the amounts of solvent to be added that would result in a lower viscosity supersaturated solution can be viewed as a variable that achieves the recognized result of successfully making the supersaturated composition and improving the properties of the product that is a result of varying the solvents and presumably the amounts of solvents (para. 7), which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Bittorf. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of solvents as nonobvious.
Bittorf does not teach Applicant’s election of methanol.
Friesen teaches that solid dispersions with HPMCAS are very soluble in solvents, such as methanol and provides an economical advantage for the spray drying process (pg. 1009).
In regards to selecting the combination of acetic acid and HPMCAS, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Since Bittorf does not teach methanol as one of their solvents, one of ordinary skill in the art would have been motivated to use methanol from Friesen’s teaching that solid dispersions with HPMCAS are very soluble in methanol with a reasonable expectation of success. A skilled artisan would be able to adjust the solvents of their composition based on the drug of choice and therefore would have been led to use methanol as one of their solvents to increase solubility of their solid dispersion. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
In regards to the amount of acetic acid in claim 1 and the ratios in claims 8, 14, and 19, Bittorf teaches examples where the solvent may comprise 40-80% of dichloromethane or 25-30% of acetone, or 3-12% of acetic acid (para. 18 and 135). However, a skilled artisan would be able to adjust and optimize the amounts of solvents based on the properties, characteristics, and solubilities of the drugs in their composition. Bittorf also provides examples of a weight ratio of dichloromethane to acetone to water, such as 75:24:1 (para. 131). That being said and in lieu of objective evidence of unexpected results, the amounts and ratios of solvents can be viewed as a variable that achieves the recognized result of successfully performing the method of making a solid dispersion. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts and ratios of solvents as nonobvious.
Response to Arguments
Applicant's arguments filed 19 March 2026 have been fully considered but they are not persuasive.
The Applicant argues that Bittorf teaches a much lower viscosity than the one in amended claim 1 (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. The Applicant points to one example of what could occur when varying the solvent and is not interpreted as representative of Bittorf’s entire teaching. In regards to the viscosity limitation in claims 1 and 21, the viscosity becoming lower after the addition of solvents, such as acetic acid and acetone, is interpreted as necessarily and inherently occurring when mixing a higher viscous solvent (acetic acid, 1.155 cP, engineeringtoolbox.com, pg. 1) and a lower viscous solvent (acetone, 0.316 cP, engineeringtoolbox.com, pg. 1). Bittorf teaches adding acetic acid in an amount of 0.1-15% (para. 18) and acetone in an amount of 20-35% (para. 18). Therefore, considering acetic acid has a viscosity that is three times higher than acetone and incorporating acetone in a higher amount than acetic acid, a skilled artisan would have been led to believe that the resulting supersaturated solution would have a lower viscosity than the first solvent.
The Applicant argues that the amount of acetic acid would not merely require a routine optimization (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. Bittorf teaches a broad range of solvent amounts appropriate for making the supersaturated solution. For example, Bittorf teaches adding acetic acid in an amount of 0.1-15% (para. 18) and acetone in an amount of 20-35% (para. 18) and that varying the solvents, and presumably the amounts of solvents, results in superior properties of the product (para. 7). The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[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). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
The Applicant argues that there is no suggestion or motivation to reduce the viscosity of the solution after dissolving the active agent with the combination of Bittorf and Friesen (Remarks, pgs. 9-10).
Applicant’s argument is not found persuasive. Friesen’s teaching is to provide motivation of using methanol as a solvent in Bittorf’s teaching. Additionally, the viscosity becoming lower after the addition of solvents, such as acetic acid and acetone, is interpreted as necessarily and inherently occurring when mixing a higher viscous solvent. In regards to the combination of Bittorf and Friesen, since Bittorf does not teach methanol as one of their solvents, one of ordinary skill in the art would have been motivated to use methanol from Friesen’s teaching that solid dispersions with HPMCAS are very soluble in methanol with a reasonable expectation of success. A skilled artisan would be able to adjust the solvents of their composition based on the drug of choice and therefore would have been led to use methanol as one of their solvents to increase solubility of their solid dispersion. Generally, it is prima facie obvious to substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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