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 .
Priority
The instant application was filed 09 June 2023 and is the national stage entry of PCT/EP2021/083622 filed 30 November 2021. The Applicant claims priority to foreign application FR2013175 filed 14 December 2020. An English translated copy of the document has not been provided. Therefore, the effective filing date of the instant application is 30 November 2021.
Examiner’s Note
The Applicant's amendments and arguments filed 23 February 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 Rejections not reiterated from previous office actions are hereby withdrawn.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 are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 23 February 2026, it is noted that claims 1-8 and 19 have been canceled, claims 9, 12, 13, and 15 have been amended, and no new claims have been added. Support for the amendment(s) can be found from the canceled claims. No new matter has been 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) 9-13, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minty et al. (WO 2018222545 A1) and Adali et al. (Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk, Processes, 2020).
Minty teaches a composition and method of making a cross-linked poly(amino acid) (abs, entire teaching). Sodium poly(glutamate), which is interpreted as salified poly glutamic acid, is dissolved in deionized water (polar solvent) (Example 1, para. 48). A crosslinker, such as ethylene glycol diglycidyl ether is added (para. 38, 48). The pH is adjusted and then the mixture is dried (abs, Example 1, para. 48). The composition may be coated with an active ingredient (para. 43), thus far addressing claim 9 and the polar solvent in claim 13. Gamma-polyglutamic acid may be used (para. 10), addressing claim 10. Sodium poly(glutamate) is interpreted as addressing the sodium glutamate monomers in claim 11. The fine powder formed is interpreted as addressing pulverulent solid in claim 12 (instant specification, pg. 3). In Example 1, 4.61g of sodium poly(glutamate) is used with 46.1 microliters in 46.1 mL of deionized water. The solution that is dried may also undergo micronization (para. 42), which is interpreted as addressing the atomizer limitation in claim 17 when the particle size is reduced. The drying step may occur at 150 °C (para. 48), addressing claim 18.
Minty does not specify spray drying in claim 9. Minty also does not teach exact percentages for the masses of the components in claim 12.
Adali teaches that spray drying helps to increase the rehydration capacity of powdered products (pg. 7).
Since Minty does not specify a spray drying step in claim 9 but does teach a drying step, one of ordinary skill in the art would have been led to use Adali’s teaching with a reasonable expectation of success. Minty teaches that their dried powder may have re-swelling difficulties (para. 46) and the drying and cross-linking step may be performed in a single step (para. 12), which may be done with spray drying. A skilled artisan would have been led to improve Minty’s method and composition by performing a spray drying step to enhance rehydration properties of the particles taught by Adali, and therefore would have been led to the claimed invention with a reasonable expectation of success.
In Example 1, 4.61g of sodium poly(glutamate) is used with 46.1 microliters in 46.1 mL of deionized water for claim 12. That being said and in lieu of objective evidence of unexpected results, the percentages can be viewed as a variable that achieves the recognized result of successfully performing the method of making the composition comprising polyglutamic acid. The optimum or workable range of mass % 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 polymer, crosslinker, and solvent as nonobvious.
Claim(s) 9-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Minty et al. (WO 2018222545 A1), Adali et al. (Spray Freeze-Drying as a Solution to Continuous Manufacturing of Pharmaceutical Products in Bulk, Processes, 2020), and Landoll (US 4304902 A).
In regards to claim(s) 9-13, 17-18, Minty and Adali, as applied supra, is herein applied in its entirety for its teachings of a composition and method of making a cross-linked polyglutamic acid.
Minty does not specifically teach an additional compound with formula XIV in claims 14-16.
Landoll teaches copolymers of ethylene oxide and epoxy-n-alkanes of 12-25 carbons (abs, entire teaching). Copolymers of epoxide monomers are well-known in the art (col. 1, lns. 20-21) and help to increase viscosity and retain solubility in water or acidic solutions (abs; col. 1, lns. 31-36). The amount range of copolymers containing the epoxy-n-alkanes may be 0.4-2% (col. 1, lns. 31-45), where a skilled artisan would understand the total amounts to add up to 100%.
Since Minty does not specifically teach formula XIV in claims 14 and 15, one of ordinary skill in the art would have been led to use Landoll’s teaching of using epoxy-n-alkanes with 12-25 carbons. A skilled artisan would have been led to combine the teachings because Landoll teaches these copolymers help to increase viscosity and retain solubility in aqueous or acidic solutions. Therefore, a person of ordinary skill in the art would have been motivated to use the teachings with a reasonable expectation of success.
Landoll teaches that the amount range of copolymers containing the epoxy-n-alkanes may be 0.4-2% (col. 1, lns. 31-45) for claim 16. That being said and in lieu of objective evidence of unexpected results, the percentages can be viewed as a variable that achieves the recognized result of successfully performing the method of making the composition comprising polyglutamic acid. The optimum or workable range of mass % 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 amount of formula XIV as nonobvious.
Response to Arguments
Applicant's arguments filed 23 February 2026 have been fully considered but they are not persuasive.
The Applicant argues that Minty and Adali used in combination do not arrive at the claimed invention (Remarks, pgs. 13-14).
Applicant’s argument is not found persuasive. Since Minty does not specify a spray drying step in claim 9 but does teach a drying step at the end, one of ordinary skill in the art would have been easily led to use Adali’s teaching with a reasonable expectation of success. Minty teaches that their dried powder may have re-swelling difficulties (para. 46) and the drying and cross-linking step may be performed in a single step (para. 12), which may be done with spray drying. A skilled artisan would have been led to improve Minty’s method and composition by performing a spray drying step to enhance rehydration properties of the particles taught by Adali, and therefore would have been led to the claimed invention with a reasonable expectation of success.
Conclusion
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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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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