DETAILED ACTION
Previous Rejections
Applicants' arguments, filed 14 April 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The indefiniteness rejection is withdrawn in view of the amendment to the claims (see remarks at page 10). And the nonstatutory double patenting rejections are withdrawn in view of the terminal disclaimer filed (see remarks at page 13). The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Claims 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of polymer (they recite additional monomers not elected), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 24 November 2025.
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.
Claims 19-24 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Minty et al. (US Patent Application Publication 2020/0095386 – published March 2020) in view of Adali et al. (Processes, 2020, 8(6), 709 – published June 2020).
Minty et al. discloses rheology modifiers comprising crosslinked poly(amino acid) microparticles (abstract). In particular, the poly(amino acid) is γ-poly(glutamic acid) (id.). An example crosslinks sodium γ-poly(glutamic acid) with ethylene glycol diglycidyl ether (example 1). This is the elected species of polymer.
In this example, the method of making the polymer involves dissolving the γ-poly(glutamic acid) in water (a polar solvent), adjusting the pH to 5.8, then adding the ethylene glycol diglycidyl ether crosslinker as an aqueous solution. The mixture is polymerized and subsequently dried in an oven.
This method differs from the method recited by independent instant claim 19 in the manner of drying, as the taught method uses an oven, whereas spraying is instantly recited. This difference is addressed by Adali et al., which discloses that pharmaceutical manufacturing is evolving from traditional batch processes to continuous ones, and further discusses that spray freeze-drying is a technology which can achieve this objective (abstract). Adali further teaches that spray drying helps to increase the rehydration capacity of powdered products (page 7, third paragraph).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have used the alternative drying method taught by Adali et al. Doing so would provide for continuous manufacturing abilities, which is the current evolution of pharmaceutical formulations. Further, Minty et al. teaches that their dried powder may have re-swelling difficulties (paragraph [46]) and the method disclosed by Adali et al. would address this issue by increasing the rehydration properties of the particles. Thus, the process recited by independent instant claim 8 is rendered prima facie obvious.
Instant claims 20-21 further limit the polymer, and the γ-poly(glutamic acid) disclosed by Minty et al. reads upon these limitations.
Instant claim 22 limits the relative amounts. The example disclosed by Minty et al. does not necessarily as required by the instant claim. However, the difference is one between the relative concentrations. And generally, differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover 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(II)(A).
Instant claim 23 further limits the crosslinker, and the above cited crosslinker reads upon these limitations.
Instant claim 24 recites that the polar solvent can be water, which ids the solvent present in the example disclosed by Minty et al.
Instant claim 28 further limits the spraying step, and spraying using air through a nozzle to perform atomization is disclosed by Adali et al. for the spray drying method (page 7, section 3).
Instant claims 29-30 further limit the temperature of this step, and while the temperature is not suggested by the references, generally, differences in concentration and tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover 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(II)(A).
Response to Arguments
The Applicant argues that the obviousness rejection is not proper. The Applicant states that Minty et al. discloses a process for preparing the polymer where the crosslinking reaction occurs during the time in the oven, then after rehydration the rehydrated polymer is dried and ground to provide a powder. In contrast, the claimed invention recites a simpler method where the polymer is prepared during the atomization drying step, and thus one of ordinary skill in the art would not consider replacing all of the steps disclosed by Minty et al. with the spray drying step discussed by Adali et al.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. It is noted that the arguments appear to be reading limitations from the disclosure into the claim. The claim does not require that all the steps subsequent to the first drying step be condensed into a single step. Rather, the claim recites a drying step. And Adali et al. teaches an alternative drying step (with reasoning to do so). The removal of additional steps from the method taught by Minty et al. is not required by the instant claims, nor asserted in the rejection rationale.
Conclusion
THIS ACTION IS MADE FINAL. 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 Brian Gulledge whose telephone number is (571) 270-5756. The examiner can normally be reached Monday - Friday 7am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brian Gulledge/Primary Examiner, Art Unit 1699
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