DETAILED ACTION
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 . 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 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.
Election/Restrictions
Applicant's election with traverse of Group II (claims 8-17) and the species of polymer (P) (γ-poly(glutamic acid) crosslinked with ethylene glycol diglycidyl ether) in the reply filed on 24 November 2025 is acknowledged. The traversal is on the ground(s) that the combination of categories precludes restriction in this instance. This is not found persuasive because as an initial matter, the claims are not drawn to only one of those categories, and further reasons for why the shared technical feature does not make a contribution over the prior art was provided. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-7 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of polymer (they recite additional monomers not elected), there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.
Claim Rejections - 35 USC § 112 - Indefiniteness
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.
Claim 17 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 17 recites the limitation "the inlet temperature". There is insufficient antecedent basis for this limitation in the claim. Also, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 8-12 and 16-17 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 in two ways from the method recited by independent instant claim 8. The first difference is the order of the steps, as the instantly recited method adjusts the pH after the ethylene glycol diglycidyl ether crosslinker has been added to the γ-poly(glutamic acid). The second difference is the manner of drying, as the taught method uses an oven, whereas spraying is instantly recited.
With respect to the first difference, since the difference is one of the order of performing steps in order to prepare the same product, the difference is not inventive. Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See MPEP 2144.04(IV)(C).
The second 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 9-10 further limit the polymer, and the γ-poly(glutamic acid) disclosed by Minty et al. reads upon these limitations.
Instant claim 11 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 12 recites that the polar solvent can be water, which ids the solvent present in the example disclosed by Minty et al.
Instant claim 16 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 claim 17 further limits 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).
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-12 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-13 and 17-18 of copending Application No. 18/256,562 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the limitations recited by the instant claims, and also recite an additional step in the method (step B – mixing the polymer with a surfactant). Thus, the copending claims are not identical. But the copending claims, being narrower, read upon the instantly recited claim as all of the steps required by the instant claims are recited by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 8-12 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-13 and 17-18 of copending Application No. 18/256,869 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims recite all of the limitations recited by the instant claims, and also recite an additional step in the method (step B – mixing the polymer with a pharmaceutical active principle). Thus, the copending claims are not identical. But the copending claims, being narrower, read upon the instantly recited claim as all of the steps required by the instant claims are recited by the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Brian Gulledge/Primary Examiner, Art Unit 1699