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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 12/30/2025 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/30/2025.
Claims 1-14 are under current examination.
Claim Objections
Please remove the line numbers in the margin of the claims document as they are distracting and unnecessary.
Allowable Subject Matter
Claims 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
See further discussion of allowable subject matter in the “Conclusion” section of this action.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. 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 1-8, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over van Erp et al. (Journal of Immunological Methods Vol 152:191-199; publication year: 1992) in view of Du et al, ((2019) ChemRxiv. Preprint) and further in view of Creative Diagnostics (Website: Practical Tips of ELISA; available online from at least 07/23/2021).
With regard to claim 1, van Erp discloses a method for adsorbing IgG Mabs (i.e. monoclonal antibody proteins) to polystyrene particles comprising incubating the particles with the antibody in sodium phosphate buffer (i.e. phosphate buffered saline; page 192).
van Erp does not disclose poly(propylene sulfone) (PPSU) nanoparticles.
Du discloses PPSU20 polymers that self-assemble into nanoscale hydrogels crystalline solid (i.e. nanoparticles abstract, page 2) and indicates that PPSU is a simple, nontoxic, and facilely synthesized homopolymer that presents a versatile platform for nanofabrication with potential applications in biomedicine, diagnostics, catalysis, and purification (page 5).
It would have been prima facie obvious to replace the polystyrene particles with the PPSU20 particles disclosed by Du. The skilled artisan would have been motivated to do so in order to take advantage of the simplicity and versatility mentioned by Du and had reasonable expectation of success because Du discloses these particles to be suitable for biomedical applications.
With regard to claims 1-3, van Erp’s method also differs from the instantly claimed method in that the incubation is for 1 hour at 30C.
Creative Diagnostics discloses that factors affecting protein binding to plastics (i.e. synthetic polymers) include ratio of the surface area being coated to the volume of the coating solution, concentration of the antigen being adsorbed, temperature, and time of adsorption (page 3).
It would have been prima facie obvious to optimize these parameters in order to achieve optimal adsorption of an antibody to the PPSU20 polymer particles disclosed by Du as a matter of routine for one of ordinary skill. For this reason, the examiner does not consider the limitations of instant claim 1 requiring 1 second to 5 minutes incubation at between about 20-22C to patentably define over the cited prior art. See MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter 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 discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claims 4 and 5, in van Erp’s method, the particles are centrifuged on completion of the adsorption incubation, followed by resuspension in buffer, then centrifuged again (paragraph bridging pages 192-193). The limitation requiring the nanoparticles to be washed between 1 and 3 times (claim 4) and resuspended in the buffer (claim 5) reads on this centrifugation followed by resuspension and subsequent second centrifugation step.
With regard to claim 6, as noted above, van Erp discloses PBS.
With regard to claims 7 and 8, as noted above van Erp discloses adsorbing an antibody. As claim 8 is worded currently, it reads on adsorbing a plurality of the same antibody on (i.e. at least two antibodies), and therefore this aspect of van Erp’s invention falls within the scope of claim 8.
With regard to claim 13, van Erp discloses a step wherein the particles are incubated with BSA (paragraph bridging pages 192 and 193).
With regard to claim 14, as noted above, Du renders obvious using nanoparticles formed from PPSU20.
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 1-3, 6-8, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-20 of copending Application No. 18639549.
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims:
Inter alia, the claims of the ‘549 application embrace a method of making a PPSU20 nanoparticle having an anti-Siglec-6 antibody adsorbed thereto by incubating the particles in buffer with the antibody for from 1 second to 5 minutes between 20 – 22C, wherein the antibody is at a higher concentration than the particle.
This is a provisional nonstatutory double patenting rejection.
Claims 4, 5, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-20 of copending Application No. 18639549 as applied to claims 1-3, 6-8, and 14 above, and further in view of van Erp et al. (Journal of Immunological Methods Vol 152:191-199; publication year: 1992).
The relevant limitations of the ‘549 claims are set forth above.
The claims are silent with respect to washing the particles, the identity of the buffer, or incubating them with BSA as required by instant claims 4, 5, and 13, respectively.
von Erp discloses that antibodies can be adsorbed to polymeric particles (polystyrene) by incubating the particles with the antibody in sodium phosphate buffer (i.e. phosphate buffered saline), and that the antibody bound particles are washed in buffer containing BSA after the incubation step (pages 192-193).
It would have been prima facie obvious to follow the more detailed protocol for antibody-polymer particle binding disclosed by von Erp because the ‘549 application does not provide any steps for processing the particles after incubation and the method disclosed by von Erp had been established as effective for other polymer particles.
Conclusion
Claims 9-12 are free of the prior art.
The closest prior art to the invention of instant claim 9 is the method rendered obvious by van Erp, Du, and Creative Diagnostics as set forth above, and also Duan et al (J Immunol. 2021 Apr 28;206(10):2290–2300) and Nocka et al. (US 2006/0269556; publication date: 11/30/2006).
Duan discloses that an antibody directed to Siglec-8 can inhibit mast cell activation, potentially reducing reaction to allergy-inducing antigens when the anti-Siglec-8 is displayed on a micelle that also displays the antigen (abstract). Duan discloses that allergen binding to IgE causes crosslinking of the mast cell IgE receptor FceRI, resulting in activation of the mast cell, degranulation, and release of the pro-inflammatory mediators that cause mild to severe allergic reactions (page 2290). Duan proposes extending the platform to also inhibit other Siglecs to attenuate signaling of the FceRI (page 2290). Nocka discloses that Siglec 6 antibodies inhibit mast cell function and may be used to treat diseases or disorders associated with mast cell function (abstract). Nocka discloses further that mast cells can be activated by crosslinking the FceRI using antibodies (0037), i.e. anti- FceRI has the effect of activating a mast cell to release factors that mediate an allergic reaction, promoting an allergic response.
Claim 9 and its dependent claims 10-12 are considered free of the prior art because there is no particular teaching in the prior art to select anti-Seglic antibodies to adsorb to PPSU nanoparticles and also independently because there is no teaching to combine an anti-Seglic antibody with an antibody directed against FceRI. In fact, cross-linking FceRI would cause mast cell activation, and encourage an allergic response, which is opposite to the goal of the prior art.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617