NON-FINAL REJECTION
This application, filed Oct. 19, 2022, claims benefit of priority to provisional application 63/257,187, filed Oct. 19, 2021.
Claims 1-15 are pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-3), drawn to compositions comprising a nanoparticle comprising an anti-inflammatory alpha-1 acid glycoprotein; and hyaluronic acid-chitosan as the species of nanoparticle material, in the reply filed on Aug. 20, 2025 is acknowledged.
The traversal is on the ground(s) that the Office has not demonstrated that searching Groups I, II, and III together would impose a serious burden. Applicant submits that the search of Groups I, II, and III can be made without undue burden because a search of these groups would be largely coextensive, since the composition of a nanoparticle comprising an anti-inflammatory alpha-1 acid glycoprotein of Group I would be a required part of the search of the method of making and using this material as recited in Groups II and III, respectively.
Thus, the Examiner can search both groups without serious burden. Moreover, examining these groups separately would impose extra costs and delays on the Office due to the duplicative search and examination that would be involved (Remarks dated Aug. 20, 2025, page 2).
This is not found persuasive because a search of all three Groups would not be co-extensive. For example, the claims of Group II, drawn to methods of preparing the compositions of Group I, comprise steps absent from Groups I and III, such as sequential ionic gelation followed by at least one spray-drying step (claim 4). Similarly, the claims of Group III, drawn to methods of treating cancer with the compositions of Group I, comprise steps absent from Groups I and II, such as treating cancer cells with the composition and an additional anti-cancer, chemotherapeutic drug (claims 10-11).
These additional limitations, unique to Groups II and III, impose an undue search burden because (1) all three Groups fall into different classifications; (2) each Group requires the use of different databases and different search queries that would not be necessary for the search of Group I; and (3) the Groups are likely to raise different issues under 35 U.S.C. 112.
Thus, the requirement is still deemed proper and is therefore made FINAL.
Claims 4-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on Aug. 20, 2025. Claims 1-3 are currently pending and under examination.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masood et al. (WO2018/190755, cited on PTO-892).
Masood et al. disclose protein-functionalized anti-inflammatory nanoparticles which are prepared by dispersing chitosan nanoparticles in acetic acid/acetate buffer, adding an equal amount of acetate buffer containing hyaluronic acid to form hyaluronic acid-coated chitosan nanoparticles (HA-CS), and functionalizing the hyaluronic acid-coated chitosan nanoparticle with surface adsorbing anti-inflammatory protein AGP (alpha-1-acid glycoprotein) (abstract).
Thus, Masood et al. disclose compositions comprising at least one nanoparticle comprising hyaluronic acid-chitosan (HA-CS) and the anti-inflammatory protein, alpha-1 acid glycoprotein (AGP), as recited by claims 1-2.
Masood et al. exemplify hyaluronic acid-chitosan nanoparticles (HA-CS-NPs) with a z-average size of 270 ± 27 nm, i.e., a size distribution of 243-297 nm (Fig. 5c, shown below), which falls within the size distribution range of between 200 and 500 nm, as recited by claim 3.
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Masood et al. exemplify protein functionalized anti-inflammatory HA-CS NPs, specifically AGP-HA-CS NPs (i.e., hyaluronic acid/chitosan nanoparticles functionalized with alpha-1-acid glycoprotein) employed in suppressing the immunity of activated breast cancer cells (MDA-MB-231 cells) (para. [0029]). This implicitly discloses that the composition is for reducing multi-drug resistance of tumor cells to chemotherapeutic drug molecules, and inhibits the proliferation and the migration of tumor cells by suppressing overexpressed pro-inflammatory cytokines (see Figs. 7a and 7b), as recited by claim 1.
As recognized by MPEP § 2111, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In addition, MPEP §2112.01 recognizes that, where the claimed and prior art products are identi-cal or substantially identical in structure or composi-tion, or are produced by identical or substantially identical processes, a prima facie case of either antici-pation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/496,799 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, reference claims 1-8 are drawn to surface functionalized nanoparticles comprising a central core comprising a hyaluronic acid coated chitosan nanoparticle (HA-CS NP), surrounded by an outer shell comprising at least one functionalized surface adsorbed anti-inflammatory protein bound thereto, which is AGP (alpha-1-acid glycoprotein), wherein the central core has an average particle size ranging from 170 nm to 270 nm, wherein the nanoparticle is configured to suppress the immunity of activated cancer cells.
Thus, the reference claims are drawn to compositions comprising at least one nanoparticle comprising hyaluronic acid-chitosan (HA-CS) and the anti-inflammatory protein, alpha-1 acid glycoprotein (AGP), as recited by examined claims 1-2, wherein the nanoparticles have an average particle size of 170 nm to 270 nm, which overlaps the size distribution range of between 200 and 500 nm, as recited by examined claim 3.
As recognized by MPEP § 2144.05 (I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art,” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990).
The reference claims do not explicitly recite that the nanoparticles reduce multi-drug resistance of tumor cells to chemotherapeutic drug molecules, or inhibit the proliferation and the migration of tumor cells by suppressing overexpressed pro-inflammatory cytokines, as recited by examined claim 1.
However, as recognized by MPEP § 2111, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In addition, MPEP §2112.01 recognizes that, where the claimed and prior art products are identi-cal or substantially identical in structure or composi-tion, or are produced by identical or substantially identical processes, a prima facie case of either antici-pation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
WO 2012/052565; Al-Malik et al. Scientific Reports 7: 10542 (2017); Al-Malik et al. Toxicol. Res. 7, 942–950 (2018); and Matsusaka et al. J. Pharm. Sci. 108, 3592-3598 (2019) (all cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629