FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Apr. 30, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claim 1 has been amended and incorporates no new matter.
No new claims have been added.
Claims 4-15 stand withdrawn as drawn to nonelected inventions and/or species.
Thus, claims 1-3 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
TERMINAL DISCLAIMER
The terminal disclaimer filed on Apr. 30, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on copending Application No. 18/496,799 has been reviewed and is NOT accepted.
The terminal disclaimer does not comply with 37 CFR 1.321 because:
This application was filed on or after September 16, 2012. The party identified in the terminal disclaimer is not the applicant of record. A request to change the applicant under 37 CFR 1.46(c) must be filed and must include an application data sheet specifying the applicant in the applicant information section and comply with 37 CFR 3.71 and 3.73. To be reconsidered, the terminal disclaimer must be filed with the request under 37 CFR 1.46(c).
MAINTAINED REJECTIONS
The following rejections are maintained from the previous Office Action dated Nov. 28, 2025, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Claim Rejections - 35 USC § 102
Claims 1-3 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Masood et al. (WO2018/190755, of record).
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).
Surface adsorption of AGP results in HA-CS nanoparticles having an outer surface "decorated with" AGP as a defined surface component, as recited by amended claim 1.
Thus, Masood et al. disclose compositions comprising at least one nanoparticle comprising hyaluronic acid-chitosan (HA-CS), wherein the nanoparticles comprise an outer surface decorated with AGP as a defined surface component, 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 lies within the size distribution range of between 200 and 500 nm 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
Claims 1-3 stand 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), forming a protein corona on an external surface of the central core,
wherein the functionalized nanoparticle forms a medical device nano-coating,
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), which reads on 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.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Apr. 30, 2026 have been fully considered but they are not persuasive.
Applicant asserts that the newly added limitation – wherein the nanoparticle comprises "an outer surface that is decorated with the AGP as a defined surface component" – defines how AGP is incorporated into the nanoparticle as part of the composition itself, not merely how the nanoparticle may later interact with proteins in a biological environment. The amended claims describe AGP decoration at the nanoparticle surface to permit the protein to inhibit the proliferation and the migration of tumor cells by suppressing pro-inflammatory cytokines. This allows the protein to respond to the environment and modulate inflammatory signaling through surface-level interactions with the surrounding environment (Remarks, p. 2).
Applicant contends that Masood does not teach this new limitation, but rather teaches hyaluronic acid-chitosan nanoparticles designed as shell-like structures, in which biological effects arise from the particle as a whole, not from a deliberately decorated surface. Applicant contends that in the nanoparticles of Masood, protein association occurs by chemisorption, where proteins form covalent ester and glycosidic bonds with the hyaluronic-acid-coated chitosan surface. Additionally, the proteins are treated as a fixed structural shell which function to support immune modulation, rather than by enabling surface-level biological interaction through a dynamic surface coating as claimed in the present application. Masood does not disclose or suggest a nanoparticle in which AGP is intentionally deposited as a decorative surface element designed to remain exposed and biologically interactive (Remarks, p. 2).
Thus, Applicant contends that Masood and the present application represent different nanoparticle compositions. Because Masood does not disclose a nanoparticle having AGP intentionally deposited on the surface as a defined component, Masood fails to disclose every limitation of amended claim 1 (Remarks, pp. 2-3).
However, the newly added limitation – wherein the nanoparticle comprises "an outer surface that is decorated with the AGP as a defined surface component" – does not further define how AGP is incorporated into the nanoparticle. The nanoparticles of Masood et al. do in fact have an outer surface "decorated with" AGP, and the AGP is a "defined surface component," regardless of how AGP is bound to the surface or incorporated into the nanoparticle.
For example, chemisorption results in covalent bonds being formed between AGP and the nanoparticle surface; whereas surface adsorption results in AGP bound to the surface by non-covalent interactions. Either way, the claimed nanoparticles comprise "an outer surface that is decorated with the AGP as a defined surface component."
Because these terms are not defined in the specification, and are thus given their broadest reasonable interpretation, the newly added limitation fails to distinguish between AGP bound to the surface of the HA-CS nanoparticle by covalent bonds (e.g., ester or glycosidic bonds), versus AGP bound to the surface of the HA-CS nanoparticle by non-covalent interactions (e.g., hydrogen bonds or electrostatic interactions).
Further, Masood et al. do not define "outer shell," other than the "outer shell comprises functionalized surface adsorbed anti-inflammatory proteins, bound to the central core" (para. [0016]). This is indistinguishable from the structure of the claimed nanoparticles.
Moreover, Masood et al. claim HA-CS nanoparticles comprising a central core and surface adsorbed anti-inflammatory proteins forming an outer shell around the central core, wherein the surface adsorbed anti-inflammatory protein is AGP (claim 2; emphasis added).
Thus, while Masood et al. indeed discloses a chemisorption process (para. [0016]), Masood et al. also expressly disclose and claim HA-CS nanoparticles wherein AGP is adsorbed on the outer surface of the nanoparticle, resulting in an outer surface that is "decorated" with AGP as a defined surface component, as recited by examined claim 1.
Finally, Applicant appears to suggest that the distinguishing feature of the claimed nanoparticles is the process by which they are formed. However, because claims 1-3 are drawn to products, the process by which these structurally and functionally identical nanoparticles are prepared is immaterial.
As recognized by MPEP § 2113, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Because Applicant has not pointed to any clear structural or functional distinction that is both (1) supported in the specification, and (2) absent from the cited references, the rejections under 35 U.S.C. § 103 and on the grounds of obviousness-type double patenting are maintained.
NEW REJECTIONS
Claim Rejections - 35 U.S.C. § 112(b) – 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Amended claim 1 is drawn to a composition comprising nanoparticles and alpha-1 acid glycoprotein (AGP), wherein the nanoparticles comprise "an outer surface that is decorated with the AGP as a defined surface component."
However, the terms "decorated with" and "defined surface component" are not defined in the specification. These terms appear to be merely descriptive shorthand for the result of the disclosed surface-adsorption process. Nothing in the specification supplies an objective boundary, structural criteria, density threshold, orientation requirement, or any other metric that would convey to a skilled artisan what "decorated with" or "defined surface component" requires beyond ordinary surface adsorption. Nor is any guidance provided to distinguish between a nanoparticle that is "decorated with" AGP versus one that is not, nor between AGP that is a defined surface component versus AGP that is not.
As recognized by MPEP § 2173.05(b), when a relative or subjective term is used in a claim, some objective standard must be provided in order to allow the public to determine the scope of the claim. Because the specification provides no such standard, "decorated with" and "defined surface component" are relative or subjective terms that introduce ambiguity and obscure the claim scope, rendering the metes and bounds of the claims indefinite.
CONCLUSION
No claims are allowed.
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.
CORRESPONDENCE
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 10:00 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 E. TOWNSLEY/Examiner, Art Unit 1629
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