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 .
DETAILED ACTION
Status of claims
The amendment filed on June 26, 2026 is acknowledged. claims 3-4, 18-22, and 27 have been withdrawn Claims 1, 2, 5, 7, and 9-16 are under examination in the instant office action.
Applicants' arguments, filed on June 26, 2026, have been fully considered but they are moot in view of a new ground of rejection which are necessitated by the amendments (addition of new limitations). Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: typographical errors. The indefinite article, [a], before “influenza” in line 3 should be corrected to --an--.
Claim Rejections - 35 USC § 112 (b)
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, 2, 5, 7, and 9-16 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 1 is amended to recite “A coronal protein-coated nanoparticle comprising one or more coronal proteins”, wherein the nanoparticle is a hyperbranched polyester (HBPE) nanoparticle that has been pre-treated in a serum sample from a influenza A virus (IAV)-infected subject to form a corona enriched in the one or more coronal proteins”.
By reciting “one or more coronal proteins”, it appears that the claim encompasses HBPE nanoparticle coated with only one coronal protein such as transferrin or albumin. However, the newly added limitation recites pre-treatment of the nanoparticle (NP) with a serum sample from an influenza A virus (IAV)-infected subject, which contains various plasma proteins, thus the NP is necessarily coated by those proteins (more than one protein) in light of the specification. It is unclear which limitation is controlling the metes and bounds of the claim. Also, it is unclear whether the claim still encompasses HBPE nanoparticles coated with only one coronal protein such as transferrin or albumin. As such, the recitation of “one or more coronal proteins” with the newly added limitation renders the scope of the claim vague and confusing. Clarification is required.
For the examination purpose, the claim is interpreted to still encompass HBPE nanoparticles coated with only one coronal protein such as transferrin or albumin.
Claim Rejections - 35 USC § 102/103
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.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 5, 7, 9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Heckert et al. (ACS Macro Lett., 6(3): 235–240, 2017 March 21; cited in IDS filed on 1/2/2024) as evidenced by US 2021/0072255.
Heckert et al. disclose HBPE-S polymeric nanoparticles (PNP) comprising a new hyperbranched polyester polymer containing sulfur-pendants (HBPE-S) in the branching points, which is composed of spherical shaped, aliphatic three-dimensional architecture with carboxylic acid groups on the surface, wherein the HBPE-S polymer’s spherical structure with amphiphilic cavities allow for the successful encapsulation of anti-tumor drugs such as taxol and optical dyes, indicating suitable for delivery of wide-range of theranostic agents for cancer diagnosis and treatment (abstract, p3, para 2, and p4, para 2, p5, para 1). Taxol (paclitaxel) is a claimed hydrophobic anti-cancer agent and encapsulated in the cavity (interior) of the NP.
Heckert et al. specifically discloses taxol encapsulating protein corona-coated HBPE-S PNPs, which was prepared by incubation with 55% plasma proteins (p4, para 2) and further teach that the protein corona-coated PNPs were found to be stable with little bigger in size (94 nm, SI Figure S6). Human plasma proteins include highly abundant proteins such as albumin and transferrin as evidenced by US 2021/0072255 ([0342]).
Thus, the protein corona-coated PNPs of Heckert et al., which is prepared by incubation with 55% plasma proteins containing the same proteins as claimed, necessarily comprise one or more of the highly abundant plasma proteins such as albumin and transferrin to the HBPE, the corona is necessarily enriched in such highly abundant plasma proteins such as albumin and transferrin, and the coronal proteins would form a homogenous shell around the HBPE-NP as claimed.
The claim 1 is amended to recite “a hyperbranched polyester (HBPE) nanoparticle that has been pre-treated in a serum sample from an influenza A virus (IAV)-infected subject to form a corona enriched in the one or more coronal proteins”. Thus, the claim is now a product-by-process claim. It should be noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this case, there is no evidence that the claimed process results in any structural difference in the claimed product. As stated above in the rejection under 35 U.S.C. 112 (b), the instant claims encompasses HBPE nanoparticles coated with only one coronal protein such as transferrin or albumin. For example, HBPE nanoparticles coated with transferrin or albumin as coronal proteins by incubation with 55% plasma proteins taught by the prior art appears to be the same as those HBPE nanoparticles coated with transferrin or albumin as coronal proteins prepared by pre-treatment in a serum sample from an influenza A virus (IAV)-infected subject because transferrin and albumin are the same regardless of whether they are from a serum sample from the subject infected with or without an influenza A virus. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113.
Again, Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by or, in the alternative, obvious over Heckert et al.
Claims 1, 2, 5, 7, and 9-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2018/0126002 (hereafter, Khaled) as evidenced by Samantha et al. (ACS Appl. Mater. Interfaces, Oct. 15, 2020, 12, 48284−48295).
Khaled discloses a nanoparticle, comprising: a polymeric nanoparticle conjugated with targeting ligand that is a substrate for a solid tumor-specific cell protein, wherein the nanoparticle further comprises one or more imaging compounds and/or one or more therapeutic agents encapsulated in the hydrophobic interior of the nanoparticle (NP), wherein the polymeric NP is hyperbranched polyester (HBPE) NPs ([0007] and claims 88, 95-96)
Khaled further discloses that the NPs comprises an imaging agent such as PET detectable compound (89Zr) (claims 105-106) or a chelating ligand such as desferrioxamine (DFO) ([0084] and claim 104).
Khaled also discloses that the therapeutic agent includes CT20p, a mutant CT20 peptide, and microtubule stabilizer (taxol) (hydrophobic anticancer agents) ([0084] and claims 108, 115 and 134).
In addition, Khaled discloses incubation of the nanoparticle preparation in serum (FBS) supplemented buffer and measuring the amount of drug release and increase in particle size (due to swelling or serum protein binding) upon incubation ([0166]). Thus, the prior art discloses coronal protein-coated NP resulted from the binding of serum proteins present in FBS. The FBS includes serum proteins such as albumin and thrombospondin-1 (TSP-1) and those proteins are identified as coronal proteins on NPs after exposure to 10% FBS as evidenced by Samantha et al. (p48286, col 1, para 3 and Table 2). Thus, the resulting NPs after incubation with FBS taught by Khaled necessarily comprise one or more coronal proteins present in FBS such as albumin and TSP-1 attached to the HBPE and the coronal proteins would form a homogenous shell around the HBPE-NP as claimed.
As to claim 10, the prior art teaches the same HBPE-NPs comprising the same therapeutic agent and chelating agent, which are coated with coronal proteins via incubation with serum, as the instant invention, the resulting coronal protein-coated NP necessarily has the size which falls within the clamed range (about 100 nm to about 200 nm) in the absence of evidence to the contrary. This is further evidenced by teachings of the prior art. Khaled specifically discloses synthesis of Fe(III)-DFO-grafted HBPE-NPs encapsulating CT20p, yielding monodispersed NP preparations that average 80 nm in size ([0180] and Fig. 17B). Khale teaches increase of particle size due to swelling or serum protein binding upon incubation with serum ([0166]). Khale further discloses that HBPE nanoparticles had an increase of 20 nm in size, due to non-specific protein absorption after incubation with FBS ([0155]). This implicitly discloses the size of Fe(III)-DFO-grafted HBPE-NPs coated with serum coronal proteins is about 100 nm, ([0068]).
The claim 1 is amended to recite “a hyperbranched polyester (HBPE) nanoparticle that has been pre-treated in a serum sample from an influenza A virus (IAV)-infected subject to form a corona enriched in the one or more coronal proteins”. Thus, the claim is now a product-by-process claim. It should be noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In this case, there is no evidence that the claimed process results in any structural difference in the claimed product. As stated above in the rejection under 35 U.S.C. 112 (b), the instant claims encompass HBPE nanoparticles coated with only one coronal protein such as albumin or TSP-1. For example, HBPE nanoparticles coated with albumin or TSP-1 as coronal protein by incubation with serum proteins present in FBS taught by the prior art appears to be the same as those HBPE nanoparticles coated with transferrin or albumin as coronal proteins prepared by pre-treatment in a serum sample from an influenza A virus (IAV)-infected subject because albumin and TSP-1 are the same proteins regardless of whether they are from a serum sample from the subject infected with or without an influenza A virus. When the reference teaches a product that appears to be the same as, or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process, either 102 or 103 rejection can be properly made. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP §2113.
Again, Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by or, in the alternative, obvious over
Khaled.
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 extension fee 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 date of this final action.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
