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
Claims 1-5, 7, 9-16, 18-22 and 27 are pending.
Election/Restrictions
Applicants’ election of Group I and the following species: thrombospondin-1 as a species of protein, in the reply filed on 1/30/2026 is acknowledged. The election was made without traverse.
While searching for the elected species, thrombospondin-1, the other species such as albumin and transferrin were found, thus the examination has been extended to include those species as well as thrombospondin-1 (TSP-1).
Accordingly, claims 3-4, 18-22, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim. Claims 1, 2, 5, 7, and 9-16 are under examination in the instant office action.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities: typographical errors. The comma (,) should be deleted in the term, “Inter alpha-trypsin inhibitor, heavy chain 4” in lines 10-11 of claim 1 and line 5 of claim 5.
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 recites “A coronal protein-coated nanoparticle comprising one or more proteins”. in line 1. It is unclear whether 1) the nanoparticle comprises “one or more proteins” as “coronal protein” or 2) the coronal protein is different from said “one or more proteins”. Clarification is required. If the first interpretation is correct, it is advised to amend “one or more proteins” to --one or more coronal proteins--.
For the examination purpose, the first interpretation will be used.
Claim 12 is 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.
Claim 12 contains the following trade name: Taxol in line 2. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
In the present case, the trademark/trade name is used to identify/describe an anti-cancer agent.
The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. See MPEP 2173.05 (u).
Applicants are advised to recite what the name of the goods is instead of the trade name. Also, it should be noted that taxol is a brand name of paclitaxel. If taxol is intended to refer to paclitaxel, it is advised to delete it since claim 12 already recites “paclitaxel”.
Claim 14 is 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.
Claim 14 recites the limitation “the anti-cancer agent” in line 2. There is insufficient antecedent basis for this limitation in the claim since the claim 1 from which claim 14 depends does not recite “anti-cancer agent”. The rejection may be overcome by amending the claim to be dependent from claim 11.
Claim Rejections - 35 USC § 102
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, 2, 5, 7, 9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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 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 protein containing the same proteins as claimed, necessarily comprise one or more of the highly abundant plasma proteins such as albumin attached and transferrin to the HBPE and the coronal proteins would form a homogenous shell around the HBPE-NP as claimed.
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 Heckert et al.
Claims 1, 2, 5, 7, and 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0126002 (hereafter, Khaled) das 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 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]).
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 Khaled.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611