DETAILED ACTION
Status of the Claims
Claims 1-2, 4-10, 12-13, 15-17, 19 and 20 are pending in the instant application. Claim 9 has been withdrawn based upon Restriction/Election. Claims 1-2, 4-8, 10, 12-13, 15-17, 19 and 20 are being examined on the merits in the instant application.
Response to Arguments:
Applicant’s position that: “Since no objection has been received, Applicant assumes that the drawings are acceptable and that no further action is necessary. Confirmation thereof in the next Office Action is respectfully requested.” (p. 5, §Drawings).
In response the examiner notes that Examiners are no longer accepting/rejecting drawings. MPEP §608.02(b)(I) – “The Office no longer considers drawings as formal or informal. Drawings are either acceptable or unacceptable. Drawings will be accepted by the Office of Patent Application Processing (OPAP) if the drawings are readable and reproducible for publication purposes.”
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All rejections and/or objections not explicitly maintained in the instant office action have been withdrawn per Applicants’ claim amendments and/or persuasive arguments.
Priority
The U.S. effective filing date has been determined to be 05/14/2021, the filing date of PCT/JP2021/018485. Applicant's claim for a priority date of, 05/15/2020 and 02/16/2021, the filing date of documents JP2020-086250 and JP2021-022612, is acknowledged, however no English translation of the foreign priority documents have been provided such that the examiner can confirm written description (112(a)) support therein. Accordingly, foreign priority to these documents cannot be afforded at this time.
Information Disclosure Statement
The information disclosure statements submitted on 09/12/2025 and 11/21/2025, were filed after the mailing date of the first office action on the merits, however Applicant has made a statement under 37 CFR 1.97(e) – §§(2) & (1), respectively. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
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, 10, 13, 16-17 and 20 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.
Claim 1 recites the limitation "the surface modification" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate clarification is required.
Claim 2 is rejected as being indefinite because the claim recites “The medicine according to claim 1 wherein the surface of the gold nanoparticle may be modified with a molecule selected from polyethylene glycol, polyether, […], and a virus-like particle.” However, claim 1 recites “wherein the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell.” (in lines 2-3). It is unclear if surface modification recited claim 2 is the same or different from “the surface modification” recited in claim 1. Appropriate clarification is required.
Claims 5-7, 10, 13, 16-17 and 20 are rejected as inheriting the above-discussed indefinite issue with claims 1 and/or 2 and doing nothing to clarify the claim(s).
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, 10, 13, 16-17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Dziawer et al.1 ("Trastuzumab-Modified Gold Nanoparticles Labeled with 211At as a Prospective Tool for Local Treatment of HER2-Positive Breast Cancer" 2019; MDPI; Nanomaterials, Vol, 9, No. 632 - 9040632; pp. 1-15).
Applicant Claims
Applicant claims a medicine for treating a proliferative disease, comprising gold nanoparticles having a particle size of 0.5 to 110 nanometers and bound to At-211, wherein the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell. (instant claim 1).
Disclosure of the Prior Art
Dziawer et al. discloses "Highly localized radiotherapy with radionuclides is a commonly used treatment modality for patients with unresectable solid tumors. Herein, we propose a novel α-nanobrachytherapy approach for selective therapy of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This uses local intratumoral injection of 5-nm-diameter gold nanoparticles (AuNPs) labeled with an α-emitter (211At), modified with polyethylene glycol (PEG) chains and attached to HER2-specific monoclonal antibody (trastuzumab)." [emphasis added](Abstract, lines 1-6; see whole document)(instant claim 1, gold nanoparticles having a particle size of 0.5 to 110 nanometers and bound to At-211; instant claims 2, 5-7, 10-20; “local intratumoral injection” is within the scope of “injection into a lesion”; cancer is breast cancer). The examiner notes that claims 6-7, and 13, 15-17, 19 and 20 are regarded as intended use claims where a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Dziawer et al. discloses that: “Using the discovery of a strong bond formation between the gold surface and the astatine atoms, we have successfully synthesized a stable astatinated-trastuzumab bioconjugate. 211At-AuNP-trastuzumab was specifically bound, internalized, and distributed to a peri-nuclear location within HER-positive cancer cells. Trastuzumab-modified 211At-AuNPs exhibited higher cytotoxicity than non-targeted 211At-AuNPs. These results are encouraging for further development of 211At-AuNP-trastuzumab as an innovative-radiation nanomedicine for local therapy of HER2-positive cancers due to high tumor retention, internalization, and specific tumor cell binding.” (p. 11, §4-conclusions, lines 1-7)(instant claim 1, gold nanoparticles […] bound to At-211; instant claims 2 & 8, “with polyethylene glycol that is not bound to a targeting molecule for a specific cell.”).
Dziawer et al. discloses that: “The synthesized AuNP-S-PEG-trastuzumab bioconjugates were labeled with 131I and 211At by adsorption radionuclides on the gold surface. The radioactivity of 211At ranged from 100 to 150 Mbq upon arrival at the laboratory.” (p. 8, 2nd paragraph, lines 1-3). And that: “The labeling yields of AuNPs and AuNP-S-trastuzumab with 211At are shown in Table 2. The AuNPs labeling efficiency with 211At was >99% and was significantly higher than that of another commonly used prosthetic group, N-succinimidyl-3-(tri-n-butylstannyl) benzoate, where the labeling efficiency ranged from 60 to 70%.” (p. 8, 3rd paragraph, lines 1-4). And further: “As presented in Table 2, 211At absorption on the gold surface in AuNP-S-PEG-trastuzumab conjugates was nearly the same as for naked AuNPs, indicating that the attachment of PEG-trastuzumab molecules to the AuNP surface changes the adsorption properties of AuNPs minimally. This is expected because, according to our calculations, half of the surface gold nanoparticles is not occupied by trastuzumab molecules and 211At can be attached there.” (Id., lines 5-10)(instant claim 1, “wherein in the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell.” particularly 211At).
Response to Arguments:
Applicant's arguments filed 09/29/2025 have been fully considered but they are not persuasive.
Applicant argues that: “The rejection asserts that Dziawer discloses all limitations of the pending claims. However, amended claim 1 now expressly requires that the surface-modifying molecule is not bound to a targeting molecule for a specific cell, and claim 8 likewise recites this limitation. This feature is neither taught nor suggested by Dziawer. On the contrary, Dziawer consistently teaches the use of polyethylene glycol (PEG) as a linker for covalent attachment of trastuzumab, a HER2-targeting antibody, to the gold nanoparticle surface. For example, on page 4, Dziawer describes: "AuNPs of 5 nm diameter ... were first coated with the PEG linker... After 24 h, a mixture of EDC and NHS was added ... to form an amide bond with the amine group of lysine. After an additional 4 h ... trastuzumab ... was attached to the AuNP-PEG-NHS." This disclosure demonstrates that PEG is not present merely as a surface-modifying molecule, but rather serves as a chemical bridge to conjugate a targeting ligand.” (p. 7, 2nd paragraph).
In response the examiner notes that claim 1 does not recite “the surface-modifying molecule is not bound to a targeting molecule for a specific cell” but rather “wherein the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell.” (claim 1, lines 3-4). A person an having ordinary level of skill in the art pertaining to nanoparticles, particularly metal nanoparticles, more particularly gold nanoparticles, would have clearly recognized that any molecule on the surface of a gold nanoparticle would modify the surface of the gold nanoparticle (i.e. surface-modification). Therefore, aside from the more-likely-than-not fact that every single PEG molecule is not linked to a Trastuzumab molecule, Dziawer et al. prima facie anticipates the claim by the inclusion of At-211 on the surface of the gold nanoparticles where At-211 is “a molecule that is not bound to a targeting molecule for a specific cell.
Applicant argues that: “In contrast, amended claim 1 and claim 8 are directed to non-targeted, surface-modified gold nanoparticles labeled with At-211, wherein the surface-modifying molecule (e.g., PEG) is present absent any conjugation to a targeting ligand. The claimed invention therefore excludes the very targeting functionality emphasized in Dziawer. Because Dziawer fails to disclose nanoparticles that contain a surface-modifying molecule unbound to a targeting molecule, the reference cannot anticipate amended claim 1 or claim 8.” (p. 7, 3rd paragraph).
In response the examiner notes that instant claim 1 clearly does not limit “the surface modifying molecule” to PEG and none of the claims do not exclude any targeting moiety such as “the very targeting functionality emphasized in Diawer.” Applicant is cautioned that if any PEG molecules remain unsubstituted in Diawer et al. the claim would be anticipated. The examiner does not have any evidence that there are in fact unsubstituted PEG molecules in Diawer et al., therefore claim 8 is not included in the ground of rejection based on anticipation.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-8, 10, 12-13, 15-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dziawer et al. ("Trastuzumab-Modified Gold Nanoparticles Labeled with 211At as a Prospective Tool for Local Treatment of HER2-Positive Breast Cancer" 2019; MDPI; Nanomaterials, Vol, 9, No. 632 - 9040632; pp. 1-15) in view of Bilewicz et al.2 (“Gold nanoparticle bioconjugates labelled with 211At for targeted alpha therapy,” 2017; RSC Advances, Vol. 7, pp. 41024-41032); Cai et al.3 (“Applications of gold nanoparticles in cancer nanotechnology,” 2008; Nanotechnology, Science and Applications, Vol. 1, pp. 17-32) and BASILION (US 2014/0044791; published February, 2014).
Applicants Claims
Applicant claims a medicine for treating a proliferative disease, comprising gold nanoparticles having a particle size of 0.5 to 110 nanometers and bound to At-211, wherein the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell. (instant claim 1). Applicant claims a gold nanoparticle which has a particle size of 0.5 to 110 nanometers, binds to At-211 and includes a surface modification with polyethylene glycol that is not bound to a targeting molecule for a specific cell (instant claim 8).
Determination of the scope
and content of the prior art (MPEP 2141.01)
Dziawer et al. teaches "Highly localized radiotherapy with radionuclides is a commonly used treatment modality for patients with unresectable solid tumors. Herein, we propose a novel α-nanobrachytherapy approach for selective therapy of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. This uses local intratumoral injection of 5-nm-diameter gold nanoparticles (AuNPs) labeled with an α-emitter (211At), modified with polyethylene glycol (PEG) chains and attached to HER2-specific monoclonal antibody (trastuzumab). " (Abstract, lines 1-6; see whole document)(instant claim 1, gold nanoparticles having a particle size of 0.5 to 110 nanometers and bound to At-211; instant claims 2, 5-7, 10-20; “local intratumoral injection” is within the scope of “injection into a lesion”; cancer is breast cancer). The examiner notes that claims 6-7, and 13-20 are regarded as intended use claims where a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Dziawer et al. teaches that: “Using the discovery of a strong bond formation between the gold surface and the astatine atoms, we have successfully synthesized a stable astatinated-trastuzumab bioconjugate. 211At-AuNP-trastuzumab was specifically bound, internalized, and distributed to a peri-nuclear location within HER-positive cancer cells. Trastuzumab-modified 211At-AuNPs exhibited higher cytotoxicity than non-targeted 211At-AuNPs. These results are encouraging for further development of 211At-AuNP-trastuzumab as an innovative-radiation nanomedicine for local therapy of HER2-positive cancers due to high tumor retention, internalization, and specific tumor cell binding.” (p. 11, §4-conclusions, lines 1-7)(instant claim 1, gold nanoparticles […] bound to At-211; instant claims 2 & 8, “with polyethylene glycol that is not bound to a targeting molecule for a specific cell.”).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of Dziawer et al. is that Dziawer et al. does not expressly teach an average molecular weight of the polyethylene glycol (PEG) is 2,000 to 20,000 (instant claim 4).
Bilewicz et al. teaches gold nanoparticle bioconjugates labelled with 211At for targeted alpha therapy (title, see whole document), which includes “Gold nanoparticles (AuNPs) with 5 and 15 nm diameter were modified with Substance P(5-11), a peptide fragment which targets the NK1 receptors on the glioma cells, through the HS–PEG–NHS linker.” (abstract, lines 9-11). And more specifically teaches that: “The biologically active fragment of Substance P(5-11), named shortly as SP(5-11), was conjugated to the gold nanoparticles to obtain bioconjugates targeting NK1 receptors on glioma cells. […] The PEG linker (2000 kDa) comprising the disulfide bridge and the N-hydroxysuccinimide esters (NHS) at the ends was used for synthesis of the SP(5-11)–PEG–SS–PEG–SP(5-11) conjugate. The process of nanoparticles biofunctionalization is summarized in Fig. 1.” [emphasis added](p. 41026, col. 2, 2nd paragraph, Figure 1)(instant claim 4).
Additionally, Cai et al. teaches applications of gold nanoparticles in cancer nanotechnology (title, see whole document). And teaches that: “The stability of gold nanoparticle bioconjugates in high ionic strength media has been characterized as a function of the nanoparticle size, PEG length, and the monolayer composition (Liu et al 2007a). It was found that nanoparticle stability increased with increasing PEG length, decreasing nanoparticle diameter, and increasing PEG mole fraction. Importantly, gold nanoparticles modified with PEG chains of molecular weight (MW) 5000 were internalized as efficiently as analogous conjugates with PEG chains of MW 900. Based on this finding, gold nanoparticles functionalized with optimal-sized PEG chains (at least of MW 5000 to efficiently bypass the RES), with circulation half-life of at least a few hours, may be the most efficacious for cancer therapy.” (paragraph bridging pp. 26-27).
BASILION teaches targeted nanoparticle conjugates (title, see whole document), particularly “A composition for treating a disorder in a subject includes a polyethylene glycolylated (PEGylated) nanoparticle, at least one hydrophobic therapeutic agent coupled to the surface of the nanoparticle; and at least one targeting moiety coupled to polyethylene glycol of the nanoparticle for targeting the composition to a cell associated with disorder.” (abstract. BASILION teaches that “
The application further relates to a method for treating brain cancer. The method includes administering systemically to a subject with brain cancer a therapeutically effective amount of a composition comprising PEGylated gold nanoparticles […].” ([0009]).
BASILION teaches that: “The targeted nanoparticle can be coated with a plurality of polymer chains and at least some of the polymer chains are coupled to at least one cellular targeting moiety. In some embodiments, a first end of a polymer chain can be coupled and/or bound to a surface of the nanoparticle and a second opposite end that extends from the surface of the nanoparticle is coupled and/or bound to a targeting moiety. The targeting moiety can allow the targeted nanoparticle conjugates to transiently interact, couple, and/or bind to the targeted cell or tissue.” ([0050]). And that: “In one embodiment, the polymer coating can include polyethylene glycol (PEG). The PEG can be a heterobifunctional PEG, such as COOH-PEG-SH (MW3000), and/or a monofunctional PEG, such as PEG-SH (MW 5000), that can readily bind to the nanoparticle to coat the nanoparticle.” ([0055]).
BASILION teaches that: “The targeting moiety can be coupled to the polymer chain prior to and/ or after coupling of the polymer chain to the nanoparticle. For example, FIG. 1 is a schematic illustration of targeted nanoparticles that are prepared: (A) by coupling the targeting moiety to the polymer chain after the polymer chain is coupled to the nanoparticle; and (B) by coupling of the targeting moiety to the polymer chain prior to coupling the polymer chain to the nanoparticle.” ([0075]). The examiner notes that Figure 1 clearly depicts conjugated PEG (arrow attached) and unconjugated PEG (no arrow attached). BASILION teaches that: “The PEG ligand on the Au NPs creates excellent water miscibility, biocompatibility, and long circulation in the blood of the conjugate system. PEG also prevents protein agglomeration on the NP surface. More importantly, the PEG layer provides bifunctionality to conjugate EGF peptides, which are internalizing and norunitogenic, to recognize EGFRs on the glioma cancer cell surface.” ([0129]-[0130]). And that: “PEGylated Au NPs were synthesized and modified with a mixture of 20% heterobifunctional COOH-PEG-SH (MW 3000) and 80% monofunctional mPEG-SH (MW 5000).” ([0131]). The examiner notes that Figure 8 clearly depicts mPEG-SH (MW 5000) that is bound to gold nanoparticle core and remains unconjugated to a targeting moiety (arrow attached - COOH-PEG-SH (MW 3000)). Therefore, it would have been prima facie obvious to include “a surface modification with polyethylene glycol that is not bound to a targeting molecule for a specific cell.” (instant claim 8) because “The PEG ligand on the Au NPs creates excellent water miscibility, biocompatibility, and long circulation in the blood of the conjugate system. PEG also prevents protein agglomeration on the NP surface.”
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a gold nanoparticle bound to At-211, as suggested by Dziawer et al. and Bilewicz et al., and to utilize an effective length of PEG for local administration (e.g. intratumoral injection), as suggested by Dziawer et al. and Bilewicz et al., and Cai et al. in order to produce the most effective cancer therapy using the same, and to included both targeted PEG ligands and unsubstituted PEG ligands for excellent water miscibility, biocompatibility, long circulation in the blood of the conjugate system, and to prevent protein agglomeration, as suggested by BASILION.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention because it would have required no more than an ordinary level of skill to include an appropriate PEG chain length in the compositions of Dziawer et al. and/or Bilewicz et al. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments:
Applicant's arguments filed 09/29/2025 have been fully considered but they are not persuasive.
Applicant argues that: “However, as amended, independent claim 1 incorporates a critical limitation: the surface-modifying PEG is not bound to a targeting molecule for a specific cell. Claim 8 recites the same limitation. This distinction is dispositive and is neither taught nor suggested by the cited art.” (p. 9, 3rd paragraph). And that: “In contrast, the present claims recite surface modification with PEG that is not used in this manner. The claimed invention therefore excludes the specific PEG functionality emphasized in Dziawer.” (p. 9, 4th paragraph). And that: “Bilewicz similarly discloses PEG as a linker to conjugate a targeting peptide (Substance P) to gold nanoparticles. Again, PEG in that disclosure is chemically designed to tether the targeting ligand, the exact use of PEG expressly excluded from the current claims.” (p. 9, 5th paragraph).
In response the examiner argues that the present claims do not exclude the specific functionality of Dziawer and/or Bilewicz because the claim that “wherein the surface modification comprises a molecule that is not bound to a targeting molecule for a specific cell.” (instant claim 1) does not limit “a molecule” to PEG. And “includes a surface modification with polyethylene glycol that is not bound to a targeting molecule for a specific cell.” (instant claim 8) does not exclude anything. The examiner notes that “comprising” (claim 1, line 1) “is inclusive or open-ended and does not exclude additional, unrecited elements” (MPEP §2111.03(I)).
Applicant argues that: “Taken together, the cited art consistently employs PEG for the purpose of attaching targeting molecules to nanoparticles. There is no teaching, suggestion, or motivation in the references to separate targeting functionality from PEG, nor is there any rationale under KSR, that would lead one of ordinary skill to arrive at the present invention. To the contrary, the prior art teaches away from the claimed configuration by emphasizing PEG' s role as a conjugation scaffold.” (paragraph bridging pp. 9-10).
In response the examiner argues that one of ordinary skill in the art would have been motivated to include PEG molecules attached to the surface of gold nanoparticles for excellent water miscibility, biocompatibility, long circulation in the blood of the conjugate system, and to prevent protein agglomeration, as suggested by BASILION which includes both PEG substituted with targeting molecules and unsubstituted PEG.
Conclusion
Claims 1-2, 4-8, 10, 12-13, 15-17, 19 and 20 are pending and have been examined on the merits. Claims 1, 2, 5-7, 10, 13, 16-17 and 20 are rejected under 35 U.S.C. 112(b); claims 1-2, 5-7, 10, 13, 16-17 and 20 are rejected under 35 U.S.C. 102(a)(1); and claims 1-2, 4-8, 10, 12-13, 15-17, 19 and 20 are rejected under 35 U.S.C. 103. No claims allowed at this time.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IVAN A GREENE whose telephone number is (571)270-5868. The examiner can normally be reached M-F, 8-5 PM PST.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
1 Of record as cited by Applicants on IDS dated 01/24/2023, non-patent literature document citation no. 4.
2 Of record as cited by Applicants on IDS dated 01/24/2023, non-patent literature document citation no. 3.
3 Of record as cited by Applicants on IDS dated 01/24/2023, non-patent literature document citation no. 1.
Prosecution Insights