DETAILED ACTION
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 .
Status of Application
Claims filed on August 23, 2023 are acknowledged and under examination in tis application.
Claims 1-18 are pending.
All pending claims are under examination.
Priority
The claim of Priority to provision application 63/400,256 filed on August 23, 2022 is acknowledged.
Claim Objections
Claims 4 and 14 are objected to because of the following informalities:
Regarding claims 4 and 14, the claims do not end in a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5-6 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.
Regarding claims 5-6, the claims recite the limitation “over about 40 to about 100 percent”. The term “about” is defined in the specification to “allow for a degree of variability in a value or range, for example within 10%, within 5%, or within 1%”. However, this recitation would allow for a greater than 100% coverage of the surface. It is unclear how said coverage would be possible. It is suggested Applicant amend the claim to recite “over about 40 and up to 100 percent”.
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 1-3, 8-9, 11, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hori et al. (US 2021/0106684).
Hori discloses the creation of stable boron isotope 10B containing nano silica particles composed of amino acids, oligosaccharides, and oligopeptides appropriate to the improvement of drug delivery system (DDS) function of delivering more boron to tumors selectively to facilitate the efficacy of boron neutron capture therapy (BNCT) (abstract).
The selectively accumulated boron isotope (10B) compounds can kill cancer cells and malignant tumor cells without any damage of surrounding normal cells to yield successful BNCT (paragraph 0003).
Regarding claim 2, as noted above, 10B is disclosed.
Regarding claim 3, as noted above, silica is disclosed.
Regarding claims 8-9, porous spherical nano silica particles used in the present invention as a drug delivery system (DDS) material have a particle diameter of from 5 nm to 2000 nm (paragraph 0020).
Regarding claim 11, Figure 1 discloses a boronated hydroxylated nanoscale substrate. See Example 1.
Regarding claim 15, oligosaccharide modified boron isotope (10B)-containing nano silica particles are selectively delivered and localized around the cell membrane of tumor cells to promote extremely high cytotoxic effects on tumor cells under neutron irradiation (paragraph 0018).
Hori, therefore, anticipates the rejected claims.
Claims 1-4, 7, 11, 15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nui et al. (US 2017/0326236).
Nui discloses a composition includes at least one nanodiamond particle and at least one neutron capture element, in which the at least one neutron capture element is embedded into the at least one nanodiamond particle by using an ion implantation system (abstract).
The at least one neutron capture element comprises boron-10 or gadolinium-157 (paragraph 0008).
Regarding claim 2, as noted above, boron-10 is disclosed.
Regarding claims 3-4 and 7, as noted above, the substrate is disclosed to be a diamond particle.
Regarding claim 11, the composition is prepared by synthesizing nanodiamond particles embedded with neutron capture elements with a targeting drug agent and such nanodiamond therapeutic agent is delivered to tumor cells for neutron capture therapy (NCT), thereby enhancing NCT effect.
Regarding claim 15, the composition comprises neutron capture elements embedded into nanodiamond particles by using ion implantation for treating tumor cells through NCT (paragraph 0052), thereby indicating the substrate was subjected to electromagnetic radiation.
Regarding claims 17-18, the NCT is used to treat malignant brain tumors, including glioblastoma multiforme (paragraph 0141).
Nui, therefore, anticipates the rejected claims.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries 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.
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.
Claims 1-3, 8-11, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US 2021/0106684) in view of Fujii et al. (EP 0 386 146).
The teachings of Hori are discussed above.
Hori does not discloses the nanoparticles are encapsulated in a liposome.
Fujii discloses liposome encapsulated compounds for neutron capture tumor therapy (abstract).
Fujii discloses it has become possible to deliver drugs and other compounds selectively to tumors using liposomes of a particular composition and structure (page 2, lines 33-34). Successful neutron capture therapy with liposomes depends on incorporating the highest concentration of 10B possible without substantially altering the liposome's favorable biodistribution characteristics (page 2, lines 39-41).
Results show that boron 10 can be delivered to tumors at levels sufficient to give therapeutic value in neutron capture therapy (page 3, lines 57-58).
Regarding claim 10 and , as noted above, the 10B is encapsulated in a liposome.
Regarding claims 13-14, phospholipids (a mixture of DSPC and cholesterol) are used to prepare the liposomes.
Regarding claim 16, the disclosed liposomes of Fujii comprise Na2B10H10.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have incorporated the boron particles of Hori into the liposomes of Fuji since Hori provides a drug for boron neutron capture therapy (BNCT) containing stable nano silica particles as matrix and a drug delivery material (DDS) having specific accumulation property in cancer cells and tumor cells, the drug being obtained by chemically bonding nano silica particles to a boron isotope (.sup.10B)-containing compound (paragraph 0012). According to Fujii, this can be accomplished by using compounds with the highest number consistent with liposomes that are stable and target the tumors (page 2, lines 39-41).
Claims 1-3, 5-6, 8-9, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US 2021/0106684) in view of Hwang et al. (Neutron capture nuclei-containing carbon nanoparticles for destruction of cancer cells, Biomaterials 31 (2010) 8419-8425).
The teaching of Hori are discussed above.
Hori does not discuss the exact percentage of the boronated portion on the silica particles.
Hwang discloses the medicinal efficacies of carbon nanoparticles can
be further optimized using pure 10B isotopes, or by increasing larger percentages of neutron capture elements in the precursors for preparation of carbon nanoparticles. Since these nanomaterials are also magnetic, they have great potential to serve
as both diagnostic MR imaging probes and therapeutic drugs simultaneously. Due to its compact structure, a single carbon nanoparticle can carry hundreds or thousands times more neutron capture atoms than a molecule-based counterpart.
It would have been obvious to one ordinary skill in the art prior to the effective filing date of the invention have optimized the percentage of 10B on the substrate of Hori since Hwang’s results clearly demonstrate that these neutron capture elements containing nanoparticles are very promising medicinal nanomaterials for NCT destruction of cancers/tumors and potentially for diagnosis as well.
Claims 1-3, 8-9, 11-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hori et al. (US 2021/0106684) in view of Beklemyshev et al. (RU 2460689C1).
The teachings of Hori are discussed above.
Hori does not disclose the boron is boron tribromide, boron trichloride, or mixtures thereof.
Beklemyshev discloses producing boron-silicon-containing nanoparticles prepared with boron trichloride (abstract).
The nanoparticles are used in cancer treatment (technical field).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used boron trichloride as taught by Beklemyshev in the preparation of the particles in Hori in order to obtain a high content of boron.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zaboronok et al. (Polymer-Stabilized Elemental Boron Nanoparticles for Boron Neutron Capture Therapy: Initial Irradiation Experiments, Pharmaceutics, 2022, 14, 761).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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