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 .
Response to Arguments
The 35 U.S.C. § 112(b) rejection of Claim 17 is withdrawn as the claim is canceled.
Applicant’s arguments, see page 7, filed 18MAR2026, with respect to the rejection(s) of claim(s) 116-29 under 35 U.S.C. § 103 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Poul in view of Yang and Ferrari. Yang teaches the required pore size of the amended claim, while Ferrari addresses the amended requirements of surface area.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 16 and 18-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190314530 A1 (Poul et al.) in view of Generalized synthesis of large-pore mesoporous metal oxides with semicrystalline frameworks, Peidong Yang et al, "Nature", Vol. 396, pp. 152-155 (Yang et al.) and US 20230338337 A1 (Ferrari et al.).
Regarding claims 16 and 18, Poul teaches a method of altering or destroying target cancerous cells in a mammal [0094] comprising administering porous, high-Z and carbon-free particles or a composition comprising said particles and a pharmaceutically acceptable carrier, vehicle or support to a mammal in need of treatment (being inorganic and therefore carbon-free [0002]), and exposing the cells to ionizing radiation [0016], and wherein the particles comprise: a) a high-Z metal phosphate, a high-Z metal oxo phosphate, a high-Z metal oxide or a high-Z mixed metal oxide, wherein the high-Z metal phosphate, high-Z metal oxo phosphate, high Z metal oxide or high-Z mixed metal oxide comprises at least one high-Z metal element, wherein the Z value of the at least one high-Z metal element is of at least 40 [0053, Claim 1];
Poul fails to teach internal pore size or surface area.
Yang teaches the synthesis of high Z metal oxides (such as ZrO2 and HfO2) with mesoporous structures [Abstract] wherein the particle surface area is at least 100 m2/g (Table 1), wherein the particles have a pore size between 0.5-50 nm (Table 1 teaching pore sizes from 35-140 Å which converts to 3.5-14 nm).
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 have modified the particles of Poul to have the dimensions taught by Yang to allow for creation of high-density particulates (thereby increasing delivery) with increased stability (Yang p. 153, ¶1, continued to p. 154).
Ferrari teaches biomarkers for cancer treatment [Abstract] wherein an increased surface area is desired to assist in absorption.
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 have modified the particle surface area of Poul in view of Yang to be higher in order to assist in absorption of delivered particles. As the ability to delivery particles and the quantity of said particles are variables that can be modified, among others, by adjusting the particle size and surface area, an increase in surface area is known to allow for increased delivery of targeted particles, thereby improving the treatment, the surface area is considered a result effective variable. As such, without showing unexpected results, the claimed surface area cannot be considered critical. Therefore, it would have been obvious to a person having ordinary skill in the art to increase surface area effecting a result of a BET surface area of at least 100 m2/g. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 19, Poul further teaches the high-Z metal is selected from a lanthanide, tantalum (Ta), tin (Sn), zirconium (Zr), cerium (Ce) hafnium (Hf), tungsten (W), niobium (Nb), titanium (Ti) or rhenium (Re) [0044].
Regarding claim 20, Poul further teaches the particles comprise a high- Z metal oxide or a mixed metal oxide of respective composition MxOy, and MxM'zOy, wherein M and M' are metal elements chosen independently from a lanthanide element, zirconium (Zr) and hafnium (Hf) (teaching hafnium oxide [0044]).
Regarding claim 21, Poul further teaches the metal oxide is selected from Nb2Os, Ta2Os, WO3, HfO2, SnO2, ZrTiO4, and ZrW2O8 (hafnium oxide [0143]).
Regarding claim 22, Poul further teaches at least part of the porous structure of the particles is occupied by at least one therapeutic agent (the targeting agent [0055], selected from an immunotherapeutic agent (at least the antibodies taught in [0055] fulfilling the Specification definition wherein the “immunotherapeutic agent can typically be any molecule, drug, oncolytic virus, DNA-based vaccine, peptide-based vaccine, toll-like receptor agonist, or any combination thereof, capable of boosting the immune system of a subject in need thereof, and recognized as such by the skilled person“.
Regarding claim 23, Poul further teaches the particles further comprise a targeting agent that recognizes an element present on a cancer cell and comprise a peptide, an oligopeptide, a protein, a nucleic acid , a hormone, a vitamin, an enzyme, the ligand of a tumor antigen, hormone receptor, cytokine receptor or growth factor receptor ([0054-0055] detailing use of targeting agents).
Regarding claim 24, Poul further teaches the cells are exposed to ionizing radiation from a radiotherapy regimen selected from the group consisting of a conventional fractionation regimen, an hyperfractionation regimen, an (accelerated) hypofractionation regimen and a stereotactic ablative body radiotherapy (SBAR) regimen [0097].
Regarding claim 25, Poul is considered to teach the fractionated regimen is given over more than ten days by providing a plurality of examples wherein treatment was provided for 20 days (at least [0116]).
Regarding claim 26, Poul further teaches the target cancerous cells belong to a solid malignant tumor (any type of malignant solid tumor [0087]) selected from a skin cancer, a central nervous system cancer, a head and neck cancer, a lung cancer, a liver cancer, a breast cancer, a gastrointestinal cancer, a male genitourinary cancer, a gynecologic cancer, an adrenal and/or retroperitoneal cancer, a sarcoma and a pediatric cancer.
Regarding claim 27, Poul teaches a composition comprising porous, high-Z and carbon-free particles or a composition comprising said particles and a pharmaceutically acceptable carrier, vehicle or support to a mammal in need of treatment (being inorganic and therefore carbon-free [0002]), and exposing the cells to ionizing radiation [0016], and wherein the particles comprise: a) a high-Z metal phosphate, a high-Z metal oxo phosphate, a high-Z metal oxide or a high-Z mixed metal oxide, wherein the high-Z metal phosphate, high-Z metal oxo phosphate, high Z metal oxide or high-Z mixed metal oxide comprises at least one high-Z metal element, wherein the Z value of the at least one high-Z metal element is of at least 40 [0053, Claim 1];
Poul fails to teach internal pore size or surface area.
Yang teaches the synthesis of high Z metal oxides (such as ZrO2 and HfO2) with mesoporous structures [Abstract] wherein the particle surface area is at least 100 m2/g (Table 1), wherein the particles have a pore size between 0.5-50 nm (Table 1 teaching pore sizes from 35-140 Å which converts to 3.5-14 nm).
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 have modified the particles of Poul to have the dimensions taught by Yang to allow for creation of high-density particulates (thereby increasing delivery) with increased stability (Yang p. 153, ¶1, continued to p. 154).
Ferrari teaches biomarkers for cancer treatment [Abstract] wherein an increased surface area is desired to assist in absorption.
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 have modified the particle surface area of Poul in view of Yang to be higher in order to assist in absorption of delivered particles. As the ability to delivery particles and the quantity of said particles are variables that can be modified, among others, by adjusting the particle size and surface area, an increase in surface area is known to allow for increased delivery of targeted particles, thereby improving the treatment, the surface area is considered a result effective variable. As such, without showing unexpected results, the claimed surface area cannot be considered critical. Therefore, it would have been obvious to a person having ordinary skill in the art to increase surface area effecting a result of a BET surface area of at least 100 m2/g. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding claim 28, the composition of claim 27 selects particles from a).
Regarding claim 29, Poul teaches a biocompatible gel [0056] which acts as the vehicle or support, which is selected from a liposome, viral vector, viral-like particle, albumin containing carrier, inorganic polymer and organic polymer [0061].
Conclusion
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.
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/HANS KALIHER/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781
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