5DETAILED 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 .
Election/Restrictions
Applicant’s election without traverse of Claims 1-19 (A method for treating a tumor) in the reply filed on 10 February 2026 is acknowledged.
Claims 20-29 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device for treating a tumor, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 February 2026.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, & 16 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by US 2003/0199726 hereinafter Gatto.
In regards to Claim 1: A method of treating a tumor, comprising:
identifying a tumor (Gatto, Paragraph 25); and
injecting a liquid including free radionuclides into the tumor (Gatto, Paragraph 60), for a duration of at least 6 hours (Gatto, Paragraph 11).
In regards to Claim 2: The method of claim 1, wherein identifying the tumor comprises identifying a tumor having a largest diameter of at least 2 centimeters (Gatto, Paragraph 5) and wherein injecting the liquid comprises injecting through a single needle (Gatto, Paragraph 46; Figure 1 Item 14).
In regards to Claim 3: injecting the liquid comprises injecting for a duration of at least 72 hours (Gatto, Paragraph 11).
In regards to Claim 4: injecting the liquid comprises injecting for a duration of at least 110 hours (Gatto, Paragraph 11).
In regards to Claim 16: The method of claim 1, further comprising:
acquiring an image of the dispersion of the radionuclides in the tumor (Gatto, Paragraph 58);
determining whether an area of the tumor is not receiving a sufficient number of radionuclides responsive to the acquired image (Gatto, Paragraph 21); and
adjusting a parameter of the injecting responsive to determining that an area of the tumor is not receiving a sufficient number of radionuclides (Gatto, Paragraph 60; Figure 6-8 Item 64).
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.
Claim(s) 5, 6, 7, & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of US 2007/0041900 hereinafter Kelson.
In regards to Claim 5: Gatto teaches all of Claim 1, but does not teach wherein injecting the liquid comprises injecting a liquid including beta-emitting radionuclides.
Keslon teaches wherein injecting the liquid comprises injecting a liquid including beta-emitting radionuclides (Kelson, Paragraph 125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add Beta-emitting radionuclide found in Kelson to the Brachytherapy apparatus taught in Gatto, the motivation being to provide low radiation to the area in order to mitigate damage to surrounding tissue.
In regards to Claim 6: Gatto teaches all of claim 6, but does not teach injecting the liquid comprises injecting a liquid including beta-emitting radionuclides.
Kelson teaches injecting the liquid comprises injecting a liquid including beta-emitting radionuclides (Kelson, Paragraphs 12 & 122-125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the liquid including alpha-emission-treatment radionuclides taught in Kelson to the Brachytherapy apparatus taught in Gatto, the motivation being to provide alpha radiation to apply to the cancer.
In regards to Claim 7: Gatto teaches all of claims 1 & 6, but does not teach injecting the liquid comprises injecting a liquid including 212Pb radionuclides.
Kelson teaches injecting the liquid comprises injecting a liquid including 212Pb radionuclides (Kelson, Paragraph 125).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the liquid including 212Pb radionuclides taught in Kelson to the apparatus for brachytherapy taught by Gatto, the motivation being to provide an element that decays by releasing beta emissions.
In regards to Claim 9: Gatto teaches all of claim 1, but does not teach injecting the liquid comprises injecting a liquid which does not include more than negligible amounts of 224Ra, 220Rn, and 216Po.
Kelson teaches injecting the liquid comprises injecting a liquid which does not include more than negligible amounts of 224Ra, 220Rn, and 216Po (Kelson, Paragraphs 122-124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the elemental radionuclides taught by kelson to the apparatus for brachytherapy taught in Gatto, the motivation being to provide an only negligible amounts of the radionuclides that decay into 212Pb.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of WO 2008/115511 hereinafter Dalke.
In regards to Claim 8: Gatto teaches all of claim 8, but does not teach wherein injecting the liquid comprises injecting a liquid including at least 2* 10^7 radionuclides of an alpha-emission-treatment isotope per microliter.
Dalke teaches wherein injecting the liquid comprises injecting a liquid including at least 2* 107 radionuclides of an alpha-emission-treatment isotope per microliter (Dalke, Paragraph Spanning Pages 23 & 24; Examiner Converted atoms to moles using mol = atoms ÷ 6.02214076 × 1023 and compared the value to the prior art).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the concentration of radionuclides found in Dalke to the method of Gatto, the motivation being to provide a non-lethal dosage of the radionuclide.
Claim(s) 10 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of 2019/0290846 hereinafter McGrogan.
In regards to Claim 10: Gatto teaches all of claim 1, but does not teach wherein injecting the liquid comprises injecting at a rate of at least 2.5 microliters per minute.
McGrogan teaches wherein injecting the liquid comprises injecting at a rate of at least 2.5 microliters per minute (McGrogan, Paragraph 11).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add rate of injection taught by McGrogan to the apparatus for brachytherapy taught in Gatto, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is volumetric flow rate which achieves the recognized result of ensuring the patient receives a consistent amount of medication therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
In regards to Claim 11: Gatto teaches all of claim 1, but does not teach wherein injecting the liquid comprises injecting at a rate of not more than 10 microliters per minute.
McGrogan teaches wherein injecting the liquid comprises injecting at a rate of not more than 10 microliters per minute (McGrogan, Paragraph 11).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add rate of injection taught by McGrogan to the apparatus for brachytherapy taught in Gatto, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is volumetric flow rate which achieves the recognized result of ensuring the patient receives a consistent amount of medication therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of 2010/0178245 hereinafter Arnsdorf.
In regards to Claim 12: Gatto teaches all of claim 1, but does not teach wherein injecting the liquid comprises pumping a liquid through a vial holding therein one or more seeds with parent radionuclides attached to the seeds in a manner that the parent radionuclides do not leave the seed, but a substantial percentage of daughter nuclides leave the seeds into the liquid, upon decay.
Arnsdorf teaches wherein injecting the liquid comprises pumping a liquid through a vial (Arnsdorf, Paragraph 38) holding therein one or more seeds with parent radionuclides attached to the seeds in a manner that the parent radionuclides do not leave the seed (Arnsdorf, Paragraph 37 & 38), but a substantial percentage of daughter nuclides leave the seeds into the liquid, upon decay(Arnsdorf, Paragraphs 37, 38, & 109).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the generation of radionuclides taught in Arnsdorf to the Brachytherapy apparatus taught in Gatto, the motivation being to provide a method to acquire the radiation needed for treatment before too much decay can occur.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of 2002/0156338 hereinafter Menuhr.
In regards to Claim 13: Gatto teaches all of claims 1 & 12, but does not teach wherein the one or more seeds carry at least 10 microcurie of 224Ra radionuclides.
Menuhr teaches wherein the one or more seeds carry at least 10 microcurie of 224Ra radionuclides (Menuhr, Paragraph 7 & 49).
It would have been obvious to one of ordinary skill in the art at the filing date of the invention to add seeds with a certain level of microcurie as taught in Menuhr to the apparatus for brachytherapy taught by Gatto, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.II. The Examiner notes that a particular parameter must be recognized as a result effective variable, in this case, that parameter is radioactivity which achieves the recognized result of providing enough radiation to the patient to achieve the desired results therefore, one of ordinary skill in the art at the filing date of the invention would have found the claimed range through routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See also In re Boesch, 617 F.2d 272, USPQ 215 (CCPA 1980).
In regards to Claim 14: A modified Gatto teaches all of claim 1, 12, 13, and wherein the one or more seeds carry at least 100 microcurie of 224Ra radionuclides (Menuhr, Paragraph 7 & 49).
In regards to Claim 15: A modified Gatto teaches all of claim 1, 12, 13, 14, and wherein the one or more seeds carry at least 250 microcurie of 224Ra radionuclides (Menuhr, Paragraph 7 & 49).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of US 2015/0320895 hereinafter Sun.
In regards to Claim 17: Gatto teaches claim 1 & 16, but does not teach wherein at least some of the radionuclides are injected coupled to nanoparticles which serve as contrast agents which appear in the acquired image.
Sun teaches wherein at least some of the radionuclides are injected coupled to nanoparticles which serve as contrast agents which appear in the acquired image (Sun, Paragraph 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the nanoparticles taught in Sun to the apparatus for brachytherapy taught in Gatto, the motivation being to allow for the treatment of a patient with radionuclide that does not require major surgery.
Claim(s) 18 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2003/0199726 hereinafter Gatto in view of US 2014/0046295 hereinafter Uber, III.
In regards to Claim 18: Gatto teaches all of claim 1 & 16, but does not teach wherein adjusting the parameter comprises changing a flow rate of injecting the liquid.
Uber, III teaches wherein adjusting the parameter comprises changing a flow rate of injecting the liquid (Uber, III, Claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the adjustment of the flow rate taught in Uber, III to apparatus for brachytherapy taught in Gatto, the motivation being to provide a method to ensure the treatment is safely administered.
In regards to Claim 19: Gatto teaches claims 1 & 16, but does not teach wherein adjusting the parameter comprises changing a concentration of the radionuclides in the liquid.
Uber, III teaches wherein adjusting the parameter comprises changing a concentration of the radionuclides in the liquid (Uber, III, Paragraph 14 & 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to add the adjustment of radiation taught by Uber III to the apparatus for brachytherapy taught by Gatto, the motivation being to provide a method to keep the concentration level in a safe place.
Conclusion
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/N.R.D./ Patent Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791