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 .
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 16 and 8 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 claim 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In addition, regarding claim 16, the phrase "other drugs" renders the claim indefinite because it is unclear what are the other drugs. The phrase "other drugs" is indefinite since there is nothing in the claim with these limitations to tell public what to do to avoid contravention in this respect; rule against indefiniteness in not only a technical one, but is to protect public and keep patentee from taking advantage to which he is not entitled.
Regarding claim 16, the phrase "a, b, and c are constants" renders the claim indefinite because it is unclear what are the numerical value of claimed constants in addition, they appear to be relative terms not defined by the claim and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In general, mathematical and physical constants are relative terms to the given context, model, or unit system, rather than being universal absolute in every scenario. While they represent fixed value within a specific formula or problem, they can act as variable in broader context. Rule against indefiniteness in not only a technical one, but is to protect public and keep patentee from taking advantage to which he is not entitled.
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.
Claims 1-8 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Romesberg, III et al. (US PAP 2008/0049898 A1) in view of Carabe-Fernandez et al. (US PAP 2022/0241615 A1).
With respect to claims 1, 2, 17 and 19, Romesberg, III et al. teaches a method and system of determining an effective local dose for a treatment procedure, comprising (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1): determining a mean dose of a particle and a particle density at least a portion of tumor and at least a portion of normal tissue (see paragraphs 0005, 0029 and 0098);
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performing a simulation or calculation comprising a Monte Carlo simulation., using the mean dose and the particle density; and determining the effective local dose, based on the simulation or calculation paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109) but fails to explicitly mention performing a microdosimetry simulation or calculation.
Carabe-Fernandez et al. discloses a system/method for particle treatment using microdosimetry technics (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) which explicitly teaches that radiation therapy can be effective in treating certain types of cancerous tumors, lesions, or other targets while a sufficient radiation dose is delivered to the tumor or lesion volume to provide user with the capabilities to generate an analytical model from microdosimetry Monte Carlo simulations data to perform fast and accurate calculations of distributions for particle beams (see paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297).
Romesberg, III et al. and Carabe-Fernandez et al. disclose similar methods/apparatuses for determining an effective local dose for a treatment procedure.
It 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 to provide teachings of performing a microdosimetry simulation or calculation as suggested by Carabe-Fernandez et al. in the method/apparatus of Romesberg, III et al., since such a modification would provide user with the capabilities to generate an analytical model from microdosimetry Monte Carlo simulations data to perform fast and accurate calculations of distributions for particle beams.
It would have been obvious to treat Romesberg, III et al. and Carabe-Fernandez et al. as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claims 1, 2, 17 and 19 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 3, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, further comprising treating a patient pursuant to the effective local dose.
With respect to claim 4, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, further comprising preparing a treatment plan for a patient pursuant to the effective local dose.
With respect to claim 5, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein the effective dose is the dose at which a given fraction of the target volume receives less than the effective dose.
With respect to claim 6, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein the effective dose is a volume percentage of the target volume that receives more than the target dose.
With respect to claim 7, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein a continuous function is used to approximate the microdosimetry simulations.
With respect to claim 8, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 7, claims formula without providing the numerical value of claimed constants appear incomplete and does not constitute a limitation in any patentable sense.
With respect to claim 13, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein at least one of the amount of radiation or drug, and/or the number of particles administered to a patient is adjusted to achieve a minimum tumor effective dose, maximum non-tumor effective dose, or both.
With respect to claim 14, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein the number of particles delivered is adjusted to maximize the tumor effective dose, divided by the non-tumor effective dose.
With respect to claim 15, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein the tumor is in the liver, lung, kidney, pancreas, or prostate.
With respect to claim 16, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, wherein the embolic particles contain a radioisotope or other drugs.
With respect to claim 17, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches a computer-implemented method for implementation by one or more data processors, the method comprising: determining a mean dose of a particle and a particle density at least a portion of tumor and at least a portion of normal tissue; performing a microdosimetry simulation or calculation, using the mean dose and the particle density; and determining the effective local dose, based on the microdosimetry simulation or calculation.
With respect to claim 18, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the computer-implemented method of claim 1, the method further comprising preparing a treatment plan for a patient pursuant to the effective local dose.
With respect to claim 19, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches a system configured to determine an effective local dose for a treatment procedure, the system comprising: a non-transitory computer readable medium comprising instructions executable by a processor to cause the processor to: determine a mean dose of a particle and a particle density at least a portion of tumor and at least a portion of normal tissue; perform a microdosimetry simulation or calculation, using the mean dose and the particle density; and determine the effective local dose, based on the microdosimetry simulation or calculation.
Allowable Subject Matter
Claims 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 9, the most relevant prior art, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 8, wherein a=36.5, b=3.42 and c=2 as claimed in combination with all of the remaining limitations of the base claim and any intervening claims.
With respect to claims 10-12, the most relevant prior art, Romesberg, III et al. (see Abstract; Figs. 1-25; paragraphs 0005, 0007, 0014, 0015, 0018-0020, 0023, 0025, 0027, 0029, 0033, 0035, 0056, 0061, 0078, 0083, 0085, 0093,0097, 0098, 0101 and 0109; claim 1) as modified by Carabe-Fernandez et al. (see abstract; Figs. 1-22B; paragraphs 0044, 0051, 0056, 0060, 0081, 0083, 0246 and 0297) teaches the method of claim 1, further comprising determining a mean dose and a particle density via a partition model as claimed in combination with all of the remaining limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRAKLI KIKNADZE whose telephone number is (571)272-6494. The examiner can normally be reached 9:00 AM - 6:00 PM.
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Irakli Kiknadze
/IRAKLI KIKNADZE/
Primary Examiner, Art Unit 2884
/I.K./ February 5, 2026