DETAILED ACTION
This Office action is in response to the amendment filed on April 6th, 2026. Claims 1 and 3-20 are pending.
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 .
Drawings
Replacement drawings were received on April 6th, 2026. These drawings are accepted and overcome the prior objection to the drawings.
Terminal Disclaimer
The terminal disclaimer filed on April 6th, 2026 is approved and the relevant double patenting rejections are withdrawn.
Claim Interpretation
The claims recite “real-time neutron dosage detected by the detection system” (multiple claims, including the independent claim). Neutron dosage is understood to mean the dose, which accumulates over time. Therefore, “real-time detection” will be considered to be the real-time output of the integrator, rather than a real-time output of the detector itself.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder such as system or part that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a neutron beam irradiation system configured to generate a neutron beam,”, “a detection system configured to detect real-time irradiation parameters during a neutron beam irradiation therapy,”, “an input part configured to input preset irradiation parameters”, “a determination part configured to determine whether irradiation parameters are needed to be corrected,” and “a correction part configured to correct a part of the irradiation parameters,” in claims 1-20; “a storage part configured to store irradiation parameters,” in claims 5-7, 13, 15, and 20 “a control part configured to perform a therapy plan according to the irradiation parameters stored in the storage part,” in claims 5-7 and 20; “a reading part configured to read the real-time irradiation parameters detected by the detection system” in claims 5-7, 13, and 20; and “a calculation part configured to calculate the irradiation parameters stored in the storage part,” in claims 6-7 and 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 9 recites correcting the remaining irradiation time using the following formulas:
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The first equation expresses that the average dosage rate over the measured time period is the dose measured in that time period divided by the length of the time period, which is tautologically true. The second equation requires the remaining time to be set to the time it would take to reach the total planned dose if the dosage rate remaining at that average value (expressed as remaining time = remaining dose/average rate), which is certainly a valid method of correcting the remaining irradiation time if the dosage rate were not being adjusted.
However, the parent claim requires that the dosage rate is being adjusted when the same 97% level is met (see claim 3), and the specification notes that in this case a different formula must be used in order to account for the change in doseage rate (see paragraphs 104-105 of applicant’s specification, using the pg-pub numbering). There is no disclosure of an embodiment that adjusts the dosage rate and also calculates the remaining time based on the previous average doseage rate. While such a calculation could of course be performed, it would result in a large under-irradiation because the irradiation time would be calculated based on the larger initial doseage rate yet the beam would be delivered using the smaller adjusted rate. Hence there is no reason a person having ordinary skill in the art would consider this, given the disclosure.
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.
Claim(s) 1, 3-8, and 10-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0250528 (Liu et al.) in view of US 2019/0054320 (Owens et al.).
Regarding claim 1, Liu et al. discloses a neutron capture therapy apparatus, comprising
a neutron beam irradiation system configured to generate a neutron beam (fig. 3, elements 10 & T),
a detection system configured to detect real-time irradiation parameters during a neutron beam irradiation therapy (fig. 3, element 60), and
a monitoring system configured to control the whole neutron beam irradiation process (fig. 3, element 70) and comprising
a correction part configured to correct a part of the irradiation parameters, (‘the charged particle beam is adjusted and the irradiation dose is controlled’ P 14, where it is understood that the corrected parameters must be calculated for the control to adjust them).
Liu et al. does not disclose an input part configured to input preset irradiation parameters. Owens discloses a particle therapy apparatus including an input part configured to input preset irradiation parameters (“The graphical user interface may also provide a menu of commands for operator selection, as well as a programming interface so that the operator may enter a predetermined set of machine instructions and parameters.” P 39). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include an input part such as the one in Owens et al. in the neutron capture therapy device of Liu et al. so that the desired dose and other beam parameters could be entered by a user.
Liu et al. also does not disclose a determination part configured to determine whether the irradiation parameters are needed to be corrected, where the correction occurs in response to the determination part determining that the irradiation parameters are needed to be corrected and the determination part of the monitoring system determining that the irradiation parameters are needed to be corrected, in response to one of plurality of conditions being met. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include a determination part to determine whether the irradiation parameters are needed to be corrected to reduce computational burden by ensuring that such correction is only carried out when needed.
Finally, Liu et al. does not disclose that the conditions include: a ratio of a real-time neutron dosage detected by the detection system to a preset neutron dosage being greater than or equal to a preset value; wherein the correction part adjusts a neutron dosage rate to be a first neutron dosage rate less than a preset neutron dosage rate, in response to the ratio of the real-time neutron dosage to the preset neutron dosage being greater than or equal to the preset value. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify the apparatus of Liu et al. to trigger a reduction in doseage rate when the cumulative dose is nearly complete because this will prevent accidental overdosage.
Regarding claim 3, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 1, wherein the correction part adjusts the neutron dosage rate to be the first neutron dosage rate less than the preset neutron dosage rate, in response to the ratio of the real-time neutron dosage to the preset neutron dosage being greater than or equal to 97% (obvious as a matter of routine optimization or experimentation, the disclosure never suggests that this value is critical and any value nearing 100% could be considered a reasonable cut-off, with the value chosen being a trade-off between less danger of overdosage with a lower cut-off and shorter irradiation times with a higher cut-off).
Regarding claim 4, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 3, wherein the first neutron dosage rate is comprised between 1/5 and 1/2 of the preset neutron dosage rate (obvious as a matter of routine optimization or experimentation, the disclosure never suggests that this range is critical and any value significantly less than the preset neutron dosage rate could be considered reasonable as a way to reduce the chance of accidental overdosage, with the value chosen representing a trade-off between less risk of overdosage at lower rates and shorter irradiation times at higher rates.).
Regarding claim 5, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 1, wherein the monitoring system further comprises a storage part configured to store irradiation parameters (obvious to include a storage part because the control will need repeated access this information and storing it ensures access to the preset values even if the values are removed at the input part), a control part configured to perform a therapy plan according to the irradiation parameters stored in the storage part (fig. 3, element 70, wherein ‘the charged particle beam is adjusted and the irradiation dose is controlled’ P 14), and a reading part configured to read the real-time irradiation parameters detected by the detection system ('detection device is used for real-time detection' abstract, where reading the detection signal is inherent in the use of it of the correction part).
Regarding claim 6, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 5, wherein the monitoring system further comprises a calculation part configured to calculate the irradiation parameters stored in the storage part ('the radiation detection system calculates the intensity of the neutron beam according to detection signal, so that the charged particle beam is adjusted and the irradiation dose is controlled.' P 14), and the determination part determines, according to a calculation result of the calculation part, whether the irradiation parameters to be corrected (inherent in the determination based on ratio of real-time and preset dosage).
Regarding claim 7, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 6, wherein the conditions further include a difference between the preset irradiation parameter and the real-time irradiation parameter calculated by the calculation part (“More particularly, the radiation detection device is an ionization chamber or a scintillator, the radiation detection system calculates the intensity of the neutron beam according to detection signal, so that the charged particle beam is adjusted and the irradiation dose is controlled.” P 14).
Liu et al. does not disclose determining that the difference is greater than a first threshold, or the real-time irradiation parameter being greater than a second threshold or less than a third threshold. Comparing values to thresholds to determine if corrections is warranted is common in the art, and it would have been obvious to a person having ordinary skill in the time the application was filed to modify the apparatus of Liu et al. to correct the irradiation parameters when the difference is greater than a first threshold, or equivalently to correct the irradiation parameters when the measured value is greater than a second threshold or smaller than a third threshold, because larger differences, or equivalently values that are a significantly greater or smaller than the target value, indicate a greater need for correction.
Regarding claim 8, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 4, wherein the neutron capture therapy apparatus of claim 4, wherein the correction part corrects a remaining irradiation time, in response to adjusting, by the correction part, the neutron dosage rate to be 1/5 of the preset neutron dosage rate, and a corrected remaining irradiation time tr is calculated by using a formula (2-4):
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where Dtotal is the preset neutron dosage, Dr is the real-time neutron dosage detected by the detection system, and Id is the preset neutron dosage rate (inherent in adjusting the neutron dosage rate to be 1/5 of the preset neutron dosage rate, the irradiation time will need to be adjusted along with the rate for the preset dose to be reached, because dose = rate x time, the formula above merely re-expresses this as remaining time = remaining dose/new rate, were the new rate is 1/5 the preset rate).
Regarding claim 10, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 1, wherein the monitoring system further comprises a display part configured to display irradiation parameters in real time (fig. 3, element 72).
Regarding claim 11, Liu et al. in view of Owens et al. disclose the neutron capture therapy apparatus of claim 3, wherein the monitoring system further comprises a display part configured to display irradiation parameters in real time (fig. 3, element 72).
Regarding claim 12, Liu et al. in view of Owens et al. disclose an operation method of the monitoring system of the neutron capture therapy apparatus of claim 1, comprising:
inputting, by the input part, the preset irradiation parameters (obvious to input so that an initial set of parameters could be set as desired); and
correcting, by the correction part, the irradiation parameters, (‘the charged particle beam is adjusted’ P 14).
Liu et al. does not disclose determining, by the determination part, whether irradiation parameters to be corrected, or performing correction in response to the determination part determining that the irradiation parameters are needed to be corrected. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include such a determination step and perform or not perform the correction based on the determination step to reduce computational burden and adjustment errors by ensuring that such correction is only carried out when needed.
Regarding claim 13, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 12, wherein the monitoring system further comprises a storage part configured to store irradiation parameters (obvious to include a storage part because the control will need to access this information and storing it ensures access), a calculation part configured to calculate the irradiation parameters stored in the storage part ('the radiation detection system calculates the intensity of the neutron beam according to detection signal, so that the charged particle beam is adjusted and the irradiation dose is controlled.' P 14), and a reading part configured to read the real-time irradiation parameters detected by the detection system ('detection device is used for real-time detection' abstract, where reading the detection signal is inherent in the use of it of the correction and calculation parts), and
the operation method of the monitoring system further comprise calculating, by the calculation part, the irradiation parameters stored in the storage part ('the radiation detection system calculates the intensity of the neutron beam according to detection signal, so that the charged particle beam is adjusted and the irradiation dose is controlled.' P 14) and the real-time irradiation parameters read by the reading part (inherent in the use of the detected values in the calculation), and the determination part determines, according to a calculation result of the calculation part, whether the irradiation parameters to be corrected (inherent in the determination based on ratio of real-time and preset dosage).
Regarding claim 13, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 12, wherein the monitoring system further comprises a display part (fig. 3, element 72), and the operation method of the monitoring system further comprise displaying, by the display part, irradiation parameters in real time (obvious to display the parameters so that the operator can view them as a method of tracking the progress of the irradiation method).
Regarding claim 15, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 14, wherein the storage part stores the preset irradiation parameters (obvious to store them to ensure they are saved and will not be overwritten or lost during control), and the display part displays a remaining irradiation time and other preset irradiation parameters in real time, before the preset irradiation parameters are corrected (obvious to display remaining time so the operator known long the irradiation will continue, obvious to display the preset parameters so operator can be assured they are correct); and the storage part stores a latest set of corrected irradiation parameters (obvious to store them to ensure they are saved and will not be overwritten or lost during control), and the display part displays a corrected remaining irradiation time and a latest set of other corrected irradiation parameters in real time, after the preset irradiation parameters are corrected (obvious to display remaining time so the operator known long the irradiation will continue, obvious to display the real time parameters so operator can view them as a method of tracking the progress of the irradiation method).
Regarding claim 16, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 12, wherein the correction part adjusts a neutron dosage rate to be a first neutron dosage rate less than a preset neutron dosage rate, in response to the ratio of the real-time neutron dosage to the preset neutron dosage being greater than or equal to the preset value (obvious to reduce dosage rate when cumulative dose is nearly complete because this will prevent accidental overdosage).
Regarding claim 17, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 16, wherein the correction part adjusts the neutron dosage rate to be the first neutron dosage rate less than the preset neutron dosage rate, in response to the ratio of the real-time neutron dosage to the preset neutron dosage being greater than or equal to 97% (obvious as a matter of routine optimization or experimentation, the disclosure never suggests that this value is critical and any value nearing 100% could be considered a reasonable cut-off, with the value chosen being a trade-off between less danger of overdosage with a lower cut-off and shorter irradiation times with a higher cut-off).
Regarding claim 18, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 17, wherein the first neutron dosage rate is comprised between 1/5 and 1/2 of the preset neutron dosage rate (obvious as a matter of routine optimization or experimentation, the disclosure never suggests that this range is critical and any value significantly less than the preset neutron dosage rate could be considered reasonable as a way to reduce the chance of accidental overdosage, with the value chosen representing a trade-off between less risk of overdosage at lower rates and shorter irradiation times at higher rates.).
Regarding claim 19, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 18, wherein the correction part corrects a remaining irradiation time, in response to adjusting, by the correction part, the neutron dosage rate to be 1/5 of the preset neutron dosage rate, and a corrected remaining irradiation time tr is calculated by using a formula (2-4):
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where Dtotai is the preset neutron dosage, Dr is the real-time neutron dosage detected by the detection system, and Id is the preset neutron dosage rate (inherent in adjusting the neutron dosage rate to be 1/5 of the preset neutron dosage rate, the irradiation time will need to be adjusted along with the rate for the preset dose to be reached, because dose = rate x time, the formula above merely re-expresses this as remaining time = remaining dose/new rate, were the new rate is 1/5 the preset rate).
Regarding claim 20, Liu et al. in view of Owens et al. disclose the operation method of the monitoring system of claim 12, wherein the monitoring system further comprises a storage part configured to store irradiation parameters (obvious to include a storage part because the control will need repeated access this information and storing it ensures access to the preset values even if the values are removed at the input part), a control part configured to perform a therapy plan according to the irradiation parameters stored in the storage part (fig. 3, element 70), and a reading part configured to read the real-time irradiation parameters detected by the detection system (inherent in the use of the detected values in the determination and correction steps).
Response to Arguments
Applicant's arguments filed April 6th, 2026 have been fully considered but they are not persuasive.
Applicant argues that examiner’s previous rationale for the obviousness of modifying Liu to include a determination part based on the ratio of neutron doseage detected to a preset neutron doseage no longer applies because the claim now allows for the possibility of determination based on other conditions. Examiner has modified the obviousness rationale to encompass the newly amended claim limitation.
Applicant challenges examiner’s taking of Official Notice of the fact that an input part configured to input present irradiation parameters is well known in the art. Examiner has provided newly cited prior art Owens et al. to show that such input parts are indeed known in the prior art.
Conclusion
Applicant's amendment and challenge of Official Notice 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 ELIZA W OSENBAUGH-STEWART whose telephone number is (571)270-5782. The examiner can normally be reached 10am - 6pm Pacific Time M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at 571-272-2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELIZA W OSENBAUGH-STEWART/Primary Examiner, Art Unit 2881
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