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
Rejections under 35 USC 101
The Examiner erroneously indicated that previously presented claims 21 and 22 would overcome the rejection under 35 USC 101. Upon further consideration, the claims are not patent eligible because the claims are directed to an abstract idea without significantly more.
Rejections under 35 USC 112(a)
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive because the amended claims and disclosure is void of an algorithm, flow chart, prose, etc. as to how the claimed results are accomplished. Although the disclosure as indicated in the Remarks points to the specification and figures as giving details as to what the determinations and claimed results are based on, the disclosure does not adequately explain how it is based on these items. There is no written description to explain how one of ordinary skill in the art could take these items that the determination/calculation is based on and use them to obtain the end result. This is required to meet the written description requirement of 35 USC 112(a). See rejections below for further details.
Rejections under 35 USC 102 and 103
Applicant’s arguments, see Remarks filed 06/09/2026, with respect to the rejections under 35 USC 103 have been fully considered and are persuasive, therefore the rejections have been withdrawn.
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.
Claims 1-20 are 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. 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.
MPEP 2161.01 I. recites, “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.”
Regarding claim 1 and claim 14:
Claim 1 recites “determining, by the processor, a plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation based upon the dose determination source model including the 3D geometry data for the MLC, wherein determining the plurality of attenuation lengths includes calculating, from the 3D geometry data, a distance that each beam segment travels through the at least one leaf of the MLC”. The disclosure merely recites similar language ([0009]-[0010], [0020], [0046], [0054], [0063], Step 404 of Fig. 4, ) without providing an algorithm as to HOW the 3D geometry data is used to calculate a distance that each beam segment travels through the at least one leaf of the MLC . There is no algorithm or steps disclosed indicating how this determination/calculation is performed based on this information. The specification and claims fail to go beyond providing an input and a desired result. There is no disclosure as to how the inventor intended the function of calculation/determination to be performed (i.e. how the input is utilized, transformed, or manipulated in order to go from the input to the result). Consequently, the disclosure fails to suggest possession of the claimed invention and is therefore rejected under 35 USC 112(a) for lack of written description.
Claim 1 recites “adjusting, by the processor, one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation, wherein adjusting the one or more parameters of the dose determination source model includes obtaining, for each of the plurality of attenuation lengths, a corresponding attenuated spectrum from the photon energy spectrum data”. The disclosure merely recites this similar language (see paragraphs [0005]-[0010], [0046], [0057]-[0058] and step 408 of Fig. 4) without providing an algorithm as to HOW the dose determination source model is adjusted based on the data and attenuation length(s). The specification and claims fail to go beyond providing an input and a desired result. There is no disclosure as to how the inventor intended the function of adjusting to be performed (i.e. how the input (photon energy spectrum data, beam angle distribution data, and plurality of attenuation lengths) is utilized, transformed, or manipulated in order to go from the input to the result (adjusted parameters of the dose determination source model)). The limitation “wherein adjusting the one or more parameters of the dose determination source model includes obtaining, for each of the plurality of attenuation lengths, a corresponding attenuated spectrum from the photon energy spectrum data” fails to provide this nexus between input and result because it is not disclosed how obtaining a corresponding attenuated spectrum from the photon energy spectrum data accomplishes adjusting parameters of the dose determination source model. Furthermore, in addition to not disclosing how the parameters are adjusted, there is no disclosure of what parameters of the dose determination source model are being adjusted based on these input. Paragraph [0030] mentions generic radiation parameters, but fails to connect these parameters to the method step claimed. The parameters listed as examples are diverse (including parameters as different as field geometry settings to side effect predictions) and there is no discussion of adjustment of these parameters in particular and how the adjustment is made. Consequently, the disclosure fails to suggest possession of the claimed invention and is therefore rejected under 35 USC 112(a) for lack of written description.
Claim 1 recites “revising, by the processor, one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model.” There is no disclosure for this limitation. The specification mentions in [0039] that “the radiotherapy machine may adjust the collimator system (FIG. 2) based on adjusted collimator settings determined by the analytics server 110a.” Other than this instance, there is no other mention of adjusted collimator settings and there is no description regarding adjusting collimator settings, and no description of how the collimator’s settings are adjusted based on the adjusted dose determination model. Consequently, the disclosure fails to suggest possession of the claimed invention and is therefore rejected under 35 USC 112(a) for lack of written description.
The rejections under 35 USC 112(a) and the evidence supporting the rejection recited above applies mutatis mutandis to claim 14, which teaches a similar limitation.
Regarding claim 10:
Claim 10 recites “wherein the adjusting step further comprises adjusting the dose determination source model based on the plurality of attenuation lengths of at least one leaf of the MLC and based on the data representing the input spectrum and the beam angle distribution for each respective beam segment of the beam of radiation; and modifying the input spectrum and beam angle distribution for each respective beam segment to account for interactions with the at least one leaf of the MLC”. The disclosure merely recites similar language (see paragraphs [0062], [0064], [0067], [0008], and [0058] and step 504 of Fig. 5) without providing an algorithm as to HOW the dose determination source model is adjusted and how the adjustment is based on the beam spectrum data and based on the plurality of attenuation lengths and how the input spectrum and beam angle distribution are modified to account for interactions with the at least one leaf of the MLC. For example, paragraph [0008] and [0067] of the disclosure states that “the adjusted dose calculation source model takes into account hardening of the input spectrum of the radiation beam in interactions with the MLC leaf material in calculating changes to spectrum and angle distribution of the radiation beam.” However, this statement does not explain how the hardening is taken into account in the calculations. There is no algorithm, prose, steps, calculation, flow chart, etc. to show the relationship and how the function is performed. As a result, one of ordinary skill in the art would not understand how the inventor intended the function to be performed. Consequently, the disclosure fails to suggest possession of the claimed invention and is therefore rejected under 35 USC 112(a) for lack of written description.
Claims 2-3 and 5-13 are rejected by virtue of their dependence on claim 1.
Claims 15 and 17-20 are rejected by virtue of their dependence on claim 14.
Claim 11 is rejected by virtue of its dependence on claim 10.
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 1-3, 5-15, and 17-20 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.
Claims 1 and 14 recite the limitation “each beam segment". There is insufficient antecedent basis for this limitation in the claim.
Claims 2-3 and 15 recite “beam segments” and “beamlet.” In light of the specification and the independent claims, it is unclear how a beam segment and a beamlet are different to each other. They appear to be referring to the same entity (the beam is described throughout the specification, such as in [0047], [0068] as being comprised of a plurality of beam segments or beamlets. Claim 1 and 14 recite “a distance that each beam segment travels through the at elast one leaf of the MLC”. ) Consequently, it is unclear how “a beamlet travels in leaf along a respective beam segment” if the beamlet and repsective beam segment are one in the same.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5-15, and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more (Prong 1: YES, Prong 2: No). The claim(s) recite(s) the steps for adjusting a dose determination source model and revising settings of an MLC by a processor using the adjusted model is a mathematical concept with additional elements that amount to mere data gathering and generically recited computer elements.
In particular, claim 1 recites a method comprising:
receiving, by a processor, a dose determination source model of a radiation therapy system including three-dimensional (3D) geometry data for a multi-leaf collimator (MLC), wherein leaves of the MLC are comprised of an attenuating material for a beam of radiation;
The processor is a generically recited computer element used for performing the calculation.
Receiving a dose determination source model of a radiation therapy system as claimed is mere data gathering, the gathered datea being used in the calculation steps.
determining, by the processor, a plurality of attenuation lengths of at least one leaf of the MLC in attenuating the beam of radiation based upon the dose determination source model including the 3D geometry data for the MLC, wherein determining the plurality of attenuation lengths includes calculating, from the 3D geometry data, a distance that each beam segment travels through the at least one leaf of the MLC;
The processor is a generically recited computer element used for performing the calculation.
Determining a plurality of attenuation lengths of at least one leaf of the MLC as claimed is a mathematical calculation, as evidenced by [0047]-[0049], [0054]-[0055] of the instant specification, and by the claim, which recites that the determination includes “calculating…”.
retrieving, by the processor, photon energy spectrum data and beam angle distribution data for the beam of radiation corresponding to the attenuating material for the beam of radiation;
Retrieving data as claimed is mere data gathering, the gathered data being used in the calculation steps.
responsive to retrieving the photon energy spectrum data and beam angle distribution data, adjusting, by the processor, one or more parameters of the dose determination source model based on the photon energy spectrum data, the beam angle distribution data, and the plurality of attenuation lengths of at least one leaf of the MLC leaves in attenuating the beam of radiation, wherein adjusting the one or more parameters of the dose determination source model includes obtaining, for each of the plurality of attenuation lengths, a corresponding attenuated spectrum from the photon energy spectrum data;
The processor is a generically recited computer element used for performing the calculation.
Adjusting one or more parameters of the model based on the data is a mathematical calculation as evidenced by [0008], [0024], [0046], [0057], [0064] of the instant specification.
And revising, by the processor, one or more settings of the MLC of the radiation therapy system based on the adjusted dose determination source model.
The processor is a generically recited computer element used for performing the calculation.
Revising one or more settings of the MLC based on the adjusted model is a calculation, as evidenced by [0039] of the instant application.
This judicial exception is not integrated into a practical application because the generically recited computer elements do not add meaningful limitation to the abstract idea because they amount to simply implementing the abstract on a computer. Additionally, data gathering does not add meaningful limitation to the abstract idea because mere data gathering amounts to insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a processor is a well-understood, routine and conventional computer element, and because the claims invoke the computer element merely as a tool to perform the abstract idea. Consequently, the claims amount to nothing more than an instruction to apply the abstract idea using a generic computer. See MPEP 2106.05(f). The data gathering steps do not add more than insignificant extra-solution acitivity to the judicial exception because storing and retrieving information in memory is well-understood, routine, and conventional (Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93). See MPEP 2106.05(d).
The above analysis applies mutatis mutandis to claim 14, which is similar to claim 1.
Claims 2-3, 5-13 and 14-15, 17-20 further limit the abstract idea, and does not amount to significantly more, therefore these claims also fail to meet the eligibility requirement for the same reasons as claim 1 and 14 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA E TANDY whose telephone number is (703)756-1720. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Kim can be reached at 5712722293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAURA E TANDY
Examiner
Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
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