DETAILED ACTION
This Office action is in response to the amendment filed on April 7th, 2026. Claims 1-9 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 .
Claim Interpretation
The term “cranial immobilization device” is used through the specification to refer to the overall device (see “As describe below, the scaffold 115 accommodates material inserts FIG. 12 shows a side-view of the exemplary cranial immobilization device 1100. The shell 1105 and material insert 1110 of the immobilization device 1100, as shown in FIGS. 11 and 12,”). Examiner has been interpreting the claims accordingly.
However, the latest amendment specifies that the cranial immobilization device “is configured to enclose the scaffold,” clearly indicating that applicant intends the term to apply to the shell alone. This is supported by the remarks filed on April 7th, 2026, which state “his portion of Wang only describes two elements: inserts 136 and a hollow frame 132. Wang does not describe three elements as recited in claim 1 or any element that even arguably constitutes the "cranial immobilization device" recited in claim 1.” Therefore, the claim element of a “cranial immobilization device” will now be interpreted to mean a shell such as the one described as element 1105 in the specification.
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.
This application includes one or more claim limitations that do not use the word “step for,” 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) recite purely functional language without reciting sufficient acts to perform the recited function. Such claim limitation(s) is/are: “identifying locations on the patient for a plurality of material inserts disposed in a cranial immobilization device based on the radiation treatment plan to provide beam-specific depth and range modulation in accordance with the radiation treatment plan” in claims 1-9.
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 acts described in the specification as performing the claimed function, and equivalents thereof.
In particular, the following are considered the corresponding acts:
“identifying locations on the patient for a plurality of material inserts disposed in a cranial immobilization device based on the radiation treatment plan to provide beam-specific depth and range modulation in accordance with the radiation treatment plan” appears to correspond to a step of reading out locations listed on the treatment plan as planned locations for the placement of inserts that represent locations where the planned beam paths intersect the planned patient location and correlate with planned modulations of the beam by said inserts. Examiner is basing this on the following disclosure in the specification “identifying locations on the patient for a plurality of material inserts disposed in a cranial immobilization device, where each material insert of the plurality of material inserts lies on at least one of the beam paths and respectively shapes a distribution of a dose to be delivered to the patient by at least one of the beams in accordance with a treatment plan.” (P 12)
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 § 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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0173363 (Wang et al.) in view of US 2015/009838 (Mac Laverty).
Regarding claim 1, Wang et al. discloses a computer-implemented method of radiation treatment planning, the method comprising:
accessing, from a memory of a computer system, parameters for a radiation treatment plan, the parameters including a number of beams and beam paths relative to a position of a patient (‘the brain lesion can be precisely positioned at the desired location relative to the radiation beam,’ P 47);
identifying locations on the patient for a plurality of material inserts disposed in a cranial immobilization device based on the radiation treatment plan to provide beam-specific depth and range modulation in accordance with the radiation treatment plan (‘In an aspect, the inserts 136 can be placed and secured within the apertures 134 of the hollow frame 132 based upon the location of the targeted lesion.’ P 49);
providing a scaffold and plurality of material inserts, the scaffold including a plurality of holes configured to receive the plurality of inserts (fig. 11-14, scaffolding is element 132/232 with holes 134/234, material inserts are elements 136/236); and
disposing the plurality of material inserts within the scaffold, the scaffold configured to enclose at least a portion of a head of the patient (‘In an aspect, the inserts 136 can be placed and secured within the apertures 134 of the hollow frame 132 based upon the location of the targeted lesion.’ P 46), wherein
each material insert of the plurality of material inserts lies on at least one of the beam paths based on the radiation treatment plan (‘the proton beam is being directed through the inserts 136 and not the frame 132,’ P 51), and
each material insert of the plurality of inserts has a thickness measured in a direction of a path of a beam of the number of beams for the range modulation of the beam to deliver a dose distribution between respective distal and proximal portions of a target in the patient prescribed in the radiation treatment plan (“In an aspect, the range shifting material employed by the range shifting device is configured to have a thickness that ensure that the radiation beam treatment includes a minimal entrance dose and a virtually absent exit dose for the shallow target.” P 14).
Wang et al. does not disclose accessing, from the memory of the computer system, a printing plan, the printing plan defining a scaffold and the plurality of material inserts; and fabricating the scaffold and the plurality of material inserts in accordance with the printing plan. Wang et al. also does not specify whether each material insert of the plurality of material inserts has a non-uniform thickness and further does not disclose disposing the scaffold with inserts within a cranial immobilization device configured to enclose the scaffold with inserts.
Mac Laverty discloses a computer-implemented method of treatment planning comprising disclose accessing, from the memory of the computer system, a printing plan, the printing plan defining for an artifact to be disposed on a patient based on the radiation treatment plan to provide beam-specific depth and range modulation in accordance with the radiation treatment plan, and fabricating the artifact accordance with the printing plan (“The planning system 204 outputs the files to the 3D printer 206, which produces the artifacts and/or molds.” P 36). It would have been obvious to a person having ordinary skill in the art at the time the application was filed to include steps of accessing the printing plan and fabricating the scaffolding and inserts from an accessed printing plan in the method of Wang et al. so that the scaffold and inserts would exist.
Printing and placing the inserts proceeds identically regardless of whether they have uniform or non-uniform thickness, and it would have been obvious to do so with inserts of non-uniform thickness if that was what the printing plan called for. Finally, it would have been obvious to a person having ordinary skill in the art to modify the method by enclosing the scaffold with inserts in an outer shell to reduce the likelihood of material inserts falling out of the specified holes, since the outer shell and head together form natural barriers to keep the inserts held in place.
Regarding claim 2, Wang et al. in view of Mac Laverty disclose the method of Claim 1, wherein the printing plan defines a number, shape, size and type of material of each of the plurality of material inserts in accordance with the radiation treatment plan such that each material insert is configured to provide the beam-specific depth and the range modulation in accordance with the radiation treatment plan to deliver the dose distribution between the respective distal and proximal portions of the target in the patient (inherent, the number, shape, size, and type material must be determined by the printing plan since that is what controlling the fabrication, which cannot occur unless these specifications are known).
Regarding claim 3, Wang et al. in view of Mac Laverty disclose the method of Claim 1, wherein the fabricating the plurality of material inserts includes at least one of three-dimensional printing or using a mold to create each of the plurality of material inserts in accordance with the printing plan such that each material insert of the plurality of material inserts is configured to provide the beam-specific depth and the range modulation in accordance with the radiation treatment plan to deliver the dose distribution between the respective distal and proximal portions of the target in the patient (“The planning system 204 outputs the files to the 3D printer 206, which produces the artifacts and/or molds.” P 36).
Regarding claim 4, Wang et al. in view of Mac Laverty disclose the method of Claim 1, wherein each of the plurality of material inserts is fabricated to provide at least one of range compensation, the range modulation, or collimation based in accordance with the radiation treatment plan (‘inserts made of range shifting material’).
Regarding claim 5, Wang et al. in view of Mac Laverty disclose the method of Claim 1, wherein each material insert of the plurality of material inserts is configured to locate a Bragg peak of each beam of the number of beams inside the target in the patient at a predetermined position in accordance with the radiation treatment plan (‘ensure that the Bragg Peak of the proton can be placed within the target volume’ P 42), each beam of the number of beams being a proton beam or an ion beam (‘proton SRS treatment’ P 11).
Regarding claim 6, Wang et al. in view of Mac Laverty disclose the method of Claim 1, wherein the scaffold is configured to support the plurality of material inserts when the scaffold and the plurality of material inserts are disposed in the cranial immobilization device (‘The range shifting helmet can include a hollow frame including a plurality of apertures in which inserts made of range shifting material can be inserted.’ abstract).
Regarding claim 7, Wang et al. in view of Mac Laverty disclose the method of Claim 6, wherein the fabricating the scaffold includes three-dimensional printing the scaffold in accordance with the printing plan, wherein the scaffold includes the plurality of holes for accommodating the plurality of material inserts based on the locations on the patient for the plurality of material inserts disposed in the cranial immobilization device (‘In an aspect, the inserts 136 can be placed and secured within the apertures 134 of the hollow frame 132 based upon the location of the targeted lesion.’ P 46).
Regarding claim 8, Wang et al. in view of Mac Laverty disclose the method of Claim 1, further comprising: placing the cranial immobilization device over the head of the patient, the cranial immobilization device configured to limit movement of the patient relative to the beam paths (‘The range shifting device can be a range shifting helmet.’).
Regarding claim 9, Wang et al. in view of Mac Laverty disclose the claimed method, except for forming the plurality of material inserts with ridge filters. Ridge filters are generally known in the art. It would have been obvious to a person having ordinary skill in the art at the time the application was filed to modify Wang et al. to use ridge filters to broaden the Bragg peak and deliver a more uniform dose to the target.
Response to Arguments
Applicant’s arguments filed April 7th, 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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.
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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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