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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS from 7/28/2023 have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular reference in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7 and 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8,644,571 (Schulte et al., hereinafter Schulte).
In regards to claims 1 and 11, Schulte discloses a proton therapy (a type of radiation therapy treatment) treatment planning system (see title and abstract; column 3, line 15-column 25, line 22). Schulte shows a therapy system (see figure 1B; column 4, line 42-column 24, line 5) that includes the following:
a processor (128); and
a memory (134 – computer readable media) storing instructions that, when executed by the processor, cause the system to perform the following steps:
access a radiation treatment plan, the radiation treatment plan including a number of beams, a direction of each of the beams, and an energy of each of the beams, wherein the direction of each of the beams is determined such that the beams do not overlap outside the target and overlap inside the target and the energy of each of the beams is determined such that a cumulative dose (see figure 2B) at sub-volumes inside the target satisfy a prescribed dose (is particular column 6, line 7 – column l2, line 24; there user input to the system controls each beam where the parameters include beam energy, direction, and intensity based on a selected treatment plan where the beams do not overlap outside of a target area); and
direct the beams into the target according to the radiation treatment plan (see figure 5; in particular column 6, line 7 – column l2, line 24, specifically column 11, line 59-column 12, line 7).
In regards to claims 2-3 and 12-13, Schulte discloses the limitations of claim 1. In addition, Schulte shows in figures 2A-B and 3A-B and column 7, lines 3-49 that the proton beams used in the therapy have a Bragg peak and that the beams are configured to position the Bragg peak in a portion of the target at a distal edge of the target based on the therapy plan.
In regards to claims 4 and 14, Schulte discloses the limitations of claims 1 and 11. Schulte further states that the number of beams directions of beams, and beam energies can be determined and adjusted (column 6, line 38- column 7, line 2 and column 8, line 50 - column 11, line 58). In addition, column 20, lines 34-43 disclose the use of an iterative process to optimize optimal therapies.
In regards to claims 5 and 15, Schulte discloses the limitations of claims 1 and 11. Schulte shows that these operations (see figure 4 and column 6, line 38- column 7, line 2 and column 8, line 50 - column 11, line 58; Block 420-435) specifically cover the accessing the minimum prescribed dose to be delivered into and across the target, determining the number of beams and direction of beams, and determining a beam energy for each of the beams where the number of beams, direction of the beams, and the beam energy for each of the beams are determined such that the entire target receives the minimum prescribed dose. Figure 5 shows an example where several beams from different directions are used and the beams do not overlap outside the target but overlap inside the target.
In regards to claims 6, 7, 16, and 17, Schulte discloses the limitations of claim 1 and 11. In addition, Schulte states that the beams can have paths that are both co-planar and non-coplanar depending on the needs of the therapy (column 6, line 52 – column 7, line 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,644,571 (Schulte et al., hereinafter Schulte) as applied to claims 1 and 11 above, and further in view of US 2007/0127623 (Goldman et al., hereinafter Goldman).
In regards to claims 9 and 19, Schulte discloses the limitations of claims 1 and 11 but do not state the presence of a gantry. In a related area, Goldman discloses method and system that optimizes dose delivery of radiation using radiation beams (see title and abstract; paragraphs [0010]-[0160]). Goldman discloses the presence of a gantry to direct treatment beams into a patient where the beams are directed on a slice-by-slice basis using tomotherapy (paragraphs [0093]-[0146]). It can be seen in the descriptions by Goldman, that gantry is used for positioning beams in relation to a patient for tomotherapy or other beam radiation modalities such as IMRT and provides an ability to use multiple beams at various angles (paragraphs [0092]-[0093]). Thus, it would have been obvious to one of ordinary skill in the art, before the filing date of the claimed invention to modify the system and method of Schulte to include a gantry to direct the beams into a target on a slice-by-slice bases as taught by Goldman as it is one of the devices used for transmitting radiation beams into a patient and allows for an ability to use multiple beams at various angles.
Claim(s) 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8,644,571 (Schulte et al., hereinafter Schulte) as applied to claims 1 and 11 above, and further in view of US 9,636,525 (Sahadevan).
In regards to claims 10 and 20, Schulte discloses the limitations of claims 1 and 11 but does not state that the beams deliver a dose of at least four grays in less than a second. In a related area, Sahadevan discloses methods of beam brachytherapy (see title and abstract). Sahadevan states that the beams can have dose rates of 10 Grays/per second (column 12, line 35-column 13, line 2), which can meet the limitations of claim 10. Sahadevan states that the particular beam configuration provides the advantage of eliminating the usual waiting periods for wound healing of a patient’s recovery and has a lower expense than traditional radiation therapy methods (column 14, line 16-column 15, line 5). Thus, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the device and method of Schulte to have beams deliver a dose of at least 4 grays per second as taught by Sahadevan in order to eliminate the usual waiting periods for wound healing of a patient’s recovery and lower the expense of radiation therapy.
Allowable Subject Matter
Claims 8 and 18 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:
In regards to claims 8 and 18, the prior art of record does not teach or suggest a method or device that implements a method, where the method includes the following:
each of the beams of the radiation treatment plan includes a plurality of beam segments and radiation treatment plan is generated by
determining a maximum beam energy for each of the beams; and
for each of the beams, determining a beam energy for each beam segment of the plurality of beam segments as a percentage of the maximum beam energy.
Most prior art does not disclose or suggest determination of the maximum energy of the beams, and none suggested determination of beam energies for each beam segment in the plurality of beams.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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