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
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Regarding claim 1, the Examiner respectfully disagree with the applicant’s arguments. Every radiation treatment patient model is by definition “predictive” as the model is generated prior to irradiation, even if very nearly real-time, and so is predictive of what the patient/tumor will look like at time of irradiation even a few seconds later. Therefore, the model being predictive is not a point of novelty with respect to the prior art of record. Regarding claim 18, non-tangible which does not satisfy the statutory requirement. Therefore the arguments are not persuasive.
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.
Claim 18 rejected under 35 U.S.C. 101 because it is directed to a computer readable medium. The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customer meaning of machine accessible storage medium. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 USC 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). A claim drawn to such a machine accessible storage medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 USC 101 by adding the limitation "non-transitory" to the claim.
Claim Rejections - 35 USC § 102
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 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) 1-6 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ohishi (US 20190001155 A1; January 3, 2019).
Regarding claim 1, Ohishi discloses a computer-implemented radiation treatment planning method, the method comprising:
obtaining intrabody imaging data and surface imaging data for determining a radiation treatment plan including a plurality of radiation treatment fraction sessions (Paragraph 23-31; Claim 1);
using the intrabody imaging data and the surface imaging data, generating a predictive model relating 1) the intrabody imaging data having a three-dimensional (3D) patient representation to 2) a two- dimensional (2D) surface patient representation (Paragraph 23-31; Claim 1);
obtaining surface camera imaging data during a particular treatment fraction session (Paragraph 23-31, Claim 4); and
using the surface camera imaging data obtained during the particular treatment fraction session and the model, calculating a 3D patient representation during the particular treatment fraction session (Paragraph 23-33, 123; Claims 5-7).
Regarding claim 2, Ohishi discloses the method of claim 1. Ohishi further discloses comprising modifying the radiation treatment plan for the particular treatment fraction session during that particular treatment fraction session (Paragraph 40).
Regarding claim 3, Ohishi discloses the method of claim 1. Ohishi further discloses wherein obtaining intrabody imaging data and surface imaging data for determining a radiation treatment plan including a plurality of radiation treatment fraction sessions includes using surface imaging data generated from the intrabody imaging data (Paragraph 23-31; Claim 1).
Regarding claim 4, Ohishi discloses the method of claim 1. Ohishi further discloses wherein obtaining intrabody imaging data and surface imaging data for determining a radiation treatment plan including a plurality of radiation treatment fraction sessions includes using surface imaging data generated from a surface camera (Paragraph 23-31; Claim 1).
Regarding claim 5, Ohishi discloses the method of claim 1. Ohishi further discloses wherein obtaining intrabody imaging data and surface imaging data is carried out during a treatment fraction session before initiating delivery of radiation therapy during that treatment fraction session (Figure 7; Paragraphs 60-62).
Regarding claim 6, Ohishi discloses the method of claim 5. Ohishi further discloses wherein obtaining intrabody imaging data comprises obtaining computed tomography (CT) imaging data during a treatment fraction session prior to delivery of radiation therapy or obtaining cone-beam CT (CBCT) imaging during a treatment fraction session prior to delivery of radiation therapy (Figure 7; Paragraphs 60-71).
Regarding claim 15, Ohishi in view of Beriault discloses the method of claim 1. Beriault further discloses comprising:
acquiring a 4D CBCT image during a particular radiation treatment fraction session (Paragraph 88);
generating a synthetic 4D CT image representation from the 4D CBCT image (Paragraph 88); and
generating an intrafractional intrabody image representation of the patient at various times during a particular radiation treatment fraction session using the synthetic 4D CT image representation (Paragraph 88).
Regarding claim 16, The method of claim 15, comprising using the generated intrafractional intrabody image representation of the patient to modify at least one parameter during that particular radiation treatment fraction session (Paragraph 40).
Regarding claim 17, Ohishi discloses the method of claim 1. Ohishi further discloses radiation treatment system configured to perform the method of claim 1 (Claim 1, Paragraph 23-31).
Regarding claim 18, Ohishi discloses the method of claim 1. Ohishi further discloses non-tangible computer readable medium encoded with instructions that, when executed by a processor, cause the processor to perform the method of claim 1 (Claim 1, Paragraph 23-31, 48).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohishi (US 20190001155 A1; January 3, 2019) in view of Beriault ( US 2020/0160972; May 21, 2020).
Regarding claim 7, Ohishi discloses the method of claim 1. However Ohishi does not disclose comprising binning projections from intrabody imaging data to create a 4D image.
Beriault discloses comprising binning projections from intrabody imaging data to create a 4D image. (Paragraph 65-77)
Therefore from the teaching of Beriault it would have been obvious at the time of filing to specify the abovementioned limitation since it is a known method of modeling patient movement while being imaged.
Regarding claim 8, Ohishi in view of Beriault discloses the method of claim 7. Beriault further discloses wherein the 4D image provides a 3D image over various respiratory phases (Paragraph 65-77).
Regarding claim 9, Ohishi in view of Beriault discloses the method of claim 8. Beriault further discloses comprising:
determining a reference external surface representation corresponding to a reference respiratory phase bin (Paragraph 47);
determining a first deformation vector field (DVF) between various respiratory phase bins and the reference respiratory phase bin (Paragraph 47); and
determining a second DVF corresponding to an external surface associated with the first DVF (Paragraph 47).
Regarding claim 10, Ohishi in view of Beriault discloses the method of claim 9. Beriault further discloses comprising using a principal component analysis (PCA) to generate the predictive model using at least one of the first DVF or the second DVF (Paragraph 84).
Regarding claim 11, Ohishi in view of Beriault discloses the method of claim 10. Beriault further discloses comprising generating, using the model, an intrafractional intrabody image representation of the patient at various times during a particular radiation treatment fraction session (Paragraph 95).
Regarding claim 12, Ohishi in view of Beriault discloses the method of claim 11. Beriault further discloses comprising:
determining, using the predictive model, at least one DVF during the particular radiation treatment fraction session (Paragraph 26, 47).
Regarding claim 13, Ohishi in view of Beriault discloses the method of claim 11. Beriault further discloses comprising using the generated intrafractional intrabody image representation of the patient to modify a radiation treatment parameter during that particular radiation treatment fraction session (Paragraph 46).
Regarding claim 14, Ohishi in view of Beriault discloses the method of claim 13. Beriault further discloses wherein modifying the radiation treatment parameter during that particular radiation treatment fraction session is to accurate localization and tracking of a tumor (Paragraph 46).
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 GISSELLE GUTIERREZ whose telephone number is (571)272-4672. The examiner can normally be reached M-F 8-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-3995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GISSELLE GUTIERREZ/
Examiner
Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884