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 .
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Aligning Patient in Radiography Machine Using Manual Review Of Blended Display of Localization and Reference Images
The specification is also objected to because two acronyms are not spelled out as follows: CBCT [0017] and MR-linac in [0022] of the instant published application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
The specification describes Fig. 5a as showing the localization image 500 while Fig. 5b shows the reference image 502 but no figure illustrates the claimed:
“display at a common display location” as recited in claim 1;
“blended display” of claims 2, 11 and 18;
controllable blended display of claims 3, 12, and 19;
blendable display being user controllable as recited in claims 4, 13, and 20;
blendable display default of claims 5, 14, and 21
Therefore, the features a)-e) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are also objected to because Fig. 5a, 5b, 6, and 7 are blurry or otherwise are poor quality reproductions that do not have satisfactory reproduction characteristics contrary to 37 CFR 1.84(l).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-23 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.
The term “optimized” in claims 1, 10, and 12 is indefinite as a relative term.
The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In further detail, “optimized” is unclear and the spec does not provide guidance on this term as follows. Does “optimized” mean 100% image registration? If so, to what accuracy? What accuracy threshold is relevant? Is mis-registration outside of 1 angstrom considered “optimized”? Would infringement occur if there is a very slight misregistration? How much misregistration is encompassed by the claim?
The ”optimization” clarity issue is further compounded by the recited phrase: “upon receiving user input confirming the at least one localization image is of acceptable quality and image registration is optimized” in claims 1, 10 and 17. It is unclear if the user input confirms both acceptable quality of the localization image and image registration optimization. Or is the user input confirming the displayed patient support adjustment values? Or perhaps the image registration optimization is performed separately and manually confirmed via user input? The unclear claim language answers none of these questions thus further illustrating the highly indefinite nature of the claims.
Still further compounding these issues is scope of the word “acceptable” and whether such “acceptability” applies to the patient support adjustment values, localization image quality, or image registration optimization as the loose and indefinite language does not clearly specify exactly what is being judged as “acceptable”.
Moreover, the independent claims 1, 10 and 17 also lack context and a full, clear recitation of the invention. These claims only require obtaining and loading images “for display for user image quality review” but don’t actually require a) displaying images or b) the user actually reviewing image quality (and maybe also registration and/or patient support adjust values, see above). Instead, only “the patient support adjustment values are displayed” not images.
Further the phrasing “for display” and “for user image quality review” are mere intended use phrases that do not require any displaying or reviewing. See marked-up claim 1 below highlighting mere intended use language using italics. While mere intended use recitations do not necessarily and in isolation render a claim indefinite the heavy reliance of such inferential claiming using mere intended use recitations and a lengthy “wherein” clause raise serious doubts about the claim scope. Considering that the claim does not require displaying any (localization or reference) image, it is unclear how the claimed invention “receiv[es[ user input confirming the at least one localization image is of acceptable image quality and image registration is optimized”.
A computer-implemented method for use in a radiotherapy workflow, comprising:
loading a reference image;
obtaining at least one localization image of a patient positioned on an adjustable patient support; and
loading the at least one localization image for display for user image quality review and for comparison with the reference image to identify patient support adjustment values and permit user image registration optimization;
wherein the at least one localization image and the reference image are loaded for display at a common display location,
wherein the patient support adjustment values are displayed for patient setup positioning error review and upon receiving user input confirming the at least one localization image is of acceptable quality and image registration is optimized, and
wherein the patient support adjustment values are sent for application to the adjustable patient support.
Still further, haphazardly strung together collection of wherein clauses wholly obscures the meaning of the claims. As noted above it is unclear exactly what the “received user input” may be confirming (patient adjustment support values, localization image quality, and/or image registration optimization). Then, “upon receiving user input confirming [… something unclear … ] the recited method leaves the reader completely hanging. What happens “upon receiving user input”? Instead of clearly reciting a result of receiving user input the claim haphazardly throws in a dangling wherein clause confusingly stating “wherein the patient support adjustment values are sent for application to the adjustable patient support.” It is unclear when and under what conditions these values are sent.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-13, 15-20, and 22-23 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Thieme (US 2019/0192881 A1).
Claim 1
In regards to claim 1, Thieme discloses a computer-implemented method for use in a radiotherapy workflow {as to computer-implemented, see remote control console 110, Figs. 1, 5, and computer implementations in [0058]-[0060] including processor, computer readable medium storing executable instructions, and memory}, comprising:
loading a reference image {Fig. 1, acquire planning (reference) 3D volume data step 201, and/or generate reference 2D views step 202, and/or dosimetry planning step 203, [0023]-[0026], Fig. 5, receive (load) initial (reference) digital value data};
obtaining at least one localization image of a patient positioned on an adjustable patient support {Fig. 2, acquire time-of-treatment 3D volume data step 212 and/or generate time-of-treatment 2D images step 213 [0028]-[0030]; Fig. 5 steps 504-505 acquire time-of-treatment digital volume image and/or generate second virtual BEV (beam’s eye view) image}, [0050]-[0052]}; and
loading the at least one localization image for display for user image quality review and for comparison with the reference image to identify patient support adjustment values and permit user image registration optimization
{Fig. 2, [0031]-[0034] including performing 2D match process 215 which may be an automated match process or, more relevant here, a manual match process performed by a therapist viewing loaded displays of the time-of-treatment 2D views (localization images) and the reference 2D views (reference images). Further, these respective images may be commonly displayed, merged, overlayed, or blended to enhance the manual review process thus matching the “blended” display disclosed and claimed by the instant invention. See also Fig. 5, [0053]-[0056] including displaying second virtual BEV image and display overlay filed outline steps 506-507};
wherein the at least one localization image and the reference image are loaded for display at a common display location {see above, particularly Fig. 2, steps 212-214},
wherein the patient support adjustment values are displayed for patient setup positioning error review and upon receiving user input confirming the at least one localization image is of acceptable quality and image registration is optimized
{see above including Fig. 2, [0031]-[0034] including performing 2D match process 215 which may be an automated match process or, more relevant here, a manual match process performed by a therapist viewed loaded displays of the time-of-treatment 2D views (localization images) and the reference 2D views (reference images. This section also discloses that the match process including detecting positional discrepancies (positioning error review) between the anatomical structures in the reference and time-of-treatment views and determining corrections to patient setup position. Thus, the manual match process which includes the claimed display for patient setup positioning error review as well as image quality acceptability and image registration. Alternatively, see [0034]-[0036] in which the match process performed by the therapist is a verification (user input confirming via match verification tool 300), Fig. 3), verifying the results of the automated match process which also determines and verifies displayed couch adjustments (patient support adjustment values) required to align the patient. See also Fig. 3, [0037]-[0043] including match verification tool which is a displayed tool that includes displayed reference image, localization image, and patient support adjustment values (e.g. couch shift indicator 307}, and
wherein the patient support adjustment values are sent for application to the adjustable patient support {Fig. 2, correct patient position step 216, [0037]}.
Claim 2
In regards to claim 2, Thieme discloses wherein the at least one localization image and the reference image are loaded for blendable display {see above claim 1 mapping including abstract, [0005], [0033]-[0034], [0037].
Claim 3
In regards to claim 3, Thieme discloses wherein the blendable display is controllable between display of localisation image only, display of reference image only and display of a blend of localisation and reference image {see mapping of claim 2 including Fig. 3 and blending slider tool in [0037] the extremes of which would include only localization image and only reference image while the middle settings would be a blend of both. See also taskbar 305 and action buttons 306 with options for selecting imaging mode}.
Claim 4
In regards to claim 4, Thieme discloses wherein the blendable display is user controllable {see mapping of claim 2 including blending slider tool in [0037], [0042]}.
Claim 6
In regards to claim 6, Thieme discloses wherein comparing the at least one localization image with the reference image to identify patient support adjustment values comprises determining a positional adjustment of the adjustable patient support to move a current position of an aspect of the at least one localization image to a position in which the aspect is more closely aligned with a corresponding aspect of the reference image {see mapping of claim 1 in which the match process 214, 215 includes comparing the images to determine discrepancies between the positions of anatomical structures in the reference and localization images to determine couch shift indicators (positional adjustments… as claimed). See also [0035]-[0036] regarding using these couch shift parameters to reposition the couch 107 so that the actual location of patient anatomy is correctly aligned to coincide with the with position specified in the reference image}.
Claim 7
In regards to claim 7, Thieme discloses wherein comparing the at least one localization image with the reference image to identify patient support adjustment values comprises identifying a patient setup positioning error and interrupting the radiotherapy workflow {see mapping for claims 1 and 6. See also Fig. 2. Treatment workflow in which the match process 214, 215 that compares the images and identifies patient support adjustment values to determine whether to correct the patient position in 216. As such, the treatment workflow is interrupted to reposition/correct the patient position before the treatment workflow progresses to delivery of the radiotherapy treatment step (“delivery of treatment can then begin as further discussed in [0035]-[0036]}.
Claim 8
In regards to claim 8, Thieme discloses wherein a patient setup positioning error is identified when the patient support adjustment values exceed a predetermined threshold {see above mapping for claims 1 and 7 while noting that the automated match process includes an inherent detectability threshold above which the couch shift parameters are output and below which they are not. Further, the match process 215 may be a manual process in which a user applies their own professional judgment that includes applying learned judgments (predetermined thresholds) while reviewing the match verification tool 300 to identify whether a patient setup positioning error has occurred based on the patient support adjust values}.
Claim 9
In regards to claim 9, Thieme discloses wherein the method is performed during a radiotherapy fraction session {see above mapping of claims 1 and 6 including Fig. 2}
Claims 10-13, 15, 16; 17-20, 22, and 23
The rejection of method claims 1-4, 7, 8; and 1-4, 7, 8 above applies mutatis mutandis to the corresponding limitations of system claims 10-13, 15, 16; and computer readable medium claims 17-20, 22, 23 while noting that the rejection above cites to both device and method disclosures as well as the computer readable medium features.
Claim Rejections - 35 USC § 103
Claims 3, 5, 12, 14, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Thieme and Waschbuesch (US 20120218290 A1).
Claim 3
Thieme is asserted above as disclosing wherein the blendable display is controllable between display of localisation image only, display of reference image only and display of a blend of localisation and reference image {see mapping of claim 2 including Fig. 3 and blending slider tool in [0037] the extremes of which would include only localization image and only reference image while the middle settings would be a blend of both. See also taskbar 305 and action buttons 306 with options for selecting imaging mode}.
Waschbuesch provides further evidence as to what a blending slider tool conventionally includes. See the “user defined blending factor” which corresponds to Thiem’s blending slider tool and applies the selected transparency/blending factor of the respective images such that the blendable display is controllable between display of localisation image only, display of reference image only and display of a blend of localisation and reference image. See Fig. 7 and related text.
It 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 to have modified Thieme which clearly discloses the blendable display of localization and reference images including blending slider tool such that the blending slider tool applies the selected transparency/blending factor of the respective images as taught by Waschbuesch such that the blendable display is controllable between display of localisation image only, display of reference image only and display of a blend of localisation and reference image because Waschbuesch merely provides highly conventional details of the blending slider tool; because such blendability increases the therapists ability to compare the images, because there is a reasonable expectation of success; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 5
In regards to claim 5, Thieme discloses wherein, after the reference image and the at least one localization image are loaded, the blendable display
Waschbuesch is an analogous reference from the same field of radiotherapy and workflows related thereto and solves a similar problem of managing radiographic images for user review. Waschbuesch also teaches a blendable display including blending factor input component 48 and blending factor sync module 38 and display module 50 as well as the highly conventional detail of an initial default display selection. See Fig. 2 image selection component 44, Figs. 2, 7, 8, 9A-9B, 10 including initial default display of one image only such as when the blending factor is initially set to zero (e.g. for the image A, which may be the localization image}.
It 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 to have modified Thieme which clearly discloses the blendable display of localization and reference images such that it includes the highly conventional detail of an initial default display selection as taught by Waschbuesch such that after the reference image and the at least one localization image are loaded, the blendable display defaults initially to display of the at least one localization image only because doing so provides the therapist performing the manual match process with a convenient alignment starting point and basis of comparison with the reference image while noting that the default selection being made between only two items is considered a routine expedient and well within obvious design choice consistent with MPEP 2144.04; because there is a reasonable expectation of success; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claims 12, 14, 19, and 21
The rejection of method claims 3, 5 above applies mutatis mutandis to the corresponding limitations of system claims 12, 14 and computer readable medium claims 19, 21 while noting that the rejection above cites to both device and method disclosures as well as the computer readable medium features.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael R Cammarata whose telephone number is (571)272-0113. The examiner can normally be reached M-Th 7am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Matthew Bella can be reached at 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ROBERT CAMMARATA/Primary Examiner, Art Unit 2667
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