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
Applicant’s arguments with respect to claim(s) 1, 16, and 20 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.
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 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 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Geng (US 20050096515 A1).
With regards to claim 20, Geng discloses a system for positioning a subject comprising:
at least one storage device including a set of instructions or programs; and
at least one processor configured to communicate with the at least one storage device, wherein when executing the set of instructions or programs, the at least one processor is configured to cause the system to perform operations including:
obtaining first information of at least part of a subject when the subject is located at a preset position, the first information including at least a first image and a first set of position data of the at least part of the subject [0032];
determining, based on the first information, a first position of each of one or more feature points located on the at least part of the subject [0039-0041], wherein the one or more feature points are located on a surface of the subject, wherein the first position includes a first coordinate of each of the one or more feature points in a coordinate system established based on a space where a radiotherapy system exists [0039-0043, 0061, 0066-0067];
obtaining, using an imaging device, second information of the at least part of the subject when the subject is located at a candidate position, the second information including at least a second image and a second set of position data of the at least part of the subject [0033, 0062];
determining, based on the second information, a second position of each of the one or more feature points [0062];
for each feature point of the one or more feature points, determining a first distance between the first position and the second position [0058, 0062]; and
generating, based at least in part on the one or more first distances, prompt information for prompting whether the subject is located at a position that the subject can receive ray safely and accurately [0033, 0063].
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 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 of this title, 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.
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.
Claims 1, 3-10, and 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geng in view of Sauer (US 20050180544 A1).
With regards to claim 1, Geng discloses an image guided therapy method and system having a computer including associated processors and storage, said method and system comprising:
obtaining first information of at least part of a subject when the subject is located at a preset position, the first information including at least a first image and a first set of position data of the at least part of the subject [0032];
determining, based on the first information, a first position of each of one or more feature points located on the at least part of the subject, wherein the one or more feature points are located on a surface of the subject [0039-0041];
obtaining, using an imaging device, second information of the at least part of the subject when the subject is located at a candidate position, the second information including at least a second image and a second set of position data of the at least part of the subject [0033];
determining, based on the second information, a second position of each of the one or more feature points [0033, 0062];
for each feature point of the one or more feature points, determining a first distance between the first position and the second position [0058, 0062]; and
generating, based at least in part on the one or more first distances, prompt information for prompting whether the subject is located at a position that the subject can receive ray safely and accurately [0033, 0063].
Geng does not specify wherein the first image or the second image includes a 4D image, and the 4D image includes information of respiratory movements of the subject. Sauer teaches a system and method for patient positioning for radiotherapy comprising acquiring respiratory signals associated with a patient’s breathing motion while acquiring image sequences [0011-0016, 0021, 0035, 0039-0045] and further teaches matching determined target positions with 4D positions acquired from a CT scan [0019, 0023, 0044, 0048], wherein the 4D CT-derived positions are correlated with respiratory signals and respiratory motion of the patient [0011-0016, 0021, 0035, 0039-0045]. It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with the claimed configuration as taught by Sauer to improve accuracy of subject positioning and radiation delivery by accounting for respiratory movement.
With regards to claim 3, Geng discloses determining, based at least in part on the one or more first distances, a target position of the subject (below threshold) [0033].
With regards to claim 4, Geng discloses wherein the determining, based at least in part on the one or more first distances, the target position includes: determining whether the one or more first distances are less than a first threshold; and determining the target position of the subject based on a determination result of whether the one or more first distances are less than the first threshold [0033].
With regards to claims 5 and 6, Geng does not explicitly teach the claimed steps. However,
Geng does disclose repeating the steps of 3D imaging, comparing images, determining spatial differences of points between the images, and repositioning the patient until the differences between the images are below a desired threshold [0033] (Fig. 1). Therefore, the steps of designating a desired target position and comparing a plurality of feature points as claimed are considered steps of optimizing patient position and would have been known and obvious.
With regards to claims 7, 16, and 17, Geng and Sauer discloses the claimed invention according to claim 1, but does not explicitly teach determining an overlapping degree and determining, based on the overlapping degree, the target position of the subject. However, Geng does disclose generating a reference surface representation of the patient and a current surface representation at a candidate position [0032-0033]; and comparing the reference surface and current surface to evaluate positional deviation and alignment quality [0058, 0062]. Since determining an overlapping degree is a known registration metric in alignment determination and IGRT, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with the claimed step in order to improve alignment accuracy.
With regards to claim 8, Geng discloses generating the virtual representation of the at least part of the subject at the preset position based on the first image [0041-0043] (Fig. 2A, 2B).
With regards to claim 9, Geng does not specify wherein the one or more feature points include at least a marker as claimed. However, Geng does disclose evaluating specific surface location and local regions for positioning accuracy [0058, 0062]. Since surface markers were generally known, those skilled in the art recognize that modifying Geng with the claimed markers would have been an obvious modification in view of designating a specific region of interest in radiotherapy to protect healthy tissue.
With regards to claim 10, Geng discloses wherein the obtaining the second image of the at least part of the subject when the subject is located at the candidate position includes: obtaining, using an imaging device, the second image of the at least part of the subject when the subject is located at the candidate position [0032-0033].
With regards to claim 12, Geng discloses further comprising: obtaining fourth information of the at least part of the subject using the imaging device at a time interval during a radiation session, the fourth information including at least a fourth set of position data of the at least part of the subject; determining, based on the fourth information, a fourth position of each of the one or more feature points; and causing, based on a third distance between the fourth position and the first position of each of the one or more feature points, a radiation assembly to perform a preset operation corresponding to the third distance [0033] (obtaining additional images (i.e. fourth information) and comparing to the reference image (i.e. first position) to determine differences (i.e. third distances)).
With regards to claim 13, Geng discloses wherein the causing, based on a third distance between the fourth position and the first position of each of the one or more feature points, a radiation assembly to perform a preset operation corresponding to the third distance includes: controlling an operation of the radiation assembly (i.e. repositioning of the patient) based on a second determination result of whether the third distance is less than the first threshold [0033] (Fig. 1).
With regards to claim 14, Geng does not teach the claimed step. However, such a modification would have been known. It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with the claimed step in order to avoid damaging healthy tissue while the patient is not properly aligned.
With regards to claim 15, Geng does not explicitly teach the claimed steps or processor. However, determining the spatial relationship between a subject and the moving parts of a treatment/imaging device was generally known in order to prevent harm to the subject. In view of the recited benefit, it would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with the claimed step.
Claims 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geng in view of Sauer and Reilly (US 20200138329).
With regards to claims 11 and 19, Geng does not teach the claimed method step. Reilly is in the field of positioning a patient on a treatment device comprising the claimed configuration (Abstract). Substituting the imaging device taught by Geng with the imaging device taught by Reilly would have been obvious since the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geng in view of Sauer and Silva (WO 2017165301 A1).
With regards to claim 21, Geng does not teach the claimed step. Silva teaches a system and method for VR/AR visualization of 3D medical images and further teaches a holographic display configured to display a holographic medical image to a user (Abstract, Figs. 1-3 and corresponding description). It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with Silva in order to improve spatial positioning evaluation thereby improving patient positioning.
Claim 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Geng in view of Sauer and Nafis (US 5740802 A).
With regards to claim 22, Geng does not teach the claimed step. Nafis teaches a system and method for enhancing visualization of body structures during a medical procedure comprising displaying internal anatomical structures and superimposing a guide image of anatomy on the body structures pf a patient such that internal anatomical information is visually aligned with the patient (column 2, lines 21-32; column 7, lines 58-67). It would have been well known, obvious, and predictably suitable to one with ordinary skill in the art to modify Geng with the claimed step as taught by Nafis in order to improve the operator’s ability to asses patient positioning and anatomical alignment during treatment setup.
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 MARCUS H TANINGCO whose telephone number is (571)272-1848. The examiner can normally be reached Monday-Friday 9am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached on 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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/MARCUS H TANINGCO/ Primary Examiner, Art Unit 2884
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