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 .
Drawings
The drawings are objected to because boxes are improperly labeled. Boxes labeled with abbreviations and numbers are insufficient alone. 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.
Claim 17 is 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.
Claim 17 states a dependency from claim 156 which is not a present claim. Claim 16 depends from method claim 1 and claim 17 is directed to further defining the method. Therefore, it is unclear as to the correct dependency of claim 17. For purposes of compact prosecution, claim 17 is being examined as depending upon claim 16.
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)(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.
Claim(s) 1-4, 7-13 and 15-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shochat et al (2022/0409282).
Regarding claim 1, Shochat et al disclose a method for monitoring an orientation of a medical object, the method comprising:
identifying planning information, the planning information having a planning orientation for the medical object with respect to a reference point on an anatomical object that is arranged within an examination object (the target and entry point are marked on the displayed images – [0100]; the position and orientation of the medical device on the subject’s body, are simulated and displayed on the monitor – [0103]);
detecting the orientation of the medical object with respect to the reference point (the actual position and orientation of the medical device is compared to the simulated position and orientation – [0152]) using an acquisition unit, wherein the acquisition unit comprises a medical imaging device (one or more new images of the region of interest are displayed. Then, steps 906 to 916 are repeated, unit the actual position and orientation of the device is determined to be valid – [0156]);
identifying a deviation between the planning orientation and the orientation of the medical object with respect to the reference point (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]); and
providing a signal depending on the identified deviation (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]).
Regarding claim 2, Shochat et al disclose wherein the planning information has a planning map of the examination object with the anatomical object arranged within the examination object (fig.4A; [0102]),
wherein a planned entry point of the medical object to the anatomical object is determinable as the reference point (the target and entry point are marked on the displayed images – [0100]), and
wherein identifying the planning information comprises determining the planning orientation based on a progression, an arrangement, or the progression and the arrangement of the anatomical object, which are mapped in the planning map (a calculated trajectory 40 from an entry point to the target in the subject’s body – [0102]).
Regarding claim 3, Shochat et al disclose further comprising identifying a map of at least one anatomical landmark in the planning map (target in the subject’s body – [0102]),
wherein the reference point, the planning orientation, or the reference point and the planning orientation are determined based on an arrangement of the at least one anatomical landmark (a calculated trajectory 40 from an entry point to the target in the subject’s body – [0102]).
Regarding claim 4, Shochat et al disclose further recording intra-operative image data using the medical imaging device (the insertion procedure is image-guided – [0085]),
wherein the intra-operative image data has a map of a distal portion of the medical object, which is arranged intra-operatively in the examination object (assisting in ensuring alignment between a tip of the medical instrument and an entry point marked on the body of the patient – [0045]), and
wherein the orientation of the medical object with respect to the reference point is detected based on the map of the distal portion of the medical object (preplanned and real-time updated 3D trajectory of a tip of the medical instrument – [0095]; one or more new images of the region of interest are displayed. Then, steps 906 to 916 are repeated, unit the actual position and orientation of the device is determined to be valid – [0156]).
Regarding claim 7, Shochat et al disclose further comprising detecting at least one positioning of a proximal portion of the medical object that is arranged intra-operatively outside the examination object using the acquisition unit, wherein the orientation of the medical object with respect to the reference point is detected based on the positioning of the proximal portion (the simulation may be the position and orientation of the robotic arm’s proximal end, e.g., its end effector – [0103]).
Regarding claim 8, Shochat et al disclose detecting a positioning of the examination object, the anatomical object or the examination object and the anatomical object using the acquisition unit (the target and entry point are marked on the displayed images – [0100]); and
registering the planning information with the detected positioning of the examination object, the anatomical object, or the examination object and the anatomical object ([0068]; fig.4A).
Regarding claim 9, Shochat et al disclose wherein providing the signal comprises outputting a visual warning signal (instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]).
Regarding claim 10, Shochat et al disclose wherein providing the signal comprises outputting a workflow instruction so as to minimize the deviation (instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]).
Regarding claim 11, Shochat et al disclose comprising comparing the identified deviation with a predetermined threshold (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning are provided – [0153]; the threshold is considered deviation or no deviation),
wherein providing the signal comprises providing the signal when, based on the camping, the predetermined threshold value is reached, exceeded, or reached and exceeded (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning are provided – [0153]).
Regarding claim 12, Shochat et al disclose a system for monitoring an orientation of a medical object, the system comprising:
an acquisition unit (imaging system – [0085]);
a provisioning unit (computer may include one or more processors – [0087]) configured to:
identify planning information, the planning information including a planning orientation for the medical object with respect to a reference point on an anatomical object that is arranged within an examination object (the target and entry point are marked on the displayed images – [0100]; the position and orientation of the medical device on the subject’s body, are simulated and displayed on the monitor – [0103]),
wherein the acquisition unit is configured to detect the orientation of the medical object with respect to the reference point (one or more new images of the region of interest are displayed. Then, steps 906 to 916 are repeated, unit the actual position and orientation of the device is determined to be valid – [0156]),
wherein the acquisition unit comprises a medical imaging device (imaging system – [0085]),
wherein the provisioning unit is configured to identify a deviation between the planning orientation and the orientation of the medical object with respect to the reference point (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]), and
wherein the provisioning unit is configured to provide a signal depending on the identified deviation (if the actual position and orientation deviate from the simulated position and orientation, instructions as to how to correct the current positioning so that it matches the simulated positioning, are provided – [0153]).
Regarding claim 13, Shochat et al disclose wherein the acquisition unit comprises the medical imaging device (imaging system – [0085]),
wherein the medical imaging device is configured to record intra-operative image data (the insertion procedure is image-guided – [0085]),
wherein the intra-operative image data has a map of a distal portion of the medical object that is arranged in an operational state of the system in the examination object (assisting in ensuring alignment between a tip of the medical instrument and an entry point marked on the body of the patient – [0045]), and
wherein the provisioning unit is further configured to detect the orientation of the medical object with respect to the reference point based on the map of the distal portion of the medical object (preplanned and real-time updated 3D trajectory of a tip of the medical instrument – [0095]; one or more new images of the region of interest are displayed. Then, steps 906 to 916 are repeated, unit the actual position and orientation of the device is determined to be valid – [0156]).
Regarding claim 15, Shochat et al disclose further comprising an apparatus for robotic remote manipulation of the medical object, wherein the provisioning unit is further configured to provide the signal to the apparatus (at least one processor configured to execute the method of assisting a user in positioning an automated medical device – [0036]; robotic device – [0086]).
Regarding claim 16 and 17, Shochat et al disclose wherein the anatomical object that is arranged within the examination object is an organ or tissue arranged within the examination object (the target region can be any internal body region, including, a lesion, tumor, organ or vessel – [0002]).
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.
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) 5, 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shochat et al (2022/0409282) in view of Kytonen et al (2023/0148979).
Regarding claims 5 and 6, Shochat et al disclose wherein the medical imaging device comprises an X-ray source and a detector that are arranged in a defined arrangement with respect to one another (the utilized modality may be X-ray fluoroscopy, CT, cone CT, CT fluoroscopy – [0085]).
Shochat et al fail to explicitly disclose wherein the medical device further comprises a light-guiding facility that is arranged on the X-ray source, wherein the light-guiding facility is configured to project a light pattern, having at least one straight line, onto a surface of the detector so as to indicate a detector reference point, and wherein the defined arrangement of the X-ray source and detector is repositioned based on the planning information, such that: the reference point of the anatomical object is arranged on a beam from the X-ray source to the detector reference point; and a projection of the planning orientation onto the surface of the detector corresponds to the at least one projected straight line, wherein the light pattern has a further geometric object that is arranged on the at least one straight line, and wherein a point of intersection of the at least one straight line with the further geometric object indicates a detector reference point.
However, Kytonen et al teach in the same medical field of endeavor, a medical device (abstract) further comprises a light-guiding facility that is arranged on an X-ray source, wherein the light-guiding facility is configured to project a light pattern, having at least one straight line, onto a surface of the detector so as to indicate a detector reference point (a light field indicator 141 – [0004];[0059], and wherein the defined arrangement of the X-ray source and detector is repositioned based on planning information, such that: the reference point of the anatomical object is arranged on a beam from the X-ray source to the detector reference point (mutual positioning of the X-ray source of the arrangement and an anatomy of an imaging exposure – [0009]); and a projection of the planning orientation onto the surface of the detector corresponds to the at least one projected straight line ([0015]; Figs.4a and 4b); wherein the light pattern has a further geometric object that is arranged on the at least one straight line, and wherein a point of intersection of the at least one straight line with the further geometric object indicates a detector reference point (projecting different light field patterns as for their shape and size, essentially the same shapes and/or sizes to which the X-ray beam collimator construction is configured to be able to line an X-ray beam – [0062]). Examiner notes claims 5 and 6 are directed to the structure of the medical device and do not provide any steps which further define the method claim.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the X-ray imaging device of Shochat et al with a light-guiding facility projecting a light pattern and to reposition the X-ray source and detector of Kytonen et al as it would provide accurate placement of the imaging equipment to correctly image a target area of interest.
Regarding claim 14, Shochat et al disclose wherein the acquisition unit comprises the medical device, wherein the medical imaging device comprises an X-ray source and a detector that are arranged in a defined arrangement with respect to one another (the utilized modality may be X-ray fluoroscopy, CT, cone CT, CT fluoroscopy – [0085]).
Shochat et al fail to explicitly disclose wherein the medical device further comprises a light-guiding facility that is arranged on the X-ray source, wherein the light-guiding facility is configured to project a light pattern, having at least one straight line, onto a surface of the detector so as to indicate a detector reference point, and wherein the defined arrangement of the X-ray source and detector is repositioned based on the planning information, such that: the reference point of the anatomical object is arranged on a beam from the X-ray source to the detector reference point; and a projection of the planning orientation onto the surface of the detector corresponds to the at least one projected straight line.
However, Kytonen et al teach in the same medical field of endeavor, a medical device (abstract) further comprises a light-guiding facility that is arranged on an X-ray source, wherein the light-guiding facility is configured to project a light pattern, having at least one straight line, onto a surface of the detector so as to indicate a detector reference point (a light field indicator 141 – [0004];[0059], and wherein the defined arrangement of the X-ray source and detector is repositioned based on planning information, such that: the reference point of the anatomical object is arranged on a beam from the X-ray source to the detector reference point (mutual positioning of the X-ray source of the arrangement and an anatomy of an imaging exposure – [0009]); and a projection of the planning orientation onto the surface of the detector corresponds to the at least one projected straight line ([0015]; Figs.4a and 4b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the X-ray imaging device of Shochat et al with a light-guiding facility projecting a light pattern and to reposition the X-ray source and detector of Kytonen et al as it would provide accurate placement of the imaging equipment to correctly image a target area of interest.
Response to Arguments
Applicant's arguments filed 31 October 2025 have been fully considered but they are not persuasive.
Regarding the drawings, Applicant states replacement sheets are provided.
Examiner’s position is the replacement drawings do not appear to have been submitted with the October filing.
Regarding claim 1, Applicant states Shochat et al do not teach or disclose “detecting the orientation of the medical object with respect to the reference point” on an anatomical object that is arranged within an examination object, with respect to which a planning orientation for the medical object is identified.
Specifically, Applicant states Shochat et al disclose an entry point “on an outer surface” of the skin of a subject. Shochat et al does not teach or disclose orienting the medical device relative to a reference point on an anatomical object that is arranged “within the subject”. Accordingly, the prior art fails to disclose the limitation as stated above.
Examiner’s positions is Shochat et al disclose “the target and entry point are marked on the displayed images” – [0100]. Examiner’s position is the “reference point on an anatomical object that is arranged within an examination object” is the “target point”. The orientation of the medical object with respect to the reference point (target point) is detected in order to ensure the trajectory of the medical object (needle) is valid to reach the reference point (target point) ([0152];[0156];[0169]) for deployment of a needle or introducer into the target ([0131]).
The “reference point” is the “target point” of Shochat et al and it is a planned entry point of the medical object (needle) into the anatomical object (target) to perform a biopsy or deliver fluid to the target within the body ([0131]). The target region can be any internal body region, including, a lesion, tumor, organ or vessel ([0002]).
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 ROCHELLE DEANNA TURCHEN whose telephone number is (571)270-7104. The examiner can normally be reached Mon - Fri 6:30-2:30.
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/ROCHELLE D TURCHEN/Primary Examiner, Art Unit 3797