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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/07/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 07/07/2025.
The amendments filed on 07/07/2025 have been entered. Applicant has presently canceled claims 10 and 12. Accordingly claims 1-9, 11, and 13 are pending. Claims 1-3, 6-8, 11, and 13 are presently amended.
The previous objection to claim 1 has been withdrawn in light of applicant's amendments to claim 1.
The previous rejection under 35 U.S.C. 101 has been withdrawn in light of applicant’s amendments and remarks.
Response to Arguments
Applicant’s arguments regarding the IDS filed 12/10/2024 have been considered and are persuasive. However, examiner notes as stated in further detail below that a copy of each cited foreign document has not been provided.
Applicant argues that the amendments to claim 1 address the 35 U.S.C. 112(b) rejection of claim 1 regarding the plurality of surface markers. Examiner respectfully disagrees because the amendment to address this issue introduces a new issue of antecedent basis as detailed below.
Applicant’s arguments with respect to the prior art rejection of the claims 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. In particular examiner notes that the Garcia reference is no longer relied on.
Information Disclosure Statement
The information disclosure statement filed 12/10/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. In particular, examiner notes that a copy of foreign reference number 12 (WO 20110063840 Edlauer) has not been provided.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“medical imaging unit” in claim 1 and all dependents thereof;
“processing unit” in claim 1 and all dependents thereof;
“measuring unit” in claim 1 and all dependents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding the “medical imaging unit” the specification discloses “a medical imaging unit 6 (e.g. a CT scanner or an MRI device)” ([0122] of the US PG Pub. version of the specification). Therefore, the means-plus-function limitation of “medical imaging unit” has been interpreted as a CT scanner, an MRI device, or any equivalents thereof in light of the specification.
Regarding the “processing unit” the specification discloses “The processing unit 7 can comprise any suitable computer.” ([0122] of the US PG Pub. version of the specification). Therefore, the means-plus-function limitation of “processing unit” has been interpreted as a computer or any equivalents thereof in light of the specification.
Regarding the “measuring unit” the specification discloses “a measuring unit (for example a stereotactic camera)” ([0027] of the US PG Pub. version of the specification). Therefore, the means-plus-function limitation of “measuring unit” has been interpreted as a stereotactic camera or any equivalents thereof in light of the specification.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9, 11, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 recites the limitation “a connecting portion incorporating a plurality of image localization features comprising radiopaque cylindrical rods and arranged randomly with respect to each of the other image localization features”. However, neither the original claims, original drawings, nor the specification as originally filed provides support for this limitation. Applicant has not indicated where support for this amendment can be found and the disclosure merely provides support for cylindrical rods being arranged obliquely with respect to one another (e.g., see [0054] and Fig. 4 of the pre-grant publication of the instant application). As such, claims 1-9, 11, and 13 contain new matter.
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 1-9, 11, and 13 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.
Claim 1 recites the limitation "the other surface fiducial markers" in line 4. There is insufficient antecedent basis for this limitation in the claim. Further clarification is required.
Claim 1 recites the limitation "the other image localization features" in lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Further clarification is required.
Claims 1, 2, 5, and 6 recite the limitations “said physical object” and “the physical object” which is indefinite because it is unclear if this physical object is related to the patient, recited in line 3 of claim 1, or is a separate physical object. For the present purposes of examination, the physical object has been treated as being related to the patient. Further clarification is required.
Regarding claim 2, the limitation “a further third coordinate transformation” in line 9 renders the claim indefinite because it is unclear whether this limitation is part of or separate from the “at least one further coordinate transformation” recited in line 2 of claim 2. For the present purposes of examination, the further third coordinate transformation has been interpreted as part of the at least one further coordinate transformation. Further clarification is required.
Regarding claim 4, the limitation “different measurement modalities” renders the claim indefinite because it is unclear whether these modalities are the same as or different from the medical imaging unit and/or the measuring unit of claim 1. Further clarification is required.
Regarding claim 8, the limitation “a connecting portion” in line 2 of claim 8 renders the claim indefinite because it is unclear whether this is the same or different connecting portion previously recited in claim 1. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required.
Regarding claim 8, the limitation “a surface fiducial marker” in line 3 of claim 8 and “the surface fiducial marker” in lines 5-6 renders the claim indefinite because it is unclear whether this is one of the plurality of surface fiducial markers previously recited in claim 1 or an additional marker. For the present purposes of examination, the limitation has been interpreted as being part of the previously recited plurality of surface fiducial markers. Further clarification is required.
Regarding claim 8, the limitation “an anchoring portion” in lines 3-4 of claim 8 renders the claim indefinite because it is unclear whether this is the same or different anchoring portion previously recited in claim 1. For the present purposes of examination, they have been interpreted as being the same. Further clarification is required.
Claim 11 depends from claim 10 which renders the claim indefinite because claim 10 is a presently canceled claim. For the present purposes of examination, the claim has been treated as being dependent on claim 1. Further clarification is required.
Regarding claim 13, the claim limitations “a surface fiducial marker” in line 3 and “the surface fiducial marker” in lines 4, 6, 9 are indefinite because it is unclear if these surface fiducial are part of the plurality of surface fiducial marker that is recited in claim 1 or an additional marker. For the present purposes of examination, the limitation has been interpreted as being part of the previously recited plurality of surface fiducial markers. Further clarification is required.
Regarding claim 13, the claim limitation “a second surface fiducial marker” in line 7 is indefinite because it is unclear if this second surface fiducial marker is part of the plurality of surface fiducial marker that is recited in claim 1. For the present purposes of examination, the limitation has been interpreted as being part of the previously recited plurality of surface fiducial markers. Further clarification is required.
Claims dependent upon a claim rejected under 35 U.S.C. 112(b) are also rejected under the same statute because they each inherit the indefiniteness of the claim(s) they respectively depend upon.
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.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Sayeh et al. (US 2018/0289982, October 11, 2018, hereinafter “Sayeh”) in view of Tillett et al. (US 2020/0155238, corresponding PCT filed August 9, 2018, hereinafter “Tillett”), Vilsmeier (US 5,769,861, June 23, 1998), Patel et al. (US 2019/0192197, June 27, 2019), and Seong et al. (US 2018/0049839, February 22, 2018, hereinafter “Seong”).
Regarding claim 1, as best understood in light of the 35 USC 112(b) rejections stated above, Sayeh discloses a medical system (radiation treatment system 1200 in Fig. 1A and corresponding description), comprising:
-a plurality of surface fiducial markers that are configured to be attached to an outer surface of a patient in arbitrary spatial configurations with respect to each of the other surface fiducial markers (external markers 180 in Fig. 3, reproduced below, and corresponding description; specifically see “one or more external markers 180 attached to the skin of the patient. The one or more external markers 180 that are attached to the skin of the patient permit the motion 182 of the abdomen or chest wall to be determined” [0040]; examiner notes that the one or more external markers are attached to the skin and therefore can be placed in arbitrary spatial configurations with respect to each other. Contrastingly in an alternative embodiment disclosed in [0040], the one or more external markers could be “attached to a belt, a flexible ring or a vest which fits around the waist of the patient” which would be a fixed spatial configuration instead.),
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-at least one adapter that is configured to be attached to an internal structure of the patient (internal markers 152 in Fig. 3 and corresponding description; also see “In particular, a surgeon may insert (e.g., establish) a set of internal markers (e.g., fiducials) in the proximity of or within the target organ during a short surgical procedure” [0043]),
-a medical imaging unit configured to generate a 3D image of said physical object and the plurality of surface fiducial markers attached to said outer surface within a predefined image coordinate system (imaging system 1210 in Fig. 1A and corresponding description; also see “Imaging system 1210 may perform computed tomography (CT) such as cone beam CT or helical megavoltage computed tomography (MVCT), and images generated by imaging system 1210 may be two-dimensional (2D) or three-dimensional (3D).” [0030]),
-a processing unit (processing device 1230 in Fig. 1A and corresponding description; also see processing devices in Fig. 8 and corresponding description);
-a measuring unit configured to acquire poses of the plurality of surface fiducial markers with respect to a coordinate system of the measuring unit when the respective surface fiducial marker is attached to said outer surface (“The external markers 180 may be automatically tracked via an external detection device with a number of optical methods, such as infrared or visible light, and the position of the external marker may be determined more than 60 times per second.” [0040]).
Sayeh fails to disclose the at least one adapter comprising an anchoring portion attached to the internal structure, a connecting portion incorporating a plurality of image localization features comprising radiopaque cylindrical rods and arranged randomly with respect to each of the other image localization features, attached to the anchoring portion and extending to an exterior surface of the patient and a portion of at least one of the plurality of surface fiducial markers releasably connected to the connecting portion on the exterior surface of the patient.
However, Tillett teaches, in the same field of endeavor, the at least one adapter comprising an anchoring portion attached to the internal structure (anchoring device 227 in Figs. 2A-D and corresponding description, e.g., [0036]; also see sharp tip end 207 in Figs. 2A-D and corresponding description), a connecting portion attached to the anchoring portion and extending to an exterior surface of the patient (outer cannula 201 in Figs. 2A-D and corresponding description; also see Figs. 3A-C and corresponding description) and a portion of at least one of the plurality of surface fiducial markers releasably connected to the connecting portion on the exterior surface of the patient (marker device 219 in Figs. 2A-D and corresponding description; also see “The marker device 219 may be locked to the cannula 201 using a suitable attachment mechanism, such as a threaded connector, a latch mechanism, a locking collar, a snap-fit connector, an interference-fit, etc.” [0034]).
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Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with the at least one adapter comprising an anchoring portion attached to the internal structure, a connecting portion attached to the anchoring portion and extending to an exterior surface of the patient and a portion of at least one of the plurality of surface fiducial markers releasably connected to the connecting portion on the exterior surface of the patient as taught by Tillett in order to prevent movement relative to the patient, including rotational movement ([0035] of Tillett).
Sayeh fails to disclose the connecting portion incorporating a plurality of image localization features comprising radiopaque cylindrical rods and arranged randomly with respect to each of the other image localization features.
However, Patel teaches, in the same field of endeavor, the connecting portion incorporating a plurality of image localization features comprising radiopaque cylindrical rods and arranged randomly with respect to each of the other image localization features (“The radiolucent guide tool 110 further includes radiopaque 305 markers embedded in or affixed to the radiolucent guide tool 110, the radiopaque 305 markers affixed and corresponding with the visual and/or tactile indicators 300. In use, the radiopaque 305 markers are visualized with fluoroscopy so as to align with bone and enable selection of desired locus for implant placement relative to a reference point established using the radiolucent guide tool 110 and/or, which reference point is either the reference securement seat 220 reference tube aperture 310 or a preplaced implant or guide wire inserted in the bone and in communication through one of the apertures 310 of the radiolucent guide tool 110. The radiopaque 305 markers may be formed using any one or more of known radiopaque 305 materials, including, for example, tantalum containing beads, rods, wires, paint and the like”[0033]).
Before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with the connecting portion incorporating a plurality of image localization features comprising radiopaque cylindrical rods and arranged randomly with respect to each of the other image localization features as taught by Patel in order to provide alignment with target structure ([0033] of Patel).
Sayeh fails to disclose the processing unit being configured for measuring each surface fiducial marker's pose within the 3D image and relative to the predefined image coordinate system and to compute a coordinate system of the plurality of surface fiducial markers from the positions of the plurality of surface fiducial markers as well as a first coordinate transformation between the predefined image coordinate system and the coordinate system of the plurality of surface fiducial markers,
-wherein the processing unit is further configured to compute a second coordinate system transformation between the coordinate system of the measuring unit and the predefined image coordinate system via the coordinate system of the plurality of surface fiducial markers, thereby allowing to reference points on said outer surface to points within the 3D image,
-wherein the medical system, through its pose-trackable placement of the at least one adapter is configured to measure with the measuring unit a pose of the at least one adapter relative to the plurality of surface fiducial markers when the at least one adapter is attached to the internal structure of said physical object, and wherein the processing unit is configured to compute a third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and a coordinate system of the internal structure.
However, Vilsmeier teaches, in the same field of endeavor, the processing unit being configured for measuring each surface fiducial marker's pose within the 3D image and relative to the predefined image coordinate system and to compute a coordinate system of the plurality of surface fiducial markers from the positions of the plurality of surface fiducial markers as well as a first coordinate transformation between the predefined image coordinate system and the coordinate system of the plurality of surface fiducial markers (“For this purpose the external marker means includes to advantage two marker means, namely a first external marker means and a second external marker means. The first external marker means is configured that it can be scanned together with the internal marker means by means of the referencing scan. Thus a relationship is determined between a first external reference system, defined by the first external marker means, and the intracorporeal reference system. Between the second external marker means and the first external marker means a fixed mechanical relationship is produced to advantage which permits conversion of the data, which are transformed into the first extracorporeal reference system into the second external reference system which is defined by the second external marker” col. 4, ll. 29-42),
-wherein the processing unit is further configured to compute a second coordinate system transformation between the coordinate system of the measuring unit and the predefined image coordinate system via the coordinate system of the plurality of surface fiducial markers, thereby allowing to reference points on said outer surface to points within the 3D image (“computing from said position and orientation in the extracorporeal reference system the position and orientation of the instrument in the intracorporeal reference system via the relationship between the intracorporeal and the extracorporeal reference systems known from the referencing step, as well as a markers device and a device for referencing.” Abstract), -wherein the medical system, through its pose-trackable placement of the at least one adapter is configured to measure with the measuring unit a pose of the at least one adapter relative to the plurality of surface fiducial markers when the at least one adapter is attached to the internal structure of said physical object, and wherein the processing unit is configured to compute a third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and a coordinate system of the internal structure (“After implantation of an internal marker means an analytical scan of the body including the internal marker means is implemented, as already described above. The position of the three-dimensional corporeal data obtained by analytical scanning is determined relative to the intracorporeal marker positions e.g. with the aid of a computer and suitable software. As a result of this for instance the location and the extent of a tumor in the reference system established by the internal marker means is determined.” col. 3, ll. 59-67; also see col. 4, ll. 1-10), and wherein the processing unit is configured to compute a third coordinate transformation between the coordinate system of the surface fiducial markers and a coordinate system of the internal structure (“Once the position of the instrument tip is then finally established in the second external reference system with the aid of the instrument position determining means, then the position of the instrument tip can be determined relative to the corporeal data obtained from the analytical scan with the aid of coordinate transformations.” col. 6, ll. 15-21).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with the processing unit being configured for measuring each surface fiducial marker's pose within the 3D image and relative to the predefined image coordinate system and to compute a coordinate system of the plurality of surface fiducial markers from the positions of the plurality of surface fiducial markers as well as a first coordinate transformation between the predefined image coordinate system and the coordinate system of the plurality of surface fiducial markers, -wherein the processing unit is further configured to compute a second coordinate system transformation between the coordinate system of the measuring unit and the predefined image coordinate system via the coordinate system of the plurality of surface fiducial markers, thereby allowing to reference points on said outer surface to points within the 3D image,-wherein the medical system, through its pose-trackable placement of the at least one adapter is configured to measure with the measuring unit a pose of the at least one adapter relative to the plurality of surface fiducial markers when the at least one adapter is attached to the internal structure of said physical object, and wherein the processing unit is configured to compute a third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and a coordinate system of the internal structure as taught by Vilsmeier in order to provide precise instrument localization “whilst simultaneously minimizing the risk of infection and stress on the patient” (col. 2, ll. 30-35 of Vilsmeier).
Sayeh modified by Vilsmeier fails to disclose and wherein the processing unit is configured to combine the second coordinate transformation with both of the first coordinate transformation and with the third coordinate transformation to create a coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the internal structure, thereby allowing the medical system to measure the pose of the at least one adapter in the coordinate system of the measuring unit.
However, Seong teaches in the same field of endeavor, wherein the processing unit is configured to combine the second coordinate transformation with both of the first coordinate transformation and with the third coordinate transformation to create a coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the internal structure, thereby allowing the medical system to measure the pose of the at least one adapter in the coordinate system of the measuring unit (“According to an embodiment, in order to convert the position on the first coordinate system 1210 of the first imaging data into the position on the fourth coordinate system 1230 of the stereotactic surgery unit 1, the coordinate on the first coordinate system 1210 of the first imaging data may be converted in sequence into the coordinate on the third coordinate system 1220 of the patient marker 174, and then into the coordinate on the fourth coordinate system 1230 of the stereotactic surgery unit 1. For such coordinate conversion, it is possible to obtain (i) the second coordinate conversion relationship for converting the coordinate from the first coordinate system 1210 of the first imaging data into the third coordinate system 1220 of the patient marker 174 and (ii) the third coordinate conversion relationship for converting the coordinate from the third coordinate system 1220 of the patient marker 174 into the fourth coordinate system 1230 of the stereotactic surgery unit 1.” [0132]; also see [0133]-[0139]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with and wherein the processing unit is configured to combine the second coordinate transformation with both of the first coordinate transformation and with the third coordinate transformation to create a coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the internal structure, thereby allowing the medical system to measure the pose of the at least one adapter in the coordinate system of the measuring unit as taught by Seong in order to reduce a control error of a stereotactic surgery robot and to easily correct an error that has occurred ( [0008] of Seong).
Regarding claim 2, as best understood in light of the 35 USC 112(b) rejections stated above, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 1 as stated above. Sayeh fails to disclose wherein the medical system is configured to establish at least one further coordinate transformation between the coordinate system of the measuring unit and a coordinate system of a further internal structure of the physical object wherein the medical system is configured to at least one of:
- measure a pose of a further adapter relative to the plurality of surface fiducial markers when the further adapter is attached to the further internal structure of said physical object and wherein the processing unit is configured to compute a further third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and the coordinate system of the further internal structure and wherein the processing unit is configured to combine the second coordinate transformation with both of the first coordinate transformation and the further third coordinate transformation to create the further coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the further internal structure thereby allowing to measure the pose of the further adapter in the coordinate system of the measuring unit, or by
- combining the coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the internal structure with a coordinate transformation between the coordinate system of the internal structure and the coordinate system of the further internal structure.
However, Vilsmeier further teaches, in the same field of endeavor, wherein the medical system is configured to establish at least one further coordinate transformation between the coordinate system of the measuring unit and a coordinate system of a further internal structure of the physical object wherein the medical system is configured to at least one of: - measure a pose of a further adapter relative to the plurality of surface fiducial markers when the further adapter is attached to the further internal structure of said physical object and wherein the processing unit is configured to compute a further third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and the coordinate system of the further internal structure (see multiple internal markers 10, i.e. further adapter, and external markers 30, i.e. surface fiducial markers, in Fig. 1, reproduced below, and corresponding description).
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Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with wherein the medical system is configured to establish at least one further coordinate transformation between the coordinate system of the measuring unit and a coordinate system of a further internal structure of the physical object wherein the medical system is configured to at least one of: - measure a pose of a further adapter relative to the plurality of surface fiducial markers when the further adapter is attached to the further internal structure of said physical object and wherein the processing unit is configured to compute a further third coordinate transformation between the coordinate system of the plurality of surface fiducial markers and the coordinate system of the further internal structure as taught by Vilsmeier in order to provide precise instrument localization “whilst simultaneously minimizing the risk of infection and stress on the patient” (col. 2, ll. 30-35 of Vilsmeier).
Sayeh modified by Vilsmeier does not disclose wherein the processing unit is configured to combine the second coordinate transformation with the first coordinate transformation and with the further third coordinate transformation to create the further coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the further internal structure thereby allowing to measure the pose of the further adapter in the coordinate system of the measuring unit.
However, Seong further teaches, in the same field of endeavor, wherein the processing unit is configured to combine the second coordinate transformation with the first coordinate transformation and with the further third coordinate transformation to create the further coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the further internal structure thereby allowing to measure the pose of the further adapter in the coordinate system of the measuring unit (“According to an embodiment, in order to convert the position on the first coordinate system 1210 of the first imaging data into the position on the fourth coordinate system 1230 of the stereotactic surgery unit 1, the coordinate on the first coordinate system 1210 of the first imaging data may be converted in sequence into the coordinate on the third coordinate system 1220 of the patient marker 174, and then into the coordinate on the fourth coordinate system 1230 of the stereotactic surgery unit 1. For such coordinate conversion, it is possible to obtain (i) the second coordinate conversion relationship for converting the coordinate from the first coordinate system 1210 of the first imaging data into the third coordinate system 1220 of the patient marker 174 and (ii) the third coordinate conversion relationship for converting the coordinate from the third coordinate system 1220 of the patient marker 174 into the fourth coordinate system 1230 of the stereotactic surgery unit 1.” [0132]; also see [0133]-[0139]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with wherein the processing unit is configured to combine the second coordinate transformation with the first coordinate transformation and with the further third coordinate transformation to create the further coordinate transformation between the coordinate system of the measuring unit and the coordinate system of the further internal structure thereby allowing to measure the pose of the further adapter in the coordinate system of the measuring unit as taught by Seong in order to reduce a control error of a stereotactic surgery robot and to easily correct an error that has occurred ([0008] of Seong).
Regarding claim 3, Sayeh modified by Vilsmeier, Seong, and Patel discloses the limitations of claim 1 as stated above and Sayeh further discloses wherein the medical system is configured to track said outer surface using one of: a. the surface fiducial markers (F), wherein particularly the medical system is configured to track a position or a pose of each individual surface fiducial marker, particularly using one of the following: an optical measurement principle, a video-optical measurement principle, an electromagnetic measurement principle, a time-of-flight measurement principle (“The external markers 180 may be automatically tracked via an external detection device with a number of optical methods, such as infrared or visible light, and the position of the external marker may be determined more than 60 times per second.” [0040]); b. tracking of the outer surface with the medical imaging unit by using one of: laser scanning of the outer surface, scanning the outer surface with structured light.
Regarding claim 4, Sayeh modified by Vilsmeier and Seong discloses the limitations of claim 1 as stated above and Sayeh further discloses wherein the medical system comprises different measurement modalities within one coordinate system to allow tracking of surface fiducial markers and the at least one adapter simultaneously using the different measurement modalities (“At block 405, processing logic generates external positional data about external motion of the body of the patient using one or more external sensors (e.g., via one or more external detection devices). At block 407, processing logic generates, by a processing device, a correlation model between the projection data and the external positional data. In one embodiment, the correlation model may be generated by fitting the plurality of projections of the internal target region to the external positional data. In one embodiment, the correlation model identifies a best fit of an analytic function to the projection data identified in the plurality of projections and the corresponding external positional data.” [0102]; also see Fig. 1A and corresponding description).
Regarding claim 5, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 1 as stated above and Sayeh further discloses wherein the medical system comprises a pose-trackable surgical device configured to generate an access to the internal structure of the physical object and to deliver the at least one adapter to the internal structure and position the at least one adapter on the internal structure (“the LINAC 1201 is mounted on the end of a robotic arm 1235 having multiple (e.g., 5 or more) degrees of freedom in order to position the LINAC 1201 to irradiate a pathological anatomy (e.g., target 120) with beams delivered from many angles, in many planes, in an operating volume around a patient.” [0027]; also see [0028]; examiner notes that the robotic arm can be moved and therefore is capable of performing the intended use of the claimed surgical robotic device).
Regarding claim 6, as best understood in light of the 35 U.S.C. 112(b) rejection stated above, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 5 as stated above and Sayeh further discloses wherein the medical imaging unit, processing unit and measuring unit of the medical system is configured to track several internal structures within the physical object independently and to establish and track several coordinate transformations between those internal structures and the outer surface, wherein at least one adapter has been delivered to each of the several internal structures by the pose-trackable surgical robotic device (“The periodic X-ray imaging (e.g., via an internal detection device) of the internal markers may be correlated with the continuous optical tracking of the external markers (via an external tracking device) to provide accurate tracking of the motion of the target organ. In order to correlate the motion of the internal and external markers, the relationship between the positions of the internal and external markers may be determined, which may occur at the start of the treatment process and will be described below with reference to FIG. 4A-4D.” [0041]; also see the multiple internal markers 152 in Fig. 3 and corresponding description; examiner notes that the wherein the at least one adapter limitation has been treated as intended use that does not result in a structural different between the claimed invention and the prior art).
Regarding claim 7, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 1 as stated above and Sayeh further discloses wherein the medical imaging unit, processing unit and measuring unit of the medical system is configured to track several internal structures relative to one another and absolutely against the outer surface simultaneously (“The periodic X-ray imaging (e.g., via an internal detection device) of the internal markers may be correlated with the continuous optical tracking of the external markers (via an external tracking device) to provide accurate tracking of the motion of the target organ. In order to correlate the motion of the internal and external markers, the relationship between the positions of the internal and external markers may be determined, which may occur at the start of the treatment process and will be described below with reference to FIG. 4A-4D.” [0041]; also see Fig. 3 and corresponding description).
Regarding claim 8, as best understood in light of the 35 USC 112(b) rejection stated above, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 1 as stated above. Sayeh fails to disclose wherein the at least one adapter comprises a connecting portion that is configured to be releasably connected to a surface fiducial marker, and an anchoring portion that is configured to be attached to the internal structure so that an initially registered pose of the surface fiducial marker relative to the internal structure is reproduced upon re-connection of the structure fiducial marker to the adapter.
However, Vilsmeier further teaches, in the same field of endeavor, wherein the at least one adapter comprises a connecting portion that is configured to be releasably connected to a surface fiducial marker (mounting means 14, in Fig. 4, reproduced below, and corresponding description; also see “needle-shaped mounting means 14 may be fitted. This fit can be selected so that, on the one hand, the mounting means 14 is releasable and, on the other, a secure seating is assured [...] As an alternative (not shown) an external marker may be secured to the mounting means 14 outside of the skin 24. In this arrangement, depending on the nature of the method of examination or analysation selected (CT, x-ray imaging or nuclear magnetic resonance tomography) a suitable marker can be connected to the mounting means 14.” col. 8, l. 55- col. 9, l. 8), and an anchoring portion that is configured to be attached to the internal structure (anchoring means 12 in Fig. 4 and corresponding description; also see “The anchoring means 12 is secured to the skeleton bone 22 e.g. by means of a thread 13 beneath the skin 24.” col. 8, ll. 50-52) so that an initially registered pose of the surface fiducial marker relative to the internal structure is reproduced upon re-connection of the surface fiducial marker to the adapter (“The mounting means 14 may be inserted in the head by simple means prior to an analytical scan and provided with a suitable external marker, e.g., a ball of titanium. After scanning, the mounting means 14 can be simply released from the anchor so that the part of the body to be examined can be disinfected with no problem prior to the operation. To produce a relationship to the corporeal data obtained from the analytical scan the mounting means 14 is then returned in place prior to the operation and provided with a suitable external marker (e.g. a reflector ball).” col. 9, ll. 9-20).
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Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with wherein the at least one adapter comprises a connecting portion that is configured to be releasably connected to a surface fiducial marker, and an anchoring portion that is configured to be attached to the internal structure so that an initially registered pose of the surface fiducial marker relative to the internal structure is reproduced upon re-connection of the structure fiducial marker to the adapter as taught by Vilsmeier so that “the part of the body to be examined can be disinfected with no problem prior to the operation” due to the releasable configuration (col. 9, ll. 10-15 of Vilsmeier).
Regarding claim 9, Sayeh modified by Vilsmeier, Patel, and Seong discloses the limitations of claim 8 as stated above, in particular Vilsmeier was relied on to teach the claimed anchoring portion. Vilsmeier, further teaches, in the same field of endeavor, wherein the anchoring portion comprises a thread on an outside of the anchoring portion for anchoring the at least one adapter to the internal structure by screwing the anchoring portion into a bore hole of the internal structure (“The anchoring means 12 is secured to the skeleton bone 22 e.g. by means of a thread 13 beneath the skin 24. It is made of e.g. titanium, carbon fiber or ceramics.” col. 8, ll. 50-52).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with wherein the anchoring portion comprises a thread on an outside of the anchoring portion for anchoring the at least one adapter to the internal structure by screwing the anchoring portion into a bore hole of the internal structure as taught by Vilsmeier in order to provide a secure connection to bone (col. 8, ll. 50-52 of Vilsmeier).
Regarding claim 11, Sayeh modified by Tillett, Vilsmeier, Patel, and Seong discloses the limitations of claim 10 as stated above and Sayeh further discloses wherein the medical system is configured to intraoperatively acquire at least one image of the internal structure and the plurality of image localization features of the adapter and to locate the internal structure and the plurality of image localization features in the at least one intraoperatively acquired image and to compute a coordinate transformation between the coordinate system of the measuring unit and a coordinate system of the internal structure (“For example, a correlation model may be generated by fitting the 2D target positions acquired at multiple time points to simultaneously acquired external measurements (e.g., external marker positions). Such a correlation model can be used for example in a radiation therapy system. In such a system, the correlation model can be generated before treatment; during treatment, the internal tumor position is estimated from the external measurements using the correlation model, and this information is used to move or shape the radiation beam dynamically with the target.” [0025]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sayeh in view of Tillett, Vilsmeier Patel, and Seong as applied to claim 1 above and further in view of Crawford et al. (EP 3578128A1, filed June 6, 2019, hereinafter “Crawford”).
Regarding claim 13, Sayeh modified by Tillett, Vilsmeier, Patel, and Seong discloses the limitations of claim 1 as stated above but fails to disclose wherein the processing unit of the medical system is configured to compute the coordinate system of the surface fiducial markers by using a position of a first surface fiducial marker as a center of the coordinate system of the surface fiducial markers, wherein the medical system is further configured to use as a first coordinate axis of the coordinate system of the surface fiducial markers a normalized vector extending from the first surface fiducial marker to a second surface fiducial marker and as a second coordinate axis a normalized vector extending from the first surface fiducial marker to a third surface fiducial marker and as a third coordinate axis the cross product between the first and the second coordinate axis.
However, Crawford teaches, in the same field of endeavor, wherein the processing unit of the medical system is configured to compute the coordinate system of the surface fiducial markers by using a position of a first surface fiducial marker as a center of the coordinate system of the surface fiducial markers, wherein the medical system is further configured to use as a first coordinate axis of the coordinate system of the surface fiducial markers a normalized vector extending from the first surface fiducial marker to a second surface fiducial marker and as a second coordinate axis a normalized vector extending from the first surface fiducial marker to a third surface fiducial marker and as a third coordinate axis the cross product between the first and the second coordinate axis (“With emphasis on FIG. 15E, the presence of the single marker 1018 being tracked as well as the four markers 804 on the tool 608, it is possible to construct the centerline vector C' of the guide tube 1014 and tool 608 and the normal vector through the single marker 1018 and through the centerline vector C'. This normal vector has an orientation that is in a known orientation relative to the forearm of the robot distal to the wrist (in this example, oriented parallel to that segment) and intersects the centerline vector C' at a specific fixed position. For convenience, three mutually orthogonal vectors k', j', i' can be constructed, as shown in FIG. 15E, defining rigid body position and orientation of the guide tube 1014. One of the three mutually orthogonal vectors k' is constructed from the centerline vector C', the second vector j' is constructed from the normal vector through the single marker 1018, and the third vector i' is the vector cross product of the first and second vectors k', j'.” [0084]; also see [0028]).
Therefore before the effective filing date of the claimed invention, it would have been obvious for one of ordinary skill in the art to modify the invention of Sayeh with wherein the processing unit of the medical system is configured to compute the coordinate system of the surface fiducial markers by using a position of a first surface fiducial marker as a center of the coordinate system of the surface fiducial markers, wherein the medical system is further configured to use as a first coordinate axis of the coordinate system of the surface fiducial markers a normalized vector extending from the first surface fiducial marker to a second surface fiducial marker and as a second coordinate axis a normalized vector extending from the first surface fiducial marker to a third surface fiducial marker and as a third coordinate axis the cross product between the first and the second coordinate axis as taught by Crawford in order to use rigid body calculations to determine the locations of the surface ([0084] of Crawford).
Conclusion
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/A.A./Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797