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 .
Status of the Claims
This Office Action is responsive to the preliminary amendment filed October 31, 2024. As directed by the preliminary amendment: Claims 3-6, 8-11, 13, and 14 have been amended. Claims 1-14 are presently pending in this application.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in European Patent on August 17, 2023. It is noted, however, that applicant has not filed a certified copy of the EP 23306386.6 application as required by 37 CFR 1.55.
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.
Regarding claims 1 and 12, the phrase “means of a localization device” uses the word “means”. It appears from applicant’s disclosure that the localization device comprises a 3D imaging sensor (¶43) and/or a depth camera (¶12).
Examiner’s Note
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.
Claim Rejections - 35 USC § 102
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, 3-10, and 12-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bozung et al. (WO 2023/141265 A2), herein referred to as Bozung.
Regarding claim 1, Bozung discloses a device (60) (figure 9) for computer guided orthopedic surgery of a target bone (figure 45) of a patient based on actions planned in a virtual environment with respect to a virtual coordinate system (¶109, ¶110, target trajectory TTRAJ, ¶343 e.g. planned bone entry point), so as to guide a physical action of a user, to be performed with a drilling surgical tool (14), the device (60) (figure 9) comprising at least one input (36) configured to (i.e. capable of) receive: surgical planning information comprising the planned actions with respect to a 3D target model (e.g. virtual object 4, ¶124, ¶249) of at least one portion of the target bone (¶109), each planned action comprising at least one planned spatial position and at least one planned drilling axis (¶20, target trajectory TTRAJ, ¶262) of the drilling surgical tool (14) and/or at least one planned bone entry point on the 3D target model (¶264), current target localization information (¶120) representative of a spatial position and/or orientation at a current time t of the at least one portion of the target bone (e.g. patient tracker 54, 56), the current localization information having been acquired by means of a localization device (44), a rigid transformation between a localization coordinate system of the localization device and a coordinate system of the drilling surgical tool (¶204, ¶205, figure 45), at least one processor (¶113, ¶129, figure 9) configured to (i.e. capable of) calculate a transformation between the localization coordinate system and a target coordinate system of the target bone by registration of the 3D target model with the current target localization information (¶124, ¶202, figure 45), apply the transformation to the surgical planning information (¶215), apply the rigid transformation between the localization coordinate system and the coordinate system of the drilling surgical tool so as to know the position and spatial orientation of the drilling surgical tool (14) in the localization coordinate system (¶206), using the position and spatial orientation of the drilling surgical tool (14) and the position and orientation of the target bone in the localization coordinate system, calculate the current spatial position and current drilling axis of the drilling surgical tool (14) and/or the current bone entry point with respect to the target bone (e.g. current pose, poses can be combined, with respect to a desired coordinate system, ¶238), compare, in the localization coordinate system, the surgical planning information with the current spatial position and current drilling axis and/or the current bone entry point in the target bone (¶239), at least one output (¶343, ¶345) configured to (i.e. capable of) provide guiding data resulting from the comparison (¶343, ¶345).
Regarding claim 3, Bozung discloses herein the rigid transformation is defined by design or by calibration (¶204).
Regarding claim 4, Bozung discloses wherein the portion of interest of the target bone is a glenoid (¶240).
Regarding claim 5, Bozung discloses wherein the target bone is a vertebra or a bone of the shoulder (¶240).
Regarding claim 6, Bozung discloses wherein the drilling surgical tool (14) is a handheld surgical power tool used to screw a pin (e.g. pedicle screw, ¶262) into the portion of interest (¶262), the pin having a tip (¶262).
Regarding claim 7, Bozung discloses wherein the guiding data (¶343, ¶345) comprises a distance between the tip of the pin (¶262) and the planned bone entry point (¶343) and an angle between a current pin direction (¶262) and the planned drilling axis (¶262).
Regarding claim 8, Bozung discloses wherein the guiding data (¶343, ¶345) comprises information indicating whether the current drilling axis (¶343) approaches or moves away from the planned drilling axis (¶262).
Regarding claim 9, Bozung discloses wherein the guiding data (¶343, ¶345) comprises a vector (figure 45) representing a translation to be performed to overlap the current and planned bone entry point (¶238).
Regarding claim 10, Bozung discloses wherein the at least one output (¶343) is provided via a screen (¶235) embedded in the drilling surgical tool (14).
Regarding claim 12, Bozung discloses a computer-implemented method (¶353) for computer guided orthopedic surgery of a target bone (figure 45) of a patient based on actions planned in a virtual environment with respect to a virtual coordinate system (¶109, ¶110, target trajectory TTRAJ, ¶343 e.g. planned bone entry point), so as to guide a physical action of a user, to be performed with a drilling surgical tool (14), the method comprising receiving surgical planning information comprising the planned actions with respect to a 3D target model (e.g. virtual object 4, ¶124, ¶249) of at least one portion of the target bone (¶109), each planned action comprising at least one planned spatial position and at least one planned drilling axis (¶20, target trajectory TTRAJ, ¶262) of the drilling surgical tool (14) and/or at least one planned bone entry point on the 3D target model (¶264), current target localization information (¶120) representative of a spatial position and/or orientation at a current time t of the at least one portion of the target bone (e.g. patient tracker 54, 56), the current localization information having been acquired by means of a localization device (44), a rigid transformation between a localization coordinate system of the localization device and a coordinate system of the drilling surgical tool (¶204, ¶205, figure 45), calculating a transformation between the localization coordinate system and a target coordinate system of the target bone by registration of the 3D target model with the current target localization information (¶124, ¶202, figure 45), applying the transformation to the surgical planning information (¶215), applying the rigid transformation between the localization coordinate system and the coordinate system of the drilling surgical tool so as to know the position and spatial orientation of the drilling surgical tool (14) in the localization coordinate system (¶206), using the position and spatial orientation of the drilling surgical tool (14) and the position and orientation of the target bone in the localization coordinate system, calculating the current spatial position and current drilling axis of the drilling surgical tool (14) and/or the current bone entry point with respect to the target bone (e.g. current pose, poses can be combined, with respect to a desired coordinate system, ¶238), comparing, in the localization coordinate system, the surgical planning information with the current spatial position and current drilling axis and/or the current bone entry point in the target bone (¶239), outputting guiding data resulting from the comparison (¶343, ¶345).
Regarding claim 13, Bozung discloses a non-transitory computer readable medium (¶352) comprising instructions which, when executed by a computer (¶352), cause the computer to carry out the steps of the method for computer guided orthopedic surgery according to claim 12 (see claim 12 above).
Regarding claim 14, Bozung discloses a computer program product (¶354) comprising instructions which, when the program is executed by a computer (¶354), cause the computer to carry out the steps of the method for computer guided orthopedic surgery of claim 12 (see claim 12 above).
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.
Claim(s) 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bozung (WO 2023/141265 A2) in view of Simoes et al. (US 2022/0211507), herein referred to as Simoes.
Regarding claim 2, Bozung’s device discloses all the features/elements as claimed but lacks a detailed description on wherein the localization device comprises a depth camera and wherein the current localization information comprises at least one 3D image.
However, Simoes teaches a localization device comprises a depth camera (532) (¶86) and wherein the current localization information comprises at least one 3D image (¶86).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bozung’s localization device with wherein the localization device comprises a depth camera and wherein the current localization information comprises at least one 3D image as taught by Simoes, since such a modification would provide the user with depth data (¶86).
Regarding claim 11, Bozung’s device discloses all the features/elements as claimed but lacks wherein the at least one output is provided via a virtual reality headset or augmented reality device.
However, Simoes teaches at least one output is provided via a virtual reality headset or augmented reality device (¶186 and figure 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Bozung’s output with a virtual reality headset or augmented reality device as taught by Simoes, since such a modification would display virtual guidance to the user for performing work on a portion of a patient’s anatomy (¶186).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SI MING KU whose telephone number is (571)270-5450. The examiner can normally be reached Monday-Friday, 9:30am-6pm.
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/SI MING KU/Primary Examiner, Art Unit 3775
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