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 .
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.
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: “visualization unit” in claims 1, 2, and 5 with specification support in published [0010]; “tracking system” in claims 1 and 12 with support in [0026]; and “input unit” in claim 9 with support in [0027].
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.
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 § 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Powell et al (US Pub 2023/0015060 -cited by applicant).
Re claims 1, 12, 13: Powell discloses a surgical intraoperative measuring system for up-to-date intraoperative measurement and representation of geometric line segment lengths or dimensions or distances in a surgical navigation, comprising:
a surgical visualization unit adapted to produce an intracorporeal capturing of an intervention region of a patient in a capturing plane (figure 2A, 3; see unit 100 and intracorporeal image);
a medical instrument comprising an instrument tip, the medical instrument being usable for an intervention in the intervention region so as to define a zero point for a measurement by means of the instrument tip [0059, 0063; see the tip 343 of instrument 301 and see a zero point/depth of 0 mm for measurement];
a navigation system adapted to track, via a tracking system, at least the instrument tip of the medical instrument (figure 1; see trackers 113a, 113b, 113n);
a visual display device for visually outputting a representation with at least the intracorporeal capturing (figure 1, 2A; see display 104 or 226); and
a control unit (figure 1; see unit 102) adapted to:
sense, by means of the navigation system, at least one position of the instrument tip of the medical instrument [0063; high precision navigation of the tracked instrument],
produce a digital overlay representation with at least the intracorporeal capturing [0062, figure 4A; see ruler 444 on the representation],
insert, in the digital overlay representation, a virtual measuring device with at least one distance marking and/or distance number which corresponds to a real distance in the intracorporeal capturing with a zero point that forms the instrument tip [0062, figure 4A; see ruler 444 as the virtual measuring device with distance markings/numbers], and
output the digital overlay representation with at least the virtual measuring device by means of the display device (figure 4A; see the output representation),
the virtual measuring device being arranged in parallel to the capturing plane to indicate a distance measurement in the capturing plane (figure 4A; see the ruler 444 with dash marks that is overlaid onto the representation image which is shown as a captured plane, thereby being arranged parallel to the captured plane), or, by means of the medical instrument, a spatial end point is definable apart from the zero point, and the connection of both points forms a straight line for the virtual measuring device that forms a virtual ruler (figure 4A; see point “80” as an end point separate from 0 mm with a straight line therebetween).
Further, Powell discloses a computer-implemented surgical intraoperative measuring method including steps of producing the capturing, sensing the tip position, producing the overlay, and outputting the representation as set forth in the corresponding citations above. Powell also discloses a computer readable storage medium and computer program to perform the measuring method [0040, 0041; see the memory storage devices and the program instructions to perform the measuring method].
Re claim 2: The medical instrument comprises, in a region of the instrument tip, a predefined optical pattern and/or a predefined geometric shape stored in a storage unit for comparison, and wherein the control unit is adapted to track, based on the predefined optical pattern and/or the predefined geometric shape, the position of the instrument tip by means of the intracorporeal capturing of the visualisation unit and by means of machine vision [0033, 0041; see the storage devices used in the processing; and see the instrument with markers that have a pattern/shape when tracked].
Re claim 3: The instrument comprises a navigation pointer and/or a suction tube and/or a surgical instrument (figure 1; see that instrument is a pointer).
Re claim 6: The measuring system is integrated in or on one single mobile cart so as to provide a complete measuring system on the single mobile cart (figure 2A; see the cart 100).
Re claim 7: A side-by-side representation of the intracorporeal capturing and a navigation view is produced in the digital overlay representation, and wherein the virtual measuring device is shown in the intracorporeal capturing and additionally in a correct pose in the navigation view so as to provide a user with two viewing modalities with the virtual measuring device (figure 3; see the 3D view 332 and 2D view 338a,b,c).
Re claim 8: The system includes an external navigation camera (see the cameras 112 in figure 2B).
Re claim 9: The system includes an input unit, wherein the control device is adapted, by means of a user input of the input unit to: set a distance dimensioning of the virtual measuring device, and/or set a geometric structure of the virtual measuring device (figure 3, 5C; 0065; see concentric circles and see the user interface 330 that can change the perspective/orientation of the view in response to user input; and see icon 342c to edit trajectory).
Re claim 10: The control unit is adapted to calculate a numerical distance between the zero point and the end point and insert the numerical distance as a distance number (figure 4A; see the distance numbers that are determined).
Re claim 11: The control unit is further adapted to insert, in the digital overlay representation, a second virtual ruler in extension of a longitudinal axis of the medical instrument, apart from the virtual measuring device (figure 5D; see the ruler with digits 8-3 and the second ruler with digits 30-80).
Re claims 15, 16: The virtual measuring device comprises a ruler or concentric distance circles (Figures 4A, 5D, 0058, 0090; see the indicators 447, 1392 that can be concentric circles in 2D or 3D).
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.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Powell, as applied to claim 1, in view of Nixon et al (US Pub 2009/0171371 -cited by applicant).
Re claims 4, 5: Powell discloses all features except that the visualization unit comprises a surgical microscope and/or a surgical exoscope and/or a surgical endoscope or that the system includes a surgical robot having a robot arm, wherein the surgical visualization unit is connected to the robot arm in a navigated manner and controllable by the control unit. However, Nixon teaches of a system to determine distance for a surgical procedure including a visualization unit that comprises a surgical microscope and/or a surgical exoscope and/or a surgical endoscope and a surgical robot having a robot arm, wherein the surgical visualization unit is connected to the robot arm in a navigated manner and controllable by the control unit [0078, claim 1; see the endoscope 140 that is used for visualization and which is connected to a robot arm for manipulation]. It would have been obvious to the skilled artisan to modify Powell, as taught by Nixon, in order to visualize a procedure more accurately via the robotic control.
Response to Arguments
Applicant's arguments filed 12/17/25 have been fully considered but they are not persuasive. Applicant has amended claim 1 to remove the second configuration regarding the virtual measuring device (note that the second configuration is still present in claim 12). Applicant argues that the first configuration of the virtual device being parallel to the capturing plane is not disclosed in Powell. Respectfully, the Examiner disagrees and finds that Powell’s virtual ruler that is overlaid onto the representation which is displayed as a capturing plane meets the limitation. The ruler is displayed in 2D or 3D and, therefore, it is parallel to the displayed representation.
The prior 112b and 101 rejections are withdrawn due to amendments. The prior 112f interpretation is now modified and replaced by the instant interpretation.
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797