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 .
Election/Restrictions
Claims 21, 28, and 35 are generic to the following disclosed patentably distinct species:
Species I: Technique 400 for positioning or orienting a camera within a surgical field of [0039] and fig. 4.
Species II: Technique 500 for positioning or orienting a camera within a surgical field of [0045] and fig. 5.
The species are independent or distinct because as disclosed the different species have mutually exclusive characteristics for each identified species. The steps in Technique 400 of Species I and Technique 500 share similar features such as a tracker affixed to a surgical device and related. However, the techniques are distinct in that they both include various different steps in achieving orientation of the camera within the surgical field. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
--the species or groupings of patentably indistinct species have acquired a separate status in the art due to their recognized divergent subject matter; and
--the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Gregory Stark, Reg. No. 62,731 (attorney of Record) on 02/25/2026 a provisional election was made without traverse to prosecute the invention of Species I, claims 21-41 . Affirmation of this election must be made by applicant in replying to this Office action.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 27, 34, and 41 are objected to because of the following informalities:
The claims should be amended to recite --wherein the training data is generated based on a specific surgical procedure--.
Appropriate correction is required.
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.
Claims 26, 33, and 40 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.
The term “optimal” in claims 26, 33, and 40 is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph 19 of the specification describes that “The optimal camera position may be determined such that it is sufficient for all required steps of the surgical procedure. In an example, the determined optimal camera position may be specific to the operating room environment (e.g., system 100), specific to a surgeon, specific to a procedure, or the like”. However, an optimal camera position that is sufficient for all required steps of the surgical procedure does not provide specificity for the “optimal performance of the camera” as recited, nor does the degree of positioning of the camera that is sufficient for all the steps required of the surgical procedure, as noted in the specification a support for a degree of performance of the camera.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: YES – Claim 21 recites a system and, therefore, is a device.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the following limitations: “determine whether the camera is within a target volume location”.
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing circuitry coupled to memory, including instructions”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processing circuitry coupled to memory, including instructions” language, the claim encompasses a user simply performing a visual observation of the surgical scene and determining that the camera is positioned at the target volume location. The mere nominal recitation of a generic network appliance does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “a camera to detect a tracker coupled to a robotic surgical device; a display device; and processing circuitry coupled to memory, including processing instructions, which when executed by the processing circuitry, cause the processing circuitry to: generate a graphical user interface for presentation on the display device, the graphical user interface including a first set of instructions to position the camera within a surgical field; in response to determining that the camera is within the target volume location, automatically output an indication that the camera is within the target volume location; output a second set of instructions for display on the graphical user interface to align the camera in reference to the tracker by changing an angle of the camera; and display a confirmation that the camera is within the target volume location and properly oriented”. The camera, tracker, robotic surgical device comprise conventional surgical operation equipment/components and the display device and the processing circuitry coupled to memory, including processing instructions, comprise generic computer components. The graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step are all recited at high level of generality (i.e., as a general means of tracking instruments using optical based sensors during a surgical procedure), and amount to mere insignificant extra-solution activity during computer-assisted surgery procedures. The camera, tracker, robotic surgical device, display device and the processing circuitry coupled to memory, including processing instructions that perform the respective steps are also recited at a high level of generality, and merely automate the routine and conventional steps identified above. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component.
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry coupled to memory, including processing instructions). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05. Here, the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step were considered to be insignificant extra-solution activities during a computer-assisted surgical procedure, in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processing circuitry coupled to memory, including processing instructions is anything other than a generic, off-the-shelf computer component, and the TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747 court decision cited in MPEP 2106.05(a)(I) indicate that mere gathering and analyzing of information using conventional techniques and displaying the result is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Claim 22 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on a selected surgical procedure”. The limitation fails to integrate the mental step identified above into a practical application as the limitation includes mere instructions to position the camera based on a specified criterion.
Claim 23 recites “wherein the generating the first set of instructions to position the camera includes optimizing camera position and orientation based on minimizing line-of-sight obstructions anticipated during the selected surgical procedure”, which does not negate the mental step identified above, as the specification of the parameters for generating the instructions does not demonstrate a practical application for which the instructions are generated.
Claim 24 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on an optical precision of the camera”, which merely comprises further instructions for positioning the camera based on a specified criterion and hence fails to integrate the abstract idea into a practical application.
Claim 25 recites “wherein the generating the first set of instructions to position the camera includes performing a precision analysis to determine the optical precision of the camera”. The performance of precision analysis for the camera position comprises further calculations, which comprise mental steps to determine the camera position.
Claim 26 recites “wherein performing the precision analysis includes determining a minimum and maximum distance for optimal performance of the camera”. This limitation merely specifies conditions for determining the camera performance and hence fails to take the precision analysis out of the mental step category.
Claim 27 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure”. The limitations merely implement the abstract idea using a training data and hence comprise mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept.
Step 1: Statutory Category: YES – Claim 28 recites method and, therefore, is a process.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the following limitations: “determining whether the camera is within a target volume location”.
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processor”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processor” language, the claim encompasses a user simply performing a visual observation of the surgical scene and determining that the camera is positioned at the target volume location. The mere nominal recitation of a generic network appliance does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “generating, using a processor, a graphical user interface for presentation on a display device, the graphical user interface including a first set of instructions to position a camera within a surgical field, wherein the camera is configured to detect a tracker coupled to a surgical instrument; in response to determining that the camera is within the target volume location, automatically outputting an indication that the camera is within the target volume location; outputting a second set of instructions for display on the graphical user interface to align the camera in reference to the tracker by changing an angle of the camera; and displaying a confirmation that the camera is within the target volume location and properly oriented”.
The graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step are all recited at high level of generality (i.e., as a general means of tracking instruments using optical based sensors during a surgical procedure), and amount to mere insignificant extra-solution activity during computer-assisted surgery procedures. The processor that performs the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step are all recited at high level of generality (i.e., as a general means of tracking instruments using optical based sensors during a surgical procedure), and amount to mere insignificant extra-solution activity during computer-assisted surgery procedures, is also recited at a high level of generality, and merely automates the steps. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component (the processor).
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processor). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05. Here, the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step were considered to be insignificant extra-solution activities during a computer-assisted surgical procedure, in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component, and the TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747 court decision cited in MPEP 2106.05(a)(I) indicate that mere gathering and analyzing of information using conventional techniques and displaying the result is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Claim 29 recites “wherein generating the first set of instructions to position the camera is based receiving an indication of a selected surgical procedure”. The limitation fails to integrate the mental step identified above into a practical application as the limitation includes mere instructions to position the camera based on a specified criterion.
Claim 30 recites “wherein the generating the first set of instructions to position the camera includes optimizing camera position and orientation based on minimizing line-of-sight obstructions anticipated during the selected surgical procedure”, which does not negate the mental step identified above, as the specification of the parameters for generating the instructions does not demonstrate a practical application for which the instructions are generated.
Claim 31 recites “wherein generating the first set of instructions to position the camera is based on an optical precision of the camera”, which merely comprises further instructions for positioning the camera based on a specified criterion and hence fails to integrate the abstract idea into a practical application.
Claim 32 recites “wherein the generating the first set of instructions to position the camera includes performing a precision analysis to determine the optical precision of the camera”. The performance of precision analysis for the camera position comprises further calculations, which comprise mental steps to determine the camera position.
Claim 33 recites “wherein performing the precision analysis includes determining a minimum and maximum distance for optimal performance of the camera”. This limitation merely specifies conditions for determining the camera performance and hence fails to take the precision analysis out of the mental step category.
Claim 34 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure”. The limitations merely implement the abstract idea using a training data and hence comprise mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept.
Step 1: Statutory Category: YES – Claim 35 recites At least one non-transitory machine-readable medium, including instructions and, therefore, is a device.
Step 2A, Prong 1, Judicial Exception: YES - The claim recites the following limitations: “determine whether the camera is within a target volume location”.
This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing circuitry”, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “processing circuitry” language, the claim encompasses a user simply performing a visual observation of the surgical scene and determining that the camera is positioned at the target volume location. The mere nominal recitation of a generic network appliance does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites additional elements: “instructions, which when executed by processing circuitry, cause the processing circuitry to: generate a graphical user interface for presentation on a display device, the graphical user interface including a first set of instructions to position a camera within a surgical field, wherein the camera is configured to detect a tracker coupled to a surgical instrument; in response to determining that the camera is within the target volume location, automatically output an indication that the camera is within the target volume location; output a second set of instructions for display on the graphical user interface to align the camera in reference to the tracker by changing an angle of the camera; and display a confirmation that the camera is within the target volume location and properly oriented”. The camera, tracker, and surgical instrument comprise conventional surgical operation equipment/components and the display device and the processing circuitry coupled to memory, including processing instructions, comprise generic computer components. The graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step are all recited at high level of generality (i.e., as a general means of tracking instruments using optical based sensors during a surgical procedure), and amount to mere insignificant extra-solution activity during computer-assisted surgery procedures. The camera, tracker, surgical instrument, the processing circuitry that performs the respective steps are also recited at a high level of generality, and merely automate the routine and conventional steps identified above. Each of the additional limitations is no more than mere instructions to apply the exception using a generic computer component.
The combination of these additional elements is no more than mere instructions to apply the exception using a generic computer component (the processing circuitry). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to the abstract idea.
Step 2B, Inventive Concept: No - As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B. This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05. Here, the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step were considered to be insignificant extra-solution activities during a computer-assisted surgical procedure, in Step 2A, and thus it is re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The background of the example does not provide any indication that the processing circuitry is anything other than a generic, off-the-shelf computer component, and the TLI Communications, 823 F.3d at 611-12, 118 USPQ2d at 1747 court decision cited in MPEP 2106.05(a)(I) indicate that mere gathering and analyzing of information using conventional techniques and displaying the result is a well‐understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the graphical user interface generation step, automatic indicator outputting step, the output of second instruction step and the confirmation displaying step is well-understood, routine, conventional activity is supported under Berkheimer Option 2. For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
Claim 36 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on a selected surgical procedure”. The limitation fails to integrate the mental step identified above into a practical application as the limitation includes mere instructions to position the camera based on a specified criterion.
Claim 37 recites “wherein the generating the first set of instructions to position the camera includes optimizing camera position and orientation based on minimizing line-of-sight obstructions anticipated during the selected surgical procedure”, which does not negate the mental step identified above, as the specification of the parameters for generating the instructions does not demonstrate a practical application for which the instructions are generated.
Claim 38 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on an optical precision of the camera”, which merely comprises further instructions for positioning the camera based on a specified criterion and hence fails to integrate the abstract idea into a practical application.
Claim 39 recites “wherein the generating the first set of instructions to position the camera includes performing a precision analysis to determine the optical precision of the camera”. The performance of precision analysis for the camera position comprises further calculations, which comprise mental steps to determine the camera position.
Claim 40 recites wherein performing the precision analysis includes determining a minimum and maximum distance for optimal performance of the camera. This limitation merely specifies conditions for determining the camera performance and hence fails to take the precision analysis out of the mental step category.
Claim 41 recites “instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure”. The limitations merely implement the abstract idea using a training data and hence comprise mere instructions to implement an abstract idea or other exception on a computer and insignificant extra-solution activity, which do not provide an inventive concept.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 21-41 are rejected under 35 U.S.C. 103 as being unpatentable over Dube, et al., US 6434329 B1 in view of Piene, et al., US 20200170718 A1.
Regarding claims 21, 28, and 35, Dube teaches a system (the abstract discloses a “A controllable camera support including a pivoting arm adapted to be rotatably connected to a pivot point defining a first rotational axis”) comprising: a camera (pair of cameras 20,22 of fig. 1 and col. 3, lines 62-65); a display device (col. 7, lines 41-46 disclose that “The interface 102 also comprises a user interface (such as a computer screen, keyboard and mouse) which is coupled to the computer system for generating a position and/or speed command signals”); and processing circuitry coupled to memory, including processing instructions, which when executed by the processing circuitry, cause the processing circuitry to: (col. 7, lines 38-41 discloses “The interface 102 includes a computer system (such as a PC) for receiving measured rotational and radial positions from the sensors. As previously discussed the sensors may be position sensor or speed sensors depending on design preference” and col. 4, lines 10-14 disclose the implementation of a software), as required by claim 21; A method (col. 1, lines 48-50 discloses “Another object of the present invention is to provide an algorithm and method that will allow a distant observer to control the camera support and the camera”) as required by claim 28; and At least one non-transitory machine-readable medium, including instructions, which when executed by processing circuitry, cause the processing circuitry to: (col. 1, lines 48-50 discloses “Another object of the present invention is to provide an algorithm and method that will allow a distant observer to control the camera support and the camera”), as required by claim 35:
generate a graphical user interface for presentation on the display device, the graphical user interface including a first set of instructions to position the camera within a surgical field (col. 9, lines 30-31 states “A user interface is provided for sending commands to camera system through the controller” and col. 9 lines 38-43 states that “Referring to FIGS. 28 and 29, a graphical interface 150 shown in FIG. 28 corresponds to the physical system shown in FIG. 29. A first window 152 of the graphical interface 150 corresponds to a top view 154 shown in FIG. 29. A second window 156 of the graphical interface 150 corresponds to a side view 158 shown in FIG. 29”);
determine whether the camera is within a target volume location (col. 4, lines 35-41 states “The flexibility of the chosen system not only lies in the chosen mechanism but also in its position inside the operating room. An optimal system may be based on the combination of the chosen camera support and its strategic position to offer the most views on the target 32. It is advantageous to choose a camera support and a position for it that avoids the surgical lamps structures 26” and col. 4 lines 61-63 states that “The positioning of the camera support 42 under the lamp structure 26 is strategic because it avoids the first layer 28 completely”. This strategic positioning of the camera is tantamount to the target volume location of the camera);
in response to determining that the camera is within the target volume location, automatically output an indication that the camera is within the target volume location (col. 9, lines 38-43 state that “Referring to FIGS. 28 and 29, a graphical interface 150 shown in FIG. 28 corresponds to the physical system shown in FIG. 29. A first window 152 of the graphical interface 150 corresponds to a top view 154 shown in FIG. 29. A second window 156 of the graphical interface 150 corresponds to a side view 158 shown in FIG. 29”. Figs. 28 and 29 have been reproduced below to show the markers indicative of the positions of the camera. Col. 10, lines 8-10 states that “Markers identified by "+" (1, 2, 3, 4, 5) represent the position of the camera 46 and the target 32”);
output a second set of instructions for display on the graphical user interface to align the camera in reference to the tracker by changing an angle of the camera (col. 10 lines 11-16 states that “The graphical interface 150 is adapted to receive the commands of the user to control the camera and its support. These commands may be sent directly with the help of a mouse, by moving the markers around the screen. The moving of the markers triggers an automatic calculation of the desired parameters by the system on the interface 150” and col. 10 lines 20-21 states that “When a user moves a marker in both the side view and top view, a command is sent to reposition the camera”. The repositioning of the camera includes repositioning the camera angle and focus according col. 7, lines 46-49); and
display a confirmation that the camera is within the target volume location and properly oriented (col. 9, lines 66-67 and col. 10 lines 1-6 state that “The graphical interface 150 shown in FIG. 28 may be separated in two parts: the real parameters and the desired parameters. The real parameters are directly provided by the acquisition card and from the system, thereby providing a continuous real position of the pivoting arm 50 and camera 46. From the direct kinematics equations, these real parameters are converted in real graphical displays showing top and side views of the system”. Meaning that the markers are continuously depicted in the graphical user interface such that upon a repositioning of the camera, a depiction of the final, desired position is depicted in the graphical interface).
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Dube fails to teach that the camera is configured to detect a tracker coupled to a robotic surgical device.
However, within the same field of endeavor, Piene teaches methods, systems, and computer-readable medium for tracking locations of one or more surgical instruments. The method includes detecting a plurality of markers disposed on a distal end of a first surgical instrument within a field of view of a camera, calculating a position of the first surgical instrument based on a location of the plurality of markers within the field of view of the camera, determining the position of the first surgical instrument in relation to a second surgical instrument (see abstract). Piene discloses in paragraph 67 that the surgical instrument 20 is supported by a robotic arm 12 and paragraph 69 discloses that the surgical instrument 20 has markers 64 attached to it. And paragraph 6 discloses “detecting a plurality of markers disposed on a distal end of a first surgical instrument within a field of view of a camera, calculating a position of the first surgical instrument based on a location of the plurality of markers detected within the field of view of the camera, and determining the position of the first surgical instrument in relation to a second surgical instrument”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Dube to detect a tracker coupled to a robotic surgical device, as taught by Piene, as such modification would improve the efficiency of tracking objects within the surgical scene (paragraph 4) and hence improving patient outcomes (paragraph 5).
Regarding claims 22, 29, and 36, Dube in view of Piene teaches all the limitations of claims 21, 28, and 35 respectively above.
Dube further teaches instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on a selected surgical procedure (col. 4, lines 64-65 state that “Referring to FIG. 3, a series of cones 34, which move as a function of time and of the type of surgery, represent some possible visual fields of the movable camera 46 toward the target 32”).
Regarding claims 23, 30, and 37, Dube in view of Piene teaches all the limitations of claim 22, 29, and 36, respectively above.
Dube further teaches wherein the generating the first set of instructions to position the camera includes optimizing camera position and orientation based on minimizing line-of-sight obstructions anticipated during the selected surgical procedure (col. 9 lines 49-55 states that “Referring to FIG. 30, there is shown an algorithm for controlling the camera system when the target becomes obstructed by an obstruction. The control system is adapted to move the camera to another predetermined position all the while focusing on the target as previously explained. Thus, the camera can be moved to another predetermined position where the obstruction does not obstruct the camera”).
Regarding claims 24, 31, and 38, Dube in view of Piene teaches all the limitations of claims 21, 28, and 35, respectively above.
further comprising instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on an optical precision of the camera (col. 9, lines 6-9 states “In use, a user observes the activities in the operating room 10 from a screen 144 connected to the camera. The user may control the position of the camera directly by means of the joystick, or indirectly by means of the PC 140”; col. 9 lines 12-13 states that “Commands are sent from the PC 140 to the command unit 132, which processes the received signals”; and col. 9, lines 18-22 states that “The command unit 132 powers the potentiometers and limit switches in the pivoting arm 50. The information received from the potentiometer, encoders and limit switches, and information received from the camera (tilt, azimuth, focal adjustment) is sent to the PC 140”).
Regarding claims 25 and 26, 32 and 33, and 39 and 40, Dube in view of Piene teaches all the limitations of claims 24, 31, and 38, respectively above.
Dube further teaches wherein the generating the first set of instructions to position the camera includes performing a precision analysis to determine the optical precision of the camera; and wherein performing the precision analysis includes determining a minimum and maximum distance for optimal performance of the camera (col. 6, lines 61-67 states that “Referring to FIGS. 13 and 14, the camera support also includes another security component by providing limit switches 76 which is adapted to shut down power to the radial and rotational motors 62, 68. The limit switch 76 is adapted to shut down the motors when the pivoting arm reaches a maximum or minimum length when extended or retracted, or when it reaches a certain rotation position”. Figs. 13 and 14 show the movable camera 46 supported by the pivoting arm, for which a maximum or minimum length limits are implemented).
Claims 27, 34, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Dube, et al., US 6434329 B1 in view of Piene, et al., US 20200170718 A1, as applied to claims 21, 28 and 35, respectively, and further in view of Zisimopoulos, et al., US 20180357514 A1.
Regarding claims 27, 34, and 41, Dube in view of Piene teaches all the limitations of claims 21, 28, and 35, respectively above.
Dube in view of Piene fails to teach instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure.
However, within the same field of endeavor, Zisimopoulos teaches a computer-assisted surgical (CAS) system comprising a surgical simulation for training detection and classification neural networks implemented cataract surgery (paragraph 24). Paragraph 73 further states that “models were trained on a simulated dataset acquired from a commercially available surgical simulator and adapted such that it could be used on real cataract images (2017 MICCAI CATARACTS challenge, https://cataracts.grand-challenge.org/). The simulator was used to generate data with variability in camera pose, lighting or instrument motion, to train machine learning models and then directly apply them to detect tools in real cataract videos. Generally, results of the example shoed that there is potential for developing this idea, with the pix2pix technique demonstrating that detecting real instruments using models trained on synthetic data is feasible”, hence teaching instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Dube as modified by Piene to include instructions that cause the processing circuitry to generate the first set of instructions to position the camera based on training data for the target volume location, wherein the training data is generated based for a specific surgical procedure by optimizing location through testing a plurality of locations during a surgical procedure, as taught by Zisimopoulos, to improve the accuracy of detection of the features of interest within the surgical scene (paragraph 25).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11490969 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the U.S. Patent.
Claims 21-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12251180 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the limitations recited in the claims mentioned above of the instant application are also recited in the claims mentioned above of the U.S. Patent.
Conclusion
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/FAROUK A BRUCE/Examiner, Art Unit 3797