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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/25/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 03/25/2026.
Status of the claims:
Claims 1 – 11, 13 – 18, and 20 – 22 are pending in the application.
Claims 1, 13, 17, and 18 are amended.
Claims 21 – 22 are new.
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 therefore, subject to the conditions and requirements of this title.
Claims 1 – 11, 13 – 18, and 20 – 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 – 11, 13 – 18, and 20 – 22 are drawn to a method (claims 1 – 11, 13 – 16, and 21 – 22) and a device (claims 17, 18, and 20) which are statutory categories of invention (Step 1: YES).
Independent claims 1, 17, and 18 recite determining a patient-specific marker arrangement, receiving three-dimensional image data of a patient, obtaining, based on the three-dimensional image data, planning data for a surgical intervention, and determining the marker arrangement for the tracker based at least on the obtained planning data.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “determining a patient-specific marker for a tracker of a surgical tracking system is presented, wherein the marker arrangement is defined by marker positions. A method implementation of the technique comprises receiving three-dimensional image data of a patient, obtaining planning data for a surgical intervention, and determining the marker arrangement for the tracker based at least on the obtained planning data” (see: abstract). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because nothing in the claim precludes the steps from practically being performed in the mind. The claims encompass a user receiving data, obtaining data, and determining the marker arrangement in his/her mind. Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
This judicial exception is not integrated into a practical application. The claims are abstract except for the additional elements including “a tracker”, “a tracker system”, “a signal generator or signal detector”, and “the signal generator or signal detector for generating or detecting an optical image”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the above elements are nominal or tangential in addition to the abstract idea and amount to insignificant post-solution activity concerning an insignificant application. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of correlating healthcare data as outlined in the recitations above. See: MPEP 2106.05(g).
Claims 17 and 18 further recite one of the additional elements including “non-transitory computer readable medium”, “at least one processor”, and/or an “apparatus” which amount to no more than mere instructions to apply the exception using a generic computer component. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because merely perform the abstract idea using generic components.
Hence, the 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. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at:
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Looking at the dependent claims 2-11, 13-16, and 20-22, the claims are only directed towards further data collection, analysis, and generating functions that are recited at a high level of generality. Except for the "a surgical instrument" of claim 8 and “a substrate” in claim 14, there are no further hardware components or additional elements to consider as forming an inventive concept. However, the "a surgical instrument" of claim 8 and “a substrate” in claim 14 do not add any meaningful limits on analyzing the data to determine placement of the trackers of the tracking system. Further, generic cameras are well-understood, routine, and conventional. As such, the claims are also ineligible.
Applicant's attention is directed towards Thales Visionix Inc. V. US, 850 F. 3d 1343 (2017) where the court ruled an inertial tracking system to be patent eligible when the particular arrangement of sensors and steps of using data from the sensors in order to calculate the position and orientation of a moving object more accurately was claimed.
In contrast to Thales Visionix, in the instant claims, there is no particular arrangement of sensors being claimed. The steps of the claims also do not improve the accuracy of the position/orientation of the moving object.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1 – 11, 13, 14, 16 – 18, and 20 – 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bova et al (US 2006/0212044 A1) (previously cited) and in view of UHDE (US 2023/0225794 A1) (filed August 12th 2020).
Regarding claim 1, Bova discloses a method for determining a patient-specific marker arrangement for a tracker (markers 510) of a surgical tracking system (article 500) (abstract, paragraphs [0032 – 0046], [0077 – 0079], and Figs. 1 – 9), wherein the marker arrangement is defined by marker positions (paragraph [0072] and [0078]), the method comprising:
receiving three-dimensional image data of a patient (paragraphs [0034], [0038], and [0089]);
obtaining, based on the three-dimensional image data, planning data for a surgical intervention (paragraph [0073 – 0074], [0093]),; and
determining the marker arrangement for the tracker based at least on the obtained planning data (paragraph [0079] and [0089 – 0094]).
However, Bova is silent regarding (i) wherein the planning data are indicative of a planned position of a signal generator or signal detector of the surgical tracking system relative to a patient anatomy represented in the three-dimensional image data, wherein the signal generator or signal detector are provided for generating or detecting, respectively, an optical signal.
As to the above, UHDE teaches, in a similar field of endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, namely a computer-implemented method for planning of associated tracking devices for referencing a position in a medical environment (abstract and claim 1), comprising the step of receiving three-dimensional image data (image data) of a patient (paragraph [0010] and claim 1), obtaining, based on the three-dimensional image data, planning data (planning image data) for a surgical intervention (placement of a surgical instrument) (paragraph [0011]), wherein the planning data are indicative a planned position (reference position data) of a signal generator or signal detector (camera) of a tracking system (tracking reference device and camera) and providing the signal generator or signal detector provided for generating or detecting an optical signal (camara), respectively, (paragraphs [0014 – 0015]) (Examiner’s note: as stated in paragraph [0015] the reference position data is determined such that the tracking reference device is visible for a tracking device such as a video camera or infrared-sensitive camera or magnetic tracking sensor when the tracking reference device attains the reference position).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method and system of Bova to incorporate the signal generator for detecting an optical signal for planning the data / the planned position of the signal generator relative to the patient’s anatomy for the purpose of being able to determine the optimal position of the surgical instrument and the markers outside of the avoidance zones and for being able to maintain the line of sight between the reference device and the associated tracking device (paragraphs [0003] and [0014 – 0017] – UHDE).
Regarding claims 2 and 3, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses further comprising generating manufacturing instructions (generated during 3D scan) for manufacturing the marker arrangement as determined based at least on the obtained planning data (paragraphs [0065], [0070 – 0073], and [0093]) wherein the manufacturing instructions comprise at least one of printing instructions and instructions for additive manufacturing (paragraphs [0065] and [0093 – 0094]).
Regarding claims 4 and 5, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses further comprising determining a surface of the patient based on the three-dimensional image data (paragraphs [0075 – 0078]), and teaches wherein the marker arrangement is determined also based on the determined surface of the patient and comprises virtually arranging one or more markers on the determined surface of the patient (paragraphs [0031], [0072], [0073], and [0078]) (Examiner’s note: the custom article is determined based on the surface of the patient and is virtually designed – paragraph [0034]; and paragraphs [0072] and [0078] recite wherein the markers are designed with the custom article. Therefore, Bova encompasses or, in the alternative at least, makes obvious determining the arrangement of the markers virtually and based on the surface of the patient so that the markers can be fully incorporated into the design from the beginning of the design process).
Regarding claims 6 and 7, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses wherein the planning data are indicative of an anatomical region of interest of the patient (paragraphs [0063 – 0065]) and wherein determining the marker arrangement comprises virtually arranging one or more markers relative to the anatomical region of interest (paragraph [0078]) (Examiner’s note: the custom article is determined based on the surface of the patient and is virtually designed – paragraph [0034]; and paragraphs [0072] and [0078] recite wherein the markers are designed with the custom article. Therefore, Bova encompasses or, in the alternative at least, makes obvious determining the arrangement of the markers virtually relative to the anatomical region of the patient so that the markers can be fully incorporated into the design from the beginning of the design process).
Regarding claims 8 and 9, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses wherein the planning data are indicative of a planned trajectory of a surgical instrument (paragraphs [0048 – 0050]) and teaches wherein determining the marker arrangement comprises virtually arranging one or more markers relative to the planned trajectory (paragraph [0078]) (Examiner’s note: the custom article is determined based on the surface of the patient and is virtually designed – paragraph [0034]; and paragraphs [0072] and [0078] recite wherein the markers are designed with the custom article. Therefore, Bova encompasses or, in the alternative at least, makes obvious determining the arrangement of the markers virtually so that the markers can be fully incorporated into the design from the beginning of the design process, and it would be obvious for the markers to be positioned relative to the ‘planned trajectory of the surgical instrument’ for the purpose of being able to direct and guide the operator during the operation).
Regarding claims 10 and 11, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses wherein the planning data are indicative of a planned incision (paragraph [0052]) and teaches the step of determining the marker arrangement comprises virtually arranging one or more markers relative to the planned incision (paragraphs [0074 – 0078]) (Examiner’s note: the custom article is determined based on the surface of the patient and is virtually designed – paragraph [0034]; and paragraphs [0072] and [0078] recite wherein the markers are designed with the custom article. Therefore, Bova encompasses or, in the alternative at least, makes obvious determining the arrangement of the markers virtually so that the markers can be fully incorporated into the design from the beginning of the design process, and it would be obvious for the markers to be positioned relative to the ‘planned incision of the surgical instrument’ for the purpose of being able to direct and guide the operator during the operation to the proper incision site).
Regarding claim 14, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses wherein the tracker comprises a substrate (custom article) supporting the marker arrangement (paragraph [0078]), the method further comprising determining a shape of the substrate based on the planning data (paragraphs [0033], [0072 – 0078] and [0089 – 0093]).
Regarding claims 13, 21, and 22, as discussed above, the current combination of Bova and UHDE teaches the method and system of claim 1.
However, the combination is silent regarding [claims 13 and 21] (i) further comprising determining a region of the three-dimensional image data that has a line-of-sight to the signal generator or signal detector based on the planning data, wherein the marker arrangement is determined based on the determined region of the three-dimensional image data and [claim 22] (ii) wherein determining the marker arrangement for the tracker based at least on the obtained planning data further comprises determining the marker arrangement such that each marker is determined to be located in a non-shaded region of the three dimensional data.
As to the above, UHDE further teaches determining a region of the three-dimensional image data that has a line-of-sight (region that is not the avoidance region) to the signal generator or signal detector based on the planning data (paragraphs [0014 – 0017]), wherein the planning data defines a field of view (none avoidance region) of the signal detector (paragraph [0015]), wherein the marker arrangement is determined based on the determined region of the three-dimensional image data such that each marker is determined to be located in a non-shaded region (non-avoidance region – shaded region – paragraph [0014]) of the three dimensional data for the purpose of making sure the tracking system is not positioned in the avoidance region (paragraphs [0014 – 0017]) (Examiner’s note: as stated in paragraphs [0014 – 0015] the trackers are positioned to be not in the avoidance region, therefore, the position is determined based on the determined region (i.e., the avoidance region) of the three-dimensional image data).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method of Bova in view of Lavallee, to incorporate determining a region of the three-dimensional image that has a line of sight to the signal detector (camera) based on the planning data such that the marker arrangement is determined based on the planned data wherein the markers are placed in a non-shaded region (i.e., a non-avoidance region), based on the teachings of UHDE, for the purpose of planning the positioning of the reference devices (i.e., markers) so that they are in full view of the signal detector / camera in order to maintain the line of sight between the reference device (i.e., the markers) and the tracking device (i.e., the signal detector / camera) (paragraphs [0002 – 0003] and [0013 – 0017] – UHDE).
Regarding claim 16, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova discloses wherein the step of determining the marker arrangement takes into account a criterion (relative position) related to a minimum distance between markers (paragraph [0078]) (Examiner’s note: the relative position between the markers is known, and the relative position relates to the minimum distance between the markers).
Regarding claim 17, Bova discloses a computer program product (computer code) stored on non-transitory computer-readable medium (Linux computer – paragraph [0069]) and comprising instructions that, when executed on at least one processor (processor of computer), cause the at least one processor to carry out the step (paragraphs [0059], [0065], [0069 – 0070], [0089 – 0093]), the steps include of:
receiving three-dimensional image data of a patient (paragraphs [0034], [0038], and [0089]);
obtaining, based on the three-dimensional image data, planning data for a surgical intervention (paragraph [0073 – 0074], [0093]); and
determining the marker arrangement for the tracker based at least on the obtained planning data (paragraph [0079] and [0089 – 0094]).
However, Bova is silent regarding (i) wherein the planning data are indicative of a planned position of a signal generator or signal detector of the surgical tracking system relative to a patient anatomy represented in the three-dimensional image data, wherein the signal generator or signal detector are provided for generating or detecting, respectively, an optical signal.
As to the above, UHDE teaches, in a similar field of endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, namely a computer-implemented method for planning of associated tracking devices for referencing a position in a medical environment (abstract and claim 1), comprising the step of receiving three-dimensional image data (image data) of a patient (paragraph [0010] and claim 1), obtaining, based on the three-dimensional image data, planning data (planning image data) for a surgical intervention (placement of a surgical instrument) (paragraph [0011]), wherein the planning data are indicative a planned position (reference position data) of a signal generator or signal detector (camera) of a tracking system (tracking reference device and camera) and providing the signal generator or signal detector provided for generating or detecting an optical signal (camara), respectively, (paragraphs [0014 – 0015]) (Examiner’s note: as stated in paragraph [0015] the reference position data is determined such that the tracking reference device is visible for a tracking device such as a video camera or infrared-sensitive camera or magnetic tracking sensor when the tracking reference device attains the reference position).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method and system of Bova to incorporate the signal generator for detecting an optical signal for planning the data / the planned position of the signal generator relative to the patient’s anatomy for the purpose of being able to determine the optimal position of the surgical instrument and the markers outside of the avoidance zones and for being able to maintain the line of sight between the reference device and the associated tracking device (paragraphs [0003] and [0014 – 0017] – UHDE).
Regarding claim 18, Bova discloses an apparatus (computer system) for determining a patient-specific marker arrangement for a tracker (markers 510) of a surgical tracking system (article 500) (abstract, paragraphs [0032 – 0046], [0077 – 0079], and Figs. 1 – 9), wherein the marker arrangement is defined by marker positions (paragraph [0072] and [0078]), the method comprising:
receiving three-dimensional image data of a patient (paragraphs [0034], [0038], and [0089]);
obtaining, based on the three-dimensional image data, planning data for a surgical intervention (paragraph [0073 – 0074], [0093]); and
determining the marker arrangement for the tracker based at least on the obtained planning data (paragraph [0079] and [0089 – 0094]).
However, Bova is silent regarding (i) wherein the planning data are indicative of a planned position of a signal generator or signal detector of the surgical tracking system relative to a patient anatomy represented in the three-dimensional image data, wherein the signal generator or signal detector are provided for generating or detecting, respectively, an optical signal.
As to the above, UHDE teaches, in a similar field of endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, namely a computer-implemented method for planning of associated tracking devices for referencing a position in a medical environment (abstract and claim 1), comprising the step of receiving three-dimensional image data (image data) of a patient (paragraph [0010] and claim 1), obtaining, based on the three-dimensional image data, planning data (planning image data) for a surgical intervention (placement of a surgical instrument) (paragraph [0011]), wherein the planning data are indicative a planned position (reference position data) of a signal generator or signal detector (camera) of a tracking system (tracking reference device and camera) and providing the signal generator or signal detector provided for generating or detecting an optical signal (camara), respectively, (paragraphs [0014 – 0015]) (Examiner’s note: as stated in paragraph [0015] the reference position data is determined such that the tracking reference device is visible for a tracking device such as a video camera or infrared-sensitive camera or magnetic tracking sensor when the tracking reference device attains the reference position).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the method and system of Bova to incorporate the signal generator for detecting an optical signal for planning the data / the planned position of the signal generator relative to the patient’s anatomy for the purpose of being able to determine the optimal position of the surgical instrument and the markers outside of the avoidance zones and for being able to maintain the line of sight between the reference device and the associated tracking device (paragraphs [0003] and [0014 – 0017] – UHDE).
Regarding claim 20, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Additionally, Bova encompasses or, at least, in the alternative, makes obvious further comprising a manufacturing device (3D printer) configured to manufacture the tracker with the determined marker arrangement (Examiner’s note: Bova discloses that the custom articles are produced via 3-D printing, and in order to 3-D print the custom article, there has to be or, at least, it would be obvious for the system to include a 3-D printer (i.e., a manufacturing device) in order to manufacture the needed custom article. Furthermore, it should be understood that the preceding limitation is an intended use limitation which requires only that the structure of the prior art be capable of functioning as claimed; with that said, a 3D printer is capable of custom printing markers in custom locations based on the STL file, therefore, Bova discloses wherein the manufacturing device is configured as claimed. Alternatively, as stated in paragraphs [0072] and [0078] the custom articles are designed with the markers, and it would be obvious for the manufacturing device to manufacture the trackers with the determined marker arrangement for the purpose of reducing the number of manufacturing steps needed to create the finished product).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bova et al (US 2006/0212044 A1) (previously cited) in view of UHDE (US 2023/0225794 A1) (filed August 12th 2020), as applied to claim 1 above, and further in view of Herrmann et al (US 2021/0322104 A1).
Regarding claim 15, as discussed above, the combination of Bova and UHDE teaches the method and system of claim 1. Bova further discloses wherein the three-dimensional image data have been captured by an imaging apparatus (paragraphs [0032 – 0033] – Bova).
However, the combination is silent regarding (i) the method further comprising receiving positional data indicative of a position of the imaging apparatus when capturing the three-dimensional image data, wherein the marker arrangement is determined based on the positional data.
As to the above, Herrmann teaches, in a similar field of endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, namely a method and device determining the respective position of one or more tracking devices in a 3D reconstruction (abstract) and further comprises wherein the three-dimensional image data (i.e., the 3D reconstruction) is used to plan the position of the markers (paragraphs [0084 – 0092]) and wherein the 3D images are captured by an imaging apparatus (camera) and receiving the positional data is indicative of a position of the imaging apparatus when capturing the three-dimensional image data, wherein the marker arrangement is determined based on the positional data (paragraphs [0029], [0063], and [0097]).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system of Bova in view of UHDE to incorporate receiving positional data of the image capturing device and determining the marker arrangement based on the positional data, based on the teachings of Herrmann, for the purpose of being able register the markers navigation / tracking system with the markers in the virtual 3-D space (paragraph [0097] – Herrmann).
Response to Arguments
Applicant’s arguments, filed 03/25/2026, with respect to the rejection of claims 1, 17, and 18 under Bova and Lavallee have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments.
Related Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Yang et al (US 11,547,497 B2), Moctezuma de la Barrera et al (US 2016/0242858 A1), and Mozes (US 2020/0054421 A1) teach planning / determining the position of markers via 3D imaging.
Conclusion
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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