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 .
Applicant filed a response dated 12/30/2025 in which claims 1, 10-11 have been amended. Thus, the claims 1-15 are pending in the application.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of providing an item of intervention information in an image recording region without significantly more.
Examiner has identified claim 13 as the claim that represents the claimed invention presented in independent claims 1, 13, and 15.
Claim 13 is directed to a device, which is one of the statutory categories of invention (Step 1: YES).
The claim 13 describes a device comprises: a sensor an output unit; and a computing unit, wherein the imaging device is designed to capture anatomical image data relating to an examination object, wherein the sensor is designed to capture an item of depth information relating to the examination object in an image recording region of the imaging device, wherein the computing unit is designed to provide an item of intervention information as a function of the item of depth information, and wherein the output unit is designed to output the item of intervention information into the image recording region which corresponds to a certain method of organizing human activity. Furthermore, if a claim limitation, under its broadest reasonable interpretation, covers interactions between people, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. The additional elements of a sensor an output unit, a computing unit, and the imaging device do not necessarily restrict the claim from reciting an abstract idea. Thus, the claim 13 recites an abstract idea (Step 2A-Prong 1: YES).
This judicial exception is not integrated into a practical application because the additional elements of an output unit and a computing unit result in no more than simply applying the abstract idea using generic computer elements. The additional elements of an output unit and a computing unit are recited at a high level of generality, and under their broadest reasonable interpretation comprises a generic computing device. The presence of a generic computing device does nothing more than to implement the claimed invention (MPRP 2106.05(f)). The additional elements of an output unit and a computing unit are no more than mere instructions to apply the exception using a generic computer element. The additional elements of a sensor and the imaging device are recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step). Therefore, the recitation of additional elements does not meaningfully apply the abstract idea and hence does not integrate the abstract idea into a practical application. Thus, the claim 13 is directed to an abstract idea (Step 2A-Prong 2: NO).
The claim does not include additional elements that is sufficient to amount to significantly more than the judicial exception because the additional elements of an output unit and a computing unit are recited at a high level of generality in that it result in no more than simply applying the abstract idea using generic computer elements. The additional elements of a sensor and the imaging device are recited at a high level of generality in that it amount to an insignificant extra-solution activity (i.e., data gathering step). The additional elements when considered separately and as an ordered combination do not amount to add significantly more as the additional elements of an output unit and a computing unit provide nothing more than to simply apply the exception in a generic computer environment (Step 2B: NO). Thus, the claim 13 is not patent eligible.
Similar arguments can be extended to other independent claims 1 (Examiner interprets the amended limitation “wherein the image recording region is characterized by a volume or a region from which image data can be recorded to be abstract in nature) and 15, and thus the claims 1 and 15 are rejected on similar grounds as claim 13.
Dependent claims 2-12, and 14 further define the abstract idea that is present in their respective independent claims 1 and 13 and thus correspond to Certain Methods of Organizing Human Activity and hence are abstract in nature for the reasons presented above. Dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 2-12 and 14 are directed to an abstract idea. Thus, the claims 1-15 are not patent-eligible.
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.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gassner et al., US Patent Application No. 2015/0371390 in view of Boettger et al., US Patent Application No. 2017/0186157.
Regarding claim 1, Gassner discloses a computer-implemented method for providing an item of intervention information in an image recording region of an imaging device, the computer-implemented method comprising:
positioning an examination object in an examination position in the image recording region (abstract);
capturing an item of depth information relating to the examination object;
capturing the item of intervention information ([0002]);
providing the item of intervention information as a function of the item of depth information ([0002]-[0003], [0008]) and
outputting the item of intervention information into the image recording region ([0002]-[0003], [0021], [0023]-[0024]),
wherein the image recording region is characterized by a volume or a region from which image data can be recorded using the imaging device (abstract, [0002]-[0003], [0021], [0023]-[0024]).
Gassner does not specifically disclose
capturing an item of depth information relating to the examination object.
However, Boettger discloses
capturing an item of depth information relating to the examination object (abstract, [0009], [0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Regarding claim 2, Gassner discloses wherein the output of the item of intervention information into the image recording region takes place on the examination object and/or a wall of the imaging device ([0002]-[0003]).
Regarding claim 3, Gassner discloses wherein the provision of the item of intervention information includes adapting the item of intervention information to the examination position of the examination object ([0002]-[0003]).
Regarding claim 4, Gassner discloses capturing anatomical image data relating to the examination object using the imaging device, wherein the provision of the item of intervention information takes place as a function of the item of depth information and the anatomical image data relating to the examination object (abstract, [0002]-[0003], [0008], [0010], [0021], conducting a navigated medical procedure).
However, Boettger discloses
depth information (abstract, [0009], [0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Regarding claim 5, Gassner discloses registering the anatomical image data relating to the examination object with the item of depth information and providing combined image data based on the registered anatomical image data and the item of depth information, wherein the provision of the item of intervention information takes place as a function of the combined image data ([0002]-[0003], [0021]).
However, Boettger discloses
depth information (abstract, [0009], [0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Regarding claim 6, Gassner discloses creating a model of the examination object as a function of the item of depth information relating to the examination object, wherein the provision of the item of intervention information includes registering the model with the item of depth information, the anatomical image data and/or combined image data, and wherein the combined image data is based on a registration of the anatomical image data relating to the examination object with the item of depth information ([0002]-[0003], [0021], [0034]).
However, Boettger discloses
depth information (abstract, [0009], [0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Regarding claim 7, Gassner discloses capturing a movement of the examination object, wherein the provision of the item of intervention information takes place as a function of the movement ([0021]).
Regarding claim 8, Gassner discloses wherein the capture of the item of intervention information includes capturing an item of instrument information, wherein the provision of the item of intervention information takes place as a function of the item of instrument information and wherein the output of the item of intervention information includes outputting the item of instrument information onto the examination object in the image recording region ([0002]-[0003]), [0016], [0023]).
Regarding claim 9, Gassner discloses wherein the capture of the item of instrument information includes capturing an intervention plan, wherein the provision of the item of intervention information includes registering the intervention plan with a model that is created as a function of the item of depth information relating to the examination object and/or with anatomical image data relating to the examination object, which is captured using the imaging device, and wherein the output of the item of intervention information includes outputting the intervention plan ([0021]).
However, Boettger discloses
depth information (abstract, [0009], [0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Regarding claim 10, Gassner discloses wherein the capture of the item of instrument information includes capturing a position and/or orientation of a medical instrument in the examination object as a function of the anatomical image data relating to the examination object, wherein the provision of the item of intervention information includes providing a representation of the medical instrument, and wherein the output of the item of intervention information includes outputting the representation of the medical instrument onto the examination object ([0002]-[0003], [0023]).
Regarding claim 11, Gassner discloses wherein the intervention plan comprises a navigation plan for the medical instrument in the examination object, wherein the capture of the item of instrument information includes determining a degree of correspondence between the navigation plan for the medical instrument and the position and/or orientation of the medical instrument, and wherein the output of the item of intervention information includes outputting an item of information relating to the degree of correspondence between the navigation plan for the medical instrument and the position and/or orientation of the medical instrument in the examination object ([0021], [0023]).
Regarding claim 12, Gassner discloses wherein the item of intervention information is an element selected from a group of elements consisting of: an intervention plan, a navigation plan for a medical instrument in the examination object, an item of instrument information, a representation of a medical instrument, a representation of an incision point, a representation of an anatomical structure, a representation of a destination position, a representation of an ablation volume, a representation of a temperature distribution, a representation of a navigation plan and/or a representation of a degree of correspondence between a navigation plan for a medical instrument and a position and/or orientation of the medical instrument in the examination object (abstract, [0002]-[0003], [0021], [0023]).
Regarding claim 13, Gassner discloses an imaging device that is designed to execute the method as claimed in claim 1 and comprises:
a sensor
an output unit; and
a computing unit ([0005],
wherein the imaging device is designed to capture anatomical image data relating to an examination object (abstract, [0008]),
wherein the sensor is designed to capture an item of depth information relating to the examination object in an image recording region of the imaging device ([0002]-[0003], [0021], [0023]-[0024]),
wherein the computing unit is designed to provide an item of intervention information as a function of the item of depth information ([0002]-[0003], [0008]), and
wherein the output unit is designed to output the item of intervention information into the image recording region ([0002]-[0003], [0021], [0023]-[0024]).
Gassner does not specifically disclose
a sensor
an output unit; and
wherein the sensor is designed to capture an item of depth information relating to the examination object in an image recording region of the imaging device.
However, Boettger discloses
a sensor ([0069])
an output unit ([0012], [0041]); and
wherein the sensor is designed to capture an item of depth information relating to the examination object ([0069]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine above-noted disclosure of Gassner with the above-noted disclosure of Boettger in order to navigate the surgical procedure.
Claims 14-15 are substantially similar to claims 7 and 1 and hence rejected on similar grounds.
Response to Arguments
Applicant's arguments filed dated 12/30/2025 have been fully considered but they are not persuasive due to the following reasons:
With respect to the rejection of claims 1-15 under 35 U.S.C. 101, Applicant states that the claims do not recite interactions between people. Rather, the claims recite technical operations involving intervention information as a function of the depth information, and outputting the intervention information into an image recording region. These are technical operations tied to specific imaging technology, not human interactions.
Examiner respectfully disagrees and notes that under Step 2A, Prong 1, the claim is initially considered in the absence of additional elements to determine if the claim recites an abstract idea. The additional elements are then considered to determine if they restrict the claim from reciting an abstract idea. The additional elements are considered in more specific detail under Step 2A, Prong 2 to determine if the additional elements integrate the abstract idea into a practical application or amount of add significantly more. In this case, when the claim is considered in the absence of additional elements, it recites an abstract idea of providing an item of intervention information in an image recording region which is displaying information. Displaying information is an abstract concept and the additional elements do not restrict the claim from reciting an abstract idea. The additional elements are further considered in more specific detail under Step 2A, Prong 2. Thus, the claim recites an abstract idea.
Applicant also states that under Step 2A, Prong 2, this is not merely displaying information on a generic monitor; it involves outputting guidance information directly into the physical space where the examination object is located during imaging. The claims provide a specific technical improvement over prior approaches. These additional elements are not generic computer components but specialized medical imaging hardware.
Examiner respectfully disagrees and notes that outputting guidance information is nothing more than displaying information which is also an abstract concept. The additional elements do not provide any technical solution to a technical problem in order for the additional elements to integrate the abstract idea into a practical application. If there is an improvement, it is to the abstract idea and not to technology and thus the claims are directed to an abstract idea.
Applicant’s arguments with respect to claims 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Moreover, Examiner notes that the office action does not rely on [0006], [0025], [0029], [0035]-[0037] of Gassner as argued by Applicant and thus these arguments are moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684
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