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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 10/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“tissue type identification unit” in claim 6. This limitation of “tissue type identification unit” has been interpreted under 35 U.S.C. 112(f) to correspond to the structure disclosed on page 17, lines 16-23 of the submitted specification including a property measurement unit that includes a camera, radiation detector, spectrometer, or photometer.
“Control device” in claims 6-7 and 18-20. The limitation of a control device has been interpreted under 35 U.S.C. 112(f) to correspond to the structure of pages 5-8 and 36-37 of the applicant’s specification of a processor for implementing computer implemented steps. (Note “control unit” 112(b) rejection below regarding claim 20).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12,458,445 hereinafter Storch ‘445. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant invention would be an obvious modification of the reference patent.
Regarding claim 1, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
A computer-implemented method executed on at least one processor of at least one computer for sampling relevant surface points of a subject for a medical navigation system (Storch ‘445, claim 1), the method comprising the steps:
determining, by the at least one processor, a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject (Storch ‘445, claim 1);
determining, by the at least one processor, a position of at least one surface point of the subject using a registration device (Storch ‘445, claim 1);
identifying, by the at least one processor, a tissue type of the subject at the determined at least one surface point (Storch ‘445, claim 1); and
automatically validating, by the at least one processor, the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one relevant surface point and/or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded (Storch ‘445, claim 1).
Regarding claim 2, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the identifying the tissue type of the subject comprises: determining, by the at least one processor, property measurements of the subject (Storch ‘445, claim 2); and
comparing, by the at least one processor, a determined property measurement of the subject with predetermined property values linked to different tissue types (Storch ‘445, claim 2).
Regarding claim 3, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the determined property measurements comprise at least one of attenuation of radiation, colour, spectral absorption, Raman spectroscopy, and fluorescence (Storch ‘445, claim 3).
Regarding claim 4, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein determining the position of the at least one surface point of the subject and identifying the tissue type of the subject at the determined at least one surface point is executed simultaneously for each surface point (Storch ‘445, claim 4).
Regarding claim 5, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
comprising the step:
switching between determining the position of the at least one surface point using a contact-based tracking device and determining the position of the at least one surface point using a contact-free tracking device dependent on a determined distance between the registration device and the at least one surface point of the subject (Storch ‘445, claim 1).
Regarding claim 6, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
A registration device for registering a subject for a medical navigation system (Storch ‘445, claim 8), the registration device comprising:
a control device (Storch ‘445, claim 8); and
a tissue type identification unit, the tissue type identification unit in operative communication with the control device (Storch ‘445, claim 8) and configured for:
identifying a tissue type of the subject at at least one surface point (Storch ‘445, claim 8); and
providing the identified tissue type to the control device (Storch ‘445, claim 8); and
wherein the control device is configured for
determining a position of the at least one surface point of the subject (Storch ‘445, claim 8),
determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject (Storch ‘445, claim 8), and
automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one relevant surface point and/or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded (Storch ‘445, claim 8).
Regarding claim 7, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
comprising:
a tracking device, configured for determining a spatial position and/or an orientation of the registration device relative to the subject (Storch ‘445, claim 9); and
providing the determined spatial position and/or the determined orientation to the control device (Storch ‘445, claim 9); and
a proximity sensor in operative communication with the control device, the proximity sensor being configured for determining a distance between the registration device and at least one surface point of the subject (Storch ‘445, claim 9); and
providing the determined distance to the control device (Storch ‘445, claim 9),
wherein the control device is configured for determining the position of at least one surface point of the subject dependent on at least one of the determined spatial position determined orientation, and determined distance (Storch ‘445, claim 9).
Regarding claim 8, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the tracking device comprises a contact-free tracking device, configured for determining the position of the at least one surface point of the subject (Storch ‘445, claim 10).
Regarding claim 9, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the contact-free tracking device comprises an optical tracking device, configured for being used for determining the position of the at least one surface point of the subject (Storch ‘445, claim 11).
Regarding claim 10, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the optical tracking device comprises: at least one optical marker, configured for being used for determining at least one of the spatial position and an orientation of the registration device relative to the subject with at least 5 degree of freedom (Storch ‘445, claim 12).
Regarding claim 11, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the tracking device comprises an electromagnetic tracking device, configured for being used for determining the position of the at least one surface point of the subject (Storch ‘445, claim 13).
Regarding claim 12, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the electromagnetic tracking device comprises: at least one electromagnetic sensor, configured for being used for determining at least one of the spatial position and an orientation of the registration device relative to the subject with at least 5 degree of freedom (Storch ‘445, claim 14).
Regarding claim 13, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the tracking device comprises a magnetic tracking device, configured for being used for determining the position of the at least one surface point of the subject (Storch ‘445, claim 15).
Regarding claim 14, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the magnet tracking device comprises at least one magnetic sensor, configured for being used for determining at least one of the spatial position and an orientation of the registration device relative to the subject with at least 5 degree of freedom (Storch ‘445, claim 16).
Regarding claim 15, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the tracking device comprises a video-based tracking device, configured for being used for determining the position of the at least one surface point of the subject (Storch ‘445, claim 17).
Regarding claim 16, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the video-based tracking device comprises: at least one video marker, configured for being used for determining at least one of the spatial position and an orientation of the registration device relative to the subject with at least 5 degree of freedom (Storch ‘445, claim 18).
Regarding claim 17, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the tracking device comprises a contact-based tracking device, configured for determining the position of the at least one surface point of the subject (Storch ‘445, claim 19).
Regarding claim 18, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the control device is configured for automatically verifying the surface matching registration comparing a real position of the registration device in view of the subject with a virtual position of a virtual representation of the registration device in view of an image dataset of the subject (Storch ‘445, claim 20).
Regarding claim 19, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the control device is configured for executing a surface matching registration, registering the subject to the medical navigation system, dependent on the accepted relevant surface points (Storch ‘445, claim 21).
Regarding claim 20, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
wherein the control unit is configured for switching between determining the position of the at least one surface point using the contact-based tracking device and determining the position of the at least one surface point using the contact-free tracking device dependent on a determined distance between the registration device and the at least one surface point of the subject (Storch ‘445, claim 8).
Regarding claim 21, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
A surgical navigation system for computer assisted surgery, the system comprising the registration device according to claim 6 (Storch ‘445, claim 22).
Regarding claim 22, reference patent Storch ‘445 (U.S. Pat. No. 12,458,445) teaches:
A program logic stored in a memory device of a computer that when running on the computer or when loaded onto the computer, causes the computer to perform a method of sampling relevant surface points of a subject for a medical navigation system (Storch ‘445, claim 23), the method comprising:
determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject (Storch ‘445, claim 23);
determining a position of at least one surface point of the subject using a registration device (Storch ‘445, claim 23);
identifying a tissue type of the subject at the determined at least one surface point (Storch ‘445, claim 23); and
automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one relevant surface point and/or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded (Storch ‘445, claim 23).
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 1-4, 6-19, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to “mental processes” or “concepts relating to data comparisons that can be performed mentally or are analogous to human mental work” without significantly more.
Regarding independent claim 1, the claim recites:
The limitation of “determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about an intended procedure for a particular tissue type and applying a surface registration type to those parameters. The limitation of “determining a position of at least one surface point of the subject using a registration device” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a position of at least one surface point. The use of a “registration device” for surface point determination forms extra solution activity of mere data gathering. The limitation of “identifying a tissue type of the subject at the determined at least one surface point” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a tissue type of the subject at the surface point that is determined. The limitation of “automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one of at least one relevant surface point or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about validating of the surface point based on a tissue type, surface registration type, and intended procedure. Human mental work further applies to the determination of a position of the relevant surface point or non-relevant surface point, and accepting or discarding each of the points. These operations could all be performed mentally. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 1): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because there are no additional limitations beyond the recited judicial exceptions. The use of a “registration device” for determining a position of a surface point forms an extra-solution activity of mere data gathering step. The additional recitation of “at least one processor” forms a generic computing device configured to execute the judicial exception on a general-purpose computer. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition.
Step 2B Analysis (Claim 1): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no additional limitations are recited outside of the judicial exception. The use of a “registration device” for determining a position of a surface point forms an extra-solution activity of mere data gathering step. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. The additional recitation of “at least one processor” forms a generic computing device configured to execute the judicial exception on a general-purpose computer. Furthermore, there are no claimed features that provide elements to identify improvements to these general computing technologies based on the claimed features. As discussed above, any limitations form insignificantly extra-solution activity, and link the judicial exception to generic computing elements within the art of medical diagnostics.
Dependent claim 2, includes limitations that are directed to determining property measurements of the subject which forms extra-solution activity of mere data gathering and limitation directed to comparing the property measurements to predetermined values which forms an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think about the comparison between the values. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 3, includes limitations that are directed to limiting the types of determined property measurements of the subject which forms narrowing of the extra-solution activity of mere data gathering of claim 2. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 4, includes limitations that are directed to determining of a position of a surface point and tissue type of the subject simultaneously which merely limits and limits and narrows how the mental processing abstract idea of independent claim 1 is performed and applied. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Regarding independent claim 6, the claim recites:
The limitation of “a tissue type identification unit, the tissue type identification unit in operative communication with the control device and configured for identifying a tissue type of the subject at at least one surface point and providing the identified tissue type to the control device” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a particular tissue type at a surface point. The limitation of “determining a position of the at least one surface point of the subject” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a position of at least one surface point. The limitation of “determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about an intended procedure for a particular tissue type and applying a surface registration type to those parameters. The limitation of “automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one of at least one relevant surface point or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about validating of the surface point based on a tissue type, surface registration type, and intended procedure. Human mental work further applies to the determination of a position of the relevant surface point or non-relevant surface point, and accepting or discarding each of the points. These operations could all be performed mentally. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 6): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional limitations recited of “tissue identification unit”, and “control device” form generic computer elements within the field of medical diagnostics which is a general-purpose computer therefore forms merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea. Furthermore, the determining a position of a surface point forms an extra-solution activity of mere data gathering step. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition.
Step 2B Analysis (Claim 6): The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations recited of “tissue identification unit”, and “control device” form generic computer elements within the field of medical diagnostics which is a general-purpose computer therefore forms merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea.. Furthermore, the determining a position of a surface point forms an extra-solution activity of mere data gathering step. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to these general computing technologies based on the claimed features. As discussed above, any limitations form insignificantly extra-solution activity, and link the judicial exception to generic computing elements within the art of medical diagnostics.
Dependent claim 7, includes limitations that are directed to determining a spatial orientation of a registration device, a proximity between the registration device and a surface point which form extra-solution activity of mere data gathering using generic sensor systems. The limitation of determining the position based upon the position, orientation or distance forms an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think about the comparison between and based upon the values. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 8, includes limitations that are directed to limiting the tracking device to a contact-free device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 9, includes limitations that are directed to limiting the tracking device to an optical device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 10, includes limitations that are directed to limiting the tracking device to an optical marker which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 11, includes limitations that are directed to limiting the tracking device to an electromagnetic device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 12, includes limitations that are directed to limiting the tracking device to include an electromagnetic sensor which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 13, includes limitations that are directed to limiting the tracking device to a magnetic device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 14, includes limitations that are directed to limiting the tracking device to include a magnetic sensor which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 15, includes limitations that are directed to limiting the tracking device to a video device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 16, includes limitations that are directed to limiting the tracking device to include a video marker which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 17, includes limitations that are directed to limiting the tracking device to a contact-based tracking device which merely limits the extra-solution activity of mere data gathering using generic sensor systems. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 18, includes limitations that are directed to comparing of a real position with virtual position which merely limits and limits and narrows how the mental processing abstract idea of independent claim 6 is performed and applied. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Dependent claim 19, includes limitations that are directed to registering a subject based upon the surface point which merely limits and limits and narrows how the mental processing abstract idea of independent claim 6 is performed and applied. Therefore, it does not integrate the judicial exception of the independent claim into a practical application or amount to significantly more.
Claim 21 includes limitations that are directed to claim 6 and therefore the rejection with respect to claim 6 similarly applied to claim 21.
Regarding independent claim 22, the claim recites:
The limitation of “determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about an intended procedure for a particular tissue type and applying a surface registration type to those parameters. The limitation of “determining a position of at least one surface point of the subject using a registration device” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a position of at least one surface point. The use of a “registration device” for surface point determination forms extra solution activity of mere data gathering. The limitation of “identifying a tissue type of the subject at the determined at least one surface point” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about a tissue type of the subject at the surface point that is determined. The limitation of “validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one of at least one relevant surface point or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded” is considered to be an abstract idea of a mental process and concept relating to data comparisons that can be performed mentally or are analogous to human mental work as a user may merely think and receive within the mind about validating of the surface point based on a tissue type, surface registration type, and intended procedure. Human mental work further applies to the determination of a position of the relevant surface point or non-relevant surface point, and accepting or discarding each of the points. These operations could all be performed mentally. Therefore, the claim is directed to an abstract idea and a judicial exception.
Step 2A Prong 2 Analysis (Claim 22): This judicial exception is not integrated into a practical application because it does not recite any elements that integrate the abstract idea into a practical application such as improving the operation of the diagnostic device, or effecting a particular treatment or prophylaxis for a disease or medical condition. The claims do not recite any features of components that integrates the judicial exception into a practical application because the additional limitations recited of “A program logic stored in a memory device of a computer that when running on the computer” form generic computer elements within the field of medical diagnostics which is a general-purpose computer therefore forms merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea. The use of a “registration device” for determining a position of a surface point forms an extra-solution activity of mere data gathering step. Therefore, all of these claimed elements are not sufficient to improve the functioning of a diagnostic device or form of technology. Furthermore, while directed to activity for medical diagnostics, the claimed steps do not effect a particular treatment or prophylaxis for a disease or medical condition.
Step 2B Analysis (Claim 22): The claims do not recite any features of components that amount to significantly more than the judicial exception because the additional limitations recited of “A program logic stored in a memory device of a computer that when running on the computer” form generic computer elements within the field of medical diagnostics which is a general-purpose computer therefore forms merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea. The use of a “registration device” for determining a position of a surface point forms an extra-solution activity of mere data gathering step. The limitations do not include improvements to the functioning of a computer or to any other technology or technical field, and the elements of the claim further do not effect a particular treatment or prophylaxis for a disease or medical condition. Furthermore, there are no claimed features that provide elements to identify improvements to these general computing technologies based on the claimed features. As discussed above, any limitations form insignificantly extra-solution activity, and link the judicial exception to generic computing elements within the art of medical diagnostics.
Claim 22 is further rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claim 22, the claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to a product that does not have a physical or tangible form. The claimed product is a program that encompasses a broadest reasonable interpretation that includes the ineligible subject matter of transitory signals. The limitation of “a program logic” is considered to encompass transitory signals, which while physical and real, does not possess concrete structure that would qualify as a device or part under the definition of a machine. While the claim includes the structure of “a computer”, claims directed to both eligible and ineligible subject matter are rejected under 35 U.S.C. 101. Thus, the product claim directed to a has no physical or tangible form, and does not fall within any statutory category. Examiner suggests positive recitation of structure of a “non-transitory” form of computer readable storage medium only to overcome the current rejection. See also MPEP 2106.03 (I). For these reasons, the claim is rejected under 35 U.S.C. 101.
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.
Claim 20 is 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.
Claim 20 recites the limitation "the control unit" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-19, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abadpour et al. (WO2017185170) hereinafter Abadpour (see attached WO publication for citations).
Regarding claim 1, Abadpour teaches:
A computer-implemented method executed on at least one processor of at least one computer for sampling relevant surface points of a subject for a medical navigation system (abstract), the method comprising the steps:
determining, by the at least one processor, a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0061], brain procedure for a subject forms an exemplary intended procedure in which a surface registration type will apply directly to the brain anatomical region; [0062]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis occurs for the anatomical region of interest and the particular anatomical tissue type relevant to the procedure; Expected surface profile of the anatomy forms the surface registration type that is utilized in the 3D point cloud process; [0073]-[0078]; [0093]-[0094]; [0111]-[0113], describe intended procedures and associated surface registrations; [0129]; [0131]-[0132]);
determining, by the at least one processor, a position of at least one surface point of the subject using a registration device ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis includes the determination of a position of at least one surface point of the measured point cloud; [0073]-[0078], further elaborate upon the 3D surface scan and point cloud; [0093]-[0094]; [0105]-[0106]; [0111]-[0113]);
identifying, by the at least one processor, a tissue type of the subject at the determined at least one surface point ([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]); and
automatically validating, by the at least one processor, the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one relevant surface point and/or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded ([0071]-[0072], filtering out of background data through comparison forms a discarding of non-relevant surface points; see also [0059]-[0063]; [0066]-[0070]; [0073]-[0078]; [0093]-[0113]; [0129]-[0133]).
Regarding claim 2, Abadpour teaches all of the limitations of claim 1. Adabpour further teaches:
wherein the identifying the tissue type of the subject comprises: determining, by the at least one processor, property measurements of the subject; and comparing, by the at least one processor, a determined property measurement of the subject with predetermined property values linked to different tissue types ([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]).
Regarding claim 3, Abadpour teaches all of the limitations of claim 2. Adabpour further teaches:
wherein the determined property measurements comprise at least one of attenuation of radiation, colour, spectral absorption, Raman spectroscopy, and fluorescence ([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile with optical radiation being a property measurement type; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]).
Regarding claim 4, Abadpour teaches all of the limitations of claim 1. Adabpour further teaches:
wherein determining the position of the at least one surface point of the subject and identifying the tissue type of the subject at the determined at least one surface point is executed simultaneously for each surface point ([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile forms measurement across each surface point of the dataset; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]) .
Regarding claim 6, Abadpour teaches:
A registration device for registering a subject for a medical navigation system (abstract), comprising:
a control device ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis includes the determination of a position of at least one surface point of the measured point cloud; [0073]-[0078], further elaborate upon the 3D surface scan and point cloud; [0093]-[0094]; [0105]-[0106]; [0111]-[0113]; The limitation of a control device has been interpreted under 35 U.S.C. 112(f) to correspond to the structure of pages 5-8 and 36-37 of the applicant’s specification of a processor for implementing computer implemented steps and corresponds to the teachings of Abadpour to computer system modules of [0067]); and
a tissue type identification unit, the tissue type identification unit in operative communication with the control device and configured for identifying a tissue type of the subject at at least one surface point and providing the identified tissue type to the control device([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]; This limitation of “tissue type identification unit” has been interpreted under 35 U.S.C. 112(f) to correspond to the structure disclosed on page 17, lines 16-23 of the submitted specification including a property measurement unit that includes a camera, radiation detector, spectrometer, or photometer and is taught by Abadpour 3D surface scan camera as in [0067]-[0069]); and
wherein the control device is configured for determining a position of the at least one surface point of the subject ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis includes the determination of a position of at least one surface point of the measured point cloud; [0073]-[0078], further elaborate upon the 3D surface scan and point cloud; [0093]-[0094]; [0105]-[0106]; [0111]-[0113]; The limitation of a control device has been interpreted under 35 U.S.C. 112(f) to correspond to the structure of pages 5-8 and 36-37 of the applicant’s specification of a processor for implementing computer implemented steps and corresponds to the teachings of Abadpour to computer system modules of [0067]),
determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0061], brain procedure for a subject forms an exemplary intended procedure in which a surface registration type will apply directly to the brain anatomical region; [0062]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis occurs for the anatomical region of interest and the particular anatomical tissue type relevant to the procedure; Expected surface profile of the anatomy forms the surface registration type that is utilized in the 3D point cloud process; [0073]-[0078]; [0093]-[0094]; [0111]-[0113], describe intended procedures and associated surface registrations; [0129]; [0131]-[0132]), and
automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one of at least one relevant surface point or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded ([0071]-[0072], filtering out of background data through comparison forms a discarding of non-relevant surface points; see also [0059]-[0063]; [0066]-[0070]; [0073]-[0078]; [0093]-[0113]; [0129]-[0133]).
Regarding claim 7, Abadpour teaches all of the limitations of claim 6. Adabpour further teaches:
comprising:
a tracking device, configured for determining at least one of a spatial position and/or an orientation of the registration device relative to the subject and providing the determined spatial position and/or the determined orientation to the control device ([0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject); and
a proximity sensor in operative communication with the control device, the proximity sensor being configured for determining a distance between the registration device and at least one surface point of the subject; and providing the determined distance to the control device ([0067]-[0069], camera for determining the 3D surface scan; [0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject);
wherein the control device is configured for determining the position of at least one surface point of the subject dependent on at least one of the determined spatial position determined orientation, and determined distance ([0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject; see also [0059]-[0100]).
Regarding claim 8, Abadpour teaches all of the limitations of claim 7. Adabpour further teaches:
wherein the tracking device comprises a contact-free tracking device, configured for determining the position of the at least one surface point of the subject ([0109]-[0111], figure 10, stereo camera 1002 forms a contact-free tracking device).
Regarding claim 9, Abadpour teaches all of the limitations of claim 8. Adabpour further teaches:
wherein the contact-free tracking device comprises an optical tracking device, configured for determining the position of the at least one surface point of the subject ([0109]-[0111], figure 10, stereo camera 1002 forms a contact-free tracking device).
Regarding claim 10, Abadpour teaches all of the limitations of claim 9. Adabpour further teaches:
wherein the optical tracking device comprises:
at least one optical marker, configured for determining at least one of the spatial position or an orientation of the registration device relative to the subject with at least 5 degrees of freedom ([0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject. Tracker of figure 10 and stereo camera setup provides for at least 5 degrees of freedom orientation tracking; see also [0065]; [0076]; [0083]-[0085], orientation is a multiple degrees of freedom measurement).
Regarding claim 11, Abadpour teaches all of the limitations of claim 8. Adabpour further teaches:
wherein the tracking device comprises an electromagnetic tracking device, configured for determining the position of the at least one surface point of the subject ([0108], electromagnetic; [0128]).
Regarding claim 12, Abadpour teaches all of the limitations of claim 11. Adabpour further teaches:
wherein the electromagnetic tracking device comprises:
at least one electromagnetic sensor, configured for determining at least one of the spatial position or an orientation of the registration device relative to the subject with at least 5 degrees of freedom ([0108], electromagnetic; [0128]; see also [0109]-[0111]).
Regarding claim 13, Abadpour teaches all of the limitations of claim 8. Adabpour further teaches:
wherein the tracking device comprises a magnetic tracking device, configured for determining the position of the at least one surface point of the subject ([0108], electromagnetic; [0128]; see also [0109]-[0111]).
Regarding claim 14, Abadpour teaches all of the limitations of claim 13. Adabpour further teaches:
wherein the magnet tracking device comprises at least one magnetic sensor, configured for determining at least one of the spatial position or the orientation of the registration device relative to the subject with at least 5 degrees of freedom ([0108], electromagnetic; [0128]; see also [0109]-[0111]).
Regarding claim 15, Abadpour teaches all of the limitations of claim 8. Adabpour further teaches:
wherein the tracking device comprises a video-based tracking device, configured for determining the position of the at least one surface point of the subject ([0109]-[0111], figure 10, the stereo camera 1002 form video-based tracking device; see also [0059]-[0100]).
Regarding claim 16, Abadpour teaches all of the limitations of claim 15. Adabpour further teaches:
wherein the video-based tracking device comprises:
at least one video marker, configured for determining at least one of the spatial position or an orientation of the registration device relative to the subject with at least 5 degrees of freedom ([0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject; see also [0059]-[0100]).
Regarding claim 17, Abadpour teaches all of the limitations of claim 8. Adabpour further teaches:
wherein the tracking device comprises a contact-based tracking device, configured for determining the position of the at least one surface point of the subject ([0109]-[0111], figure 10, first tracker 1004 and second tracker 1006 in combination with the stereo camera 1002 form spatial position and orientation determination of the registration device relative to the subject with the camera being contact free and the trackers being contact based tracking devices; see also [0059]-[0100]).
Regarding claim 18, Abadpour teaches all of the limitations of claim 6. Adabpour further teaches:
wherein the control device is configured for verifying a surface matching registration by comparing a real position of the registration device in view of the subject with a virtual position of a virtual representation of the registration device in view of an image dataset of the subject ([0093]-[0094], model used to identify relevant anatomy for 3D scanning and visual feedback forms a virtual representation of the device with respect to the imaged dataset and matching and registering the real position to the virtual points; [0105]-[0106], verification using a known surface profile; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]).
Regarding claim 19, Abadpour teaches all of the limitations of claim 6. Adabpour further teaches:
wherein the control device is configured for executing a surface matching registration, which comprises registering the subject to the medical navigation system, dependent on the accepted at least one relevant surface point ([0086]-[0088], medical navigation; see also [0059]-[0099]; [0109]-[0113]).
Regarding claim 21, Abadpour teaches all of the limitations of claim 6. Adabpour further teaches:
A surgical navigation system for computer assisted surgery, the system comprising the registration device according to claim 6 (see rejection of claim 6 above; and [0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0061], brain procedure for a subject forms an exemplary intended procedure in which a surface registration type will apply directly to the brain anatomical region; [0111]-[0113]).
Regarding claim 22, Abadpour teaches:
A program logic stored in a memory device of a computer that when running on the computer or when loaded onto the computer, causes the computer to perform a method of sampling relevant surface points of a subject for a medical navigation system (abstract), the method comprising:
determining a surface registration type for an intended procedure on the subject dependent on the intended procedure, wherein the surface registration type comprises at least one relevant tissue type of at least part of the subject ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0061], brain procedure for a subject forms an exemplary intended procedure in which a surface registration type will apply directly to the brain anatomical region; [0062]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis occurs for the anatomical region of interest and the particular anatomical tissue type relevant to the procedure; Expected surface profile of the anatomy forms the surface registration type that is utilized in the 3D point cloud process; [0073]-[0078]; [0093]-[0094]; [0111]-[0113], describe intended procedures and associated surface registrations; [0129]; [0131]-[0132]);
determining a position of at least one surface point of the subject using a registration device ([0005]-[0006]; [0011], expected surface profile of the anatomy; [0013]-[0016]; [0059]-[0063], surface registration occurs with respect to anatomical landmarks which are specific based upon the procedure being directed to a particular region; [0066]-[0072], 3D point cloud analysis includes the determination of a position of at least one surface point of the measured point cloud; [0073]-[0078], further elaborate upon the 3D surface scan and point cloud; [0093]-[0094]; [0105]-[0106]; [0111]-[0113]);
identifying a tissue type of the subject at the determined at least one surface point ([0093], model used to identify relevant anatomy for 3D scanning; [0105]-[0106], verification using a known surface profile; [0129], type of material and tissue type is determined using the surface scanning; [0131]-[0132]; [0133]; see also [0059]-[0063]; [0066]-[0072]; [0073]-[0078]); and
automatically validating the at least one surface point dependent on the identified tissue type and the determined surface registration type of the intended procedure, thereby determining a position of at least one of at least one relevant surface point or at least one non-relevant surface point, wherein the at least one relevant surface point is accepted and the at least one non-relevant surface point is discarded ([0071]-[0072], filtering out of background data through comparison forms a discarding of non-relevant surface points; see also [0059]-[0063]; [0066]-[0070]; [0073]-[0078]; [0093]-[0113]; [0129]-[0133]).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The claims are currently rejected as indicated above, and thus are not currently in condition for allowance.
Claims 5 and 20 are similar to the parent case, issued patent U.S. Pat. No. 12,458,445. The claims are otherwise similar in scope and contain the subject matter found allowable in the parent application, in that they include switching between contact-based and non-contact tracking devices based upon determined distances. If incorporated into the independent claims, the claims would form a nonobvious combination of features that differentiate from the closest prior art references, in light of the similar features to the parent case.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Farooq et al. (U.S. Pub. No. 20190104980) teaches to a skin surface image data acquisition device that includes non-contact imaging to obtain the collection of surface data in three dimensions. The reference further fails to teach to contact based sensing of surface points.
Yamamoto et al. (U.S. Pub. No. 20110054300) teaches to a surgical support system that includes a laser scanning surface registration system that provides for 3D measurements of the patient’s surface in conjunction with MRI imaging systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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