DETAILED ACTION
Summary
Claims 1-14 and 16 are pending in the application. Claims 1-13 are rejected under 35 USC 112(a). Claims 1-13 are rejected under 35 USC 112(b). Claims 1-14 and 16 are rejected under 35 USC 103.
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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is longer than 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Pg. 2, line 12 recites “a n apparatus”. It should recite “an apparatus”.
Pg. 2, line 32 recites “tube or tubus”. It should recite “tube or tubes”.
Pg. 5, line 22 recites “finding an applying”. It should recite “finding and applying”.
Pg. 18, line 21 recites “X-ray imaged is mapped”. It should recite “the X-ray image is mapped”.
Appropriate correction is required.
Claim Objections
Claim 1 objected to because of the following informalities:
Claim 1 recites “an input unit (20)” in line 2. It should recite “an input unit”.
Claim 1 recites “the end of the catheter or tube” in line 20. It should recite “the end of the catheter or the tube”.
Appropriate correction is required.
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: “input unit” in claim 1 and “input unit” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 11, claim limitation “input unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is silent as to the structure of the input unit, and as such fails to disclose the corresponding structure, material, or acts for performing the entire claimed function of the input unit (See MPEP 2181(IV)). Therefore, the claim is lacks written description support, and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
All claims dependent from the above claims rejected under 35 USC 112(a) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 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.
Regarding claims 1 and 11, claim limitation “input unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is silent as to the structure of the input unit, and as such fails to disclose the corresponding structure, material, or acts for performing the entire claimed function of the input unit. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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 1-2, 11-12, 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Besser (U.S PGPub 2022/0117676 A1) in view of Wallace et al. (U.S PGPub 2013/0072787 A1).
Regarding Claim 1, Besser teaches an apparatus for tracing a catheter or a tube (Abstract) (Fig. 3A shows the traced tube), comprising:
an input unit [0081]+[0085] (a memory of the computer); and
a processor (Fig. 1, 110) [0085];
wherein the input unit is configured to receive a medical image of a patient [0081] (uploaded image) [0113]-[0114];
wherein the input unit is configured to provide the medical image of the patient to the processor [0081] [0113]-[0114] (the processor is performing processing on the image, which means the image was provided to the processor);
wherein the input unit is configured to receive a live data stream [0113] (data from the sensor is obtained continuously in the procedure, which means it is a live data stream) from one or more sensors [0081] (signals from reference sensor), wherein the live data stream comprises data of the patient [0082] (position of the torso), and wherein a sensor coordinate system is defined with respect to the one or more sensors [0082] (reference coordinate system);
wherein the input unit is configured to provide the live data stream to the processor [0088];
wherein the processor is configured to receive a sensed location of an end of the catheter or the tube [0027] that is to be inserted into the patient [0044]-[0045];
wherein the processor is configured to map the medical image of the patient to the sensor coordinate system [0088];
wherein the processor is configured to determine a location of the end of the catheter or the tube in the sensor coordinate system comprising utilization of the sensed location of the end of the catheter or tube [0109]+[0112] (as the end of the catheter is displayed on the images which are displayed in the sensor coordinate system, the location of the end of the tube is also determined in the sensor coordinate system); and
wherein the processor is configured to generate a representation of the sensed location of the end of the catheter or the tube with respect to the medical image (Fig. 3A) comprising utilization of the medical image of the patient mapped to the sensor coordinate system and the location of the end of the catheter or the tube in the sensor coordinate system [0110]-[0112].
Besser is silent regarding wherein the processor is configured to align the data of the patient received from the one or more sensors with the sensor coordinate system.
Wallace teaches a system for different features to a unified coordinate system (Abstract). This system unifies the data from a patient sensor (i.e. a patient coordinate system) with a device coordinate system (i.e. aligns data of the patient with a sensor coordinate system) [0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date to align the data of the patient with the sensor coordinate system, as taught by Wallace, because this improves the ease and reliability of navigating a minimally invasive devices, as recognized by Wallace [0010].
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Besser further teaches wherein the processor is configured to generate a mapped medical image of the patient (Fig. 3A, the catheter is mapped on the image, and it is a mapped medical image) [0110] comprising utilization of the medical image of the patient mapped to the sensor coordinate system [0112], and
wherein the generation of the representation of the sensed location of the end of the catheter or the tube with respect to the medical image comprises a generation of the representation of the sensed location of the end of the catheter or the tube in the mapped medical image of the patient (Fig. 3A, the tip of the catheter is represented on the image) [0112]+[0113].
Regarding Claim 11, Besser teaches a system for tracing a catheter or a tube (Abstract) (Fig. 3A shows the traced tube), comprising:
an input unit [0081]+[0085] (a memory of the computer); and
a processor (Fig. 1, 110) [0085];
one or more sensors [0081] (signals from reference sensor);
a visual display [0109];
wherein the input unit is configured to receive a medical image of a patient [0081] (uploaded image) [0113]-[0114];
wherein the input unit is configured to provide the medical image of the patient to the processor [0081] [0113]-[0114] (the processor is performing processing on the image, which means the image was provided to the processor);
wherein the input unit is configured to receive a live data stream [0113] (data from the sensor is obtained continuously in the procedure, which means it is a live data stream) from one or more sensors [0081] (signals from reference sensor), wherein the live data stream comprises data of the patient [0082] (position of the torso), and wherein a sensor coordinate system is defined with respect to the one or more sensors [0082] (reference coordinate system);
wherein the input unit is configured to provide the live data stream to the processor [0088];
wherein the processor is configured to receive a sensed location of an end of the catheter or the tube [0027] that is to be inserted into the patient [0044]-[0045];
wherein the processor is configured to map the medical image of the patient to the sensor coordinate system [0088];
wherein the processor is configured to determine a location of the end of the catheter or the tube in the sensor coordinate system comprising utilization of the sensed location of the end of the catheter or tube [0109]+[0112] (as the end of the catheter is displayed on the images which are displayed in the sensor coordinate system, the location of the end of the tube is also determined in the sensor coordinate system); and
wherein the processor is configured to generate a representation of the sensed location of the end of the catheter or the tube with respect to the medical image on the visual display (Fig. 3A) [0110] comprising utilization of the medical image of the patient mapped to the sensor coordinate system and the location of the end of the catheter or the tube in the sensor coordinate system [0110]-[0112].
Besser is silent regarding wherein the processor is configured to align the data of the patient received from the one or more sensors with the sensor coordinate system.
Wallace teaches a system for different features to a unified coordinate system (Abstract). This system unifies the data from a patient sensor (i.e. a patient coordinate system) with a device coordinate system (i.e. aligns data of the patient with a sensor coordinate system) [0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date to align the data of the patient with the sensor coordinate system, as taught by Wallace, because this improves the ease and reliability of navigating a minimally invasive devices, as recognized by Wallace [0010].
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Besser further teaches wherein the processor is configured to generate a mapped medical image of the patient (Fig. 3A, the catheter is mapped on the image, and it is a mapped medical image) [0110] comprising utilization of the medical image of the patient mapped to the sensor coordinate system [0112],
wherein the processor is configured to present the mapped medical image on the visual display [0110], and
wherein the generation of the representation of the sensed location of the end of the catheter or the tube with respect to the medical image comprises a generation of the representation of the sensed location of the end of the catheter or the tube in the mapped medical image of the patient of the patient presented on the visual display (Fig. 3A, the tip of the catheter is represented on the image) [0110]+[0112]-[0113].
Regarding Claim 14, Besser teaches a method for tracing a catheter or a tube (Abstract) (Fig. 3A shows the traced tube), comprising:
receiving a medical image of a patient [0081] (uploaded image) [0113]-[0114];
providing the medical image of the patient to the processor [0081] [0113]-[0114] (the processor is performing processing on the image, which means the image was provided to the processor);
receiving a live data stream [0113] (data from the sensor is obtained continuously in the procedure, which means it is a live data stream) from one or more sensors [0081] (signals from reference sensor), wherein the live data stream comprises data of the patient [0082] (position of the torso), and wherein a sensor coordinate system is defined with respect to the one or more sensors [0082] (reference coordinate system);
providing the live data stream to the processor [0088];
receiving a sensed location of an end of the catheter or the tube [0027] that is to be inserted into the patient [0044]-[0045];
mapping the medical image of the patient to the sensor coordinate system [0088];
determining a location of the end of the catheter or the tube in the sensor coordinate system comprising utilization of the sensed location of the end of the catheter or tube [0109]+[0112] (as the end of the catheter is displayed on the images which are displayed in the sensor coordinate system, the location of the end of the tube is also determined in the sensor coordinate system); and
generating a representation of the sensed location of the end of the catheter or the tube with respect to the medical image (Fig. 3A) comprising utilization of the medical image of the patient mapped to the sensor coordinate system and the location of the end of the catheter or the tube in the sensor coordinate system [0110]-[0112].
Besser is silent regarding aligning the data of the patient received from the one or more sensors with the sensor coordinate system.
Wallace teaches a system for different features to a unified coordinate system (Abstract). This system unifies the data from a patient sensor (i.e. a patient coordinate system) with a device coordinate system (i.e. aligns data of the patient with a sensor coordinate system) [0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date to align the data of the patient with the sensor coordinate system, as taught by Wallace, because this improves the ease and reliability of navigating a minimally invasive devices, as recognized by Wallace [0010].
Regarding Claim 16, Besser teaches a non-transitory computer readable medium for storing executable instructions that, when executed [0121]-[0122], cause the method of claim 14 to be performed (See rejection of claim 14 above).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace as applied to claim 1 above, and further in view of Olson et al. (U.S PGPub 2008/0221425 A1).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Besser further teaches wherein the generation of the representation of the sensed location of the end of the catheter or the tube with respect to the medical image comprises a generation of the representation of the sensed location of the end of the catheter or the tube in the medical image of the patient (Fig. 3A, the tip of the catheter is represented on the image) [0112]+[0113].
Besser fails to explicitly teach wherein the processor is configured to generate a modified sensor coordinate system comprising utilization of the medical image of the patient mapped to the sensor coordinate system, wherein the determination of the location of the end of the catheter or the tube in the sensor coordinate system comprises a determination of the location of the end of the catheter or the tube in the modified sensor coordinate system.
Olsen teaches a method of registering a catheter navigation system to a medical image (Abstract). This system generates a modified sensor coordinate system utilizing the medical image of the patent mapped to the sensor coordinate system [0056]. The system determined the location of the end of the catheter in the modified sensor coordinate system [0045]-[0046] (the roving electrode 17 is on the distal tip of the catheter [0034]).
It would have bene obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to generate a modified sensor coordinate system, as taught by Olsen, because this more accurately transforms the coordinate system to the external model, thereby allowing for more accurate navigation, as recognized by Olsen [0007]-[0010].
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Besser further teaches wherein the processor is configured to present the medical image on the visual display [0110], wherein the generation of the representation of the sensed location of the end of the catheter or the tube with respect to the medical image comprises a generation of the representation of the sensed location of the end of the catheter or the tube in the medical image of the patient presented on the visual display (Fig. 3A, the tip of the catheter is represented on the image) [0110]+[0112]-[0113].
Besser fails to explicitly teach wherein the processor is configured to generate a modified sensor coordinate system comprising utilization of the medical image of the patient mapped to the sensor coordinate system, wherein the determination of the location of the end of the catheter or the tube in the sensor coordinate system comprises a determination of the location of the end of the catheter or the tube in the modified sensor coordinate system.
Olsen teaches a method of registering a catheter navigation system to a medical image (Abstract). This system generates a modified sensor coordinate system utilizing the medical image of the patent mapped to the sensor coordinate system [0056]. The system determined the location of the end of the catheter in the modified sensor coordinate system [0045]-[0046] (the roving electrode 17 is on the distal tip of the catheter [0034]).
It would have bene obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to generate a modified sensor coordinate system, as taught by Olsen, because this more accurately transforms the coordinate system to the external model, thereby allowing for more accurate navigation, as recognized by Olsen [0007]-[0010].
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace as applied to claim 1 above, and further in view of Vesely et al. (U.S Patent 6,246,898 B1).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Besser fails to explicitly teach wherein the one or more sensors comprises a plurality of sensors, and wherein the live data stream comprises data from each of the plurality of sensors.
Vesely teaches a surgical navigation system (Abstract). This system uses a plurality of references sensors (Fig. 16, 1674) (Col 12-13, lines 62-15), and has a live data stream from the plurality of reference sensors (Col 5, lines 52-53)+(Col 13, lines 17-27)+(Col 13, lines 34-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a plurality of sensors, as taught by Vesely, because this allows the system to detect and correct for deformation of the patient, thereby maintaining accuracy during the navigation, as recognized by Vesely (Col 13, lines 46-51)+(Col 14, lines 13-21).
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Besser fails to explicitly teach wherein the alignment of the data of the patient with the sensor coordinate system comprises utilization of data of the patient from each of the plurality of sensors.
Vesely further teaches using the data from each of the sensors (Col 13, lines 28-56). This data is used by the system to align the patient data with the image data (Col 14, lines 1-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use a plurality of sensors for alignment, as taught by Vesely, because this allows the system to detect and correct for deformation of the patient, thereby maintaining accuracy during the navigation, as recognized by Vesely (Col 13, lines 46-51)+(Col 14, lines 13-21). One of ordinary skill would recognize that, as the system of Besser performs the alignment in the sensor coordinate space, the combination would similarly perform the alignment in the sensor coordinate system.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace and Vesely as applied to claim 4 above, and further in view of Rahimian et al. (U.S PGPub 2012/0215094 A1).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Besser fails to explicitly teach wherein the live data stream comprises data of the end of the catheter or the tube, and wherein the sensed location of the end of the catheter or the tube that is to be inserted into the patient is determined from the data of the end of the catheter or the tube from each of the plurality of sensors.
Rahimian teaches a catheterization system (Abstract). This system uses a plurality of sensors (Fig. 5, 508) to detect live data from the tip of the catheter [0066]+[0069]. The location of the catheter is determined by the data from each of the plurality of sensors [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to have live data include an end of the catheter, and to determine the location from the plurality of sensors, as taught by Rahimian, because this allows the catheter tip to be localized in 6 degrees of freedom, thereby allowing for more accurate navigation without ionizing radiation, as recognized by Rahimian [0015]+[0069].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace as applied to claim 1 above, and further in view of Ganapathy et al. (U.S PGPub 2018/0008802 A1).
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Besser further teaches sense the location of the end of the catheter or the tube [0027] and to provide the sensed location of the end of the catheter or the tube to the processor [0027]+[0044]-[0045].
Besser fails to explicitly teach a radiolocation system.
Ganapathy teaches a surgical system (Abstract). This system uses radiolocation to determine the tip of a medical instrument within a body [0097].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of tracking the catheter with a radiolocation system, as taught by Ganapathy, as the substitution for one known method for determining a medical device location with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a radiolocation system to determine the location of the tip of the catheter are reasonably predictable.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace as applied to claim 1 above, and further in view of Noonan et al. (U.S PGPub 2017/0281282 A1).
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Besser further teaches the location of the end of the catheter or the tube [0027] and to provide the sensed location of the end of the catheter or the tube to the processor [0027]+[0044]-[0045].
Besser fails to explicitly teach wherein the catheter or the tube comprises a fiber optic shape sensing system.
Noonan teaches an optical shape sensing system for determining position and orientation of a medical device (Abstract). This fiber optic shape sensing system [0037] is used to determine the position and orientation of a catheter [0066]. The position information is analyzed by a processor [0030].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of obtaining the position information with a fiber optic shape sensing, as taught by Noonan, as the substitution for one known method of determining position with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of using a fiber optic shape sensing device to determine the position are reasonably predictable.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace as applied to claim 1 above, and further in view of Mire et al. (U.S PGPub 2007/0066887 A1).
Regarding Claim 9, the combination of references teaches the invention substantially as claimed.
While it is implied the live data of Besser is registered with the medical image [0112]-[0113] (the external image is aligned (registered) with the reference coordinate system), Besser is silent regarding wherein mapping the medical image of the patient to the sensor coordinate system comprises registration between the medical image of the patient and at least one frame of the live data stream.
Mire teaches a surgical navigation system (Abstract). This system registers the medical image with at least one frame of live data from the reference sensor [0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to register the medical image with live data, as taught by Mire, because this ensures that the navigation remains accurate even during patient movement, as recognized by Mire [0050].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Besser in view of Wallace and Mire as applied to claim 9 above, and further in view of Vesely et al. (U.S Patent 6,246,898 B1).
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Besser fails to explicitly teach wherein registration between the medical image of the patient and at least one frame of the live data stream comprises utilization of a warping transformation to align the medical image of the patient body with the data of the patient in the at least one frame of the live data stream.
Vesely teaches a surgical navigation system (Abstract). This system performs a warping transform to align the medical image of the patient body with date of the patient in the live data stream (Col 14, lines 13-21).
It would have been obvious to one of ordinary skill in the art to modify the combined system to use warping transform to align the data during the registration step, as taught by Vesely, because this allows the system corrects for deformation of the patient, thereby maintaining accuracy during the navigation, as recognized by Vesely (Col 13, lines 46-51)+(Col 14, lines 13-21)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Webler et al. (U.S PGPub 2007/0055142 A1), which teaches an image guided percutaneous procedure.
Besser et al. (U.S PGPub 2020/0121399 A1), which teaches a method for guiding a catheter that further utilizes a plate sensor.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798