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 .
Status of Claims
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as
set forth in 37 CFR 1.136(a).
Claims 1-17 are pending in this application. Claims 1, 13, and 15 have been amended and claims 16-17 have been added. Claims 1-17 have been examined on the merits.
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:
“a curvature marker structure with a display element that is configured to quantify a curvature of a distal section” in Claim 13, line 3
“an adjustment element that is configured for adjusting the curvature of the distal section” in claim 14, line 2
“the medical imaging device is configured for capturing medical imaging data” in Claim 15, line 4.
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 § 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 1-12 and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites capturing medical imaging data by a medical imaging device, having an image of a medical object, identifying a positioning of the curvature plane, and providing the curvature parameter. The limitation of capturing medical imaging data by a medical imaging device, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components within the art. That is, other than reciting “medical imaging device”, nothing in the claim element precludes the step from practically being performed in the mind i.e., capturing the medical image visually in your mind. Similarly, identifying a positioning of the curvature plane, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind i.e., visually observing the image of the medical object to view where the curvature plane is. If a Claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Similarly, providing the curvature parameter, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind i.e., calculating the parameter of a curve using pen and paper. If a Claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Further, (although it is not required) if these processes are performed by an “inherent” processor, these claimed steps could easily be performed by a generic computer component as the claimed limitations do not require any specialized processor Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only
recites one additional element — using one or more generic processors for execution. The processors are recited at a high-level of generality (i.e., the medical imaging device, a processor) such that it amounts no more than mere instructions to apply the exception using processors. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using processors to perform the identifying and determining steps amounts to no more than mere instructions to apply the exception using generic processors. Mere instructions to apply an exception using generic processors cannot provide an inventive concept. The claim is not patent eligible. The other independent claim 15 also recites similar limitations as claim 1, which is also found to be not patent eligible at least for the reasons noted above.
The dependent claims 2-12 and 16-17 are also directed to an abstract idea as the depending claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception i.e. capturing and identifying of the positioning of the curvature plane, identifying a positioning of a curvature marker structure, receiving pre-operative planning data, providing a workflow note that has an instruction for repositioning the curvature plane by repositioning of the medical object. The elements in those claims do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. Therefore, the depending claims, are, also not patent eligible.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 8-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nevo (US20230134815A1).
Regarding claim 1,
Nevo teaches a method for providing a curvature parameter (corresponding disclosure in at least [0056], where various parameters of the curved needle are provided “the system 10 of the invention is configured to provide the following parameters to the user or to the automated system in order for the user to know how to manipulate device 12 so that curved needle 14 reaches target tissue location 64 in an accurate manner”), the method comprising: capturing medical imaging data by a medical imaging device (corresponding disclosure in at least [0008], where there is an imaging portion capturing the needle “The system further includes a tracking system configured for tracking a position of the curved needle and the straight needle guide in the body, wherein the tracking system further includes an imaging component”),
having an image of a medical object that is arranged at least partly in an examination object (corresponding disclosure in at least [0014], where an image of the needle in the tissue (examination object) is captured “providing an imaging component for providing images of the target tissue and of the curved needle with respect to the target tissue”),
wherein at least one distal section of the medical object is curvable parallel to a curvature plane (corresponding disclosure in at least [0008], where the needle is curved and will have a parallel plane that is associated with the curve “The system includes a curved needle having a curved section, the curved section configured to curve in a flexion plane”);
identifying, by a processor, a positioning of the curvature plane with the aid of the medical imaging data (corresponding disclosure in at least [0048], where there is a tracking system for positioning “Position tracking system 100 includes an imaging component 102 for imaging of the body tissue, and a sensing component 104 for sensing a position of curved needle 14 within the body tissue”);
and providing the curvature parameter having an indication for positioning of the curvature plane (corresponding disclosure in at least [0048] and further in [0052], where the curved plane is known “Since the needle 14 is oriented with respect to probe 103 at a known angle 109, the flexion plane with respect to imaging component 102 is known”).
Regarding Claim 2,
Nevo further teaches wherein identifying the positioning of the curvature plane comprises checking whether an imaging direction of the imaging device is essentially aligned at right angles to the curvature plane, wherein when, based on the checking, the imaging direction of the imaging device is not essentially aligned at right angles to the curvature plane (corresponding disclosure in at least [0032] and Figure 13b ,where the imaging device images in one direction, and the curvature plane of the needle is essentially at a right angle to the imaging direction “an imaging component having a probe with a scanning element depicting a needle attached to the probe in an angled orientation and in an aligned orientation, respectively, in accordance with embodiments of the invention”),
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Figure 13B of Nevo
the method further comprises: adjusting a relative positioning between the medical object and the imaging device (corresponding disclosure in at least [0053], where the needle is adjusted automatically, meaning the position between the needle and the imaging probe would be changed “an automated system may include a configuration wherein processor 30 is configured to provide output directly to an automated controller for curved needle 14 so that a position of curved needle 14 can automatically be adjusted based on data from processor 30”);
and carrying out the capturing and the identifying of the positioning of the curvature plane repeatedly (corresponding disclosure in at least [0080], where this step can be completed multiple times until a target is reached “If the target location has not been reached, then a new entry point may be determined, and new calculations may be made. In some embodiments, this process may be repeated until the target tissue is reached. Tracking system and/or imaging system continues to track the deployment of the curved needle and to calculate adjustments so that the curved needle reaches the target.”).
Regarding Claim 8,
Nevo further teaches receiving pre-operative planning data of the examination object; and registering the pre-operative planning data with the medical imaging data, wherein providing the curvature parameter comprises displaying a graphical representation of the registered pre-operative planning data and of the curvature parameter (corresponding disclosure in at least [0083], where there the real-time positioning of the curvature parameter, or the curved needle (medical imaging data) can be overlaid with the target tissue image (pre-operative planning) “is display 114, designed to present real-time position and orientation of curved needle 14 and needle guide 20 (as provided by position tracking system 100) overlaid on an image of target tissue 64”).
Regarding Claim 9,
Nevo further teaches wherein the pre-operative planning data comprises a pre-operative planning image of the examination object (corresponding disclosure in at least Figure 9 and [0084], where there is a planning image of the examined region, and the registration (view of the needle within the region) is viewed 110, “an image from the imaging component 102 of tracking system 100, having target tissue 64 therein, and annotation of the intersection line 93 between the flexion plane 92 of the needle and the image plane”).
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Figure 9 of Nevo
Regarding Claim 10,
Nevo further teaches wherein providing the curvature parameter comprises providing a workflow note that has an instruction for repositioning the curvature plane by repositioning of the medical object, an instruction for adjusting the curvature of the distal section, or a combination thereof (corresponding disclosure in at least [0015], where the needle (medical object) can be repositioned “retracting the curved needle back into the needle guide, repositioning the needle guide at the second needle guide insertion length, and advancing the curved needle distally past a distal end of the straight needle guide by the second needle deployment length”, and further in [0080], where the curvature can be adjusted “Tracking system and/or imaging system continues to track the deployment of the curved needle and to calculate adjustments so that the curved needle reaches the target”). Further, it has been held that when the claimed printed matter (workflow note) is not functionally related to the curved medical object it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the curved medical object may render the device more convenient by providing an individual with a specific type of instruction does not alter the functional relationship. Mere support by the curved medical object for the printed matter is not the kind of functional relationship necessary for patentability. Thus, there is no novel and unobvious functional relationship between the printed matter and the curved medical object, which is required for patentability.
Regarding Claim 11,
Nevo further teaches wherein the workflow note is provided as a function of the identified positioning of the curvature plane and the planning data (corresponding disclosure in at least [0053], where the needle is adjusted automatically, based on where the needle is positioned alongside the planning data, the needle positioning changing the curvature plane “an automated system may include a configuration wherein processor 30 is configured to provide output directly to an automated controller for curved needle 14 so that a position of curved needle 14 can automatically be adjusted based on data from processor 30”). Further, it has been held that when the claimed printed matter (workflow note) is not functionally related to the curved medical object it will not distinguish the invention from the prior art in terms of patentability. In re Gulack, 217 USPQ 401, (CAFC 1983). The fact that the content of the printed matter placed on the curved medical object may render the device more convenient by providing an individual with a specific type of instruction does not alter the functional relationship. Mere support by the curved medical object for the printed matter is not the kind of functional relationship necessary for patentability. Thus, there is no novel and unobvious functional relationship between the printed matter and the curved medical object, which is required for patentability.
Regarding Claim 12,
Nevo further teaches wherein the capturing, the identifying, and the providing are carried out repeatedly until the occurrence of an abort condition (corresponding disclosure in at least [0080], where the image is captured with the tracking of the needle repeatedly until the target is reached (abort) “If the target location has not been reached, then a new entry point may be determined, and new calculations may be made. In some embodiments, this process may be repeated until the target tissue is reached. Tracking system and/or imaging system continues to track the deployment of the curved needle and to calculate adjustments so that the curved needle reaches the target”).
Regarding Claim 15,
Nevo teaches a system comprising: a medical imaging device; and a provision unit comprising a processor, wherein the medical imaging device is configured to capture medical imaging data (This element is interpreted under 35 U.S.C. 112(f) as described in Para [0072]: medical imaging device for recording the image data may include a medical X-ray device (e.g., a medical C-arm X-ray device and/or a cone-beam computed tomography system (cone-beam CT, CBCT)), and/or a computed tomography (CT) system and/or a magnetic resonance tomography (MRT) system and/or a positron emission tomography (PET) system and/or an ultrasound device.), having an image of a medical object that is at least partly arranged in an examination object (corresponding disclosure in at least least [0014], where an image of the needle in the tissue (examination object) is captured “providing an imaging component for providing images of the target tissue and of the curved needle with respect to the target tissue”),
wherein at least one distal section of the medical object is curveable parallel to a curvature plane (corresponding disclosure in at least [0008], where the needle is curved and will have a parallel plane that is associated with the curve “The system includes a curved needle having a curved section, the curved section configured to curve in a flexion plane”),
wherein the processor of the provision unit is configured to: identify a positioning of the curvature plane with the aid of the image data (corresponding disclosure in at least [0048], where there is a tracking system for positioning “Position tracking system 100 includes an imaging component 102 for imaging of the body tissue, and a sensing component 104 for sensing a position of curved needle 14 within the body tissue”);
and providing a curvature parameter, having an indication for positioning of the curvature plane (corresponding disclosure in at least [0048] and further in [0052], where the curved plane is known “Since the needle 14 is oriented with respect to probe 103 at a known angle 109, the flexion plane with respect to imaging component 102 is known”).
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.
Claims 3-5, 13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nevo (US20230134815A1) in view of Bittner (US20200008885A1).
Regarding Claim 3, the combination noted above teaches all of the claimed limitations.
Specifically, Nevo teaches identifying the positioning of the curvature plane (corresponding disclosure in at least [0048] and further in [0052], where the curved plane is known “Since the needle 14 is oriented with respect to probe 103 at a known angle 109, the flexion plane with respect to imaging component 102 is known”) and epiction in the medical imaging data (corresponding disclosure in at least [0008], where there is an imaging portion capturing the needle “The system further includes a tracking system configured for tracking a position of the curved needle and the straight needle guide in the body, wherein the tracking system further includes an imaging component”).
Nevo does not teach identifying a positioning of a curvature marker structure on the medical object.
Bittner, in a similar field of endeavor, teaches a similar concept (imaging of curved medical objects), identifying a positioning of a curvature marker structure on the medical object (Corresponding disclosure in at least [0037], where there are markers on the curved wire “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms and calculation of the triangular area), but the method also functions with all other guide wires”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the curvature marker structure on the medical object into the teachings of Nevo. One of the ordinary skill in the art would have been motivated to incorporate this because the markers on the curved structure would help better identify the location of the curved portion when viewing through images taken via modalities, such as ultrasound.
Regarding Claim 4, the combination noted above teaches all of the claimed limitations.
Specifically, Bittner teaches wherein a curvature of a distal section of the at least one distal section of the medical object at that moment is identified with the aid of the positioning of the curvature marker structure (corresponding disclosure in at least [0037], where the tip (distal end) of the wire is marked and can be used with image recognition “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms”),
and wherein the curvature parameter is provided, having information about the curvature at that moment (corresponding disclosure in at least [0037], where given the information from the marker at the tip, calculations can be completed regarding the curvature (triangular area) “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms and calculation of the triangular area),”).
Regarding Claim 5, the combination noted above teaches all of the claimed limitations.
Specifically, Nevo teaches wherein providing the curvature parameter comprises displaying a graphical representation of the medical imaging data and of the curvature parameter by a visual display unit (corresponding disclosure in at least [0083], where a display shows the designated imaged area (tissue) and the curved needle “is display 114, designed to present real-time position and orientation of curved needle 14 and needle guide 20 (as provided by position tracking system 100) overlaid on an image of target tissue 64”).
Nevo does not teach wherein the curvature marker structure has a display element that is depicted in the medical imaging data, and quantifies the curvature of the distal section at that moment.
Bittner, in a similar field of endeavor, teaches a similar concept (imaging a marker point on a medical object), wherein the curvature marker structure has a display element that is depicted in the medical imaging data, and quantifies the curvature of the distal section at that moment (corresponding disclosure in at least [0037], where there are markers on the tip of the wire, which can be used for imaging purposes “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms and calculation of the triangular area), but the method also functions with all other guide wires”; further in [0026], where imaging is completed in real-time “The following acts two to eight are carried out during the first acts (e.g., during real-time monitoring by X-ray images)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the marker for depiction in the medical imaging data for quantifying the curvature. One of the ordinary skill in the art would have been motivated to incorporate this because the marker as a parameter in the medical image allows for calculating the curvature, which can be used for repeating the exact parameter for future imaging.
Regarding Claim 13,
Nevo teaches a medical object comprising: at least one distal section that is curvable parallel to a curvature plane (corresponding disclosure in at least [0008], where the needle is curved and will have a parallel plane that is associated with the curve “The system includes a curved needle having a curved section, the curved section configured to curve in a flexion plane”).
Nevo does not teach a curvature marker structure with a display element that is configured to quantify a curvature of a distal section of the at least one distal section at that moment.
Bittner, in a similar field of endeavor, teaches a similar concept (curved medical objects), where there is a curvature marker structure with a display element that is configured to quantify a curvature of a distal section (This element is interpreted under 35 U.S.C. 112(f) as described in Para [0036]: the curvature marker structure may have a display element that is depicted in the image data and quantifies the curvature of the distal section at that moment. In this case, the provision of the curvature parameter may include a display of a graphical representation of the image data and of the curvature parameter by a visual display unit) of the at least one distal section at that moment (corresponding disclosure in at least [0037], where there is a marker structure that acts as a display element for quantifying the curvature “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms and calculation of the triangular area)”).
Regarding Claim 16, the combined references of Nevo and Bittner teach the limitations of Claim 1, and Bittner further teaches wherein the medical object comprises a curvature marker structure with a display element (This element is interpreted under 35 U.S.C. 112(f) as described in Para [0036]: the curvature marker structure may have a display element that is depicted in the image data and quantifies the curvature of the distal section at that moment. In this case, the provision of the curvature parameter may include a display of a graphical representation of the image data and of the curvature parameter by a visual display unit) that is configured to quantify a curvature of the at least one distal section at a moment (corresponding disclosure in at least [0037], where there is a marker structure that acts as a display element for quantifying the curvature “The use of markers in the tip 5 of the guide wire, on the curvature, and on the first section of the guide wire may optimize the method (e.g., with regard to image recognition algorithms and calculation of the triangular area)”).
Regarding Claim 17, the combined references of Nevo and Bittner teach the limitations of Claim 1, and Bittner further teaches wherein providing the curvature parameter comprises displaying, by a display, a graphical representation of the curvature parameter (corresponding disclosure in at least [0083], where a display shows the designated imaged area (tissue) and the curved needle “is display 114, designed to present real-time position and orientation of curved needle 14 and needle guide 20 (as provided by position tracking system 100) overlaid on an image of target tissue 64”).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Nevo (US20230134815A1) in view of Bittner (US20200008885A1) as applied to claim 4 and in further view of Prior (US20220047259A1).
Regarding Claim 6, the combined references of Nevo and Bittner teach the claimed invention and the curved structure with a marker ([0037] of Bittner), but does not teach wherein the graphical representation of the curvature parameter comprises a virtual continuation of the distal section in accordance with the curvature at that moment.
Prior, in a similar field of endeavor, teaches a similar concept (curved medical structure), of the graphical representation of the curvature parameter comprises a virtual continuation of the distal section in accordance with the curvature at that moment (corresponding disclosure in at least [0052], where there is a prediction algorithm that will show the trajectory needed for the needle (virtual continuation) “The AI algorithm may include a prediction algorithm to predict a future position and orientation of the suture needle based on the previous and current 3D endoscopic images or ultrasound images. The future position and orientation information may be used to determine and display a where the suture needle will exit the tissue after passing through the tissue”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a display showing the virtual continuation of the curvature with the combined references. One of the ordinary skill in the art would have been motivated to incorporate this because the prediction helps with ensuring the needle curves to the appropriate location necessary within the examined region, avoiding any critical structures.
Regarding Claim 7, the combined references of Nevo and Bittner teach the claimed invention and the curved structure with a marker ([0037] of Bittner), but does not teach capturing a material parameter for the medical object, wherein the virtual continuation is provided based on the material parameter and the curvature at that moment.
Prior teaches capturing a material parameter for the medical object, wherein the virtual continuation is provided based on the material parameter and the curvature at that moment (corresponding disclosure in at least [0052], where the predicted trajectory (virtual continuation) is based on the current curvature ““The AI algorithm may include a prediction algorithm to predict a future position and orientation of the suture needle based on the previous and current 3D endoscopic images or ultrasound images. The future position and orientation information may be used to determine and display a where the suture needle will exit the tissue after passing through the tissue”)”.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nevo (US20230134815A1) in view of Bittner (US20200008885A1) as applied to claim 13 and in further view of Dix (US20170035484A1).
Regarding Claim 14, the combined references of Nevo and Bittner teach the claimed invention and the curved structure with a marker ([0037] of Bittner), but does not teach the adjustment element and further operations.
Dix, in a similar field of endeavor, teaches a similar concept (curved medical object), where there is an adjustment element that is configured for adjusting the curvature (This element is interpreted under 35 U.S.C. 112(f) as described in Para [0058]: the workflow note may include a control specification for manipulation of the adjustment element (e.g., of a cable and/or of a rotary grip). The curvature of the distal section is able to be adjusted by the manipulation of the adjustment element.) of the distal section (corresponding disclosure in at least [0019], where there is an adjustment control for the curvature “operably connected proximally to an adjustment control, such as a wheel, dial, or other element that can be adjusted by the physician to adjust the tension on the pullwire(s) and thus adjust the degree of curvature of the distal end of the needle”),
wherein the adjustment element comprises an indicator structure, wherein a relative positioning between the indicator structure and the curvature marker structure changes during an adjustment of the curvature of the distal section, and wherein the relative positioning between the indicator structure and the curvature marker structure quantifies the curvature of the distal section at that moment (Corresponding disclosure in at least [0016], where there is an indicia (indicator structure) on the curvable needle).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have an adjustment element and an indicator structure between the curvature marker for quantifying the curvature incorporated into the teachings of the combined reference. One of the ordinary skill in the art would have been motivated to incorporate this because the indicator structure is viewable during imaging, and when adjustments are being made in the curvature, the adjustment is viewed and measured in real-time.
Response to Arguments
Applicant's arguments filed 10/16/25 regarding the claim objections have been fully considered and are withdrawn.
Applicant's arguments filed 10/16/25 regarding the 35 U.S.C. 101 have been fully considered but they are not persuasive. Claim 1 has been amended to include “identifying, by a processor, a positioning of the curvature plane. However, the process is still being performed by an inherent processor, which does not integrate the judicial exception into a practical application (see office action above).
Applicant's arguments filed 10/16/25 regarding the 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 rejection have been fully considered but they are not persuasive.
Regarding Claim 1 (and similarly claim 15), Applicant argues that Nevo does not teach identifying a positioning of a curvature plane, parallel to which at least one distal section of a medical object is curvable, with the aid of medical imaging data. However, [0048] of Nevo recites positioning of a curvable medical object (curvable needle) which is parallel to a curvature plane (the flexion plane) “ position tracking system 100 is provided to allow a user to accurately direct curved needle 14 to targets in radial positions away from a needle insertion path and to register tissue acquisition sites on images of the targeted organ. Position tracking system 100 includes an imaging component 102 for imaging of the body tissue, and a sensing component 104 for sensing a position of curved needle 14 within the body tissue… Imaging component 102 may be, for example, MRI, CT, ultrasound, or any other suitable imaging system”. The plane as well as the curvature of the object are determined using medical imaging data ([0049] “The EndoScout™ Tracking System uses gradient fields of an MRI scanner to determine positioning of a device such as a biopsy needle in reference to MR images”). The calculated plane is determined using the known parameters, which are established using the medical imaging data.
Regarding Claim 13, Applicant argues that the combined references of Nevo and Bittner do not teach “a curvature marker structure with a display element that is configured to quantify a curvature of a distal section of the at least one distal section at that moment”, specifically that Bittner does not teach the markers having a display element. However, Bittner teaches the markers, which appear at the tip of the wire ([0037]), which would be further displayed (display element) ([0038] “The method includes recording a sequence of live X-ray images of the guide wire and presenting the X-ray images on a display unit”).
With respect to Applicant’s arguments to the remaining claims, see pages 4-5, regarding claims 2-12, 14, 16 and 17, these claims are not allowable based on their dependence to the independent claim 5 for at least the reasonings provided above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/K.E.K./Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797