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 .
Response to Amendment
This office action is in response to the remarks filed on appeal brief filed on 10/24/2025.
Claims 1-20 remain pending in the application, claims 4 and 6-20 have been previously withdrawn.
Response to Appeal Brief
In view of the appeal brief filed on 10/24/2025, PROSECUTION IS HEREBY REOPENED. A new ground of rejection set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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 1-3 and 5 are rejected under 35 U.S.C. 101.
Regarding claim 1,
Step 1: Statutory category: Yes- An optical shape sensing registration system is disclosed, and therefore, is an apparatus.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations “automatically detect at least one sensing feature of the optical shape sensing guidewire from an optical shape sensing of a translation of the optical shape sensing guidewire within the over-the-wire device” and “automatically determine at least one registration characteristic of the over- the-wire device from an automatic detection of the at least one sensing feature of the optical shape sensing guidewire within the over-the-wire device”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. One of ordinary skill in the art can determine “at least one registration characteristic” (i.e. (e.g., a type, a length, a diameter, a color, a hub, treatment device(s), anatomical image(s), anatomical model(s), anatomical location(s), etc., as described in [0011] of the instant specification), by looking at an image of the optical shape sensing guidewire within the over the over-the-wire device, further, a curve/twist/a sensing feature can be visualized on an image as well. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No- The claim additionally recites “optical shape sensing guidewire”, an “over-the-wire device”, and “and an optical shape sensing registration controller for controlling an autonomous device registration of the over-the-wire device”. However, these additional elements do not integrate the judicial exception into a practical application. This is because the additional elements of “optical shape sensing guidewire”, an “over-the-wire device”, and “and an optical shape sensing registration controller for controlling an autonomous device registration of the over-the-wire device” generally link the use of a judicial exception to a particular technological environment or field of use, see MPEP § 2106.04(d)(I), as this limits the claim to the optical shape sensing guidewire field.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements do not amount to significantly more than the judicial exception. The controller merely applies to the judicial exception to perform an abstract idea. The optical shape sensing guidewire” an “over the wire device” are merely linking the use of the judicial exception to a particular technological environment or field of use. Further, the use of a controller, optical shape sensing guidewire, and over-the-wire device are well-known, routine, and conventional. Barrish et al. (US 20170157363 A1) disclose the use of known sensor technologies, including optical fiber shape sensors for an articulated system ([0128]), i.e. catheter/guidewire system.
For these reasons, there is no inventive concept in the claim.
Accordingly, claim 1 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 2,
Step 1: Statutory category: Yes- An optical shape sensing registration system is disclosed, and therefore, is an apparatus.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations “wherein the at least one registration characteristic of the over-the-wire device is a hub”, and “wherein the optical shape sensing registration controller is configured to automatically identify the hub from the automatic detection of the at least one sensing feature of the optical shape sensing guidewire”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. One of ordinary skill in the art can determine “wherein the at least one registration characteristic of the over-the-wire device is a hub” and “wherein the optical shape sensing registration controller is configured to automatically identify the hub from the automatic detection of the at least one sensing feature of the optical shape sensing guidewire” by looking at an image of the optical shape sensing guidewire over the over-the-wire device and determining the hub type from the image. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim additional recites a hub. However, these additional elements do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea. However, these additional elements do not integrate the judicial exception into a practical application. This is because the additional element generally link the use of a judicial exception to a particular technological environment or field of use, see MPEP § 2106.04(d)(I), in this case, the additional element limits the claim to the optical shape sensing guidewire/catheter field.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. The hub merely linking the use of the judicial exception to a particular technological environment or field of use. Optical shape sensing on an articulated system/catheter with a guidewire is well-known, routine, and conventional. Barrish et al. (US 20170157363 A1) disclose the use of known sensor technologies, including optical fiber shape sensors for an articulated system ([0128]), i.e. catheter/guidewire system with a “hub” which is made of optical fibers to get feedback on the shape of the catheter.
Accordingly, claim 2 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 3,
Step 1: Statutory category: Yes- An optical shape sensing registration system is disclosed, and therefore, is an apparatus.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations
”a hub template; and wherein, when the hub is attached to the over-the-wire device, the optical shape sensing registration controller being configured to automatically identify the hub from the automatic detection of the at least one sensing feature of the optical shape sensing guidewire includes the optical shape sensing registration controller configured to: compare the optical shape sensing of a translation of the optical shape sensing guidewire through the hub to a plurality of pre-defined hub templates; and select a one of the pre-defined hub templates having a best shape match to the hub template”.
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. One of ordinary skill in the art can perform this step by looking at images of hub templates, and comparing the hub to the set of images containing hub types. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim additional recites a hub. However, these additional elements do not integrate the judicial exception into a practical application. This is because the additional element generally link the use of a judicial exception to a particular technological environment or field of use, see MPEP § 2106.04(d)(I), in this case, the additional element limits the claim to the optical shape sensing guidewire/catheter field. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. The hub merely linking the use of the judicial exception to a particular technological environment or field of use. Optical shape sensing on an articulated system/catheter with a guidewire is well-known, routine, and conventional. Barrish et al. (US 20170157363 A1) disclose the use of known sensor technologies, including optical fiber shape sensors for an articulated system ([0128]), i.e. catheter/guidewire system with a “hub” which is made of optical fibers to get feedback on the shape of the catheter.
Accordingly, claim 3 is directed to non-eligible patent subject matter and is therefore rejected.
Regarding claim 5,
Step 1: Statutory category: Yes- An optical shape sensing registration system is disclosed, and therefore, is a device.
Step 2: Step 2A, Prong 1, Judicial Exception: Yes- This claim recites the limitations
“wherein the optical shape sensing registration controller being configured to automatically determine the at least one registration characteristic of the over-the-wire device from an automatic detection of the at least one sensing feature of the optical
shape sensing guidewire includes the optical shape sensing registration controller being configured to: measure a length of the over-the-wire device based on an analysis of a curvature of the optical shape sensing of the translation of the optical shape sensing guidewire through the over-the-wire device”
This limitation, as drafted, according to its broadest reasonable interpretation, recites a mental-process, which can practically be performed in the mind and/or with the with the aid of pen and paper or with a generic computer, in a computer environment, or merely using the generic computer as a tool to perform the steps. One of ordinary skill in the art can perform this step by measuring the length of the device based of the curvature of the optical shape sensing guidewire, by calculating the length using an image of the optical shape sensing guidewire by hand using an image.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or be reasonably performed with an aid of pen and paper or on a generic computer. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – The claim does not
contain additional elements. Therefore, the claim does not integrate the judicial
exception into a practical application.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim.
Accordingly, claim 5 is directed to non-eligible patent subject matter and is therefore rejected.
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 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Bydlon et al. (WO 2018096491 A1, of record, hereinafter "Bydlon") in view Ekin (EP 3545847 A1).
Regarding claim 1, Bydlon teaches an optical shape sensing registration system, comprising:
an optical shape sensing guidewire (shape sensing system 104 includes one or more optical fibers which may be arranged in a set pattern or patterns… 104 with fiber optics may be based on fiber optic Bragg grating sensors, Rayleigh scattering, or other types of scattering, Page 11 line 22-Page 12 line 4) translatable within an over-the-wire device (The guidewire 108 is configured to receive the system 104 therethrough or thereabout the devices 102 and 109 may include a catheter… or other medical component having a lumen, etc., page 11 lines 13-18; workstation 112 is configured to receive feedback from the shape sensing device 104 and record accumulated position data as to where the sensing device 104 has been within a volume 130. The shape sensing information within the space or volume 130 can be displayed on a display device 118; page 13 lines 1-4; the shape-sensing guidewire 104 is translatable within the over-the-wire device 108 which has a sheath, within the volume/lumen of 130 of the device, as shown in fig.1)
and an optical shape sensing registration controller (Workstation 112 preferably includes one or more processors 114 and memory 116 for storing programs and applications. Memory 116 may store an optical sensing module 122 configured to interpret optical feedback signals from a shape sensing device or system 104, page 11 lines 1-4) for controlling an [automatic] device registration of the over-the-wire device (Mapping the shape sensed data to the locations of the devices can be done in a plurality of ways. … the devices 102, 109 may be placed and attached to the hub 106 (or hubs) in an x-ray field of view (FOV) and have its length/dimension automatically detected from the resulting image, page 14 lines 13-24) wherein the optical shape sensing registration controller (114) is configured to:
automatically detect (search algorithm in the image processing module 148 may be employed that looks at shape sensed data along the shape sensed device (108) and identifies a template from within the shape data. This could be done fully automatically (search algorithm looks along a straight guidewire and finds the most likely hub or other reference candidate); with user input to confirm the automatically detected hub or reference, or to limit the search range to find the hub or reference, or to position the hub or reference in two different locations (to help the algorithm find the thing that changed); with full user input to select the hub or reference from the shape, with x-ray (or other imaging such as optical, ultrasound, MRI, etc.) to image the hub or reference and then detect the path, page 15 line 23- Page 16 line 6) at least one sensing feature of the optical shape sensing guidewire (a length of one or both devices 102, 109 may be input to an image processing module 148, which renders a position and dimension(s) of the devices using visualization software, page 14 lines 12-15) from an optical shape sensing of a translation of the optical shape sensing guidewire within the over-the-wire device (The guidewire 108 is configured to receive the system 104 therethrough or thereabout the devices 102 and 109 may include a catheter… or other medical component having a lumen, etc, page 11 lines 13-18; workstation 112 is configured to receive feedback from the shape sensing device 104 and record accumulated position data as to where the sensing device 104 has been within a volume 130. The shape sensing information within the space or volume 130 can be displayed on a display device 118; page 13 lines 1-4; shape-sensing guidewire 104 is translatable within the over-the-wire device 108 which has a sheath, within the volume/lumen of 130 of the device, as shown in fig.1); and
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automatically determine (search algorithm in the image processing module 148 may be employed that looks at shape sensed data along the shape sensed device (108) and identifies a template from within the shape data. This could be done fully automatically (search algorithm looks along a straight guidewire and finds the most likely hub or other reference candidate); page 15 line 23- Page 16 line 6) at least one registration characteristic of the over- the-wire device (employ the 'hub' with a known profile which can be stored as a template. When a shape sensed device is inside a non-shape sensed device, the shape information from the sensed device can be used to infer information about the shape and position of the unsensed device. The registration needed may include a longitudinal translation between the two or more devices. This registration can be performed by using a known shape deformation of the sensed device at a specific location along the unsensed device or devices. The shape deformation can be detected through curvature detection, axial strain (from heating or tension), 2D or 3D shape matching, etc., Page 6 lines 1-21; the registration characteristic a hub in light of claim 2) from an automatic detection of the at least one sensing feature of the optical shape sensing guidewire (the shape sensed device can utilize Fiber- Optical RealShape™ (FORS™ also known as "Optical Shape Sensing" page 7 lines 17-18; The shape sensing may include a FORS™ system that can pass through a lumen of the guidewire, page 21 line 21; a length of one or both devices 102, 109 may be input to an image processing module 148, which renders a position and dimension(s) of the devices using visualization software, page 14 lines 12-15) within the over-the-wire device (The guidewire 108 is configured to receive the system 104 therethrough or thereabout the devices 102 and 109 may include a catheter… or other medical component having a lumen, etc., page 11 lines 13-18; workstation 112 is configured to receive feedback from the shape sensing device 104 and record accumulated position data as to where the sensing device 104 has been within a volume 130. The shape sensing information within the space or volume 130 can be displayed on a display device 118; page 13 lines 1-4; shape-sensing guidewire 104 is translatable within the over-the-wire device 108 which has a sheath, within the volume/lumen of 130 of the device, as shown in fig.1, i.e. the optical shape sensing guidewire within the over-the-wire device).
Bydlon, however, is silent regarding [an optical shape sensing registration controller for controlling an] autonomous [device registration of the over-the-wire device].
Ekin is considered analogous to the instant application as “Assessing device for assessing an instrument's shape with respect to its registration suitability” is disclosed (title). Ekin teaches an optical shape sensing registration controller (optical shape sensing device being adapted for determining the further position and shape of the catheter 33 by optical shape sensing. The registration device 12 is constructed to also register the further position and shape determination device 11 with the position and shape determination device 10 [0034]; when the computer program is run on a computer controlling the assessing device [0020]) for controlling an autonomous device registration of the over-the-wire device (The registration device 12 is adapted to detect the guidewire in an image generated by the imaging device 2 and to use this guidewire detection in the image together with the current position and shape of the guidewire as provided by the position and shape determination device 10 for registering the imaging device 2 with the position and shape determination device 10. The detection of the guidewire in the image can be carried out fully automatically, semi-automatically or fully manually… [0029]1; For this predetermination, known machine learning algorithms can be used. The comparison with a predefined shape feature value range can also be a comparison with a single threshold, wherein in this case a range includes all values above or below the threshold [0011]; [0046], [0056]-[0057] discloses a learning algorithm for registration).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bydlon to include an optical shape sensing registration controller for controlling an autonomous device registration of the over-the-wire device, as taught by Ekin. Doing so would allow for proved assisting of the user in finding a shape which is suitable for the registration, as suggested by Ekin ([0057]).
Alternatively, while Bydlon is silent on is silent regarding [an optical shape sensing registration controller for controlling an] autonomous [device registration of the over-the-wire device], it is noted that the Applicant’s specification does not impute any significance and/or criticality to the claimed “autonomous device registration. More specifically, the Applicant’s specification discloses in paragraph [0033] that “(1) terms of the art including, but not limited to,… “automatic (and tenses thereof)” are to be interpreted as known in the art of the present disclosure and as exemplary described in the present disclosure”. Further, it is known in the art that that “autonomous” is to be defined as “(of a machine, device, etc.) able to operate with little or no human control or intervention.") able to operate with little or no human control or intervention”2, and “automatic” is defined as “(of a device, mechanism, etc.) able to activate, move, or regulate itself” 3. A device/mechanism that us autonomous and device/mechanism that is automatic are synonymous as both are able to operate without a user. Accordingly, it is herein asserted that the claimed “autonomous device registration device registration of the over-the-wire device” is neither significant nor critical, therefore, it would have been to would have been obvious to one of the ordinary skill in the art before the effective filing date, to change the autonomous device registration device registration of the over-the-wire device in Bydlon to be autonomous, in order to facilitate navigation of a catheter or other over-the-wire device during a surgical procedure. See MPEP 2144.04.III. Automating a manual activity. Such an automating of a manual activity would provide one with ordinary skill in the art with a system with minimal human intervention and, therefore, ensure minimal human error. Furthermore, the automation would ensure consistent and precise operation of a system over a series of operations.
Regarding claim 2, modified Bydlon teaches the optical shape sensing registration system of claim 1, as discussed above. Bydlon further teaches wherein the at least one registration characteristic of the over-the-wire device is a hub (A method to induce such a shape, curvature or strain profile is to employ the 'hub' with a known profile which can be stored as a template. When a shape sensed device is inside a non-shape sensed device, the shape information from the sensed device can be used to infer information about the shape and position of the unsensed device. The registration needed may include a longitudinal translation between the two or more devices. This registration can be performed by using a known shape deformation of the sensed device at a specific location along the unsensed device or devices. The shape deformation can be detected through curvature detection, axial strain (from heating or tension), 2D or 3D shape matching, etc., Page 6 lines 1-21);
and wherein the optical shape sensing registration controller is configured to automatically identify the hub from the automatic detection of the at least one sensing feature of the optical shape sensing guidewire (search algorithm in the image processing module 148 may be employed that looks at shape sensed data along the shape sensed device (108) and identifies a template from within the shape data. This could be done fully automatically (search algorithm looks along a straight guidewire and finds the most likely hub or other reference candidate), page 15 line 23- page 16 line 9).
Regarding claim 3, modified Bydlon teaches the optical shape sensing registration system of claim 2, as discussed above. Bydlon further teaches:
wherein the hub includes a hub template ('hub' with a known profile which can be stored as a template. Page 6 lines 1-21);
and wherein, when the hub is attached to the over-the-wire device, the optical shape sensing registration controller being configured to automatically identify the hub from the automatic detection of the at least one sensing feature of the optical shape sensing guidewire includes the optical shape sensing registration controller (employ the 'hub' with a known profile which can be stored as a template. When a shape sensed device is inside a non-shape sensed device, the shape information from the sensed device can be used to infer information about the shape and position of the unsensed device. The registration needed may include a longitudinal translation between the two or more devices. This registration can be performed by using a known shape deformation of the sensed device at a specific location along the unsensed device or devices. The shape deformation can be detected through curvature detection, axial strain (from heating or tension), 2D or 3D shape matching, etc., Page 6 lines 1-21) configured to:
compare the optical shape sensing of a translation of the optical shape sensing guidewire through the hub to a plurality of pre-defined hub templates (search algorithm in the image processing module 148 may be employed that looks at shape sensed data along the shape sensed device (108) and identifies a template from within the shape data. This could be done fully automatically (search algorithm looks along a straight guidewire and finds the most likely hub or other reference candidate), page 15 line 23- page 16 line 9);
and select a one of the pre-defined hub templates having a best shape match to the hub template (The full template can be detected, or a pattern-matching algorithm in the image processing module 148 could match the x-ray view of the hub or reference to potential template matches in a database, page 15 line 23- page 16 line -9
Regarding claim 5, modified Bydlon teaches the optical shape sensing registration system of claim 1, as discussed above. Bydlon further teaches:
wherein the optical shape sensing registration controller (Workstation 112 preferably includes one or more processors 114 and memory 116 for storing programs and applications. Memory 116 may store an optical sensing module 122 configured to interpret optical feedback signals from a shape sensing device or system 104, page 11 lines 1-4) being configured to automatically determine the at least one registration characteristic of the over-the-wire device from an automatic detection of the at least one sensing feature of the optical shape sensing guidewire includes the optical shape sensing registration controller (Mapping the shape sensed data to the locations of the devices can be done in a plurality of ways. … the devices 102, 109 may be placed and attached to the hub 106 (or hubs) in an x-ray field of view (FOV) and have its length/dimension automatically detected from the resulting image, page 14 lines 13-24) being configured to:
measure a length of the over-the-wire device based on an analysis of a curvature of the optical shape sensing of the translation of the optical shape sensing guidewire through the over-the-wire device (a length of one or both devices 102, 109 may be input to an image processing module 148, which renders a position and dimension(s) of the devices using visualization software, the devices 102, 109 may be placed and attached to the hub 106 (or hubs) in an x-ray field of view (FOV) and have its length/dimension automatically detected from the resulting image- Page 14, line 12-23).
Response to Arguments
Applicant’s arguments, see appeal brief, filed 10/24/2025, with respect to the rejection of claim 1 under 35 U.S.C. § 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ekin (EP 3545847 A1) to teach autonomous device registration.
Regarding the 35 U.S.C. §101 rejection of claim 1, applicant argues the following on remarks:
Page 5-6: “No abstract idea is identified in the rejection of claim 1…. There is no such characterization of claim 1 in the rejection, and instead the rejection characterizes about 3/5 of the features loosely as being performable in the mind”. In response, the examiner respectfully disagrees. MPEP 2106.04(a) lists the Abstract Ideas categories, which states “The enumerated groupings of abstract ideas are defined as:…3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion)”.
Page 6-8: The claims are not directed to a mental process performable in the human mind. In response, the examiner respectfully disagrees. The examiner respectfully disagrees. A judgement/decision is being made on a) a feature/registration characteristic of the device (hub type, length, etc.), and b) a “sensing feature” of the device (such as a curve, twist, etc.). These steps are judgements/evaluations that can be made by viewing an image of the device. The optical shaping guidewire and the OTW device are used to linking the use of the judicial exception to a particular technological environment or field of use
Pages 9-10: The "optical shape sensing guidewire," "over-the-wire device" and "optical shape sensing registration controller" are not properly characterized as additional elements that only generally link the use of a judicial exception to a particular technological environment or field of use” …The Advisory Action then argues that "these elements are well-known, routine, and conventional" as if taken as true this would justify ignoring these features from the eligibility analysis. There is no justification for any such intentional ignorance of claim features in an eligibility analysis, not in the MPEP and not in the caselaw. In response, the examiner respectfully disagrees. Examiner notes on page 4 of remarks that “Barrish et al. (US 20170157363 A1) disclose the use of known sensor technologies, including optical fiber shape sensors for an articulated system ([0128]), i.e. catheter/guidewire system, which is used to show that that the use of a controller, optical shape sensing guidewire, and over-the-wire device are well-known, routine, and conventional.
Pages 10-15: The claims also amount to significantly more than any judicial exception…For the instant application, the technology problem that requires the claimed technology solutions is that registration characteristics of a medical device must be known to support spatial tracking of the medical device during a minimally invasive procedure using OSS. The details for how this registration is performed do not comprise an abstract idea, but even if they were properly considered to comprise an abstract idea, the "how" is well established in the claims and application, and this includes in claims withdrawn by the Examiner… As described above, the technology problem that requires the claimed technology solutions described in the instant application is that registration characteristics of a medical device must be known to support spatial tracking of the medical device during a minimally invasive procedure using OSS. In response, the examiner respectfully disagrees. In response to applicant’s argument, examiner respectfully disagrees. There is no recitation of a procedure in which the steps are performed. The claims merely recite automatically detect at least one sensing feature of the optical shape sensing guidewire, and automatically determine at least one registration characteristic of the over-the- wire device, with no specific steps/procedure listed.
Accordingly, the argument is not persuasive and the 35 U.S.C. §101 rejection is maintained.
Conclusion
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/N.B./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
1 Applicant’s own specification, in paragraph 0033 establishes “(1) terms of the art including, but not limited to,…“autonomous (and tenses thereof)”…are to be interpreted as known in the art of the present disclosure and as exemplary described in the present disclosure…” (emphasis added). It is well-known in the art that “autonomous” means “(of a machine, device, etc.) able to operate with little or no human control or intervention.” (Link: https://www.dictionary.com/browse/autonomous) and “automatic” means “having the capability of starting, operating, moving, etc., independently.” (Link: https://www.dictionary.com/browse/automatic). These two terms both are regarding the ability of a device/mechanism being able to function on their own and without human intervention. This is the commonly understood definition of the terms and is consistent with Applicant’s admission in the specification that “autonomous” is “to be interpreted as known in the art of the present disclosure” (Paragraph 0033).
Furthermore, Ekin establishes in paragraph 0029 that the operation can be fully automatic, semi-automatic, or fully manual. Given that Ekin provides the three embodiments, where two of them are with partial control by the operator or complete control by the operator, one with ordinary skill in the art would understand that “fully automatically” means that the device is able to operate completely without the operator or human intervention.
Additionally, it should be noted that the term “automatically” is entirely consistent with “autonomous” and encompasses the later term as Applicant themselves have admitted “the term ‘automatic’ broadly encompasses autonomous action or actions performed by a controller” in paragraph 0033 (emphasis added). That is, even Applicant at the time of filing has admitted that the term “automatic” includes the term “autonomous”. Therefore, Ekin’s teaching of “fully automatically” encompasses the claim element of “autonomous”. It is consistent with the interpretation required by Applicant’s specification, it is consistent with the understanding of the art for one with ordinary skill in the art, and it is consistent with Applicant’s own admission that “the term ‘automatic’ broadly encompasses autonomous action or actions performed by a controller” (Paragraph 0033).
2 https://www.dictionary.com/browse/autonomous
3 https://www.dictionary.com/browse/automatic