Office Action Predictor
Last updated: April 15, 2026
Application No. 18/220,463

INSERTION APPARATUS FOR AN INVASIVE PROCEDURE AND METHOD

Final Rejection §103
Filed
Jul 11, 2023
Examiner
KIM, KAITLYN EUNJI
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Siemens Healthcare GMBH
OA Round
2 (Final)
58%
Grant Probability
Moderate
3-4
OA Rounds
2y 6m
To Grant
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allow Rate
7 granted / 12 resolved
-11.7% vs TC avg
Strong +66% interview lift
Without
With
+65.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
37 currently pending
Career history
49
Total Applications
across all art units

Statute-Specific Performance

§101
12.0%
-28.0% vs TC avg
§103
41.6%
+1.6% vs TC avg
§102
21.5%
-18.5% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 12 resolved cases

Office Action

§103
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, 4, 7, 13 are amended. Claims 1-18 remain pending in this application. 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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 20150338477 A1) in view of Scheffler (US 20050245811 A1) and further in view of Nock et al (US20200405276A1). Regarding Claim 1, Schmidt teaches an insertion apparatus for inserting a predefined needle-shaped instrument during an MR image-guided invasive procedure (corresponding disclosure in at least [0043], where a needle-shaped instrument is used during an MR-guided procedure; “structuring a passive composite system as a metallic/non-metallic composite needle facilitates the MR-guided interventional procedure”), the insertion apparatus comprising: a pen shaped main body including a longitudinal axis, wherein the pen shaped main body is not inserted into the body of the patient (corresponding disclosure in at least Fig. 1 and Fig. 2, where fig. 1 displays the “pen”-shaped body with the needle 100 within, and fig. 2 is a zoomed display of the needle 100 with the coil, or guidance sensor 200); PNG media_image1.png 115 419 media_image1.png Greyscale Figure 1 PNG media_image2.png 205 359 media_image2.png Greyscale Figure 2 a guidance facility (i.e. coil) in or on the pen shaped main body, the guidance facility (i.e. coil) configured for guiding the predefined needle-shaped instrument parallel to the longitudinal axis of the pen shaped main body (corresponding disclosure in at least [0048], [0046], and fig. 3, where the coil acts as a guidance facility for guiding the needle instrument inside the pen shaped main body and the coil 200 is inside the main body; “coil judiciously structured to enable accurate and quick tracking of the fully-metallic catheter needle, or quide-wire inside the MRI system”; “active-tracking is the use of an attachment… to the devices. Each of the alternative and practically-used, at the moment, approaches enables positioning of the tracking sensor(s)”); PNG media_image3.png 182 396 media_image3.png Greyscale Figure 3 a 3D magnetic field sensor (i.e. coil) in the pen shaped main body, the 3D magnetic field sensor configured for measuring magnetic field values (corresponding disclosure in at least [0038], where the coil acting as the 3D field sensor acquires 3D positioning and values; “The pulse sequence is used to multiplex the acquisition of the coil position information and to provide a description of the coil's 3D coordinates with four pulse excitations”); Although the “3 orthogonal directions” is known to be taught by Schmidt, it does not make mention of the 3 orthogonal directions. For compact prosecution, Scheffler is brought in to specifically show measuring the magnetic field values with respect to three orthogonal spatial directions. Scheffler teaches Hall sensors for measuring the magnetic field gradient along the 3 orthogonal directions (x, y and z direction) (corresponding disclosure in at least [0043], where “Hall sensors generate a Hall voltage that is proportional to the local magnetic field applied perpendicular to the Hall plate. The two main sources of magnetic fields generated within the imaging space of the MR scanner are (i) a very strong and static (i.e., homogenous) magnetic field Bo of about 1.5 T to 3 T, and (ii) the additional field gradients along the x, y, and z directions”). Further, Schmidt does not teach the signal interface configured for conveying the magnetic field values to an analysis facility external to the insertion apparatus. Scheffler further teaches a signal interface configured for conveying the magnetic field values to an analysis facility external to the insertion apparatus (corresponding disclosure in at least [0010] and [0037], where signal processing is all completed externally, where the processor can take direct measurement of the local magnetic field; “The system control unit 60 is also connected to send control signals to the RF transmission unit 15, which is connected to send signals to RF coil 14 so that an RF magnetic field gradient is generated in the measuring space as well. The signal detection unit 35 is connected to the probe 16 and detects the MR signals induced in the probe. When MR signals are detected, the signal detection unit 35 sends detection signals to the signal processing unit 50, where they are processed and converted to image signals by calculation.”) It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the combination noted above to include the signal interface for conveying the magnetic field values to an external analysis facility and specify the 3 orthogonal directions as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because sending the values out externally can allow for processing and conversion to image signals to be later stored into a memory (corresponding disclosure in at least [0037] of Scheffler). As can be clearly and factually seen above, Schmidt and Scheffler teach all the broad claimed limitations. Yet, in any case or in any interpretation, if one argues that the Schmidt and Scheffler do not teach pen shaped main body as claimed (i.e., pen shaped main body including a longitudinal axis, wherein the pen shaped main body is not inserted into the body of the patient) which the office does not concede, Nock’s reference (US20200405276A1) is brought in to also show that these features are further taught in an effort to provide compact prosecution. In the same field of endeavor, Nock teaches a similar concept (insertion device during MRI procedures) of a pen shaped main body including a longitudinal axis, wherein the pen shaped main body is not inserted into the body of the patient (corresponding disclosure in at least Figure 1, where there is a pen-shaped main body, which is not inserted into the body of the patient, which also contains a magnetic sensor further described in [0040] of Nock “probe (100) includes a magnet (not shown) that is detected by a Hall Effect sensor (not shown) or some other type of sensor in holster (200) when probe (100) is coupled with holster”). PNG media_image4.png 450 602 media_image4.png Greyscale Figure 1 of Nock It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pen shaped main body including a longitudinal axis, wherein the pen shaped main body is not inserted into the body of the patient as taught by Nock because it helps to provide selectively attachable to probe to provide actuation of various components within probe which in turn provides, a holster that is a reusable component, while probe and tissue sample holder are disposable ([0039] of Nock). Regarding Claim 2, 8, and 17, the combination noted teaches all the claimed limitations. Specifically, Scheffler teaches the apparatus wherein the 3D magnetic field sensor is a 3D Hall sensor (corresponding disclosure in at least [0020], where “the magnetic sensor navigation system of the second apparatus embodiment is modified so the one or more magnetic non-Faradaic sensors are selected from the group consisting of Hall sensors and magneto-optical sensors ...includes a single three-axis Hall sensor.”). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the combination noted above to include the 3D Hall sensor as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because the use of such sensor provides a measuring principle totally independent from MR image generation (corresponding disclosure in at least [0016] of Scheffler). Regarding Claim 3 and 9, the combination noted teaches all the claimed limitations. Specifically, Scheffler teaches the apparatus wherein the signal interface is configured for wired transfer (corresponding disclosure in at least [0037], [0038], and fig. 4, where the system control unit for signal transmission is externally wired and connected; “The magnetic sensor navigation system 10, in accordance with the present invention, includes a magnetic sensor array 20 electrically connected via a wire or connector 25 so as to send electric signals to an electronic sensor interface 30”). PNG media_image5.png 404 667 media_image5.png Greyscale Figure 3 It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the combination noted above to configure the signal interface for wired transfer as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because it allows for the signals to be processed to later be generated as image signals and further displayed (corresponding disclosure in at least [0038] of Scheffler). Regarding Claim 4 and 10, the combination noted teaches all the claimed limitations. Specifically, Scheffler teaches the apparatus wherein the guidance facility (i.e. magnetic sensor array) is arranged externally on the pen shaped main body (corresponding disclosure in at least [0040] and fig. 5, where the guidance facility (or the magnetic sensory array) is mounted on the body; “the magnetic sensor array 20 includes one or more magnetic sensors 22 that are mounted along, or mounted inside of, a guidewire or catheter 17”) PNG media_image6.png 203 516 media_image6.png Greyscale Figure 5 and includes a guidance axis at a displacement parallel to the longitudinal axis (corresponding disclosure in at least [0044] and fig. 5, where the guidance sensors 22 are parallel along the longitudinal axis; “the base member 24 is a guidance device and the sensors 22 are attached on the guidance device. In this illustration, the interventional device is a needle 19 and the needle position can be calculated, by the system control unit 60, from the measured orientation, (i.e. the Hall effect signals provided by one or more sensors 22), of the guidance device”), wherein the displacement is provided via the signal interface (corresponding disclosure in at least [0045], where the sensor signals can be processed with the system control unit (signal interface); “signals from the sensors 22 are processed by the processing and control unit 40, which in turn sends calculated position signals to the system control unit 60”). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the combination noted above to include the guidance facility arranged on the apparatus with the displacement of the guidance facility being provided via a signal interface as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because the guidance facility can assist in providing the needle position (corresponding disclosure in at least [0044] of Scheffler). Regarding Claim 5 and 11, the combination noted above teaches all the claimed limitations. Specifically, Schmidt teaches the apparatus wherein the guidance facility (i.e. the coils) is arranged centrally in the main body and has a guidance axis that is identical to the longitudinal axis of the main body (corresponding disclosure in at least fig. 6, where the coils 200, or the guidance facility, are central in the main body and the axis is identical to the longitudinal axis. PNG media_image7.png 181 395 media_image7.png Greyscale Figure 6 Regarding 6 and 12, the combination noted above teaches all the claimed limitations. Specifically, Schmidt teaches the apparatus wherein the predefined needle-shaped instrument includes a catheter, a guidewire, a brachytherapy needle, a biopsy needle or an ablation needle (corresponding disclosure in at least [0065], where a brachytherapy needle is employed; “the ability of the MRI-system to actively track metallic brachytherapy needles equipped with a flat RF-receiver coil-on-a-flexible-substrate was demonstrated”). Regarding Claim 7, the combination noted above teaches all the claimed limitations. Specifically, Schmidt teaches a magnetic resonance system comprising: a magnet unit configured to produce a magnetic field in an examination space (corresponding disclosure in at least [0025], where an MRI system produces a magnetic field within the examination space; “the ambient medium defined to carry the simulation of the radio-frequency (RF) magnetic field distribution around the needle while inside the MRI-system”); an MR image processing facility configured to produce an MR image according to the magnetic field in the examination space (corresponding disclosure in at least [0072] and fig. 7, where an MR image is produced from the examination space, with the produced MR image being shown in fig. 7; “MR image 2050 identifying the two microcoils 1630, 1632”); PNG media_image8.png 500 574 media_image8.png Greyscale Figure 7 an insertion apparatus configured to be placed and remain on a surface of a body of a patient, the insertion apparatus comprising: a pen shaped main body including a longitudinal axis (corresponding disclosure in at least Fig. 1 and Fig. 2, where fig. 1 displays the “pen”-shaped body with the needle 100 within, and fig. 2 is a zoomed display of the needle 100 with the coil, or guidance sensor 200); a guidance facility (i.e. coil) in or on the pen shaped main body, the guidance facility (i.e. coil) configured for guiding an insertion of a needle shaped instrument parallel to the longitudinal axis of the pen shaped main body, the needle shaped instrument to be inserted into the body of the patient (corresponding disclosure in at least [0048], [0046], and fig. 3, where the coil acts as a guidance facility for guiding the needle instrument inside the pen shaped main body and the coil 200 is inside the main body; “coil judiciously structured to enable accurate and quick tracking of the fully-metallic catheter needle, or quide-wire inside the MRI system”; “active-tracking is the use of an attachment… to the devices. Each of the alternative and practically-used, at the moment, approaches enables positioning of the tracking sensor(s)”); a 3D magnetic field sensor (i.e. coil) in the pen shaped main body, the 3D magnetic field sensor configured for measuring magnetic field values (corresponding disclosure in at least [0038], where the coil acting as the 3D field sensor acquires 3D positioning and values; “The pulse sequence is used to multiplex the acquisition of the coil position information and to provide a description of the coil's 3D coordinates with four pulse excitations”); Although the “3 orthogonal directions” is known to be taught by Schmidt, it does not make mention of the 3 orthogonal directions. For compact prosecution, Scheffler is brought in to specifically show measuring the magnetic field values with respect to three orthogonal spatial directions. Scheffler teaches Hall sensors for measuring the magnetic field gradient along the 3 orthogonal directions (x, y and z direction) (corresponding disclosure in at least [0043], where “Hall sensors generate a Hall voltage that is proportional to the local magnetic field applied perpendicular to the Hall plate. The two main sources of magnetic fields generated within the imaging space of the MR scanner are (i) a very strong and static (i.e., homogenous) magnetic field Bo of about 1.5 T to 3 T, and (ii) the additional field gradients along the x, y, and z directions”). Further, Schmidt does not teach the signal interface configured for conveying the magnetic field values to an analysis facility external to the insertion apparatus. Scheffler further teaches a signal interface configured for conveying the magnetic field values to an analysis facility external to the insertion apparatus (corresponding disclosure in at least [0010] and [0037], where signal processing is all completed externally, where the processor can take direct measurement of the local magnetic field; “The system control unit 60 is also connected to send control signals to the RF transmission unit 15, which is connected to send signals to RF coil 14 so that an RF magnetic field gradient is generated in the measuring space as well. The signal detection unit 35 is connected to the probe 16 and detects the MR signals induced in the probe. When MR signals are detected, the signal detection unit 35 sends detection signals to the signal processing unit 50, where they are processed and converted to image signals by calculation.”) It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the combination noted above to include the signal interface for conveying the magnetic field values to an external analysis facility and specify the 3 orthogonal directions as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because sending the values out externally can allow for processing and conversion to image signals to be later stored into a memory (corresponding disclosure in at least [0037] of Scheffler). As can be clearly and factually seen above, Schmidt and Scheffler teach all the claimed limitations. Yet, in any case or in any interpretation, if one argues that the Schmidt and Scheffler do not teach insertion apparatus remain on a surface of a body as claimed (i.e., an insertion apparatus configured to be placed and remain on a surface of a body of a patient) which the office does not concede, Nock’s reference (US20200405276A1) is brought in to also show that these steps are further taught in an effort to provide compact prosecution. In the same field of endeavor, Nock teaches a similar concept (insertion device during MRI procedures) of an insertion apparatus configured to be placed and remain on a surface of a body of a patient (corresponding disclosure in at least Figure 1, where there is a pen-shaped main body, which is not inserted into the body of the patient, which also contains a magnetic sensor further described in [0040] of Nock “probe (100) includes a magnet (not shown) that is detected by a Hall Effect sensor (not shown) or some other type of sensor in holster (200) when probe (100) is coupled with holster”). PNG media_image4.png 450 602 media_image4.png Greyscale Figure 1 of Nock It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pen shaped main body including a longitudinal axis, wherein the pen shaped main body is not inserted into the body of the patient as taught by Nock because it helps to provide selectively attachable to probe to provide actuation of various components within probe which in turn provides, a holster that is a reusable component, while probe and tissue sample holder are disposable ([0039] of Nock). Regarding Claim 13, Schmidt teaches a method for placing and aligning a needle-shaped instrument for an MR image- guided invasive procedure (corresponding disclosure in at least [0048], where there is a “task of precise and accurate localization of devices placed around, or within, a patient during MRI diagnostic imaging or MRI-guided interventions (sensors, probes, guidewires, sheathes, catheters, needles, etc.)”), the method comprising: specifying a needle trajectory for the needle-shaped instrument (corresponding disclosure in at least [0084], where “tracking data representing location and trajectory of the needle can be overlaid on pre-acquired MR image(s) and used to control the MRI imaging location and orientation thereby further improving real-time navigational guidance”); placing an insertion apparatus that includes the needle-shaped instrument and a 3D magnetic field sensor (i.e. coil 200), in an examination space (corresponding disclosure in at least [0038] and fig. 1, wherein the insertion apparatus of the needle 100, there is coil 200 providing 3D coordinates; “the pulse sequence is used to multiplex the acquisition of the coil position information and to provide a description of the coil's 3D coordinates with four pulse excitations”) ; PNG media_image9.png 211 424 media_image9.png Greyscale Figure 1 producing an MR image of the examination space with a representation of the needle trajectory (corresponding disclosure in at least [0081], where an MR image is provided by the MRI system to create an image of the needle and needle position; “governing the operation of the needle tracking, collecting the data representing the needle position and cooperating such data with data representing MR images provided by the MRI system to create a visually perceivable representation of the needle 1600, on a display device 2130”); automatically capturing signals from the 3D magnetic field sensor of the insertion apparatus in the examination space (corresponding disclosure in at least [0007], where the coils, which act as the 3D magnetic field sensor, of the insertion device can instantaneously capture the signals; “If a needle or catheter, equipped with active tracking micro-coils, is placed inside the anatomy, then this device can sense the instantaneous direction and magnitude of the motion. As a result, MRI imaging sequences can be constructed that interleave between active tracking and imaging segments”); depicting the insertion apparatus including the needle-shaped instrument accurately in terms of position and orientation in the MR image on a basis of the captured signals from the 3D magnetic field sensor (corresponding disclosure in at least [0009], where the image provided is not distorted and therefore provides accurate position and orientation data of the needle based on the coil, or 3D magnetic field sensor; “creation of conditions that help avoid distortions of the image provided by the MRI system on the one hand and yet are able to position the needle accurately with respect to a desired location in the tissue”; and [0066], where “the overall length of the needle 1600 retains its metallic properties, in practice the entire length of the needle remains trackable with the use of active and passive methods compatible with the MRI procedure, thereby providing a clinician with accurate detection data representing the position and orientation of the needle to arrive at an informed decision about the need to further reposition the needle”). Schmidt does not specify the insertion of the needle-shaped instrument into a body of a patient. Scheffler, in a similar field of endeavor, teaches a similar concept (MRI guided needles), of and inserting the needle-shaped instrument into a body of a patient (corresponding disclosure in at least [0039], where the needle-shaped instrument is inserted into the body “such as guidewire or catheter 17 or needle or needle holder 19, such as would be inserted into the test subject TS during a medical or surgical interventional procedure”). It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated specifying the insertion of the needle-shaped instrument into the patient body as taught by Scheffler. One of the ordinary skill in the art would have been motivated to incorporate this because the device is used for invasive procedures, specifically to be inserted into a patient. As can be clearly and factually seen above, Schmidt and Scheffler teach all the claimed limitations. Yet, in any case or in any interpretation, if one argues that the Schmidt and Scheffler do not teach (i.e., inserting the needle-shaped instrument into a body of a patient) which the office does not concede, Nock’s reference (US20200405276A1) is brought in to also show that these steps are further taught in an effort to provide compact prosecution. In the same field of endeavor, Nock teaches a similar concept (insertion device during MRI procedures) of an insertion apparatus configured to be placed and remain on a surface of a body of a patient (corresponding disclosure in at least Figure 1, where there is a pen-shaped main body, which is not inserted into the body of the patient, which also contains a magnetic sensor further described in [0040] of Nock “probe (100) includes a magnet (not shown) that is detected by a Hall Effect sensor (not shown) or some other type of sensor in holster (200) when probe (100) is coupled with holster”). It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with pen shaped main body including a longitudinal axis, wherein the inserted into the body of the patient as taught by Nock because it helps to provide selectively attachable to probe to provide actuation of various components within probe which in turn provides, a holster that is a reusable component, while probe and tissue sample holder are disposable ([0039] of Nock). Regarding Claim 14, the combined references of Schmidt and Scheffler teach all of Claim 13 and Schmidt further teaches a method wherein the needle trajectory in the MR image is specified by marking a needle entry point and a needle target point (corresponding disclosure in at least [0084], where the needle tip can be visualized as well as the full trajectory. “visualization of the needle tip with respect to the internal patient anatomy. The tracking data representing location and trajectory of the needle can be overlaid on pre-acquired MR image(s)”). Regarding Claim 15, Schmidt teaches the limitations of Claim 14 and further teaches a method wherein the needle trajectory is extrapolated beyond the needle entry point by an extrapolation trajectory (corresponding disclosure in at least [0079], where the position of the needle can be extrapolated using the coils, which act as the sensor; “The orientation of the needle device can be calculated by using the positional information provided by multiple (at least two) coils. The tip position of the needle can then be computed by extrapolating along the vector connecting two (or more) microcoils”). Regarding Claim 16, Schmidt teaches the limitations of Claim 15 and further teaches a method wherein the insertion apparatus is positioned and aligned in the examination space by the extrapolation trajectory of the MR image (corresponding disclosure in at least [0079], where the extrapolation method can be used by the clinician for practical use of the needle tip position; “The tip position of the needle can then be computed by extrapolating along the vector connecting two (or more) microcoils. Both the position and orientation information are transferred to a graphical workstation… Reducing this “jitter” aids in practical use of the needle tip position by the clinician”). Regarding Claim 18, the combined references of Schmidt and Scheffler teach all of Claim 13 and Schmidt further teaches a method wherein the needle-shaped instrument includes a catheter, a guidewire, a brachytherapy needle, a biopsy needle or an ablation needle (corresponding disclosure in at least [0065], where a brachytherapy needle is employed; “the ability of the MRI-system to actively track metallic brachytherapy needles equipped with a flat RF-receiver coil-on-a-flexible-substrate was demonstrated”). Response to Arguments In regards to the Drawing objections, the updated Drawings sheet dated 06/20/2025 has been considered and the objection is withdrawn. Applicant’s arguments filed 06/20/2025 with respect to the rejections under 35 U.S.C. 102(a)(1) and 35 U.S.C. 103 have been fully considered but they are not persuasive. With respect to the rejection regarding Claim 1, Applicant’s arguments have been considered but are moot because a new ground of rejection has been applied to the amended claims (wherein the pen shaped main body is not inserted into the body of the patient). Applicant argues that the insertion apparatus does not include a needle-shaped instrument as the insertion apparatus is not the instrument that is being inserted into the body of the patient. Rather, the insertion apparatus guides the needle-shaped instrument, for example, using the guidance facility that is in or on the pen shaped main body. However, Schmidt meets the limitation as there is an apparatus that would be used to guide the needle shaped instrument (in the red box of Figure 20A of Schmidt) with the needle attached (green box of Figure 20A of Schmidt). PNG media_image10.png 315 536 media_image10.png Greyscale Figure 20A of Schmidt Further, the reference Nock (US20200405276A1) has been brought in light of the amendments to also show that these steps are further taught in an effort to provide compact prosecution. Applicant further argues in Claim 1 that Schmidt would still fail to teach where the 3D magnetic field sensor is in or part of the pen shaped main body of the insertion apparatus that is not inserted into the body of the patient as Schmidt clearly teaches where the sensor is inserted with the needle into the body of the patient, but the argument is moot because a new ground of rejection has been applied to the amended claims. However, it can be further argued that Scheffler teaches the limitation in Figure 2A, where the main apparatus portion (pen shaped main body) is where the magnetic field sensor is located PNG media_image11.png 302 505 media_image11.png Greyscale Figure 2A of Scheffler Regarding Claim 4, Applicant argues in page 10 that Scheffler deals with a scenario where a needle and the pen are not aligned centrally, in other words where the distance to the axis is constant due to the mechanic construction, but the direction of the displacement relative to the pen may change depending on the way the user holds the pen. Examiner notes that Claim 4 only claims a “guidance facility” that is “arranged externally on the pen shaped mian body and includes a guidance axis at a displacement parallel to the longitudinal axis”, which is shown in Figure 2A of Scheffler. The guidance facility is arranged externally and parallel to the longitudinal axis. Applicant further argues Scheffler does not explicitly disclose computing or calculating any displacement, only where the signals can be "processed", and that there is no indication of an offset or displacement in the construction. [0044] of Scheffler notes the sensors calculates the needle position, which would provide the displacement between the guidance facility and where the needle is located (“the interventional device is a needle 19 and the needle position can be calculated, by the system control unit 60, from the measured orientation, (i.e. the Hall effect signals provided by one or more sensors 22), of the guidance device” [0044] of Scheffler). Further, there is a system control unit (60), which is interpreted as the signal interface disclosed in Claim 4. With respect to Applicant’s arguments to the remaining claims, see pages 6-16 regarding Claims 2, 3, 5-18, these claims are not allowable based on their dependence to the independent claims (1, 7, and 13) 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). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /K.E.K./Examiner, Art Unit 3797 /SERKAN AKAR/Primary Examiner, Art Unit 3797
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Prosecution Timeline

Jul 11, 2023
Application Filed
Oct 30, 2023
Response after Non-Final Action
Mar 18, 2025
Non-Final Rejection — §103
Jun 20, 2025
Response Filed
Aug 22, 2025
Final Rejection — §103
Mar 30, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+65.7%)
2y 6m
Median Time to Grant
Moderate
PTA Risk
Based on 12 resolved cases by this examiner. Grant probability derived from career allow rate.

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