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
Claims 13, 14, 18-20, and 22-24 are pending in this application. Claims 15-17, and 21 are cancelled, claims 13, 14, 18-20 have been amended, Claims 23 and 24 are newly added, and Claims 13, 14, 18-20, and 22-24 have been examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 14, 18-20, and 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 (and similarly Claim 13) recites the limitation of “outputting information based on an evaluation result of evaluating the implantation state wherein the method further comprises measuring,”. It is unclear what the evaluation result is or how this evaluation was completed. Further, it is unclear if the following methods are in regards to the evaluation result. For purposes of examination, the limitation has been construed as outputting evaluation results upon determining the implantation state, with the evaluation results being further defined by the methods proceeding. However, further clarification is required.
Claim 19 recites the limitation “measure the dimension of the device before a tensile test based on the three- dimensional medical image collected before the tensile test of the device and the dimension of the device after a tensile test based on the three-dimensional medical image collected after the tensile test of the device”. It is unclear if the tensile test mentioned in line 3 is the same tensile test in line 5. For purposes of examination, the limitation has been construed as a measurement of the device before a tensile test based on the three-dimensional medical image, and the dimension of the device after the tensile test base on the three-dimensional medical image. However, further clarification is required.
The remaining claims are rejected due to their dependency to the independent claim.
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 13-14 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US20170132796A1) in view of Datta (US20220000445A1).
Regarding Claim 13,
Popovic teaches an ultrasonic image processing method (corresponding disclosure in at least [0015], where the device contains an ultrasound transducer for ultrasound images “The echocardiography imaging device is to be understood as an imaging device having a probe containing an ultrasound transducer at its tip”), comprising:
Generating a medical image relating to a target part in which a device is implanted based on an echo signal from an ultrasonic probe that receives or transmits an ultrasonic wave from and to a subject in which the device is implanted in the target the target part (corresponding disclosure in at least [0054], where the ultrasound image (TEE image) shows the device implant (plug) in the target part (left atrial appendage) “3D TEE image and FIG. 3B is a schematic drawing of a 2D TEE image, both showing a cross-section of the plug 50 used to close the left atrial appendage”);
evaluating an implantation state of the device with respect to the target part from multiple angles using the medical image (corresponding disclosure in at least [0062], where there are various angles that can be used based on a secondary imaging to view the targeted part “3D echocardiographic preparation image showing a cross-section of the plug 50 and an overlay of the indicator line 41 similar to the X-ray image of FIG. 2. The 3D TEE preparation image is oriented at the same projection angle as the X-ray image”; the evaluation being performed is whether or not the implant achieves the target implantation state, i.e. the target implantation location)
and outputting information based on an evaluation result of evaluating the implantation state,
(corresponding disclosure in at least [0055], where there is outputted information of the implantation (plug) and the implantation state (where the implant is located) “3D TEE image showing a cross-section of the plug 50. An additional indication 42 is defined in the TEE image. The additional indication 42 determines, together with an indicator defined in an X-ray image, another viewing plane, which is non-perpendicular or oblique to the X-ray imaging plane”),
wherein the method further comprises
measuring, by processing an image region for the device included in the three- dimensional medical image, a device diameter of the device in the implantation state at each of the respective multiple angles around an axis core of the device implanted in the target part (corresponding disclosure in at least [0057] and Figure 5, where the diameter is determined at each angle around the axis of the device; there is a point selected from the device with the size and shape being determined, which includes the diameter, this viewing plane being changed based on the various orientations, or angles; “This point projects from the 2D X-ray image onto the 3D TEE volume as a projection line since the 2D X-ray image does not have depth information. This projection line is also perpendicular to the X-ray image. A volume of interest can then be cropped out of the 3D TEE image centered on the line. The size and shape of the volume can be selected by the user to focus in on the device. In addition, an alternative 2D TEE viewing plane of the device and its surrounding region of interest can be generated by assigning a thickness to that line and extracting the data encompassed within the line from the 3D TEE image volume into a 2D TEE image band or viewing plane. To generate a 2D TEE image band or viewing plane at a specific device orientation, the 3D TEE image can be rotated around the projection line first to find a desired viewing plane, before changing the thickness of the line which defines the thickness of the 2D TEE image band”),
generating a map or a graph showing the device diameters (visually viewing the images in the 2D planes implicitly shows the diameter of the device; an image is a type of “map”) and
displaying, on a display, the generated map or graph (as in Figure 5, the image is displayed).
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Figure 5 of Popovic
While Popovic teaches measuring the device diameters and generating an image map showing the device diameters, as recited above, Popovic does not teach showing “predetermined proper values at the respective multiple angles” on the image map.
In the same field of endeavor, Datta teaches wherein the method further comprises measuring, by processing an image region for the device included in the three- dimensional medical image, a device diameter of the device in the implantation state at each of the respective multiple angles around an axis core of the device implanted in the target part (corresponding disclosure in at least [0121], where the device diameter is determined using the 3D image “the imaging unit 406 may be configured to facilitate resolution of diameter change of the device 404 when inserted into the left atrial appendage” and further in [0139], where it’s further described that multiple angles are shown to view the device, which would show the diameters of the device in each perspective “The detected imaging catheter 752 is shown as the practitioner navigates and guides the imaging catheter and an associated device to a desired location in the heart. The second depiction 760 shows a detected device 754 inside a heart chamber as seen from the perspective of the imaging plane 751. The second depiction 760 may be obtained using the imaging catheter 752”).
Datta further teaches a similar concept (measurement of LAA implants) of generating a map or a graph showing the device diameters and predetermined proper values at the respective multiple angles, and displaying, on a display, the generated map or graph (corresponding disclosure in at least [0138] and Figure 7B, where a map of the multiple angles (multiple depictions, or angles, of the device) is displayed “FIG. 7B comprises a plurality of depictions 750, 760, 770 of a detected imaging catheter 752 and a detected device inside a 3D rendering of a chamber of a heart. The depictions 750, 760, 770 may be shown on a user interface 790” and further in [0137], where the map is used to determine the predetermined proper values and the device diameters; through the multiple depictions that are shown, the proper fit of the device within the LAA is displayed, where the user can visually determine the diameter and whether the implanted device is appropriately adhered; “landmarks for one or more of an LAA position, location, and approximate diameter may be identified and shown to confirm that a selected device, such as an LAA occluder device, will fit properly without creating too much radial force or too little interference with the anatomy”; that is, the landmarks are used to depict the target/proper diameter value).
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Figure 7B of Datta
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a map or graph displaying the diameter of the device as taught by Datta. One of the ordinary skill in the art would have been motivated to incorporate this because it provides further information to the user regarding whether the device is implanted properly based on a quantitatively assured approach of ensuring proper adhesion of the implant at various angles.
Regarding Claim 14,
Popovic teaches An ultrasonic diagnosis apparatus comprising: signal processing circuitry configured to generate a medical image relating to a target part in which a device is implanted based on an echo signal from an ultrasonic probe that receives or transmits an ultrasonic wave from and to a subject in which the device is implanted in the target part (corresponding disclosure in at least [0054], where the ultrasound image (TEE image) shows the device implant (plug) in the target part (left atrial appendage) “3D TEE image and FIG. 3B is a schematic drawing of a 2D TEE image, both showing a cross-section of the plug 50 used to close the left atrial appendage”);
and processing circuitry configured to determine an implantation state of the device with respect to the target part from multiple respective angles using the three-dimensional medical data (corresponding disclosure in at least [0062], where there are various angles that can be used based on a secondary imaging to view the targeted part “3D echocardiographic preparation image showing a cross-section of the plug 50 and an overlay of the indicator line 41 similar to the X-ray image of FIG. 2. The 3D TEE preparation image is oriented at the same projection angle as the X-ray image”; the evaluation being performed is whether or not the implant achieves the target implantation state, i.e. the target implantation location),
and output information based on a result of the evaluation of the implantation state (corresponding disclosure in at least [0055], where there is outputted information of the implantation (plug) and the implantation state (where the implant is located) “3D TEE image showing a cross-section of the plug 50. An additional indication 42 is defined in the TEE image. The additional indication 42 determines, together with an indicator defined in an X-ray image, another viewing plane, which is non-perpendicular or oblique to the X-ray imaging plane”),
wherein the processing circuitry is further configured to measure, by processing an image region for the device included in the three- dimensional medical image, a device diameter of the device in the implantation state at each of the respective multiple angles around an axis core of the device implanted in the target part (corresponding disclosure in at least [0057] and Figure 5, where the diameter is determined at each angle around the axis of the device; there is a point selected from the device with the size and shape being determined, which includes the diameter, this viewing plane being changed based on the various orientations, or angles; “This point projects from the 2D X-ray image onto the 3D TEE volume as a projection line since the 2D X-ray image does not have depth information. This projection line is also perpendicular to the X-ray image. A volume of interest can then be cropped out of the 3D TEE image centered on the line. The size and shape of the volume can be selected by the user to focus in on the device. In addition, an alternative 2D TEE viewing plane of the device and its surrounding region of interest can be generated by assigning a thickness to that line and extracting the data encompassed within the line from the 3D TEE image volume into a 2D TEE image band or viewing plane. To generate a 2D TEE image band or viewing plane at a specific device orientation, the 3D TEE image can be rotated around the projection line first to find a desired viewing plane, before changing the thickness of the line which defines the thickness of the 2D TEE image band”),
generate a map or a graph showing the device diameters (visually viewing the images in the 2D planes implicitly shows the diameter of the device; an image is a type of “map”) and
display, on a display, the generated map or graph (as in Figure 5, the image is displayed).
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Figure 5 of Popovic
While Popovic teaches measuring the device diameters and generating an image map showing the device diameters, as recited above, Popovic does not teach showing “predetermined proper values at the respective multiple angles” on the image map.
In the same field of endeavor, Datta teaches wherein the method further comprises measuring, by processing an image region for the device included in the three- dimensional medical image, a device diameter of the device in the implantation state at each of the respective multiple angles around an axis core of the device implanted in the target part (corresponding disclosure in at least [0121], where the device diameter is determined using the 3D image “the imaging unit 406 may be configured to facilitate resolution of diameter change of the device 404 when inserted into the left atrial appendage” and further in [0139], where it’s further described that multiple angles are shown to view the device, which would show the diameters of the device in each perspective “The detected imaging catheter 752 is shown as the practitioner navigates and guides the imaging catheter and an associated device to a desired location in the heart. The second depiction 760 shows a detected device 754 inside a heart chamber as seen from the perspective of the imaging plane 751. The second depiction 760 may be obtained using the imaging catheter 752”).
Datta further teaches a similar concept (measurement of LAA implants) of generating a map or a graph showing the device diameters and predetermined proper values at the respective multiple angles, and displaying, on a display, the generated map or graph (corresponding disclosure in at least [0138] and Figure 7B, where a map of the multiple angles (multiple depictions, or angles, of the device) is displayed “FIG. 7B comprises a plurality of depictions 750, 760, 770 of a detected imaging catheter 752 and a detected device inside a 3D rendering of a chamber of a heart. The depictions 750, 760, 770 may be shown on a user interface 790” and further in [0137], where the map is used to determine the predetermined proper values and the device diameters; through the multiple depictions that are shown, the proper fit of the device within the LAA is displayed, where the user can visually determine the diameter and whether the implanted device is appropriately adhered; “landmarks for one or more of an LAA position, location, and approximate diameter may be identified and shown to confirm that a selected device, such as an LAA occluder device, will fit properly without creating too much radial force or too little interference with the anatomy”; that is, the landmarks are used to depict the target/proper diameter value).
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Figure 7B of Datta
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a map or graph displaying the diameter of the device as taught by Datta. One of the ordinary skill in the art would have been motivated to incorporate this because it provides further information to the user regarding whether the device is implanted properly based on a quantitatively assured approach of ensuring proper adhesion of the implant at various angles.
Regarding Claim 22, Popovic and Datta teach the limitations of Claim 14, and Popovic further teaches wherein the target part is a left atrial appendage, and the device is a left atrial appendage closure device (corresponding disclosure in at least [0052], where the targeted imaging region is the left atrial appendage, and there is a closure device (plug) “an X-ray image showing a device, in particular a plug 50, used to close a left atrial appendage (LAA) of a heart.”).
Regarding Claim 23, Popovic and Datta teach the limitations of Claim 14, and Popovic further teaches the ultrasonic probe that transmits the ultrasonic wave to the subject and receives the ultrasonic wave from the subject, and wherein the three-dimensional medical image is a three-dimensional ultrasonic image (corresponding disclosure in at least [0015], where there is an ultrasound probe being used, which transmits ultrasound waves to the subject with ultrasound waves being received for a 3D ultrasound image (three-dimensional) “an imaging device having a probe containing an ultrasound transducer at its tip, which probe may be passed into or placed onto the patient's body, for providing live ultrasound images and/or Doppler evaluation. The probe may be chosen from a variety of different probes, such as a transesophageal echocardiography (TEE) probe, which is to be inserted into the patient's esophagus, or a transthoracic echocardiography (TTE) probe, which is to be placed onto the patient's thorax. In particular, TEE provides cardiologists with real-time three-dimensional (3D) ultrasound imaging of cardiac anatomy”).
Claim 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US20170132796A1) and Datta (US20220000445A1) as applied in Claim 14, and in further view of Raikar (US20230074481A1).
Regarding Claim 18, the combined references of Popovic and Datta teach the limitations of Claim 14, and Datta further teaches displaying the measured value and the proper values of the dimension at each of the angles on the image (corresponding disclosure in at least [0138] and Figure 7B, where a map of the multiple angles (multiple depictions, or angles, of the device) is displayed “FIG. 7B comprises a plurality of depictions 750, 760, 770 of a detected imaging catheter 752 and a detected device inside a 3D rendering of a chamber of a heart. The depictions 750, 760, 770 may be shown on a user interface 790” and further in [0137], where the map is used to determine the predetermined proper values and the device diameters; through the multiple depictions that are shown, the proper fit of the device within the LAA is displayed, where the user can visually determine the diameter and whether the implanted device is appropriately adhered; “landmarks for one or more of an LAA position, location, and approximate diameter may be identified and shown to confirm that a selected device, such as an LAA occluder device, will fit properly without creating too much radial force or too little interference with the anatomy”; that is, the landmarks are used to depict the target/proper diameter value), but does not teach displaying a cross-sectional image and the measured values on the cross-sectional image.
Raikar, in a similar field of endeavor, teaches a similar concept (imaging of an implant) of wherein the processing circuitry is further configured to: display a cross-sectional image of a cross section orthogonal to an axis core of the device in the three-dimensional medical image (corresponding disclosure in at least [0054] and Figure 6 of Popovic, where a cross-sectional image is viewed of the device “3D echocardiographic preparation image showing a cross-section of the plug 50 and an overlay of the indicator line 41”);
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Figure 6 of Popovic
and display the measured value and the proper values of the dimension at each of the angles on the cross-sectional image (corresponding disclosure in at least Figure 10 and [0065] of Raikar, where there is a graphical representation for the implanted device with various angles it’s viewed from “the screen display includes a representation of the confidence of a position measurement, such as a numerical indicator, or a graphical representation similar or identical to the graph 1020. In some embodiments, the graphical indicator of the therapeutic device and/or a different indicator on the screen display may indicate the orientation of the therapeutic device with respect to the field of view of the image being used”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated displaying the cross-sectional image of the device in the three-dimensional medical image and the measured value of the cross-sectional image as taught by Raikar. One of the ordinary skill in the art would have been motivated to incorporate this because observing the cross-section of the device in the image is used to quantitively track the device for proper assurance of the adhesion of the device to its target.
Regarding Claim 24, Popovic and Datta teach the limitations of Claim 14, but do not teach wherein the processing circuitry is further configured to extract the image region from the three-dimensional medical image using a trained neural network that takes the three-dimensional medical image as an input.
Raikar, in a similar field of endeavor, teaches a similar concept of wherein the processing circuitry is further configured to extract the image region from the three-dimensional medical image using a trained neural network that takes the three-dimensional medical image as an input (corresponding disclosure in at least [0067], where the three-dimensional medical image (the 3D image data) is used as an input for a neural network “the device state can be derived based on the ability of convolutional neural networks to model complex patterns observed in natural and medical images. This data-driven method can be used to directly derive device state from the 3D image data”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the 3D medical image data as an input for a trained neural network as taught by Raikar. One of the ordinary skill in the art would have been motivated to incorporate this because using a neural network model with the 3D images as an input increases the robustness of the required task.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US20170132796A1) and Datta (US20220000445A1) as applied in Claim 14, and in further view of Clark (“Quantifying 3D Strain in Scaffold Implants for Regenerative Medicine”, 2020, Materials, 13(17), 3890)
Regarding Claim 19, Popovic and Datta teaches the limitations of 14, but does not teach wherein the processing circuitry is further configured to: measure the diameter of the device before a tensile test based on the three- dimensional medical image collected before the tensile test of the device and the diameter of the device after the tensile test based on the three-dimensional medical image collected after the tensile test of the device; and display the measured value of the diameter before the tensile test of the device and the measured value of the dimension after the tensile test.
Clark, in a similar field of endeavor, teaches a similar concept (3D imaging of implants) of measuring the dimension of the device before a tensile test based on the three- dimensional medical image collected before the tensile test of the device and the dimension of the device after a tensile test based on the three-dimensional medical image collected after the tensile test of the device; and display the measured value of the dimension before the tensile test of the device and the measured value of the dimension after the tensile test (corresponding disclosure in at least [2.2.2 “two-dimensional imaging], where initial measurements prior to the tensile test were recorded “. In combination with the mechanical loading, images were taken with a digital camera (750D, EF-S 60 mm lens and 34 mm extension tubes, Canon, Tyoko, Japan) mounted on a tripod (MKC3-P02, Manfrotto, Cassola, Italy) at a distance of approximately 20 cm from the sample to provide localised displacement and derived strain measurements when combined with digital image correlation software” and [3.2. “Three-Dimensional Implant Imaging and Strain Visualisation”], where 3D image post-tensile test (strain) data collection was completed “Samples were successfully imaged in 3D” and further in Figure 5, where the tensile test (strain) was displayed )’
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Figure 5 of Clark
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have used the 3D image to complete a tensile test measurement as taught by Clark. One of the ordinary skill in the art would have been motivated to incorporate this because after the implementation of the device, using a 3D medical image of the located device to determine such properties would alleviate further uses of other equipment to determine the strain put on the device in the surrounding area.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US20170132796A1) and Datta (US20220000445A1) as applied in Claim 14, and in further view of Thakur (US20200001092A1).
Regarding Claim 20, Popovic and Datta teaches the limitations of Claim 14 and the electrocardiograph (corresponding disclosure in at least [0009], where there is an electrocardiographic I mage viewed alongside the medical image “The processing unit is adapted for registering or fusing the X-ray image and the echocardiographic image together, and for then selecting or providing a view of the electrocardiographic image in accordance with the identified viewing plane”), measuring the diameter of the device based on the three-dimensional medical image of a frame and display the measured value of the diameter of the device (corresponding disclosure in at least [0057] and Figure 4, where the measured value (size) of the device can be seen “It is also possible to generate a viewing plane from a single indicator point placed on a device, such as the plug 50 or a catheter tip, in the X-ray image. This point projects from the 2D X-ray image onto the 3D TEE volume as a projection line since the 2D X-ray image does not have depth information. This projection line is also perpendicular to the X-ray image. A volume of interest can then be cropped out of the 3D TEE image centered on the line. The size and shape of the volume can be selected by the user to focus in on the device”)
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Figure 4 of Popovic
Popovic does not teach a memory storing chronological frame data of the three-dimensional medical image. the frame data being associated with an electrocardiographic time phase, wherein the processing circuitry is further configured to: specify, in the electrocardiographic time phase. a maximum time phase at which the diameter of the device becomes a maximum value and/or a minimum time phase at which the diameter of the device becomes a minimum value.
Thakur, in a similar field of endeavor, teaches a similar concept (electrocardiographic time phases) of specifying, in the electrocardiographic time phase, a maximum time phase at which the diameter of the device becomes a maximum value and/or a minimum time phase at which the diameter of the device becomes a minimum value (corresponding disclosure in at least [0080], where information is provided at the maximum contraction (maximum value) of the ECG “The pressure sensor 640 and/or electrodes 620, 622 may provide information to the circuitry regarding the cardiac cycle to allow the gyroscope 642 to be selectively activated at useful times, such as during a maximum contraction of the heart (at max positive dP/dt) and/or during max filling (at max negative dP/dt). In some cases, the gyroscope 642 may continuously acquire data related to the movement of the heart, at least for a period of time”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the electrocardiographic time phase to receive a maximum time phase value as taught by Thakur. One of the ordinary skill in the art would have been motivated to incorporate this because the ECG is another method of monitoring the heart and how it behaves in combination with the device implanted.
Response to Arguments
Applicant’s arguments in regards to the 35 U.S.C. 101 rejection filed 02/06/2026 has been considered and the rejection is withdrawn in light of the amendments.
Applicant’s arguments in regards to the 35 U.S.C. 112b rejection filed 02/06/2026 has been considered and the rejection is withdrawn in light of the amendments.
Applicant’s arguments with respect to claims 13 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797
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