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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
The amendment filed on June 15, 2026 has been entered.
The amendment of claims 1, 15, and 17 has been acknowledged.
In view of the amendment, the claim objections have been withdrawn.
Response to Arguments
Applicant’s arguments filed on June 15, 2026, with respect to claims 1 and 17-20, have been fully considered but they are not persuasive.
Applicant’s Representative submits that the prior art of record (Freifeld) does not teach internal and external inspection data including a time or a position of capture of the data.
The examiner respectfully disagrees. Freifeld ¶¶0011 teaches that “[a] first digital camera and lens are capable of imaging an exterior surface of the object. A borescope has a reflector at its distal end. This reflector redirects a field of view of the borescope to capture a view of the inner surface of the object by a second digital camera located at a proximal end of the borescope. A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data” (emphasis added).
The prior art teaches that the relative positions of the cameras and the object being inspected are calculated using the encoder signals in order to capture the interior and exterior images. In addition, the claim language requires only one of the alternative limitations (time or position).
In view of this reasonable interpretation of the claims and the prior art, the examiner respectfully submits that the rejections set forth below remain proper.
Applicant's arguments filed on June 15, 2026, with respect to claims 9 and 14-16, have been fully considered but they are not persuasive.
Applicant’s Representative submits that the prior art of record (Freifeld) does not teach a body having an interior surface defining an interior space as in claim 9 because the article 19 being inspected is held in fixture 37 that rotates and translates through operation of rotary stage 39 and linear stage, wherein the article is held in open space and moves with the fixture as the fixture is moved by the respective stages. Applicant’s Representative further submits that no part of Freifeld provides an interior surface defining an interior space through which a medical device passes during inspection of the medical device.
The examiner respectfully disagrees. Freifeld teaches that the borescope is for viewing an interior surface of a cylindrical article (Freifeld Abstract), and further teaches that medical stents and rifle barrels are two example objects being inspected using the borescope, wherein the cylindrical component has a relatively small inner diameter (Freifeld ¶¶0006). The prior art further teaches that the article 19 is a cylindrical object, e.g., a medical stent, having an inner surface 102 and an outer surface 104 (Freifeld ¶¶0018).
In view of this reasonable interpretation of the claims and the prior art, the examiner respectfully submits that the rejections set forth below remain proper.
Claim Rejections - 35 USC § 102
Claim(s) 1-13 and 17 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Freifeld et al. (US 2016/0231555 A1), hereinafter referred to as Freifeld.
Regarding claim 1, Freifeld teaches a medical device inspection system comprising:
an internal inspection device configured to inspect an interior of a medical device (Freifeld ¶¶0006: “Medical stents and rifle barrels are two exemplary members of this class”; Freifeld ¶¶0010: “there is provided a borescope configured to view an inner surface of an object under inspection”; Freifeld ¶¶0024: “a borescope 10 for use with the inspection system … has an image conducting tube 70 populated with internal relay lenses (not visible)”) to obtain internal inspection data, wherein the internal inspection data includes at least one of (Note that only one of the alternative limitations is required by the claim language):
a time the internal inspection data is captured; and
a position with respect to the medical device at which the internal inspection data is captured (Freifeld ¶¶0011: “A first digital camera and lens are capable of imaging an exterior surface of the object. A borescope has a reflector at its distal end. This reflector redirects a field of view of the borescope to capture a view of the inner surface of the object by a second digital camera located at a proximal end of the borescope. A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data”); and
an external inspection device configured to inspect an exterior of the medical device (Freifeld ¶¶0011: “This reflector redirects a field of view of the borescope to capture a view of the inner surface of the object by a second digital camera located at a proximal end of the borescope. A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data”; Freifeld ¶¶0021: “where the cylindrical component under inspection is not fully opaque, such as a medical stent, placing the light source outside the part under inspection and shining light towards the surface being imaged through the beamsplitter cube can create a uniformly illuminated image”; Freifeld ¶¶0025: “If the inspection protocol calls for an image to be captured from an outer surface of the object under inspection this same process is repeated, except this time using an outer diameter camera 31”) to obtain external inspection data, wherein the external inspection data includes at least one of (Note that only one of the alternative limitations is required by the claim language):
a time the external inspection data is captured; and
a position with respect to the medical device at which the external inspection data is captured (Freifeld ¶¶0011 discussed above).
Regarding claim 2, Freifeld teaches the medical device inspection system of claim 1, wherein the internal inspection device comprises an internal inspection scope including at least one camera, the internal inspection scope configured to capture images of the interior of the medical device (Freifeld ¶¶0010 & ¶¶0024 discussed above teaches a borescope for inspecting an inner surface).
Regarding claim 3, Freifeld teaches the medical device inspection system of claim 1, wherein the external inspection device comprises at least one camera configured to capture at least one image of the exterior of the medical device (Freifeld ¶¶0011 & ¶¶0025 discussed above teaches at least two cameras, including an outer diameter camera configured to capture an outer surface).
Regarding claim 4, Freifeld teaches the medical device inspection system of claim 3, wherein the external inspection device is configured to rotate the at least one camera about the exterior of the medical device (Freifeld ¶¶0011: “The inspection system includes a source of illumination, a fixture configured to support the object, a rotary stage configured to support the fixture such that rotation of the rotary stage rotates the object about a central cylindrical axis of that portion of the object that is generally rotationally symmetric”; Freifeld ¶¶0028: “A precision Y-Z alignment stage 29 along with a tip-tilt adjustment 28 can align the borescope 10 with the X-Axis stage holding the rotary stage 39 to enable the borescope 10 to focus on and accommodate parts 19 of varying diameter and shape”).
Regarding claim 5, Freifeld teaches the medical device inspection system of claim 4, wherein the external inspection device comprises a body rotatably mounted to a support structure for rotating the at least one camera about the exterior of the medical device (Freifeld ¶¶0011 discussed above teaches a rotary stage configured to support the fixture; Freifeld ¶¶0019: “The object under inspection is held in a fixture and rotated about its central cylindrical axis by a motorized rotary stage”; Freifeld Fig. 5: teaches an inspection system wherein the external inspection device is configured to rotate one camera about the exterior of a shaft. The external inspection device comprises a body rotatable mounted to a support structure for rotating the at least one camera about the exterior of the medical device).
Regarding claim 6, Freifeld teaches the medical device inspection system of claim 1, further comprising a support structure configured to support the internal inspection device and the external inspection device during the inspection of the interior and the exterior of the medical device (Freifeld ¶¶0011, ¶¶0019, & ¶¶0028 discussed above).
Regarding claim 7, Freifeld teaches the medical device inspection system of claim 1, further comprising a computing device that controls and coordinates the operation of the internal inspection device and the external inspection device (Freifeld ¶¶0011: “A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data. A computer is programmed to receive and process the image data and is also capable of one or more of displaying and performing quality analysis of the processed image data”).
Regarding claim 8, Freifeld teaches the medical device inspection system of claim 1, wherein the internal inspection device comprises a borescope (Freifeld ¶¶0010 & ¶¶0024 discussed above).
Regarding claim 9, Freifeld teaches an external inspection system for inspecting an exterior of a medical device, the external inspection system comprising an external inspection device, the external inspection device comprising:
a body having an interior surface defining an interior space, wherein the interior space is configured for the medical device to pass therethrough during an inspection of the medical device (Freifeld Abstract: “A first borescope for viewing an interior surface of a cylindrical article has an image conducting tube with a beamsplitter cube adjacent a distal end of the image conducting tube”; Freifeld Figs. 1, 3, & 5; Freifeld ¶¶0006: “Borescopes are commonly used to assess the quality of inner surfaces of a wide variety of industrial components … Medical stents and rifle barrels are two exemplary members of this class. When the cylindrical component has a relatively large inner diameter, it is easier and more practical to insert a traditional camera and lens fully within the cylinder. When the cylindrical component has a relatively small inside diameter, nominally 12 millimeters or less, a borescope is preferred”; Freifeld ¶¶0010: “there is provided a borescope configured to view an inner surface of an object under inspection”; Freifeld ¶¶0024: “a borescope 10 for use with the inspection system … has an image conducting tube 70 populated with internal relay lenses (not visible)”); and
a camera supported by the body and directed toward the interior space to capture images of the exterior of the medical device during the inspection (Freifeld ¶¶0011: “This reflector redirects a field of view of the borescope to capture a view of the inner surface of the object by a second digital camera located at a proximal end of the borescope. A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data”; Freifeld ¶¶0018: “the inspection system is particularly suitable for generally cylindrical objects 19 having an inner surface 102 and an outer surface 104 … such as a medical stent”; Freifeld ¶¶0019: “The object under inspection is held in a fixture and rotated about its central cylindrical axis by a motorized rotary stage”; Freifeld ¶¶0025: “If the inspection protocol calls for an image to be captured from an outer surface of the object under inspection this same process is repeated, except this time using an outer diameter camera 31”; Freifeld ¶¶0028: “A precision Y-Z alignment stage 29 along with a tip-tilt adjustment 28 can align the borescope 10 with the X-Axis stage holding the rotary stage 39 to enable the borescope 10 to focus on and accommodate parts 19 of varying diameter and shape”).
Regarding claim 10, Freifeld teaches the external inspection system of claim 9, further comprising a position tracker for determining a relative position of the external inspection device with respect to the medical device (Freifeld ¶¶0011: “A motion controller collects encoder signals from the rotary stage and using those encoder signals calculates a set of rotary positions at which to trigger the first and second digital cameras to acquire image data”).
Regarding claim 11, Freifeld teaches the external inspection system of claim 9, further comprising a computing device comprising an inspection analyzer, wherein the inspection analyzer analyzes the images of the exterior of the medical device to identify possible abnormalities of the medical device (Freifeld ¶¶0007: “automatically acquire and analyze …for machine vision algorithms to make measurements and find defects robustly”; Freifeld ¶¶0011 discussed above teaches performing quality analysis of the processed image data; Freifeld ¶¶0025: “The borescope camera 11 provides digital image data 92 to the computer 80 to display to an operator or conduct a quality assessment of the object being imaged”).
Regarding claim 12, Freifeld teaches the external inspection system of claim 11, wherein the inspection analyzer further comprises an abnormality detector that automatically identifies possible abnormalities of the medical device (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 discussed above).
Regarding claim 13, Freifeld teaches the external inspection system of claim 12, wherein the abnormality detector automatically detects the possible abnormalities of the medical device by processing the images of the exterior of the medical device (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 discussed above).
Regarding claim 17, Freifeld teaches that the system performs the processes described in claim 1, and further teaches inspecting the medical device for abnormalities using the images of the interior of the medical device and the images of the exterior of the medical device based on the respective times or the respective positions the images of the interior and exterior are captured (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 discussed above).
Therefore, claim 17 is rejected using the same rationale as applied to claim 1 discussed above.
Claim Rejections - 35 USC § 103
Claim(s) 14-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freifeld et al. (US 2016/0231555 A1), in view of Jackson et al. (US 2021/0386508 A1), hereinafter referred to as Freifeld and Jackson, respectively.
Regarding claim 14, Freifeld teaches the external inspection system of claim 11, but does not appear to explicitly teach that the inspection analyzer comprises one or more trained machine learning models operating on one or more neural networks.
Pertaining to the same field of endeavor, Jackson teaches that the inspection analyzer comprises one or more trained machine learning models operating on one or more neural networks (Jackson ¶¶0017: “a trained machine learning model may be used to analyze the image data and classify damage or abnormal states of an endoscope channel”).
Freifeld and Jackson are considered to be analogous art because they are directed to inspection devices. 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 borescope inspection system (as taught by Freifeld) to use a trained machine learning model (as taught by Jackson) because the combination can classify damage or abnormal dates of a medical device from newly captured images (Jackson ¶¶0078).
Regarding claim 15, Freifeld teaches the external inspection system of claim 9, but does not appear to explicitly teach that the system further comprises a wireless transceiver for wireless transmitting data from the camera.
Pertaining to the same field of endeavor, Jackson teaches a wireless transceiver for wireless transmitting data from the camera (Jackson ¶¶0030: “the testing and cleaning unit 128 is operably coupled (e.g., with a wireless or wired communication channel) with each of the visual magnification device 127, the borescope 126, and the visual processing system 130”).
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 borescope inspection system (as taught by Freifeld) to use a wireless transceiver (as taught by Jackson) because the combination can be used in portable and/or handheld systems (Jackson ¶¶0029).
Regarding claim 16, Freifeld, in view of Jackson, teaches the external inspection system of claim 15, further comprising at least one battery power source for powering the camera and the wireless transceiver (Freifeld Fig. 2; Jackson Fig. 6 & ¶¶0082: “a power source 630”).
Regarding claim 18, Freifeld teaches the method of claim 17, further comprising:
generating inspection data including the images of the interior of the medical device and the images of the exterior of the medical device (Freifeld ¶¶0006, ¶¶0010, & ¶¶0024 discussed above);
analyzing the inspection data and generating analysis data based on the analysis of the inspection data (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 discussed above); and
generating one or more outputs based on the analysis data (Freifeld ¶¶0026: “Application software running on the computer 80 allows a user to interact with the inspection system via a user interface 97 and specify, axially and rotationally, what areas of the object to image. The software is further configured to stitch together multiple image data of an inner surface or an outer surface enabling the computer to display a single unrolled view of the inner bore of the object”).
However, Freifeld does not appear to explicitly teach analyzing the inspection data using a machine learning model.
Pertaining to the same field of endeavor, Jackson teaches analyzing the inspection data using a machine learning model (Jackson ¶¶0017 discussed above).
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 borescope inspection system (as taught by Freifeld) to use a trained machine learning model (as taught by Jackson) because the combination can classify damage or abnormal dates of a medical device from newly captured images (Jackson ¶¶0078).
Regarding claim 19, Freifeld, in view of Jackson, teaches the method of claim 18, wherein the inspection data includes any one or more of:
(a) image data; (b) video data; (c) inspection metadata; (d) operational data documenting the operation of the inspection system; or (e) any combination of (a), (b), (c), and (d) (Note that only one of the alternative limitations is required by the claim language. Freifeld ¶¶0011: “receive and process the image data”; Freifeld Fig. 6).
Regarding claim 20, Freifeld, in view of Jackson, teaches the method of claim 18, wherein the analysis data includes a prediction of whether the medical device may have an abnormality (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 and Jackson ¶¶0017 discussed 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 SOO J SHIN whose telephone number is (571)272-9753. The examiner can normally be reached M-F; 10-6.
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, Matthew Bella can be reached at (571)272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Soo Shin/Primary Examiner, Art Unit 2667 571-272-9753
soo.shin@uspto.gov
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