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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Claim Objections
Claims 15-16 are objected to because of the following informalities:
Claim 15 recites the limitation “[t]he external inspection system of claim 8.” However, the “external inspection system” is initially recited in claim 9. Based on the order of the claims, it appears that claim 15 contains a clerical error (claim 15 should depend from claim 9 rather than claim 8).
For the purpose of further examination, claim 15 has been interpreted as dependent on claim 9.
Claim 16 depends from claim 15 and therefore inherit all of the deficiencies of claim 15 discussed above.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “an internal inspection device configured to inspect,” “an external inspection device configured to inspect,” “an internal inspection scope configured to capture,” “a support structure configured to support,” and “interior space is configured for the medical device” in claims 1-16.
One of ordinary skill in the art would understand that the claims are directed to elements with sufficient structure, materials, and/or acts (e.g., medical device inspection, borescope, camera, etc.).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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)”); 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”).
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 Figs. 1, 3, & 5; Freifeld ¶¶0010 & ¶¶0024 discussed above teaches a borescope for inspecting an inner surface); 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, ¶¶0019, ¶¶0025 & ¶¶0028 discussed above).
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 a method of inspecting a medical device, the method comprising:
capturing images of an interior of a medical device (Freifeld ¶¶0006, ¶¶0010, & ¶¶0024 discussed above);
capturing images of an exterior of the medical device (Freifeld ¶¶0011, ¶¶0021, & ¶¶0025 discussed above); and
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 (Freifeld ¶¶0007, ¶¶0011, & ¶¶0025 discussed above).
Claim Rejections - 35 USC § 103
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.
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 8, 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
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.
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/Soo Shin/Primary Examiner, Art Unit 2667 571-272-9753
soo.shin@uspto.gov