DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 07/07/2026 has been entered.
4. Currently claims 1, 4, 5, 9, 12, 13, 17 and 19 have been amended; whereas claims 2 and 10 are canceled. Therefore, claims 1, 3-9 and 11-23 are pending in this application.
Claim Rejections - 35 USC § 112
5. The following is a quotation of the first paragraph of 35 U.S.C.112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C.112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
● Claims 1, 3-9 and 11-23 are rejected under 35 U.S.C.112(a) or 35 U.S.C.112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Each of claims 1, 9, 17 recites the process of detecting a medical instrument within a phantom object based on sensor data captured by a sensor—namely, a camera that captures video or image data; wherein the process further comprises:
(i) capturing a first image of a tip of the medical instrument and a target point associated with a spherical tipped protruding marker positioned within an interior area of the phantom object;
(ii) capturing a second image of a region of the medical instrument different than the tip to determine an orientation of the medical instrument and the target point; and
(iii) measuring a distance between the medical instrument and the target point associated the spherical tipped protruding marker based on (a) the sensor data, (b) the first image and (c) the second image.
However, the original disclosure does not have sufficient written description regarding the above implementation.
For instance, the original specification lacks written description regarding the claimed implementation, wherein three different parameters—namely, (a) the sensor data (which is itself an image), (b) the first image and (iii) the second image, are evaluated to determine the distance between the medical instrument and the target point, as currently claimed.
Note that even the sections ([0024] to [0028]) that Applicant identified from the specification do not provide support regarding the claimed implementation above. For instance, the first section ([0024]) is describing the use of multiple cameras, which are positioned in various locations within the phantom object, in order to capture different views of the instrument and the target, as depicted per FIGs 1C to 1E.
The second section ([0025]) is describing the use of computer vision to measure the 3D coordinates of the instrument and the target; including the process of calibrating at least two cameras, which appear to form part of an optical measurement system; and evaluating the accuracy of this optical measurement system—such as, by comparing its distance measurement results (e.g., the distances it determined between three spherical targets) with distance measurement results obtained via CT scans.
The third section ([0026]) is describing the process of capturing of two images once the instrument reaches a desired position; wherein (i) the target, (ii) the tip of the instrument and (iii) a point on the instrument (which can be used to determine the orientation of the instrument) can be identified on both of the images; and subsequently, the distance between the target and the instrument tip, as well as the instrument line, can be obtained.
Although the section above appears to partially suggest some of the features of the current claims, it still does not support the claimed process which requires determining the distance between the medical instrument and the target point based on three different parameters—namely, (a) the sensor data, (b) the first image, and further (c) the second image. In fact, per the description above ([0026]), each of the first image and second image includes (1) the instrument tip, (2) the target, and (3) a region of the instrument different than the tip. In contrast, per the current claims, the first image includes just (1) the tip of the instrument, and (2) the target; whereas, the second image includes only (3) a region of the instrument different than the tip.
Of course, besides the inconsistencies above, the current claims also require additional parameter; namely, “sensor data”, which is also considered as part of measuring the distance between the medical instrument and the target point associated with the spherical tip protruding marker.
The fourth section ([0027]) is describing (a) a calibration/manual process that allows the user to select and define—via an interface—the target location, or (b) an automatic alternative for detecting the target location based on one or more markers and software. This section does not contemplate any specific feature directed to measuring a distance.
The fifth section ([0028]) is describing the process of displaying one or more distance measurements—such as, displaying the distance from one or more different parts (e.g., the tip, and/or the line) of the instrument and the target; and wherein the target can be defined as a marker.
Thus, the above section also does not describe any feature specific to measuring a distance; rather, it is describing the different options to display distance measurements that are already acquired.
The observation above conforms that the original disclosure, which includes the sections that Applicant specified from the specification, does not have sufficient support regarding the specific features current claimed. Consequently, the current claims constitute new subject matter at least for the reasons above.
Note that, when an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112(a), or first paragraph (pre-AIA ), a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure (see MPEP 2163.06).
6. 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 1, 3-9 and 11-23 are rejected under 35 U.S.C.112(b), or second paragraph (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Each of claims 1, 9, 17 recites the process of detecting a medical instrument within a phantom object based on sensor data captured by a sensor—namely, a camera that captures video or image data; wherein the process further comprises:
(i) capturing a first image of a tip of the medical instrument and a target point associated with a spherical tipped protruding marker positioned within an interior area of the phantom object;
(ii) capturing a second image of a region of the medical instrument different than the tip to determine an orientation of the medical instrument and the target point; and
(iii) measuring a distance between the medical instrument and the target point associated the spherical tipped protruding marker based on (a) the sensor data, (b) the first image and (c) the second image.
Accordingly, it is unclear what is encompassed per the claimed “sensor data”, which is considered as a separate parameter—i.e., a parameter different from the claimed “first image” and “second image”. In particular, given the fact that the claimed “sensor” is itself a camera, which confirms that the claimed “sensor data” is itself an “image” (i.e., the “first image” and/or the “second image”), it is unclear what third parameter is being considered, besides the “first image” and the “second image”, to measure the distance between the medical instrument and the target point associated
with the spherical tipped protruding marker.
Thus, at least for the reason above, the current claims are ambiguous. Applicant is further advised to evaluate each of the current claims and make appropriate corrections if additional discrepancies are discovered.
Prior Art
7 Considering each of claims 1, 9 and 17 as a whole, which includes the specific limitations noted under §112(a) and §112(b), the prior art does not teach the claims.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUK A GEBREMICHAEL whose telephone number is (571) 270-3079. The examiner can normally be reached from 7:00 AM - 3:00 PM.
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/BRUK A GEBREMICHAEL/Primary Examiner, Art Unit 3715
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