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 .
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 1-20 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.
Regarding claims 1 and 12, it is unclear what is and is not meant by “region marker information”. For the purpose of examination, coordinate information, biological/anatomical information, diagnostic information, or any other data which provides information about a “region” or “regions” of the interrogated area is considered to meet this limitation, so long as it includes at least a location of a lesion in some form (the location and the information are undefined in the way in which they are presented, displayed, etc. in the ultrasonic image). This could include the image pixels themselves being discernable, coordinates, intensity, anatomical data, linear data strings, SoS in the region, and other possible ways to convey differences in an ultrasound image.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10, 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam et al (US20200078103A1) in view of Steinberg et al (US 2019/0357883).
Regarding claims 1-6, and 12-15, Duindam et al discloses and teaches an ultrasound processor including configuration for acquiring an image which includes region(s) which can comprise a lesion (0035-0040, 0093), calculate an angle of a biopsy needle (0062-0066, see below for optimal angle setting) in the image or in projection data for insertion into a lesion based on a range of potential movement of a needle and the region(s) information (0093-0095), control of an actuator for mechanically directing an actuator toward a lesion, presentation of imaging data (0089-0095, 0071-0073), including angular data of the biopsy needle, as well as depth of the biopsy needle for insertion planning to the lesion (0058, 0089-0093), and the presentation of images/imaging data with respect to the actuator performing such a biopsy procedure (0091-0095, 0063-0064) including the historical angles of approach to the lesion, as well as updated guidance to approach from a desired angle (0091-0095, 0063-0065).
Specifically with respect to amended claims 1 and 12, Duindam et al discloses and teaches the setting of particular angles (optimal angle) of the biopsy needle based on imaging data (Camera data, 0062-0066, endoscopic data, 0063, Claim 9 in view of 6 and 1, 0091-0095) but does not derive such calculations from ultrasound data which includes the probe and needle.
Attention is hereby directed to the teaching reference to Steinberg et al which expressly discloses and teaches the treatment planning and guidance via ultrasonic endoscopy for biopsy treatment (0003, 0035-0036). The Steinberg et al reference includes the disclosure of a guide to adjust the angle of a biopsy needle (0005, 0040), as well as the inclusion of ultrasonic imaging components on the endoscopic probe with needle (0040, Fig 16, 0031-0032, 0037). The targeted lesion/region position is calculated relative to probe/needle positioning and the guidance is for a biopsy (0035-0037). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the ultrasonic acquisition of Steinberg added onto a biopsy system like that of Duindam et al which includes coordinate data, pathway overlays, and historical approach angles as well as instant angle calculations (from the coordinate data) in order to provide guidance and tracking during a biopsy procedure (Duindam et al, abs).
Regarding claims 7-10, and 16-19, Duindam et al discloses and teaches the calculation and display of lesion position relative to the pathway for the probe and biopsy needle and whereby the display includes coordinate information to provide indication to adjust the angle of the probe if needed (0091-0093, 0062-0064, 0072, 0079, 0084). Duindam et al discloses the adjustment of the needle to an “ideal” range (0062-0066). It would have been obvious to one of ordinary skill in the art to adjust the needle to an “allowable/movable” range given the physical limitations and constraints of the needle device during normal operation and tracking/guidance as the range of motion of a device is a parameter of routine optimization (see 0062-0063, A16-A17, 0096 for adjustments).
Additionally, Duindam et al discloses and teaches the display of tissue region(s) on the image including coordinate information and pathway information for the projection of the needle from a target location (Claim 1, 4, 11, Fig 9, 13, 0062-0064, 0090-0093). Finally, information regarding regions of the lesion and tissues of the (Fig 4, 5, 0072-0079) body to be avoided are determined and displayed for feedback control of the device during biopsy (element 530).
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam et al (US20200078103A1) in view of Steinberg et al (US 2019/0357883).
Duindam et al in view of Steinberg et al discloses and teaches an ultrasound biopsy system as indicated above, but fails to disclose detecting the region market information with a “trained model”, though regions are defined and identified as disclosed above in the rejections of claims 7-10 and 16-19, and modeling from pre-operative or intra-operative data is disclosed and taught (0037-0038, 0053, 0061-0063, Duindam et al).
Attention is hereby directed to the teaching reference to Bharat et al which specifically discloses and teaches the processor-based algorithmic identification through image analysis of image data/frames to identify target, to be avoided, tissue, and pathway regions of the interrogated region(s) (0038-0039).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized these trained learning systems to determine the imaging plane and views to display for guidance during biopsy (Bharat, 0038).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. The rejection under 112(b) with respect to the “region marker information” remains simply to denote that “region marker information”, in the realm and art of image processing, typically denotes information related to a “marker” or fiducial element, and not simply to a location in some form of coordinate data. Region “marking” information, would provide clarity based on the instant amendment to include “at least a location of a region of the lesion” recited.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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, Keith Raymond can be reached at (571)270-1790. 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.
/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798
Prosecution Insights