CTNF 19/221,533 CTNF 82797 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Drawings 06-37 AIA The drawings were received on 5/29/2025 . These drawings are accepted for examination . Claim Rejections - 35 USC § 112 07-30-02 AIA 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 2, 11-12 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 2, 11 and 12, it is unclear what is meant by “based on predetermined distance information to the distal end of the inner sleeve”, from claim 2, and similarly “as in a case where in the inner sleeve protrudes from the outer sleeve, before the inner sleeve protrudes from the outer sleeve” of claims 11-12. The claims are appearing to recite an overlaid position of a catheter with inner and outer sleeve in a particular arrangement, but the recitation is unclear exactly what is being physically recited or required by the method/CRM. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1-4 and 11-12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Glossop et al (US 2010/0217117) . Regarding claims 1-2, 11, and 12, Glossop et al discloses and teaches a processor configured to acquire a radiation image (0047) of a subject with a biopsy needle which protrudes from an outer sleeve via inner sleeve (0044, 0049-0050), detection of a needle in the image, and superposing the needle on the radiation image (0044). The virtual position of the needle is placed based on the coordinate data of the tip and the image data (0044). Regarding claims 3-4, the coordinate data is included in the superposition of the virtual position onto the image data (0043-0044) and the display of the coordinates of the distal end of the inner sleeve in an image of the region(0025, Fig 5-9) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 5-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glossop et al (US 2010/0217117) in view of Duffy et al (US 20200205775) . Glossop et al discloses what is listed above in the 102 rejection, ad also discloses the processing of sections (segmenting) for pathway planning, centerline, and the needle portions (Claims 11, 16-17, 19, 0044) including the identification of needle portions which extend from the end (beyond the sleeve, 0006, 0014, 0044, 0049-0050, coordinate data 0013, 0018, 0021), but does not disclose that the identification is based on density value for pixels and thresholded to identify the needle element. The detection of the needle portion beyond the sleeve is disclosed in the coordinate data tracking aspect to indicate the needle portion when deployed (0044, 0049-0050). Attention is hereby directed to the teaching reference to Duffy et al which expressly discloses the acquisition of needle data via radiation imaging (0051, ultrasonic imaging, inherently intensity based (density and SoS, 0011 , 0013, claim 9, 0054)), the thresholding of signal to identify the needle or other particular structures (0053-0054, Fig 14, Claims 12-15). Furthermore, Duffy et al discloses the detection of the tip of the needle element (0005, 0036-0038) and the display of the superposed data (Claim 12, Fig 12-15). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the acquisition of needle data via imaging including the density/intensity data as taught by Duffy with the teachings of Glossop et al in order to guide a biopsy procedure with needle for extension beyond a catheter (Glossop et al Claim 1, 0042 Duffy) . 07-21-aia AIA Claim (s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glossop et al (US 2010/0217117) in view of Duffy et al (US 20200205775) and in further view of Nishide et al (JP 2003325503) While Glossop et al in view of Duffy et al identifies and locates the needle tip, the calculation of a “central pixel” and identification of edge data to decide if pixels are part of the needle or not is not disclosed. While Glossop et al in view of Duffy et al definitely identifies a central axis (longitudinal for pathway planning and direction guidance towards the biopsy target), attention is hereby directed to the teaching reference which clearly discloses a candidate point evaluation and central pixel identification for a needle biopsy device in imaging data (0004, instant specification; S1209-S1210, Fig 14, 15, 18, Claim 17). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the center line/axis/pixel teaching of Nishide et al with the processing and image guidance of Glossop et al in view of Duffy et al for the purpose of facilitating guidance during a biopsy procedure (Glossop, abs) . Conclusion 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 Application/Control Number: 19/221,533 Page 2 Art Unit: 3798 Application/Control Number: 19/221,533 Page 3 Art Unit: 3798 Application/Control Number: 19/221,533 Page 4 Art Unit: 3798 Application/Control Number: 19/221,533 Page 5 Art Unit: 3798 Application/Control Number: 19/221,533 Page 6 Art Unit: 3798 Application/Control Number: 19/221,533 Page 7 Art Unit: 3798
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