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 Interpretation
For the purposes of examination, claim 1 of the invention will be given an effective filing date of 11/18/2021. The limitation “estimating a distance from the needle to the tissue or the space based on the identification and the OCT system” is not disclosed within the specification/drawings/claims of the provisional document (17/530,131), and so claim 1 cannot be given the filing date of 11/18/2020.
Response to Amendment
The amendment filed July 17th, 2026 has been entered. Claims 1, 4-13, and 16-22 remain pending in the application. Applicant’s amendments to the claims have overcome the 112(a) rejection previously set forth in the Non-Final Office Action mailed April 16th, 2026.
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 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.
Claims 1, 4, 8, 9, 11-13, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio et al (U.S. Patent Application Publication 2023/0108133, hereinafter “Kunio”) in view of Briggs et al (“Integrated Device for in Vivo Fine Needle Aspiration Biopsy and Elastic Scattering Spectroscopy in Preoperative Thyroid Nodules”, hereinafter “Briggs”), Sobol et al (U.S. Patent Application Publication 2021/0378505, hereinafter “Sobol”), and Page (U.S. Patent Application Publication 2019/0223759, hereinafter “Page”). Kunio teaches a method comprising:
obtaining an endoscope (paragraph 35 “an endoscope as disclosed”)
obtaining a needle comprising a hollow bore and a tip (paragraph 62 “such as one or more components of a probe… a needle”)
inserting the system into an animal body (paragraph 44 “inserted into a blood vessel of the patient”)
obtaining an image of a tissue or a space in the animal body using the endoscope and optical coherence tomography (OCT) (paragraph 1 “detecting external elastic lamina (EEL) from OCT image(s)”)
performing identification of the tissue or the space using an OCT system (paragraph 48 “(ii) detecting a lumen”)
determining at least one of (1) an estimated distance from the tip of the needle to the tissue or (2) an estimated distance from the tip of the needle to the space based on the identification, using the OCT system (paragraph 48 “(iii) determining whether the lumen is located within a predetermined distance (e.g., within 3.0 mm, within 2.0 mm, within 1.0 mm-3.0 mm, etc.) from a catheter center”)
However, Kunio fails to teach a method comprising:
inserting the endoscope into the hollow bore of the needle to obtain a system
performing identification of the tissue or the space using a first convolutional neural network (CNN) comprising a classification model
using a second CNN comprising a regression model
using the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to perform a procedure with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space
Briggs teaches a method comprising inserting the endoscope into the hollow bore of the needle to obtain a system (see figure 2 below the fiber optic probe is inserted into the needle). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio with the inserted probe and needle configuration of Briggs in order to minimize patient discomfort and speed recovery, as stated in the first paragraph of the section titled “Design Tradeoffs”.
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Briggs fails to teach a method comprising:
performing identification of the tissue or the space using a first convolutional neural network (CNN) comprising a classification model
using a second CNN comprising a regression model
using the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to perform a procedure with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space
Sobol teaches a method comprising:
performing identification of the tissue or the space using a first convolutional neural network (CNN) comprising a classification model (paragraph 65 “the OCT image classifier 154 can be implemented as an encoder/decoder convolutional neural network (CNN)”, with two CNN’s being the encoder and decoder)
using a second CNN comprising a regression model (paragraph 65 “the OCT image classifier 154 can implement any of a variety of techniques for generating the models… regression models”)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio and Briggs with the convolutional neural networks of Sobol in order to improve the image recognition and classification ability of the method to better diagnose the health of the patient.
Sobol fails to teach a method comprising:
using the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to perform a procedure with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space
Page teaches a method comprising using the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to perform a procedure with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space (paragraph 64 details real time control of the puncture device (needle) using sensors to avoid certain regions of the tissue referred to as “keepout volumes”).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the methods of Kunio, Briggs, and Sobol with the keepout volume of Page in order to implement a protective protocol for prevention of damage to the patient due to unintended needle punctures during an operation.
Regarding claim 4, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 1 and Page teaches a method wherein the needle is a Veress needle (paragraph 53 “the puncture device 106 is a Veress needle”).
Regarding claim 8, Page further teaches a method wherein the space is an abdominal space (paragraph 3 “Laparoscopy is a form of endoscopy involving minimally invasive inspection and surgery inside the abdominal cavity”)
Regarding claim 9, Page further teaches a method wherein the space is an epidural space (paragraph 121 “The puncture device 106 is inserted into patient tissue to access the epidural space, and the needle is inserted into the epidural space to administer the anesthesia”).
Regarding claim 11, Page further teaches a method wherein the procedure is laparoscopy (paragraph 51 “In some cases, the surgical operation is a laparoscopic surgical operation to be performed in the peritoneal cavity of the patient”).
Regarding claim 12, Page further teaches a method wherein the procedure is epidural anesthesia (paragraph 121 “the puncture device 106 can be used to position a needle for administering epidural anesthesia”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, and Sobol with the Veress needle of Page in order to improve patient safety with the spring-loaded retraction design of the sharp needle tip upon entry into the target area, protecting vital organs from inadvertent puncture, and it would have been obvious to perform said method in an epidural or abdominal space, or perform laparoscopy in order to minimally invasively target the patient’s specific needs, whether it be identification/anesthesia of epidural tissue or identification of abdominal tissue.
Regarding claim 13, Kunio teaches a system comprising:
a needle comprising a hollow bore and a tip and configured to insert into an animal body (paragraph 62 “such as one or more components of a probe… a needle”)
an endoscope configured to obtain an image of a tissue or a space in an animal body using optical coherence tomography (OCT) (paragraph 1 “detecting external elastic lamina (EEL) from OCT image(s)”)
a processor (paragraph 45 “processor”) configured to:
perform identification of the tissue or the space based on an OCT system (paragraph 48 “(ii) detecting a lumen”)
determine at least one of (1) an estimated distance from the tip of the needle to the tissue or (2) an estimated distance from the tip of the needle to the space (paragraph 48 “(iii) determining whether the lumen is located within a predetermined distance (e.g., within 3.0 mm, within 2.0 mm, within 1.0 mm-3.0 mm, etc.) from a catheter center”) by using the OCT system
provide the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to a user of the system to enable a procedure to be performed with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space (paragraph 48 procedure outlined from step (iv) to step (xiii) as well as detailing that procedure can be used to plan and perform an operation involving the insertion and navigation of a probe)
However, Kunio fails to teach a system comprising an endoscope configured to insert into hollow bore of the needle, and a processor configured to:
perform identification of the tissue or the space based on using a first convolutional neural network (CNN) comprising a classification mode
determine at least one of (1) an estimated distance from the tip of the needle to the tissue or (2) an estimated distance from the tip of the needle to the space, by using a second CNN comprising a regression model
provide the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to a user of the system to enable a procedure to be performed with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space.
Briggs teaches system comprising an endoscope configured to insert into the hollow bore of the needle (see figure 2 below the fiber optic probe is inserted into the needle). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio with the inserted probe and needle configuration of Briggs in order to minimize patient discomfort and speed recovery, as stated in the first paragraph of the section titled “Design Tradeoffs”.
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Briggs fails to teach a processor configured to:
perform identification of the tissue or the space based on using a first convolutional neural network (CNN) comprising a classification mode
determine at least one of (1) an estimated distance from the tip of the needle to the tissue or (2) an estimated distance from the tip of the needle to the space, by using a second CNN comprising a regression model
Sobol teaches a processor configured to:
perform identification of the tissue or the space based on using a first convolutional neural network (CNN) comprising a classification mode (paragraph 65 “the OCT image classifier 154 can be implemented as an encoder/decoder convolutional neural network (CNN)”, with two CNN’s being the encoder and decoder)
determine at least one of (1) an estimated distance from the tip of the needle to the tissue or (2) an estimated distance from the tip of the needle to the space, by using a second CNN comprising a regression model (paragraph 65 “the OCT image classifier 154 can implement any of a variety of techniques for generating the models… regression models”)
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio and Briggs with the convolutional neural networks of Sobol in order to improve the image recognition and classification ability of the method to better diagnose the health of the patient. While Sobol does not teach specifically determining an estimated distance between a tissue and needle, it would have been obvious to combine the method’s ability to determine a thickness of a retina (detailed in paragraph 65) to instead determine a measured distance within the captured image as opposed to a thickness of an object within the captured image.
Sobol fails to teach a processor configured to provide the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to a user of the system to enable a procedure to be performed with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space.
Page teaches a processor configured to provide the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space to a user of the system to enable a procedure to be performed with the needle by controlling, during advancement of the needle, further advancement of the needle to avoid penetration of the tissue by the tip of the needle or to avoid positioning the tip of the needle in the space (paragraph 64 details real time control of the puncture device (needle) using sensors to avoid certain regions of the tissue referred to as “keepout volumes”).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the processors of Kunio, Briggs, and Sobol with the keepout volume of Page in order to implement a protective protocol for prevention of damage to the patient due to unintended needle punctures during an operation.
Regarding claim 16, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 13, andd Page further teaches a system wherein the needle is a Veress needle or a Tuohy needle paragraph 53 “the puncture device 106 is a Veress needle”).
Regarding claim 19, Page further teaches a system wherein the space is an abdominal space or an epidural space (paragraph 3 “Laparoscopy is a form of endoscopy involving minimally invasive inspection and surgery inside the abdominal cavity” and paragraph 121 “The puncture device 106 is inserted into patient tissue to access the epidural space, and the needle is inserted into the epidural space to administer the anesthesia”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, and Sobol with the Veress needle of Page in order to improve patient safety with the spring-loaded retraction design of the sharp needle tip upon entry into the target area, protecting vital organs from inadvertent puncture, and it would have been obvious to perform said method in an epidural or abdominal space in order to target patient issues originating in those body regions.
Claims 5-7, 17-18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio, Briggs, Sobol, and Page in view of Anderson et al (U.S. Patent Application Publication 2017/0173275, hereinafter “Anderson”). Regarding claim 5, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 1 but fail to teach a method wherein the needle is a Tuohy needle. Anderson teaches a method wherein the needle is a Tuohy needle (paragraph 69 “probe can be adapted to fit inside a standard 17 gauge Tuohy needle”).
Regarding claim 6, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 1 but fail to teach a method wherein the tissue is subcutaneous fat. Anderson teaches a method wherein the tissue is subcutaneous fat (paragraph 124 details differentiation of subcutaneous fat).
Regarding claim 7, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 1 but fail to teach a method wherein the tissue is a backbone tissue, and wherein the backbone tissue is fat. Anderson teaches a method wherein the tissue is a backbone tissue, and wherein the backbone tissue is fat (claim 21 “wherein the different layers of tissue comprise two or more of... epidural fat, supra-/intra-spinous ligament, ligamentum flavum… or spinal cord tissue”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, and Sobol with the Tuohy needle and tissue targets of Anderson as its blunt tip allows for safer navigation of the patient’s tissue layers, minimizing damage done to the patient during needle entry, and the tissue targets which allow for operations to be carried out in various parts of the patient’s body that need treatment.
Regarding claim 17, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 13, but fail to teach a system wherein the tissue is subcutaneous fat. Anderson teaches a system wherein the tissue is subcutaneous fat (paragraph 124 details differentiation of subcutaneous fat).
Regarding claim 18, Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 13, but fail to teach a system wherein the tissue is a backbone tissue, and wherein the backbone tissue is fat. Anderson teaches a system wherein the tissue is a backbone tissue, and wherein the backbone tissue is fat (claim 21 “wherein the different layers of tissue comprise two or more of... epidural fat, supra-/intra-spinous ligament, ligamentum flavum… or spinal cord tissue”). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, Sobol, and Page with the tissue targets of Anderson to allow for treatment of patients that need procedures completed in those body regions.
Regarding claim 21, Kunio, Briggs, Sobol, and Page fail to teach a method wherein the tissue is a muscle or an intestine. Anderson teaches a method wherein the tissue is a muscle or an intestine (claim 21 “wherein the different layers of tissue comprise two or more of… skeletal muscle… intestine”).
Regarding claim 22, Kunio, Briggs, Sobol, and Page fail to teach a method wherein the tissue is a backbone tissue, and wherein the backbone tissue is an interspinous ligament, a ligamentum flavum, or a spinal cord. Anderson teaches a method wherein the tissue is a backbone tissue, and wherein the backbone tissue is an interspinous ligament, a ligamentum flavum, or a spinal cord claim 21 “wherein the different layers of tissue comprise two or more of... supra-/intra-spinous ligament, ligamentum flavum… or spinal cord tissue.
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, Sobol, and Page with the tissue targets of Anderson which allow for operations to be carried out in various parts of the patient’s body that need treatment.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio, Briggs, Sobol, and Page in view of Luo (U.S. Patent Application Publication 2016/0144126). Regarding claim 10, while Kunio, Briggs, Sobol, and Page combined teach the limitations of claim 1, they fail to teach a method further comprising further performing the procedure independent of loss of resistance (LOR). Luo teaches a method further comprising further performing the procedure independent of loss of resistance (LOR) (paragraphs 5-7 of Luo teach a new method without LOR due to issues with LOR). It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the method of Kunio, Briggs, Sobol, and Page with the procedure independent of loss of resistance to rectify the issue with loss of resistance as outlined in paragraph 6 of Luo.
Regarding claim 20, while Kunio, Briggs, Sobol, and Page teach the limitations of claim 13, and teach a system wherein the needle (Kunio paragraph 1 “one or more needles”) is further configured to perform the procedure (Kunio paragraph 48 procedure outlined from step (iv) to step (xiii)) based on the identification (Kunio paragraph 48 “(ii) detecting a lumen”), based on the estimated distance from the tip of the needle to the tissue or the estimated distance from the tip of the needle to the space, (Kunio paragraph 48 “(iii) determining whether the lumen is located within a predetermined distance (e.g., within 3.0 mm, within 2.0 mm, within 1.0 mm-3.0 mm, etc.) from a catheter center”) and wherein the procedure is laparoscopy or epidural anesthesia (paragraph 51 “In some cases, the surgical operation is a laparoscopic surgical operation to be performed in the peritoneal cavity of the patient”) they fail to teach a system wherein the needle is further configured to perform a procedure independent of loss of resistance (LOR). Luo teaches a system wherein the needle is further configured to perform a procedure independent of loss of resistance (LOR) (paragraphs 5-7 Luo teaches a new method without LOR due to issues with LOR), but fails to teach wherein the procedure is laparoscopy or epidural anesthesia. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the system of Kunio, Briggs, Sobol, and Page with the procedure independent of loss of resistance to rectify the issue with loss of resistance as outlined in paragraph 6 of Luo in order to examine the abdominal or pelvic areas in a minimally invasive way.
Response to Arguments
Applicant's arguments filed July 17th, 2026 have been fully considered but they are not persuasive.
The Applicant’s Arguments filed July 17th, 2026 list the addition of claims 23 and 24, but said claims were not present within the amended claim set mailed on the same date. The examiner recommends that claims 23 and 24 are added to the claim set if the applicant intends to have them presented for examination.
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 DAYTON BARKER whose telephone number is (571)272-0912. The examiner can normally be reached between 9:00 and 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAYTON HYUN JIN BARKER/Patent Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
