DETAILED ACTION
This office action is in response to the communication received on August 18, 2024 concerning application No. 18/658,327 filed on May 8, 2024.
Claims 1-20 are currently pending.
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 .
Response to Arguments
Applicant's arguments filed 08/14/2025 regarding the 35 USC 112 rejection have been fully considered. Applicant’s arguments overcome the 35 USC 112 rejection of claim 9 previously set forth.
Applicant’s arguments with respect to claim(s) 1, 13, and 16 regarding the newly filed claim amendments 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.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16, line 9, “captured a different” should read “captured at a different”.
Appropriate correction is required.
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) 1-2, 4, and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable by Zhu et al. (CN113749695A, as cited in applicant’s 09/06/2024 IDS, hereinafter Zhu, The English translation of Zhu is being relied upon for the rejection) in view of Silver et al. (US 20090259174, hereinafter Silver).
Regarding claim 1, Zhu teaches a medical system (the medical system presented in figs. 1-2) comprising:
a first medical device defining a channel between a proximal end and a distal end of the first medical device (pg. 4, para. 1, discloses base 1 (first medical device) in fig. 1 includes outer tube 7 (channel) which has a proximal end and distal end); and
a second medical device having a central longitudinal axis (fig. 1 shows the ureteroscope has a central longitudinal axis) including a tube, a plunger, and a needle, wherein a distal portion of the tube includes an imager (pg. 4, para. 1, discloses ureteroscope 2 and puncture needle 3 which make up the second medical device. The puncture cannula 6 represents the tube. The proximal portion of the needle 3 is considered the plunger. Fig. 1 additional shows the distal portion of the tube includes an ultrasound probe 5 (imager)), and wherein the needle is translatable along the tube relative to the plunger (pg. 4, para. 1, “the rear end of overtube 7 is provided for driving the puncture needle 3 along drive mechanism that moves forward with the puncture sleeve 6”, therefore the needle is translatable along the tube relative to the plunger);
wherein the second medical device is insertable in, and translatable along, the channel of the first medical device (pg. 4, para. 1, “extend the ureteroscope 2 into the overtube 7 and insert the puncture needle 3 into the puncture sleeve 6”).
Zhu does not specifically teach the imager includes a plurality of sensors or transducer arranged in an annular configuration about the central longitudinal axis.
However,
Silver in a similar field of endeavor teaches an imager includes a plurality of sensors or transducer arranged in an annular configuration about the central longitudinal axis ([003] “the imaging transducer 22 comprises an annular array of individual crystals or elements”. Fig. 1A shows the annular array is configured about the central longitudinal axis of a medical device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the imager of Zhu for the imager including an annular array of transducers of Silver because it amounts to simple substitution of one known element for another to obtain the predictable results of providing images of a target structure.
Regarding claim 2, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu further teaches the first medical device includes a distal tube surrounding at least a distal portion of the channel, and wherein the distal tube is configured to be inserted within a urethra (fig. 1 shows the base 1 includes the outer tube 7 surrounding a distal portion of the channel. Pg. 4, para. 1, further teaches “an overtube 7 for inserting into the urethra”, therefore the distal tube is configured to be inserted into the urethra).
Regarding claim 4, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu further teaches the tube of the second medical device includes a radial opening proximate the imager, the needle being extendable through the radial opening (figs. 1-2 show the cannula 6 includes a radial opening at its distal end that the needle extends through. Figs. 9-10 show the position where the needle extends from the distal end is proximal to the imager location (probe 5), therefore the radial opening is proximate the imager).
Regarding claim 10, Zhu in view of Silver teaches the system of claim 1, as set forth above. Silver further teaches the imager is configured to capture a 360-degree view around the distal portion of the tube of the second medical device ([0030] “the imaging transducer 22 comprises a phased array IVUS transducer that is operative to image 360 degree around the catheter body 14”. Fig. 1A further shows the transducer located at the distal portion of the tube of the medical device).
Regarding claim 11, Zhu in view of Silver teaches the system of claim 1, as set forth above. Silver further teaches the imager comprises an annular phased array of ultrasound transducers ([0030] “the imaging transducer 22 comprises a phased array IVUS transducer that is operative to image 360 degree around the catheter body 14. The imaging transducer 22 comprises an annular array of individual crystals or elements”).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver as applied to claim 1 above, and further in view of Sharma (US 20170367755).
Regarding claim 3, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu in view of Silver does not specifically teach an outer surface of at least one of the first medical device or the second medical device includes a marking for alignment of the second medical device relative to the first medical device.
However,
Sharma in a similar field of endeavor teaches an outer surface of at least one of the first medical device or the second medical device includes a marking for alignment of the second medical device relative to the first medical device ([0254] “the second handle component 1666 includes a plurality of markings 1663 along its body…the markings 1663 are numbers. The first handle component 1665 includes a window 1664 proximal its distal end which aligns with one of said markings as the first handle component 1665 is moved longitudinally relative to the second handle component”, each of the handle components correspond to a medical device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the medical device include a marking for alignment of the second medical device relative to the first medical device of Sharma to the system of Zhu in view of Silver to allow for the predictable results of ensuring the medical device are being combined correctly, thereby ensuring an accurate procedure is being performed.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver as applied to claim 4 above, and further in view of Sauer (US 20070167868).
Regarding claim 5, Zhu in view of Silver teaches the system of claim 4, as set forth above. Zhu in view of Silver does not specifically teach the plunger includes a plurality of markings, each marking of the plurality of markings corresponding to a distance the needle extends through the radial opening.
However,
Sauer in a similar field of biopsy tools teaches the plunger (claim 21, “a reciprocating plunger, movable from a retracted position to an extended position”) includes a plurality of markings, each marking of the plurality of markings corresponding to a distance the needle extends through the radial opening ([0070] “a means to accurately gauge the deployment of later described features is provided by a shaft adjustment scale 22R and 24R…and a needle control adjustment scale 22S and 24S”, the scale corresponds markings which show to the distance the needle extends from the opening).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the plunger include a plurality of markings, each marking of the plurality of markings corresponding to a distance the needle extends through the radial opening of Sauer to the system of Zhu in view of Silver to allow for the predictable results of indicating to the user how deep the biopsy location is, therefore making it easier to return for subsequent biopsies.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver and Sauer as applied to claim 5 above, and further in view of Karino (US 20130281844, hereinafter Karino).
Regarding claim 6, Zhu in view of Silver and Sauer teaches the system of claim 5, as set forth above. Zhu in view of Silver and Sauer does not specifically teach the second medical device is rotatable relative to the first medical device when inserted into the channel so that an orientation of the radial opening relative to the first medical device is adjustable.
However,
Karino in a similar field of endeavor teaches the second medical device is rotatable relative to the first medical device when inserted into the channel so that an orientation of the radial opening relative to the first medical device is adjustable ([0084] “the operator rotates the ultrasonic probe 2 so that the protrusion port 15 is directed toward the bioptic target part M1”, the ultrasound probe (second medical device) is rotatable relative to the guide sheath (first medical device) when inserted into the channel so that the orientation of the opening (port 15) relative to the first medical device is adjustable).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the second medical device be rotatable relative to the first medical device when inserted into the channel so that an orientation of the radial opening relative to the first medical device is adjustable of Karino to the system of Zhu in view of Silver and Sauer to allow for the predictable results of reducing irritation to the urethra, thereby reducing the chanced of infection forming.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver as applied to claim 1 above, and further in view of Forney (US 20220211411).
Regarding claim 7, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu in view of Silver does not specifically teach a proximal end of the plunger includes a base and a proximal end of the needle includes a needle hub, the needle hub configured to abut the base when the needle is fully extended within the tube.
However,
Forney in a similar field of endeavor teaches a proximal end of the plunger includes a base ([0022] “proximal end face 62” of the plunger 16 in fig. 3) and a proximal end of the needle includes a needle hub ([0022] “proximal end portion 84” in fig. 3), the needle hub configured to abut the base when the needle is fully extended within the tube (fig. 1 shows the proximal end portion of the needle hub abuts the proximal end face of the plunger when the needle is extended fully within the tube (cannula 12)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plunger of Zhu in view of Silver for the plunger of Forney because it amounts to simple substitution of one known element for another to obtain the predictable results of ensuring the needle does not get lost within the tube.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver as applied to claim 1 above, and further in view of Deckman et al. (US 20170290626, hereinafter Deckman).
Regarding claim 8, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu in view of Silver does not specifically teach the needle is pre-formed to bend at an angle.
However,
Deckman in a similar field of endeavor teaches the needle is pre-formed to bend at an angle ([0077] “the needle angle is then selected by the physician from a plurality of needles 14 having different curvature”, since each needle has a different curvature, the needles are pre-formed to bend at an angle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the needle of Zhu in view of Silver for the needle of Deckman because it amounts to simple substitution of one known element for another to obtain the predictable results of ensuring the needle is able to make contact with the region of interest on the prostate, thereby increasing the accuracy of the system.
Regarding claim 9, Zhu in view of Silver and Deckman teaches the system of claim 8, as set forth above. Deckman further teaches the angle is between about 60 degrees to about 90 degrees ([0019] “the angle of needle curvature…preferably the angle is about 70 degrees”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the needle of Zhu for the needle of Silver and Deckman because it amounts to simple substitution of one known element for another to obtain the predictable results of ensuring the needle is able to make contact with the region of interest on the prostate, thereby increasing the accuracy of the system.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Silver as applied to claim 1 above, and further in view of Paltieli et al. (US 20020035864, hereinafter Paltieli).
Regarding claim 12, Zhu in view of Silver teaches the system of claim 1, as set forth above. Zhu in view of Silver does not specifically teach the imager of the second medical device includes a sensor electronically marked for calibration of the medical system.
However,
Paltieli in a similar field of biopsy teaches the imager of the medical device includes a sensor electronically marked for calibration of the medical system ([0053] “the present invention calibrates the location and orientation of the ultrasound scanning plane with respect to the position sensor 4 (position measuring component) of the ultrasound transducer 3”, fig. 1a shows the position sensor (sensor) is attached to the transducer 3 (medical device)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhu in view of Silver to have the second medical device include a sensor electronically marked for calibration of the medical system in order to accurately guide the biopsy needle to the target, as recognized by Paltieli ([0001]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable by Zhu et al. (CN113749695A, as cited in applicant’s 09/06/2024 IDS, hereinafter Zhu, The English translation of Zhu is being relied upon for the rejection) in view of Govari (US 20040254458).
Regarding claim 13, Zhu teaches a medical system (the medical system presented in figs. 1-2) comprising:
a first medical device defining a channel between an opening of a proximal end and an opening of a distal end of the first medical device (pg. 4, para. 1, discloses base 1 (first medical device) in fig. 1 includes outer tube 7 (channel) which has a proximal end and distal end); and
a second medical device including a tube, a plunger, and a needle, wherein a distal portion of the tube includes an ultrasound imager (pg. 4, para. 1, discloses ureteroscope 2 and puncture needle 3 which make up the second medical device. The puncture cannula 6 represents the tube. The proximal portion of the needle 3 is considered the plunger. Fig. 1 additional shows the distal portion of the tube includes an ultrasound probe 5 (imager)), wherein the needle is translatable along the tube relative to the plunger (pg. 4, para. 1, “the rear end of overtube 7 is provided for driving the puncture needle 3 along drive mechanism that moves forward with the puncture sleeve 6”, therefore the needle is translatable along the tube relative to the plunger), and wherein the tube includes a radial opening, the needle being extendable through the radial opening (figs. 1-2 show the cannula 6 includes a radial opening at its distal end that the needle extends through);
wherein the second medical device is insertable in, and translatable along, the channel of the first medical device (pg. 4, para. 1, “extend the ureteroscope 2 into the overtube 7 and insert the puncture needle 3 into the puncture sleeve 6”).
Zhu does not specifically teach the first medical device includes a first marking, an outer surface of the second medical device includes a second marking, and a sensor electronically marked for calibration of the medical system, wherein the sensor is configured to be calibrated upon alignment of the first marking and the second marking.
However,
Govari in a similar field of endeavor teaches the first medical device includes a first marking ([0121] discloses the radiator coil pairs of the jig 77 shown in fig. 3A define the magnetic field direction which are used for alignment, therefore the radiator coils themselves are considered the marking), an outer surface of the second medical device includes a second marking ([0121] discloses the catheters outer surface includes fiducial markers), and a sensor electronically marked for calibration of the medical system ([0121] calibrating position sensing device 28 which fig. 2 shows in part of the catheter), wherein the sensor is configured to be calibrated upon alignment of the first marking and the second marking ([0121] discloses using the fiducial marks and the catheter axes to align the catheter with the radiator coils of the jig 77. Claim 1 further discloses using the position sensor to perform calibration upon alignment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Zhu to have the first medical device includes a first marking, an outer surface of the second medical device includes a second marking, and a sensor electronically marked for calibration of the medical system, wherein the sensor is configured to be calibrated upon alignment of the first marking and the second marking in order to increase the accuracy of the procedure, as recognized by Govari ([0015]).
Regarding claim 15, Zhu in view of Govari teaches the system of claim 13, as set forth above. Govari further teaches the second medical device is rotatable relative to the first medical device when inserted into the channel so that an orientation of the radial opening relative to the first medical device is adjustable ([0017] discloses the catheter (second medical device) is rotatable relative to the groove (channel) clamp (first medical device), thereby allowing the radial opening position to be adjusted).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the second medical device be rotatable relative to the first medical device when inserted into the channel so that an orientation of the radial opening relative to the first medical device is adjustable of Govari to the system of Zhu in view of Govari to allow for the predictable results of reducing irritation to the urethra, thereby reducing the chances of infection forming.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Govari as applied to claim 13 above, and further in view of Barry et al. (US 20240024628, hereinafter Barry).
Regarding claim 14, Zhu in view of Govari teaches the system of claim 13, as set forth above. Zhu in view of Govari does not specifically teach the second marking of the second medical device includes an arrow.
However,
Barry in a similar field of endeavor teaches using an arrow as a marking on a second medical device for alignment ([0073] discloses using alignment tab 45b shown in fig. 1I as being an arrow in order to align the coupler and the hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the fiducial mark of Zhu in view of Govari for the arrow of Barry because it amounts to simple substitution of one known element for another to obtain the predictable results of aligning the first and second medical devices.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable by Zhu et al. (CN113749695A, as cited in applicant’s 09/06/2024 IDS, hereinafter Zhu, The English translation of Zhu is being relied upon for the rejection) in view of Mantri et al. (US 20200360100, hereinafter Mantri).
Regarding claim 16, Zhu teaches a method of treating a subject (pg. 2, para. 10, “method for using a multiple visualization transurethral prostate biopsy system”), the method comprising:
inserting a first medical device into a bodily orifice or lumen of the subject (pg. 5, para. 9, “insert the overtube 7 of the base 1 into the urethra” the over tube and base are the first medical device);
inserting a second medical device into a channel of the first medical device and translating the second medical device along the channel until a distal portion of the second medical device is within a body cavity of the subject (pg. 5, para. 9, “extend the ureteroscope into the overtube 7 and insert the puncture needle 3 into the puncture sleeve 6…move the ureteroscope 2 to the position of the prostate”;
capturing at least one image of the body cavity via an imager of the distal portion of the second medical device (pg. 5, para. 9, “use the ultrasound probe 5 to contact the prostate, observe the diseased tissue”, in order to observe the diseased tissue an image is generated. The ultrasound probe is considered the imager);
analyzing the at least one image to identify an area of interest of the body cavity (pg. 5, para. 9, “use the ultrasound probe 5 to contact the prostate, observe the diseased tissue inside the prostate”. By observing the diseased tissue an area of interest is being identified); and
taking a sample of tissue from the area of interest by extending a needle of the second medical device through a radial opening of the second medical device (pg. 5, para. 9, “aim at the diseased tissue…the hammer 11 pushes the puncture needle 3 moves forward along the puncture sleeve 6 and enters the prostate tissue to obtain the prostate specimen”. The distal end of the puncture sleeve is considered the radial opening the needle extends through).
Zhu does not specifically teach capturing a plurality of images of the body cavity, wherein each image of the plurality of images is captured a different axial position along a length of the bodily orifice or lumen; and analyzing the plurality of images to identify an area of interest.
However,
Mantri in a similar field of endeavor teaches capturing a plurality of images of the body cavity ([0085] discloses obtaining a sequence of images using the imaging probe), wherein each image of the plurality of images is captured a different axial position along a length of the bodily orifice or lumen ([0085] discloses the sequence of image is obtained of a treatment site from multiple views); and analyzing the plurality of images to identify an area of interest ([0148] discloses “tumors may be identified from the images of the target site obtained with the automated scanning of the target site with the imaging probe”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of capturing a plurality of images of the body cavity, wherein each image of the plurality of images is captured a different axial position along a length of the bodily orifice or lumen; and analyzing the plurality of images to identify an area of interest of Mantri to the method of Zhu to allow for the predictable results or ensuring the entire region is being analyzed an no potential targets are being missed, thereby increasing the quality and accuracy of the procedure.
Regarding claim 17, Zhu in view of Mantri teaches the method of claim 16, as set forth above. Zhu further teaches the bodily orifice is a urethra (pg. 5, para. 9, “insert the overtube 7 of the base 1 into the urethra”).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Mantri as applied to claim 16 above, and further in view of De Ruijter et al. (WO2016145259A1, hereinafter De Ruijter).
Regarding claim 18, Zhu in view of Mantri teaches the method of claim 16, as set forth above. Zhu in view of Mantri does not specifically teach calibrating a position and/or orientation of the second medical device relative to the body cavity after capturing the plurality of images and before taking the sample of tissue.
However,
De Ruijter in a similar field of endeavor teaches calibrating a position and/or orientation of the second medical device relative to the body cavity after capturing the image and before taking the sample of tissue ([0045] “to help guide the endobronchial instruments to increase biopsy accuracy under visualization, there is an additional need to calibrate the manipulation of the biopsy needle based on characteristics of the ultrasound imaging”. [0057] further teaches the calibration method is applied using the ultrasound image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Zhu in view of Mantri to calibrate a position and/or orientation of the second medical device relative to the body cavity after capturing the image and before taking the sample of tissue in order to increase biopsy accuracy, as recognized by De Ruijter ([0045]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Mantri as applied to claim 16 above, and further in view of Karino et al. (US 20130281844, hereinafter Karino).
Regarding claim 19, Zhu in view of Mantri teaches the method of claim 16, as set forth above. Zhu in view of Mantri does not specifically teach analyzing the plurality of images includes identifying a distance between a central axis of the second medical device and the area of interest.
However,
Karino in a similar field of endeavor teaches analyzing the image includes identifying a distance between a central axis of the second medical device and the area of interest ([0087] “the control unit 81 automatically searches the bioptic target part M1 from the ultrasonic image and measures the distance D”, fig. 7 shows the distance is from the ultrasound probe 2 to the biopsy target M1 (area of interest)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of analyzing the image includes identifying a distance between a central axis of the second medical device and the area of interest of Karino to the method of Zhu in view of Mantri to allow for the predictable results of determining how far the needle needs to travel to obtain the biopsy, thereby ensuring the needle deployment obtains the biopsy.
Regarding claim 20, Zhu in view of Mantri and Karino teaches the method of claim 19, as set forth above. Zhu further teaches the needle is extended the distance through the radial opening (pg. 5, para. 9, “the puncture needle 3 moves forward along the puncture sleeve 6 and enters the prostate tissue to obtain the prostate specimen”. Figs. 9-10 shows the needle 3 extends the distance to the prostate target location).
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 ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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/ANDREW W BEGEMAN/Examiner, Art Unit 3798
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