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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Amendment
This office action is in response to the remarks filed on 12/22/2025.
The amendment filed 12/22/2025 has been entered. Claims 1-12, 13-15 and 17-20 remain pending in the application, and claims 13 and 16 have been canceled.
The 112(b) rejection has been withdrawn in light of claim amendments.
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.
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.
Claims 1-6, 8-9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”) in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”).
Regarding claim 1, Fleury teaches a medical device, comprising:
an elongate member (330 [0023]; fig. 1) having a proximal end (proximal end annotated in fig. 3a below), a distal end (distal end annotated in fig. 3A below), a first lumen extending from the proximal end to a first distal opening proximate the distal end (lumen 318 [0023]; fig. 3A), a second lumen extending from the proximal end to the distal end (lumen 316 [0023] fig. 3A),
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Fig. 3A of Fleury Reproduced above
an instrument (350) having a retracted state (retracted state shown in fig. 3A above), and an extended state (extended state shown in fig. 3B below), wherein when the instrument is in the retracted state it is disposed within the first lumen (instrument 350 is in retracted state within first lumen 318 as shown in fig. 3A above), and when the instrument (350) is in the extended state it extends out the first distal opening (opening 318A shown in fig. 3B below; 318 a [0023]; (instrument 350 is in the extended state coming out of opening 318a coming out of lumen);
a rotational transducer (ultrasound transducer 340… ultrasound transducer may include a radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]) disposed in the second lumen, the rotational transducer configured to generate a radial image from within the second lumen (radial ultrasound transducer may also provide real-time visualization of the target pulmonary nodule [0020]; radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]).
Fleury, however does not teach an embedded transducer disposed in a wall of the elongate member between the distal end and the proximal end, wherein the embedded transducer is offset a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state.
Yun is considered analogous to the instant application as an endoscope is disclosed (abstract).
Yun teaches an embedded transducer disposed in a wall of the elongate member between the distal end and the proximal end (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332]), wherein the embedded transducer is offset a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state (puncturing needle 31 or the irrigation tube 60 to form a right angle with the sheath opening 1233 when exiting the sheath 123 via the sheath opening 1233 [0274]; needle comes out in a right angle/90 degrees with respect to the embedded transducer that passes through wall 124; fig. 27C reproduced below which shows the location of the embedded transducer 124 with respect to the instrument 30 which exits in a right angle).
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Fig. 27 of Yun reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleury to include teach an embedded transducer disposed in a wall of the elongate member between the distal end and the proximal end, wherein the embedded transducer is offset a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state, as taught by Yun. Doing so would facilitate proper positioning of the needle.
Regarding claim 2, modified Fleury teaches the medical device of claim 1, as discussed above. Fleury, however does not teach the embedded transducer comprising at least a portion of an imaging transducer.
Yun, however, teaches the embedded transducer comprising at least a portion of an imaging transducer (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleury to include the embedded transducer comprising at least a portion of an imaging transducer, as taught by Yun. Doing so would facilitate proper positioning of the needle.
Regarding claim 3, modified Fleury teaches the medical device of claim 2, as discussed above. Fleury, however, does not teach the embedded transducer comprising a distal portion of a fiber optic sensor.
Yun, however, teaches the embedded transducer comprising a distal portion of a fiber optic sensor (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include the embedded transducer comprising a distal portion of a fiber optic sensor, as taught, as taught by Yun. Doing so would facilitate proper positioning of the needle.
Regarding claim 4, modified Fleury teaches the medical device of claim 2, as discussed above. Fleury further teaches the rotational transducer comprising a rotational imaging transducer (radial ultrasound transducer may also provide real-time visualization of the target pulmonary nodule [0020]; radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]).
Regarding claim 5, modified Fleury teaches the medical device of claim 4, as discussed above. Fleury further teaches the rotational imaging transducer comprising an ultrasound transducer (radial ultrasound transducer may also provide real-time visualization of the target pulmonary nodule [0020]; radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]).
Regarding claim 6, modified Fleury teaches the medical device of claim 1, as discussed above. Fleury teaches a second lumen of the elongate member ((lumen 316 [0023] fig. 3A)
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Fig. 3A of Fleury Reproduced above
Fleury, however, does not teach wherein the embedded transducer is disposed within a wall of [the second lumen of the elongate member].
Yun, however, teaches wherein the embedded transducer (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332]), is disposed within a wall of the second lumen of the elongate member (puncturing needle 31 or the irrigation tube 60 to form a right angle with the sheath opening 1233 when exiting the sheath 123 via the sheath opening 1233 [0274]; needle comes out in a right angle/90 degrees with respect to the embedded transducer that passes through wall 124; fig. 27C reproduced below which shows the location of the embedded transducer 124 with respect to the instrument 30 which exits in a right angle).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleury, by modifying the second lumen in Fleury to include the embedded transducer is disposed within a wall, as taught by Yun. Doing so would facilitate proper positioning of the needle.
Regarding claim 8, modified Fleury teaches the medical device of claim 1, as discussed above. Fleury further teaches wherein the instrument comprises a pre-curved instrument (FIG. 3B, the tissue sampling element 350 may be distally advanced along ramped surface 322 a of the endcap 310 such that the tissue sampling element 350 deflects (e.g., bends) away from a longitudinal axis of the endcap 310 upon exiting the second opening 318 a [0023]).
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Fig. 3b of Fleury reproduced above
Regarding claim 9, modified Fleury teaches the medical device of claim 8, as discussed above. Fleury further teaches wherein the pre-curved instrument comprises one or both of a needle (tissue sampling element 350 (e.g., biopsy needle), and an ablation probe.
Regarding claim 15, Fleury teaches a system, comprising:
an elongate member (330 [0023]; fig. 1) having a proximal end (proximal end annotated in fig. 3a below), a distal end (distal end annotated in fig. 3A below), a first lumen extending from the proximal end to a first distal opening proximate the distal end (lumen 318 [0023]; fig. 3A; lumen has an opening on the top of the device as shown fig. 3A), a second lumen extending from the proximal end to the distal end (lumen 316 [0023] fig. 3A; lumen 316 extends from proximal end to distal end, shown in fig. 3A below),
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Fig. 3A of Fleury Reproduced above
an instrument (350) disposed in the first lumen (instrument 350 in lumen 318 shown above), and having a retracted state (retracted state shown in fig. 3A above) and an extended state (extended state shown in fig. 3B below), wherein when the instrument is in the retracted state it is disposed within the first lumen (instrument 350 is in retracted state within first lumen 318 as shown in fig. 3A above), and when the instrument is in the extended state it extends out a distal opening (opening 318A shown in fig. 3B below; 318 a [0023]) of the first lumen (instrument 350 is in the extended state coming out of opening 318a coming out of lumen ),
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Fig. 3b of Fleury reproduced above
a rotational transducer (ultrasound transducer 340… ultrasound transducer may include a radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]) disposed in the second lumen, the rotational transducer configured to generate a radial image from within the second lumen (radial ultrasound transducer may also provide real-time visualization of the target pulmonary nodule [0020]; radial ultrasound probe which is rotatably disposed within the sheath 344 [0023])
wherein the instrument comprises a pre-curved needle (FIG. 3B, the tissue sampling element 350 may be distally advanced along ramped surface 322 a of the endcap 310 such that the tissue sampling element 350 deflects (e.g., bends) away from a longitudinal axis of the endcap 310 upon exiting the second opening 318 a [0023]).
Fleury, however, does not teach: and wherein the embedded transducer is positioned with a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state.
Yun is considered analogous to the instant application as an endoscope is disclosed (abstract).
Yun teaches wherein the embedded transducer is positioned with a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332]; puncturing needle 31 or the irrigation tube 60 to form a right angle with the sheath opening 1233 when exiting the sheath 123 via the sheath opening 1233 [0274]; needle comes out in a right angle/90 degrees with respect to the embedded transducer that passes through wall 124; fig. 27C reproduced below which shows the location of the embedded transducer 124 with respect to the instrument 30 which exits in a right angle).
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Fig. 27 of Yun reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleury to include the embedded transducer is positioned with a predefined angle between 90 and 270 degrees about a cross-sectional axis with respect to a projected position of the instrument in the extended state, as taught by Yun. Doing so would facilitate proper positioning of the needle.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”), in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”) and Yu (US 20220378400 A)
Regarding claim 7, modified Fleury teaches the medical device of claim 1. Fleury, however, does not teach, wherein the second lumen is positioned in the elongate member between the first lumen and the embedded transducer.
Yu is considered analogous to the instant application as “Combined ultrasound and endoscopy” is disclosed (title).
Yu, however, teaches wherein the second lumen (working channel 1020 [0054]; working channel … that standard surgical devices can be disposed therein to carry out various surgical procedures [0047]) is positioned in the elongate member between the first lumen (lower lumen or channel 920 [0053]) and the embedded transducer (camera module 320, LEDs 330 and 332 and possibly other electrical and/or fiber optic cable(s) [0053]; figs. 10A and 10C depict the second lumen 1020 between the embedded transducer 330+332 first lumen 920).
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Figs. 10A and 10B of Yu
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include wherein the second lumen is positioned in the elongate member between the first lumen and the embedded transducer, as taught by Yu. Doing so would allow for improved diagnosis and therapy to a patient, as suggested by Yu ([0058]). This modification would also can provide valuable information and feedback to the operator as to the current orientation and position of ultrasound probe head, as suggested by Yu ([0052]).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”), in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”), and Sung et. al (US 20170079519 A1, hereafter “Sung”) .
Regarding claim 10, modified Fleury teaches the medical device of claim 8, as discussed above. Fleury, however is silent regarding, wherein the elongate member is configured to bend in a first direction when a distal end of the pre-curved instrument is positioned a first distance from the distal opening of the first lumen.
Sung is considered analogous to the instant application as “Biopsy devices, systems, and methods for use” is disclosed (title).
Sung teaches wherein the elongate member (catheter 210 [0076]) is configured to bend in a first direction (the catheter 210 may be substantially rigid, semi-rigid, or flexible, e.g., having a variable rigidity along its length, e.g., being more rigid at the proximal portion to facilitate advancement, rotation, and/or other manipulation of the distal portion 214 from outside the patient's body, and being flexible at the distal portion 214 to facilitate introduction through tortuous anatomy [0076]) when a distal end of the pre-curved instrument is positioned a first distance from the distal opening of the first lumen (a conduit attached to a needle such that the needle exits from a distal portion of the catheter at a desired angle. During use, a physician or other user of the catheter may control the advancement and retraction of the needle and/or the rotational orientation of the needle [0015]; as the instrument exits the first lumen 216, as shown in fig.4A, and the catheter can have variable rigidity as discussed in [0076], the catheter can be configured to bend in a first direction while the needle exits the catheter as to reach the target tissue, figs. 4A and 4B, reproduced below, depicts the elongate member 210 in a bent and straight position).
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Figs. 4A and 4B of Sung reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include the elongate member is configured to bend in a first direction when a distal end of the pre-curved instrument is positioned a first distance from the distal opening of the first lumen, as taught by Sung. Doing so would facilitate introduction through tortuous anatomy, (Sung-[0076]), and facilitate performing a biopsy within a lung, as suggested by Sung ([0005]).
Regarding claim 11, modified Fleury teaches the medical device of claim 10, as discussed above. Fleury, however is silent regarding wherein the elongate member is configured to straighten as the pre-curved instrument is moved from the first distance to the distal opening of the first lumen.
Sung, however, teaches wherein the elongate member is configured to straighten (the catheter 210 may be substantially rigid, semi-rigid, or flexible, e.g., having a variable rigidity along its length, e.g., being more rigid at the proximal portion to facilitate advancement, rotation, and/or other manipulation of the distal portion 214 from outside the patient's body, and being flexible at the distal portion 214 to facilitate introduction through tortuous anatomy [0076]) as the pre-curved instrument is moved from the first distance to the distal opening of the first lumen (a conduit attached to a needle such that the needle exits from a distal portion of the catheter at a desired angle. During use, a physician or other user of the catheter may control the advancement and retraction of the needle and/or the rotational orientation of the needle [0015]; as the instrument exits the first lumen 216, as shown in fig.4A, and the catheter can have variable rigidity as discussed in [0076], the catheter can be configured to straighten as the pre-curved instrument is moved from the first distance to the distal opening of the first lumen, figs. 4A and 4B, reproduced below, depicts the elongate member 210 in a bent and straight position).
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Figs. 4A and 4B of Sung reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include the elongate member is configured to straighten as the pre-curved instrument is moved from the first distance to the distal opening of the first lumen as taught by Sung. Doing so would facilitate introduction through tortuous anatomy, (Sung-[0076]), and facilitate performing a biopsy within a lung , as suggested by Sung ([0005]).
Regarding claim 12, modified Fleury teaches the medical device of claim 11, as discussed above. Fleury further teaches wherein the elongate member (330) is configured to remain substantially straight (fig. 3b shows the elongate member substantially straight with the instrument 350 is outside of the device) when the pre-curved instrument (350 [0023]) is extended out of the distal opening (318 a [0023]; fig. 3b) of the first lumen (lumen 318 [0023]; fig. 3A).
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Fig. 3B of Fleury reproduced above
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”), in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”), and Warnking et al. (US 20230135085 A1, hereinafter “Warnking”)
Regarding claim 14, modified Fleury teaches the medical device of claim 1 as discussed above. Fleury, however, is silent regarding wherein the elongate member has an outer diameter of less than 2 mm.
Warnking, is considered analogous to the instant application as an ultrasonic system is disclosed (abstract).
Warnking teaches, wherein the elongate member has an outer diameter of less than 2 mm (The outer diameter of the transducer 11 is approximately 1.5-3 mm in diameter [0041]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include wherein the elongate member has an outer diameter of less than 2 mm, as taught by Warnking. Doing so would allow the device to move within the bronchial wall and surrounding tissue (“The diameter of the transducer 11 may vary between 1.5 mm and 3.0 mm, … in order to encompass the bronchial section treated and adjacent bronchial nerves [0060]).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”), in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”), and Deckman et al. (US 20170290626 A, hereinafter “Deckman”).
Regarding claim 17, modified Fleury teaches the system of claim 15, as discussed above. Fleury, however is silent regarding the instrument comprises a pre-curved ablation probe.
Deckman is considered analogous to the instant application as the relates to delivery systems having an ultrasound probe for improved imaging and a curved needle for ablation treatment ([0002]).
Deckman, however, teaches the instrument comprises a pre-curved ablation probe (a curved needle for ablation treatment [0033]; The curved needle 14 has a needle body 50 with a shaped needle distal end 52 and a solid needle distal tip 54, as best seen in FIGS. 1B-1E and 4A-E. Needle 14 is configured to deliver, to the target site 16 including fibroid 18 (as shown in FIG. 5E), radio frequency energy generated at a relatively low power and for relatively a short duration of time from an ablative energy generator 400 (such as, but not limited to, electromagnetic energy including microwave, resistive heating, cryogenic) including a radio frequency (RF) energy generator 410 [0051]; fig. 1B reproduced below).
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Fig. 1B of Deckman reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include regarding the instrument comprises a pre-curved ablation probe, as taught by Deckman. Doing so would allow to enhance the therapeutic effect provided by the treatment needle, as suggested by Deckman ([0027]).
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US 20180153531 A1,hereinafter “Fleury”) in view of Yun et al. (US 20200054353 A1, hereinafter “Yun”), and Cheline et. al (US 20140100440 A1, hereinafter “Cheline”)
Regarding claim 18, Fleury teaches a method, comprising:
inserting a distal end (distal end annotated in fig. 3A below) of an elongate member (330 [0023]; fig. 1) into a body lumen (pulmonary endoscopy [0005]), the elongate member having a proximal end (proximal end annotated in fig. 3a below), the distal end (distal end annotated in fig. 3A below), a first lumen extending from the proximal end to a first distal opening proximate the distal end (lumen 318 [0023]; fig. 3A; lumen 318 extends from proximal end to distal end, shown in fig. 3A below), a second lumen extending from the proximal end to the distal end (lumen 316 [0023] fig. 3A; lumen 316 extends from proximal end to distal end, shown in fig. 3A below), an instrument disposed within the first lumen (instrument 350 in lumen 318 shown above),
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Fig. 3A of Fleury Reproduced above
generating a radial image with a rotational transducer (ultrasound transducer 340… ultrasound transducer may include a radial ultrasound probe which is rotatably disposed within the sheath 344 [0023]) disposed in the second lumen of the elongate member (lumen 316 is where the rotational transducer 340 is located ; [0023] fig. 3A
Fleury, however, does not teach: an embedded transducer, and the radial image comprising indicia of the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening wherein the embedded transducer is embedded in a wall of the elongate member between the distal end and the proximal end.
Yun is considered analogous to the instant application as an endoscope is disclosed (abstract).
Yun teaches:
an embedded transducer (only optical fibers and an image line pass through the endoscope insertion passage 124 [0332]);
the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening wherein the embedded transducer is embedded in a wall of the elongate member between the distal end and the proximal end (puncturing needle 31 or the irrigation tube 60 to form a right angle with the sheath opening 1233 when exiting the sheath 123 via the sheath opening 1233 [0274]; needle comes out in a right angle/90 degrees with respect to the embedded transducer that passes through wall 124; fig. 27C reproduced below which shows the location of the embedded transducer 124 with respect to the instrument 30 which exits in a right angle).
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Fig. 27 of Yun reproduced above
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Fleury to include the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening wherein the embedded transducer is embedded in a wall of the elongate member between the distal end and the proximal end, as taught by Yun. Doing so would facilitate proper positioning of the needle.
The combined invention still does not teach: the radial image comprising indicia [of the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening].
Cheline is considered analogous to the instant application as an intravascular imaging system is disclosed ([0077]).
Cheline teaches: the radial image (where each frame provides a 360° slice of the vessel at different longitudinal locations [0105]) comprising indicia of the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening. (data corresponding to internal reflections from the catheter region (arising from a fiber optic cable, mirror, sheath, or other internal components of the imaging device) and present in the B-scan can be removed, for example, by setting the pixel intensity amplitude inside the outer diameter of the sheath equal to the noise floor [0121]; as there is “noise” in the image that corresponds to multiple components of the transducer, there is inherently indicia/shadows/markings of the fiber optic cable, i.e. the embedded transducer, and the internal components i.e. the instrument/with respect to the projected position of the instrument, within the image prior to removal).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Fleury to include the radial image comprising indicia of the embedded transducer at a predefined angle between 90 and 270 degrees about a cross sectional axis with respect to a projected position of the instrument extended out of the first distal opening, as taught by Cheline. Doing so would allow for prevention of image data signals from interfering with an edge detection procedure for the determination of the vessel lumen, as suggested by Cheline ([0121]).
Regarding claim 19, modified Fleury teaches the method of claim 18 as discussed above. Fleury further teaches rotating the elongate member to align a target tissue at the predefined rotational angle with respect the projected position of the instrument (the medical professional may retract the tissue sampling element 350 into the endcap 310, rotate the entire delivery device 330 based on the relative location of the tissue sampling element 350 and eccentric nodule 8 (FIGS. 5C-5D) to align the second opening 318 a with the eccentric nodule 8 (FIG. 5E), and then re-actuate the tissue sampling element 350 through the second opening 318 a of the endcap 310 into the eccentric nodule 8 (FIG. 5F) [0025]).
Regarding claim 20, modified Fleury teaches the method of claim 19 as discussed above. Fleury further teaches extending the instrument out of the distal opening of the first lumen of the elongate member to obtain a biopsy of the target tissue (the medical professional may retract the tissue sampling element 350 into the endcap 310, rotate the entire delivery device 330 based on the relative location of the tissue sampling element 350 and eccentric nodule 8 (FIGS. 5C-5D) to align the second opening 318 a with the eccentric nodule 8 (FIG. 5E), and then re-actuate the tissue sampling element 350 through the second opening 318 a of the endcap 310 into the eccentric nodule 8 (FIG. 5F) [0025]; the instrument obtains the biopsy of the tissue as shown in fig. 5f ).
Response to Arguments
Applicant's arguments have been fully considered but they are not moot.
Applicant argues on page 7-9 of remarks, regarding the 35 USC 103 rejection of claim 1, that the cited prior art does not teach the limitation the newly added limitation “. Accordingly, this argument is not persuasive as the claim is rejected on new grounds of rejection which relies upon Yun et al (US20200054353A1, hereinafter “Yun”) to teach this limitation. Accordingly, this argument is moot.
Applicant argues that claims 15 and 18 are allowable for the same reasons as stated above. The examiner respectfully disagree for the reasons above.
Regarding the 35 USC 103 rejections of claims 2-12,17, and 19-20, applicant’s arguments on pages 8-10 are premised upon the assertion that the claims are allowable due to dependency on claim 1, 15, and 18. The examiner respectfully disagrees for the reasons discussed above. Accordingly the argument is moot in view of new grounds of rejection.
Conclusion
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/N.B./ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798