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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “spring-loaded tip” as claimed in claim 3 where the spring is positioned and detailed must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim recites the limitation of “an imaging transducer provided at a distal end of the device shaft providing an ultrasound tip” which should rather recite -- an ultrasound imaging transducer provided at a distal end of the device shaft providing an ultrasound tip--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 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.
Claim 1 recites the limitation of “an expandable element configured to articulate the ultrasound tip” however, it is not clear what does the expandable element do or perform to articulate the ultrasound tip.
The term “substantially” in claim 5 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
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 1-2, 4-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Owens et al (US 20190350648 A1) in view of Maini (US20210085384A1).
Regarding claim 1, Owens teaches a tissue ablation device (“The tissue ablation element may comprise one or more of a radiofrequency (RF) ablation element, an ultrasonic ablation element, a heat-based ablation element, or a cryoablation element” [0009]) comprising:
a device shaft (“The shaft may be flexible. The shaft may be controllably 1flexed along a longitudinal axis thereof via a flex mechanism” [0011]; see figs. 1-6 and the associated pars.);
an imaging transducer provided at a distal end of the device shaft providing an ultrasound tip (“[0086] FIG. 1A shows an illustration of an imaging component 100, in accordance with some embodiments. Imaging component 100 may comprise a handle portion 101 connected to an imaging shaft 103. At the distal end of imaging shaft 103 may be coupled an imaging transducer 107” [0086]); and
an expandable element configured to articulate the ultrasound tip.
Although, Owens teaches an expandable element (e.g., needle assembly comprising needle 235 and, optionally, tines 233 which expands and the shaft of the ablation instrument 231 may be deployed from the shaft of an imaging component 103. Additionally, or alternatively, the needle may be deployed from a lumen of a tube 115. Under the BRI) articulate the ultrasound tip (“[0099] The imaging transducer 107 may be configured to be deflectable. The imaging transducer may be configured to deflect relative to the longitudinal axis of the shaft of the imaging component. In some embodiments, the distal end of an imaging component comprises a hinge to facilitate deflection of an imaging transducer.” [0099]). One may argue that the expandable element may not be “configured to ARTICULATE” the ultrasound tip despite the ultrasound tip (e.g., imaging transducer 107 may be configured to be deflectable) being articulated.
Yet, if one argues in a narrow interpretation that Owens does not teach the expandable element configured to articulate the ultrasound tip, Maini reference is introduced below to clearly show the narrow interpretation of balloon articulating an ultrasound tip.
Maini teaches reference to FIGS. 3A-3B, catheter shaft 312 that includes center lumen shaft 311 and hypotubes 317 connected to multiple balloons 314. FIG. 3A is a side view of sheath or catheter shaft 312, and FIG. 3B is a front cross-sectional view of sheath or catheter shaft 312 [0062].
Orientations of ultrasound chips or transducers 326 may depend on whether balloons 314 are inflated or not. When balloons 314 are fully inflated, ultrasound chips or transducers 326 may be forward facing. However, when balloons 314 are deflated, ultrasound chips or transducer 326 may be folded flat and positioned on side of distal tip 313 of center lumen 315. Hence, when balloons 314 are deflated, ultrasound chips or transducer 326 may be side-facing. During inflation, orientation of ultrasound chips or transducers 326 may change as balloons 314 inflate (moving from side-facing orientation to forward facing orientation). Accordingly, operator(s) of transseptal insertion device 300 may vary the inflation of balloons 314 to achieve different orientations of ultrasound chips or transducers 326 for different imaging views [0065].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with balloon to articulate and/or position the ultrasound tip by inflation force of the balloon as taught by Maini because it helps properly placing the distal end of the puncturing device at the desired location ([0005] of Maini).
In the alternative, Edwardsen also teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall.
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with balloon to articulate and/or position the ultrasound tip by inflation force of the balloon as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 2, Owens teaches wherein the imaging transducer is pivotable between a straight position in which the imaging transducer forms a straight angle with the device shaft, and a pivoted position in which the imaging transducer is angled relative to the device shaft (see fig. 1, 4 and 7 as well as the associated pars.).
Regarding claims 4 and 12, Owens teaches wherein the expandable element is directly coupled to the device shaft proximal to the imaging transducer (see fig. 2C and the associated pars).
Maini also teaches expandable element is directly coupled to the device shaft (FIGS. 3A-3B, catheter shaft 312 that includes center lumen shaft 311 and hypotubes 317 connected to multiple balloons 314. FIG. 3A is a side view of sheath or catheter shaft 312, and FIG. 3B is a front cross-sectional view of sheath or catheter shaft 312 [0062]).
Edwardsen also teaches expandable element is directly coupled to the device shaft (see fig. 2 and the associated pars)
Regarding claim 5, the above noted combination does not teach wherein the expandable element is configured to expand in a backwards direction.
Edwardsen teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall.
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with to expand in a backwards direction as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 6, the above noted combination does not teach balloon.
Edwardsen teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall.
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with balloon as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 7, the above noted combination does not teach wherein the balloon comprises a plurality of chambers, wherein each chamber can be controlled individually.
Maini teaches as seen in fig. 3A balloons 314 are fully inflated, ultrasound chips or transducers 326 may be forward facing. However, when balloons 314 are deflated, ultrasound chips or transducer 326 may be folded flat and positioned on side of distal tip 313 of center lumen 315. Hence, when balloons 314 are deflated, ultrasound chips or transducer 326 may be side-facing. During inflation, orientation of ultrasound chips or transducers 326 may change as balloons 314 inflate (moving from side-facing orientation to forward facing orientation). Accordingly, operator(s) of transseptal insertion device 300 may vary the inflation of balloons 314 to achieve different orientations of ultrasound chips or transducers 326 for different imaging views [0065].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with b balloon comprises a plurality of chambers, wherein each chamber can be controlled individually as taught by Maini because it helps properly placing the distal end of the puncturing device at the desired location ([0005] of Maini).
Regarding claim 8 and 9, the above noted combination does not teach wherein the balloon is configured to be expanded by being filled with a filler fluid and gas.
Edwardsen teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall. The scanhead 220 includes the flexible pouch 240, the transducer 230, and an inflation duct 320. The inflation duct 320 allows fluid, such as a liquid or gas, to flow between the flexible pouch 240 and the control handle [0030].
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with balloon as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 10, the above noted combination does not teach wherein the filler fluid is a high temperature filler fluid.
Edwardsen teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall [i.e., operating in a living body that is around 98F, hence high temp] at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall. The scanhead 220 includes the flexible pouch 240, the transducer 230, and an inflation duct 320. The inflation duct 320 allows fluid, such as a liquid or gas, to flow between the flexible pouch 240 and the control handle [0030].
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with filler fluid is a high temperature filler fluid as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 11, the above noted combination does not teach wherein the balloon is configured to expand between the imaging transducer and tissue being imaged by the imaging transducer,
such that the balloon acts as an acoustic standoff to couple the imaging transducer with the tissue.
Edwardsen teaches the bending of the endoscope 110 forces the scanhead 120 to engage the esophageal wall at an angle which may negatively impact the transducer's 130 ability to image the internal structure. That is, the operative surface of the transducer 130 on the scanhead 120 is not parallel with the esophageal wall. Instead, the transducer 130 is angled into the esophageal wall. The scanhead 220 includes the flexible pouch 240, the transducer 230, and an inflation duct 320. The inflation duct 320 allows fluid, such as a liquid or gas, to flow between the flexible pouch 240 and the control handle [0030].
It would also have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with balloon is configured to expand between the imaging transducer and tissue being imaged by the imaging transducer, such that the balloon acts as an acoustic standoff to couple the imaging transducer with the tissue as taught by Edwardsen because in order to obtain accurate images of internal organs and structures, it is preferable that the transducer maintain uniform and close contact with the organs and structures ([0005] of Edwardsen).
Regarding claim 14, Owens teaches wherein the device shaft comprises a straight shaft (see e.g., figs. 1-5 and the associated pars.).
Regarding claim 15, Owens teaches wherein the tissue ablation device is configured for uterine fibroid ablation (see [0140]-[0143] as well as fig. 7).
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Owens et al (US 20190350648 A1) in view of Maini (US20210085384A1) and further in view of Deckman et al (US 20100056926 A1).
Regarding claims 3 and 13, the above noted combination does not teach expandable element is an unwinding spring and spring-loaded tip, the spring-loaded tip configured to apply a force to restore the imaging transducer from a pivoted position toward the straight position.
However, in the same field of endeavor, Deckman teaches tip 18 which is adapted to receive an ultrasonic imaging array [0025]. The lever 28 can be released by pressing the pin 52 against spring 62 so that the pin 56 is lifted out of the pocket 58, as shown in FIG. 3A. In this configuration, the lever may be moved freely back and forth to deploy the tip 18. When the tip 18 is in its desired location, the locking pin 52 may be released to permit pin 56 to engage the closest pocket 58 where it is held in place by spring 62. It will be appreciated that the lever 28 will typically be advanced forwardly to close the tip 18 to a low profile configuration for introducing the imaging and therapy delivery system 10 to the patient for treatment, for example through the cervix into the uterus [0028].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with a spring-loaded tip, the spring-loaded tip configured to apply a force to restore the imaging transducer from a pivoted position toward the straight position as taught by Deckman because it would be desirable to provide alternative devices and methods for treating, ablating, or removing uterine fibroids and other tissue masses. It would be particularly desirable if such methods and devices were able to treat uterine fibroids which are large, difficult to penetrate, or which otherwise resist treatment with curved and laterally deployed ([0007] of Deckman).
Conclusion
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797