DETAILED ACTION
The amendment filed August 18, 2025, has been entered and fully considered. Claims 30-49 are pending. Claims 30, 37 and 44 are pending.
Notice of Pre-AIA or AIA Status
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.
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 second arm pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30, 37 and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 30, the specification fails to describe the newly added limitation “the second arm is rotatable and pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction.” Regarding claim 37, similarly the specification fails to describe the newly added limitation “the second arm is pivotable to adjust a distance between the first arm and the second arm in an angular direction.” Lastly, regarding claim 44, the specification fails to describe the newly added limitation “the second arm is configured to pivot to adjust a distance between the first arm and the second arm in an angular direction.” Further, Figure 4C fails to illustrate the second arm ‘pivoting’ relative to the first arm to adjust the distance or positioning the second arm in an angular direction. Figure 4C illustrates first arm (402) and second arm (404) parallel to one another.
Paragraph [0040] states “When the connector (418) is adjustable relative to the connection portion (414), the track (420) may be rotated and/or slid relative to the pin (424). Rotation of the connector (418) may rotate the second arm (404) relative to the first arm (402), while sliding of the connector (418) may adjust the distance between the second arm (404) and the first arm (402). Accordingly, the position of the second arm (404) may be adjusted to set a specific relation between the first arm (402) and the second arm (404), and the knob (422) may be adjusted to temporarily lock the position of the second arm (404) relative to the first arm (402). When the first arm (402) and the second arm (404) are placed in first and second vessels, respectively, the relative positioning between the first and second arms may also dictate the relative positioning between the first and second vessels.”
Applicant indicates in Applicant’s Remarks (p. 10) that, “[a]s illustrated above, and as described in para. [0040] of the Specification, the second arm 404 is adjustably connected to connector 418, which is in turn coupled to the connection portion 414 via pin 424. Accordingly, rotation of the connector 418 (e.g., about the pin 424) may similarly rotate (e.g., pivot) the second arm 404 relative the first arm 402. Specification, para. [0040]. It should be appreciated that, in the embodiment depicted in FIG. 4C, rotation of the second arm 404 relative the first arm 402 may allow a user to adjust an angular direction of the second arm relative the first arm, which may further aid in positioning the device.” However, the specification does not describe the pivoting motion or the angular direction as claimed. Paragraph [0040], and the remainder of the specification, fail to describe what axis the rotation of the connector (418) occurs to rotate the second arm (404) relative to the first arm (402). The specification further does not provide a description of pivoting or an angular direction as claimed.
Claims 31-36 are rejected due to their dependency on claim 30. Claims 38-43 are rejected due to their dependency on claim 37. Claims 45-49 are rejected due to their dependency on claim 44.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 30-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller et al., (hereinafter ‘Miller,” U.S. PGPub. No. 2012/0302935) in view of Kunis et al., (hereinafter ‘Kunis,’ U.S. Pat. 7,850,685) and Whitbrook et al., (hereinafter 'Whitbrook,' U.S. PGPub. No. 2017/0319235.
Regarding independent claim 30 and claim 34, Miller ([0031]-[0032]; [0037]-[0038]; [0102]; Figs. 37A-37B) discloses a device for forming a fistula between two vessels comprising: a handle; a first arm fixedly connected to the handle; and a second arm, wherein at least one of the first arm and the second arm comprises a fistula forming element ([0031], “in some instances a catheter may be placed in each of the two blood vessels.” [0032], “each catheter will have a proximal end, a distal end, and an intermediate portion connecting the proximal and distal ends. The proximal end may comprise one or more adaptors or handles, which may be utilized to help aid in advancement, positioning and control of the catheter within the vasculature, and may further be used to actuate one or more components of the catheter and/or introduce one or more fluids or substances into and/or through the catheter. The catheter may comprise one or more elements that may aid in fistula formation.” [0037], “the catheters described here may comprise one or more elements for forming a fistula. These fistula-forming elements may utilize any structure or mechanism capable of cutting, ablating, vaporizing, dissolving, or otherwise removing tissue between adjoining vessels,” [0038]; [0102]; Figs. 37A-37B illustrate catheter 3700).
Although Miller teaches a second arm, Miller is silent regarding the second arm adjustably connected to the handle, such that the second arm is translatable relative the handle; and further comprising an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm.
However, in the same field of endeavor, Kunis teaches a similar device comprising a first and second control shaft (122, 121 in Fig. 7), wherein the control shafts are operably connected to a control such as a knob or lever in a handle on the proximal end of ablation catheter (70) (col. 15, ll. 45-48). “The handle may include various knobs, such as rotating or sliding knobs which are operably connected to advanceable conduits, or are operably connected to gear trains or cams which are connected to advanceable conduits. These knobs, such as knobs use to deflect a distal portion of a conduit, or to advance or retract the carrier assembly, preferably include a reversible locking mechanism such that a particular…deployment amount can be maintained through various manipulations of the system.” (col. 26, ll. 18-27, thereby meeting the limitation of translation relative to the handle). It would be desirable to provide such an adjustment knob and associated lock in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this configuration might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include the second arm adjustably connected to the handle, such that the second arm is translatable relative the handle; and further comprising an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm, as taught by Kunis in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this modification might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53).
Miller in view of Kunis are silent regarding the second arm is rotatable relative the first arm to rotationally position the second arm relative the first arm.
However, in the same field of endeavor, Drasler teaches a similar device wherein the catheter shaft (15) can be moved in an axial direction (245) or rotational direction (250) via a mechanical rotating or axial vibrating means ([0103]). It is well known in the art (as can be seen in Drasler) to provide both rotational and axial movement to the catheter shaft in order to aid in the alignment and positioning of the catheter shaft, thereby improving efficiency and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller in view of Kunis to provide rotation to the second arm, as taught by Drasler, in order to aid in the alignment and positioning of the second arm, thereby improving efficiency and accuracy of treatment.
Miller in view of Kunis and Drasler are silent regarding the second arm is pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction.
However, in the same field of endeavor, Whitbrook (Figs. 21-22) teaches a similar device (70) comprising a first arm and second arm (72, 76) connected by a handle (78). Whitbrook teaches “[t]he guide/handle 78 of the treatment device 70 of FIG. 21 serves to precisely position the energy delivery elements relative to a stable anatomic structure . . . Proper alignment of the energy delivery elements may need to be adjusted and set differently for different patients. Guide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft.” ([0090], thereby meeting the limitation of a pivotable second arm to rotationally position the second arm relative the first arm in an angular direction). It is desirable to provide a handle capable of angular adjustment such that the user can modify the angle of the device to meet the anatomical configuration of the specific patient and provide proper alignment of the first arm and second arm, thereby increasing control, accuracy of placement, and overall safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller in view of Kunis and Drasler to include the second arm is pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction, as taught by Whitbrook, in order to best accommodate the anatomical configuration of the patient being treated and aid in the proper alignment of the device, thereby increasing control, accuracy of placement, and overall safety.
Regarding claim 31, Miller in view of Kunis and Whitbrook teach all of the limitations of the device according to claim 30. Miller discloses wherein the fistula forming element comprises a rotatable blade (3702 in Figs. 37A-37B; [0085]-[0086]).
Regarding claim 32, Miller in view of Kunis and Whitbrook teach all of the limitations of the device according to claim 31. Miller discloses wherein the rotatable blade (3702) is rotatably connected to a distal portion of the first arm (Figs. 37A-37B).
Regarding claim 33, Miller in view of Kunis and Whitbrook teach all of the limitations of the device according to claim 32. Miller discloses wherein the handle comprises a first control configured to rotate the rotatable blade relative to the first arm ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.” Also see [0087] for activation wire 3708 to manipulate blade 3702).
Regarding claim 35, Miller in view of Kunis and Whitbrook teach all of the limitations of the device according to claim 30. Miller discloses wherein the first arm is formed from a first rigid material such that placement of the first arm in a first vessel causes the first vessel to conform to a shape of the first arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Regarding claim 36, Miller in view of Kunis and Whitbrook teach all of the limitations of the device according to claim 35. Miller discloses wherein the second arm is formed from a second rigid material such that placement of the second arm in a second vessel causes the second vessel to conform to a shape of the second arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Claim 30-36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Kunis and Glines et al., (hereinafter ‘Glines,’ U.S. Pat. 6,309,375).
Regarding independent claim 30 and claim 34, Miller ([0031]-[0032]; [0037]-[0038]; [0102]; Figs. 37A-37B) discloses a device for forming a fistula between two vessels comprising: a handle; a first arm fixedly connected to the handle; and a second arm, wherein at least one of the first arm and the second arm comprises a fistula forming element ([0031], “in some instances a catheter may be placed in each of the two blood vessels.” [0032], “each catheter will have a proximal end, a distal end, and an intermediate portion connecting the proximal and distal ends. The proximal end may comprise one or more adaptors or handles, which may be utilized to help aid in advancement, positioning and control of the catheter within the vasculature, and may further be used to actuate one or more components of the catheter and/or introduce one or more fluids or substances into and/or through the catheter. The catheter may comprise one or more elements that may aid in fistula formation.” [0037], “the catheters described here may comprise one or more elements for forming a fistula. These fistula-forming elements may utilize any structure or mechanism capable of cutting, ablating, vaporizing, dissolving, or otherwise removing tissue between adjoining vessels,” [0038]; [0102]; Figs. 37A-37B illustrate catheter 3700).
Although Miller teaches a second arm, Miller is silent regarding the second arm adjustably connected to the handle, such that the second arm is translatable relative the handle; and further comprising an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm.
However, in the same field of endeavor, Kunis teaches a similar device comprising a first and second control shaft (122, 121 in Fig. 7), wherein the control shafts are operably connected to a control such as a knob or lever in a handle on the proximal end of ablation catheter (70) (col. 15, ll. 45-48). “The handle may include various knobs, such as rotating or sliding knobs which are operably connected to advanceable conduits, or are operably connected to gear trains or cams which are connected to advanceable conduits. These knobs, such as knobs use to deflect a distal portion of a conduit, or to advance or retract the carrier assembly, preferably include a reversible locking mechanism such that a particular…deployment amount can be maintained through various manipulations of the system.” (col. 26, ll. 18-27, thereby meeting the limitation of translation relative to the handle). It would be desirable to provide such an adjustment knob and associated lock in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this configuration might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include the second arm adjustably connected to the handle, such that the second arm is translatable relative the handle; and further comprising an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm, as taught by Kunis in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this modification might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53).
Miller in view of Kunis are silent regarding the second arm is rotatable and pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction.
However, in the same field of endeavor, Glines teaches an arm (208 in Fig. 2E) that is rotatable and pivotable relative the device (10) at pivot connection (209) to rotationally position the arm (208) in an angular direction (as best illustrated in Fig. 2E). Glines teaches “Pivot connection 209 allows rotational movement between the endoscope 202 and the endoscope mount portion 207, thus allowing selection of functional angle Θ. In operation, a surgeon or cardiologist will find the controllability and selectability of functional angle Θ a feature which increases efficiency, ease of operation and adaptability to specialized or general applications. Selection of functional angle Θ is based on the intended application, however, it will be understood that an angle between about 45 degrees and about 135 degrees, or more or less, is typically used.” (col. 29, ll. 56-65). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller in view of Kunis to include the second arm is rotatable and pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction, as taught by Glines, in order to allow selection of a functional angle, thereby increasing efficiency, ease of operation and adaptability to specialized or general application.
Regarding claim 31, Miller in view of Kunis and Glines teach all of the limitations of the device according to claim 30. Miller discloses wherein the fistula forming element comprises a rotatable blade (3702 in Figs. 37A-37B; [0085]-[0086]).
Regarding claim 32, Miller in view of Kunis and Glines teach all of the limitations of the device according to claim 30. Miller discloses wherein the rotatable blade (3702) is rotatably connected to a distal portion of the first arm (Figs. 37A-37B).
Regarding claim 33, Miller in view of Kunis and Glines teach all of the limitations of the device according to claim 30. Miller discloses wherein the handle comprises a first control configured to rotate the rotatable blade relative to the first arm ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.” Also see [0087] for activation wire 3708 to manipulate blade 3702).
Regarding claim 35, Miller in view of Kunis and Glines teach all of the limitations of the device according to claim 30. Miller discloses wherein the first arm is formed from a first rigid material such that placement of the first arm in a first vessel causes the first vessel to conform to a shape of the first arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Regarding claim 36, Miller in view of Kunis and Glines teach all of the limitations of the device according to claim 30. Miller discloses wherein the second arm is formed from a second rigid material such that placement of the second arm in a second vessel causes the second vessel to conform to a shape of the second arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Claim 37 and 44 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Whitbrook and Drasler.
Regarding claim 37, Miller (Figs. 15A-15B) discloses a device for forming a fistula between two vessels comprising: a handle ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”) comprising: a grip portion (see adaptor 1502 having a grip portion; it is noted, that when brought together by alignment projections 1506, adaptors 1502 form a handle); and a connection portion (1506) connected to the grip portion (1502); a first arm connected to the connection portion (as broadly claimed, catheter 1500 is connected to alignment projection 1506); and a second arm (1500 in Fig. 15B) connected to the connection portion (1506) ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”).
Although Miller teaches a second arm, Miller is silent regarding wherein the second arm is pivotable to adjust a distance between the first arm and the second arm in an angular direction.
However, in the same field of endeavor, Whitbrook (Figs. 21-22) teaches a similar device (70) comprising a first arm and second arm (72, 76) connected by a handle (78). Whitbrook teaches “[t]he guide/handle 78 of the treatment device 70 of FIG. 21 serves to precisely position the energy delivery elements relative to a stable anatomic structure . . . Proper alignment of the energy delivery elements may need to be adjusted and set differently for different patients. Guide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft.” ([0090], thereby meeting the limitation of a pivotable second arm as claimed). It is desirable to provide a handle capable of angular adjustment such that the user can modify the angle of the device to meet the anatomical configuration of the specific patient and provide proper alignment of the first arm and second arm, thereby increasing control, accuracy of placement, and overall safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include wherein the second arm is pivotable to adjust a distance between the first arm and the second arm in an angular direction, as taught by Whitbrook, in order to best accommodate the anatomical configuration of the patient being treated and aid in the proper alignment of the device, thereby increasing control, accuracy of placement, and overall safety.
Miller in view of Whitbrook are silent regarding the second arm is rotatable relative the first arm to rotationally position the second arm relative the first arm.
However, in the same field of endeavor, Drasler teaches a similar device wherein the catheter shaft (15) can be moved in an axial direction (245) or rotational direction (250) via a mechanical rotating or axial vibrating means ([0103]). It is well known in the art (as can be seen in Drasler) to provide both rotational and axial movement to the catheter shaft in order to aid in the alignment and positioning of the catheter shaft, thereby improving efficiency and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to provide rotation to the second arm, as taught by Drasler, in order to aid in the alignment and positioning of the second arm, thereby improving efficiency and accuracy of treatment.
Regarding claim 44, Miller (Figs. 15A-15B; [0005]; [0156]) discloses a device for forming a fistula between two vessels comprising: a handle ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”) comprising: a grip portion (see adaptor 1502 having a grip portion; it is noted, that when brought together by alignment projections 1506, adaptors 1502 form a handle); and a connection portion (1506) connected to the grip portion (1502); a first arm (1500) connected to the connection portion (1506); and a second arm (1500 in Fig. 15B) comprising a fistula forming element (1508), wherein the second arm is connected to the connection portion (1506) ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”).
Although Miller teaches a second arm, Miller is silent regarding the second arm is configured to pivot to adjust a distance between the first arm and the second arm in an angular direction.
However, in the same field of endeavor, Whitbrook (Figs. 21-22) teaches a similar device (70) comprising a first arm and second arm (72, 76) connected by a handle (78). Whitbrook teaches “[t]he guide/handle 78 of the treatment device 70 of FIG. 21 serves to precisely position the energy delivery elements relative to a stable anatomic structure . . . Proper alignment of the energy delivery elements may need to be adjusted and set differently for different patients. Guide/handle 78 may include one or more adjustments, as shown in FIG. 22. Here, the vertical height may be adjusted by elongating the guide/handle 78. Although not shown, guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft.” ([0090], thereby meeting the limitation of a pivotable second arm as claimed). It is desirable to provide a handle capable of angular adjustment such that the user can modify the angle of the device to meet the anatomical configuration of the specific patient and provide proper alignment of the first arm and second arm, thereby increasing control, accuracy of placement, and overall safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include the second arm is configured to pivot to adjust a distance between the first arm and the second arm in an angular direction, as taught by Whitbrook, in order to best accommodate the anatomical configuration of the patient being treated and aid in the proper alignment of the device, thereby increasing control, accuracy of placement, and overall safety.
Miller in view of Whitbrook are silent regarding to rotate relative the first arm to rotationally position the second arm relative the first arm.
However, in the same field of endeavor, Drasler teaches a similar device wherein the catheter shaft (15) can be moved in an axial direction (245) or rotational direction (250) via a mechanical rotating or axial vibrating means ([0103]). It is well known in the art (as can be seen in Drasler) to provide both rotational and axial movement to the catheter shaft in order to aid in the alignment and positioning of the catheter shaft, thereby improving efficiency and accuracy of treatment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to provide rotation to the second arm, as taught by Drasler, in order to aid in the alignment and positioning of the second arm, thereby improving efficiency and accuracy of treatment.
Claims 37-40 and 42-49 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Glines.
Regarding claim 37, Miller (Figs. 15A-15B) discloses a device for forming a fistula between two vessels comprising: a handle ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”) comprising: a grip portion (see adaptor 1502 having a grip portion; it is noted, that when brought together by alignment projections 1506, adaptors 1502 form a handle); and a connection portion (1506) connected to the grip portion (1502); a first arm connected to the connection portion (as broadly claimed, catheter 1500 is connected to alignment projection 1506); and a second arm (1500 in Fig. 15B) connected to the connection portion (1506) ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”).
Although Miller teaches a second arm, Miller is silent regarding wherein the second arm is pivotable to adjust a distance between the first arm and the second arm in an angular direction and the second arm is rotatable relative the first arm to rotationally position the second arm relative the first arm.
However, in the same field of endeavor, Glines teaches an arm (208 in Fig. 2E) that is rotatable and pivotable relative the device (10) at pivot connection (209) to rotationally position the arm (208) in an angular direction (as best illustrated in Fig. 2E). Glines teaches “Pivot connection 209 allows rotational movement between the endoscope 202 and the endoscope mount portion 207, thus allowing selection of functional angle Θ. In operation, a surgeon or cardiologist will find the controllability and selectability of functional angle Θ a feature which increases efficiency, ease of operation and adaptability to specialized or general applications. Selection of functional angle Θ is based on the intended application, however, it will be understood that an angle between about 45 degrees and about 135 degrees, or more or less, is typically used.” (col. 29, ll. 56-65). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include wherein the second arm is pivotable to adjust a distance between the first arm and the second arm in an angular direction and the second arm is rotatable relative the first arm to rotationally position the second arm relative the first arm, as taught by Glines. Doing so allows for selection of a functional angle, thereby increasing efficiency, ease of operation and adaptability to specialized or general application.
Regarding claim 38, Miller in view of Glines teach all of the limitations of the device according to claim 37. Miller (Figs. 15A-15B; [0005]; [0156]) further discloses the first arm (1500) is fixedly connected to the connection portion (1506). In view of the prior modification of Miller in view of Glines, Glines (Fig. 2E) teaches the second arm is adjustably connected to the connection portion (see arm 208 adjustably connected and inserted into pivot connection 209).
Regarding claim 39, Miller in view of Glines teach all of the limitations of the device according to claim 38. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the second arm (1500 in Fig. 15B) is lockable in a position relative to the first arm (as broadly claimed, the first and second catheters 1500 are locked in a position relative to each other by alignment projections 1506).
Regarding claim 40, Miller in view of Glines teach all of the limitations of the device according to claim 37. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the first arm (1500) is configured to be inserted into a first vessel and the second arm (1500) is configured to be positioned into a second vessel, and wherein an adjustment of a position of the second arm relative to the first arm with the connection portion (1506) repositions the second vessel relative to the first vessel ([0156], “when two catheters (1500) are placed in two adjoining blood vessels (not shown), the alignment projections (1506) of each catheter (1500) may be aligned with each other to align the respective fistula-forming components (1508) on each catheter.” Also see [0006] for magnetic alignment elements used to draw two or more catheters closer together within the vasculature, to axially and/or rotationally align two or more catheters).
Regarding claim 42, Miller in view of Glines teach all of the limitations of the device according to claim 37. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the first arm is formed from a first rigid material such that placement of the first arm in a first vessel causes the first vessel to conform to a shape of the first arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Regarding claim 43, Miller in view of Glines teach all of the limitations of the device according to claim 42. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the second arm is formed from a second rigid material such that placement of the second arm in a second vessel causes the second vessel to conform to a shape of the second arm (see [0055], for catheter made of ‘nesting material’ including “ceramic materials, parylene, one or more polymeric resins (e.g., polyetherimide, polyetheretherketone, one or more phenolic resins, or the like), silica, one or more metal oxides (e.g., aluminum oxide), combinations thereof, or the like.”).
Regarding claim 44, Miller (Figs. 15A-15B; [0005]; [0156]) discloses a device for forming a fistula between two vessels comprising: a handle ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”) comprising: a grip portion (see adaptor 1502 having a grip portion; it is noted, that when brought together by alignment projections 1506, adaptors 1502 form a handle); and a connection portion (1506) connected to the grip portion (1502); a first arm (1500) connected to the connection portion (1506); and a second arm (1500 in Fig. 15B) comprising a fistula forming element (1508), wherein the second arm is connected to the connection portion (1506) ([0005], “The proximal end of the catheter may comprise one or more handles or adaptors, which may be used to control or manipulate the catheter.”).
Although Miller teaches a second arm, Miller is silent regarding the second arm is configured to pivot to adjust a distance between the first arm and the second arm in an angular direction and to rotate relative the first arm to rotationally position the second arm relative the first arm.
However, in the same field of endeavor, Glines teaches an arm (208 in Fig. 2E) that is rotatable and pivotable relative the device (10) at pivot connection (209) to rotationally position the arm (208) in an angular direction (as best illustrated in Fig. 2E). Glines teaches “Pivot connection 209 allows rotational movement between the endoscope 202 and the endoscope mount portion 207, thus allowing selection of functional angle Θ. In operation, a surgeon or cardiologist will find the controllability and selectability of functional angle Θ a feature which increases efficiency, ease of operation and adaptability to specialized or general applications. Selection of functional angle Θ is based on the intended application, however, it will be understood that an angle between about 45 degrees and about 135 degrees, or more or less, is typically used.” (col. 29, ll. 56-65). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller to include wherein the second arm is configured to pivot to adjust a distance between the first arm and the second arm in an angular direction and to rotate relative the first arm to rotationally position the second arm relative the first arm, as taught by Glines. Doing so allows for selection of a functional angle, thereby increasing efficiency, ease of operation and adaptability to specialized or general application.
Regarding claim 45, Miller in view of Glines teach all of the limitations of the device according to claim 44. Miller (Figs. 15A-15B; [0005]; [0156]) further discloses the first arm (1500) is fixedly connected to the connection portion (1506). In view of the prior modification of Miller in view of Glines, Glines (Fig. 2E) teaches the second arm is adjustably connected to the connection portion (see arm 208 adjustably connected and inserted into pivot connection 209).
Regarding claim 46, Miller in view of Glines teach all of the limitations of the device according to claim 45. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the second arm (1500 in Fig. 15B) is lockable in a position relative to the first arm (as broadly claimed, the first and second catheters 1500 are locked in a position relative to each other by alignment projections 1506).
Regarding claim 47, Miller in view of Glines teach all of the limitations of the device according to claim 44. Miller (Figs. 15A-15B; [0005]; [0156]) discloses wherein the first arm (1500) is configured to be inserted into a first vessel and the second arm (1500) is configured to be positioned into a second vessel, and wherein an adjustment of a position of the second arm relative to the first arm with the connection portion (1506) repositions the second vessel relative to the first vessel ([0156], “when two catheters (1500) are placed in two adjoining blood vessels (not shown), the alignment projections (1506) of each catheter (1500) may be aligned with each other to align the respective fistula-forming components (1508) on each catheter.” Also see [0006] for magnetic alignment elements used to draw two or more catheters closer together within the vasculature, to axially and/or rotationally align two or more catheters).
Regarding claims 48 and 49, Miller in view of Glines teach all of the limitations of the device according to claim 44. Although Miller discloses a fistula-forming element (1508 in Fig. 15B), Miller in view of Glines are silent regarding wherein the fistula forming element comprises a rotatable blade, and wherein the rotatable blade is rotatable connected to a distal portion of the second arm.
However, in an alternate embodiment, Miller teaches wherein the fistula forming element comprises a rotatable blade and is rotatably connected to a distal portion of the first arm (3702 in Figs. 37A-37B; [0085]-[0086]). Miller teaches “in some variations the catheter may comprise one or more mechanical cutting elements, such as, for example, a blade, a needle, a lancet, or the like. In other variations, the catheter may comprise one or more electrodes for ablating or otherwise vaporizing tissue between two blood vessels. In some variations, the electrodes comprise one or more ablation surfaces for ablating tissues.” ([0008]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified Miller in view of Glines such that the fistula forming element comprises a rotatable blade, and wherein the rotatable blade is rotatable connected to a distal portion of the second arm, as taught by Miller. This modification would have merely comprised a simple substitution of one well known fistula forming element for another in order to produce a predictable result, MPEP 2143(I)(B).
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Miller in view of Glines, as applied to claim 37 above, and further in view of Kunis.
Regarding claim 41, Miller in view of Glines teach all of the limitations of the device according to claim 37, but are silent regarding further comprising an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm.
However, in the same field of endeavor, Kunis teaches a similar device comprising a first and second control shaft (122, 121 in Fig. 7), wherein the control shafts are operably connected to a control such as a knob or lever in a handle on the proximal end of ablation catheter (70) (col. 15, ll. 45-48). “The handle may include various knobs, such as rotating or sliding knobs which are operably connected to advanceable conduits, or are operably connected to gear trains or cams which are connected to advanceable conduits. These knobs, such as knobs use to deflect a distal portion of a conduit, or to advance or retract the carrier assembly, preferably include a reversible locking mechanism such that a particular…deployment amount can be maintained through various manipulations of the system.” (col. 26, ll. 18-27). It would be desirable to provide such an adjustment knob and associated lock in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this configuration might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device as taught by Miller in view of Glines to include an adjustment knob, wherein the adjustment knob is moveable between a first configuration to lock the second arm relative to the first arm and a second configuration to allow adjustment of the second arm relative to the first arm, as taught by Kunis in order to achieve and maintain a desired position of the device throughout treatment, thereby increasing control, accuracy and safety. Further, this modification might allow for repositioning of the treatment components of the device to achieve better conformance to various tissues, thereby increasing versatility of the device (col. 15, ll. 51-53).
Response to Arguments
Applicant’s arguments with respect to claim(s) 30-49 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant has argued (p. 7) “independent claims 30, 37, and 44 do not merely recite that the second arm is rotatable. Rather, independent claims 30, 37, and 44 are amended herein to explicitly recite that the second arm is rotatable and "pivotable relative the first arm to rotationally position the second arm relative the first arm in an angular direction." (emphasis added).”
Applicant is directed to the 112(a) Rejection set forth above. See rejection for further clarification. It is the Examiner’s position that Whitbrook et al., (U.S. 2017/0319235) teaches the amended limitations. A different and later priority date is given to these limitations. In the event the 112(a) Rejection is overcome, Examiner has provided a second rejection using Glines et al. (U.S. Pat. 6,309,375) to teach the amended limitations.
Applicant’s arguments (p. 7) regarding Drasler are moot in view of the new rejection set forth above. Specifically, Applicant has argued that Drasler is “plainly not pivotable.” (p. 8). It is the Examiner’s position Whitbrook and Glines both teach the pivotable rotation as claimed and cure any perceived deficiency in the prior art.
Further, Applicant states (p. 10), “[a]s illustrated above, and as described in para. [0040] of the Specification, the second arm 404 is adjustably connected to connector 418, which is in turn coupled to the connection portion 414 via pin 424. Accordingly, rotation of the connector 418 (e.g., about the pin 424) may similarly rotate (e.g., pivot) the second arm 404 relative the first arm 402. Specification, para. [0040]. It should be appreciated that, in the embodiment depicted in FIG. 4C, rotation of the second arm 404 relative the first arm 402 may allow a user to adjust an angular direction of the second arm relative the first arm, which may further aid in positioning the device.” In view of Applicant’s arguments and overall explanation of the rotational/pivoting movement, it is the Examiner’s position that Whitbrook and Glines meet these limitations. Whitbrook provides a handle capable of rotation, and therefore pivoting, of the second arm relative to the first arm ([0090], “guide/handle 78 may further be configured to adjust the entry angle of the energy delivery elements relative to the shaft.). See rejection above for further clarification. Similarly, Glines also provides a handle capable of rotation, and therefore pivoting, of the second arm relative to the first arm at pivot connection (209) in Figure 2E.
Applicant’s argument (p. 10) that Kunis could not be modified to pivot is not found persuasive. Nothing in Kunis limits the modification. Further, it is the Examiner’s position that Whitbrook does teach a configuration that could be incorporated into Kunis. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
No further arguments have been set forth regarding the dependent claims.
Conclusion
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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794