Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pat. No. 6,746,422 to Noriega et al (“Noriega”).
Regarding claim 1, Noriega discloses a medical device (10) comprising: a tube (12) including: a proximal portion (14); and a distal portion (16) having a slotted section with a plurality of slots formed therein (see Fig. 5), wherein a proximalmost slot of the plurality of slots has a first length in a circumferential direction about the tube, wherein a distalmost slot of the plurality of slots has a second length in the circumferential direction about the tube, and wherein the first length is smaller than the second length (see annotated Fig 5 below and col. 5, ll. 44-54 which discloses that the slots can be tapered toward or away from the distal end); and a hub (18) coupled to a proximal portion of the tube (14), wherein rotation of the hub is configured to rotate the proximal portion of the tube about a longitudinal axis of the proximal portion of the tube (considered inherently necessary since Figs. 6-8 show rotation of the steerable guidewire system 10 and col. 5, ll. 55+ states “To continue advancement, the user can twist or torque the proximal end of the hollow guidewire system until the distal tip is clear of the body lumen wall and aligned with the body lumen (FIG. 8).” Therefore, twisting or torquing of the proximal end of the hollow guidewire system will by necessity be carried out by twisting or torquing (rotation) of the hub 18).
Regarding claim 2, Noriega teaches the medical device of claim 1 and also teaches wherein each slot of the plurality of slots extends approximately perpendicularly to a longitudinal axis the tube (shown in Fig. 5).
Regarding claim 3, Noriega teaches the medical device of claim 1 and also teaches wherein the slotted section includes a longitudinally extending unslotted spine. See annotated Fig. 5 below.
Regarding claim 4, Noriega teaches the medical device of claim 3 and also teaches wherein the spine is a first spine, and wherein the slotted section includes a second longitudinally extending unslotted spine. See col. 5, ll. 33-36 which states, “While not shown, in other embodiments, the ribs 32a can be formed on opposite sides of the distal tip 28 so as to facilitate deflecting in two directions.” and annotated Fig. 5 below which has been modified to show ribs on opposite sides of the distal tip and the creation of a second longitudinally extending unslotted spine on the opposite side (hidden) of the tube.
Regarding claim 5, Noriega teaches the medical device of claim 4 and also teaches wherein each slot of the plurality of slots extends between the first spine and the second spine. See annotated Fig. 5 below.
Regarding claim 6, Noriega teaches the medical device of claim 1 and also teaches wherein the tube includes an array of slots having a first, proximal portion of slots and a second, distal portion. See annotated Fig. 5 below.
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Regarding claim 15, Noriega meet the claim limitations of claim 1 and further teach an unslotted section distal to the slotted section. See Fig. 5.
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.
Claim(s) 1-6 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No. 2002/0165461 to Hayzelden et al. (“Hayselden”) in view of Noriega.
Regarding claim 1, if Noriega is not found to teach a hub (18) coupled to a proximal portion of the tube (14) and wherein rotation of the hub is configured to rotate the proximal portion of the tube about a longitudinal axis of the proximal portion of the tube. This combination of limitations would be obvious in light of the teachings of Hayzelden in view of Noriega.
Hayselden discloses a steerable catheter with shaft that includes a tube (22) including: a proximal portion (26/52); and a distal portion (24) having a slotted section with a plurality of slots formed therein (see Fig. 7D), wherein a proximalmost slot of the plurality of slots has a first length in a circumferential direction about the tube, wherein a distalmost slot of the plurality of slots has a second length in the circumferential direction about the tube (see Fig. 7D and in this figure the first and second lengths are about the same length), a hub (42) coupled (bonded, see para. [0038]) to a proximal portion (52) of the tube (22) and wherein rotation of the hub is configured to rotate the proximal portion of the tube about a longitudinal axis of the proximal portion of the tube (see para. [0044] stating, “More specifically, as the handle 42 is rotated, the torsional forces that are exerted transfer to the proximal region 26 of the sheath 22 because of the attachment means between the handle and the sheath.”).
Hayselden meets the claim limitations as described above but fails to teach wherein a distalmost slot of the plurality of slots has a second length in the circumferential direction about the tube, and wherein the first length is smaller than the second length.
However, Noriega discloses a medical device (10) comprising: a tube (12) including: a proximal portion (14); and a distal portion (16) having a slotted section with a plurality of slots formed therein (see Fig. 5), wherein a proximalmost slot of the plurality of slots has a first length in a circumferential direction about the tube, wherein a distalmost slot of the plurality of slots has a second length in the circumferential direction about the tube, and wherein the first length is smaller than the second length (see annotated Fig 5 below and col. 5, ll. 44-54 which discloses that the slots can be tapered toward or away from the distal end). Furthermore, Noriega discloses at col. 5, ll. 52-54, “With such a variation, there will be a larger bending radius at the distal end of the tip and a smaller bending radius at the proximal end of the tip 28.”
Therefore, at the time of filing, it would have been obvious to incorporate the tapering of the slot on both sides of the longitudinal axis of the tube as taught by Noriega into the invention of Hayselden. Both devices are analogous in the art of steerable catheters; therefore, a combination is proper. Additionally, one would have been motivated by Noriega itself which discloses the advantage of varying the bending radius toward the distal tip thereby providing the medical technician with an enhanced steering system.
Regarding claim 2, Hayzelden in view of Noriega teach the medical device of claim 1 and also Hayzelden in view of Noriega each teach wherein each slot of the plurality of slots extends approximately perpendicularly to a longitudinal axis the tube (shown in Hayzelden Fig. 7D and Noriega Fig. 5).
Regarding claim 3, Hayzelden in view of Noriega teach the medical device of claim 1 and also Hayzelden in view of Noriega each teach wherein the slotted section includes a longitudinally extending unslotted spine. See Hayzelden Fig. 7D and Noriega annotated Fig. 5 above.
Regarding claim 4, Hayzelden in view of Noriega teach the medical device of claim 3 and also teaches wherein the spine is a first spine, and wherein the slotted section includes a second longitudinally extending unslotted spine. See Hayselden Fig. 7D where the first spine is shown in the figure and the second spine is partly shown inside the front tip of the tube. See also Noriega col. 5, ll. 33-36 which states, “While not shown, in other embodiments, the ribs 32a can be formed on opposite sides of the distal tip 28 so as to facilitate deflecting in two directions.” and annotated Fig. 5 below which has been modified to show ribs on opposite sides of the distal tip and the creation of a second longitudinally extending unslotted spine on the opposite side (hidden) of the tube.
Regarding claim 5, Hayzelden in view of Noriega teach the medical device of claim 4 and also teaches wherein each slot of the plurality of slots extends between the first spine and the second spine. See Hayzelden Fig. 7D and Noriega annotated Fig. 5 above.
Regarding claim 6, Hayzelden in view of Noriega teach the medical device of claim 1 and also teaches wherein the tube includes an array of slots having a first, proximal portion of slots and a second, distal portion. Each of Hayzelden and Noriega can be divided into first proximal portion of slots and second distal portion of slots.
Regarding claim 15, Hayzelden in view of Noriega meet the claim limitations of claim 1 and Noriega further teaches an unslotted section distal to the slotted section. See Fig. 5.
Claim(s) 7-8 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Noriega in view of US Pub. No. 2018/0049873 to Manash et al (“Manash”) or Hayzelden in view of Noriega in further view of Manash.
Regarding claims 7-8 and 19, Noriega alone or Hayzelden in view of Noriega meet the claim limitations as described above for claim 6 and Noriega alone or Hayzelden in view of Noriega meet the same limitations present in independent claim 19 as independent claim 1, see above. However, Noriega alone or Hayzelden in view of Noriega fail to teach that each slot of the plurality of slots of the second portion has approximately a same circumferential length (claims 7 and 19) and wherein lengths of the plurality of slots in the first portion taper from a first circumferential length at a proximal end of the first portion to a second circumferential length at a distal end of the first portion, and wherein the second circumferential length is greater than the first circumferential length (claims 8 and 19).
However, Manash discloses a steerable delivery system that includes the use of a first portion (see annotated Fig. 8B below) of slots that taper from a first length at a proximal end of the first portion to a second length at a distal end of the first portion where the second length is greater and a second portion (1025) of slots where each slot of the plurality of slots of the second portion has approximately the same length. See annotated Fig. 8B below.
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Manash also discloses that the different portions of slots allow for different portions of the catheter to bend at difference times which provides better control of the articulation and the tapering sections allows for a gradual change which can provide stress relief. See Manash paras [0101-0104].
At the time of filing, it would have been obvious to one skilled in the to incorporate the two different portions of slots as taught by Manash into the invention of Noriega alone or Hayzelden in view of Noriega. All three references are analogous in the art of steerable delivery systems; therefore, a combination is proper. Additionally, Manash provides the motivation for making the incorporation as providing better control of the articulation and stress relief.
Claim(s) 9-10 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega in view of US Pat. No. 4,033,331 to Guss et al (“Guss”) or Hayzelden in view of Noriega in further view of Guss.
Regarding claims 9-10 and 16, Noriega alone or Hayzelden in view of Noriega meet the claim limitations as described above for claim 1 and Noriega alone or Hayzelden in view of Noriega meet the same limitations present in independent claim 16 as independent claim 1, see above. However, Noriega alone or Hayzelden in view of Noriega fail to teach wherein, in a relaxed state, the distal portion includes a curved portion having a curved central longitudinal axis (claims 9 and 16) and wherein, in the relaxed state, the tube has an approximately “J” shape. (claims 10 and 16).
However, Guss teaches a cardiac catheter that uses a preformed distal end with a J shaped memory curvature. See Figs. 2-4. Guss discloses at col. 2, ll. 38-42 that, “The trauma to the patient involved in using the catheter of the present invention is greatly diminished because the guide wire is inserted only once and the catheter is inserted only once for the three above described procedures.”
At the time of filing, one skilled in the art would have found it obvious to incorporate the preformed curve of Guss into the invention of Noriega alone or Hayzelden in view of Noriega. All three references are analogues in the art of catheters for navigation of the vasculature; therefore, a combination is proper. Additionally, the motivation for the incorporation would have come from Guss itself which provides the advantage of providing the steering system with already predetermined curves in order to decrease trauma to the patient.
Regarding claims 17-18, Noriega alone or Hayzelden in view of Noriega teaches wherein the spine is a first spine, and wherein the slotted section includes a second longitudinally extending unslotted spine (claim 17) and wherein each slot of the plurality of slots extends between the first spine and the second spine (claim 18). See claims 4 and 5 above in the rejections by Noriega alone and Hayzelden in view of Noriega.
Claim(s) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Noriega in view of US Pub. No. 2001/0044624 to Seraj et al (“Seraj”) or Hayzelden in view of Noriega in further view of Seraj.
Regarding claims 11-13, Noriega alone or Hayzelden in view of Noriega meet the claim limitations as described above for claim 1 but fail to teach further comprising a jacket covering at least a portion of the tube (claim 11); wherein the jacket extends distally beyond a distalmost end of the tube such that the jacket forms a distal tip of the medical device (claim 12); and wherein the distal tip tapers radially inward toward a distal end of the distal tip (claim 13).
However, Seraj discloses a intraluminal system with deflectable mechanism. The distal end of the device 306 (see Fig. 3) including distal tip 308 is covered by a jacket (see para. [0063] stating, “Distal deflection region 306 is preferably covered with compliant polymeric medical grade tubing, such as polyester, PEBAX, and tetrafluoroethylene. Especially preferred is a polymer of tetrafluoroethylene hexafluoropropylene and vinylidene fluoride known by its acronym as THV. This prevents fluid intrusion into the deflection mechanism.”
At the time of filing, it would have been obvious to one skilled in the art to include the jacket as taught by Seraj into the invention of Noriega alone or Hayzelden in view of Noriega. All three references are analogous in the art of intralumenal deflection mechanisms; therefore, a combination is proper. Additionally, the incorporation of the jacket by Seraj would have been motivated by Seraj itself in the teaching of that the jacket prevents fluid intrusion into the deflection mechanism. One skilled in the art would have understood the advantage of preventing fluid intrusion into the mechanism and thereby enhancing the performance of the device.
Additionally, at the time of filing, it would have been obvious to one skilled in the art to make the distal tip tapered. Fig. 3 of Seraj shows that the distal tip has a smaller diameter and therefore would require a smaller diameter jacket. One skilled in the art would also have understood that a tapered distal tip reduces intralumenal trauma and improves the outcome of the procedure to the patient.
Regarding claim 14 Noriega alone or Hayzelden in view of Noriega meet the claim limitations as described above for claim 1 but fail to teach further comprising an electrosurgical component that is configured to advance over the tube.
However, Seraj claim 8 discloses that the deflection device is capable of being inserted into an electrophysiology catheter (electrosurgical component) lumen and deflecting the tip of the electrophysiology catheter.
At the time of filing, it would have been obvious to incorporate the deflection catheter as taught by Noriega in view of Seraj or Hayzelden in view of Noriega and further in view of Seraj into an electrophysiology catheter lumen in order to provide a system to navigate the electrophysiology catheter to its target location. One skilled in the art would have understood this to be an appropriate application for the steering/deflection mechanism.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Noriega in view of Manash or Hayzelden in view of Noriega in further view of Manash in further view of Guss.
Regarding claim 20, Noriega in view of Manash or Hayzelden in view of Noriega in further view of Manash meet the claim limitations as described above for claim 19, see above. However, Noriega in view of Manash or Hayzelden in view of Noriega in further view of Manash fail to teach wherein, in a relaxed state, the distal portion includes a curved portion having a curved central longitudinal axis.
However, Guss teaches a cardiac catheter that uses a preformed distal end with a J shaped memory curvature. See Figs. 2-4. Guss discloses at col. 2, ll. 38-42 that, “The trauma to the patient involved in using the catheter of the present invention is greatly diminished because the guide wire is inserted only once and the catheter is inserted only once for the three above described procedures.”
At the time of filing, one skilled in the art would have found it obvious to incorporate the preformed curve of Guss into the invention of Noriega in view of Manash or Hayzelden in view of Noriega in further view of Manash. All these references are analogues in the art of catheters for navigation of the vasculature; therefore, a combination is proper. Additionally, the motivation for the incorporation would have come from Guss itself which provides the advantage of providing the steering system with already predetermined curves in order to decrease trauma to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/Primary Examiner, Art Unit 3993
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