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 .
Detail Action
This is in response to the amendment filed 11/12/2025
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 8, 12, 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.)
Regarding claims 1-3, 12, 17 Davis et al. discloses as shown in Figure 3, a guidewire (guidewire 244, see paragraph [0067]) capable of performing a transseptal puncture, the guidewire comprising: a distal end and a proximal end with an elongated length therebetween, the elongated length including at least one recess (channel 248, see paragraph [0067]) being located, at least in part, therealong; the distal end capable of puncturing tissue (if advanced hard enough or a hole is formed in the tissue); and, at least one guidewire marker (coil 252, see paragraph [0067]), wherein the at least one guidewire marker is configured to be securely positioned, respectively at said at least one recess of the elongated length of the guidewire, wherein the guidewire has a nominal outer diameter and the at least one guidewire marker remains within the nominal outer diameter of the guidewire, wherein the at least one guidewire marker is visually distinct from the guidewire, wherein the at least one guidewire marker comprises marker contact surfaces and wherein the at least one recess comprises a guidewire contact surface and wherein the guidewire contact surface is configured to securely contact the marker contact surface, wherein the at least one guidewire marker mitigates the reduction in stiffness of the at least one recess, wherein the at least one guidewire comprises sharp edges, wherein the at least one guidewire marker is capable of providing structural reinforcement to the at least one recess thereby mitigating the reduction in stiffness of the at least one recess associated therewith (by simply being a sold object with the recess).
Davis fails to disclose the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter.
Schock et al., from a related field of endeavor teaches a similar guidewire as shown in Figure 4D, where the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter for the purpose of optimizing stiffness. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis such that the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter as taught by Schock et al. in order to optimize stiffness of the guidewire.
Regarding claim 8, Davis et al. discloses wherein the at least one guidewire marker is an inert guidewire marker (gold and platinum are known inert metals). see paragraph [0067].
Regarding claim 15, Davis et al. discloses wherein the at least one guidewire marker is capable of indicating rotational positioning of the guidewire (if rotated about an axis non-parallel to the central axis of the marker). See paragraph [0048].
Claim(s) 1, 13, 14, 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0065434 (Bavaro et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.)
Regarding claims 1, 13, 14, 17 Bavaro et al. discloses as shown in Figure 5, a guidewire (guidewire 50, see paragraph [0048]) capable of performing a transseptal puncture, the guidewire comprising: a distal end and a proximal end with an elongated length therebetween, the elongated length including at least one recess (at least one of recesses where markers 56 sit, see paragraph [0048]) being located, at least in part, therealong; the distal end capable of puncturing tissue (if advanced hard enough or a hole is formed in the tissue); and, at least one guidewire marker (at least one of markers 56, see paragraph [0048]), wherein the at least one guidewire marker is configured to be securely positioned, respectively at said at least one recess of the elongated length of the guidewire, wherein the at least one recess comprises two or more recesses and wherein the two or more recesses are spaced apart from one another along the elongated length of the guidewire, wherein the two or more recesses form a pattern along the elongated length, wherein the at least one guidewire marker mitigates the reduction in stiffness of the at least one recess, wherein the at least one guidewire comprises sharp edges, wherein the at least one guidewire marker is capable of providing structural reinforcement to the at least one recess thereby mitigating the reduction in stiffness of the at least one recess associated therewith (by simply being a sold object with the recess).
Bavaro et al. fails to disclose the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter.
Schock et al., from a related field of endeavor teaches a similar guidewire as shown in Figure 4D, where the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter for the purpose of optimizing stiffness. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis such that the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter as taught by Schock et al. in order to optimize stiffness of the guidewire.
Regarding claim 15, Bavaro et al. discloses wherein the at least one guidewire marker is capable of indicating rotational positioning of the guidewire (if rotated about an axis non-parallel to the central axis of the marker). See paragraph [0048].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2015/0297139 (Toth)
Regarding claim 4, Davis fails to disclose wherein the distal end comprises an energy emitting device.
Toth, from a related field of endeavor teaches a similar guidewire as shown in Figure 2, where the distal end of the guidewire includes an energy emitting device (electrode) for the purpose of delivering energy into a region of target tissue in the vicinity thereof. See paragraph [0267].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis to include the energy emitting device at the distal end in order to configure the guidewire to deliver energy into a region of target tissue in the vicinity of the distal end.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2016/0175009 (Davies et al.)
Regarding claim 5, Davis et al. fails to disclose wherein the guidewire further comprises an outer layer that is electrically insulating.
Davies et al., from a related field of endeavor teaches a similar guidewire as shown in Figures 5D, 5C where the guidewire further comprises an outer layer that is electrically insulating.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis et al. to include the outer layer that is electrically insulting for the purpose of electrically insulating a portion of the guidewire.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.), U.S. Patent Publication Number 2016/0175009 (Davies et al.) as applied to claim 5 above, and further in view of U.S. Patent Publication Number 2011/0118735 (Abou-Marie et al.)
Regarding claim 6, Davis et al. fails to disclose wherein the outer layer encapsulates the at least one guidewire marker.
Abou-Marie et al., from related field of endeavor teaches a similar guidewire as shown in figure 1b, where an outer layer encapsulates the at least one guidewire marker. See paragraph [0047]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis et al. to encapsulate the guidewire marker as taught by Abou-Marie et al. in order to insulate the guidewire marker.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.), U.S. Patent Publication Number 2016/0175009 (Davies et al.) as applied to claim 5 above, and further in view of U.S. Patent Publication Number 2003/0220637 (Truckai)
Regarding claim 7, Davis et al. fails to disclose wherein the outer layer is a clear, insulating layer.
Truckai, from related field of endeavor teaches a similar insulating layer wherein the outer layer is a clear, insulating layer. See paragraph [0145]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Davis et al. by substituting the insulating layer disclosed by Davis in view of Davies with the insulating layer taught by Truckai because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.) as applied to claim 8 above, and further in view of U.S. Patent Publication Number 2005/0090856 (Porter et al.)
Regarding claim 9, Davis fails to disclose wherein the inert guidewire marker is composed of a non-inert guidewire marker comprising an inert coating over the non-inert guidewire marker.
Porter et al., from a related field of endeavor teaches a similar inert marker which is composed of a non-inert guidewire marker comprising an inert coating over the non-inert guidewire marker. See paragraph [0029].
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the inert guidewire marker disclosed by Davis by substituting it wit the inert marker taught by Porter et al. because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 10, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al.) as applied to claim 1 above, and further in view of U.S. Patent Publication Number 2016/0015505 (Johnson et al.)
Regarding claims 10, 11 Davis fails to disclose wherein the at least one guidewire marker further comprises an exotic surface configured to promote visibility, wherein the exotic surface comprises one or more reflective metallic coils, dimple bands, and knurls.
Johnson et al. from the same field of endeavor teaches a similar marker as shown Figure 27Cx1 where at least one guidewire marker further comprises an exotic surface configured to promote visibility, wherein the exotic surface comprises one or more reflective metallic coils, dimple bands, and knurls for the purpose configuring the marker to have echogenic features.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to include the holes taught by Johnson in the marker taught by Davis in order to increase the echogenic feature of the marker.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0216771 (Osypka et al.)
Regarding claim 18, Davis et al. discloses as shown in Figure 3, an assembly for performing a transseptal puncture, the assembly comprising: a guidewire (guidewire 244, see paragraph [0067]) capable of puncturing tissue, the guidewire comprising: a guidewire distal end and a guidewire proximal end with an elongated length therebetween, the elongated length including at least one recess (channel 248, see paragraph [0067]) being located, at least in part, therealong; the guidewire distal end capable of puncturing tissue; and, at least one guidewire marker (at least one of markers 56, see paragraph [0048]), wherein the at least one guidewire marker is configured to be securely positioned, respectively at said at least one recess of the elongated length of the guidewire, wherein the at least one guidewire marker is capable of providing structural reinforcement to the at least one recess thereby mitigating the reduction in stiffness of the at least one recess associated therewith (by simply being a sold object with the recess).
Davis et al. fails to disclose an ancillary device comprising an ancillary device distal end and an ancillary device proximal end with a lumen for receiving the guidewire therebetween; and, wherein when the guidewire is inserted within the lumen, the at least one guidewire marker allows the guidewire to be positioned relative to the ancillary device proximal end.
Osypka et al., from the same field of endeavor teaches a similar assembly as shown in Figure 5 where the assembly includes an ancillary device (dilator 28, see paragraph [0049]) comprising an ancillary device distal end and an ancillary device proximal end with a lumen for receiving the guidewire therebetween; and, wherein when the guidewire is inserted within the lumen, the at least one guidewire marker allows the guidewire to be positioned relative to the ancillary device proximal end for the purpose of dilating tissue.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the assembly disclosed by Davis et al. to include the ancillary device taught by Osypka et al in the assembly disclosed by Davis in order to configure the assembly to dilate tissue.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2006/0189896 (Davis et al.) in view of U.S. Patent Publication Number 2003/0216771 (Osypka et al.) as applied to claim 18 above, and further in view of U.S. Patent Publication Number 2008/0132933 (Gerber)
Regarding claim 19, Davis in view of Osypka fail to disclose wherein the ancillary device proximal end comprises an ancillary device marker.
Gerber, from the same field of endeavor teaches a similar assembly as shown in Figure 3A where the ancillary device proximal end includes an ancillary device marker (marker 49A, see paragraph [0049]) for the purpose of tracking the proximal end of the ancillary device. Se paragraph [0049].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the assembly disclosed by Davis in view of Osypka to include the ancillary device marker taught by Gerber in order to track the proximal end of the ancillary device taught by Davis.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2005/0065434 (Bavaro et al.) in view of U.S. Patent Publication Number 2016/0175009 (Davies et al.), U.S. Patent Publication Number 2003/0171642 (Schock et al.), U.S. Patent Publication Number 2011/0118735 (Abou-Marie et al.)
Regarding claim 20, Bavaro et al. discloses as shown in Figure 5 a method of manufacturing a guidewire comprising at least one recess (at least one of recesses where markers 56 sit, see paragraph [0048]) and at least one guidewire marker (at least one of markers 56, see paragraph [0048]), securely contacting said at least one recess, the method of manufacturing comprising the steps of: forming the at least one recess on the guidewire; positioning the at least one guidewire marker in the at least one recess; fixing the at least one guidewire marker in the at least one recess; and applying an outer layer overtop the guidewire, encapsulating the at least one guidewire marker, wherein the at least one guidewire marker is capable of providing structural reinforcement to the at least one recess thereby mitigating the reduction in stiffness of the at least one recess associated therewith (by simply being a sold object with the recess).
Davies et al., from a related field of endeavor teaches a similar method that uses a guidewire as shown in Figures 5D, 5C where the guidewire further comprises an outer layer that is electrically insulating.
It would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Bavaro et al. to include the outer layer that is electrically insulting for the purpose of electrically insulating a portion of the guidewire.
Abou-Marie et al., from related field of endeavor teaches a similar guidewire as shown in figure 1b, where an outer layer encapsulates the at least one guidewire marker. See paragraph [0047]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method disclosed by Bavaro et al. to encapsulate the guidewire marker as taught by Abou-Marie et al. in order to insulate the guidewire marker.
Davis fails to disclose the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter.
Schock et al., from a related field of endeavor teaches a similar guidewire as shown in Figure 4D, where the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter for the purpose of optimizing stiffness. See paragraph [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the guidewire disclosed by Bavaro et al. such that the at least one recess including a tapered section, tapering from a larger outer diameter to a smaller outer diameter, the smaller outer diameter continuing along the elongated length and ending at another tapered section tapering from the smaller diameter to the larger diameter as taught by Schock et al. in order to optimize stiffness of the guidewire.
Response to Arguments
Applicant’s arguments filed 10/09/2025 with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771