DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendments filed on 5/12/2026. Claims 1, 12 and 19 are amended. Claims 1-20 are pending and addressed below.
Response to Arguments
Applicant’s arguments regarding claim 1, filed on 5/12/2026, have been fully considered but are not persuasive.
Regarding arguments on page 7, the applicant states that “The Examiner cites Abdul-Karim as disclosing an abrasive burr 16. The Examiner notes that Abdul-Karim is directed to a transseptal device. Abdul-Karim does not disclose the abrasive burr configured to shave bone and form a pocket in the bone in combination with the other claimed limitations”. The examiner disagrees with the applicant because since Paragraph 0043 of Abdul-Karim discloses that element 16 is configured with drill bit-like or screw-like cutting surfaces, then Gammie modified by Abdul-Karim as a whole would be fully configured in having the abrasive burr to shave bone and form a pocket in the bone. The examiner wants to note that claims 1, 12 and 19 are apparatus claims and not method claims therefore, the recitation of specific method steps does not provide substantial weight to the claim since the patentability of an apparatus does not depend on its method of use. Also, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Therefore, the rejection is proper.
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 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 of this title, 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.
Claims 1-7, 10, 12-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gammie (US Pub No. 2020/0155132) in view of Abdul-Karim (US Pub No. 2014/0046356).
Regarding claim 1, Gammie discloses (Figures 2-3D) an endovascular device (10), comprising: a catheter (16) defining a lumen (clearly shown in Figure 2A); a needle (22) extending within the lumen of the catheter and being movable within the catheter (Paragraph 0044), the needle defining a lumen and having a distal needle tip (clearly shown in Figure 2A), wherein distal movement of the needle advances the distal needle tip out of the catheter and proximal movement of the needle retracts the distal needle tip within the lumen of the catheter (Figures 3A-3D) (Fully capable in doing this since Paragraph 0044 discloses that one or more actuatable knobs is connectable to the needle allowing the needle to move in order to extend and retract the needle); and a guidewire (24) at least partially arranged within the lumen of the needle (clearly shown in Figure 2A) (Paragraphs 0042-0045).
Gammie fails to disclose the guidewire being a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, the abrasive burr configured to shave bone and form a pocket in the bone.
Abdul-Karim, in the analogous art of transseptal devices using a guidewire, teaches (Figures 1-5E) a transeptal device assembly (20) comprising a guidewire (10) being a shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), the shaving mechanism having an abrasive burr (16) (clearly shown in Figures 2A-4B) (Paragraph 0043), wherein the abrasive burr is rotatable upon activation of the shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), the abrasive burr configured to shave bone and form a pocket in the bone [Since Abdul-Karim discloses all of the structural elements in the same arrangement as claimed and also, Paragraph 0043 of Abdul-Karim discloses that element 16 is configured with drill bit-like or screw-like cutting surfaces, then this will result in the abrasive burr of Abdul-Karim to be fully configured in shaving bone and forming a pocket in the bone]. Since both Gammie and Abdul-Karim are directed to transseptal devices using a guidewire, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidewire of Gammie to be a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, the abrasive burr configured to shave bone and form a pocket in the bone as taught by Abdul-Karim, in order to facilitate the surgical procedure by using the guidewire to cut an access hole in the septum and also, to advantageously reduces the risk of inadvertent, uncontrolled advancement of a guidewire through the left atrium during the transseptal access phase (Abdul-Karim, Paragraphs 0031 and 0043). [Gammie modified by Abdul-Karim as a whole would result in the guidewire to be a shaving mechanism at least partially arranged within a lumen of the needle, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, the abrasive burr being fully configured in shaving bone and forming a pocket in the bone]
Regarding claim 2, Gammie modified by Abdul-Karim further discloses wherein the catheter includes a window (Gammie, 18) positioned proximate a distal end of the catheter, wherein advancement of the needle extends the needle outside the catheter through the window (Gammie, Figure 2A).
Regarding claim 3, Gammie modified by Abdul-Karim further discloses a first slider mechanism (One or more actuatable knobs or screws connectable to needle 22 as disclosed in Paragraph 0044 of Gammie) operably connected to the needle for advancing the needle from the catheter.
Regarding claim 4, Gammie modified by Abdul-Karim further discloses an actuator (Abdul-Karim, 22) operably connected to the shaving mechanism for causing rotation of the abrasive burr (Abdul-Karim, Paragraph 0045).
Regarding claim 5, Gammie modified by Abdul-Karim further discloses a second slider mechanism (One or more actuatable knobs or screws connectable to the guidewire 24 as disclosed in Paragraph 0044 of Gammie) configured to distally advance the abrasive burr at least partially beyond the distal needle tip.
Regarding claim 6, Gammie modified by Abdul-Karim further discloses a first slider mechanism (One or more actuatable knobs or screws connectable to needle 22 as disclosed in Paragraph 0044 of Gammie) operably connected to the needle for advancing the needle from the catheter and an actuator (Abdul-Karim, 22) operably connected to the shaving mechanism for causing rotation of the abrasive burr (Abdul-Karim, Paragraph 0045).
Regarding claim 7, Gammie modified by Abdul-Karim further discloses a second slider mechanism (One or more actuatable knobs or screws connectable to the guidewire 24 as disclosed in Paragraph 0044 of Gammie) configured to distally advance the abrasive burr at least partially beyond the distal needle tip.
Regarding claim 10, Gammie modified by Abdul-Karim further discloses wherein the catheter comprises a polymer material (Gammie, Paragraph 0056).
Regarding claim 12, Gammie discloses (Figures 2-3D) an endovascular device (10), comprising: a catheter (16) defining a lumen (clearly shown in Figure 2A); a needle (22) extending within the lumen of the catheter having a distal needle tip and being movable within the catheter between retracted and extended positions (Paragraph 0044), and a guidewire (24) at least partially arranged within the lumen of the needle (clearly shown in Figure 2A) (Paragraphs 0042-0045), and wherein, in the retracted position, the guidewire is located within the lumen of the catheter (Figure 3A) and, in the extended position, the guidewire is located outside the lumen of the catheter (Figure 3D).
Gammie fails to disclose the guidewire being a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, and wherein, in the retracted position, the abrasive burr is located within the lumen of the catheter and, in the extended position, the abrasive burr is located outside the lumen of the catheter, and being configured to shave bone and form a pocket in the bone.
Abdul-Karim, in the analogous art of transseptal devices using a guidewire, teaches (Figures 1-5E) a transeptal device assembly (20) comprising a guidewire (10) being a shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), the shaving mechanism having an abrasive burr (16) (clearly shown in Figures 2A-4B) (Paragraph 0043), wherein the abrasive burr is rotatable upon activation of the shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), the abrasive burr configured to shave bone and form a pocket in the bone [Since Abdul-Karim discloses all of the structural elements in the same arrangement as claimed and also, Paragraph 0043 of Abdul-Karim discloses that element 16 is configured with drill bit-like or screw-like cutting surfaces, then this will result in the abrasive burr of Abdul-Karim to be fully configured in shaving bone and forming a pocket in the bone]. Since both Gammie and Abdul-Karim are directed to transseptal devices using a guidewire, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidewire of Gammie to be a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, the abrasive burr configured to shave bone and form a pocket in the bone as taught by Abdul-Karim, in order to facilitate the surgical procedure by using the guidewire to cut an access hole in the septum and also, to advantageously reduces the risk of inadvertent, uncontrolled advancement of a guidewire through the left atrium during the transseptal access phase (Abdul-Karim, Paragraphs 0031 and 0043). [Gammie modified by Abdul-Karim as a whole would result in the guidewire to be a shaving mechanism at least partially arranged within a lumen of the needle, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism, and wherein, in the retracted position, the abrasive burr is located within the lumen of the catheter and, in the extended position, the abrasive burr is located outside the lumen of the catheter, and being fully configured to shave bone to form a pocket in the bone]
Regarding claim 13, Gammie modified by Abdul-Karim further discloses wherein the catheter includes a window (Gammie, 18) positioned proximate a distal end of the catheter and, the extended position, the distal needle tip is extending through the window (Gammie, Figure 2A).
Regarding claim 14, Gammie modified by Abdul-Karim further discloses a first slider mechanism (One or more actuatable knobs or screws connectable to needle 22 as disclosed in Paragraph 0044 of Gammie) operably connected to the needle for advancing the needle out of the catheter.
Regarding claim 15, Gammie modified by Abdul-Karim further discloses an actuator (Abdul-Karim, 22) operably connected to the shaving mechanism for causing rotation of the abrasive burr (Abdul-Karim, Paragraph 0045).
Regarding claim 16, Gammie modified by Abdul-Karim further discloses a second slider mechanism (One or more actuatable knobs or screws connectable to the guidewire 24 as disclosed in Paragraph 0044 of Gammie) configured to distally advance the abrasive burr at least partially beyond the distal needle tip.
Regarding claim 19, Gammie discloses (Figures 2-3D) an endovascular device (10), comprising: a catheter (16) defining a lumen (clearly shown in Figure 2A), the catheter includes a window (18) on a sidewall of the catheter positioned proximate a distal end of the catheter (clearly shown in Figure 2A); a needle (22) extending within the lumen of the catheter and being movable within the catheter (Paragraph 0044), the needle defining a lumen and having a distal needle tip (clearly shown in Figure 2A), wherein distal movement of the needle advances the distal needle tip through the window and out of the catheter and proximal movement of the needle retracts the distal needle tip through the window and within the lumen of the catheter (Figures 3A-3D) (Fully capable in doing this since Paragraph 0044 discloses that one or more actuatable knobs is connectable to the needle allowing the needle to move in order to extend and retract the needle); and a guidewire (24) at least partially arranged within the lumen of the needle (clearly shown in Figure 2A) (Paragraphs 0042-0045), a sliding mechanism (One or more actuatable knobs or screws connectable to needle 22 as disclosed in Paragraph 0044) operably connected to the needle for advancing the needle into an extended position (Paragraph 0044), where the needle extends through the window and out of the catheter (Figure 3D).
Gammie fails to disclose the guidewire being a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism and the slider mechanism comprising an actuator operably connected to the abrasive burr for causing rotation of the abrasive burr, the abrasive burr configured to shave bone and form a pocket in the bone.
Abdul-Karim, in the analogous art of transseptal devices using a guidewire, teaches (Figures 1-5E) a transeptal device assembly (20) comprising a guidewire (10) being a shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), the shaving mechanism having an abrasive burr (16) (clearly shown in Figures 2A-4B) (Paragraph 0043), wherein the abrasive burr is rotatable upon activation of the shaving mechanism (Figure 1D) (Paragraphs 0039 and 0043), and an actuator (22) operably connected to the abrasive burr for causing rotation of the abrasive burr (Paragraph 0045), the abrasive burr configured to shave bone and form a pocket in the bone [Since Abdul-Karim discloses all of the structural elements in the same arrangement as claimed and also, Paragraph 0043 of Abdul-Karim discloses that element 16 is configured with drill bit-like or screw-like cutting surfaces, then this will result in the abrasive burr of Abdul-Karim to be fully configured in shaving bone and forming a pocket in the bone]. Since both Gammie and Abdul-Karim are directed to transseptal devices using a guidewire, then it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the guidewire of Gammie to be a shaving mechanism, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism and an actuator operably connected to the abrasive burr for causing rotation of the abrasive burr, the abrasive burr configured to shave bone and form a pocket in the bone as taught by Abdul-Karim, in order to facilitate the surgical procedure by using the guidewire to cut an access hole in the septum and also, to advantageously reduces the risk of inadvertent, uncontrolled advancement of a guidewire through the left atrium during the transseptal access phase (Abdul-Karim, Paragraphs 0031 and 0043). [Gammie modified by Abdul-Karim as a whole would result in the guidewire to be a shaving mechanism at least partially arranged within a lumen of the needle, the shaving mechanism having an abrasive burr positioned proximate the distal needle tip, wherein the abrasive burr is rotatable relative to the needle upon activation of the shaving mechanism and the slider mechanism comprising an actuator operably connected to the abrasive burr for causing rotation of the abrasive burr, the abrasive burr fully configured shaving bone and forming a pocket in the bone]
Regarding claim 20, Gammie modified by Abdul-Karim further discloses another slider mechanism (One or more actuatable knobs or screws connectable to the guidewire 24 as disclosed in Paragraph 0044 of Gammie) configured to distally advance the abrasive burr at least partially beyond the distal needle tip when in the extended position (Gammie, Paragraph 0044).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gammie (US Pub No. 2020/0155132) in view of Abdul-Karim (US Pub No. 2014/0046356) as applied to claims 1 and 12 above, and further in view of Ozawa (US Pub No. 2022/0233190).
Regarding claims 8 and 17, Gammie modified by Abdul-Karim discloses the invention above except for wherein the needle is configured to apply vacuum aspiration within the lumen of the needle and thereby create suction at the distal needle tip.
Ozawa, in the analogous art of needles used in surgery, teaches (Figure 5B) a needle (216) configured to apply vacuum aspiration within the lumen of the needle and thereby create suction at the distal needle tip (Paragraphs 0031 and 0034). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Gammie modified by Abdul-Karim to be configured to apply vacuum aspiration within the lumen of the needle and thereby create suction at the distal needle tip as taught by Ozawa, in order to facilitate the surgical procedure by removing any injected fluid around the surgical area (Ozawa, Paragraphs 0031 and 0034).
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Gammie (US Pub No. 2020/0155132) in view of Abdul-Karim (US Pub No. 2014/0046356) as applied to claims 1 and 12 above, and further in view of Stearns (US Pub No. 2017/0340443).
Regarding claims 9 and 18, Gammie modified by Abdul-Karim discloses the invention above except for wherein the needle comprises a curved heat set super-elastic Nitinol needle.
Stearns, in the analogous art of needles used in heart surgery, teaches (Figures 10-11) a needle (330) comprising a curved heat set super-elastic Nitinol needle (Paragraph 0077). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Gammie modified by Abdul-Karim to comprise a curved heat set super-elastic Nitinol needle as taught by Stearns, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gammie (US Pub No. 2020/0155132) in view of Abdul-Karim (US Pub No. 2014/0046356) as applied to claims 1 and 12 above, and further in view of Miller (US Pub No. 2022/0022914).
Regarding claim 11, Gammie modified by Abdul-Karim discloses the invention above except for wherein the needle comprise platinum marker bands for aiding its placement.
Miller, in the analogous art of needles used in heart surgery, teaches (Figures 1-2) a needle (102) comprising platinum marker bands for aiding its placement (Paragraph 0033). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle of Gammie modified by Abdul-Karim to comprise platinum marker bands as taught by Miller, in order to facilitate viewing of the needle under fluoroscopy (Miller, Paragraph 0033).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAJID JAMIALAHMADI whose telephone number is (571) 270-0172. The examiner can normally be reached on Monday-Friday 7am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAJID JAMIALAHMADI/Primary Examiner, Art Unit 3771
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