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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/19/2026 has been entered.
Response to Amendment
In response to the amendment entered on 1/19/2026, claims 1-20 are pending.
Response to Arguments
Applicant’s arguments with respect to the prior art rejections have been considered but are moot because the arguments do not apply to any of the new combination of references being used in the current rejection. Applicant has amended the claims, thus changing the scope and requiring additional consideration. A new grounds of rejections is set forth below which cites an additional prior art (JP 2003265618) to teach the limitations regarding the rotational lock between a guide catheter and a dilator.
Claim Rejections - 35 USC § 102
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) 1-4, 6-14, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (JP 2003265618).
Sato discloses the following limitations:
Claims 1 and 11. A medical device assembly capable of accessing a left atrial appendage ([0001], sized for blood vessels which are smaller than the heart and therefore the medical device assembly of Sato is capable of accessing a left atrial appendage), comprising:
a first elongate medical device/guide catheter (5) comprising:
a first elongate shaft/guide catheter shaft (5) having a first proximal region (region closer to user) and a first distal region (region closer to treatment site); and
a first proximal hub/guide catheter hub (6) secured to the first proximal region/a proximal region of the guide catheter shaft;
the first proximal hub/guide catheter hub including a plurality of slots (11) (Fig. 2; [0018]); and
a second elongate medical device/an elongate dilator (2) comprising:
a second elongate shaft/an elongate dilator shaft (2) having a second proximal region (region closer to user) and a second distal region (region closer to treatment site) including the distal region adapted to create and/or enlarge an aperture in tissue ([0018]); and
a second proximal hub/dilator hub (3) secured to the second proximal region/a proximal region of the elongate dilator shaft;
the second proximal hub/dilator hub including a plurality of ribs (12) that are adapted to fit into the plurality of slots to provide a releasable rotational lock between the first elongate medical device device/guide catheter and the second elongate medical device/elongate dilator, wherein when the plurality of ribs are fully inserted into the plurality of slots, the releasable rotation lock prevents any rotation of the first elongate medical device relative to the second elongate medical device (Fig. 2; [0018]).
Claims 2 and 12. The medical device assembly of claim 1/11, wherein the second elongate shaft/elongate dilator shaft is adapted to fit within a lumen extending through the first elongate shaft/guide catheter shaft (Fig. 2; [0018]).
Claims 3 and 13. The medical device of claim 2/12, wherein the second proximal hub/dilator hub (3) is adapted to releasably couple to the first proximal hub/guide catheter hub (6) when the second elongate shaft/elongate dilator shaft (2) is disposed within the lumen extending through the first elongate shaft/guide catheter shaft (5) (Fig. 2; abstract, [0018]).
Claims 4 and 14. The medical device of claim 1/11, wherein:
the plurality of slots (11) are equally spaced about the first proximal hub/guide catheter hub (6) (Fig. 2; [0018]); and
the plurality of ribs (12) are equally spaced about the second proximal hub/dilator hub (3) (Figs. 2; [0018]).
Claims 6 and 16. The medical device assembly of claim 1/11, wherein the first elongate medical device/guide catheter (5) is adapted to be advanced over a guidewire in order to reach an atrial septum (the guidewire is not positively recited as an element of the medical device assembly, and the catheter with its lumen as seen in cross-sectional views of Figs. 3-4 would be capable of being advanced over a guidewire to reach an atrial septum).
Claims 7 and 17. The medical device assembly of claim 6/16, wherein the second elongate medical device/elongate dilator (2) is adapted to be advanced over the guidewire in combination with the first elongate medical device/guide catheter (5) in order to create or enlarge an aperture formed in the atrial septum (Fig. 2; [0002], [0018]; the guidewire is not positively recited as an element of the medical device assembly, and the elongate dilator and catheter with its lumens as seen in cross-sectional views of Figs. 3-4 would be capable of being advanced over a guidewire together (due to the rotational lock keeping them together) to reach an atrial septum).
Claim 8. The medical device assembly of claim 1, wherein the first elongate medical device comprises a guide catheter (5) ([0018]).
Claim 9. The medical device assembly of claim 1, wherein the second elongate medical device comprises an elongate dilator (2) ([0018]).
Claims 10 and 18. The medical device assembly of claim 9/11, wherein the second proximal hub/dilator hub (3) comprises a graspable profile (Fig. 2).
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.
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) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sato in view of Okada (US 5672158).
Claims 5 and 15. Sato discloses the invention substantially as claimed above, but fails to disclose the second proximal hub/dilator hub (3) is further adapted to also form a releasable axial lock with the first proximal hub/guide catheter hub (6) via an annular engagement between the first proximal hub/guide catheter hub and the second proximal hub/dilator hub.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Okada teaches a dilator assembly (33) disposed within a lumen of a guide catheter assembly (31), wherein a dilator hub (36) is provided on the proximal region of the dilator shaft (38) and a guide catheter hub (34) is provided on the proximal region of the guide catheter shaft (35). The dilator hub (36) is adapted to form a releasable axial lock with the guide catheter hub (34) via an annular engagement between the guide catheter hub and the dilator hub (via circular protrusion 39 on dilator hub 36 and circular groove 40 on guide catheter hub 34) (Fig. 9; col. 4, ll. 35-59).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the medical device assembly of Sato with an annular engagement forming a releasable axial lock between the first proximal hub/guide catheter hub and the second proximal hub/dilator hub as taught by Okada to provide undesired or inadvertent axial displacement during the surgical procedure.
Claim(s) 1-4, 6-14, 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock (US 2007/0021767) in view of Sato.
Claims 1 and 11. Breznock discloses a medical device assembly (100) (Fig. 1) for accessing a left atrial appendage ([0003]), comprising:
a first elongate medical device/guide catheter (106) comprising:
a first elongate shaft/guide catheter shaft (106) having a first proximal region (region closer to user) and a first distal region (region closer to treatment site); and
a first proximal hub/guide catheter hub (118) secured to the first proximal region/ proximal region of the guide catheter shaft ([0024], [0025]); and
a second elongate medical device/an elongate dilator (104) ([0028]; “In another embodiment, the bevel is removed and the distal tip of the intermediate tube 104 is a gentle inward taper or fairing moving distally that serves as a dilator”) comprising:
a second elongate shaft/an elongate dilator shaft (104) including a second proximal region (region closer to user) and a second distal region/a distal region (region closer to treatment site) adapted to create and/or enlarge an aperture in tissue; and
a second proximal hub/dilator hub (116) secured to the second proximal region/a proximal region of the elongate dilator shaft ([0024], [0025], [0028])
Breznock discloses the first elongate medical device/guide catheter and the second elongate medical device/elongate dilator are adapted to form a releasable rotational lock therebetween ([0025]) but fails to disclose the first proximal hub/guide catheter hub including a plurality of slots and the second proximal hub/dilator hub including a plurality of ribs that are adapted to fit into the plurality of slots to provide the releasable rotational lock, wherein when the plurality of ribs are fully inserted into the plurality of slots, the releasable rotation lock prevents any rotation of the first elongate medical device relative to the second elongate medical device.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Sato teaches a medical device assembly for accessing the body, the device comprising a guide catheter (5) comprising: guide catheter shaft (5) and guide catheter hub (6); the guide catheter hub including a plurality of slots (11) (Fig. 2; [0018]); and an elongate dilator (2) comprising: an elongate dilator shaft (2); and a dilator hub (3); the dilator hub including a plurality of ribs (12) that are adapted to fit into the plurality of slots to provide a releasable rotational lock between the guide catheter and the elongate dilator, wherein when the plurality of ribs are fully inserted into the plurality of slots, the releasable rotation lock prevents any rotation of the first elongate medical device relative to the second elongate medical device (Fig. 2; [0018]).
Therefore, since Breznock discloses the desire for a rotational lock but simply fails to provide details regarding the lock structure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hubs of Brozneck with the plurality of slots and ribs as claimed based on the teachings of Sato to achieve the predictable result of providing a releasable rotational lock of the assembly to prevent undesired or inadvertent rotation between the first elongate medical device/guide catheter and the second elongate medical device/dilator during the surgical procedure.
Claims 2, 12. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the second elongate shaft/elongate dilator shaft (104) is adapted to fit within a lumen extending through the first elongate shaft/guide catheter shaft (106) (Fig. 1; [0024], [0025]).
Claims 3, 13. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the second proximal hub/dilator hub (116) is adapted to releasably couple to the first proximal hub/guide catheter hub (118) when the second/elongate shaft/elongate dilator shaft (104) is disposed within the lumen extending through the first elongate shaft/guide catheter shaft (106) (Figs. 1 and 6; [0025], [0038]-[0040]).
Claims 4, 14. The combination discloses the invention substantially as claimed above, wherein Sato further discloses the plurality of slots (11) are equally spaced about the first proximal hub/guide catheter hub (6); and the plurality of ribs (12) are equally spaced about the second proximal hub/dilator hub (3) (Figs. 2; [0018]).
Claims 6, 16. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the first elongate medical device/guide catheter (106) is adapted to be advanced over a guidewire in order to reach an atrial septum ([0012]).
Claims 7, 17. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the second elongate medical device/elongate dilator (104) is adapted to be advanced over the guidewire in combination with the first elongate medical device/guide catheter in order to create or enlarge an aperture formed in the atrial septum ([0012]).
Claim 8. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the first elongate medical device comprises a guide catheter (106) ([0024], [0025]).
Claim 9. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the second elongate medical device comprises an elongate dilator (104) ([0028]).
Claims 10, 18. The combination discloses the invention substantially as claimed above, wherein Breznock further discloses the second proximal hub/dilator hub (116) comprises a graspable profile (Fig. 1).
Claim(s) 5, 15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Sato, and further in view of Okada.
Claims 5, 15. The combination of Breznock in view of Sato discloses the invention substantially as claimed above in claims 1 and 11, respectively, wherein Breznock further discloses the second proximal hub/dilator hub (116) is adapted to form a releasable axial lock with the first proximal hub/guide catheter hub (118) (Figs. 1 and 6; [0025], [0038]-[0040]) but fails to disclose the releasable axial lock is formed via an annular engagement between the first proximal hub/guide catheter hub and the second proximal hub/dilator hub.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Okada teaches a dilator assembly (33) disposed within a lumen of a guide catheter assembly (31), wherein a dilator hub (36) is provided on the proximal region of the dilator shaft (38) and a guide catheter hub (34) is provided on the proximal region of the guide catheter shaft (35). The dilator hub (36) is adapted to form a releasable axial lock with the guide catheter hub (34) via an annular engagement between the guide catheter hub and the dilator hub (via circular protrusion 39 on dilator hub 36 and circular groove 40 on guide catheter hub 34) (Fig. 9; col. 4, ll. 35-59).
Therefore, since Breznock discloses the desire for an axial lock but simply fails to provide details regarding the lock structure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hubs of Brozneck with the annular engagement as claimed to achieve the predictable result of providing a releasable axial lock of the assembly to prevent undesired or inadvertent axial displacement between the first elongate medical device/guide catheter and the second elongate medical device/dilator during the surgical procedure.
Claim 19. Brozneck discloses a medical device assembly (100) (Fig. 1) for accessing a left atrial appendage and for implanting a left atrial appendage closure (LAAC) ([0003]), comprising:
a guide catheter (106) comprising:
a guide catheter shaft (106) having a first proximal region (region closer to user) and a first distal region (region closer to treatment site); and
a guide catheter hub (118) secured to a proximal region of the guide catheter shaft ([0024], [0025]); and
an elongate dilator (104) ([0028]; “In another embodiment, the bevel is removed and the distal tip of the intermediate tube 104 is a gentle inward taper or fairing moving distally that serves as a dilator”) comprising:
an elongate dilator shaft (104) including a second proximal region (region closer to user) and a second distal region/a distal region (region closer to treatment site) adapted to create and/or enlarge an aperture in tissue; and
a dilator hub (116) secured to a proximal region of the elongate dilator shaft ([0024], [0025], [0028]).
Breznock discloses the guide catheter and the elongate dilator are adapted to form a releasable rotational lock therebetween ([0025]) but fails to disclose the first guide catheter hub including a plurality of slots thar are circumferentially equally spaced and the dilator hub including a plurality of ribs that are adapted to fit into the plurality of slots to provide the releasable rotational lock between the guide catheter and the elongate dilator, wherein when the plurality of ribs are fully inserted into the plurality of slots, the releasable rotation lock prevents any rotation of the first guide catheter relative to the elongate dilator.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Sato teaches a medical device assembly for accessing the body, the device comprising a guide catheter (5) comprising: guide catheter shaft (5) and guide catheter hub (6); the guide catheter hub including a plurality of slots (11) (Fig. 2; [0018]); and an elongate dilator (2) comprising: an elongate dilator shaft (2); and a dilator hub (3); the dilator hub including a plurality of ribs (12) that are adapted to fit into the plurality of slots to provide a releasable rotational lock between the guide catheter and the elongate dilator, wherein when the plurality of ribs are fully inserted into the plurality of slots, the releasable rotation lock prevents any rotation of the guide catheter relative to the elongate dilator (Fig. 2; [0018]).
Therefore, since Breznock discloses the desire for a rotational lock but simply fails to provide details regarding the lock structure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hubs of Brozneck with the plurality of slots and ribs as claimed based on the teachings of Sato to achieve the predictable result of providing a releasable rotational lock of the assembly to prevent undesired or inadvertent rotation between the guide catheter and dilator during the surgical procedure.
Breznock further discloses the dilator hub (116) is adapted to form a releasable axial lock with the guide catheter hub (118) (Figs. 1 and 6; [0025], [0038]-[0040]) but fails to disclose the releasable axial lock is formed via an annular engagement between the guide catheter hub and the dilator hub.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Okada teaches a dilator assembly (33) disposed within a lumen of a guide catheter assembly (31), wherein a dilator hub (36) is provided on the proximal region of the dilator shaft (38) and a guide catheter hub (34) is provided on the proximal region of the guide catheter shaft (35). The dilator hub (36) is adapted to form a releasable axial lock with the guide catheter hub (34) via an annular engagement between the guide catheter hub and the dilator hub (via circular protrusion 39 on dilator hub 36 and circular groove 40 on guide catheter hub 34) (Fig. 9; col. 4, ll. 35-59).
Therefore, since Breznock discloses the desire for an axial lock but simply fails to provide details regarding the lock structure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the hubs of Brozneck with the annular engagement as claimed to achieve the predictable result of providing a releasable axial lock of the assembly to prevent undesired or inadvertent axial displacement between the guide catheter and the dilator during the surgical procedure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Breznock in view of Sato and Okada as applied to claim 19 above, and further in view of Moriyama et al (US 2021/0275246).
Claim 20. The combination discloses the invention substantially as claimed above, including the device is for puncturing and dilating to therefore access a left atrium. Breznock discloses access to the left atrium is useful for left atrial appendage plug placement (closure) ([0003]) but fails to disclose the assembly further comprising an LAAC device delivery catheter that is adapted to be advanced through the guide catheter once the elongate dilator has been removed.
However, in the same field of endeavor, Moriyama et al teaches a medical device assembly for puncturing and accessing the left atrium ([0002], [0027]) using an elongate dilator (30B) and positioned within the lumen of an guide catheter (20) (Figs. 6A-6H). Moriyama et al teaches an LAAC device delivery catheter (end therapy device for left atrial appendage occlusion) can be advanced through the guide catheter once the elongate dilator has been removed (abstract, [0263], [0264]). Therefore, in light of Breznock’s disclosure in paragraph [0003], it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to the medical device assembly of the combination to further include an LAAC deice delivery catheter that is adapted to be advanced through the guide catheter once the elongate dilator has been removed as taught by Moriyama et al to provide a means for closing off the left atrial appendage (LAA) to minimize the risk of strokes by minimizing blood clot migration from the LAA.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The plurality of ribs fully inserted into a plurality of slots to form a releasable rotation lock between two hubs that prevents any rotation when the ribs are fully inserted into the slots are known in the art as discussed in Rasmussen et al (US 7377915), Klein (US 5334157), Lampropoulos et al (US 2016/0331929).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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