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
In response to the amendment filed on 10/17/2025, claims 1-20 are pending. Applicant’s amendments obviate the previous 35 U.S.C. 112 rejection and that rejection is hereby withdrawn.
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 additional prior arts (US 2004/0204629 and US 5672158) to teach the limitations regarding the rotational lock and the axial 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 Knapp (US 2004/0204629).
Claims 1 and 11. A medical device assembly capable of accessing a left atrial appendage ([0001], sized for the ureter which is smaller than the heart and therefore the medical device assembly of Knapp is capable of accessing a left atrial appendage), comprising:
a first elongate medical device/guide catheter (12) comprising:
a first elongate shaft/guide catheter shaft (16) 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 (18) secured to the first proximal region/a proximal region of the guide catheter shaft [(0061]);
the first proximal hub/guide catheter hub including a plurality of slots (41a, 41b) (Figs. 2, 4, 5; [0064], [0083]); and
a second elongate medical device/an elongate dilator (14) comprising:
a second elongate shaft/an elongate dilator shaft (26) 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 (with its tapering distal structure) ([0062]); and
a second proximal hub/dilator hub (28) 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 (29a, 29b) 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 (Figs. 1, 2, 4, 5, 21; [0062], [0064], [0083]).
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. 21; [0082]).
Claims 3 and 13. The medical device of claim 2/12, wherein the second proximal hub/dilator hub (28) is adapted to releasably couple to the first proximal hub/guide catheter hub (18) when the second elongate shaft/elongate dilator shaft (26) is disposed within the lumen extending through the first elongate shaft/guide catheter shaft (16) (Fig. 21; [0083]).
Claims 4 and 14. The medical device of claim 1/11, wherein:
the plurality of slots (41a, 41b) are equally spaced about the first proximal hub/guide catheter hub (18) (Fig. 4); and
the plurality of ribs (29a, 29b) are equally spaced about the second proximal hub/dilator hub (28) (Figs. 1, 21).
Claims 6 and 16. The medical device assembly of claim 1/11, wherein the first elongate medical device/guide catheter (12) is adapted to be advanced over a guidewire (120) in order to reach an atrial septum (Fig. 21; [0084], [0085]).
Claims 7 and 17. The medical device assembly of claim 6/16, wherein the second elongate medical device/elongate dilator (14) is adapted to be advanced over the guidewire (120) in combination with the first elongate medical device/guide catheter (12) in order to create or enlarge an aperture formed in the atrial septum (Fig. 21; [0084], [0085]).
Claim 8. The medical device assembly of claim 1, wherein the first elongate medical device comprises a guide catheter (12) ([0061]).
Claim 9. The medical device assembly of claim 1, wherein the second elongate medical device comprises an elongate dilator (14) ([0062]).
Claims 10 and 18. The medical device assembly of claim 9/11, wherein the second proximal hub/dilator hub comprises a graspable profile (Figs. 1, 21).
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 Knapp in view of Okada (US 5672158).
Claims 5 and 15. Knapp discloses the invention substantially as claimed above, but fails to disclose the second proximal hub/dilator hub (28) is further adapted to also form a releasable axial lock with the first proximal hub/guide catheter hub (18) 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 Knapp 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 Knapp.
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.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Knapp teaches a medical device assembly for accessing the body, the device comprising a guide catheter (12) comprising: guide catheter shaft (16) and guide catheter hub (18) [(0061]); the guide catheter hub including a plurality of slots (41a, 41b) (Figs. 2, 4, 5; [0064], [0083]); and an elongate dilator (14) comprising:
an elongate dilator shaft (26) ([0062]); and a dilator hub (28); the dilator hub including a plurality of ribs (29a, 29b) that are adapted to fit into the plurality of slots to provide a releasable rotational lock between the guide catheter and the elongate dilator (Figs. 1, 2, 4, 5, 21; [0062], [0064], [0083]). 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 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 Knapp further discloses the plurality of slots (41a, 41b) are equally spaced about the first proximal hub/guide catheter hub (18) (Fig. 4); and the plurality of ribs (29a, 29b) are equally spaced about the second proximal hub/dilator hub (28) (Figs. 1, 21).
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 Knapp, and further in view of Okada.
Claims 5, 15. The combination discloses the invention substantially as claimed above, 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.
However, in a field reasonably pertinent to the particular problem with which Applicant was concerned with, Knapp teaches a medical device assembly for accessing the body, the device comprising a guide catheter (12) comprising: guide catheter shaft (16) and guide catheter hub (18) [(0061]); the guide catheter hub including a plurality of slots (41a, 41b) that are circumferentially equally spaced (Figs. 2, 4, 5; [0064], [0083]); and an elongate dilator (14) comprising: an elongate dilator shaft (26) ([0062]); and a dilator hub (28); the dilator hub including a plurality of ribs (29a, 29b) that are adapted to fit into the plurality of slots to provide a releasable rotational lock between the guide catheter and the elongate dilator (Figs. 1, 2, 4, 5, 21; [0062], [0064], [0083]). 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 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.
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 Knapp 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.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE M SHI/Primary Examiner, Art Unit 3771