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 .
Claim Objections
Claims 7-8, 10, and 12-13 are objected to because of the following informalities:
Claim 7, line 3: this claim recites “the central annular ring”, yet claim 1, which claim 7 depends from, only introduces “a central ring”. It is recommended that the terminology for this component be standardized to provide clear antecedent basis.
Claim 8, line 3: this claim recites “the central annular ring”, yet claim 1, which claim 8 depends from, only introduces “a central ring”. It is recommended that the terminology for this component be standardized to provide clear antecedent basis.
Claim 10, end of line 1: this claim does not end in any punctuation, it is recommended that a colon be provided after “comprises” to match the grammatical pattern established in other claims, such as claim 9 (see line 2 which ends in “the LAAC device comprising:”).
Claims 12 and 13, see page 3: there is no spacing between these two claims. It is recommended that proper spacing between the claims be added.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites the limitation "the central annular ring" in line 3. There is insufficient antecedent basis for this limitation in the claim, as a central annular ring is not introduced in claims 9 or 10, which claim 14 depends from. It is recommended that claim 10 be amended to include a central ring (or a central annular ring, see objections to claims 7-8 above) but that the chosen terminology stay consistent.
Claim 15 recites the limitation "the central annular ring" in line 3. There is insufficient antecedent basis for this limitation in the claim, as a central annular ring is not introduced in claims 9 or 10, which claim 15 depends from. It is recommended that claim 10 be amended to include a central ring (or a central annular ring, see objections to claims 7-8 above) but that the chosen terminology stay consistent.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski et al. (US PGPub 2023/0263531 A1).
With respect to claim 1, Lashinski et al. discloses a left atrial appendage closure (LAAC) device (6300 in Figs. 4A-B) adapted to pull a left atrial appendage (LAA) closed on itself (see PP [0011]), the LAAC device (6300) comprising:
a plurality of engagement arms (6316) extending radially outwardly from a central ring (PP [0148]: “a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”), each of the plurality of engagement arms (6316) including a free end adapted to engage tissue within an ostium of the LAA (PP [0151]: “the distal end portion 6316b of each of the struts can have a sloped or angled surface 6329 that can assist with the penetration of the distal end portion 6316b into the tissue”, see comparable embodiment in Figs. 2A-F where securing element 110 engages internal tissue of ostium ‘O’, PP [0144]: “FIGS. 4A-4J show another arrangement of a treatment system 6300 having an arrangement of an implant 6302 having a contact member 6304, a retention element 6308, and a securing element 6310. In any arrangements disclosed herein, the treatment system 6300 and/or implant device 6302 can have any of the components, features, or other details of any other treatment device arrangements or implant device arrangements disclosed herein, including without limitation any of the other arrangements of the treatment devices 100, 140, 4000, 6000, 6100 and/or implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and/or the implant device 6302 shown in FIGS. 4A-4J”);
the free end (6329) of each of the plurality of engagement arms (6316) adapted to move proximally relative to the LAA (see comparable embodiment in Figs. 2A-F, the securing element moves closer to the LAA and thus moves proximally relative to the LAA) and pull tissue of the LAA radially inward as each of the plurality of engagement arms (6316) move from an initial actuation level towards a final actuation level (see 120 move proximally along arrow A3 in Fig. 2D to pull the ostium tissue, 6300 in Fig. 4A works in the same way); and
a drive assembly (6331, 6333, 6339, 6309 in Figs. 4A-F) adapted to drive the plurality of engagement arms (6316) from the initial actuation level towards the final actuation level (PP [0146]: “rotating the threaded shaft 6309 in a first direction can cause the securing element 6310 to advance axially toward the contact member 6304 and rotating the threaded shaft 6309 in a second, opposite direction can cause the securing element 6310 to move axially away from the contact member 6304”).
Regarding claim 2, Lashinski et al. further discloses wherein the drive assembly (6331, 6333, 6339, 6309 in Figs. 4A-F) comprises:
a threaded core rod (6309 in Figs. 4E-F) aligned with a longitudinal axis of the LAAC device (see 6309 extending along length of device in Fig. 4E); and
a threaded member (6331) threadedly engaged with the threaded core rod (6309), the threaded member (6331) adapted to translate as the threaded core rod (6309) is rotated relative to the threaded member (6331, PP [0155]: “some arrangements of the implant 6302 can be configured to permit the drive element 6331 to move axially along the length of the body portion 6311 of the securing element 6310 as the threaded shaft 6309 is rotated. In this configuration, the drive element 6331 can be advanced axially in either direction by rotating the threaded shaft 6309”);
wherein the threaded member (6331) is adapted to push the plurality of engagement arms (6316 in Fig. 4A, see 6310 in Figs. 4E-F) towards the final actuation level as the threaded member (6331) translates (see Figs. 4E-F and PP [0155] cited above).
Regarding claim 3, Lashinski et al. further discloses wherein the threaded member (6331 in Figs. 4E-F) comprises:
a threaded nut (body of 6331) threadedly engaged with the threaded core rod (6309, PP [0155]: “a threaded drive element 6331 that can have a threaded opening 6332 axially therethrough that can be configured to receive the threaded shaft 6309 therethrough”); and
a nut sleeve (6333 and 6332) secured relative to the threaded nut (body of 6331), the nut sleeve (6333 and 6332) adapted to engage and push the plurality of engagement arms (6316) towards the final actuation level (PP [0156]: “A retainer cap 6333 can be used to couple the drive element 6331 to a proximal end 6304a of the contact member 6304”, this coupling makes 6333 adapted to push the engagement arms towards the final actuation level, as this coupling secures 6304 to drive element 6331 to facilitate the translation of the arms).
Regarding claim 4, Lashinski et al. further discloses wherein the nut sleeve (6333 and 6332 in Figs. 4E-F, see also Fig. 4H) comprises a proximal facing tissue engagement feature (6331 and 6334) that is adapted to hold tissue of the LAA together when the plurality of engagement arms (6316) are driven towards the final actuation level (PP [0156]: “the drive element 6331 can have posts or tabs 6334 that can extend into the slots 6312 of the body portion 6311 of the securing element 6310 to inhibit (e.g., prevent) the drive element 6331 from rotating when the threaded shaft 6309 is rotated into the drive element 6331. Additionally, in some arrangements, the tabs 6334 can engage with recesses 6337 formed in the retainer cap 6333 to provide an overlap between the drive element 6331 and the retainer cap 6333 and thereby improve the connection between the drive element 6331 and the retainer cap 6333”, posts/engagement features 6331 and 6334 are adapted to hold tissue of the LAA together by securing the drive element 6331 to hold tissue in place).
Regarding claim 5, Lashinski et al. further discloses wherein the threaded core rod (6309 in Figs. 4E-F) is adapted to be rotated by a delivery device (PP [0155]: “the retention element 6308 can have a head 6330 coupled with the threaded shaft 6309, the head 6330 being configured to couple with an end portion of an intermediate member of the catheter (such as the end portion 8098b of the catheter shown in FIG. 96C) so that a rotation or torque applied to the intermediate member can cause an equal rotation or torque to be applied to the head 6330 and the threaded shaft 6309 of the retention element 6308”, PP [0159]: “the securing element 6310 can be moved toward or away from the contact member 6304 by rotating the head portion 6330 of the threaded shaft 6309 of the retention element 6308”).
Regarding claim 6, Lashinski et al. further discloses wherein the threaded core rod (6309 in Figs. 4E-F) includes a proximal end (right end of 6309 in Fig. 4E) having a releasable coupling (6330) disposed thereon (PP [0155]: “the retention element 6308 can have a head 6330 coupled with the threaded shaft 6309, the head 6330 being configured to couple with an end portion of an intermediate member of the catheter (such as the end portion 8098b of the catheter shown in FIG. 96C) so that a rotation or torque applied to the intermediate member can cause an equal rotation or torque to be applied to the head 6330 and the threaded shaft 6309 of the retention element 6308”, 6330 is configured to releasably couple to an actuation member of a catheter and is a releasable coupling).
Regarding claim 7, Lashinski et al. further discloses wherein the plurality of engagement arms (6316 in Fig. 4A) have an initial actuation level profile in which each of the plurality of engagement arms (6316) extend proximally from the central annular ring (PP [0148]: “a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”) a short distance, then curve and extend distally (see Fig. 4B, 6316 extends from 6311a as seen in Fig. 4D, and then curves and extends distally as the arms 6316 extend in multiple dimensions).
Regarding claim 8, Lashinski et al. further discloses wherein the plurality of engagement arms (6316 in Fig. 4A) have an initial actuation level profile in which each of the plurality of engagement arms (6316) extend proximally from the central annular ring (PP [0148]: “a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”, see Fig. 4D and 2F, the arms extend proximally at least partially from 6311a).
With respect to claim 9, Lashinski et al. discloses a left atrial appendage closure (LAAC) device (6300 in Figs. 4A-B) adapted to pull a left atrial appendage (LAA) closed on itself (see PP [0011]), the LAAC device (6300) comprising:
a tissue engagement structure (6310 in Figs. 4A-F) adapted to engage tissue within the LAA and pull the tissue inwardly when the tissue engagement structure (6310) is driven from an initial actuation level towards a final actuation level (PP [0151]: “the distal end portion 6316b of each of the struts can have a sloped or angled surface 6329 that can assist with the penetration of the distal end portion 6316b into the tissue”, see comparable embodiment in Figs. 2A-F where securing element 110 engages internal tissue of ostium ‘O’, PP [0144]: “FIGS. 4A-4J show another arrangement of a treatment system 6300 having an arrangement of an implant 6302 having a contact member 6304, a retention element 6308, and a securing element 6310. In any arrangements disclosed herein, the treatment system 6300 and/or implant device 6302 can have any of the components, features, or other details of any other treatment device arrangements or implant device arrangements disclosed herein, including without limitation any of the other arrangements of the treatment devices 100, 140, 4000, 6000, 6100 and/or implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and/or the implant device 6302 shown in FIGS. 4A-4J”); and
a drive assembly (6331, 6333, 6339, 6309 in Figs. 4A-F) adapted to drive the tissue engagement structure (6310 in Figs. 4A-F) from the initial actuation level towards the final actuation level (PP [0146]: “rotating the threaded shaft 6309 in a first direction can cause the securing element 6310 to advance axially toward the contact member 6304 and rotating the threaded shaft 6309 in a second, opposite direction can cause the securing element 6310 to move axially away from the contact member 6304”).
Regarding claim 10, Lashinski et al. further discloses wherein the tissue engagement structure (6310 in Figs. 4A-F) comprises
a plurality of engagement arms (6316 in Figs. 4A-B) that each have a conjoined end (see base end extending from and out of 6311a, see also Fig. 4D) and a free end (6329), the conjoined end of each of the plurality of engagement arms secured together (PP [0148]: “the securing element 6310 can have a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”), and the free end (6329) of each of the plurality of engagement arms (6316) adapted to engage tissue within an ostium of the LAA (PP [0151]: “the distal end portion 6316b of each of the struts can have a sloped or angled surface 6329 that can assist with the penetration of the distal end portion 6316b into the tissue”, see comparable embodiment in Figs. 2A-F where securing element 110 engages internal tissue of ostium ‘O’, PP [0144]: “FIGS. 4A-4J show another arrangement of a treatment system 6300 having an arrangement of an implant 6302 having a contact member 6304, a retention element 6308, and a securing element 6310. In any arrangements disclosed herein, the treatment system 6300 and/or implant device 6302 can have any of the components, features, or other details of any other treatment device arrangements or implant device arrangements disclosed herein, including without limitation any of the other arrangements of the treatment devices 100, 140, 4000, 6000, 6100 and/or implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and/or the implant device 6302 shown in FIGS. 4A-4J”).
Regarding claim 11, Lashinski et al. further discloses wherein the free end (6329 in Figs. 4A-F) of each of the plurality of engagement arms (6316) is adapted to move proximally relative to the LAA as each of the plurality of engagement arms move from an initial actuation level towards a final actuation level (see comparable embodiment in Figs. 2A-F, the securing element moves closer to the LAA and thus moves proximally relative to the LAA).
Regarding claim 12, Lashinski et al. further discloses wherein the drive assembly (6331, 6333, 6339, 6309 in Figs. 4A-F) comprises:
a threaded core rod (6309 in Figs. 4E-F) aligned with a longitudinal axis of the LAAC device (see 6309 extending along length of device in Fig. 4E); and
a threaded member (6331) threadedly engaged with the threaded core rod (6309), the threaded member (6331) adapted to translate as the threaded core rod (6309) is rotated relative to the threaded member (6331, PP [0155]: “some arrangements of the implant 6302 can be configured to permit the drive element 6331 to move axially along the length of the body portion 6311 of the securing element 6310 as the threaded shaft 6309 is rotated. In this configuration, the drive element 6331 can be advanced axially in either direction by rotating the threaded shaft 6309”);
wherein the threaded member (6331) is adapted to push the plurality of engagement arms (6316 in Fig. 4A, see 6310 in Figs. 4E-F) together as the threaded member (6331) translates (see Figs. 4E-F and PP [0155] cited above, 6331 is adapted to push each of the engagement arms 6316 together, as a single unit).
Regarding claim 13, Lashinski et al. further discloses wherein the threaded member (6331 in Figs. 4E-F) comprises:
a threaded nut (body of 6331) threadedly engaged with the threaded core rod (6309, PP [0155]: “a threaded drive element 6331 that can have a threaded opening 6332 axially therethrough that can be configured to receive the threaded shaft 6309 therethrough”); and
a nut sleeve (6333 and 6332) secured relative to the threaded nut (body of 6331), the nut sleeve (6333 and 6332) adapted to engage and push the plurality of engagement arms (6316) towards the final actuation level (PP [0156]: “A retainer cap 6333 can be used to couple the drive element 6331 to a proximal end 6304a of the contact member 6304”, this coupling makes 6333 adapted to push the engagement arms towards the final actuation level, as this coupling secures 6304 to drive element 6331 to facilitate the translation of the arms).
Regarding claim 14, Lashinski et al. further discloses wherein the plurality of engagement arms (6316 in Fig. 4A) have an initial actuation level profile in which each of the plurality of engagement arms (6316) extend proximally from the central annular ring (PP [0148]: “a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”) a short distance, then curve and extend distally (see Fig. 4B, 6316 extends from 6311a as seen in Fig. 4D, and then curves and extends distally as the arms 6316 extend in multiple dimensions).
Regarding claim 15, Lashinski et al. further discloses wherein the plurality of engagement arms (6316 in Fig. 4A) have an initial actuation level profile in which each of the plurality of engagement arms (6316) extend proximally from the central annular ring (PP [0148]: “a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”, see Fig. 4D and 2F, the arms extend proximally at least partially from 6311a).
With respect to claim 16, Lashinski et al. discloses a left atrial appendage closure (LAAC) device (6300 in Figs. 4A-B) adapted to pull a left atrial appendage (LAA) closed on itself (see PP [0011]), the LAAC device (6300) comprising:
a tissue engagement structure (6310 in Figs. 4A-F) adapted to engage tissue within the LAA and pull the tissue inwardly when the tissue engagement structure (6310) is driven from an initial actuation level towards a final actuation level (PP [0151]: “the distal end portion 6316b of each of the struts can have a sloped or angled surface 6329 that can assist with the penetration of the distal end portion 6316b into the tissue”, see comparable embodiment in Figs. 2A-F where securing element 110 engages internal tissue of ostium ‘O’, PP [0144]: “FIGS. 4A-4J show another arrangement of a treatment system 6300 having an arrangement of an implant 6302 having a contact member 6304, a retention element 6308, and a securing element 6310. In any arrangements disclosed herein, the treatment system 6300 and/or implant device 6302 can have any of the components, features, or other details of any other treatment device arrangements or implant device arrangements disclosed herein, including without limitation any of the other arrangements of the treatment devices 100, 140, 4000, 6000, 6100 and/or implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and/or the implant device 6302 shown in FIGS. 4A-4J”), the tissue engagement structure (6310) including a plurality of engagement arms (6316 in Figs. 4A-B) that each have a conjoined end (see base end extending from and out of 6311a, see also Fig. 4D) and a free end (6329), the conjoined end of each of the plurality of engagement arms secured together (PP [0148]: “the securing element 6310 can have a plurality of arms or struts 6316 extending away from a proximal end portion 6311a of the body portion 6311 of the securing element 6310”), and the free end (6329) of each of the plurality of engagement arms (6316) adapted to engage tissue within an ostium of the LAA (PP [0151]: “the distal end portion 6316b of each of the struts can have a sloped or angled surface 6329 that can assist with the penetration of the distal end portion 6316b into the tissue”, see comparable embodiment in Figs. 2A-F where securing element 110 engages internal tissue of ostium ‘O’, PP [0144]: “FIGS. 4A-4J show another arrangement of a treatment system 6300 having an arrangement of an implant 6302 having a contact member 6304, a retention element 6308, and a securing element 6310. In any arrangements disclosed herein, the treatment system 6300 and/or implant device 6302 can have any of the components, features, or other details of any other treatment device arrangements or implant device arrangements disclosed herein, including without limitation any of the other arrangements of the treatment devices 100, 140, 4000, 6000, 6100 and/or implant devices 102, 104, 4002, 6002, 6102 disclosed herein, in any combination with any of the components, features, or details of the treatment system 6300 and/or the implant device 6302 shown in FIGS. 4A-4J”).; and
a drive assembly (6331, 6333, 6339, 6309 in Figs. 4A-F) adapted to drive the tissue engagement structure (6310 in Figs. 4A-F) from the initial actuation level towards the final actuation level (PP [0146]: “rotating the threaded shaft 6309 in a first direction can cause the securing element 6310 to advance axially toward the contact member 6304 and rotating the threaded shaft 6309 in a second, opposite direction can cause the securing element 6310 to move axially away from the contact member 6304”).
Regarding claim 17, Lashinski et al. further discloses wherein the threaded member (6331) is adapted to push the plurality of engagement arms (6316 in Fig. 4A, see 6310 in Figs. 4E-F) towards the final actuation level as the threaded member (6331) translates (see Figs. 4E-F and PP [0155] cited above).
Regarding claim 18, Lashinski et al. further discloses wherein the threaded member (6331 in Figs. 4E-F) comprises:
a threaded nut (body of 6331) threadedly engaged with the threaded core rod (6309, PP [0155]: “a threaded drive element 6331 that can have a threaded opening 6332 axially therethrough that can be configured to receive the threaded shaft 6309 therethrough”); and
a nut sleeve (6333 and 6332) secured relative to the threaded nut (body of 6331), the nut sleeve (6333 and 6332) adapted to engage and push the plurality of engagement arms (6316) towards the final actuation level (PP [0156]: “A retainer cap 6333 can be used to couple the drive element 6331 to a proximal end 6304a of the contact member 6304”, this coupling makes 6333 adapted to push the engagement arms towards the final actuation level, as this coupling secures 6304 to drive element 6331 to facilitate the translation of the arms).
Regarding claim 19, Lashinski et al. further discloses wherein the nut sleeve (6333 and 6332 in Figs. 4E-F, see also Fig. 4H) comprises a proximal facing tissue engagement feature (6331 and 6334) that is adapted to hold tissue of the LAA together when the plurality of engagement arms (6316) are driven towards the final actuation level (PP [0156]: “the drive element 6331 can have posts or tabs 6334 that can extend into the slots 6312 of the body portion 6311 of the securing element 6310 to inhibit (e.g., prevent) the drive element 6331 from rotating when the threaded shaft 6309 is rotated into the drive element 6331. Additionally, in some arrangements, the tabs 6334 can engage with recesses 6337 formed in the retainer cap 6333 to provide an overlap between the drive element 6331 and the retainer cap 6333 and thereby improve the connection between the drive element 6331 and the retainer cap 6333”, posts/engagement features 6331 and 6334 are adapted to hold tissue of the LAA together by securing the drive element 6331 to hold tissue in place).
Regarding claim 20, Lashinski et al. further discloses wherein the threaded core rod (6309 in Figs. 4E-F) is adapted to be releasably secured to and rotated by a delivery device (PP [0155]: “the retention element 6308 can have a head 6330 coupled with the threaded shaft 6309, the head 6330 being configured to couple with an end portion of an intermediate member of the catheter (such as the end portion 8098b of the catheter shown in FIG. 96C) so that a rotation or torque applied to the intermediate member can cause an equal rotation or torque to be applied to the head 6330 and the threaded shaft 6309 of the retention element 6308”, PP [0159]: “the securing element 6310 can be moved toward or away from the contact member 6304 by rotating the head portion 6330 of the threaded shaft 6309 of the retention element 6308”).
Conclusion
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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