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 amendment filed March 02, 2026. Claims 41 and 63 are amended. Claims 1-40, 44, and 55 are canceled. Claims 41-43, 45-54, and 56-63 are pending and addressed below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 41 and 63 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 (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 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) 41-43, 45-49, 51-53, 56-57, 59, and 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marchand et. al. (U.S. Pub. No. 2011/0152993)(cited in IDS) hereinafter, “Marchand,” in view of Rees (U.S. Pub. No. 2013/0296917).
Regarding claim 41, Marchand teaches a method for treating a cerebral aneurysm having an interior cavity and a neck (Fig. 60, it is noted, the method of delivery shown in Figs. 60-62 can be used with any of the embodiments taught in the disclosure, pp. [0255]), comprising the steps of:
advancing an implant (336; Fig. 52) coupled to a pusher (“core wire” 114; Fig. 12) in a microcatheter (61; Fig. 52D) in an unflexed configuration (e.g., Figs. 12 & 52D) to a region of interest in a cerebral artery (pp. [0171]), wherein the implant (336) comprises a permeable shell (“outer lobe” 346; Fig. 52) having a proximal end (see Fig. 52A), a distal end (see Fig. 52A), a radially constrained elongated state (see Fig. 52D) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 52) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 52D), and a plurality of elongate filaments (14; Fig. 52) that are woven together to form a mesh (337; Fig. 52), wherein the implant (336) is coupled to the pusher (114) through a flexible connection (“tether,” 72; see Fig. 6; alternatively, it is noted the implant 336 is formed of “flexible filaments” 14, pp. [0161], therefore the body of the implant is considered an indirect flexible connection between the permeable shell and the pusher), wherein in the unflexed configuration (Figs. 12 & 52D), an angle of deflection of the implant (336) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (element 10 in Fig. 12));
advancing the permeable shell (346) into the interior cavity of the cerebral aneurysm with the flexible connection (72) in a flexed configuration (see Fig. 26 showing the delivery configuration between the implant 40 and the flexible connection 72 when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the flexible connection as seen in Fig. 26, the flexible connection would be in a flexed configuration to deliver and position the implant at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an flexed configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method) such that a longitudinal axis of the permeable shell (346) is angled relative to a longitudinal axis of the pusher (114); and
deploying the permeable shell (346) within the cerebral aneurysm, wherein the permeable shell (346) expands to the expanded state in the interior cavity of the aneurysm (see, e.g., Fig. 65).
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
Rees is considered to be analogous to the claimed invention because it is in the same field of delivering devices for filling an aneurysm. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Regarding claim 42, Marchand teaches the invention as discussed above in claim 41. Marchand further teaches the flexible connection (72 and body of implant 336) comprises an elongate proximal extension of the permeable shell (see annotated Fig. 52A below).
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Regarding claim 43, Marchand teaches the invention as discussed above in claim 42. Marchand further teaches the implant further comprises a second permeable shell (348; Fig. 52A) having a proximal end (see Fig. 52A), a distal end (see Fig. 52A), a radially constrained elongated state (see Fig. 53) configured for delivery within the lumen of the microcatheter (61), an expanded state (see Fig. 52A) with a longitudinally shortened configuration relative to the radially constrained state of the second permeable shell (348), and a plurality of elongate filaments that are woven together to form a mesh (see Fig. 52), wherein the expanded state of the second permeable shell (348) is configured to sit within a concave section of the expanded state of the permeable shell (346, see Fig. 52A).
Regarding claim 45, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the permeable shell (346) is coupled to the pusher (114) through the elongate proximal extension (see annotated Fig. 52A above) and the second permeable shell (348; it is noted, the pusher would connect to the permeable shell through the elongate proximal extension and the second permeable shell through the “proximal hub” 352).
Regarding claim 46, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the second permeable shell (348) is releasably coupled to the pusher (114, it is noted, the second permeable shell 348 is releasably coupled to the pusher through the proximal hub” 352; see, e.g., Fig. 28, pp. [0177]).
Regarding claim 47, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the second permeable shell (348) does not extend proximally past a plane defined by a proximal most edge of the permeable shell (346) when both the permeable shell (346) and the second permeable shell (348) are in their expanded states (see Fig, 52A, pp. [0241]).
Regarding claim 48, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the expanded state of the second permeable shell (348) further contains a distal concave section at the distal end of the second permeable shell (348, see annotated Fig. 52A above), wherein the distal concave section is configured to receive the elongate proximal extension of the permeable shell (346; it is noted the distal concave section is configured to receive the elongate proximal extension because they are braided together, pp. [0241]).
Regarding claim 49, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the permeable shell (346) and the second permeable shell (348) are formed from the same plurality of filaments (pp. [0241]).
Regarding claim 51, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches a proximal hub (352; Fig. 52A) attached to the proximal end of the second permeable shell (348, it is noted, “inner lobe” 350 can be considered the proximal portion of the second permeable shell).
Regarding claim 52, Marchand teaches the invention as discussed above in claim 41. Marchand further teaches a distal hub (342; Fig. 52A) attached to the distal end of the permeable shell (346).
Regarding claim 53, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the proximal end of the second permeable shell (348) is coupled to the pusher (114, it is noted, “inner lobe” 350 can be considered the proximal portion of the second permeable shell for which the pusher connects to the through “proximal hub” 352).
Regarding claim 56, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the elongate proximal extension is a wire braid (the whole implant is taught as being a braid, pp. [0241]).
Regarding claim 57, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the permeable shell (346) is capable of deflecting relative to a longitudinal axis formed by the pusher (114) and the second permeable shell (pp. [0201]-[0202], Fig. 27, see also Figs. 61 & 62, the curved/angled deployment method provides a way for the permeable shell to deflect relative to the pusher and permeable shell).
Regarding claim 59, Marchand teaches the invention as discussed above in claim 41. Marchand further teaches the flexible connection allows for the permeable shell (346) to deflect at an angle relative to the longitudinal axis formed by the pusher (114, pp. [0201]-[0202], Fig. 27,see also Figs. 61 & 62, the curved/angled deployment method provides a way for the permeable shell to deflect relative to the pusher).
Regarding claim 62, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the steps of: deploying the second permeable shell (348), wherein the second permeable shell (348) expands to the expanded state and sits within the concave section of the permeable shell (346; see Fig. 52A); and detaching the second permeable shell (348) from the pusher (114, see, e.g., Fig. 26).
Regarding claim 63, Marchand teaches a system for treatment of a patient's cerebral aneurysm (Fig. 52), comprising:
a microcatheter having a lumen (61; Fig. 52D);
a pusher (“core wire” 114; Fig. 12 ) configured to be advanced through the lumen of the microcatheter (61); and
an implant (336; Fig. 52) coupled to the pusher (114), the implant (336) comprising a permeable shell (“outer lobe” 346; Fig. 52) having a proximal end (see Fig. 52A), a distal end (see Fig. 52A), a radially constrained elongated state (see Fig. 52D) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 52) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 52D), and a plurality of elongate filaments (14; Fig. 52) that are woven together to form a mesh (337; Fig. 52), wherein the implant (336) is coupled to the pusher (114) through a flexible connection (“tether,” 72; see Fig. 6; alternatively, it is noted the implant 336 is formed of “flexible filaments” 14, pp. [0161], therefore the body of the implant is considered an indirect flexible connection between the permeable shell and the pusher), wherein in an unflexed configuration (e.g., Figs. 12 & 52D), an angle of deflection of the implant (336) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (element 10 in Fig. 12));
wherein the implant (336) has a flexed configuration during delivery into the patient’s cerebral aneurysm when the permeable shell (346) is in the expanded state (see, e.g., Fig. 25 showing the implant expanding as it is delivered), wherein in the flexed configuration, the permeable shell (346) is angled such that a longitudinal axis of the permeable shell (346) is angled relative to a longitudinal axis of the of the pusher (114, see Fig. 26 showing the delivery configuration between the implant 40 and the pusher (within catheter 151) when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the pusher as seen in Fig. 26, the permeable shell would be angled relative to the pusher to be delivered and positioned at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an angled configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method.
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Claim(s) 41, 54 and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over the following different embodiment of Marchand in view of Rees.
Regarding claim 41, Marchand teaches a method for treating a cerebral aneurysm having an interior cavity and a neck (Fig. 60, it is noted, the method of delivery shown in Figs. 60-62 can be used with any of the embodiments taught in the disclosure, pp. [0255]), comprising the steps of:
advancing an implant (10; Fig. 6) coupled to a pusher (“core wire” 114; Fig. 12 ) in a microcatheter (61; Fig. 11) in an unflexed configuration (e.g., Figs. 11 & 12) to a region of interest in a cerebral artery (pp. [0171]), wherein the implant (10) comprises a permeable shell (40; Fig. 6) having a proximal end (see Fig. 6), a distal end (see Fig. 6), a radially constrained elongated state (see Fig. 11) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 6) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 11), and a plurality of elongate filaments (14; Fig. 6) that are woven together to form a mesh (see Fig. 6), wherein the implant (10) is coupled to the pusher (114) through a flexible connection (“tether” 72; Fig. 6, pp. [0177]), wherein in the unflexed configuration (Figs. 11 & 12), an angle of deflection of the implant (10) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (10));
advancing the permeable shell (40) into the interior cavity of the cerebral aneurysm with the flexible connection (72) in a flexed configuration (see Fig. 26 showing the delivery configuration between the implant 40 and the flexible connection 72 when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the flexible connection as seen in Fig. 26, the flexible connection would be in a flexed configuration to deliver and position the implant at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an angled configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method) such that a longitudinal axis of the permeable shell (40) is angled relative to a longitudinal axis of the pusher (114); and
deploying the permeable shell (40) within the cerebral aneurysm, wherein the permeable shell (40) expands to the expanded state in the interior cavity of the aneurysm (see, e.g., Fig. 65).
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Regarding claim 54, Marchand teaches the invention as discussed above in claim 41. Marchand further teaches the permeable shell (40) further comprises an elongate distal extension (62; Fig. 6) and a distal concave section (90; Fig. 6), wherein at least a portion of the elongate distal extension (62) sits within the distal concave section (90) of the permeable shell (40).
Regarding claim 63, Marchand teaches a system for treatment of a patient's cerebral aneurysm (Fig. 6), comprising:
a microcatheter having a lumen (61; Fig. 11);
a pusher (“core wire” 114; Fig. 12 ) configured to be advanced through the lumen of the microcatheter (61); and
an implant (10; Fig. 6) coupled to the pusher (114), the implant (6) comprising a permeable shell (40; Fig. 6) having a proximal end (see Fig. 6), a distal end (see Fig. 6), a radially constrained elongated state (see Fig. 11) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 6) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 11), and a plurality of elongate filaments (14; Fig. 6) that are woven together to form a mesh (see Fig. 6), wherein the implant (10) is coupled to the pusher (114) through a flexible connection (“tether,” 72; see Fig. 6; alternatively, it is noted the implant 10 is formed of “flexible filaments” 14, pp. [0161], therefore the body of the implant is considered an indirect flexible connection between the permeable shell and the pusher), wherein in an unflexed configuration (e.g., Figs. 11 & 12), an angle of deflection of the implant (10) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (10));
wherein the implant (10) has a flexed configuration during delivery into the patient’s cerebral aneurysm when the permeable shell (40) is in the expanded state (see, e.g., Fig. 25 showing the implant expanding as it is delivered), wherein in the flexed configuration, the permeable shell (40) is angled such that a longitudinal axis of the permeable shell (40) is angled relative to a longitudinal axis of the pusher (114, see Fig. 26 showing the delivery configuration between the implant 40 and the pusher (within catheter 151) when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the pusher as seen in Fig. 26, the permeable shell would be angled relative to the pusher to be delivered and positioned at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an angled configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method).
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Claim(s) 41-43, 50, 60-61, and 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over the following different embodiment of Marchand in view of Rees.
Regarding claim 41, Marchand teaches a method for treating a cerebral aneurysm having an interior cavity and a neck (Fig. 60, it is noted, the method of delivery shown in Figs. 60-62 can be used with any of the embodiments taught in the disclosure, pp. [0255]), comprising the steps of:
advancing an implant (376; Fig. 55) coupled to a pusher (core wire” 114; Fig. 12 ) in a microcatheter (61; Fig. 55B) in an unflexed configuration (e.g., Figs. 12 & 55B) to a region of interest in a cerebral artery (pp. [0171]), wherein the implant (376) comprises a permeable shell (384; Fig. 55) having a proximal end (see Fig. 55), a distal end (see Fig. 55), a radially constrained elongated state (see Fig. 55B) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 55) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 55B), and a plurality of elongate filaments (14; pp. [0248]) that are woven together to form a mesh (see Fig. 55A), wherein the implant (376) is coupled to the pusher (114) through a flexible connection (it is noted the implant 376 is formed of “flexible filaments” 14, pp. [0161], therefore the entire implant is considered flexibly connected), wherein in the unflexed configuration (Figs. 12 & 55B), an angle of deflection of the implant (376) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (element 10 in Fig. 12));
advancing the permeable shell (376) into the interior cavity of the cerebral aneurysm with the flexible connection (72) in a flexed configuration (see Fig. 26 showing the delivery configuration between the implant 40 and the flexible connection 72 when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the flexible connection as seen in Fig. 26, the flexible connection would be in a flexed configuration to deliver and position the implant at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an angled configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method) such that a longitudinal axis of the permeable shell (384) is angled relative to a longitudinal axis of the pusher (114); and
deploying the permeable shell (376) within the cerebral aneurysm, wherein the permeable shell (376) expands to the expanded state in the interior cavity of the aneurysm (see, e.g., Fig. 65).
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Regarding claim 42, Marchand teaches the invention as discussed above in claim 41. Marchand further teaches the flexible connection comprises an elongate proximal extension of the permeable shell (see portion of the permeable shell 384 that extends into “proximal hub” 388).
Regarding claim 43, Marchand teaches the invention as discussed above in claim 42. Marchand further teaches the implant further comprises a second permeable shell (380; Fig. 55) having a proximal end (see Fig. 55), a distal end (see Fig. 55), a radially constrained elongated state (see Fig. 55B) configured for delivery within the lumen of the microcatheter (61), an expanded state (see Fig. 55) with a longitudinally shortened configuration relative to the radially constrained state, and a plurality of elongate filaments (14; pp. [0248]) that are woven together to form a mesh ([0248]), wherein the expanded state of the second permeable shell (380) is configured to sit within a concave section of the permeable shell (384, see Fig. 55).
Regarding claim 50, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the plurality of filaments forming the permeable shell (384) is different from the plurality of filaments forming the second permeable shell (380; “inner structure 380 forms a separate lobe from the shell 384,” pp. [0248], and “the mesh density of the inner structure 380 may be higher than a density of the mesh structure of the outer shell or structure 384,” pp. [0251]).
Regarding claim 60, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the permeable shell (384) is more flexible than the second permeable shell (380; it is noted, the second permeable shell 380 having a higher mesh density than the permeable shell 384 would make the permeable shell 384 more flexible than the second permeable shell 380).
Regarding claim 61, Marchand teaches the invention as discussed above in claim 43. Marchand further teaches the second permeable shell (384) is stiffer than the permeable shell (384; it is noted, the second permeable shell 380 having a higher mesh density than the permeable shell 384 would make the second permeable shell 380 more stiffer than the permeable shell 384).
Regarding claim 63, Marchand teaches a system for treatment of a patient's cerebral aneurysm (Fig. 55), comprising:
a microcatheter having a lumen (61; Fig. 55B);
a pusher (core wire” 114; Fig. 12 ) configured to be advanced through the lumen of the microcatheter (61); and
an implant (376; Fig. 55) coupled to the pusher (114), the implant (376) comprising a permeable shell (384; Fig. 55) having a proximal end (see Fig. 55), a distal end (see Fig. 55), a radially constrained elongated state (see Fig. 55B) configured for delivery within a lumen of the microcatheter (61), an expanded state (see Fig. 55) with a longitudinally shortened configuration relative to the radially constrained state (Fig. 55B), and a plurality of elongate filaments (14; pp. [0248]) that are woven together to form a mesh (see Fig. 55A), wherein the implant (376) is coupled to the pusher (114) through a flexible connection (“tether,” 72; see Fig. 6; alternatively, it is noted the implant 336 is formed of “flexible filaments” 14, pp. [0161], therefore the body of the implant is considered an indirect flexible connection between the permeable shell and the pusher), wherein in an unflexed configuration (e.g., Figs. 12 & 55B), an angle of deflection of the implant (376) relative to a distal end of the pusher (114) is about 0° (it is noted, in the unflexed configuration, Fig. 12 shows the pusher 114 extends parallel to the implant (element 10 in Fig. 12));
wherein the implant (376) has a flexed configuration during delivery into the patient’s cerebral aneurysm when the permeable shell (384) is in the expanded state (see, e.g., Fig. 25 showing the implant expanding as it is delivered), wherein in the flexed configuration, the permeable shell (384) is angled such that a longitudinal axis of the permeable shell (384) is angled relative to a longitudinal axis of the pusher (114, see Fig. 26 showing the delivery configuration between the implant 40 and the pusher (within catheter 151) when the longitudinal axis 46 of the device 10 is substantially aligned with a longitudinal axis of the defect 160 (pp. 0201]). See also, Fig. 27 showing the longitudinal axis 46 of the implanted device 10 is canted at an angle of about 10 degrees to about 90 degrees relative to a longitudinal axis of the target vascular defect 160 (pp. [0202]). Marchand further teaches the device 10 may be manipulated by the user to position the device 10 within the vascular site or defect 160 during or after deployment but prior to detachment (pp. [0201]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art that given the delivery configuration between the implant and the pusher as seen in Fig. 26, the permeable shell would be angled relative to the pusher to be delivered and positioned at an angle as seen in Fig. 27), (Additionally, see Figs. 60-62 which teaches a method of using a “deflecting device” 400 to deliver the implant in an angled configuration; see pp. [0255] discussing how any of the device embodiments can be delivered through this method).
However, Marchand does not explicitly disclose the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Marchand teaches how the pusher and implant can be connected in Figs. 12-15, but also teaches any other suitable means of securement between the pusher and implant may be used (pp. [0171]).
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection between the implant and distal end of the pusher of Marchand to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Further, Rees does not explicitly disclose the angle of deflection of the implant relative to the distal end of the pusher is up to about 150°; however, there is no evidence of record that establishes that changing the angle of the flexed configuration would result in a difference in function of Marchand in view of Rees. Further, a person having ordinary skill in the art, being faced with modifying the flexed configuration of Marchand in view of Rees, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed angles. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the angle may be within the claimed range, and offering other acceptable ranges (e.g., 10- degrees, specification at para. [00101]) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the flexed configuration of Marchand in view of Rees to have the angle of deflection of the implant relative to the distal end of the pusher is up to about 150° as an obvious matter of design choice within the skill of the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 41, 42, 43, 57, 58, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,291,453 in view of Marchand and further in view of Rees.
Although the claims at issue are not identical, they are not patentably distinct from each other in view of Marchand.
Regarding claims 41-43, claim 17 of ‘453 claims a device for treatment of a patient's cerebral aneurysm comprising a first and second permeable shell formed from a plurality of elongate filaments that are woven together to form a mesh, the shells having constrained and expanded states, a catheter, pusher, and an elongate proximal extension which allows deflection between the first and second permeable shells, however ‘453 does not explicitly claim that the extension is part of a flexible connection that couples the implant to a distal end of the pusher and .
Marchand teaches an elongate proximal extension (“tether,” 72; Fig. 6) that is a flexible connection that couples the implant to the pusher.
Marchand is considered to be analogous to the claimed invention because it is in the same field of filamentary devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘453 to incorporate the teachings of Marchand by making the elongate proximal extension part of a flexible connection between the implant and the pusher. Doing so would provide a means and method of delivering the filamentary device into a cerebral aneurysm efficiently at an angle as taught by Marchand (see Figs. 60-62 of Marchand).
Further, claim 9 of ‘453 does not explicitly claim a method for treating a cerebral aneurysm having an interior cavity and a neck, comprising the steps of advancing an implant coupled to a pusher in a microcatheter in an unflexed configuration to a region of interest in a cerebral artery advancing the permeable shell into the interior cavity of the cerebral aneurysm, wherein in the unflexed configuration, an angle of deflection of the implant relative to a distal end of the pusher is about 0°, with the flexible connection in an angled configuration between the pusher and implant while the implant is coupled to the pusher and deploying the permeable shell within the cerebral aneurysm wherein the permeable shell expands to the expanded state in the interior cavity of the aneurysm.
Marchand further teaches a method of treating a cerebral aneurysm by the above listed steps (see Figs. 12 and 60-62, pps. [0255]-[0256]). The steps of delivering the device are not novel in view of Marchand because Marchand teaches the same structure and can be delivered in the method claimed.
Further, claim 9 of ‘453 does not claim the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘453 to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
Regarding claims 57 & 58, claim 17 of ‘453 claims the recited features.
Regarding claim 63, claim 17 of ‘453 claims a device for treatment of a patient's cerebral aneurysm comprising a first and second permeable shell formed from a plurality of elongate filaments that are woven together to form a mesh, the shells having constrained and expanded states, a catheter, pusher, and an elongate proximal extension which allows deflection between the first and second permeable shells, however ‘453 does not explicitly claim in the extension is part of a flexible connection that couples the implant to a distal end of the pusher.
Marchand teaches an elongate proximal extension (“tether,” 72; Fig. 6) that is a flexible connection that couples the implant to the pusher.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘453 to incorporate the teachings of Marchand by making the elongate proximal extension part of a flexible connection between the implant and the pusher. Doing so would provide a means and method of delivering the filamentary device into a cerebral aneurysm efficiently at an angle as taught by Marchand (see Figs. 60-62 of Marchand).
Further, claim 17 of ‘453 does not explicitly claim an unflexed configuration, wherein in the unflexed configuration, an angle of deflection of the implant relative to the pusher is about 0°.
Marchand further teaches an unflexed configuration (see Fig. 12).
Further, claim 9 of ‘453 does not claim the flexed configuration such that a longitudinal axis of the permeable shell is angled relative to a longitudinal axis of the distal end of the pusher while the implant is coupled to the pusher.
Rees teaches a delivery device for use with a generic embolic device (1; Fig. 8I) with a pusher (90; see Fig. 8H), wherein the implant (1) is coupled to the pusher (90) through a flexible connection (110; Fig. 8I) that has and unflexed configuration with an angle of deflection of the implant (1) relative to a distal end of the pusher (90) of about 0° (pp. [0128]), and
a flexed configuration such that a longitudinal axis of the implant (1) is angled relative to a longitudinal axis of the distal end of the pusher (90) while the implant (1) is coupled to the pusher (1, pp. [0128]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘453 to incorporate the teachings of Rees by providing an angled relation between the distal end of the pusher and the implant. Doing so would facilitate nesting into tissues and prevent tissue perforation as taught by Rees (pp. [0128]).
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 DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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