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 Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 21-33 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.
In response to applicant's argument that Capes and Trocki are nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Capes and Trocki teaches a connection between two tubular members.
Claim Objections
Claim 29 objected to because of the following informalities: "the one or more angled protrusions" in line 1 should read "the one or more angles projections". Appropriate correction is required.
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) 1 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe (US 2002/0052641 A1) in view of Cohen (US 2019/0060057 A1).
Regarding claim 1, Monroe teaches a delivery system for a prosthetic heart valve (88, catheter assembly, fig. 5), the delivery system comprising:
an elongate shaft (82, inner tube, fig. 5) having a distal end (see annotated fig. 5, below) and a proximal end (see annotated fig. 5, below) and including an implant retention area for retaining the prosthetic heart valve (66, annular space, figs, 1-2);
a nose cone (86, distal tip, fig. 5); and
one or more angled projections configured to couple the nose cone to the distal end of the elongate shaft (84, barbs, fig. 6).
Monroe fails to teach a prosthetic heart valve including a frame and leaflets. However, Cohen teaches a delivery apparatus that includes a prosthetic heart valve (100, prosthetic heart valve, fig. 1) including a frame (102, frame, fig. 1) and prosthetic valve leaflets (112, leaflets, fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe to include a prosthetic heart valve including a frame and leaflets as taught by Cohen in order to replace the native vale when a human heart suffered from valvular diseases (¶ [0003], Cohen).
Regarding claim 30, Monroe fails to teach a handle. However, Cohen further teaches a handle positioned at the proximal end of the elongate shaft (210, handle, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe to include a handle as taught by Cohen in order to radially expand the frame of the prosthetic valve (¶ [0076], Cohen).
Regarding claim 31, Monroe fails to teach a release mechanism including a motor. However, Cohen further teaches a release mechanism including a motor for releasing the prosthetic heart valve from the implant retention area (212, motor, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe to include a release mechanism including a motor as taught by Cohen in order to radially expand the frame of the prosthetic valve (¶ [0076], Cohen).
Regarding claim 32, Monroe fails to teach a control device for operating the motor. However, Cohen further teaches a control device for operating the motor of the release mechanism ¶ [0058]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe to include a control device for operating the motor as taught by Cohen in order to radially expand the frame of the prosthetic valve (¶ [0076], Cohen).
Regarding claim 33, Monroe fails to teach a deflection mechanism. However, Cohen further teaches a deflection mechanism configured to cause controlled deflection of the elongate shaft (¶ [0055], ¶ [0059]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe to include a deflection mechanism as taught by Cohen in order to radially expand the frame of the prosthetic valve (¶ [0076], Cohen).
Claim(s) 2-3, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Cohen as applied to claim 1 above, and further in view of Capes (US 2002/0007147 A1).
Regarding claim 2, Monroe and Cohen fail to teach a retention ring. However, Capes teaches two tubular components connected together that includes a retention ring coupled to the elongate shaft (53, projection, fig. 5, ¶ [0038] states the projection can extend 360 degrees around the hub), and wherein the one or more angled projections (34, locking tabs, fig. 5) are configured to engage the retention ring to couple the nose cone to the distal end of the elongate shaft (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connection of components in the delivery system of Monroe and Cohen to include a retention ring as taught by Capes since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members.
Regarding claim 3, Monroe and Cohen fail to teach one or more angled projection extend inward from the inner surface of the nose cone. However, Capes teaches two tubular components connected together that includes the one or more angled projections extend inward from an inner surface of the nose cone (fig. 5) and are angled toward a distal end of the nose cone (see annotated fig. 5), the one or more angled projections each having a tip (see annotated fig. 5) configured to engage a proximal end of the retention ring to couple the nose cone to the distal end of the elongate shaft (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connection of components in the delivery system of Monroe and Cohen to include the one or more angled projection extends inward from the inner surface of the nose cone as taught by Capes since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members.
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Regarding claim 21, Monroe and Cohen fail to teach an inner surface of the retention ring contacts a portion of an outer surface of the elongate shaft. However, Capes further teaches an inner surface of the retention ring contacts a portion of an outer surface of the elongate shaft (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connection of components in the delivery system of Monroe and Cohen to include an inner surface of the retention ring contacts a portion of an outer surface of the elongate shaft as taught by Capes since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members. Further, it would have been obvious to one having ordinary skill in the art at the time the invention was made to separate the retention ring from the elongate shaft, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (MPEP 2144.04).
Regarding claim 22, Monroe further teaches a nose cone lumen (fig. 5). Monroe and Cohen fail to teach a retention ring portion sized to receive the retention ring. However, Capes further teach a retention ring portion sized to receive the retention ring therein (fig. 5). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the connection of components in the delivery system of Monroe and Cohen to include a retention ring portion sized to receive the retention ring as taught by Capes since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Cohen as applied to claim 1 above, and further in view of Trocki (US 2001/0047153 A1).
Regarding claim 4, Monroe and Cohen fail to teach a retention ring and a gap. However, Trocki discloses a connection between two tubular members that includes
a retention ring coupled to the elongate shaft (see annotated fig. 18, below) and having a distal end (see annotated fig. 18, below), a proximal end (see annotated fig. 18, below), and an outer surface (see annotated fig. 18, below),
wherein the one or more angled projections extend outward from the outer surface of the retention ring (30, tabs, fig. 18) and are angled toward the proximal end of the retention ring (fig. 18), and
wherein the nose cone further comprises a gap located along an inner surface of the nose cone (see annotated fig. 18, below) and configured to be engaged by the one or more angled projections to couple the nose cone to the distal end of the elongate shaft (fig. 19). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe and Cohen to include a retention ring and a gap as taught by Trocki since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members.
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Claim(s) 5 and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Cohen and Trocki as applied to claim 4 above, and further in view of Chiang (US 5,899,890).
Regarding claim 5, Monroe in view of Cohen and Trocki fail to teach a support ring with an outer surface configured to contact the inner surface of the nose cone. However, Chiang teaches a tubular delivery device that includes a support ring located within a lumen of the nose cone (32, ring fig. 2) and having a proximal end (see annotated fig. 2, below), a distal end (see annotated fig. 2, below), and an outer surface configured to contact the inner surface of the nose cone (see annotated fig. 2, below), the distal end of the support ring forming a surface of the gap of the nose cone (see annotated fig. 18, below, Trocki). It would be obvious to place the marker ring at any location that would be expedient for the purpose of indicated a position of the device to the operator, including a position where the nose cone contacts the elongate shaft. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe, Cohen and Trocki to include a support ring as taught by Chiang since it reduces the chance that the marker will be lost from the catheter (col 7 lines 16-36, Chiang) and it is combining prior art elements according to known methods to yield predictable result, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 28, Monroe and Cohen fail to teach the one or more angled projections are angled toward a proximal end of the nose cone. However, Trocki further teaches the one or more angled projections are angled toward a proximal end of the nose cone when the nose cone is coupled to the distal end of the elongate shaft (fig. 19). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe and Cohen to include the one or more angled projections are angled toward a proximal end of the nose cone as taught by Trocki since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members.
Regarding claim 29, Monroe and Cohen fail to teach the one or more angled protrusions are configured to contact the support ring when the nose cone is coupled to the distal end of the elongate shaft. However, Trocki further teaches the one or more angled protrusions are configured to contact the support ring when the nose cone is coupled to the distal end of the elongate shaft. The phrase “the one or more angled protrusions are configured to contact the support ring when the nose cone is coupled to the distal end of the elongate shaft” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the projections are considered to be capable of contacting the support ring when the nose cone is coupled to the distal end of the elongate shaft. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe and Cohen to include the one or more angled protrusions are configured to contact the support ring when the nose cone is coupled to the distal end of the elongate shaft as taught by Trocki since it is a simple substitution of one known element for another to obtain predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143). In this case it is a known connection method between two tubular members.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Cohen as applied to claim 1 above, and further in view of Hannon (US 2015/0352321 A1).
Regarding claim 6, Monroe and Cohen fail to teach a retention sleeve. However, Hannon discloses a connection between two tubular members that includes the one or more angled projections are coupled to a retention sleeve (620, insert, fig. 28) configured to be positioned between the nose cone and the elongate shaft (fig. 27). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe and Cohen to include a retention sleeve as taught by Hannon in order to prevent the catheter from being retracted or withdrawn from the tip (¶ [0110], Hannon).
Regarding claim 7, Monroe and Cohen fail to teach angled projection extending from the inner and outer surfaces of the retention sleeve. However, Hannon further discloses the retention sleeve includes an outer surface (see annotated fig. 29, below) and an inner surface (see annotated fig. 29, below), and the one or more angled projections include one or more angled projections extending from the outer surface of the retention sleeve (see annotated fig. 29, below) and one or more angled projections extending from the inner surface of the retention sleeve (630, projection, fig. 29). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Monroe and Cohen to include angled projection extending from the inner and outer surfaces of the retention sleeve as taught by Hannon in order to prevent the catheter from being retracted or withdrawn from the tip (¶ [0110], Hannon).
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Claim(s) 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monroe in view of Cohen and Capes as applied to claim 22 above, and further in view of Blake (US 2017/0045168 A1).
Regarding claim 23, Monroe in view of Cohen and Capes fails to teach the retention ring portion has a first width, and the nose cone lumen includes a shaft tip portion positioned distal of the retention ring portion and having a second width that is less than the first. However, Blake teaches a connection between two tubular components that includes the retention ring portion has a first width, and the nose cone lumen includes a shaft tip portion positioned distal of the retention ring portion and having a second width that is less than the first width (see annotated fig. 3, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe, Cohen and Capes to include the retention ring portion has a first width, and the nose cone lumen includes a shaft tip portion positioned distal of the retention ring portion and having a second width that is less than the first width as taught by Blake in order to prevent removal of the male connector (¶ [0061], Blake).
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Regarding claim 24, Monroe in view of Cohen and Capes fails to teach the retention ring portion includes a wall for contacting a distal end of the retention ring. However, Blake further teaches the retention ring portion includes a wall for contacting a distal end of the retention ring when the retention ring is inserted into the retention ring portion (see annotated fig. 3). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe, Cohen and Capes to include the retention ring portion includes a wall for contacting a distal end of the retention ring when the retention ring as taught by Blake in order to prevent removal of the male connector (¶ [0061], Blake).
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Regarding claim 25, Monroe in view of Cohen and Capes fails to teach the nose cone includes a proximal opening and a proximal portion located between the one or more angled projections and the proximal opening. However, Blake further teaches the nose cone includes a proximal opening for receiving the retention ring, and the inner surface of the nose cone includes a proximal portion located between the one or more angled projections and the proximal opening (see annotated fig. 3, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe, Cohen and Capes to include the nose cone includes a proximal opening a proximal portion located between the one or more angled projections and the proximal opening as taught by Blake in order to prevent removal of the male connector (¶ [0061], Blake).
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Regarding claim 26, Monroe in view of Cohen and Capes fails to teach the one or more angled projections are coupled to a support ring that is positioned within the nose cone. However, Blake further teaches the one or more angled projections are coupled to a support ring that is positioned within the nose cone (3, locking ring, fig. 3). . Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe, Cohen and Capes to include the one or more angled projections are coupled to a support ring that is positioned within the nose cone as taught by Blake in order to prevent removal of the male connector (¶ [0061], Blake).
Regarding claim 27, Monroe in view of Cohen and Capes fails to teach a support ring portion having a third width that is greater than the first width. However, Blake further teaches the nose cone lumen includes a support ring portion positioned proximal of the retention ring portion and retaining the support ring (4, housing, fig. 3), the support ring portion having a third width that is greater than the first width (see annotated fig. 3, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the delivery system of Monroe, Cohen and Capes to include a support ring portion having a third width that is greater than the first width as taught by Blake in order to prevent removal of the male connector (¶ [0061], Blake).
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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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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