DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 3, 28, and 31 is/are amended and claim(s) 20, 30 and 32-33 is/are canceled. Claims 34-36 are added. Claims 5, 11-19, 21, and 25 were previously canceled. Claims 1-4, 6-10, 22-24, 26-29, 31, and 34-36 are now pending examination.
Response to Arguments
Applicant’s arguments, filed 4/23/2026, with respect to the rejection(s) of claim(s) 1 under U.S.C. 103 have been fully considered but are not persuasive, in combination with the amendments to the claims, and the rejection has been modified due to the amendments to the claims.
Specifically, the rejections were withdrawn because the newly added limitations of “the deployment apparatus including a handle positioned at the proximal end of the elongate shaft; a first sheath coupled to or comprising a retainer configured to extend over the filter body to retain the filter body in an undeployed state, the first sheath including a first longitudinal cut extending along a length of the first sheath, the first sheath being configured to be slid onto the elongate shaft between the handle and the implant retention area by the elongate shaft passing through the first longitudinal cut, wherein the first sheath is configured to move distally along the elongate shaft; and a second sheath coupled to the filter body and configured to slide along the elongate shaft to vary a position of the filter body along the elongate shaft, the second sheath including a second longitudinal cut extending along a length of the second sheath, the second sheath being configured to be slid onto the elongate shaft between the handle and the implant retention area by the elongate shaft passing through the second longitudinal cut, wherein the second sheath is configured to move distally along the elongate shaft” overcome the previous rejection to claim 1 as written. However, upon further consideration, a new ground(s) of rejection is made in view of Sutton, Macoviak, Sachar, White, Sos, and Tsugita. Applicant argues Sutton, Macoviak and Sachar fail to disclose the newly added features of claim 1, to which Examiner agrees, however, Tsugita is relied upon to teach the deficiencies. Applicant argues Tsugita fails to disclose, teach, or suggest sliding a sheath onto an elongate shaft between a handle and an implant retention area by the elongate shaft passing through a longitudinal cut of the sheath (Remarks Page 8). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The device of Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita would teach a device fully capable of performing the added limitations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-10, 22-24, 26-29, 31 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Sutton et al. (US 20130158654 A1) in view of Macoviak et al. (US 20020161394 A1) (previously of record) in view of Sachar et al. (US 20160089228 A1) (previously of record) in view of White (US 20110066224 A1) (previously of record), further in view of Sos (US 20160367285 A1) (previously of record) and Tsugita et al. (US 20020095174 A1) (previously of record).
Regarding claims 1-3, 28, Sutton discloses a deployment system for deploying a filter in a subject, the deployment system comprising:
a deployment apparatus (10) including an elongate shaft (100) having an implant retention area (distal portion of 120), the elongate shaft having a proximal end (Figure 3);
a prosthetic heart valve (410) configured to be retained at the implant retention area (Figure 3; Paragraph 0029);
a filter body (200) having a proximal portion and a distal portion (Figure 3; Paragraph 0015), and configured to have a deployed state in which the filter body extends radially outward from the elongate shaft and increases in size from the proximal portion to the distal portion (Figure 3; Paragraph 0016), the filter body configured to trap particles in the filter body (Paragraph 0024);
a filter support (220) being positioned distal of the distal portion of the filter body (Figure 1D; Paragraph 0015);
one or more support tethers (210) being coupled to the filter support and being coupled to the distal portion of the filter body (Figure 3; Paragraph 0015).
Sutton fails to explicitly disclose the deployment apparatus including a handle positioned at the proximal end of the elongate shaft; a prosthetic heart valve including a frame; a filter support configured to couple to the elongate shaft and slide relative to the filter body; the one or more support tethers extending proximally from the filter support and a control tether passing distally through the proximal portion of the filter body and coupling to the filter support, the control tether configured to be slid relative to the filter body to slide the filter support to move the one or more support tethers and controlling a size of the distal portion of the filter body to transition the filter body to the deployed state; wherein the control tether is configured to be slid proximally relative to the filter body to slide the filter support proximally to move the one or more support tethers and transition the filter body to the deployed state; wherein the control tether is configured to be slid distally relative to the filter body to slide the filter support distally to move the one or more support tethers and transition the filter body to an undeployed state; a first sheath coupled to or comprising a retainer configured to extend over the filter body to retain the filter body in an undeployed state, the first sheath including a first longitudinal cut extending along a length of the first sheath, the first sheath being configured to be slid onto the elongate shaft between the handle and the implant retention area by the elongate shaft passing through the first longitudinal cut, wherein the first sheath is configured to move distally along the elongate shaft; and a second sheath coupled to the filter body and configured to slide along the elongate shaft to vary a position of the filter body along the elongate shaft, the second sheath including a second longitudinal cut extending along a length of the second sheath, the second sheath being configured to be slid onto the elongate shaft between the handle and the implant retention area by the elongate shaft passing through the second longitudinal cut, wherein the second sheath is configured to move distally along the elongate shaft.
However, Macoviak is directed to a deployment system for deploying a filter in a subject (Figure 1, 4-6; Paragraph 0043) and teaches a filter support (126) being positioned distal of the proximal portion of the filter body (102) and configured to couple to the elongate shaft and slide relative to the filter body (Figure 6; Paragraph 0046); and one or more support tethers (118) being coupled to the filter support and extending proximally from the filter support and being coupled to the distal portion of the filter body (Figure 6; Paragraph 0046).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sutton to include a filter support configured to couple to the elongate shaft and slide relative to the filter body; the one or more support tethers extending proximally from the filter support, as taught by Macoviak, as both references and the claimed invention are directed to filter deployment systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton with the teachings of Macoviak by incorporating a filter support configured to couple to the elongate shaft and slide relative to the filter body; one or more support tethers extending proximally from the filter support in order to easily control movement of the filter.
The combination of Sutton and Macoviak fails to explicitly disclose a control tether passing distally through the proximal portion of the filter body and coupling to the filter support, the control tether configured to be slid relative to the filter body to slide the filter support to move the one or more support tethers and controlling a size of the distal portion of the filter body to transition the filter body to the deployed state; wherein the control tether is configured to be slid proximally relative to the filter body to slide the filter support proximally to move the one or more support tethers and transition the filter body to the deployed state; wherein the control tether is configured to be slid distally relative to the filter body to slide the filter support distally to move the one or more support tethers and transition the filter body to an undeployed state.
However, Sachar is directed to a filter device (10) and teaches a control tether (84) passing distally through the proximal portion of the filter body (50) and coupling to the filter support (54) (Figure 3B, 4A-B; Paragraph 0044), the control tether configured to be slid relative to the filter body to slide the filter support to move the one or more support tethers (52) and controlling a size of the distal portion of the filter body to transition the filter body to the deployed state (Paragraph 0050); wherein the control tether is configured to be slid proximally relative to the filter body to slide the filter support proximally to move the one or more support tethers and transition the filter body to the deployed state (Figure 4B; Paragraph 0044; 0050); wherein the control tether is configured to be slid distally relative to the filter body to slide the filter support distally to move the one or more support tethers and transition the filter body to an undeployed state (Paragraph 0044; 0050).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak with the teachings of Sachar by incorporating Sachar’s control tether to expand and collapse the filter as a simple substitution. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Further, White is directed to a valve deployment system and teaches a prosthetic heart valve (100) including a frame (105) supporting a plurality of prosthetic valve leaflets (101a, 101b, 101c) (Figure 8, 10; Paragraph 0063).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sutton as modified by Macoviak and Sachar such that the prosthetic heart valve includes a frame supporting a plurality of prosthetic valve leaflets, as taught by White, as both references and the claimed invention are directed to valve deployment devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak and Sachar with the teachings of White by incorporating the prosthetic heart valve includes a frame supporting a plurality of prosthetic valve leaflets in order to open and close the valve to allow and restrict blood flow (White Paragraph 0070). Further, Sutton is silent to the features of its valve replacement implant, thus the modification would be obvious as the leaflets would allow for proper functioning of the valve as a replacement valve.
Additionally, Sos is directed to a filter deployment apparatus and teaches a handle (101) positioned at the proximal end of the elongate shaft (100) (Figure 6B; Paragraph 0108).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sutton as modified by Macoviak, Sachar, and White such that modification, as taught by Sos, as both references and the claimed invention are directed to filter devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak, Sachar, and White with the teachings of Sos by incorporating modification in order to allow user manipulation of the device and Sutton is silent to features of the proximal housing of the shaft.
Furthermore, Sos teaches a first sheath (140) comprising a retainer (outer surface of 140) configured to extend over the filter body to retain the filter body (110) in an undeployed state (Figure 11; Paragraph 0086), wherein the first sheath is configured to move distally along the elongate shaft (Paragraph 0094); and a second sheath (170) coupled to the filter body and configured to slide along the elongate shaft to vary a position of the filter body along the elongate shaft (the filter body is within outer sheath 170, thus the two are coupled), wherein the second sheath is configured to move distally along the elongate shaft (Figure 11; Paragraph 0086; 0108),
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak, Sachar, and White with the teachings of Sos by incorporating a first sheath comprising a retainer configured to extend over the filter body to retain the filter body in an undeployed state; wherein the first sheath is configured to move distally along the elongate shaft to allow the filter body to move to the deployed state in order to prevent premature expansion of the filter.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak, Sachar, and White with the teachings of Sos by incorporating wherein the sheath is a first sheath, and further comprising a second sheath coupled to the filter body and configured to slide along the elongate shaft to vary a position of the filter body along the elongate shaft in order to cover protruding components of the deployment system (Sos Paragraph 0093) or facilitate placement of the system (Sos Paragraph 0101).
Lastly, Tsugita is directed to a filter deployment system and teaches wherein a first sheath (50) and a second sheath (55) each include a longitudinal cut extending along a length of the respective first sheath and the second sheath (Paragraph 0083). As a result of the modification with Sutton as modified by Macoviak, Sachar, and Sos, the elongate shaft would be configured to pass through the longitudinal cut of the first sheath and the longitudinal cut of the second sheath to couple with the first sheath and the second sheath, since the elongate shaft is located inside both the first sheath and the second sheath, and is fully capable of at least partially sliding within the longitudinal cuts. Further, the second sheath would be fully capable of being configured to be slid onto the elongate shaft between the handle and the implant retention area by the elongate shaft passing through the second longitudinal cut.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Sutton as modified by Macoviak, Sachar, White and Sos such that wherein the first sheath and the second sheath each include a longitudinal cut extending along a length of the respective first sheath and the second sheath, and the elongate shaft is configured to pass through the longitudinal cut of the first sheath and the longitudinal cut of the second sheath to couple with the first sheath and the second sheath, as taught by Tsugita as both references and the claimed invention are directed to filter deployment systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sutton as modified by Macoviak, Sachar, White and Sos with the teachings of Tsugita by incorporating wherein the first sheath and the second sheath each include a longitudinal cut extending along a length of the respective first sheath and the second sheath, and the elongate shaft is configured to pass through the longitudinal cut of the first sheath and the longitudinal cut of the second sheath to couple with the first sheath and the second sheath in order to allow components of the deployment system to slidably enter the sheaths (Tsugita Paragraph 0017).
Regarding claim 4, Sutton as modified by Macoviak and Sachar further teaches wherein the control tether is configured to be slid distally through the proximal portion of the filter body to reduce a size of the distal portion (As the filter is collapsed, the distal portion of the filter would reduce in size) (Sachar Paragraph 0044; 0050).
Regarding claim 6, Sutton further discloses wherein the filter support comprises a ring configured to extend around the elongate shaft (Figure 1B; Paragraph 0015).
Regarding claim 7, Sutton further discloses wherein the filter body has a conical shape in the deployed state, the conical shape increasing in size from the proximal portion of the filter body to the distal portion of the filter body (Figure 3; Paragraph 0023).
Regarding claim 8, Sutton further discloses wherein the filter body includes an opening (interior of conical filter) of an interior cavity for retaining the particles, the opening being positioned at the distal portion of the filter body, and the filter body extending around the interior cavity (Figure 3; Paragraph 0023).
Regarding claim 9, Sutton further discloses wherein the filter body is configured to slide relative to the elongate shaft (the filter body and elongate shaft are capable of sliding together; thus, the filter body is configured to slide relative to the elongate shaft) (Figure 1-3; Paragraph 0016).
Regarding claim 10, Sutton further discloses wherein the filter body is configured to be positioned proximal of the implant retention area (Paragraph 0021).
Regarding claim 22, Sutton further discloses wherein the deployment apparatus includes a capsule (300) extending over the implant retention area (Figure 3; Paragraph 0027).
Regarding claim 23, Sutton further discloses wherein the capsule is configured to be retracted to allow the prosthetic heart valve to be deployed from the implant retention area (Paragraph 0027).
Regarding claim 24, Sutton further discloses wherein the filter body is positioned proximal of the capsule (Figure 3; Paragraph 0015; 0027).
Regarding claim 26, Sutton further discloses wherein the prosthetic heart valve is a prosthetic aortic heart valve, as the disclosed valve is fully capable of being used as an aortic valve replacement. ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.)
Regarding claim 27, Sutton further discloses wherein the opening faces distally and towards the implant retention area (Figure 3).
Regarding claim 29, Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita teaches the deployment system of claim 1, but fails to explicitly disclose wherein the elongate shaft includes a nose cone forming a tip of the elongate shaft and positioned distal of the implant retention area.
However, Sachar further teaches wherein the elongate shaft includes a nose cone (18) forming a tip of the elongate shaft (14) (Figure 1; Paragraph 0052). When combined with the elongate shaft of Sutton, the modification would result in the nose cone being positioned distal of the implant retention area, as the nose cone is formed on the distalmost end of the shaft.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shaft of Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita with the teachings of Sachar by incorporating wherein the elongate shaft includes a nose cone forming a tip of the elongate shaft in order to prevent trauma to the blood vessels as the shaft is guided in.
Regarding claim 31, Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita teaches the deployment system of claim 1, and Sos further teaches wherein the first sheath is configured to be retracted to allow the filter body to move to the deployed state (Paragraph 0086).
Regarding claim 34, the combination of Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita further discloses wherein the first sheath is fully capable of being configured such that a proximal movement of the first sheath along the elongate shaft is controlled by a length of the first sheath that is slid off of the elongate shaft between the handle and the implant retention area (Sos teaches proximal retraction of the first sheath (Paragraph 0014; 0086), which is considered to be capable of this limitation because proximal retraction would encompass sliding the sheath off of portions of the shaft). ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.)
Regarding claim 35, the combination of Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita further teaches wherein the second sheath is fully capable of being configured such that a proximal movement of the second sheath along the elongate shaft is controlled by a length of the second sheath that is slid off of the elongate shaft between the handle and the implant retention area (Sos teaches proximal retraction of the catheter (Paragraph 0101), which is considered to be capable of this limitation because proximal retraction would encompass sliding the sheath off of portions of the shaft). ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
Regarding claim 36, Sutton as modified by Macoviak, Sachar, White, Sos, and Tsugita teaches the deployment system of claim 35, and Sos further teaches wherein the second sheath includes a distal portion (Distal end of 170) and a proximal portion (proximal end of 170) (Paragraph 0087), and wherein the distal portion of the second sheath is configured to be engaged with the elongate shaft when the filter body is in the deployed state (Figure 2D-E; Paragraph 0093) and the combination of Sos and Tsugita teach the proximal portion of the second sheath is fully capable of being configured to be disengaged with the elongate shaft when the filter body is in the deployed state (i.e., if the outer sheath is removed entirely along with catheter 100 (Paragraph 0101)) ("[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.).
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 ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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