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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/19/2025 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 10, 22-24, 26 is/are amended and claim(s) 21 and 25 is/are canceled. Claims 27-33 are added. Claims 1-4, 6-10, 20. 22-24, and 26-33 are now pending examination.
Response to Arguments
Applicant’s arguments, filed, with respect to the rejection of claims 1 under Macoviak in view of Sachar have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because the newly added limitations of “an elongate shaft having an implant retention area; a prosthetic heart valve configured to be retained at the implant retention area” overcome the previous rejection as written. It is noted that a new rejection has been made over Sutton in view of Macoviak et al. in view of Sachar et al.
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, 26-27 and 29 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).
Regarding claims 1-3, 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) (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 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..
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.
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 and Sachar 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 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.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutton as modified by Macoviak and Sachar and further in view of White (US 20110066224 A1).
Regarding claim 28, Sutton as modified by Macoviak and Sachar teaches the deployment system of claim 1, but fails to explicitly disclose wherein the prosthetic heart valve includes a frame supporting a plurality of prosthetic valve leaflets.
However, 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.
Claim(s) 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutton in view of Macoviak and Sachar and further in view of Sos (US 20160367285 A1).
Regarding claim 30-31, Sutton as modified by Macoviak and Sachar teaches the deployment system of claim 1, further comprising a sheath configured to extend over the filter body to retain the filter body in an undeployed state; wherein the sheath is configured to be retracted to allow the filter body to move to the deployed state.
However, Sos is directed to a deployment system and teaches a sheath (140) configured to extend over the filter body (110) to retain the filter body in an undeployed state (Figure 11; Paragraph 0086); wherein the sheath is configured to be retracted to allow the filter body to move to the deployed state (Paragraph 0086).
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 to include a sheath configured to extend over the filter body to retain the filter body in an undeployed state; wherein the sheath is configured to be retracted to allow the filter body to move to the deployed state, as taught by Sos, as both references and the claimed invention are directed to filter delivery 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 and Sachar with the teachings of Sos by incorporating a sheath configured to extend over the filter body to retain the filter body in an undeployed state; wherein the sheath is configured to be retracted to allow the filter body to move to the deployed state in order to prevent premature expansion of the filter.
Regarding claim 32, Sutton as modified by Macoviak, Sachar and Sos teaches the deployment system of claim 30, but fails to specifically disclose 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.
Sos further teaches wherein the sheath is a first sheath (140) (Figure 11; Paragraph 0086), and further comprising a second sheath (170) coupled to the filter body (the filter body is within outer sheath 170, thus the two are coupled) and is fully capable of being configured to slide along the elongate shaft to vary a position of the filter body 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 and Sachar a 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).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutton in view of Macoviak, Sachar and Sos, as applied to claim 32 above, and further in view of Tsugita et al. (US 20020095174 A1).
Regarding claim 33, Sutton as modified by Macoviak, Sachar, and Sos teaches the deployment system of claim 32, but fails to explicitly disclose 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.
However, 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.
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 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, 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).
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DARWIN EREZO can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771