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
Claims filed on February 27th, 2026 have been entered. Claims 1- 20 are pending in the application. Claims 9- 20 remain withdrawn for being drawn to an unelected invention or species.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1-8 under 35 U.S.C. 103 over Spenser (US 2013/0226223) in view of Salahieh et al. (US 2005/0137697) has been withdrawn in light of applicant’s amendments; specifically Spenser does not teach a cinch element adapted to shift between an open configuration in which the mouth is open and a closed configuration in which the mouth is closed by the cinch element.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spenser (US 2013/0226223) in view of Salahieh et al. (US 2005/0137697) and in view of Bergheim (US 2005/0119688).
Regarding claims 1 and 6, Spenser teaches a replacement heart valve system (abstract)(Figs. 19- 22) comprising: a replacement heart valve implant (190), and a filter element (184) configured to be deployed downstream of the expandable framework, the filter element having a closed downstream end and the filter element including an open mouth at an upstream end, wherein the open mouth is spaced apart from the heart valve implant (see annotated Fig. 22 below)(Paragraph 0060).
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Spenser does not teach the replacement heart valve implant comprising an expandable framework and a plurality of valve leaflets disposed within the expandable framework or wherein the filter element is secured to the expandable framework.
Salahieh (Salahieh et al.) teaches a similar replacement heart valve system (100’)(Figs. 6A- 6F) comprising a replacement heart valve implant (replacement valve 20, anchor 30) comprising an expandable framework (anchor 30)(Paragraphs 0035 and 0065), and a plurality of valve leaflets (replacement valve 20) disposed within the expandable framework (Paragraph 0035), and a filter element (filter structure 61A) secured to the expandable framework (Paragraphs 0067 and 0069).
It would have been obvious to one of ordinary skill in the art to modify the replacement heart valve implant as taught by Spenser to be the replacement heart valve implant as taught by Salahieh for the purpose of providing a replacement heart valve (Spenser, Paragraphs 0006 and 0060; Salahieh, abstract and Paragraph 0064). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one replacement heart valve implant for another because both implants are disclosed as equivalent structures for providing a heart valve within a patient (Spenser, Paragraphs 0006 and 0060; Salahieh, abstract and Paragraph 0064). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one known method for another known method taught and suggested by Salahieh for attaching/fastening the filter element to the replacement heart valve implant in the device of Spenser since the results of the substitution would have been predictable and resulted in the device operating as intended, such that the filter element captures embolic material downstream from the heart valve implant (Spenser, Paragraphs 0008, 0009, and 0060; Salahieh, Paragraph 0067). Therefore, the simple substitution of one known element for another producing a predictable result renders the claim obvious. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Spenser and Salahieh do not teach a cinch element adapted to shift between an open configuration in which the mouth is open and a closed configuration in which the mouth is closed by the cinch element.
Bergheim teaches a device (distal embolic protection assembly 30)(Figs. 4A- 4B) comprising a filter element (filter assembly 42) for use within the vasculature for capturing embolic material (abstract, Paragraph 0060) comprising an open mouth (open proximal end 46) at an upstream end and a closed downstream end (see annotated Fig. 4A below)(Paragraph 0046) and a cinch element (actuation member 36) adapted to shift between an open configuration in which the mouth is open and a closed configuration in which the mouth is closed by the cinch element (Paragraphs 0061- 0062).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by the combination to have a cinch element as taught by Bergheim, since Bergheim teaches that this element aids in capturing embolic material within the filter and keeps embolic material within the filter while it is being removed (Paragraphs 0060- 0062).
Regarding claim 2, Spenser, Salahieh, and Bergheim make obvious the replacement heart valve system, including the filter element secured to the expandable framework, as discussed above.
Spenser further teaches wherein the filter element is configured to be deployed before the replacement heart valve implant (Paragraph 0060)(see Figs. 19- 22).
Regarding claim 3 and claim 5, Spenser, Salahieh, and Bergheim make obvious the replacement heart valve system, including the filter element secured to the expandable framework, as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute one known method for another known method taught and suggested by Salahieh for attaching/fastening the filter element to the replacement heart valve implant in the device of Spenser since the results of the substitution would have been predictable and resulted in the device operating as intended, such that the filter element captures embolic material downstream from the heart valve implant (Spenser, Paragraphs 0008, 0009, and 0060; Salahieh, Paragraph 0067). Therefore, the simple substitution of one known element for another producing a predictable result renders the claim obvious. KSR, 550 U.S. at, 82 USPQ2d at 1396.
The combination further teaches wherein the filter element is detachable from the expandable framework in situ (Salahieh, Paragraphs 0067 and 069) and wherein the filter element is retrievable downstream from the replacement heart valve implant while leaving the replacement heart valve implant in place (Salahieh, Paragraph 0069 and see Figs. 6D, 6F).
Regarding claim 4, Spenser, Salahieh, and Bergheim make obvious the replacement heart valve system, including the filter element secured to the expandable framework, as discussed above.
The combination does not teach wherein the filter element is retrievable upstream through the replacement heart valve implant while leaving the replacement heart valve implant in place.
However, it has been held that choosing any solution from a finite number of solutions to obtain a predictable result is well within the purview of ordinary skill in the art. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S., 82 USPQ2d 1385 (2007). It can be seen that there are only a finite number of retrieval options in relation to the heart valve, that of retrieving the filter element upstream and through the heart valve or retrieving the filter element downstream from the heart valve. Therefore, it would have been obvious to one of ordinary skill in the art to modify the filter element to be retrievable upstream through the replacement heart valve implant would have yielded, with a reasonable expectation of success, a retrievable filter element. Therefore, it would have been obvious to try retrieving the filter element upstream through the heart valve implant. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rationale E, outlined in MPEP 2143.
Regarding claim 7, Spenser, Salahieh, and Bergheim make obvious the replacement heart valve system, including the filter element secured to the expandable framework, as discussed above.
Spenser further teaches wherein the filter element is configured to capture particulates while permitting blood to pass through the filter element (Paragraph 0060).
Regarding claim 8, Spenser, Salahieh, and Bergheim make obvious the replacement heart valve system, including the filter element secured to the expandable framework, as discussed above.
Spenser further teaches the system further comprising a delivery sheath (filter delivery catheter 182) configured to transport the replacement heart valve implant and the filter element to a position upstream of a native heart valve (Paragraph 0060).
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 1-8 have been considered but are moot since, as discussed above, the previous prior art rejection was withdrawn in view of applicant’s amendments. However, it is noted the Spenser and Salahieh are still relied upon for limitations not argued.
Applicant’s arguments, see Page 7, regarding that Spenser does not teach wherein the filter structure has an open mouth at an upstream end has been fully considered but is not convincing. As discussed above, Spenser teaches an open mouth at an upstream end (see annotated Fig. 22 below), and as Spenser teaches that the filter is capable of capturing embolic debris, it would have an open mouth at an upstream end (Paragraph 0060).
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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.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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