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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. § 102 and 103 rejections of claim(s) 1-15 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claim to recite wherein the portion is “substantially 120 degrees” of the outer circumference of the attachment cuff. In response to Applicant’s amendment Examiner has added reference Gabbay (US Pub No.: 2005/0075727).
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.
Claims 1-4, 6, 8-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) further in view of Gabbay (US Pub No.: 2005/0075727 A1).
Regarding Claim 1, Woo discloses a synthetic blood vessel graft (abstract) and teaches a valve prosthesis assembly (Fig. 4, composite device formed by valve 10 and graft 100; see Col. 3, Lines 24-25) for replacement of a valve and a portion of an artery in a patient (see Col. 1, Lines 33-34 and 59-60, valve prosthesis assembly is configured to be used for Bentall procedure), the valve prosthesis assembly comprising:
a replacement valve (Figs. 1 and 2, artificial heart valve 10) comprising an attachment cuff (Figs. 1 and 2, sewing cuff 20 is included in valve 10), the attachment cuff comprising an outer perimeter (being the outer perimeter of part 20 shown in figures 2 and 4); wherein the other perimeter includes an outer circumference of the replacement valve (the outer perimeter part 20 has an outer circumference as shown in figure 4);
and a graft (Fig. 4, Graft 100) coupled to the attachment cuff of the replacement valve (Fig. 4, Graft 100 is coupled to sewing cuff 20 of valve 10, also see Col. 3, lines 7-13),
wherein the graft extends around a portion of the attachment cuff of the outer perimeter (See Col. 2, Lines 61-62, mounting cuff 120 is part of Graft 100; Fig. 4, mounting cuff 120 extends around sewing cuff 20; also see Col. 3, lines 13-23. As cuff 120 extends around sewing cuff 20),
wherein the portion is at least 120 degrees of the outer circumference of the attachment cuff (the graft in figure 4 is depicted as extending about the entire periphery of the device, a portion of at least 120 degrees is present).
However, Woo does not teach wherein the portion is substantially 120 degrees of the outer circumference of the attachment cuff.
However, Woo in view of Henderson does not teach wherein the portion is 120 degrees of the outer circumference of the cuff.
Instead, Gabbay (US Patent No.: 6,419,695) teaches wherein the portion is 120 degrees of the outer circumference of the cuff (in figures 1-2 with the portion being part 20 that is wrapped about cuff part 12 in column 3 lines 27-36).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Gabbay into the device of Woo, since these are result effective variables that contribute to operation of the device of Woo it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and the modification as suggested would allow a buttress that provides a surface “with which a leaflet of the heart valve may move into and out of engagement for helping control blood flow relative to the apparatus and heart valve” as per the abstract of Gabbay, where the arrangement of the buttress is designed to interface with a leaflet as per column 5 lines 13-33. MPEP 2144.05.
Examiner also notes that, as a tricuspid valve is disclosed in column 9 lines 14-21, it stands to reason that each leaflet occupies 1/3 or 120 degrees of the valve device. With the buttresses matching up to the leaflet in column 5 lines 13-33, it stands to reason that part 20 can be configured to extend to 120 degrees in a tricuspid valve.
Regarding Claim 2, Woo in view of Gabbay teaches a valve prosthesis assembly
wherein Woo teaches the replacement valve comprises one of a mechanical valve or a tissue valve (Figs. 1 and 2, shows valve 10 as a tissue valve; also see Col. 5, lines 33-36).
Regarding Claim 3, Woo in view of Gabbay teaches a valve prosthesis assembly
wherein Woo teaches a size of the graft comprises a dimension corresponding to the portion of the outer perimeter of the attachment cuff along which the graft is coupled to the replacement valve (Fig. 4 size of graft 100 along mounting cuff 120 is similar to size of sewing cuff 20; also see Col. 3, Lines 15-18. The size of the graft 100 corresponds to the size of the sewing cuff 20 which includes the outer perimeter of said cuff).
Regarding Claim 4, Woo in view of Gabbay teaches a valve prosthesis assembly
wherein Woo teaches the graft is sewn to the replacement valve (Fig. 4, valve 10 and graft 100 can be sutured together in this configuration; also see Col. 3, lines 24-27).
Regarding Claim 6, Woo in view of Gabbay teaches a valve prosthesis assembly
wherein Woo teaches the replacement valve (Modified Fig. 1 and 2, and Modified Fig. 4, valve 10) comprises
a bottom surface and a top surface (Modified Figs. 1 and 2, bottom surface and top surface of valve 10),
and a main portion of the graft (Modified Fig. 4, hollow tube 110 of graft 100) is adjacent the top surface of the replacement valve (Modified Fig. 4, graft 100 is adjacent to top surface of valve 10; also see Col. 3, Lines 7-10).
Regarding Claim 8, Woo in view of Gabbay teaches a valve prosthesis assembly
wherein Woo teaches the replacement valve comprises a plurality of posts (Modified Figs. 1 and 2, valve 10 has commissure posts) annularly extending from the attachment cuff (Modified Figs. 1 and 2, the commissure posts extend from the valve 10 in the direction from the cuff 20, which has a scalloped shape that is adjacent to the commissure posts; also see Col. 2, Lines 53-59).
Regarding Claim 9, Woo teaches a method of replacing a valve and a portion of an artery in a patient (see Col. 1, Lines 33-34 and 59-60, graft is configured for use with valve to perform Bentall procedure), the method comprising:
providing a valve prosthesis assembly (Fig. 4, composite device formed by valve 10 and graft 100) comprising:
a replacement valve (Figs. 1 and 2, artificial heart valve 10) comprising an attachment cuff (Figs. 1 and 2, sewing cuff 20 is included in valve 10);
and a graft (Fig. 4, Graft 100) coupled to the attachment cuff of the replacement valve (Fig. 4, Graft 100 is coupled to sewing cuff 20 of valve 10 at, also see Col. 3, lines 7-13), the attachment cuff comprising an outer perimeter (being the outer perimeter of part 20 shown in figures 2 and 4); wherein the other perimeter includes an outer circumference of the replacement valve (the outer perimeter part 20 has an outer circumference as shown in figure 4)
wherein the graft extends around a portion of the outer perimeter of the attachment cuff (See Col. 2, Lines 61-62, mounting cuff 120 is part of Graft 100; Fig. 4, mounting cuff 120 extends around sewing cuff 20; also see Col. 3, lines 13-23);
and suturing the valve prosthesis assembly into the patient (See Col. 2, lines 47-50), and
wherein the portion is at least 120 degrees of the outer circumference of the attachment cuff (the graft in figure 4 is depicted as extending about the entire periphery of the device, a portion of at least 120 degrees is present).
However, Woo does not teach wherein the portion is less than an entirety of the outer circumference of the attachment cuff.
Instead, Gabbay (US Patent No.: 6,419,695) teaches wherein the portion is 120 degrees of the outer circumference of the cuff (in figures 1-2 with the portion being part 20 that is wrapped about cuff part 12 in column 3 lines 27-36).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Gabbay into the device of Woo, since these are result effective variables that contribute to operation of the device of Woo it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and the modification as suggested would allow a buttress that provides a surface “with which a leaflet of the heart valve may move into and out of engagement for helping control blood flow relative to the apparatus and heart valve” as per the abstract of Gabbay, where the arrangement of the buttress is designed to interface with a leaflet as per column 5 lines 13-33. MPEP 2144.05.
Examiner also notes that, as a tricuspid valve is disclosed in column 9 lines 14-21, it stands to reason that each leaflet occupies 1/3 or 120 degrees of the valve device. With the buttresses matching up to the leaflet in column 5 lines 13-33, it stands to reason that part 20 can be configured to extend to 120 degrees in a tricuspid valve.
Regarding Claim 10, Woo in view of Gabbay teaches a method
wherein Woo teaches the replacement valve comprises one of a mechanical valve or a tissue valve (Figs. 1 and 2, shows valve 10 as a tissue valve; also see Col. 5, lines 33-36).
Regarding Claim 11, Woo in view of Gabbay teaches a method
wherein Woo teaches the graft is sewn to the replacement valve (Fig. 4, valve 10 and graft 100 can be sutured together in this configuration; also see Col. 3, lines 24-27).
Regarding Claim 13, Woo in view of Gabbay teaches a method
wherein Woo teaches the replacement valve (Modified Figs. 1 and 2, and Modified Fig. 4, valve 10) comprises
a bottom surface and a top surface (Modified Figs. 1 and 2, bottom surface and top surface of valve 10),
and a main portion of the graft (Modified Fig. 4, hollow tube 110 of graft 100) is adjacent the top surface of the replacement valve (Modified Fig. 4, graft 100 is adjacent to top surface of valve 10; also see Col. 3, Lines 7-10).
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Gabbay (US Patent No.: 6,419,695) as applied to claims 1 and 9 above, and further in view of Leonhardt (US5957949A) and Murad (US20190046317A1).
Regarding Claim 5, Woo in view of Gabbay teaches a graft coupled to the replacement valve (Fig. 4, composite device formed by valve 10 and graft 100), but does not teach that the coupling is done by an adhesive.
Leonhardt discloses an artificial valve that includes a tubular graft (abstract) and further teaches
a graft (Fig. 1, graft material 24) is coupled to a replacement valve (Fig. 1, valve 22) by a biocompatible adhesive (Fig. 1, graft material 24 is coupled to valve 22 by sutures or a biocompatible adhesive; also see Col. 6, Lines 25-28). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the graft and replacement valve as taught by Woo using a biocompatible adhesive as taught by Leonhardt in order to improve seal between the graft and valve by filling microcracks to prevent microleaks as taught by Leonhardt (see Col. 8, Lines 52-54 and 62-64). Additionally, Murad teaches that sutures could introduce leaks and that using an adhesive with sutures would improve the seal when attaching a graft (Figs. 39A and 40, conduit graft 452) to an attachment cuff (Figs. 39A and 40, sewing ring 456, also see [0142]). Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have been further motivated to make the above modification in order to prevent potential leaks caused by sewing as taught by Murad (see [0142]).
Regarding Claim 12, Woo in view of Gabbay teaches a graft coupled to the replacement valve (Woo, Fig. 4, composite device formed by valve 10 and graft 100), but does not teach that the coupling is done by an adhesive.
Leonhardt further teaches
a graft (Fig. 1, graft material 24) is coupled to a replacement valve (Fig. 1, valve 22) by a biocompatible adhesive (Fig. 1, graft material 24 is coupled to valve 22 by sutures or a biocompatible adhesive; also see Col. 6, Lines 25-28).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the graft and replacement valve as taught by Woo using a biocompatible adhesive as taught by Leonhardt in order to improve seal between the graft and valve by filling microcracks to prevent microleaks as taught by Leonhardt (see Col. 8, Lines 52-54 and 62-64). Additionally, Murad teaches that sutures could introduce leaks and that using an adhesive with sutures would improve the seal when attaching a graft (Figs. 39A and 40, conduit graft 452) to an attachment cuff (Figs. 39A and 40, sewing ring 456, also see [0142]). Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention would have been further motivated to make the above modification in order to prevent potential leaks caused by sewing as taught by Murad (see [0142]).
Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Gabbay (US Patent No.: 6,419,695) as applied to claims 1,6, 9 and 13 above, and further in view of Campbell (US9301835B2).
Regarding Claim 7, Woo in view of Gabbay teaches a portion of the graft is adjacent to the replacement valve (Modified Fig. 4, graft 100 is adjacent to top surface of valve 10).
Woo does not teach that the graft is adjacent the bottom surface of the valve, however, Campbell discloses a valved conduit including a bioprosthetic valve (abstract) and further teaches
a further portion of the graft (Modified Figs. 2A and 2B, conduit 50 has a further portion in the form of conduit segment 54) is adjacent the bottom surface of the replacement valve (Modified Figs. 2A and 2B, conduit segment 54 is coupled to bottom surface of valve 52; see Col. 8, Lines 39-41).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a further portion of a graft as taught by Campbell to the valve prosthesis assembly as taught by Woo in order to provide trimmable graft on either side of the valve that can be trimmed for use in different parts of the body (see Col 8, Lines 43-49 and 60-61).
Regarding Claim 14, Woo in view of Gabbay teaches a portion of the graft is adjacent to the replacement valve (Modified Fig. 4, graft 100 is adjacent to top surface of valve 10).
Woo does not teach that the graft is adjacent the bottom surface of the valve, however, Campbell further teaches
a further portion of the graft (Modified Figs. 2A and 2B, conduit 50 has a further portion in the form of conduit segment 54) is adjacent the bottom surface of the replacement valve (Modified Figs. 2A and 2B, conduit segment 54 is coupled to bottom surface of valve 52; see Col. 8, Lines 39-41).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a further portion of a graft as taught by Campbell to the valve prosthesis assembly as taught by Woo in order to provide trimmable graft on either side of the valve that can be trimmed for use in different parts of the body (see Col 8, Lines 43-49 and 60-61).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eidenschink (US Pub No.: 2007/0055351) discloses a stent assembly with arcuate length details in [0060]. Ginn (US Pub No.: 2017/0014232) discloses a stent device in the abstract with wherein the “distal portion may be selected to have a length approximately equivalent to the arcuate length of the subject aortic arch” in [0053].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774