DETAILED ACTION
Notice of Pre-AIA or AIA Status
Response to Arguments
Applicant's arguments filed 12/02/2026 have been fully considered but they are not persuasive.
The amendments filed 12/02/2025 have been fully considered.
The nonstatutory double patenting rejection has been withdrawn.
The amendments to claim 10 overcame the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Rejected under 35 U.S.C. 103 as being unpatentable over Kiss (EP 3 184 082 A1) in view of Ashworth et al (2019/0001023).
Applicant has amended claims 1, 10 and 21, “a dry valve made of dry bovine pericardium”. These claims are product claims; any intended method step(s) does not differentiate the final product. Ashworth further teaches the tissue (xenograft) may be dried before or after construction of a valve assembly or before or after construction of a tissue valve (par. 0033).
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.
Claims 1-9, 11-16, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kiss (EP 3 184 082 A1) in view of Ashworth et al (2019/0001023). Evidenced by Zong (11,406,100).
Kiss teaches a self-expandable stent comprising:
PNG
media_image1.png
760
548
media_image1.png
Greyscale
the stent 10 comprising eyelets 16 arranged at the proximal end 1 of the stent to fix the stent at a point of interest, with the point of interest comprising one of a vena cava superior and a vena cava inferior (see figures 4-5 and par. 0002-0003, 0007);
valve 26 comprising biological material or xenograft (see par. 0073) arranged at a proximal end of the stent;
a skirt (cuff 22) surrounding the valve (at least par. 0063) at the proximal end of the stent and made of one of a xenograft and synthetic material (par. 0062);
However, Kiss fails to teach both the xenograft/biological material valve and the xenograft skirt are made of bovine pericardium and that they are dry.
Ashworth teaches it is well known in prosthetic heart valve art to use bovine pericardial tissue for a xenograft; see at least par. 0022. Ashworth further teaches the tissue (xenograft) may be dried before or after construction of a valve assembly or before or after construction of a tissue valve (par. 0033).
It would have been obvious to one having ordinary skill in the art to have used dried bovine pericardium as taught by Ashworth for the xenograft material/biological material for both the valve and the skirt of Kiss to form a calcification-resistant xenograft heart valve. Wherein the dry valve is configured to be rehydrated when placed in contact with a solution; see at least par. 0012, 0047 of Ashworth teaching rehydrating prior to use.
Claim 2, further comprising a distal end 3 and a middle part 2 arranged between the proximal end and the distal end, and the middle part spaced approximately 20 to 40% from the distal end and approximately 20 to 40% from the proximal end. See at least par. 0036 of Kiss teaching ranges that fulfills this language. Also, see par. 0032.
Claim 2, said frame including a plurality of arms (stent struts) forming three interconnected parts 1, 2, 3.
Claim 3, self-expandable stent according to claim 3, wherein, in an expanded state, the plurality of arms (struts) is outwardly directed (longitudinally and/or circumferentially) in a distal end of the frame.
Claim 5, wherein the frame is composed of Nitinol; see par. 0059 of Kiss.
Claim 6, further comprising a device configured to attach the proximal end of the stent at the vena cava or at a transition between the vena cava and a right atrium of a heart; see par. 0038 of Kiss teaching at least sutures.
Claim 7, Kiss and Ashworth et al teach the self-expandable stent, however, fail to disclose the wherein the dry bovine pericardium has a maximum tensile stress selected in the range of 15 to 25 MPa, or the rehydrated bovine pericardium has a tensile stress selected in the range of 15 to 20 MPa. The examiner provides Zhong et al as evidence that rehydrated bovine pericardium has a tensile stress selected in the range of 12.7 +/- 5.8 MPa within the claimed range of 15 to 20 MPa (see 9:56 et seq.). It would have been obvious to one having ordinary skill in the art to have used the bovine pericardium tensile strength of Zong in the combination of Kiss and Ashworth because all function as heart valve leaflets.
Claim 8, claims wherein the dry bovine pericardium has a calcium content selected in the range of 0.01 to 0.1 g/Kg (mg/g). Ashworth et al describes in the abstract a method of preparing calcification-resistant bioprosthetic tissue. Table 2, group 3, shows mean calcium for 0.11+/- 0.01 which is almost within in the claimed range after being implanted for 63 days. It would have been obvious to Ashworth et al that the calcium level should be low/lower, including the claim range, prior to implantation, because calcium results in undesirable stiffening or degradation of the pericardium.
Claim 9, wherein the dry valve comprises between two and six leaflets; see par. 0029 of Kiss.
Claim 11, the stent is configured to be placed in the vena cava superior; see figures 4-5 and par. 0002-0003, 0007).
Claim 12, further comprising a distal end 3 and a middle part 2 arranged between the proximal end 1 and the distal end, and in an expanded state, a maximum outer diameter (D2) of the middle part is larger than a maximum outer diameter (D1) of the proximal end; see figures 1, 4-5 of Kiss.
Claim 13, the stent according to claim 12, wherein a transition between the middle part and the distal end (T2) has an outer diameter that is less than the maximum outer diameter of the middle part 2 and less than an outer diameter (D3b) of the distal end 3 in the expanded state. See figures 1, 4-5 of Kiss.
Claim 14, the self-expandable stent according to claim 11, further comprising a distal end 3 and a middle part 2 arranged between the proximal end 1 and the distal end 3, and the skirt 22 surrounds at least the proximal end and parts of the middle part of the stent as shown in figures 3-5 of Kiss.
Claim 15, the self-expandable stent according to claim 11, further comprising a distal end 3 and a middle part 1 arranged between the proximal end 1 and the distal end, and in an expanded state, the maximum outer diameter of the distal end and a maximum outer diameter of the proximal end are generally the same. See claim 3 of Kiss.
Claim 16, the self-expandable stent according to claim 11, further comprising a frame (interpreted as the same thing as the stent) including a plurality of arms (struts) forming three interconnected parts (proximal section, middle section, distal section), and a distal end 3, and the ends of the arms 14 at the distal end lie in a common plane (what is reasonably shown to one skilled in the art) and comprise eyelets 18.
Claim 21, see figure 4 of Kiss teaching two self-expendable stents configured to be placed in the vena cava superior and a second stent of the two self-expendable stents configured to be placed in the vena cava inferior.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The combination rejection of Kiss in view of Ashworth et al teaches all limitations of claim 1, however, fails to teach wherein the dry bovine pericardium is formed by using a method comprising[[ ]]:soaking of the dry bovine pericardium treated with a crosslinking agent with a saline solution; contacting the soaked bovine pericardium with an aqueous solution comprising Hydrogen Peroxide hydrogen peroxide;contacting the bovine pericardium with an aqueous solution comprising [[PBS]]a phosphate buffered saline and [[EDTA]]ethylenediaminetetraacetic acid;contacting the bovine pericardium with a solution comprising glycerol, ethanol and [[EDTA]] ethylenediaminetetraacetic acid; and contacting the bovine pericardium with a glycerol solution.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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, Melanie Tyson can be reached at 5712729062. 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.
/BRUCE E SNOW/ Primary Examiner, Art Unit 3774