DETAILED ACTION
Notice of AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Priority
This application claims priority from provisional application 60/684,443. However, the provisional does not provide support for the elected embodiment of the specific positioning, advancing, and expelling steps/configurations. The earliest support is found in application 11/441406, which was filed on 05/24/2006.
Status of Claims
Claims 1-3, 6-13, 15, and 17-24 are pending.
Claims 7-8 and 17-19 have been withdrawn from consideration.
Claims 4, 5, 14, and 16 have been cancelled.
Election/Restrictions
Applicant elected Species 16 (Figures 18-19) without traverse on 04/22/2025.
Drawings
The objections to the drawings has been withdrawn in view of the applicant’s amendments.
Information Disclosure Statement
The Information Disclosure Statement filed on 12/24/2025 has been considered by the examiner, but is objected to in view of the large number of references (over 41 pages) and later stage of the filing (after several office actions).
It appears that many of the cited references are relevant to the patentability of the claims. For example cited references:
WO2024/009540 is directed at a data processing system
WO2023244454 is directed at a stabilizing system
WO0135878 is directed at a warming device for hands and arms
DE2246526 is directed at a trach tube
3472230 is directed at an umbrella catheter not usable with a heart valve
5591185 is directed at a corneal implant
Other references are treating sinuses, are valves without support structures, or are stents do not even include heart valves.
The applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 6, 9, and 10is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garrison et al (Garrison) USPN 6,425,916 B1 in view of Gabbay US 2002/0032481 A1.
1. Garrison discloses the invention substantially as claimed being a method of implanting a prosthetic heart valve in a native heart valve annulus of a patient (Figure 6), the method comprising:
providing a prosthetic heart valve (6 Figure 9) having an outer anchoring member 8 and an inner valve member 6 coupled thereto (Figure 9), the outer anchoring member having a collapsible tubular structure (Figures 7-8) covered with a sleeve of fabric (17 Figure 8) and the inner valve member 6 including commissural posts (32 Figure 10) supporting flexible one-way leaflets adapted to permit blood flow only in an outflow direction (38 Figure 10 5:42-60), wherein the anchoring member is configured to be constricted to a contracted state and enlarged to an expanded state sized to contact the heart valve annulus (Figures 3-4);
positioning the anchoring member and the valve member within a delivery tube (sheath 10 of catheter 4) with the anchoring member in the contracted state (4:15-22);
advancing the delivery tube to a position within the heart valve annulus (Figure 3); and
expelling the anchoring member from within the delivery tube and allowing the anchoring member to expand to the expanded state in which the anchoring member contacts the heart valve annulus (sheath is withdrawn to allow the nitinol anchor member to expand 4:20-22 5:4-6);
wherein, after deployment, the anchoring member in the expanded state engages the heart valve annulus for securing the prosthetic heart valve in the patient's heart and the valve member is secured within the anchoring member for permitting blood to flow through the frame in the outflow direction (Figure 6).
wherein the anchoring member has a flared inflow end portion (extending from the middle of the member to the tip 18 Figures 9-10) defining an inflow terminal end of the anchoring member (also extending from the middle of the member to the tip 18 Figures 9-10) and an outflow end portion (extending from the middle of the member to the tip 16 Figures 9-10) defining an outflow terminal end of the anchoring member (also extending from the middle of the member to the tip 16 Figures 9-10), wherein when the anchoring member is in the expanded state
Garrison discloses an anchoring member with flared inflow and outflow ends as see in Figure 9. Garrison even shows the implantation of the device in an area with the inflow end positioned in an area showing a taper to an greater diameter than the inflow end (Figure 6). However, Garrison does not disclose an elongated frame at the inflow end with a diameter that is larger than a diameter of the outflow end..
Gabbay teaches the use of a heart valve with an outer stent comprising elongated tapered inflow and outflow ends, wherein when expanded both expand to match the diameter of the implant site (Figure 2 shows the additional rows of struts at each end above and below the valve, Figures 4 and 11 show how the flared ends expand to the maximum allowed by the implant site) in the same field of endeavor for the purpose of providing additional surface area for anchoring and ingrowth as well as expanding to match the shape of the implant site.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inflow end of Garrison to have a longer more flared inflow end as taught by Gabbay in order to better match the shape of implant site and provide increased surface contact for attaching to the implant site.
(As previously explained in the advisory action mailed on 11/20/2025, the diameters of the end portions and terminal ends are still open to broad interpretation because they these portions of the prior art have a variety of diameters, the claims fail to require the diameters as being at the terminal most end, the distal most end, proximal most end, or even be the largest diameter of the end portions. Furthermore, both the inflow and outflow ends are identified by the claims as portions of the anchor member that define the terminal ends, therefore any section or piece can be identified as part of or not part of the “portion”, this would allow for only including some of the peaks of the inflow end thereby reducing the diameter. Finally, the claims are comparing the diameters after expansion within the heart valve annulus and these expanded diameters depend upon the precise location and condition of the implant site. For example if the valve as inserted in Figure 6 of Garrison is inserted into a patient with deteriorated or removed native leaflets or slightly lower than depicted, then the lower end would be able to expand more than the upper end because of the natural wider shape of the implant site near the inflow end. In view of all of these factors the inflow end portion of Garrison has a largest diameter at its lowest widest most terminal tip, as extended by the teaching of Gabbay, when placed into a heart valve as depicted in Figure 6 which will expand to a diameter greater than a diameter of a smaller outflow portion not including the widest end, defining the terminal end being the region close but not the terminal most end).
3. Garrison discloses the valve member is compressible in diameter (Figures 3-4), and the method includes allowing the valve member to expand when expelled from within the delivery tube (sheath keeps the valve in the compressed position until it is withdrawn expelling the valve and allowing it to expand as shown in Figure 4 4:19-22).
6. Garrison discloses the valve member is coupled within the anchoring member (Figure 9) so that an annular space is formed between the valve member and an inner wall of the collapsible tubular structure in the expanded state (Garrison discloses the same type of annular space as the applicant’s invention because they both include radially inward bowing leaflets that define the space).
9. Garrison discloses the anchoring member is expanded to the expanded state and into contact with the heart valve annulus prior to coupling the valve member thereto (Figure 4).
10. Garrison discloses the delivery tube has an outwardly bulged portion (46/50), and the method includes dilating the heart valve annulus with the outwardly bulged portion prior to expelling the anchoring member from within the delivery tube (Figure 3 shows the balloon dilates the closed natural valve annulus even before it is expanded).
Claim 2 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garrison and Gabbay as applied to claims 1, 3, 6, 9 and 10 above, and further in view of Schulte USPN 3,445,916.
Garrison discloses the invention substantially as claimed comprising an inner valve frame which can be formed from a variety of materials such as self-expanding and flexible materials. However, Garrison does not disclose the use of a non-expandable and non-collapsible frame material that is inserted directly with direct vision of the annulus.
The use of non-expandable and non-collapsible heart valves is old and extremely well known and the insertion method taking a direct path with direct vision of the annulus is the original/earliest way used by surgeons to insert the valves. The expandable materials and less invasive approach are both moder approaches because the materials and insertion tools were not available to the early surgeons. Schulte discloses a non-expandable and non-collapsible heart valve dating back to the 1960s. The only way to insert it is using a direct path with direct vision of the annulus because it cannot be contracted to be within a minimally invasive delivery device.
It would have been obvious to one of ordinary skill in the art to replace the inner valve of Garrison with the non-expandable and non-collapsible valve of Schulte and insert it directly into the patient with a direct line of site on the implant site in order to eliminate the risk of the heart valve frame collapsing or compressing after insertion and to eliminate the need for healthy surrounding vasculature to pass through and provide the operator with direct hands on and eyes on the implant site.
Allowable Subject Matter
Claims 11-13, 15, and 20-24 are allowed.
The prior art of record fails to disclose or render obvious the method of implanting a prosthetic heart valve in a native heart valve annulus wherein the heart valve comprises the expandable outer anchoring member and an inner one-way valve member with leaflets, wherein the valve is secured within the anchor with a plurality of radially inward extending connectors such that the inflow end portion including a terminal end is radially spaced inward from and does not contact an inner wall of the tubular body of the anchor, thereby defining an annular space between the valve
It is noted that withdrawn claims 17-19 do not appear to be consistent with the scope of independent claim which they depend upon. They are not ready for rejoinder and it is recommended they are cancelled to place the application in better condition for allowance.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
The applicant argues that the prior art does not disclose the diameter of the inflow terminal end is larger than the diameter of the outflow terminal end. As explained above the claims are still broad when referencing the diameters and fail to limit them to what the applicant actually intends. For example the claims define end portions that define the terminal ends. The outflow portion can be interpreted to be positioned short of the extreme ends and not include all of the end structures. Additionally the claims do not require the diameter to be the terminal most end, the proximal/distal most end, or the largest diameter. Therefore the diameter of the outflow end can be offset from the extreme terminal end and identified without only some of the flared sections making it smaller. Additionally the modification in view of Gabby has elongated the inflow end which expands to the larger shape of the implant site. Noting these factors one could identify a diameter of the inflow terminal end that is larger than a diameter of the outflow terminal end.
The applicant is advised to amend the claims to identify the terminal most ends and the largest diameter of them.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/ Primary Examiner, Art Unit 3774