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 .
Priority
This application claims priority from provisional application 61/941,123, filed 02/18/2014.
Status of Claims
Claims 1-6, 8-14, and 16-20 are pending.
Claims 11 and 14 have been withdrawn from consideration.
It is noted that withdrawn claims will need amendments to place them in condition for rejoinder. Claim 11 includes a 6th row which is not disclosed as part of the original disclosure and claim 14 has drawing and 112 issues.
Election/Restrictions
Applicant elected Species 1 (Figures 1-5) on 06/27/2025 without traverse.
Drawings
In response to the applicant’s amendments the previous objections to the drawings have been withdrawn.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the no row of angled struts between the first row of angled struts and the second row of angled struts (claims 1, 17, and 19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
In response to the applicant’s amendments the previous objection to the specification have been withdrawn.
Claim Objection
Claim 1 is objected to because the amendments to lines 11-12 were not properly indicated as new limitations with underlining. It appears all other recitations were underlined, but confirmation from the applicant is required.
Information Disclosure Statement
The information disclosure statement filed on 02/23/2026 has been considered. Applicant should note that the large number of references (over 18 pages) in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b).
Additionally many of the cited references are relevant to the patentability of the claims. For example cited reference 4,574,803 is directed at a tissue cutter and a plethora of the references are directed at stents without valve or a valve without frames comprising struts. 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-6, 8-10, 12, 13, and 16-20 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 17, and 19 are considered to include new matter because of the recitation “there is no row of angled struts between the first row of angled struts and the second row of angled struts”. It appears the applicant means that there are no zigzag type rows between the first and second rows. However the broadest reasonable interpretation of this clause would include the row of axial frame members. The axial frame members are a row of struts angled at 90 degrees. The applicant is advised to amend the claims to better define this limitation such that it does not include the types of struts in the axial frame member row.
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 1-6, 8-10, 12, 13, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Levi et al (Levi) US 2012/0123529 A1 (This publication has common inventors and assignment with the current application but was published more than a year before the earliest priority date of the current application) in view of Kheradvar et al (Kheradvar) US 2008/0195199 A1.
1. Levi discloses an implantable prosthetic valve (10 Figures 1-5), comprising:
an annular frame 12 comprising: an inflow end (near V Figure 5); an outflow end (near I Figure 5);
a first row of angled struts (V) defining the outflow end (Figure 5);
a second row of angled struts (IV) upstream of the first row of angled struts (Figure 5) and there is no row of angled struts between the first row of angled struts and the second row of angled struts (in view of 112 rejection above Levi reads upon this limitation as much as the applicant’s current application);
a third row of angled struts (III) immediately upstream of the second row of angled struts (Figure 5);
a fourth row of angled struts (II) upstream of the third row of angled struts;
a plurality of axial frame members (30/31) having respective first ends and second ends, the first ends being linked by the first row of angled struts and the second ends being linked by the second row of angled struts (Figure 5); and
a leaflet structure 14/40 positioned within the annular frame (Figure 2) and configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end (this is an inherent property of all prosthetic heart valves),
an inner skirt (16) disposed inside the frame (Figures 1-3), wherein an upper edge portion of the inner skirt is attached to the second row of angled struts (Figures 1-3) and a lower edge portion of the inner skirt is located at the inflow end of the frame (Figures 1-3); and
an outer skirt (18) disposed outside the frame, wherein an upper edge portion of the outer skirt is attached to the fourth row of angled struts (Figures 1-3) and a lower edge portion of the outer skirt is located at the inflow end of the frame (Figures 1-3),
wherein an outflow end of the leaflet structure is positioned downstream of the upper edge portion of the inner skirt and the upper edge portion of the outer skirt (Figure 1),
wherein the second row of angled struts and the third row of angled struts define a row of second cells of the frame (diamond shaped openings between IV and III Figure 5),
wherein the third row of angled struts and the fourth row of angled struts define a row of third cells of the frame (diamond shaped openings between III and II Figure 5).
However, Levi discloses 3 axial struts between each of the three axial leaflet attachment members.
Kheradvar teaches the use of an expandable heart valve comprising frame comprising a plurality of rows of angled struts wherein there are exactly six axial frame members (vertical struts) including three axially extending leaflet attachment members and three axial struts (Figure 1) in the same field of endeavor for the purpose of providing a more open flexible frame that allows for more ingrowth and applies less force to 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 stent frame of Levi remove the two axial frame members on each side of the leaflet attachment members as taught by Kheradvar in order to provide a more open frame with increased flexibility that allows for more ingrowth and applies less force to the implant site.
In view of the modification, the frame now includes exactly four angled struts in the second row of angled struts connecting each two adjacent second ends of the plurality of axial frame members (removing the 2 struts results Figure 5 being identical to Figure 5 of the current application), wherein the first row of angled struts, the second row of angled struts, and the plurality of axial frame members define a row of first cells of the frame (removing the 2 struts results Figure 5 being identical to Figure 5 of the current application), and wherein the first cells are wider than the second cells in a circumferential direction (removing the 2 struts results Figure 5 being identical to Figure 5 of the current application).
2. and 3. Levi as modified by Kheradvar discloses there are exactly six axial frame members (see obviousness rejection of claim 1 above), wherein the six axial frame members comprises three axially extending leaflet attachment members and three axial struts (see obviousness rejection of claim 1 above), wherein the three leaflet attachment members are connected to respective commissures of the leaflet structure (Figures 1-3), wherein each leaflet attachment member is located between two axial struts and each axial strut is located between two leaflet attachment members (see obviousness rejection of claim 1 above).
4. Levi as modified by Kheradvar discloses the first row of angled struts is the only row of angled struts extending in the circumferential direction and linking the first ends of the plurality of axial frame members (Figure 5), wherein the second row of angled struts is the only row of angled struts extending in the circumferential direction and linking the second ends of the plurality of axial frame members (Figure 5).
5. Levi as modified by Kheradvar discloses each first cell is twice as wide as each second cell in the circumferential direction (removing the 2 struts results Figure 5 being identical to Figure 5 of the current application).
6. Levi as modified by Kheradvar discloses each second cell is four-sided, formed by two angled struts of the second row of angled struts and two angled struts of the third row of angled struts (removing the 2 struts results Figure 5 being identical to Figure 5 of the current application).
8. Levi as modified by Kheradvar discloses the second cells and the third cells have the same width in the circumferential direction (Figure 5).
9. Levi as modified by Kheradvar discloses each third cell is four-sided, formed by two angled struts of the third row of angled struts and two angled struts of the fourth row of angled struts (diamond shaped openings in Figure 5).
10. Levi as modified by Kheradvar discloses the annular frame further comprises one or more rows of angled struts upstream of the fourth row of angled struts (I Figure 5).
12. Levi as modified by Kheradvar discloses the first ends of the axial frame members converge with lower ends of adjacent angled struts of the first row of angled struts, wherein the second ends of the axial frame members converge with upper ends of adjacent angled struts of the second row of angled struts (Figure 5 shows the straight vertical struts connect valleys of the first row to peaks of the second row).
13. Levi as modified by Kheradvar discloses the first ends of the axial frame members are upstream of the outflow end (Shown in Figure 5).
16. Levi as modified by Kheradvar discloses the outer skirt has a substantially straight lower edge (bottom of Figure 1).
17. Levi as modified above by Kheradvar discloses an implantable prosthetic valve (10 Figures 1-5), comprising:
an annular frame 12 comprising: an inflow end (near V Figure 5); an outflow end (near I Figure 5);
a first row of angled struts (V) defining the outflow end (Figure 5);
a second row of angled struts (IV) upstream of the first row of angled struts (Figure 5) and there is no row of angled struts between the first row of angled struts and the second row of angled struts (in view of 112 rejection above Levi reads upon this limitation as much as the applicant’s current application);
a third row of angled struts (III) immediately upstream of the second row of angled struts (Figure 5);
a fourth row of angled struts (II) immediately upstream of the third row of angled struts;
a plurality of axial frame members (30/31) having respective first ends and second ends, the first ends being linked by the first row of angled struts and the second ends being linked by the second row of angled struts (Figure 5);
a leaflet structure 14/40 positioned within the annular frame (Figure 2) and configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end (this is an inherent property of all prosthetic heart valves),
an outer skirt (18) disposed outside the frame, wherein an upper edge portion of the outer skirt is attached to the fourth row of angled struts (Figures 1-3),
wherein the first row of angled struts, the second row of angled struts, and the plurality of axial frame members define a row of first cells of the frame (removing the 2 struts results in the cells of Figure 5 being identical to those of Figure 5 of the current application), wherein the second row of angled struts and the third row of angled struts define a row of second cells of the frame (diamond shaped openings between rows IV and III of Figure 5), wherein the third row of angled struts and the fourth row of angled struts define a row of third cells of the frame (diamond shaped openings between rows III and II of Figure 5), wherein the first cells are wider in a circumferential direction than the second cells (removing the 2 struts results in the cells of Figure 5 being identical to those of Figure 5 of the current application), wherein the second cells and the third cells have the same width in the circumferential direction (Figure 5).
18. Levi as modified by Kheradvar discloses each second cell or third cell is four-sided (diamond shaped openings in Figure 5).
19. Levi as modified above by Kheradvar discloses an implantable prosthetic valve (10 Figures 1-5), comprising:
an annular frame 12 comprising: an inflow end (near V Figure 5); an outflow end (near I Figure 5);
a first row of angled struts (V) defining the outflow end (Figure 5);
a second row of angled struts (IV) upstream of the first row of angled struts (Figure 5) and there is no row of angled struts between the first row of angled struts and the second row of angled struts (in view of 112 rejection above Levi reads upon this limitation as much as the applicant’s current application);
a third row of angled struts (III) immediately upstream of the second row of angled struts (Figure 5);
a plurality of axial frame members (30/31) having respective first ends and second ends, the first ends being linked by the first row of angled struts and the second ends being linked by the second row of angled struts (Figure 5);
a leaflet structure 14/40 positioned within the annular frame (Figure 2) and configured to permit blood flow from the inflow end to the outflow end and block blood fluid flow from the outflow end to the inflow end (this is an inherent property of all prosthetic heart valves),
an inner skirt (16) disposed inside the frame (Figures 1-3), wherein an upper edge portion of the inner skirt is attached to the second row of angled struts (Figures 1-3),
wherein an outflow end of the leaflet structure is positioned downstream of the upper edge portion of the inner skirt (Figure 1),
wherein the first row of angled struts, the second row of angled struts, and the plurality of axial frame members define a row of first cells of the frame (removing the 2 struts results in the cells of Figure 5 being identical to those of Figure 5 of the current application), wherein the second row of angled struts and the third row of angled struts define a row of second cells of the frame (diamond shaped openings between rows IV and III of Figure 5), wherein each first cell is twice as wide as each second cell in circumferential direction (removing the 2 struts results in the cells of Figure 5 being identical to those of Figure 5 of the current application).
20. Levi as modified above by Kheradvar discloses the annular frame further comprises a fourth row of angled struts (II Figure 5) immediately upstream of the third row of angled struts (Figure 5), wherein the third row of angled struts and the fourth row of angled struts define a row of third cells of the frame (diamond shaped openings between rows II and III of Figure 5), wherein the second cells and the third cells have the same width in the circumferential direction (Figure 5).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8-10, 12, 13, and 16-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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 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
/Christopher D. Prone/Primary Examiner, Art Unit 3774