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
This action is entered in response to Applicant's amendment and reply of 3/17/26. The claims 1, 4-11, and 13-20 are pending. The claim 1, 5-11, 13-19 have been amended. Claims 19 and 20 remain withdrawn.
Response to Arguments
Applicant’s arguments, filed 3/17/26 with respect to the rejections of claims 1, 4-11, 13-17 under 35 U.S.C. 103 as being unpatentable over Nasr (US2018/0125648) in view of Erzberger (US2017/0325944) have been fully considered and the amendments overcome the previous rejection. However, a new grounds of rejection has been made in view of Nasr (US2018/0125648) in view of Erzberger (US2017/0325944) and Cooper (US2017/0095328).
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “the network in the shrunken state” should be changed to “the network in the collapsed state”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-11, 13-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the struts of a network". It is unclear if the “network” recited is the same or a different structure entirely than the previously recited “network”.
Claims 4-11, 13-18 are rejected by dependency from claim 1.
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, 4-11, 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nasr (US2018/0125648) in view of Erzberger (US2017/0325944) and Cooper (US2017/0095328).
Regarding claim 1, Nasr discloses an artificial heart valve (Abstract) configured to replace a natural valve in an annulus between an atrium and a ventricle of a heart (for mitral valve replacement, [0022]), the artificial heart valve comprising:
a network (struts of body 5, see Fig. 14, [0028]) configured to be in a collapsed state and an expanded state (struts are expanded [0060], struts are compressed within a catheter, [0063]), wherein the network comprises a first region (see annotated Fig. 14 and is at a ventricular side) at a front side of the network, a second region (defined by struts 9, see annotated Fig. 14), and a third region (defined by struts 12 of tubular body 5, see annotated Fig. 14 and is at the atrial side) at a rear side of the network relative to a direction of movement of the network (see annotated Fig. 14);
a plurality of leaflets (45, [0063]) attached to the network ([0063]); and
a coating (fabric 25 on the surface of body 5 may include a coating, [0028]-[0029]; alternatively, adhesive that secures fabric 25 to body 5 is interpreted as a coating, [0030]) at least partially coating the network ([0029], [0030]).,
wherein the network comprises a plurality of struts (9, see Fig. 14), and
wherein the number of struts in the first region is higher than the number of struts in the third region (see Fig. 14, [0063]),
wherein in the expanded state, the first region is configured to engage a ventricular side of the annulus (inflow end extends to a ventricular side, [0023]) and the third region is configured to engage an atrial side of the annulus (outflow end extends to an atrial side, [0054]), such that the annulus is entrapped between the first region and the third region ([0064]),
wherein all the struts of the second region are relatively longer than the struts of a network configured to bend backward (the struts of the second region are longer than the struts that could bend backwards).
Nasr does not explicitly disclose wherein the first region, the second region, and the third region differ in flexibility. Erzberger teaches a prosthetic heart valve including a stent having a plurality of struts defining a plurality of cells forming an aortic section (first region), a transition section (second region) and an annulus section (third region) ([0042]). Where the stent may be formed such that it transitions from a high cell density to a low cell density and then back to a high cell density ([0042]). Additionally, the stent may be formed that has different cell density for each row of cells, or section of cells ([0042]). In one example the first cell density of the annulus section is twelve cells per row and the second cell density of the aortic section is nine cells per row, and the transition section having a different amount than both other sections ([0044]-[0045]). Therefore, with each the aortic section, transition section, and annulus section having different rows of cells, would have different flexibilities. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first region, second region, and third region to differ in flexibility as taught by Erzberger in order provide greater cell density for first and third regions of the stent to expand with greater radial force and be more rigid when expanded, reducing the risk of under-expansion of the stent ([0026]) and also providing less cell density for the second region of the stent to minimize interference with blood flow ([0031]). Erzberger provides evidence of the relationship with cell density and flexibility of the section, where a higher cell density would mean less flexibility ([0026]).
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The modified invention does not explicitly wherein all the struts of the network extend forward when the network extends from the collapsed state to the expanded state such that the network extends to a mushroom-like structure. Cooper teaches a prosthetic heart valve with a frame 802 with a first section 716 (ventricular side), second section 708, and a third section 720 (atrial side) as shown in Fig. 22. Where the struts of the frame extend forward in the same direction when the frame is expanded and form a mushroom-like structure, since the anchors 716 overturn (see Figs. 21 and 23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shape of the frame of Nasr/Erzberger for the shape of the frame that is mushroom-like of Cooper since the substitution would have yielded the same predictable result of having the implant have a shape for being positioned in the annulus between the ventricular and atrial side of the heart.
Regarding claim 4, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the network in the collapsed state is uni-layered (the tubular body 5 is a single layer and generally cylindrical in shape, [0024]).
Regarding claim 5, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the network is configured to be in a collapsed state during transfer of the artificial heart valve through blood vessels to a heart ([0063], [0064]).
Regarding claim 6, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the expanded state is a default state of the network (self-expanding tubular body 5, [0023]).
Regarding claim 7, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the artificial heart valve in the collapsed state is configured to be transferred to a heart through veins ([0065]).
Regarding claim 8, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr discloses wherein the artificial heart valve in the expanded state is configured to be implanted in a heart between an atrium and a corresponding ventricle (implanted in the mitral valve, [0064]).
Regarding claim 9, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the artificial heart valve in the expanded state is configured to be anchored to an annulus (groove 7 is located on the annulus and is intended to be implanted, [0064]).
Regarding claim 10, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the artificial heart valve in the expanded state is configured to entrap chords of the natural valve in a manner that prevents interference to the function of the artificial heart valve by the chords ([0067]).
Regarding claim 11, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein the artificial heart valve in the expanded state is configured to entrap natural leaflets of the natural valve in a manner that prevents interference to the function of the artificial heart valve by the natural leaflets ([0067]).
Regarding claim 13, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, the modified invention further discloses wherein in the collapsed state of the network, the second region of the network is more flexible than the first region and the third region of the network (the modified invention teaches the second region has less cell density is and therefore more flexible than the first and third regions, where when in the collapsed state of Nasr when compressed within catheter as stated in paragraph [0063] of Nasr and the modified invention would have the same flexibility modifications in the collapsed state).
Regarding claim 14, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein in the expanded state the struts bend forward and exert a radial force (the struts bend radially outward/forward, and are self-expandable to exert a force on the native valve, [0023], [0067]).
Regarding claim 15, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, Nasr further discloses wherein in the expanded state the struts bend backward and exert an axial force (the struts on the atrial end that bend backward as in the substituted shape of Cooper as shown in Fig. 22 and would exert an axial force in the direction of the free end of the struts).
Regarding claim 16, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, the modified invention discloses wherein in the expanded state some of the struts bend forward and exert a radial force (see direction of arrow outward at the inflow end 10 in Fig. 10 of Nasr, where the shape as modified by Cooper in Fig. 22 would bend forward in the same manner and forward bending is interpreted as radially outward) and some of the struts bend backward and exert an axial force (the struts on the atrial end that bend backward as in the substituted shape of Cooper as shown in Fig. 22 and would exert an axial force in the direction of the free end of the struts, where backward bending is interpreted as radially inward).
Regarding claim 17, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1, the modified invention further discloses wherein in the expanded state the network has a toroidal structure (where toroidal is defined as “doughnut shaped” from Merriam-Webster dictionary see reference U in the PTO-892 from the rejection mailed 11/20/24, where the structure as shown in Fig. 22 of Cooper is a donut-shape).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nasr (US2018/0125648) in view of Erzberger (US2017/0325944) and Cooper (US2017/0095328) as applied to claim 1, and further in view of Murphy (US2020/0060814)
Regarding claim 18, Nasr/Erzberger/Cooper makes obvious the artificial heart valve of claim 1; yet, does not explicitly disclose wherein the artificial heart valve in the collapsed state is at least substantially 50 mm long.
The modified invention does not disclose a collapsed state length. However, Murphy teaches the collapsed state length is a result effective variable, selected based on the consideration of size and shape native valve ([0077]). Where the prosthesis implanted at the native valve may have a size that may vary because of a disease condition or the type of mammal being treated (0077]). Thus, it would have been obvious to one of ordinary skill in the art to select a length of the collapsed state of the artificial heart valve based on the size considerations for the native valve. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art at the effective filing date of the application. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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