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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0035], “outer skirt 60” should recite - - outer skirt 80 - -.
In paragraphs [0060] and [0061], “outflow section 1330” should recite - - inflow section 1330 - -.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 8 recites “the inflow flare is curved and has a first radius of curvature and the outflow flare has a second radius of curvature, the ratio of the first radius of curvature to the second radius of curvature being between 3:1 and 1.1:1”. However, the specification appears to disclose the opposite. In paragraph [0061], Applicant discloses “the ratio of radius of curvature β1 to radius curvature β2 is 3:1, 2.5:1, 2:1, 1.75:1, 1.5:1, 1.4:1, 1.3:1, 1.2:1, 1.1:1 or 1:1”, wherein β1 is in reference to the outflow end and β2 is in reference to the inflow end. Therefore, Applicant discloses the ratio of the second radius of curvature to the first radius of curvature is between 3:1 and 1.1:1.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: first flare1360 ([0061]). 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. 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-13, 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pellegrini et al (US 2021/0077256) in view of Hoang et al (US 2019/0365530).
Claim 1. Pellegrini et al discloses a balloon-expandable prosthetic heart valve ([0039], [0041]) (Figs. 1-4; 13, 18) comprising:
a collapsible and expandable stent (10, 30, 32, 34, 42, 120, 202) comprising a plurality of commissure attachment features ([0051]; conical crowns), the collapsible and expandable stent having at least one of an inflow flare (14, 142, 208) and an outflow flare (12, 140, 210); and
a valve assembly (44, 204) coupled to the collapsible and expandable stent, the valve assembly comprising a plurality of leaflets ([0038], [0039], [0051], [0053], [0073]), the plurality of leaflets defining a noncylindrical profile with a narrowed waist (Figs. 4 and 17 show the leaflets follow the shape of the stent and the stent is seen with a narrowed waist and therefore the leaflets also contain a narrowed waist. More specifically, Fig. 22 shows a cross-sectional figure of an example of a valve assembly 312 which follows the shape of the stent and contains a narrowed waist (where arrow 312 is pointed towards).
Pellegrini et al fails to explicitly disclose the valve assembly comprises a cuff. However, in the same field of endeavor, Hoang et al teaches a balloon-expandable prosthetic heart valve (10) comprising a stent frame (12) and a valve assembly (14) comprising a cuff (16) and a plurality leaflets (40) ([0074], [0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the valve assembly of Pellegrini et al to include a cuff based upon the teachings of Hoang et al to assist in securing the valve assembly to the stent and to assist in forming a good seal between the prosthetic valve and the native annulus by blocking the flow of blood through the open cells of the stent ([0085]).
Claim 4. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the outflow flare is tilted to a greater extent than the inflow flare (Fig. 2C, 13, 18).
Claim 5. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the inflow flare is curved and has a first radius of curvature, and the outflow flare has a second radius of curvature greater than the first radius of curvature (Figs. 2C, 13, 18).
Claims 6-8. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al discloses the inflow flare is curved and has a first radius of curvature and the outflow flare is curved and has a second radius of curvature (Figs. 1, 2, 4, 13, 18) but the combination fails to disclose the first radius of curvature is between 10 and 20 mm, and the outflow flare has a second radius of curvature greater than the first radius of curvature (as per claim 6), the second radius of curvature of between 10 and 20 mm, and the inflow flare has a first radius of curvature greater than the second radius of curvature (as per claim 7), or the ratio of the first radius of curvature to the second radius of curvature being between 3:1 and 1.1:1 (as per claim 8).
Instead, Pellegrini et al discloses the diameters of the flared ends may vary, which would in effect alter its radius of curvature (i.e. a larger diameter extending from the same cylindrical section would have a larger radius as compared to a smaller diameter) ([0050]). As seen in Figs. 1, 2, 4, 13 and 18, the inflow flare and outflow flare are considered curve with their struts flaring in a non-linear manner. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the radius of curvature of the inflow flare and outflow flare of the Pellegrini et al device to have radius of curvature within the claimed range, resulting in one flare being larger than the other flare as claimed, as it involves only adjusting the dimension of a component disclosed as being adjustable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the combination by making the inflow flare and outflow flare to have a radius of curvature between 10 and 20 mm, as a matter of routine optimization since it has been held that “where 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).
Furthermore, Applicant has not provided evidence of the criticality of the claimed range in the instant specification. In paragraph [0061] of the instant specification, Applicant discloses exemplary radius of curvatures and further discloses there may be combinations of straight, flared and curved embodiments as well. However, Applicant has not provided evidence, such as how the claimed range of 10 and 20 mm have unexpected results over the prior art or if one flare is larger than the other. Applicant discloses the prosthetic heart valve is for implantation in the aortic valve or other valves ([0024]). Similarly, the prosthetic valve of Pellegrini et al is designed for the aortic valves or other valves ([0037] of Pellegrini et al) and the flared ends are designed to minimize or prevent leakage and provide a docking feature to prevent migration of the prosthetic valve ([0050] of Pellegrini et al). It is the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions of the valve to be treated and determined the necessary radius of curvatures of the inflow flare and outflow flare to achieve the desired effects. Therefore, the claimed ranges are merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claims 6-8 from the prior art.
Claim 9. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the plurality of leaflets defines a first diameter adjacent an inflow end (bottom end), a third diameter adjacent an outflow end (top end), and a second diameter between the inflow end and the outflow end, the second diameter being less than the first diameter and the third diameter (Fig. 4).
Claims 10 and 11. The combination discloses the invention substantially as claimed above, including the second diameter is smaller than both the first and third diameter (Fig. 4) but fails to disclose the second diameter is between 5% and 20% smaller than the first diameter (as per claim 10), or the second diameter is between 5% and 20% smaller than the third diameter (as per claim 11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pellegrini et al to have the second diameter be between 5% and 20% of both the first diameter and the third diameter since I has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the prosthetic heart valve of Pellegrini et al would not operate differently with the claimed diameter difference since the shape of the stent is intended for aortic valves or other valves ([0037] of Pellegrini et al), similar to Applicant’s prosthetic heart valve being for implantation in the aortic valve or other valves ([0024] of the application specification). Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter difference “may” be within the claimed ranges ([0062] of the application specification).
Claim 12. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the plurality of leaflets (44) define a concave profile (Fig. 4; leaflets of valve 44 follows the curvature of stent frame 40 which includes a concavity in the central section).
Claim 13. Pellegrini et al discloses a balloon-expandable prosthetic heart valve ([0039], [0041]) (Figs. 1-4; 13, 18) comprising:
a collapsible and expandable stent (10, 30, 32, 34, 42, 120, 202) comprising a plurality of commissure attachment features ([0051]; conical crowns), the collapsible and expandable stent having a main cylindrical section (narrowed middle waist section, see annotated figure from claim 2 below as an example), an inflow flare (14, 142, 208) and an outflow flare (12, 140, 210); and
a valve assembly (44, 204) coupled to the collapsible and expandable stent, the valve assembly comprising a plurality of leaflets ([0038], [0039], [0051], [0053], [0073]), the plurality of leaflets defining a noncylindrical profile with a narrowed waist, the noncylindrical profile matching flaring of the inflow flare and the outflow flare of the stent which would in effect increase laminar blood flow through the plurality of leaflets (Figs. 4 and 17 show the leaflets follow the shape of the stent and the stent is seen with a narrowed waist and therefore the leaflets also contain a narrowed waist. More specifically, Fig. 22 shows a cross-sectional figure of an example of a valve assembly 312 which follows the shape of the stent and contains a narrowed waist (where arrow 312 is pointed towards). Applicant’s direction is MPEP 2112.01, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Pellegrini et al fails to explicitly disclose the valve assembly comprises a cuff. However, in the same field of endeavor, Hoang et al teaches a balloon-expandable prosthetic heart valve (10) comprising a stent frame (12) and a valve assembly (14) comprising a cuff (16) and a plurality leaflets (40) ([0074], [0085]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the valve assembly of Pellegrini et al to include a cuff based upon the teachings of Hoang et al to assist in securing the valve assembly to the stent and to assist in forming a good seal between the prosthetic valve and the native annulus by blocking the flow of blood through the open cells of the stent ([0085]).
Claim 15. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the outflow flare is tilted to a greater extent than the inflow flare (Fig. 2C, 13, 18).
Claim 16. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al discloses the inflow flare is curved and has a first radius of curvature and the outflow flare is curved and has a second radius of curvature, and the outflow flare has a second radius of curvature greater than the first radius of curvature (Figs. 2C, 13 and 18) but the combination fails to disclose the first radius of curvature is between 10 and 20 mm.
Instead, Pellegrini et al discloses the diameters of the flared ends may vary, which would in effect alter its radius of curvature (i.e. a larger diameter extending from the same cylindrical section would have a larger radius as compared to a smaller diameter) ([0050]). As seen in the figures, the inflow flare and outflow flare are considered curve with their struts flaring in a non-linear manner. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the radius of curvature of the inflow flare of the prosthetic heart valve of Pellegrini et al to have radius of curvature within the claimed range, as it involves only adjusting the dimension of a component disclosed as being adjustable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the combination by making the inflow flare to have a radius of curvature between 10 and 20 mm, as a matter of routine optimization since it has been held that “where 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).
Furthermore, Applicant has not provided evidence of the criticality of the claimed range in the instant specification. In paragraph [0061] of the instant specification, Applicant discloses exemplary radius of curvatures and further discloses there may be combinations of straight, flared and curved embodiments as well. However, Applicant has not provided evidence, such as how the claimed range of 10 and 20 mm have unexpected results over the prior art. Applicant discloses the prosthetic heart valve is for implantation in the aortic valve or other valves ([0024]). Similarly, the prosthetic valve of Pellegrini et al is designed for the aortic valves or other valves ([0037] of Pellegrini et al) and the flared ends are designed to minimize or prevent leakage and provide a docking feature to prevent migration of the prosthetic valve ([0050] of Pellegrini et al). It is the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions of the valve to be treated and determined the necessary radius of curvature of the inflow flare to achieve the desired effects. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 16 from the prior art.
Claim 17. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al further discloses the plurality of leaflets defines a first diameter adjacent an inflow end (bottom end), a third diameter adjacent an outflow end (top end), and a second diameter between the inflow end and the outflow end, the second diameter being less than the first diameter and the third diameter (Fig. 4).
Claims 18 and 19.The combination discloses the invention substantially as claimed above, including the second diameter is smaller than both the first and third diameter (Fig. 4) but fails to disclose the second diameter is between 5% and 20% smaller than the first diameter (as per claim 18), or the second diameter is between 5% and 20% smaller than the third diameter (as per claim 19). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Pellegrini et al to have the second diameter be between 5% and 20% of both the first diameter and the third diameter since I has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the prosthetic heart valve of Pellegrini et al would not operate differently with the claimed diameter difference since the shape of the stent is intended for aortic valves or other valves ([0037] of Pellegrini et al), similar to Applicant’s prosthetic heart valve being for implantation in the aortic valve or other valves ([0024] of the application specification). Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter difference “may” be within the claimed ranges ([0062] of the application specification).
Claim 20. The combination discloses the invention substantially as claimed above, wherein Pellgrini et al further discloses wherein the first diameter is approximately equal to the third diameter ([0050]).
Claim(s) 2, 3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pellegrini et al in view of Hoang et al as applied to claims 1 and 13 above, and further in view of Chen et al (US 2024/0197469).
Claims 2, 3 and 14. The combination discloses the invention substantially as claimed above, wherein Pellegrini et al discloses the collapsible and expandable stent comprises a main cylindrical section (see boxed region in annotated figure below), and the inflow flare and outflow flare each comprises an angle (see example of inflow flare in annotated figure below, the outflow flare is similar in the upwards direction) with respect to a longitudinal axis of the collapsible and expandable stent. However, the combination fails to disclose the angle of the inflow flare is between 15 and 35 degrees or the angle of the outflow flare I between 15 and 35 degrees. Instead, Pellegrini et al discloses the diameters of the flared ends may vary, which would in effect alter its angle (i.e. a larger diameter extending from the same cylindrical section would have a larger angle as compared to a smaller diameter) ([0050]).
However, in the same field of endeavor Chen et al teaches a balloon-expandable prosthetic heart valve (Fig. 9), wherein an inflow flare (bottom 414) and outflow flare (top 414) are provided with angles between 20 to 60 degrees, overlapping the claimed range ([0175]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the angles of the inflow flare and outflow flare between 20 and 60 as taught by the prior art to the overlapping range of between 20 and 35 degrees as applicant appears to have placed no criticality on the claimed range ([0060] discloses exemplary angles indicating the angle “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the angle of the inflow flare of the Pellegrini et al device to have an angle within the claimed range, as it involves only adjusting the dimension of a component disclosed as being adjustable. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the combination by making the inflow flare angle and outflow flare angle to be between 15 and 35 degrees as a matter of routine optimization since it has been held that “where 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).
Furthermore, Applicant has not provided evidence of the criticality of the claimed range in the instant specification. In paragraph [0060] of the instant specification, Applicant discloses exemplary angles of the inflow flare to reduce entrance effects of fluid passing into the valve at high velocity. However, Applicant has not provided evidence, such as how the claimed range of 15 to 35 degrees have unexpected results over the prior art. Applicant discloses the angles may be beyond the claimed range, including angles between 0 to 45 degrees. Applicant discloses the prosthetic heart valve is for implantation in the aortic valve or other valves ([0024]). Similarly, the prosthetic valve of Pellegrini et al is designed for the aortic valves or other valves ([0037] of Pellegrini et al) and the flared ends are designed to minimize or prevent leakage and provide a docking feature to prevent migration of the prosthetic valve ([0050] of Pellegrini et al). It is the Examiner's position that one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions of the valve to be treated and determined the necessary angles of the inflow flare and outflow flare to achieve the desired effects. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claims 2, 3 and 14 from the prior art.
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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