DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-14, drawn to a stent valve, classified in A61F 2/24818.
Claims 15-23, drawn to method of using a stent valve, classified in A61F 2/243.
The inventions are independent or distinct, each from the other because: Inventions I. and II. are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In this case, the product as claimed can be used to practice another and materially different process. For example, instead of supporting an atrial valve it could be used to support a pulmonary valve. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions or processes have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and/or the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention. The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Ariela Yevich on 12/17/2025 a provisional election was made without traverse to prosecute the invention of I., claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-23 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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
Obviousness
Claim(s) 1-5 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chambers et al. US 20180042721 A1, herein referred to as Chambers, and in view of Keranen et al. US 2020150351735, herein referred to as Keranen.
Regarding claim 1, Chambers discloses: A prosthetic heart valve (Fig 14, valve 400) stent (Fig 15, stent 100) for implanting in an atrium of a heart (Figure 6), the stent (Fig 15, stent 100) comprising an inner valve support section (not labeled in figure, central cylinder 406, [0062]) extending upward within the outer section (Fig 7, outer surface104) and defining a second central axis (Annotated Fig 7 below) oblique to the first central axis (Fig 14, [0088]: “In addition the transition points may comprise one or more sharp angles, so that either transition points 1, 2, 3 and/or 4 may comprise a sharp angle or a radiused transition, or there may be a combination of sharp angle and radiused transition points 1, 2”, changes of transition points 3 and 4 aligns central axes as described); wherein when the stent (Fig 15, stent 100) is implanted in the atrium such that a bottom portion (Fig 14, lower surface 106) of the stent (Fig 14, stent 100) is positioned on an upper annular surface of an annulus ([63], Figures 6 and 7); and the inner valve support section (Fig 14, central cylinder 406) directs blood through the annulus toward a posterior wall of the ventricle ([0005], Directing blood to mirror a native one-way valve would direct blood as claimed).
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Annotated Figure 7, Chambers et al.
But does not disclose with an outer section defining a first central axis; wherein when the stent is implanted in the atrium such that a bottom portion of the stent is positioned on an upper annular surface of an annulus and the second central axis is oblique to an annular plane defined by the upper annular surface.
But Keranen discloses a similar a prosthetic heart support (Fig 6, heart support 100). Keranen teaches with an outer section (Fig 6, atrium support member 101) defining a first central axis [defined by outer section] (Fig 6, [0068]); wherein when the stent is implanted in the atrium (Fig 6) such that a bottom portion of the stent is positioned on an upper annular surface of an annulus (Fig 6, [0068]) and the second central axis [defined by inner valve support (Fig 6, channel 105)] is oblique to an annular plane defined by the upper annular surface [0068].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Chambers to incorporate with an outer section defining a first central axis; wherein when the stent is implanted in the atrium such that a bottom portion of the stent is positioned on an upper annular surface of an annulus and the second central axis is oblique to an annular plane defined by the upper annular surface in order to improve alignment and secure of heart treatment element ([0068]).
Regarding Claim 2, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches when the stent is implanted in the atrium such that the bottom portion (106) of the stent is positioned on the upper annular surface (Fig 14, ¶ 0061, lines 1-3), the first central axis (Fig 14) is perpendicular to the annular plane (Annotated Fig 14).
Regarding Claim 3 the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches where the inner valve support section (Keranen Fig 6, channel 105) comprises an inflow end and an outflow end (Chambers ¶ 0096, line 2-3); and blood moves through a blood flow channel defined between the inflow and outflow ends (Chambers ¶ 0062, lines 7-10).
Regarding Claim 4, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein when the stent (Chambers Fig 14, stent 100) is implanted in the atrium such that the bottom portion (Chambers Fig 14, lower surface 106) of the stent is positioned on the upper annular surface (Chambers ¶ 0006, lines 4-6), the first central axis (Keranen Fig 6) is oblique to the annular plane (Keranen Fig 6).
Regarding Claim 5, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein the inner valve support section (406) is configured to support prosthetic valve leaflets (Chambers Fig 9, leaflets 402, [0064]) that allow blood flow from the inflow end to the outflow end and prevent blood flow from the outflow end to the inflow end (Chambers ¶ 0076, lines 7-8).
Regarding Claim 8, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein the stent (Chambers Fig 14, stent 100) does not extend into the annulus (Chambers ¶ 0049, lines 4-6, Fig 14).
Regarding Claim 9, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein the inner valve support section (Fig 7, central cylinder 406) is configured to direct blood through the annulus toward a posterior lateral wall of the ventricle (Chambers is silent regarding direction of blood flow beyond preventing retrograde flow. Stent configure to stop retrograde flow would direct blood flow to posterior lateral wall, as well as other portions of the ventricle. Therefore, Chamber’s stent operates functionally the same as claimed in applicants’ invention.).
Regarding Claim 10, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein the blood directed by the inner valve support section (Keranen Fig 6, channel 105) is a flow of blood (¶ 0062, lines 7-10).
Regarding Claim 11, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches wherein: the blood directed by the inner valve support section (Keranen Fig 6, channel 105; Chambers [0062]) is a flow of blood; and the flow of blood is directed toward a posterior lateral wall of the ventricle (Chambers is silent regarding direction of blood flow beyond preventing retrograde flow. A stent configured to stop retrograde flow would direct blood flow to posterior lateral wall, as well as other portions of the ventricle. Therefore, Chambers’ stent functions the same as claimed in applicants’ invention.)
Regarding Claim 12, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches the stent of claim 1 wherein the first central axis extends between a top of the stent and a bottom of the stent (Annotated Fig 7 above).
Regarding Claim 13, the combination of Chambers and Keranen as discussed above with regard to claim 1 teaches further comprising a transition section (Annotated Figure 14 below) extending between the outer section (Chambers Fig 7, outer surface 104) and the inner valve support section (Keranen Fig 6, channel 105, Chambers [0062]), the transition section being positioned at the bottom (Fig 14, lower surface 106) of the stent.
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Annotated Figure 14, Chambers et al.
Regarding Claim 14, Chambers: wherein the second central axis (Annotated Fig 7 above) extends along a blood flow channel ([0005]) circumscribed by the inner valve support section (Keranen Fig 6, channel 105, Chambers ¶ 0062).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chambers in view of Keranen as applied to claim 3 above, and in view of McLean et al. US 9034033 B2, herein referred to as McLean
Regarding Claim 6, the combination Chambers and Kernanen does not explicitly disclose: wherein the first central axis and the second central axis intersect at an angle of approximately 12 degrees.
But McLean discloses a similar prosthetic heart valve stent for implanting in an atrium of a heart. McLean teaches a prosthetic heart valve stent (Fig. 73, element 1700), wherein the first central axis (Fig 73, L-axis) and the second central axis (Fig 73, P-axis) intersect at an angle of approximately 12 degrees (Col. 79, 39-47).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Chambers to incorporate wherein the first central axis and the second central axis intersect at an angle of approximately 12 degrees, as taught and suggested by McLean in order to better mimic natural valve blood flow (Col 32, lines 8-32).
Regarding Claim 7, the combination of Chambers, Keranen, and McLean as discussed above with respect to claim 6 teaches: wherein the first central axis (Fig 73, L-axis) and the second central axis (Fig 73, P-axis) intersect at an angle in the range of 5-30 degrees (Fig. 16D, Col. 34, 32-40, McLean teaches the sited range).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie 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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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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