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 .
Information Disclosure Statement
The information disclosure statements filed 11/06/2022 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a translated abstract or a copy of the NPL of the following has not been provided: 2002329324, 1439800, 1551274, 1551336, 1562515, 1589902, “Trans-catheter implantation of Balloon-Expandable Prosthetic Heart Valves,” and 1271508. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
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 1st/2nd/3rd position, the outer skirt, and the thickness 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.
Claim Objections
Claims 11-13 objected to because of the following informalities:
The claims recite “leaflets is configured,” “leaflets is fixedly attached,” and “commissures is disposed” but should use the term “are.”
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 1-20 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.
Regarding claim 1, 10, and 15, the claim recites “each frame strut having a thickness in a radial direction from the central longitudinal axis.” It is unclear on whether this limitation is describing the diameter of the device as a whole or the individual thickness of the physical struts. For the purposes of examination, the thickness is being considered to refer to the device as a whole.
Regarding claims 1-20, the claims recite many alternative labels for the frame struts, such as “plurality of frame struts,” “other frame struts,” “some frame struts,” “each frame strut,” “of frame strut,” and “all frame struts.” This language makes it unclear about which struts are being compared. Additionally, only one frame strut thickness is defined in the independent claims, a second thickness is being discussed without antecedent basis.
Dependent claims are likewise rejected.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mantanus (US 20160228249 A1) in view of Yohanan (US 9168131 B2).
Regarding claim 1, Mantanus teaches an expandable framework ([0048]) for use in a replacement heart valve implant (abstract), comprising: a plurality of frame struts (see struts, annotated fig 2) defining a lattice structure around a central longitudinal axis (see lattice structure around central longitudinal axis, annotated fig 2), each frame strut having a thickness in a radial direction from the central longitudinal axis (the struts have thicknesses, annotated fig 2); wherein the plurality of frame struts defines a lower crown (inferior crown 20a, fig 2) proximate an inflow end of the lattice structure (see orientation in annotated fig 2, end structure capable of allowing inflow) and upper crown (superior crown 20b, fig 2) proximate an outflow end of the lattice structure (see orientation in annotated fig 2, end structure capable of allowing outflow) and a plurality of stabilization arches (wings or arches 24, fig 2) extending downstream from the outflow end of the lattice structure (see orientation in annotated fig 2); wherein the lattice structure includes a first circumferential row of x-connectors (see annotated fig 2) upstream of the upper crown (see orientation in annotated fig 2) and a second circumferential row of x-connectors (see annotated fig 2) downstream of the lower crown (see orientation in annotated fig 2).
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Annotated Figure 2
Mantanus appears to teach wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of other frame struts of the plurality of frame struts (the thickness of the struts connecting the x connectors is less than the thickness of the other frame struts in the very last row near the inferior crown, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of other frame struts of the plurality of frame struts (see annotated fig 13 and col 11, lines 1-26).
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Annotated figure 13
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 2, Mantanus appears to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of frame struts downstream of the first circumferential row of x-connectors (the thickness of the struts connecting the x connectors is less than the thickness of the other frame struts in the very last row that make up the superior crown, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of frame struts downstream of the first circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 3, Mantanus fails to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of all frame struts downstream of the first circumferential row of x-connectors. However, Yohanan teaches a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of all frame struts downstream of the first circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 4, Mantanus appears to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of frame struts upstream of the second circumferential row of x-connectors (the thickness of the struts connecting the x connectors is less than the thickness of the other frame struts in the very last row near the inferior crown, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of frame struts upstream of the second circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 5, Mantanus appears to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of all frame struts upstream of the second circumferential row of x-connectors (the thickness of the struts connecting the x connectors is less than the thickness of the other frame struts in the very last row near the inferior crown, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of all frame struts upstream of the second circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 6, Mantanus fails to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward toward a medial portion of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors. However, Yohanan teaches a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward toward a medial portion of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 7, Mantanus fails to teach wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers from a first thickness at a first position adjacent the first circumferential row of x-connectors and a second thickness at a second position adjacent the second circumferential row of x-connectors to a minimum thickness at a third position disposed longitudinally between the first position and the second position; wherein the minimum thickness is less than the first thickness and the second thickness. However, Yohanan teaches a heart valve with supports (abstract) wherein the thickness of the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers from a first thickness at a first position adjacent the first circumferential row of x-connectors and a second thickness at a second position adjacent the second circumferential row of x-connectors to a minimum thickness at a third position disposed longitudinally between the first position and the second position; wherein the minimum thickness is less than the first thickness and the second thickness (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 8, Mantanus fails to teach wherein the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors includes all frame struts of the plurality of frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x- connectors. However, Yohanan teaches a heart valve with supports (abstract) wherein the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors includes all frame struts of the plurality of frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x- connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 9, Mantanus appears to teach wherein the upper crown defines a first maximum outer extent of the lattice structure (superior crown 20b is widest part of lattice, fig 2), and the lower crown defines a second maximum outer extent of the lattice structure inferior crown 20a is second widest part of lattice, fig 2; wherein the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors defines a third maximum outer extent of the lattice structure less than the first maximum outer extent and the second maximum outer extent (the struts in between the connectors have a third extent that is smaller than the crown extents). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the upper crown defines a first maximum outer extent of the lattice structure (upper outflow crown at D4 is wider than D3, see annotated fig 13 and col 11, lines 1-26), and the lower crown defines a second maximum outer extent of the lattice structure (lower inflow crown at D2 is wider than D3, see annotated fig 13 and col 11, lines 1-26); wherein the at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors defines a third maximum outer extent of the lattice structure less than the first maximum outer extent and the second maximum outer extent (see D3 in annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 10, Mantanus teaches a replacement heart valve implant (abstract), comprising an expandable framework ([0048]) comprising a plurality of frame struts (see struts, annotated fig 2) defining a lattice structure around a central longitudinal axis (see lattice structure around central longitudinal axis, annotated fig 2), each frame strut having a thickness in a radial direction from the central longitudinal axis (the struts have thicknesses, annotated fig 2); and a plurality of valve leaflets coupled to the expandable framework (element 16 fig 1, [0057]); wherein the plurality of frame struts defines a lower crown (inferior crown 20a, fig 2) proximate an inflow end of the lattice structure (see orientation in annotated fig 2) and upper crown (superior crown 20b, fig 2) proximate an outflow end of the lattice structure (see orientation in annotated fig 2) and a plurality of stabilization arches (wings or arches 24, fig 2) extending downstream from the outflow end of the lattice structure (see orientation in annotated fig 2); wherein the lattice structure includes a first circumferential row of x-connectors (see annotated fig 2) upstream of the upper crown (see orientation in annotated fig 2) and a second circumferential row of x-connectors (see annotated fig 2) downstream of the lower crown (see orientation in annotated fig 2);
Mantanus appears to teach wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of other frame struts of the plurality of frame struts (the thickness of the struts connecting the x connectors is less than the thickness of the other frame struts in the very last row near the inferior crown, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of other frame struts of the plurality of frame struts (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 11, Mantanus further teaches wherein the plurality of valve leaflets is configured to substantially restrict fluid from flowing through the replacement heart valve implant in a closed position ([0057]).
Regarding claim 12, Mantanus further teaches to the expandable framework at a plurality of commissures disposed adjacent the plurality of stabilization arches ([0055]). Mantanus does not specifically disclose wherein the plurality of valve leaflets is fixedly attached. However, Yohanan teaches a heart valve with supports (abstract) wherein the plurality of valve leaflets is fixedly attached (col 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 13, Mantanus further teaches wherein the plurality of commissures is disposed longitudinally between the plurality of stabilization arches and the upper crown (see orientation of commissural support posts 22a, fig 2).
Regarding claim 14, Mantanus further teaches wherein the device comprises an outer skirt disposed on an abluminal surface of the expandable framework ([0057]).
Regarding claim 15, Mantanus teaches a replacement heart valve implant (abstract), comprising a plurality of frame struts (see struts, annotated fig 2) defining a lattice structure around a central longitudinal axis (see lattice structure around central longitudinal axis, annotated fig 2), each frame strut having a thickness in a radial direction from the central longitudinal axis (the struts have thicknesses, annotated fig 2); wherein the plurality of frame struts defines a lower crown (inferior crown 20a, fig 2) proximate an inflow end of the lattice structure (see orientation in annotated fig 2) and upper crown (superior crown 20b, fig 2) proximate an outflow end of the lattice structure (see orientation in annotated fig 2) and a plurality of stabilization arches (wings or arches 24, fig 2) extending downstream from the outflow end of the lattice structure (see orientation in annotated fig 2); wherein the lattice structure includes a first circumferential row of x-connectors (see annotated fig 2) and a second circumferential row of x-connectors (see annotated fig 2) longitudinally spaced apart from the first circumferential row of x-connectors (see orientation in annotated fig 2);
Mantanus appears to teach wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies (the thickness of the struts connecting the x connectors varies, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of at least some frame struts connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors is less than the thickness of other frame struts of the plurality of frame struts (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 16, Mantanus appears to teach wherein the thickness of at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies in a longitudinal direction (the thickness of the struts connecting the x connectors varies longitudinally, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies in a longitudinal direction (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 17, Mantanus appears to teach wherein the thickness of each frame strut directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies (the thickness of the struts connecting the x connectors varies, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of each frame strut directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 18, Mantanus appears to teach wherein the thickness of each frame strut directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies in a longitudinal direction (the thickness of the struts connecting the x connectors varies longitudinally, annotated fig 2). However, Yohanan provides more extensive detail on a heart valve with supports (abstract) wherein the thickness of each frame strut directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors varies in a longitudinal direction (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 19, Mantanus fails to teach wherein the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward toward a medial portion of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors. However, Yohanan teaches a heart valve with supports (abstract) wherein the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward toward a medial portion of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors (see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Regarding claim 20, Mantanus fails to teach wherein the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward from the first circumferential row of x-connectors toward the second circumferential row of x-connectors and the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward from the second circumferential row of x-connectors toward the first circumferential row of x-connectors. However, Yohanan teaches a heart valve with supports (abstract) wherein the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward from the first circumferential row of x-connectors toward the second circumferential row of x-connectors and the thickness of the at least some frame struts directly connecting the first circumferential row of x-connectors to the second circumferential row of x-connectors tapers radially inward from the second circumferential row of x-connectors toward the first circumferential row of x-connectors(see annotated fig 13 and col 11, lines 1-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mantanus by including the diameter orientation, as taught by Yohana. It appears the device taught by Mantanus already comprises a similar structure based on the drawing of figure 2. It would be obvious to incorporate the structure details from Yohana because it would only be minor alterations to the shape of the structure of Mantanus and would provide several advantages such as reduced trauma, reduced obstruction, secure implantation, improved positioning and better contact (col 12-13).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774