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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 9-15 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Within claims 9 and 10, lines 3-4: Applicant claims, “a heart valve prosthesis (3) comprising […] a suture ring (32)”; although the term “suture ring” is used many time throughout the disclosure the term is used in a way not fully understood by Examiner. Within paragraphs [0018, 0057, 0060] Applicant states a “suture ring fixes the leaflet assembly together”; and the suture ring, which is labelled as feature 32, is shown in different locations within figs. 1 and 3. Thus it appears the “suture ring” is more of a tube (that circumscribes the stent/ valve). It is unclear if Applicant is trying to be their own lexicographer or if this maybe due to a translation issue. Claim(s) 11-15, which depend from claim 10, inherit all the problems associated with claim 10.
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.
Claim(s) 3-4, 13 is/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 3 recites the limitation "the elastic joint member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the length of the elastic stretching part" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the length of the leaflet junction" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim.
Within claim 4, lines 5-6: Applicant claims, “the length of the elastic stretching part is the same as the length of the leaflet junction”; it is unclear, and therefore indefinite, what the length of the stretching part would be or how is would be determined since the leaflet junction is not part of the invention (which is to the stent ALONE) and the stent does not control the structure of the leaflet junction.
Claim 13 recites the limitation "the length of the elastic stretching part" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the length of the leaflet junction" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Valdez et al. (US 2014/0228945 A1).
With respect to claim 1:
Valdez et al. discloses a heart valve stent (stent 102), as can be seen in figs. 1-4B (paragraph [0030]), characterized by comprising:
a stent body (1) (all of stent 102 except the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) (paragraphs [0039-0040]);
a joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) comprising a fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118) and an elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) connected to the fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118), wherein an end of the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) away from the fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118) is a movable end (capable of movement/ flexing).
With respect to claim 2:
Characterized in that the joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) has a long strip shape (has a straight strip shape), as can be seen in fig. 4A.
With respect to claim 3:
Characterized in that, when the elastic joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) is in an original state 9either the collapsed or expanded state), a central axis of the joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) is parallel to a central axis (central longitudinal axis 116) of the stent body (1) (all of stent 102 except the portions of attachment posts 112 above (closer to the top of the page in fig 4A) (paragraph [0039]).
With respect to claim 4:
Characterized in that the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) is connected to a leaflet junction (at the connection between side portions 162), as can be seen in fig. 1, wherein the leaflet junction (at the connection between side portions 162) is a connection junction between every two adjacent leaflets (leaflets 152) in a heart valve prosthesis (3) (prosthetic valve 100) (paragraphs [0030, 0037]);
the length of the elastic stretching part is the same as the length of the leaflet junction; and/ OR the number of the joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) is the same as the number of the leaflet junction (at the connection between side portions 162), wherein one joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) is fixed at each leaflet junction (at the connection between side portions 162), as can be seen in fig. 1.
With respect to claim 5:
Characterized in that the joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) is formed by an elastic material with biocompatibility (the implantable ballon expandable/ elastic materials) (paragraph [0032]).
With respect to claim 6:
Characterized in that the fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118) is integrally formed (is shown as one piece in figs. 1-4B) with the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof).
With respect to claim 7:
Characterized in that the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) extends beyond (by a distance D3) the stent body (1) (all of stent 102 except the portions of attachment posts 112 above (closer to the top of the page in fig 4A) in an axial direction (along the longitudinal axis 116) of the stent body (1) (all of stent 102 except the portions of attachment posts 112 above (closer to the top of the page in fig 4A) (paragraph [0047]).
With respect to claim 8:
Characterized in that cross-section of the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) has a rectangular shape, as can be seen in figs. 1 and 3.
With respect to claim 9:
Valdez et al. discloses a prosthetic heart valve structure (prosthetic valve 100), comprising:
a heart valve stent (stent 102) according to claims 1 (see above),
a heart valve prosthesis (3) (skirt 106 and leaflet structure 104) comprising a leaflet assembly (31) (leaflet structure 104) and a suture ring (32) (skirt 106) that fixes the leaflet assembly (31) (leaflet structure 104) together (paragraphs [0030, 0034, 0036-0037]), wherein the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) is connected to a leaflet junction (at the connection between side portions 162) of the heart valve prosthesis (3) (skirt 106 and leaflet structure 104) which is a connection junction between every two adjacent leaflets of the leaflet assembly (31) (leaflet structure 104).
With respect to claim 10:
Valdez et al. discloses a prosthetic heart valve structure (prosthetic valve 100), as can be seen in figs. 1-4B, characterized by comprising:
a stent body (1) (all of stent 102 except the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) (paragraphs [0039-0040]);
a heart valve prosthesis (3) (skirt 106 and leaflet structure 104) comprising a leaflet assembly (31) (leaflet structure 104) and a suture ring (32) (skirt 106) that fixes leaflet assembly (31) (leaflet structure 104) together (paragraphs [0030, 0034, 0036-0037]), wherein a connection junction between every two adjacent leaflets of the leaflet assembly (31) (leaflet structure 104) forms a leaflet junction (at the connection between side portions 162) of the heart valve prosthesis (3) (prosthetic valve 100), as can be seen in fig. 1;
a joint member (2) (the portions of attachment posts 112 above (closer to the top of the page in fig 4A) the attachment point of the main row 118 with the attachment posts 112) comprising a fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118) and an elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) connected to the fixed part (subsection of the portion of attachment posts 112 closer to the intersection with the main row 118), wherein the fixed part subsection of the portion of attachment posts 112 closer to the intersection with the main row 118) is connected (via sutures 168) to the suture ring (32) (skirt 106) (paragraph [0037]), and the elastic stretching part (subsection of the portion of attachment posts 112 closer to the free end thereof) is connected (via sutures 168) to the leaflet junction (at the connection between side portions 162) (paragraph [0037]).
Claim(s) 1-3, 5-10, 12-15 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Chung et al. (US 2018/0289475 A1).
With respect to claim 1:
Chung et al. discloses a heart valve stent, as can be seen in figs. 14A-14F (paragraph [0126]), characterized by comprising:
a stent body (1) (outer band 158, as seen in figs. 6A-6B, OR inner band 242, as seen in figs. 11A-11F) (paragraphs [0102-0103, 0110]);
a joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) comprising a fixed part (subsection of commissural support closer to curved segments 260) and an elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) connected to the fixed part (subsection of commissural support closer to curved segments 260) (paragraph [0112]), wherein an end (the free end thereof) of the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) away from the fixed part (subsection of commissural support closer to curved segments 260) is a movable end (is considered moveable as it is not restrained from flexing by another structure).
With respect to claim 2:
Characterized in that the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) has a long strip shape (Examiner is considering the commissural supports to have a “strip shape”).
With respect to claim 3:
Characterized in that, when the elastic joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is in an original state (the state as seen in the figures), a central axis of the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is parallel to (as it is not shown or disclosed to be angled/ tapered in or out) a central axis of the stent body (1) (outer band 158, as seen in figs. 6A-6B, OR inner band 242, as seen in figs. 11A-11F).
With respect to claim 5:
Characterized in that the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is formed by an elastic material with biocompatibility (stretchable material that is configured to be implanted) (paragraph [0103]).
With respect to claim 6:
Characterized in that the fixed part (subsection of commissural support closer to curved segments 260) is integrally formed with the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof), as can be seen in figs. 6B or 11E.
With respect to claim 7:
Characterized in that the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) extends beyond the stent body (1) in an axial direction of the stent body (1) (outer band 158, as seen in figs. 6A-6B, OR inner band 242, as seen in figs. 11A-11F), as can be seen in figs. 6B or 11E.
With respect to claim 8:
Characterized in that cross-section of the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) has a rectangular shape, as can be seen in fig. 6B.
With respect to claim 9:
Chung et al. discloses a prosthetic heart valve structure (prosthetic heart valve 280), comprising:
a heart valve stent according to claim 1 (see above),
a heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts) comprising a leaflet assembly (31) (leaflets) and a suture ring (32) (sewing ring 292, and skirts) that fixes the leaflet assembly (31) (leaflets) together (paragraph [0126]), wherein the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) is connected to a leaflet junction (where the leaflets touch as they wrap around the commissural supports) of the heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts) which is a connection junction between every two adjacent leaflets of the leaflet assembly (31) (leaflets).
With respect to claim 10:
Chung et al. discloses a prosthetic heart valve structure (prosthetic heart valve 280), as can be seen in figs. 14A-14F (paragraph [0126]), characterized by comprising:
a stent body (1) (outer band 158, as seen in figs. 6A-6B, OR inner band 242, as seen in figs. 11A-11F) (paragraphs [0102-0103, 0110]);
a heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts) comprising a leaflet assembly (31) (leaflets) and a suture ring (32) (sewing ring 292, and skirts) that fixes leaflet assembly (31) (leaflets) together (paragraph [0126]), wherein a connection junction (at the commissural supports) between every two adjacent leaflets of the leaflet assembly (31) (leaflets) forms a leaflet junction (where the leaflets touch as they wrap around the commissural supports) of the heart valve prosthesis (3) (prosthetic heart valve 280);
a joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) comprising a fixed part (subsection of commissural support closer to curved segments 260) and an elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) connected to the fixed part (subsection of commissural support closer to curved segments 260) (paragraph [0112]), wherein the fixed part (subsection of commissural support closer to curved segments 260) is connected to (will be surrounded by) the suture ring (32) (sewing ring 292, and skirts), and the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) is connected to the leaflet junction (where the leaflets touch as they wrap around the commissural supports), as can be seen in figs. 5A.
With respect to claim 12:
Characterized in that the fixed part (subsection of commissural support closer to curved segments 260) of the joint member (2) (subsection of outer band 244, as can be seen in figs. 11A-11F) is located between the stent body (1) (inner band 242, as seen in figs. 11A-11F) and the suture ring (32) (sewing ring 292, and skirts) (paragraphs [0102-0103, 0110, 0126]).
With respect to claim 13:
Characterized in that the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) has a long strip shape (Examiner is considering the commissural supports to have a “strip shape”), and a central axis of the joint member (2) (commissural support of inner band 156 or outer band 244) is parallel to (as it is not shown or disclosed to be angled/ tapered in or out) a central axis of the stent body (1) (outer band 158, as seen in figs. 6A-6B, OR inner band 242, as seen in figs. 11A-11F); the length of the elastic stretching part (subsection of commissural supports 262 closer to the free ends thereof) is the same as the length of the leaflet junction (where the leaflets touch as they wrap around the commissural supports) (PLEASE NOTE: the commissural support can be subdivided in such a manner a portion thereof can be the same length as the leaflet junction).
With respect to claim 14:
Characterized in that the number of the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is the same as the number of the leaflet junction (where the leaflets touch as they wrap around the commissural supports), wherein one joint member (2) is fixed at each leaflet junction, as can be seen in the figures.
With respect to claim 15:
Characterized in that the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is formed by an elastic material with biocompatibility (stretchable material that is configured to be implanted) (paragraph [0103]).
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chung et al. (US 2018/0289475 A1) in view of Schreck (US 2004/0186565 A1).
With respect to claim 11:
Chung et al. discloses the invention substantially as claimed, as discussed above. Additionally, Chung et al. discloses the heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts) is a fabric (comprises a cloth covering) (paragraphs [0126, 0131]), and the joint member (2) (subsection of inner band 156 with commissural support, as can be seen in figs. 6A-6B OR subsection of outer band 244 with commissural support, as can be seen in figs. 11A-11F) is arranged inside (radially inside from an inner surface of the leaflet material at the commissural support, as can be seen in the figures) the fabric of the heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts). However, Chung et al. does not disclose the fabric (cloth covering) to be woven.
Schreck teaches a prosthetic heart valve, as can be seen in figs. 1-2, comprising a fabric section (34) covering a frame (tubular base 40) (paragraph [0050]). The fabric section (34) comprises a woven fabric (woven polyester) (paragraph [0049]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the woven fabric (woven polyester), as taught by Schreck, to make the suture ring (32) (sewing ring 292, and skirts) of the heart valve prosthesis (3) (including leaflets, sewing ring 292, and skirts), as disclosed by Chung et al., as both structures (the fabric section (34), as taught by Schreck, and sewing ring 292, and skirts), as disclosed by Chung et al.) are used for similar purposes (both are used to within prosthetic heart valve to attach a leaflets to a frame and to create a sealing mechanism around the frame) and should therefore be made from interchangeable materials.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774