CTNF 18/482,636 CTNF 101379 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 11 is objected to because of the following informalities: For omitting the word “wherein” . Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoang et al. US 20190365530 A1, herein referred to as Hoang, in view of Rasmussen et al. US 20120171917 A1, herein referred to as Rasmussen . Regarding claim 1, Hoang discloses an implantable medical device (Fig 1, 10) comprising: an annular frame (12) having an inflow end (Fig 5, row I; [0079]) , an outflow end (Fig 5, row V; [0079] teaches inflow end, leaving the other end to be considered the outflow end) , and a longitudinal axis ([0130] central axis) and comprising a plurality of struts (Fig 5, struts 22, struts 24, and struts 34) ; and a textile ([0041] sealing member/skirt; Fig 33, 200) defined by a first surface (Fig 34, 208 ) and an opposite second surface (Fig 34, 206) , having a longitudinal axis and a transverse axis (See Annotated Fig 34 below) , wherein the longitudinal axis of the textile is substantially parallel to the longitudinal axis of the annular frame ([0124] teaches parallel positioning axes) ; and wherein the textile has a proximal end (Annotated Fig 34 below) and a distal end (Annotated Fig 34 below) and is mounted circumferentially around a first portion of the annular frame (Fig 1, skirt 18, Hoang teaches skirt 18 being composed of textile 200) , wherein the first portion has a proximal end (Fig 5, rows I-III) and a distal end (Fig 5, rows IV-V) , wherein the proximal end of the first portion is at the inflow end of the annular frame (Fig 1) ; wherein at least a portion of the textile comprises at least one composite material comprising a first material (Fig 34, 206/208) and a second material (Fig 34, 214; [0086]) coupled together such that a crimped profile of the implantable medical device is reduced when compared to a substantially identical reference implantable medical device in the absence of the at least one composite material ([0090] Hoang teaches angled weaving of two materials to allows greater expansion) ; wherein the first material exhibits a flexibility and stretchability lower than a flexibility and stretchability of the second material ([0126-0127] teaches 214 having higher rigidity (stretch) , therefore difference in stretchability between materials used); and wherein the implantable medical device is configured to radially expand to an expanded configuration from the crimped profile ([0121]) . PNG media_image1.png 302 632 media_image1.png Greyscale But does not disclose wherein the first material has a higher mechanical strength than a mechanical strength of the second material. Rasmussen teaches wherein the first material (Fig 1, 110) has a higher mechanical strength than a mechanical strength of the second material (Fig 1, 120) ([0028] Rasmussen teaches a first material strong enough for load bearing; but is silent regarding the strength of the second material and explicitly states the second material having different characteristics than the first material [0024]) . 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 Hoang to incorporate wherein the first material has a higher mechanical strength than a mechanical strength of the second material, as taught and suggested by Rasmussen in order to have sustain load bearing (Rasmussen [0028]) . Regarding claim 2, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the proximal end of the textile is coupled to the proximal end of the first portion of the annular frame (Hoang Fig 1) , and the distal end of the textile is coupled to the distal end of the first portion of the annular frame (Hoang Fig 1) . Regarding claim 3, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the first material and the second material are at least partially superposed (Hoang Fig 1) . Regarding claim 4, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the first material is a woven material (Hoang [0107]) and/or wherein the second material is a knitted material (Hoang [0101]) . Regarding claim 5, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the second material is at least partially superposed on the first material (Rasmussen Fig 1) . Regarding claim 6, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the first material has a first length and a first width (Hoang Fig 1) , wherein the first length is measured between a proximal end and a distal end of the first material; wherein the second material has a second length and a second width (Hoang Fig 1) , wherein the second length is measured between a proximal end and a distal end of the first material (Hoang Fig 1; fully capable of being measured) ; wherein the second length is the same or different from the first length (Hoang Fig 1; lengths appear to be the same) ; and wherein the second width is the same or different from the first width (Hoang Fig 1; shown to be the same widths) . Regarding claim 7, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the first width is substantially identical to a circumference of the annular frame (Hoang [0148]) and: 1. a) wherein the second width is substantially identical to a circumference of the annular frame (Hoang Fig 1) , or 2. b) wherein the second width is smaller than a circumference of the annular frame. Regarding claim 8, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the first length is substantially identical to a length of the first portion of the annular frame (Hoang Fig 1; design choice) , or wherein the first length is shorter than a length of the first portion of the annular frame, or wherein the first length is longer than a length of the first portion of the annular frame. Regarding claim 9, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the second length is substantially identical to a length of the first portion of the annular frame (Hoang Fig 1) , or wherein the second length is shorter than a length of the first portion of the annular frame, or wherein the second length is longer than a length of the first portion of the annular frame. Regarding claim 10, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the first material and the second material are coupled by an ultrasonic welding such that at least one joining region is formed (Hoang [0118]) . Regarding claim 11, Hoang Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 10, and additionally teaches wherein two or more joining regions (Fig 5, Struts 24) are disposed randomly or wherein two or more joining regions are disposed in a predetermined pattern (Fig 5) . Regarding claim 12, Hoang Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches wherein a thickness of the textile at the at least one of joining regions is different from a thickness of the textile outside of the joining regions ([0113] Hoang teaches the thickness of the textile varying from areas of the frame, that would be over at least one joining region) . Regarding claim 13, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches wherein the two or more joining regions are arranged as a plurality of islands along a length of the composite material and along a circumference of the annular frame (Hoang Fig 5) . Regarding claim 14, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally teaches wherein the two or more joining regions are arranged such that the crimped profile of the implantable medical device is reduced when compared to a substantially identical reference implantable medical device in the absence of the at least one composite material (Hoang teaches thickness in the range of millimeters, without this member included the implantable device profile would be substantially identical) . Regarding claim 15, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 10, and additionally teaches wherein the at least one joining region is along the proximal end of the first portion of the annular frame and/or wherein the at least one joining region is along the distal end of the first portion of the annular frame (Hoang Fig 5) . Regarding claim 16, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 15, and additionally teaches wherein the textile is coupled to the proximal end of the first portion of the annular frame through the joining region of the composite material and/or wherein the textile is coupled to the distal end of the first portion of the annular frame through the joining region of the composite material (Hoang Fig 1) . Regarding claim 17, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and but does not explicitly disclose wherein the textile further comprises at least a portion where the first and the second materials do not overlay each other. However, in another embodiment Hoang also teaches wherein the textile further comprises at least a portion where the first and the second materials do not overlay each other ([0143]; See Fig 41, 402 and 406b) . 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 incorporate wherein the textile further comprises at least a portion where the first and the second materials do not overlay each other, as taught and suggested by Hoang in order to control skirt density (Hoang [0143]) . Regarding claim 18, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the surface of the annular frame has a second portion that is free of the textile (Hoang Fig 1) , and wherein the second portion extends between the outflow end of the annular frame and the distal end of the first portion of the annular frame (Hoang Fig 1) . Regarding claim 19, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the textile is disposed on an outer surface of the annular frame (Hoang Fig 1) and is an outer skirt (Hoang Fig 29; [0124]) . Regarding claim 20, Hoang/Rasmussen discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches: A method of forming an implantable medical device ([0112] Hoang specifically discusses the assembly of the implantable medical device) comprising: a) providing an annular frame (Hoang Fig 1, 12) having an inflow end, an outflow end, and a longitudinal axis (Hoang [0130] central axis) and comprising a plurality of struts (Fig 5, row I; [0079]) , an outflow end (Fig 5, row V; [0079] teaches inflow end, leaving the other end to be considered the outflow end) ; b) circumferentially mounting a textile defined by a first surface and an opposite second surface (Hoang Fig 29) , having a longitudinal axis and a transverse axis (Hoang Fig 1, skirt 18, Hoang teaches skirt 18 being composed of textile 200) , wherein the longitudinal axis of the textile is substantially parallel to the longitudinal axis of the annular frame (Hoang [0124] teaches parallel positioning axes) ; and wherein the textile has a proximal end and a distal end (Hoang annotated Fig 34 above) and is mounted circumferentially around a first portion of the annular frame (Fig 1, skirt 18, Hoang teaches skirt 18 being composed of textile 200) , wherein the first portion has a proximal end (Fig 5, rows I-III and a distal end Fig 5, rows IV-V) , wherein the proximal end of the first portion is at the inflow end of the annular frame (Fig 5, row V; [0079] teaches inflow end, leaving the other end to be considered the outflow end) ; wherein at least a portion of the textile comprises at least one composite material comprising a first material (Hoang Fig 34, 206/208) and a second material (Hoang Fig 34, 214; [0086]) coupled together such that a crimped profile of the implantable medical device is reduced when compared to a substantially identical reference implantable medical device in the absence of the at least one composite material ([0090] Hoang teaches angled weaving of two materials to allows greater expansion) ; wherein the first material exhibits a flexibility and stretchability lower than a flexibility and stretchability of the second material ([0126-0127] teaches 214 having higher rigidity (stretch); therefore difference in stretchability between materials used) ; and wherein the first material has higher a mechanical strength than a mechanical strength of the second material ([0028] Rasmussen teaches a first material strong enough for load bearing; but is silent regarding the strength of the second material and explicitly states the second material having different characteristics than the first material [0024; Fig 1, 120]) , and wherein the implantable medical device is configured to radially expand to an expanded configuration from the crimped profile (Hoang [0121]) . 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ADRIAN FLORES/Patent Examiner, Art Unit 3774 /THOMAS C BARRETT/ SPE, Art Unit 3799 Application/Control Number: 18/482,636 Page 2 Art Unit: 3774 Application/Control Number: 18/482,636 Page 3 Art Unit: 3774 Application/Control Number: 18/482,636 Page 4 Art Unit: 3774 Application/Control Number: 18/482,636 Page 5 Art Unit: 3774 Application/Control Number: 18/482,636 Page 6 Art Unit: 3774 Application/Control Number: 18/482,636 Page 7 Art Unit: 3774 Application/Control Number: 18/482,636 Page 8 Art Unit: 3774 Application/Control Number: 18/482,636 Page 9 Art Unit: 3774
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