CTNF 18/421,461 CTNF 89723 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 8 is objected to because of the following informalities: line 2 states “is positioned interior of to the folded-over” (emphasis added); this is grammatically incorrect, and it is suggested either the word “of” or the word “to” be deleted . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-20 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. Regarding claim 1, which recites the limitation “the at least a portion of the medial region”, on the 2 nd to last line of the claim; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the word “the”, before the words “at least”, be deleted. Regarding claim 5, which recites the limitation “the stent”, on the last line of the claim; there is insufficient antecedent basis for this limitation in the claim. In order to overcome this rejection, it is suggested the word “stent” be deleted and replaced with the words “tubular scaffold” or “expandable medical device”. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1, 6-13, 18 and 20 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Binmoeller et al. (US PG Pub. 2016/0135941), as disclosed in the IDS dated 04/23/2024, hereinafter Binmoeller . Regarding claims 1, 9 and 10, Binmoeller discloses an expandable medical device (142), illustrated in Figures 7A and 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines a folded-over portion (146) extending from the distal end region toward the proximal end region; and a membrane disposed along the at least a portion of the medial region (110) of the tubular scaffold, wherein the membrane is configured to maintain a passageway for fluid to flow therethrough and is formed from an elastic material, illustrated in Figures 7A and 7B ([0024]; [0041]; [0042] & [0066]). Regarding claim 6, Binmoeller discloses the medical device of claim 1, wherein the membrane extends along an inner surface of the medial region (110) of the tubular scaffold from the distal end region to the proximal end region, illustrated in Figure 7A ([0042]). Regarding claim 7, Binmoeller discloses the medical device of claim 1, wherein the membrane extends along a portion of an inner surface of the medial region (110) of the tubular scaffold, and wherein a portion of the medial region is devoid of the membrane (148), illustrated in Figure 7B ([0042] & [0066]). Regarding claim 8, Binmoeller discloses the medical device of claim 7, wherein the portion of the medial region which is devoid of the membrane (148) is positioned radially interior to the folded-over portion (146), illustrated in Figure 7B. Regarding claim 11, Binmoeller discloses the medical device of claim 1, wherein the medical device further comprises a retention member (144) extending radially away from the outer surface at the proximal end region, wherein the retention member (144) has a distally facing surface positioned substantially parallel to a proximally facing surface, illustrated in Figures 7A and 7B ([0066]). Regarding claims 12 and 13, Binmoeller discloses the medical device of claim 11, wherein the tubular scaffold includes interstices extending from the outer surface of the tubular scaffold to the inner surface of the tubular scaffold, and wherein the membrane spans the interstices of, and is in direct contact with the inner surface of, the portion of the tubular scaffold which defines the retention member (144), illustrated in Figures 7A and 7B ([0042] & [0066]). Regarding claim 18, Binmoeller discloses an expandable medical device (142), illustrated in Figure 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines an everted portion (146) extending from the distal end region toward the proximal end region; a membrane disposed along a first portion of the medial region (110) of the tubular scaffold, wherein a second portion (148) of the medial region (110) is devoid of the membrane, and positioned radially interior to the everted portion (146), illustrated in Figure 7B ([0024]; [0041]; [0042] & [0066]). Regarding claim 20, Binmoeller discloses an expandable medical device (142), illustrated in Figure 7B, comprising a tubular scaffold including an inner surface, an outer surface, a proximal end region, a distal end region, and a medial region (110) extending between the proximal end region and the distal end region, wherein the tubular scaffold defines a folded-over portion (146) extending from the distal end region toward the proximal end region; and a membrane disposed along a first portion of the medial region (100) of the tubular scaffold, wherein a second portion (148) of the medial region (110) is devoid of the membrane, and positioned radially interior to and spaced apart from the folded-over portion (146); and wherein the tubular scaffold further comprises a retention member (144) extending radially away from the medial region (110), wherein the retention member (144) is a double-walled flange having a distal wall positioned substantially parallel to and spaced apart from a proximal wall of the double-walled flange, illustrated in Figure 7B ([0024]; [0041]; [0042] & [0066]) . 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. 07-21-aia AIA Claim s 2-5, 14-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Binmoeller . Regarding claims 2 and 19, Binmoeller discloses the medical device of claims 1 and 18, wherein the folded-over/everted portion (146) extends away from the outer surface of the medial region (110) toward the proximal end region, illustrated in Figures 7A and 7B; and though it is not specifically disclosed that the folded-over/everted portion extends away from the outer surface at an acute angle, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the folded-over/everted portion, including extending away from the outer surface at an acute angle, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over/everted portion extending at an acute angle, as opposed to any other angle/having any other shape/form. Regarding claim 3, Binmoeller discloses the medical device of claim 2, wherein the folded-over portion (146) includes interstices extending from an outer surface of the folded-over portion to an inner surface of the folded-over portion, illustrated in Figures 7A and 7B; and though the embodiment of medical device (142), illustrated in Figures 7A and 7B, illustrate that the interstices of the folded-over portion (146) have a membrane to inhibit tissue growth, Binmoeller does state that it is possible for the membrane to only be formed around the central saddle/medial region ([0042], Last 4 Lines). Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the medical device to only have the member at the central saddle/medial region, as taught by Binmoeller, such that the interstices of the folded-over portion permit tissue to grow therein, based on intended use and/or patient need. Regarding claim 4, Binmoeller discloses the medical device of claim 3, wherein the folded-over portion (146) extends circumferentially around a longitudinal axis of the tubular scaffold, illustrated in Figures 7A and 7B. Regarding claim 5, Binmoeller discloses the medical device of claim 1, and though it is not specifically disclosed that the folded-over portion is positioned substantially parallel to a central longitudinal axis of the stent, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the folded-over portion, including being substantially parallel to a central longitudinal axis of the stent, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the folded-over portion being positioned substantially parallel to a central longitudinal axis of the stent, as opposed to having other angle/shape/form. Regarding claims 14-16, Binmoeller discloses the medical device of claim 13, wherein the distal end region (148) of the tubular scaffold includes interstices extending from the outer surface to the inner surface, and is devoid of the membrane such that tissue is permitted to grow through the interstices; and the folded-over portion (146) is spaced apart from and extends away from the outer surface of distal end region (148), illustrated in Figure 7B ([0066]); and though it is not specifically disclose that the distal end region includes a flared portion and that the folded- over portion extends at an acute angle, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the distal end region devoid of the membrane and the folded-over portion, including the distal end region having a flared portion and that the folded-over portion extending away from the outer surface at an acute angle, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Additionally, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the distal end region having a flared portion and/or the folded-over/everted portion extending at an acute angle, as opposed to any other shapes/forms. Regarding claim 17, Binmoeller discloses the medical device of claim 16, wherein the retention member (144) has an outermost diameter (D1), the folded-over portion (146) has an outermost diameter (D2), the flared portion (148) has an outermost diameter; and wherein the outmost diameter (D1) of the retention member (144) is greater than the outmost diameter (D2) of the folded-over portion (146), illustrated in Figure 7B and modified figure 7B, below. PNG media_image1.png 711 322 media_image1.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm. 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, 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. 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. /DINAH BARIA/Primary Examiner, Art Unit 3774 05/27/2026 Application/Control Number: 18/421,461 Page 2 Art Unit: 3774 Application/Control Number: 18/421,461 Page 3 Art Unit: 3774 Application/Control Number: 18/421,461 Page 4 Art Unit: 3774 Application/Control Number: 18/421,461 Page 5 Art Unit: 3774 Application/Control Number: 18/421,461 Page 6 Art Unit: 3774 Application/Control Number: 18/421,461 Page 7 Art Unit: 3774 Application/Control Number: 18/421,461 Page 8 Art Unit: 3774 Application/Control Number: 18/421,461 Page 9 Art Unit: 3774
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