CTNF 18/553,894 CTNF 99352 DETAILED ACTION 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. 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 “naked segment” of claim 1 and the “groove” of claim 9 must be shown or the features canceled from the claims. No new matter should be entered. 06-22 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 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 7-9 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 7 recites the limitation "the second constraint member" in lines 3-7. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to initially state “an annular second constraint member ” in lines 1-2 rather than “an annular second constraint piece” to clarify. Claims 8-9 are rejected by dependency. Claim 7 recites the limitation "the external force" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this force is synonymous with the “radial constraint force” of the claim, or an entirely different force acting upon the device. Claims 8-9 are rejected by dependency. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-12-aia AIA (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. 07-15 AIA Claim s 1, 3-6, and 10 are rejected under 35 U.S.C. 102( a)(1) and (a)(2 ) as being anticipated by Armstrong et al. (US 2002/0198588 A1), “Armstrong” . Regarding claim 1, Armstrong teaches A medical stent (Fig. 1, endoprosthesis 10) , comprising a covered segment (Fig. 1, first segment 14) and a naked segment (Fig. 1, second segment 16) ; wherein the covered segment comprises a cut stent body (Fig. 1, first segment 14 comprises stent element 12) and a film material arranged on the cut stent body (Fig. 1, cover 18 is provided along length of stent element 12 of first segment 14 [0048]) ; at least one end of the covered segment is connected with a naked segment (Fig. 1, endoprosthesis 10 comprises junction between first and second segments 14, 16 [0051]) , and at least one of the naked segments comprises a braided stent body (Fig. 1, second segment 16 comprises a chain-linked stent pattern [0050]) ; wherein the covered segment comprises a first section (Fig. 1, center portion of first segment 14) , and the medical stent is configured such that an inner diameter of the first section in a first expansion state is smaller than an inner diameter of the cut stent body in a free state (Fig. 1, diameter of second segment 16 is larger than first segment 14 [0053]) , and when the first section is subjected to a radially outward force, the first section expands radially outward (Fig. 4, endoprosthesis 10 expands to an enlarged deployed diameter a [0091]) . Regarding claim 3, Armstrong teaches wherein the braided stent body is in hot-melting connection with the film material (Fig. 1, first segment 14 and cover 18 are adhered together [0049] through heat treatment [0070]) ; and/or, the medical stent further comprises a connecting tape, and the connecting tape passes through a hole on the braided stent body and is in hot-melting connection with the film material (this limitation is seen as non-limiting due to the “and/or” statement) . Regarding claim 4, Armstrong teaches wherein 3-9 holes are formed on the braided stent body in an axial direction of the medical stent (Fig. 3, second segment 16 comprises 3-4 holes in stent pattern 20) ; and/or, 4-8 holes are formed on the braided stent body in a circumferential direction of the medical stent (this limitation is seen as non-limiting due to the “and/or” statement) . Regarding claim 5, Armstrong teaches wherein the medical stent is a self-expanding stent (Fig. 1, stent element 12 self-expands to deployed configuration [0052]) , and when the medical stent is in the first expansion state (Fig. 4, compacted diameter b) , a region of the cut stent body corresponding to the first section is subjected to a radial constraint force that is greater than the self-expanding force of the cut stent body in the free state (Fig. 4, center portion of first segment 14 is subjected to a compacting force that minimizes its diameter [0091]) . Regarding claim 6, Armstrong teaches wherein the film material is at least coated on an outer surface of the cut stent body (Fig. 1, cover 18 may line the outside of stent element 12 [0049]) , and an inner diameter of a region of the film material arranged on the outer surface of the cut stent body corresponding to the first section is smaller than an outer diameter of the cut stent body in the free state when the medical stent is in the first expansion state (Fig. 4, diameter b of endoprosthesis 10 expands from constrained state (first expansion state) to an expanded deployed state having a larger diameter a (free state) [0053-0054]) so that the film material exerts the radial constraint force on the cut stent body (Fig. 1, cover 18 helps maintain the dimensions of the endoprosthesis 10 and prevents uncontrolled elongation of stent element 12 [0057]) . Regarding claim 10, Armstrong teaches wherein when the first section (Fig. 1, first segment 14) is subjected to the external force (Fig. 4, endoprosthesis 10 expands to an enlarged deployed diameter a [0091]) , the region of the film material (Fig. 1, cover 18) corresponding to the first section is plastically deformed so that the radial constraint force is reduced and the first section expands radially outward (Fig. 1, cover 18 is elastic in nature and has sufficient excess material incorporated to allow for stretching to its fully deployed diameter [0091-0095]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Armstrong et al. (US 2002/0198588 A1), “Armstrong” in view of Shahriari et al. (US 2017/0128243 A1), “Shahriari” . Regarding claim 2, Armstrong teaches wherein the braided stent body is formed by braiding a wire (Fig. 1, second segment 16 comprises a chain-linked stent pattern of wire 22 [0050]) , but fails to teach a first constraint member, and the first constraint member is arranged on the braided stent body and constrains an end of the wire. Shahriari teaches a stent device comprising a first constraint member (Fig. 1, radially constraining members 24) , and the first constraint member is arranged on the braided stent body and constrains an end of the wire (Fig. 1, radially constraining members 24 are configured to release first segment 94 of stent device 26 [0050]) . Shahriari discloses that the release of each constraining member allows the stent to be deployed in a manner which best fits the aorta [0063] . Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the braided stent body taught by Armstrong with the constraint members and their features in order to deploy the stent in a controlled manner for a best fit in the vasculature. Regarding claim 7, Armstrong teaches the first section (Fig. 1, center portion of first segment 14) and covered segment (Fig. 1, first segment 14) , but fails to teach further comprising an annular second constraint piece sleeved over the first section; wherein the second constraint member is configured such that an inner diameter of the second constraint member in the first expansion state is smaller than an outer diameter of the covered segment in the free state, and the second constraint member exerts the radial constraint force on the cut stent body, and when the first section is subjected to the external force, the second constraint member is plastically deformed or broken and the radial constraint force is reduced, so that the first section is caused to expand radially outward. Shahriari teaches a stent device comprising an annular second constraint piece sleeved over the first section (Fig. 1, radially constraining members 24) ; wherein the second constraint member is configured such that an inner diameter of the second constraint member in the first expansion state is smaller than an outer diameter of the covered segment in the free state (Fig. 1, radially constraining members 24 constrain a diameter of stent device 26 (first state) and then releases to allow first segment 94 of stent device 26 to expand to its deployed configuration 82 (free state) [0047-0050]) , and the second constraint member exerts the radial constraint force on the cut stent body (Fig. 1, radially constraining members 24 constrain a diameter of stent device 26 [0047]) , and when the first section is subjected to the external force, the second constraint member is plastically deformed or broken and the radial constraint force is reduced, so that the first section is caused to expand radially outward (Fig. 1, radially constraining members 24 are configured to release a first segment 94 of stent device 26 into expanded configuration 82 [0047-0050]) . Shahriari discloses that the release of each constraining member allows the stent to be deployed in a manner which best fits the aorta [0063] . Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the covered segment and first section taught by Armstrong with the constraint members and their features in order to deploy the stent in a controlled manner for a best fit in the vasculature. Regarding claim 8, Armstrong fails to teach the limitations of claim 8. Shahriari teaches a stent device wherein the second constraint member is formed by connecting both ends of a linear structure (Fig. 15, constraining members 24 are sheaths 53) ; and/or, the second constraint member is provided with a weakened structure to reduce a strength of the second constraint member (Fig. 15, sheaths 53 comprise eyelets 76) . Shahriari discloses that the release of each constraining member allows the stent to be deployed in a manner which best fits the aorta [0063] . Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Armstrong with the constraint members and their features in order to deploy the stent in a controlled manner for a best fit in the vasculature. Regarding claim 9, Armstrong fails to teach the limitations of claim 9. Shahriari teaches a stent wherein the weakened structure comprises at least one of a hole and a groove (Fig. 15, sheaths 53 comprise eyelets 76) . Shahriari discloses that the release of each constraining member allows the stent to be deployed in a manner which best fits the aorta [0063] . Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Armstrong with the constraint members and their features in order to deploy the stent in a controlled manner for a best fit in the vasculature. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST. 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, THOMAS BARRETT can be reached at (571) 272-4746. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /G.G.R./Examiner, Art Unit 3774 /THOMAS C BARRETT/SPE, Art Unit 3799 Application/Control Number: 18/553,894 Page 2 Art Unit: 3774 Application/Control Number: 18/553,894 Page 3 Art Unit: 3774 Application/Control Number: 18/553,894 Page 4 Art Unit: 3774 Application/Control Number: 18/553,894 Page 5 Art Unit: 3774 Application/Control Number: 18/553,894 Page 6 Art Unit: 3774 Application/Control Number: 18/553,894 Page 7 Art Unit: 3774 Application/Control Number: 18/553,894 Page 8 Art Unit: 3774 Application/Control Number: 18/553,894 Page 9 Art Unit: 3774 Application/Control Number: 18/553,894 Page 10 Art Unit: 3774 Application/Control Number: 18/553,894 Page 11 Art Unit: 3774 Application/Control Number: 18/553,894 Page 12 Art Unit: 3774