CTNF 18/509,005 CTNF 78798 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Election/Restrictions 08-08 AIA 2. Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-6 , drawn to a method , classified in A61F 2/954 . II. Claim s 7-20 , drawn to a system for use with a branching implant site , classified in A61M 25/10 . The inventions are distinct, each from the other because of the following reasons: 08-17 3. Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In the instant case, the apparatus as claimed can be used to practice another and materially different process . For example, instead of placing a stent into a diseased bifurcated vessel, the apparatus may be used to perform an angioplasty of an aorto-iliac bifurcation. Or the device may be used for implantation within a lung bronchial tube to monitor bronchial activity. Alternatively, the process as claimed can be practiced by another and materially different apparatus or by hand . For example, instead of using a balloon-expandable stent, the process can be practiced with a self-expandable stent. 08-21 AIA 4. Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph . Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 5. This application contains claims directed to the following patentably distinct species: DEPLOYMENT SYSTEM Species A - embodied in Figure 3 Species B - embodied in Figure 4 (includes a sock 406, and one or more sock wire(s) 408; deployment system 402 is not covered by the catheter sleeve 312 during placement; sock 406 may be a rolled up sleeve that surrounds the catheter lumen 314. As illustrated, when in the rolled up configuration, the sock 406 is in a distal position relative to the balloon 404) 6. The species are independent or distinct because claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record. Applicant is required under 35 U.S.C. 121 to elect a single disclosed species for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. 08-01 There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species , including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election. The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species. Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141. 7. During a telephone conversation with Attorney Jeremy Barton on 11 March 2026 a provisional election was made without traverse to prosecute the invention of Group/Invention II ( drawn to a system for use with a branching implant site) , claims 7-20. Affirmation of this election must be made by applicant in replying to this Office action. 8. During a telephone conversation with Attorney Jeremy Barton on 11 March 2026 a provisional election was made without traverse to prosecute the invention of DEPLOYMENT SYSTEM – Species B ( embodied in Figure 4). Affirmation of this election must be made by applicant in replying to this Office action. 9. Claims 1-6 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 10. 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. 07-15 AIA 11. Claim s 7-10 and 13-18 are rejected under 35 U.S.C. 102( a)(1 ) as being clearly anticipated by White et al. (US 6,045,557) . Regarding independent claim 7 and independent claim 14, White et al. ‘557 discloses a deployment system for use with a branching implant site (Figure 1) having a trunk (11), a first branch (12), and a second branch (13), the system comprising: an expandable branching stent prosthesis (C2:L23-26) having a trunk portion (10), a first branching portion (19a, or 19a + 10b), and a second branching portion (19b, or 19b + 10a); a balloon (Figure 6 – balloon 20) within the expandable branching stent prosthesis; a distal end of a floss wire (Figure 6 – wire 26) that passes through the first branching portion of the expandable branching stent prosthesis and out the second branching portion of the expandable branching stent prosthesis (Abstract; C6:L63 to C7:L3; C7:L13-16); and a catheter lumen (Figure 6 – catheter lumen 25, or catheter lumen 56, or catheter lumen 24) configured to support the distal end of the floss wire, the expandable branching stent prosthesis, and the balloon during a delivery of the distal end of the floss wire, the expandable branching stent prosthesis, and the balloon to the branching implant site (C6:L63 to C7:L10). Regarding claim 8, White et al. ‘557 discloses wherein the distal end of the floss wire terminates in a catch (Figures 6a-6c – catch 55; Figure 6d – catch 70/72). Notice - the particular structure of the “a catch” is NOT recited in the claim. Regarding claim 9, White et al. ‘557 discloses wherein the balloon is configured to inflate to deploy the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis (C3:L44-46; C4:L17-20; C4:L38-41; C6:L19-28; C7:L24-30). Regarding claim 10, White et al. ‘557 discloses wherein the balloon is further configured to inflate to deploy the second branching portion of the expandable branching stent prosthesis (C3:L44-46; C4:L17-20; C4:L38-41; C6:L19-28; C7:L24-30). Regarding claim 13, White et al. ‘557 discloses wherein the branching implant site is within a vascular system (aorta 11). Regarding claim 15, White et al. ‘557 discloses further comprising a catheter sleeve (Figure 6 – catheter sleeve 56) configured to surround the distal end of the floss wire, the expandable branching stent prosthesis, the balloon, and the catheter lumen during the delivery. Regarding claim 16, White et al. ‘557 discloses wherein the distal end of the floss wire terminates in a catch (Figures 6a-6c – catch 55; Figure 6d – catch 70/72). Notice - the particular structure of the “a catch” is NOT recited in the claim. Regarding claim 17, White et al. ‘557 discloses wherein the balloon is configured to inflate to deploy the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis (C3:L44-46; C4:L17-20; C4:L38-41; C6:L19-28; C7:L24-30). Regarding claim 18, White et al. ‘557 discloses wherein the balloon is further configured to inflate to deploy the second branching portion of the expandable branching stent prosthesis (C3:L44-46; C4:L17-20; C4:L38-41; C6:L19-28; C7:L24-30) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 12. 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 13. Claim s 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 6,045,557) in view of Brucker et al. (US PG Pub No. 2007/0168020 A1; cited in Applicant’s IDS) and Harari et al. (US PG Pub No. 2004/0049204 A1) . Regarding claim 11, White et al. ‘557 discloses the invention as claimed, except for particularly disclosing further comprising a sock configured to be pulled over the balloon. However, this is already known in the art. For example: Brucker et al. ‘020 teaches (Figures 1, 2, and 7) a housing 32 may be characterized as a sheath, sleeve, or sock suitable for retaining a stent in its collapsed state onto a stent receiving region 38 of the catheter 10, wherein the stent receiving region 38 includes the balloons 80, 82, wherein sleeves 34 and 36 which formed the housing 32 may be self-retracting or include one or more pullback mechanisms (see paragraphs [0050]-[0052]; figures 1-2, 6-7). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a sock configured to be pulled over the balloon, as taught by Brucker et al. ‘020 , with the invention of White et al. ‘557 , in order to retain the balloon in a collapsed state onto a catheter. Harari et al. ‘204 teaches (Figure 2) a sock (27) configured to be pulled over a balloon (26) in order to hold the balloon in its contracted state on a catheter ([0021]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a sock configured to be pulled over the balloon, as taught by Harari et al. ‘204 , with the invention of White et al. ‘557 , in order to hold the balloon in its contracted state on a catheter. Regarding claim 12, at the time of the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to have used polytetrafluoroethylene (PTFE) as the material of the sock of White et al. ‘557 in view of Brucker et al. ‘020 and Harari et al. ‘204, s ince it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin , 125 USPQ 416 . 07-21-aia AIA 14. Claim s 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 6,045,557) in view of Brucker et al. (US PG Pub No. 2007/0168020 A1; cited in Applicant’s IDS) and Harari et al. (US PG Pub No. 2004/0049204 A1) . Regarding claim 19, White et al. ‘557 discloses the invention as claimed, except for particularly disclosing further comprising a sock configured to be pulled over the balloon. However, this is already known in the art. For example: Brucker et al. ‘020 teaches (Figures 1, 2, and 7) a housing 32 may be characterized as a sheath, sleeve, or sock suitable for retaining a stent in its collapsed state onto a stent receiving region 38 of the catheter 10, wherein the stent receiving region 38 includes the balloons 80, 82, wherein sleeves 34 and 36 which formed the housing 32 may be self-retracting or include one or more pullback mechanisms (see paragraphs [0050]-[0052]; figures 1-2, 6-7). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a sock configured to be pulled over the balloon, as taught by Brucker et al. ‘020 , with the invention of White et al. ‘557 , in order to retain the balloon in a collapsed state onto a catheter. Harari et al. ‘204 teaches (Figure 2) a sock (27) configured to be pulled over a balloon (26) in order to hold the balloon in its contracted state on a catheter ([0021]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of further comprising a sock configured to be pulled over the balloon, as taught by Harari et al. ‘204 , with the invention of White et al. ‘557 , in order to hold the balloon in its contracted state on a catheter. Regarding claim 20, White et al. ‘557 discloses further comprising a catheter sleeve (Figure 6 – catheter sleeve 56) configured to surround the distal end of the floss wire, the expandable branching stent prosthesis, the balloon, and the catheter lumen during the delivery. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm). If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JAVIER G BLANCO/ Primary Examiner, Art Unit 3774 Application/Control Number: 18/509,005 Page 2 Art Unit: 3774 Application/Control Number: 18/509,005 Page 3 Art Unit: 3774 Application/Control Number: 18/509,005 Page 4 Art Unit: 3774 Application/Control Number: 18/509,005 Page 5 Art Unit: 3774 Application/Control Number: 18/509,005 Page 6 Art Unit: 3774 Application/Control Number: 18/509,005 Page 7 Art Unit: 3774 Application/Control Number: 18/509,005 Page 8 Art Unit: 3774 Application/Control Number: 18/509,005 Page 9 Art Unit: 3774 Application/Control Number: 18/509,005 Page 10 Art Unit: 3774 Application/Control Number: 18/509,005 Page 11 Art Unit: 3774 Application/Control Number: 18/509,005 Page 12 Art Unit: 3774 Application/Control Number: 18/509,005 Page 13 Art Unit: 3774