CTFR 17/552,780 CTFR 100842 DETAILED ACTION Response to Amendment This Office Action is responsive to the Amendment filed 8 April 2026. Claims 1-3, 5-6, 8-22 are now pending. The Examiner acknowledges the amendments to claims 1, 16, 17, 19, 20. 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 Claims 12, 1 3, 16, 19 are obje cted to because of the following informalities: -Clai m 12 recites “the respective end of the main body” in line 2. Examiner recommends amending to –the respective end of the pair of ends— -Claim 13 recites “the respective end of the main body” in line 2. Examiner recommends amending to –the respective end of the pair of ends— -Claim 16 recites “a respective housing” in line 22. Examiner recommends amending to –a respective housing of the at least one housing— -Claim 19 recites “a respective housing” in line 22. Examiner recommends amending to –a respective housing of the at least one housing— Appropriate correction is required. 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) 1, 2, 5, 6, 11, 12, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelto n (U.S. 20200197154) in view of Kugler (U.S. 20050283235). Regard ing Claim 1, Shelton teaches an apparatus comprising:(a) a plurality of beads [Fig. 5A/B, element 30 ( beads )], wherein each bead of the plurality of beads comprises:(i) at least one housing [Fig. 5A/B, elements 32, 24 ( housings )], and(ii) at least one magnet positioned within the at least one housing [Fig. 5A/B, element 60 ( magnets )]; and(b) a plurality of interconnection elements [Fig. 5A/B, element 42 ( wire )], wherein each interconnection element of the plurality of interconnection elements movably joins together a corresponding pair of beads of the plurality of beads [0054]—describes links and beads sliding along links, wherein at least a portion of each interconnection element of the plurality of interconnection elements comprises at least one composite material [Fig. 7, element 108 ( spacer )]—where the spacer is considered a portion of the interconnection elements, wherein each interconnection element of the plurality of interconnection elements comprises:(i) a main body extending between a pair of ends [Fig. 7, element 102 ( wire )], and(ii) a pair of heads [Fig. 7, elements 104, 106 ( ball tips )], wherein each head of the pair of heads is positioned at a respective end of the pair of ends [0064; “terminate into ball tips on opposite ends”]; wherein the plurality of beads and the plurality of interconnection elements are sized and configured to form a loop around an anatomical structure in a patient [Fig. 5A/B, element 6 ( LES )]; wherein the loop formed by the plurality of beads and the plurality of interconnection elements is configured to transition between a constricted configuration and an expanded configuration [0110]; wherein the loop in the constricted configuration is configured to prevent fluid flow through the anatomical structure [Fig. 5B]; wherein the loop in the expanded configuration is configured to permit fluid flow through the anatomical structure [Fig. 5A]; wherein the at least one magnet is configured to magnetically bias the loop toward the constricted configuration [0056]; and wherein the main body has a first shear strength [0085; “Therefore, it may be desirable to increase the strength of connection between ball tips (44) and wire (42).”], wherein each head of the pair of heads has a second shear strength greater than the first shear strength [0085; “In some instances, it may be desirable to increase the strength of connection between ball tips (44) and wire (42) such that the connection is stronger than the shear strength of wire (42) itself.”] Shelton is silent on wherein each head of the pair of heads includes an annular groove configured to engage with a respective housing of the at least one housing, and (iii) a washer positioned around the main body. Kugler teaches wherein each head of the pair of heads includes an annular groove configured to engage with a respective housing of the at least one housing [0040; “The lips of the cups 60 and 70 that form a bead 20 abut one another annularly around the bead. Thus the interiors of the cups 60 and 70 of a bead 20 form a hollow annular space inside the bead and concentrically around the post 62 inside the bead.”], and (iii) a washer positioned around the main body [0042; “The other end of a link 30 can be passed successively through the aperture in the bottom of a cup 60 (not yet attached to a cup 70) and the aperture in a washer-like cap 72 (also not yet attached to a cup 70).”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include features such as annular grooves and washers as taught by Kugler to design coupling features with strength properties as suggested by Shelton, as Shelton discusses attaching components to the wire via welding and orbiting methods to improve coupling strength in tension [0087] with Kugler because Kugler teaches the importance of linking components allowing for controlling the position of each bead and for allowing diameter increases of the prosthesis [0038]. Regarding Claim 2, Shelton teaches wherein the at least one composite material includes at least one polymer [0115]—where the spacer is considered a portion of the interconnection elements. Regarding Claim 5, Shelton teaches wherein the main body comprises the at least one composite material [0115]—where the spacer is considered a portion of the interconnection element and therefore, considered a portion of the main body shown to be located in the middle of the main body in Fig. 7. Regarding Claim 6, Shelton teaches wherein each head of the pair of heads comprises the at least one composite material [0066; “For example, spacer bead (108) may be formed on wire (102), may be placed on wire (102) via a resilient clip relationship, a threaded relationship, welding, adhesives, etc., or may be unitarily formed from the same material as wire (102) or ball tips (104, 106), etc.”] and [0115]. Regarding Claim 11, Shelton teaches wherein the main body includes at least one of a wire or a cable [0121]—references the link comprising a wire. Regarding Claim 12, Shelton teaches wherein each head of the pair of heads is molded onto the respective end of the main body [0107]—references the links being manufactured using metal injection molding techniques. Regarding Claim 14, Shelton teaches wherein each head of the pair of heads includes at least one crimped collar [Fig. 20, element 204 ( threaded end cap ) and 205 ( knurled surface )] . 07-21-aia AIA Claim (s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Kugler (U.S. 20050283235) and in further view of Biesel (U.S. 11864767) . Regarding Claim 3, Shelton and Kugler are silent on wherein the at least one polymer includes a liquid crystal polymer. Biesel teaches wherein the at least one polymer includes a liquid crystal polymer [Col 25, lines 40-42]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a liquid crystal polymer material as taught by Biesel as a more specific example of a polymer as suggested by Shelton and Kugler, as Shelton discusses the use of polymer and non-ferrous materials for spacer elements [0066] and Kugler which discloses the linking component made with an elastic polymer [0061] with Biesel because Biesel teaches the use of liquid crystal polymer based materials such as Kevlar due to the high-tensile strength of the material [Col 25, lines 42-46] . 07-21-aia AIA Claim(s) 8, 9 is/a re rejected under 35 U.S.C. 103 as being unpatentable over Shel ton (U.S. 20200197154) in view of Kugler (U.S. 20050283235) and in further view of Dominguez (U.S. 20120095494). Rega rding Claim 8, Shelton and Kugler are silent on wherein the main body comprises a first material, wherein each head of the pair of heads comprises a second material different from the first material, and wherein one of the first material or second material includes the at least one composite material, wherein the first material has a lower shear strength and a lower tensile strength than the second material. Dominguez teaches wherein the main body comprises a first material, wherein each head of the pair of heads comprises a second material different from the first material, and wherein one of the first material or second material includes the at least one composite material [0011] and [0049]—which discloses the adjustability element and outer tube made of composite materials PTFE, NiTi, PEEK, wherein the first material has a lower shear strength and a lower tensile strength than the second material [0049]—describes the adjustability element (interpreted to be the second material/pair of heads) has a high tensile strength and [0050]—which further describes hoop stresses applied to the object to return it to its original position while maintaining compliance of the frame. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the materials that comprise the heads and main body as taught by Dominguez to optimize structural characteristics of the materials as suggested by Shelton and Kugler, as Shelton discusses increasing the connection between the wires and ball tips [0084] and Kugler which discloses the use of elastic and polymer materials for springs and connection elements [0061] with Dominguez because Dominguez teaches the advantages of using nitinol for inert behaviors, elasticity and low frictional coefficient and silicone for its resistance to deterioration and lubricity and polymers to withstand the stomach environment for prolonged periods [0032]. Regarding Claim 9, Shelton and Kugler are silent on wherein the main body comprises a first form of the at least one composite material, and wherein each head of the pair of heads comprises a second form of the at least one composite material different from the first form of the at least one composite material. Dominguez teaches wherein the main body comprises a first form of the at least one composite material, and wherein each head of the pair of heads comprises a second form of the at least one composite material different from the first form of the at least one composite material 0011]—where the use of the recitation “form” is broadly interpreted to include different types and classifications of materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary the materials that comprise the heads and main body as taught by Dominguez to optimize structural characteristics of the materials as suggested by Shelton and Kugler, as Shelton discusses increasing the connection between the wires and ball tips [0084] and Kugler which discloses inter-bead links creating through continuous elastic material [0067] with Dominguez because Dominguez teaches the advantages of using nitinol for inert behaviors, elasticity and low frictional coefficient and silicone for its resistance to deterioration and lubricity and polymers to withstand the stomach environment for prolonged periods [0032] . 07-21-aia AIA Claim (s) 10, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Kugler (U.S. 20050283235) and in further view of Ekvall (U.S. 20130053874) . Regarding Claim 10, Shelton and Kugler are silent on wherein the main body includes a sheath comprising a plurality of interwoven fibers. Ekvall teaches wherein the main body includes a sheath comprising a plurality of interwoven fibers [0006; “Bead-shaped housings also may be linked via interwoven flexible strands, individual links, or chain links. Alternatively, bead-shaped housings may also be linked together by flexible fabric or can be encapsulated in a flexible fabric or polymeric structure ( e.g., a band) to contain the bead-shaped housings.”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a sheath with interwoven fibers as taught by Ekvall to connect spacing between housings as suggested by Shelton and Kugler, as Shelton discusses using sleeves and shoulders to align and nest housings creating a continuous weld path [0102] and Kugler which discloses degradation of links over time due to tissue over-growth [0058] with Ekvall because Ekvall teaches the use of these fibers to control tissue ingrowth around the housing structures [0006]. Regarding Claim 15, Shelton and Kugler are silent on wherein each interconnection element of the plurality of interconnection elements further comprises a rivet having a deformable shaft. Ekvall teaches wherein each interconnection element of the plurality of interconnection elements further comprises a rivet having a deformable shaft [0046; “In some embodiments, the member may elastically expand or deform ( e.g., bend) as the circumference of the medical device is expanded.” And “The ability of the medical device to expand and contract from one state to another may depend on structural features of the member ( e.g., folds, creases, links, etc.), which allow the medical implant to vary its circumferential size without varying the overall length of the member.”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a deformable shaft with a rivet as taught by Ekvall to receive portions of the interconnection elements as suggested by Shelton and Kugler, as Shelton discusses using sleeves and shoulders to align and nest housings creating a continuous weld path [0102] and Kugler which discusses pivoting connections on the adjacent ends of links [0065] with Ekvall because Ekvall teaches these elements allowing for movement and translation along the length of the structure and distance between housings [0046] . 07-21-aia AIA Claim (s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Kugler (U.S. 20050283235) and in further view of Bishop (U.S. 20090088836) . Regarding Claim 13, Shelton and Kugler are silent on wherein each head of the pair of heads flares outwardly from the respective end of the main body. Bishop teaches wherein each head of the pair of heads flares outwardly from the respective end of the main body [0324; “FIG. 51 illustrated another embodiment of a retrieval device/system. 500. In this embodiment, the distal end of the inner sheath 502 includes a spilt section 510 that is flared to funnel the implant into the device 500.”] It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include outwardly flared heads as taught by Bishop to connect spacing between housings as suggested by Shelton and Kugler, as Shelton discloses the use of flared heads [Fig. 9, elements 114, 116] and Kugler which discloses the use of springs to increase proportions of spacing between beads [0062] with Bishop because Bishop teaches the preferred increased flexibility of the structure after implantation [0313]. Allowable Subject Matter Claims 16-22 are allowable over the prior art of record. The following is a statement of reasons for the indication of allowable subject matter: regarding claims 16-18, and 21-22, while the prior art teaches an apparatus configured to be implanted within a biological structure, the apparatus comprising:(a) a plurality of beads, wherein each bead of the plurality of beads comprises: (i) at least one housing, and(ii) at least one magnet positioned within the at least one housing; and(b) a plurality of interconnection elements, wherein each interconnection element of the plurality of interconnection elements movably joins together a corresponding pair of beads of the plurality of beads, wherein each interconnection element of the plurality of interconnection elements comprises: (i) a main body extending between a pair of ends and comprising a first material, [[and]] (ii) a pair of heads, wherein each head of the pair of heads is positioned at a respective end of the pair of ends and comprises a second material different from the first material, wherein the second material is positioned within a respective bead of the corresponding pair of beads, the prior art of record does not teach or fairly suggest wherein each head of the pair of heads includes a collar which includes an annular groove configured to engage with a respective housing, and (iv) a pair of rivets, as claimed by the applicant wherein each rivet is affixed to a respective bead of the corresponding pair of beads as claimed by the applicant. Regarding claims 19-20, while the prior art teaches An apparatus configured to be implanted within a biological structure, the apparatus comprising:(a) a plurality of beads, wherein each bead of the plurality of beads comprises:(i) at least one housing having an edge, and(ii) at least one magnet positioned within the at least one housing; and(b) a plurality of interconnection elements, wherein each interconnection element of the plurality of interconnection elements movably joins together a corresponding pair of beads of the plurality of beads, wherein each interconnection element of the plurality of interconnection elements comprises: (i) a metallic core extending between a pair of ends, wherein the metallic core includes a titanium wire core, the prior art of record does not teach or fairly suggest (ii) a composite sheath positioned over the metallic core, wherein the composite sheath includes a terminal end and a woven liquid crystal polymer having a plurality of fibers, wherein each fiber of the plurality of fibers is coated with a polyurethane antibacterial coating, (iii) a collar coupled to the terminal end to thereby be configured to engage a respective bead of the corresponding pair of beads, wherein the collar includes an annular groove configured to engage with the edge of a respective housing, wherein the collar further includes an inner portion positioned within the composite sheath and an outer portion positioned outside of the composite sheath such that the composite sheath is between the inner portion and the outer portion, and (iv) a washer positioned around the composite sheath. Response to Arguments Applicant’s arguments filed 8 April 2026 with respect to the rejection of claims 1, 2, 5, 6, 11, 12, 14 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive, however new grounds of rejection are presented in light of the amendments citing Shelton in view of Kugler. Conclusion 07-40 AIA Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL . See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm 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, Charles Marmor II can be reached at 571-272-4730. 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. /B.N.K./Examiner, Art Unit 3791 /CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791 Application/Control Number: 17/552,780 Page 2 Art Unit: 3791 Application/Control Number: 17/552,780 Page 3 Art Unit: 3791 Application/Control Number: 17/552,780 Page 4 Art Unit: 3791 Application/Control Number: 17/552,780 Page 5 Art Unit: 3791 Application/Control Number: 17/552,780 Page 6 Art Unit: 3791 Application/Control Number: 17/552,780 Page 7 Art Unit: 3791 Application/Control Number: 17/552,780 Page 8 Art Unit: 3791 Application/Control Number: 17/552,780 Page 9 Art Unit: 3791 Application/Control Number: 17/552,780 Page 10 Art Unit: 3791 Application/Control Number: 17/552,780 Page 11 Art Unit: 3791 Application/Control Number: 17/552,780 Page 12 Art Unit: 3791 Application/Control Number: 17/552,780 Page 13 Art Unit: 3791 Application/Control Number: 17/552,780 Page 14 Art Unit: 3791
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