DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 December 2025 has been entered.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is responsive to the Amendment filed 4 December 2025. Claims 1-3, 5-6, 8-22 are now pending. The Examiner acknowledges the amendments to claims 1, 5, 8, 9, 10, 16, 19, 20 and newly added claims 21, 22.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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.
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 –
(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.
Claim(s) 1, 2, 5, 6, 11, 12, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (U.S. 20200197154).
Regarding 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.”].
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)].
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Biesel (U.S. 11864767).
Regarding Claim 3, Shelton is 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, as Shelton discusses the use of polymer and non-ferrous materials for spacer elements [0066] 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].
Claim(s) 8, 9, 16, 17, 18, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Dominguez (U.S. 20120095494).
Regarding Claim 8, Shelton is 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, as Shelton discusses increasing the connection between the wires and ball tips [0084] 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 is 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, as Shelton discusses increasing the connection between the wires and ball tips [0084] 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 16, Shelton teaches an apparatus configured to be implanted within a biological structure [0052]—reference to inserting the implant around a malfunctioning LES, the 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 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)] wherein each head of the pair of heads includes an annular groove configured to engage with a respective bead of the plurality of beads [Fig. 35, element (weld line) and [0103; “having housings connected together at a weld lines (356)”] wherein the second material is positioned within a respective bead of the corresponding pair of beads [Fig. 5A/B, element 44 (ball tips)],
Shelton is silent on 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. Dominguez teaches 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 [0011] and [0049]—which discloses the adjustability element and outer tube made of composite materials PTFE, NiTi, PEEK,,
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, as Shelton discusses increasing the connection between the wires and ball tips [0084] 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 17, Shelton further teaches wherein the first material includes titanium [0095]—reference to the wire made of nickel titanium alloy, Nitinol.
Regarding Claim 18, Shelton further teaches wherein the second material includes a polymer [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 22, Shelton teaches wherein the main body has a first strength, wherein each head of the pair of heads has a second strength greater than the first 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.”]
Claim(s) 10, 15, 19, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Ekvall (U.S. 20130053874).
Regarding Claim 10, Shelton is 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, as Shelton discusses using sleeves and shoulders to align and nest housings creating a continuous weld path [0102] with Ekvall because Ekvall teaches the use of these fibers to control tissue ingrowth around the housing structures [0006].
Regarding Claim 15, Shelton is 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, as Shelton discusses using sleeves and shoulders to align and nest housings creating a continuous weld path [0102] with Ekvall because Ekvall teaches these elements allowing for movement and translation along the length of the structure and distance between housings [0046].
Regarding Claim 19, Shelton further teaches an apparatus configured to be implanted within a biological structure [0052]—reference to inserting the implant around a malfunctioning LES, the 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, and (iii) a collar coupled to the terminal end to thereby be configured to engage a respective bead of the corresponding pair of beads [Fig. 20, element 204 (threaded end cap), 205 (knurled surface) and 206 (terminating end)].
Shelton is silent on wherein each interconnection element of the plurality of interconnection elements comprises:(i) a metallic core extending between a pair of ends, (ii) a composite sheath positioned over the metallic core, wherein the composite sheath includes a terminal end. Ekvall teaches wherein each interconnection element of the plurality of interconnection elements comprises:(i) a metallic core extending between a pair of ends [0066] and [0048] and [0038], (ii) a composite sheath positioned over the metallic core, wherein the composite sheath includes a terminal end [Fig. 9A, elements 910 and 912 (terminal ends)].
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 metallic core and composite sheath between the linking elements as taught by Ekvall to allow for movement and translation of linked structures as suggested by Shelton, as Shelton discusses the beads sliding along links to expand and contract the device [0060] with Ekvall because Ekvall teaches the housing elements translating across the independent links and sheaths [0065].
Regarding Claim 20, Shelton further teaches wherein each interconnection element of the plurality of interconnection elements further comprises a pair of composite heads [0115] and [0066]—describes the spacer being made of a polymer material and the ball tips being made of the same material, wherein each composite head of the pair of composite heads is positioned at a respective end of the pair of ends [Fig. 7, elements 104, 106 (ball tips)] and [0064; “terminate into ball tips on opposite ends”], wherein each collar includes a composite head of the pair of composite heads [Fig. 20, element 204 (threaded end cap), 205 (knurled surface) and 206 (terminating end)] and [Fig. 35, element (weld line) and [0103; “having housings connected together at a weld lines (356)”].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Bishop (U.S. 20090088836).
Regarding Claim 13, Shelton is 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, as Shelton discloses the use of flared heads [Fig. 9, elements 114, 116] with Bishop because Bishop teaches the preferred increased flexibility of the structure after implantation [0313].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (U.S. 20200197154) in view of Dominguez (U.S. 20120095494) and in further view of Andreas (U.S. 2007064319).
Regarding Claim 21, Shelton and Dominguez are silent on wherein the main body has a first tensile strength, wherein each head of the pair of heads has a second tensile strength greater than the first tensile strength. Andreas teaches wherein the main body [Fig. 16C, elements 986 (stent segments)] has a first tensile strength [0122]—describes the segments connected under tension, wherein each head of the pair of heads [Fig. 16C, element 992 (coupling links)] has a second tensile strength greater than the first tensile strength [0139]—describes hooks disengaged by exerting axial tensile force on the segments, meaning that the force of the hooks or coupling links would be greater than that of the tensile force of the main body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design the implant and interconnection elements to elicit sufficient tensile strength and forces on one another as taught by Andreas to prevent undesired movement and interference as suggested by Shelton and Dominguez, as Shelton discloses the incorporation of a spacer bead to prevent unwanted interference [0063] and Dominguez which discloses prevention of implant migrations to allow for deformation of the structure accommodating stomach shapes/sizes and compressibility during stomach contraction [0035] with Andreas because Andreas teaches prevent of stent segments from moving, dislodging or tilting post-deployment [0012].
Response to Arguments
Applicant’s arguments filed 4 December 2025 with respect to the rejection of
claims 1, 2, 5, 7, 10, 11, 15, 19, 20 under 35 U.S.C.102(a)(1) have been fully considered and are persuasive, however, new rejections are presented above in light of the amendments for claims 1, 2, 5, 6, 11, 12, 14 in view of Shelton (U.S. 20200197154) (claims 1, 2, 5, 6, 11, 12, 14).
Applicant’s arguments filed 4 December 2025, with respect to the rejection(s)
of claim(s) 3, 6, 8, 9, 16-18, 20 under 35 U.S.C. 103 have been fully considered and are persuasive, however, new rejections are presented in light of the amendments. New ground of rejection presented above under 35 U.S.C. 103 citing Shelton in view of Biesel (claim 3), Dominguez (claims 8, 9, 16, 17, 18, 22), Ekvall (claims 10, 15, 19, 20), Bishop (claim 13) and Andreas (claim 21).
Conclusion
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791