DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 April 2026 has been entered.
Claims 1 – 15 and 21 - 25 are pending in the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 25 recites the limitation “dampening fluid”. Specification discloses “dampening material” in paragraphs [0085] – [0091]. Thus, the specification is devoid of any structure corresponding to the limitation “dampening fluid” as recited in the claim 25.
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.
Claim 25 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 25, they are also indefinite as Applicant does not appear to have support for a “dampening fluid” in the disclosure (thus the metes and bounds of the claim are uncertain) and alternatively has discussed the dampening material to by polypropylene.
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.
Claims 1 – 2, 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Auld et al (US 20190274689 A1, hereinafter Auld) in view of Ekvall et al (US 20130053874 A1, hereinafter “Ekvall”).
Regarding claim 1 , Auld teaches a sphincter augmentation device (“a sphincter augmentation device that may be adjusted to vary a restrictive force imposed by the device on an anatomical structure”, [0001]) comprising:
(a) a plurality of bodies (“a plurality of beads (30)”, [0038], Figures 3 – 5B), wherein each of the bodies includes:
(i) a housing (“housings (32, 34)”, [0038], Figures 3 - 5B) including a central axis (see annotated Auld’s Figure 4 below) therethrough, and
(ii) a plurality of magnets (“magnets (60)”, [0038], Figures 4 - 5B) positioned within the housing (32, 34),
wherein the plurality of magnets (60) of each body are configured to magnetically bias the bodies (30) toward one another ([0041]),
wherein the plurality of magnets (60) of each body are configured to move within the housing (32, 34) of the respective body ([0041], Figure 5B; Examiner interprets when the device is in a contracted configuration, the magnets move within the housing, considering there is a bit of space in Auld’s Figure 4.); and
(b) a linking structure (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B) configured to link the plurality of bodies (30) together to form the bodies (30) in an annular array ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is sized to be positioned around a human lower esophageal sphincter (“LES (6)”, [0035] – [0038], [0051]) so that the bodies (30) and the linking structure (40) bear inwardly against the lower esophageal sphincter (6) ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is configured to transition between a radially expanded state (Figures 5A and 5B, [0041]) and a radially contracted state (Figures 5A and 5B, [0041]) to constrict the lower esophageal sphincter (6) (Figure 5A, [0041])
wherein, with respect to a body (30) of the plurality of bodies (plurality of 30), the linking structure (40) is between two magnets (60) of the plurality of magnets (60) (see annotated Auld’s Figure 4 below) (Examiner interprets Figure 4 that the linking structure (42) is between two magnets of the plurality of magnets.).
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Auld does not teach the plurality of magnets of each respective body are configured to move relative to the housing of the respective body between a first position and a second position,
wherein, in the first position, the plurality of magnets of each body are magnetically aligned with each other,
wherein, in the second position, the plurality of magnets of each body are aligned with an externally applied magnetic field
wherein the first position is different from the second position.
However, Ekvall discloses “Systems and methods are described for the use of floating magnetic elements in medical implants” (abstract) and teaches the plurality of magnets (“magnetic elements” [0005], [0034] [0049], Figure 1) of each respective body (Figure 1) are configured to move relative to the housing (Figure 1) of the respective body between a first position and a second position (“The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1),
wherein, in the first position, the plurality of magnets of each body are magnetically aligned with each other (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]),
wherein, in the second position, the plurality of magnets of each body are aligned with an externally applied magnetic field (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]),
wherein the first position is different from the second position ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld such that the plurality of magnets of each respective body are configured to move relative to the housing of the respective body between a first position and a second position, wherein, in the first position, the plurality of magnets of each body are magnetically aligned with each other, wherein, in the second position, the plurality of magnets of each body are aligned with an externally applied magnetic field, wherein the first position is different from the second position, as taught by Ekvall, for the benefit of preventing “magnetic material in a medical implant to depolarize or repolarize [or] induce undesirable forces on the medical implant” (Ekvall: [0003]).
Regarding claim 2, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the magnets (“magnets (60)”, [0038], Figures 4 - 5B) of each body (“a plurality of beads (30)”, [0038], Figures 3 – 5B) are positioned within the housing (“housings (32, 34)”, [0038], Figures 3 - 5B) in an annular array (Figures 3 – 5B; see annotated Auld’s Figure 4 under claim 1) about the central axis (Figures 3 – 5B; see annotated Auld’s Figure 4 under claim 1).
Regarding claim 4, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the magnets (“magnets (60)”, [0038], Figures 4 - 5B) of each body (“a plurality of beads (30)”, [0038], Figures 3 – 5B) are positioned within the housing (“housings (32, 34)”, [0038], Figures 3 - 5B) in a pair of coaxial annular arrays about the central axis (see annotated Auld’s Figure 4 under claim 1) (Figure 4).
Regarding claim 12, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the linking structure includes a plurality of bands (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B),
wherein each of the bands includes a first end (see annotated Auld’s Figure 4 below) and a second end (see annotated Auld’s Figure 4 below),
wherein the first ends are configured to slidably link with the second ends (see annotated Auld’s Figure 4 below; Examiner interprets the bands’ ends are linked/connected since the wires are within a bead.).
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Claims 3 and 9 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Auld in view of Shelton et al (US 20190029794 A1, hereinafter Shelton ‘794).
Regarding claim 3, Auld and Ekvall teach all limitations of claim 2. Auld and Ekvall do not teach each magnet of the plurality of magnets has a spherical shape.
However, Shelton ‘794 discloses “the invention pertains to implants and insertion tools for a biological lumen and/or passageway” ([0001]) and teaches each magnet of the plurality of magnets has a spherical shape (“spherical magnets (452)”, [0128], [0130] - [0131], [0133]; Figures 15A – 15B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that each magnet of the plurality of magnets has a spherical shape, as taught by Shelton ‘794, for the benefit of having the spherical magnets move relative to each other radially (Shleton ‘794: [0148]).
Regarding claim 9, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teach the linking structure (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B) includes a band (“wire (42)”, [0039]),
wherein the band is configured to transition between a first state ([0064] – [0067], Figures 5A, 12A and 14A) when not acted upon by the externally applied magnetic field ([0064] – [0067], Figures 5A, 12A and 14A) and a second state ([0064] – [0067], Figures 5B, 12B and 14B) when acted upon by the externally applied magnetic field (“the exposure to the substantially strong external magnetic field applied from magnetic device (400) reduces the magnetic strength of magnets (60).”, [0064] – [0067], “exposing magnets (60) to the substantially strong electromagnetic field”, [0069] – [0070], Figures 5B, 12B and 14B),
wherein the band in the second state is configured to allow the plurality of bodies (“a plurality of beads (30)”, [0038], Figures 3 – 5B) to align with the externally applied magnetic field ([0064] – [0067], “exposing magnets (60) to the substantially strong electromagnetic field”, [0069] – [0070], Figures 5B, 12B and 14B; Examiner interprets the end result position of bodies reads on the limitation “… align with the external magnetic field”.),
wherein when no longer acted upon by the externally applied magnetic field the band is configured to return to the first state ([0064] – [0067], Figures 5A, 12A and 14A) without damaging or distorting the band (“magnetic bias of magnets (60) will return device (20) to the contracted state shown in FIG. 5B”, [0042], [0064] – [0067], Figures 5A, 12A and 14A; Examiner interprets the device contracts and expands without damaging or distorting the band in order to not hurt the user.).
Auld and Ekvall do not teach the band is flexible and the flexible band is elastic.
However, Shelton ‘794 discloses “implants and insertion tools for a biological lumen and/or passageway” ([0001]) and teaches a flexible band (“a flexible cord (454)”, [0129]),
wherein the flexible band (454) is elastic (“Cord (454) may flex to accommodate movement of spherical magnets”, [0129]; Examiner interprets the cord flexing reads on the limitation “elastic”.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall to incorporate the flexible band and the flexible band is elastic, as taught by Shelton ‘794, for the benefit of “help[ing] form a seal, thereby transitioning occludable opening (160) from the opened state back to the occluded state” (Shelton ‘794: [0082]).
Regarding claim 10, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the linking structure (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B) includes a band having a first end (see annotated Auld’s Figure 4 below) and a second end (see annotated Auld’s Figure 4 below),
wherein the first end and the second end (see annotated Auld’s Figure 4 below) are slidably linked together ([0039], [0042], [0045] – [0046],Figures 4, 5A – 5B).
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The modified invention of Auld and Ekvall does not teach the band is flexible.
However, Shelton ‘794 discloses “implants and insertion tools for a biological lumen and/or passageway” ([0001]) and teaches a flexible band (“a flexible cord (454)”, [0129]),
wherein the flexible band (454) is elastic (“Cord (454) may flex to accommodate movement of spherical magnets”, [0129]; Examiner interprets the cord flexing reads on the limitation “elastic”.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall to incorporate the flexible band and the flexible band is elastic, as taught by Shelton ‘794, for the benefit of “help[ing] form a seal, thereby transitioning occludable opening (160) from the opened state back to the occluded state” (Shelton ‘794: [0082]).
Claims 5 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over Auld and Ekvall, as applied in claim 1, in view of Choi (US 20120032534 A1).
Regarding claim 5, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the housing (Auld: “housings (32, 34)”, [0038], Figures 3 - 5B), the magnets (“magnets (60)”, [0038], Figures 4 - 5B), the first position (Ekvall: “The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1) and second position (Ekvall: “The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1).
The modified invention of Auld and Ekvall does not teach a dampening feature configured to reduce movement of the magnets when transitioning from the first position to the second position.
However, Choi discloses “a linear vibrator, including: a stator including a coil; and a vibrator including a magnet opposite to the coil” (abstract) and teaches a dampening feature (“a damper 121”, [0044]) configured to reduce movement of the magnets (“magnet 170”, [0034], [0045]) when transitioning from a first position to a second position (“prevent touch noise and abrasion”, [0044]; Examiner interprets the magnet moves as Choi’s device vibrates.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that a dampening feature configured to reduce movement of the magnets when transitioning from the first position to the second position, as taught by Choi, for the benefit of “prevent[ing] touch noise and abrasion” (Choi: [0044]) and “absorbing impact” (Choi: [0044]).
Regarding claim 6, Auld and Choi teach all limitations of claim 5. The modified invention of Auld and Choi teaches the dampening feature (Choi: “a damper 121”, [0044]) comprises polypropylene (“as a material of the damper, not only a magnetic fluid capable of absorbing impact of the vibrator but also various materials capable of absorbing impact such as rubber, cork, polypropylene, or the like may be used [0044]).
Claims 7 - 8 are rejected under 35 U.S.C. 103 as being unpatentable over Auld in view of Kratzberg et al (US 20160113654 A1, hereinafter Kratzberg).
Regarding claim 7, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall teaches the housing (Auld: “housings (32, 34)”, [0038], Figures 3 - 5B) includes two end caps (see annotated Auld’s Figure 5B below) and a middle section (see annotated Auld’s Figure 5B below).
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The modified invention of Auld and Ekvall does not teach wherein the end caps are constructed of a different material than the middle section.
However, Kratzberg discloses “[m]agnetically actuated gating devices” (abstract) and teaches two end caps (see annotated Kratzberg’s Figure 1 below) are constructed of a different material than a middle section (see annotated Kratzberg’s Figure 1 below) ([0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that the end caps are constructed of a different material than the middle section, as taught by Kratzberg, for the benefit of providing a suitable combination of materials based on various considerations (Kratzberg: [0058]).
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Regarding claim 8, Auld, Ekvall and Kratzberg teach all limitations of claim 7. The modified invention of Auld, Ekvall and Kratzberg teaches the two end caps (Auld: see annotated Auld’s Figure 5B under claim 7) are constructed of a non-ferromagnetic material (Auld: “formed of a non-ferrous material (e.g., titanium, plastic, etc.)”, [0038]).
The modified invention of Auld, Ekvall and Kratzberg does not teach the middle section is constructed of a ferromagnetic material.
However, Kratzberg discloses “[m]agnetically actuated gating devices” (abstract) and discloses a middle section is constructed of a ferromagnetic material (“a cap include […] metals such as stainless steel, titanium, nickel-titanium alloy (e.g., Nitinol), polymers, Pebax, nylon, polyethylene, polyurethane, silicone, combinations of the materials described herein”, [0058]; Examiner interprets stainless steel to read on the limitation “a ferromagnetic material”.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld, Ekvall and Kratzberg such that the middle section is constructed of a ferromagnetic material, as taught by Kratzberg, for the benefit of providing a suitable material under various considerations (Kratzberg: [0058]) and “reducing the complications associated with AVFs and assist with fistula maturation” (Kratzberg: [0058]).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Auld and Ekvall, as applied in claim 10, in view of Dlugos et al (US 20110071558 A1, Dlugos).
Regarding claim 11, Auld and Ekvall teach all limitations of claim 10. The modified invention of Auld and Ekvall teaches the first end (see annotated Auld’s Figure 4 below) is located on a first portion (see annotated Auld’s Figure 4 below) of the flexible (Shelton ‘794: “a flexible cord (454)”, [0129]) band (Auld: “wire (42)”, [0039]) and the second end (see annotated Auld’s Figure 4 below) is located on a second portion (see annotated Auld’s Figure 4 below) of the flexible band.
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The modified invention of Auld and Ekvall does not teach wherein the first portion is configured to slide within the second portion of the band.
However, Dlugos discloses an “laparoscopic implanted restriction system designed to be implanted in the body of a patient around a biological organ having a pouch or duct to regulate functioning of the organ or duct” ([0002]) and teaches the first portion ([0130], see annotated Dlugos’s Figure 30 below) is configured to slide within the second portion ([0130], see annotated Dlugos’s Figure 30 below) of the band (Examiner interprets the band as shaft 208 and shaft 210 of Dlugos.) ([0130], see annotated Dlugos’s Figure 30 below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that the first portion is configured to slide within the second portion of the band, as taught by Dlugos, for the benefit of to “minimize[ing] patient discomfort and recuperation time” (Dlugos: [0011]) and “regulating functioning of a body organ or duct that provides high precision in controlling the degree of constriction imposed upon the organ or duct, without the drawbacks” (Dlugos: [0012]).
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Regarding claim 13, Auld and Ekvall teach all limitations of claim 12. The modified invention of Auld and Ekvall teaches the first end (see annotated Auld’s Figure 4 below) is located on a first portion (see annotated Auld’s Figure 4 below) of each band (“links (40)”, [0007], [0038], Figures 3 – 5B) and the second end (see annotated Auld’s Figure 4 below) is located on a second portion (see annotated Auld’s Figure 4 below) of each band (40).
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The modified invention of Auld and Ekvall does not teach wherein the first portion is configured to slide within the second portion of the band.
However, Dlugos discloses an “laparoscopic implanted restriction system designed to be implanted in the body of a patient around a biological organ having a pouch or duct to regulate functioning of the organ or duct” ([0002]) and teaches the first portion ([0130], see annotated Dlugos’s Figure 30 below) is configured to slide within the second portion ([0130], see annotated Dlugos’s Figure 30 below) of the band (Examiner interprets the band as shaft 208 and shaft 210 of Dlugos.) ([0130], see annotated Dlugos’s Figure 30 below). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that the first portion is configured to slide within the second portion of the band, as taught by Dlugos, for the benefit of to “minimize[ing] patient discomfort and recuperation time” (Dlugos: [0011]) and “regulating functioning of a body organ or duct that provides high precision in controlling the degree of constriction imposed upon the organ or duct, without the drawbacks” (Dlugos: [0012]).
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Claims 14 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Auld in view of Ren et al (CN 106264651 A, see attached translation, hereinafter Ren).
Regarding claim 14, Auld and Ekvall teach all limitations of claim 1. The modified invention of Auld and Ekvall does not teach the central axis of the housing is offset from the linking structure.
However, Ren discloses a “novel arteria radialis hemostat” (abstract) and teaches a central axis of a housing (“outer frame 4”, page 4, paragraph 1; Figure 1) is offset from a linking structure (“disposable bandage 6”, page 4, paragraph 1; Figure 1) (Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall to incorporate the central axis of the housing is offset from the linking structure, as taught by Ren, for the benefit of providing fine adjustment to the housing and not easily shift (Ren: page 2, paragraph 5).
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Regarding claim 15, Auld, Ekvall and Ren teach all limitations of claim 14. The modified invention of Auld, Ekvall and Ren does not teach the housing is rotatably coupled to the linking structure with a pin extending transversely through the linking structure and retained by a tab on a side opposite the housing.
However, Ren discloses a “novel arteria radialis haemostat” (abstract) and teaches a housing (“outer frame 4”, page 4, paragraph 1; Figure 1) is rotatably coupled to a linking structure (“disposable bandage 6”, page 4, paragraph 1; Figure 1) with a pin (see annotated Ren’s Figure 1 under claim 14) extending transversely (Examiner interprets Ren’s Figure 1 where in the pin does extend transversely through as Figure 1 portrays.) through the linking structure (6) and retained by a tab (see annotated Ren’s Figure 1 under claim 14) on a side opposite the housing (4) (see annotated Ren’s Figure 1 under claim 14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Ekvall such that the housing is rotatably coupled to the linking structure with a pin extending transversely through the linking structure and retained by a tab on a side opposite the housing, as taught by Ren, for the benefit of providing fine adjustment to the housing and improving the locking function (Ren: page 2, paragraph 5).
Claims 21 - 25 are rejected under 35 U.S.C. 103 as being unpatentable over Auld in view of Choi in further view of Ekvall.
Regarding claim 21, Auld teaches a sphincter augmentation device (“a sphincter augmentation device that may be adjusted to vary a restrictive force imposed by the device on an anatomical structure”, [0001]) comprising:
(a) a plurality of bodies (“a plurality of beads (30)”, [0038], Figures 3 – 5B), wherein at least one of the bodies includes:
(i) a housing (“housings (32, 34)”, [0038], Figures 3 - 5B) including a central axis (see annotated Auld’s Figure 4 below) therethrough,
(ii) at least one magnet (“magnets (60)”, [0038], Figures 4 - 5B) positioned within the housing (32, 34), wherein the at least one magnet (60) is configured to magnetically bias the bodies (30) toward one another ([0041]),
wherein the at least one magnet (60) is configured to move within the housing (32, 34) ([0041], Figure 5B Examiner interprets when the device is in a contracted configuration, the magnets move within the housing, considering there is a bit of space in Auld’s Figure 4.); and
(b) a linking structure (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B) configured to link the plurality of bodies (30) together to form the bodies (30) in an annular array ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is sized to be positioned around a human lower esophageal sphincter (“LES (6)”, [0035] – [0038], [0051]) so that the bodies (30) and the linking structure (40) bear inwardly against the lower esophageal sphincter (6) ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is configured to transition between a radially expanded state (Figures 5A and 5B, [0041]) and a radially contracted state (Figures 5A and 5B, [0041]) to constrict the lower esophageal sphincter (6) (Figure 5A, [0041]).
Auld does not teach (iii) a dampening feature in contact with the at least one magnet, wherein the dampening feature is configured to dampen a movement of the magnet relative to the housing;
wherein the at least one magnet of each at least one body is configured to move relative to a respective housing of each respective at least one body between a first position and a second position,
wherein, in the first position, the at least one magnet is magnetically misaligned with either an externally applied magnetic field being in a first state or an absence of the externally applied magnetic field,
wherein, in the second position, the at least one magnet is aligned with the externally applied magnetic field being in a second state,
wherein the first position is different from the second position,
wherein the first state and the second state are different.
However, Choi discloses “a linear vibrator, including: a stator including a coil; and a vibrator including a magnet opposite to the coil” (abstract) and teaches (iii) a dampening feature (Choi: “magnetic fluid band 172”, [0049], [0051], [0053], Figure 1) in contact with the at least one magnet (“magnet 170”, [0052] – [0053], Figure 1), wherein the dampening feature (172) is configured to dampen a rotation of the at least one magnet (170) relative to the housing (“case 110”, [0034] – [0035], [0042], Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld to incorporate (iii) a dampening feature in contact with the at least one magnet, wherein the dampening feature is configured to dampen a movement of the magnet relative to the housing, as taught by Choi, for the benefit of preventing the inner components such as the magnet to move/vibrate due to impact (Choi: [0049]).
The modified invention of Auld and Choi does not teach wherein the at least one magnet of each at least one body is configured to move relative to a respective housing of each respective at least one body between a first position and a second position,
wherein, in the first position, the at least one magnet is magnetically misaligned with either an externally applied magnetic field being in a first state or an absence of the externally applied magnetic field,
wherein, in the second position, the at least one magnet is aligned with the externally applied magnetic field being in a second state,
wherein the first position is different from the second position,
wherein the first state and the second state are different.
However, Ekvall discloses “Systems and methods are described for the use of floating magnetic elements in medical implants” (abstract) and teaches the at least one magnet (“magnetic elements” [0005], [0034] [0049], Figure 1) of each at least one body (Figure 1) is configured to move relative to a respective housing (Figure 1) of each respective at least one body between a first position and a second position (“The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1),
wherein, in the first position, the at least one magnet is magnetically misaligned with either an externally applied magnetic field being in a first state or an absence of the externally applied magnetic field, (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]),
wherein, in the second position, the at least one magnet is aligned with the externally applied magnetic field being in a second state (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]),
wherein the first position (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]) is different from the second position (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]) are different ([0034]),
wherein the first state (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]) and the second state (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]) are different ([0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Choi such that wherein the at least one magnet of each at least one body is configured to move relative to a respective housing of each respective at least one body between a first position and a second position, wherein, in the first position, the at least one magnet is magnetically misaligned with either an externally applied magnetic field being in a first state or an absence of the externally applied magnetic field, wherein, in the second position, the at least one magnet is aligned with the externally applied magnetic field being in a second state, wherein the first position is different from the second position, wherein the first state and the second state are different, as taught by Ekvall, for the benefit of preventing “magnetic material in a medical implant to depolarize or repolarize [or] induce undesirable forces on the medical implant” (Ekvall: [0003]).
Regarding claim 22, Auld, Choi and Ekvall teach all limitations of claim 21. The modified invention of Auld, Choi and Ekvall teaches the at least one magnet (Auld: “magnets (60)”, [0038], Figures 4 - 5B) of the at least one body (Auld: “a plurality of beads (30)”, [0038], Figures 3 – 5B) is positioned within the housing (Auld: “housings (32, 34)”, [0038], Figures 3 - 5B) in an annular array about the central axis (see annotated Auld’s Figure 4 under claim 22) (Auld: Figure 4).
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Regarding claim 23, Auld, Choi and Ekvall teach all limitations of claim 22. The modified invention of Auld and Ekvall teaches at least a portion of the at least one magnet (Auld: “magnets (60)”, [0038], Figures 4 - 5B) is configured to rotate within the respective housing (Auld: “housings (32, 34)”, [0038], Figures 3 - 5B) when moving between the first position (Ekvall:“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]) and second position (Ekvall: “the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]) (Ekvall: “The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1).
Regarding claim 24, Auld, Choi and Ekvall teach all limitations of claim 21. The modified invention of Auld and Ekvall teaches the at least one magnet (Auld: “magnets (60)”, [0038], Figures 4 - 5B) of the at least one body (Auld: “a plurality of beads (30)”, [0038], Figures 3 – 5B) is positioned within the housing (Auld: “housings (32, 34)”, [0038], Figures 3 - 5B) in a coaxial annular array about the central axis (see annotated Auld’s Figure 4 under claim 21) (Auld: Figure 4).
Regarding claim 25, a sphincter augmentation device (“a sphincter augmentation device that may be adjusted to vary a restrictive force imposed by the device on an anatomical structure”, [0001]) comprising:
(a) a plurality of bodies (“a plurality of beads (30)”, [0038], Figures 3 – 5B), wherein each of the bodies includes:
(i) a housing (“housings (32, 34)”, [0038], Figures 3 - 5B) including a central axis (see annotated Auld’s Figure 4 below) therethrough, and
(ii) at least one magnet (“magnets (60)”, [0038], Figures 4 - 5B) positioned within the housing (32, 34),
wherein the at least one magnet (“magnets (60)”, [0038], Figures 4 - 5B) is configured to magnetically bias the bodies (30) toward one another ([0041]),
wherein the at least one magnet (30) is configured to move within the housing (32, 34); and
(b) a linking structure (“a plurality of links (40)”, [0007], [0038], Figures 3 – 5B) configured to link the plurality of bodies (30) together to form the bodies (30) in an annular array ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is sized to be positioned around a human lower esophageal sphincter (“LES (6)”, [0035] – [0038], [0051]) so that the bodies (30) and the linking structure (40) bear inwardly against the lower esophageal sphincter (6) ([0041] – [0042], Figures 5A and 5B);
wherein the annular array ([0041] – [0042], Figures 5A and 5B) is configured to transition between a radially expanded state (Figures 5A and 5B, [0041]) and a radially contracted state (Figures 5A and 5B, [0041]) to constrict the lower esophageal sphincter (6) (Figure 5A, [0041]).
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Auld does not teach (iii) a dampening fluid in contact with the at least one magnet, wherein the dampening fluid is configured to dampen a rotation of the at least one magnet relative to the housing;
wherein the at least one magnet of each respective body is configured to move relative to a respective housing of each respective body between a first position and a second position,
wherein, in the first position, the at least one magnet of a first body of the pluralities of bodies is magnetically misaligned with the at least one magnet of a second body of the plurality of bodies,
wherein, in the second position, each of the at least one magnet of the first body and the second body are aligned with an externally applied magnetic field to thereby also be aligned with each other,
wherein the first position is different from the second position.
However, Choi discloses “a linear vibrator, including: a stator including a coil; and a vibrator including a magnet opposite to the coil” (abstract) and teaches (iii) a dampening fluid (Choi: “magnetic fluid band 172”, [0049], [0051], [0053], Figure 1) in contact with the at least one magnet (“magnet 170”, [0052] – [0053], Figure 1), wherein the dampening fluid (172) is configured to dampen a rotation of the at least one magnet (170) relative to the housing (“case 110”, [0034] – [0035], [0042], Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld to incorporate a dampening fluid in contact with the at least one magnet, wherein the dampening fluid is configured to dampen a rotation of the at least one magnet relative to the housing, as taught by Choi, for the benefit of preventing the inner components such as the magnet to move/vibrate due to impact (Choi: [0049]).
The modified invention of Auld and Choi does not teach wherein the at least one magnet of each respective body is configured to move relative to a respective housing of each respective body between a first position and a second position,
wherein, in the first position, the at least one magnet of a first body of the pluralities of bodies is magnetically misaligned with the at least one magnet of a second body of the plurality of bodies,
wherein, in the second position, each of the at least one magnet of the first body and the second body are aligned with an externally applied magnetic field to thereby also be aligned with each other,
wherein the first position is different from the second position.
However, Ekvall discloses “Systems and methods are described for the use of floating magnetic elements in medical implants” (abstract) and teaches wherein the at least one magnet (“magnetic elements” [0005], [0034] [0049], Figure 1) of each respective body (Figure 1) is configured to move relative to a respective housing (Figure 1) of each respective body between a first position and a second position (“The flexible linkage may engage each of the housings in numerous ways provided that the connection between the flexible linkage and each of the housings does not impair the ability of magnetic elements within each of the housings to freely rotate”, [0005], [0034] [0049], Figure 1),
wherein, in the first position, the at least one magnet of a first body of the pluralities of bodies is magnetically misaligned with the at least one magnet of a second body of the plurality of bodies (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]),
wherein, in the second position, each of the at least one magnet of the first body and the second body are aligned with an externally applied magnetic field to thereby also be aligned with each other (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]),
wherein the first position (“after removal of the stronger magnetic fields (e.g., outside an MRI scanner), the magnetic elements may rotate and align themselves with each other and resume their medical functionality.”, [0034]) is different from the second position (“the magnetic elements within the medical implant are allowed to rotate freely to align with an external magnetic field, such as that of an MRI scanner”, [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Auld and Choi such that wherein the at least one magnet of each respective body is configured to move relative to a respective housing of each respective body between a first position and a second position, wherein, in the first position, the at least one magnet of a first body of the pluralities of bodies is magnetically misaligned with the at least one magnet of a second body of the plurality of bodies, wherein, in the second position, each of the at least one magnet of the first body and the second body are aligned with an externally applied magnetic field to thereby also be aligned with each other, wherein the first position is different from the second position, as taught by Ekvall, for the benefit of preventing “magnetic material in a medical implant to depolarize or repolarize [or] induce undesirable forces on the medical implant” (Ekvall: [0003]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejections above.
Conclusion
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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