DETAILED ACTION
This Office Action is responsive to the Amendment filed 18 August 2025. Claims 1 - 24 are now pending. The Examiner acknowledges the amendments to claims 1 – 9, 11 – 13, 16 – 21 and 24.
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 .
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 Objections
Claims 1, 7, 17 and 20 are objected to because of the following informalities:
Claim 1, line 17, “and integrated support device” should read –and the integrated support device--.
Claim 7, line 4, “fixate the support device” should read --fixate the integrated support device--.
Claim 17, line 2, "to said magnets" should read --to said two magnets--.
Claim 20, line 1, "the cover" should read --the tubular cover--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1 – 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, line 13, the limitation "affixing the fundus" renders the claim unclear as it raises the question whether it is the “fundus” from esophagus or stomach, considering “a fundus side of the esophagus” of line 5 and “a fundus of a stomach” of line 10.
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 – 12 and 21 - 24 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US 20140148645 A1) in view of Jakobsson et al (US 6102922 A, hereinafter Jakobsson).
Regarding claim 1, Forsell teaches a method of treating reflux disease in a human patient ([0029]) by implanting an apparatus (abstract) comprising a movement restriction device (“movement restriction device 10”, [0096], [0098], Figures 1A – 1C), the movement restriction device (10) is at arranged on a fundus side of the esophagus (Figures 1A – 1C) to restrict movement of a cardia in relation to a diaphragm to hinder the cardia from sliding through a diaphragm opening into the patient's thorax ([0011], [0037]), the method comprising the steps of:
introducing the apparatus (abstract) into the abdominal cavity (Figures 1A – 1C; “ introducing the movement restriction device into the abdominal cavity”, claim 1);
placing the apparatus (abstract) such that the movement restriction device (10) rests against the outside of the stomach's fundus (Figures 1A – 1C, “placing the movement restriction device contacting the stomach fundus wall”, claim 1);
wrapping a portion of the fundus around at least a part of the movement restriction device (10) (Figures 1A – 1C, “affixing the device contacting the stomach fundus wall”, claim 1);
affixing the fundus to the esophagus such that the movement restriction device (10) is arranged at a position between the diaphragm and the cardiac sphincter (Figures 1A – 1C), and such that a part of the fundus is arranged between the movement restriction device (10) and the esophagus (Figures 1A – 1C, “ affixing the stomach fundus wall, the movement restriction device, or the stomach fundus wall and the movement restriction device, to the lower part of the patient's esophagus by providing sutures or staples”, claim 4).
Forsell does not teach with an integrated support device, such that the integrated support device at least partly encircles an esophagus of the patient, methods comprising the steps of: arranging the integrated support device to at least partly encircle the esophagus; wherein the device and integrated support device form a ring-shaped body extending at least partly encircling the esophagus.
However, Jakobsson discloses a “surgical method for reducing the food intake of a patient includes the steps of dissecting the lower part of the Esophagus, applying a band to form a loop around the Esophagus, displacing an upper part of the stomach through the loop, so as to form a small pouch” (abstract) and teaches with an integrated support device (“band 11”, column 6, lines 23 - 24, Figures 1 and 2), such that the integrated support device (11) at least partly encircles an esophagus of the patient (column 7, lines 24 - 26 Figure 1), methods comprising the steps of:
arranging the integrated support device (11) to at least partly encircle the esophagus (column 7, lines 24 – 26; Figure 1);
wherein the device (11) and integrated support device (11; Examiner interprets as the integrated support device.) form a ring-shaped body extending at least partly encircle the esophagus (Figure 1). Examiner interprets Jakobsson’s “band 11” (column 6, lines 23 - 24, Figures 1 and 2) to attach to Forsell’s “movement restriction device 10” ([0096], [0098]) such that to form a ring-shaped body extending through a pouch to at least partly encircle the esophagus.
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 method of Forsell and Jakobsson to incorporate with an integrated support device, such that the support device at least partly encircles the esophagus of the patient, methods comprising the steps of: arranging the support device to at least partly encircle the esophagus; wherein the combination of the movement restriction device from Forsell and the second portion form a ring-shaped body extending through the pouch to at least partly encircle the esophagus, as taught by Jakobsson’s, for the benefit of reducing the food intake of a patient (column 2, lines 54 - 56) and decreasing the band hurting and migrating through the wall of the esophagus (Jakobsson: column 3, lines 15 - 17).
Regarding claim 2, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method comprising placing the apparatus (Forsell: abstract) such that the movement restriction device (Forsell: “movement restriction device 10”, [0096], [0098], Figures 1A – 1C) rests against the outside of the fundus at a position between the cardiac sphincter and a portion of the fundus that is to be affixed to the esophagus (Forsell: Figures 1A – 1C).
Regarding claim 3, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method comprising placing the apparatus (Forsell: abstract) such that a portion of the fundus that is affixed to the esophagus is arranged between the cardiac sphincter and the movement restriction device (Forsell: Figures 1A – 1C).
Regarding claim 4, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the pouch is formed to be open in at least two positions to form a tunnel through which the apparatus extends (Examiner interprets Jakobsson’s “band 11” (column 6, lines 23 - 24, Figures 1 and 2) to attach Forsell’s “movement restriction device 10” ([0096], [0098]) such that the pouch is formed to be open in at least two positions to form a tunnel through which the apparatus extends. See annotated Forsell’s Figure 1A below.).
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Regarding claim 5, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method comprising affixing a portion of the fundus to the patient's diaphragm (Forsell: “affixing the stomach fundus wall to the patient's diaphragm muscle or associated muscles”, [0040]).
Regarding claim 6, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method affixing the fundus to the esophagus includes suturing or stapling (Forsell: “affixing the stomach fundus wall to the lower part of the patient's esophagus by providing sutures or staples”, [0040]).
Regarding claim 7, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) comprises a first end portion and a second end portion (Jakobsson: “ends 15, 17”, column 6, lines 28 – 32, Figure 2) between which the esophagus can be introduced (Jakobsson: column 7 , lines 24 – 26, Figure 1), and
wherein the first end portion and the second end portion (Jakobsson: respectively, 15, 17) can be coupled to each other (Jakobsson: “The ends 15, 17 of the outer wall 13 may be joined to each other, e.g., by suturing, by a snap-lock connection, or by any other suitable joining means”, column 6, lines 28 - 32) so as to fixate the support device (Jakobsson: 11) to the esophagus in an encircling manner (Jakobsson: column 7 , lines 24 – 26, Figure 1; column 6, lines 28 – 32, Figure 2).
Regarding claim 8, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method further comprising:
inserting a needle or a tubular instrument into the patient's abdomen (Forsell: “inserting a needle or a tube like instrument into the abdomen of the patient's”, [0037]);
using the needle or the tubular instrument to fill the abdomen with a gas (Forsell: “using the needle or tube like instrument to fill the patient's abdomen with gas” [0037]); placing at least two laparoscopic trocars in the abdomen (Forsell: “placing at least two laparoscopic trocars in the patient's body” [0037]);
inserting a camera through one of the laparoscopic trocars into the abdomen (Forsell: “inserting a camera through one of the laparoscopic trocars into the patient's abdomen” [0037]);
inserting at least one dissecting tool through one of the laparoscopic trocars (Forsell: “inserting at least one dissecting tool through one of said at least two laparoscopic trocars” [0037]);
dissecting a portion of the stomach (Forsell: “; dissecting an area of the stomach” [0037]); and
at least partly closing the pouch by means of sutures, or staples (Forsell: “providing sutures or staples to the stomach fundus wall” [0037]).
Regarding claim 9, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) comprises a variable length (Jakobsson: “adjusted to have its maximum size just after the operation”, column 7, lines 38 - 39) for allowing the apparatus be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing. The limitation “for allowing the apparatus be arranged in a constricting state for hindering fluid from passing from the stomach into the esophagus and in an expanded state for allowing food to pass into the stomach in response to the patient swallowing” is intended use. Since Jakobsson teaches the device’s length can be adjusted (Jakobsson: column 7, lines 37 - 47), the device of Jakobsson is capable of performing the intended use as claimed.
Regarding claim 10, Forsell and Jakobsson teach all limitations of claim 9. The modified invention of Forsell and Jakobsson teaches the movement restriction device (Forsell: “movement restriction device 10”, [0096], [0098], Figures 1A – 1C) has a substantially fixed shape during operation of the apparatus (Forsell: [0022] – [0023], Figures 1A – 1C).
Regarding claim 11, Forsell and Jakobsson teach all limitations of claim 9. The modified invention of Forsell and Jakobsson teaches the support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) is configured to allow a transition from the constricting state into the expanded state caused by the food passing through the esophagus (Jakobsson: column 7, lines 37 – 47; Figure 1).
Regarding claim 12, Forsell and Jakobsson teach all limitations of claim 9. The modified invention of Forsell and Jakobsson teaches the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) is configured to exert an encircling pressure (Jakobsson: “the band to be inflated under a pressure in said cavity”, column 3, lines 30 - 33) on the esophagus in the constricting state (Jakobsson: column 6, lines 23 - 24, Figures 1 and 2).
Regarding claim 21, Forsell and Jakobsson teach all limitations of claim 1. Forsell teaches the apparatus (Forsell: abstract) further comprises an electrode arrangement (Forsell: [0032]) comprising an electrode element (Forsell: [0032]) and configured to electrically stimulate muscle tissue of the esophagus (Forsell: [0032]) but does not teach that the electrode element is supported by the integrated support device.
However, Jakobsson discloses a “surgical method for reducing the food intake of a patient includes the steps of dissecting the lower part of the Esophagus, applying a band to form a loop around the Esophagus, displacing an upper part of the stomach through the loop, so as to form a small pouch” (abstract) and teaches an element (“support portion 25”, column 7, lines 6 - 8) is supported by an integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2). 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 method of Forsell and Jakobsson such that the apparatus further comprises an electrode arrangement comprising an electrode element supported by the support device, as taught by Jakobsson, for the benefit of “send[ing] out stimulation pulses to the cardia muscle to stimulate the cardia muscle and thereby further close the cardia to additionally prevent reflux disease” (Forsell: [0032]).
Regarding claim 22, Forsell and Jakobsson teach all limitations of claim 21. The modified invention of Forsell and Jakobsson teaches the electrode arrangement (Forsell: [0032]) is configured to electrically stimulate the cardiac sphincter of the patient to cause the cardiac sphincter to contract (“in which the cardia sphincter is stimulated with said energy pulses”, [0032]). The limitation “to cause the cardiac sphincter to contract” is intended use. Since Forsell teaches the device the cardia sphincter is stimulated with said energy pulses (Forsell: [0032]), the device of Forsell is capable of performing the intended use as claimed.
Regarding claim 23, Forsell and Jakobsson teach all limitations of claim 22. The modified invention of Forsell and Jakobsson teaches the electrode arrangement (Forsell: [0032]) is configured to stimulate opposing sides of the cardiac sphincter (Forsell: [0032], [0117]).
Regarding claim 24, Forsell and Jakobsson teach all limitations of claim 1. The modified invention of Forsell and Jakobsson teaches the method comprising an electrode arrangement (Forsell: [0032]) configured to be arranged between the movement restriction device (Forsell: “movement restriction device 10”, [0096], [0098], Figures 1A – 1C) and the portion of the fundus. Examiner interprets the combination of Forsell and Jakobsson to meet the limitation “to be arranged between the movement restriction device and the portion of the fundus”.
The limitation “to exercise the muscle tissue to improve conditions for long-term implantation of the movement restriction device” is intended use. Since Forsell and Jakobsson, in combination, teach the device (Jakobsson: “band 11”, column 7, lines 19 - 22) accomplishing a satisfying long-term result of the method of the invention, (Jakobsson: column 7, lines 19 - 22), the device of Forsell and Jakobsson is capable of performing the intended use as claimed.
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 method of Forsell and Jakobsson such that the method comprising an electrode arrangement, as taught by Jakobsson, for the benefit of “send[ing] out stimulation pulses to the cardia muscle to stimulate the cardia muscle and thereby further close the cardia to additionally prevent reflux disease” (Forsell: [0032]).
Claims 13 - 17 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell and Jakobsson in view of Kugler et al (US-20050283235-A1, hereinafter Kugler).
Regarding claim 13, Forsell and Jakobsson teach all limitations of claim 12. The modified invention of Forsell and Jakobsson teaches the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) but does not teach an attractor for resiliently attracting portions to one another to generate the encircling pressure.
However, Kugler discloses a “plurality of structures that resiliently attract one another are provided for implanting in a patient around a body tissue structure of the patient” and teaches an attractor (“links 30", [0038], Figures 1 - 6) for resiliently attracting portions (“beads 20”, [0038]-[0040], Figures 1 - 6) to one another to generate the encircling pressure ([0045], Figure 2). 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 method of Forsell and Jakobsson, as taught by Kugler, for the benefit of preventing the device from applying excessive pressure to tissue passing through that area (Kugler: abstract).
Regarding claim 14, Forsell, Jakobsson and Kugler teach all limitations of claim 13. The modified invention of Forsell, Jakobsson and Kugler teaches the attractor (Kugler: “links 30", [0038], Figures 1 - 6) comprises an elastic element (Kugler: “elastic material”, [0067]).
Regarding claim 15, Forsell, Jakobsson and Kugler teach all limitations of claim 13. The modified invention of Forsell, Jakobsson and Kugler teaches the attractor (Kugler: “links 30", [0038], Figures 1 - 6) comprises at least two mutually attracting magnets (Kugler: [0039], “magnets 80”, [0040], Figures 3 - 5).
Regarding claim 16, Forsell, Jakobsson and Kugler teach limitations of claim 15. The modified invention of Forsell, Jakobsson and Kugler teaches the integrated support device comprises a link (Kugler: “links 30", [0038], Figures 1 - 6) connecting a first and a second one of said at least two magnets (Kugler: “magnets 80”, [0040]; see annotated Kugler’s Figure 3 below) to each other (Kugler: [0039], [0040], Figures 3 - 5).
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Regarding claim 17, Forsell, Jakobsson and Kugler teach all limitations of claim 16. The modified invention of Forsell, Jakobsson and Kugler teaches the link (Kugler: “links 30", [0038], Figures 1 - 6) is configured to extend into at least one of said two magnets (Kugler: “magnets 80”, [0040]) in response to said magnets (Kugler: 80) moving towards each other (Kugler: [0039], [0040], Figures 3 - 5).
Claims 18 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Forsell and Jakobsson in view of Lee et al (US 20060241748 A1, hereinafter Lee).
Regarding claim 18, Forsell and Jakobsson teach all limitations of claim 9. The modified invention of Forsell and Jakobsson teaches the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2).
The modified invention of Forsell and Jakobsson does not teach a tubular cover enclosing at least a part of the integrated support device and comprising a plurality of cover portions adapted to bend relative to each other to allow the integrated support device to change between the constricting state and the expanded state, when the tubular cover is at least partly covered by fibrotic tissue, without being substantially hindered or impeded by a presence of said fibrotic tissue.
However, Lee discloses an “implantable device is provided for controlling at least one of shape and size of an anatomical structure or lumen” and teaches a tubular cover (“an outer fabric implant sheath 810”, [0136], Figures 25 and 26) enclosing at least a part of an integrated support device (part of the “band 805”, [0136], Figure 27) and comprising a plurality of cover portions (Figures 25 - 27) adapted to bend relative to each other to allow an integrated support device (another part of the “band 805”, [0136], Figure 27) to change between the constricting state and the expanded state (“circumference of the implant body 800 is adjusted”, [0136]; Examiner interprets the “corrugated sections” are the same as Lee’s Figure 1 in which does “corrugated sections 20 fold and unfold as the circumference of the implant body 15 shortens or lengthens” ([0115])). The limitation “when the tubular cover is at least partly covered by fibrotic tissue, without being substantially hindered or impeded by a presence of said fibrotic tissue” is intended use. Since Lee teaches the device can “fold and unfold as the circumference [changes]” ([0115]), the device of Lee is capable of performing the intended use as claimed. 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 method of Forsell and Jakobsson a tubular cover enclosing at least a part of the integrated support device and comprising a plurality of cover portions adapted to bend relative to each other to allow the integrated support device to change between the constricting state and the expanded state, as taught by Lee, for the benefit of controlling at least one of shape and size of an internal structure or lumen (Lee: [0022]).
Regarding claim 19, Forsell, Jakobsson and Lee teach all limitations of claim 18. The modified invention of Forsell, Jakobsson and Lee teaches the tubular cover (Lee: “an outer fabric implant sheath 810”, [0136], Figures 25 and 26) comprises at least one predefined fold along which the cover (Lee: 810) is allowed to fold in response to the integrated support device (Jakobsson: “band 11”, column 6, lines 23 - 24, Figures 1 and 2) varying its length (Lee: [0115]).
Regarding claim 20, Forsell, Jakobsson and Lee teaches all limitations of claim 20. The modified invention of Forsell, Jakobsson and Lee teaches the cover (Lee: “an outer fabric implant sheath 810”, [0136], Figures 25 and 26) comprises lowered and elevated portions (see Lee’s annotated Figure 25 below) allowing the tubular cover (Lee: 810) to vary its length while maintaining its surface area (Lee: Figures 25 – 27; Examiner interprets Lee’s device to maintain its surface area while in use.).
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Response to Arguments
Applicant’s arguments, see page 7, filed 18 August 2025, with respect to claim objections have been fully considered and are persuasive in light of the amendments. The claim objections for claims 1, 4, 8, 11 and 18 of 19 February 2025 have been withdrawn.
Applicant’s arguments, see page 7, filed 18 August 2025, with respect to 35 U.S.C 112(b) rejections have been fully considered and are persuasive in light of the amendments. The 35 U.S.C 112(b) rejections for claims 1 – 24 of 19 February 2025 have been withdrawn in light of the amendments except for the ones below.
Claim 1, line 13, the limitation "affixing the fundus" renders the claim unclear as it raises the question whether it is the “fundus” from esophagus or stomach, considering “a fundus side of the esophagus” of line 5 and “a fundus of a stomach” of line 10.
Applicant’s arguments, see page 7, filed 18 August 2025, with respect to double patenting have been fully considered and are persuasive in light of the amendments. The double patenting for claims 1 and 8 of 19 February 2025 have been withdrawn.
Applicant’s arguments with respect to claim(s) 1 – 24 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 rejection above.
Conclusion
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 JULIE T TRAN whose telephone number is (703)756-4677. The examiner can normally be reached Monday - Friday from 8:30 am - 5:00 pm.
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791