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 .
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 348-349, 351-354 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Pugsley, Jr. et al. (US 20020161381 A1).
Regarding claim 348, Pugsley discloses a method of treating a reflux disease in a patient (para. [0001], [0025]) by implanting a movement restriction device (Fig. 2A including 205, 210, 220, 200) comprising a plurality of segments 205, 210, 220 the method comprising outside of the body of the patient, assembling the plurality of segments to form an assembled movement restriction device (i.e., the device is manufactured such that the segments are assembled and introduced into 215); introducing the assembled movement restriction device into the body of the patient (para. [0034]); and placing the assembled movement restriction device against a stomach fundus wall of the patient (paras. [0034]-[0040]; para. [0010] discloses fundoplasty and fundoplication).
Regarding claim 349, Pugsley discloses the method according to claim 348. Pugsley also discloses further comprising after assembling the plurality of segments to form the assembled movement restriction device, and before introducing the assembled movement restriction device into the body of the patient, securing the segments in an assembled position by means of a thread or wire 200 (i.e., as shown in Fig. 2A; para. [0027]-[0028]).
Regarding claim 351, Pugsley discloses the method according to claim 348. Pugsley also discloses comprising securing the assembled movement restriction device against said stomach fundus wall by means of suturing (paras. [0034]-[0040] by way of wire 200 which acts as suture to secure the anchors) and/or stapling.
Regarding claim 352, Pugsley discloses the method according to claim 351. Pugsley also discloses wherein securing the movement restriction device against said stomach fundus wall is achieved by means of suturing (paras. [0034]-[0040] by way of wire 200) and/or stapling the movement restriction device to the stomach fundus wall (paras. [0034]-[0040] by way of wire 200; para. [0010] discloses fundoplasty and fundoplication).
Regarding claim 353, Pugsley discloses the method according to claim 351. Pugsley also discloses wherein securing the movement restriction device against said stomach fundus wall is achieved by means of suturing and/or stapling stomach fundus wall tissue of the patient to stomach wall tissue of the patient (paras. [0034]-[0040] by way of wire 200; para. [0010] discloses fundoplasty and fundoplication).
Regarding claim 354, Pugsley discloses the method according to claim 351. Pugsley also discloses wherein securing the movement restriction device against said stomach fundus wall is achieved by attaching together stomach fundus wall tissue of the patient by means of suturing and/or stapling(paras. [0034]-[0040] by way of wire 200).
Claims 348-350, 355-367 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Kagan et al. (US 2004/0092892 A1).
Regarding claim 348, Kagan discloses a method of treating a reflux disease in a patient (para. [0010]) by implanting a movement restriction device 100 comprising a plurality of segments (i.e., attachment points as disclosed in para. [0134]), the method comprising outside of the body of the patient, assembling the plurality of segments to form an assembled movement restriction device (i.e., the device is manufactured such that the segments are assembled and introduced); introducing the assembled movement restriction device into the body of the patient (para. [0131]); and placing the assembled movement restriction device against a stomach fundus wall of the patient (para. [0016] discloses the stoma is anchored in the wall of the stomach and specifically with relation to the esophagus which is directly attached to the fundus of the stomach and [0288] discloses one location for implantation of the device being in the fundus of the stomach; i.e., see also para. [0131]).
Regarding claim 349, Kagan discloses the method according to claim 348. Kagan also discloses further comprising after assembling the plurality of segments to form the assembled movement restriction device(i.e., after manufacturing), and before introducing the assembled movement restriction device into the body of the patient (i.e., but before use), securing the segments in an assembled position by means of a thread or wire (para. [0132]).
Regarding claim 350, Kagan discloses the method according to claim 349, wherein the thread or wire is made from a biodegradable material (i.e., although not directly disclosed in para. [0132], para. [0219] discloses similar sutures being biodegradable).
Regarding claim 355, Kagan discloses the method according to claim 348. Kagan also discloses comprising a step of creating a pouch (i.e., gastroplasty pouch as disclosed in para. [0131]) comprising stomach fundus wall tissue of the patient and invaginating the movement restriction device in said pouch to thereby fully enclose the device in the pouch (para. [0131]).
Regarding claim 356, Kagan discloses the method according to claim 348. Kagan also discloses comprising a step of creating a pouch (para. [0131]) comprising stomach fundus wall tissue and invaginating the movement restriction device in said pouch (para. [0131]; i.e., see also para. [0271] which discloses the cardiofundal border which includes a wall of the fundus connecting to the cardia), wherein the steps of creating the pouch and invaginating the movement restriction device in the pouch comprise invaginating the movement restriction device such that the movement restriction device is not fully enclosed in the pouch, wherein the pouch is at least partly open (i.e., by way of a narrow passage as disclosed by para. [0131]) and exhibits only one opening (para. [0131]), or exhibits at least two openings.
Regarding claim 357, Kagan discloses a method of treating a reflux disease in a patient (para. [0010]) by implanting a movement restriction device 100 comprising a plurality of segments (para. [0134]), the method comprising affixing a stomach fundus wall of the patient to the patient's esophagus (para. [0035] i.e., thereby creating a fold); outside of the body of the patient, assembling the plurality of segments to form an assembled movement restriction device (i.e., the device is manufactured such that the segments are assembled and introduced); introducing the assembled movement restriction device into the body of the patient (para. [0131]); and placing the assembled movement restriction device against a stomach fundus wall of the patient (i.e., para. [0131]; para. [0035] against the fold).
Regarding claim 358, Kagan discloses the method according to claim 357. Kagan also discloses further comprising after assembling the plurality of segments to form the assembled movement restriction device (i.e., after manufacturing), and before introducing the assembled movement restriction device into the body of the patient (i.e., but before use), securing the segments in an assembled position by means of a thread or wire (para. [0132]).
Regarding claim 359, Kagan discloses the method according to claim 358. Kagan also discloses wherein the thread or wire is made from a biodegradable material (i.e., although not directly disclosed in para. [0132], para. [0219] discloses similar sutures being biodegradable).
Regarding claim 360, Kagan discloses the method according to claim 357. Kagan also discloses wherein affixing the stomach fundus wall to the patient's esophagus comprises affixing a first portion of the stomach fundus wall to the esophagus (i.e., see para. [0010] which discloses fundoplasty and fundoplication and para. [0016] which discloses placing a stoma may be anchored to the fold; see also para. [0034]), and wherein placing the movement restriction device against the stomach fundus wall comprises placing the movement restriction device against a second portion of the stomach fundus wall (para. [0035]-[0036]).
Regarding claim 361, Kagan discloses the method according to claim 357. Kagan also discloses wherein affixing the stomach fundus wall to the patient's esophagus is achieved by suturing or stapling (para. [0016], [0035]-[0036]).
Regarding claim 362, Kagan discloses the method according to claim 357. Kagan also discloses wherein the stomach fundus wall is affixed to a lower portion of the patient's esophagus (para. [0016]).
Regarding claim 363, Kagan discloses the method according to claim 357. Kagan also discloses comprising securing the assembled movement restriction device against said stomach fundus wall by means of suturing and/or stapling (para. [0016]).
Regarding claim 364, Kagan discloses the method according to claim 363. Kagan also discloses wherein securing the movement restriction device against said stomach fundus wall is achieved by means of suturing and/or stapling stomach fundus wall tissue of the patient to stomach wall tissue of the patient (para. [0016]).
Regarding claim 365, Kagan discloses the method according to claim 363. Kagan also discloses wherein securing the movement restriction device against said stomach fundus wall is achieved by attaching together stomach fundus wall tissue of the patient by means of suturing and/or stapling (para. [0016]).
Regarding claim 366, Kagan discloses the method according to claim 357. Kagan also discloses comprising a step of creating a pouch (i.e., gastroplasty pouch as disclosed in para. [0131]) comprising stomach fundus wall tissue of the patient and invaginating the movement restriction device in said pouch to thereby fully enclose the device in the pouch (para. [0131]).
Regarding claim 367, Kagan discloses the method according to claim 357. Kagan also discloses comprising a step of creating a pouch (i.e., para. [0131] discloses a gastroplasty pouch) comprising stomach fundus wall tissue (para. [0010] discloses fundoplasty and fundoplication) and invaginating the movement restriction device in said pouch (para. [0131]), wherein the steps of creating the pouch and invaginating the movement restriction device in the pouch comprise invaginating the movement restriction device such that the movement restriction device is not fully enclosed in the pouch (i.e., by way of a narrow passage as disclosed by para. [0131]), wherein the pouch is at least partly open (i.e., by way of a narrow passage as disclosed by para. [0131]) and exhibits only one opening (para. [0131]), or exhibits at least two openings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771