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 .
Priority
It is noted that this application was not given the benefit of an earlier filing date. According to the Application Data Sheet, filed 11/05/2024, applicant claimed the benefit of prior-filed application number 17/463,626. It is noted a Continuation application is an application for the invention(s) disclosed in a prior-filed copending nonprovisional application (parent application). The disclosure presented in the Continuation must not include any subject matter which would constitute new matter if submitted as an amendment to the parent application. MPEP 201.07.
Claim Rejections - 35 USC § 103
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) 53- 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forsell (US Pub. No. 2017/0348128 A1).
Regarding claim 53, Forsell discloses a surgical or laparoscopic method of treating obesity of a patient having a stomach with a food cavity, the surgical or laparoscopic method comprising:
- cutting a hole (12b) (Figs. 4c- 4d, 5b- 5d) in the abdominal wall (12a) (Figs. 4c- 4d) of said patient using a surgical cutting instrument (615) (P. [0096] - - The cutting edge 615 of the inner sleeve then cuts a hole in the stomach wall so as to allow subsequent insertion of the volume filling device 10 into and through this hole, see FIG. 4d),
- dissecting an area around the stomach using a surgical dissection instrument (P. [0289] - - the dissection of an area of the stomach),
- at least substantially invaginating at least one volume filling device (10) (Figs. 1- 4d, 5c- 5d, 6a- 18h, 19i- 19j, 22- 49b) by a stomach wall portion (12a) (Figs. 4c- 4d) of the patient, such that the volume of the food cavity is reduced in size (P. [0074] - - By invaginating the volume filling device 10 in part of the stomach wall, the size of the food cavity, generally designated 12b in FIG. 2b, will be reduced, resulting in a more rapid feeling of satiety after food intake),
- placing at least one implantable operable stretching device (50) (Figs. 12- 16) adapted to stretch a portion of the stomach wall (12a) of the patient for creating a sensation of satiety (Ps. [0135], [0138] - - in FIG. 13 there is shown an adjustable volume filling device 10, which is invaginated in the stomach wall of a patient's stomach 12. Additionally, an adjustable stretching device 50 with the previously described function is invaginated in the stomach fundus wall of the patient. It is preferred that the volume filling device 10 is substantially larger than the stretching device 50; when the stretching device 50 is enlarged by pumping fluid from the volume filling device 10 and to the stretching device 50 by means of the pump 54, the stomach fundus wall is stretched, creating a feeling of satiety for the patient), and
- placing an operation device (54) (Figs. 13) for non-invasively operating the stretching device (50) when implanted, to stretch the stomach wall portion (12a) such that satiety is created (P. [0138] - - when the stretching device 50 is enlarged by pumping fluid from the volume filling device 10 and to the stretching device 50 by means of the pump 54, the stomach fundus wall is stretched, creating a feeling of satiety for the patient).
Note: Forsell discloses equivalent methods for regulating the at least one volume filling device (10) are found in reference to FIGS. 22-41 (P. [0124]). Additionally, Forsell discloses that a skilled person is in the position of combining steps, changing the order of steps, and combining elements of the different embodiments of the invention without inventive effort, and without departing from the scope of the invention (P. [0327]). As such, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to substitute the operation device (1007) and its equivalents found in Figs. 22- 41 for the operation device (54) found in Fig. 13, since the substitution(s) would have yielded predictable results, namely, regulating the at least one volume filling device (10). KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 54, Forsell further discloses wherein the device further comprises a subcutaneous switch connected to said operation device (1007) (Figs. 25, 33, 39), and wherein the method further comprises placing the subcutaneous switch (1026) (Fig. 36) subcutaneously in the patient (Ps. [0197], [0214] - - The system 1000 comprises a battery 1022 connected to the apparatus 10 via a subcutaneous electric switch 1026; an external switch 1026 is interconnected between the external energy source 1004a and an operation device, such as an electric motor 1007 operating the apparatus 10. An external control unit 1004b controls the operation of the external switch 1026 to effect proper operation of the apparatus 10).
Regarding claim 55, Forsell further discloses wherein the device further comprises a sensor (1025) (Fig. 35) for sensing a variable related to the patient eating, and wherein the method further comprises implanting the sensor in the body of the patient (P. [0193] - -A feedback device, preferably comprising a sensor or measuring device 1025, may be implanted in the patient for sensing a physical parameter of the patient. The physical parameter may be at least one selected from the group consisting of pressure, volume, diameter, stretching, elongation, extension, movement, bending, elasticity, muscle contraction, nerve impulse, body temperature, blood pressure, blood flow, heartbeats and breathing).
Regarding claim 56, Forsell further discloses wherein the step of cutting a hole in the abdominal wall in the skin comprises:
inserting a tube or needle into the patient's body (P. [0276] - - a needle or a tube-like instrument is inserted into the abdomen of the patient's body),
filling the body through the tube or needle with a gas and thereby expanding a cavity within the patient's body (P. [0276] - - said needle or tube-like instrument is then used to fill the patient's abdomen with gas),
inserting at least two laparoscopic trocars into said cavity (P. [0276] - - at least two laparoscopic trocars are inserted into the patient's body),
inserting at least one camera through at least one laparoscopic trocar (P. [0276] - - a camera is inserted through one of said at least two laparoscopic trocars), and
inserting at least one dissecting tool through at least one laparoscopic trocar (P. [0276] - -at least one dissecting tool through one of said at least two laparoscopic trocars).
Regarding claim 57, Forsell further discloses wherein the at least one implantable operable stretching device (50) comprises a first portion adapted to be fixated to a first area of the stomach wall of the patient, a second portion adapted to be fixated to a second area of the stomach wall of the patient, and a non-invasive operation device connected to the first and second portions and adapted to actively and non-invasively operate to move the first and second portions away from each other to thereby actively stretch the stomach wall between the first and second area of the stomach, the wherein the method comprises the steps of:
fixating the first portion to the first area of the stomach wall (12a) of the patient,
fixating the second portion to the second area of the stomach wall (12a) of the patient (See Fig. 12) (Ps. [0039] , [0059] - - the apparatus further comprises a stretching device comprising two or more hydraulic parts engaged with different parts of the stomach wall, one part each, wherein the engagement includes suturing or stapling to hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures, wherein the two or more hydraulic parts are adapted to move in relation to each other adapted to stretch three different wall portions, the stretching device further adapted to having the wall portions stretched independently from each other both regarding force used for stretching the stomach wall portion as well as, time periods the stretching is applied, and when the stretching is applied; (See Fig. 12) (Ps. [0039], [0059] - - wherein the engagement includes suturing or stapling to hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures; FIG. 12 shows an embodiment wherein the volume filling device adapted also for treating reflux is combined with stretching devices for stretching part of the stomach fundus wall).
Regarding claim 58, Forsell further discloses wherein:
the step of fixating the first portion to the first area of the stomach wall (12a) comprises invaginating, at least partially, the first portion in the stomach wall at the first area, or
the step of fixating the second portion to the second area of the stomach wall (12a) comprises invaginating, at least partially, the second portion in the stomach wall (12a) at the second area (See Fig. 12) (Ps. [0039], [0059] - - wherein the engagement includes suturing or stapling to hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures; FIG. 12 shows an embodiment wherein the volume filling device adapted also for treating reflux is combined with stretching devices for stretching part of the stomach fundus wall).
Regarding claim 59, Forsell further discloses wherein the step of invaginating the first or second portion in the stomach wall comprises suturing or stapling stomach to stomach (See Fig. 12) (Ps. [0039], [0059] - - wherein the engagement includes suturing or stapling to hydraulic part to the stomach wall or invaginating the hydraulic parts in the stomach wall part, with stomach to stomach sutures; FIG. 12 shows an embodiment wherein the volume filling device adapted also for treating reflux is combined with stretching devices for stretching part of the stomach fundus wall).
Regarding claim 60, Forsell further discloses further comprising the step of implanting an internal energy source (1002) for powering the operation device (10) (Ps. [0124], [0161] - - The internal energy source can for example be a chargeable implanted battery or a capacitor or a device for receiving wireless energy transmitted from outside the body of the patient. Different ways of regulating the inflatable device 10 will be described below with reference to FIGS. 22-41; An implanted energy-transforming device 1002 is adapted to supply energy consuming components of the apparatus with energy via a power supply line 1003).
Regarding claim 61, Forsell further discloses further comprising the step of implanting a wireless energy receiver for non-invasively charging the internal energy source (P. [0170] - - The external energy-transmission device 1004 also includes a wireless remote control having an external signal transmitter for transmitting a wireless control signal for non-invasively controlling the apparatus. The control signal is received by an implanted signal receiver which may be incorporated in the implanted energy-transforming device 1002 or be separate there from).
Regarding claim 62, Forsell further discloses wherein fixating the first portion to the first area of the stomach wall of the patient comprises fixating the first portion to a first area of the fundus of the stomach (12a) (See Fig. 12) (P. [0059] - -FIG. 12 shows an embodiment wherein the volume filling device adapted also for treating reflux is combined with stretching devices for stretching part of the stomach fundus wall).
Regarding claim 63, Forsell further discloses wherein fixating the second portion to the second area of the stomach wall of the patient comprises fixating the second portion to a second area of the fundus of the stomach (See Fig. 12) (P. [0059] - -FIG. 12 shows an embodiment wherein the volume filling device adapted also for treating reflux is combined with stretching devices for stretching part of the stomach fundus wall).
Regarding claim 64, Forsell further discloses further comprising the step of implanting an internal data communicator, adapted to wirelessly communicate with an external data communicator, subcutaneously in the patient (P. [0199] - - The system may include an external data communicator and an implantable internal data communicator communicating with the external data communicator. The internal communicator feeds data related to the apparatus or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator).
Regarding claim 65, Forsell further discloses wherein the step of placing an operation device for non-invasively operating the stretching device comprises placing a hydraulic operation device (1014) (P. [0180] - - FIG. 27 shows an embodiment of the invention comprising the external energy-transmission device 1004 with its wireless remote control, the apparatus 10, in this case hydraulically operated, and the implanted energy-transforming device 1002, and further comprising a hydraulic fluid reservoir 1013, a motor/pump unit 1009 and an reversing device in the form of a hydraulic valve shifting device 1014, all implanted in the patient).
Regarding claim 66, Forsell further discloses wherein the step of placing a hydraulic operation device (1009) comprises placing a fluid reservoir and a hydraulic pump (P. [0180] - - FIG. 27 shows an embodiment of the invention comprising the external energy-transmission device 1004 with its wireless remote control, the apparatus 10, in this case hydraulically operated, and the implanted energy-transforming device 1002, and further comprising a hydraulic fluid reservoir 1013, a motor/pump unit 1009 and an reversing device in the form of a hydraulic valve shifting device 1014, all implanted in the patient).
Regarding claim 67, Forsell further discloses wherein the step of placing an operation device (1007) (Figs. 25, 33, 39) for non-invasively operating the stretching device (50) comprises placing an operation device (1007) comprising an electrical motor (P. [0175] - - This operation device can be in the form of a motor 1007, such as an electric servomotor).
Regarding claim 68, Forsell further discloses wherein the step of at least substantially invaginating at least one volume filling device (10) comprises at least substantially invaginating at least one volume filling device (10) comprising a bio-compatible, elastic and homogenous material (Ps. [0013], [0014], [0076] - - he volume filling device may include a homogenous material; The volume filling device may comprise a rigid, elastic or flexible outer surface; By providing the volume filling device from a bio-compatible material, the risk of the patient's body rejecting the implant is to a very large extent. Reduced).
Regarding claim 69, Forsell further discloses wherein the step of at least substantially invaginating at least one volume filling device (10) comprises at least substantially invaginating at least one volume filling device (10) having an elongated shape (P. [0073] - - the volume filling device 10 is invaginated in the wall 12a of the patient's stomach 12 on the outside of the stomach wall. The body of the volume filling device 10 is elongated and shaped to rest against the wall 12a of the stomach 12 and further has an outer surface suitable to rest against this wall).
Regarding claim 70, Forsell further discloses wherein the step of at least substantially invaginating at least one volume filling device (10) comprises at least substantially invaginating at least one volume filling device (10) having a maximum circumference of at least 50 millimeters (Ps. [0024], [0073] - - The volume filling device may have a maximum circumference of at least 50 millimeters, preferably at least 80 millimeters; the volume filling device 10 is invaginated in the wall 12a of the patient's stomach 12 on the outside of the stomach wall).
Regarding claim 71, Forsell further discloses wherein the step of at least substantially invaginating at least one volume filling device (10) comprises at least substantially invaginating at least one volume filling device having a volume between 0.00001m3 and 0.001m3 (Ps. [0019], [0073] - - the volume filling device has a volume in the range of 0.0001 to 0.001 m.sup.3, or 0.00001 to 0.001 m.sup.3, or 0.00001 to 0.0002 m.sup.3. The volume of the volume filling device has a volume of less than 0.0002 m.sup.3; the volume filling device 10 is invaginated in the wall 12a of the patient's stomach 12 on the outside of the stomach wall).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, (Jackie) Tan-Uyen Ho can be reached at 571 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KANKINDI RWEGO/Primary Examiner, Art Unit 3771