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 § 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) 1-2, 4-5, 8-12, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over O'Dea (US 20120277525) in view of Ishikawa et al. (US 20030229296 hereinafter “Ishikawa”).
Regarding Claim 1, O’Dea teaches (Figs 1-5) a sleeve gastrectomy aid device (1) comprising:
a guide (15) configured to be inserted into a stomach (4) of a patient;
a plurality of expanders (19, 20) configured to be disposed in a longitudinal direction of the guide (15) and have a volume that changes according to an amount of air therein (See [0087] teaching how both 19 and 20 are balloons that are inflatable);
an injector (42,50) configured to inject air into the plurality expander (See [0093] teaching how lumen 42 allows for inflation of 19; [0095] teaches 50 is for inflation of 20; [0125] teaches inflation could be done with air instead of saline); and
a measurer (69, 71) configured to be disposed inside one of the plurality of expanders and measure a pressure value of the one of the plurality of expanders (See [0101-0102] teaching 69 and 71 are pressure transducers).
O’Dea does not teach a sealer configured to be installed at the guide and seal the plurality of expanders with each other; and that the injector is configured to be connected to the sealer.
Ishikawa teaches (Figs 1-3) a guide (1) with a plurality of expanders (15), a sealer (11) configured to be installed at the guide (2) and seal the plurality of expanders (15) and are configured to be connected to the injector (where tubes 12 are connected to 11 in Fig 1 and 3).
It would have been obvious to modify the device of O’Dea such that it includes a sealer configured to be installed at the guide and seal the plurality of expanders with each other and is configured to be connected with the injector as taught by Ishikawa. One of ordinary skill in the art would have been motivated to do so in order to both seal and separate the balloons by forming an interval (See [0049]). One of ordinary skill in the art would recognize this as an alternative form of adhering the balloon to the guide.
The combination teaches wherein the injector is movably connected to the sealer (Ishikawa 11; with the modification done in claim 1, the injector is connected to the sealer, they both will move with the device as the device is moved into position within the stomach, therefore the injector and sealer are considered to be ‘movably connected’; the examiner notes that the claim language is broad in the limitation is being interpreted as the injector and the sealer are movable and connected since the device must be movable to be placed within the body while connected this combination meets this limitation), and a communication state between the injector (O’Dea 42, 50) and the expander (O’Dea 19, 20) is changed according to a direction of movement of the injector (the communication state is considered changed based on location of the overall device, when the device is outside the stomach the expander is not inflated, when device is moved into the stomach, the injector is also moved into the stomach and there for ready for the expander to be inflated, this is considered to be a ‘communication state’).
Regarding Claim 2, the combination of O’Dea and Ishikawa teaches the sleeve gastrectomy aid device of claim 1, wherein the sealer (Ishikawa 11) comprises:
a plurality of sealer bodies (See Ishikawa Fig 3, multiple sealers 11) configured to be disposed to surround the guide (Ishikawa 1, or in modification O'Dea 15), an end of each of the plurality of expanders being fixed to one of the plurality of sealer bodies (Ishikawa 15, or in modification O'Dea 19, 20);
a first insertion portion (O'Dea Fig 1 area where 25 points to) configured to pass through the plurality of sealer bodies (25 is where the sealer 11 of Ishikawa is added, therefore that portion passes through 11) and have the guide (15) inserted thereinto; and
a second insertion portion (portion close to 47 of Odea Fig 1) configured to pass through the plurality of sealer bodies (Ishikawa 11 would be added there) and have the injector inserted thereinto (Since lumen 50 inflates balloon 20, it would necessarily be inserted through the proximal portion of balloon 20, close to where 47 is labeled).
Regarding Claim 5, the combination of O’Dea and Ishikawa teaches the sleeve gastrectomy aid device of claim 1, wherein the injector is provided as a plurality of injectors, and each of the plurality of injectors separately controls the volume of one of the plurality of expanders (See 42, 50 separate lumens /injectors to inflate balloons).
Regarding Claim 8, the combination of O’Dea and Ishikawa teaches all elements of claim 1 as described above. O’Dea further teaches the sleeve gastrectomy aid device further comprising a monitor (39, 41) configured to be connected to the measurer and provide resection position information through a pressure value measured by the measurer (See [0101-0102] teaching how values of measurer 69 and 71 are displayed on 39 and 41; also see [0128]).
Regarding Claim 9, the combination of O’Dea and Ishikawa teaches all elements of claim 8 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the resection position information is information on a distance from the one of the plurality of expanders to a resection tool (See [0108-0109] teaching how the position of the device is determined from the data collected by the pressure transducers and distance/diameter of the device).
Regarding Claim 10, the combination of O’Dea and Ishikawa teaches all elements of claim 9 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the monitor (39, 41) comprises:
a controller (36) configured to determine a resection position based on the pressure value measured by the measurer (69, 71); and
a display (41) configured to display the information determined by the controller to an outside (See [0092]).
Regarding Claim 11, the combination of O’Dea and Ishikawa teaches all elements of claim 10 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the controller is configured to determine resection position sections according to a size of the pressure value measured by the measurer (See [0108-0109] teaching how the position of the device is determined from the data collected by the pressure transducers and distance/diameter of the device).
Regarding Claim 12, the combination of O’Dea and Ishikawa teaches the sleeve gastrectomy aid device of claim 11, wherein the resection position sections comprise:an approach-necessary section indicating a case in which the size of the pressure measured by the measurer is lower than or equal to a first set pressure (See [0104] teaching how the physician may be monitoring the pressure of expander 20 to make sure the size/pressure is not excessive);
a separation-necessary section indicating a case in which the size of the pressure measured by the measurer is higher than or equal to a second set pressure (See [0110] teaching how the pressure of expander 19 is monitored to ensure it is not higher than predefined value, and if it is that there will be an alarm); and
a resection-possible section indicating that the size of the pressure measured by the measurer is between the first set pressure and the second set pressure (See [0112] teaching how the pressures of the first and second expanders 19 and 20 may be different and chosen based on the desired procedure).
Regarding Claim 14, the combination of O’Dea and Ishikawa teaches all elements of claim 10 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the measurer is provided as a plurality of measurers (69, 71), and each of the plurality of measurers independently measures a pressure applied to a corresponding one of the plurality of expanders (See [0101-0102] teaching 69 is measuring for expander 19 and 71 is measuring for expander 20).
Regarding Claim 15, the combination of O’Dea and Ishikawa teaches all elements of claim 14 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the controller is configured to compare pressure values measured by the plurality of measurers to determine whether the resection tool is being incorrectly operated (See [0101-0112] teaching how the controller may gather pressure data from both expanders, and how the expansion/pressure from the balloons is used to determine position of the device).
Regarding Claim 16, the combination of O’Dea and Ishikawa teaches all elements of claim 15 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein the controller is configured to determine whether a difference between the pressure values measured by any one pair of measurers among the plurality of measurers exceeds a set size (See [0112] teaching controller may determine differences in primary and secondary balloon).
Regarding Claim 17, the combination of O’Dea and Ishikawa teaches all elements of claim 16 as described above. O’Dea further teaches the sleeve gastrectomy aid device wherein, in a case in which the difference between the pressure values measured by any one pair of measurers is the set size or more, the display is configured to generate a warning signal (See [0110] teaching a warning alarm if expander is past a certain size/value).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over O'Dea (US 20120277525) in view of Ishikawa (US 20030229296) as applied to claim 2 above, and further in view of Wiita (US 20140107573).
Regarding Claim 3, the combination of O’Dea and Ishikawa teaches all elements of claim 2 as described above. The combination does not specify the sleeve gastrectomy aid device wherein the sealer further comprises a plurality of packings configured to be disposed to surround outer side surfaces of the plurality of sealer bodies and bring the ends of the plurality of expanders in close contact with the plurality of sealer bodies.
Wiita [0062] and Fig 14 teaches a packing (252) disposed between the expanders.
This modification would result in a packing that is disposed to surround an outer side surface of the sealer body and bring the expander in close contact with the sealer body (See how Wiita Fig 14 shows 252 between the two expanders 214 and 213 similar to how the sealers 11 are between the expanders 15 in Ishikawa Fig 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of O’Dea such that it includes a packing as taught by Wiita. One of ordinary skill in the art would have been motivated to do so in order to minimize the effects of lateral motion on the expanders (Wiita [0062]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over O'Dea (US 20120277525) in view of Ishikawa (US 20030229296) as applied to claim 11 above, and further in view of Davidson et al. (US 20150099925 hereinafter “Davidson”).
Regarding Claim 13, the combination of O’Dea and Ishikawa teaches all elements of claim 11 as described above. The combination does not specify the sleeve gastrectomy aid device wherein the display is configured to display different colors according to the resection position sections.
Davidson teaches (Figs 7-8) a display that shows different colors in different curves based on the pressure (See [0088-0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display of O'Dea such that the display displays different colors according to the resection position sections as taught by Davidson. One of ordinary skill in the art would have been motivated to do so in order to provide a clearer visual indication to the physician (Davidson [0088-0089]).
Allowable Subject Matter
Claims 6-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to Claim 6, the combination of O’Dea and Ishikawa teaches all elements of claim 4 as described above. The combination does not specify wherein the injector includes:
an injector body configured to be slidably connected to the sealer;
a communicator configured to pass through the injector body and have a communication state with the expander changed in accordance with movement of the injector body; and
a stopper portion configured to extend from the injector body and come in contact with the sealer to limit a movement range of the injector body. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify O’Dea to satisfy these limitations in combination with the claim(s) from which it depends.
Claim 7 depends on claim 6.
Response to Arguments
Applicant's arguments filed 7/21/2026 have been fully considered but they are not persuasive.
As to the remarks on Pg. 8-9, the applicant argues that the combination of O’Dea and Ishikawa does not teach or suggest “wherein the injector is movably connected to the sealer and a communication state between the injector and the plurality od expanders is changed according to a direction of movement of the injector”. The examiner does not find this persuasive. While it appears the applicant intends for the injector to be movably connected relative to the sealer, the current claim language is broad, and only requires that the injector and sealer are “movably connected”. Therefore, the examiner has taken the interpretation that the two elements are connected and are movable based on the position of the overall device relative to the positioning of the device in the patient for use. Furthermore, the communication state is considered to be changed based on when the device is placed within the patient and the injector is allowing fluid flow to the expanders, compared to when the device is not in the patient and there is no fluid flow to the expanders (in other words; the communication state is considered changed based on location of the overall device, when the device is outside the stomach the expander is not inflated, when device is moved into the stomach, the injector is also moved into the stomach and there for ready for the expander to be inflated). For these reasons the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kotsanis (US 4447227) teaches a device with a plurality of expanders and that can be used for procedures in the gastrointestinal system.
Miesse et al. (US 20150133772) teaches a device and method for facilitating a sleeve gastrectomy procedure.
Wang et al. (US 20210113742) teaches a catheter with multiple expanders and sealers.
THIS ACTION IS MADE FINAL. 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 NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
