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 .
Status of the Claims
The amendment filed 11/27/2025 has been entered. Claims 11-20 are remain withdrawn. Claims 1-10 are pending and under consideration.
Response to Arguments
In response to applicant’s arguments with respect 35 USC 102 rejection have been fully considered but they are not persuasive.
In response to applicant’s argument with respect 35 USC 102 rejection that Levine et al (US 20040220682) does not describe “a gastric outflow device”, as the device of Levine is secured to the stomach wall in the upper part of the stomach, near the entrance to the stomach towards the esophagus in order to selectively divide the stomach into two chambers, effectively reducing the size of the stomach immediately available for the uptake of food. Notably, this is not to control the gastric outflow or to delay the exit of gastric contents from the stomach into the intestine. Rather, the device of Levine is instead designed to reduce the volume of food that may be added to the stomach by decreasing the volume of the stomach that may be used to hold food. Examiner respectfully disagrees for the flowing reasons below.
Claim 1 recites “a gastric outflow device, comprising: a ring having a ring aperture; and a topper having a topper aperture, the topper attachable to the ring, the topper aperture alienable with the ring aperture to form the gastric outflow device aperture” (emphasize added). The phrase “a gastric outflow device” is a statement of intended use or purpose of the device in preamble that does not patentably distinguish the claim from the prior art (see MPEP 2112.02). For instance, Levine explicitly discloses every structural element of claim 1, e.g., a ring having a ring aperture, a topper having a topper aperture and the topper attachable to the ring and alignable with the ring aperture (see claim 1 rejection as set forth in the nonfinal rejection), Levine anticipates the claimed device regardless of whether Levine describes the identical intended use.
Furthermore, even if the preamble were accorded any patentable weight, Levine still inherently anticipates “gastric outflow”. For instance, restricting the entry of food into the stomach, i.e., limiting the rate at which food can pass from the esophagus portion of the stomach, necessarily results in controlling and delay the rate of gastric outflow from the stomach into the duodenum.
There are no distinct argument directed to USC 103 rejection and dependent claims.
For the reasons above, applicant’s argument is not persuasive and the rejection is maintained.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 line 4 recites “the gastric outflow device aperture” which should read “a gastric outflow device aperture”
Appropriate correction is required.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al (US 20040220682 A1).
Regarding Claim 1, Levine teaches a gastric outflow device comprising:
a ring (figure 2 and 3a, anchoring ring 226 defining an aperture) having a ring aperture; and
a topper (figure 2 and 3b, restrictive member 225 with an aperture 218) having a topper aperture, the topper attachable to the ring ([0058]), the topper aperture alignable with the ring aperture to form the gastric outflow device aperture (figure 2, the aperture 218 the anchoring ringer aperture and forms outflow aperture).
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.
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al (US 20040220682 A1) in view of Kuzmak (US 5449368 A).
Regarding Claim 2, Levine teaches the gastric outflow device of claim 1.
Levin does not teach the topper comprising screws spaced near an outer perimeter of the topper, the ring comprising holes alignable for receiving the screws.
In the same field of endeavor, namely a gastric banding device, Kuzmak teaches the topper comprising screws (figure 3a, screw threaded locking bolt 30) spaced near an outer perimeter of the topper, the ring comprising holes (figure 2a and col 5 lines 5-20, locking element 20 comprising opening 20a is alignable for receiving the locking bolt 30) alignable for receiving the screws.
Kuzmak teaches the banding device comprising screw threaded locking bolt and a corresponding threaded opening. This permits implantation of the device in an unassembled configuration, which enables minimal invasive surgery for implantation, provides a secure coupling, and further allows adjust of the device’s size after the implantation (col 2 lines 45-60).
Therefore, 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 Levine to incorporate the teachings of Kuzmak and substitutes the slots and hooks of Levine with the screws and holes of Kuzmak for the purpose of permitting implantation of the device in an unassembled configuration, thereby providing secure and permanent coupling.
Regarding Claim 10, Levine teaches the gastric outflow device according to claim 1.
Levine further teaches the ring further comprising staples attachable to a pyloric sphincter (Levine; [0059] “The anchoring ring 226 can be secured to the stomach 102 using sutures, surgical staples”).
Levine does not teach the topper further comprising screws securable to the ring.
In the same field of endeavor, namely a gastric banding device, Kuzmak teaches the topper further comprising screws securable to the ring (figure 3a and col 5 lines 5-20, screw threaded locking bolt 30 securable to the locking element).
Kuzmak teaches the banding device comprising screw threaded locking bolt and a corresponding threaded opening. This permits implantation of the device in an unassembled configuration, which enables minimal invasive surgery for implantation, provides a secure coupling, and further allows adjust of the device’s size after the implantation (col 2 lines 45-60).
Therefore, 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 Levine to incorporate the teachings of Kuzmak and provides the topper as claimed for the purpose of permitting implantation of the device in an unassembled configuration, thereby enabling replacement of the topper to achieve a desired aperture size and ensuring a secure coupling.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al (US 20040220682 A1).
Regarding Claim 5, Levine teaches the gastric outflow device of claim 1.
Levine does not teach the gastric outflow device aperture extending to an outer perimeter of the gastric outflow device.
However, 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 Levine such that the gastric outflow device aperture extending to an outer perimeter of the gastric outflow device as such a modification would have been an obvious matter of design choice involving a change in shape. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04.IV). One of skill in the art motivated to do so for the purpose of providing desired flow restriction through the aperture.
Regarding Claim 6, Levine teaches the gastric outflow device of claim 1.
Levine does not teach the gastric outflow device aperture defining a portion of an outer perimeter of the gastric outflow device.
However, 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 Levine such that the gastric outflow device aperture defining a portion of an outer perimeter of the gastric outflow device as such a modification would have been an obvious matter of design choice involving a change in shape. A change in shape is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04.IV). One of skill in the art motivated to do so for the purpose of providing desired flow restriction through the aperture.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al (US 20040220682 A1) in view of Levine et al (US 20080071383 A1, hereinafter Levine’383).
Regarding Claim 7, Levine teaches the gastric outflow device of claim 1.
Levine does not teach the topper aperture adjustable by wireless signal.
In the same field of endeavor, namely an anti-obesity devices, Levine’383 teaches the topper aperture adjustable by wireless signal ([0074] “adjustments to the aperture can be accomplished remotely”).
Therefore, 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 Levine to incorporate the teachings of Levine’383 and provide the topper aperture adjustable by wireless signal for the purpose of selectively increasing and/or decreasing the diameter of the device after implantation to provide desired flow restriction, as taught by Levine’383 ([0074]).
Regarding Claim 8, Levine teaches the gastric outflow device of claim 1.
Levine does not teach the topper aperture adjustable by percutaneous control.
In the same field of endeavor, namely an anti-obesity devices, Levine’383 teaches the topper aperture adjustable by percutaneous control ([0074] “Alternatively or in addition, adjustment can be accomplished through a remote, subcutaneous route”).
Therefore, 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 Levine to incorporate the teachings of Levine’383 and provide the topper aperture adjustable by percutaneous control for the purpose of selectively increasing and/or decreasing the diameter of the device after implantation to provide desired flow restriction, as taught by Levine’383 ([0074]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Levine et al (US 20040220682 A1) in view of Peters et al (US 20110270331 A1).
Regarding Claim 9, Levine teaches the gastric outflow device of claim 1.
Levine does not teach the topper aperture adjustable by an ultrasonic motor.
In the same field of endeavor, namely an implantable heart assist device, Peters teaches the topper aperture adjustable by an ultrasonic motor ([0063], [0072] and [0105] diameter of cuff can be inflated of deflated by ultrasonic motor).
Therefore, 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 Levine to incorporate the teachings of Peters and provides topper aperture adjustable by an ultrasonic motor for the purpose of selectively increasing and/or decreasing the diameter of the device after implantation to provide desired flow restriction. One of skill in the art would have been motivated to use ultrasonic motor, since it is known for energy efficiency, reliability, and compact size, making them well-suited for use in implantable devices.
Allowable Subject Matter
Claims 3 and 4 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.
The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found to teach (Claims 2 and 3) the topper comprising screws spaced near an outer perimeter of the topper, the ring comprising holes alignable for receiving the screws, and further comprising protrusions spaced along a surface of the topper, the ring further comprising grooves alignable for receiving the protrusions.
Levine et al (US 20040220682 A1) teaches claimed protrusions and grooves, but does not teach the claimed screws and holes. Kuzmak (US 5449368 A) addresses this deficiency by teaching the screws and hole coupling mechanism (figure 3a, screw threaded locking bolt 30 and locking element 20 comprising opening 20a). However, in the examiner’s view, it would not have been obvious to one of skill in the art to combine the teachings of Levine and Kuzmak to arrive at the claimed invention, because incorporating the screws and hole coupling mechanism from Kuzmak into the device of Levine, which already employs a groove and protrusion coupling mechanism, would be redundant and would not provide improvement over Levine.
Conclusion
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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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/S.H./Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781