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 .
Election/Restrictions
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026.
Drawings
The drawings are objected to because Figure 96 uses the wrong reference number for the anastomosis anchor. It appears that element 996 is meant to be anastomosis anchor 696. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Abu Dayyeh (US 20200390580).
Regarding claim 1, ref A discloses a delivery system adapted for delivering a gastric bypass device, the gastric bypass device including an occlusion device (50) adapted to be secured in place within a patient's stomach relative to the patient's pylorus (fig. 4, occlusion device 50 within, as described in fig. 1, the pyloric sphincter 20), an anastomosis anchor (fig. 3, anchor member 72 of bypass device 70) adapted to be secured in place relative to an anastomosis (fig. 4, anastomosis 26) formed between the patient's stomach wall and the patient's small intestine (fig. 4, anastomosis 26 formed between stomach 14 and small intestine 16) and a tether adapted to extend through the patient's small intestine, the tether secured at a first end to the occlusion device (fig. 4, tether extending through the small intestine 16, with the occlusion device being the balloon at the distal end) the delivery system comprising:
a guidewire adapted to be delivered in a looped path down the patient's esophagus through the patient's pylorus, up through the anastomosis and up the patient's esophagus such that a distal wire end and a proximal wire end of the guidewire are both accessible outside the patient's mouth (paragraph 0047, “a wire can be passed through the anastomosis 26 to the duodenum 18 and out the pyloric sphincter 20. In some cases, both ends of the wire extend out of the patient’s mouth”);
a gastric bypass device (70) adapted to be delivered by advancing the gastric bypass device relative to the guidewire (fig. 4, bypass device 70, paragraph 0056 describes the wire articulating to place the bypass device.); and
a delivery device adapted to carry the gastric bypass device (paragraph 0056, “The wire can be used to articulate on a delivery shuttle system of the esophageal occlusion device 78. The delivery shuttle system has the bypass device 70 collapsed around it and can be pulled in place”).
Regarding claim 2, ref A discloses wherein the delivery device comprises a delivery shuttle (paragraph 0056), and the gastric bypass device is coupled to the delivery shuttle (paragraph 0056, “The wire can be used to articulate on a delivery shuttle system of the esophageal occlusion device 78. The delivery shuttle system has the bypass device 70 collapsed around it”).
Regarding claim 3, ref A discloses wherein the delivery shuttle is adapted to be releasably coupled to the anastomosis anchor of the gastric bypass device (Paragraph 0056, “The delivery shuttle system has the bypass device 70 [that contains the anastomosis anchor 72] collapsed around it… Once across the appropriate anatomy the bypass device 70 is detached from the shuttle system and expanded in place)
Regarding claim 4, ref A discloses wherein the delivery shuttle is secured to the guidewire such that translation of the guidewire results in a corresponding translation of the delivery shuttle (paragraph 0056, “The wire can be used to articulate on a delivery shuttle system of the esophageal occlusion device).
Regarding claim 16, ref A discloses the device further comprising a dynamic leash that is adapted to be subsequently delivered and secured relative to the gastric bypass device (fig. 5, expandable coil 100 that secures occlusion device 50 to bypass device 70, including hooks that connect to bypass device 70, paragraph 0050).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over ref A in view of Magal (US 20110040232)
Regarding claim 5, ref A does not teach the device further comprising a delivery catheter adapted to be advanced over the guidewire, wherein the delivery device comprises a delivery shuttle that is coupled to the delivery catheter.
However, Magal teaches further comprising a delivery catheter adapted to be advanced over the guidewire (paragraph 0250 describes the use of a balloon catheter for deployment, with paragraph 0211 describing a balloon catheter guided along tether 44 functioning as a guidewire), wherein the delivery device comprises a delivery shuttle that is coupled to the delivery catheter (paragraph 0211 describes the balloon catheter attached to cannula 70 which may be interpreted as a delivery shuttle)
Therefore, 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 device disclosed in ref A such that it comprises a delivery catheter adapted to be advanced over the guidewire, wherein the delivery device comprises the delivery shuttle coupled to the delivery catheter, as taught by Magal, for the purpose of providing a suitable structure that can inflate to push apart tissue to accommodate instruments (see Magal, paragraph 0211)
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over ref A in view of Thompson (US 20120184893).
Regarding claim 6, ref A does not teach wherein the delivery device comprises a garage catheter including a garage that is adapted to hold the gastric bypass device within the garage.
However, Thompson teaches a garage catheter (170) with a garage adapted to hold the gastric bypass device within the garage (fig. 10, distal outer sheath 170 to hold the bypass sleeve 180).
Therefore, 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 device disclosed in ref A such that the delivery device comprises a garage catheter including a garage that is adapted to hold the gastric bypass device within the garage, as taught by Thompson, for the purpose of providing a suitable structure that actuates the implant into the patient (see Thompson, paragraph 0152)
Regarding claim 7, ref A does not teach a pusher adapted to push the gastric bypass out of the garage
However, Thompson teaches further comprising a pusher adapted to push the gastric bypass out of the garage (fig. 10, implant pusher 178 to push implant out of outer sheath, paragraph 0152)
Therefore, 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 device disclosed in ref A such that it comprises a pusher adapted to push the gastric bypass out of the garage, as taught by Thompson, for the purpose of providing a suitable structure that actuates the implant into the patient (see Thompson, paragraph 0152)
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over ref A in view of Thompson, and further in view of Kariniemi (US 20120245623)
Regarding claim 8, ref A, as modified by Thompson, does not teach wherein the pusher includes a threaded engagement with the gastric bypass device.
However, Kariniemi teaches wherein the pusher includes a threaded engagement with an implant (paragraph 0068)
Therefore, 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 device disclosed in ref A in view of Thompson such that the pusher includes a threaded engagement with the gastric bypass device, as taught by Kariniemi, for the purpose of providing a suitable structure that allows for selective disengagement with the implant while positioning said implant (paragraph 0068)
Regarding claim 9, ref A, as modified by Thompson, does not teach wherein the pusher includes a distal region having a shape complementary to that of the gastric bypass device.
However, Karinemi teaches wherein a pusher includes a threaded engagement with an implant (paragraph 0068, describing a threaded end of the pusher wire engaging with a threaded bore 161).
Therefore, 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 device disclosed in ref A in view of Thompson such that the pusher includes a distal region having a shape complementary to that of the gastric bypass device, as taught and suggested by Karinemi, for the purpose of providing a suitable structure that allows for selective disengagement with the implant while positioning said implant (paragraph 0068).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over ref A in view of Thompson, and further in view of Hess (WO 2012013246)
Regarding claim 10, ref A, as modified by Thompson, does not teach wherein the pusher includes a proximal region adapted to be secured relative to an endoscope
However, Hess teaches wherein a pusher includes a proximal region adapted to be secured relative to an endoscope (describing an endoluminal pusher 40 to connect with endoscope 18)
Therefore, 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 device disclosed in ref A in view of Thompson such that the pusher includes a proximal region adapted to be secured relative to an endoscope, as taught by Hess, for the purpose of providing a suitable structure that also allows for other instruments to be introduced through the endoscope (see Hess, paragraph 0242)
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over ref A in view of Pattison (US 20180116850)
Regarding claim 12, ref A does not teach the device further comprising a cutting tool adapted to be advanced through an endoscope in order to release the gastric bypass device from the delivery shuttle.
However, Pattison teaches a cutting tool (321) adapted to be advanced through an endoscope in order to release the gastric bypass device from the delivery shuttle (paragraph 0063, “an endoscope 320 may be used to release or remove the storage element, thereby freeing the elongated sleeve distal end from the gastric balloon surface via cutting or removing the storage fastener from the inside aspect of the storage element”)
Therefore, 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 device disclosed in ref A such that it further comprising a cutting tool adapted to be advanced through an endoscope in order to release the gastric bypass device from the delivery shuttle, as taught by Pattison, for the purpose of providing a suitable structure that can release/remove the storing element to free the device for implantation (see Pattison, paragraph 0063).
Allowable Subject Matter
Claims 11 and 13-15 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.
Regarding claim 11, ref A, as modified by Thompson, does not teach wherein the pusher comprises a two stage pusher including a shaft having:
a stage one component coupled to the shaft and adapted to engage an anastomosis anchor of the gastric bypass device, and
a stage two component coupled to the shaft and adapted to engage an occlusion device of the gastric bypass device
Thompson appears to teach a more standard plunger to push out the implant, and does not teach implanting the same type of anastomosis device as in ref A. Thus it does not appear obvious from ref A in view of Thompson to modify the pusher to be a two stage pusher as claimed.
For these reasons, claim 11 contains allowable subject material.
Regarding claim 13, ref A does not teach wherein the guidewire comprises:
a first guidewire component having a distal end
a first coupler secured to the distal end of the first guidewire component
a second guidewire component having a distal end
a second coupler secured to the distal end of the second guidewire component
wherein the second coupler is adapted to be secured to the first coupler in order to join together the first guidewire component and the second guidewire component.
There are several devices that use two wire parts that are connectable via magnetism (such as in Aguiree [US 20120035628]). However, these devices involve creating an anastomosis with necrosis. It would not have been obvious to modify the guidewire of ref A that is utilized to deliver a device to the anastomosis with the wire system of Aguirre that is utilized to create an anastomosis and not deliver an implant.
Tacchino (US 20110130775) utilizes a looped guidewire that utilizes another tool to bring the guidewire up, but does not fairly teach the guidewire with two components having two couplers as claimed.
For these reasons, claim 13 contains allowable subject matter
Claims 14-15 have allowable subject matter by virtue of being dependent on claims 14-15
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781
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