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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2026 has been entered.
Status of the Claims
Claims filed 07/24/2026 has been entered. Claims 1, 3-14 and 16-18 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/08/2026 was filed after the mailing date of the final office action on 06/09/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
In response to the applicant’s argument mailed 07/24/2026 with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Rejections - 35 USC § 103
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 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 1, 3-8, 10, 13, 14, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Albrecht et al (US 20130030350 A1)
Regarding claim 1, Abu Dayyeh substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An implantable medical device system (figures 5 and 7-9, [0050 0065], small intestinal occlusion device 134 corresponds to occlusion device 50 illustrated in figure 5 + expandable coil 100), comprising:
an occlusion device (figures 5, 7-9, occlusion member 136 adapted to secure relative to a pyloric sphincter 20) adapted to be secured in place relative to a pylorus;
an anastomosis anchor (figures 5 and 8 [0065], anchor member 140 corresponds to anchor member 72 configured to be anchored on anastomosis formed between a stomach and jejunum 24) adapted to be secured in place relative to an anastomosis formed between a stomach wall and a small intestine;
a tether (figure 7, tubular body 138 corresponds to tubular body 52 extending through duodenum) adapted to extend through a duodenum, the tether secured at a first end to the occlusion device and at a second end to the anastomosis anchor (figure 7, opposite ends of tubular body 138 coupled to the occlusion member 136 and anchor member 140), the tether comprising a first coil spring with a first spring constant ([0050, 0059 0065] the tubular body 138 comprises stretchable material, i.e, latex, rubber expandable tubing or an expandable coil, which has a spring constant), the tether further adapted to provide a first tensile force to the occlusion device ([0050, 0059 and 0065] the stretchable material having a spring constant generates a tension force to the occlusion member and anchor member when it stretches); and
a dynamic leash (figure 5 and [0050, 0059 0065] expandable coil 100 extend through a stomach side) adapted to extend through a stomach, the dynamic leash comprising a second coil spring with a second spring constant, the dynamic leash further adapted to provide a second tensile force to the occlusion device that is in opposition to the first tensile force provided by the tether.
wherein the first spring constant and the second spring constant are selected such that the first tensile force and the second tensile force dynamically balance each other to maintain the occlusion device in position relative to the pylorus.
Abu Dayyeh does not expressly teach the dynamic leash comprising a second coil spring with a second spring constant, the dynamic leash further adapted to provide a second tensile force.
In the same field of endeavor, namely a device and methods for anchoring an endoluminal sleeve in the GI tract, Albrecht teaches the dynamic leash (figure 6, pull resistant tether 9 ) comprising a second coil spring (figure 6 [0072], elastic coil spring 28 having a spring constant and provide a tensile force when it stretches) with a second spring constant.
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 Abu Dayyeh, to incorporate the teachings of Albrecht and provide the dynamic leash as claimed for the purpose of enabling the dynamic leash to stretch and retract to adapt to gastric and duodenum peristaltic movements as taught by Albrecht ([0070]).
The combination does not expressly teach the second force acts in opposition to the first tensile force provided by the tether; and
wherein the first spring constant and the second spring constant are selected such that the first tensile force and the second tensile force dynamically balance each other to maintain the occlusion device in position relative to the pylorus; though
Abu Dayyeh teaches the tether and dynamic leashes are provided in a form of coil that prevents migration and/or movement of the occlusion device and anastomosis anchor ([0065]), and Albrecht teaches the elastic coil is configured to stretch and retract to adapt to gastric and duodenum peristaltic movements ([0070])
Therefore, a person of ordinary skill in the art would have had a good reason to select the relative spring constants and tensile forces of the first and second spring to maintain the occlusion device at a desired location while accommodating gastric duodenal peristaltic movement and minimizing excessive stress on the anastomosis anchor, as Abu Dayyeh expressly teaches using the dynamic leash and tether to maintain the occlusion device in position relative to the pylorus (Abu Dayyeh; [0065]), while Albrecht teaches the spring is configured to stretch and retract to adapt to gastric and duodenal peristaltic movement (Albrecht; [0070]). The relative spring constant and tensile forces controls the restoring force of the respective springs, which adapt gastric and duodenal peristaltic movement. One of skill in the art have had a finite number of identified options, i.e., selecting the first spring to be greater than, equal to, or less than the second spring constant, with a reasonable expectation of success in maintaining the occlusion device in desired location. Accordingly, selecting the relative spring constants and tensile forces that dynamically balance each other to maintain the occlusion device in a position relative to the pylorus would have been an obvious-to-try see MPEP 2143(E).
Regarding claim 3, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 1.
The combination does not expressly teach wherein the second spring constant is different from the first spring constant.
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 Abu Dayyeh, as modified by Albrecht, with a reasonable expectation of success, to have the second spring constant is different from the first spring constant as a person of ordinary skill has a good reason to peruse the known options (the first spring constant being equal or different to the second spring constant) within his or her technical grasp. If this leads to the anticipated success (providing desired tensile forces to the occlusion device and the anastomosis anchor that overcomes gastric and duodenal peristatic movement thereby placing them in desired place, e.g., pyloric sphincter and anastomosis), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant case, that the modification involves obvious to try see MPEP2143.
Regarding claim 4, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 2.
The combination further teaches wherein the first coil spring is adapted to resist gastrointestinal system movements that could otherwise cause the occlusion device to move into the patient's stomach (Abu Dayyeh; [0050, 0059 0065] connecting occlusion member 56 and bypass device 70 through tubular body prevent migration or unnecessary movement within the small intestine and/or the stomach )
Regarding claim 5, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 2.
The combination further teaches wherein the second coil spring is adapted to resist gastrointestinal system movements that could otherwise cause the occlusion device to move into the patient's duodenum (Albrecht; [0070])
Regarding claim 6, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 2.
The combination further teaches wherein the first coil spring is adapted to work together with the second coil spring to keep the occlusion device in place relative to the patient's pylorus (Abu Dayyeh; figure 5, [0050, 0059 0065] connecting the occluding member and bypass device with the tubular body and expandable coil keep the occluding member in place and Albrecht; [0070])
Regarding claim 7, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 1.
The combination further teaches wherein the dynamic leash is adapted to be secured at one end to the occlusion device and at an opposing end to the anastomosis anchor (Abu Dayyeh; figure 5 and [0050, 0059 0065] one end of expandable coil 100 secured to occlusion member 56 and opposing end secured to anchor member 72).
Regarding Claim 8, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 7.
The combination further teaches wherein the occlusion device (Abu Dayyeh; figure 10, occlusion member 136) comprises a supporting frame (figure 10, wires 108) and an impermeable membrane (Abu Dayyeh; figure 10, [0015] and [0060] webbing 106 made of latex or silicone that prevent passage of fluid) spanning the supporting frame.
Regarding claim 10, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 8.
The combination does not expressly teach wherein the dynamic leash is adapted to be secured at one end to the impermeable membrane of the occlusion device;
In the same field of endeavor, namely a device and methods for anchoring an endoluminal sleeve in the GI tract, Albrecht teaches wherein the dynamic leash is adapted to be secured at one end to the impermeable membrane of the occlusion device (figure 7 and [0073], spring 28 directly connected to the proximal sleeve end 4).
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 Abu Dayyeh, as modified by Albrecht, to incorporate the teachings of Albrecht and provide the dynamic leash as claimed for the purpose of improving access to the opening of the occlusion device as taught by Albrecht ([0073]).
Regarding claim 13, Abu Dayyeh teaches a dynamic leash (figures 2 and 5, and [0050, 0059 and 0065] expandable coil 100) adapted for use in a gastric bypass system (figures 5 and 7-9, [0050, 0059 0065], small intestinal occlusion device 134 corresponds to occlusion device 50 illustrated in figure 5 + expandable coil 100) including an occlusion device (figure 9, 136) and a tether (figure 9, 138) secured to the occlusion device, the dynamic leash adapted to extend within a patient's stomach between an occlusion device adapted to be deployed relative to a patient's pylorus (figure 5) and a securement point (Figures 5 and 7-9, anchor member 140), the dynamic leash comprising:
An elastic member (figure 5, expandable coil 100, and ends of the coil configured to be secured to occlusion device 134 and anchor member 140) having a first end adapted to be secured relative to the occlusion device (figure 5, expandable coil 100 secured at the occlusion member 134) and a second end (figure 5, opposite end secured to the anchor member 140) adapted to be secured to the securement point;
wherein the tether (figures 5 and 7 and [0050, 0059 and 0065], tubular body 138 comprises stretchable material, i.e., latex, rubber, or coil, configured to provide a tensile force to the occlusion member 136 when it stretches) is adapted to provide a first tensile force to the occlusion device;
wherein the elastic member is adapted to provide a second tensile force to the occlusion device in opposition to the first tensile fore;
wherein the first tensile force and the second tensile force dynamically balance one another to maintain the occlusion device in position relative to the pylorus; and
wherein the securement point comprises a stomach wall of the stomach (figure 5, the expandable coil anchored to a stomach wall through the anchor member 140).
Abu Dayyeh does not teach the member is elastic;
wherein the elastic member is adapted to provide a second tensile force to the occlusion device.
In the same field of endeavor, namely a device and methods for anchoring an endoluminal sleeve in the GI tract, Albrecht teaches the member is being elastic (figure 6 and [0072], pull resistant tether 9 comprising elastic coil 28);
Wherein the elastic member is adapted to provide a second tensile force to the occlusion device ([[0072] elastic coil spring 28 having a spring constant and provide a tensile force when it stretches)
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 Abu Dayyeh, to incorporate the teachings of Albrecht and provide the dynamic leash as claimed for the purpose of enabling the dynamic leash to stretch and retract to adapt to gastric and duodenum peristaltic movements as taught by Albrecht ([0070]).
The combination does not expressly teach the second tensile force acts in opposition to the first tensile force;
wherein the first tensile force and the second tensile force dynamically balance one another to maintain the occlusion device in position relative to the pylorus; though
Abu Dayyeh teaches the tether and dynamic leashes are provided in a form of coil that prevents migration and/or movement of the occlusion device and anastomosis anchor ([0065]), and Albrecht teaches the elastic coil is configured to stretch and retract to adapt to gastric and duodenum peristaltic movements ([0070])
Therefore, a person of ordinary skill in the art would have had a good reason to select the relative spring constants and tensile forces of the first and second spring to maintain the occlusion device at a desired location while accommodating gastric duodenal peristaltic movement and minimizing excessive stress on the anastomosis anchor, as Abu Dayyeh expressly teaches using the dynamic leash and tether to maintain the occlusion device in position relative to the pylorus (Abu Dayyeh; [0065]), while Albrecht teaches the spring is configured to stretch and retract to adapt to gastric and duodenal peristaltic movement (Albrecht; [0070]). The relative spring constant and tensile forces controls the restoring force of the respective springs, which adapt gastric and duodenal peristaltic movement. One of skill in the art have had a finite number of identified options, i.e., selecting the first spring to be greater than, equal to, or less than the second spring constant, with a reasonable expectation of success in maintaining the occlusion device in desired location. Accordingly, selecting the relative spring constants and tensile forces that dynamically balance each other to maintain the occlusion device in a position relative to the pylorus would have been an obvious-to-try see MPEP 2143(E).
Regarding claim 14, Abu Dayyeh, as modified by Albrecht, teaches the dynamic leash of claim 13.
The combination further teaches wherein the securement point comprises an anastomosis anchor adapted to be secured in place relative to an anastomosis formed between the stomach wall and a small intestine (Abu Dayyeh; figure 5 and [0050, 0059 and 0065], anchor member 72 ).
Regarding claim 16, Abu Dayyeh, as modified by Albrecht, teaches the dynamic leash of claim 13.
The combination further teaches wherein the elastic member comprises a spring (figure 6 and [0072], pull resistant tether 9 comprising elastic coil 28).
Regarding claim 18, Abu Dayyeh, as modified by Albrecht, teaches the dynamic leash of claim 13.
The combination further teaches wherein the elastic member is adapted to resist gastrointestinal system movements that could otherwise cause the occlusion device to move into the patient’s duodenum (Abu Dayyeh; [0050, 0059 and 0065])
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Albrecht et al (US 20130030350 A1), and in further view of Vidlund et al (US 20140214159 A1).
Regarding claim 9, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 8.
The combination does not expressly teach wherein the dynamic leash is adapted to be secured at one end to the supporting frame of the occlusion device; though
Abu Dayyeh teaches the dynamic leash is adapted to be secured to the occlusion device (figure 5 and [0050]).
In the same field of endeavor, namely a prosthetic valves and related inventions, Vidlund teaches the dynamic leash ([0423-0425] tether 138) is adapted to be secured at one end to the supporting frame of the occlusion device (figure 10 [0423-0425] tethers 138 is secured at one end to the frame of the tubular stent 112).
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 Abu Dayyeh, as modified by Albrecht, to incorporate the teachings of Vidlund and provides the dynamic leash as claimed, and one of skill in the art motivated to do so, for the purpose of ensuring the implantable medical device system effectively overcomes continuous stretching and retracting movement of gastric and duodenal peristaltic movement, thereby securely anchoring the device at desired location.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) Albrecht et al (US 20130030350 A1), and in further view of Magal (US 20110040232 A1).
Regarding claim 11. Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 1.
The combination further teaches wherein the dynamic leash is adapted to be secured at one end to the occlusion device (Abu Dayyeh; figure 5 and [0050] expandable coil 100 is secured at one end of the occlusion member 56)
The combination does not teach wherein the dynamic leash is adapted to be secured at an opposing end to the stomach wall
In the same field of endeavor, namely duodenal liner device, Magal teaches wherein the dynamic leash (figure 3, [0165] and claim 44, tether is secured to stomach wall through anchor 84) is adapted to be secured to the stomach wall.
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 Abu Dayyeh to incorporate the teachings of Magal and provide the dynamic leash as claimed in order to distribute tensile forces over the wall of the stomach, as taught by Magal ([0165]), which would minimize excessive stress to the anchor.
Regarding claim 12. Abu Dayyeh teaches the implantable medical device system of claim 1.
Abu Dayyeh further teaches wherein the dynamic leash is adapted to be secured at one end to the occlusion device (figure 5 and [0050] expandable coil 100 is secured at one end of the occlusion member 56).
Abu Dayyeh does not teach wherein the dynamic leash is adapted to be secured an anti-migration anchor.
In the same field of endeavor, namely duodenal liner device, Magal teaches wherein the dynamic leash is adapted to be secured at an opposing end to an anti-migration anchor (figure 3f and [0165] tether 44 is configured to be secured to subcutaneous anchor 84).
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 Abu Dayyeh to incorporate the teachings of Magal and provide the dynamic leash as claimed in order to distribute tensile forces over the wall of the stomach, as taught by Magal ([0165]) and effectively secure the device system in place.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Albrecht et al (US 20130030350 A1), and in further view of Maude-Griffin et al (US 20190021891 A1).
Regarding claim 17, Abu Dayyeh, as modified by Albrecht, teaches the implantable medical device system of claim 13.
The combination does not teach wherein the elastic member comprises a pneumatic tube.
In the same field of endeavor, namely a device for gastrointestinal bypass, Maude-Griffin teaches a dynamic leash (figure 62, tether 1310) comprising an elastic member, wherein the elastic member comprises a pneumatic tube (figure 8a, elongation element 1330 being hydraulic or gas-filled cylinder 1331).
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 Abu Dayyeh, as modified by Albrecht, to incorporate the teachings of Maude-Griffin and provide the dynamic leash as claimed for the purpose of reducing tugging sensation and/or tissue damage caused by movement of spring element as taught by Maude ([0113]), and further prevent the spring material damaging from exposure to the acidic gastric environment.
Conclusion
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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/SETH HAN/Examiner, Art Unit 3781
