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 Claims
Claim 1-20 are currently pending. Claims 1-12 and 15-17 are currently amended. No new subject matter is added.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-10 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Schaer et al. (US 20190167407 A1), hereinafter referred to as “Schaer”.
Regarding Claim 1, Abu Dayyeh teaches An implantable gastric bypass system (see Figure 4), comprising:
an occlusion device (occlusion member 56) adapted to be secured in place relative to a patient's pylorus (occlusion member 56 secured relative to a patient's pyloric sphincter 20, see Figure 4);
an anastomosis anchor (anchor member 72) adapted to be secured in place relative to an anastomosis formed between a stomach wall of a stomach and a small intestine (anchor member 72 secured relative to an anastomosis formed between the patient’s stomach wall 14 and the patient's small intestine 16, see Figure 4); and
a tether (tubular member 52 having delivery loop 60 functions as a tether and falls under the definition of tethers) adapted to extend through a duodenum (extending through the duodenum 18, see Figure 4), the tether secured at a first end to the occlusion device (secured to occlusion member 56, see Figure 2) and at a second end to the anastomosis anchor (when the occlusion member 56 and the anchor member 72 are assembled, see Figure 4), the tether adapted to resist degradation upon exposure to gastric liquids (the member 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]; used in a gastric environment, it is this "resistant" to gastric liquids); wherein the tether is further adapted to hold the occlusion device in position relative to the pylorus as the stomach attempts to dislodge the occlusion device from the pylorus (delivery loop 60 configured to aid in delivery, positioning, and removal of the occlusion device 50, see Paragraph [0040]; Figure 4; the member 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]; used in a gastric environment, it is this "resistant" to gastric liquids).
However, Abu Dayyeh does not explicitly disclose wherein the tether is further adapted to reversibly lengthen and shorten in order to hold the occlusion device in position relative to the pylorus.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2), wherein the tether is further adapted to reversibly lengthen and shorten in order (the tether 1004 comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the tether comprises one or more springs adapted to reversibly lengthen and shorten in order, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Regarding Claim 2, Abu Dayyeh teaches all of the limitations as discuss above in claim 1. However, Abu Dayyeh does not explicitly disclose wherein the tether comprises one or more springs that are adapted to extend from the first end of the tether to the second end of the tether.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2) comprising: the tether (tether 1004) comprises one or more springs that are adapted to extend from the first end of the tether to the second end of the tether (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26). Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the tether comprises one or more springs that are adapted to extend from the first end of the tether to the second end of the tether, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Regarding Claim 3, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 2 and Schaer further teaches a covering disposed over at least a portion of the tether (tether 10330 can have a deflector/tether extension 10322, see Figure 48; Paragraph [0146]).
Regarding Claim 4, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 3 and Schaer further teaches wherein the covering (deflector 10322 could be a tubular structure, see Figure 48) is adapted to move independently of the one or more springs (independently moves over tether 10330, see Figure 48; Paragraph [0146]).
Regarding Claim 5, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 3 and Schaer further teaches wherein the covering is adapted to move in conjunction with movement of the one or more springs (the deflector 10322 could also be formed of a coil or braid or any combination of these; heat set polymers, nitinol, or stainless steel could be used to provide the spring shape, see Paragraph [0146]; therefore moving together with the spring tether).
Regarding Claim 7, Abu Dayyeh teaches all of the limitation as discussed above in claim 1 and Abu Dayyeh further teaches wherein the tether comprises:
a first attachment member adapted to be secured to the occlusion device (occlusion member 56 can be positioned on a distal portion of tubular member 52, see Figures 2 and 4);
a second attachment member adapted to be secured to the anastomosis anchor (anchor member 72 can be configured to engage with the anchor member 54 of tubular member 52, see Figure 4; Paragraph [0043]).
However, Abu Dayyeh does not explicitly disclose a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2) comprising: the tether (tether 1004) having a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the tether comprises one or more springs that are adapted to extend from the first end of the tether to the second end of the tether, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Abu Dayyeh and Schaer teaches all of the limitations as discussed above. However, Abu Dayyeh and Schaer do not explicitly disclose wherein the first attachment member is secured to the second end of the spring and the second attachment member is secured to the first end of the spring such that an applied tensile force to either the first attachment member or the second attachment member acts to compress the spring.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to try and secure the first attachment member of the tether to a second end of the spring and the second attachment member of the tether to a first end of the spring such that an applied tensile force to either the first attachment member or the second attachment member acts to compress the spring since it has been held "a person of ordinary skill has good reason to pursue the known options (attaching to first end of the spring or attaching to the second of the spring) within his or her technical grasp. If this leads to the anticipated success (an elastic tether that provides controlled movement), it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
Regarding Claim 8, Abu Dayyeh teaches all of the limitation as discussed above in claim 1. However, Abu Dayyeh does not explicitly disclose wherein the tether comprises a torsion spring or a leaf spring.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2) comprising: the tether (tether 1004) having a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]), wherein the tether comprises a torsion spring or a leaf spring (tether comprises a spring or spring-like element set to resemble a torsional spring, see Figure 28).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the tether comprises a torsion spring or a leaf spring, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Regarding Claim 9, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 2 and Abu Dayyeh further teaches wherein the tether comprises a braided member (tubular body 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]).
Regarding Claim 10, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 2 and Abu Dayyeh further teaches wherein the tether further comprises a covering disposed over at least a portion of the braided member (tubular body 52 can be made of a braided metal (such as nitinol) covered with silicon, see Paragraph [0037]).
Regarding Claim 17, Abu Dayyeh teaches a tether (tubular member 52 functions as a tether and falls under the definition of tethers) adapted for use in a gastric bypass system (a system for bypassing a portion of a small intestine, see Abstract), the tether adapted to extend within a duodenum (duodenum 18) between an occlusion device (occlusion member 56) adapted to be deployed relative to a pylorus (occlusion member 56 secured relative to a patient's pyloric sphincter 20, see Figure 4) and an anastomosis anchor (anchor member 72) adapted to be secured in place relative to an anastomosis formed between a stomach wall of a stomach and a small intestine (anchor member 72 secured relative to an anastomosis formed between the patient’s stomach wall 14 and the patient's small intestine 16, see Figure 4), the tether comprising:
an elastic member that is adapted to extend from the first end of the tether to the second end of the tether (tubular member 52 can be flexible, see Paragraph [0037]), the elastic member to resist stomach-induced movement of the occlusion device relative to the pylorus (the member 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]; used in a gastric environment, it is this "resistant" to gastric liquids); and
an impervious cover disposed over the elastic member (tubular body 52 can be made of a braided metal (such as nitinol) covered with silicon, see Paragraph [0037]).
However, Abu Dayyeh does not explicitly disclose wherein the elastic member is changing in length.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2), wherein the elastic member changing in length (the tether 1004 comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the elastic member is changing in length, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Regarding Claim 18, Abu Dayyeh teaches all of the limitation as discussed above in claim 17. However, Abu Dayyeh does not explicitly disclose wherein the impervious covering is adapted to move independently of the elastic member.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figure 48) comprising: an elastic member (tether 10330) having an impervious covering (deflector 10322 could be a tubular structure, see Figure 48) is adapted to move independently of the elastic member (independently moves over tether 10330, see Paragraph [0146]).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the impervious covering is adapted to move independently of the elastic member, as taught by Schaer. Schaer teaches the tension extension (cover) may also serve to strain relieve the transition between the line and tubular element to reduce the chance of fatiguing and fracturing (see Paragraph [0146]).
Regarding Claim 19, Abu Dayyeh teaches all of the limitation as discussed above in claim 17. However, Abu Dayyeh does not explicitly disclose wherein the impervious covering is adapted to move in conjunction with movement of the elastic member.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2) comprising: an elastic member (tether 1004) having a spring extending from a first end closer to the first attachment member to a second end closer to the second attachment member (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]), wherein an impervious covering is adapted to move in conjunction with movement of the movement of the elastic member (the deflector 10322 could also be formed of a coil or braid or any combination of these; heat set polymers, nitinol, or stainless steel could be used to provide the spring shape, see Paragraph [0146]; therefore moving together with the spring tether).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the impervious covering is adapted to move in conjunction with movement of the elastic member, as taught by Schaer. Schaer teaches the tension extension (cover) may also serve to strain relieve the transition between the line and tubular element to reduce the chance of fatiguing and fracturing (see Paragraph [0146]).
Regarding Claim 20, Abu Dayyeh and Schaer teach all of the limitation as discussed above in claim 17 and Schaer further teaches an elastic member (tether 1004) comprises one or more metallic springs (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26; the tension tether line may also be a strand or braid of round or flattened metal wire, such as stainless steel or nitinol, see Paragraph [0141]; various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination, see Paragraph [0066]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh and Schaer, as applied to claim 2, in further view of Shalon et al. (US 8323300 B2), hereinafter referred to as “Shalon”.
Regarding Claim 6, Abu Dayyeh and Schaer teach all of the limitations, as discussed above in claim 2. However, Abu Dayyeh and Schaer do not explicitly disclose wherein the tether has a thread extending through the one or more springs, limiting extension of the one or more springs.
Shalon teaches a tissue anchorable device (see Figures 1g) comprising a tether (14) wherein the tether has a thread extending through the one or more springs, limiting extension of the one or more springs (tether 14 can be inelastic, thread 14, and attached to an elastic structure, spring element 36, disposed under device body 152 to allow for an elastic effect with inelastic tether materials., see Col. 8 ln 39-52; see Figure 1g).
Abu Dayyeh, Schaer, and Shalon are analogous art because all teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of modified Abu Dayyeh and further include wherein the tether has a thread extending through the one or more springs, limiting extension of the one or more springs, as taught by Shalon. Shalon teaches the elastic tether provides minimum or a controlled resistance to tissue motion (see Col. 8 ln 37-38).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh and Schaer, as applied in claim 1, and in further view of Grubac et al. (US 20160310747 A1), hereinafter referred to as “Grubac”.
Regarding Claim 11, Abu Dayyeh and Schaer teach all of the limitations, as discussed above in claim 1. However, Abu Dayyeh and Schaer do not explicitly disclose wherein the tether comprises a collet that allows the tether to move in a first direction relative to the collet but not move in an opposing direction such that the collet is adapted to provide a one-way length adjustment of the tether.
Grubac teaches a tethering assembly (500, see Figure 2A) wherein the tether (580) comprises a collet (520) that allows the tether to move in a first direction relative to the collet but not move in an opposing direction such that the collet is adapted to provide a one-way length adjustment of the tether (see Figure 2A; Paragraph [0021]).
Abu Dayyeh, Schaer and Grubac are analogous art because both teach a tethering assembly.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of modified Abu Dayyeh and further include wherein the tether comprises a collet that allows the tether to move in a first direction relative to the collet but not move in an opposing direction such that the collet is adapted to provide a one-way length adjustment of the tether, as taught by Grubac. Grubac teaches improved apparatus and methods related to the tethering of implantable medical devices in the context of deploying the devices at an implant site (see Paragraph [0005]).
Claims 12-13 and 15-16 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh (US 20200390580 A1) in view of Stack et al. (US 20150342772 A1), hereinafter referred to as “Stack”.
Regarding Claim 12, Abu Dayyeh teaches a tether (tubular member 52 functions as a tether and falls under the definition of tethers) adapted for use in a gastric bypass system (a system for bypassing a portion of a small intestine, see Abstract), the tether adapted to extend within a duodenum (duodenum 18) between an occlusion device (occlusion member 56) adapted to be deployed relative to a pylorus (occlusion member 56 secured relative to a patient's pyloric sphincter 20, see Figure 4) and an anastomosis anchor (anchor member 72) adapted to be secured in place relative to an anastomosis formed between a stomach wall of a stomach and a small intestine (anchor member 72 secured relative to an anastomosis formed between the patient’s stomach wall 14 and the patient's small intestine 16, see Figure 4), the tether comprising:
an elongate member extending from a first region adapted to be secured to an occlusion device (tubular body 52 secured to the occlusion member 56, see Figure 2) to a second region adapted to be secured to the anastomosis anchor (when the occlusion member 56 and the anchor member 72 are assembled, see Figure 4);
the elongate member including an intermediate portion disposed between the first region and the second region (intermediate portion of tubular member 52, see Figure 2); and wherein the tether is adapted to hold the occlusion device in position relative to the pylorus against dislodgement attempts made by the stomach to dislodge the occlusion device (the member 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]; used in a gastric environment, it is this "resistant" to gastric liquids).
However, Abu Dayyeh does not explicitly disclose the intermediate portion adapted to avoid contact with a Papilla of Vater in order to avoid irritating the Papilla of Vater.
Stack teaches a tether (tubing 52 and narrow tether 50, see Figure 11) having an intermediate portion (50) adapted to avoid contact with a Papilla of Vater in order to avoid irritating the Papilla of Vater (narrow tether 50 may connect the proximal portion 52a of the tube to the distal portion 52b of the tube so as to avoid obstructing the ampulla, see Paragraph [0058]; Figure 11).
Abu Dayyeh and Stack are analogous art because both teach a gastrointestinal implant comprising a tether.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the intermediate portion is adapted to avoid contact with a patient's Papilla of Vater in order to avoid irritating the patient's Papilla of Vater, as taught by Stack. Stack teaches it may be desirable to position the tube so that it does not contact the ampulla of Vader (an opening in the duodenum through which bile passes into the duodenum) so as to minimize the chance of irritation and cholecystitis (see Paragraph [0058]).
Regarding Claim 13, Abu Dayyeh and Stack teach all of the limitations as discussed above in claim 12 and Stack further teaches wherein the intermediate portion (narrow tether 50) has a reduced outer diameter relative to an outer diameter of the first region or an outer diameter of the second region (outer diameter of tube proximal portion 52a or distal portion 52b, see Figure 11).
Regarding Claim 15, Abu Dayyeh and Stack teach all of the limitations as discussed above in claim 12 and Abu Dayyeh further teaches a tubular member disposed over the tether (tubular body 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]), the tubular member adapted to space the tether away from the Papilla of Vater (intermediate portion of the tether avoids contact with Papilla of Vater, as described above in claim 12).
Regarding Claim 16, Abu Dayyeh and Stack teach all of the limitations as discussed above in claim 12 and Abu Dayyeh further teaches wherein the intermediate portion (intermediate portion of tubing 52) of the elongate member comprises a bow-shaped member adapted to fit around the Papilla of Vater (tubing 52 is bow shaped, see Figure 4).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Abu Dayyeh and Stack, as applied to claim 12, in further view of Schaer (US 20190167407 A1).
Regarding Claim 14, Abu Dayyeh and Stack teach all of the limitations as discussed above in claim 12 and Abu Dayyeh further teaches wherein the first region (stretchable areas 104 may be composed of a material that is more stretchable or pliable than the material of the rest of the tubular body 138, see Paragraph [0059]; Figure 9) and the second region (stretchable area 104; various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination, see Paragraph [0066]).
However, Abu Dayyeh does not explicitly disclose wherein the first region comprises a first spring and the second region comprises a second spring.
Schaer teaches an anchoring system which in turn comprises at least two anchors connected to one another by a tethering structure (see Paragraph [0007]; Figures 1-2) comprising: the tether (tether 1004) comprises one or more springs that are adapted to extend from the first end of the tether to the second end of the tether (the tether comprises a spring or spring-like element, the spring can be stretched to an extended length, see Paragraph [0114]; Figure 26).
Abu Dayyeh and Schaer are analogous art because both teach a tethering and anchoring system used within human body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the tether of Abu Dayyeh and further include wherein the tether comprises wherein the first region comprises a first spring and the second region comprises a second spring, as taught by Schaer. Schaer teaches the springs allows the distance between an at least one proximal and one or more distal anchor(s) to be adjustable such that the distance may be increased, or decreased (see Paragraph [0008]).
Response to Arguments
Applicant’s arguments, see pg. 1, filed 12/02/2025, with respect to claim 12 have been fully considered and are persuasive. The objection of claim 12 has been withdrawn.
Applicant’s arguments, see pg. 1, filed 12/02/2025, with respect to claim 12 have been fully considered and are persuasive. The 112(b) rejection of claim 6 has been withdrawn.
Applicant’s arguments, see pg. 1, filed 12/02/2025, with respect to claim 15 have been fully considered and are persuasive. The 112(f) interpretation of claim 15 has been withdrawn.
Applicant’s arguments with respect to claims 1, 9-10, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
Specifically Applicant argues in claim 2, that Abu Dayyeh and Schaer are non-analogous art. The applicant also argues that a tether used in the lung is not designed to stand against the movement within the gastrointestinal tract when a foreign object is present.
In response to applicant's argument that Schaer is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Abu Dayyeh and Schaer are reasonably pertinent to the particular problem with which the inventor was concerned (providing an adjustable tether to an occlusion device). Also, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, Claim 2 and its dependents would remain rejected under Abu Dayyeh in view of Schaer.
Specifically Applicant argues in claim 12, that Abu Dayyeh would fail to read on the newly amended limitations “wherein the tether is adapted to hold the occlusion device in position relative to the pylorus against dislodgement attempts made by the stomach to dislodge the occlusion device”.
The examiner respectfully disagrees with the applicant that Abu Dayyeh would fail to read on the newly amended limitations. As discussed above, Abu Dayyeh teaches that the member 52 can be made of a braided metal (such as nitinol), see Paragraph [0037]; used in a gastric environment, it is this "resistant" to gastric liquids. The material of the tether is therefore resistant to a gastric environment allowing the tether to be adapted to hold the occlusion device. Also, Paragraph [0041] discloses the distal tip 64 of tubular member 52 to include a delivery loop 60 configured to aid in delivery, positioning, and removal of the occlusion device 50. Abu Dayyeh would read on the newly amended limitations. Therefore, Claim 12 and would remain rejected under Abu Dayyeh
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/ERIC RASSAVONG/ (3/7/2026)Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781