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 .
Response to Amendment
The amendments filed on 10/24/2025 have been entered. Claims 1-13 and 23-25 remain pending in the application.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
Applicant argues on page 6-7 that element 107/507 is not a “cylindrical spiral cut tube” because it does not meet the definition of “the surface traced by a straight line moving parallel to a fixed straight line and intersecting a fixed planar closed curve. Examiner first notes that the claim does not require a “cylinder”. Applicants’ argument and provided definition are directed to a cylinder, which is a shape with a specific geometric definition. However, the claim limitation is “cylindrical”, which is a broader adjective used to describe a general shape of an object. With respect to providing a reasonable interpretation of the limitation in view of the disclosure of the present invention, it is noted that the originally filed claimed and the specification do not use the word “cylindrical” or “cylinder” to describe the spiral cut tubing. At best, FIG 8A-8B show the shape of the spiral cut tubing being generally cylindrical. However, the disclosed bulking component 71 fails to meet applicants provided definition of a cylinder as well. Due to the spiral cuts, the bulking component cannot meet the geometric definition of “a solid geometric figure with straight parallel sides and a circular or oval cross section”. Therefore, it is the examiners position that applicant’s argument is an overly narrow interpretation of “cylindrical spiral cut tubing”.
Applicant further states the “sphere of Grau would not be bendable along its length, considering its shape and length. As previously argued, it is the examiners position that the spiral cut tube of Grau is taught to be flexible. [0076-0077] disclose the entire implant (therefore including element 507) is “compliant and generally flexible and bendable” and that materials for the implant are “selected for their ability to yield and flex during implantation and removal of the implant. These properties also protect the patient and the tissues and organs with which the implant comes into contact”. Further, [0086] states that the spiral cuts in the tubing are intended to enhance the flexibility. Therefore, the spiral cut tubing is disclosed as being flexible and is at least configured to bend along its length. Therefore, applicants’ argument is not persuasive.
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.
Claim(s) 1-3, 5-10, and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Grau et al. (US 2009/0259239).
Regarding claim 1, Grau et al. discloses an intragastric device (500, FIG 10, paragraphs [0122-0137]), comprising: a wire elongated member (84, 86, 91, FIG 13); a wire anchor (73, [0123]) connected to or formed with the wire elongated member (FIG 13; handle 73 is fixed to 86 and forms an anchor because it can be used to hold member 86 in place); and a bulking component (502, 507, 508) covering a portion of the elongated member or the anchor (84, 86 passes through a lumen of elements 502, 507, 508 therefore a portion is covered, FIG 13), the bulking component providing an increased surface area compared to the wire elongate member (The circumferential size and diameter of 502, 507, 508 is larger than that of the elongate member, therefore providing an increased surface are) to protect body tissue from damage from contact pressure with the wire elongate member (See FIG 13 where wire elongate member 86, 91 is shown at least partially housed within 502, 507 of the bulking component. Therefore, the bulking component is serving to protect surrounding tissue from contacting the elongate member in at least these regions), the bulking component comprising cut tubing (Element 507 is interpreted as cut tubing because it comprises slots 510 formed therein).
Grau et al. is silent regarding the cut tubing being spiral cut tubing.
However, Grau et al. discloses in the embodiment of FIG 2, an implant (100) having a comparable bulking component (102, 107, 108) wherein the region of cut tubing (107) comprises spiral slots (110) therefore forming spiral cut tubing (FIG 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the slots of the present embodiment to be angled with respect to the longitudinal axis of the device as taught by the alternative embodiment of FIG 2, for the purpose of enhancing the flexibility of this region while providing the predictable result of allowing for the passage of chime into the interior portion of the device (Paragraph [0086]). In the device as modified to have angled slots, a region of spiral cut tubing is formed as required by the claim. The device as modified further discloses the spiral cut tubing being flexible and bendable along its length to follow the curvature of the wire elongate member or the wire anchor ([0076-0077] disclose the entire implant is “compliant and generally flexible and bendable” and that materials for the implant are “selected for their ability to yield and flex during implantation and removal of the implant. These properties also protect the patient and the tissues and organs with which the implant comes into contact”. Further, [0086] states that the spiral cuts in the tubing are intended to enhance the flexibility. Therefore, the spiral cut tubing is disclosed as being flexible and is at least configured to follow curvature of the wire elongate member because it can bend along its length in the same manner as the elongate member in order to accommodate positioning and removal).
Regarding claim 2, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. further discloses a sleeve (509, paragraph [0123]; this element is generally cylindrical in shape and comprises a lumen. Therefore it is interpreted as a sleeve) attached to the elongated member at a distal end thereof (The entirety of device 500 is attached at a distal end of 84, 86 and therefore sleeve 509 is also attached through mechanical connection), the sleeve configured to slide distally along the elongated member (Paragraph [0128] discloses the body of implant 500 is able to move freely along 84 and therefore 509 is at least configured to slide distally along 86 as well) to form a plurality of radially expanded flow reduction elements (Best shown in FIGs 13-14, each radially flaring rib of 509 is interpreted as a flow reduction element because its disk shape is configured to impede flow. Further, paragraph [0123] discloses 509 having a contracted diameter and an extended diameter, therefore each of the ribs are understood to be radially expanded in the deployed configuration).
Regarding claim 3, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 2. Grau et al. further discloses the bulking component covers a portion of the elongated member (FIG 13 shows the portion of the bulking component through which 84, 86 passes, therefor being covered) and is positioned such that, when the sleeve is unexpanded, a gap of 0.5 inches or less is between the bulking component and a proximal end of the sleeve (Although not shown in the unexpanded configuration, the bulking component and the sleeve are connected and therefore the distance between the two elements would be the same in the unexpanded configuration as it is in the expanded configuration. Further, because sleeve 509 is directly attached to element 508 of the bulking component, the distance between the two elements is less than 0.5 inches).
Regarding claims 5-6, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Grau et al. discloses the spiral cuts have a pitch relative to the longitudinal axis (Paragraph [0086]) but is silent regarding the pitch being approximately 0.125 inches.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Grau et al. to have a pitch of approximately 0.125 inches since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Grau et al. would not operate differently with the claimed pitch and since the slots are intended to be angle to promote flexibility, the device would function appropriately having the claimed spiral pitch. Further, applicant places no criticality on the value claimed, indicating simply that the pitch “can be approximately 0.125 inches” (specification pp. [0019]).
Regarding claim 7, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses an inner diameter of the bulking component is greater than an outer diameter of the portion of the elongated member or the anchor such that there is a gap therebetween (FIG 13 shows the relationship between an inner diameter of 507 and 507 of the bulking component relative to the outer diameter of 84, 86, showing a gap between the two).
Regarding claim 8, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses the bulking component is attached to the elongate member only at an end of the spiral cut tubing (FIG 16 shows the bottom end of the spiral cut tubing is mechanically connected to 538/539, through which 91 passes and it fixed to. The wire 84 is received within 91 and therefore is attached at this point as well through mechanical contact).
Regarding claim 23, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses the bulking component covers a portion of the elongated member (See FIG 13 where wire elongate member 86, 91 is shown at least partially housed within 502, 507 of the bulking component).
Regarding claim 24, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses a sleeve (509, paragraph [0123]; this element is generally cylindrical in shape and comprises a lumen. Therefore, it is interpreted as a sleeve) attached to the elongated member (509 is attached to 91 through mechanical contact as 91 is received in the recess of the flange of 509., FIGs 10-11. [0088] discloses with respect to the other embodiments, “Recesses 114 are configured to allow a tube, such as small tube 86 and/or medium tube 91, to pass therethrough and along flanges 109”, which is interpreted as applying to the present embodiment as shown), the sleeve configured to slide along the elongate member (because 91 of the elongate member is positioned within the cut out/recess on 509, but is not permanent fixed at this location. Therefore 91 can slide within the recess) to form a plurality of radially expanded flow reduction elements (FIG 10, the presences of 91 within the recess as shown thereby reduces flow through that recess at least some degree).
Regarding claim 1, Grau et al. discloses in an alternative interpretation, an intragastric device (500, FIG 10, paragraphs [0122-0137]), comprising: a wire elongated member (523, 98, 89, FIG 13); a wire anchor (530) connected to or formed with the wire elongated member (FIG 13; anchor 530 is used to fix wire 523 in place and therefore is interpreted as a wire anchor); and a bulking component (502, 507, 508, 509) covering a portion of the elongated member or the anchor (530 and a distal end of 523 is covered by 509 of the bulking component, FIG 13), the bulking component comprising cut tubing (Element 507 is interpreted as cut tubing because it comprises slots 510 formed therein), the bulking component providing an increased surface area compared to the wire elongate member (The circumferential size and diameter of 502, 507, 508 is larger than that of the elongate member, therefore providing an increased surface are) to protect body tissue from damage from contact pressure with the wire elongate member (See FIG 11-13 where wire elongate member 523, 89 is shown to have a smaller profile than 502, 507 of the bulking component. Therefore, the bulking component is serving to protect surrounding tissue from contacting the elongate member).
Grau et al. is silent regarding the cut tubing being spiral cut tubing.
However, Grau et al. discloses in the embodiment of FIG 2, an implant (100) having a comparable bulking component (102, 107, 108) wherein the region of cut tubing (107) comprises spiral slots (110) therefore forming spiral cut tubing (FIG 2).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the slots of the present embodiment to be angled with respect to the longitudinal axis of the device as taught by the alternative embodiment of FIG 2, for the purpose of enhancing the flexibility of this region while providing the predictable result of allowing for the passage of chime into the interior portion of the device (Paragraph [0086]). In the device as modified to have angled slots, a region of spiral cut tubing is formed as required by the claim. The device as modified further discloses the spiral cut tubing being flexible to follow the curvature of the wire elongate member or the wire anchor ([0076-0077] disclose the entire implant is “compliant and generally flexible and bendable” and that materials for the implant are “selected for their ability to yield and flex during implantation and removal of the implant. These properties also protect the patient and the tissues and organs with which the implant comes into contact”. Further, [0086] states that the spiral cuts in the tubing are intended to enhance the flexibility. Therefore, the spiral cut tubing is disclosed as being flexible and is at least configured to follow curvature of the wire elongate member because it can bend in the same manner as the elongate member in order to accommodate positioning and removal).
Regarding claim 9, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses the bulking component is attached to the portion of the elongated member or the anchor (Element 509 is fixed to anchor 530, FIG 16. Paragraph [0137] further discloses 530 as being not removable from its position even when tension is applied to snare 98, such that the suture must instead be cut to release the implant).
Grau et al. is silent regarding the anchor being attached with glue.
However, Grau et al. teaches that various component of the device which are manufactured separately may be assembled and glued together using a silicone based glue (Paragraph [0079]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device such that glue is used to attach the bulking component to the anchor, since Grau et al. teaches this is a commonly known means for attaching two assembled components and would achieve the predictable result of configuring the bulking component and the anchor such that they do not become separated when a force is applied to the snare.
Regarding claim 10, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 9. Grau et al. discloses the portion of the elongated member (i.e. the portion covered by the bulking member) includes a groove therein configured to hold glue (526 is an element of 523 and in interpreted as forming a groove, [0122, 0124, 0128]. Examiner notes that the glue recited in claim 10 is not necessarily the same glue as recited in claim 9 which attaches the bulking component).
Regarding claim 25, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. discloses the bulking component covers a portion of the anchor (FIG 13 shows 508 of the bulking component covers anchor 530).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Grau et al. (US 2009/0259239) in view of Reo et al. (US 2014/0276337).
Regarding claim 4, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. further discloses the bulking component comprises a pliable polymeric material (Paragraph [0077]) and discloses the desired characteristics of being compliant and having the ability to yield and flex.
Grau et al. is silent regarding the polymer specifically being polyethylene terephthalate.
However, Reo et al. discloses a gastric implant (10, FIG 1A, abstract) made of a “deformable or suitably flexible material” such as polyethylene terephthalate (Paragraph [0010]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select polyethylene terephthalate as the pliable polymer material, as taught by Reo et al., for the purpose of forming the bulking component of a biocompatible material known commonly in the art for having the desired compliance and flexibility for the particular gastric application.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Grau et al. (US 2009/0259239) in view of Rabbitte et al. (US 2010/0069950).
Regarding claims 11 and 12, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau discloses the implant may be made of nitinol ([0077]).
Grau et al. is silent regarding specifically the wire elongated member comprising nitinol and wherein the nitinol is electropolished.
However, Rabbitte et al. discloses a guidewire (100, equivalent to the wire elongated member of Grau et al. which is also a guidewire) made of electropolished nitinol (Paragraph [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the material of the wire elongate member to be electropolished nitinol, as taught by Rabbitte et al., for the purpose of selecting a commonly known material in the art for forming a guidewire and a achieving the predictable result of an wire elongated member having the desired flexibility for navigating to a target treatment site while also being biocompatible and manufactured using a commonly known process.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Grau et al. (US 2009/0259239) in view of Brooks et al. (US 2009/0287231).
Regarding claim 13, Grau et al. discloses the invention substantially as claimed, as set forth above for claim 1. Grau et al. further discloses the bulking component has an outer diameter of between .050 inches and .15 inches (Paragraph [0082] discloses that the device is insertable through a working channel of a gastroscope having a diameter of 0.11 inches. Therefore, the bulking component in a collapsed configuration is understood to have a diameter slightly less than that of the working channel, thus falling within the range of 0.050 and 0.15 inches).
Grau et al. is silent regarding the wire elongated member having an outer diameter of between 0.015 and 0.030 inches.
However, Brooks et al. teaches in the same field of endeavor of devices deliverable to the stomach (Abstract) a guidewire having an outer diameter of 0.028 inches (Paragraph [0177]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the wire of Grau et al., which is also a guidewire, to have an outer diameter of 0.028 inches, as taught by Brooks et al., because Brooks discloses this diameter is suitable for a standard guidewire and is “well known in the art” (Paragraph [0177]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771