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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 26, 2026 has been entered.
Response to Amendment
The previous 35 USC 112(b) rejection of claim 4 is withdrawn in response to amendments to the claim.
The previous 35 USC 112(f) interpretations of “tissue-contacting component” and “anti-migration component” of claim 1 is withdrawn in response to amendments to claim 1.
Response to Arguments
Applicant’s arguments regarding Gupta and Drasler are not persuasive. Applicant argues that neither Gupta nor Drasler shows or suggests an anti-migration component which is “positioned in and extending through” a lumen of a tissue-contacting component and which has a portion which is located external to and extending radially-outwardly from the lumen and is configured to exert a radially outward anti-migration force. Drasler discloses an implantable device for occlusion of a body lumen (see Figs. 27A-27C; par. 197-199) with a tissue-contacting component 85 and a plug 740 within a lumen of the tissue-contacting component that occludes the lumen of the tissue-contacting component (see Fig. 27C) as well as positions the tissue-contacting component in place, acting as an anti-migration component (see par. 198), wherein at least one portion (see Fig. 27C, the distal portion 640) of the anti-migration component is located external to and extending radially-outwardly from the lumen and is configured to exert a radially-outward anti-migration force (see Fig. 27C, par. 198). This teaching of Drasler is obvious to combine with that of Gupta, as explained in rejections below, and due to Gupta disclosing the desired positioning of the stent in the pylorus and the distal end 640 of the balloon 240 in Drasler helping to position the stent, these parts disclosed by Gupta and Drasler would act as required by claim 1.
Applicant’s arguments regarding claim 6 are not persuasive. Applicant argues that since Drasler does not show or suggest any element which may be considered a retention member which contacts tissue in the gastrointestinal tract and Gupta does not show or suggest a component extending through a lumen of a tissue-contacting component as recited in claim 1, these references combined cannot disclose the required teachings of claim 6. In response to applicant's argument, it is pointed out that the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art and not only what the prior art teaches separately. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Gupta discloses the desired positioning of the stent in the pylorus and the distal end 640 of the balloon 240 in Drasler helping to position the stent, which would require the balloon to contact tissue in the gastrointestinal tract in order to hold the required position.
Applicant’s arguments regarding claim 15 are not persuasive. Applicant argues that neither Gupta nor Drasler disclose a second component which is positioned in and extends through the lumen of the first component with a portion located external to and extending radially-outwardly from the lumen and “configured to contact tissue to resist migration of said implantable device with respect to the pylorus.” As explained above, Gupta discloses the desired positioning of the stent in the pylorus and the distal end 640 of the balloon 240 in Drasler helping to position the stent, which would require the balloon to contact tissue in the gastrointestinal tract in order to hold the required position, therefore resisting migration of the implantable device with respect to the pylorus.
Applicant’s argument regarding claim 16 is not persuasive. Applicant makes similar arguments to those made for claims 1, 6, and 15 above and those arguments are not persuasive for the same reasons as explained above.
Applicant’s arguments regarding claim 10 are not persuasive. Applicant makes similar arguments to those made for claim 1 above and those arguments are not persuasive for the same reasons as explained above.
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.
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.
Claim(s) 1-9 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gupta et al. (US 2019/0298559) in view of Drasler (US 2018/0360461).
Regarding claim 1, Gupta discloses an implantable device (see Figs. 7, 9F; par. 7, 44, 47) for occlusion of a body lumen (see Abstract), the device comprising: a tissue-contacting component (see par. 7, 35, 44, 47 and Fig. 9F, stent including first flange, second flange, and saddle) configured to resist tissue ingrowth (see par. 7) and shaped to be placed in a gastrointestinal tract (see Abstract, deployed across pylorus), the tissue contacting component defining a lumen therethrough (see Fig. 9F and par. 47).
Gupta does not disclose an anti-migration component separately formed from said tissue-contacting component and configured to hold said tissue-contacting component in place with respect to tissue at a deployment site, wherein at least one portion of the anti-migration component is located external to and extending radially-outwardly from the lumen and is configured to exert a radially outward anti-migration force, though Gupta discloses a component in the form of a plug 960 as a closure element in the lumen of the tissue-contacting component, positioned in and extending through the lumen (see Fig. 9F).
Drasler discloses an implantable device for occlusion of a body lumen (see Figs. 27A-27C; par. 197-199) with a tissue-contacting component 85 and a plug 740 within a lumen of the tissue-contacting component that occludes the lumen of the tissue-contacting component (see Fig. 27C) as well as positions the tissue-contacting component in place, acting as an anti-migration component (see par. 198), wherein at least one portion (see Fig. 27C, the distal portion 640) of the anti-migration component is located external to and extending radially-outwardly from the lumen and is configured to exert a radially-outward anti-migration force (see Fig. 27C, par. 198). Therefore, Drasler discloses an anti-migration component (plug) separately formed from said tissue-contacting component and configured to hold said tissue-contacting component in place with respect to tissue at a deployment site (see Fig. 27C, par. 198). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the plug of Gupta be one such as disclosed by Drasler in order to help position the tissue-contacting component into place in addition to providing for occlusion (see par. 197-199), as disclosed by Drasler, predictably resulting in preventing of flow through the lumen of the tissue-contacting component. Due to the positioning of the anti-migration component within the tissue-contacting component that is designed for use in the gastrointestinal tract (see Gupta, Abstract), as the anti-migration component would be placed in the tissue-contacting component, it would be configured to hold said tissue-contacting component in place with respect to the gastrointestinal tract during use (“use” interpreted broadly, as any time of use including during deployment).
Regarding claim 2, Gupta and Drasler disclose the limitations of claim 1, and Gupta further discloses aid tissue-contacting component is coated with a material resistant to tissue ingrowth (see par. 7).
Regarding claim 3, Gupta and Drasler disclose the limitations of claim 1 and further disclose wherein said device is configured to be implanted across a pylorus (see Gupta, Abstract and rejection of claim 1 above) at least one of said tissue-contacting component or said anti-migration component is expandable from a compact delivery configuration to an expanded deployment configuration shaped to be placed across a pylorus (see Gupta, par. 32 disclosing compressed device for delivery and expanded after delivery and Abstract describing pylorus position and Drasler, Figs. 27A-27C showing compact delivery configuration and then expanded deployment configuration).
Regarding claim 4, Gupta and Drasler disclose the limitations of claim 1, and Gupta further discloses said tissue-contacting component has a lumen defined therethrough (see Figs. 7, 9G; par. 47) and Drasler further discloses the anti-migration component is expandable within the lumen defined through said tissue-contacting component to exert an anti-migration force on said tissue contacting component to hold said tissue-contacting component in place with respect to tissue at the deployment site (see Figs. 27A-27C; par. 197-198), which would be at the pylorus in the gastrointestinal tract as that is where Gupta discloses the deployment site.
Regarding claim 5, Gupta and Drasler disclose the limitations of claim 1, and Gupta further discloses said tissue-contacting component is an expandable stent (see Figs. 7, 9F; par. 7, 32, 44, 47) and Drasler said anti-migration component is an expandable balloon 240 configured to exert a radially outward directed anti-migration force against the tissue contacting component during use (see Figs. 27A-27C; par. 197-198).
Regarding claim 6, Gupta and Drasler disclose the limitations of claim 1 and Drasler further discloses said anti-migration component includes at least one retention member 640 extending radially-outwardly therefrom (see Fig. 27C). As the position of the tissue-contacting component would be at the pylorus (see Fig. 9F, par. 47), which is part of the gastrointestinal tract with other parts before and after, the anti-migration component, due to the required positioning with respect to the tissue-contacting component, would contact tissue of the gastrointestinal tract to help with positioning of the tissue-contacting component.
Regarding claim 7, Gupta and Drasler disclose the limitations of claim 6, and further disclose said at least one retention member extends radially outwardly from an end of said anti-migration component (see rejection of claim 6 describing balloon distal body 640, and therefor modifying the implantable device to include the retention member from an end of the anti-migration component).
Regarding claim 8, Gupta and Drasler disclose the limitations of claim 4, and Gupta further discloses said tissue-contacting component has a proximal end configured to be seated in a stomach, a distal end configured to be seated in a duodenum, and a saddle region extending between the proximal end and the distal end and configured to be seated in a pylorus (see par. 7, 35 describing saddle 715, a flange for gastric wall, and flange for duodenum wall); and with Drasler disclosing the anti-migration component being a balloon expanding to the inner lumen of the stent (see Fig. 27A-27C; par. 197-198), said anti-migration component of Gupta and Drasler would have a proximal end with a proximal retention member extending radially therefrom and configured to be seated in the stomach, a distal end with a distal retention member extending radially therefrom and configured to be seated in the duodenum, and a saddle region extending between the proximal end and the distal end and configured to extend through the saddle region of said tissue-contacting component due to the configuration of the saddle and flanges of the tissue-contacting component that the balloon expands into for both occlusion and positioning of the tissue-contacting component.
Regarding claim 9, Gupta and Drasler disclose the limitations of claim 8, and the resulting device would have said distal retention member curved to correspond to the curve of the duodenum in which said distal retention member is seated due to the curvature of the tissue-contacting component (see Figs. 7, 9F) within the duodenum in which the distal retention member, being created by the balloon portion expanding in the duodenum area, is placed and expanded fully (see rejection of claim 8).
Regarding claim 15, Gupta discloses an occlusion device configured to occlude a body passage (see Figs. 7, 9F; par. 7, 44, 47), said occlusion device comprising: a first component defining a lumen therethrough and configured to extend through the body passage (see par. 7, 35, 44, 47 and Fig. 9F, stent), the first component having a lumen extending therethrough and covered with a coating prevent tissue ingrowth therein (see par. 7 for coating and Figs. 7, 9F and par. 35, 44, 47 for lumen). Gupta further discloses a second component in the lumen in the form of a plug for occluding the lumen during use (see Fig. 9F; par. 47) and the first component is an expandable stent configured to be positioned across a pylorus (see Fig. 9F, par. 47).
Gupta does not disclose a second component formed separately form said first component, positioned in and extending through the lumen of said first component, and at least a portion of said second component is located external to and extending radially-outwardly from the lumen, said second component exerting a radially outward anti-migration force on said first component to retain said first component in place with respect to the body passage during use. Gupta also does not disclose the second component is an expandable balloon with the portion located external to the lumen of the first component being configured to contact tissue to resist migration of said implantable device with respect to the pylorus.
Drasler discloses an implantable device for occlusion of a body lumen and related method of occluding flow of materials through a body passage (see Figs. 27A-27D; par. 197-199) comprising a first component 85 and a plug/second component 240 within the first component that occludes the lumen of the first component as well as helps to position the first component (see Figs. 198), therefore Drasler discloses delivering a second component (plug) through the lumen of the first component and expanding the second component to hold the first component in place within the body passage (see par. 145-147). Drasler discloses the first component being separate from the second component, the second component positioned in and extending through the lumen of the first component (see Fig. 27C), and at least a portion 640 of said second component is located external to and extending radially-outwardly from the lumen (see Fig. 27C), said second component exerting a radially outward anti-migration force on said first component to retain said first component in place with respect to the body passage during use (see par. 198). Drasler also discloses the second component is an expandable balloon with the portion located external to the lumen of the first component being configured to contact tissue to resist migration of said implantable device (see Fig. 27C, par. 198).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the plug of Gupta be one such as disclosed by Drasler in order to help expand the tissue-contacting component into place in addition to providing for occlusion (see par. 145) and therefore deliver a second component through the lumen of the first component and expand the second component to hold the first component in place within the body passage, as disclosed by Drasler, predictably resulting in preventing of flow through the lumen of the first component. Therefore, Gupta discloses the first component would be the expandable stent configured to be positioned across a pylorus (see Abstract, par. 7, 35, 44, 47 and Fig. 9F, stent) and the second component is an expandable balloon 240 which, due to the position of the first component with respect to the pylorus, would have the expandable balloon having the external portion configured to contact tissue to resist migration of said implantable device with respect to the pylorus (see Fig. 27C, as the end of the second component would be expanded to position the first component similar to distal end 640 of Drasler, in order to position securely, there would have to be contact with the body passage due to the distal end being outside the area of the first component).
Regarding claim 16, Gupta discloses a method of occluding flow of materials through a body passage (see Figs. 7, 9F; par. 7, 44, 47), said method comprising: delivering a first component of an occlusion device through the body passage (see par. 7, 35, 44, 47 and Fig. 9F, stent including first flange, second flange, and saddle), the first component having a lumen extending therethrough and covered with a coating prevent tissue ingrowth therein (see par. 7 for coating and Figs. 7, 9F and par. 35, 44, 47 for lumen). Gupta further discloses a second component in the lumen in the form of a plug for occluding the lumen (see Fig. 9F; par. 47).
Gupta does not disclose delivering a second component of an occlusion device through the lumen of the first component, wherein the second component is positioned in and extends through the lumen; and expanding the second component to hold the first component in place within the body passage such that at least a portion of the second component is located external to and extending radially-outwardly from the lumen to exert a radially-outward anti-migration force; and deploying the occlusion device with the second component exerting a radially outward force on the first component to retain the first component and the second component in place during use.
Drasler discloses an implantable device for occlusion of a body lumen and related method of occluding flow of materials through a body passage (see Figs. 27A-27C; par. 197-198) comprising delivering a first component 85 and a plug/second component 240 within first component that occludes the lumen of the first component as well as helps position the first component (see Figs. 197-198), therefore Drasler discloses delivering a second component (plug) through the lumen of the first component, wherein the second component is positioned in and extendsd through the lumen, and expanding the second component to hold the first component in place within the body passage such that at least a portion of the second component is located external to and extending radially-outwardly from the lumen to exert a radially-outward anti-migration force (see Fig. 27C, par. 198). Drasler further discloses deploying the occlusion device within the second component exerting a radially outward force on the first component to retain the first component and the second component in place during use (see Fig. 27C, “use” interpreted broadly, as any time of use including during deployment). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the plug of Gupta be one such as disclosed by Drasler in order to help position the tissue-contacting component into place in addition to providing for occlusion (see par. 145) and therefore deliver a second component through the lumen of the first component and expand the second component to hold the first component in place within the body passage, as disclosed by Drasler, predictably resulting in preventing of flow through the lumen of the first component.
Regarding claim 17, Gupta and Drasler disclose the limitations of claim 16, and Gupta further discloses the body passage is a pylorus (see par. 7, saddle region bridging pylorus), said method comprising extending a saddle region of the first component through the pylorus (see par. 7, 35, 44), and Drasler discloses expanding the second component within the lumen defined through the first component to retain the first component (see Figs. 27A-27C; par. 197-198) and due to the positioning disclosed by Gupta (see par. 7), the retaining of the first component would be within the pylorus.
Regarding claim 18, Gupta and Drasler disclose the limitations of claim 17, and further disclose expanding at least one end of the second component to have a diameter greater than the diameter of the lumen defined through the first component and to resist migration of the second component with respect to the first component (see Gupta, Fig. 7 showing curvature of the first component – the second component as disclosed by Drasler, Figs. 27A-27C, would expand to that curvature and therefore have a diameter when in the flanges of the first component of Gupta that is greater than the lumen in the saddle disclosed by Gupta and due to the second component expanding and helping the first component to stay in place, as disclosed by Drasler in par. 198, resists migration).
Regarding claim 19, Gupta and Drasler disclose the limitations of claim 18, and further disclose expanding the at least one end of the second component to have a diameter greater than the diameter of the body passage and to resist migration of the second component with respect to the body passage (see Gupta, Fig. 7 and par. 7, 35 – body passage would be that along pylorus with narrowed saddle and flanges are above and below saddle such that when the second component expands into the flanges, one which would be in the duodenum and one towards the gastric wall, it would have a diameter greater than a diameter of the body passage and would resist migration of the second component with respect to the body passage). Additionally, as the end of the second component would be expanded to position the first component similar to distal end 640 of Drasler (see Fig. 27C), in order to position securely, there would have to be contact with the body passage due to the distal end being outside the area of the first component.
Regarding claim 20, Gupta and Drasler disclose the limitations of claim 16, and Drasler further discloses delivering the second component after delivering the first component (see Figs. 27A-27D; stent is fully expanded before balloon is released).
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler (US 2018/0360461) in view of Ragheb et al. (US 2003/0036794).
Regarding claim 10, Drasler discloses an occlusion device configured to occlude a body passage (see Figs. 7A-7C), said occlusion device comprising: a first component 85 defining a lumen therethrough and configured to extend through the body passage (see Figs. 27A-27C; par. 197-199); and a second component 240 formed separately from said first component, positioned in and extending through the lumen of said first component (see Figs. 27A-27C; par. 198); wherein: at least a portion of said component is located external to and extending radially-outward from the lumen (see Figs. 27A-27C), said second component exerts a radially outward anti-migration force on said first component to retain said first component in place with respect to the body passage (see Figs. 27A-27C showing expansion of balloon and par. 198 disclosing expansion that would result in anti-migration force and holding tissue-contacting component in place) during use (see par. 145, instead of having a separate covering and blocking fabric, the occlusion balloon services as that covering and blocking fabric to prevent blood flow through the lumen and stent, so it is not removed and as shown in 7C is released and stays in the stent).
Drasler does not disclose said first component is coated to prevent tissue ingrowth therein.
Ragheb discloses a tissue-contacting component in the form of a stent that is configured to resist tissue ingrowth via a coating so as to prevent the intrusion to tissue or other matter into or through any space in the shape, framework or scaffold it covers (see par. 126). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tissue-contacting component of Drasler, which is in the form of a stent (see par. 145-146) and therefore similar to that disclosed by Ragheb, configured to resist tissue ingrowth via a coating so as to prevent the intrusion to tissue or other matter into or through any space in the shape, framework or scaffold it covers. This would help in allowing for easier replacement of the device if required.
Regarding claim 11, Drasler and Ragheb disclose the limitations of claim 10, and Drasler further discloses said second component occludes flow of materials through the lumen defined through said first component (see par. 197, occlusion ballon is 240).
Regarding claim 12, Drasler and Ragheb disclose the limitations of claim 10, and Drasler further rdisclsoes the second component includes at least one retention member extending radially-outwardly therefrom (see Figs. 27B-27C).
Regarding claim 13, Drasler and Ragheb disclose the limitations of claim 10, and Drasler further discloses said at least one retention member extends radially outwardly from an end of said second component (see Fig. 27C; par. 198) and has a diameter 740 greater than the diameter of the lumen through said first component (see Fig. 27C) and is configured to resist migration through said first component (see par. 198).
Regarding claim 14, Drasler and Ragheb disclose the limitations of claim 13, and Drasler further discloses the diameter of said at least one retention member extending radially outwardly from an end of said second component is greater than the diameter of the body passage through which said first component is configured to extend (see Figs. 27B-27C; par. 197-198) and is configured to resist migration of said first component and said second component through the body passage (see par. 198).
Conclusion
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781