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
Applicant’s amendments filed on 12/23/2025 have been fully considered. Claims 1-3 and 5-20 are pending in this application. Claims 1, 5-10, 12, 16-20 are amended. Claim 4 is cancelled.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 12, and 20 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. More specifically, the amendment of the claim limitation “a tether secured relative to the funnel device and adapted to limit proximal movement of the funnel device relative to the pylorus”.
Though some of the same prior art reference is re-used herein, amended claims 1, 12, and 20 required a change in the grounds of rejection relying on additional prior art as detailed below in the prior art rejection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 10, 12-13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vargas et al. (Publication No. US 2013/0079603 A1).
Regarding claim 1, Vargas discloses an implantable medical device (Figure 19; Paragraph 0117), comprising:
an occlusion device adapted to be disposed within a stomach relative to a pylorus in order to prevent stomach contents from flowing around the occlusion device (sliding seal 1904 can be placed in the antrum of the stomach and relative to the pylorus; Figure 19; Paragraph 0117), the occlusion device including a distal outflow end (distal end of sliding seal 1904 allows for fluid to travel toward and through the sleeve 1903; Paragraph 0117; Figure 19);
a liner extending distally from the occlusion device (sleeve 1903 extends distally from sliding seal 1904; Paragraph 0117; Figure 19), the liner defining a lumen extending through the liner (sleeve 1903 has a lumen through the sleeve 1903; Figure 19), the liner having a proximal end fluidly coupled with the distal outflow end (sleeve 1903 is fluidly coupled to distal end of sliding seal 1904; Paragraph 0117; Figure 19) and a distal end adapted to be disposed within a jejunum such that stomach contents entering the occlusion device flow through the liner and exit through the distal end (distal end of sleeve 1903 is disposed within the jejunum so that fluid exits from the device at the distal opening; Figure 19; Paragraph 0067 and 0117); and
a tether secured relative to the occlusion device and adapted to limit proximal movement of the occlusion device relative to the pylorus (length of anchor 1900 is the tether that is secured to the sliding seal 1904 through the connecting structure 1906 and is adapted to limit proximal movement of the device relative to the pylorus with the C shape rigid structure of the tether with the distal end atraumatic feature to frictionally hold the device in place and not move proximally or distally; Figure 19; Paragraph 0008 and 0117), the tether including a proximal end secured to the occlusion device (proximal end of anchor 1900 is secured to sliding seal 1904; Figure 19) and a distal end secured to an anchor (distal end of anchor 1900 is secured to distal end atraumatic feature 1902; Figure 19).
Regarding claim 2, Vargas discloses the device of claim 1. Vargas further discloses wherein the tether is adapted to extend within the lumen of the liner (anchor 1900 length, or tether, extends within the lumen of the sleeve 1903; Figure 19).
Regarding claim 10, Vargas discloses the device of claim 1. Vargas further discloses wherein the occlusion device is adapted to extend into an antrum (sliding seal 1904 can be placed in the antrum of the stomach and relative to the pylorus; Figure 19; Paragraph 0117).
Regarding claim 12, Vargas discloses a gastric bypass device (Figure 19; Paragraph 0117), comprising:
a funnel device adapted to be disposed within a stomach relative to a pylorus in order to direct stomach contents to flow through the funnel device (sliding seal 1904 can be placed in the antrum of the stomach and relative to the pylorus; Figure 19; Paragraph 0117);
a tubular extension fluidly coupled with the funnel device and extending distally from the funnel device (sleeve 1903 extends distally from sliding seal 1904; Paragraph 0117; Figure 19), the tubular extension adapted to extend at through an upper portion of a small intestine in order to prevent the stomach contents flowing through the funnel device and the tubular extension from contacting the upper portion of the small intestine (sleeve 1903 extends through the upper part of the small intestine and towards the jejunum so that fluid exits from the device at the distal opening; Figure 19; Paragraph 0067 and 0117); and
a tether secured relative to the funnel device and adapted to limit the funnel device from moving proximally of the pylorus (length of anchor 1900 is the tether that is secured to the sliding seal 1904 through the connecting structure 1906 and is adapted to limit proximal movement of the device relative to the pylorus with the C shape rigid structure of the tether with the distal end atraumatic feature to frictionally hold the device in place and not move proximally or distally; Figure 19; Paragraph 0008 and 0117).
Regarding claim 13, Vargas discloses the device of claim 12. Vargas further discloses wherein the tether is adapted to extend within the tubular extension (anchor 1900 length, or tether, extends within the lumen of the sleeve 1903; Figure 19).
Regarding claim 15, Vargas discloses the device of claim 12. Vargas further discloses wherein the tether includes a proximal end by which the tether is securable relative to the funnel device (proximal end of anchor 1900 is secured to sliding seal 1904; Figure 19) and a distal end by which the tether is securable to an anchor (distal end of anchor 1900 is secured to distal end atraumatic feature 1902; Figure 19).
Regarding claim 16, Vargas discloses the device of claim 15. Vargas further discloses further comprising the anchor (distal end atraumatic feature 1902; Figure 19; Paragraph 0117).
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.
Claim(s) 3, 5-6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (Publication No. US 2013/0079603 A1) in view of Harris et al. (Publication No. US 2019/0151130 A1).
Regarding claim 3, Vargas discloses the device of claim 1. Vargas does not teach wherein the tether is adapted to extend outside of the liner.
However, Harris teaches wherein the tether is adapted to extend outside of the liner (resilient member 650 extends out of the sleeve 610; Figure 7E-7G; Paragraph 0053).
Vargas and Harris are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Harris and have the tether of Harris extend out of the liner of the sleeve of Vargas. This allows for the ends of the anchors to engage directly on the mucosa of the stomach and the duodenum to have the sleeve unfurl and hold its place within the small intestine (Harris; Paragraph 0053; Figures 7E-7G).
Regarding claim 5, Vargas in view of Harris teaches the device of claim 3. The combination of Vargas in view of Harris does not teach wherein the anchor is adapted to be secured in place relative to a small intestine or stomach wall.
However, Harris teaches wherein the anchor is adapted to be secured in place relative to a small intestine or stomach wall (anchor end 230 has barbs; Paragraph 0027).
Vargas and Harris are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas in view of Harris to incorporate the teachings of Harris and have the anchor of Vargas have the barbs of Harris. This allows for an increased adherence of the anchor to the mucosa of the duodenum to increase the fixture of the sleeve in place (Harris; Paragraph 0027).
Regarding claim 6, Vargas in view of Harris teaches the device of claim 5. The combination of Vargas in view of Harris further teaches wherein the anchor is adapted to pierce tissue of the small intestine or the stomach wall (anchor end 230 has barbs to piece the tissue of the small intestine; Paragraph 0027).
Regarding claim 14, Vargas discloses the device of claim 12. Vargas does not teach wherein the tether is adapted to extend outside of the tubular extension.
However, Harris teaches wherein the tether is adapted to extend outside of the tubular extension (resilient member 650 extends out of the sleeve 610; Figure 7E-7G; Paragraph 0053).
Vargas and Harris are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Harris and have the tether of Harris extend out of the liner of the sleeve of Vargas. This allows for the ends of the anchors to engage directly on the mucosa of the stomach and the duodenum to have the sleeve unfurl and hold its place within the small intestine (Harris; Paragraph 0053; Figures 7E-7G).
Claim(s) 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (Publication No. US 2013/0079603 A1) in view of Harris et al. (Publication No. US 2019/0151130 A1), as applied to claim 5 and 16 above, and further in view of Favreau et al. (Publication No. US 2021/0128334 A1).
Regarding claim 7, Vargas in view of Harris teaches the device of claim 5. The combination of Vargas in view of Harris does not teach wherein the anchor comprises a self- expanding element that is adapted to be disposed within the small intestine.
However, Favreau teaches wherein the anchor comprises a self- expanding element that is adapted to be disposed within the small intestine (stent 302 is self-expanding to be disposed within the small intestine; Figure 3D; Paragraph 0035).
Vargas in view of Harris and Favreau are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas in view of Harris to incorporate the teachings of Favreau and have the stent of Favreau be the anchor of Vargas in view of Harris. This allows for the stent to self-expand to fit to the anatomy of the small intestine and hold the sleeve in place within the small intestine (Favreau; Figure 3D; Paragraph 0035).
Regarding claim 8, Vargas in view of Harris teaches the device of claim 5. The combination of Vargas in view of Harris does not teach wherein the tether further comprises an elongate frictional anchor that is adapted to extend within the small intestine.
However, Favreau teaches wherein the tether further comprises an elongate frictional anchor that is adapted to extend within the small intestine (expandable stent 305 anchors the sleeve in the middle section of the small intestine; Figure 3D; Paragraph 0035).
Vargas in view of Harris and Favreau are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas in view of Harris to incorporate the teachings of Favreau and have the stent of Favreau be on the tether of Vargas in view of Harris. This allows for the stent to self-expand to fit to the anatomy of the small intestine and additionally hold the sleeve in place within the small intestine at the middle section of small intestine (Favreau; Figure 3D; Paragraph 0035).
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (Publication No. US 2013/0079603 A1) in view of Favreau et al. (Publication No. US 2021/0128334 A1).
Regarding claim 17, Vargas discloses the device of claim 16. Vargas does not teach wherein the anchor comprises a self- expanding element that is adapted to be disposed within the small intestine.
However, Favreau teaches wherein the anchor comprises a self- expanding element that is adapted to be disposed within the small intestine (stent 302 is self-expanding to be disposed within the small intestine; Figure 3D; Paragraph 0035).
Vargas and Favreau are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Favreau and have the stent of Favreau be the anchor of Vargas. This allows for the stent to self-expand to fit to the anatomy of the small intestine and hold the sleeve in place within the small intestine (Favreau; Figure 3D; Paragraph 0035).
Regarding claim 18, Vargas discloses the device of claim 16. Vargas does not teach wherein the tether further comprises an elongate frictional anchor that is adapted to extend within the small intestine.
However, Favreau teaches wherein the tether further comprises an elongate frictional anchor that is adapted to extend within the small intestine (expandable stent 305 anchors the sleeve in the middle section of the small intestine; Figure 3D; Paragraph 0035).
Vargas and Favreau are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Favreau and have the stent of Favreau be on the tether of Vargas. This allows for the stent to self-expand to fit to the anatomy of the small intestine and additionally hold the sleeve in place within the small intestine at the middle section of small intestine (Favreau; Figure 3D; Paragraph 0035).
Claim(s) 9 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (Publication No. US 2013/0079603 A1) in view of Pattinson et al. (Publication No. US 2014/0276338 A1).
Regarding claim 9, Vargas discloses the device of claim 1. Vargas does not teach further comprising a dynamic leash that extends from the occlusion device to an anchor site within the stomach.
However, Pattinson teaches further comprising a dynamic leash that extends from the occlusion device to an anchor site within the stomach (length of catheter 28/dynamic leash extends from port 18 within the patient’s stomach to the system 10; Figure 3; Paragraph 0033).
Vargas and Pattinson are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Pattinson and have the dynamic leash with the anchor site of Pattinson connected to the occlusion device of Vargas. This allows for the fixing in place of the sleeve of the device in the small intestine of the patient (Pattinson; Paragraph 0033).
Regarding claim 19, Vargas discloses the device of claim 12. Vargas does not teach further comprising a dynamic leash that extends from the funnel device to an anchor site within the stomach.
However, Pattinson teaches further comprising a dynamic leash that extends from the occlusion device to an anchor site within the stomach (length of catheter 28/dynamic leash extends from port 18 within the patient’s stomach to the system 10; Figure 3; Paragraph 0033).
Vargas and Pattinson are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Pattinson and have the dynamic leash with the anchor site of Pattinson connected to the occlusion device of Vargas. This allows for the fixing in place of the sleeve of the device in the small intestine of the patient (Pattinson; Paragraph 0033).
Regarding claim 20, Vargas discloses a gastric bypass device (Figure 19; Paragraph 0117), comprising:
a funnel device adapted to be disposed within a stomach relative to a pylorus in order to direct stomach contents to flow through the funnel device (sliding seal 1904 can be placed in the antrum of the stomach and relative to the pylorus; Figure 19; Paragraph 0117);
a tubular extension fluidly coupled with the funnel device and extending distally from the funnel device (sleeve 1903 extends distally from sliding seal 1904; Paragraph 0117; Figure 19), the tubular extension adapted to extend at through an upper portion of a small intestine in order to prevent the stomach contents flowing through the funnel device and the tubular extension from contacting the upper portion of a small intestine (sleeve 1903 extends through the upper part of the small intestine and towards the jejunum so that fluid exits from the device at the distal opening; Figure 19; Paragraph 0067 and 0117);
a tether secured relative to the funnel device and adapted to limit proximal movement of the funnel device relative to the pylorus (length of anchor 1900 is the tether that is secured to the sliding seal 1904 through the connecting structure 1906 and is adapted to limit proximal movement of the device relative to the pylorus with the C shape rigid structure of the tether with the distal end atraumatic feature to frictionally hold the device in place and not move proximally or distally; Figure 19; Paragraph 0008 and 0117).
Vargas does not teach a dynamic leash extending from the funnel device in opposition to the tether.
However, Pattinson teaches a dynamic leash extending from the funnel device in opposition to the tether. (length of catheter 28/dynamic leash extends from port 18 within the patient’s stomach to the system 10; Figure 3; Paragraph 0033).
Vargas and Pattinson are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Vargas to incorporate the teachings of Pattinson and have the dynamic leash with the anchor site of Pattinson connected to the occlusion device of Vargas. This allows for the fixing in place of the sleeve of the device in the small intestine of the patient (Pattinson; Paragraph 0033).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vargas et al. (Publication No. US 2013/0079603 A1) in view of Priplata et al. (Publication No. US 2013/0281909 A1).
Regarding claim 11, Vargas discloses the device of claim 1. Vargas does not teach wherein the liner comprises a polymeric tube.
However, Priplata teaches wherein the liner comprises a polymeric tube (sleeve is made of a polyethylene-reinforced silicone; Paragraph 0099).
Priplata and Vargas are both considered to be analogous to the claimed invention because they are in the same field of gastro-intestinal bypass devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Pattinson to incorporate the teachings of Priplata and have the sleeve of Vargas to be made of the polymer material, as taught by Priplata. This allows for the sleeve to have a material property to allow for the structure of the sleeve to revert back to its initial shape (Priplata; Paragraph 0080).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781