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
This office action is responsive to the amendment filed on 11/25/2025. As directed by the amendment: claim 1 have been amended and claims 10, 13, and 15-20 remain withdrawn. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 5, filed 11/25/2025, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see pages 5-6, filed 11/25/2025, with respect to the rejection(s) of claim(s) 1-9, 11, 13, and 14 under 35 U.S.C. 102(a)(1) as being anticipated by Gobel (US 20200276040 A1), herein referenced to as “Gobel” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “with said inner portion expanded against an inner surface of said outer portion to anchor said implantable device with respect to the deployment site”. The examiner agrees that Gobel does not explicitly disclose this amended limitation.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gobel in view of O’Neill et al (US 20150313741 A1).
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) 1-9, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 20200276040 A1), herein referenced to as “Gobel” in view of O’Neill et al (US 20150313741 A1), herein referenced to as “O’Neill”.
Claim 1
Gobel discloses: An implantable device bypass device (see Fig. 3B, [0163] and [0020], sealing component of the bypass) configured to be delivered to and deployed at a deployment site (see [0029], transpyloric), said implantable device bypass device (see Fig. 3B) comprising: an inner scaffold portion 9 (see Fig. 3B, [0163], elastically erecting) shiftable between a delivery configuration (see [0163], elastically erecting, in which the element expands when released/when not constricted) and an expanded deployed configuration (see [0163], the sleeve element are used to fix the balloon segments, expanding and stabilizing the flexible balloon); and an outer portion 6 + 8 (see Fig. 3b, [0163]) formed separately from said inner portion (see Fig. 3B, [0163], the balloon is separated from 9, 9 is inserted into the lumen of the balloon, coaxially constructed, the balloon consists of a single balloon film, that forms a continuously formed body) and positioned over said inner portion 9 such that, upon deployment, said outer portion 6 + 8 is configured to be positioned between a body wall (see [0163], pylorus) at the deployment site (see [0163]) and said inner portion 9 of said implantable device bypass device.
Gobel does not explicitly disclose: with said inner portion expanded against an inner surface of said outer portion to anchor said implantable device with respect to the deployment site.
However, O’Neill in a similar field of invention teaches an implantable device 10 (see Figs. 1-7) configured to be delivered to an deployed at a deployment site (see [0033], pyloric sphincter) with an outer portion 82 (see Fig. 7) and inner portion 12 + 16 (see Figs. 1-7). O’Neill further teaches: with said inner portion 12 + 16 expanded against an inner surface (see Fig. 7, [0055], 82 conforms against the outer surface of 12, hence an inner surface of 82 is expanded against by 12) of said outer portion 82 to anchor said implantable device 10 with respect to the deployment site (see [0055], device is deployed, see Fig. 1)
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner portion/rings of Gobel to incorporate the teachings of O’Neill and teach an implantable device with said inner portion expanded against an inner surface of said outer portion to anchor said implantable device with respect to the deployment site. Motivation for such can be found in O’Neill as this improves anchoring techniques which avoids the complications associated with barbed elements (see [0031]-[0033]) while preventing migration of the implantable device (see [0040]) and preventing tissue in-growth with the outer portion to allowed for eventual removal of the device with minimal trauma (see [0055]). In addition, this creates a minimally viable surface area of contact with the device using the inner portion to reduce the area of interaction between the device and duodenum, reducing the risk for irritation of the duodenal tissue lining (see [0042]) versus relying on a larger surface area of contact where the anchoring force is dispersed.
Claim 2
The combination of Gobel and O’Neill teaches: The implantable device of claim 1, see 103 rejection above. Gobel further discloses: wherein said inner portion 9 comprises a first inner portion a first 9 associated with 6 (see Fig. 3B, [0163]) and a second inner portion a second 9 associated with 8 (see Fig. 3B, [0163]).
Claim 3
The combination of Gobel and O’Neill teaches: The implantable device of claim 2, see 103 rejection above. Gobel further discloses: wherein said first inner portion a first 9 associated with 6 and said second inner portion second 9 associated with 8 are movable with respect to said outer portion 6 + 8 and with respect to each other (see [0163], a first and second 9 are not connected to each other, and are elastically erecting, hence they separately expand and are movable with respect each other, and furthermore, are not directly connected with 6 + 8, hence they are movable with respect to 6 + 8).
Claim 4
The combination of Gobel and O’Neill teaches: The implantable device of claim 3, see 103 rejection above. Gobel further discloses: wherein said first inner portion and said second inner portion are movable away from each other in response to force applied to said outer portion.
The language, "wherein said first inner portion and said second inner portion are movable away from each other in response to force applied to said outer portion," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Gobel and O’Neill meets the structural limitations of the claim, and is capable of moving the first and second inner portion when a force is applied to outer portion 6 + 8, as sufficient external force would be able to independently move the elastically erecting sleeves 9, as they are not connected with one another, and could push them apart. Furthermore, as with O’Neill superelastic materials can elastically move when a sufficient force is applied them.
Claim 5
The combination of Gobel and O’Neill teaches: The implantable device of claim 1, see 103 rejection above. Gobel further discloses: wherein said outer portion 6 + 8 is a balloon (see [0163], a single balloon film) enclosing said inner portion 9 (see Fig. 3B, the balloon encloses 9 as 9 is inserted within 6 + 8, see [0163]).
Claim 6
The combination of Gobel and O’Neill teaches: The implantable device of claim 5, see 103 rejection above. Gobel further discloses: wherein an end of said balloon 6 + 8 is tapered 15b (see Fig. 3B, [0163], 16b is tapered) to guide said implantable device to a deployment site.
The language, " to guide said implantable device to a deployment site," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Gobel meets the structural limitations of the claim, and is capable of the tapered section of the balloon to guide said implantable device to a deployment site, as the taper would assist in pushing the device into the pyloric sphincter.
Claim 7
The combination of Gobel and O’Neill teaches: The implantable device of claim 5, see 103 rejection above. Gobel further discloses: wherein said balloon 6 + 8 includes an inflation valve valve-like, self-closing components (see [0070]) separably couplable with an inflation lumen supply lines (see [0070]) to allow inflation of said balloon (see [0069], balloon can be inflated, performing a sealing occlusion) and separation (see [0070], the supply lines can be mechanically decoupled from valve-like self-closing components) from the inflation lumen supply lines upon deployment of said balloon (see [0069]-[0070], supply lines are decoupled after the balloon is inflated and deployed to perform a sealing occlusion).
Claim 8
The combination of Gobel and O’Neill teaches: The implantable device of claim 1, see 103 rejection above. Gobel further discloses: wherein said inner portion 9 comprises one or more ring-shaped retention members (see Fig. 9, sleeve elements, a sleeve is a tube, and as these are discrete, separated segments, they are rings).
Claim 9
The combination of Gobel and O’Neill teaches: The implantable device of claim 8, see 103 rejection above. Gobel further discloses: wherein said inner portion 9 comprises first and second toroidal retention members (see Fig. 9, sleeve elements, a sleeve is a tube, and as these are discrete, separated segments, they are toroidal in shape as they are ring-like with a thickness, resembling a donut, furthermore in [0100], Gobel discusses that the invention a balloon segment is not a “closed” torus but rather a ring shape, and as it can be seen in Fig. 3B, 9 matches 6 in overall shape, just smaller, hence it is also a torus).
Claim 11
The combination of Gobel and O’Neill teaches: The implantable device of claim 1, see 103 rejection above. Gobel further discloses: further comprising a shaft 7 (see Fig. 3b, [0163]) extending through said implantable device bypass device (see [0163]).
Claim 12
The combination of Gobel and O’Neill teaches: The implantable device of claim 11, see 103 rejection above. Gobel further discloses: wherein said shaft 7 extends axially (see Fig. 3B, 7 extends within the balloon device) within said implantable device bypass device, and said inner portion 9 comprises a first inner portion a first 9 associated with 6 (see Fig. 3B, [0163]) and a second inner portion a second 9 associated with 8 (see Fig. 3B, [0163]) movable with respect to said shaft in response to radially-inwardly directed force applied to said implantable device when said implantable device is deployed at a deployment site.
The language, " movable with respect to said shaft in response to radially-inwardly directed force applied to said implantable device when said implantable device is deployed at a deployment site," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Gobel meets the structural limitations of the claim, and is capable of moving the first and second inner portion when a force is applied to outer portion 6 + 8, as sufficient radially-inward external force would be able to independently move the elastically erecting sleeves 9, as they are not connected with one another, and could push them apart.
Claim 14
The combination of Gobel and O’Neill teaches: The implantable device of claim 1, see 103 rejection above. Gobel further discloses: wherein said outer portion 6 + 8 is expandable upon shifting (see [0163], 9 helps accept and fix the balloon segments, to form an axial rolling movement of the balloon segments to seal onto the tissue of the pylorus, during deployment) of said inner portion 9 from the delivery configuration to the deployed configuration.
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 RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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