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 Arguments
The previous objection of claims 1 and 18-20 due to minor informalities has been withdrawn in light of applicant’s amendments made 11/12/2025.
Applicant’s arguments, see pages 5-8, filed 11/12/2025, with respect to Bakos (US 2018/0214151) have been fully considered and are persuasive. Specifically, Bakos fails to disclose the first and second zones being flexibly connected in series. The rejection of claims 1, 7-15 and 17-19 has been withdrawn.
Applicant's arguments filed 11/12/2025 with respect to Gagner (WO 2021/207821) have been fully considered but they are not persuasive. In response to applicant's argument that the clamping device of Gagner is intended to be inserted into the abdominal cavity of the patient and applied extraluminally around the outer surface of the target hollow organ rather than insertable within the lumen of a hollow organ, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the clamping device of Gagner is structurally equivalent to that claimed because it includes a magnet assembly (magnet assembly 12), wherein the magnet assembly comprises: a first zone (first zone 38) comprising a first magnet element (magnetic element 16); and a second zone (second zone 40) comprising a second magnet element (16), the first (38) and second (40) zones being flexibly connected in series (via area comprising connection between 38 and 40 or elongated members 28, 30 and the elongated members at each extremity are flexible; [113]); and the magnet assembly (12) being configured to be positioned at a base of a protruding portion to magnetically couple the first zone and the second zone (Figs. 2, 6-10), the first magnet element and the second magnet element being configured to exert an attractive force selected to compress opposite walls of the protruding portion therebetween ([115]) and subject the opposite walls of the inwardly protruding portion to ischemic pressure necrosis to fuse the opposite walls of the inwardly protruding portion together during a healing time period ([132]).
Further, the clamping device of Gagner is sized appropriately to fit within a lumen of a hollow organ of a patient and resect an inwardly protruding portion of the hollow organ. Applicant states that “magnet elements 16 designed to remove the appendix through the lumen of the large intestine may have a size ranging from about 5 mm to about 40 mm, with the total length of each of the first and second zones 38, 40 totaling between about 10 mm and about 50 mm, or between about 20 mm and 40 mm; whereas magnet elements 16 designed to resection an inwardly protruding portion 50 of a stomach may have a size ranging from about 5 mm to about 100 mm, with the total length of each of the first and second zones 38, 40 totaling between about 30 mm and about 100 mm, or about 80 mm” ([0113]). Gagner discloses magnet elements 16 may have a size ranging from about 2 mm to about 10 mm or from about 20 mm to about 100 mm ([121]). Accordingly, the size of the magnet elements 16 of Gagner overlap those of applicant’s, making the clamping device of Gagner sized to fit at least with a stomach, i.e., a hollow organ. Thus, the clamping device of Gagner does not have any structural difference to that claimed and there is nothing to prevent the user from implanting it within a lumen of a hollow organ and resecting an inwardly protruding portion as claimed.
Applicant argues that the forces acted on a device configured to be implanted within an abdominal cavity of the human body outside the lumen of a hollow organ differ compared to those occurring within the lumen of the hollow organ. However, as discussed above, there are no structural differences found between the clamping device of Gagner and that claimed; therefore, the device 10 is considered to be capable of being placed in a lumen of a hollow organ. Further, applicant acknowledges “one of ordinary skill in the art would recognize that the partitioning device 10 of Gagner would be necessarily configured for implantation within the lumen of a hollow organ, as asserted in the Action” (page 9, paragraph 3 of applicant’s arguments filed 11/12/2025).
Applicant argues that no guidance can be derived from Gagner that would enable one of ordinary skill in the art to conclude that notwithstanding the disclosure of Gagner being focused on a partitioning device to partition a hollow organ of the digestive track, the partitioning device of Gagner could be inserted into the hollow organ and positioned at a base of an inwardly protruding portion present in the lumen of the hollow organ. The examiner respectfully disagrees. As discussed above, the magnets 16 of Gagner are the same size as the magnets 16 of the claimed invention. Thus, the magnets are capable of providing the appropriate amount of force to an inwardly protruding portion and are sized appropriately for being inserted at least into a stomach of a patient.
Applicant’s argument that it is not sufficient to constitute an anticipated that the device relied upon might, by modification, be made to accomplish the function performed by the patent in question, if it were not designed by its maker, nor adapted, nor actually used, for the performance of such functions is not found persuasive because the device of Gagner is not being modified. Because the structure of Gagner is arranged in the same way and is substantially identical to the claimed invention, it is inherently configured to compress opposite walls of an inwardly protruding portion of a hollow organ as claimed.
With respect to claim 20, applicant argues that one of ordinary skill in the art would not have been led to substitute the compression clip of Monassevitch for the partitioning device of Gagner to perform the method claimed, at least because one of ordinary skill in the art would have readily recognized that a partitioning device configured to be positioned onto the outer surface of a hollow organ would not be configured for implantation within the lumen of a hollow organ. At least for the reasons discussed above with respect to Gagner in view of claim 1, applicant’s argument is not found persuasive.
Applicant argues that the compression clip of 10 of Monassevitch already performs the required closure over the polyp or pouch and achieving the desired effect of necrosis and healing of the resected site, therefore, one of ordinary skill in the art would have no motivation to substitute the compression clip 10 of Monassevitch by the partitioning device of Gagner as alleged in the Action. However, the Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. One such example of rationales is simple substitution of one known element for another to obtain predictable results (MPEP 2143). The rejection below articulates the following: (1) a finding that the prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components (e.g., the method of Monassevitch contains a clamping device that differs from the claimed clamping device by the substation of the clamping device of Gagner); (2) a finding that the substituted components and their functions were known in the art (e.g., both clamping devices of Monassevitch and Gagner were known in the art to cause ischemic pressure necrosis to tissue); (3) a finding that one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable (e.g., substitution one known necrosis inducing clamping device for another would have yielded the predictable result of fusing tissue together); and (4) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness (e.g., the clamping devices of Monassevitch and Gagner are found to be known equivalents as they both are used to fuse together via ischemic pressure necrosis tissue within a body). Accordingly, applicant’s arguments over lack of motivation are not found persuasive.
In response to applicant's arguments against the references individually (i.e., details of the compression clip 10 of Monassevitch), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the compression clip 10 of Monassevitch is being substituted for the clamping device of Gagner. Therefore, any arguments directed to the clip of Monassevitch are found moot as the structure of the clip of Monassevitch is not being applied to the current rejection.
Applicant argues that while the partitioning device of Gagner and the compression clip 10 of Monassevitch are both used for inducing necrosis, their principle of operation are starkly different. However, the clip of Monassevitch is not being modified with parts of the clamp of Gagner, thereby changing the principle operation of the clip of Monassevitch. Instead, the clamp of Gagner is being substituted for the clip of Monassevitch. Accordingly, the clamp of Gagner would work as intended in the method of Monassevitch.
Applicant again argues the compression clip 10 of Monassevitch already includes features maintaining the compressing elements 16A, 16B in a closed configured one at the base of the polyp or the pouch so there would be no reason arising from Monassevitch that would motivate one of ordinary skill in the art to substitute compression clip 10 for a partitioning device with magnets as taught in Gagner. As discussed above, motivation as been established through equivalency and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
For at least these reasons, the application is not found in condition for allowance at this time.
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) 1-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gagner (WO2021/207821 A1).
Regarding claim 1, Gagner discloses a clamping device (partitioning device 10; Figs. 1-2) capable of resectioning an inwardly protruding portion present in a lumen of a hollow organ of a patient (for example, within the stomach based on the user’s manipulation of the device; Fig. 10), the clamping device comprising: a magnet assembly (magnet assembly 12) implantable into the lumen of the hollow organ of the patient, wherein the magnet assembly comprises: a first zone (first zone 38) comprising a first magnet element (magnetic element 16); and a second zone (second zone 40) comprising a second magnet element (16), the first (38) and second (40) zones being flexibly connected in series (via area comprising connection between 38 and 40 or elongated members 28, 30 and the elongated members at each extremity are flexible; [113]); and the magnet assembly (12) being configured to be positioned at a base of the inwardly protruding portion to magnetically couple the first zone and the second zone (based on the user’s manipulation of the device as the first and second zones couple to one another; Fig. 2), the first magnet element and the second magnet element being configured to exert an attractive force selected to compress opposite walls of the inwardly protruding portion therebetween ([115]) and subject the opposite walls of the inwardly protruding portion to ischemic pressure necrosis to fuse the opposite walls of the inwardly protruding portion together during a healing time period ([132]).
Regarding claim 2, Gagner discloses wherein the first and second zones of the magnet assembly are flexibly connected in series via a transition zone (area comprising connection between 38 and 40 or elongated members 28, 30) extending between the first zone and the second zone (Figs. 1-2), the transition zone comprising a fastener (connection between 38 and 40 or elongated members 28, 30) configured to couple a leading end of the first zone to a trailing end of the second zone (Figs. 1-2).
Regarding claim 3, Gagner discloses wherein the fastener comprises a flexible fastener (as the connection between 38 and 40 is flexible as the device closes and elongated members 28 and 30 are flexible; [113]).
Regarding claim 4, Gagner discloses wherein the fastener comprises a releasable fastener (28 and 30 are a releasable fastener as they may be tied/untied).
Regarding claim 5, Gagner discloses wherein the transition zone (connection between 38, 40) is configured to provide a pivotal transition between the first zone and the second zone (Figs. 1-2).
Regarding claim 6, Gagner discloses wherein the transition zone (connection between 38, 40) further comprises a flexible connector (as the connector flexes from a straight position to a curved position; Figs. 1-2).
Regarding claim 7, Gagner discloses wherein at least one of the first and second magnet elements comprises a plurality of magnet elements (plurality of magnet elements 16), the magnet elements of the plurality of magnet elements being connected to each other in series by a magnet element connector (housing 14).
Regarding claim 8, Gagner discloses wherein the magnet element connector (14) is flexible (at the portion between 38 and 40; Figs. 1-2).
Regarding claim 9, Gagner discloses wherein the magnet element connector is a rigid or semi-rigid connector (as 14 is rigid within 38 and 40 as it does not bend when clamped; Figs. 1-2).
Regarding claim 10, Gagner discloses wherein at least one of the first and second magnet elements comprise bevelled edges or rounded edges (rounded; Figs. 1-2; [033]-[034]).
Regarding claim 11, Gagner discloses wherein the clamping device is configurable between an uncoupled pre-clamping configuration (Fig. 1) and a clamping configuration (Fig. 2).
Regarding claim 12, Gagner discloses wherein the clamping device is configurable between an enclosed pre-clamping (Fig. 2) configuration and a clamping configuration (when 28 and 30 are tied).
Regarding claim 13, Gagner discloses wherein at least one of the first and second magnet element (16) comprises a housing (housing 14) comprising an organ-contacting side (inner surfaces of 38, 40) and being configured to receive the at least one of the first and second magnet element therein (Figs. 1-2).
Regarding claim 14, Gagner discloses wherein the organ-contacting side of the housing comprises an elongated flat contact surface (Figs. 1-2).
Regarding claim 15, Gagner discloses wherein the housing comprises bevelled edges ([023]).
Regarding claim 16, Gagner discloses wherein the first and second magnet elements (16) are received in a housing (14), the housing comprising a first end and a second end (each end of 14), and wherein the first end and the second end of the housing are releasably coupled to each other with a fastener (28, 30).
Regarding claim 17, Gagner discloses wherein the first and second magnet elements (16) are received in a corresponding housing (14).
Regarding claim 18, Gagner discloses wherein the attractive force of the first and second magnet elements is determined at least in part in accordance with a thickness and/or a composition of the opposite walls of the inwardly protruding portion ([040]).
Regarding claim 19, Gagner discloses wherein the attractive force of the first and second magnet elements is determined so as to facilitate placement and implantation of the clamping device around a portion of the inwardly protruding portion ([041]).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monassevitch et al. (US 2010/0331862 A1) in view of Gagner (WO 2021/207821 A1).
Regarding claim 20, Monassevitch discloses a method for resectioning (via necrosis) an inwardly protruding portion (tissue pouch; T; PCH) present in a hollow organ of a patient (Figs. 81-85; [0338]), the method comprising the steps of: inserting a clamping device (clip 10) into a lumen of the hollow organ (opening in the stomach; Figs. 82-85), the clamping device comprising a first zone (securing element 14A) and a second zone (securing element 14B); positioning the clamping device (10) at a base of the inwardly protruding portion (Figs. 82-83); coupling the first zone (14A) and the second zone (14B) together to compress opposite walls of the inwardly protruding portion therebetween (Figs. 82-85); and allowing the opposite walls of the inwardly protruding portion to fuse together via ischemic pressure necrosis while the first zone and the second zone remain coupled during a healing time period (as the clip 10 induces necrosis of the pouch area, and after necrosis is completed, the region around the necrotic area heals leaving an organ with an effective smaller volume i.e. without the pouch; [0338]).
Monassevitch fails to disclose wherein the clamping device includes a magnet assembly implantable into the lumen of the hollow organ of the patient, wherein the magnet assembly comprises: a first zone comprising a first magnet element; and a second zone comprising a second magnet element; and the magnet assembly being configured to be positioned at a base of the inwardly protruding portion to magnetically couple the first zone and the second zone, the first magnet element and the second magnet element being configured to exert an attractive force selected to compress opposite walls of the inwardly protruding portion therebetween and subject the opposite walls of the inwardly protruding portion to ischemic pressure necrosis to fuse the opposite walls of the inwardly protruding portion together during a healing time period; each of the first and second magnetic elements having a magnetic-engaging side; positioning the magnetic assembly such that the magnetic-engaging side of the first zone and the magnet-engaging side of the second zone face each other; magnetically coupling the first zone and the second zone together to compress opposite walls of the inwardly protruding portion therebetween; and allowing the opposite walls of the inwardly protruding portion to fuse together via ischemic pressure necrosis while the first zone and the second zone remain magnetically coupled during a healing time period.
However, Gagner teaches a clamping device (partitioning device 10; Figs. 1-2) capable of resectioning an inwardly protruding portion present in a lumen of a hollow organ of a patient (for example, within the stomach based on the user’s manipulation of the device; Fig. 10), the clamping device comprising: a magnet assembly (magnet assembly 12) implantable into the lumen of the hollow organ of the patient, wherein the magnet assembly comprises: a first zone (first zone 38) comprising a first magnet element (magnetic element 16); and a second zone (second zone 40) comprising a second magnet element (16); and the magnet assembly (12) being configured to be positioned at a base of the inwardly protruding portion to magnetically couple the first zone and the second zone (based on the user’s manipulation of the device as the first and second zones couple to one another; Fig. 2), the first magnet element and the second magnet element being configured to exert an attractive force selected to compress opposite walls of the protruding portion therebetween ([115]) and subject the opposite walls of the inwardly protruding portion to ischemic pressure necrosis to fuse the opposite walls of the inwardly protruding portion together during a healing time period ([132]); each of the first and second magnetic elements (16) having a magnetic-engaging side (inner surfaces of 38, 40); positioning the magnetic assembly such that the magnetic-engaging side of the first zone and the magnet-engaging side of the second zone face each other (Fig. 2); magnetically coupling the first zone and the second zone together to compress opposite walls of a protruding portion therebetween (Fig. 10); and allowing the opposite walls of the protruding portion to fuse together via ischemic pressure necrosis while the first zone and the second zone remain magnetically coupled during a healing time period ([132]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute for the clamping device of Monassevitch the clamping device of Gagner which includes a magnet assembly comprising a first zone and a second zone, each of the first zone and the second zone comprising at least one magnet element having a magnetic-engaging side for coupling and compressing tissue together as claimed. The claim would have been obvious because the substitution of one known clamping device for another would have yielded the predictable result of clamping, compressing, and fusing tissue via ischemic pressure necrosis.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771