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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/15/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered but they are not persuasive.
Applicant argues independent claim 1 requires a specific intraluminal clamping arrangement. However, the term “luminal lining” in “a first luminal lining contacting surface” and “a second luminal lining contacting surface” is functional in that it is a limitation used to describe how the device is intended to be used i.e., on an intraluminal lining of a hollow organ. The only additional structure required is contacting surfaces that are configured to be used on an intraluminal lining of a hollow organ. Regardless of what the contacting surfaces are called, as long as they are able to be used on luminal lining, then the contacting surfaces meet the claimed limitation. The examiner maintains that the partitioning device 10 of Gagner (WO 2021/207821) includes a first zone (first zone 38) comprising a first magnet element (magnetic element 16), the first magnet element (16) comprising a first contacting surface (organ contacting side/inner surface of 38; Fig. 2) capable of contacting luminal lining of a stomach i.e., “a first luminal lining contacting surface”; and a second zone (second zone 40) comprising a second magnet element (16), the second magnet element comprising a second contacting surface (organ contacting side/inner surface of 40; Fig. 2) capable of contacting luminal lining of a stomach i.e., “a second luminal contacting surface”.
Applicant argues Gagner expressly discloses an extraluminal partitioning device, not the claimed intraluminal clamping device. However, applicant has not provided any evidence or structural differences between the partitioning device 10 of Gagner and that claimed. Simply stating that the two devices are intended to be used differently is insufficient because 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 partitioning device 10 of Gagner is structurally equivalent to the claimed clamping device, as discussed below.
Applicant argues that the position of the Office Action regarding “intended use” does not address the claim limitations because the features of the claim define the claimed clamping device by the surfaces it includes and their function, and the positional arrangement between the first luminal lining contacting surface and the second luminal lining contacting surface, i.e., on respective sides of an inwardly protruding portion. The examiner respectfully disagrees. As discussed above, the structure is the contacting surfaces themselves and their position to be able to complete the function of contacting luminal lining of a hollow organ. Gagner discloses the first magnet element (16) comprising a first contacting surface (organ contacting side/inner surface of 38; Fig. 2) and the second magnet element comprising a second contacting surface (organ contacting side/inner surface of 40; Fig. 2). Because the contacting surfaces of Gagner face one another (Fig. 2) and contact respective sides of a hollow organ, they are contacting surfaces. Thus, Gagner discloses the positional arrangement required by the claims.
Applicant argues that at most, examiner’s statements about the capability of the device 10 of Gagner assert that a user could deploy the partitioning device of Gagner in the way claimed, but the Office Action does not point to any identified teaching in Gagner that supports this mere possibility. The examiner respectfully disagrees.
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), the first magnet element (16) comprising a first contacting surface (organ contacting side/inner surface of 38; Fig. 2) capable of contacting luminal lining of a stomach i.e., “a first luminal lining contacting surface”; and a second zone (second zone 40) comprising a second magnet element (16), the second magnet element comprising a second contacting surface (organ contacting side/inner surface of 40; Fig. 2) capable of contacting luminal lining of a stomach i.e., “a second luminal contacting surface”, 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]).
Additionally, as noted in the Final Rejection mailed 1/16/2026, 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.
The examiner further points to Figs. 1 and 2 of Gagner which are identical to Figs. 1 and 2 of the present disclosure. Not close or substantially the same, identical. Based on the identical structure of the partitioning device 10 of Gagner to the present disclosure, the only difference found in the claimed invention and Gagner is the intended use of the partitioning device 10. Because of the overlapping/equivalent sizing of the device 10 of Gagner and the identical structure of the partitioning device 10 of Gagner with the present disclosure, it is not a mere possibility that the partitioning device 10 of Gagner would be capable of meeting the claimed functions, it is a fact.
Applicant argues the Office Action does not identify any passage in Gagner expressly disclosing a magnet assembly being configured to be positioned at a base of the inwardly protruding portion inside a hollow organ to magnetically couple the first zone and the second zone of the magnet assembly to exert an attractive force selected to compress opposite walls of the inwardly protruding portion therebetween.
Again, 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. As established above, there is no structural difference between the claimed invention and the prior.
Applicant argues that the Office Action does not establish inherency because the fact that certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. However, as discussed above, the structure of the partitioning device 10 of Gagner is identical to the clamping device claimed. Thus, the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus.
Applicant argues the Office Action assumes equivalence instead of showing disclosure of the claimed arrangement. The examiner respectfully disagrees and has repeatedly shown the structural equivalence between the partitioning device 10 of Gagner and the clamping device claimed, as discussed above. In other words, Gagner does disclose the specific structural limitations and positional arrangements as claimed. The fact that Gagner discloses the partitioning device 10 can be used extraluminally is irrelevant because Gagner discloses each and every structural element of the claimed invention. Applicant has not pointed to a single non-functional difference between the partitioning device 10 of Gagner and the present disclosure and has not provided any evidence as to why or how the partitioning device 10 of Gagner would not be capable of meeting the functional claim language.
With respect to claim 20, applicant argues the clip of Monassevitch (US 2010/0331862 A1) would not have been substituted by the partitioning device of Gagner because it is not sufficient to label two devices “equivalents” simply because both relate broadly to necrosis. However, both do not just relate broadly to necrosis. They both deal with clamping to create necrosis in the stomach to reduce the volume of the stomach in order to encourage weight loss in obese individuals. Monassevitch recites “Gastroplastic surgical procedures are used to reduce the volume of the stomach in order to encourage weight loss in obese individuals. A portion of the stomach is grasped, pulled and held within a compression clip 10 as shown in FIG. 85” ([0338]) and Gagner recites “Bariatric surgery procedures can be used to treat obesity, and are generally aimed at restricting the size of an organ such as the stomach, and/or bypassing a portion of the stomach and/or the intestine” ([002]). Thus, both references look to the same problem of clamping a stomach to create necrosis in order to reduce the size of the stomach. Accordingly, one of ordinary skill in the art would have looked to the partitioning device 10 of Gagner and found the partitioning device 10 of Gagner as an equivalent clamping device. Thus, the specific substitution does not lack a reasoned basis and is supported by the references in the manner proposed.
Applicant argues the Office Action’s principle of operation response does not address applicant’s underlying incompatibility/motivation because the analysis does not explain why one of ordinary skill in the art would expect the substituted device to work in the primary reference’s method context, and why that substitution would have been motivated. It is the examiner’s position that one of ordinary skill in the art would have expected the partitioning device 10 of Gagner to work in the method of Monassevitch because the partitioning device 10 of Gagner is intended to provide necrosis to the stomach of a patient to effectively reduce the size of the stomach, similar to the compression clip 10 shown in Fig. 85 of Monassevitch. Further, the substitution would have been motivated by the equivalence of the two clamping devices as discussed above.
Applicant argues the Office Action’s equivalency assertion does not, without more, supply a motivation to substitute. 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 substitution 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 stomach tissue to reduce the volume of a stomach); (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 stomach 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.
For at least these reasons, applicant’s arguments are not found persuasive and 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; it is noted that 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]) and applicant discloses 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; therefore, the device 10 of Gagner is sized to fit within a stomach), 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), the first magnet element (16) comprising a first luminal lining contacting surface (organ contacting side/inner surface of 38; capable of contacting luminal lining of a stomach i.e., “a first luminal lining contacting surface”; Fig. 2); and a second zone (second zone 40) comprising a second magnet element (16), the second magnet element comprising a second luminal lining contacting surface (organ contacting side/inner surface of 40 capable of contacting luminal lining of a stomach i.e., “a second luminal contacting surface”; Fig. 2), 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 first luminal lining contacting surface (organ contacting side/inner surface of 38) of the first magnet element (16) and the second luminal lining contacting surface (organ contacting side/inner surface of 40) of the second magnet element (16) being configured to be positioned at a base of the inwardly protruding portion, on respective sides thereof (as the organ contacting sides face one another; Fig. 2), 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 defining a corresponding one of the first luminal lining contacting surface or the second luminal lining contacting surface (inner surfaces of 38, 40), the housing 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 corresponding one of the first luminal lining contacting surface or the second luminal lining contacting surface (inner surfaces of 38, 40) 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 such that a first luminal lining contacting surface (inner surface of one side of 10) and a second luminal lining contacting surface (inner surface of other side of 10) face each other (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, the first magnet element comprising a first luminal lining contacting surface; and a second zone comprising a second magnet element, the second magnet element comprising a second luminal lining contacting surface; and the first luminal lining contacting surface of the first magnet element and the second luminal lining contacting surface of the second magnet element being configured to be positioned at a base of the inwardly protruding portion, on respective sides thereof, 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 first luminal lining contacting surface of the first magnet element and the second luminal lining contacting surface of the second magnet element 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; [002]), 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), the first magnet element comprising a first luminal lining contacting surface (organ contacting side/inner surface of 38; capable of contacting luminal lining of a stomach i.e., “a first luminal lining contacting surface”; Fig. 2); and a second zone (second zone 40) comprising a second magnet element (16), the second magnet element comprising a second luminal lining contacting surface (organ contacting side/inner surface of 40 capable of contacting luminal lining of a stomach i.e., “a second luminal contacting surface”; Fig. 2); 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]); positioning the magnetic assembly such that the first luminal lining contacting surface (inner side of 38) of the first magnet element (16) and the second luminal lining contacting surface (inner side of 40) of the second magnet element (40) 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 luminal lining contacting surface 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
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
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