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
The amendments filed on 01/30/2026 have been entered. Claims 1, 4-20, and 23-27 remain pending in the application. The drawing objection set forth in the office action dated 10/30/2025 has been withdrawn.
Response to Arguments
Applicant's arguments filed 01/30/2026 have been fully considered but they are not persuasive. Applicant argues on page 10 that it would not have been obvious to modify the annular space of Liu because Lui discloses that the two intestine layers are held in overlap such that the serous membrane of the intestines are contacted with each other, not the submucosal layers. However, it is the examiner’s position that urging submucosal layers of the intestines into contact is an intended use of the device and need not be explicitly recited by the prior art. Further, Lui is silent regarding what annular spacing is used to achieved their desired intestine wall contact, and because each body and particular treatment area is different and can have varying intestine wall thickness to some degree, there is not evidence that Lui teaches away from the spacing being 1.0 mm or smaller.
Applicant states that the proposed modification requires “narrowing the annular space” of Lui. However, because Lui is silent regarding dimensions of the annular space, one cannot determine that selecting a spacing of 1mm or smaller is more narrow that what is disclosed by Lui or not, because there is no dimension disclosed. Stating that the device is intended to compress the serous membrane of the wall layers does not establish a specific dimension because every wall layer can have variations in thickness.
Applicant further argues on page 11 that there would be no purpose of rendering an annular space to receive only one layer of wall. However, examiner is not suggesting there is a motivation to modify a device to be sized to receive and compress only one layer of wall. The device of Lui already teaches this, as shown in FIG 9 where at least some segment of the annular space only receives a single layer. Because Lui is silent regarding the size of the annular spacing at this point, the purpose of the modification is only to provide a thickness which would be configured for receiving a single layer. Since Swain teaches a single layer can be 1 mm thick, selecting a spacing of 1 mm or less would allow the rings of Lui to receive and apply a pressure for grasping the single wall layer therebetween as desired. Therefore, it is the examiner’s position that there is sufficient motivation for the teaching of the annular space sizing and applicants’ arguments are not found to be persuasive.
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.
Claim(s) 1, 4-11, 13-15, and 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Lui (US 2011/0264121) in view of Swain et al. (US 2009/0227828).
Regarding claims 1, 4, and 5, Lui discloses a kit of parts (FIG 1, the method disclosed [0032] states the inner and outer rings are separately introduced and positioned before being connected to one another. Therefore the parts are understood to be separately provided thereby defining a kit) for forming a device (Wherein the implanted and assembled piece of FIG 9 is interpreted as the device) for performing anastomosis of a first gastro-intestinal tract section (3, [0032]) and a second gastro-intestinal tract section (4, [0032]), the kit of parts comprising: an inner ring (1, FIG 1, 2, 4, 5, 8-5 and 9, [0029-0032]), defining a passage for faecal matter through the inner ring in a generally axial direction (The axial lumen through the center of inner ring 1 forms a passage through which fecal matter can pass), and comprising an outer surface (Outer surface along 13, 12, and 11) generally facing away from the passage (FIG 2, 5, 8-5, 9); an outer ring (2, FIG 1, 3, 9), defining a reception volume (Central lumen passing through outer ring 2, FIG 1) for receiving at least part of the inner ring therein (FIG 9), the outer ring comprising an inner surface (Inner wall surface of 2) facing at least partially towards the reception volume (FIG 9); wherein the inner ring and the outer ring are arranged to, in an assembled state in which the inner ring is at least partially positioned in the reception volume of the outer ring (As such in FIG 9, [0029, 0032]), have at least part of the outer surface of the inner ring facing towards the inner surface of the outer ring (The outer surface of 1 along at least section 12 and 13 faces towards the inner surface of the outer ring, FIG 9), and to have the outer surface and the inner surface together define an annular space between them (Annular space is shown in the assembled state of FIG 9 where intestines 3 and 4 are received within the annular space), wherein at least part of the annular space converges in the generally axial direction (The region outlined below shows at least a part of the annular space which converges in the direction shown by the annotated arrows).
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Lui is silent regarding the inner diameter of the outer ring and the outer diameter of the inner ring, and therefore is silent regarding any dimensions of the annular space. However, Lui does show that in the assembled state, the annular space is sized to receive one layer of the intestinal wall in one portion and two layers in another portion (see FIG 9).
Lui is silent regarding in the assembled state with parts of two gastro-intestinal tract sections positioned in the annular space, a thickness of at least a part of the annular space in a radial direction perpendicular to the axial direction is 1.0 mm or smaller, such that, in the assembled state, the inner ring and outer ring are configured to urge submucosal layers of the first and second gastro-intestinal tract sections into contact with each other (claim 1) and further wherein in the assembled state with parts of two gastro-intestinal tract sections positioned in the annular space, a thickness of the annular space perpendicular to a centreline of the annular space is 1.0 mm or smaller for part of the annular space, and 1.0 mm or larger for another part of the annular space, such that in assembled state submucosal layers of the gastro-intestinal tract sections can be contacted (claims 4 and 5).
However, Swain et al. teaches that the tissue of the small intestine or colon is approximately 1-1.5 mm in width ([0055]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the annular space at is most narrow point to be 1.0mm or smaller, for the purpose of receiving one layer of the intestinal wall and applying a compressive force thereto. Further it would have been obvious to select a thickness at a widest point of the annular space to be 1.0mm or larger, in order to accommodate and apply a compressive force to two layers of the intestinal wall. “The annular space perpendicular to a centreline of the annular space” and “the annular space in a radial direction perpendicular to the axial direction” are interpreted to be the same sections and measurements.
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Regarding claim 6, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses at least one of the outer surface and the inner surface is provided by a rigid material comprised by the respective at least one of the inner ring and the outer ring ([0030] discloses the inner ring 1 is made of a hard plastic, therefore the outer surface is provided by a rigid material).
Regarding claim 7, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses the annular space between the outer surface of the inner ring and the inner surface of the outer ring comprises a non-diverging part with a constant cross-sectional area in a plane perpendicular to the axial direction (See annotated FIG 9 above. The cross section is constant in a plane perpendicular to the axial direction/direction of convergence arrows).
Regarding claim 8, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses a height of the annular space in a direction parallel to the axial direction is between 2-20 mm (A height of the annular lumen is defined by the height of outer ring 2 since it is the shortest of the two rings. [0031] discloses the height is 3-6mm, which falls within the claimed range of 2-20 mm).
Regarding claim 9, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses the outer ring comprises an inner flange protruding towards the passage for fecal matter (See bottom of outer ring 2 which forms an inwardly protruding flange, FIG 3, 8-4, and 9).
Regarding claim 10, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 9. Lui further discloses an inner diameter of the inner flange corresponds to an outer diameter of part of the outer surface of the inner ring (As shown in FIG 9, the inner and outer diameters are interpreted as ‘corresponding’ because they are configured to allow for the inner ring to be seated within the outer ring. Examiners notes that ‘corresponding’ does not necessarily require that they be the same diameters or directly in contact with one another).
Regarding claim 11, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses the outer ring comprises an inward shoulder section (See annotated FIG 9 below), the inner ring comprises an outward shoulder section (See annotated FIG 9 below), and in the assembled state, the inward shoulder section is arranged to abut the outward shoulder section (The two sections are at least arranged such that they can contact one another in the absence of tissue therebetween).
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Regarding claim 13, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses the inner ring comprises an outward protruding shoulder (111, FIG 8-5 and 9).
Regarding claim 14, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 13. Lui further discloses in the assembled state, at least part of the outward protruding shoulder axially extends beyond the inner ring (FIG 9).
Regarding claim 15, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses the outer ring has a shorter height than the inner ring when an end of the inner ring is aligned with an end of the outer ring (FIG 9).
Regarding claim 23, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1.
Lui discloses a height of the outer ring is 3-6mm ([0031]) but fails to disclose a height of the portion of the outer ring which forms the inwardly tapered protrusion (i.e. the section which forms the 1 mm or smaller annular space), therefore it is silent regarding the height being 1.0-5.0 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the height along which the 1 mm annular spacing is formed to be 1-5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Lui et al. would not operate differently with the claimed height and since these dimensions fall within the overall sizing of the outer ring which is disclosed, the device would function appropriately having the claimed height along the reduced annular space portion. Further, applicant places no criticality on the range claimed, indicating simply that “This minimal thickness is preferably achieved over a certain height, in Fig. 8 denoted as Hp. This height Hp may be between 1.0-5.0 mm, in particular between 1.0-2.0 mm”.
Regarding claim 24, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses in the assembled state, the outer ring contributes to the annular space over a height Ho of between 2.0-6.0 mm (A height of the annular space is defined by the height of outer ring 2 since it is the shortest of the two rings. [0031] discloses the height is 3-6mm, which falls within the claimed range of 2-6 mm).
Regarding claim 25, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses in the assembled state, the total height of the annular space is between 3.5-8.5 mm (A height of the annular space is defined by the height of outer ring 2 since it is the shortest of the two rings. [0031] discloses the height is 3-6mm, which falls within the claimed range of 3.5-8.5 mm).
Regarding claim 26, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 1. Lui further discloses in the assembled state, the thickness of the annular space gradually reduces to 1.0 mm or smaller (FIG 9 shows the assembled state; the inward tapering of the outer ring reduces the thickness of the annular space gradually).
Regarding claim 27, Lui/ Swain discloses the invention substantially as claimed, as set forth above for claim 10. Lui further discloses the inner diameter of the inner flange makes an interference fit or a light interference fit to the outer diameter of part of the outer surface of the inner ring ([0029] describes “the protruded ring 21 is clamped to the connecting portion 12 of the inner ring, the lower edge of the connecting portion of the inner ring is formed a circle or several flanges 121” thus forming an interference fit because the inner ring an inner flange of the outer ring are is direct frictional contact).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lui (US 2011/0264121) in view of Swain et al. (US 2009/0227828), further in view of Swain (US 2012/0116426).
Regarding claim 12, Lui/Swain discloses the invention substantially as claimed, as set forth above for claim 11.
Lui is silent regarding the inward shoulder section of the outer ring is provided with one or more serrations protruding from a surface of the inward shoulder section, which surface faces at least partially in the axial direction.
However, Swain ‘426 teaches an anastomosis device (60, FIG 6A-6C, abstract) for clamping a tissue ([0047]) wherein serrations are provided along the tissue contacting surface in order to aid in grasping the tissue ([0050]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the inward shoulder section of the outer ring to have with one or more serrations protruding from a surface of the inward shoulder section, for the purpose of increasing the ability of the inward shoulder section to grasp the tissue layers positioned between the inward shoulder section and the outward shoulder section.
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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771