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
In response to the amendment filed on 11/12/2025, No Claims have been cancelled, and Claims 1-16 are pending. Claims 17-20 are withdrawn from consideration.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant argues that Adams fails to teach “an axially and circumferentially extending tissue capture device configured to operate axially to circumferentially engage tissue selected for rection” however the Examiner respectfully disagrees.
Adams teaches that when the “anvil member 10 [the cap] has reached the distal most position, a known grasping device 108 is advanced through the sheath 4 and through the working head assembly 2 to enter the gap between the anvil member 10 and the distal end 12a [of the body]” (see Column 6, Lines 46-50; Adams). Therefore Adams does indeed operate axially to engage tissue. Furthermore Adams teaches “In operation, either one or two grasping devices 108 may then be used to pull a section of the tubular organ between the anvil member 10 and the distal end 12a of the proximal housing 12 and into the cavity 30.” And as Clearly shown in Figure 3, tissue grasping device is disposed radially outside the space between distal cap 10 and body 12, and this is circumferentially engaging tissue as the proximal end is being operated axially distally to extend the tissue grasping device 12.
Therefore, it is the Examiner’s position that Adams does indeed teach the amended claim language of Claims 1 and 14, and the rejections are previously set forth are being maintained.
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, 3-11, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto (US Patent 5,395,030) in view of Belson (US PGPub 2003/0171775) and in further view of Adams (US Patent 6,126,058).
Regarding Claim 1, Kuramoto teaches a device (165) for tissue resection in a body lumen, said device comprising (Figures 35A-35E-36; Column 19, Lines 56-67 to Column 22, Lines 26):
a body (138/165) extending along an axis and configured to selectively anchor with respect to a proximal location along a wall of a body lumen proximal to a selected tissue for resection (177; see Figure 35; Column 19, Lines 58-64);
a cap (174) distal to said body (138) and configured to engage the wall of the body lumen (as clearly seen in Figure 35D; see Column 20. Lines 13-15 which state “The folded portions 177b of the intestine 177 are clamped between the housing 138 and the anvil 174.”) at a location distal to the selected tissue for resection (as seen in Figure 35B), said body (138) and said cap (174) coupled together for axial movement relative to each other (see Figures 35A-35E);
a tissue capture device (179; Figure 36) configured to engage tissue selected for resection (Column 19, Lines 65-69 and Column 20 Lines 1-15);
a tissue closure device (125; Figure 36) circumferentially spaced apparat from the tissue capture device (Figure 36) and configured to close the engaged tissue circumferentially (Column 20, Lines 16-21); and
a tissue resecting device (138a; annular cutter; best seen in Figure 36) configured to resect tissue radially inward of the closed tissue (Column 20, Lines 22-25).
Kuramoto fails to explicitly teach:
The cap is configured to engage the wall of the body to selectively anchor with respect to the wall of the body at a location distal to the selected tissue for resection.
Belson teaches a device for endoscopic colectomy wherein during deployment of the colectomy device, a diseased portion of the colon is positioned in between the tissue approximation devices. The tissue approximation devices are radially expanded such that they contact and grasp the colon wall at two sites adjacent to the diseased portion of the colon. The diseased portion is separated from the omentum and is transected using a laparoscope or is drawn into the colonoscope for later removal. The tissue approximation devices are then urged towards one another over the colonoscope to approximate the two free edges of the colon into contact together where they are fastened to one another using the tissue approximation device as a surgical stapler to create an end-to-end anastomosis (Abstract; Belton).
Belton teaches a distal component (104; Figures 2-5), which is analogous to the distal cap taught by Kuramoto, wherein the distal component/cap is configured to engage the wall of the body lumen to selectively anchor (via element 108 which is an expandable member; Paragraph 0022) with respect to the wall of the body lumen at a location distal to the selected tissue for resection (see Figures 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Kuramoto, such that the distal cap is capable of selectively anchoring to the wall of a body lumen by means of an expandable member, as taught by Belton, for the advantage that the “expanded members will assure a very accurate end-to-end anastomosis and prevent stenosis that can happen as a result of inaccurate approximation of the two ends.” (Paragraph 0026; Belton).
The combination of references fails to disclose wherein the tissue capture device is an axially and circumferentially tissue capture device configured to operate axially to circumferentially engage tissue selected for resection. While Kuramoto teaches a holding forceps (150; Figure 23 and 25; Column 17, Lines 35-42) which extends axially and circumferentially to axially engage tissue for resection, Kuramoto teaches this in a separate embodiment of Figures 23-25 as an alternative to using the suction.
Adams teaches a device for full thickness resectioning (abstract; Figure 3) in which the device utilizes suction to draw the tissue into the space used to cut/staple the tissue (Column 13, Lines 41-51) and also an axially and circumferentially extending tissue capture device (108; Figure 3), the tissue capture device (108) configured to operate axially (Column 6, Lines 47-51) to circumferentially engage tissue selected for resection (as shown in see Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the combination of references to include the forceps as an axially and circumferentially extending tissue capture device, in addition to the suction device, for the advantage of further grasping tissue that is too rigid to be moved by suction alone such that the tissue is properly placed for resection and to assist in grasping tissue that is radially outside the space between the cap and the body of the device.
Regarding Claim 3, the combination of references disclosed above teaches the device according to claim 1, wherein Adams teaches said tissue capture device (108) extends circumferentially around said device to pull the engaged tissue radially inward into said device (see Figure 3 of Adams; see Column 7, Lines 19-22);
Regarding Claim 4, the combination of references disclosed above teaches the device according to claim 1, wherein Kuramoto teaches said tissue capture device comprises a suction device (Column 19, Lines 33-45).
Regarding Claim 5, the combination of references disclosed above teaches the device according to claim 4, wherein Kuramoto teaches said tissue closure device (125; staples) and said tissue resecting device (139a; annular cutter) are actuatable independently of said tissue capture device (169/171; suction device) and axial movement of said cap (174) (See Column 19, Lines 65-67 and Column 20, Lines 1-25 in which both the staples and cutting are independently actuated relative to the suction device and axial movement of the cap. See Figures 3A-35B in which the distal cap is moved but the stapling and annular cutter has not been engaged and see Figures 35C in which the suction is engaged however the stapling and cutting has not occurred. See Figures 35D in which the stapling and cutting has occurred even though the cap is not moving and the suction was already applied).
Regarding Claim 6, the combination of references disclosed above teaches the device according to claim 1, wherein Adams teaches said tissue capture device (108) is disposed circumferentially around the interior of said device and axially moves to engage and capture tissue selected for resection (see Figure 3 of Adams; see Column 7, Lines 19-22).
Regarding Claim 7, the combination of references disclosed above teaches the device according to claim 1, wherein Adams teaches said tissue capture device extends circumferentially around the exterior of said device (see Figure 3 of Adams; see Column 7, Lines 19-22)
Regarding Claim 8, the combination of references disclosed above teaches the device according to claim 1, wherein Adams teaches the tissue closure device (the staples) and said tissue resecting device (the cutter) are actuable independently of one another (Column 14, Lines 21-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date to make the cutter and staples be independently actuated for the advantage of making sure that the tissue is properly stapled before cutting.
Regarding Claim 9, the combination of references disclosed above teaches the device according to claim 1, wherein Kuramoto teaches said tissue closure device comprises a plurality of staples (125 in Figure 34).
Regarding Claim 10, the combination of references disclosed above teaches the device according to claim 1, wherein Kuramoto teaches said tissue resecting device (annular cutter) extends axially to resect tissue (see element 138 in Figure 36 which extends axially distally to cut).
Regarding Claim 11, the combination of references disclosed above teaches the device according to claim 1, wherein Kuramoto teaches said tissue resecting device comprises a blade (138a; see Figure 36).
Regarding Claim 13, the combination of references disclosed above teaches the device according to claim 1, wherein Kuramoto teaches movement of said body (138/165) of said body and said cap (174) together causes the selected tissue for resection to be compressed (see Figures 35D; Column 20, Lines 9-15).
Regarding Claim 14, Kuramoto teaches a system for tissue resection in a body lumen, said system comprising: a tissue resection device comprising:
a body (138/165) extending along an axis and configured to selectively anchor with respect to a wall of a body lumen proximal to a selected tissue for resection (177; see Figure 35; Column 19, Lines 58-64);
a cap (174) distal to said body (138) and configured to engage the wall of the body lumen (as clearly seen in Figure 35D; see Column 20. Lines 13-15 which state “The folded portions 177b of the intestine 177 are clamped between the housing 138 and the anvil 174.”) at a location distal to the selected tissue for resection (as seen in Figure 35B), said body (138) and said cap (174) coupled together for axial movement relative to each other (see Figures 35A-35E);
a tissue capture device (179; Figure 36) configured to engage tissue selected for resection (Column 19, Lines 65-69 and Column 20 Lines 1-15);
a tissue closure device (125; Figure 36) circumferentially spaced apparat from the tissue capture device (Figure 36) and configured to close the engaged tissue circumferentially (Column 20, Lines 16-21); and
a tissue resecting device (138a; annular cutter; best seen in Figure 36) configured to resect tissue radially inward of the closed tissue (Column 20, Lines 22-25).
a visualization device (167) for visualizing positioning of said tissue resection device in the body lumen relative to the selected tissue for resection (Figure 32, 34, and 36, individually; Column 19, Lines 50-55).
Kuramoto fails to explicitly teach:
The cap is configured to engage the wall of the body to selectively anchor with respect to the wall of the body at a location distal to the selected tissue for resection.
Belson teaches a device for endoscopic colectomy wherein during deployment of the colectomy device, a diseased portion of the colon is positioned in between the tissue approximation devices. The tissue approximation devices are radially expanded such that they contact and grasp the colon wall at two sites adjacent to the diseased portion of the colon. The diseased portion is separated from the omentum and is transected using a laparoscope or is drawn into the colonoscope for later removal. The tissue approximation devices are then urged towards one another over the colonoscope to approximate the two free edges of the colon into contact together where they are fastened to one another using the tissue approximation device as a surgical stapler to create an end-to-end anastomosis (Abstract; Belton).
Belton teaches a distal component (104; Figures 2-5), which is analogous to the distal cap taught by Kuramoto, wherein the distal component/cap is configured to engage the wall of the body lumen to selectively anchor (via element 108 which is an expandable member; Paragraph 0022) with respect to the wall of the body lumen at a location distal to the selected tissue for resection (see Figures 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Kuramoto, such that the distal cap is capable of selectively anchoring to the wall of a body lumen by means of an expandable member, as taught by Belton, for the advantage that the “expanded members will assure a very accurate end-to-end anastomosis and prevent stenosis that can happen as a result of inaccurate approximation of the two ends.” (Paragraph 0026; Belton).
The combination of references fails to disclose wherein the tissue capture device is an axially and circumferentially tissue capture device configured to operate axially to circumferentially engage tissue selected for resection. While Kuramoto teaches a holding forceps (150; Figure 23 and 25; Column 17, Lines 35-42) which extends axially and circumferentially to axially engage tissue for resection, Kuramoto teaches this in a separate embodiment of Figures 23-25 as an alternative to using the suction.
Adams teaches a device for full thickness resectioning (abstract; Figure 3) in which the device utilizes suction to draw the tissue into the space used to cut/staple the tissue (Column 13, Lines 41-51) and also an axially and circumferentially extending tissue capture device (108; Figure 3), the tissue capture device (108) configured to operate axially (Column 6, Lines 47-51) to circumferentially engage tissue selected for resection (as shown in see Figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the combination of references to include the forceps as an axially and circumferentially extending tissue capture device, in addition to the suction device, for the advantage of further grasping tissue that is too rigid to be moved by suction alone such that the tissue is properly placed for resection and to assist in grasping tissue that is radially outside the space between the cap and the body of the device.
Regarding Claim 15, the combination of references disclosed above teaches the system according to claim 14, wherein Kuramoto teaches said body (138/165) and said cap (174) are configured for passage of said visualization device (167) therethrough (see Figures 34 and 36, individually, wherein the passage of light extends through the body portion and the cap; the examiner notes that the claim does not recite that the visualization system is slidably disposed within the cap and body) .
Regarding Claim 16, the combination of references disclosed above teaches the system according to claim 14, wherein Kuramoto teaches said visualization device (167) is an endoscope (see Figure 34; in which observation system is a fiber optic scope, and it’s the Examiners position that the term endoscope is a broad term which just means an instrument insertable into the body to give a view of its internal parts, and that’s precisely what the observation system of Kuramoto does).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kuramoto (US Patent 5,395,030), Belson (US PGPub 2003/0171775), and Adams (US Patent 6,126,058) as applied to claim 1 above, and further in view of Balazs (US Patent 5,669,918).
Regarding Claim 2, the combination of references disclosed above teaches the device according to claim 1, but fails to disclose wherein said tissue capture device is a mechanical grasping device selected from the group consisting of: axially extending posts, mechanical fasteners, an expandable and contractable ring attachable to tissue, or a balloon with mechanical fasteners attachable to tissue.
Balazs teaches an anastomosis device having a body (60) and a distally extending cap (1a) (see Figure 2A), wherein the body comprises a tissue capture device (20; Figure 2A), wherein said tissue capture device is a mechanical grasping device (20) selected from the group consisting of: axially extending posts (20; see Figure 2B), mechanical fasteners, an expandable and contractable ring attachable to tissue, or a balloon with mechanical fasteners attachable to tissue.
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute tissue capture device taught by Kuramoto with the axially extending gripper arms as taught by Balazs since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, the arms taught by Balazs would function as intended to grasp the tissue and bring it radially in to be cut and stapled (Column 8, Lines 21-32; Balazs).
Regarding Claim 12, the combination of references disclosed above teaches the device according to claim 1, but fails to disclose wherein said tissue resecting device extends from said cap to resect tissue.
Balazs teaches an anastomosis device having a body (60) and a distally extending cap (1a) (see Figure 2A), wherein elements 22 which are spikes/prongs which cooperate with blade 11 as a tissue resecting device, wherein the spikes/prongs of the tissue resecting device extend from the cap to resect tissue (see Figure 5).
Since Kuramoto discloses the claimed invention except for the tissue resecting device extending from the cap (Kuramoto teaches the tissue resecting device extends from the body distally). It would have been obvious to one having ordinary skill in the art at the time the invention was made to place the tissue resecting device on the cap and extending proximally, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Matar (US Patent 3,837,345) which discloses axial posts (22) for tissue grasping (see Figures 2-5).
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 MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached on (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MOHAMED G GABR/Primary Examiner, Art Unit 3771