DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 06/25/2026. Claim 13 is amended. Claims 21-27 are cancelled. Claims 1-20 are currently pending, with claims 1-12 withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/25/2026, with respect to the rejection(s) of claim(s) 13-16, 18 and 20 under 35 U.S.C. 103 as being unpatentable over Thompson in view of Zand; and claims 17 and 19 under 35 U.S.C. 103 as being unpatentable over Thompson in view of Zand and Arnold, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendments to the claims.
1) Applicant argues Thompson fails to disclose the proximal arms 13 having a distal side and a proximal side each movable along the tubular support member, because the arms are fixed on one side to hinge outward (Remarks, pg. 7).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. Thompson discloses center ring 11 held stationary via catch means 53 (paras. [0053]-[0054]), such that center ring 11 is considered to be movable when catch means 53 is not utilized to lock the center ring 11 in place. Proximal arms 13 are connected to center ring 11, such that proximal arms 13 are considered to be movable at both ends when center ring 11 is not locked by catch means 53. The claim language does not define a specific configuration in which the proximal arms need to be movable. Further, proximal arms 13 are considered to be movable along the shaft when the arms are hinged radially outward; in other words, a portion of the inner and outer arm segments of the proximal arms 13 are hinged radially outward, and are therefore moved along the shaft from the initial, unactuated position, to the hinged position depicted in fig. 4. Accordingly, the rejection is maintained.
2) Applicant further argues Zand fails to teach the controller determining whether the anastomosis has been formed, because the sensing devices are disclosed for predicting a likelihood of success for a planned procedure not yet performed (Remarks, pg. 7).
In response to applicant’s second argument, it is respectfully submitted paras. [0067] and [0069] describe the sensing capabilities of the stapler when the tissue segments have been joined. Zand further describes how the sensing elements monitor the tissue between the tissue contacting surfaces, including sensing depth, compression pressure, etc. (para. [0066]). Zand is therefore considered to meet the claim limitations, because Zand teaches how the sensing parameters change upon engagement with tissue, such that the controller is considered to be capable of determining whether an anastomosis has been formed upon receiving data including sensing depth and compression pressure.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-16, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US 2008/0221596 A1) in view of Zand (US 2009/0234248 A1) (all references previously of record).
Regarding claim 13, Thompson discloses (see abstract; paras. [0030]-[0062]; figs. 1-22) a system for forming an anastomosis (abstract), the system comprising:
a compression ring assembly (includes ring device 9 and latching mechanism, para. [0045]; figs. 14-17) including:
a tubular support member (includes 22 and 42, paras. [0031] and [0045]; fig. 4);
a first ring (formed by distal arms 14, para. [0030]; figs. 3-4) securely coupled to the tubular support member (figs. 3-4), the first ring configured to engage a first segment of an alimentary tract portion (tissue wall 4, para. [0030]; figs. 1-2); and
a second ring (formed by arms 13) with a distal side (arms distal of hinge at inner arm segment 17, para. [0030]; figs. 2 and 4) and a proximal side (arms proximal of hinge at outer arm segment 19, para. [0030]; figs. 2 and 4), the second ring slidably disposed on the tubular support member (movable along the shaft when slide controls 23 and 24 are activated, causing arms to hinge outwardly, para. [0032]; figs. 3-4) such that the distal side and the proximal side are each movable along the tubular support member and relative to the first ring (via slide control, considered to be movable along the shaft when arms move radially outward at hinge, further note paras. [0053]-[0054] describe catch means holding center ring 11 stationary, such that center ring 11 is considered to be movable when catch means is not deployed along the shaft, paras. [0031]-[0032] and [0053]-[0054]), the second ring configured to engage a second segment of the alimentary tract portion (figs. 1-2); and
a surgical device including:
an annular reload (proximal actuating member 32, para. [0035]) configured to support the second ring (para. [0035]);
an anvil assembly (distal actuating member 28, para. [0034]) configured to engage the tubular support member (via window slots, figs. 6-7), wherein at least one of the first ring and the second ring are configured to be approximated relative to each other to compress the first segment and the second segment to form an anastomosis (para. [0030]; figs. 1-2 and 4).
However, Thompson fails to disclose the surgical device being powered; a sensor configured to measure at least one property of the alimentary tract portion; and a controller configured to determine whether the anastomosis has been formed based on the at least one property.
Zand teaches (paras. [0065]-[0069]; fig. 1), in the same field of endeavor, a system for forming an anastomosis (abstract) comprising a powered surgical device (paras. [0055] and [0067]), a sensor (includes 113 and 115, para. [0065]) configured to measure at least one property of an alimentary tract portion (takes measurements of tissue, paras. [0065]-[0066]), and a controller (131) configured to determine whether the anastomosis has been formed based on the at least one property (receives signals to make assessment of procedure, paras. [0065] and [0069]), for the purpose of sensing mechanical or biological properties of the tissue to provide data to the user regarding tension on the tissue for indication of the likelihood of success of the procedure in current conditions (paras. [0065]-[0066] and [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Thompson to include a powered sensor and controller, in order to provide the capability of communicating mechanical or biological properties of the tissue to the user, which would indicate the likelihood of success of the procedure in current conditions, based on the suggestions and teachings of Zand (paras. [0065]-[0066] and [0080]).
Regarding claim 14, Thompson (as modified) teaches the system according to claim 13. Thompson further discloses wherein the tubular support member includes at least one protrusion (window slots 26 and 27 considered to form protrusions, para. [0033]) configured to engage the anvil assembly (figs. 3-4).
Regarding claim 15, Thompson (as modified) teaches the system according to claim 13. Thompson further discloses wherein the compression ring assembly further includes a lock ring (latching mechanism) disposed on the tubular support member (figs. 14-15), the lock ring movable along the tubular support member and relative to the second ring (includes longitudinally translatable push portions 43, para. [0045]), the lock ring configured to retain the second ring (latches ring device in actuated shape, para. [0045]).
Regarding claim 16, Thompson (as modified) teaches the system according to claim 15. Thompson further discloses wherein the tubular support member includes a barbed surface (48, para. [0046]) configured to permit movement of the lock ring in a direction toward the second ring (paras. [0045]-[0046]).
Regarding claim 18, Thompson (as modified) teaches the system according to claim 13. Thompson further discloses wherein the annular reload includes: a first driver (pull rod 31 including geometric coupling 36, considered to be a driver, fig. 9) longitudinally movable within the annular reload (para. [0036]; fig. 9) and configured to engage the second ring (considered to be capable of at least indirectly engaging arms 13 via catches 35, figs. 3-4 and 14).
Regarding claim 20, Thompson (as modified) teaches the system according to claim 15. Thompson further discloses wherein the annular reload includes: a second driver (pull rod 31 including geometric coupling 36, considered to be a driver, fig. 9) longitudinally movable within the annular reload (para. [0036]; fig. 9) and configured to engage the lock ring (considered to be capable of engaging push portions 43 via catches 35, see fig. 17).
Claim(s) 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson in view of Zand as applied to claim 13 above, and further in view of Arnold (US 2022/0008075 A1).
Regarding claim 17, Thompson (as modified) teaches the system according to claim 13.
Thompson further discloses a first transmission assembly (distal ring slide control 23) coupled to the anvil assembly (para. [0034]).
However, Thompson (as modified) fails to teach wherein the powered surgical device further includes: a first motor; and the first transmission assembly coupled to the first motor and the anvil assembly, the first motor configured to move the anvil assembly.
Arnold teaches (para. [0063]), in the same field of endeavor, a system for forming an anastomosis (abstract, para. [0029]) comprising an actuator including a motor in place of a rotatable knob (para. [0063]).
The substitution of one known element (actuator being a motor) for another (actuator being a rotatable knob, para. [0063] of Arnold, para. [0031] of Thompson) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the motor as taught by Arnold, would have yielded predictable results, specifically, providing automatic actuation of the anvil assembly when desired.
Thompson (as modified) further teaches wherein the powered surgical device further includes: a first motor (combination considered to further teach motor in place of knob 37 of Thompson); and the first transmission assembly coupled to the first motor and the anvil assembly, the first motor configured to move the anvil assembly (combination considered to further teach slide control 23 coupled similarly to motor as knob 37, para. [0037] of Thompson).
Regarding claim 19, Thompson (as modified) teaches the system according to claim 18.
Thompson further discloses a second transmission assembly (proximal ring slide control 24, para. [0035]) coupled to the first driver (via geometric coupling 36 such that proximal and distal actuating members are locked to each other in rotation, para. [0036]) configured to move the second ring (when actuating members are locked in rotation).
However, Thompson (as modified) fails to teach wherein the powered surgical device further includes: a second motor; and the second transmission assembly coupled to the second motor and the first driver, the second motor configured to move the second ring.
Arnold teaches (para. [0063]), in the same field of endeavor, a system for forming an anastomosis (abstract, para. [0029]) comprising an actuator including a motor in place of a rotatable knob (para. [0063]).
The substitution of one known element (actuator being a motor) for another (actuator being a rotatable knob, para. [0063] of Arnold, para. [0031] of Thompson) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the motor as taught by Arnold, would have yielded predictable results, specifically, providing automatic actuation of the second ring when desired.
Thompson (as modified) further teaches wherein the powered surgical device further includes: a second motor (combination considered to further teach motor in place of knob 37 of Thompson); and the second transmission assembly coupled to the second motor and the first driver, the second motor configured to move the second ring (combination considered to further teach slide control 24 coupled similarly to motor as knob 37, para. [0037] of Thompson).
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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