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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. - US 11596400 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because they are substantially co-extensive in scope, at least in regard to the novel subject matter, and differ merely in equivalent terminology used as to function. Both claim a surgical tool having an elongate shaft/rod with a wrist at end having an effector having a - releasable connection (current claim 1 & patented claims 1 and 12) where in the effector includes a data storage device (current claim 1 & patented claims 1 and 12) and detect presence of attachment (current claims 1, 9, 16 & patented claims 1-2, 10-13, 16, 20-21), maximum/minimum cutting strokes (current claims 7-19 & patented claims 5, 9, 16 and 20) and a controller (current claims 1 and 16 & patented claims 1, 6, 11-12, 17 and 22). Generally, all of the dependent claims of the patent set forth the equivalent subject matter of the dependent claims of the current application. Therefore, it would have been obvious to one skilled in the art to substitute the terminology recited in the current claims with the equivalent components of the patented claims, since to do so provides nothing new or unexpected.
See claim match below-
19213082 (claims)
US 11596400 B2 (claims)
1, 9, 16
1-2, 10-13, 16, 20-21
3-4
2, 10, 13, and 21
7-19
5, 9, 16 and 20
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 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) 1-20 is/are rejected under 35 U.S.C. 103 as obvious over Contini et al. (US 20160310134 A1) in view of Huanget al. (US 20100264194 A1) and further in view of Stauch et al. (US 20050065530 A1).
Regarding claim 1, Contini et al. discloses an annular surgical stapling system (100/900A [0279] figs. 1 and 69) comprising: a controller housing (101- motor controller circuit board 142); an adapter assembly (200) coupled to and extending from the controller housing; a removable reload (900A) couplable to a distal portion of the adapter assembly, the reload comprising: an annular array of staples; an annular staple pusher for ejecting the staples; an annular knife [0446-0456]; and
a data storage device (internal memory chip and/or Circuit board 294 of adapter 200, circuit board 142) storing data about the reload; and a controller (Circuit board 294 of adapter 200, circuit board 142) programmed to cause operations to be performed by annular surgical stapling system ([0192, 0361-0365, 0388-0398, 0428-0434, 0446], figs. 71 and 82),
the operations comprising: while the removable reload is connected to the distal portion of the adapter assembly, reading the data stored on the data storage device within the reload (900A [0068, 0079, 0142, 0162, 0173, 0388-0398, 0428-0434, 0446]; and setting a cut stroke for the annular knife based on the data read from the data storage device (cutting sequence, cutting calibration [0317, 0444-0456, 0461]) and teaches having operation data stored [0192-0196, 0361-0365, 0388-0398, 0428-0430, 0446, 0479] figs. 1-69).
Contini et al. fails to disclose setting a maximum cut stroke for the annular knife based on the data read from the data storage device.
Huanget al. teaches a surgical instrument (1400) with a knife (1392) and setting a maximum cut stroke for a knife (1392) based on the data read from a data storage device (computer/encoder system - “advance the cutting member 1392 a predetermined, or set, distance” [0273-0288]).
Stauch et al. also teaches a surgical instrument (internal saw R3) with a annular knife (base body 1 is round with knife 5 at distal end and knife 5 goes all the around and is curved at front end with teeth are arranged in a “arc shape” [0021], figs. 1-6) that can be moved axially manually and/or automatically and setting a maximum cut stroke for the knife (5) based on the data read from a data storage device (actuator 15/control means 16 in conjunction with force sensor 17 [0037-0042]).
Given the teachings of Contini et al. to have a removable reload with a data storage device that provides a cutting sequence and cutting calibration, it 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 to modify the data storage device with setting a maximum cut stroke for the annular knife based on the data read from the data storage device to have precise adjustment of speed/torque of the knife for more precise operation of the tool and more precise action on a surgical member (avoid overshoot/damage), have the knife cut to the correct/desired distance enhance device performance and/or for feedback purposes as taught by Huanget al. and Stauch et al.
Regarding claims 9 and 12-13, Contini et al. discloses a method performed by an annular surgical stapling system (100/900A [0279] figs. 1 and 69) comprising a first removable reload and a second removable reload (900 A/B/C or plurality of each fig. 69), the method comprising: detecting attachment of the first removable reload to an adapter assembly of the annular surgical stapling system reading data stored on a first data storage device of the first removable reload; and detecting attachment of the second removable reload to an adapter assembly of the annular surgical stapling system; reading data stored on a second data storage device of the second removable reload (900A/B/C [0068, 0079, 0142, 0162, 0173, 0388-0398, 0428-0434, 0446]) via a data storage device (internal memory chip and/or Circuit board 294 of adapter 200, circuit board 142) storing data about the reload; and a controller (Circuit board 294 of adapter 200, circuit board 142) programmed to cause operations to be performed by annular surgical stapling system ([0192, 0361-0365, 0388-0398, 0428-0434, 0446], figs. 71 and 82) and teaches cutting sequence, cutting calibration [0317, 0444-0456, 0461]) and teaches having operation data stored [0192-0196, 0361-0365, 0388-0398, 0428-0430, 0446, 0479] figs. 1-69).
Contini et al. fails to disclose setting at least one of a minimum or a maximum cut stroke for a first annular knife based on the data read from the first data storage device of the first removable reload and setting at least one of a minimum or a maximum cut stroke for a second annular knife of the second removable reload based on the data read from the second data storage device of the second removable reload.
Huanget al. teaches a surgical instrument (1400) with a knife (1392) and setting a maximum cut stroke for a knife (1392) based on the data read from a data storage device (computer/encoder system - “advance the cutting member 1392 a predetermined, or set, distance” [0273-0288]).
Stauch et al. also teaches a surgical instrument (internal saw R3) with a annular knife (base body 1 is round with knife 5 at distal end and knife 5 goes all the around and is curved at front end with teeth are arranged in a “arc shape” [0021], figs. 1-6) that can be moved axially manually and/or automatically and setting a maximum cut stroke for the knife (5) based on the data read from a data storage device (actuator 15/control means 16 in conjunction with force sensor 17 [0037-0042]).
Given the teachings of Contini et al. to have a removable reload with a data storage device that provides a cutting sequence and cutting calibration, it 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 to modify the data storage device with setting at least one of a minimum or a maximum cut stroke for a first annular knife based on the data read from the first data storage device of the first removable reload and setting at least one of a minimum or a maximum cut stroke for a second annular knife of the second removable reload based on the data read from the second data storage device of the second removable reload to have precise adjustment of speed/torque of the knife for more precise operation of each tool and more precise action on a surgical member (avoid overshoot/damage), have the knife cut to the correct/desired distance enhance device performance and/or for feedback purposes as taught by Huanget al. and Stauch et al.
Regarding claims 1, 5, 7, 9, 12-13, and 16, Contini et al. discloses an annular surgical stapling system (100/900A [0279] figs. 1 and 69) comprising: a controller housing (101- motor controller circuit board 142); an adapter assembly (200) coupled to and extending from the controller housing; a first removable reload (900A) couplable to a distal portion of the adapter assembly, the first removable reload comprising: a first annular array of staples; a first annular staple pusher for ejecting the first annular array of staples; a first annular knife; and a first data storage device (internal memory chip and/or Circuit board 294 of adapter 200, circuit board 142) storing first data about the first removable reload; a second removable reload (900 B/C/D) couplable to a distal portion of the adapter assembly, the second removable reload comprising: a second annular array of staples; a second annular staple pusher for ejecting the second annular array of staples; a second annular knife (plurality of 900A or 900 B/C/D are “annular”); and a second data storage device (internal memory chip and/or Circuit board 294 of adapter 200, circuit board 142) storing second data about the second removable reload;
a controller (Circuit board 294 of adapter 200, circuit board 142) programmed to cause operations to be performed by the annular surgical stapling system, the operations comprising:while the first removable reload is connected to the distal portion of the adapter assembly, reading the first data stored on the first data storage device and while the second removable reload is connected to the distal portion of the adapter assembly, reading the second data stored on the second data storage device (teaches cutting sequence, cutting calibration [0317, 0444-0456, 0461]) and teaches having operation data stored [0192-0196, 0361-0365, 0388-0398, 0428-0430, 0446, 0479] figs. 1-69).
Contini et al. fails to disclose setting at least one of a maximum cut stroke or a minimum cut stroke for the first annular knife based on the first data read from the first data storage device and setting at least one of a maximum cut stroke or a minimum cut stroke for the second annular knife based on the second data read from the second data storage device.
Huanget al. teaches a surgical instrument (1400) with a knife (1392) and setting a maximum cut stroke for a knife (1392) based on the data read from a data storage device (computer/encoder system - “advance the cutting member 1392 a predetermined, or set, distance” [0273-0288]).
Stauch et al. also teaches a surgical instrument (internal saw R3) with a annular knife (base body 1 is round with knife 5 at distal end and knife 5 goes all the around and is curved at front end with teeth are arranged in a “arc shape” [0021], figs. 1-6) that can be moved axially manually and/or automatically and setting a maximum cut stroke for the knife (5) based on the data read from a data storage device (actuator 15/control means 16 in conjunction with force sensor 17 [0037-0042]).
Given the teachings of Contini et al. to have a removable reload with a data storage device that provides a cutting sequence and cutting calibration, it 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 to modify the data storage device with setting at least one of a maximum cut stroke or a minimum cut stroke for the first annular knife based on the first data read from the first data storage device and setting at least one of a maximum cut stroke or a minimum cut stroke for the second annular knife based on the second data read from the second data storage device to have precise adjustment of speed/torque of the knife for more precise operation of each tool and more precise action on a surgical member (avoid overshoot/damage), have the knife cut to the correct/desired distance, enhance device performance and/or for feedback purposes as taught by Huanget al. and Stauch et al.
Regarding claims 3, 11, and 17, Contini et al. discloses the data stored on the data storage device includes at least one of staple size, knife diameter, lumen size, minimum cut stroke length, or maximum cut stroke length for the reload [0379].
Regarding claims 2, 4, 6, 8, 10, 14-15, and 18-20, Contini et al. teaches having a plurality of reloads with different operation parameters stored on each and each with a data storage device that provides a cutting sequence and cutting calibration (fig. 69) but fails to explicitly disclose the operations further comprise monitoring an axial position of the annular knife of the reload relative to a housing of the reload, wherein the operations further comprise setting a minimum cut stroke for the annular knife based on the data read from the data storage device, wherein the maximum cut stroke for the annular knife of the first removable reload is different than the maximum cut stroke for the annular knife of the second removable reload, wherein the minimum cut stroke for the annular knife of the first removable reload is different than the minimum cut stroke for the annular knife of the second removable reload, wherein the maximum cut stroke is set for the first annular knife and the second annular knife, wherein the minimum cut stroke is set for the first annular knife and the second annular knife, wherein the maximum cut stroke length for the first annular knife is different than the maximum cut stroke length for the second annular knife.
Huanget al. teaches a surgical instrument (1400) with a knife (1392) and setting a maximum cut stroke for a knife (1392) based on the data read from a data storage device (computer/encoder system - “advance the cutting member 1392 a predetermined, or set, distance” [0273-0288]).
Stauch et al. also teaches a surgical instrument (internal saw R3) with a annular knife (base body 1 is round with knife 5 at distal end and knife 5 goes all the around and is curved at front end with teeth are arranged in a “arc shape” [0021], figs. 1-6) that can be moved axially manually and/or automatically and setting a maximum cut stroke for the knife (5) based on the data read from a data storage device (actuator 15/control means 16 in conjunction with force sensor 17 [0037-0042]).
Given the teachings of Contini et al. to have plurality of reloads with different operation parameters stored on each and each with a data storage device that provides a cutting sequence and cutting calibration, it 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 to modify the data storage device with the operations further comprise monitoring an axial position of the annular knife of the reload relative to a housing of the reload, wherein the operations further comprise setting a minimum cut stroke for the annular knife based on the data read from the data storage device, wherein the maximum cut stroke for the annular knife of the first removable reload is different than the maximum cut stroke for the annular knife of the second removable reload, wherein the minimum cut stroke for the annular knife of the first removable reload is different than the minimum cut stroke for the annular knife of the second removable reload, wherein the maximum cut stroke is set for the first annular knife and the second annular knife, wherein the minimum cut stroke is set for the first annular knife and the second annular knife, wherein the maximum cut stroke length for the first annular knife is different than the maximum cut stroke length for the second annular knife to have precise adjustment of speed/torque of the knife for more precise operation of each tool and more precise action on a surgical member (avoid overshoot/damage), have the knife cut to the correct/desired distance, enhance device performance and/or for feedback purposes as taught by Huanget al. and Stauch et al.
Conclusion
Additional prior art considered pertinent: see form 892.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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