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 .
Election/Restrictions/Response to Amendment
Applicant’s election without traverse of Group I (Claims 1-13 and 20) and Species A (Figures 1-3, 10-12, 18-20) in the reply filed on 7/24/2025 is acknowledged.
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Note Claims 8-10 are also drawn to a different Species as Species A does not readily comprise a sensing member configured to detect a distance between jaws, a load on the jaws, or a rotation angle. For examination purposes, Claims 8-10 will also be treated as withdrawn.
Applicant’s amendment filed 7/24/2025 has been entered.
Claims 1-13 and 20 remain pending.
Claims 14-19 have been cancelled.
Claims 1-3, 5-7, 11-13 and 20 are pending, drawn to the elected invention, and examined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/17/2025 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1, 5-7, and 13 are objected to because of the following informalities:
-Claim 1, line 1, “a jaw” would be better recited as “jaw assembly” as later claims recite multiple jaws (i.e. see Claim 6).
-Claim 5, “an overlapped position when” would be better recited as “an overlapped position with the working member when”
-Claim 6, 7, and 13, “the jaw” would be better recited as “the jaw assembly”.
Appropriate correction is required.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, 11-13 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 24, 25, and 35 of copending Application No. 18/765,537.
Regarding Claim 1 of the instant application, Claim 1 of Application 18/765,537 discloses an end tool (“end tool”) of a surgical instrument, the end tool comprising a jaw and a sensing member (“detection member”), wherein the jaw is configured to accommodate at least one area of a working member (“one region of an operation member”) that is movable in one direction, and the sensing member (“operation member”) is configured to sense information about a position (“position information”) of the working member (“operation member”). Therefore Claim 1 of Application 18/765,537 renders Claim 1 of the instant application patentably indistinct.
Regarding Claim 2 of the instant application, Claim 1 of Application 18/765,537 renders the claim patentably indistinct as although Claim 1 of Application 18/765,537 does not disclose the detection member/the sensing member is configured to sense a distance to the working member, such a feature is not viewed as a patentably distinguishable feature as “position information” can be readily implied as comprising a distance measurement from a reference point. Note contact sensors measure a zero distance when contacted.
Regarding Claim 3 of the instant application, Claim 1 of Application 18/765,537 renders the claim patentably indistinct as although Claim 1 of Application 18/765,537 does not disclose the sensing member is disposed closer to a proximal portion of the end tool than the working member, such a feature is not patentably distinguishable as it would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have arranged the sensing/detection member as claimed, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations.
Regarding Claim 5 of the instant application, Claim 1 of Application 18/765,537 renders the claim patentably indistinct as although Claim 1 of Application 18/765,537 does not disclose the sensing member is disposed in an overlapped position when the working member moves and is configured to sense the position of the working member, such a feature is not patentably distinguishable as it would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have arranged the sensing/detection member as claimed, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations.
Regarding Claims 6 and 7 of the instant application, Claim 1 of Application 18/765,537 renders the claim patentably indistinct as although Claim 1 of Application 18/765,537 does not disclose the jaw comprises a first jaw and a second jaw facing each other and configured to rotate around one shaft to move closer to or farther away from each other, such a features are well known in the art of surgical instruments such as staplers in order to readily clamp tissue.
Alternatively, regarding Claims 6 and 7 of the instant application, Claim 24 of Application 18/765,537 renders the claim patentably indistinct.
Regarding Claims 11-13 of the instant application, Claim 25 of Application 18/765,537 renders the claim patentably indistinct.
Regarding Claim 20 of the instant application, Claim 35 of Application 18/765,537 renders the claim patentably indistinct.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-7, 11-13 and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Swayze (US PGPUB 2017/0209145).
Regarding Claim 1, Swayze discloses an end tool (4050; Figure 72) of a surgical instrument (10; Figure 1), the end tool (4050) comprising a jaw (4052, 4054) and a sensing member (4060), wherein the jaw (4054) is configured to accommodate at least one area of a working member (knife 4062) that is movable in one direction (along 4068; Para. 0364, 0365), and the sensing member (4060) is configured to sense information about a position of the working member (4062 via 4064; Para. 0364 discloses the sensor 4060 communicates (a signal corresponding to a position) to the processor 2006 (Figure 21a) which determines the position of the knife).
Regarding Claim 2, Swayze discloses the sensing member (4060) is further configured to sense a distance to the working member (4062; Para. 0364 discloses sensing a position of the knife and therefore a distance of the working member must be determined from a reference point to the “position”).
Regarding Claim 3, Swayze discloses the sensing member (4060) is disposed closer to a proximal portion of the end tool (4050) than the working member (4062; Para. 0364 discloses “an optical sensor 4060 located near the proximal end of the slot 4058”; as shown in Figure 72).
Regarding Claim 5, Swayze discloses the sensing member (4060) is disposed in an overlapped position (overlapped with knife bar 4064) when the working member (4062) moves and is configured to sense the position of the working member (4062; Para. 0364as shown in Figure 72).
Regarding Claim 6, Swayze discloses the jaw (4052, 4054) comprises a first jaw (4052) and a second jaw (4054) facing each other and disposed to move closer to or farther away from each other (Para. 0364 recites “The end effector 4050 comprises a first jaw member or anvil 4052 pivotally coupled to a second jaw member or elongated channel 4054”).
Regarding Claim 7, Swayze discloses the first jaw (4052) and the second jaw (4054) of the jaw are configured to rotate around one shaft (about a pivot pin 152; Figure 20) so as to be closer to or farther away from each other (Para. 0224; note the embodiment of Figure 72 can be readily assumed to comprise a similar pivot setup).
Regarding Claim 11, Swayze discloses the jaw (4052, 4054) is further configured so that a staple (see 191 of Figure 20) is disposed thereon (via cartridge 4056), and the staple moves through movement of the working member (4062) to perform stapling (see Para. 0224 as it can be reasonably assumed that the staples of the cartridge 4056 of Figure 72 are fired in the same manner with a wedge such as wedge 190 in Figure 20).
Regarding Claim 12, Swayze discloses a wedge portion (190 of Figure 20) of the working member (4062; note it can be readily assumed that a wedge is incorporated in the embodiment of Figure 72 in order to fire the staples) pushes up the staple (191) through the movement of the working member (4062), and the stapling is performed while a blade (of knife 4062) of the working member (4062) performs a cutting operation (Para. 0364; as outlined above, it can be readily assumed that the staples of cartridge 4056 are fired as the knife 4062 moves through firing).
Regarding Claim 13, Swayze discloses the jaw is further configured to accommodate a cartridge (4056), and the staple is provided in plurality in the cartridge (4056; Para. 0364).
Regarding Claim 20, Swayze discloses the end tool (4050) of claim 1 (see rejection of Claim 1 above); a manipulation portion (handle 14) configured to control an operation of the end tool (4050); and a connection portion (shaft assembly 200) connecting the manipulation portion (14) to the end tool (4050; note that end effector 4050 is an embodiment of end effector 300 and therefore can be assumed as being manipulated in the same manner; Para. 0183).
Claims 1-3, 5-7, 11-13, and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Leimbach (US PGPUB 2022/0218344).
Regarding Claim 1, Leimbach discloses an end tool (3200; Figure 65) of a surgical instrument (10; Figure 1), the end tool (3200) comprising a jaw (3202) and a sensing member (sensors 3210, 3212), wherein the jaw (3202) is configured to accommodate at least one area of a working member (3122; Figure 64) that is movable in one direction (distally), and the sensing member (3210, 3212) is configured to sense information about a position of the working member (3122; Para. 0370- “the sensors 3210, 3212 can detect the position of the sled 3122 as the sled 3122 moves during a firing stroke”).
Regarding Claim 2, Leimbach discloses the sensing member (3210, 3212) is further configured to sense a distance to the working member (3122; note Para. 0370 outlines the sensors being Hall Effect sensors and therefore the sensors will readily sense a distance based on the magnetic field detected; note alternative 103 rejection below).
Regarding Claim 3, Leimbach discloses the sensing member (3210, 3212) is disposed closer to a proximal portion of the end tool (3200) than the working member (3122; note sensor 3212 will be closer to a proximal end during the firing stroke).
Regarding Claim 5, Leimbach discloses the sensing member (3210, 3212) is disposed in an overlapped position (see Figure 65) when the working member (3122) moves and is configured to sense the position of the working member (3122; Para. 0370).
Regarding Claim 6, Leimbach discloses the jaw comprises a first jaw (3202) and a second jaw (anvil clearly shown in Figures 64-65) facing each other and disposed to move closer to or farther away from each other (as can be readily assumed to function as disclosed; see Para. 0214 with reference to jaws 302, 306 of Figure 1).
Regarding Claim 7, Leimbach discloses the first jaw (3202) and the second jaw (anvil as shown) of the jaw are configured to rotate around one shaft so as to be closer to or farther away from each other (note the pivotal connection outlined in Para. 0214 readily assumes a pivot shaft/pin about which the jaws move around).
Regarding Claim 11, Leimbach discloses the jaw (3202) is further configured so that a staple (of “fastener cartridge 3120”) is disposed thereon, and the staple moves through movement of the working member (3122) to perform stapling (during “firing stroke”; Para. 0370; see Para. 0219 which outlines firing the staple cartridge when knife bar 280 is advanced).
Regarding Claim 12, Leimbach discloses a wedge portion (3122; Figure 64) of the working member (3122) pushes up the staple through the movement of the working member (3122), and the stapling is performed while a blade (of knife pushing the sled 3122) of the working member performs a cutting operation (note the knife and sled can be viewed as the working member as claimed as the knife bar will readily engage and move together with the sled 3122 as shown and known in the art) .
Regarding Claim 13, Leimbach discloses the jaw (3202) is further configured to accommodate a cartridge (“fastener cartridge 3120”), and the staple is provided in plurality in the cartridge (3120; Para. 0370).
Regarding Claim 20, Leimbach discloses a surgical instrument (10; Figure 1) comprising: the end tool (3200) of claim 1 (as outlined above); a manipulation portion (handle 14) configured to control an operation of the end tool (3200); and a connection portion (200) connecting the manipulation portion (14) to the end tool (3200; note that end effector 4200 is an embodiment of end effector 300 and therefore can be assumed as being manipulated in the same manner; Para. 0203).
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.
Alternatively, Claims 11-13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Swayze (US PGPUB 2017/0209145).
Alternatively, regarding Claims 11-13, assuming arguendo that the embodiment of end tool (4050) of Figure 72 does not comprise staples, cartridge, and a wedge cooperating with a blade/cutting member that fires the staples when the working member (knife 4062) is moved and the blade (4062) performs a cutting in the manner as outlined by the embodiment of end tool of Figure 20, in which the Examiner does not concede to, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized a sled/wedge (190; Figure 20) to fire staples (191) from a cartridge (194) as taught by the embodiment of end tool (300; Figure 1, 20) of Figure 20 (Para. 0224).
Firing of staples in a surgical stapler by use of a wedge that is engaged with a knife member/working member is well known in the art of surgical staplers. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized cartridge structure including a wedge and its interaction with the knife member as taught by the embodiment of Figure 20 of Swayze in the embodiment of end tool of Figure 72 of Swayze. By utilizing such known structures of an end tool/end effector, the staples of the cartridge of Swayze can be effectively fired while the tissue is transected and further staples across multiple rows can be fired simultaneously.
Alternatively, regarding Claim 20, assuming arguendo that the end tool (4050; Figure 72) of Figure 72 of Swayze (see rejection of Claim 1 above) cannot be assumed to be used with the instrument (10) of Figure 1, in which the Examiner does not concede to, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have utilized the end tool (4050) of Figure 72 with the instrument (10) of Figure 1 which comprises a manipulation portion (handle 14) and a connection portion as claimed. Such handles/manipulation portion and shaft assemblies/connection portion are well known in the art of surgical staplers to allow the clinician/operator to control the end tool from a distance and manipulate such a tool in multiple manners/dimensions.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Leimbach (US PGPUB 2022/0218344).
Regarding Claim 2, Leimbach assuming arguendo that the sensing member (3210, 3212) of Leimbach is not configured to sense a distance to the working member (3122), in which the Examiner does not concede to, attention can be brought to the embodiment a further embodiment of sensor system of Figure 74 which includes a sensor (11266) that is configured as a linear hall sensor which is configured to monitor the position of the cutting member within an end effector (2006) of an instrument (2000; Figure 32) which is used to calculate speed of the cutting member and therefore the position feedback must be measured in distance measurements (see Para. 0453).
It would have been obvious to one of ordinary skill in the art to have utilized the sensing member of Leimbach to sense a distance to the working member as taught by the embodiment of Figure 74 of Leimbach in order to allow for calculation of other parameters such as speed as outlined by Leimbach (see Para. 0453).
Regarding Claim 3, Leimbach, as modified, discloses the sensing member (3210, 3212) is disposed closer to a proximal portion of the end tool (3200) than the working member (3122; note sensor 3212 will be closer to a proximal end during the firing stroke). Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have arranged the sensing/detection member of Leimbach in the manner as claimed, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Please note that in the instant application, applicant has not disclosed any criticality for the claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. see “Notice of References Cited”.
-Note specifically Shelton (US PGPUB 2022/0167971) discloses an end tool comprising a sled detection circuit (2073, 2160) which readily reads on the several features of the Claims but is not readily relied upon.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA G KOTIS whose telephone number is (571)270-0165. The examiner can normally be reached Monday - Thursday 6am-430pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA G KOTIS/Examiner, Art Unit 3731 1/28/2026