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 previous reply filed on 7/24/2025 is acknowledged.
Claims 4 and 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Applicant’s amendment filed 5/5/2026 has been entered.
Claims 1-4, 6-13, and 20 remain pending.
Claims 5, 14-19 have been cancelled.
Claims 1-3, 6, 7, 11-13, and 20 are pending, drawn to the elected invention, and examined below.
Examiner notes that the claim limitation of the “sensing member is disposed in an overlapped position with the working member” appears to have support in the elected embodiment in Figure 10 although the specification refers to such overlap with respect to a non-elected species.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/28/2026 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 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, 2, 6, 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 assembly (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, knife bar 4064) 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, 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), wherein the sensing member (4060) is disposed in an overlapped position (overlapped with knife bar 4064) with the working member (4062, 4064) when the working member (4062, 4064) moves and is configured to sense the position of the working member (4062, 4064; Para. 0364 as shown in Figure 72).
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 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, 6, 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”),
wherein the sensing member (3210, 3212) is disposed in an overlapped position (see Figure 65) with the working member (3122) when the working member (3122) moves and is configured to sense the position of the working member (3122; Para. 0370).
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 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.
Response to Arguments
Applicant's arguments filed 5/5/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments on Pages 6-8 that:
PNG
media_image1.png
125
630
media_image1.png
Greyscale
…
PNG
media_image2.png
202
631
media_image2.png
Greyscale
…
PNG
media_image3.png
246
631
media_image3.png
Greyscale
PNG
media_image4.png
358
633
media_image4.png
Greyscale
Examiner respectfully asserts that the knife (4062) as well as the knife bar (4064) of Swayze can, in combination, be viewed as the claimed “working member”. Further as depicted in Figure 72, the knife bar clearly overlaps the optical sensor (4060) as the bar is positioned vertically above the sensor and it is lastly noted that two structures do not need to be in contact with one another in order to be viewed as “overlapping”. Therefore, it can be readily concluded that the sensing member (4060) of Swayze is disposed in an overlapped position with the working member (4062, 4064) when the working member (4062, 4064) moves and is configured to sense the position of the working member as outlined above.
In response to Applicant’s arguments on Pages 8-9 that:
PNG
media_image5.png
169
635
media_image5.png
Greyscale
…
PNG
media_image6.png
317
639
media_image6.png
Greyscale
…
PNG
media_image7.png
461
631
media_image7.png
Greyscale
Examiner respectfully asserts merely because the sensors of Leimbach remotely sense the working member and does not physically contact the working member, does not preclude one from interpreting the sensors/sensing members (3210, 3212) as overlapping with the working member. In this instance the working member vertically overlaps the sensing members.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Note Shelton (US PGPUB 2019/0000446-previously cited) discloses “the absolute positioning system 11100 can, in effect, track the displacement of the cutting instrument I-beam 3005, 2514 (FIGS. 12, 29-30) by tracking the displacement of a longitudinally movable drive member. In various other aspects, the displacement member 11111 may be coupled to any sensor suitable for measuring displacement…. Displacement sensors may include contact or non-contact displacement sensors. Displacement sensors may comprise linear variable differential transformers (LVDT), differential variable reluctance transducers (DVRT), a slide potentiometer, a magnetic sensing system comprising a movable magnet and a series of linearly arranged Hall effect sensors, a magnetic sensing system comprising a fixed magnet and a series of movable linearly arranged Hall effect sensors, an optical sensing system comprising a movable light source and a series of linearly arranged photo diodes or photo detectors, or an optical sensing system comprising a fixed light source and a series of movable linearly arranged photo diodes or photo detectors, or any combination thereof.” (Para. 0146).
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 JOSHUA G KOTIS whose telephone number is (571)270-0165. The examiner can normally be reached Monday - Thursday 6am-430pm.
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, 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.
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.
/JOSHUA G KOTIS/Examiner, Art Unit 3731 6/30/2026
Prosecution Insights