DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Species a (figs. 58-74) in the reply filed on 11 August 2026 is acknowledged.
The subject matter of claims 25 and 35 recite, “wherein the end effector is rotatable relative to the elongate shaft about a first articulation axis oriented transverse to the shaft axis and is rotatable about a second articulation axis oriented transverse to the first articulation axis and to the shaft axis” (emphasis added). These limitations are not found in elected Species a (figs. 58-74), but are instead recited in unelected species f (figs. 164-169). As such, claims 25 and 35, along with claims 26-27 and 36-38 which respectively depend from claims 25 and 35, are deemed withdrawn as being directed toward non-elected subject matter.
Regarding claim 28, the subject matter recites, “further comprising a beam comprising a pair of laterally extending flanges positioned to slidably engage the staple forming anvil jaw”. This feature is not recited in elected Species a (figs. 58-74). The language of the “a beam comprising a pair of laterally extending flanges positioned to slidably engage the staple forming anvil jaw” is best understood to be referring to non-elected Species d with drive beam 3682 (see Applicant’s PG Publication para 0387) or non-elected Species e with drive beam 3860 (see Applicant’s PG Publication para 0393). As such claim 28 (and claims 29-30 which depend from claim 28) are deemed withdrawn.
Regarding claim 39, the subject matter recites, “wherein the distal beam head further comprises a knife”. It is noted that the subject matter of parent claim 33 was recited as “a longitudinally translatable driver comprising a distal beam head, wherein the longitudinally translatable driver is translatable based on an actuation of the first driver to move the end effector into the clamped state”. However, in elected embodiment Species a (figs. 58-74) the longitudinally translatable driver that actuates the end effector into the clamped state is the distal closure tube 12042 that engages anvil 12024 (see Applicant’s PG Publication para 0313). This means that the distal head beam as best understood in this context is the closure tube 12042. This element does not comprise a knife as claimed in claim 39. The language of the “distal beam head further comprising a knife” is best understood to be referring to non-elected Species d with drive beam 3682 (see Applicant’s PG Publication para 0387) or non-elected Species e with drive beam 3860 (see Applicant’s PG Publication para 0393). As such, claim 39 is deemed withdrawn.
In summary, claims 25-37 and 35-39 are withdrawn as being directed toward non-elected subject matter.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 23 October 2025 was considered by the examiner. However, there were numerous NPL documents submitted that were not provided a date and have been labeled “IPR2018-00938-Part X of 53” in the IDS, but they are annotated as such in their submissions so there is no way to know which NPL document corresponds to which part. As such these documents have not been considered. However, it is noted that the case file of IPR2018-00938 has been considered and is annotated as such in the search notes.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 40 recites the limitation "the elongate channel" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 21-24, 31-34 and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dach, II et al. (US 2011/0118754 A1) hereinafter referred to as Dach in view of Whitman et al. (US 2009/0095790 A1) hereinafter referred to as Whitman.
Regarding claim 21, Dach discloses a robotic surgical tool (70, 132 and/or 260; figs. 6, 9 and/or 20), comprising:
a plurality of rotatable drivers (#96, 100, 86 with associated elements detailed in paragraph 0078; and #102, 106, 88 with associated elements detailed in paragraph 0081; and 108, 112; and 90, 94) comprising a first driver (86 or 88);
a mounting plate (76; 134) rotatably supporting the plurality of rotatable drivers in a mounting plane;
an elongate shaft (74; 264) extending along a shaft axis (figs. 6, 8, 9 and 20), wherein the elongate shaft is rotatable (paragraph 0065, 0095) about the shaft axis;
an end effector (72; 140; 266) extending from the elongate shaft, wherein the end effector is configurable between an open state and a clamped state (paragraphs 0064, 0095, 0098), and wherein the end effector comprises:
stapling jaws (figs. 9 and 20; paragraphs 0064, 0095 and 0098);
an articulation joint (84; paragraph 0065 – “wrist mechanism”; 268, fig. 20, paragraph 0095), wherein the end effector is rotatable relative to the elongate shaft at the articulation joint; and
a clamping drive (78 or 80; paragraph 0064 – “The first actuation mechanism 78 and the second actuation mechanism 80 are shaft driven and can be used to actuate and/or articulate a variety of end effector features and/or devices, for example, a clamping feature, a movable cutting feature, a cutting and stapling device, or another suitable end effector feature and/or device that can be actuated and/or articulated with a shaft driven mechanism”; paragraphs 0066, 0095, 0098) comprising a translatable driver (78 or 80), wherein the translatable driver is translatable to move the end effector into the clamped state based on actuation of the first driver (paragraphs 0064, 0066, 0095, 0098).
Dach discloses an end effector comprises stapling jaws and a clamping drive with a translatable driver, but fails to disclose wherein the end effector comprises a staple forming anvil jaw and an elongate channel dimensioned to receive a staple cartridge; and a clamping drive comprising a longitudinally translatable driver.
However, Whitman teaches an end effector (11a) extending from the elongate shaft (11b), wherein the end effector is configurable between an open state and a clamped state (figs. 3i-3l), and wherein the end effector comprises: a staple forming anvil jaw (50, 700; paragraph 0062); and an elongate channel (80) dimensioned to receive a staple cartridge (600; paragraphs 0063, 0082, 0097 – “When the staple cartridge 600 is inserted into the second jaw 80…”, 0101); an articulation joint (paragraph 0060 – “pivot axis B”; figs. 3a-3c), wherein the end effector is rotatable relative to the elongate shaft at the articulation joint; a clamping drive (522, 524, 5011) comprising a longitudinally translatable driver (522, 524; figs. 3i-3l), wherein the longitudinally translatable driver is translatable to move the end effector into the clamped state based on actuation of the first driver (514, 520; paragraphs 0076, 0092, 0094, 0096, 0111-0114).
Given the teachings of Whitman, it would have been obvious to one of ordinary skill in the art before the time of the invention to modify the invention of Dach with the teachings of Whitman. Dach already discloses stapling jaws. Whitman further teaches the old and well-known stapling jaws that incorporate a staple forming anvil jaw and a channel dimensioned to receive a staple cartridge. Having anvil features allows for the staples to be deformed into a particular desired shape and pattern. Having a channel and cartridge allows for the end effector to be repeatedly used after loading of a new cartridge thus reducing waste and setup time. Dach already discloses a clamping drive comprising a translatable driver which clamps based on actuation of a rotatable first driver (para 0064). Whitman teaches a clamping drive that makes use of a longitudinally translatable driver which is actuated based on a rotatable first driver. It would have been obvious to make use of this clamping device because Dach already suggests making use of shaft driven mechanisms is desiring for a clamping motion. Doing so would allow the operator of the device to clamp down a precise amount by having the clamping be directly tied to the amount of rotation of the first driver. Wherein the Applicant may argue that an articulation mechanism is not specifically disclosed by Dach, Whitman further teaches an articulation mechanism which provides the benefit of orienting the end effector to a desired angle needed for an operation.
Regarding claim 22, Dach as modified by Whitman discloses further comprising the staple cartridge (Whitman - 600; paragraphs 0063, 0082, 0097).
Given the teachings of Whitman, it would have been obvious to one of ordinary skill in the art before the time of the invention to modify the invention of Dach with the teachings of Whitman. Dach already discloses stapling jaws. Whitman further teaches the old and well-known stapling jaws that incorporate channel and a staple cartridge. Having a channel and cartridge allows for the end effector to be repeatedly used after loading of a new cartridge thus reducing waste and setup time.
Regarding claim 23, Dach as modified by Whitman discloses wherein the staple cartridge (Whitman - 600) comprises a plurality of staples (Whitman - 606) and a sled (Whitman - 603) drivable through the staple cartridge to eject the plurality of staples (Whitman – paragraphs 0083, 0085).
Regarding claim 24, Dach as modified by Whitman discloses wherein the plurality of rotatable drivers (Dach - #96, 100, 86 with associated elements detailed in paragraph 0078; and #102, 106, 88 with associated elements detailed in paragraph 0081; and 108, 112; and 90, 94) further comprises an articulation driver (Dach - 108, 112; alternatively Whitman – 500, 550) actuatable to rotate (Dach - paragraphs 0068, 0083; Whitman – paragraph 0088) the end effector relative to the elongate shaft.
Regarding claim 31, Dach as modified by Whitman discloses wherein the staple forming anvil jaw (Whitman - 50, 700; paragraph 0062) is pivotable (Whitman - figs. 3i-3l) relative to the elongate channel (Whitman - 80) to move the end effector into the clamped state (Whitman - paragraphs 0076, 0092, 0094, 0096, 0111-0114).
Regarding claim 32, Dach as modified by Whitman discloses wherein the articulation joint (Whitman - paragraph 0060 – “pivot axis B”; figs. 3a-3c) comprises a series of articulation links (Whitman – fig. 3b; 502, 504, 505, 554, 556 and other associated links).
Regarding claim 33, Dach discloses a robotic stapler (70, 132 and/or 260; figs. 6, 9 and/or 20; paragraph 0064 “a cutting and stapling device”; paragraph 0095 – “a stapling mechanism”), comprising:
a mounting plate (76; 134) rotatably supporting a plurality of rotatable drivers (#96, 100, 86 with associated elements detailed in paragraph 0078; and #102, 106, 88 with associated elements detailed in paragraph 0081; and 108, 112; and 90, 94) in a mounting plane, wherein the plurality of rotatable drivers comprises a first driver (86 or 88);
an elongate shaft (74; 264) extending along a shaft axis (figs. 6, 8, 9 and 20), wherein the elongate shaft is rotatable (paragraph 0065, 0095) relative to the mounting plate about the shaft axis;
an end effector (72; 140; 266) extending from the elongate shaft, wherein the end effector is configurable between an open state and a clamped state (paragraphs 0064, 0095, 0098), and wherein the end effector comprises:
a first jaw (figs. 9 and 20); and
a second jaw (figs. 9 and 20);
an articulation joint (84; paragraph 0065 – “wrist mechanism”; 268, fig. 20, paragraph 0095), wherein the end effector is rotatable relative to the elongate shaft at the articulation joint; and
a translatable driver (78 or 80), wherein the translatable driver is translatable based on an actuation of the first driver to move the end effector into the clamped state (paragraphs 0064, 0066, 0095, 0098).
Dach discloses an end effector comprises first and second stapling jaws and a clamping drive with a translatable driver, but fails to disclose a longitudinally translatable driver comprising a distal beam head, wherein the longitudinally translatable driver is translatable based on an actuation of the first driver to move the end effector into the clamped state.
However, Whitman teaches an end effector (11a) extending from the elongate shaft (11b), wherein the end effector is configurable between an open state and a clamped state (figs. 3i-3l), and wherein the end effector comprises a first jaw (50, 700) and a second jaw (80); an articulation joint (paragraph 0060 – “pivot axis B”; figs. 3a-3c), wherein the end effector is rotatable relative to the elongate shaft at the articulation joint; a longitudinally translatable driver (522, 524; figs. 3i-3l) comprising a distal beam head (522, 524), wherein the longitudinally translatable driver is translatable based on an actuation of the first driver to move the end effector into the clamped state (514, 520; paragraphs 0076, 0092, 0094, 0096, 0111-0114).
Given the teachings of Whitman, it would have been obvious to one of ordinary skill in the art before the time of the invention to modify the invention of Dach with the teachings of Whitman. Dach already discloses a clamping drive comprising a translatable driver which clamps based on actuation of a rotatable first driver (para 0064). Whitman teaches a clamping drive that makes use of a longitudinally translatable driver comprising a distal beam head which is actuated based on a rotatable first driver. It would have been obvious to make use of this clamping device because Dach already suggests making use of shaft driven mechanisms is desiring for a clamping motion. Doing so would allow the operator of the device to clamp down a precise amount by having the clamping be directly tied to the amount of rotation of the first driver. Wherein the Applicant may argue that an articulation mechanism is not specifically disclosed by Dach, Whitman further teaches an articulation mechanism which provides the benefit of orienting the end effector to a desired angle needed for an operation.
Regarding claim 34, Dach as modified by Whitman discloses wherein the plurality of rotatable drivers (Dach - #96, 100, 86 with associated elements detailed in paragraph 0078; and #102, 106, 88 with associated elements detailed in paragraph 0081; and 108, 112; and 90, 94) further comprises: an articulation driver (Dach - 108, 112; alternatively Whitman – 500, 550) actuatable to rotate the end effector relative to the elongate shaft; and a shaft rotation driver (Dach – 90, 94; paragraph 0068) actuatable to rotate the elongate shaft about the shaft axis.
Regarding claim 40, Dach as modified by Whitman discloses wherein the first jaw (Whitman – 50, 700) is pivotable (Whitman - figs. 3i-3l) relative to the elongate channel (Whitman - 80) to move the end effector into the clamped state (Whitman - paragraphs 0076, 0092, 0094, 0096, 0111-0114).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited. The art not relied upon generally pertains to robotic surgical end effectors with Millman et al. (US 2007/0016174 A1) being exemplary of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW M TECCO whose telephone number is (571)270-3694. The examiner can normally be reached M-F 11a-7p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571) 270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW M TECCO/ Primary Examiner, Art Unit 3731
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