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 Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 09/04/2025, with respect to 102 rejections under Orban have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under U.S.C. 102 in view of Tierney, and U.S.C. 103 in view of Tierney and Orban; Tierney, Orban, and Aoki; Tierney, Orban, and Romo; and Tierney, Orban, and Taylor. Specifically, Orban does not teach the configuration of the landing pads required of the newly amended claim language. Orban continues to teach aspects of the dependent claims regarding the usage of a pouch to cover the sterile adapter, and is still used as a secondary reference in the new rejections.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-2, 9-10, 14-16, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20020072736 awarded to Tierney et al, hereinafter Tierney (cited on Applicant’s IDS dated 11/19/2025).
Regarding Claim 1, Tierney teaches a medical device (abstract) comprising: an instrument sterile adapter (ISA) (adapter 128, Figs 7A/7B, Para. 0009, “An adapter is disposed adjacent the sterile drape between the holder and the interface. The adapter comprises a plurality of movable bodies. Each movable body has a first surface driven by the drive elements of the holder, and a second surface driving the driven elements of the tool”) comprising a first plate (holder side 132, Fig. 7A) and a second plate (tool side 130, Fig 7B), the ISA configured to be mounted to and between a carriage (Fig. 7F, holder 129) including actuators (Para. 0063, “Axial movement of the floating plate helps decouple the rotatable bodies from the tool when the levers along the sides of housing 108 are actuated (See FIG. 4)”) and a surgical instrument (Para. 0009, “An adapter is disposed adjacent the sterile drape between the holder and the interface. The adapter comprises a plurality of movable bodies. Each movable body has a first surface driven by the drive elements of the holder, and a second surface driving the driven elements of the tool”); wherein the first plate comprises a mounting surface (plate 136) and a plurality of landing pads (rotatable bodies 134) extending from and fixed relative to a second surface of the plate opposite the mounting surface (landing pads 134 extending through openings 140, Para. 0065, “This limited rotation can be used to help drivingly engage the rotatable bodies with drive pins of the holder, as the drive pins will push the rotatable bodies into the limited rotation position until the pins are aligned with (and slide into) openings 140”); wherein the mounting surface lie in a first datum plane (plane between plates 130 and 132 containing latch 145), the first datum plane controlling a position of the ISA relative to the carriage in a mounted state of the ISA to the carriage (Para. 0067, “A latch 145 releasably affixes the adaptor to the holder. A lip on the tool side 130 of adaptor 128 slidably receives laterally extending tabs of housing 108 adjacent to interface 110. The interaction between pins 122 and openings 140 helps restrain the tool in the engaged position until the levers along the sides of the tool housing push the floating plate axially from the interface so as to release the tool. The holder 129 and drive elements 119 are shown (without the adjacent manipulator structure) in FIGS. 7F through M”); and wherein the plurality of landing pads extend through the second plate and lie in a second datum plane (top of plate 130), the second datum plane controlling a position of the surgical instrument relative to the ISA in a mounted state of the surgical instrument to the ISA (landing pads 134 extending through openings 140, Para. 0065, “This limited rotation can be used to help drivingly engage the rotatable bodies with drive pins of the holder, as the drive pins will push the rotatable bodies into the limited rotation position until the pins are aligned with (and slide into) openings 140”), wherein the first datum plane and the second datum plane are parallel and separated by a fixed distance (Figs. 7A-7E).
Regarding Claim 2, Tierney teaches the medical device of claim 1, further comprising: a plastic sheet comprising a first side and a second side reverse of the first side; wherein the first plate is located on the first side of the plastic sheet; and wherein the second plate is located on the second side of the plastic sheet (Figs. 14A-14B, Para. 0092, “Methods for mounting adaptor 128 (together with a sterile drape) to the holder of manipulator 58 can be understood with reference to FIGS. 14A and B. Subsequent mounting of tool 54 to adapter 128 generally comprises inserting the surgical end effector distally through cannula 72 and sliding interface 110 of tool 54 into engagement with a mounted adapter, as illustrated in FIG. 14C. The tool can be removed and replaced by reversing the tool mounting procedure illustrated in FIG. 14C and mounting an alternative tool in its place”).
Regarding Claim 9, Tierney teaches the medical device of claim 1, wherein: the first plate comprises a pocket having a third opening in a surface of the first plate oriented away from the second plate, the second plate comprises a fourth opening in a surface of the second plate oriented away from the first plate;, the ISA further comprises a presence pin retained in the pocket, and a portion of the presence pin extends through the fourth opening (Para. 0083, Prior to perfecting mechanical coupling between the holder drive elements and the rotatable bodies, pins of driving elements (which are similar in configuration to the driven elements 118 of interface 110) will push the rotatable bodies away from holder side 132 of adapter 128 and toward tool side 130. In this rotationally limited axial position, tabs 138 of rotatable bodies 134 engage detents of the floating plate so as to prevent rotation of more than about 90.degree.. This can ensure that the pins of the driving elements rotate relative to the rotatable bodies by driving the servo motors of the manipulator by more than 90.degree”).
Regarding Claim 10, Tierney teaches the medical device of claim 9, wherein: at least a portion of the pocket is within a protrusion that extends from the surface of the first plate (Para. 0083, Prior to perfecting mechanical coupling between the holder drive elements and the rotatable bodies, pins of driving elements (which are similar in configuration to the driven elements 118 of interface 110) will push the rotatable bodies away from holder side 132 of adapter 128 and toward tool side 130. In this rotationally limited axial position, tabs 138 of rotatable bodies 134 engage detents of the floating plate so as to prevent rotation of more than about 90.degree.. This can ensure that the pins of the driving elements rotate relative to the rotatable bodies by driving the servo motors of the manipulator by more than 90.degree”).
Regarding Claim 14, Tierney teaches the medical device of claim 1, wherein: in a state of the surgical instrument mounted to the mounting surface of the ISA and the ISA mounted to the carriage, the fixed distance between the first datum plane and the second datum plane fixes a distance between the surgical instrument and the carriage (Tierney does not teach a changeable distance between the plates when mounted).
Regarding Claim 15, Tierney teaches the medical device of claim 1, further comprising a sterile barrier drape, wherein: the first plate and the second plate are coupled together with a portion of the sterile barrier drape held between the first plate and the second plate ((Figs. 14A-14B, Para. 0092, “Methods for mounting adaptor 128 (together with a sterile drape) to the holder of manipulator 58 can be understood with reference to FIGS. 14A and B. Subsequent mounting of tool 54 to adapter 128 generally comprises inserting the surgical end effector distally through cannula 72 and sliding interface 110 of tool 54 into engagement with a mounted adapter, as illustrated in FIG. 14C. The tool can be removed and replaced by reversing the tool mounting procedure illustrated in FIG. 14C and mounting an alternative tool in its place”); and in a state of the surgical instrument mounted to the mounting surface of the ISA and the ISA mounted to the landing pads of the carriage, a distance between the surgical instrument and the carriage is controlled by the first plate such that variations in the dimensions of the second plate and variations in the dimensions of the portion of the sterile barrier drape, within a range, do not affect the distance between the surgical instrument and the carriage (Tierney does not teach a changeable distance between the plates when mounted).
Regarding Claim 16, Tierney teaches the medical device of claim 1, wherein: the ISA further comprises one or more couplers configured to, in a state of the surgical instrument mounted to the mounting surface of the ISA and the ISA mounted to the landing pads of the carriage, engage with control features of the carriage and with control features of the surgical instrument to transfer actuation forces from the carriage to the instrument (Para. 0083, Prior to perfecting mechanical coupling between the holder drive elements and the rotatable bodies, pins of driving elements (which are similar in configuration to the driven elements 118 of interface 110) will push the rotatable bodies away from holder side 132 of adapter 128 and toward tool side 130. In this rotationally limited axial position, tabs 138 of rotatable bodies 134 engage detents of the floating plate so as to prevent rotation of more than about 90.degree.. This can ensure that the pins of the driving elements rotate relative to the rotatable bodies by driving the servo motors of the manipulator by more than 90.degree”).
Regarding Claim 18, Tierney teaches the medical device of claim 1, wherein: in a state of the surgical instrument mounted to the mounting surface of the ISA and the ISA mounted to the landing pads of the carriage, the second plate is disposed between the first plate and the instrument (second tool facing plate 130 between plates 132 and instrument housing 108, Fig. 14c).
Regarding Claim 19, Tierney teaches the medical device of claim 1, wherein: the first plate comprises a second surface (back side of tool-facing plate 130) opposite the mounting surface (plate 136), the first plate and second plate are couplable together, and in a coupled state of the first plate to the second plate the second surface faces the second plate (Fig. 7D).
Regarding Claim 20, Tierney teaches the medical device of claim 19, wherein: the second plate comprises a third surface (surface of tool-facing plate 130 that couples plate 132) and a fourth surface (face of tool-facing plate 130 that faces interface 110) opposite the third surface (Fig. 7D); and in the coupled state of the first plate to the second plate and in a state of the surgical instrument mounted to the mounting surface of the ISA, the fourth surface faces an instrument control surface of the surgical instrument (Fig. 14C); the third surface faces the second surface (Fig. 7D); and the landing pads protrude from the second surface and extend through the second plate beyond the fourth surface to define the second datum plane abutting the instrument control surface of the surgical instrument (Fig. 7D).
Regarding Claim 21, Tierney teaches the medical device of claim 1, wherein the first plate comprises a monolithic body and the mounting surface and the plurality of landing pads are integrally connected parts of the body (Figs. 7A-7E).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20020072736 awarded to Tierney et al, hereinafter Tierney (cited on Applicant’s IDS dated 11/19/2025), as applied to the claims above, and further in view of JP Publication 2005505379 awarded to Aoki et al, hereinafter Aoki.
Regarding Claim 3, Tierney teaches the medical device of Claim 2. Tierney does not teach wherein the sheet is about 100 micrometers of polyurethane and includes a lubricant.
However, Aoki teaches the usage of a thermoplastic material including a lubricant (Para. 0015, “Thermoplastic materials also include, but are not limited to, fillers, fibers, antistatic agents, lubricants, wetting agents, foaming agents, surfactants, pigments, dyes, coupling agents, plasticizers, suspending agents, And additives such as hydrophilic / hydrophobic additives).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tierney by Aoki, i.e. by using a lubricant with the thermoplastic sheet as the drape system of Tierney, for simply substituting one known thermoplastic usage for another.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tierney, i.e. by making the sheet thickness about 100 micrometers, as it is well within the skill of the artisan to determine sizing parameters based on the particular usage of the drape.
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20020072736 awarded to Tierney et al, hereinafter Tierney (cited on Applicant’s IDS dated 11/19/2025), as applied to the claims above, and further in view of U.S. Patent Publication 20060161138 awarded to Orban et al, hereinafter Orban.
Regarding Claims 4-7 and 12, Tierney teaches the medical device of Claim 1, including a drape (Figs. 14a-14b). Tierney does not teach wherein the sheet plastic sheet comprises a first opening; and a pouch comprising a second opening; wherein the pouch is coupled to the plastic sheet at the first opening; wherein the pouch is shaped to fit around the carriage; and wherein the ISA is coupled to the pouch at the second opening, the pouch comprises a first side and a second side reverse of the first side; the first plate is located on the first side of the pouch; and the second plate is located on the second side of the pouch, held between the first and second plate, wherein the pouch is polyurethane and shaped to fit around the carriage.
However, in the art of surgical device (abstract), Orban teaches a plastic sheet comprising a first opening (Fig. 11); and a pouch comprising a second opening (pouch 402, Para. 0068), wherein the pouch is coupled to the plastic sheet at the first opening, wherein the pouch is shaped to fit around the carriage; and wherein the ISA is coupled to the pouch at the second opening (Para. 0068, Figs. 11c-11k) wherein: the pouch comprises a first side and a second side reverse of the first side; the first plate is located on the first side of the pouch; and the second plate is located on the second side of the pouch (Para. 0076, Figs 11e and 12a-c) wherein: the pouch is shaped to provide a form fit around the carriage (Fig. 11d, Para. 0069) and the pouch is made from a polyurethane (Para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tierney by Orban, i.e. by using the drape pouch system of Orban in the system of Tierney, for the predictable purpose of protecting the carriage of Tierney in the same way as the carriage in Orban.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20020072736 awarded to Tierney et al, hereinafter Tierney (cited on Applicant’s IDS dated 11/19/2025), as applied to the claims above, and further in view of in view of .S. Patent Publication 20060161138 awarded to Orban et al, hereinafter Orban, and U.S. Patent Publication 20100170519 awarded to Romo et al, hereinafter Romo.
Regarding Claims 8 and 17, Tierney teaches the medical device of Claim 4. Orban further teaches wherein: the second plate is joined to the first plate by passing pins between the first and second plates and through the pouch (Fig. 12c shows plate 312 having indents oriented away from 306 with pins mated in the gaps)). Neither Tierney or Orban teach wherein the pins are heat staked to form a permanent device.
However, Romo does teach about using heat staking for the purpose for fastening/attaching other components of the device (Para. 0072, “In certain embodiments described herein, the shield 1226 may be fastened or attached to the drape 1220 using a variety of mechanisms, which include but are not limited to heat bonding or affixing with adhesives”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Tierney modified by Orban further by Romo, i.e. using heat staking as the fastening method, for the predictable purpose of simply substituting one known method of fastening for another.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20020072736 awarded to Tierney et al, hereinafter Tierney (cited on Applicant’s IDS dated 11/19/2025), as applied to the claims above, and further in view of U.S. Patent Publication 20060161138 awarded to Orban et al, hereinafter Orban, and U.S. Patent 5419343 awarded to Taylor, hereinafter Taylor
Regarding Claim 13, Tierney modified by Orban makes obvious the medical device of Claim 4. Tierney does not teach the pouch comprises a stiff portion, the stiff portion being stiffer than a remainder of the pouch, and the stiff portion of the pouch surrounds the second opening and is held between the first plate and the second plate.
However, in the art of surgical drapes (abstract), Taylor teaches using a stiffer portion than the remainder of the pouch around the opening (Fig. 6, Col. 3, Lines 49-54, “Encircling the upper edge of the collection pouch 110 is a malleable stiffening member 118. The stiffening member 118 is provided so that the pouch 110 in which the body 114 is formed from a flexible yet waterproof material, can be held in a generally conical configuration as is illustrated in FIG. 4”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Tierney modified by Orban further by Taylor, i.e. by making the pouch opening out of out of a stiff material, for the predictable purpose of improving the strength of the pouch as set forth in the citation from Taylor above.
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.
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/JLM/
Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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