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 .
Claim Objections
Claim 20 is objected to because of the following informalities: lines 1-2 claim “the plate-shaped body…is coplanar with an edge the separator main body”. This phrase appears to missing a word, and should read “the plate-shaped body…is coplanar with an edge of the separator main body” or another clarifying term. Appropriate correction by Applicant is required.
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 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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scheib et al. (US PGPUB 2018/0168753 – “Scheib”).
Regarding Claim 1, Scheib discloses:
A drape (Scheib FIG. 12B, sterile drape 1270) for covering a medical robot (Scheib paragraph [0006], “a sterile adapter for use in a robotic surgical system”), the drape comprising:
an attachment (Scheib FIG. 12B, surgical tool 20 attached to frame 1210) detachably attached to the medical robot (Scheib FIG. 12B, tool driver 10 detachably attached to frame 1210);
a flexible sheet (Scheib FIG. 12B, sterile drape 1270) covering the medical robot, the flexible sheet being fixed to the attachment (Scheib paragraph [0060], “a sterile drape 1270 may be coupled to the peripheral projection 1260, such as through thermal bonding, thereby forming a sterile barrier that may be used to cover the tool driver”); and
a flexible body (Scheib FIG. 12B, peripheral projection 1260) that prevents the sheet from being pinched between the attachment and the medical robot (Scheib paragraph [0061], “the peripheral projection 1260 may extend between about 0.2 cm and about 1.5 cm, between about 0.5 cm and about 1.0 cm, or between about 0.5 cm and 0.7 cm (e.g., about 0.6 cm)”, thereby preventing drape 1270 from being pinched between frame 1210 and tool driver 10).
Regarding Claim 2, Scheib discloses the features of Claim 1, as described above.
Scheib further discloses wherein the flexible body (Scheib FIG. 12B, peripheral projection 1260) has a flexibility greater than a flexibility of the attachment (Scheib FIG. 12B, frame 1210; Scheib paragraph [0062], “the frame 1210 may be made of a material that is relatively rigid, such as polycarbonate or ABS, while the peripheral projection 1260 may include a relatively more flexible material”) and less than a flexibility of the sheet (Scheib paragraph [0062], “One exemplary method of making a sterile adapter with a peripheral projection includes co-injection molding a frame and at least one peripheral projection that extends laterally around at least a portion of the perimeter of the frame, and coupling a sterile drape to the peripheral projection. The co-injection molding may include introducing a first material into a first portion of a mold corresponding to the frame, and introducing a second material that is less rigid than the first material into a second portion of the mold corresponding to the peripheral projection.”).
Regarding Claim 4, Scheib discloses the features of Claim 1, as described above.
Scheib further discloses wherein the flexible body comprises a plate-shaped body that has an extending portion that extends outward from an outer surface of the attachment (Scheib FIG. 12B, showing peripheral projection 1260 having a plate-shaped body and extending portions that extend outward from frame 1210).
Regarding Claim 5, Scheib discloses the features of Claim 4, as described above.
Scheib further discloses wherein the plate-shaped body (Scheib FIG. 12B, peripheral projection 1260) is fixed to the sheet (Scheib FIG. 12B, sterile drape 1270) in an area including an end portion of the extended portion (Scheib paragraph [0060], “a sterile drape 1270 may be coupled to the peripheral projection 1260”).
Regarding Claim 6, Scheib discloses the features of Claim 1, as described above.
Scheib further discloses wherein a first adhesive layer is provided on at least a part of an outer surface of the flexible body, the sheet is attached to the flexible body by the first adhesive layer (Scheib paragraph [0060], “a sterile drape 1270 may be coupled to the peripheral projection 1260”; Scheib paragraph [0063], “Coupling the sterile drape to the peripheral projection may include…epoxy or other adhesive”).
Regarding Claim 7, Scheib discloses the features of Claim 6, as described above.
Scheib further discloses wherein the flexible body comprises a plate-shaped body that has an extended portion that extends outward from an outer surface of the attachment (Scheib FIG. 12B, showing peripheral projection 1260 having a plate-shaped body and extending portions that extend outward from frame 1210), and the first adhesive layer is provided on a surface of the plate-shaped body and extends to an end portion of the extended portion of the plate-shaped body (Scheib paragraph [0060], “a sterile drape 1270 may be coupled to the peripheral projection 1260”; Scheib paragraph [0063], “Coupling the sterile drape to the peripheral projection may include…epoxy or other adhesive”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Richmond et al. (US PGPUB 2017/0143429 – “Richmond”).
Regarding Claim 3, Scheib discloses the features of Claim 1, as described above.
Scheib does not explicitly disclose wherein the flexible body is translucent.
Richmond teaches wherein the flexible body is translucent (Richmond FIG. 6A, translucent protective dome 645).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Richmond’s translucent protective dome with the drape disclosed by Scheib. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a drape the is prevented from being pinched both by Scheib’s peripheral projection 1260 and Richmond’s dome 645, in order to provide redundant protection against drape pinching.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Hörer (US PGPUB 2012/0227751 – “Hörer”).
Regarding Claim 8, Scheib discloses the features of Claim 6, as described above.
Scheib does not explicitly disclose wherein the drape further comprises a second adhesive layer provided on a side of the sheet opposite to a side to which the first adhesive layer is attached, and the sheet comprises an interposed portion between the first adhesive layer and the second adhesive layer.
Hörer teaches wherein the drape further comprises a second adhesive layer provided on a side of the sheet opposite to a side to which the first adhesive layer is attached, and the sheet comprises an interposed portion between the first adhesive layer and the second adhesive layer (Hörer FIG. 4, surgical drape 10 and tape 15; Hörer paragraph [0057], “the surgical drape 10 has an opposed upper end 11. To fix the placement tool 1 to the patient 2, the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hörer’s double-sided tape with the drape disclosed by Scheib. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a drape that can be affixed to both a placement tool and the patient, in order to secure the placement tool to a specific position relative to the patient.
Regarding Claim 9, Scheib in view of Hörer teaches the features of Claim 8, as described above.
Hörer further teaches wherein the attachment is on a side of the second adhesive layer opposite to a side facing the sheet (Hörer paragraph [0057], “the surgical drape 10 has an opposed upper end 11. To fix the placement tool 1 to the patient 2, the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto”).
Regarding Claim 10, Scheib in view of Hörer teaches the features of Claim 8, as described above.
Hörer further teaches wherein a cover film is provided on a side of the second adhesive layer opposite to a side facing the sheet and configured to protect the second adhesive layer (Hörer paragraph [0057], “To fix the placement tool 1 to the patient 2, the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto, the other side carrying a removable protective film.”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Hörer (US PGPUB 2012/0227751 – “Hörer”) and Wall (US Patent 3,025,957 – “Wall”).
Regarding Claim 11, Scheib in view of Hörer teaches the features of Claim 8, as described above.
Scheib in view of Hörer do not explicitly teach wherein the interposed portion of the sheet comprises a folded portion of the sheet.
Wall teaches wherein the interposed portion of the sheet comprises a folded portion of the sheet (Wall FIG. 1, folded portion of surgical drape 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Wall’s pleat with the drape taught by Scheib in view of Hörer. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a drape that can be folded during storage in order to save space, and also being capable of unfolding without self-entanglement.
Claims 12-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Wang et al. (US PGPUB 2011/0087238 – “Wang”).
Regarding Claim 12, Scheib discloses the features of Claim 1, as described above.
Scheib further discloses wherein the drape (Scheib FIG. 12B, drape 1270) is further configured to cover a holder (Scheib FIG. 12B, adapter 1200) at an end of an arm of the medical robot, the holder being detachable from the end of the arm (Scheib FIG. 12B, tool driver 10 detachably attached to frame 1210), and configured to hold an insertion member (Scheib FIG. 1, tool shaft connected to surgical tool 20) to be inserted into a patient.
Scheib does not explicitly disclose that the holder is rotatable around the arm;
wherein the attachment comprises a bearing structure, and the bearing structure comprises:
a ring-shaped fixation member that is attached to the arm in a state in which the holder is inserted into the fixation member; and
a ring-shaped rotating member that is slidably and rotatably attached to the fixation member in a state in which the holder is inserted into the rotating member and that is rotatable together with the holder, and
wherein the sheet comprises:
a first sheet that is attached to the fixation member and that is configured to cover the arm; and
a second sheet that is attached to the rotating member and rotatable together with the rotating member, and that is configured to cover the holder.
Wang teaches that the holder (Wang FIG. 7, tool driver 84) is rotatable around the arm (Wang FIG. 7, robotic arm assembly 26);
wherein the attachment comprises a bearing structure, and the bearing structure comprises:
a ring-shaped fixation member that is attached to the arm in a state in which the holder is inserted into the fixation member (Wang FIG. 7, quick disconnect 98 for connection to tool driver 84); and
a ring-shaped rotating member that is slidably and rotatably attached to the fixation member in a state in which the holder is inserted into the rotating member and that is rotatable together with the holder (Wang FIG. 7, input piston 106 for connection to output piston 108 in tool driver 84), and
wherein the sheet comprises:
a first sheet (Wang, FIG. 7, drape 125) that is attached to the fixation member and that is configured to cover the arm (Wang FIG. 7, showing drape 125 connected to quick disconnect 98 and covering robotic arm assembly 26); and
a second sheet (Wang, FIG. 7, drape 124) that is attached to the rotating member and rotatable together with the rotating member, and that is configured to cover the holder (Wang FIG. 7, showing drape 124 connected to output piston 108 and covering tool driver 84).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to replace Scheib’s single drape with Wang’s two drapes. A person having ordinary skill in the art would be motivated to make this simple substitution of one known element for another to obtain the predictable result of dedicated drapes for different components of the robotic device, in order to make the different components detachable without sacrificing sterile protection thereof.
Regarding Claim 13, Scheib in view of Wang teaches the features of Claim 12, as described above.
Wang further reaches wherein the flexible body (Wang FIG. 7, quick disconnect 98) comprises a tube (Wang FIG. 7, outer sleeve 96) that is provided on an outer periphery of the fixation member (Wang paragraph [0103], “an outer sleeve 96 which cooperates with a spring biased ball quick disconnect fastener 98“).
Regarding Claim 14, Scheib in view of Wang teaches the features of Claim 13, as described above.
Wang further teaches wherein the tube extends in a direction away from the rotating member (Wang FIG. 7, showing outer sleeve 96 extending away from quick disconnect 98).
Regarding Claim 15, Scheib in view of Wang teaches the features of Claim 12, as described above.
Wang further teaches:
wherein the rotating member comprises a recessed portion on an outer periphery of the rotating member (Wang FIG. 7, showing recessed portion(s) of tool driver 84 to which drape 124 is secured) in which an adhesive layer is disposed, and
wherein the adhesive layer is configured to attach the rotating member to the second sheet (Wang FIG. 7, showing drape 124 attached to tool driver 84; Wang paragraph [0107], “drape 125 also includes a plurality of tape 308 having adhesive 310 disposed thereon. At least one piece of tape 308 is opposedly arranged the other pieces of tape 308 to effectuate the closing of the drape 125 about the arm assembly 26”; see also Wang paragraph [0146]).
Regarding Claim 16, Scheib discloses the features of Claim 1, as described above.
Scheib does not explicitly disclose:
wherein the attachment comprises a separator is disposed between the medical robot and an insertion member, the insertion member being held by the medical robot and configured to be inserted into a patient, the separator being configured to isolate the insertion member from the medical robot and transmit power in forward and backward directions from a power transmitter of the medical robot to a movable part of the insertion member, and
wherein the separator comprises:
a slider having a first engagement portion engaged with the power transmitter and a second engagement portion engaged with the movable part of the insertion member, the slider being configured to transmit the power received from the power transmitter to the movable part; and
a separator main body comprising a through-hole through which a part of the slider is inserted, the separator main body being detachably attached to the medical robot.
Wang teaches:
wherein the attachment (Wang FIG. 7, holder 86) comprises a separator (Wang FIG. 7, quick disconnect fastener 98) is disposed between the medical robot (Wang FIG. 7, arm 26) and an insertion member (Wang FIG. 7, end effector 80), the insertion member being held by the medical robot and configured to be inserted into a patient, the separator being configured to isolate the insertion member from the medical robot and transmit power in forward and backward directions from a power transmitter of the medical robot to a movable part of the insertion member (Wang FIG. 7, worm gear 87; Wang paragraph [0102], “holder 86 includes a worm gear 87 that is driven by a motor in the robotic arm assembly 26 to rotate the collar 85 and in turn rotate the instrument 82 about its longitudinal axis”) , and
wherein the separator comprises:
a slider (Wang FIG. 7, rod 92) having a first engagement portion engaged with the power transmitter and a second engagement portion engaged with the movable part of the insertion member, the slider being configured to transmit the power received from the power transmitter to the movable part (Wang paragraph [0103], “first finger 90 is coupled to a rod 92 that extends through a center channel 94 of the instrument 82”); and
a separator main body (Wang FIG. 7, outer sleeve 96 of instrument 82) comprising a through-hole through which a part of the slider is inserted, the separator main body being detachably attached to the medical robot.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s surgical instrument 82 with the drape assembly disclosed by Scheib. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a robotic system that is capable of cutting and/or stapling (see Wang paragraph [0103]).
Regarding Claim 19, Scheib in view of Wang teaches the features of Claim 16, as described above.
Scheib further discloses wherein the flexible body comprises a plate-shaped body (Scheib FIG. 12B, showing peripheral projection 1260 having a plate-shaped body).
Regarding Claim 20, Scheib in view of Wang teaches the features of Claim 19, as described above.
wherein an edge of a portion of the plate-shaped body (Wang FIG. 7, showing plate-shaped body to which sterile drape 124 is attached located around the slider (Wang FIG. 7, rod 92 and quick disconnect fastener 98 when connected to front loading tool driver 84) is coplanar with an edge the separator main body (Wang FIG. 7, quick disconnect fastener 98) located around the slider.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Wang et al. (US PGPUB 2011/0087238 – “Wang”) and Hörer (US PGPUB 2012/0227751 – “Hörer”).
Regarding Claim 17, Scheib in view of Wang teaches the features of Claim 16, as described above.
Scheib in view of Wang does not explicitly teach:
the drape comprises a first adhesive layer provided on a side of the flexible body facing the separator main body and a second adhesive layer provided on a side of the separator main body facing the flexible body, and
wherein the sheet comprises an interposed portion interposed between the first adhesive layer and the second adhesive layer.
Hörer teaches:
the drape comprises a first adhesive layer provided on a side of the flexible body facing the separator main body and a second adhesive layer provided on a side of the separator main body facing the flexible body (Hörer FIG. 4, surgical drape 10 and tape 15; Hörer paragraph [0057], “the surgical drape 10 has an opposed upper end 11. To fix the placement tool 1 to the patient 2, the upper end 11 has one side of a piece of tape 15 having adhesive on both sides adhered thereto”), and
wherein the sheet comprises an interposed portion interposed between the first adhesive layer and the second adhesive layer (Hörer FIG. 1, interior layer of surgical drape 10).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hörer’s double-sided tape with the drape taught by Scheib in view of Wang. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a drape that can be affixed to both a placement tool and the patient, in order to secure the placement tool to a specific position relative to the patient.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Scheib et al. (US PGPUB 2018/0168753 – “Scheib”) in view of Wang et al. (US PGPUB 2011/0087238 – “Wang”), Hörer (US PGPUB 2012/0227751 – “Hörer”), and Calderwood (US PGPUB 2002/0133058 – “Calderwood”).
Regarding Claim 18, Scheib in view of Wang and Hörer teaches the features of Claim 17, as described above.
Scheib further discloses wherein the sheet is attached to the first adhesive layer (Scheib paragraph [0063], “Coupling the sterile drape to the peripheral projection may include…epoxy or other adhesive”).
Scheib in view of Wang and Hörer does not explicitly teach:
wherein the flexible body comprises an opening portion, and
wherein the sheet is attached so as not to cover the opening portion.
Calderwood teaches:
wherein the flexible body (Calderwood FIG. 3, ring segments 18) comprises an opening portion (Calderwood FIG. 3, showing opening within ring segments 18), and
wherein the sheet (Calderwood FIG. 3, flexible plastic material 20) is attached so as not to cover the opening portion (Calderwood FIG. 3, showing flexible plastic material 20 connected to the outer periphery of ring segments 18).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Calderwood’s ring segments with the drape taught by Scheib in view of Wang and Hörer. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a drape that allows an instrument to pass through the flexible body (see Calderwood FIG. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include, but are not limited to:
Luck et al. (US PGPUB 20200205641 – “Luck”), which teaches in Luck FIG. 13 a terminal portion 13 of a robotic manipulator/arm 11 covered by a first sterile drape 18a, and a surgical device assembly 14 covered by a second sterile drape 18b.
Soto et al. (US PGPUB 2019/0099232 – “Soto”), which teaches in Soto FIG. 6 a surgical arm that is protected by different sections of a surgical drape 22, which are defined by different rigid belt assemblies 56.
Lynn (US Patent 5,785,643 – “Lynn”), which teaches in Lynn FIG. 2 a drape joint 34 that has a permanently attached drape 38, and mates with a fitting on an arm assembly 24 of a positioner 20 for a scope 26 (see Lynn FIG. 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
02/19/2026