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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/09/2022 an 03/24/2025 are being considered by the examiner.
Election/Restriction
Applicant’s election of Group II (claims 10-13, 15-18, 21, and 29-30) with traverse in the reply filed on 09/15/2025 is acknowledged. The restriction requirement filed on 07/16/2025 relies on a priori analysis of Unity of Invention, arguing that Group I does not include a non-sterile robotic manipulator. However, Groups I and II share technical features such as the surgical drape and sterile adapter. The restriction requirement does not provide evidence as to whether or not shared features are special technical features. Therefore, the restriction requirement is withdrawn.
Status of Claims
Claims 1-13, 15-18, 21, and 29-30 are currently pending and under examination. Claims 14, 19-20, and 22-28 are canceled.
Priority
The instant application (filed on 08/09/2022) is a national stage of PCT/IB2021/051028 (filed on 02/09/2021), filed under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on applications IT 102020000002536 and IT 102020000002545 filed on 02/10/2020. Instant claims 1-13, 15-18, 21, and 29-30 are sufficiently supported in IT 102020000002536 or IT 102020000002545 to receive an effective filing date of 02/10/2020. Therefore, all prior art will be evaluated with respect to this date.
Claim Objections
The following claims are objected to because of the following informalities:
• Claims 2 and 29: The phrase “said at least sterile adapter” would be more understandable as “said at least one sterile adapter”
• Claim 4: The limitation “the at least one sterile adapter is suitable to pivot with respect the at least one connector of the surgical drape” would more understandable as “the at least one sterile adapter is suitable to pivot with respect to the at least one connector of the surgical drape”
• Claim 7: The limitation “a surgical drape having_a pair of drape openings” appears to have an unnecessary underscore which is not related to amendments.
• Claim 8: The limitation “wherein the surgical drape is in single piece” should be amended to
“wherein the surgical drape is in a single piece” or “wherein the surgical drape is a single piece”
Appropriate correction is required.
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.
Claims 4-5 and 21 are 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 4: The term “the geometric center of the connector” lacks an antecedent basis.
Claim 5: The term “the body of the surgical drape” lacks an antecedent basis.
Claim 21: The limitation “wherein said at least two pouches of the surgical drape at least two non-sterile robotic manipulators, respectively” appears to be missing a connecting word. This is currently being interpreted as two pouches being used to drape the non-sterile robotic manipulators, but the meaning of the word surgical is unclear.
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 1-6 and 10-13, 15-16, and 29 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Beira (US PG Pub 2018/0000472 A1, see IDS filed on 08/09/2022).
Regarding Claim 1, Beira discloses a sterile barrier assembly for a robotic surgery system (Figure 15, [0001]) comprising:
• a surgical drape having at least one drape opening (Figure 15, [0032-0033] – device placed through drape opening);
• at least one connector contouring said at least one drape opening (Figure 26 – fixation ring 37 and rotating ring 38 sandwich the flexible sleeve 30 and couple the flexible sleeve over the non-sterile robotic manipulator as generally seen in Figure 16) and suitable for coupling with a case of a non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 couples with core component 31, which is coupled with housing 23, although the case could refer to any structural housing element in surgical platform 21); and
• at least one sterile adapter having a frame comprising a coupling device for coupling with at least one surgical instrument (Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5), said at least one sterile adapter being suitable to be coupled with at least one rolling body of the non-sterile robotic manipulator (Figures 19, [0034-0035], [0040] – core component 31 connects to the non-sterile robotic manipulator housing 23 containing cylindrical elements 25-27), wherein said at least one rolling body is suitable to pivot with respect to said case ([0040] – “core component 31 is rotated around the axis 20 by the platform 21”; Figure 14, [0031] - where platform 21 contains rotating element 17-19 which are driven by movement in cylindrical elements 25-27 in housing 23 and the surgical platform 21 housing);
• wherein:
- the at least one connector of the surgical drape and the at least one sterile adapter are made in separate pieces (Figure 26, [0040] – rotating ring 38 and core component 31 are able to rotate separately from each other);
- the at least one sterile adapter is suitable to pivot with respect to the at least one connector of the surgical drape (Figure 26, [0040] – rotating ring 38 can freely rotate as a separate element around core component 31);
- a gap is provided between the at least one connector of the surgical drape and the at least one sterile adapter (Figure 26, [0040] – a gap between core component 31 and rotating ring 28 is shown in the connection between the two elements where 38 can freely rotate because of this gap – see Figure I of this office action where this gap is highlighted);
- said at least one connector of the surgical drape comprises a distal surface facing distally (Figure 26 – rotating ring 38 has a distal surface in the gap indentation which faces distally – see Figure I of this office action where this surface is highlighted) and said sterile adapter comprises a proximal surface facing proximally (Figure 26 – core component 31 has a proximal surface in the gap indentation which faces proximally – see Figure I of this office action where this surface is highlighted); and
- said distal surface of the connector faces said proximal surface of the sterile adapter delimiting said gap (Figure 26 – these two surfaces in part define the gap between rotating ring 38 and core component 31 – see Figure I of this office action where these surfaces are highlighted).
Therefore, Claim 1 is anticipated by Beira.
Regarding Claim 2, Beira anticipates the sterile barrier assembly according to Claim 1, as indicated hereinabove. Beira further discloses wherein said at least one connector of the surgical drape has an annular rim and said at least sterile adapter has an annular frame so that said gap is an annular gap (Figure 6, [0040] – the gap between rotating ring 38 and core component 31 extends along the circular perimeter of the core component, thereby making the gap annular).
Therefore, Claim 2 is anticipated by Beira.
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Figure I – Modifications of Figures 21 and 26 of Beira by Examiner in Red: (Top) Embodiment with element 37 attached to core component 31 and (Bottom) Embodiment with connector elements 37 and 38 unattached to core component 31 to allow rotation.
Regarding Claim 3, Beira anticipates the sterile barrier assembly according to Claim 2, as indicated hereinabove. Beira further discloses wherein the annular rim and annular frame of the sterile adapter are arranged coaxially (Figure 6, [0040] – the rotating ring 38 and core component 31 cross sections are coaxially arranged around axis 20).
Therefore, Claim 3 is anticipated by Beira.
Regarding Claim 4, Beira anticipates the sterile barrier assembly according to Claim 1, as indicated hereinabove. Beira further discloses wherein the at least one sterile adapter is suitable to pivot with respect the at least one connector of the surgical drape about an axis that passes through the geometric center of the connector (Figure 6, [0040] – the rotating ring 38 and core component 31 cross sections are coaxially arranged around axis 20 where rotating ring 38 freely rotates around core component 31 during rotation of the robotic manipulator in order to prevent torsion on flexible sleeve 30).
Therefore, Claim 4 is anticipated by Beira.
Regarding Claim 5, Beira anticipates the sterile barrier assembly according to Claim 1, as indicated hereinabove. Beira further discloses wherein the connector is integral with the body of the surgical drape ([0040] – the flexible sleeve is squeezed between components 37 and 38, [0039] – having separate components 37 and 38 allows the connector to be reuseable, however previous art uses welded or glued components to make the sleeve and connector an integral product for applications where the connector and sleeve are both disposable between applications).
Therefore, Claim 5 is anticipated by Beira.
Regarding Claim 6, Beira anticipates the sterile barrier assembly according to Claim 1, as indicated hereinabove. Beira further discloses wherein the sterile adapter comprises a projection or skirt facing proximally said gap, said skirt comprising said proximal surface (Figure 26, [0040] – the indentation forming the gap on core component 31 is defined by proximal and distal side walls).
Therefore, Claim 6 is anticipated by Beira.
Regarding Claim 10, Beira discloses a robotic surgery system (Figure 1, [0001]) comprising:
• at least one non-sterile robotic manipulator ([0032] – surgical platform 21 is not sterile) comprising:
- a case ([0031] - housing element 23 or any structural housing element in surgical platform 21);
- a roll motor (Figures 1-2 , [0028-0029] – transmission of motions from proximal element 2 to the distal manipulator);
- a rolling body suitable to pivot with respect to said case ([0031] – “The cylindrical elements 25, 26, 27, which are mounted inside the housing element 23, are able to translate along circular paths that are collinear with the axis 20”); and
• a sterile barrier (Figure 1, [0031] - sterile interface 28) comprising:
a surgical drape having at least one drape opening (Figure 15, [0032-0033] – device placed through drape opening),
at least one connector contouring said at least one drape opening (Figure 26 – fixation ring 37 and rotating ring 38 sandwich the flexible sleeve 30 and couple the flexible sleeve over the non-sterile robotic manipulator as generally seen in Figure 16) and suitable for coupling with the case of the at least one non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 couples with core component 31, which is coupled with housing 23 or housing of surgical platform 21 generally); and
at least one sterile adapter having a frame comprising a coupling device for coupling with at least one surgical instrument (Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5),
said at least one sterile adapter being suitable to be coupled with said rolling body of the at least one non-sterile robotic manipulator (Figure 19, [0034-0035], [0040] – core component 31 connects to the non-sterile robotic manipulator housing 23 containing cylindrical elements 25-27), wherein rolling body is suitable to pivot with respect to said case ([0040] – “core component 31 is rotated around the axis 20 by the platform 21”; Figures 12-13, [0031] - where platform 21 contains rotating element 17-19 which are driven by movement in cylindrical elements 25-27 within housing 23);
wherein:
the at least one connector of the surgical drape and the at least one sterile adapter are made in separate pieces (Figure 26, [0040] – rotating ring 38 and core component 31 are able to rotate separately from each other);
the at least one sterile adapter is suitable to pivot in respect of the at least one connector of the surgical drape (Figure 26, [0040] – rotating ring 38 can freely rotate as a separate element around core component 31); and
a gap is provided between the at least one connector of the surgical drape and the at least one sterile adapter (Figure 26, [0040] – a gap between core component 31 and rotating ring 28 is shown in the connection between the two elements where 38 can freely rotate because of this gap – see Figure I of this office action where this gap is highlighted); and
wherein:
said at least one connector of the surgical drape is coupled with said case of the at least one non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 and fixation ring 37 sandwich flexible sleeve, where rotating ring is coupled to housing 23 or any housing of surgical platform 21 via the connection to core component 31 which is in contact with housing 23);
said at least one sterile adapter is coupled with said rolling body of the at least one non-sterile robotic manipulator (Figure 19, [0031] – cylindrical elements 25-27 are contained in housing 23 and connect with proximal hub 5 where both are coupled to core component 31);
said roll motor is suitable to move said rolling body together with said at least one sterile adapter in a pivoting movement with respect to said case ([0028] – “mechanical transmission systems that deliver motion from the different articulations of the proximal handle 2 to the equivalent articulations of the end-effector 3”, [0029-0031] – the mechanical transmission systems pass articulations through rotating elements 17-19 contained in housing 23 or any housing of surgical platform 21 and core component 31); and
said gap between the at least one connector of the surgical drape and the at least one sterile adapter prevents the at least one non-sterile robotic manipulator from contaminating a sterile operatory field (Figure 19, [0035] – the connection between housing 23 and proximal hub 5 is meant to prevent contamination of elements in housing 23 via the three miniature cups 32 in core component 31; the gap allowing rotation in Figure 26, [0040] would similarly be designed to prevent contamination of the non-sterile elements within flexible sleeve 30).
Therefore, Claim 10 is anticipated by Beira.
Regarding Claim 11, Beira anticipates the robotic surgery system according to Claim 10, as indicated hereinabove. Beira further discloses wherein said at least one connector of the surgical drape of the sterile barrier assembly is coupled detachably and rigidly with said case of the at least one non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 and fixation ring 37 sandwich flexible sleeve, where rotating ring is coupled to the housing 23 via the connection to core component 31 which is in contact with the housing 23 or any housing of surgical platform 21). Note housing 23 can be detached from the core component connection as seen in [0034-0036] and connector 29 (which describes the whole sterile adapter) is described as rigid in [0035].
Therefore, Claim 11 is anticipated by Beira.
Regarding Claim 12, Beira anticipates the robotic surgery system according to Claim 10, as indicated hereinabove. Beira further discloses said at least one sterile adapter of the sterile barrier assembly is coupled detachably and rigidly with said rolling body of the at least one non-sterile robotic manipulator (Figure 19, [0034-0035], Figure 26, [0040] – core component 31 allows for detachable coupling between cylindrical elements 25-27 in housing 23, through miniature cups 32, with rotating elements 17-19 in proximal hub 5). Note connector 29 (which describes the whole sterile adapter) is described as rigid in [0035].
Therefore, Claim 12 is anticipated by Beira.
Regarding Claim 13, Beira anticipates the robotic surgery system according to Claim 10 as indicated hereinabove. Beira further discloses wherein said rolling body of the non-sterile robotic manipulator comprises a manipulator connecting element (miniature cups 32, Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5); and
wherein said sterile adapter is detachably engaged with said manipulator connecting element ([0034-0036] - the miniature cups 32 detachable connect cylindrical elements 25-27 and rotating elements 17-19 while core component 31 detachable engages the housing 23 and proximal hub 5, both to facilitate this connection), and
wherein the engagement between said sterile adapter and said manipulator connecting element is distal to said case (Figure 24 – the miniature cups 32 are distal to housing 23 and surgical platform 21 housing in general so as to engage with proximal hub 5) and/or distal to said connector of the surgical drape (Figure 21 – miniature cups 32 extend distally to the connection with the sleeve 30, where the same relationship is observed in Figure 26 with rotating ring 28).
Therefore, Claim 13 is anticipated by Beira.
Regarding Claim 15, Beira anticipates the robotic surgery system according to Claim 13, as indicated hereinabove. Beira further discloses wherein said manipulator connecting element is at least partially within said case ([0034-0036] – the miniature cup elements 32 connect between cylindrical elements 25-27 and rotating elements 17-19, where the portion with the cylindrical elements 25-27 are contained in housing 23).
Therefore, Claim 15 is anticipated by Beira.
Regarding Claim 16, Beira anticipates the robotic surgery system according to Claim 13, as indicated hereinabove. Beira further discloses wherein said sterile adapter is out of said case and distal to said case (Figure 19, [0036] – core component 31 is placed over housing 23 and proximal hub 5 where the core component extends distally further than housing 23).
Therefore, Claim 16 is anticipated by Beira.
Regarding Claim 29, Beira anticipates the robotic surgery system according to Claim 10, as indicated hereinabove. Beira further discloses comprising at least one surgical instrument coupled to said at least sterile adapter (Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5 of the surgical instrument), so that said at least one surgical instrument is integrally coupled to said at least one rolling body of the non-sterile robotic manipulator ([0031] – motion transmitted from cylindrical elements 25-27 to the distal elements 7-13 of the surgical instrument).
Therefore, Claim 29 is anticipated by Beira.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 7-9 and 17-18 are rejected under U.S.C 103 as being unpatentable over Beira (US PG Pub 2018/0000472 A1, see IDS filed on 08/09/2022) in view of Choi (KR 20110057108 A1, see “Notice of References Cited”). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 7, Beira discloses a sterile barrier assembly for a robotic surgery system (Figure 15, [0001]) comprising:
• a surgical drape having a drape opening (Figure 15, [0032-0033] – device placed through drape opening);
• a connector, the connector contouring a respective drape opening (Figure 26 – fixation ring 37 and rotating ring 38 sandwich the flexible sleeve 30 and couple the flexible sleeve over the non-sterile robotic manipulator as generally seen in Figure 16) and being suitable for coupling with a case of a non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 couples with core component 31, which is coupled with housing 23, although the case could refer to any structural housing element in surgical platform 21);
• a sterile adapter, the sterile adapter having a frame comprising a coupling device for coupling with a respective surgical instrument (Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5), the sterile adapter being also suitable to be coupled with a respective rolling body of the non-sterile robotic manipulator (Figures 19, [0034-0035], [0040] – core component 31 connects to the non-sterile robotic manipulator housing 23 containing cylindrical elements 25-27), said at least one rolling body being suitable to pivot with respect to said case ([0040] – “core component 31 is rotated around the axis 20 by the platform 21”; Figure 14, [0031] - where platform 21 contains rotating element 17-19 which are driven by movement in cylindrical elements 25-27 in housing 23 and the surgical platform 21 housing);
wherein:
the connector of the surgical drape and the respective sterile adapter are made in separate pieces (Figure 26, [0040] – rotating ring 38 and core component 31 are able to rotate separately from each other);
the sterile adapter is suitable to pivot with respect to the respective connector of the surgical drape (Figure 26, [0040] – rotating ring 38 can freely rotate as a separate element around core component 31);
a gap is provided between the connector of the surgical drape and the respective sterile adapter (Figure 26, [0040] – a gap between core component 31 and rotating ring 28 is shown in the connection between the two elements where 38 can freely rotate because of this gap – see Figure I of this office action where this gap is highlighted);
the connector of the surgical drape comprises a distal surface facing distally (Figure 26 – rotating ring 38 has a distal surface in the gap indentation which faces distally – see Figure I of this office action where this surface is highlighted))
the sterile adapter comprises a proximal surface facing proximally (Figure 26 – core component 31 has a proximal surface in the gap indentation which faces proximally – see Figure I of this office action where this surface is highlighted); and
said distal surface of the connector faces said proximal surface of the respective sterile adapter delimiting said gap (Figure 26 – these two surfaces in part define the gap between rotating ring 38 and core component 31 – see Figure I of this office action where these surfaces are highlighted).
However, Beira does not disclose a surgical drape having (1) a pair drape openings, (2) a pair of connectors, and (3) a pair of sterile adapters.
Choi, in the same field of endeavor of a robot arm covered with a sterile drape for use in surgeries ([0004]), teaches a plurality of robot instrument arms attached to a main body where a single drape with multiple sleeves are placed over the main body and arms of the robot (Figure 5, [0080] – “each robot arm may be individually draped, but it may be simpler to drape the entire robot at once with a single drape, and for this purpose, the sterilization drape (20) according to the present embodiment is composed of a body part (32) that covers the main body part (3) of the robot, and a plurality of arm parts (34) that cover each of the plurality of robot arms (5), as illustrated in FIG. 5”). Each sleeve in Figure 5 has an open hole 28, where the adapters for the robotic arms are placed through at the distal ends of each sleeve ([0060]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Beira’s sterile interface for surgical instruments by incorporating the single drape with multiple sleeves and multiple arms attached to a common body of the surgical robot in Choi. This would have been obvious because both Beira and Choi discuss surgical robots covered in sterile drapes and Choi provides a solution/improvement with a design to incorporate multiple instrument arms to allow the simultaneous use of different end effectors (where two telemanipulators in Beira would be combined to a common housing with separate instrument arms and handles) and creating a more simply applied single drape to cover multiple instrument arms (as opposed to covering each instrument arm individually with separate drapes). Therefore, a person of ordinary skill in the art would be motivated to improve the device of Beira by incorporating the single drape with multiple sleeves and multiple arms attached to a common body of the surgical robot in Choi.
Therefore, Claim 7 is obvious over Beira in view of Choi.
Regarding Claim 8, the sterile barrier assembly according to Claim 7 is obvious over Beira in view of Choi, as indicated hereinabove. Beira does not disclose a surgical drape having a pair of drape openings. The surgical drape in claim 7 taught by Choi further discloses wherein the surgical drape is in single piece (Figure 5, [0080] – drape as a single piece with multiple sleeves).
Therefore, Claim 8 is obvious over Beira in view of Choi.
Regarding Claim 9, the sterile barrier assembly according to Claim 7 is obvious over Beira in view of Choi, as indicated hereinabove. Beira does not disclose a surgical drape having a pair of drape openings. The surgical drape in claim 7 taught by Choi further discloses wherein the surgical drape comprises a pair of pouches, each pouch delimiting a respective drape opening of the pair of drape openings, each pouch being suitable for draping one non-sterile robotic manipulator (Figure 5, [0080] – drape as a single piece with multiple sleeves for placing over robot instrument arms).
Therefore, Claim 9 is obvious over Beira in view of Choi.
Regarding Claim 17, Beira discloses a robotic surgery system (Figure 1, [0001]) comprising:
• a non-sterile robotic manipulators, the non-sterile robotic manipulator ([0032] – surgical platform 21 is not sterile) comprising:
- a case ([0031] - housing element 23 or any structural housing element in surgical platform 21);
- a roll motor (Figures 1-2 , [0028-0029] – transmission of motions from proximal element 2 to the distal manipulator); and
- a rolling body suitable to pivot with respect to said case ([0031] – “The cylindrical elements 25, 26, 27, which are mounted inside the housing element 23, are able to translate along circular paths that are collinear with the axis 20”); and
• a surgical drape (Figure 1, [0031] - sterile interface 28) having:
- a drape opening (Figure 15, [0032-0033] – device placed through drape opening);
- a connector, the connector contouring a respective drape opening (Figure 26 – fixation ring 37 and rotating ring 38 sandwich the flexible sleeve 30 and couple the flexible sleeve over the non-sterile robotic manipulator as generally seen in Figure 16) and being coupled with the case of a respective non-sterile robotic manipulator (Figure 26, [0040] – rotating ring 38 couples with core component 31, which is coupled with housing 23 or housing of surgical platform 21 generally); and
- a sterile adapter, the sterile adapter having a frame comprising a coupling device for coupling with a respective surgical instrument (Figure 19, [0034-0035], [0040] – core component 31 allows for coupling between cylindrical elements 25-27 in housing 23 through miniature cups 32 with rotating elements 17-19 in proximal hub 5), the sterile adapter being also coupled with the rolling body of a respective non-sterile robotic manipulator (Figures 19, [0034-0035], [0040] – core component 31 connects to the non-sterile robotic manipulator housing 23 containing cylindrical elements 25-27), said rolling body being suitable to pivot with respect to said case ([0040] – “core component 31 is rotated around the axis 20 by the platform 21”; Figures 12-13, [0031] - where proximal hub 5 contains rotating element 17-19 which are driven by movement in cylindrical elements 25-27 in housing 23);
wherein:
the connector of the surgical drape and the respective sterile adapter are made in separate pieces (Figure 26, [0040] – rotating ring 38 and core component 31 are able to rotate separately from each other);
the sterile adapter is suitable to pivot in respect of the respective connector of the surgical drape (Figure 26, [0040] – rotating ring 38 can freely rotate as a separate element around core component 31);
the roll motor is suitable to move a respective rolling body together with said the respective sterile adapter of a pivoting movement with respect to the case of the respective non-sterile robotic manipulator ([0028] – “mechanical transmission systems that deliver motion from the different articulations of the proximal handle 2 to the equivalent articulations of the end-effector 3”, [0029-0031] – translational motion of cylindrical elements 25-27 inside housing 23 causes rotation of connected elements 17-19, which further moves the distal articulations in the surgical instrument); and
a gap is provided between the connector of the surgical drape and the respective sterile adapter (Figure 26, [0040] – a gap between core component 31 and rotating ring 28 is shown in the connection between the two elements where 38 can freely rotate because of this gap – see Figure I of this office action where this gap is highlighted); and wherein:
the connector of the surgical drape comprises a distal surface facing distally (Figure 26 – rotating ring 38 has a distal surface in the gap indentation which faces distally – see Figure I of this office action where this surface is highlighted);
the sterile adapter comprises a proximal surface facing proximally (Figure 26 – core component 31 has a proximal surface in the gap indentation which faces proximally – see Figure I of this office action where this surface is highlighted);
said distal surface of the connector faces said proximal surface of the respective sterile adapter delimiting said gap (Figure 26 – these two surfaces in part define the gap between rotating ring 38 and core component 31 – see Figure I of this office action where these surfaces are highlighted); and
said gap between the connector of the surgical drape and the respective sterile adapter prevents the non-sterile robotic manipulator from contaminating a sterile operatory field (Figure 19, [0035] – the connection between housing 23 and proximal hub 5 is meant to prevent contamination of elements in housing 23 via the three miniature cups 32 in core component 31; the gap allowing rotation in Figure 26, [0040] would similarly be designed to prevent contamination of the non-sterile elements within flexible sleeve 30).
Note the mechanical telemanipulator can be arranged with different kinematics by adding/subtracting or rearranging elements such as seen in alternative embodiments 22 and 23 ([0041]). However, Beira does not disclose (1) a pair of non-sterile robotic manipulators each having a case, roll motor, and rolling body and (2) a surgical drape having a pair of drape openings, a pair of connectors, and a pair of sterile adapters.
Choi, in the same field of endeavor of a robot arm covered with a sterile drape for use in surgeries ([0004]), teaches a plurality of robot instrument arms attached to a main body where a single drape with multiple sleeves are placed over the main body and arms of the robot (Figure 5, [0080] – “each robot arm may be individually draped, but it may be simpler to drape the entire robot at once with a single drape, and for this purpose, the sterilization drape (20) according to the present embodiment is composed of a body part (32) that covers the main body part (3) of the robot, and a plurality of arm parts (34) that cover each of the plurality of robot arms (5), as illustrated in FIG. 5”). Each sleeve in Figure 5 has an open hole 28, where the adapters for the robotic arms are placed through open holes 28 at the distal ends of each sleeve ([0060]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Beira’s robotic surgery system by incorporating the single drape with multiple sleeves and multiple arms attached to a common body of the surgical robot in Choi. This would have been obvious because both Beira and Choi discuss surgical robots covered in sterile drapes and Choi provides a solution/improvement with a design to incorporate multiple instrument arms to allow the simultaneous use of different end effectors (where two telemanipulators in Beira would be combined to a common housing with separate instrument arms and handles) and creating a more simply applied single drape to cover multiple instrument arms (as opposed to covering each instrument arm individually with separate drapes). Therefore, a person of ordinary skill in the art would be motivated to improve the system of Beira by incorporating the single drape with multiple sleeves and multiple arms attached to a common body of the surgical robot in Choi.
Therefore, Claim 17 is obvious over Beira in view of Choi.
Regarding Claim 18, the robotic surgery system according to Claim 17 is obvious over Beira in view of Choi, as indicated hereinabove. Beira does not disclose a surgical drape having a pair of drape openings. The surgical drape in claim 7 taught by Choi further discloses wherein the surgical drape comprises a pair of pouches, each pouch of the pair delimiting a respective drape opening of the pair of drape openings, each pouch drapes one non-sterile robotic manipulator of the pair (Figure 5, [0080] – drape as a single piece with multiple sleeves for placing over robot instrument arms).
Therefore, Claim 18 is obvious over Beira in view of Choi.
Claim 21 is rejected under U.S.C 103 as being unpatentable over Beira (US PG Pub 2018/0000472 A1, see “Notice of References Cited”) in view of Choi (KR 20110057108 A1, see “Notice of References Cited”) and Schuh (US 2017/0065365 A1, see “Notice of References Cited”). Note a machine translation via Espacenet (https://worldwide.espacenet.com) is used to interpret the disclosure in Choi - see attached for copy of translation.
Regarding Claim 21, the robotic surgery system according to Claim 18 is obvious over Beira in view of Choi, as indicated hereinabove. Beira discloses a surgical instrument arm controlled with telemanipulator 1 (Figure 1, [0027-0028]). However, Beira does not discloses further comprising a robotic cart and at least one robotic arm extending from the robotic cart, wherein said at least two pouches of the surgical drape at least two non-sterile robotic manipulators, respectively.
Choi, as previously described in the obviousness rejection of claim 18, teaches a plurality of robot instrument arms attached to a main body where a single drape with multiple sleeves/pouches are placed over the main body and arms of the robot (Figure 5, [0080]).
Schuh, in the same field of endeavor of robotic instrument arms ([0027]) covered with a sterile drape for protection of non-sterile elements during surgery ([0047]), teaches a robotic cart containing a base 101 on wheels 115 where robotic arms 16 are attached to base 101 (Fig. 1, [0027-0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Beira’s telemanipulator structure by incorporating the mobile cart in Schuh. This would have been obvious because both Beira and Schuh discuss surgical robots covered in sterile drapes and Schuh provides a solution/improvement where a surgical instrument arm is mounted on a mobile cart to improve positioning of the device. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Beira by incorporating the mobile cart in Schuh.
Therefore, Claim 21 is obvious over Beira in view of Choi and Schuh.
Claim 30 is rejected under U.S.C 103 as being unpatentable over Beira (US PG Pub 2018/0000472 A1, see IDS filed on 08/09/2022) in view of Schuh (US 2017/0065365 A1, see “Notice of References Cited”).
Regarding Claim 30, Beira anticipates the robotic surgery system according to Claim 29, as indicated hereinabove. Beira discloses “the cylindrical elements 25, 26, 27, which are mounted inside the housing element 23, are able to translate along circular paths that are collinear with the axis 20” ([0031]). However, Beira does not disclose wherein bearings are provided between said at least one rolling body and a respective case of the non-sterile robotic manipulator.
Schuh, in the same field of endeavor of robotic instrument arms ([0027]) covered with a sterile drape for protection of non-sterile elements during surgery ([0047]), teaches a roll mechanism in the instrument device manipulator which contains bearings, where bearings are described as “a mechanical component that reduces friction between moving parts and facilitates rotation around a fixed axis. One bearing alone is capable of supporting the radial or torsional loading as the surgical tool holder 308 rotates within the outer housing 306. In the embodiment of FIG. 10B, the IDM 300 includes two bearings 1006a, 1006b fixedly attached to the surgical tool holder 308 such that a plurality of components (such as balls or cylinders) within the bearings 1006 contacts the outer housing 306” ([0075]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Beira’s telemanipulator structure with a rolling body inside a housing by incorporating the bearings to reduce friction in a rotating roll mechanism in Schuh. This would have been obvious because both Beira and Schuh discuss surgical robots with rotational motion covered in sterile drapes and Schuh provides a solution/improvement where friction is minimized to reduce the energy requirements and wear as the rolling body moves. Therefore, a person of ordinary skill in the art would be motivated to improve the device of Beira by incorporating the bearings to reduce friction in a rotating roll mechanism in Schuh.
Therefore, Claim 30 is obvious over Beira in view of Schuh.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights