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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 02/10/2026, with respect to the 102 rejections in view of Wang 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 Therefore, the rejection has been withdrawn.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 in view of U.S. 20080215065 awarded to Wang et al and U.S 20060076024 to Duarte.
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 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:
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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-6, 11, 15, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080215065 awarded to Wang et al, in view of U.S. Patent Publication 20060076024 awarded to Duarte.
Regarding Claim 1, Wang teaches a system comprising: a shroud (base housing 25, Fig. 1) comprising an inner channel that defines a sterile volume (Fig. 1, Para. 0065, “Each robotic arm assembly 26 has a base motor 34 which moves the arm assembly 26 in a linear fashion, relative to the base housing 25, as indicated by arrows Q” the inner channel is unnumbered internal path of housing 25); and a computer-assisted manipulator assembly configured to manipulate a medical instrument (arm assembly 26), the medical instrument removably couplable to the computer-assisted manipulator assembly (Para. 0065, “The robotic arm assemblies 26 also have a coupling mechanism 45 to couple the instruments 22 and 24, or endoscope 28 thereto”), the computer assisted manipulator assembly comprising a link slidable within the sterile volume of the inner channel of the shroud and a position extended outside of the shroud (Fig. 1, portion of arm 26 that enters base housing 25, shown by arrow Q, Para. 0065), and wherein the link is covered by an external sterile cover positioned at least partially between the shroud and the link (Para. 0164, “Additionally, the robotic arm assembly 26 is preferably covered with a sterile drape 125 so that it does not have to be sterilized either”). Wang does not teach wherein the shroud is rotatable relative to an operating table in one or more rotational degrees of freedom.
However, in the art of surgical shroud devices (abstract), Duarte teaches a base of a surgical arm rotatable relative to the operating table (Para. 0018, Fig. 2) to help maintain sterility while allowing freedom of movement of the device (Para. 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang by Duarte, i.e. by using a rotatable base in Wang as in Duarte, for the predictable purpose of improving freedom of movement in the sterile system of Wang as in Duarte.
Regarding Claim 3, Wang modified by Duarte makes obvious the system of claim 1. Wang further teaches wherein the link is non-sterile and is covered by the external sterile cover, the external sterile cover being a sterile drape, sterile sleeve, or sterile cover (Para. 0164, “Additionally, the robotic arm assembly 26 is preferably covered with a sterile drape 125 so that it does not have to be sterilized either”).
Regarding Claim 5, Wang modified by Duarte makes obvious the system of claim 1. Wang further teaches wherein at least a portion of the sterile volume created by the shroud extends into a non-sterile field in a surgical environment (Fig. 1, the sterile field of a surgical field above the table, the non-sterile below).
Regarding Claim 6, Wang modified by Duarte makes obvious the system of claim 5. Wang further teaches wherein the non-sterile field is defined below a plane defined by a top surface of an operating table (Fig. 1, the sterile field of a surgical field above the table, the non-sterile below).
Regarding Claim 11, Wang modified by Duarte makes obvious the system of claim 1. Wang further teaches the system further comprising: an operating table comprising a top surface (operating table 14, the top surface the surface where patient 12 lays), wherein: a sterile field for surgery is defined above the top surface of the operating table, and a non-sterile field is defined below the top surface of the operating table (Fig. 1, the sterile field of a surgical field above the table, the non-sterile below); the shroud is coupled to the operating table (Fig. 1), and at least a portion of the sterile volume of the shroud extends into the non-sterile field (Fig. 1, housing 25 extending below the table); and the link of the manipulator assembly extends from the sterile volume of the shroud into the sterile field (Fig. 1, Para. 0065, “Each robotic arm assembly 26 has a base motor 34 which moves the arm assembly 26 in a linear fashion, relative to the base housing 25, as indicated by arrows Q” the inner channel is unnumbered internal path of housing 25).
Regarding Claim 15, Wang modified by Duarte makes obvious the system of claim 1. Wang further teaches wherein at least a portion of the shroud is straight such that the link of the manipulator assembly is slidingly received within the sterile volume along a straight path (Fig. 1, Para. 0065, “Each robotic arm assembly 26 has a base motor 34 which moves the arm assembly 26 in a linear fashion, relative to the base housing 25, as indicated by arrows Q” the inner channel is unnumbered internal path of housing 25).
Regarding Claim 25, Wang modified by Duarte makes obvious the system of Claim 1. Wang further teaches wherein: the link of the manipulator assembly is slidingly received within the sterile volume of the shroud at a proximal portion of the shroud (Fig. 1, arrow Q showing the link sliding below the table, the non-sterile field being defined as below the table). Wang does not explicitly teach wherein the distal portion of the shroud is closed.
However, Wang does teach other forms of housing that are closed for the purposes of protecting interior components (Para. 0200, “The articulable tool driver 500 includes a substantially hollow housing 502 having a closed first end 504 and a substantially open second end 504. Securely disposed interiorly the housing 502 is a gripper motor 506, and a pair of wrist motors 508 and 510. Each of the motors are in electrical connection with the controller 46”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, i.e. by specifying that the end of housing 25 is closed, for the predictable purpose of protecting the internal elements as proposed in the separate embodiment of Para. 0200.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080215065 awarded to Wang et al, in view of U.S. Patent Publication 20060076024 awarded to Duarte, further in view of U.S. Patent Publication 20090240204 awarded to Taylor et al.
Regarding Claim 4, Wang modified by Duarte makes obvious the system of Claim 3. Wang does not teach wherein the shroud is formed by an inverted portion of the external sterile cover.
However, in the art of surgical drapes and instrumentation (abstract), Taylor teaches the creation of a shroud using an inverted shroud portion (Para. 0007) made of an elastomeric material (Para. 0038) for the purposes of minimizing tearing of the material (Para. 0006).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang by Taylor, i.e. by creating an inverted shroud of Wang’s drape covering as in Taylor, for the predictable purpose of improving the durability of the draping system as set forth above in Para. 0006 of Taylor.
Claims 18, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20080215065 awarded to Wang et al, in view of U.S. Patent Publication 20060076024 awarded to Duarte, in view of U.S. Patent Publication 20080177285 awarded to Brock et al.
Regarding Claims 18 and 22, Wang modified by Duarte makes obvious the system of Claim 1. Wang further teaches the system further comprising: an operating table clamp (Para. 0061 “The system 10 is used to perform a procedure on a patient 12 that is typically lying on an operating table 14. Mounted to the operating table 14 is a first articulate arm 16, a second articulate arm 18 and a third articulate arm 20”). Wang does not teach wherein the shroud is coupled to the operating table clamp at a coupling member having one or more rotational degrees of freedom, or wherein the shroud is coupled to the operating table clamp at a coupling member having one or more translational degrees of freedom separate from a degree of freedom defined by the link of the manipulator assembly sliding within the sterile volume of the shroud.
However, in the art of surgical robots (abstract), Brock teaches a mounted surgical system (Fig. 8) provided on a rail for translation movement (rails 224) mounted to housing/shroud 8 (Fig. 8), configured for rotational movement of the instrument system to allow precise positioning of the tool (Fig. 2b, “A rotational movement J3 of just the guide tube results in the end of the guide tube and end of the inner shaft being taken out of the plane, following a circular path or orbit in accordance with rotation of the guide tube shaft. These three movements J1, J2 and J3 are defined as setting the position of the wrist joint 303 of the tool”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang by Brock, i.e. by using the positioning rail of Brock in the system of Wang, for the predictable purpose of improving the positioning abilities in Wang as is shown in Brock.
Regarding Claim 24, Wang modified by Duarte and Brock makes obvious the system of Claim 22, further teaches wherein: at least a portion of the shroud extends into a non-sterile field (Wang Fig. 1, showing housing 25 extending below the table, the non-sterile field being defined as below the table), translation of the coupling member moves at least a portion of the sterile volume of the shroud within the non-sterile field (using the rail system of Brock, Wang’s housing would be translationally moved in the non-sterile field.
Conclusion
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/JLM/
Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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