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 .
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 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.
Status of the Claims
The current office action is made responsive to claims filed 05/12/2026.
Acknowledgement is made to the amendment of claims 2 and 12-21.
Acknowledgement is made to the cancellation of claim 1.
Acknowledgement is made to the withdrawal of claims 8, 11, 15, and 18-20.
Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions.
Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention.
Claims 2-7, 9-10, 12-14, 16-17, and 21 are pending as rejected below. A complete action on the merits appears below.
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.
Claims 12-14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakare (US 20120323079 A1).
Regarding claim 12, Bakare teaches a colpotomy system (Abstract, [0051]), comprising:
a uterine manipulator (Fig. 2-5; instrument 5 for manipulating the uterus of a patient) including an elongated shaft assembly (Fig. 2-5; hollow shaft 20) defining a longitudinal axis and supporting a drive assembly (Fig. 2-5; handle 35); and
a colpotomy cup (Fig. 2-5; cup 15) supported on the elongated shaft assembly, wherein the colpotomy cup is radially movable relative to the longitudinal axis in response to actuation of the drive assembly ([0054]).
Regarding claim 13, Bakare teaches the colpotomy system of claim 12, wherein the colpotomy cup includes at least one leaflet that is movable relative to the longitudinal axis ([0073]).
Regarding claim 14, Bakare teaches the colpotomy system of claim 13, wherein the at least one leaflet includes at least two leaflets that are movable relative to one another ([0073]).
Regarding claim 16, Bakare teaches the colpotomy system of claim 14, wherein the at least two leaflets are spaced apart from one another ([0073]).
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:
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.
Claim 2-7, 9-10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bakare (US 20120323079 A1) in view of Omori (US 20100331859 A1).
Regarding claim 2, Bakare teaches a colpotomy system (Abstract, [0051]), comprising:
a uterine manipulator (Fig. 2-5; instrument 5 for manipulating the uterus of a patient) including an elongated shaft assembly (Fig. 2-5; hollow shaft 20) defining a longitudinal axis; and
a colpotomy cup (Fig. 2-5; cup 15) supported on the elongated shaft assembly, wherein the colpotomy cup is radially movable relative to the longitudinal axis ([0054]).
However, Bakare fails to teach the colpotomy system as being a robotic system.
Omori teaches a medical robot system including a uterine manipulator which is a medical manipulator for supporting a uterus of a patient and is applied to procedures, such as hysterectomies ([0031]). This system being provided so as to account for the differences in shapes of organs, such as uteruses, which standard devices, such as medical manipulators, do not account for ([0007]).
Omori further teaches the robotic system ([0031]) comprising: a robotic arm (Fig. 7 uterine manipulator 34 is detachably provided onto a slider 50 of the from end of robot arm 24); and the instrument drive unit being supported on the robotic arm (Fig. 2; slider 50 is provided with motors 52, 54, and 56 for controlling the movement of the medical device, in this case, uterine manipulator 34 which is utilized for performing the above discussed medical procedure).
Therefore, it would have been obvious to incorporate these robotic features of Omori into the device of Bakare to provide a system which can take into account differences in organs shapes and size, such as is relevant with the uterus, to appropriately support the organ during procedures such as hysterectomies, as is taught by Omori.
Regarding claim 3, Bakare teaches the robotic colpotomy system of claim 2, further comprising a distal tip (Fig. 2-5; hollow projection 95 comprised of a proximal frustoconical portion 100 having a helical thread 110 and a distal tubular portion 105 having guide assembly 115) that extends distally beyond the colpotomy cup ([0055]).
Regarding claim 4, Bakare teaches the robotic colpotomy system of claim 3, wherein the distal tip is coupled to a drive assembly and is movable relative to the colpotomy cup ([0053], [0068]).
Regarding claim 5, Bakare teaches the robotic colpotomy system of claim 3, wherein the distal tip is rotatable about the longitudinal axis ([0064] discusses the helical thread of the hollow projection as engaging the cervix by a forward motion which is provided by rotationally turning the projection by the control of the device therefore rotating the distal tip relative specifically to the longitudinal axis, therefore teaching this limitation as broadly as is currently claimed).
Regarding claim 6, Bakare teaches the robotic colpotomy system of claim 5, wherein the colpotomy cup moves relative to the longitudinal axis in response to rotation of the distal tip ([0064] teaches this limitation as broadly as is currently claimed, as movement of the longitudinal axis encompasses rotational, linear, etc. movements).
Regarding claim 7, Bakare teaches the robotic colpotomy system of claim 6, wherein the distal tip is axially movable relative to the colpotomy cup ([0059] discusses the atraumatic tip of the guide of the guide assembly as being moveable between retracted and projected positions).
Regarding claim 9, Bakare teaches the robotic colpotomy system of claim 2, wherein the colpotomy cup includes at least one leaflet that is movable relative to the longitudinal axis ([0073]).
Regarding claim 10, Bakare teaches the robotic colpotomy system of claim 9, wherein the at least one leaflet includes at least two leaflets that are movable relative to one another ([0073]).
Regarding claim 21, Bakare teaches a colpotomy system (Abstract, [0051]), comprising:
a uterine manipulator (Fig. 2-5; instrument 5 for manipulating the uterus of a patient)) supporting a drive assembly (Fig. 2-5; handle 35) and including an elongated shaft assembly (Fig. 2-5; hollow shaft 20); and
a colpotomy cup (Fig. 2-5; cup 15) supported on the elongated shaft assembly and including at least two leaflets that are radially movable relative to one another in response to actuation of the drive assembly ([0054], [0073]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bakare (US 20120323079 A1) in view of Richard (US 6383195 B1).
Regarding claim 17, Bakare teaches the colpotomy system of claim 16.
However, Bakare fails to teach the system wherein the drive assembly includes a cinch that is actuatable to tighten or loosen cinch to selectively move the at least two leaflets relative to one another.
Richard teaches an apparatus for surgical use (Fig. 2; apparatus 100) having a cage assembly (Fig. 2; cage assembly 15) located at a distal end of an outer tube assembly (Fig. 2; outer tube assembly 40), the cage assembly having a plurality of spring loaded strips (Fig. 2-4; strips 21-26) which form the cage and an instrument (Fig. 2; instrument 80) having a distal end located within the cage assembly, where the cage assembly is adjustable between an open position and a closed position (Col. 7, Lines 10-15).
Richard further teaches the cage as being cinched closed by a drawstring positioned at the distal tips of the specimen cage supporting means (Col. 9, Lines 40-45).
Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the drawstring which is attached to the distal elements in the cage assembly, as is taught by Richard, into the instrument which has portions which can be adjusted between opened and closed positions as is taught by Bakare, to produce the predictable result of moving the distal element which opens and closes between the open and closed positions, as is taught by Richard, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.L./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights