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 .
Reply to Response to Restriction Requirement and Election
This is a Non-Final office action in response to communications filed on June 10,
2026. In response to Examiner’s restriction requirement and election, Applicant elected without traverse, Group I, claims 1-8, for prosecution on the merits. Therefore, Claims 1-8 remain pending in the application.
Claim Objections
Claims 2 and 4 are objected to because of the following informalities.
• Claim 2, line 2, “a motor” should read as “said motor”.
• Claim 4, line 2, “a pump” should read as “said pump”.
Appropriate correction is required.
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:
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 nonobviousness.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable under US 20080138780 A1 (“Eggert”) in view of US 20170011659 A1 (“Watanabe”).
In regards to claim 1, Eggert discloses the following limitations with the exception of the underlined limitations.
A smart urinary ([0104], “The … simulator … may comprise … a urinary tract”) catheterization ([0109], “The torso … provides a site for catheterization”) training device comprising ([0121], “The program … provides … training”): a body model representative of human anatomy and defining at least ([0011], “The method includes … a model … of a human body”): a urinary bladder model;
and a proximal urethra model defining a first canal in fluid communication with said urinary bladder model ([0088], “Lines … protrude from the torso … for providing … fluid connections”);
an actuator ([0243], “the driver … drives … actuators”) disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model ([0145], “the solenoid is disposed within the … simulator … adjacent the actuator”);
a motor operatively connected to said actuator ([0273], “module … is configured to actuate a motor”);
and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model ([0069], “the system … contains a microcontroller”).
Watanabe discloses
a urinary bladder model ([0041], “A plan view of the urinary bladder model”);
and a proximal urethra model ([0043], “An explanatory view … for the urine duct”)
Eggert and Watanabe are considered analogous to the claimed invention because they are in the field of patient simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, as disclosed by Eggert, a urinary bladder model and a proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training. One skilled in the art would recognize and value the addition of a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training.
In regards to claim 2, Eggert discloses the following limitations with the exception of the underlined limitation.
wherein said actuator comprises a motor ([0273], “module … is configured to actuate a motor”) and at least one of a clamp, a cam, a snare-link compression band, and a pressure plate operable to move between a first position, in which said cam impinges upon said portion of ([0101], “the cams … may be located at places along the tracks”) said proximal urethra model to at least partially obstruct ([0182], “The … control module … is a pneumatic module configured to … partially obstruct an airway”) said first canal, and a second position, in which ([0088], “Lines … protrude from the torso … for providing … fluid connections”) said cam does not impinge upon said portion of said proximal urethra model ([0101], “the cams … may be located at places along the tracks”).
Watanabe discloses
said proximal urethra model to ([0043], “An explanatory view … for the urine duct”)
Eggert and Watanabe are considered analogous to the claimed invention because they are in the field of patient simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, wherein said actuator comprises a motor and at least one of a clamp, a cam, a snare-link compression band, and a pressure plate operable to move between a first position, in which said cam impinges upon said portion of at least partially obstruct said first canal, and a second position, in which said cam does not impinge upon said portion of said proximal urethra model, as disclosed by Eggert, a urinary bladder model and a proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training. One skilled in the art would recognize and value the addition of a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training.
In regards to claim 3, Eggert discloses the following limitations with the exception of the underlined limitation.
wherein said actuator comprises ([0243], “the driver … drives … actuators”) a pump operable to move ([0092], “the electric pump may be controlled … through a computer system”) at least one of a hydraulic actuator and a pneumatic operator between a first position, in which said at least one of said hydraulic actuator and said pneumatic operator impinges upon ([0243], “the driver … drives … mechanical actuators, pneumatic actuators”) said portion of said proximal urethra model to
at least partially obstruct said first canal, and a second position, in which said hydraulic actuator and said pneumatic operator does not impinge upon said portion of said proximal urethra model ([0182], “The … control module … is a pneumatic module configured to … partially obstruct an airway”).
Watanabe discloses
said portion of said proximal urethra model to ([0043], “An explanatory view … for the urine duct”)
Eggert and Watanabe are considered analogous to the claimed invention because they are in the field of patient simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, as disclosed by Eggert, a urinary bladder model and a proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training. One skilled in the art would recognize and value the addition of a urinary bladder model and a urine duct for a peritoneal cavity simulator used in laparoscopic surgery training.
In regards to claim 4, Eggert discloses the following limitations with the exception of the underlined limitations.
wherein said actuator comprises ([0243], “the driver … drives … actuators”) a pump operable to control ([0092], “the electric pump may be controlled … through a computer system”) inflation of ([0178], “movement … is actuated by … the inflation and deflation”) a bladder between a first state, in which said bladder impinges upon said portion of said proximal urethra model to at least partially obstruct said first canal, and a second state, in which said bladder does not impinge upon said portion of said proximal urethra model.
Watanabe discloses
a bladder between a first state ([0064], “a urinary bladder model … is disposed detachably to the … simulator”), in which said bladder impinges upon ([0062], “the … simulator … is equipment for training of suturing the urinary bladder model … and the urine duct”) said portion of said proximal urethra model to at least partially obstruct said first canal, and a second state, in which said bladder does not impinge upon said portion of said proximal urethra model ([0043], “An explanatory view … for the urine duct”).
Eggert and Watanabe are considered analogous to the claimed invention because they are in the field of patient simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, wherein said actuator comprises a pump operable to control inflation of, as disclosed by Eggert, a urinary bladder model and a proximal urethra model, a bladder between a first state, in which said bladder impinges upon said portion of said proximal urethra model to at least partially obstruct said first canal, and a second state, in which said bladder does not impinge upon said portion of said proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model, a urine duct, and a simulator for a peritoneal cavity simulator used in laparoscopic surgery training. One skilled in the art would recognize and value the addition of a urinary bladder model, a urine duct, and a simulator for a peritoneal cavity simulator used in laparoscopic surgery training.
In regards to claim 5, Eggert discloses
further comprising an input device comprising at least one user-operable button usable to provide input to select a training mode ([0129], “a selectable On button … for turning on the monitor”), said microcontroller being configured to control said motor as a function of a user-selected training mode ([0069], “the system … contains a microcontroller”).
In regards to claim 7, Eggert discloses
wherein said input device comprises a display ([0096], “The user interface can include a graphical display”), and said at least one user-operable button is separate from said display ([0129], “a selectable On button … for turning on the monitor”).
In regards to claim 8, Eggert discloses the following limitations with the exception of the underlined limitation.
wherein said proximal urethra model terminates in a connector, said smart urinary catheterization training device further comprising ([0121], “The program … provides … training”): at least one genitalia accessory having a configuration of one of human male and human female genitalia, said at least one genitalia accessory defining a distal urethra model comprising a second canal terminating in ([0131], “The torso … includes an interchangeable genitalia site … that is adapted to receive both male and female genitalia pieces”) a corresponding connector, said corresponding connector being operable to form ([0086], “the connectors may be equipped with adhesive to … hold them in place”) a mechanical interconnection with said connector of said proximal urethra model to form a fluid-tight interconnection therewith ([0086], “The interaction between … connectors … confirms proper placement”), and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model ([0088], “Lines … protrude from the torso … for providing … fluid connections”).
Watanabe discloses
wherein said proximal urethra model terminates in a connector ([0019], “The urinary bladder model and the urethra connected thereto”)
Eggert and Watanabe are considered analogous to the claimed invention because they are in the field of patient simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, as disclosed by Eggert, a urinary bladder model and a proximal urethra model, wherein said proximal urethra model terminates in a connector, as disclosed by Watanabe, to provide a urinary bladder model, a urine duct, and urethra for a peritoneal cavity simulator used in laparoscopic surgery training. One skilled in the art would recognize and value the addition of a urinary bladder model, a urine duct, and urethra for a peritoneal cavity simulator used in laparoscopic surgery training.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable under Eggert in view of Watanabe and US 20200237452 A1 (“Wolf”).
In regards to claim 6, Eggert discloses the following limitation with the exception of the underlined limitation.
wherein said input device comprises a touchscreen display, and said at least one user-operable button is displayed on said touchscreen display ([0129], “a selectable On button … for turning on the monitor”).
Wolf discloses
wherein said input device comprises a touchscreen display ([0113], “selecting the marker may include … touching the marker on a touch sensitive screen”)
Eggert and Wolf combined are considered analogous to the claimed invention because they are in the field of patient simulators and surgical video analysis. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a smart urinary catheterization training device comprising: a body model representative of human anatomy and defining at least; defining a first canal in fluid communication with said urinary bladder model; an actuator disposed adjacent said proximal urethra model and operable to impinge upon a portion of said proximal urethra model; a motor operatively connected to said actuator; and a microcontroller operatively connected to said motor to control said motor to cause said actuator to selectively impinge upon said portion of said proximal urethra model, as disclosed by Eggert, wherein said input device comprises a touchscreen display, as disclosed by Wolf, to provide a marker and a touch-sensitive screen for systems and methods that analyze surgical procedure videos. One skilled in the art would recognize and value the addition of a marker and a touch-sensitive screen for systems and methods that analyze surgical procedure videos.
Contact Information
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Lisa Antoine whose telephone number is
(571) 272-4252 and whose email address is lantoine@uspto.gov. The examiner can be reached Monday-Thursday, 7:30 am-5:30 pm CT. 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, Xuan Thai, can be reached on (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/LISA H ANTOINE/
Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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