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
Claims 1, 4, 8-10, 22, and 26-27 are objected to because of the following informalities.
Claim 1, lines 15-16, “said connector” should read “said corresponding connector”.
Claim 4, lines 2-3, “said housing” should read “said rigid housing”.
Claim 8, line 1, “rigid housing” should read “said rigid housing”.
Claim 9, line 1, “rigid housing” should read “said rigid housing”.
Claim 10, line 1, “rigid housing” should read “said rigid housing”.
Claim 22, line 1, “rigid housing” should read “said rigid housing”.
Claim 26, lines 2-3, “said housing” should read “said rigid housing”.
Claim 26, line 5, “said housing” should read “said rigid housing”.
Claim 27, line 1, “rigid housing” should read “said rigid housing”.
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 1-28 are rejected under 35 U.S.C. 103 as being unpatentable under US 20080138780 A1 (“Eggert”) in view of US 5524816 A (“Zriny”) and US 20170011659 A1 (“Watanabe”).
In regards to claim 1, Eggert discloses the following limitations with the exception of the underlined limitations.
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, a body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body ([0090], “A pelvic region … of the torso … receives a pair of legs”), said body model further comprising: a urinary bladder model housed within said lightweight material;
a proximal urethra model housed at least partially within said lightweight material ([0104], “the vulva … may comprise … a urinary tract” Examiner notes that the urethra is a part of the urinary tract.), said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector ([0088], “Lines … protrude from the torso … for providing … fluid connections” Examiner notes that a line may represent a first canal.);
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 urethral model comprising ([0131], “The torso … includes an interchangeable genitalia … that is adapted to receive both male and female genitalia pieces” Examiner notes that a male or female genitalia can be used to create urethral models.) a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith ([0088], “Lines … protrude from the torso … for providing … pneumatic or fluid connections” Examiner notes that a line may represent a second canal and that a pneumatic connection can be a mechanical connection.), 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 … pneumatic or fluid connections” Examiner notes that the urethra and bladder are located inside the torso.).
Zriny discloses
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, as disclosed by Zriny, to provide a storage box and storage lid for creating a storage area underneath a bed.
Watanabe discloses
said body model further comprising: a urinary bladder model housed within said lightweight material ([0019], “The urinary bladder model and the urethra connected … employ a soft raw material”);
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material, as disclosed by Watanabe, to provide a urinary bladder model and urethra for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 2, Eggert discloses
wherein at least a portion of said body model is permanently attached to an internal surface of said rigid housing ([0144], “The locking portion … and housing … can be permanently secured together (e.g. glued)” Examiner notes that the body model may be permanently attached or glued to the storage box disclosed by Zriny.).
In regards to claim 3, Eggert discloses
wherein at least a portion of said body model is releasably attached to an internal surface of said rigid housing ([0144], “The locking portion … and housing … can be … temporarily secured together” Examiner notes that the body model may be temporarily secured to the storage box lid disclosed by Zriny.).
In regards to claim 4, Eggert does not disclose wherein said rigid housing comprises a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration.
Zriny discloses
wherein said rigid housing comprises a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed and wherein said rigid housing comprises a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration, as disclosed by Zriny, to provide a storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 5, Eggert discloses
wherein at least a portion of said body model is attached to an internal surface of said movable flap ([0144], “The locking portion … and housing … can be … temporarily secured together” Examiner notes that the body model may be attached to the lid of the storage box disclosed by Zriny.).
In regards to claim 6, Eggert does not disclose wherein said rigid housing is dimensioned to accommodate said body model and said at least one genitalia accessory when said rigid housing is in the closed configuration.
Zriny discloses
wherein said rigid housing is dimensioned to accommodate said body model and said at least one genitalia accessory when said rigid housing is in the closed configuration (column 7, lines 35-37, “The storage boxes can be specially designed to create a storage box system which matches the box size to the dimensions of the specific bed sizes” Examiner notes that the height underneath a typical standard bed is at least 22 inches and that the depth of a training manikin laid flat ranges from 10 inches to 18 inches.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed and wherein said rigid housing is dimensioned to accommodate said body model and said at least one genitalia accessory when said rigid housing is in the closed configuration, as disclosed by Zriny, to provide a customizable storage box for creating a storage area underneath a bed.
In regards to claim 7, Eggert does not disclose wherein said rigid housing is further dimensioned to further accommodate materials associated with at least one of a printed instruction guide, a urinary catheter, adhesive tape, a box of examination gloves, and cleaning materials/wipes.
Zriny discloses
wherein said rigid housing is further dimensioned to further accommodate materials associated with at least one of a printed instruction guide, a urinary catheter, adhesive tape, a box of examination gloves, and cleaning materials/wipes (column 7, lines 47-49, “the storage box length is approximately 1/2 of the bed width and the storage box width approximately 1/3 the bed length” Examiner notes that the size of the storage box can accommodate materials associated with at least one of a printed instruction guide, a urinary catheter, adhesive tape, a box of examination gloves, and cleaning materials/wipes.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, wherein said rigid housing is dimensioned to accommodate said body model and said at least one genitalia accessory when said rigid housing is in the closed configuration, and wherein said rigid housing is further dimensioned to further accommodate materials associated with at least one of a printed instruction guide, a urinary catheter, adhesive tape, a box of examination gloves, and cleaning materials/wipes, as disclosed by Zriny, to provide a storage box for creating a storage area underneath a bed.
In regards to claim 8, Eggert does not disclose wherein rigid housing is configured to be stackable by having a box-like shape.
Zriny discloses
wherein rigid housing is configured to be stackable by having a box-like shape (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that a rectangular shape is considered a box-like structure.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed and wherein rigid housing is configured to be stackable by having a box-like shape, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 9, Eggert does not disclose wherein rigid housing is configured to be stackable by having one of a strictly cuboid and a not strictly cuboid shape.
Zriny discloses
wherein rigid housing is configured to be stackable by having one of a strictly cuboid and a not strictly cuboid shape (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that a rectangular shape can be a cuboid shape or not a cuboid shape.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed and wherein rigid housing is configured to be stackable by having one of a strictly cuboid and a not strictly cuboid shape, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 10, Eggert does not disclose wherein rigid housing defines at least one of an external flange and a handle to facilitate manually grasping of said rigid housing.
Zriny discloses
wherein rigid housing defines at least one of an external flange and a handle to facilitate manually grasping of said rigid housing (column 4, lines 33-34, “handle extends through … front panel”).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed and wherein rigid housing defines at least one of an external flange and a handle to facilitate manually grasping of said rigid housing, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 11, Eggert discloses
wherein said body model is constructed of a sheet material filled with a stuffing material ([0015], “The patient simulator includes a patient body comprising … simulated body portions.” Examiner notes that simulated body portions can be comprised of sheet material and stuffing material.).
In regards to claim 12, Eggert discloses
wherein said body model is constructed of a fabric-type material selected from a group consisting of vinyl, polyethylene and polypropylene fabric, and said stuffing material is selected from a group consisting of foam and polyester wool filling ([0015], “The patient simulator includes a patient body comprising … simulated body portions.” Examiner notes that simulated body portions can be comprised of fabric-type (vinyl, etc.) material and stuffing material comprised of foam and wool.).
In regards to claim 13, Eggert discloses
wherein at least one of said torso element and said pair of leg elements comprises a mounting structure ([0023], “FIG. 5a is a … view of the patient simulator” Examiner notes that annotated Eggert Fig. 5a depicts a torso and legs comprising a mounting structure.), and wherein said at least one genitalia accessory comprises a complementary mounting structure, for mounting said at least one genitalia accessory in an anatomically correct position adjacent a juncture of said pair of leg elements ([0131], “The torso … also includes an interchangeable genitalia site … that is adapted to receive both male and female genitalia pieces (not shown).”).
In regards to claim 14, Eggert discloses
wherein said at least one genitalia accessory comprises a female genitalia model accessory and a male genitalia model accessory ([0131], “The torso … also includes an interchangeable genitalia site … that is adapted to receive both male and female genitalia pieces (not shown).”).
In regards to claim 15, Eggert discloses
wherein said female genitalia model accessory is fixedly attached to said body model, and wherein said male genitalia model accessory is configured for attachment over said female genitalia accessory by way of a mounting structure ([0131], “The torso … also includes an interchangeable genitalia site … that is adapted to receive both male and female genitalia pieces (not shown).” Examiner notes that annotated Eggert Fig. 5a depicts a torso and legs comprising a mounting structure that can be used for male genitalia configured for attachment over female genitalia.).
In regards to claim 16, Eggert does not disclose wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body.
Watanabe discloses
wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body ([0062], “the … cavity simulator … is equipment for training of suturing the urinary bladder model” Examiner notes that a urinary bladder model can be constructed using a body bottle with a lid defining an outlet and that a urinary bladder model inherently has a fluid-tight seal.).
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material and wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body, as disclosed by Watanabe, to provide a urinary bladder model for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 17, Eggert does not disclose wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet.
Watanabe discloses
wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet ([0062], “the … cavity simulator … is equipment for training of suturing the urinary bladder model” Examiner notes that a urinary bladder model can be constructed using a body bottle with a lid defining an outlet and that a urinary bladder model typically does have a cavity with a substantially larger cross section than its outlet.).
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material, wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body, and wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet, as disclosed by Watanabe, to provide a urinary bladder model for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 18, Eggert does not disclose wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model.
Watanabe discloses
wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model ([0074], “the model gripping portion … can store the urinary bladder model in the recession … extensively attached to the side of the pelvis” Examiner notes that the recession may represent the internal pocket of claimed invention, since the recession stores the urinary bladder model and may store a portion of the urethra model.).
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material, wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body, and wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet and wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model, model gripping portion, and recession for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 19, Eggert discloses the following limitations with the exception of the underlined limitations.
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration;
a body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body ([0090], “A pelvic region … of the torso … receives a pair of legs”), said body model further comprising: a urinary bladder model housed within said lightweight material;
a proximal urethra model housed at least partially within said lightweight material ([0104], “the vulva … may comprise … a urinary tract” Examiner notes that the urethra is a part of the urinary tract.), said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector ([0088], “Lines … protrude from the torso … for providing … fluid connections” Examiner notes that a line may represent a first canal.);
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 urethral model comprising ([0131], “The torso … includes an interchangeable genitalia … that is adapted to receive both male and female genitalia pieces” Examiner notes that a male or female genitalia can be used to create urethral models.) a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith ([0088], “Lines … protrude from the torso … for providing … pneumatic or fluid connections” Examiner notes that a line may represent a second canal and that a pneumatic connection can be a mechanical connection.), 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 … pneumatic or fluid connections” Examiner notes that the urethra and bladder are located inside the torso.).
Zriny discloses
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.), said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.);
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
Watanabe discloses
said body model further comprising: a urinary bladder model housed within said lightweight material ([0019], “The urinary bladder model and the urethra connected … employ a soft raw material”);
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration, as disclosed by Watanabe, to provide a urinary bladder model and urethra for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 20, Eggert discloses
wherein at least a portion of said body model is attached to an internal surface of said rigid housing ([0144], “The locking portion … and housing … can be permanently secured together (e.g. glued)” Examiner notes that the body model may be permanently attached or glued to the rigid container disclosed by Zriny.).
In regards to claim 21, Eggert discloses
wherein at least a portion of said body model is attached to an internal surface of said movable flap ([0144], “The locking portion … and housing … can be … secured together” Examiner notes that the body model may be attached to the lid of the rigid container disclosed by Zriny.).
In regards to claim 22, Eggert does not disclose wherein rigid housing is configured to be stackable by having a box-like shape.
Zriny discloses
wherein rigid housing is configured to be stackable by having a box-like shape (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that a rectangular shape is considered a box-like structure.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration and wherein rigid housing is configured to be stackable by having a box-like shape, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 23, Eggert discloses
wherein said body model is constructed of a sheet material and filled with a stuffing material ([0015], “The patient simulator includes a patient body comprising … simulated body portions.” Examiner notes that simulated body portions can be comprised of sheet material and stuffing material.).
In regards to claim 24, Eggert discloses
wherein at least one of said torso element and said pair of leg elements comprises a mounting structure ([0023], “FIG. 5a is a … view of the patient simulator” Examiner notes that annotated Eggert Fig. 5a depicts a torso and legs comprising a mounting structure.), and wherein said at least one genitalia accessory comprises a complementary mounting structure, for mounting said at least one genitalia accessory in an anatomically correct position adjacent a juncture of said pair of leg elements ([0131], “The torso … also includes an interchangeable genitalia site … that is adapted to receive both male and female genitalia pieces (not shown).”).
In regards to claim 25, Eggert does not disclose wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model.
Watanabe discloses
wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model ([0074], “the model gripping portion … can store the urinary bladder model in the recession … extensively attached to the side of the pelvis” Examiner notes that the recession may represent the internal pocket of claimed invention, since the recession stores the urinary bladder model and may store a portion of the urethra model.).
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material, wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body, and wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet, wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model, and wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model, model gripping portion, and recession for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 26, Eggert discloses the following limitations with the exception of the underlined limitations.
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration; a body model constructed of a lightweight sheet material filled with a stuffing material ([0015], “The patient simulator includes a patient body comprising … simulated body portions.” Examiner notes that simulated body portions can be comprised of sheet material and stuffing material.), said body model defining a torso element and a pair of leg elements configured in correspondence to a human body ([0090], “A pelvic region … of the torso … receives a pair of legs”), at least a portion of said body model is attached to an internal surface of said moveable flap ([0144], “The locking portion … and housing … can be … secured together” Examiner notes that the body model may be attached to the lid of the rigid container disclosed by Zriny.), said body model further comprising: a urinary bladder model housed within said lightweight material;
a proximal urethra model housed at least partially within said lightweight material ([0104], “the vulva … may comprise … a urinary tract” Examiner notes that the urethra is a part of the urinary tract.), said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector ([0088], “Lines … protrude from the torso … for providing … fluid connections” Examiner notes that a line may represent a first canal.);
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 urethral model comprising ([0131], “The torso … includes an interchangeable genitalia … that is adapted to receive both male and female genitalia pieces” Examiner notes that a male or female genitalia can be used to create urethral models.) a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith ([0088], “Lines … protrude from the torso … for providing … pneumatic or fluid connections” Examiner notes that a line may represent a second canal and that a pneumatic connection can be a mechanical connection.), 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 … pneumatic or fluid connections” Examiner notes that the urethra and bladder are located inside the torso.).
Zriny discloses
A catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.), said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that securing the lid over the storage box places the storage box in a closed configuration and that removing the lid from the storage box places the storage box in an open configuration.);
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
Watanabe discloses
said body model further comprising: a urinary bladder model housed within said lightweight material ([0019], “The urinary bladder model and the urethra connected … employ a soft raw material”);
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration, as disclosed by Watanabe, to provide a urinary bladder model and urethra for a peritoneal cavity simulator that teaches laparoscopic surgery.
In regards to claim 27, Eggert does not disclose wherein rigid housing is configured to be stackable by having a box-like shape.
Zriny discloses
wherein rigid housing is configured to be stackable by having a box-like shape (column 2, lines 48-51, “The storage box … is defined by storage box lid … and lower storage box …, both of which are rectangular in shape” Examiner notes that a rectangular shape is considered a box-like structure.).
Eggert and Zriny combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, a catheterization training device comprising: a rigid housing being configurable in each of a closed configuration in which said housing defines an enclosed internal cavity having a volume, and an open configuration in which said internal cavity is not enclosed, said rigid housing comprising a movable flap operable to move between a first position in which said housing is in the closed configuration, and a second position in which said rigid housing is in the open configuration and wherein rigid housing is configured to be stackable by having a box-like shape, as disclosed by Zriny, to provide a rectangular-shaped storage box and storage lid for creating a storage area underneath a bed.
In regards to claim 28, Eggert does not disclose wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model.
Watanabe discloses
wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model ([0074], “the model gripping portion … can store the urinary bladder model in the recession … extensively attached to the side of the pelvis” Examiner notes that the recession may represent the internal pocket of claimed invention, since the recession stores the urinary bladder model and may store a portion of the urethra model.).
Eggert and Watanabe combined are considered analogous to the claimed invention because they are in the field of patient simulator systems and storage boxes. 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 body model constructed of lightweight material defining a torso element and a pair of leg elements configured in correspondence to a human body, said body model further comprising: a urinary bladder model housed within said lightweight material; a proximal urethra model housed at least partially within said lightweight material, said proximal urethra model defining a first canal in fluid communication with said urinary bladder model and terminating in a connector; 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 urethral model comprising a second canal terminating in a corresponding connector, said corresponding connector being operable to form a mechanical interconnection with said connector of said body model to form a fluid-tight interconnection therewith, and a continuous canal through said distal urethra model and said proximal urethra model and into said urinary bladder model, as disclosed by Eggert, said body model further comprising: a urinary bladder model housed within said lightweight material, wherein said urinary bladder model comprises a bottle body and a reclosable matable lid defining an outlet, said lid being configured to form a fluid-tight seal with said bottle body, and wherein said bottle body defines a bladder cavity having a cross-section substantially larger in cross-section than a cross-section of said outlet and wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model, and wherein said body model defines a pocket internal to said body model and closable by a reclosable fastener, said pocket being dimensioned to house said urinary bladder model and at least a portion of said proximal urethra model, as disclosed by Watanabe, to provide a urinary bladder model, model gripping portion, and recession for a peritoneal cavity simulator that teaches laparoscopic surgery.
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 normally 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.
Publication Information
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/LISA H ANTOINE/Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715