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 .
Response to Amendment with RCE
The amendment filed August 5, 2026 has been entered. Claims 1 and 16 have been amended. Claim 17 was cancelled. Claims 1-16 and 18-20 remain pending in the application.
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 1-2, 4-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable under US 20210196165 A1 (“Aoyagi”) in view of US 20170372639 A1 (“Cowperthwait”), US 20130330700 A1 (“Feins”), US 20180338806 A1 (“Grubbs”), and US 20090130646 A1 (“Fletcher”).
In regards to claim 1, Aoyagi discloses the following limitations with the exception of the underlined limitations.
A simulation device allowing a user to practice use of a capillary blood collection device, the simulation device comprising ([0001], “The disclosure … relates … to a device for … collecting a tiny amount of blood from a blood capillary”):
a base support ([0013], “FIG. 1 is … a blood collection device fixed to a support”);
a puncture target connected to the base support and configured to be repeatedly punctured by a lancet of the capillary blood collection device to practice use of the capillary blood collection device, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers;
and a fluid circulating system comprising a fluid reservoir, at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, tubing extending at least partially through the puncture target between the reservoir and the at least one port, and a pump for circulating fluid from the reservoir to the at least one port, wherein the puncture target is sized to be connected to the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established ([0032], “the device … is … comprised of … intermediaries for fluid communication between the … tube … and the pressure source.” Examiner notes that the pressure source can be a reservoir.) and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device, and wherein the at least one port comprises a sealed cavity recessed within the plurality of elongated members and fluidly connected to the tubing, the cover comprises an elastomeric sheet, and both the at least one port or the cover are self-sealing such that, upon removal of the lancet from the puncture target, the at least one port and the cover reseal puncture openings formed by the lancet puncturing the puncture target.
Cowperthwait discloses
A simulation device allowing a user to practice use of ([0002], “The present invention relates … to simulation devices … to provide medical treatment”)
a lancet of the capillary blood collection device to practice use of the capillary blood collection device ([0078], “insertion of a metal needle” Examiner notes that a lancet is a metal needle.);
and a fluid circulating system comprising a fluid reservoir ([0061], “device … may include … reservoirs … adapted to store fluid”),
tubing extending at least partially through the puncture target between the reservoir and the at least one port ([0005], “The reservoir is coupled to provide the fluid to the at least one tube.”), and a pump for circulating fluid from the reservoir to the at least one port ([0061], “The reservoirs fluid … may further include … pumps … for pushing fluid into tubes … during the simulated treatment of the patient.”), and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device ([0075], “Collector … may include … drainage outlets … to allow drainage of the fluid in collector ... reservoir ... and collector … provide … control over the pumping of fluid” Examiner notes that drainage outlets can be used as containers to collect fluid.)
the cover comprises an elastomeric sheet ([0068], “layer … is formed from … rubber”)
Aoyagi and Cowperthwait combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a simulation device allowing a user to practice use of, a lancet of the capillary blood collection device to practice use of the capillary blood collection device; and a fluid circulating system comprising a fluid reservoir, tubing extending at least partially through the puncture target between the reservoir and the at least one port, and a pump for circulating fluid from the reservoir to the at least one port, and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device, the cover comprises an elastomeric sheet, as disclosed by Cowperthwait, to provide a metal needle, reservoirs, a tube, pumps, a collector, drainage outlets, and rubber for simulation devices that train care providers who provide medical treatment. One skilled in the art would understand and recognize the value of the addition of a metal needle, reservoirs, a tube, pumps, a collector, drainage outlets, and rubber for simulation devices that train care providers who provide medical treatment.
Feins discloses
a puncture target connected to the base support configured to be repeatedly punctured by ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that in the claimed invention the puncture target may be “an anatomically accurate model … of a human hand” [0078].);
at least one port ([0019], “The mannequin may include … holes”) positioned within the plurality of elongated members such that ([0010], “FIG. 1 … may include … mannequin hands”), wherein the puncture target is sized to be connected to ([0017], “Some mannequin … pieces may be sized”)
and comprising a plurality of elongated members representing fingers ([0014], “FIG. 1 is a top view of a segmented mannequin” Examiner notes that FIG. 1 depicts a plurality of members representing fingers.)
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that and comprising a plurality of elongated members representing fingers, as disclosed by Feins, to provide mannequin hands, holes, and sized pieces for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands, holes, and sized pieces for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
Grubbs discloses
the cover covers the at least one port ([0351], “an enlarged view … shows … simulated human skin covering”)
the puncture target formed from an internal frame structure and a cover over the internal frame structure ([0340], “Markers can be placed in the mannequin … The markers help create the three-dimensional … frame”)
and wherein the at least one port comprises a sealed cavity recessed within the plurality of elongated members and fluidly connected to the tubing ([0117], “The mannequin may include … holes to remove excess … from the … cavity)
Aoyagi and Grubbs combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, the cover covers the at least one port the puncture target formed from an internal frame structure and a cover over the internal frame structure and wherein the at least one port comprises a sealed cavity recessed within the plurality of elongated members and fluidly connected to the tubing, as disclosed by Grubbs, to provide simulated human skin covering, markers, a frame, and a cavity for robotic surgery systems and sensing the forces experienced by the patient during robotic surgery. One skilled in the art would understand and recognize the value of the addition of simulated human skin covering, markers, a frame, and a cavity for robotic surgery systems and sensing the forces experienced by the patient during robotic surgery.
Fletcher discloses
and both the at least one port or the cover are self-sealing such that, upon removal of the lancet from the puncture target, the at least one port and the cover reseal puncture openings formed by the lancet puncturing the puncture target ([0023], “The … cavities … may be sealed … with septums or self-healing seals)
Aoyagi and Fletcher combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, and both the at least one port or the cover are self-sealing such that, upon removal of the lancet from the puncture target, the at least one port and the cover reseal puncture openings formed by the lancet puncturing the puncture target, as disclosed by Fletcher, to provide septums or self-healing seals for fluid collection devices wherein multiple, individual samples of fluid from the same source can be withdrawn simultaneously. One skilled in the art would understand and recognize the value of the addition of septums or self-healing seals for fluid collection devices wherein multiple, individual samples of fluid from the same source can be withdrawn simultaneously.
In regards to claim 2, Aoyagi discloses
wherein the base support is configured to support the puncture target with at least 6.0 inches of vertical clearance between the puncture target and a bottom of the base support ([0028], “the device … is … secured to a … support … The support … is provided with a pedestal … and a post … vertically standing on and secured to the pedestal” Examiner notes that in annotated Aoyagi Fig. 1 the support depicts the base support, the pedestal depicts the bottom of the base, and that the vertical distance between the pedestal and the device can be at least 6.0 inches.).
PNG
media_image1.png
838
830
media_image1.png
Greyscale
In regards to claim 4, Aoyagi discloses
wherein the base support comprises a flexible arm rotatably and/or pivotally mounted to a support member ([0029], “The support … may be provided with an actuator … for automatically and controllably moving the device” Examiner notes that an actuator can replace flexible arms in simulation devices by mimicking their bending, extension, and movements.).
In regards to claim 5, Aoyagi discloses
wherein the flexible arm comprises at least one hinge configured to bend in one or multiple directions to adjust a position of the puncture target relative to the support member ([0029], “The support … may be provided with an actuator … for automatically and controllably moving the device” Examiner notes that an actuator can replace flexible arms in simulation devices by mimicking their bending, extension, and movements.).
In regards to claim 6, Aoyagi discloses
wherein the flexible arm pivots and/or rotates to raise or lower a height of the puncture target relative to a bottom of the base support ([0029], “The support … may be provided with an actuator … for automatically and controllably moving the device” Examiner notes that an actuator can replace flexible arms in simulation devices by mimicking their bending, extension, and movements.).
In regards to claim 7, Aoyagi discloses
wherein the pump comprises an electric pump ([0053], “The device … is used in combination with … an electric … pump”).
In regards to claim 8, Aoyagi discloses
wherein the pump comprises a manually operated mechanical pump ([0053], “The device … is used in combination with … a manual pump”).
In regards to claim 9, Aoyagi discloses
wherein the fluid circulating system further comprises a remote control operatively connected to the pump configured to operate and/or control a flow rate of the pump ([0054], “The procedure of blood collection … may be … executed under control by any controller”).
In regards to claim 10, Aoyagi does not disclose wherein the pump draws fluid from the reservoir at a flow rate of about 5 µL/s.
Cowperthwait discloses
wherein the pump draws fluid from the reservoir at a flow rate of about 5 µL/s ([0074], “The … pump is adapted to apply pressure to the fluid in reservoir … in order to cause the fluid to flow into and through tube” Examiner notes that a flow rate of 5 µL/s (0.3 mL/min) is feasible for a pump drawing simulated blood and that low flow rates typically range from 0.1 µL/min to 20 mL/min.).
Aoyagi and Cowperthwait combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a simulation device allowing a user to practice use of, a lancet of the capillary blood collection device to practice use of the capillary blood collection device; and a fluid circulating system comprising a fluid reservoir, tubing extending at least partially through the puncture target between the reservoir and the at least one port, and a pump for circulating fluid from the reservoir to the at least one port, and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device, wherein the pump draws fluid from the reservoir at a flow rate of about 5 µL/s, as disclosed by Cowperthwait, to provide a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment. One skilled in the art would understand and recognize the value of the addition of a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment.
In regards to claim 11, Aoyagi does not disclose wherein the fluid in the reservoir comprises fake blood liquid.
Cowperthwait discloses
wherein the fluid in the reservoir comprises fake blood liquid ([0073], “reservoir … stores simulated blood during the simulated intravenous treatment”).
Aoyagi and Cowperthwait combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a simulation device allowing a user to practice use of, a lancet of the capillary blood collection device to practice use of the capillary blood collection device; and a fluid circulating system comprising a fluid reservoir, tubing extending at least partially through the puncture target between the reservoir and the at least one port, and a pump for circulating fluid from the reservoir to the at least one port, and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device, wherein the fluid in the reservoir comprises fake blood liquid, as disclosed by Cowperthwait, to provide a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment. One skilled in the art would understand and recognize the value of the addition of a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment.
In regards to claim 12, Aoyagi does not disclose wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers.
Feins discloses
wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that the mannequin hand comprises fingers and that holes representing ports can be created in the mannequin fingers.).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 13, Aoyagi does not disclose wherein dimensions of the hand model are selected based on 50th percentile anatomical measurements for hand size for an adult.
Feins discloses
wherein dimensions of the hand model are selected based on 50th percentile anatomical measurements for hand size for an adult ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that a standard adult mannequin hand is generally based on 50th percentile (average) anatomical measurements.).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein dimensions of the hand model are selected based on 50th percentile anatomical measurements for hand size for an adult, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 14, Aoyagi does not disclose wherein the plurality of elongated members of the hand model comprise at least a ring finger member sized to receive a first size of the capillary blood collection device and a middle finger member sized to receive a second size of the capillary blood collection device that is larger than the first size.
Feins discloses
wherein the plurality of elongated members of the hand model comprise at least a ring finger member sized to receive a first size of the capillary blood collection device and a middle finger member sized to receive a second size of the capillary blood collection device that is larger than the first size ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that a mannequin hand includes a ring finger and a middle finger (consistent with the human hand), where the middle finger is larger than the ring finger.).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein the plurality of elongated members of the hand model comprise at least a ring finger member sized to receive a first size of the capillary blood collection device and a middle finger member sized to receive a second size of the capillary blood collection device that is larger than the first size, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 15, Aoyagi does not disclose wherein the hand model is oriented in a left-hand orientation, and wherein the hand model is positioned with a flat downwardly facing palm and with the plurality elongated members representing fingers spaced apart.
Feins discloses
wherein the hand model is oriented in a left-hand orientation, and wherein the hand model is positioned with a flat downwardly facing palm and with the plurality elongated members representing fingers spaced apart ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that a mannequin hand may be left-handed or right-handed with palms facing downward and fingers spaced apart.).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein the hand model is oriented in a left-hand orientation, and wherein the hand model is positioned with a flat downwardly facing palm and with the plurality elongated members representing fingers spaced apart, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 16, Aoyagi does not disclose wherein the internal frame mimics bones of a human hand and the cover mimics a look and feel of human skin.
Feins discloses
wherein the internal frame mimics bones of a human hand and the cover mimics a look and feel of human skin ([0014], “The mannequin may include … permanent features such as … mannequin hands … These permanent features may be made of a material that roughly approximates the feel and weight of a human component”).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein the internal frame mimics bones of a human hand and the cover comprises an elastomeric cover configured to mimic a look and feel of human skin, as disclosed by Feins, to provide mannequin hands and material for the process of simulating medical trauma and maladies that train or certify medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands and material for the process of simulating medical trauma and maladies that train or certify medical professionals.
In regards to claim 18, Aoyagi does not disclose wherein a first port of the plurality of ports is positioned in an elongated member of the plurality of elongated members that represents a middle finger, and a second port of the plurality of ports is positioned in an elongated member representative of a ring finger.
Feins discloses
wherein a first port of the plurality of ports is positioned in an elongated member of the plurality of elongated members that represents a middle finger, and a second port of the plurality of ports is positioned in an elongated member representative of a ring finger ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that a mannequin hand includes a ring finger and a middle finger, and that holes representing ports can be created in the mannequin’s middle finger and ring finger.).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein a first port of the plurality of ports is positioned in an elongated member of the plurality of elongated members that represents a middle finger, and a second port of the plurality of ports is positioned in an elongated member representative of a ring finger, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 19, Aoyagi does not disclose wherein elongated members representative of fingers other than the middle finger or the ring finger are bendable, capable of being bent away from the middle finger and/or the ring finger thereby allowing the user to access and manipulate the middle finger and/or ring fingers to practice a procedure.
Feins discloses
wherein elongated members representative of fingers other than the middle finger or the ring finger are bendable, capable of being bent away from the middle finger and/or the ring finger thereby allowing the user to access and manipulate the middle finger and/or ring fingers to practice a procedure ([0014], “mannequin hands … used … are there to assist in the perception in the staged reality that the patient is a living person.”).
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, wherein the puncture target comprises a substantially anatomically accurate hand model comprising a proximal end portion connected to the base support and a distal end portion comprising the plurality of elongated members representing fingers, and wherein the fluid circulating system comprises a plurality of ports positioned in the elongated members representing the fingers, wherein a first port of the plurality of ports is positioned in an elongated member of the plurality of elongated members that represents a middle finger, and a second port of the plurality of ports is positioned in an elongated member representative of a ring finger, wherein elongated members representative of fingers other than the middle finger or the ring finger are bendable, capable of being bent away from the middle finger and/or the ring finger thereby allowing the user to access and manipulate the middle finger and/or ring fingers to practice a procedure, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
In regards to claim 20, Aoyagi discloses the following limitations with the exception of the underlined limitations.
A method for practicing sizing and use of a capillary blood collection device with the simulation device of claim 1, the method comprising ([0001], “The disclosure … relates … to a device for … collecting a tiny amount of blood from a blood capillary”): inserting an elongated member of the puncture target of the simulation device of claim 1 through one or more openings in a sizing card to identify an opening that best fits the elongated member of the puncture target ([0055], “the user … sets the user's finger on the rest” See annotated Aoyagi FIG. 1, which depicts the rest. Examiner notes that the rest can be used as an opening in a sizing card.);
inserting a holder of the capillary blood collection device of a size corresponding to the identified openings onto the elongated member of the puncture target ([0055], “the user … puts the pointed cannula section … close to a finger” Examiner notes that the cannula section is a component of the capillary blood collection device.);
activating the capillary blood collection device to puncture the elongated member and at least one puncture portion of the capillary blood collection device ([0056], “The user … starts the motor … to actuate the … tube … and further gets the device … down toward the finger to make the cannula section … puncture the skin thereof.”);
and activating the pump of the fluid circulation system, thereby allowed circulating fluid to collect in a container of the capillary blood collection device.
Cowperthwait discloses
a method for practicing sizing and use of ([0002], “The present invention relates … to simulation devices … to provide medical treatment”)
and activating the pump of the fluid circulation system ([0061], “The reservoirs fluid … may further include … pumps … for pushing fluid into tubes … during the simulated treatment of the patient.”), thereby allowed circulating fluid to collect in a container of the capillary blood collection device ([0075], “Collector ... may include ... drainage outlets ... to allow drainage of the fluid in collector ... reservoir ... and collector ... provide ... control over the pumping of fluid” Examiner notes that drainage outlets can be used as containers to collect fluid.).
Aoyagi and Cowperthwait combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, through one or more openings in a sizing card to identify an opening that best fits the elongated member of the puncture target; inserting a holder of the capillary blood collection device of a size corresponding to the identified openings onto the elongated member of the puncture target; activating the capillary blood collection device to puncture the elongated member and at least one puncture portion of the capillary blood collection device, as disclosed by Aoyagi, a simulation device allowing a user to practice use of, a lancet of the capillary blood collection device to practice use of the capillary blood collection device; and a fluid circulating system comprising a fluid reservoir, tubing extending at least partially through the puncture target between the reservoir and the at least one port, and a pump for circulating fluid from the reservoir to the at least one port, and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device, a method for practicing sizing and use of and activating the pump of the fluid circulation system, thereby allowed circulating fluid to collect in a container of the capillary blood collection device, as disclosed by Cowperthwait, to provide a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment. One skilled in the art would understand and recognize the value of the addition of a metal needle, reservoirs, a tube, pumps, a collector, and drainage outlets for simulation devices that train care providers who provide medical treatment.
Feins discloses
inserting an elongated member of the puncture target of the simulation device of claim 1 ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that in the claimed invention the puncture target may be “an anatomically accurate model … of a human hand” [0078].)
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established, and wherein the at least one port or the cover is self-sealing, through one or more openings in a sizing card to identify an opening that best fits the elongated member of the puncture target; inserting a holder of the capillary blood collection device of a size corresponding to the identified openings onto the elongated member of the puncture target; activating the capillary blood collection device to puncture the elongated member and at least one puncture portion of the capillary blood collection device, as disclosed by Aoyagi, a puncture target connected to the base support configured to be repeatedly punctured by; at least one port positioned within the plurality of elongated members such that the cover covers the at least one port, wherein the puncture target is sized to be connected to, the puncture target formed from an internal frame structure and a cover over the internal frame structure and comprising a plurality of elongated members representing fingers, inserting an elongated member of the puncture target of the simulation device of claim 1, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals. One skilled in the art would understand and recognize the value of the addition of mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable under Aoyagi in view of Cowperthwait, Feins, and US 20050187485 A1 (“Fumuro”).
In regards to claim 3, Aoyagi discloses the following limitation with the exception of the underlined limitations.
Wherein the base support comprises a first member configured to rest on a surface and a second member extending from the first member ([0028], “the device … is … secured to a … support … The support … is provided with a pedestal … and a post … vertically standing on and secured to the pedestal” Examiner notes that in annotated Aoyagi Fig. 1 the support depicts the base support of claimed invention, resting on the pedestal which depicts the bottom of the base.), wherein the puncture target extends from the second member of the base support.
Feins discloses
wherein the puncture target extends ([0010], “FIG. 1 … may include … mannequin hands ”Examiner notes that in the claimed invention the puncture target may be “an anatomically accurate model … of a human hand” [0078].)
Aoyagi and Feins combined are considered analogous to the claimed invention because they are in the field of blood collection devices and medical trauma simulations for training purposes. 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 capillary blood collection device, the simulation device comprising: a base support, and the capillary blood collection device so that the capillary blood collection device punctures the target and the at least one port to establish fluid communication with the tubing and reservoir, and wherein, when the fluid communication is established, and wherein the base support comprises a first member configured to rest on a surface and a second member extending from the first member, as disclosed by Aoyagi, a puncture target connected, at least one port positioned within the puncture target, and wherein the puncture target extends, as disclosed by Feins, to provide mannequin hands for the process of simulating medical trauma and maladies for the purpose of training or certifying medical professionals.
Fumuro discloses
from the second member of the base support ([0038], “FIG. 14A is a … view showing the cuff ring” Examiner notes that Fumuro provides the opening that allows extension of the mannequin hand from the support of Aoyagi. See annotated Aoyagi Fig. 1.).
Aoyagi and Fumuro combined are considered analogous to the claimed invention because they are in the field of blood collection devices and blood pressure measurements. 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 capillary blood collection device, the simulation device comprising: a base support, and the capillary blood collection device so that the capillary blood collection device punctures the target and the at least one port to establish fluid communication with the tubing and reservoir, wherein, when the fluid communication is established and wherein the base support comprises a first member configured to rest on a surface and a second member extending from the first member, as disclosed by Aoyagi, to the base support configured to be repeatedly punctured by and from the second member of the base support, as disclosed by Fumuro, to provide a cuff ring for measuring blood pressure using an arm.
Response to Arguments
Applicant's arguments filed August 5, 2026 have been fully considered but are not persuasive. Claims 1-16 and 18-20 are pending in this application. With respect to amended claim 1, Applicant argues “Feins is silent as to any such opening, access point, or holes in the mannequin hands and is further silent as to any connection of the mannequin hands to a device” (See AMENDMENT WITH RCE, REMARKS, page 7, paragraph 2.), “Feins is silent as to any such internal frame structure and cover, and is further silent as to the cover comprising an elastomeric sheet” (See AMENDMENT WITH RCE, REMARKS, page 7, paragraph 2), “there is no teaching or suggestion in Feins that the mannequin hands include a port comprising a sealed cavity recessed within the fingers and fluidly connected to tubing. Similarly, there is no teaching or suggestion regarding both a port and a cover being self-sealing such that, upon removal of the lancet from the puncture target, the at least one port and the cover reseal puncture openings formed by the lancet puncturing the puncture target” (See AMENDMENT WITH RCE, REMARKS, page 8, paragraph 1.), and “Feins is still entirely silent as to any opening in the ‘mannequin hands’” (See AMENDMENT WITH RCE, REMARKS, page 8, paragraph 3.). Examiner acknowledges Applicant’s remarks. Pertaining to claim 1, Aoyagi discloses a capillary blood collection device, the simulation device comprising ([0001], “The disclosure … relates … to a device for … collecting a tiny amount of blood from a blood capillary”): a base support ([0013], “FIG. 1 is … a blood collection device fixed to a support”); the capillary blood collection device so that the capillary blood collection device punctures the puncture target and the at least one port to establish fluid communication with the tubing and the reservoir, wherein, when the fluid communication is established ([0032], “the device … is … comprised of … intermediaries for fluid communication between the … tube … and the pressure source.” Examiner notes that the pressure source can be a reservoir.), Cowperthwait discloses a simulation device allowing a user to practice use of ([0002], “The present invention relates … to simulation devices … to provide medical treatment”)
a lancet of the capillary blood collection device to practice use of the capillary blood collection device ([0078], “insertion of a metal needle” Examiner notes that a lancet is a metal needle.); and a fluid circulating system comprising a fluid reservoir ([0061], “device … may include … reservoirs … adapted to store fluid”), tubing extending at least partially through the puncture target between the reservoir and the at least one port ([0005], “The reservoir is coupled to provide the fluid to the at least one tube.”), and a pump for circulating fluid from the reservoir to the at least one port ([0061], “The reservoirs fluid … may further include … pumps … for pushing fluid into tubes … during the simulated treatment of the patient.”), and the pump is circulating the fluid from the reservoir, the fluid is expelled from the at least one port and is collected within a container of the capillary blood collection device ([0075], “Collector … may include … drainage outlets … to allow drainage of the fluid in collector ... reservoir ... and collector … provide … control over the pumping of fluid” Examiner notes that drainage outlets can be used as containers to collect fluid.) the cover comprises an elastomeric sheet ([0068], “layer … is formed from … rubber”), Feins discloses a puncture target connected to the base support configured to be repeatedly punctured by ([0010], “FIG. 1 … may include … mannequin hands” Examiner notes that in the claimed invention the puncture target may be “an anatomically accurate model … of a human hand” [0078].);
at least one port ([0019], “The mannequin may include … holes”) positioned within the plurality of elongated members such that ([0010], “FIG. 1 … may include … mannequin hands”), wherein the puncture target is sized to be connected to ([0017], “Some mannequin … pieces may be sized”) and comprising a plurality of elongated members representing fingers ([0014], “FIG. 1 is a top view of a segmented mannequin” Examiner notes that FIG. 1 depicts a plurality of members representing fingers.), Grubbs discloses the cover covers the at least one port ([0351], “an enlarged view … shows … simulated human skin covering”) the puncture target formed from an internal frame structure and a cover over the internal frame structure ([0340], “Markers can be placed in the mannequin … The markers help create the three-dimensional … frame”) and wherein the at least one port comprises a sealed cavity recessed within the plurality of elongated members and fluidly connected to the tubing ([0117], “The mannequin may include … holes to remove excess … from the … cavity), and Fletcher discloses
and both the at least one port or the cover are self-sealing such that, upon removal of the lancet from the puncture target, the at least one port and the cover reseal puncture openings formed by the lancet puncturing the puncture target ([0023], “The … cavities … may be sealed … with septums or self-healing seals).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during
examination. Under BRI, the words of a claim must be given their plain meaning unless
such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, claim 1, as obvious over Aoyagi in view of Cowperthwait, Feins, Grubbs, and Fletcher, is rejected. Consequently, dependent claims 2-16 and 18-20 are rejected.
The guidelines of MPEP 2141 express the Office’s current understanding of the law, and are believed to be fully consistent with the binding precedent of the Supreme Court. Furthermore, the Office required Examiners to identify record evidence of a teaching, suggestion, or motivation to combine references because “[o]mission of a relevant factor required by precedent is both legal error and arbitrary agency action.” However, this did not preclude Examiners from employing common sense. More recently [in DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1366 (Fed. Cir. 2006)], the Office explained that use of common sense does not require a “specific hint or suggestion in a particular reference,” only a reasoned explanation that avoids conclusory generalizations. Examiner includes additional rationale to disclose features that include puncture target, frame structure, a cover, and at least one port. Furthermore, Examiner relies on common sense to articulate the reasons that the claimed invention would have been obvious under Aoyagi in view of Cowperthwait, Feins, Grubbs, and Fletcher. Therefore, claim 1, as obvious over Aoyagi in view of Cowperthwait, Feins, Grubbs, and Fletcher, is rejected. Consequently, dependent claims 2-16 and 18-20 are rejected.
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.
Publication Information
Information regarding the status of published or unpublished applications may be
obtained from the Patent Center. Unpublished application information in the Patent
Center is available to registered users. To file and manage patent submissions in the
Patent Center, visit: https://patentcenter.uspto.gov. Visit
https://www.uspto.gov/patents/apply/patent-center for more information about the
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.
/LISA H ANTOINE/
Examiner, Art Unit 3715
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
Prosecution Insights