DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1-2, 5, 7, 9-11, 14, and 16-21 objected to because of the following informalities:
Claim 1, line 2, “said training module” should read “said IV training module”.
Claim 1, line 3, “the size and shape of a neonate appendage” should read “a size and shape of a neonate appendage”.
Claim 1, line 5, “the size and appearance of a neonate appendage” should read “a size and appearance of a neonate appendage”.
Claim 1, line 6, “the outer skin glove” should read “the removable outer skin glove”.
Claim 2, line 2, “the Shore A scale” should read “a Shore A scale”.
Claim 5, line 2, “the Shore 00 scale” should read “a Shore 00 scale”.
Claim 9, line 1, “the blood vessel tubing” should read “the at least one flexible blood vessel tubing”.
Claim 10 fails to refer back to a preceding claim. A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim. A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Claim 11, line 3, “the blood vessel tubing” should read “the at least one flexible blood vessel tubing”.
Claim 14, line 3, “the size and appearance of neonate appendage” should read “a size and appearance of neonate appendage”.
Claim 14, line 12, “the at least one blood vessel channel” should read “the at least one shallow blood vessel channel”.
Claim 16, line 2, “the Shore A scale” should read “a Shore A scale”.
Claim 17, line 2, “the Shore 00 scale” should read “a Shore 00 scale”.
Claim 18, line 1, “the blood vessel tubing” should read “the at least one flexible blood vessel tubing”.
Claim 19, line 3, “the blood vessel tubing” should read “the at least one flexible blood vessel tubing”.
Claim 20, line 4, “the visibility of the blood vessel tubing” should read “the visibility of the at least one flexible blood vessel tubing”.
Claim 21, line 3, “the size and appearance of neonate appendage” should read “a size and appearance of neonate appendage”.
Claim 21, line 7, “the Shore A scale” should read “a Shore A scale”.
Claim 21, line 11, “the Shore 00 scale” should read “a Shore 00 scale”.
Claim 21, line 15, “the at least one blood vessel channel” should read “the at least one shallow blood vessel channel”.
Claim 21, lines 15, 16, and 21, “the blood vessel tubing” should read “the at least one flexible blood vessel tubing”.
Claim 21, line 21, “a dispensing tube” should read “the dispensing tube”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5-12 and 17-21 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation “a flexible material” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a flexible material” of claim 2 from which claim 5 depends or a second flexible material. For purposes of examination, it is assumed that “a flexible material” refers to the same ones of “a flexible material” found in claim 2.
Claim 7 recites the limitation “a translucent material” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a translucent material” of claim 3 from which claim 7 depends or a second translucent material. For purposes of examination, it is assumed that “a translucent material” refers to the same ones of “a translucent material” found in claim 3.
Claim 9 recites the limitation “a flexible material” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a flexible material” of claim 2 from which claim 9 depends or a second flexible material. For purposes of examination, it is assumed that “a flexible material” refers to the same ones of “a flexible material” found in claim 2.
Claim 17 recites the limitation “a translucent, flexible material” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a translucent, flexible material” of claim 16 from which claim 17 depends or a second translucent, flexible material. For purposes of examination, it is assumed that “a translucent, flexible material” refers to the same ones of “a translucent, flexible material” found in claim 16.
Claim 18 recites the limitation “a flexible material” in line 2. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a translucent, flexible material” of claim 16 from which claim 18 depends or a second translucent, flexible material. For purposes of examination, it is assumed that “a flexible material” refers to the same ones of “a translucent, flexible material” found in claim 16.
Claim 21 recites the limitation “a flexible and translucent material” in line 9. Since the claim language does not use antecedent basis (e.g. “the” or “said”), it is unclear if applicant is referring to the same ones of “a flexible and translucent material” of claim 21 line 6 or a second flexible and translucent material. For purposes of examination, it is assumed that “a flexible and translucent material” refers to the same ones of “a flexible and translucent material” found in claim 21 line 6.
Claims 6, 8, 10-16, and 19-20 objected to as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaumard Scientific Company (S408 NEWBORN INJECTION TRAINING ARM; hereinafter S408).
Regarding claim 1, S408 discloses a neonate intravenous (IV) training module for practicing critical nursing skills (newborn injection training arm shown in Page 4), said training module comprising: an inner core structured to have the size and shape of a neonate appendage (structure under the skin of the training arm must have the size and shape of a newborn arm as shown Page 4), the inner core comprising at least one shallow blood vessel channel formed therein (venous and arterial grooves; Page 2 - Introduction 2nd paragraph); a removable outer skin glove structured to have the size and appearance of a neonate appendage (removable skin and washable skin; Page 2 - Introduction 2nd paragraph), the outer skin glove being removably disposable over at least a portion the inner core (stretched over the training arm; Page 2 - Introduction 2nd paragraph); and at least one flexible blood vessel tubing that is removably disposable within the at least one blood vessel channel (soft latex tubes fitted in the arterial grooves in Page 2 - Introduction 2nd paragraph and they can be removed in Page 3 - Disassembly and Re-Assembly), the at least one flexible tubing structure to have an outer diameter and wall thickness of a neonate blood vessel (closely simulating the consistency of veins; Page 2 - Introduction 2nd paragraph).
Regarding claim 13, S408 discloses wherein the blood vessel channels comprise a plurality of retention tabs (plurality of venous and arterial grooves; Page 2 - Introduction 2nd paragraph) structured and operable to retain the respective blood vessel tubing therein (fitted with soft latex tubes; Page 2 - Introduction 2nd paragraph).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-12 are rejected under 35 U.S.C. 103 as being unpatentable over S408 in view of Trotta et al. (US20130192741 A1; hereinafter Trotta).
Regarding claim 2, S408 does not explicitly disclose the inner core is fabricated of a flexible material having a durometer of between 10 and 30 on the Shore A scale.
However, Trotta teaches the inner core is fabricated of a flexible material having a durometer of between 10 and 30 on the Shore A scale (inner layer that encapsulates muscle as platinum-cured silicone with a shore hardness ranging from 00-10 to 30 A; ¶50).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable and can provide the necessary flexibility and visibility for the inner core.
Regarding claim 3, S408 does not explicitly disclose wherein the inner core is fabricated of a translucent material.
However, Trotta teaches wherein the inner core is fabricated of a translucent material (platinum cured silicone is inherently translucent; ¶50).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable and can provide the necessary flexibility and visibility for the inner core.
Regarding claim 4, S408 does not explicitly disclose wherein the inner core is fabricated of silicone.
However, Trotta teaches wherein the inner core is fabricated of silicone (platinum cured silicone is made of silicone; ¶50).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable and can provide the necessary flexibility and visibility for the inner core.
Regarding claim 5, S408 discloses wherein the outer skin glove is fabricated of a flexible material (translucent pliable latex skin stretched over the training arm; Page 2 – Introduction 2nd paragraph). S408 does not explicitly disclose wherein the outer skin glove is fabricated of a flexible material having a durometer of between 00-10 and 00-30 on the Shore 00 scale.
However, Trotta teaches wherein the outer skin glove is fabricated of a flexible material having a durometer of between 00-10 and 00-30 on the Shore 00 scale (skin layer made up of a platinum-cured silicone thermoset or a platinum-cured silicone thermoset blend with a shore hardness as low as 00-10 but no higher than 30 A; ¶46).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, provides a realistic feel to the skin, and can provide the necessary flexibility and visibility for the outer skin glove.
Regarding claim 6, S408 discloses wherein the outer skin glove is fabricated of a material that has flexion and extension properties (translucent pliable latex skin stretched over the training arm; Page 2 – Introduction 2nd paragraph). S408 does not explicitly discloses the outer skin glove is 'self- concealing' of puncture holes.
However, Trotta teaches the outer skin glove is fabricated of a material that has flexion and extension properties such that outer skin glove is 'self- concealing' of puncture holes (low durometer platinum cured silicone is used in ¶46). For further clarification, the properties of ‘self-concealing’ of puncture holes is a property of the material itself. Low durometer platinum cured silicone has these properties as stated on ¶47-48 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, provides a realistic feel to the skin, and can provide puncture “self-concealing” characteristics when pierced by an IV needle. When pierced, the silicone can contract and close the hole after the needle is withdrawn.
Regarding claim 7, S408 discloses wherein the outer skin glove is fabricated of a translucent material (translucent material for skin; Page 2 – Introduction 2nd paragraph).
Regarding claim 8, S408 does not explicitly disclose wherein the outer skin glove is fabricated of silicone.
However, Trotta teaches wherein the outer skin glove is fabricated of silicone (platinum cured silicone is used and this is made of silicone; ¶46).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, provides a realistic feel to the skin, and can provide the necessary flexibility and visibility for the outer skin glove.
Regarding claim 9, S408 discloses wherein the blood vessel tubing is fabricated of a flexible material that has flexion and extension properties such that outer skin glove is 'self- concealing' of puncture holes (soft latex tubes being used and soft latex have flexion and extension properties by design; Page 2 - Introduction 2nd paragraph).
For further clarification, the properties of ‘self-concealing’ of puncture holes is a property of the material itself. Latex has these properties as stated on ¶46 of the present invention.
Regarding claim 10, S408 discloses wherein the blood vessel tubing is fabricated of latex (soft latex tubes ; Page 2 - Introduction 2nd paragraph).
Regarding claim 11, S408 does not explicitly disclose wherein the translucent inner core and the translucent outer skin glove are structured and operable to allow transillumination whereby the blood vessel tubing is visible through the outer skin glove when a light to be shined on the IV training module.
However, Trotta teaches wherein the translucent inner core and the translucent outer skin glove (platinum cured silicone used for skin and inner layer; ¶46 and ¶50) are structured and operable to allow transillumination (platinum cured silicone allows transillumination because it is translucent) whereby the blood vessel tubing is visible through the outer skin glove when a light to be shined on the IV training module (this is how transillumination works).
For further clarification, these properties come from the material being used, such as a low-durometer soft premium silicone rubber has the necessary translucent properties to allows transillumination as mentioned in ¶49 of the present invention. Premium low durometer platinum cured silicone is a low-durometer soft premium silicone rubber as mentioned in ¶47 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, has a realistic feel to the skin, and has translucent properties to provide the necessary visibility to perform transillumination.
Regarding claim 12, S408 discloses does not explicitly disclose wherein the flexible inner core, the flexible outer skin glove, and the flexible blood vessel tubing are structured and operable to allow hyperflexion and plantarflex of the IV training module whereby the IV training module is hyper-flexed and hyper-plantar-flexed to increase the visibility of the blood vessel tubing beneath the outer skin glove.
However, Trotta teaches wherein the flexible inner core, the flexible outer skin glove, and the flexible blood vessel tubing are structured and operable to allow hyperflexion and plantarflex of the IV training module whereby the IV training module is hyper-flexed and hyper-plantar-flexed to increase the visibility of the blood vessel tubing beneath the outer skin glove (platinum cured silicone used for skin and inner layer; ¶46 and ¶50).
For further clarification, these properties come from the structure of the material being used, such as a low-durometer soft premium silicone rubber has the necessary properties to allow hyperflexion and hyper-plantar-flex as mentioned in ¶51 of the present invention. Premium low durometer platinum cured is a low-durometer soft premium silicone rubber as mentioned in ¶47 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, has a realistic feel to the skin, and has high elasticity and high flexibility properties to allow for hyperflexion and plantarflex.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over S408 in view of Gaumard Scientific Company (PEDIATRIC IV AND ARTERIAL ACCESS TRAINING ARM User Guide; hereinafter Gaumard).
Regarding claim 14, S408 discloses a neonate intravenous (IV) task trainer system (newborn injection training arm shown in Page 4) for practicing critical nursing skills, said system comprising: a neonate IV training module that is structured to have the size and appearance of neonate appendage (arm with size and shape of a newborn arm as shown Page 4), the IV training module comprises: an inner core (structure under skin of the training arm must have the size and shape of a newborn arm as shown Page 4) that comprises at least one shallow blood vessel channel formed therein (venous and arterial grooves; Page 2 - Introduction 2nd paragraph); and a removable outer skin glove (removable skin and washable skin; Page 2 - Introduction 2nd paragraph) that is removably disposable over at least a portion the inner core (stretched over the training arm; Page 2 - Introduction 2nd paragraph); a fluid supply module (blood dispensing bag; Page 2 - Introduction 2nd paragraph); and at least one flexible blood vessel tubing that is removably disposable within the at least one blood vessel channel (soft latex tubes fitted in the arterial grooves in Page 2 - Introduction 2nd paragraph and they can be removed in Page 3 - Disassembly and Re-Assembly), the at least one flexible tubing structure to have an outer diameter and wall thickness of a neonate blood vessel (closely simulating the consistency of veins; Page 2 - Introduction 2nd paragraph). S408 does not explicitly disclose a fluid supply module that is removably and fluidly connectable to the IV training module.
However, Gaumard teaches a fluid supply module that is removably and fluidly connectable to the IV training module (all pieces are shown to be removable; Page 10 – Package contents image).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Gaumard because having a removable fluid supply module is allows for a modular model to easily remove or replace the fluid supply module during training or after training. Furthermore, it also allows for cleaning or maintenance to be done separately and more efficiently for each part.
Regarding claim 15, S408 discloses further comprising a pump connected to a dispensing tube of the fluid supply module and the blood vessel tubing (squeeze bulb; Page 4). S408 does not explicitly disclose a pump that is removably connectable to a dispensing tube of the fluid supply module and the blood vessel tubing.
However, Gaumard teaches a pump that is removably connectable to a dispensing tube of the fluid supply module and the blood vessel tubing (control box acts a pump and is shown to be detachable through multiple tubing; See Page 16).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Gaumard because having a removable pump because it allows for a modular model to easily remove or replace the pump during training or after training. Furthermore, it also allows for cleaning or maintenance to be done separately and more efficiently for each part.
Claims 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over S408 in view of Gaumard in view of Trotta.
Regarding claim 16, S408 does not explicitly disclose wherein the inner core is fabricated of a translucent, flexible material having a durometer of between 10 and 30 on the Shore A scale.
However, Trotta teaches wherein the inner core is fabricated of a translucent, flexible material having a durometer of between 10 and 30 on the Shore A scale (inner layer that encapsulates muscle as platinum-cured silicone with a shore hardness ranging from 00-10 to 30 A and this material is inherently translucent; ¶50).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable and can provide the necessary flexibility and visibility for the inner core.
Regarding claim 17, S408 discloses wherein the outer skin glove is fabricated of a translucent, flexible material (translucent pliable latex skin stretched over the training arm; Page 2 – Introduction 2nd paragraph). S408 does not explicitly disclose the outer skin glove having a durometer of between 00-10 and 00-30 on the Shore 00 scale, wherein the outer skin glove has flexion and extension properties such that outer skin glove is 'self-concealing' of puncture holes.
However, Trotta teaches the outer skin glove having a durometer of between 00-10 and 00-30 on the Shore 00 scale (skin layer made up of a platinum-cured silicone thermoset or a platinum-cured silicone thermoset blend with a shore hardness as low as 00-10 but no higher than 30 A and platinum cured silicone is inherently translucent; ¶46), wherein the outer skin glove has flexion and extension properties such that outer skin glove is 'self-concealing' of puncture holes (low durometer platinum cured has these properties). For further clarification, the properties of ‘self-concealing’ of puncture holes is a property of the material itself. Low durometer platinum cured silicone has these properties as stated on ¶47-48 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, provides a realistic feel to the skin, and can provide puncture “self-concealing” characteristics when pierced by an IV needle. When pierced, the silicone can contract and close the hole after the needle is withdrawn.
Regarding claim 18, S408 discloses wherein the blood vessel tubing is fabricated of a flexible material that has flexion and extension properties such that outer skin glove is 'self- concealing' of puncture holes (soft latex tubes being used and soft latex have flexion and extension properties by design; Page 2 - Introduction 2nd paragraph).
For further clarification, the properties of ‘self-concealing’ of puncture holes is a property of the material itself. Latex has these properties as stated on ¶46 of the present invention.
Regarding claim 19, S408 does not explicitly disclose wherein the translucent inner core and the translucent outer skin glove are structured and operable to allow transillumination whereby the blood vessel tubing is visible through the outer skin glove when a light to be shined on the IV training module.
However, Trotta teaches wherein the translucent inner core and the translucent outer skin glove (platinum cured silicone used for skin and inner layer; ¶46 and ¶50) are structured and operable to allow transillumination (platinum cured silicone allows transillumination because it is translucent) whereby the blood vessel tubing is visible through the outer skin glove when a light to be shined on the IV training module (this is how transillumination works).
For further clarification, these properties come from the material being used, such as a low-durometer soft premium silicone rubber has the necessary translucent properties to allows transillumination as mentioned in ¶49 of the present invention. Premium low durometer platinum cured silicone is a low-durometer soft premium silicone rubber as mentioned in ¶47 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, has a realistic feel to the skin, and has translucent properties to provide the necessary visibility to perform transillumination.
Regarding claim 20, S408 discloses does not explicitly disclose wherein the flexible inner core, the flexible outer skin glove, and the flexible blood vessel tubing are structured and operable to allow hyperflexion and plantarflex of the IV training module whereby the IV training module is hyper-flexed and hyper-plantar-flexed to increase the visibility of the blood vessel tubing beneath the outer skin glove.
However, Trotta teaches wherein the flexible inner core, the flexible outer skin glove, and the flexible blood vessel tubing are structured and operable to allow hyperflexion and plantarflex of the IV training module whereby the IV training module is hyper-flexed and hyper-plantar-flexed to increase the visibility of the blood vessel tubing beneath the outer skin glove (platinum cured silicone used for skin and inner layer; ¶46 and ¶50).
For further clarification, these properties come from the structure of the material being used, such as a low-durometer soft premium silicone rubber has the necessary properties to allow hyperflexion and hyper-plantar-flex as mentioned in ¶51 of the present invention. Premium low durometer platinum cured is a low-durometer soft premium silicone rubber as mentioned in ¶47 of the present invention.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, has a realistic feel to the skin, and has high elasticity and high flexibility properties to allow for hyperflexion and plantarflex.
Regarding claim 21, S408 discloses a neonate intravenous (IV) task trainer system for practicing critical nursing skills (newborn injection training arm shown in Page 4), said system comprising: a neonate IV training module that is structured to have the size and appearance of neonate appendage (arm with size and shape of a newborn arm as shown Page 4), the IV training module comprises: an inner core (structure under skin of the training arm must have the size and shape of a newborn arm as shown Page 4) that comprises at least one shallow blood vessel channel 30 formed therein (venous and arterial grooves; Page 2 - Introduction 2nd paragraph); and a removable outer skin glove (removable skin and washable skin; Page 2 - Introduction 2nd paragraph) that is removably disposable over at least a portion the inner core (stretched over the training arm; Page 2 - Introduction 2nd paragraph), the outer skin glove being fabricated of a flexible and translucent material (translucent pliable latex skin stretched over the training arm; Page 2 – Introduction 2nd paragraph); at least one flexible blood vessel tubing that is removably disposable within the at least one blood vessel channel (soft latex tubes fitted in the arterial grooves in Page 2 - Introduction 2nd paragraph and they can be removed in Page 3 - Disassembly and Re-Assembly), the blood vessel tubing fabricated of a material that has flexion and extension properties such that blood vessel tubing is 'self-concealing' of puncture holes (soft latex tubes being used and soft latex has flexion, extension, and self-concealing properties for small punctures; Page 2 - Introduction 2nd paragraph. For further clarification, the properties of ‘self-concealing’ of puncture holes is a property of the material itself. Latex has these properties as stated on ¶46 of the present invention); a fluid supply module comprising: a fluid reservoir (blood dispensing bag; Page 2 - Introduction 2nd paragraph); and a dispensing tube connectable to the fluid reservoir (blood dispensing bag has a dispensing tube shown in Page 4); and a pump (squeeze bulb shown in Page 4) connected to a dispensing tube and the blood vessel tubing (pump connected to a dispensing tube connected to the fluid source, which connects to the soft latex tubes as shown in Page 4). S408 does not explicitly disclose the inner core being fabricated of a flexible and translucent material having a durometer of between 10 and 30 on the Shore A scale; the outer skin glove having: a durometer of between 00-10 and 00-30 on the Shore 00 scale; and flexion and extension properties such that outer skin glove is 'self- concealing' of puncture holes; a pump that is removably connected to a dispensing tube and the blood vessel tubing.
However, Gaumard teaches a pump that is removably connected to a dispensing tube and the blood vessel tubing (control box acts a pump is shown to be detachable through tubing; See Page 16).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Gaumard because having a removable pump because it allows for a modular model to easily remove or replace the pump during training or after training. Furthermore, it also allows for cleaning or maintenance to be done separately and more efficiently for each part.
Trotta teaches the inner core being fabricated of a flexible and translucent material having a durometer of between 10 and 30 on the Shore A scale (inner layer that encapsulates muscle as platinum-cured silicone with a shore hardness ranging from 00-10 to 30 A and platinum cured silicone is inherently translucent; ¶50); the outer skin glove having: a durometer of between 00-10 and 00-30 on the Shore 00 scale (skin layer made up of a platinum-cured silicone thermoset or a platinum-cured silicone thermoset blend with a shore hardness as low as 00-10 but no higher than 30 A and platinum cured silicone is inherently translucent; ¶46); and flexion and extension properties such that outer skin glove is 'self- concealing' of puncture holes (low durometer platinum cured has these properties as stated on ¶47-48 of the present invention).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified S408 to implement the teachings of Trotta because platinum cured silicone is durable, provides a realistic feel to the skin, and can provide the necessary flexibility and visibility for the outer skin glove and under the outer skin glove (inner core). Furthermore, it can provide puncture “self-concealing” characteristics when pierced by an IV needle. When pierced, the silicone can contract and close the hole after the needle is withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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/JOSE ANGELES/Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715