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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/13/2026 has been entered.
Applicant's Submission of a Response
Applicant's submission filed on 03/13/2026 has been entered. Presently, claims 1-14 are pending, with claims 1-4 withdrawn.
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 14 is 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 14 recites “the structure body comprises a portion of the pseudo abdominal cavity layer that is less than all of the pseudo abdominal cavity layer, and remainder portions of the pseudo abdominal cavity layer other than the structure body portion are comprised of resin” in the claim. It is not clear the size of the of “the structure body” and then how much of the pseudo abdominal cavity layer is comprised of resin. For the purpose of examination, the structure body will be any size within the pseudo abdominal cavity layer, and the layer is comprised of resin.
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 5-6, 8-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Honma Kiyoaki (JP 2015125231 A; hereinafter Kiyoaki) in view of Thomas E. Graham and Eric E. Sabelman (US 4481001 A; hereinafter Graham) in further view of Christopher Toly (US 20050026125 A1; hereinafter Toly).
Regarding claim 5, Kiyoaki discloses a mucosal tissue model for endoscopic procedure training comprising (“Simulated mucosal tissue of an endoscope remedy training model” (recited in at least: Kiyoaki [Abstract])), in order, a simulated mucosal layer and
a simulated submucosal layer (“a two-layer laminate of different hardness (softness), the material of which is silicone elastomer. Specifically, the Shore hardness of the elastomer of the simulated submucosal layer (first layer) is about 0 to 5, and the Shore hardness of the elastomer of the muscle layer (second layer)” (recited in at least: Kiyoaki paragraph [0008]), wherein the mucosal tissue model has a liquid injection part provided inside either one of the simulated mucosal layer and the simulated submucosal layer, or disposed between the layers (“a local injection storage site of about 16 mm consisting of the above-mentioned button-like PVA molding is provided in the muscle layer” (recited in at least: Kiyoaki paragraph [0008])), a structure body (“in a laminate of a simulated submucosal layer and a muscle layer, a recess (pocket) having a size corresponding to a simulated lesion in the muscle layer” (recited in at least: Kiyoaki paragraph [0009])).
The claim language does not further limit or define the structure of the structure body. The original Specification recites in paragraph [0007]:
“…wherein the pseudo abdominal cavity layer comprises a structure body formed from a material having a lower hardness than that of the simulated submucosal layer, or comprises a space.”
For the purposes of examination, the Examiner will use the definition provided by the instant application’s Specification of a “structure body” which means that the structure body can be that it’s a material having a lower hardness than that of the simulated submucosal layer, or that it comprises a space.
Kiyoaki does not explicitly disclose further having a pseudo abdominal cavity layer below the simulated submucosal layer, and the pseudo abdominal cavity layer comprises at least structure body (Kiyoaki does disclose the structure body as stated above) which is colored a different color from the simulated submucosal layer.
Graham teaches a pseudo abdominal cavity layer below the simulated submucosal layer, and the pseudo abdominal cavity layer comprises at least structure body (a space as disclosed by Kiyoaki with structural support from the instant application’s specification) “(The interconnecting network of pores 16 (FIG. 2) permits fluid to be injected into the layer without causing substantial dimensional change (ie, noticable bulging) of the layer” (recited in at least: Graham [column 2, lines 32-36])).
It would have been obvious to a person having ordinary skill in the art to have used the layering of Graham into the model of Kiyoaki for the added benefit of simulating layers of an organ for students to practice injecting accurately.
Toly teaches a simulated organ/mucosal model that can be colored a different color (“A first image layer corresponds to skin, and includes variations in shading and color, as exhibited by real human skin. Preferably, the image layer will be printed onto a fabric substrate, using a real image of human skin as the source of the image. Such an image should include features normally associated with human skin, including such features as hair, freckles, variations in color and shading, and occasional imperfections, such as scars, bruises, abrasions, and tattoos” (recited in at least: Toly paragraph [0010])).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have added coloring layers differently in an organ simulation as taught by Toly into the model of Kiyoaki for the added benefit of showing students different layers in the human body and to show them accurately.
Regarding claim 6, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above, and Kiyoaki further teaches wherein the structure body is formed from a material having a lower hardness than that of the simulated submucosal layer (“a recess (pocket) having a size corresponding to a simulated lesion in the muscle layer” (recited in at least: Kiyoaki paragraph [0009])).
Regarding claim 8, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above, and Kiyoaki further teaches wherein the mucosal tissue model is capable of being incised and/or dissected by an energy device (“sufficient local injection amount can be secured. Thus, the procedure can be learned by raising the simulated lesion and burning it off with a high-frequency electric knife or a snare” (recited in at least: Kiyoaki paragraph [0011])).
Regarding claim 9, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above, and Kiyoaki further teaches wherein the liquid injection part comprises a material that expands upon absorbing a liquid, the material being an absorbent polymer or a sponge-type soft resin (“PVA was used as a material of a local injection liquid storage site (a site corresponding to a simulated lesion in a simulated muscle layer), other hydrophilic polymer materials can also be used. In the present invention, since the hydrophilic polymer material is embedded in the hydrophobic silicone, a sufficient local injection amount can be secured” (recited in at least: Kiyoaki paragraph [0011])).
Regarding claim 10, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above, and Kiyoaki further teaches wherein each layer has a type E hardness within a range of 5 to 55 (“two-layer laminate of different hardness (softness), the material of which is silicone elastomer. Specifically, the Shore hardness of the elastomer of the simulated submucosal layer (first layer) is about 0 to 5, and the Shore hardness of the elastomer of the muscle layer (second layer) is about 20 to 30, various as a result of the experiment, the submucosa layer (first layer) had a Shore hardness of 5 and the muscle layer (a second layer) had a Shore hardness of 20” (recited in at least: Kiyoaki paragraph [0008])).
Regarding claim 13, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above, and Kiyoaki further teaches wherein the mucosal tissue model is a model of a small intestine, or a large intestine, (“a training model for endoscopic treatment, in which the simulated intestinal wall tissue of the training model” (recited in at least: Kiyoaki paragraph [0005])).
Claims 7, 11-12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kiyoaki in view of Graham and Toly, in further view of Hiroshi Misawa (US 20120028231 A1; hereinafter Misawa).
Regarding claim 7, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the material having a lower hardness than that of the simulated submucosal layer is a sponge material.
Misawa teaches wherein the material having a lower hardness than that of the simulated submucosal layer is a sponge material (a biological model for training and the model uses sponge-type materials. In the biological model for training 1 shown in FIG. 49, a reinforcement member 307C is constituted by a foaming elastic body (sponge) (recited in at least: Misawa paragraph [0432])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have used sponge-type materials within a biological or simulated mucosal training model for the added benefit of having a sponge-type bounce that is found in humans naturally.
Regarding claim 11, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein at least one layer comprises a hydrous polyvinyl alcohol-based resin.
Misawa teaches wherein at least one layer comprises a hydrous polyvinyl alcohol-based resin (a biological model for training and the model uses a hydrous polyvinyl alcohol-based resin (recited in at least: Kiyoaki paragraph [0240]; printed below)).
Regarding claim 12, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein at least one layer comprises a hydrocarbon resin-based resin.
Misawa teaches wherein at least one layer comprises a hydrocarbon resin-based resin (a biological model for training and the model uses a hydrous polyvinyl alcohol-based resin (recited in at least: Kiyoaki paragraph [0240]; printed below)).
“[0240] For the constituent material…, although it is not limited in particular, various kinds of resin materials are used preferably and specifically, there can be cited various kinds of resin materials such as…, polyvinyl chloride, polyvinylidene chloride…, polyalylate, aromatic polyester (liquid crystal polymer)… and it is possible to use one kind within those or to use two kinds or more by combination.”
Regarding claim 14, Kiyoaki in view of Graham and Toly teach the claimed matter as stated above; however, they do not explicitly teach wherein the structure body comprises a portion of the pseudo abdominal cavity layer that is less than all of the pseudo abdominal cavity layer, and remainder portions of the pseudo abdominal cavity layer other than the structure body portion are comprised of resin.
Misawa wherein the structure body comprises a portion of the pseudo abdominal cavity layer that is less than all of the pseudo abdominal cavity layer, and remainder portions of the pseudo abdominal cavity layer other than the structure body portion are comprised of resin (the use of resin within a modeled organ (The right coronary artery 4 is constituted by a plastically deformable material and for the material thereof, it is not limited in particular, but there can be cited a thermoplastic resin) (recited in at least: Misawa paragraph [0263])).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use different types of materials such as resin to create simulated tissue models for the added benefit of controlling the hardness level of the organ/tissue for better accuracy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELWA A ALSOMAIRY whose telephone number is (703)756-5323. The examiner can normally be reached M-F 7:30AM to 5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Vasat can be reached at (571) 270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SELWA A ALSOMAIRY/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715