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 .
Response to Amendments
Applicant’s submission of a response was received on 06/26/2026. Presently, claims 1-14 are pending 1-4 are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant application’s Specification is devoid of support for the negative limitation found in independent claim 5 line 6 of the claim. The Specification does not recite that the claimed “structure body” cannot be a space.
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 which is not a space (“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 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. A recess (a pocket) as taught by Kiyoaki is still formed from a material having a lower hardness (it’s a pocket filled with air). The Examiner suggests using clear and concise language to explain the structure body on the record with support from the instant application’s Specification.
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.
Response to Arguments
35 U.S.C. § 112(b):
Rejection made to dependent claim 14 under 35 U.S.C. 112(b) has been withdrawn.
35 U.S.C. § 103:
Applicant states on page 6 of the remarks “Paragraph [0007] of the specification describes "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." Because of the recitation and location of the "comprises" terms in this description, it is clear that what is described is that the pseudo abdominal cavity layer (1) comprises a structure body or (2) comprises a space. In other words, the sentence structure is clear that the last "comprises" before "a space" relates to the same portion of the sentence as the first "comprises" before "a structure body", i.e., both "comprises" relate to the pseudo abdominal cavity layer. Thus, while the description indicates that the pseudo abdominal cavity layer may be a space, the description does not indicate that the structure body may be a space. Rather, the description is clear that a structure body and a space are distinct and separate embodiments of the pseudo abdominal cavity layer. The Patent Office's allegation that the structure body can be a space is thus clearly incorrect and improper, as no such indication is included in the present specification.” It is unclear if the Applicant is stating that the Specification should or should not be relied on when trying to interpret the claims. The Specification states 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.” The Examiner is looking to the Specification for a definition of what could make up a structure body. Furthermore, the Specification is devoid of support for the structure body not being a space. The rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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
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