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 Amendment
In response to the amendment filed 10/15/2025; claims 1-5, 7 are pending.
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 7 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 7 is a dependent claim of claim 6, however, claim 6 has been cancelled. Therefore, the dependency of the claim 7 is unclear.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Sakezles et al. (US 2020/0184851 A1) in view of Bioseb, "Rat Training Simulator", https://www.bioseblab.com/en/experimental-models/583-rat-training-simulator.html, pages. 1 – 7, Year: 2018, (known herein as Bioseb) and Lytle (US 9,552,747 B1).
Re claim 1:
Sakezles teaches 1. A biomodel for training medical craniotomy techniques (Sakezles, Abstract) comprising
a body (2) with four legs (21) and a tail (22), and a head (1) (Sakezles, fig. 1), similar to those of a mouse, characterized by the fact that the body (2) and the head (1) are attachable (3) (Sakezles, figs. 8 – 10; [0118]),
where the head (1) comprises a rigid skull (Sakezles, fig. 1, 6; [0008], “FIG. 1 shows a diagram of a canine skeleton (left) and a canine model with skin removed (right)”; the skeleton model includes a skull).
Sakezles teaches a canine model instead of a rat model. Bioseb teaches a rat training simulator. Bioseb teaches a rat training simulator with tail and tail vein (Bioseb, pg. 3-4). The substitution of one known element (rat model as shown in Bioseb) for another (canine model as shown in Sakezles) would have been obvious to one of ordinary skill in the art, before the effectiveness filing date of the claimed invention, since the substitution of the rat model shown in Bioseb would have yielded predictable results, namely, to provide an ideal model for learning the skills required for humane and ethical handling and procedural competencies, without the need to use a live rat (Bioseb, pg. 1).
Sakezles teaches a hydrophobic moldable silicone film (Sakezles, [0057]; [0090]; [0097]; [0058]). Sakezles does not disclose wherein the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film.
Lytle (US 9,552,747 B1) teaches a head impact test apparatus is configured to enable viewing a head model including a brain component that may be at least partially surrounded by a fluid component and within a skull component (Lytle, Abstract). Lytle teaches wherein the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film (Lytle, Abstract; col. 2, line 30 – col. 3, line 3, “the brain component may be made out of a material that has a similar density and elasticity as a real brain including, but not limited to, an elastomer, such as silicone or urethane … A transparent cover may be a transparent panel that extends across and is attached to the skull component. A dura component, such as a liner around a portion of the brain component, or around the perimeter of the brain component, may simulate an actual human dura and may be recognized by imaging analysis to determine the surface area and/or perimeter of the brain component … enabling viewing of the brain component through the clear dura component portion and identification of the shaded dura component portion around the perimeter of the brain component”). Therefore, in view of Lytle, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by providing the silicone clear dura component portion as Lytle, in order to enable viewing of the brain component through the clear dura component portion and identification of the shaded dura component portion around the perimeter of the brain component (Lytle, col. 2, line 30 – col. 3, line 3).
Re claim 5:
5. The rat biomodel according to claim 1, characterized in that the body (2) of the biomodel is manufactured from silicone, wherein the body includes elements selected from the group consisting of: pharynx, larynx, trachea, stomach, and tail vein (22) anatomically similar to a real rat (Sakezles, fig. 1; figs. 6 – 10; [0113]; [0121]; [0024]; [0058]).
Sakezles does not explicitly disclose a tail vein. Bioseb teaches a tail vein. Therefore, in view of Bioseb, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by providing a tail vein as taught by Bioseb, since Bioseb suggests realistic removable tail with two lateral tail veins ideal for: Blood sampling, Intravenous administration, Insertion of a flexible catheter (Angiocath), additional tail can be purchased separately, artificial realistic non-toxic blood available and internal reservoir to hold artificial blood or remain empty to contain intravenous administration of saline (Bioseb, pg. 3).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sakezles, Bioseb and Lytle as applied to claim 1 above, and further in view of Seitz et al. (US 2020/0316850 A1).
Re claim 3:
Sakezles does not explicitly disclose 3. The rat biomodel according to claim 1, characterized in that the biomodel is manufactured by 3D printing technique.
Seitz et al. (US 2020/0316850 A1) teaches an invention relates to a method for the additive production of an anatomical model using a 3D printing device (Seitz, Abstract). Seitz further teaches 3. The rat biomodel according to claim 1, characterized in that the biomodel is manufactured by 3D printing technique (Seitz, [0095] – [0096]; [0103] – [0104]). Therefore, in view of Seitz, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by 3d printed a biomodel as taught by Seitz, since 3d printer allows a user to create different types of tissue with different colors and densities (Seitz, Abstract).
Claims 2 are rejected under 35 U.S.C. 103 as being unpatentable over Sakezles, Bioseb and Lytle as applied to claim 1 above, and further in view of Norikane et al. (US 2017/0270831 A1)
Re claim 2:
Sakezles does not explicitly disclose 2. The rat biomodel according to claim 1, characterized in that the rigid skull is filled with reddish colored gelatinous material (10).
Norikane et al. (US 20170270831 A1) teaches a solid freeform fabrication object includes a hydrogel including a polymer, water, and a coloring material inclusion substance. Norikane teaches 2. The rat biomodel according to claim 1, characterized in that the rigid skull is filled with reddish colored gelatinous material (10) (Norikane, [0089], “The internal organ model of the present disclosure has no particular limit and can reproduce every internal organ in a human body, including brain, heart, gullet, stomach, bladder, small intestine, large intestine, liver, kidney, spleen, pancreas, and womb”; [0254], “A solid freeform fabrication object (internal organ model) was obtained in the same manner as in Example 1 except that the hydrogel having a blood vessel was changed to the red-colored gel having a cylindrical blood vessel-like form.”). Therefore, in view of Norikane, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by providing red gel as taught by Norikane, in order to mimic the real appearance of a rat brain.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sakezles, Bioseb, Lytle and Norikane as applied to claim 2 above, and further in view of Schwindt et la. (US 2019/0259304 A1)
Re claim 4:
Sakezles does not explicltly disclose 4. The rat biomodel according to claim 2, characterized in that the rigid skull is manufactured using acrylonitrile-butadiene-styrene (ABS) monofilament in ivory white color.
Schwindt et la. (US 2019/0259304 A1) teaches a patient simulator. Schwindt teaches 4. The rat biomodel according to claim 2, characterized in that the rigid skull is manufactured using acrylonitrile-butadiene-styrene (ABS) monofilament in ivory white color (Schwindt, [0038], “A homogenous illumination of the simulated skin is preferably also achieved in that the simulated skull is made of a polymer, translucent, in particular white, material and the simulated skin is formed transparent or translucent, in particular of a silicone material”). Therefore, in view of Schwindt, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by white skull as taught by Schwindt, since it was known in the art that skull / bones are usually white. The white simulated skull resembles a real skull.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sakezles, Bioseb and Lytle as applied to claim 6 above, and further in view of Schornagel et al. (US 2021/0085340 A1).
Re claim 7:
Sakezles does not disclose 7. The rat biomodel according to claim 6, characterized in that the biomodel comprises Strain Gauge type sensors adapted to measure the depth of the rigid skull, and the force stress applied to the rigid skull.
Schornagel et al. (US 2021/0085340 A1) teaches a system for drilling a bore in a bone (7) and measuring a depth of the bore during surgery (Schornagel, Abstract). Schornagel teaches Strain Gauge type sensors adapted to measure the depth of the rigid skull, and the force stress applied to the rigid skull (Schornagel, Abstract; [0001], “produce a signal representing a force exerted”). Therefore, in view of Schornagel, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biomodel described in Sakezles, by strain gauge as taught by Schornagel, in order to the displaying part receives measurements from the measurement system and processes the data. The force and distance data is combined to calculate a point where the bone starts and where it ends. This results in the recommended screw length which is displayed to the surgeon (Schornagel, [00037]).
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
Applicant argues:
Without acquiescing to the merits of the rejection and solely to advance prosecution, Applicant has amended claim I (from which claim 5 depends) to recite "wherein the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film". The claim as amended is neither disclosed nor suggested by Sakezles or Bioseb, either individually or in combination.
Sakezles is directed to a canine anatomical model but fails to disclose or suggest the use of a semitransparent hydrophobic moldable silicone film as an internal component of the skull. Bioseb, while describing a rat training simulator, likewise does not disclose or suggest the inclusion of a semitransparent hydrophobic moldable silicone film as an internal component of the skull.
The examiner submits that the primary reference Sakezles teaches a hydrophobic moldable silicone film (Sakezles, [0057]; [0090]; [0097]; [0058]) without specifying the hydrophobic moldable silicone film is transparent or not. The newly cited reference Lytle (US 9,552,747 B1) teaches the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film (Lytle, Abstract; col. 2, line 30 – col. 3, line 3, “head model comprises a head exterior component, an interior cavity, a skull component, a brain component, a fluid component, an interior cavity surface and a translucent cover … the brain component may be made out of a material that has a similar density and elasticity as a real brain including, but not limited to, an elastomer, such as silicone or urethane … A transparent cover may be a transparent panel that extends across and is attached to the skull component. A dura component, such as a liner around a portion of the brain component, or around the perimeter of the brain component, may simulate an actual human dura and may be recognized by imaging analysis to determine the surface area and/or perimeter of the brain component … enabling viewing of the brain component through the clear dura component portion and identification of the shaded dura component portion around the perimeter of the brain component”).
Applicant argues: … The cited references lack any motivation or suggestion to employ such a material inside the rigid skull of the rat biomodel and also fail to recognize the advantages provided by this feature for craniotomy training with the aim of providing a training model as anatomically accurate as possible. None of the cited references teach, suggest or render obvious the unique inventive concept embodied in the present claims, which is a rat biomodel specifically designed as a specialized training apparatus to facilitate the acquisition of practical surgical techniques required for craniotomy procedures in rats. Claim 1 as amended and claim 5 (dependent on claim 1) are distinguished over the references at least by this specific structural limitation, which is not merely a substitution of known elements, but represents a novel and non-obvious improvement in the field.
In response to applicant's argument that is Sakezles’s canine model, Lida’s human model, nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, all the cited references are in the field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor was concerned. Specifically, Applicant’s invention relates to an animal simulator model or anatomy model of a living organism. According to Applicant’s own specification, para. [0002], “scientific studies have been using rodents as models due to their physiological and genetic characteristics that are close to those of humans.” One of an ordinary skill in the art would have combine Sakezles’s canine model, Lytle’s human model, Bioseb’s rat model, since rodent’s model and human model are physiological and genetic similar.
Applicant argues: Norikane is directed exclusively to models of human organs and does not disclose or suggest anatomical models of rat organs. The anatomical and physiological differences between human and rat organs are significant, particularly with respect to the training needs for medical craniotomy techniques. Norikane' s teachings are limited to the construction and use of human anatomical models and do not address the unique anatomical structures or proportions associated with rat models-particularly for craniotomy procedures. The Office's suggestion that it would be obvious to apply Norikane's teaching of a colored gel to mimic the appearance of a rat brain fails to recognize these fundamental differences. Norikane provides neither the motivation nor the technical guidance to adapt its human organ models to the context of a rat biomodel, nor does it address the technical challenges inherent in replicating rat anatomy for the purpose of training medical craniotomy techniques.
Again, Applicant’s own specification suggests (para. [0002]) that “scientific studies have been using rodents as models due to their physiological and genetic characteristics that are close to those of humans.” One of an ordinary skill in the art would have combine Sakezles’s canine model, Lytle’s human model, Bioseb’s rat model, since rodent’s model and human model are physiological and genetic similar. Fruthermore, Norikane suggests that (para. [0089]) the internal organ model of the present disclosure has no particular limit and can reproduce every internal organ in a human body, including brain, heart, gullet, stomach, bladder, small intestine, large intestine, liver, kidney, spleen, pancreas, and womb. A rodent biomodel would have similar organ configurations to that of a human being.
Applicant argues: Schwindt describes anatomical models and simulators, but its teachings are directed primarily to human medical training. There is no teaching or suggestion in Schwindt of a rat biomodel, nor does Schwindt teach or motivate the combination of features recited in claims 1, 2, and 4. Specifically, Schwindt does not describe a rat biomodel having a rigid skull internally comprising a semitransparent hydrophobic moldable silicone film, with the rigid skull being filled with a reddish colored gelatinous material and with the rigid skull manufactured using acrylonitrile-butadiene-styrene (ABS) monofilament in ivory white color. Furthermore, the combination of Sakezles, Bioseb, Norikane, or Schwindt does not result in the present claims, as none of the cited references disclose all of the elements of claim 4.
Applicant’s own specification suggests that rodent models are similar to physiological and genetic characteristics of humans. Furthermore, Applicant’s invention and Schwindt are both related to model for studying anatomy structures of mammals. Hence, Schwindt is an analogous art to applicant’s invention.
Applicant argues: Seitz et al. is directed to anatomical models and simulators for surgical training, but its teachings are focused exclusively on human anatomical models. Seitz does not disclose or suggest a rat biomodel comprising a rigid skull internally lined with a semitransparent hydrophobic moldable silicone film manufactured by 3D printing.
Applicant’s own specification suggests that rodent models are similar to physiological and genetic characteristics of humans. Furthermore, Applicant’s invention and Seitz are both related to model for studying anatomy structures of mammals. Hence, Seitz is an analogous art to applicant’s invention.
Applicant argues: The Office Action asserts that Iida teaches a skull internally comprising a semitransparent hydrophobic moldable silicone film. Applicant respectfully argues that this assertion is not supported by the disclosure of Iida. Iida describes a human head model intended for imaging calibration, manufactured via stereolithography using a rigid transparent or semitransparent resin, not a semitransparent hydrophobic moldable silicone film. The internal structures of Iida' s model are continuous hollow cavities designed for liquid injection to simulate radiodensity for brain imaging technologies such as PET/SPECT, not for training in craniotomy techniques. Iida does not teach or suggest a rat biomodel for training medical craniotomy techniques with a rigid skull, wherein the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film.
The Office cites Lytle (US 9,552,747 B1) for the limitations: the rigid skull internally comprises a semitransparent hydrophobic moldable silicone film.
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.
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/JACK YIP/Primary Examiner, Art Unit 3715