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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/30/2026 has been entered. Claims 1 – 5 and 7 are pending. Claim 6 has been cancelled.
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 disposed as an internal anatomical liner lining an inner surface of the rigid skull to simulate a rat dura mater, which is a biological film existing in a brain.
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”) disposed as an internal anatomical liner lining an inner surface of the rigid skull to simulate a rat dura mater, which is a biological film existing in a brain (Lytle, fig. 2, 69; fig. 4, 23; fig. 6, 23; fig. 8, 23; col. 10, lines 43 – 60, “A dura 55 component may be transparent when configured along the imaging side of the head model”). 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 7/30/2026 have been fully considered but they are not persuasive.
Applicant argues:
Lytle's "dura component" is described merely as a flat liner around a portion or perimeter of a brain component to facilitate camera-based imaging analysis (Lytle, col. 2, lines 50-54). Lytle does not teach or suggest a specialized, moldable, hydrophobic, semitransparent silicone film disposed as an internal anatomical liner lining the inner surface of a rigid skull to simulate the unique tactile and visual resistance of a rat's dura mater during a delicate microsurgical craniotomy.
The Office submits that the dura component in Lytle meets that limitation of semi-transparent dura mater… disposed as an internal anatomical liner lining of a skull. For example, Lytle teaches a semi-transparent dura mater inside of a skull (Lytle, Abstract; col. 2, line 30 – col. 3, line 3, “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”; fig. 2, 69; fig. 4, 23; fig. 6, 23; fig. 8, 23; col. 10, lines 43 – 60, “The dura component 23, or lining around the perimeter 27 of the brain component in the image side 87 plane … A dura component may be transparent when configured along the imaging side of the head model”). For example, fig. 8, 23 in Lytle is a transparent dura mater.
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Applicant argues:
The Office's rejection relies on a combination of a canine model (Sakezles), a generic rat handler (Bioseb), and a human helmet impact simulator (Lytle). In the Advisory Action, the Office attempts to establish a motivation to combine by citing Applicant's own specification (paragraph [0002]) regarding the physiological similarities between rodents and humans. Applicant respectfully submits that a person of ordinary skill in the art seeking to build an anatomically accurate micro-surgical training model for rat craniotomy would have no rational motivation to look to a human crash-test/impact simulator (Lytle) to find an internal anatomical liner. Lytle' s design is driven by physical impact resistance and optical clarity for camera tracking, not by the tactile, micro-scale incision feedback required for training surgeons on live rodent tissue. Furthermore, the Office's use of the Applicant's own disclosure as a roadmap to combine references amounts to impermissible hindsight.
First, According to MPEP 608.01(C) “Basis of the invention” or “Background of the Invention” according to,
“608.01(c) Background of the Invention [R-07.2022] The Background of the Invention may (but is not required to) include the following parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable Cooperative Patent Classification (CPC) definitions. The statement should be directed to the subject matter of the claimed invention.
(2) Description of the related art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A paragraph(s) describing to the extent practical the state of the prior art or other information disclosed known to the applicant, including references to specific prior art or other information where appropriate. Where applicable, the problems involved in the prior art or other information disclosed which are solved by the applicant’s invention should be indicated. See also MPEP § 608.01(a), § 608.01(p) and § 707.05(b).
According Background of Invention describes to the extent practical the state of the prior art or other information disclosed known to the applicant, including references to specific prior art or other information where appropriate. Applicant didn’t combine rodent model and human model in its’ specification. Para. [0002] merely states it is a well-known fact that rodents share many physiological and genetic characteristics to that of a human. Basically, para. [0002] contradicts with applicant’s own argument that Rodents and humans have significantly different anatomical features.
Second, nowhere in claims 1 -5 and 7 make reference to micro-surgical training model. Claim 1 merely states “A rat biomodel for training medical craniotomy techniques” in the preamble. When reading the preamble in the context of the entire claim, the recitation “training medical craniotomy technique” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Third, 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, Sakezles, Bioseb and Lytle are related to anatomical models which are in the field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor (i.e., medical simulator).
Conclusion
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/JACK YIP/Primary Examiner, Art Unit 3715
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