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
The amendment filed March 17, 2026 has been entered. Claims 1-22 remain pending in the application; claims 11-22 are withdrawn from consideration. Claims 1 and 3 are noted as amended. Applicant’s amendments to the claims have overcome all previous 112(b) rejections set forth in the Non-Final Office Action mailed December 17, 2025 and all rejections therein have been withdrawn. However, new rejections are discussed below.
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 1-10 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.
Claim 1 recites the limitation “wherein the first part and the second part are hydrogel compositions tuned to match the viscosities of different parts of a biological brain at both static and different shear strain rates caused by concussion or TBI” which lacks sufficient support from the original disclosure and specification amounting to new matter. Specifically, while the specification provides support for hydrogel compositions to achieve desired viscosities with corresponding static and different shear strain rates, the claim limitation implies the rates are different under a concussion or TBI from the supported compositions. The specification does not provide support that the viscosities or rates would be different “caused by a concussion or TBI”. As further discussed below, the “caused by concussion or TBI” is an intended use of a claimed brain phantom as the specification does not provide support for some material or compositional change caused by concussion or TBI. For the sake of compact prosecution, the limitation is interpreted as the parts being form by hydrogel compositions tuned to match biological brains including static and different shear strain rates which would be exhibited in an intended test/use including concussion or TBI.
Claims 2-10 are rejected by virtue of their dependency from claim 1.
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.
Claims 1-10 are 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.
Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-10 are rejected by virtue of their dependency from claim 1.
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.
Claim(s) 1-3, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron et al. (US PGPub 20160155364), hereinafter referred to as Piron, in view of Wu et al. (US PGPub 20170261416), hereinafter referred to as Wu.
With regard to claim 1, Piron teaches a brain phantom (Abstract; Paragraphs 0043, 0047 teach a brain model and/or phantom), comprising:
a first part with a first viscoelasticity (Abstract; Paragraphs 0048, 0059, 0080, 0096, 0100 teach the brain model includes a plurality of layers and regions mimicking a real brain wherein the brain features and regions are intended to mimic the biomechanical properties of a real brain including viscosity and elastic properties); and
a second part with a second viscoelasticity which differs from the first viscoelasticity (Abstract; Paragraphs 0048, 0059, 0080, 0096, 0100, 0125 teach the brain model includes a plurality of layers and regions mimicking a real brain wherein the brain features and regions are intended to mimic the biomechanical properties of a real brain including viscosity and elastic properties such that the regions/features are differentiated thereby having different properties including viscoelasticity);
wherein the brain phantom is shaped and sized to correspond with a biological brain including having different parts which correspond respectively with different biological brain regions (Paragraphs 0070, 0088, 0099, 0101 teach the brain model is based on MRI images to generate a real human brain which can even be for a specific patient including different features and sections/regions of the brain),
wherein the first part and the second part are hydrogel compositions tuned to match the viscosities of different parts of a biological brain at both static and different shear strain rates (Paragraphs 0048, 0059, 0080, 0096, 0100, 0123, 0125 teach the brain model includes a plurality of layers and regions mimicking a real brain wherein the brain features and regions are intended to mimic the biomechanical properties of a real brain including viscosity and elastic properties wherein the produced parts including gyri and sulci exhibit combinations of elastic modulus, shear modulus, tensile strength, and nonlinear elastic properties (static and different shear strain rates) comparable to a real brain wherein the brain material is molded from materials including hydrogel compositions to achieve the appropriate biomechanical properties of the brain).
Piron may not explicitly teach configured for assessing brain injuries such as concussion and traumatic brain injury (TBI); one or more sensors embedded in one or more of the first part and the second part and configured for measuring impact forces in the brain phantom; caused by concussion or TBI. However, it is noted that the limitations of configured for assessing brain injuries such as concussion and traumatic brain injury (TBI) and wherein the static and different shear strain rates caused by concussion or TBI are interpreted as intended use and/or functional language wherein the limitations do not require a structural difference beyond the other claimed limitations taught by Piron as the brain model of Piron does not exclude or teach away from usage for a concussion or TBI modeling by reciting the use of surgical training as the mere absence of an intended use is not evidence against the usage (see MPEP 2111.02 and 2114). Therefore, Piron is sufficient for the claimed limitations and can perform the intended use/functional limitation without further modification. However, assuming in arguendo Piron does not teach the claimed limitations, Wu teaches a method and apparatus for examining brain injuries due to impact including a head model including a brain component wherein the brain component can be made out of a material that has a similar density and elasticity as a real brain wherein the material may be a gel or composite material and wherein the model includes a plurality of sensors including accelerometers and stress-strain gauges for measuring impact events to the head model including injuries (Abstract; Paragraphs 0029, 0037, 0040, 0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron to incorporate the teachings of Wu by incorporating the teaching of placing a plurality of sensors in various locations of a brain model and using the model for impact testing of Wu for the brain model/phantom of Piron, as both references and the claimed invention are directed to brain models made using gel and composition materials and mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron by integrating sensors into the model in various locations such as various layers or the sulci and gyri of the brain model and using the brain model for simulating the reaction of a brain during an impact causing an injury such as concussion or TBI. Upon such modification, the method and system of Piron would include configured for assessing brain injuries such as concussion and traumatic brain injury (TBI); one or more sensors embedded in one or more of the first part and the second part and configured for measuring impact forces in the brain phantom; caused by concussion or TBI. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wu with Piron’s system and method in order to gather desired data on the organ and interactions and simulations with the organ and study impacts on the brain (Wu Paragraph 0030).
With regard to claim 2, Prion further teaches wherein the first viscoelasticity matches a viscoelasticity of grey matter (Paragraph 0083, 0096, 0125 teach the brain model includes mimicking grey matter including the properties and “feel”), wherein the second viscoelasticity matches a viscoelasticity of white matter (Paragraph 0083, 0096, 0125 teach the brain model includes mimicking white matter including the properties and “feel”).
With regard to claim 3, Piron may not explicitly teach wherein the one or more sensors are configured to collect at least acceleration data or strain measurements. However, as discussed above, Wu teaches a method and apparatus for examining brain injuries due to impact including a head model including a brain component wherein the model includes a plurality of sensors including accelerometers and stress-strain gauges for measuring impact events to the head model (Paragraphs 0037, 0044, 0048).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron to incorporate the teachings of Wu by incorporating the teaching of placing a plurality of sensors in various locations of a brain model of Wu for the brain model/phantom of Piron, as both references and the claimed invention are directed to brain models made using gel and composition materials and mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron by integrating sensors into the model in various locations such as various layers or the sulci and gyri of the brain model wherein the sensors include accelerometers and stress-strain gauges for measuring acceleration data and strain measurements. Upon such modification, the method and system of Piron would include wherein the one or more sensors are configured to collect at least acceleration data or strain measurements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wu with Piron’s system and method in order to gather desired data on the organ and interactions and simulations with the organ and study impacts on the brain (Wu Paragraph 0030).
With regard to claim 5, Piron further teaches wherein the first and second parts of the brain phantom comprise at least a first region and a second region which is different from the first region (Paragraphs 0059, 0070, 0083, 0096 teach the brain model includes grey and white matter tissue/layers and can include specific regions including a tumor target or other regions mimicking a real brain) but may not explicitly teach wherein the one or more sensors comprise at least a first accelerometer embedded in the first region of the brain phantom and a second accelerometer embedded in the second region of the brain phantom. However, Wu further teaches the model may include a number of sensors configured in various locations of the brain component wherein the sensors may be accelerometers such that the model includes a first and second accelerometers embedded in different (first and second) regions of the brain component as shown in Figure 4 (Figure 4, Ref 88; Paragraphs 0037, 0044).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron to incorporate the teachings of Wu by incorporating the teaching of placing a plurality of sensors in various locations of a brain model of Wu for the brain model/phantom of Piron, as both references and the claimed invention are directed to brain models made using gel and composition materials and mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron by integrating sensors into the model in various locations such as various layers or the sulci and gyri of the brain model wherein the sensors may be accelerometers positioned in different (first and second) layers/regions. Upon such modification, the method and system of Piron would include wherein the one or more sensors comprise at least a first accelerometer embedded in the first region of the brain phantom and a second accelerometer embedded in the second region of the brain phantom. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wu with Piron’s system and method in order to gather desired data on the organ and interactions and simulations with the organ and study impacts on the brain (Wu Paragraph 0030).
With regard to claim 6, Piron further teaches wherein the brain phantom is free of incisions, piercings, and tears (Paragraphs 0089, 0099, 0123 teaches the model is 3D printed and mimics a real brain for surgical training such that it is in a condition to allow a surgeon to train on the model and avoid “tearing or harming” the model which means the model must be free of incisions, piercings, and tears before training).
With regard to claim 7, Piron further teaches wherein the brain phantom is shaped and sized to correspond with the biological brain of an individual patient so that the brain phantom is personalized to the individual patient (Paragraphs 0099, 0101 teach the brain model is 3D printed based on MRI scans which can be patient specific such that the model is a model of the patient’s actual brain thereby personalized/patient-specific for that patient).
With regard to claim 9, Piron in view of Wu teaches a system for assessing brain injuries, comprising the brain phantom of claim 3 (see prior art rejection of claim 3 above; Examiner notes that “assessing brain injuries” is an intended use and could be performed by the model of Piron in view of McAlpine without further modification), but may not explicitly teach a controller configured to collect measurements made by the one or more sensors. However, Wu further teaches the model can include a data and power cable which is configured to acquire data from the one or more sensors and provide the data to a data acquisition system (controller) (Paragraph 0039).
As discussed above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron to incorporate the teachings of Wu by incorporating the teaching of placing a plurality of sensors in various locations of a brain model and including a data acquisition system of Wu for the brain model/phantom of Piron, as both references and the claimed invention are directed to brain models made using gel and composition materials and mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron by integrating sensors into the model in various locations such as various layers or the sulci and gyri of the brain model wherein the sensor data is acquired and provided to a data acquisition system for collecting and processing the data. Upon such modification, the method and system of Piron would include wherein the one or more sensors comprise at least a first accelerometer embedded in the first region of the brain phantom and a second accelerometer embedded in the second region of the brain phantom. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Wu with Piron’s system and method in order to gather desired data on the organ and interactions and process the data for analysis (Wu Paragraphs 0030, 0039).
With regard to claim 10, Piron further teaches wherein the first viscoelasticity matches a viscoelasticity of grey matter (Paragraph 0083, 0096, 0125 teach the brain model includes mimicking grey matter including the properties and “feel”), wherein the second viscoelasticity matches a viscoelasticity of white matter (Paragraph 0083, 0096, 0125 teach the brain model includes mimicking white matter including the properties and “feel”).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron in view of Wu, as applied to claim 1 above, and further in view of Niimi et al. (US PGPub 20180061279), hereinafter referred to as Niimi.
With regard to claim 4, Piron in view of Wu may not explicitly teach wherein the first part and second part have different hydrogel precursor-to-crosslinking agent ratios. However, Niimi teaches hydrogel organ models and methods of manufacturing them including using adjusting mixing ratios of the hydrogel to impart physical properties to the model including adjusting precursor to crosslinking ratios (Paragraphs 0050, 0106, 0238-0239, 0252, 0410).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron in view of Wu to incorporate the teachings of Niimi by applying the teaching of using various hydrogel ratios to achieve desired properties of Niimi for the brain model/phantom of Piron, as both references and the claimed invention are directed to surgical models including brain models mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron in view of Wu by modifying the ratio of precursor to crosslinking agent to achieve desired properties as Piron already teaches adjusting a hydrogel concentration and doping the concentrations with suitable agents to achieve desired properties of the human brain model (Paragraph 0125). Upon such modification, the method and system of Piron in view of Wu would include wherein the first part and second part have different hydrogel precursor-to-crosslinking agent ratios. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Niimi with Piron in view of Wu’s system and method in order to produce desired properties for each feature and section of the brain model in order to further differentiate the features.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piron in view of Wu, as applied to claim 1 above, and further in view of Niimi and further in view of Satchi-Fainaro et al. (US PGPub 20240167001), hereinafter referred to as Satchi.
With regard to claim 8, Piron in view of Niimi teach using different hydrogel ratios to achieve desired properties (see prior art rejection of claim 4 above), but may not explicitly teach wherein the first part and the second part each comprise hydrogel, gelatin, and transglutaminase (TG), wherein the first part has a different ratio of hydrogel:gelatin:TG than does the second part. However, Satchi teaches a 3D brain and tumor model and method for making the model wherein the model is made using hydrogel mixtures including concentrations and ratios of fibrin or fibrinogen (hydrogel), gelatin, and transglutaminase in order to achieve desired properties (Abstract; Paragraphs 0054, 0099, 0113, 0307-0308).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Piron in view of Wu and Niimi to incorporate the teachings of Satchi by incorporating the teaching of using various hydrogel ratios including hydrogel, gelatin, and transglutaminase of Satchi for the brain model/phantom of Piron using various ratios to achieve desired biomechanical properties as taught by Niimi, as the references and the claimed invention are directed to surgical/organ models including brain models mimicking biomechanical properties of real organs. One of ordinary skill in the art would modify Piron in view of Wu and Niimi by modifying the hydrogel mixtures to include fibrin or fibrinogen, gelatin, and transglutaminase in various ratios in order to achieve desired properties of the features and regions of the brain model such as the grey and white matter as Piron already teaches adjusting a hydrogel concentration and doping the concentrations with suitable agents to achieve desired properties of the human brain model (Piron Paragraph 0125). Upon such modification, the method and system of Piron in view of Wu and Niimi would include wherein the first part and the second part each comprise hydrogel, gelatin, and transglutaminase (TG), wherein the first part has a different ratio of hydrogel:gelatin:TG than does the second part. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate these teachings from Satchi with Piron in view of Wu and Niimi’s system and method in order to produce desired properties for each feature and section of the brain model in order to further differentiate the features including using 3D printing material optimized for mimicking certain properties (Satchi paragraph 0113).
Response to Arguments
Applicant’s arguments, see Remarks, filed March 17, 2026, with respect to the rejection(s) of claim(s) 1-10 under 35 U.S.C. 102/103 have been fully considered and are persuasive in part by virtue of Applicant’s amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. 103 in view of the newly cited combination of prior art discussed above. With regard to Applicant’s arguments, Applicant argues Piron describes two sorts of brain phantoms and the disclosure “is tacit acknowledgement that phantom materials” do not necessarily align and Piron would impress upon one of ordinary skill in the art “that form follows function”. However, Piron does not explicitly state what Applicant asserts and even explicitly states the phantoms may be embodied as a single phantom having both the imaging and biomechanical properties per the abstract and Piron Paragraph 0130. Applicant’s subsequent arguments are directed to the intended use of the phantom and “subjecting a phantom to any forces greater than those involved in brain surgery”. As discussed above, the instant application does not discuss or present evidence of any structural or compositional differences between the claimed phantom and the claimed phantom “caused by a concussion or TBI” and regardless the limitation is an intended use as the structure of Piron is designed to mimic the viscosity and elasticity of a real human brain which meets the broadest reasonable interpretation of the claimed invention as, if it is used for the intended use of a concussion or TBI, does not require further modification to have the claimed structural properties. Assuming in arguendo the intended use is beyond functional language, the rejection has been withdrawn and amended in view of Wu under 35 U.S.C. 103 as discussed above and in view of Piron failing to teach the other amended limitation of “one or more sensors embedded in one or more of the first part and the second part and configured for measuring impact forces in the brain phantom”. Finally, Applicant’s argument that Piron fails to teach the compositions “tuned to match the viscosities” is not persuasive as the claim language is interpreted under its broadest reasonable interpretation and Applicant has not claimed a specific composition or the properties shown in Figures 2A, 2B, and 2C. Even assuming this argument is persuasive, such intent and teaching can then be drawn from Wu to compose the materials to simulate anatomy of a real brain being subjected to an impact using the gel and composite materials of Piron (Wu Paragraphs 0032, 0050).
Conclusion
Accordingly, claims 1-10 are rejected and claims 11-22 are withdrawn.
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 CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached at (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715
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