DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to claims in application 19/111,433 filed on 3/13/2025.
The instant application claims benefit to foreign application # IT102022000018696 with a priority date of 9/13/2022.
The Pre-Grant publication # 20260094538 is published on 4/2/2026
Claims 1-19 are pending.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Patent Application Publication Number US 20220082500 A1 to DACOSTA et al. (Dacosta) in view of Patent Application Publication Number US 20160155364 A1 to Piron et al. (Piron) and further in view of US 20070135355 A1 to Bezwada.
Claim 1. Dacosta teaches a composition for making a model for simulating a soft tissue with ICG (Indocyanine green) type fluorescence (Para 0035 tissue phantom configured to fluoresce green when illuminated with excitation light having a wavelength of between 400 nm and about 450 nm; indocyanine green ICG, a green dye such as Pacific Green IRDye 800CW, or other fluorophores of interest may be used) comprising
a material in particle form suitable for emitting a fluorescence in the near infrared (Para 0036 appropriate excitation light emits a red fluorescence; Para 0041, optical properties allow to mimic tissue response to illumination by excitation light in the ultraviolet/blue range, near infrared range) , and
Decosta teaches a teaches a composition for making a model for simulating a soft tissue (Para 0035) but that does not explicitly be comprising of calcium oxide (CaO), copper oxide (CuO), silicon dioxide (SiO2) or comprising CaCuO2(SiO2)4 particles.
Piron, however, in an analogous field of surgical training and imaging brain phantom reasonably pertinent to the problem faced by inventor for reasonable expectation of success teaches a composition for making a model for simulating a soft tissue that could be comprising of calcium oxide (CaO), copper oxide (CuO), silicon dioxide (SiO2) or comprising CaCuO2(SiO2)4 particles. (¶ Para 0076 silicone product or urethane may be used for the purpose of mimicking biomechanical properties of the dural layer; para 0090 0093 copper sulphate also used so that calcium oxide (CaO), copper oxide (CuO), silicon dioxide (SiO2) or comprising CaCuO2(SiO2)4 particles be formed). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to incorporate calcium oxide (CaO), copper oxide (CuO), silicon dioxide (SiO2) or comprising CaCuO2(SiO2)4 particles, as taught by Piron, into the composition for making a model simulating a soft portion of the tissue phantom of Dacosta , in order to allow the tissue phantom to cure into a long-lasting, reproducible shape that mimics the connective tissue making an efficient contribution towards an overall simulating goal.
Claim 2. Dacosta in combination with Piron teaches a mixture for making a model for simulating a soft brain tissue with ICG- type fluorescence, comprising silicone and a composition comprising a material in particle form suitable for emitting a fluorescence in the near infrared (Dacosta: Para 0035, 0046 tissue phantoms representative of brain and comprising of silicone; Piron: Para 003 models mammalian brain).
Claim 3. Dacosta in combination with Piron teaches the mixture of claim 2, wherein the composition is the composition of claim 1 (Para 0042 composition).
Claim 4. Dacosta in combination with Piron teaches mixture according to The mixture of claim 3, comprising silicone and between 1% and 5% (w/w) of the composition according to claim 1 (Para 0042 possible to determine the appropriate amount or dose inducing composition w/w that should be administered to the patient).
Claim 5. Dacosta in combination teaches a model for simulating a soft brain tissue with ICG-type fluorescence comprising the mixture according to any one of claims claim 2 to 4 (Para 0076 imaging device may emit white light (WL), fluorescence (FL), infrared (IR), or a mixture ).
Claim 6. Dacosta in combination teaches a model for simulating a soft brain tissue with ICG-type fluorescence comprising a first mixture according to any one of claims 2 to 4 and a second mixture for simulating a soft brain tissue with 5-ALA fluorescence (Para 0097, 0150 fluorescein type; Para 5-ALA) but
said second mixture not comprising silicone and a polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye.
Bezwada, however teaches a second mixture comprising silicone and a polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye (¶ Para 0091 absorbable polymers, including but not limited to polyesters, polyester amides, polyurethanes, polyamides, and polyanhydrides by simple polycondensation reactions; para 0124 polymer resins, toluenesulfonic) . Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to incorporate second mixture comprising silicone and a polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye, as taught by Bezwada, into the mixture of Dacosta combination , in order to allow enabling them to release an active component over a desired time range.
Bezwada in combination with Dacosta modified by Piron do not further categorize said polycondensate being suitable for emitting a fluorescence observed in a field of 620-710 nm, when exposed to visible light with UV in a range of 375-440 nm. It would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to obtain polycondensate available in art being suitable for emitting a fluorescence observed in a field of 620-710 nm, when exposed to visible light with UV in a range of 375-440 nm] because the polycondensate available being suitable for emitting a fluorescence do not appear to provide any unexpected results in the field of application.
Claim 7. Dacosta in combination with Piron teaches a model for simulating a soft brain tissue with ICG-type fluorescence comprising a first mixture according to any one of claims 2 to 4 and a third mixture for simulating a soft brain tissue using fluorescein-type fluorescence (Para 0150 fluorescein type), said third mixture comprising silicone (Para 0035, 0046 a third tissue phantoms could be comprising of silicone) .
Bezwada in combination with Dacosta modified by Piron do not further categorize said a polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye when polycondensate being suitable for emitting a fluorescence peak observed in a field of 480-530 nm, when excited by ultraviolet rays at 254 nm and/or in the blue range between 465 and 490 nm. It would have been a matter of obvious design choice to one having ordinary skill in the art before the effective filing date of the claimed invention to obtain polycondensate available in art being suitable for being suitable for emitting a fluorescence peak observed in a field of 480-530 nm, since excited by ultraviolet rays at 254 nm and/or in the blue range between 465 and 490 nm do not appear to provide any unexpected results in the field of application.
Claim 8. Dacosta in combination teaches a model for simulating a soft brain tissue using ICG-type fluorescence comprising a first mixture according to any one of claims 2 to 4, a second mixture for simulating a soft brain tissue using 5-ALA fluorescence (Para 0090 carcinoma cells were treated with 5-ALA,), said second mixture comprising silicone and a polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye, said polycondensate being suitable for emitting a fluorescence observed in [[the]] a field of 620-710 nm, when exposed to UV visible light in a range of 375-440 nm, and a third mixture for simulating a soft brain tissue using fluorescein-type fluorescence (Para 0150 fluorescein type), said third mixture comprising silicone and a second polycondensate comprising melamine resin, toluene sulfonamide and a synthetic dye, said second polycondensate being suitable for emitting a fluorescence peak observed in a field of 480-530 nm, when excited by ultraviolet rays at 254 nm and/or in the blue range between 465 nm and 490 nm ( as obvious under similar condition of rejection under previous claims depending on claims 2 to 4).
Claim 9. Dacosta in combination teaches a model according to The model of claim 6, wherein the first mixture is included in an ICG portion of the model positioned at a distance from a 5-ALA portion of the model comprising the second mixture (Para 0090 carcinoma cells were treated with 5-ALA; Para 0097 distances).
Claim 10. Dacosta in combination teaches a model according to claim 7, wherein the first mixture is included in an ICG portion of the model positioned at a distance from a fluorescein portion of the model comprising the third mixture (Para 0150 fluorescein type for a subsequent mixture model development without providing any unexpected results).
Claim 11. Dacosta in combination teaches a model according to claim 8, wherein the first mixture is included in an ICG portion of the model positioned at a distance from a 5-ALA portion of the model comprising the second mixture and from a fluorescein portion of the model comprising the third mixture (Para 0069 distance dependencies model).
Claim 12. Dacosta in combination teaches a model according to claim 9 or 10 or 11, wherein a spacer made of silicone material is interposed between the fluorescein portion and the 5- ALA portion, or between the ICG portion and the fluorescein portion, or between the ICG portion and the 5-ALA portion (Para 0069. 0150 fluorescein type and distances).
Claim 13. Dacosta in combination teaches a model according to any one of claims 11 to 12, wherein said model morphologically reproduces a portion of brain comprising a deep front seat, an insular surface and a Sylvian fissure, and wherein the ICG portion comprises at least one vessel or aneurysm, and wherein fluorescein (Para 0150 fluorescein type) is positioned in the deep front seat, and wherein the 5-ALA portion is positioned in a valley of the Sylvian fissure (Para 0101 Piron describes insertion of the surgical port into the brain via the sulci, requires the model to be life size and with the deep sulci morphology for brain phantoms).
Claim 14. Dacosta in combination teaches a model according to any one of claims The model of claim 5 to-comprising:[[-]] a first portion (301) for simulating a healthy tissue; and[[-]] a second portion (302) for simulating a neoplastic tissue, wherein said second portion comprises a mixture according to any one of claims 2 to 4 for making a model for simulating a soft brain tissue with ICG-type fluorescence, comprising silicone and a composition comprising a material in particle form suitable for emitting a fluorescence in the near infrared, and wherein said first portion (301) comprises water, gelatin, glycerin and sorbitol, and wherein [[the]] a content by weight of glycerin and sorbitol is predominant with respect to [[the]] a content by weight of gelatin (Piron: Para 0105 consistency may range from gelatinous to rigid).
Claim 15. Dacosta teaches use of the composition according to claim 1 A method for making a model for simulating a soft brain tissue using ICG-type fluorescence suitable for being used in surgical training procedures, the method comprising using the composition of claim 1 ( Para 0002 tissue phantoms may be used to train or educate surgeons).
Claim 16. Dacosta in combination teaches use of the mixture according to any one of claims 2 to 4 A method for making a model for simulating a soft brain tissue using ICG-type fluorescence suitable for being used in surgical training procedures, the method comprising using the mixture of claim 2 ( Para 0002 surgical training; Para 0125 mixtures ).
Claim 17. Dacosta in combination teaches use of a model for simulating a soft brain tissue according to any one of claims 5 to 14 in A method for performing surgical training procedures, the method comprising utilizing the model of claim 8 (Para 0034, 0088 training models).
Claim 18. Dacosta in combination teaches the model of claim 9, wherein a spacer made of silicone material is interposed between the ICG portion and the 5-ALA portion (Piron: Para 0069 it is necessary to understand the distance between the excitation light source and the material configured to represent diseased tissue).
Claim 19. Dacosta in combination teaches the model of claim 10, wherein a spacer made of silicone material is interposed between the ICG portion and the fluorescein portion (Para 0076 silicone could be used for spacer material also).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10749114 B2 Adamovich; Vadim et al.
Organic electroluminescent materials and devices
US 20060056580 A1 Frangioni; John V. et al.
Tissue-like phantoms
US 10024785 B2 Jang; Hyounguk et al.
Solid hemoglobin-polymer biophotonic phantoms and their use
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/S.Z/Examiner, Art Unit 3715 September 19, 2026
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715
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