DETAILED CORRESPONDENCE
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
As to the amended claims and remarks filed 6/16/26, the previous rejections have been withdrawn and modified to address the claim amendments.
Claim Status
Claims 1-20 are pending with claims 1-13 being examined and claims 14-20 deemed withdrawn.
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.
Claims 1-13 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.
Claim 1 contains the trademark/trade name Gellan gum “LT100”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name “LT100” is used to identify/describe the gellan gum and, accordingly, the identification/description is indefinite.
Claims 2-13 are rejected based on further claim dependency.
As to claim 7, it is unclear if the gellan gum of claim 7 is the same gellan gum LT100 that has been amended in claim 1. The examiner believes they are the same, but it is unclear to a potential infringer.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ding et al (US 20250250438; hereinafter “Ding”; already of record. Ding maps to application 18855134, where in the IFW of application 18855134 a certified copy of the foreign priority document GB2205490.2 application was filed on 10/8/24 as a 66 page document, where all of the information relied upon in the rejection using Ding (US 20250250438) is supported in the certified copy of the foreign priority document GB2205490.2) in view of Green et al (US 20180050088 ; hereinafter “Green”).
As to claims 1 and 7, Ding teaches a hydrolyzed collagen hydrogel with water (Ding teaches a collagen hydrogel where the gel would have water to form the gel; [9, 10, 16, 22, 95]) that includes a polymer to increase control of the mechanical properties and stiffness, where the polymer includes gellan gum, xanthan gum, guar gum, agar (Ding; [29, 34, 35, 38, 39]), and the composition includes a coloring agent (Ding teaches a dye; [72, 100]). Ding teaches up to 34% w/v of hydrolyzed collagen (Ding teaches between 15-30% collagen; [24]). The examiner notes that this composition would be capable of being used as a thrombus simulant because the composition is formed of substantially similar materials, because Ding teaches the material is a biomaterial (Ding; [2]), and also because how the material is used is a matter of intended use.
Note: The instant Claims contain a large amount of functional language (ex: “for use…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Although Ding teaches gellan gum, as best understood, Ding does not specifically teach LT100. However, Green teaches the analogous art of a hydrogel (Green; [179]) where LT100 is used as a gelling agent because it helps to form non-brittle gels (Green; [181]). It would have been obvious to one of ordinary skill in the art to have substituted the gellan gum in the gel of Ding to be LT100 as in Green because Green teaches that LT100 helps form non-brittle gels (Green; [181]) and also because Green teaches that LT100 helps to serve as a gelling agent (Green; [181]). Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date to choose the gellan gum LT100 as the specific gellan gum from Ding because choosing “from a finite number of identified, predictable solutions, with a reasonable expectation of success” is obvious to one of ordinary skill in the art (see KSR rationale E). MPEP § 2144.07 states ‘The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)’.
Claim 7 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ding et al (US 20250250438; hereinafter “Ding”; already of record) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of in view of Rossi et al(US 20210170027 ; hereinafter “Rossi”; already of record) in view of EE et al (US 20240261475; hereinafter “EE”; already of record).
As to claim 7, Ding teaches the synthetic material of claim 1 (see above), with between 25% and 34% w/v of hydrolyzed collagen (Ding teaches between 15-30% collagen; [24]) and gellan gum, xanthan gum, guar gum, agar (Ding; [29, 34, 38, 39. Ding teaches various polymers including gellan gum, guar gum, xanthan gum, and agar that can be used in combination). It would have been obvious to have selected the collagen of Ding to have been in the claimed range of 25-30%, also disclosed in Ding, because varying the collagen would help vary the stiffness and strength of the gel. Further, in the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
Ding does not specifically teach 0.2% and 1% w/v xanthan gum, 0.2% to 1% w/v agar agar, and 0.1% and 0.5% w/v guar gum. However, Rossi teaches the analogous art of a hydrogel (Rossi; [103]) where the gelling agent/viscosity enhancers include 0.01-2% xanthum gum, 0.04-1.2% agar, and 0.1-1% guar gum (Rossi; [105]). It would have been obvious to one of ordinary skill in the art to have modified the polymer viscosity enhancers of xanthan gum, agar, and guar gum of Ding to include the percentages of additional viscosity enhancers/gelling agents 0.01-2% xanthum gum, 0.04-1.2% agar, and 0.1-1% guar gum as in Rossi because Rossi teaches that these gelling agents are commonly used to sufficiently thicken the composition and can be used with other gelling agents or thickeners thereby showing the materials as obvious variants (Rossi; [105]). In the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
Ding does not specifically teach 0-2% w/v gellan gum. However, EE teaches the analogous art of a collagen hydrogel with gellan gum (EE; [7, 30]) where the gellan gum is present in about 0.8% (EE; [35]). It would have been obvious to one of ordinary skill in the art to have modified the collagen hydrogel with gellan gum of modified Ding to have 0.8% gellan gum as in EE because EE teaches that this concentration of gellan gum can enhance the viscosity (EE; [33-36]).
Claims 1, 3, 10, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 1, Thrombotech teaches a synthetic material suitable for use as a thrombus simulant, comprising: water; hydrolyzed collagen; gellan gum (Thrombotech teaches a synthetic blood clot to mimic the density and texture of an actual human blood clot, where the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes water, collagen, gellan gum, and barium sulfate; p. 1. Evidentiary reference SDS shows that collagen is CAS 9007-34-5 includes synonyms such as “collagen hydrolysate” which is hydrolyzed collagen).
Note: The instant Claims contain a large amount of functional language (ex: “for use…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Thrombotech teaches the use of the clot as a training material and teaches the use of a radiolucent agent for surgeons to visualize the material during training (Thrombotech; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1). Thrombotech does not teach that a coloring agent is added. However, Wortmann teaches the analogous art of synthetic clots (Wortmann; Title, abstract, p. 286, table 1) where a coloring agent is added to make the synthetic clot distinguishable (Wortmann; p. 290-292). It would have been obvious to one of ordinary skill in the art to have modified the synthetic clot used to train surgeons of Thrombotech to include the coloring agent to make the material visually distinguishable for visualization as in Wortmann because Wortmann teaches that the coloring agent makes the synthetic clot distinguishable (Wortmann; p. 290). Further, one of ordinary skill in the art would have modified the synthetic clot used to train surgeons of Thrombotech to include the coloring agent to make the material visually distinguishable for visualization as in Wortmann as a design choice to make the clot appear more realistic while training the surgeons.
Although Thrombotech teaches gellan gum, as best understood, Thrombotech does not specifically teach LT100. However, Green teaches the analogous art of a hydrogel (Green; [179]) where LT100 is used as a gelling agent because it helps to form non-brittle gels (Green; [181]). It would have been obvious to one of ordinary skill in the art to have substituted the gellan gum in the gel of Thrombotech to be LT100 as in Green because Green teaches that LT100 helps form non-brittle gels (Green; [181]) and also because Green teaches that LT100 helps to serve as a gelling agent (Green; [181]). Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date to choose the gellan gum LT100 as the specific gellan gum from Thrombotech because choosing “from a finite number of identified, predictable solutions, with a reasonable expectation of success” is obvious to one of ordinary skill in the art (see KSR rationale E). MPEP § 2144.07 states ‘The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)’.
Thrombotech teaches up to 34% w/v hydrolyzed collagen (The examiner notes that Thrombotech teaches that the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes the various components, but states that the concentration of the ingredients is proprietary; p. 1. Evidentiary reference SDS shows that Thrombotech includes collagen and gellan gum, but states that the concentration of the ingredients is proprietary; p. 1). The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to be formed of the same % of materials since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112). If it is deemed that Thrombotech does not teach up to 34% collagen, then it would have been obvious to a person having ordinary skill in the art to modify Thrombotech’s collagen concentration to be up to 34% for the purpose of providing enough strength via the collagen but not too much collagen that the clot was too rigid/hard since the clot texture can vary from soft, to medium, to hard as described in Thrombotech (Thrombotech; p. 1). Therefore, it is evident that Thrombotech recognizes that the texture is a result effective variable, that would vary based on the percentage compositions, since the materials of Thrombotech remain the same where the only variant would be the concentration to achieve the varying textures. Therefore, it would have been obvious to optimize Thrombotech’s collagen % to be up to 34% for the purpose of ensuring that enough strength via the collagen but not too much collagen that the clot was too rigid/hard to accurately mimic a clot.
Alternatively, if it is deemed that modified Thrombotech does not teach up to 34% w/v of hydrolyzed collagen then Wortmann teaches the analogous art of synthetic clots (Wortmann; Title, abstract, p. 286, table 1) where gelatine is used to form the synthetic clot, and where increasing gelatin improved peroration resistance as well as flow reduction and decreasing collagen decreases fragmentation (Wortmann teaches gelatin/collagen in varying concentrations, where increasing the content increases the perforation resistance and flow reduction; p. 295. See also Fig. 14 which shows that increasing concentrations of gelatin/collagen increase the hardness). Wortmann also teaches the properties that are evaluated when creating a synthetic clot include flow reduction, perforation resistance, fragmentation, and elasticity (Wortmann; Fig. 13). Wortmann further teaches that based on the type of clot that different perforation resistances are desirable (Wortmann; Fig. 14). Therefore, Wortmann teaches that changing the gelatin/collagen concentration affects the properties of the synthetic clot, and that the desired properties of the synthetic clot can change based on the type of clot mimicked. Thus, it is evident that Wortmann recognizes that the concentration of gelatin/collagen and the desired type of clot to be mimicked are result effective variables and that the concentration of the collagen can vary where increasing the collagen content can increase perforation resistance and where decreasing the collagen can decrease the fragility (Wortmann; Fig. 14, Fig. 13). It would have been obvious to one of ordinary skill in the art to have modified the amount of hydrolyzed collagen in the various clot types in modified Thrombotech to be up to 34% collagen because Wortmann teaches that increasing collagen/gelatin would increase the perforation resistance while decreasing collagen/gelatin can decrease the fragmentation and one of ordinary skill in the art would be motivated to increase the hardness by increasing the collagen/gelatin content (or vice vera) or decrease the fragmentation by decreasing the collagen/gelatin content (or vice versa) depending on the type of clot/thrombi that was desired to be mimicked. One of ordinary skill in the art would be motivated to increase the hardness by increasing the collagen/gelatin content when a harder and calcium rich thrombi was desired to be mimicked, and one of ordinary skill in the art would have been motivated to decrease the collagen content when a softer thrombi was desired to be mimicked, where Thrombotech teaches that both soft and hard textures can be desired based on the clot type to be mimicked.
Alternatively, if it is deemed that modified Thrombotech does not teach that the synthetic material comprises up to 34% w/v of hydrolyzed collagen then Radisic teaches the analogous art of a collagen hydrogel with at least about 10% collagen and no more than about 35% collagen (Radisic; [175, 176]). It would have been obvious to one of ordinary skill in the art to have modified the collagen hydrogel of modified Thrombotech to be at least about 10% and no more than 35% collagen as in Radisic because Radisic teaches that it is known to vary the collagen content of hydrogels (Radisic; [175, 176]). In the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
Modified Thrombotech does not specifically teach that the material includes xanthan gum, agar agar, and guar gum. EE teaches the analogous art of a hydrogel and EE does suggest that xanthan gum, agar, and guar gum are all known viscosity enhancers (EE; [38]). It would have been obvious to one of ordinary skill in the art to have used in the gellan gum of modified Thrombotech any other known viscosity enhancers including xanthan gum, agar, and guar gum as disclosed in EE because EE teaches that these are all obvious variants and known viscosity enhancers (EE; [38]). Alternatively, Rossi teaches the analogous art of a hydrogel (Rossi; [103]) where gellan gum is known as a gelling agent (Rossi; [104]), and where the gelling agent/viscosity enhancers include xanthum gum, agar, and guar gum (Rossi; [105]). It would have been obvious to one of ordinary skill in the art to have modified the gellan gum viscosity enhancer in the hydrogel of modified Thrombotech to include the percentages of additional viscosity enhancers/gelling agents xanthum gum, agar, and guar gum as in Rossi because Rossi teaches that these gelling agents are commonly used to sufficiently thicken the composition and can be used with other gelling agents or thickeners thereby showing the materials as obvious variants (Rossi; [105]).
As to claim 3, modified Thrombotech teaches the synthetic material of claim 1, further comprising a radiolucent agent (Thrombotech; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1).
As to claim 10, modified Thrombotech teaches the synthetic material of claim 1, wherein the synthetic material is configured to replicate properties of at least one selected from the group of newly formed thrombi, acute thrombi, and chronic thrombi, and is configured to have a shelf-life of at least six weeks (The examiner notes that Thrombotech teaches that the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes the various components, but states that the concentration of the ingredients is proprietary; p. 1). The combination of prior art teaches all of the claimed components in claim 1, and the examiner believes that the combination of components in claim 1 (based on applicants specification in [9, 26-28]) would result in the claimed properties. The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to replicate the clot properties and have a shelf life of at least six weeks since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
As to claim 13, modified Thrombotech teaches the synthetic material of claim 1, wherein the water, hydrolyzed collagen, gellan gum, xanthan gum, agar agar, and guar gum are mixed, heated, and cooled to form the synthetic material, and resembles a venous thrombus (Thrombotech teaches the collagen, water and gum that form the synthetic material that would be expected to form the same resulting structure as claimed. Additionally, it is known in the art that in order to form collagen and gum into gel in the presence of water that the composition is typically heated to assist with solubility. For example, this is how Jello is made. Further, Product-by-process claims are not limited to the manipulations of the recited steps, only to the resulting structure or structure implied by the steps. MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)). (The examiner notes that Thrombotech teaches that the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes the various components, but states that the concentration of the ingredients is proprietary; p. 1). The combination of prior art teaches all of the claimed components in claim 1, and the examiner believes that the combination of components in claim 1 (based on applicants specification in [9, 26-28]) would result in the claimed properties. The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to replicate the clot properties since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record) in view of Reiser et al (US 20090208612; hereinafter “Reiser”).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 2, modified Thrombotech teaches the synthetic material of claim 1, with a coloring agent via food colouring to make the thrombus distinguishable (see above).
Modified Thrombotech does not specifically teach the coloring agent comprises Allura Red AC. However, Reiser teaches the analogous art of coloring agents that impart color changes where Allura red AC can be used (Reiser; [37]). It would have been obvious to one of ordinary skill in the art to have modified the coloring agent to distinguish the synthetic clot used to train surgeons of modified Thrombotech to be Allura Red AC as in Reiser because Reiser teaches that Allura red AC is a known coloring agent (Reiser; [37]) and further because one of ordinary skill in the art would have modified the synthetic clot used to train surgeons of modified Thrombotech to include Allura Red AC as in Reiser because this would provide a red clot as a design choice to make the clot appear more realistic and blood-like while training the surgeons.
Claim 2 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record) in view of Grubbs et al (US 20230126091; hereinafter “Grubbs”; already of record).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 2, modified Thrombotech teaches the synthetic material of claim 1, with a coloring agent via food colouring to make the thrombus distinguishable (see above).
Modified Thrombotech does not specifically teach the coloring agent comprises Allura Red AC. However, Grubbs teaches the analogous art of coloring agents that mimic blood for surgical procedures, where the colorant can include red dye #40 (Grubbs teaches red dye #40 which is Allura Red AC; [17], Title). It would have been obvious to one of ordinary skill in the art to have modified the coloring agent to distinguish the synthetic clot used to train surgeons of modified Thrombotech to be Allura Red AC as in Grubbs because Grubbs teaches that Allura red AC is a known coloring agent which can be used to mimic blood (Grubbs; [37]) and further because one of ordinary skill in the art would have modified the synthetic clot used to train surgeons of modified Thrombotech to include Allura Red AC as in Grubbs because this would provide a red clot as a design choice to make the clot appear more realistic and blood-like while training the surgeons.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record) in view of Schmid et al (US 20200308319; hereinafter “Schmid”).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 4, modified Thrombotech teaches the synthetic material of claim 3, with the radiolucent agent (Thrombotech; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1).
Modified Thrombotech does not specifically teach wherein the radiolucent agent is iodine. However, Schmid teaches the analogous art of radiolucent agents which include barium sulfate or iodine (Schmid; [47]). It would have been obvious to one of ordinary skill in the art to have modified the barium sulfate radiolucent imaging agent of modified Thrombotech to be iodine as in Schmid because Schmid teaches that iodine is an obvious variant of barium sulfate (Schmid; [47]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record) in view of Omenetto et al (US 20150307728; hereinafter “Omenetto”; already of record).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 5, modified Thrombotech teaches the synthetic material of claim 1 (see above).
Although modified Thrombotech teaches a visible colorant in the synthetic material (see modification in claim 1), modified Thrombotech does not teach that the synthetic clot material also includes an optical brightener. However, Omenetto teaches the analogous art of a material with various uses in synthetic biology where the material can include a biopolymer made from collagen (Omenetto; [8, 244]) and where the material includes an optical brightener (Omenetto teaches that a UV fluorophore can be used as an optical brightener in addition to visible colorants; [165], see also [161-164]). It would have been obvious to one of ordinary skill in the art to have modified the synthetic clot material with a colorant of modified Thrombotech to include an optical brightener as in Omenetto because Omenetto teaches that it is well-known to include an optical brightener in addition to visible colorants (Omenetto; [165]).
As to claim 6, modified Thrombotech teaches the synthetic material of claim 5, wherein the optical brightener is a fluorescent brightening agent (The modification of the synthetic clot material with a colorant of modified Thrombotech to include an optical brightener as in Omenetto has already been discussed above. Omenetto teaches the optical brightener is a UV fluorophore; [165]).
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) and in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record)
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 7, modified Thrombotech teaches the synthetic material of claim 1, wherein the synthetic material comprises gellan gum, and between 25% and 34% w/v hydrolyzed collagen w/v hydrolyzed collagen (The examiner notes that Thrombotech teaches that the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes the various components, but states that the concentration of the ingredients is proprietary; p. 1. Evidentiary reference SDS shows that Thrombotech includes collagen and gellan gum, but states that the concentration of the ingredients is proprietary; p. 1). The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to be formed of the same % of materials since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112). If it is deemed that Thrombotech does not teach up to 34% collagen, then it would have been obvious to a person having ordinary skill in the art to modify Thrombotech’s collagen concentration to be between 25% and 34% w/v hydrolyzed collagen for the purpose of providing enough strength via the collagen but not too much collagen that the clot was too rigid/hard since the clot texture can vary from soft, to medium, to hard as described in Thrombotech (Thrombotech; p. 1). Therefore, it is evident that Thrombotech recognizes that the texture is a result effective variable, that would vary based on the percentage compositions, since the materials of Thrombotech remain the same where the only variant would be the concentration to achieve the varying textures. Therefore, it would have been obvious to optimize Thrombotech’s collagen % to be between 25% and 34% w/v hydrolyzed collagen for the purpose of ensuring that enough strength via the collagen but not too much collagen that the clot was too rigid/hard to accurately mimic a clot.
Alternatively, if it is deemed that modified Thrombotech does not teach between 25% and 34% w/v of hydrolyzed collagen then Wortmann teaches the analogous art of synthetic clots (Wortmann; Title, abstract, p. 286, table 1) where gelatine is used to form the synthetic clot, and where increasing gelatin improved peroration resistance as well as flow reduction and decreasing collagen decreases fragmentation (Wortmann teaches gelatin/collagen in varying concentrations, where increasing the content increases the perforation resistance and flow reduction; p. 295. See also Fig. 14 which shows that increasing concentrations of gelatin/collagen increase the hardness). Wortmann also teaches the properties that are evaluated when creating a synthetic clot include flow reduction, perforation resistance, fragmentation, and elasticity (Wortmann; Fig. 13). Wortmann further teaches that based on the type of clot that different perforation resistances are desirable (Wortmann; Fig. 14). Therefore, Wortmann teaches that changing the gelatin/collagen concentration affects the properties of the synthetic clot, and that the desired properties of the synthetic clot can change based on the type of clot mimicked. Thus, it is evident that Wortmann recognizes that the concentration of gelatin/collagen and the desired type of clot to be mimicked are result effective variables and that the concentration of the collagen can vary where increasing the collagen content can increase perforation resistance and where decreasing the collagen can decrease the fragility (Wortmann; Fig. 14, Fig. 13). It would have been obvious to one of ordinary skill in the art to have modified the amount of hydrolyzed collagen in the various clot types in modified Thrombotech to be between 25% and 34% w/v collagen because Wortmann teaches that increasing collagen/gelatin would increase the perforation resistance while decreasing collagen/gelatin can decrease the fragmentation and one of ordinary skill in the art would be motivated to increase the hardness by increasing the collagen/gelatin content (or vice vera) or decrease the fragmentation by decreasing the collagen/gelatin content (or vice versa) depending on the type of clot/thrombi that was desired to be mimicked. One of ordinary skill in the art would be motivated to increase the hardness by increasing the collagen/gelatin content when a harder and calcium rich thrombi was desired to be mimicked, and one of ordinary skill in the art would have been motivated to decrease the collagen content when a softer thrombi was desired to be mimicked, where Thrombotech teaches that both soft and hard textures can be desired based on the clot type to be mimicked.
Alternatively, if it is deemed that modified Thrombotech does not teach that the synthetic material comprises between 25% and 34% w/v of hydrolyzed collagen then Radisic teaches the analogous art of a collagen hydrogel with at least about 10% collagen and no more than about 35% collagen (Radisic; [175, 176]). It would have been obvious to one of ordinary skill in the art to have modified the collagen hydrogel of modified Thrombotech to be at least about 10% and no more than 35% collagen as in Radisic because Radisic teaches that it is known to vary the collagen content of hydrogels (Radisic; [175, 176]). In the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
Although Thrombotech teaches gellan gum, if it is deemed that modified Thrombotech does not teach that the synthetic material comprises between 0% and 2% w/v gellan gum then EE teaches the analogous art of a collagen hydrogel with gellan gum (EE; [7, 30]) where the gellan gum is present in about 0.8% (EE; [35]). It would have been obvious to one of ordinary skill in the art to have modified the collagen hydrogel with gellan gum of modified Thrombotech to have 0.8% gellan gum as in EE because EE teaches that this concentration of gellan gum can enhance the viscosity (EE; [33-36]) and one of ordinary skill in the art would have been omotivated to modify the viscosity of the synthetic clot which can mimic various clot types to be more viscous in situations where the clot type was more viscous.
Modified Thrombotech does not teach that the synthetic material includes: between 0.2% and 1% w/v xanthan gum; between 0.2% to 1% w/v agar agar; and between 0.1% and 0.5% w/v guar gum. However, EE teaches the analogous art of a hydrogel and EE does suggest that xanthan gum, agar, and guar gum are all known viscosity enhancers (EE; [38]). It would have been obvious to one of ordinary skill in the art to have used in the gellan gum of modified Thrombotech any other known viscosity enhancers including xanthan gum, agar, and guar gum as disclosed in EE because EE teaches that these are all obvious variants and known viscosity enhancers (EE; [38]).
Modified Thrombotech does not teach the claimed % compositions of synthetic material includes: between 0.2% and 1% w/v xanthan gum; between 0.2% to 1% w/v agar agar; and between 0.1% and 0.5% w/v guar gum. However, Rossi teaches the analogous art of a hydrogel (Rossi; [103]) where gellan gum is known as a gelling agent (Rossi; [104]), and where the gelling agent/viscosity enhancers include 0.01-2% xanthum gum, 0.04-1.2% agar, and 0.1-1% guar gum (Rossi; [105]). It would have been obvious to one of ordinary skill in the art to have modified the gellan gum viscosity enhancer in the hydrogel of modified Thrombotech to include the percentages of additional viscosity enhancers/gelling agents 0.01-2% xanthum gum, 0.04-1.2% agar, and 0.1-1% guar gum as in Rossi because Rossi teaches that these gelling agents are commonly used to sufficiently thicken the composition and can be used with other gelling agents or thickeners thereby showing the materials as obvious variants (Rossi; [105]). In the case where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exits (see MPEP 2144.05).
As to claim 8, modified Thrombotech teaches the synthetic material of claim 7, wherein the synthetic material is configured to maintain haptic properties resembling those of an actual human thrombus for a period of at least six weeks. The combination of prior art teaches all of the claimed components in claim 1, and the examiner believes that the combination of components in claim 1 (based on applicants specification in [9, 26-28]) would result in the claimed properties. The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to replicate the clot properties and have a shelf life of at least six weeks since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
As to claim 9, modified Thrombotech teaches the synthetic material of claim 1 (see above).
Thrombotech does not specifically teach that the material also includes either oil or saline solution. However, Wortmann teaches the analogous art of synthetic clots (Wortmann; Title, abstract, p. 286, table 1) where the material includes either oil or saline solution (Wortmann teaches storing the clot in saline; p. 292. Wortmann also teaches storage in oil; p. 291, 292, 296, 297). It would have been obvious to one of ordinary skill in the art to have modified the synthetic clot used to train surgeons of Thrombotech to be stored in oil or water as taught by Wortmann because Wortmann teaches that oil or water is commonly used to store synthetic clots (Wortmann; p. 292) and because Wortmann teaches that oil can help to reduce the materials stickiness (Wortmann; p. 291).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech (Biomodex launches synthetic clot product for neurovascular training; published 10/23/21; 1 page; already of record provided in the IDS on 11/6/24; hereinafter “Thrombotech” ; already of record) in view of Wortmann et al (Wortmann, N et al. Development of synthetic thrombus models to simulate stroke treatment in a physical neurointerventional training model; ALLLIFE; 15:1; pages 283-301; published 3/4/22 and submitted on 9/28/21; already of record provided in the IDS on 11/6/24; hereinafter “Wortmann”) in view of Green et al (US 20180050088 ; hereinafter “Green”) in view of Radisic et al (US 20210380950; hereinafter “Radisic” ; already of record) in view of EE et al (US 20240261475; hereinafter “EE”) or alternatively in view of Rossi et al (US 20210170027 ; hereinafter “Rossi”; already of record) in view of Vascular CME (How big are blood clots; https://web.archive.org/web/20190822005608/https://vascularcme.com/2016/01/15/how-big-are-blood-clots/; published 1/15/16; pages 1-3; hereinafter “Vascular CME”; already of record).
The safety data sheet for Thrombotech made by Biomodex (Safety Data Sheet; published 8/24/21; 4 pages; already of record provided in the IDS on 11/6/24; hereinafter “SDS”) is used as an evidentiary reference to show the composition of Thrombotech.
The CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) is an evidentiary reference showing that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”.
As to claim 11, modified Thrombotech teaches the synthetic material of claim 1 (see above).
Thrombotech does not specifically teach that the material has a diameter of 1-15 mm. However, Wortmann teaches the analogous art of synthetic clots (Wortmann; Title, abstract, p. 286, table 1) wherein the material is 1-15 mm in diameter (Wortmann; table 1, p. 288, 290). It would have been obvious to one of ordinary skill in the art to have modified the synthetic clot used to train surgeons of Thrombotech to have a diameter between 1-3 mm as taught by Wortmann because Wortmann teaches that when forming synthetic clots that the diameter of 1-3 mm is preferable (Wortmann; p. 288). Additionally, it would have been obvious to one of ordinary skill in the art to have modified the synthetic clot used to train surgeons of Thrombotech to have a diameter between 1-3 mm as taught by Wortmann because this would mimic the size of some neural clots when training for interventional thrombectomy to cure ischemic stroke.
Modified Thrombotech does not specifically teach the synthetic material is about 10 cm in length. However, Vascular CME teaches the analogous art of blood clots, and teaches that clots can be of all sizes and range from a few mm to 80 cm (Vascular CME; p. 1). Overlapping ranges are prima facie evidence of obviousness. It would have been obvious to one having ordinary skill in the art to have sized the clot length of Thrombotech by selecting the portion of Vascular CME that corresponds to the claimed range. In re Malagari, 184 USPQ 549 (CCPA 1974). Additionally, it would have been obvious to one of ordinary skill in the art to have modified the synthetic clot used to train surgeons of Thrombotech to have a length of a natural clot of 10 cm as claimed because Vascular CME teaches that clots come in various sizes from a few mm to 80 cm and it would have been obvious to have used a size of 10 cm to train the surgeons on a 10 cm long clot to mimic real world scenarios.
As to claim 12, modified Thrombotech teaches the synthetic material of claim 11 (see above), where the synthetic material, when formed, resembles a venous thrombus. The combination of prior art teaches all of the claimed components in claim 11, and the examiner believes that the combination of components in claim 11 (based on applicants specification in [9, 26-28]) would result in the claimed properties. The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to replicate the clot properties and have a shelf life of at least six weeks since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Babcock et al (US 20140193474; hereinafter “Babcock” ; already of record) teaches that hydrolyzed collagen and gelatin are synonymous; [149].
Oklu et al (US 20230310697; hereinafter “Oklu”; already of record) teaches a synthetic embolization hydrogel with about 20% gelatin and with a radiopaque material; [9, 24].
Grubbs et al (US 20230126091; hereinafter “Grubbs”; already of record) teaches a composition to mimic blood for training simulations where thickeners such as xanthum gum and starches help to thicken the material to mimic a blood clot; [53]. Grubbs also teaches using dye to achieve a realistic color; [17].
Jeong et al (US 20240156694; hereinafter “Jeong” ; already of record) teaches hydrogel forming materials as gelling agents including gums and agar; [17].
Niederhauser et al (US 20240016143; hereinafter “Niederhauser”; already of record) teaches common thickeners for hydrogels include gums and agar; [81, 82].
Goentoro et al (US 20220016127; hereinafter “Goentoro”; already of record) teaches the gums and agars are used as stabilizers; [169].
Response to Arguments
Applicant’s arguments filed 6/16/26 have been considered but are moot because the arguments are towards the claim amendments and not the new grounds of rejection presented based on the amended claims.
Applicants do provide arguments with respect to some prior art and the arguments which still apply to the current rejection will be addressed below.
Applicants argue on page 7 of their remarks that Ding (US 20250250438) cannot be prior art because the effective filing date is the PCT filing of 4/12/23, and not of the date of filing of the Foreign Application filed in Great Britan GB2205490.2 that was filed on 4/13/22. The examiner respectfully disagrees. Ding (US 20250250438) maps to application 18855134, where in the IFW of application 18855134 a certified copy of the foreign priority document GB2205490.2 application was filed on 10/8/24 as a 66 page document, where all of the information relied upon in the rejection using Ding (US 20250250438) is supported in the certified copy of the foreign priority document GB2205490.2. The filing date of prior art Ding is therefore the filing date of the foreign priority document GB2205490.2 that was filed on 4/13/22.
Applicants argue on page 7 of their remarks that Ding (US 20250250438) is not “a material suitable for use as a thrombus simulant” as claimed in the preamble of claim 1. Applicants argue that Ding teaches a leather-like biomaterial only for furniture or shoes which would not be “suitable for use” as a thrombus simulant. The examiner respectfully disagrees. First, how the material is used in a matter of function and/or intended use. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this case, Ding is a biomaterial that is capable of any use depending on the requirements of the end user, including that of a thrombus simulant if the properties were deemed desirable. Further, Ding does not limit the material to furniture or shoes. Although Ding does give exemplary uses of shoes or furniture, of a manufactured article (Ding; [134]), one of ordinary skill in the art would not ignore the overall discussion of Ding as teaching a material that is a biomaterial. As discussed in the Biomaterials Journal (Biomaterials; Aims and scope; accessed via the wayback machine https://web.archive.org/web/20220316232939/https://www.sciencedirect.com/journal/biomaterials/about/aims-and-scope; published online on 3/16/22; hereinafter “Biomaterials Journal”) a biomaterial is a substance that is used to direct therapeutic or diagnostic procedures, and includes polymer synthesis. In this case, Ding specifically uses the term “biomaterial” and is therefore capable of suitable for use as any biomaterial, including as a thrombus simulant as claimed.
Applicants argue on pages 8-13 of their remarks that the amended claims are not taught by the prior art. These arguments are not found persuasive as they are directed to the claim amendments and not the current rejection.
Applicants further argue on pages 9 and 11 that Thrombotech and the corresponding SDS cannot be used as references because the SDS states that the Thrombotech compositions are not disclosed to the public. The examiner respectfully disagrees with applicants assertion. While the SDS does specifically state that the exact composition/concentration (i.e. % of materials) are proprietary and not disclosed, the SDS and Thrombotech are both published documents that are disclosed to the public and the rejection is only relying on the disclosed references for what they teach.
Applicants argue on page 8 that the SDS referencing of CAS 9007-34-5 is not hydrolyzed collagen. However, the examiner respectfully disagrees. First, applicants have not provided any evidence on why this is not considered hydrolyzed collagen. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Further, CAS Database (Chemical Book CAS Database; CAS 9007-34-5; https://web.archive.org/web/20220703225135/https://www.chemicalbook.com/CASEN_9007-34-5.htm published 7/3/22; hereinafter “CAS Database”) teaches that CAS 9007-34-5 includes synonyms such as “collagen hydrolysate”, and discusses the various uses of hydrolysis products of collagen such as in thickening agents (ie. gelling agents).
Applicants on pages 9 and 11 of their remarks argue that the prior art cannot have similar properties because the composition is very different from what is disclosed in the SDS. Applicants argue on page 9 of their remarks that the rejection cannot rely on inherency because the rejection has not established that the % collagen and shelf life are inherent characteristics. The examiner respectfully disagrees. First, there are modificaitons present where the modification to the concentrations and composition result in a material that is identical to the claimed material and the material disclosed in the instant application. The examiner notes that Thrombotech teaches that the clot comes in three different textures of soft, medium, and hard to mimic different clot types; p. 1. Evidentiary reference SDS shows that Thrombotech includes the various components, but states that the concentration of the ingredients is proprietary; p. 1). The combination of prior art teaches all of the claimed components in claim 1, and the examiner believes that the combination of components in claim 1 (based on applicants specification in [9, 26-28]) would result in the claimed properties. The examiner believes that because applicants goal is to replicate the properties of a natural blood clot, and because applicants use the same materials of collagen, and gum as the prior art (see [9, 26-28] of the instant specification), and because the prior art also aims to replicate the properties of natural clots that the prior art which uses the same materials and has the same goal of achieving the same properties would be expected to replicate the clot properties and have a shelf life of at least six weeks since both the prior art and application use identical materials and have the same goal of replicating clot properties. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, the prior art products necessarily possess the characteristics of the claimed product. See MPEP 2112.01. As stated in In re Best, 562 F.2d 1252, 1255 (CCPA 1977): Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112).
Applicants argue on pages 9 and 12 of their remarks that Wortmann does not teach or suggest up to 34% hydrolyzed collagen and then goes on to state that Wortmann disqualifies gelatin as a thrombus model on page 295. The examiner respectfully disagrees. First, the examiner is citing Wortmann as teaching that collagen is a result effective variable that modifies the clot properties. See Fig. 14 which shows that increasing concentrations of gelatin/collagen increase the hardness. Wortmann also teaches the properties that are evaluated when creating a synthetic clot include flow reduction, perforation resistance, fragmentation, and elasticity (Wortmann; Fig. 13). Wortmann further teaches that based on the type of clot that different perforation resistances are desirable (Wortmann; Fig. 14). Therefore, Wortmann teaches that changing the gelatin/collagen concentration affects the properties of the synthetic clot, and that the desired properties of the synthetic clot can change based on the type of clot mimicked. Thus, it is evident that Wortmann recognizes that the concentration of gelatin/collagen and the desired type of clot to be mimicked are result effective variables and that the concentration of the collagen can vary where increasing the collagen content can increase perforation resistance and where decreasing the collagen can decrease the fragility (Wortmann; Fig. 14, Fig. 13). It would have been obvious to one of ordinary skill in the art to have modified the amount of hydrolyzed collagen in the various clot types in modified Thrombotech to be between 25% and 34% collagen because Wortmann teaches that increasing collagen/gelatin would increase the perforation resistance while decreasing collagen/gelatin can decrease the fragmentation and one of ordinary skill in the art would be motivated to increase the hardness by increasing the collagen/gelatin content (or vice vera) or decrease the fragmentation by decreasing the collagen/gelatin content (or vice versa) depending on the type of clot/thrombi that was desired to be mimicked. Wortmann does not disqualify gelatin as an option and in fact Wortmann discusses the use of the material as a Thrombus model, but rather Wortmann states that gelatin was not investigated further by Wortmann because it is not an animal free ingredient. Thus, the reason Wortmann did not further investigate the material was solely do to the fact that it was not animal free and not due to any potential issues with concentration of use as a thrombus model. Lastly, additional rejections were made beyond the Wortmann reference (see rejection above).
Applicants argue on page 10 of their remarks that Radisic is not the same field of endeavor as synthetic thrombus simulants. However, the examiner respectfully disagrees. Thrombotech and the instant application teach the analogous art of a collagen based hydrogel. Radisic teaches the analogous art of a collagen hydrogel, which is the same field of endeavor. Further still, the synthetic thrombus of the instant application is achieved through material science and biomedical engineering by forming hydrogels, which is taught by Thrombotech. A biomedical engineer with a specialty in materials science or biomaterials would be the field of endeavor of both Thrombotech and the instant application. Radisic is directed towards tissue engineering materials, which are biomaterials in the field of biomedical engineering. Thus, Radisic is in the same field of endeavor of biomedical engineered materials.
Applicants argue that Rossi is non-analogous art because it is directed towards compositions for hair growth. The examiner respectfully disagrees. First, with respect to claim 1, Rossi is provided for in an alternative rejection. Although Rossi is recited alternatively, Rossi teaches the analogous art of a hydrogel (Rossi; [103]) where gellan gum is known as a gelling agent (Rossi; [104]), and where the gelling agent/viscosity enhancers include xanthum gum, agar, and guar gum (Rossi; [105]). The use of a hydrogel and gelling agent is analogous to the field of endeavor of Thromboech as well as the instant application.
Applicants argue on page 11 of their remarks that Thrombotech does not mention collagen, xanthan gum, agar agar, guar gum, or coloring agent as required. The examiner respectfully disagrees. The examiner is relying on Thrombotech as teaching some of these components as evidenced by SDS, where various references have been used to make modifications to the materials with rationales provided. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See rejection above which addresses these materials.
Applicants argue on page 12 of their remarks that EE does not provide a teaching, suggestion, or motivation to combine all three of xanthan gum, agar, and guar gum. The examiner respectfully disagrees. The examiner is relying on Thrombotech as teaching some of these components as evidenced by SDS, where various references have been used to make modifications to the materials with rationales provided. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See rejection above which addresses these materials.
Applicants argue on page 12 of their remarks that Rossi does not provide a teaching, suggestion, or motivation to combine all three of xanthan gum, agar, and guar gum. The examiner respectfully disagrees. The examiner is relying on Thrombotech as teaching some of these components as evidenced by SDS, where various references have been used to make modifications to the materials with rationales provided. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See rejection above which addresses these materials.
Applicants argue on pages 12-13 of their remarks that due to the number of references relied upon that there is a breadth of the gap between the primary reference and claimed invention. The examiner respectfully disagrees. Additionally, in response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991). The number of references is not pertinent so long as the modifications would have been obvious to one of ordinary skill in the art. The primary reference teaches a thrombus simulant with very similar materials and similar goals (to simulate a thrombus) where the disclosed concentrations in the Thrombotech reference are proprietary. Although the examiner believes many of the properties claimed are present in Thrombotech due to the similarities in materials and goals of mimicking a thrombus with varying textures, the additional references are added to show why one of ordinary skill in the art would modify to specific concentrations, sizes, or to include certain materials. See the modifications with proposed rationales in the rejections above.
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 BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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