Prosecution Insights
Last updated: April 19, 2026
Application No. 18/482,320

SYNTHETIC BLOOD CLOT

Non-Final OA §102§103§DP
Filed
Oct 06, 2023
Examiner
WHATLEY, BENJAMIN R
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Life Model Designs LLC
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
3y 4m
To Grant
99%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
265 granted / 387 resolved
+3.5% vs TC avg
Strong +68% interview lift
Without
With
+68.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
57 currently pending
Career history
444
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
36.6%
-3.4% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
32.9%
-7.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 387 resolved cases

Office Action

§102 §103 §DP
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. Election/Restriction Restriction to one of the follo wing inventions is required under 35 U.S.C. 121: I. Claim s 1-13 , drawn to a synthetic material with color agent , classified in C09B23/30 . II. Claim s 14-15 , drawn to synthetic material , classified in C09B23/30 . III. Claims 16-20, drawn to a method of forming a synthetic material, classified in C09B23/30, C08K3/02 . The inventions are independent or distinct, each from the other because: Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions of group I present distinct products from the invention of group II because the inventions as claimed have a materially different design, are mutually exclusive, and would require a different field of search. Specifically, group I requires a coloring agent, none of which is required by group II ; and group II requires specific percentages of each of the compositions, and requires all of the gums not in the alternative, and requires the material to be made by heating and cooling , none of which is required by group I . Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Inventions I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed in group I can be made by another process such as just mixing the components, and alternatively, the process of group III can be used to make another different product such as a jello -like hydrogel for food . Inventions I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed in group II can be made by another process so long as the resulting product was the same (product-by-process) or a process that did not use coloring agent, and alternatively, the process of group III can be used to make another different product such as a jello -like hydrogel for food and with different % compositions and with only one of the gums in the alternative . Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: a. The inventions have acquired a separate status in the art in view of their different classification ; and/or b. The inventions have acquired a separate status in the art due to their recognized divergent subject matter ; and/or c. The inventions require a different field of search ( for example , searching different class/subclasses or electronic resources, or employing different search strategies or search queries) ; and/or d. T he prior art applicable to one invention would not likely be applicable to another invention; and/or e. T he inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Applicant is advised that the reply to this requirement to be complete must include ( i ) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. During a telephone conversation with Bryan Finneran on 3/9/26 a provisional election was made without traverse to prosecute the invention of group I , claim s 1-13 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 14-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. Information Disclosure Statement The information disclosure statements (IDS) submitted on 2/7/24 and 11/6/24 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Status Claims 1- 20 are pending with claims 1-13 being examined and claims 14-20 deemed withdrawn . Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ding et al (US 20250250438; hereinafter “Ding”) . As to claim 1, 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 xanthan gum, guar gum, agar (Ding; [29, 34, 38 , 39 ]) , and the composition includes a coloring agent (Ding teaches a dye; [72, 100]). The examiner notes that this composition would be capable of being used as a thrombus simulant. 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. 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 s 1 - 4 , 9 - 11 , 13 are rejected under 35 U.S.C. 103 as being unpatentable over Thrombotech ( Biom o dex lau n ches 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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”). Biomedex lauches synthetic c lot product for neurovascular training; published 10/23/21; and already of record provided in the IDS on 11/6/24) . 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 . As to claim 1, Thrombotech teaches a synthetic material suitable for use as a thrombus simulant, comprising: water; hydrolyzed collagen; at least one selected from the group of gellan gum, xanthan gum, agar agar , and guar 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, colla gen, gellan gum, and barium sulfate; p. 1) . 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 ( Throm b otech ; 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 di stinguishable for visualization as in Wortmann as a design choice to make the clot appear more realistic while training the surgeons. As to claim 2, modified Thrombotech teaches the synthetic material of claim 1, wherein the synthetic material comprises up to 34% w/v of 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) . 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 ). 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 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 (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, 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 (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 and 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. As to claim 3, modified Thrombotech teaches the synthetic material of claim 1, further comprising a radiolucent agent ( Throm b otech ; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1) . As to claim 4, modified Thrombotech teaches the synthetic material of claim 3, wherein the radiolucent agent is at least one selected from the group of iodine and barium sulfate ( Throm b otech ; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1) . 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). 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 week s (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 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 11, 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) 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 m odified 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. As to claim 13, modified Thrombotech teaches the synthetic material of claim 1, wherein the water, hydrolyzed collagen, and at least one selected from the group of gellan gum, xanthan gum, agar agar , and guar gum are mixed, heated, and cooled to form the synthetic material ( Throm b otech 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 prod uct 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) ) . 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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 Radisic et al (US ; hereinafter “Radisic”). As to claim 2, modified Thrombotech teaches the synthetic material of claim 1, wherein the synthetic material comprises up to 34% w/v of 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). 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 ). 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 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 (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, 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 (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 and 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. Alternatively, 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). 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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 Omenetto et al (US 20150307728; hereinafter “ Omenetto ”). 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]) . C laims 7-8 are rejected under 35 U.S.C. 10 3 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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 Radisic et al (US ; hereinafter “Radisic”) and in view of EE et al (US 20240261475; hereinafter “EE”) and in view of Rossi et al(US 20210170027 ; hereinafter “Rossi”) . As to claim 7 , modified Thrombotech teaches the synthetic material of claim 1, wherein the synthetic material comprises between 0% and 2% w/v gellan gum; between 25% and 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 ). 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 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% 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. 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]). I n 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). Alternatively, 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 hydrogen 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, further comprising at least one selected from the group of a radiolucent agent and an optical brightener ( Thrombotech ; p. 1. Evidentiary reference SDS shows that Thrombotech includes imaging agent barium sulfate; p. 1). Claim 12 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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 Vascular CME (How big are blood clots; https://web.archive.org/web/20190822005608/https://vascularcme.com/2016/01/15/how-big-are-blood-clo ts/; published 1/15/16; pages 1-3; hereinafter “Vascular CME”). As to claim 12, modified Thrombotech teaches the synthetic material of claim 1 (see above). 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. C laim 7 is rejected under 35 U.S.C. 10 3 as being unpatentable over Ding et al (US 20250250438; hereinafter “Ding”) 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 ”) FILLIN "Insert the prior art reference(s) relied upon for the obviousness rejection." \d "[ 2 ]" 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 Radisic et al (US ; hereinafter “Radisic”) and in view of EE et al (US 20240261475; hereinafter “EE”) and in view of Rossi et al(US 20210170027 ; hereinafter “Rossi”). 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 0-2% gellan gum (Ding teaches various polymers including guar gum, xanthan gum, and agar that can be used in combination, and Ding does not require gellan gum and thus gellan gum is optional and not required and 0% satisfies the limitation). 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 enhancer s 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). 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 ” ) teaches that hydrolyzed collagen and gelatin are synonymous ; [1 49 ]. Oklu et al (US 20230310697 ; hereinafter “ Oklu ”) teaches a synthetic embolization hydrogel with about 20% gelatin and with a radiopaque material; [9, 24]. Grubbs et al (US 20230126091; hereinafter “Grubbs”) 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”) teaches hydrogel forming materials as gelling agents including gums and agar; [17]. Niederhauser et al (US 20240016143 ; hereinafter “ Niederhauser ”) teaches common thickeners for hydrogels include gums and agar; [81, 82]. Goentoro et al (US 20220016127 ; hereinafter “ Goentoro ”) teaches the gums and agars are used as stabilizers; [169]. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BENJAMIN R WHATLEY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571) 272-9892 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon- Fri 8am-5pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Charles Capozzi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-3638 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Benjamin R Whatley/ Primary Examiner, Art Unit 1798
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Prosecution Timeline

Oct 06, 2023
Application Filed
Mar 16, 2026
Non-Final Rejection — §102, §103, §DP (current)

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