DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 6/9/26 has been entered with claims 1-3 pending and being examined on their merits in this U.S. Patent Application. Applicant amendments have overcome the specification and claim objections set forth in the last Office action mailed on 4/7/26. Claim 1, line 7, has been amended to delete “and/or” in relation between the pectin properties and the gelatin type, and now requires “and” both the pectin with the claimed properties and the gelatin type(s). Claim 3, lines 9 and 11, has been amended to delete “and/or” in relation to the concentration of the glutamine transaminase and the functional dietary fiber and mass ratio of the functional dietary fiber to the pectin, to now requiring “and” all of elements (a-c) with their respective concentrations, the concentration of the glutamine transaminase in the raw material mixed aqueous solution being 0.5%-1.5%, and the functional dietary fiber, and the mass ratio of the functional dietary fiber to the pectin in the raw materials being 1:(5-10).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan et al. [CN 114711326 A], hereinafter Fan, in view of Scionti [US 20210345643 A1], Matsumoto et al. [US 20120021063 A1], hereinafter Matsumoto, Ghasemzadeh-Barvarz et al. [WO2022261116A1], hereinafter Ghasemzadeh, Petrini et al. [US20130177656A1], hereinafter Petrini, Tran [US20150306038A1], Staples et al. [US20050250735A1], hereinafter Staples, and Bishop et al. [US 5834232 A], hereinafter Bishop, evidenced by Guo [Effect of Glutamine Transaminase on the Gel Properties of Mutton, 2020], hereinafter Guo, PubChem [Rhamnose, 2005], Gerschenson [The production of galacturonic acid enriched fractions and their functionality, 2017].
Regarding claim 1, Fan teaches a bioink (edible muscle ink) [Fan, abstract], wherein raw materials for preparing the bioink comprise pectin [Fan, 0098], glutamine transaminase (also known as transglutaminase, see Guo, p.1, Introduction) [Fan, claim 3, claim 7, 0104, Espacenet Translation; p.47, par.2, PE2E Translation], a first protein component and a second protein component (more than one of various protein components, i.e., potato protein, soy protein isolate) [Fan, claim 2 element 4, 0021-0024, 0091, 0093].
Fan does not teach the first protein component is gelatin and/or collagen.
Scionti teaches an edible micro-extruded product that can be carried out by 3D printing, using a viscoelastic composition comprising proteins and pseudoplastic polymers as injectable ink (bioinks [Scionti, 0256, 0259, 0262]) for 3D printing from which the micro-extruded elements are made [Scionti, 0029, 0194]. The edible micro-extruded product comprises proteins and pseudoplastic polymers including pseudoplastic proteins such as gelatin and/or collagen. Scionti further disclose pseudoplastic proteins also include proteins already disclosed by Fan such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins [Scionti, 0112, 0114; Fan, 0022].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the first protein component of gelatin and/or collagen as taught by Scionti, in the bioink of Fan, because both are in the same field of endeavor of 3D printing for production of edible food, and also because Scionti teaches that gelatin/collagen can be used in a similar manner as plant proteins as taught by Fan. Furthermore, it would have obvious to one of ordinary skill in the art to include the first protein component of gelatin and/or collagen as taught by Scionti, because Scionti teaches that the use of these proteins (pseudoplastic proteins polymers, i.e., gelatin and collagen [Scionti, 0110, 0112, 0114]) and mixtures of these pseudoplastic proteins with pseudoplastic polysaccharide polymers (i.e., polysaccharide such as pectin [Scionti, 0110-0111, 0113]) would make possible to produce micro-extrudable homogeneous pastes, of variable viscosity [Scionti, 0205] due to the rheological properties of said viscoelastic composition comprising these pseudoplastic proteins/polysaccharide polymers [Scionti, 0029].
Fan does not teach the second protein component is protamine.
Matsumoto teaches a crosslinked material suitable for various uses such as biomedical applications such as scaffold materials [Matsumoto, abstract]. The crosslinked material comprising proteins (collagen/elastin) may additionally comprise protamine [Matsumoto, 0119]. It is also noted that protamine is a fish derived protein [Matsumoto, 0119], and Scionti discloses including fish protein [Scionti, 0106], and that animal proteins and plant proteins can be used in a similar manner [Scionti, 0112].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the second protein component of protamine as taught by Matsumoto, in the bioink of Fan, because both are in the same field of endeavor of crosslinked materials (polymers such as proteins and polysaccharides) [Fan, 0091; Matsumoto, abstract], (“cross-linking of proteins polypeptides/polysaccharides”, as disclosed in par.[0014-0015] of the instant Specification), for the production of protein containing compositions including foods and/or medical (biomedicine) applications [Matsumoto, abstract], (“biomedicine”, as disclosed in par.[0046] of the instant Specification), and because Matsumoto teaches that the addition of protamine to the crosslinked material would provide beneficial effects such as antibacterial effect [Matsumoto, 0121], and the combination of protamine with other proteins (collagen/elastin) may be blended in such a blending amount that the objective physical properties, properties or functions can be provided in a crosslinked material [Matsumoto, 0123].
Fan teaches a bioink that can gel and comprises pectin [Fan, 0012, 0098], but does not teach the pectin has a molecular weight of 250-350 kDa, an esterification degree of greater than 75%, and a mass ratio of neutral sugar to acidic sugar of 1:(2-3).
Ghasemzadeh teaches gelling citrus fiber materials (i.e., pectin containing cellulosic material [Ghasemzadeh, 0002-0003]) useful for modifying the texture of food compositions [Ghasemzadeh, 0017]. The pectin may be a high ester pectin from citrus [Ghasemzadeh, 0025], having a molecular weight of 200-300 kDa [Ghasemzadeh, 0010-0011], and having a degree of esterification greater than 75% (up to 80%) [Ghasemzadeh, 0007].
Moreover, Petrini, directed to compositions comprising pectin [Petrini, abstract] and suitable for food applications [Petrini, 0002], teaches that pectins are classified by their degree of esterification (DE) with high-ester pectin having a DE of more than 50% (high methoxyl (HM, DE>50)) [Petrini, 0004], where various pectins with different molecular weight and different degree of esterification are available on the market [Petrini, 0012]. Further, Petrini teaches that the viscosity of a gel increases as a result of cross-linking, and depends on the amount of cross-linker and the degree of esterification of pectin. The properties range from a viscous gel to solid materials. The properties are highly dependent on the molecular weight of pectin and on the pH of the environment [Petrini, 0011], and the molecular weight of pectins may vary to up to 350 kDa [Petrini, 0059, 0083].
Because Ghasemzadeh teaches:
- Using the same pectin type (sourced from citrus extracted from protopectin) [Ghasemzadeh, 0002, 0007, 0056] as the pectin used in the instant invention (high ester pectin from citrus as disclosed on [0020] of the instant specification);
- Wherein the pectin component is associated or within the cellulosic matrix (not a mere mixture) forming the gelling citrus fiber [Ghasemzadeh, 0002-0003, 0008, 0055-0056], and the gelling citrus fiber material comprising pectin may have a molecular weight of about 260 kDa or up to 300 kDa [Ghasemzadeh, 0007, 0010-0011];
- Wherein said pectin containing cellulosic material can be monitored while being modified to obtain end products capable of making gels having the desired gel strength [Ghasemzadeh, 0001]; and,
Petrini teaches:
- Pectins with a molecular weight of up to 350 kDa are useful for controlling viscosity and solidity of gels [Petrini, 0011];
One of ordinary skill in the art would have recognized the use of pectins with a molecular weight of 260-300 kDa [Ghasemzadeh, 0010-0011], and a degree of esterification greater than 75% (up to 80%) [Ghasemzadeh, 0007] in order to obtain products capable of making gels having the desired gel strength [Ghasemzadeh, 0001], and pectins with a molecular weight of up to 350 kDa for controlling viscosity and solidity of gels [Petrini, 0011].
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fan’s pectin to have a degree of esterification of 80% and a molecular weight of 300 kDa as taught by Ghasemzadeh, to obtain end products capable of making gels having the desired gel strength [Ghasemzadeh, 0001], as well as for controlling the viscosity and solidity of gels [Petrini, 0011].
In regards to the mass ratio of neutral sugar to acidic sugar of 1:(2-3);
Fan in view of Ghasemzadeh and Petrini teaches the pectin with a molecular weight of 250-350 kDa, and an esterification degree of greater than 75%, however, while Ghasemzadeh does not mention that the pectin has a mass ratio of neutral sugar to acidic sugar of 1:(2-3) as claimed, as explained above Ghasemzadeh teaches using a pectin containing cellulosic material useful for modifying the texture of food compositions, where the pectin may be a high ester pectin from citrus, having a molecular weight of 200-300 kDa, and having a degree of esterification greater than 75% (up to 80%). Further, Petrini teaches pectins with a molecular weight of up to 350 kDa are useful for controlling viscosity and solidity of gels. Therefore, because Ghasemzadeh teaches using citrus pectin, and because Applicant’s specification discloses citrus pectin has a mass ratio of neutral sugar to acidic sugar of 1:2 (see Applicant’s specification [0074] as filed) it is reasonable to expect that the pectin of Ghasemzadeh would have the similar properties. Regarding composition claims, if the composition is the same, it must have the same properties (see MPEP § 2112.01, II.). “Products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP §2112.01.
Moreover, Tran teaches adjusting/manipulating the amounts of the neutral sugar compared to the amount of acidic sugar for controlling the flexibility of the molecules, and that pectin has a galacturonic acid (galacturonic acid is an acidic sugar, see Gerschenson, p.23, Introduction, right column, par.3, section 2. Pectin) content of more than 70%, and a rhamnose (rhamnose is a neutral sugar with a pH: 7.00, see PubChem, p.14, section 5.2.1, pH) content of less than 2%, and increases in rhamnose content (neutral sugar content increase) [Tran, 0034-0035].
As such, it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the amounts of rhamnose for controlling the flexibility of the molecules.
Alternatively, Staples teaches naturally-occurring pectins and methods for making and using modified pectins [Staples, 0002], wherein said modified pectins may comprise rhamnose (neutral sugar) in amounts of less than 25-10%, galactose (neutral sugar) in amounts of less than 50-30%, arabinose (neutral sugar) in amounts of less than 15-5%, and galacturonic acid (acidic sugar) in amounts of 50-80% or more, therefore teaching a pectin having a mass ratio of neutral sugar to acidic sugar that encompass and/or falls within the claimed ratio of neutral sugar to acidic sugar 1:(2-3) [Staples, 0088], (i.e., 11.1% rhamnose, 11.1% galactose, 11.1% arabinose, and 66.7% galacturonic acid, would be a pectin having a mass ratio of neutral sugar to acidic sugar of 1:3.
Therefore, it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fan’s bioink comprising pectin with the modified pectin of Staples having a mass ratio of neutral sugar to acidic sugar of 1:(2-3), because Staples teaches that the modified pectin obtained by the process may have improved potency, purity and composition uniformity, and the methods of manufacture permit these benefits to be achieved reliably and reproducibly compared to existing methods used to prepare modified pectins which generally suffer from poorly controlled chemical processes and difficult product isolation and purification processes, resulting in widely varying therapeutic activities, molecular weights, polydispersities, concentrations, monosaccharide compositions, linkage makeup, potency and impurity profiles [Staples, 0006], and also provide modified pectins that are substantially free of organic solvents such as ethanol and acetone [Staples, 0007], which can create explosion hazards and toxicological effects from residual solvent and require expensive disposal of solvent waste [Staples, 0006].
Fan does not teach the gelatin is type A gelatin and/or type A+B gelatin.
Bishop teaches a crosslinked protein gel materials [Bishop, abstract] such as gelatin and collagen [Bishop, col.3, l.67; col.4, l.1-2, col.5, l.55-56], and the gelatin may be a type A gelatin [Bishop, Example 1, col.10, l.66] and/or type A+B gelatin [Bishop, col.9, l.46-47].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a type A gelatin and/or type A+B gelatin as taught by Bishop, in the bioink of Fan, because both are in the same field of endeavor of crosslinked polymeric materials (polypeptides) [Fan, 0091; Bishop, abstract], (“cross-linking of proteins polypeptides/polysaccharides under the action of glutamine transaminase also known as transglutaminase”, as disclosed in par.[0014-0015] of the instant Specification), for the production of protein containing compositions including foods [Bishop, col.9, l.23-30] and/or medical (biomedicine) applications [Bishop, abstract, col.8, l.66-67], (“biomedicine”, as disclosed in par.[0046] of the instant Specification), and because Bishop teaches that the crosslinked gel materials of the invention comprising type A gelatin and/or type A+B gelatin provide the advantages of uniformity and specific cross-linking in combination with high thermal stability, which permit use of the gels within new and expanded applications including medical and food applications [Bishop, col.9, l.1-8], and wherein the foodstuffs prepared with the crosslinked gel materials and methods of the invention would allow for the preparation of protein-containing food products, with improved functional properties of said proteinaceous foods [Bishop, col.9, l.23-26].
Regarding claim 2, modified Fan teaches the bioink according to claim 1, Fan further teaches the bioink comprising the first protein component (potato protein), and the second protein component (soy protein isolate) [Fan, 0093], Scionti teaches the edible viscoelastic composition comprising proteins and pseudoplastic polymers as bioink [Scionti, 0256, 0259, 0262], where the proteins are pseudoplastic proteins such as gelatin and/or collagen [Scionti, 0112, 0114], and Matsumoto teaches the crosslinked material comprising proteins (collagen/elastin) and additionally comprise protamine [Matsumoto, 0119] as discussed above in claim 1; and Fan further teaches the mass ratio of the first protein component (potato protein) to the second protein component (soy protein isolate) is 4.2:8.4 [Fan, 0093], which is equivalent to a ratio of 1:2, and falls within the claimed range mass ratio of the first protein component to the second protein component of 1:(1.6-3).
Therefore, because Fan teaches the first protein component and the second protein component, wherein the mass ratio of the first protein component (potato protein) to the second protein component (soy protein isolate) is 4.2:8.4 (1:2), Scionti teaches the proteins (pseudoplastic proteins) such as gelatin and/or collagen (which are the instantly claimed first protein component), and Matsumoto teaches the crosslinked material comprising proteins such as collagen (which is also the instantly claimed first protein component already taught by Scionti) in combination with protamine (which is the instantly claimed second protein component), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the gelatin and/or collagen (as taught by Scionti) as the first protein component, and the protamine (as taught by Matsumoto) as the second protein component, into the bioink having a mass ratio of the first protein component to the second protein component of 1:2 of Fan, because simple substitution of one known element (i.e., potato protein “first protein component” and soy protein isolate “second protein component” of Fan) for another (i.e., gelatin and/or collagen “first protein component” of Scionti, and protamine “second protein component” of Matsumoto) would have yielded predictable results to one of ordinary skill in the art, particularly because as explained above, Scionti disclose pseudoplastic proteins also include proteins already disclosed by Fan such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins [Scionti, 0112, 0114; Fan, 0022] and that gelatin/collagen can be used in a similar manner as plant proteins as taught by Fan [Scionti, 0112]. Moreover, additionally to Scionti already teaching gelatin and/or collagen, Matsumoto also teach using collagen (first protein component) further combined with protamine (second protein component), wherein the blending amount (ratio) of the collagen component to protamine component is not limited, and may be blended in such a blending amount that the objective physical properties, properties or functions can be provided in a crosslinked material [Matsumoto, 0117, 0123]. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the claimed mass ratio of the first protein component to the second protein component during the course of normal experimentation and optimization in the method of Fan in view of Scionti, Matsumoto and Bishop, due to factors such as the individual rheological properties of proteins and pseudoplastic proteins/polymers of said viscoelastic compositions comprising these, the type and quantities of the various ingredients, and/or the desired final viscosity of the final product as taught by Scionti [Scionti, 0029, 0205].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fan [CN 114711326 A], in view of Scionti [US 20210345643 A1], Matsumoto [US 20120021063 A1], Ghasemzadeh [WO2022261116A1], and Bishop [US 5834232 A], evidenced by Guo [Effect of Glutamine Transaminase on the Gel Properties of Mutton, 2020], Zhou [CN111820407A], Petrini [US20130177656A1], Tran [US20150306038A1], PubChem [Rhamnose, 2005], and Gerschenson [The production of galacturonic acid enriched fractions and their functionality, 2017] as applied to claim 1 above, and further in view of Huang et al. [CN110743041A], hereinafter Huang, evidenced by Yue et al. [Structural analysis of photocrosslinkable methacryloyl-modified protein derivatives, 2017], hereinafter Yue.
Regarding claim 3, modified Fan teaches the bioink comprising pectin [Fan, 0098], glutamine transaminase (transglutaminase which is the cross-linking agent) [Fan, 0052, claim 3], the first protein component (gelatin and/or collagen [Scionti, 0112, 0114]), and the second protein component (protamine [Matsumoto, 0119]) [Fan, 0091] as discussed above in claim 1, and further teaches the bioink comprises water [Fan, 0110], and mixing the above mentioned materials (pectin, glutamine transaminase, the first protein component, the second protein component, and water) [Fan, 0112], thus, forming a solution wherein the components are cross-linked under the action of a cross-linking agent (glutamine transaminase) [Fan, 0044], (where the pectin, the first protein component, and the second protein component are cross-linked under the action of the glutamine transaminase (transglutaminase) which is the cross-linking agent as explained above, and as disclosed by Applicant on par.[0015] of the instant Specification).
Regarding claim 3, element (a):
Fan further teaches the pectin (curing component) may be in various concentration amounts in relation to the protein (protein:pectin mass ratio) [Fan, 0099], but does not explicitly teach the concentration of the pectin being 8-12% in the raw material mixed aqueous solution.
Scionti teaches the bioink comprising pectin [Scionti, 0034] as discussed above in claim 1 rejection, wherein said pectin component may be in concentration amounts of from 0.2-40 wt% of the composition (which is in solution since all ingredients in the composition are dissolved in an edible solvent, such as water [Scionti, 0029, 0033], therefore Scionti also teaching a mixed aqueous solution) [Scionti, 0034, 0170].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include pectin in concentration amounts of from 0.2-40 wt% in the mixed aqueous solution as taught by Scionti, in the bioink of Fan, because Scionti teaches that the presence of the pectin (pseudoplastic polymer) in the viscoelastic composition provides the appropriate viscoelastic parameters for 3D printing [Scionti, 0032], as well as homogeneous aqueous compositions of pectin, proteins and water that not phase-separate [Scionti, 0155].
Regarding claim 3, element (b-c):
Fan teaches the bioink comprising a first protein component and a second protein component [Fan, claim 2 element 4, 0021-0024, 0091, 0093], as discussed in claim 1 rejection above, wherein the protein components may be in various concentration amounts (i.e., protein:pectin mass ratio) in relation to the pectin and in relation to other raw materials (i.e., fiber, cross-link component, flavors, etc.), but does not explicitly teach the concentration of the first protein component is 1-5%, and the concentration of the second protein component is 3-8% in the raw material mixed aqueous solution.
Huang teaches a bioink (biological ink) [Huang, abstract], also comprising a first protein component and a second protein component (already taught by Fan), wherein the first protein component (fibre-protein or fibrinogen is a glycoprotein, see Espacenet Translation [Huang, 0047]) in concentration amounts of from 0.1-50%, and the second protein component (methacrylic anhydride gelatin, also a protein, see Yue, p.1, abstract) in concentration amounts of from 0.1-50% [Huang, abstract].
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the first protein component and the second protein component in concentration amounts of from 0.1-50% as taught by Huang, into the bioink of Fan, because Huang teaches that using these first and second protein components at the disclosed amounts provides for a double-network type gel system containing bioactive cells in bioinks formed by printing with high cell compatibility, proliferation, differentiation and delay characteristics of high mechanical strength, degradability and no cell toxicity [Huang, abstract, and 0029-0032 of Espacenet Translation].
Fan does not explicitly teach the concentration of the glutamine transaminase is 0.5%-1.5% in the raw material mixed aqueous solution discussed above.
However;
Fan teaches that the bioink comprise crosslinking agents including glutamine transaminase (transglutaminase) and calcium chloride [Fan, 0052, claim 3], and teach the crosslinking agent of calcium chloride being used in an amount of 0.89% as crosslinking agent [Fan, 0141]. Therefore, one of ordinary skill in the art would recognize the use of the glutamine transaminase as crosslinking agent in the same amount of the crosslinking agent of calcium chloride being used by Fan at 0.89%, which is an amount that falls within the claimed range of 0.5%-1.5% for the concentration of the crosslinking agent glutamine transaminase.
Because Fan teaches that calcium chloride can be similarly used as glutamine transaminase for crosslinking components [Fan, 0052], it would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a concentration of 0.89% of the crosslinking agent glutamine transaminase in the raw material mixed aqueous solution taught by Fan above, because Fan teaches that these crosslinking agents would enable the bioink (muscle printing ink) to quickly gel [Fan, 0052] (crosslinking of polypeptide/polysaccharide components in the solution, such as pectin, gelatin/collagen, and protamine in the bioink of modified Fan) and solidify by the action of said crosslinking agents [Fan, 0044]. Additionally, it would have obvious to one of ordinary skill in the art to have used glutamine transaminase concentrations that falls within or encompass the claimed range during the course of normal experimentation and optimization in the method of modified Fan, due to factors such as the type and quantities of the various polypeptide/polysaccharide ingredients, the desired final texture and solidity of the final product, and/or the desired crosslinking effect (quickly cross-linkage of proteins with good printing performance) [Fan, 0091, 0104].
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969), MPEP 2144.05, II. A.
Regarding claim 3, functional dietary fiber and mass ratio of the functional dietary fiber to the pectin being 1:(5-10):
Fan teaches the bioink comprises pectin [Fan, 0098], and further comprise a functional dietary fiber [Fan, 0100], and the mass ratio of the functional dietary fiber to the protein is (0.02-2):12 [Fan, 0101], and the mass ratio of the pectin (glue or solidifying component) to the protein is (0.02-2):12. While Fan does not explicitly recites a mass ratio of the functional dietary fiber to the pectin is 1:(5-10), because Fan teaches the functional dietary fiber may be present at a mass ratio of (0.02-2) and the pectin may be also present at a mass ratio of (0.02-2), both in relation to the protein, one of ordinary skill in the art would recognize that the bioink of Fan may have a mass ratio of protein:fiber:pectin of 12:(0.02-2.0):(0.02-2.0), and more specifically a ratio of 12:0.4:2.0, wherein a mass ratio of fiber:pectin of 0.4:2 which is equivalent to a fiber:pectin mass ratio of 1:5.
It would have obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a mass ratio of the functional dietary fiber to the pectin of 1:5 as taught by Fan, because Fan teaches that the pectin in these amounts helps the bioink to cure rapidly during the printing process [Fan, 0098], and the fiber in these amounts enhances the bioink mechanical strength of the extrudate [Fan, 0100]. Further, it would have obvious to one of ordinary skill in the art to use a mass ratio of the functional dietary fiber to the pectin of 1:5 during the course of normal experimentation and optimization procedures in the method of Fan, due to factors such as the type and amounts of the various raw materials in the bioink of Fan, and/or the desired curing/solidity and mechanical strength or degree in the final bioink product of Fan.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The rejection has been modified in view of Applicant’s amendments to the claims, as discussed above under “Response to Amendments” in further detail. The new rejection relies on the prior art of record over Fan in view of Scionti, Matsumoto, Ghasemzadeh, and Bishop, evidenced by Guo, Zhou, Yamashita, Petrini, Tran, PubChem, and Gerschenson for claims 1-2, and over Fan in view of Scionti, Matsumoto, Ghasemzadeh, and Bishop, evidenced by Guo, Zhou, Yamashita, Petrini, Tran, PubChem, and Gerschenson as applied to claim 1, and further in view of Huang, evidenced by Yue for claim 3.
Applicant's arguments filed 6/9/26 have been fully considered but they are not persuasive.
In page 7 last two paragraphs and page 8, first paragraph, Applicant urges that the proteins taught by Fan are plant derived proteins and not animal source proteins, and that Fan does not teach using pectin and instead teaches using “a pseudoplastic edible polysaccharide” selected from gum arabic, xanthan gum, hyaluronic acid, locust bean gum, and guar gum.
The arguments above are not persuasive because Fan explicitly teaches using pectin [Fan, claim 4, 0098] as an option among other curing components, and while Fan teaches plant derived proteins as alternative protein sources, Fan does not explicitly precludes the use of animal derived proteins, and Scionti further teaches the use of gelatin and/or collagen as proteins, as well as not only the suitability of the same plant derived proteins disclosed by Fan [Scionti, 0112, 0114; Fan, 0022] in bioink compositions for 3D printing, but also the suitability of both plant and animal proteins useful in bioink compositions for 3D printing [Scionti, 0190, 0256, 0259, 0262, 0029, 0194]. Therefore, Scionti teaches that animal protein sources can be used in an 3D ink in a similar manner as Fan’s protein sources.
In page 8, paragraph 2, Applicant argues that in Fan, pectin is mentioned only as one option among several for an entirely different functional category “a solidifying component”.
This argument is not persuasive because the claim is directed to a bioink comprising pectin, and Fan explicitly teaches a bioink comprising pectin regardless of the function of the pectin, which meets the claim limitation. Further, while Fan disclose the pectin helps as “a solidifying component” or “curing component” nonetheless Fan positively teaches the bioink comprising the claimed pectin component.
In page 8, paragraph 2, Applicant argues that Fan teaches a 3D printing ink and not a 3D printing bioink. This argument in not persuasive because while Fan does not uses the same language as Applicant or mentions the term “bioink”, the 3D printing ink in Fan is an edible muscle printing ink made from the same materials used by Applicant such as pectin, glutamine transaminase, and proteins, which are all biomaterials. Therefore, Fan does teaches a bioink.
In page 8, paragraph 3, Applicant argues elements (a) protamine as the second protein component, (b) pectin with defined parameters, (c) gelatin type A and/or A+B. Regarding element (a) protamine as the second protein component and element (c), as explained in claim 1 rejection above, Scionti which is relied upon for teaching gelatin type A and/or A+B, also teaches using fish protein and protamine is a fish derived protein, and that animal proteins and plant proteins can be used in a similar manner. Further, Matsumoto is relied upon for explicitly teaching using protamine, therefore not only there is explicit teaching of using protamine by Matsumoto but also an implicit teaching of protamine by Scionti because Scionti teaches using fish protein which comprises protamine, but simply did not mention protamine. Regarding element (b) pectin with defined parameters, this limitation is a new limitation for the currently amended claims which has been addressed by the new prior art of record of Ghasemzadeh, Petrini, and Tran. Moreover, regarding element (c) gelatin type A and/or A+B, the claim requires “the first protein component is gelatin AND/OR collagen”, therefore a composition comprising collagen meets the claim since the gelatin is an optional component and the claim does not require both gelatin and collagen (i.e., the first protein component is gelatin AND collagen, wherein the gelatin is gelatin type A and/or A+B).
In page 10, paragraph 4, element (a), Applicant urges the references are not analogous to each other and/or the instantly claimed invention.
In response to applicant's argument that Matsumoto is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Fan and Matsumoto are considered analogous and directed to the same field of endeavor because both are concerned with the use of crosslinked materials (polymers such as proteins and polysaccharides) [Fan, 0091; Matsumoto, abstract], and while Matsumoto is relied upon for teaching the specific second protein component of protamine, which is a fish derived protein [Matsumoto, 0119], Scionti as noted already teaches the inclusion of fish protein [Scionti, 0106], and that animal proteins and plant proteins can be used in a similar manner [Scionti, 0112].
In page 10, paragraph 5, element (b), Applicant urges the references provides no teaching of the four component combination (i.e., a single reference teaching the four component combination).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Fan teaches a bioink (edible muscle ink) comprising pectin, glutamine transaminase, a first protein component and a second protein component, Scionti teaches viscoelastic composition comprising proteins and pseudoplastic polymers as injectable ink (bioinks) comprising gelatin and/or collagen, including fish protein, as well as the suitability of plant derived proteins already disclosed by Fan such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins, and Matsumoto teaches crosslinked material suitable for various uses such as scaffold materials (3D structural frameworks designed to support cell attachment, growth, and tissue), said crosslinked material comprising proteins (collagen/elastin) and protamine. Therefore, based on the combined teachings of Fan in view of Scionti and Matsumoto, one of ordinary skill in the art would recognize the use of protamine as taught by Matsumoto, and the gelatin and/or collagen, including fish protein (containing protamine), as well as the suitability of plant derived proteins as taught by Scionti, into the bioink of Fan, with reasonable expectation of success, as there are more ways to combine the teachings of the references than those disclosed by Applicant.
In page 10, paragraph 5, element (c), Applicant urges there is no motivation to import a biomedical antibacterial additive into a food bioink.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as similarly discussed above in element (b), based on the combined teachings of Fan in view of Scionti and Matsumoto, one of ordinary skill in the art would recognize the use of protamine as taught by Matsumoto, and the gelatin and/or collagen, including fish protein (containing protamine), as well as the suitability of plant derived proteins as taught by Scionti, into the bioink of Fan, with reasonable expectation of success. Furthermore, the instant claims do not limit the bioink only for food applications. The claims are directed to a bioink composition comprising pectin, wherein the pectin has a molecular weight of 250-350 kDa, an esterification degree of greater than 75%, and a mass ratio of neutral sugar to acidic sugar of 1:(2-3); a first protein components of gelatin and/or collagen, wherein the gelatin is type A gelatin and/or type A+B gelatin, and a second protein component being protamine. There is no mention of foods or the bioink being only used in foods in the claims. Moreover, Matsumoto teaches that protamine has antibacterial properties, therefore one of ordinary skill in the art would immediately envisage the use of protamine as taught by Matsumoto in the bioink of Fan to advantageously avoid spoilage of the bioink.
In page 8, paragraphs 3-7, and pages 9-15 Applicant argues the prior art of record fails to disclose the newly required combinations of all elements of claim 1 of the first protein component being gelatin and/or collagen; the second protein component being protamine; the pectin having a molecular weight of 250-350 kDa, an esterification degree of greater than 75%, and a mass ratio of neutral sugar to acidic sugar of 1:(2-3); and the gelatin is type A gelatin and/or type A+B gelatin. Further Applicant also argues the prior art of record fails to disclose the newly required combinations of all elements a-c, the glutamine transaminase, functional dietary fiber, all with their respective concentrations and the mass ratio of the functional dietary fiber to the pectin of claim 3.
This argument is not persuasive because while Fan does not teach all of the components or raw materials in the bioink, including the claimed specific concentrations (i.e., Fan reference not being a 102 reference) the rejection is based on a combination of references that are all analogous and directed to compositions comprising pectin an proteins or compositions comprising polysaccharides and polypeptides suitable for bioink or 3D printing compositions of tissues. Furthermore, the new prior arts of records relied upon of Ghasemzadeh-Barvarz et al. [WO2022261116A1], hereinafter Ghasemzadeh, and Huang et al. [CN110743041A], hereinafter Huang, address these new limitations as discussed above.
In page 11, paragraphs 2-4, Applicant argues that Bishop teaches type A and type B gelatin in connection with two-protein photographic microcapsules for a photographic gel that operates independently of cell culture. This argument is not persuasive because while Bishop discloses the use of gelatin type A and/or type A+B gelatin to prepare drug delivery vehicles such as gelatin microcapsules, Bishop also teaches the methods and materials of the invention are suitable for foodstuff applications [Bishop, col.8, l.18-24], where those skilled in the art recognize that time to gel formation is a factor of temperature and protein concentration [Bishop, col.7, l.64-67] in order to achieve the gelation point for a type A gelatin [Bishop, col.8, l.1-3] and achieve the desired degree of cross-linkage and penetration depth, to obtain a gel with a desired strength (i.e., thin or thick gels) [Bishop, col.8, l.16-24].
In page 12, last paragraph, Applicant argues the examiner’s “simple substitution” rationale in regards to the substitution of plant proteins in Fan for the animal proteins in Scionti (substituting Fan's potato/soy proteins with gelatin/collagen + protamine at a 1:2 mass ratio) is not a substitution of one known element for another that performs the same function. This argument is not persuasive because Scionti teaches 3D printing methods and compositions, and explicitly teaches that gelatin/collagen can be used in a similar manner as plant proteins such as pea protein, mung bean protein, peanut protein, rice protein and other plant proteins, which are the same proteins taught by Fan.
In page 13, paragraph 2, Applicant urges the lack of rational motivation to add protamine at any particular amount because the use of protamine in Matsumoto is application-dependent and Matsumoto teaches protamine in biomedical applications and not in 3D printed edible bioink for cultivated meat. This argument is not persuasive because the claim does not limit the use of the raw materials and/or compositions for foodstuffs, edible compositions and 3D printing. Moreover, the examiner provided motivation for adding the protamine of Matsumoto (which was already implicitly taught by Scionti because Scionti teaches fish proteins are suitable for 3D printing products and protamine is a fish derived protein [Matsumoto, 0119]), the motivation being that the addition of protamine to the crosslinked material would provide beneficial effects such as antibacterial effect [Matsumoto, 0121], which would be advantageous in the bioink of Fan to avoid spoilage.
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 LUIS EUGENIO DIOU BERDECIA whose telephone number is (571)270-0963. The examiner can normally be reached Monday-Friday 7:30-4:30.
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, Erik Kashnikow can be reached at (571) 270-3475. 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.
/LUIS EUGENIO DIOU BERDECIA/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
Prosecution Insights