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 .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114) and the Response and Amendment filed 30 December 2025 is acknowledged.
Applicant has overcome the 35 U.S.C. § 112(b) rejection of claim 38 by cancellation of the claim. Accordingly, the rejection has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 36-37 and 39-55
Withdrawn claims: 48-55
Previously canceled claims: 1-35
Newly canceled claims: 38
Amended claims: 36
New claims: None
Claims currently under consideration: 36-37 and 39-47
Currently rejected claims: 36-37 and 39-47
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 30 December 2025 has been entered.
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.
Claims 36-37, 39, 42, 44, and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Lötzbeyer et al. (Lötzbeyer et al., "Towards printing a meat-like structure using sustainable plant proteins", http://3dfoodprintingconference.com/wp-content/uploads/2016/04/Anna-kn%C3%A4ulein.pdf, December 2016, 17 pages, cited on IDS filed 22 August 2022) in view of Nishimura et al. (US 2014/0010920 A1, cited on the IDS filed on 23 May 2024), McMindes et al. (US 2007/0269567 A1, cited on the IDS filed on 22 August 2022), and Miri et al. (Miri, T., Barigou, M., Fryer, P. J., & Cox, P. W. (2005). Flow induced fibre alignment in mycoprotein paste. Food research international, 38(10), 1151-1160. https://doi.org/10.1016/j.foodres.2005.04.005).
It is noted that the limitation “digitally printed” in claim 36 renders claim 36 and its dependent claims product-by-process claims. MPEP § 2113(I) states, “‘[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).” Therefore, as long as the structure of the final product is the same between the claimed invention and the prior art, the method of production is non-limiting.
Regarding claim 36, Lötzbeyer teaches a meat substitute (p. 1, Title), comprising: one or more layers of protein-containing strands, wherein each layer of the one or more layers comprises a plurality of strands such that the plurality of strands are arranged essentially parallel along their longitudinal axis – strands of 3D printed plant protein are arranged in multiple layers, each comprising a plurality of strands that are arranged essentially parallel along the longitudinal axis thereof (p. 15, Images). The “Project Objective” indicates 3D printing a real meat structure, such as chicken breast (p. 4), therefore a whole muscle meat substitute.
Lötzbeyer does not teach that the strands comprise one or more bundles of axially aligned texturized protein fibers, wherein at least a portion of the axially aligned texturized protein fibers comprises elongated fibers having a length above 5mm; and wherein the axially aligned texturized protein fibers within a segment of a strand of the single strand or the plurality of strands have a nominal direction that is not more than ±45° from the direction of the segment of the strand when a bundle of the one or more bundles of axially aligned texturized protein fibers is viewed from a direction perpendicular to the segment's direction (i.e., side/horizontal view).
However, Nishimura teaches a meat-like foodstuff comprising texturized protein; and wherein at least a portion of the texturized protein comprises elongated fibers having a length of above 5 mm ([0015] – [0018]). The objective of the invention is to provide a meat-like foodstuff that provides a texture and appearance similar to that of natural meat ([0014]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the 3D printed meat substitute of Lötzbeyer to include texturized protein fibers in the protein composition forming the strand(s), including those having a length of above 5 mm. One of ordinary skill in the art would have been motivated to consult Nishimura to identify a way to give the 3D printed meat substitute a texture similar to animal meat. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Nishimura discloses that in a sensory evaluation of the prepared meat-like foodstuff comprising elongated fibers having a length of above 5 mm, the slices were found to provide a good fibrous sensation, firmness, and a preferable tough beef-like texture. ([0081]).
Regarding the axial alignment of the texturized protein fibers, McMindes teaches extrusion of plant protein products as a way to obtain “substantially aligned” fibers ([0008]), referring to the arrangement of protein fibers such that, in some embodiments, at least 90% of the fibers are contiguous to each other at less than approximately a 45° angle when viewed from a horizontal plane ([0069]). The structured protein products are used in a restructured meat composition ([0009]). McMindes further teaches that because the protein fibers are substantially aligned, the structured protein products generally have the texture and consistency of cooked muscle meat, and in extrudates having fibers that are randomly oriented or crosshatched, the texture is soft or spongy ([0070]). However, McMindes teaches that the aligned fibers are obtained by extrusion cooking of a plant protein slurry ([0037] – [0043]), which is in contrast to Lötzbeyer as modified by Nishimura, which is a raw plant protein slurry comprising protein fibers with a length of 5 mm or more. Nonetheless, McMindes teaches one of ordinary skill in the art that an extruded plant protein comprising fibers with at least 90% of the fibers being contiguous to each other at less than approximately a 45° angle when viewed from a horizontal plane is desirable because when the fibers are so aligned, the cooked product generally has the texture and consistency of cooked muscle meat, and when the fibers are not aligned, the texture is soft or spongy.
In the analogous art of using mycoprotein paste in the production of meat alternatives (p. 1151, col. 1, ¶ 2), Miri teaches that extrusion of native, isotropic, mycoprotein filamentous paste leads to a high degree of fiber alignment in the direction of flow with ∼80–90% of the fiber population being realigned (Abstract). Miri teaches that extruding a paste comprising fibers of about 200 µm in length (p. 1153, col. 2, last ¶) through a die with a diameter of 300 µm results in a fiber orientation ranging from -35° to +35° with a peak around 0° (p. 1156, col. 2, ¶ 3; see also Figs. 4, 7, and 9). Miri further teaches that die size determines fiber alignment (p. 1158, col. 1, ¶ 1), and decreasing the die size closer to the fiber length increases the fraction of the fiber population whose orientation is affected by the flow process (f) (p. 1157, Table 2), and thus the proportion of aligned fibers. Therefore, Miri teaches one of ordinary skill in the art that a fiber orientation ranging from -35° to +35° with a peak around 0° from the direction of extrusion can be readily achieved for fibrous pastes by controlling the extrusion die size.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified the 3D printed meat substitute of Lötzbeyer comprising the texturized protein fibers of Nishimura to incorporate the teachings of McMindes and Miri such that the texturized protein fibers are substantially aligned, having a nominal direction that is not more than ±45°, even not more than ±35° from the direction of the segment of the strand when viewed from a direction horizontal to the strand. First, Modified Lötzbeyer teaches a base product of a 3D printed meat substitute comprising strands comprising one or more bundles of axially aligned texturized protein fibers extruded through a 3D printer nozzle (pp. 12 & 14, Images). McMindes teaches thermal extrusion of plant protein such that the protein fibers of the extrudate are substantially aligned, and that structured protein products with substantially aligned fibers are seen as an improvement over structured protein products with randomly oriented of crosshatched fibers due to the former having the texture and consistency of cooked muscle meat. Miri teaches that a fiber orientation ranging from -35° to +35° with a peak around 0° from the direction of extrusion can be readily achieved for fibrous pastes by controlling the extrusion die size. Therefore, one of ordinary skill in the art would have been motivated to apply the teachings of McMindes and Miri to the composition of modified Lötzbeyer to further improve the texture and consistency of the 3D printed meat substitute. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Miri teaches how to align the fibers in a fibrous paste, such as that of modified Lötzbeyer, such that the fiber orientation ranges from -35° to +35° with a peak around 0° from the direction of extrusion.
Claim 36 is therefore rendered obvious.
Regarding claims 37, 44, and 45, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
Lötzbeyer also teaches that at least a portion of the segments of the plurality of strands are interconnected one to a neighboring strand thereof (re: claim 37), the whole muscle meat substitute further comprising two or more layers of said digitally printed protein-containing strands (re: claim 44), and wherein two or more layers are in interconnected at one or more points along each layer (re: claim 45) – at least the 3rd image on p. 15 of Lötzbeyer shows that at least a portion of the plurality of strands among and between at least 3 layers are interconnected (i.e., making contact and held together). The instant specification provides that interconnection encompasses physical linkage including “any type of hydrogen bond or van der Waals forces” (p. 8, ¶1), as would be the case in Lötzbeyer.
Claims 37, 44, and 45 are therefore rendered obvious.
Regarding claim 39, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
Lötzbeyer and Nishimura do not discuss that the axially aligned texturized protein fibers within a segment of a strand have a nominal direction that is not more than ±45° from the direction of the segment of the strand when the bundle of axially aligned fibers is viewed from a direction perpendicular to a plane defined by the layer comprising the segment of the strand (i.e., top horizontal view).
However, further modification of Lötzbeyer as modified by Nishimura with the teachings of McMindes and Miri, as described regarding claim 36, would also lead to the 3D printed meat substitute having axially aligned texturized protein fibers within a segment of a strand have a nominal direction that is not more than ±45° from the direction of the segment of the strand when the bundle of axially aligned fibers is viewed from a direction perpendicular to a plane defined by the layer comprising the segment of the strand (i.e., top horizontal view), as claimed. This is at least because the extrusion head of Lötzbeyer produces cylindrical strands (pp. 12 & 14, Images). As such, fiber alignment would be in the same orientation when viewed perpendicularly to the direction of the strand from the side, top, or any angle around the circumference of the strand.
Therefore, claim 39 is obvious for the same reasons and with the same expectation of success as described regarding claim 36.
Regarding claim 42, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
Lötzbeyer and Nishimura do not teach that the whole muscle substitute has a modified shear resistance above 10N when measured in a P direction that is parallel to the strands' nominal direction.
However, McMindes teaches that “In addition to having protein fibers that are substantially aligned, the structured protein products also typically have shear strength substantially similar to whole meat muscle. In this context of the invention, the term ‘shear strength’ provides one means to quantify the formation of a sufficient fibrous network to impart whole-muscle like texture and appearance to the structured protein product.” ([0071]). McMindes further teaches that the structured protein products have an average shear strength of at least 1400 grams ([0072]). This is above the claimed 10 N, which equates to 1019.7 grams.
Given the teachings of McMindes, it is considered that the substantially aligned fibers contribute to the shear strength of the strands of modified Lötzbeyer. Moreover, the number of strands, dimensions of the strands, temperature, and properties of the ingredients used in making the whole muscle meat substitute are all contributing factors to the overall shear strength.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have adjusted at least the amount of texturized protein fibers in the strands of the whole muscle meat analogue by routine optimization. MPEP § 2144.05(II) states, “‘[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)”. McMindes teaches that the structured protein products typically have shear strength substantially similar to whole meat muscle ([0071]), measuring at least 1400 grams (i.e., 13.7N) ([0072]). Therefore, one of ordinary skill in the art would have adjusted the amount of texturized protein fibers in the whole muscle meat substitute to arrive at a product with shear strength mimicking that of whole meat muscle (i.e., at least 1400 grams), including above 10N as claimed.
Claim 42 is therefore rendered obvious.
Claims 40, 41, 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Lötzbeyer et al., Nishimura et al., McMindes et al., and Miri et al., as applied to claim 36 above, and further in view of Vrljic et al. (US 2015/0305390 A1).
Regarding claim 40, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
The cited prior art does not teach that the whole muscle meat substitute has a modified tensile strength above 0.02MPa when measured in a direction parallel to the strand nominal direction.
However, Vrljic teaches a meat substitute constructed from a muscle replica, a fat replica, and a connective tissue replica, or a sub-combination thereof. The muscle replica, adipose tissue replica, and/or connective tissue replica can be assembled in a manner that approximates the physical organization of meat ([0254]). The individual tissue replicas can be assembled in layers, sheets, blocks, and strings in defined positions and orientations ([0271]). Vrljic further teaches that the tensile strength of the fat replica can be increased by incorporation of fibers ([0214]), and the fiber-containing fat replica by itself had a tensile strength of 23 kPa (i.e., 0.023 MPa), whereas the fat replica without fibers had a tensile strength of 20 kPa (i.e., 0.020 MPa) ([0383]). Hard connective tissue replica had a tensile strength of 3 MPa, similar to animal connective tissue ([0444]), and soft connective tissue replica had a tensile strength of <0.1 MPa ([0446]).
Given the teachings of Vrljic, it is considered that the substantially aligned fibers contribute to the tensile strength of the strands of modified Lötzbeyer, and thereby the overall whole meat substitute. Moreover, the number of strands, dimensions of the strands, temperature, and properties of the ingredients used in making the whole muscle meat substitute are all contributing factors to the overall tensile strength.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have adjusted at least the amount of texturized protein fibers in the strands of the whole muscle meat analogue by routine optimization. MPEP § 2144.05(II) states, “‘[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)”. Vrljic teaches the tensile strength of the fat replica can be increased by incorporation of fibers ([0214]), measuring 0.023 MPa ([0383]). Therefore, analogously, one of ordinary skill in the art would have adjusted the amount of texturized protein fibers in the whole muscle meat substitute to arrive at a product with tensile strength mimicking that of whole meat muscle, including above 0.02 MPa as claimed.
Claim 40 is therefore rendered obvious.
Regarding claim 41, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
The whole muscle meat substitute would inherently have a first modified tensile strength value measured in a P direction that is parallel to the strands’ nominal direction and a second modified tensile strength value measured in a XP direction that is perpendicular to the strands’ nominal direction and parallel to a layer's plane by virtue of being a 3D physical structure. See MPEP § 2112(II), which states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)”.
The cited prior art does not teach that the first modified tensile strength value is at least 50% higher than the second modified tensile strength value.
However, Vrljic teaches a meat substitute constructed from a muscle replica, a fat replica, and a connective tissue replica, or a sub-combination thereof. The muscle replica, adipose tissue replica, and/or connective tissue replica can be assembled in a manner that approximates the physical organization of meat ([0254]). In some embodiments, the 3-dimensional matrix of fibers is stabilized by protein crosslinks to replicate the tensile strength of animal connective tissue ([0169]). Vrljic further teaches that the tensile strength of the fat replica can be increased by incorporation of fibers ([0214]), and the fiber-containing fat replica by itself had a tensile strength of 23 kPa (i.e., 0.023 MPa), whereas the fat replica without fibers had a tensile strength of 20 kPa (i.e., 0.020 MPa) ([0383]).
Given the teachings of Vrljic, it is considered that the substantially aligned fibers contribute to the tensile strength of the strands of modified Lötzbeyer, and thereby the overall whole meat substitute in the claimed P direction (i.e., first modified tensile strength). It is also considered that the degree of interconnectivity between the strands contributes to the tensile strength of the overall whole meat substitute in the claimed XP direction (i.e., second modified tensile strength). Moreover, the number of strands, dimensions of the strands, temperature, and properties of the ingredients used in making the whole muscle meat substitute are all contributing factors to the overall tensile strength.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have adjusted at least the amount of texturized protein fibers in the strands of the whole muscle meat analogue, as well as the degree of interconnectivity between strands, by routine optimization. MPEP § 2144.05(II) states, “‘[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)”. Vrljic teaches the tensile strength of the fat replica can be increased by incorporation of fibers ([0214]), measuring 0.023 MPa ([0383]), and the 3-dimensional matrix of fibers is stabilized by protein crosslinks (i.e., interconnectivity) to replicate the tensile strength of animal connective tissue ([0169]). Therefore, analogously, one of ordinary skill in the art would have adjusted the amount of texturized protein fibers in the whole muscle meat substitute and adjust the level of crosslinking to arrive at a product with tensile strength mimicking that of whole meat muscle. In this way, it is reasonable to expect that one of ordinary skill in the art would arrive at a product wherein the first modified tensile strength value is at least 50% higher than the second modified tensile strength value, as claimed. Indeed, the 3D printed meat substitute of Lötzbeyer, which seems to be held together by van der Waals forces alone, likely already meets these criteria.
Claim 41 is therefore rendered obvious.
Regarding claims 46 and 47, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
The cited prior art does not teach that a fat-based component and/or a water-based component are disposed or dispersed in between said digitally printed protein containing strands (re: claim 46) or that at least a portion of the one or more layers comprise said fat-based component (re: claim 47).
However, Vrljic teaches a meat substitute constructed from a muscle replica, a fat replica, and a connective tissue replica, or a sub-combination thereof. The muscle replica, adipose tissue replica, and/or connective tissue replica can be assembled in a manner that approximates the physical organization of meat ([0254]). The individual tissue replicas can be assembled in layers, sheets, blocks, and strings in defined positions and orientations ([0271]), and in some embodiments, the adipose tissue replica is added to the muscle tissue replica in strands and sheets to replicate the effect of “marbling” ([0281]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the 3D printed meat substitute of Lötzbeyer to incorporate a fat replica component as taught by Vrljic between the protein containing strands such that at a portion of the layers comprise the fat component as claimed. One of ordinary skill in the art would have been motivated to consult Vrljic to identify additional components beyond protein fibers to add to the 3D printed meat substitute to give the product organoleptic properties closer to those of real meat. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because Vrljic teaches that combining muscle tissue replicas and adipose tissue replicas provide different flavor profiles ([0268]) and can be combined to give the appearance of “marbling” (([0281]).
Claims 46 and 47 are therefore rendered obvious.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Lötzbeyer et al., Nishimura et al., McMindes et al., and Miri et al., as applied to claim 36 above, and further in view of Kivelä et al. (WO 2018/189161 A1, cited on the IDS filed on 23 May 2024).
Regarding claim 43, Lötzbeyer, Nishimura, McMindes, and Miri teach the whole muscle meat substitute of claim 36.
The whole muscle meat substitute would inherently have a first modified shear resistance value that is measured in a direction parallel to the strands’ nominal direction and a second modified shear resistance value that is measured in a direction perpendicular to the strands’ nominal direction and parallel to a layer's plane by virtue of being a 3D physical structure. See MPEP § 2112(II), which states, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)”.
The cited prior art does not teach that the second modified shear resistance value is at least 100% greater than the first modified shear resistance value.
However, Kivelä teaches a ready-to-eat textured protein product prepared from legume protein material and comprising parallelly aligned fibers (Abstract). The product has resistance forces corresponding to bite resistance (i.e., shear resistance) described by peak positive force values (i.e., shear resistance values), that indicate similar structure and feel to beef jerky (p. 3, lines 22-31). A first peak positive force value is measured perpendicular to the length direction of the fibers (i.e., claimed second modified shear resistance value), and a second peak positive force value is measured parallel to the length direction of the fibers (i.e., claimed first modified shear resistance value) (p. 3, lines 22-31, see also Fig. 2). The ratio of the second peak positive force value (parallel direction) to the first peak positive force value (perpendicular direction) may be in the range of 40 - 85 %. This provides a pleasant biting experience, without making the product gum-like or too chewy. The first peak positive force value (perpendicular direction) may be, for example, in the range of 2000 - 8000 g and the second peak positive force (parallel direction) may be in the range of 1000 - 5000 g (p. 4, lines 1-7). Since the first and second value definitions are opposite between Kivelä and the instant claim, the ratio is also inverse. Therefore, since the disclosed range comprises a ratio of 50% (1:2), it also discloses the claimed ratio of at least 100% greater (2:1). For example, the disclosed ratio of 1000g (parallel) to 2000g (perpendicular) is inverted to 2000g (perpendicular) to 1000 g (parallel), which discloses the claimed second modified shear value being at least 100% greater than the first modified shear resistance value. Kivelä further teaches that the combination of protein content and fibrous structure enable pleasing chewy structure, as measured by peak positive forces (p. 9, lines 6-25).
Given the teachings of Kivelä, it is considered that the texturized protein fibers contribute to the shear strength of the strands of modified Lötzbeyer, and thereby the overall whole meat substitute. Moreover, the number of strands, dimensions of the strands, temperature, and properties of the ingredients used in making the whole muscle meat substitute are all contributing factors to the overall shear strength resistance.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have adjusted at least the amount of texturized protein fibers in the strands of the whole muscle meat analogue by routine optimization. MPEP § 2144.05(II) states, “‘[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)”. Modified Lötzbeyer teaches a 3D printed meat substitute comprising strands of texturized protein fibers as described regarding claim 36. Kivelä teaches that the combination of protein content and fibrous structure enable pleasing chewy structure, as measured by peak positive forces (p. 9, lines 6-25), and that a protein product comprised of parallelly aligned legume protein material exhibits a modified shear resistance value in the perpendicular direction of the strands is at least 100% greater than a modified shear resistance value in the parallel direction of the strands (see above). Therefore, one of ordinary skill in the art would have adjusted the amount of at least the texturized protein fibers in the whole muscle meat substitute to arrive at a product with shear strength mimicking that of whole meat muscle. In this way, it is reasonable to expect that one of ordinary skill in the art would arrive at a product that exhibits a modified shear resistance value in the perpendicular direction of the strands is at least 100% greater than a modified shear resistance value in the parallel direction of the strands, as claimed.
Claim 43 is therefore rendered obvious.
Response to Arguments
Claim Rejections – 35 U.S.C. § 103:
Applicant’s arguments, see Remarks p. 6, ¶ 1 – p. 7, ¶ 3 and p. 7, ¶ 5 – p. 8, ¶ 2, filed 30 December 2025, with respect to the rejection of claims 36, 37, 44, and 45 under 35 U.S.C. § 103, have been fully considered and are persuasive – Lötzbeyer and Nishimura do not teach fiber-level alignment such that “the axially aligned texturized protein fibers within a segment of a strand of the single strand or the plurality of strands have a nominal direction that is not more than ±45° from the direction of the segment of the strand when a bundle of the one or more bundles of axially aligned texturized protein fibers is viewed from a direction perpendicular to the segment's direction”, as recited in amended claim 36. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground of rejection is made in view of Lötzbeyer, Nishimura, McMindes, and Miri.
Additionally, Applicant’s arguments, see Remarks p. 9, ¶ 4 – p. 10, ¶ 3, filed 30 December 2025, with respect to the rejection of dependent claims 43 and 46-47 under 35 U.S.C. § 103, have been fully considered and are persuasive for the same reason that Lötzbeyer and Nishimura do not teach fiber-level alignment such that “the axially aligned texturized protein fibers within a segment of a strand of the single strand or the plurality of strands have a nominal direction that is not more than ±45° from the direction of the segment of the strand when a bundle of the one or more bundles of axially aligned texturized protein fibers is viewed from a direction perpendicular to the segment's direction”, as recited in amended claim 36, and the additional cited references do not cure this deficiency.
However, upon further consideration, new grounds of rejection are made in view of Lötzbeyer, Nishimura, McMindes, and Miri as applied to amended claim 36 and further in view of Vrljic (claims 40-41 and 46-47) or Kivelä (claim 43) as presented hereinabove.
Applicant’s arguments, see Remarks p. 7, ¶ 4 and p. 8, ¶ 3 – p. 9, ¶ 3, filed on 30 December 2025 have been fully considered, but they are not persuasive.
Applicant argued that Lötzbeyer may be considered teaching away from fiber orientation as Lötzbeyer appears to employ a slurry-based deposition process that produces a homogeneous internal matrix, which is directly contrary to the claimed configuration in which strands contain bundles of elongated texturized fibers, and these fibers within each segment of a strand have a nominal direction within ±45° of the segment's direction (p. 7, ¶ 4).
Applicant’s argument has been considered, but it is not persuasive. Lötzbeyer does not teach away from the claimed invention because it does not “criticize, discredit or otherwise discourage investigation into the invention claimed”. See MPEP § 2145(X)(D)(1). That is, Lötzbeyer does not criticize, discredit or otherwise discourage investigation into the strands containing bundles of elongated texturized fibers, and these fibers within each segment of a strand have a nominal direction within ±45° of the segment's direction.
Applicant next argued that the fiber alignment described in McMindes is relative to extrusion direction, and not relative to the longitudinal direction of the strands (containing the fibers), which may curve, fold, or change direction as deposited, and that there is nothing in McMindes suggesting that fiber orientation must remain within ±45° of the path of a strand segment (p. 8, ¶¶ 3-4).
In response, where McMindes teaches extrusion of plant protein with fibers oriented within ±45° of the direction of extrusion, the extruded strand has fiber orientation in the same direction. Even if the extruded strands curve, fold, or change direction, it is still expected that the fibers maintain their orientation relative to the direction of the strand because extrusion through the die aligns the fibers in the direction of the strand. Additionally, it is noted that strands that curve, fold, or change direction are not required by the rejected claim(s). Applicant’s argument is therefore not persuasive.
Applicant next argued that the Examiner has not identified any teaching that fiber alignment must be coordinated with strand alignment in order to improve organoleptic properties of the resulting whole muscle meat substitute (p. 8, ¶ 5). Applicant argued that none of the cited references teaches or suggests that one must match microscopic fiber orientation to macroscopic strand geometry, nor that doing so would improve structure or texture (Id.).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., improved organoleptic properties, structure, or texture) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, McMindes teaches that because the protein fibers are substantially aligned, the structured protein products generally have the texture and consistency of cooked muscle meat, and in extrudates having fibers that are randomly oriented or crosshatched, the texture is soft or spongy ([0070]). Applicant’s argument is therefore not persuasive.
Applicant asserted that fiber-to-strand directional relationship defines a unique structural hierarchy which results in the unexpectedly improved organoleptic properties of the whole muscle meat substitute (pp. 8-9, bridging ¶).
Applicant’s assertion of unexpected results is acknowledged. Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”.
“To be of probative value, any objective evidence should be supported by actual proof. Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) (“It is well settled that unexpected results must be established by factual evidence.” “[A]ppellants have not presented any experimental data showing that prior heat-shrinkable articles split. Due to the absence of tests comparing appellant’s heat shrinkable articles with those of the closest prior art, we conclude that appellant’s assertions of unexpected results constitute mere argument.”). See also In re Lindner, 457 F.2d 506, 508, 173 USPQ 356, 358 (CCPA 1972); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991).” See MPEP § 716.01(c)(I).
“Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). Examples of statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor.” See MPEP § 716.01(c)(II).
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. See MPEP § 716.02(d)
In the present case, Applicant’s assertion of unexpected, superior characteristics is based on argument, and not on objective evidence. “Argument does not replace evidence where evidence is necessary”. MPEP § 2145(I). Objective evidence of unexpected results must be submitted in an appropriate affidavit or declaration. MPEP § 716.01(c) §§ (I)&(II). Therefore, Applicant’s assertion cannot be found persuasive.
In summary, claims 36-37 and 39-47 are rejected under 35 U.S.C. § 103 as presented hereinabove.
Applicant requested that the Examiner provide references supporting the teachings that the Examiner may have relied, explicitly or implicitly, on Official Notice, and to provide the required motivation or suggestion to combine the references with the other art of record (p. 10, ¶ 4).
Applicant is reminded that “[t]o adequately traverse a finding based on official notice, an applicant must specifically point out the supposed errors in the examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A mere request by the applicant that the examiner provide documentary evidence in support of an officially-noticed fact is not a proper traversal. See 37 CFR 1.111(b). See also Chevenard, 139 F.2d at 713, 60 USPQ at 241. A general allegation that the claims define a patentable invention without any reference to the examiner’s assertion of official notice would be inadequate. If applicant adequately traverses the examiner’s assertion of official notice, the examiner must provide documentary evidence in the next Office action if the rejection is to be maintained”. See MPEP § 2144.03(C).
Applicant’s mere request that the Examiner provide documentary evidence is not a proper traversal of any alleged Official Notice taken. Any common knowledge or well-known in the art statement is taken to be admitted prior art because Applicant has failed to adequately traverse any assertion of Official Notice.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793