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 Claims
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 25-42
Withdrawn claims: 40-41
Previously canceled claims: 1-24
Newly canceled claims: None
Amended claims: None
New claims: 25-42
Claims currently under consideration: 25-39 and 42
Currently rejected claims: 25-39 and 42
Allowed claims: None
Election/Restrictions
Applicant’s election without traverse of Group I, claims 25-39 and 42 in the reply filed on 31 December 2025 is acknowledged.
Claims 40-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 31 December 2025.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/265,176, filed on 1 February 2021.
Claim Objections
Claims 25 and 32 are objected to because of the following informalities:
Claim 25 should end in a period, as each claim should be a single sentence. See MPEP § 608.01(m), which states, “Each claim begins with a capital letter and ends with a period. Periods may not be used elsewhere in the claims except for abbreviations.”
In claim 32, lines 5-7, “…composition ; being the storage modulus G’ equal to or higher than 1700 Pa and the loss modulus G’’ equal to or higher than 350 Pa, and the ratio G’’/G’ in the viscoelastic composition being from 0.24 to 0.88” should read, ““…composition; wherein the storage modulus G’ is equal to or higher than 1700 Pa and the loss modulus G’’ is equal to or higher than 350 Pa, and the ratio G’’/G’ in the viscoelastic composition is from 0.24 to 0.88.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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 for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 25-31, 34-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over van Nunen (van Nunen, D. (2015, October 29). 3D “meat” printer. Just another weblog. https://web.archive.org/web/20170421051849/https:/meat2015.weblog.tudelft.nl/, cited on the IDS filed 9 October 2023) in view of Shenouda (US 4,423,083 A, cited on the IDS filed 9 October 2023), Chen et al. (Chen, E.J., Novakofski, J., Jenkins, K., & O’Brien Jr, W.D. (1994). Ultrasound elasticity measurements of soft tissues with application to elasticity imaging. ULTSYM-94, 3, 1459-1462. https://doi.org/10.1109/ULTSYM.1994.401867, cited on the IDS filed 9 October 2023), Lapin et al. (Lapin, M. R., Gonzalez, J. M., & Johnson, S. E. (2013). Substrate elasticity affects bovine satellite cell activation kinetics in vitro. Journal of Animal Science, 91(5), 2083-2090, cited on the IDS filed on 9 October 2023), and Freeman et al. (Freeman, F.E., and Kelly, D.J. (2017). Tuning Alginate Bioink Stiffness and Composition for Controlled Growth Factor Delivery and to Spatially Direct MSC Fate within Bioprinted Tissues. Scientific Reports, 7(17042), 1-12, cited on the IDS filed on 9 October 2023).
Regarding claim 25, van Nunen teaches an edible microextruded product comprising one or more viscoelastic microextruded elements, wherein each extruded element comprises protein, an edible pseudoplastic polymer and an appropriate edible solvent, wherein the one or more microextruded elements have a cross section width from 10 µm to 1000 µm – van Nunen teaches a 3D printed “artificial meat in shape and texture resembling a chicken breast” (p. 1, ¶ 1). A recipe of lupine protein, alginate (i.e., a pseudoplastic polymer) and water (i.e., an edible solvent) is extruded through a 0.5 mm (i.e., 500 µm) needle to form strands (i.e., microextruded elements) (see p. 10, “New printing recipe”, p. 11, last 2 ¶s, and p. 12, images). These microextruded elements make up the 3D printed artificial chicken breast (see p. 4, images).
Van Nunen does not specifically discuss that the percentage by weight of protein in relation with total weight of the microextruded element is from 19 % to 49 %, the percentage by weight of edible pseudoplastic polymer in relation with the total weight of the microextruded element is from 0.2 % to 40 %, and the percentage by weight of edible solvent in relation with total weight of the microextruded element is at least 45 %; said edible solvent balancing up to 100% by weight of the microextruded element. Van Nunen also does not discuss that the compressive elastic modulus of the edible microextruded product is from 1.0x103 Pa to 5.0x106 Pa and the tensile Young's modulus of the edible microextruded product is from 5.0x103 Pa to 11.0x106 Pa, said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded product from 45 % to an amount balancing up to 100% w/w of the microextruded product.
However, van Nunen discloses that “the recipe needs more attention” to overcome the problem in “getting a smooth and constant extrusion” (see p. 1, “Obstacles”). Van Nunen used a recipe of 20 g lupine, 7 g alginate, and an undisclosed amount of water (p. 11, ¶ 5). This recipe contained 30% less alginate than a prior recipe, and was found to have “higher fluidity, making it better suitable to extrude from a syringe or even a needle” (p. 11, ¶ 2).
Shenouda teaches protein-alginate mixtures that produce a product with “certain textural and nutritional properties of natural meat and can be flavored, colored, texturized, shaped, molded, cooked, and substituted for meat” (see Abstract). The mixture comprises heat coagulable protein at about 10 to about 25 wt% and a water-soluble alginate content of from about 0.25 to about 3 wt% (see claim 6). The protein may be any protein or combination of proteins as long as at least one of the proteins is soluble or partially soluble in water and can be coagulated by heat treatment (col. 2, lines 50-65). Shenouda demonstrates in Example 1 that water is present to balance to 100% (col. 9, lines 20-27). The composition comprises 20 wt% protein, 1 wt% alginate, and 79 wt% water (Id.). Shenouda further teaches that the compositions may be extruded (see claim 11).
Chen teaches that the compressive elastic modulus of beef longissimus dorsi muscle (p. 1460, col. 1, ¶ 3) is 3.0 kPa (p. 1461, col. 1, ¶ 1). Therefore, Chen teaches one of ordinary skill in the art seeking to prepare a beef steak meat analogue that the compressive elastic modulus should be about 3.0 kPa.
Lapin teaches that the tensile Young’s moduli (p. 2085, col. 1, ¶ 1) of longissimus muscle (LM) and semimembranosus muscle (SM) of adult cows are 15 kPa and 10 kPa, respectively (p. 2086, Figure 1). Lapin also teaches that the tensile Young’s moduli of LM and SM in young bulls are 8 kPa and 7.5 kPa, respectively (Id.). Together, Lapin teaches one of ordinary skill in the art seeking to prepare a beef steak meat analogue that the tensile Young’s modulus should be between 7.5 and 15 kPa.
Freeman teaches that mechanical properties, including the Young’s modulus, of an alginate bioink can be tuned through varying the crosslinking ratio (alginate:crosslinker) (p. 4, ¶ 3; see also p. 5, Figure 3C). Crosslinkers include CaSO4, CaCO3, and CaCl2 (p. 4, ¶ 2).
Regarding the amounts of protein, edible pseudoplastic polymer, and water, 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 recipe of van Nunen with the teachings of Shenouda to include protein in an amount from about 10 to about 25 wt%, alginate in an amount from about 0.25 to about 3 wt%, and water to balance to 100% (ranging from about 72 to 89.75 wt%). The claimed range of from 19 to 49 wt% protein overlaps the disclosed range of about 10 to about 25 wt% protein. The claimed range of from 0.2 to 40 wt% edible pseudoplastic polymer overlaps the disclosed range of about 0.25 to about 3 wt% alginate. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). One of ordinary skill in the art would have been motivated to adjust the amounts of these ingredients because van Nunen discloses that “the recipe needs more attention” to overcome the problem in “getting a smooth and constant extrusion” (see p. 1, “Obstacles”), and that upon reducing alginate, the mixture had increased fluidity, was less of a gelatin fluid and had fewer chunks (p. 11, ¶ 5). One of ordinary skill in the art would have had a reasonable expectation of success because Shenouda teaches that similar blends of protein, alginate, and water are suitable for preparing meat analogue products (Abstract) and for extrusion (see claim 11).
Regarding the compressive elastic and tensile Young’s moduli, 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 meat analogue of van Nunen to produce a meat analogue product with a compressive elastic modulus of about 3.0 kPa as taught by Chen and a tensile Young’s modulus of between 7.5 kPa and 15 kPa as taught by Lapin in order to provide the product with textural properties that mimic real beef muscle. While van Nunen uses chicken breast as an example shape of the artificial meat, one of ordinary skill in the art of additive manufacturing would have been able to produce any shape, including a beef steak, and van Nunen speaks to the broader market possibilities of 3D printed meat replacers (p. 2, ¶¶ 1-2). One of ordinary skill in the art would have had a reasonable expectation of success in providing microextruded elements with a compressive elastic modulus of between 1.0x103 Pa to 5.0x106 Pa and a tensile Young’s modulus of between 5.0x103 Pa to 11.0x106 Pa because Freeman teaches that mechanical properties, including the Young’s modulus can be tuned, through routine experimentation, by adjusting the alginate:crosslinker ratio, and van Nunen uses alginate and a CaCl2 crosslinker to prepare the 3D printed meat analogue and demonstrates similar results of modulating the amount of CaCl2 on strand strength (p. 13, ¶ 4 – p. 14, ¶ 3). Changes in compression would be expected to be modulated as well because compression/squeezing is similar to, but opposite from tension/pulling. That is, stronger crosslinking resulting in an increased tensile modulus would also be expected to increase the compression modulus.
Regarding the limitation, “said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded product from 45 % to an amount balancing up to 100% w/w of the microextruded product”, this is a process limitation in a product claim. It is noted that “[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). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP § 2113. In the present case, where the cited prior art render obvious the claimed product, this process limitation is does not render the claim patentable.
Therefore, claim 25 is rendered obvious.
Regarding claim 26, van Nunen also teaches that the one or more viscoelastic microextruded elements comprise a viscoelastic composition comprising the protein, the edible pseudoplastic polymer, and the appropriate edible solvent, wherein the percentage by weight of protein, edible pseudoplastic polymer and of the edible solvent with respect to the viscoelastic composition is the same percentage as in the viscoelastic microextruded element – the protein, alginate, and water are mixed to form a composition and the composition is microextruded (see p. 10, “New printing recipe”, p. 11, last 2 ¶s, and p. 12, images).
Claim 26 is therefore rendered obvious.
Regarding claim 27, van Nunen also teaches that the one or more viscoelastic microextruded elements are microextruded filaments – van Nunen refers to the microextruded elements as “strands” (p 12, ¶ 2), which is synonymous with “filaments”.
Claim 27 is therefore rendered obvious.
Regarding claim 28, van Nunen as modified by Shenouda also teaches that the percentage by weight of protein is from 25 % to 49 %, and the percentage by weight of edible solvent is at least 45% – As described regarding claim 25, Shenouda teaches that the amount of protein ranges from at about 10 to about 25 wt%. The claimed range overlaps the disclosed range. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Shenouda teaches a water-soluble alginate content of from about 0.25 to about 3 wt% (see claim 6). Shenouda demonstrates in Example 1 that water is present to balance to 100% (col. 9, lines 20-27). In a composition comprising 25% protein and 0.25 to 3% alginate, the weight of water would be 72 to 74.75%, which is “at least 45%” as claimed.
Claim 28 is therefore obvious for the same reasons and with the same expectation of success as described regarding claim 25.
Regarding claim 29, van Nunen teaches that the protein is selected from non-human animal origin protein, plant origin protein, algae origin protein, yeast origin protein, bacterial origin protein, and combinations thereof – van Nunen discloses a recipe made from lupine protein (p. 11, ¶ 5). Van Nunen also discloses soy protein concentrate and vital wheat gluten (p. 14, last ¶), and a lupine/soy protein isolate mixture (p. 15, ¶ 1). Therefore, van Nunen discloses that the protein is plant origin protein.
Claim 29 is therefore rendered obvious.
Regarding claims 30-31, van Nunen teaches that the edible pseudoplastic polymer is a polysaccharide (re: claim 30), selelected from alginic acid and an edible salt of alginic acid (re: claim 31) – van Nunen teaches that the pseudoplastic polymer is alginate (p. 11, ¶ 5).
Claims 30-31 are therefore rendered obvious.
Regarding claim 34, van Nunen teaches that the one or more viscoelastic microextruded elements further comprise flavour compounds – van Nunen discloses adding flavor to the recipe before printing (p. 1, last ¶).
Claim 34 is therefore rendered obvious.
Regarding claim 35, van Nunen teaches that the viscoelastic microextruded elements form at least one layer that comprises microextruded filaments disposed in parallel and adjacent orientations, and wherein the percentage of microextruded filaments in the surface of the layer is from 25 % to 100 % – van Nunen discloses concentric infill patterns and linear cross/crosslinked infill patterns with 98% and 90% infill density (p. 5, last ¶ – p. 7).
Claim 35 is therefore rendered obvious.
Regarding claim 36, van Nunen teaches that the edible microextruded product comprises two or more layers of one or more viscoelastic microextruded elements and the two or more layers of the one or more microextruded elements are stacked in such a way that a vertical section of the edible microextruded product shows intersected microextruded elements within a layer – van Nunen teaches a cross-linked (grid) infill (p. 7, last ¶; see also p. 5, last ¶, “linear cross infill”) with layers that stick to each other (p. 7, last ¶). Moreover, MPEP § 2144.04(IV)(B) provides that a change in shape is a matter of choice that is obvious absent persuasive evidence that the particular configuration is significant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 36 is therefore rendered obvious.
Regarding claim 37, van Nunen teaches that the microextruded product is a meat replacer or a meat analogue – van Nunen teaches that the microextruded product is an artificial meat (p. 1, ¶ 1).
Claim 37 is therefore rendered obvious.
Regarding claim 39, van Nunen teaches an edible microextruded layer comprising one or more viscoelastic microextruded elements, wherein each extruded element comprises protein, an edible pseudoplastic polymer and an appropriate edible solvent, wherein the one or more microextruded elements have a cross section width from 10 µm to 1000 µm – van Nunen teaches a 3D printed “artificial meat in shape and texture resembling a chicken breast” (p. 1, ¶ 1). The artificial meat is made of several layers; example layers are shown in the images on p. 8. A recipe of lupine protein, alginate (i.e., a pseudoplastic polymer) and water (i.e., an edible solvent) is extruded through a 0.5 mm (i.e., 500 µm) needle to form strands (i.e., microextruded elements) (see p. 10, “New printing recipe”, p. 11, last 2 ¶s, and p. 12, images). These microextruded elements make up the layers of the 3D printed artificial chicken breast (see p. 4, images).
Van Nunen does not specifically discuss that the percentage by weight of protein in relation with total weight of the microextruded element is from 19 % to 49 %, the percentage by weight of edible pseudoplastic polymer in relation with the total weight of the microextruded element is from 0.2 % to 40 %, and the percentage by weight of edible solvent in relation with total weight of the microextruded element is at least 45 %; said edible solvent balancing up to 100% by weight of the microextruded element. Van Nunen also does not discuss that the compressive elastic modulus of the edible microextruded layer is from 1.0x103 Pa to 5.0x106 Pa and the tensile Young's modulus of the edible microextruded layer is from 5.0x103 Pa to 11.0x106 Pa, said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded layer from 45 % to an amount balancing up to 100% w/w of the microextruded layer.
However, van Nunen discloses that “the recipe needs more attention” to overcome the problem in “getting a smooth and constant extrusion” (see p. 1, “Obstacles”). Van Nunen used a recipe of 20 g lupine, 7 g alginate, and an undisclosed amount of water (p. 11, ¶ 5). This recipe contained 30% less alginate than a prior recipe, and was found to have “higher fluidity, making it better suitable to extrude from a syringe or even a needle” (p. 11, ¶ 2).
Shenouda teaches protein-alginate mixtures that produce a product with “certain textural and nutritional properties of natural meat and can be flavored, colored, texturized, shaped, molded, cooked, and substituted for meat” (see Abstract). The mixture comprises heat coagulable protein at about 10 to about 25 wt% and a water-soluble alginate content of from about 0.25 to about 3 wt% (see claim 6). The protein may be any protein or combination of proteins as long as at least one of the proteins is soluble or partially soluble in water and can be coagulated by heat treatment (col. 2, lines 50-65). Shenouda demonstrates in Example 1 that water is present to balance to 100% (col. 9, lines 20-27). The composition comprises 20 wt% protein, 1 wt% alginate, and 79 wt% water (Id.). Shenouda further teaches that the compositions may be extruded (see claim 11).
Chen teaches that the compressive elastic modulus of beef longissimus dorsi muscle (p. 1460, col. 1, ¶ 3) is 3.0 kPa (p. 1461, col. 1, ¶ 1). Therefore, Chen teaches one of ordinary skill in the art seeking to prepare a beef steak meat analogue that the compressive elastic modulus should be about 3.0 kPa.
Lapin teaches that the tensile Young’s moduli (p. 2085, col. 1, ¶ 1) of longissimus muscle (LM) and semimembranosus muscle (SM) of adult cows are 15 kPa and 10 kPa, respectively (p. 2086, Figure 1). Lapin also teaches that the tensile Young’s moduli of LM and SM in young bulls are 8 kPa and 7.5 kPa, respectively (Id.). Together, Lapin teaches one of ordinary skill in the art seeking to prepare a beef steak meat analogue that the tensile Young’s modulus should be between 7.5 and 15 kPa.
Freeman teaches that mechanical properties, including the Young’s modulus, of an alginate bioink can be tuned through varying the crosslinking ratio (alginate:crosslinker) (p. 4, ¶ 3; see also p. 5, Figure 3C). Crosslinkers include CaSO4, CaCO3, and CaCl2 (p. 4, ¶ 2).
Regarding the amounts of protein, edible pseudoplastic polymer, and water, 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 recipe of van Nunen with the teachings of Shenouda to include protein in an amount from about 10 to about 25 wt%, alginate in an amount from about 0.25 to about 3 wt%, and water to balance to 100% (ranging from about 72 to 89.75 wt%). The claimed range of from 19 to 49 wt% protein overlaps the disclosed range of about 10 to about 25 wt% protein. The claimed range of from 0.2 to 40 wt% edible pseudoplastic polymer overlaps the disclosed range of about 0.25 to about 3 wt% alginate. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). One of ordinary skill in the art would have been motivated to adjust the amounts of these ingredients because van Nunen discloses that “the recipe needs more attention” to overcome the problem in “getting a smooth and constant extrusion” (see p. 1, “Obstacles”), and that upon reducing alginate, the mixture had increased fluidity, was less of a gelatin fluid and had fewer chunks (p. 11, ¶ 5). One of ordinary skill in the art would have had a reasonable expectation of success because Shenouda teaches that similar blends of protein, alginate, and water are suitable for preparing meat analogue products (Abstract) and for extrusion (see claim 11).
Regarding the compressive elastic and tensile Young’s moduli, 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 meat analogue of van Nunen to produce a meat analogue product layer with a compressive elastic modulus of about 3.0 kPa as taught by Chen and a tensile Young’s modulus of between 7.5 kPa and 15 kPa as taught by Lapin in order to provide the product with textural properties that mimic real beef muscle. While van Nunen uses chicken breast as an example shape of the artificial meat, one of ordinary skill in the art of additive manufacturing would have been able to produce any shape, including a beef steak, and van Nunen speaks to the broader market possibilities of 3D printed meat replacers (p. 2, ¶¶ 1-2). One of ordinary skill in the art would have had a reasonable expectation of success in providing microextruded elements with a compressive elastic modulus of between 1.0x103 Pa to 5.0x106 Pa and a tensile Young’s modulus of between 5.0x103 Pa to 11.0x106 Pa because Freeman teaches that mechanical properties, including the Young’s modulus can be tuned, through routine experimentation, by adjusting the alginate:crosslinker ratio, and van Nunen uses alginate and a CaCl2 crosslinker to prepare the 3D printed meat analogue layers and demonstrates similar results of modulating the amount of CaCl2 on strand strength (p. 13, ¶ 4 – p. 14, ¶ 3). Changes in compression would be expected to be modulated as well because compression/squeezing is similar to, but opposite from tension/pulling. That is, stronger crosslinking resulting in an increased tensile modulus would also be expected to increase the compression modulus.
Regarding the limitation, “said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded layer from 45 % to an amount balancing up to 100% w/w of the microextruded layer”, this is a process limitation in a product claim. It is noted that “[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). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP § 2113. In the present case, where the cited prior art render obvious the claimed product, this process limitation is does not render the claim patentable.
Therefore, claim 39 is rendered obvious.
Claims 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over van Nunen in view of Shenouda, Chen et al., Lapin et al., and Freeman et al. as applied to claim 25 above, and further in view of Wang et al. (Wang, L., Zhang, M., Bhandari, B., & Yang, C. (2018). Investigation on fish surimi gel as promising food material for 3D printing. Journal of Food Engineering, 220, 101-108. https://doi.org/10.1016/j.jfoodeng.2017.02.029).
Regarding claims 32-33, the cited prior art does not discuss that the said viscoelastic composition has a storage modulus G' higher than the loss modulus G" when measured at 0.16 Hz and at a temperature of 23 "C in a pair of parallel serrated plates and with a solvent amount in the edible microextrudable composition from 45 % to an amount balancing up to 100 % w/w of the microextrudable composition; being the storage modulus G' equal to or higher than 1700 Pa and the loss modulus G" equal to or higher than 350 Pa, and the ratio G"/G' in the viscoelastic composition being from 0.24 to 0.88 (re: claim 32), or that the storage modulus G' of the viscoelastic composition is from 1700 Pa to 140000 Pa, and the loss modulus G" of the viscoelastic composition is from 350 Pa to 40000 Pa (re: claim 33).
However, Wang teaches a surimi gel system as a material for 3D printing, wherein the properties of a 1.5 g NaCl/100g surimi mixture had beneficial properties for slurry flow from the nozzle and final shape holding (Abstract). Wang further teaches that the surimi gel with 1.5% NaCl has a storage modulus G’ of about 20,000 Pa, a loss modulus G’’ of about 4,000 Pa, and the G’’/G’ (tan δ) of about 0.24 to 0.45 (p. 103, Fig. 1B-D).
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 product of van Nunen with the teachings of Wang to provide the composition with a storage modulus G’ of about 20,000 Pa, a loss modulus G’’ of about 4,000 Pa, and the G’’/G’ (tan δ) of about 0.24 to 0.45. These values lie inside the claimed ranges. One of ordinary skill in the art would have been motivated to do so because van Nunen discloses that “the recipe needs more attention” to overcome the problem in “getting a smooth and constant extrusion” (see p. 1, “Obstacles”), and Wang teaches that these moduli result in a mixture with good slurry flow from the nozzle and final shape holding (Abstract). One of ordinary skill in the art would have had a reasonable expectation of success because Wang teaches that a higher G’ compared to G’’ indicates a higher potential to form elastic gel or gel-like structure (p. 103, col, 1, ¶ 1), and as described regarding claim 25, Freeman teaches that modifying the alginate:crosslinker ratio modulates the properties of the gel. As such, one of ordinary skill in the art would expect that through routine experimentation with the amounts of alginate and/or crosslinker, the storage and loss moduli could be tuned as desired.
Therefore, claims 32-33 are rendered obvious.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over van Nunen in view of Shenouda, Chen et al., Lapin et al., and Freeman et al. as applied to claim 25 above, and further in view of Vrljic et al. (US 20150305390 A1).
Regarding claim 38, the cited prior art does not discuss an edible composite product comprising a portion of the edible microextruded product according to claim 25, and a portion of a solidified composition comprising a fat selected from one or more triglycerides, cholesterol, one or more phospholipids, one or more fatty acids and combination thereof; and/or a portion of a solidified composition comprising cartilaginous material; and/or a portion comprising bone material, said portion of composition comprising fat and/or cartilaginous material and/or bone material, adjacently and in contact with the portion of the edible microextruded product.
However, Vrljic teaches a meat substitute constructed from a muscle replica, a fat replica, and/or a connective tissue replica assembled in a manner that approximates the physical organization of meat ([0254]). The percentage of the different components may be controlled, and may include inedible portions, such as bone, cartilage, connective tissue, or other gristle components ([0255]). A binding agent is used to help bind the replicas to each other ([0254]). As such, the materials are adjacent and in contact.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the edible microextruded product as taught by van Nunen, Shenouda, Chen, Lapin, and Freeman with the fat replica, connective tissue replica, bone, cartilage, and/or connective tissue material as taught by Vrljic in order to provide consumers with a product that has the appearance of real meat. One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Vrljic teaches a meat substitute constructed from a muscle replica, that may also include a fat replica, connective tissue replica, and/or inedible portions such as bone, cartilage, connective tissue or other gristle components.
Claim 38 is therefore rendered obvious.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Shenouda (US 4,423,083 A, cited on the IDS filed 9 October 2023).
Regarding claim 42, Shenouda teaches an edible viscoelastic composition – protein-alginate mixtures that produce a product with “certain textural and nutritional properties of natural meat and can be flavored, colored, texturized, shaped, molded, cooked, and substituted for meat” (see Abstract).
comprising, in an appropriate edible solvent, protein in a percentage by weight in relation with the total weight of the viscoelastic composition from 19 % to 49 %, said protein selected from plant-origin protein, insect protein, algae-origin protein, bacterial origin protein, and combinations thereof – The mixture comprises heat coagulable protein at about 10 to about 25 wt% (see claim 6). The claimed range of from 19 to 49 wt% protein overlaps the disclosed range of about 10 to about 25 wt% protein. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I). The protein may be any edible protein or combination of proteins as long as at least one of the proteins is soluble or partially soluble in water and can be coagulated by heat treatment, such as soy isolates, gluten, and single cell protein (col. 2, lines 50-65).
and an edible pseudoplastic polysaccharide selected from alginate, xanthan gum, glycosaminoglycans, agarose, gellan gum, pectin, carrageenan and combinations thereof, in a percentage by weight, in relation with the total viscoelastic composition, from 0.5 % to 40 % – The mixture comprises a water-soluble alginate content of from about 0.25 to about 3 wt% (see claim 6). The claimed range of from 0.5 to 40 wt% edible pseudoplastic polymer overlaps the disclosed range of about 0.25 to about 3 wt% alginate. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
and wherein the viscoelastic composition comprises at least 45 % by weight of edible solvent, in relation with the total weight of the composition – Shenouda demonstrates in Example 1 that water is present to balance to 100% (col. 9, lines 20-27). The composition comprises 20 wt% protein (egg albumin and milk casein), 1 wt% sodium alginate, and 79 wt% water (Id.). Given the disclosed ranges for protein and alginate, the disclosed range of water to balance is from about 72 to 89.75 wt%. Shenouda further teaches that the compositions may be extruded (see claim 11).
It is noted that the language “microextrudable” is an intended use of the claimed composition, and does not limit the claim insofar as the structure of the product is concerned. In order to patentably distinguish the claimed invention from the prior art, a claimed intended use must result in a structural difference between the claimed invention and the prior art. See MPEP § 2111.02(II). In the present case there is no difference between the composition in the prior art and the claimed composition.
Claim 42 is therefore rendered obvious.
Double Patenting - Statutory
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 42 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 16 of prior U.S. Patent No. 11,779,033 (hereinafter “the ‘033 patent”). This is a statutory double patenting rejection.
Regarding claim 42, claim 16 of the ‘033 patent recites, “An edible viscoelastic microextrudable composition comprising, in an appropriate edible solvent, protein in a percentage by weight from 19 % to 49 %, said protein selected from the group consisting of plant-origin protein, insect protein, algae-origin protein, bacterial origin protein, and combinations thereof; and an edible pseudoplastic polysaccharide selected from the group consisting of alginate, xanthan gum, glycosaminoglycans, agarose, gellan gum, pectin, carrageenan and combinations thereof, in a percentage by weight from 0.5 % to 40 %; wherein the viscoelastic composition comprises at least 45 % by weight of edible solvent.” Weight percentages are considered a priori to be in relation with the total weight of the viscoelastic composition. There is no distinguishing feature between the two claims such that they are not drawn to identical subject matter.
Double Patenting – Non-statutory
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-27, 36 and 38-39, rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,779,033 (hereinafter “the ‘033 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 25, the product of claim 13 of the ‘033 patent is an edible microextruded product comprising one or more viscoelastic microextruded elements, wherein each extruded element comprises protein, an edible pseudoplastic polymer and an appropriate edible solvent, wherein the percentage by weight of protein in relation with total weight of the microextruded element is from 19 % to 49 %, the percentage by weight of edible pseudoplastic polymer in relation with the total weight of the microextruded element is from 0.2 % to 40 %, and the percentage by weight of edible solvent in relation with total weight of the microextruded element is at least 45 %; said edible solvent balancing up to 100% by weight of the microextruded element; the one or more microextruded elements have a cross section width from 10 µm to 1000 µm; the compressive elastic modulus of the edible microextruded product is from 1.0x103 Pa to 5.0x106 Pa and the tensile Young's modulus of the edible microextruded product is from 5.0x103 Pa to 11.0x106 Pa, said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded product from 45 % to an amount balancing up to 100% w/w of the microextruded product. Claim 25 is therefore rendered obvious.
Regarding claim 26, the product of claim 13 of the ‘033 patent is formed from a viscoelastic composition comprising the protein, the edible pseudoplastic polymer, and the appropriate edible solvent, wherein the percentage by weight of protein, edible pseudoplastic polymer, and of the edible solvent with respect to the viscoelastic composition is the same percentage as in the viscoelastic microextruded element (see ‘033 patent claim 1(i)). Claim 26 is therefore rendered obvious.
Regarding claim 27, these limitations are the same as those of ‘033 patent claim 14. Claim 27 is therefore rendered obvious.
Regarding claim 36, the product of claim 13 of the ‘033 patent comprises two or more layers of one or more viscoelastic microextruded elements and the two or more layers of the one or more microextruded elements are stacked in such a way that a vertical section of the edible microextruded product shows intersected microextruded elements within a layer, or microextruded elements superimposed and differentially oriented between the different layers; or alternatively the two or more layers are stacked in such a way that mixeroextruded elements between layers are oriented in parallel. (see ‘033 patent claim 1(iii)). Claim 36 is therefore rendered obvious.
Regarding claim 38, these limitations are the same as those of ‘033 patent claim 19. Claim 38 is therefore rendered obvious.
Regarding claim 39, the product of claim 13 of the ‘033 patent comprises edible microextruded layers comprising one or more viscoelastic microextruded elements, wherein each extruded element comprises protein, an edible pseudoplastic polymer and an appropriate edible solvent, wherein the percentage by weight of protein in relation with total weight of the microextruded element is from 19 % to 49 %, the percentage by weight of edible pseudoplastic polymer in relation with the total weight of the microextruded element is from 0.2 % to 40 %, and the percentage by weight of edible solvent in relation with total weight of the microextruded element is at least 45 %; said edible solvent balancing up to 100% by weight of the microextruded element; the one or more microextruded elements have a cross section width from 10 µm to 1000 µm; the compressive elastic modulus of the edible microextruded layers is from 1.0x103 Pa to 5.0x106 Pa and the tensile Young's modulus of the edible microextruded layers is from 5.0x103 Pa to 11.0x106 Pa, said compressive elastic and the tensile Young's moduli measured in a servo- hydraulic test system with a clamp displacement rate equal to 1 mm/min, at 23 °C and with a solvent amount in the edible microextruded layers from 45 % to an amount balancing up to 100% w/w of the microextruded layers. Claim 39 is therefore rendered obvious.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793