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 .
This office action is in response to the application filed on December 13, 2023. The earliest effective filing date of the application is September 7, 2023.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d), filed on September 7, 2023.
Election/Restrictions
Claims 1 – 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 2, 2025.
Applicant’s election without traverse of Group II, claims 17 – 23, in the reply filed on December 2, 2025 is acknowledged.
Status of Application
The Response to Restriction Requirement has been acknowledged. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 23
Withdrawn claims: 1 – 16
Claims currently under examination: 17 – 23
Claim Objections
Claims 17 and 18 are objected to because of the following informalities:
Claim 17 recites “the protein food material having a fibrous region…” which should be “wherein the protein food material has a fibrous region…”.
Claim 18 recites “0.5 number/mm2” which should be “0.5 voids/mm2” according to the context of the claim language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites “a standard deviation a value” which renders the claim indefinite. There is no definition or clarification to what “value” is being measured and evaluated to determine the standard deviation in claim 22. Any value could be measured at the recited data collection points. For the purpose of examination, “a standard deviation of a value” is interpreted to mean “a standard deviation of the percentage of the number of voids having a cross-sectional area of 0.1 mm2 or less in the cross section parallel to the direction orthogonal to the fiber direction” as measured within the precisely claimed parameters.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 17 – 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gwiazda et al. (Microstructural Studies on Texturized Vegetable Protein Products: Effects of Oil Addition and Transformation of Raw Materials in Various Sections of a Twin Screw Extruder. National food Research Institute, Yatabe, Tsukuba Ibaraki, Japan 305. Food Microstructure. (USA), 1987 Vol. 6, pp. 57-61, Scanning Microscopy lnternational, Chicago (AMF O'Hare) , IL 60666 USA – IDS Filed on August 28, 2025).
Regarding claim 17, Gwiazda teaches a texturized protein product (i.e., a protein food material) comprising defatted soybean meal comprising 55% crude protein (i.e., vegetable protein) and 10.5% moisture (p. 58, paragraph 2). Gwiazda teaches the texturized protein product is extrusion-cooked, resulting in well-aligned fiber-like structures within the texturized protein product (i.e., the protein product has a fibrous region in at least a part thereof – p. 58, paragraph 8). Gwiazda teaches the texturized protein product comprises air cells within the fibrous structure (i.e., the protein food material has a porous structure – p. 58, paragraph 8).
With respect to the limitation that the protein food material has “a percentage of a number of voids having a cross-sectional area of 0.1 mm2 or less in a cross section parallel to a direction orthogonal to a fiber direction is 50% or more with respect to a number of all voids present in the cross section”, the instant specification states microvoids form a dense porous structure, for example, in a cross section parallel to a direction orthogonal to the fiber direction, a percentage of the number of voids having a cross-sectional area of 0.1 mm2 or less to the number of all voids present in the cross section is 50% or more ([0054]). The small and dense voids in the porous structure are correlated with the fibrous texture imitating livestock meat and the chewy texture ([0054]). Therefore, it is interpreted “the cross section parallel to a direction orthogonal to a fiber direction” is a cross section of the protein food material that is sliced “against the grain” of the protein food material. In other words, it is sliced orthogonal to the protein food material fibers, and the resulted cross section is evaluated. Such a cross section is illustrated below for clarity of the record:
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Gwiazda shows sample crosswise (i.e., orthogonal) sections of the texturized protein product (i.e., a protein food material) in Figure 4, samples E – H shown below (with added 0.1 mm2 scale example):
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Gwiazda teaches the fibers are stained (they are black), therefore the pores (i.e., voids) are white in the figure above. By comparing the area of the white pores (i.e., voids) in the samples E – H to the exemplary 0.1 mm2 square, it is determined that 50% or more of the total pores (i.e., voids) in the crosswise sections of the texturized protein products E – H (i.e., a protein food material) have a cross-sectional area of 0.1 mm2 or less.
With respect to the limitation that the protein food material has “an average thickness of a wall separating the voids from each other is 200 μm or less”, attention is drawn to the scale indicator of 500 µm at the bottom right of the Figure 4 of Gwiazda above. The average thickness of a wall separating the voids from each other is 200 μm or less in the texturized protein product (i.e., a protein food material) of Gwiazda.
While Gwiazda does not explicitly state the texturized protein product (i.e., a protein food material) has the precisely claimed pore (i.e., void) size and distance between voids, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Gwiazda is silent with respect to the pore (i.e., void) size and distance between voids in the texturized protein product (i.e., a protein food material) does not render novel the previously unappreciated characteristics of the texturized protein product (i.e., a protein food material) of Gwiazda.
Regarding claim 18, attention is drawn to the scale indicator of 500 µm at the bottom right of the Figure 4 of Gwiazda above. The number of pores (i.e., voids) in the crosswise sections of the texturized protein products E – H (i.e., a protein food material) is inherently greater than 0.5 voids/ mm2.
Regarding claim 19, with respect to the limitation that the protein food material has “an average value of ratios of a length of a major axis to a length of a minor axis of the voids present in a cross section parallel to the fiber direction of the protein food material is 2 or more”, the instant specification states among the points constituting the outline of the void, two points having the longest distance there between are selected, a line segment connecting the two points is defined as a major axis, and a length of the line segment is defined as a length of the major axis ([0096]). Among straight line groups orthogonal to the major axis line, a straight line group having two or more intersections with the contour of the void is defined as a minor axis group ([0096]). In the minor axis group, a straight line having the longest distance between the most distant intersections is selected as a minor axis line ([0096]). A line segment connecting an intersection of the minor axis line and two points farthest from each other on the contour of the void is defined as a minor axis, and a length thereof is defined as a length of the minor axis of the void ([0096]). The aspect ratio of the void is calculated using the following equation: Aspect ratio of void = Length of major axis of void/Length of minor axis of void ([0096]). According to the description of the major and minor axis lengths above, an illustration is provided below to add clarity to the record:
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Therefore, “an average value of ratios of a length of a major axis to a length of a minor axis of the voids present in a cross section parallel to the fiber direction of the protein food material is 2 or more” is interpreted to indicate that the voids are, on average, at least twice as long as they are wide in a lengthwise section (i.e., a cross section that runs parallel to the fibers).
Gwiazda shows sample lengthwise (i.e., parallel) sections of the texturized protein product (i.e., a protein food material) in Figure 4, samples A – D shown below (with exemplary void that has a ratio of major axis length to minor axis length of 2):
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Gwiazda teaches the fibers are stained (they are black), therefore the pores (i.e., voids) are white in the figure above. Therefore, by comparing the length and width of the (i.e., voids) in the samples A – D to the exemplary void with a ratio of major axis length to minor axis length of 2, it is determined that the pores (i.e., voids) in present in a cross section parallel to the fiber direction of the texturized protein products A – C (i.e., a protein food material) inherently have an average value of ratios of a length of a major axis to a length of a minor axis of 2 or more.
Regarding claim 20, Gwiazda teaches after extrusion cooking, the texturized protein products observed in lengthwise sections show well aligned fiber-like structures (p. 58, paragraph 8; Figure 4, Samples A – D). Figure 4, samples A – D is shown below with exemplary 30° angle:
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Given the pores (i.e., voids) in samples A – C of Figure 4 of Gwiazda above are highly aligned, the average angle between the major axes of the pores (i.e., voids) is below 30 °.
Regarding claim 21, the recitation “wherein a degree of orientation XA/XB satisfies 1.005 ≤ XA/XB, in which, in an infrared absorption spectrum obtained by measuring the fibrous region by a polarized infrared total reflection absorption measurement method, XA is an intensity ratio of a peak intensity of an amide I band to a peak intensity of an amide II band measured by irradiating the fibrous region with polarized light parallel to the fiber direction of the fibrous region, and XB is an intensity ratio of a peak intensity of an amide I band to a peak intensity of an amide II band measured by irradiating the fibrous region with polarized light perpendicular to the fiber direction of the fibrous region”, is a recitation of how a property of the composition of claim 17 is measured. In this case, the instant specification states the fact that the degree of orientation XA/XB in the fibrous region satisfies 1.005 ≤ XA/XB means that the protein (that is, the protein fibers) included in the fibrous region is highly oriented ([0108]). Therefore, the recitation above is interpreted to indicate the fibrous region is highly oriented (i.e., well aligned).
Gwiazda teaches after extrusion cooking, the texturized protein products observed in lengthwise sections show well aligned fiber-like structures (p. 58, paragraph 8; Figure 4, Samples A – D).
Therefore, while Gwiazda does not explicitly state the texturized protein product (i.e., a protein food material) has a degree of orientation XA/XB satisfies 1.005 ≤ XA/XB, in which, in an infrared absorption spectrum obtained by measuring the fibrous region by a polarized infrared total reflection absorption measurement method, XA is an intensity ratio of a peak intensity of an amide I band to a peak intensity of an amide II band measured by irradiating the fibrous region with polarized light parallel to the fiber direction of the fibrous region, and XB is an intensity ratio of a peak intensity of an amide I band to a peak intensity of an amide II band measured by irradiating the fibrous region with polarized light perpendicular to the fiber direction of the fibrous region, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Gwiazda is silent with respect to the degree of orientation XA/XB of the texturized protein product (i.e., a protein food material) does not render novel the previously unappreciated characteristics of the texturized protein product (i.e., a protein food material) of Gwiazda.
Regarding claim 22, Gwiazda teaches the texturized protein product (i.e., a protein food material) is produced by kneading defatted soybean meal (i.e., vegetable protein), and soybean oil (p. 58, paragraph 2); then extruding the kneaded mixture through a twin screw extruder at 180 °C (p. 58, paragraph 4). Gwiazda teaches after extrusion cooking, the texturized protein products observed in lengthwise sections show well aligned fiber-like structures (p. 58, paragraph 8; Figure 4, Samples A – D).
While Gwiazda does not explicitly state the texturized protein product (i.e., a protein food material) has a standard deviation of the percentage of the number of voids having a cross-sectional area of 0.1 mm2 or less in the cross section parallel to the direction orthogonal to the fiber direction, as measured within the precisely claimed parameters, the instant specification states protein food material is produced by kneading a protein-containing mixture containing a vegetable protein and water by pressurizing and heating the protein-containing mixture in an extrusion section of a twin screw extruder; and after kneading, extruding the kneaded protein-containing mixture at a temperature of from 150°C to lower than 180°C in an outlet of the extrusion section while swelling the kneaded protein-containing mixture inside a discharge die mounted at a downstream end of the extrusion section in an extrusion direction ([0008]). Therefore, because the texturized protein product (i.e., a protein food material) is produced by kneading defatted soybean meal (i.e., vegetable protein), and soybean oil; then extruding the kneaded mixture through a twin screw extruder at 180 °C, as in the method of producing the protein food material of the instant application, the texturized protein product (i.e., a protein food material) inherently has a standard deviation of the percentage of the number of voids having a cross-sectional area of 0.1 mm2 or less in the cross section parallel to the direction orthogonal to the fiber direction, as measured within the precisely claimed parameters. MPEP § 2112.01.I states where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In this case, the texturized protein product (i.e., a protein food material) of Gwiazda and the protein food material of claim 22 are produced by substantially identical processes, therefore they inherently have the same properties, including texture.
Furthermore, MPEP § 2112.I states “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer”. In this case, the fact that Gwiazda is silent with respect to whether the texturized protein product (i.e., a protein food material) has a standard deviation of the percentage of the number of voids having a cross-sectional area of 0.1 mm2 or less in the cross section parallel to the direction orthogonal to the fiber direction, as measured within the precisely claimed parameters, does not render novel the previously unappreciated precisely claimed properties of the protein food product.
Regarding claim 23, Gwiazda teaches extrusion is often utilized to produce meat analogs (i.e., molded meat alternatives) from defatted vegetable proteins (p. 57, paragraph 1). Gwiazda teaches the texturized protein product is made from defatted soybean meal (i.e., vegetable protein) and is extruded (p. 58, paragraphs 2 – 4). Therefore, the texturized protein product of Gwiazda is considered to be a molded meat alternative.
Double Patenting
Claims 17 and 21 of this application are patentably indistinct from claim 6 of Application No. 18/822,296. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
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.
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.
Claim 21 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 6 of copending Application No. 18/822,296. (reference application).
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim 17 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of copending Application No. 18/822,296 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 17 of the instant application is broader than claim 6 of the reference application 18/822,296. Therefore, claim 6 of reference application 18/822,296 anticipates claim 17 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793