DETAILED ACTION
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 Response and Amendment after Non-Final Office Action filed 08/20/2025 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: (1) the objections to claims 2 and 3 have been withdrawn; (2) the 35 U.S.C. §112(a) rejections of claims 18, 21, 24, 28, and 31 have been withdrawn; (3) the 35 U.S.C. §112(b) rejections of claims 1-24, 26, and 28-32 have been withdrawn; (4) the 35 U.S.C. §103 of claims 1-4, 6-20, 26, and 29-32 over Ajami have been withdrawn; and (5) the 35 U.S.C. §103 of claim 5 over Ajami and Häkämies has been withdrawn;.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 33-50
Withdrawn claims: None
Previously cancelled claims: 25, 27
Newly cancelled claims: 1-24, 26, 28-32
Amended claims: None
New claims: 33-50
Claims currently under consideration: 33-50
Currently rejected claims: 33-50
Allowed claims: None
Claim Objections
Claims 37, 41, 46, and 49 are objected to because of the following informalities:
In claim 37, “wherein the composition further comprises a a high moisture meat analogue” should be read as “wherein the composition further comprises a high moisture meat analogue”.
In claim 41, “The plant-based meat composition of claim 33, wherein the composition, wherein the unsaturated fat” should be read as “The plant-based meat composition of claim 33, wherein the unsaturated fat”.
In claim 46, “barley rice protein” should be read as “barley, rice protein”.
In claim 49, “The plant-based protein composition of claim 33, is the shape of a burger patty, a sausage, a pepeeroni” should be read as “The plant-based protein composition of claim 33, wherein the composition is in the shape of a burger, a sausage, a pepperoni”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33-36 and 38-50 are rejected under 35 U.S.C. 103 as being unpatentable over Ajami (US 2021/0259290; previously cited).
Regarding claim 33, Ajami teaches a plant-based meat composition (corresponding to a meat-like food product containing about 2% to about 80% plant protein) [0106] comprising: about 1 wt.% to about 10 wt.% of an encapsulated formulation (corresponding to agent release system in the form of a lipogel), wherein the encapsulated formulation comprises unsaturated fat (corresponding to oil) and glucose-based polymer (corresponding to carbohydrate polymer networks, polysaccharides, fiber, and starch) [0127], [0199], [0203]. This disclosed content of encapsulated formulation in the composition encompasses the claimed concentration. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I.
In regard to the encapsulated formulation being a spray-dried powder, Ajami teaches that the formulation may be sprayed in dried form into the plant-based meat composition [0237], which means that the formulation is in a powdered form. However, it is noted that claim 33 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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). MPEP §2113.I. Since the claimed spray-dried encapsulated formulation is the same as the powder encapsulated formulation disclosed in Ajami, the patentability of the claimed plant-based meat composition is not dependent on the method of producing the encapsulated formulation.
Ajami teaches that the encapsulated formulation is a lipogel comprising the fat in combination with the glucose-based polymer [0203] and a protein stabilizer [0201], wherein the encapsulated formulation comprises at least about 45 wt.% unsaturated fat [0132], [0203], at least about 30 wt.% glucose-based polymer [0199], and about 10 wt.% to about 20 wt.% protein stabilizer [0201]. Therefore, the encapsulated formulation comprises unsaturated fat in an amount of about 45 wt.% to about 60 wt.% and glucose-based polymer in an amount of about 30 wt.% to about 45 wt.%, which fall within the claimed concentrations of unsaturated fat and glucose-based polymer. Ajami teaches that the plant-based meat composition also comprises plant-based protein derived from one or more non-animal sources in an amount of about 10 wt.% to about 35 wt.% [0106], [0122]-[0123]; and saturated fat in an amount less than about 7 wt.% [0107], which fall within the claimed concentrations of plant-based protein and saturated fat.
Regarding claims 34 and 35, Ajami teaches the invention as described above in claim 33, including the composition contains about 2 wt.% to about 10 wt.% monounsaturated fats [0107]; therefore, the total amount of unsaturated fat in the composition is about 2 wt.% to about 10 wt.%, which falls within the claimed concentrations recited in present claims 34 and 35.
Regarding claim 36, Ajami teaches the invention as described above in claim 33, including the composition further comprising a fat (corresponding to the lipids in the lipogel) [0203], a color [0111], a flavor (page 42, claim 101), and/or texturant (corresponding to texturizing agents) [0186].
Regarding claim 38, Ajami teaches the invention as described above in claim 33 including the amount of water in the composition is about 30 wt.% to about 60 wt.% [0110], which falls within the claimed concentration.
Regarding claims 39 and 40, Ajami teaches the invention as described above in claim 33, including the unsaturated fat is sunflower oil [0203].
Regarding claim 41, Ajami teaches the invention as described above in claim 33, including the unsaturated fat comprises vitamin A, vitamin D, vitamin E, tocopherol, tocotrienols, vitamin K [0251], and/or beta-carotene [0252].
Regarding claim 42, Ajami teaches the invention as described above in claim 33, including the encapsulated formulation is a lipogel comprising lipids and glucose-based polymer or protein matrix [0199]-[0201], [0203]. Therefore, Ajami teaches that the encapsulated formulation may contain 0 wt.% water, which falls within the claimed concentration.
Regarding claim 43, Ajami teaches the invention as described above in claim 33, including the encapsulated formulation comprises about 15 wt.% to about 20 wt.% carbohydrate polymer networks [0199] and about 10 wt.% to about 20 wt.% protein, fiber, and/or starch [0201]; therefore, the content of glucose-based polymer and protein matrix in the encapsulated formulation is about 25 wt.% to about 40 wt.%, which falls within the claimed concentration. Ajami teaches that the encapsulated formulation is a lipogel comprising the fat in combination with the glucose-based polymer [0203]. Since the content of glucose-based polymer in the encapsulated formulation is about 25 wt.% to about 40 wt.%, the content of unsaturated fats in the encapsulated formulation is about 60 wt.% to about 75 wt.%, which falls within the claimed concentration of unsaturated fat. Since Ajami discloses a concentration of unsaturated fats and a concentration of glucose-based polymer and protein matrix which fall within the concentrations recited by claim 33, Ajami at least suggests that the bulk density of the encapsulated formulation includes a range of values which overlaps the claimed bulk density. The selection of a value within the overlapping range renders the claimed bulk density obvious. MPEP §2144.05.I.
Regarding claim 44, Ajami teaches the invention as described above in claim 33, including the glucose-based polymer comprises starch and/or cellulose [0199]-[0201].
Regarding claim 45, Ajami teaches the invention as described above in claim 33, including the glucose-based polymer comprises modified food starch and/or maltodextrin [0200].
Regarding claim 46, Ajami teaches the invention as described above in claim 33, including the plant-based protein comprises pea protein [0107], soy protein, oat protein, canola protein, rice protein, and/or fava bean protein [0123].
Regarding claim 47, Ajami teaches the invention as described above in claim 33, including the plant-based protein comprises pea [0107], soy, fava bean, lentil, chickpeas, beans, and/or algae [0123].
Regarding claim 48, Ajami teaches the invention as described above in claim 33, including the composition contains about 10 wt.% to about 20 wt.% protein [0106]; about 30 wt.% to about 60 wt.% water [0110]; and about 3 wt.% to about 10 wt.% of the encapsulated formulation. These disclosed contents of protein and water fall within the claimed concentrations while this disclosed content of encapsulated formulation overlaps the claimed concentration. The selection of a value within the overlapping range renders the claimed concentration obvious. MPEP §2144.05.I.
Regarding claim 49, Ajami teaches the invention as described above in claim 33, including the composition is in the shape of a burger patty [0099], sausage [0102], and/or bacon (corresponding to thin strips) [0121].
Regarding claim 50, Ajami teaches the invention as described above in claim 33, including the composition comprises 0 g saturated fat per serving (corresponding to the meat-like food products having no unhealthy saturated fat) [0100], which falls within the claimed concentration.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Ajami (US 2021/0259290; previously cited) as applied to claim 33 above, and further in view of Häkämies (WO 2022/229500; previously cited).
Regarding claim 37, Ajami teaches the invention as described above in claim 33, including the plant-based meat composition further comprising other plant-derived protein products and delivering active ingredients such as vitamins, minerals, and nutrients [0104]. Ajami does not teach that the composition further comprises a high moisture meat analogue containing protein co-extruded with macro- and/or micronutrients and additives.
However, Häkämies teaches an extruded meat analogue food ingredient (page 5, lines 20-24) containing plant protein, iron, vitamins (page 5, line 29- page 6, line 11), salt, and spices (page 5, lines 20-24). Häkämies teaches that the meat analogue food ingredient is a high moisture meat analogue (page 16, lines 8-11). Therefore, Häkämies teaches an extruded high moisture meat analogue comprising protein, macro and/or micronutrients (corresponding to iron and vitamins), and additives (corresponding to salt and spices).
It would have been obvious for a person of ordinary skill in the art to have modified the plant-based meat composition of Ajami to include the high moisture meat analogue of Häkämies. Since Ajami teaches that its composition further comprises other plant-derived protein products and delivers active ingredients such as vitamins, minerals, and nutrients [0104], but does not disclose a source of the additional plant-derived protein product comprising such active ingredients, a skilled practitioner would have been motivated to consult an additional reference such as Häkämies in order to determine a suitable plant-derived protein product, thereby rendering the claimed extruded high moisture meat analogue comprising protein, macro and/or micronutrients and additives obvious. Although the cited combination of prior art does not teach that the high moisture meat analogue was co-extruded, the claim merely requires the analogue to be an extruded product as specifying the type of extrusion as being co-extrusion is not considered to meaningfully limit the product claim.
Response to Arguments
Claim Objections: Applicant canceled the claims; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §112(a) of claims 18, 21-24, 28, and 31: Applicant canceled the claims; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §112(b) of claims 1-24, 26, and 28-32: Applicant canceled the claims; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-4, 6-20, 26, and 29-32 over Ajami; claim 5 over Ajami and Häkämies: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant canceled claims 1-24, 26, and 28-32. Applicant argued that the claimed encapsulated formulation is critical to the claimed invention in that the formulation mimics the functionality of saturated fat in the plant-based meat composition. Applicant argued that the Examiner is not properly considering the “spray-dried powder” characteristics of the claimed encapsulated formulations as the claimed encapsulated formulations maintain their powder characteristics, even when in contact with the other components of the plant-based meat composition. Applicant argued that compositions not in spray-dried powder form are not within the scope of the claimed invention. Applicant argued that the Examiner’s rationale regarding the lipogels of Ajami corresponding to the claimed encapsulated spray-dried powder formulation does not supporting maintaining the rejection. Applicant argued that the Examiner has used the Applicant’s specification to engage in impermissible hindsight (Applicant’s Remarks, pages 5-7, section labeled “35 U.S.C. § 103 Rejections”).
However, the rejections of claims 1-24, 26, and 28-32 are moot due to Applicant’s cancellation of the claims. In the rejections of new claims 33-50, Ajami is still used as a primary reference. Claim 33 recites the same spray-dried encapsulation formulation that was previously recited in claim 1. As described above in the rejection of new claim 33, in regard to the encapsulated formulation being a spray-dried powder, Ajami teaches that the formulation may be sprayed in dried form into the plant-based meat composition [0237], which means that the formulation is in a powdered form. However, it is noted that claim 33 is a product-by-process claim and “even though product-by-process claims are limited by and defined by the process, determination of patentability is based upon 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). MPEP §2113.I. Since the claimed spray-dried encapsulated formulation is the same as the powder encapsulated formulation disclosed in Ajami, the patentability of the claimed plant-based meat composition is not dependent on the method of producing the encapsulated formulation.
It is also noted that the present claims do not require the encapsulated formulation to have any particular rheological characteristics. The present specification does not disclose the spray dried encapsulated formulation to have any specific rheological properties. The present specification also does not compare the spray dried encapsulated formulation powder to a non-spray-dried encapsulated formulation powder; the present specification merely compares a liquid unsaturated oil with an encapsulated formulation powder which may or may not have been formed by spray drying as the examples do not specify the method of producing the encapsulated formulations (specification [0069]). Therefore, Applicant has not demonstrated that the claimed spray-dried powder is any different than the dried powder of Ajami. Furthermore, any asserted rheological characteristics that the spray-dried powder has may not be necessarily observed in the claimed overall plant-based meat composition since the spray-dried powder would be interacting with the other ingredients in the composition such as the moisture. Applicant has not provided evidence to the contrary. Therefore, Applicant has not demonstrated criticality of spray drying the encapsulated formulation so Applicant’s arguments directed to such criticality are unpersuasive. As such, claims 33-36 and 38-50 are rejected over Ajami and claim 37 is rejected over the combination of Ajami and Häkämies as written herein.
In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kelly Kershaw whose telephone number is (571)272-2847. The examiner can normally be reached Monday - Thursday 9:00 am - 4:00 pm.
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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791