Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Status of Claims
Note: The amendment of March 3rd 2026 has been considered.
Claims 2-23 have been amended.
Claim 1 is cancelled.
Claims 2-23 are pending and examined in the current application.
Any rejections not recited below have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35 of the U.S. Code not included in this action can be found in a prior Office action.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 2-15 and 17-23 are rejected under 35 U.S.C. 103(a) as being unpatentable over Rolan et al (US 2008/0268112) in view of NPL Proulx et al., “Iron Bioavailability of Hemoglobin from Soy Root Nodules Using a Caco-2 Cell Culture Model” (from J. Agric. Food Chem. 54, pp. 1518-1522) and NPL Asgar et al., "Nonmeat Protein Alternatives as Meat Extenders and Meat Analogs" (from Comprehensive Reviews in Food Science and Food Safety Vol. 9).
Regarding claims 2, 12, 13, 15, 17 and 20-23: Rolan discloses a ground uncooked meat analog comprising structural plant protein, which simulates ground beef comprising plant protein fibers aligned to simulate meat fibers (see Rolan abstract; paragraphs [0005]-[0007] and [0017]-[0018]). Moreover, Rolan discloses the ground meat analog comprises one or more non-animal proteins (e.g., gluten) (see Rolan paragraph [0027] and [0029]). Rolan also discloses that before it is cooked, the ground meat analog mimics the color texture and/or aroma of raw meat, and after it is cooked, the ground meat analog mimics the color texture and/or aroma of cooked meat (see Rolan paragraphs [0004] and [0080]-[0089]), but fails to disclose of a heme, or a plant, fungal, bacterial or algal heme- iron-containing protein, such as leghemoglobin that is added to attain a color of raw meat when uncooked and the color of cooked meat when cooked; However, Proulx discloses of using the Heme-iron containing globin, leghemoglobin, that is isolated from soybean root nodules, to successfully fortify foods, such as tortillas, with hemed-iron (see Proulx abstract). Proulx also discloses that the leghemoglobin provided a stable source of iron, and since soy root nodules are not used in agriculture production, leghemoglobin is also readily available and provides value added product for soy producers (see Proulx bottom of right column on page 1521 to top left column on page 1522). In view of the fact that beef is a known source of iron, and since the product in Rolan is a ground meat analog to be fortified with nutrients typically found in meat at desired amounts (see Rolan paragraphs [0075]-[0078] and [0099]-[0102]), it would have been obvious to a skilled artisan to have modified Rolan and to have fortified the meat analog with leghemoglobin in order to provide the consumer with a meat analog with improved nutritional value as it is fortified with iron, and also with a meat analog that is nutritionally similar to real ground meat, and thus arrive at the claimed limitations.
As to the relative amount of heme-containing protein recited in claim 2: In light of the fact that the therapeutic effect of a compound is known to be a function of dosing, and since the iron bioavailability from leghemoglobin in food matrix is also known (see Proulx whole document), it would have been obvious to a skilled artisan to modify Rolan in view of Proulx and to adjust the content of leghemoglobin in the meat analog in order to attain the desired therapeutic benefits associated with iron fortification, and thus arrive at the claimed limitations. As set forth in MPEP §2144.05, it has been held that discovering an optimum value of a result effective variable, involves only routine skill in the art.
In the alternative, in view of the fact that the iron content of leghemoglobin is known, it would have been obvious to a skilled artisan to have modified the amount of leghemoglobin added in order to meet a desired level of iron fortification, and thus arrive at the claimed limitations.
As to the sugar recited in claim 2: Rolan discloses that the ground meat analog comprises reducing sugars, such as glucose (see Rolan paragraphs [0021] and [0035]-[0037]).
As to the sulfur compound recited in claim 2: Rolan discloses adding L-cysteine (a sulfur containing amino acid) to the composition compound (see Rolan paragraph [0029]).
As to the fat replica recited in claim 2: Rolan discloses in paragraph [0097] the ground meat analog comprises a vegetable emulsion base as disclosed in Cavallini et al. (US 2006/0204644). Cavalini (a reference incorporated by reference to Rolan) discloses the emulsion base comprises plant protein and plant oil and improves texture and mouthfeel to meat analogs (see Cavallini abstract; paragraphs [0012]-[0015] and [0024]). Furthermore, Cavallini discloses the plant protein is cooked to 60°C-105°C, which renders a denatured protein (see Cavallini paragraph [0031]), which meets the claimed limitations.
Regarding claims 3-5: Rolan discloses of a ground meat analog comprising structural plant protein, which simulates ground beef comprising plant protein fibers aligned to simulate meat fibers (see Rolan abstract; paragraphs [0005]-[0007], [0017]-[0018] and [0067]-[0071]). Since skeletal muscles comprise asymmetric and isotropic fibers, Rolan meets the claimed limitations.
Regarding claims 6-7: Rolan discloses the fibers are extruded (see Rolan paragraphs [0040]-[0052]). Even though Rolan fails to disclose attaining the protein fibers by mixing (i.e., spun), it is noted that the recited corn meal product is limited and defined by process limitations, as such, the patentability of the corn meal product and not the recited process steps must be established. As set forth in MPEP §2113, “even 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). In this case, Rolan discloses of a ground meat analog comprising structural plant protein, which simulates ground beef comprising plant protein fibers aligned to simulate meat fibers (see Rolan abstract; paragraphs 20, 75-78 and 101-103). Given the fact that attaining meat like protein fibers through extruding or spinning is well known, the ground meat analog in modified Rolan appears to be either identical or similar to the ground meat analog recited in the claims.
In the alternative, any slight differences in the composition as a result of the recited process steps would have been obvious to one of ordinary skill in the art and well within the ordinary level of skill to have produced. Modifications to a well-established process that are minor is considered well within the realm of ordinary skill.
Regarding claims 8-10: Rolan discloses in paragraph [0097] the ground meat analog comprises a vegetable gel as disclosed in Cavallini et al. (US 7,070,827 B2). Cavalini (a reference incorporated by reference to Rolan) discloses the vegetable gel (i.e., carrageenan gel) is mixed with oil (see Cavallini column 2, lines 25-49).
Regarding 11: Rolan discloses the fibers comprise a cross-linking enzyme or are stabilized by protein crosslinks (see Rolan paragraph [0022]).
Regarding claim 14: Rolan discloses that the ground meat analog comprises from 40% to 100% plant protein material (see Rolan paragraphs 24-25), but Rolan and Cavallini fail to disclose the relative amounts of the meat replica and flavored emulsion or gel, Rolan discloses including the flavored emulsion and/or flavored gel in Cavallini to the ground meat analog (see Rolan paragraph [0097]. Given the fact the ground meat analog in Rolan simulates real ground meat that emulates meat fibers (see Rolan paragraphs [0005]-[0007] and [0017]-[0018]), with the added flavored emulsion and/or gel from Cavallini (see Rolan paragraphs [0097]) it would have been obvious to a skilled artisan at the time the application was filed to have adjusted the relative contents of the ground meat analog fibers from Rolan with the flavored emulsion and/or gel from Cavallini in order to closely emulate real ground meat, and thus arrive at the claimed limitations.
Regarding claim 15: Rolan discloses the ground meat analog comprises one or more non-animal proteins (e.g., gluten) (see Rolan paragraph [0027])
Regarding claim 18: Rolan discloses of using wheat germ oil in the ground meat analog (see Rolan paragraph [0095]).
Regarding claim 19: Rolan discloses that the ground meat analog comprises structural plant protein and optionally animal protein from animal sources (e.g., meat, dairy) (see Rolan abstract; paragraphs [0019]-[0020]). Since the desire to provide consumers with food products comprising only vegetable based ingredients without any animal based ingredients for dietary and/or religious reasons, is well known (see Asgar page 514, left column; page 520, right column), it would have been obvious to a skilled artisan at the time the invention was made to have modified Rolan and to have used proteins from non-animal sources in order to appeal to consumers who desire foods comprising non-animal ingredients, and thus arrive at the claimed limitations.
Claim 16 is rejected under 35 U.S.C. 103(a) as being unpatentable over Rolan et al., Proulx et al., and Asgar et al. and further in view of NPL Mallika et al., “Low Fat Meat Products – An Overview”. (from Veterinary World Vol. 2(9): 364-366).
Regarding claim 16: Rolan discloses a ground meat analog comprising structural plant protein, which simulates ground beef comprising plant protein fibers aligned to simulate meat fibers (see Rolan abstract; paragraphs [0005]-[0007] and [0017]-[0018]), but fails to disclose connective tissue analogs; However, Mallika discloses that konjac gels can be used as connective tissue replacers as konjac gels stimulate the sensory properties and appearance of hardened fat and connective tissue in the mouth (see Mallika page 365, right column). Therefore, it would have been obvious to a skilled artisan at the time the application was filed to have modified Rolan and to have used konjac gels as connective tissue replicas, as konjac gels stimulate the sensory properties and appearance of connective tissue, and thus arrive at the claimed limitations.
Response to Arguments
Applicant's arguments filed on March 3rd 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 6-7 of the “Remarks” that the prior art references fail to render the claimed invention obvious, because the prior art references fail to disclose of an uncooked meat replica. The examiner respectfully disagrees.
Rolan discloses a ground uncooked meat analog (see Rolan paragraphs [0081] and [0082]), which meets the claimed limitations.
Moreover, while Rolan discloses the plant proteins where heated to be denatured, the ground meat analog as a whole was never cooked, as evidenced by paragraphs [0081] and [0082] Rolan. Since cooking an ingredient before it is introduced into the a final product, does not equate to cooking the final product (i.e., a cooked final product), the prior art references render the claimed invention obvious.
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 ASSAF ZILBERING whose telephone number is (571)270-3029. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ASSAF ZILBERING/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792