DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 121 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 121 recites “wherein the meat replica is a taco filling, a casserole, a sauce, a topping, soup, stew or a loaf.” The present specification states the meat replica can be a ground tissue replica wherein the ground tissue replica can be used in a variety of dishes such as taco filling, casseroles, sauces, toppings, soups, stews, or loaves. There is no support to claims the meat replica is a taco filling, a casserole, a sauce, a topping, soup, stew or a loaf.
Claim 127 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.
Regarding claim 127, the recitation “wherein upon cooking of the meat replica, at least two volatile compounds are generated that are associated with a beef-like aroma” renders the claim indefinite. Given a sugar and an amino acid are required to generate the claimed volatile compounds by heating, since the composition of claim 105 does not require a sugar or an amino acid, it is not clear how the volatiles develop.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 105-120 and 122-128 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cavallini et al. (US 2005/0003071) in view of Proulx et al. (Iron Bioavailability of Hemoglobin from Soy Root Nodules Using Caco-2 Cell Culture Model”, J. Agricultural and Food Chemistry, 54 (4), (February 2006), pp. 1518-1522 – IDS filed October 30, 2024) and Cammack et al. (“Nitrite and nitrosyl compounds in food preservation”, Biochimica et Biophysica Acta, 1411, (1999), pp. 475-488).
Regarding claims 105, 107-109, 113 and 116, Cavallini et al. disclose a meat analog comprising methyl cellulose, modified gluten, vegetable protein (i.e., plant protein), oil, modified food starch and flavoring ([0012]-[0016]).
Cavallini et al. is silent with respect to a heme-containing protein and a nitrite.
Proulx et al. teach a method of fortifying foods, such as tortillas, with iron using purified leghemoglobin isolated from soybean root nodules, wherein the method comprises the steps of: (a) adding leghemoglobin in lyophilized form to masa harina; (b) mixing the combination by shaking for 2 minutes; (c) reconstituting the masa harina mixture with water in a ratio of 1:2 to form a dough (i.e. a food product); (d) weighing out 25 g. portions of the dough; (e) flattening the 25 g. portions of dough with a tortilla press; and (f) frying at 200ºC on a Teflon pan (p. 1519/Tortilla Preparation). Proulx et al. disclose the adding of 50 ppm iron (i.e. 0.005%). Proulx et al. disclose the leghemoglobin used for the tortillas comprised 1.4 mg. heme iron per gram of leghemoglobin (p. 1520/Results and Discussion). Therefore, about 3.6 g. or 3.6% (w/w) of leghemoglobin is added in Proulx et al.
Cavallini et al. and Proulx et al. are combinable because they are concerned with the same field of endeavor, namely healthful foodstuff. Given Proulx et al. teach the use of leghemoglobin, isolated from soybean root nodules, to successfully fortify foods, since Cavallini et al. disclose a food product, i.e., meat analog, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have added leghemoglobin to the meat analogue of Cavallini et al. to fortify the product with iron.
Cammack et al. teach adding nitrite to foods (Abstract, p. 476/1. The nitrite controversy). Cammack et al. teach add nitrite is used to inhibit the development of rancid off-flavors and inhibit the growth of food spoilage bacteria, including Clostridium botulinum.
Cavallini et al. and Cammack et al. are combinable because they are concerned with the same field of endeavor, namely food compositions. It would have been obvious to one of ordinary skill in the art to have added nitrite to the meat analog of Cavallini et al. as modified by Proulx et al. to inhibit rancid flavor development and bacterial spoilage.
Regarding claim 106, modified Cavallini et al. disclose all of the claim limitations as set forth above. Proulx et al. teach l leghemoglobin isolated from soybean root nodules. Given Proulx et al. teach leghemoglobin, inherently it would having an amino acid sequence with at least 70% sequence identity to the amino acid sequence set forth in SEQ ID NO. 1.
Regarding claims 110-112, modified Cavallini et al. disclose all of the claim limitations as set forth above. While Proulx et al. teach a food product, i.e., tortilla, with 3.6 g. or 3.6% (w/w) added leghemoglobin, the reference is silent with respect to added lower amounts.
However, given Proulx et al. teach heme iron from plant sources, i.e. leghemoglobin, provides bioavailable iron as food fortifier (Abstract), the skilled artisan would have been motivated to adjust, in routine processing, the amount of leghemoglobin to add to the meat analog of Cavallini et al. based on a desired dosing.
Regarding claim 114, modified Cavallini et al. disclose all of the claim limitations as set forth above. Cavallini et al. disclose wherein the vegetable protein is soy protein isolate (i.e., legume protein) and vital wheat gluten ([0009], [0024]).
Regarding claim 115, modified Cavallini et al. disclose all of the claim limitations as set forth above. Given Cavallini et al. disclose soy protein and gluten, the limitations of claim 115 are satisfied.
Regarding claim 117, modified Cavallini et al. disclose all of the claim limitations as set forth above. Cavallini et al. disclose a meat analog composition comprising 3-10% of gluten and 10-20% by weight of soy protein ([0033]-[0034]). In the 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).
Regarding claims 118 and 120, modified Cavallini et al. disclose all of the claim limitations as set forth above. Cavallini et al. disclose wherein the flavoring ingredients include sucrose and salt (i.e., sodium chloride).
Regarding claim 119, modified Cavallini et al. disclose all of the claim limitations as set forth above. Given Cavallini et al. disclose a meat analog comprising vegetable protein wherein the vegetable protein is a combination of soy protein and gluten ([0024]), inherently the composition comprises a sulfur compound selected from methionine and cysteine. Methionine and cysteine naturally occur in gluten and soy proteins.
Regarding claim 122, modified Cavallini et al. disclose all of the claim limitations as set forth above. Cavallini et al. disclose wherein the meat analog is a sausage product (Abstract, [0029], [0042]-[0044]).
Regarding claims 124-26, modified Cavallini et al. disclose all of the claim limitations as set forth above. Cavallini et al. disclose the meat analog comprises oil is any vegetable oil including soybean oil, canola oil, corn oil or peanut oil ([0024]). Here, the oil is considered a replica of adipose tissue. Cavallini et al. disclose the oil incorporated with other ingredients to make an emulsion (i.e., emulsified- [0023]).
Regarding claims 127 and 128, modified Cavallini et al. disclose all of the claim limitations as set forth above. Given the combination of Cavallini et al., Proulx et al. and Cammack et al. result in the claimed composition, inherently, wherein upon cooking of the meat analog at least two of the claimed volatiles, associated with a beef-like aroma, would be generated.
Claim 123 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cavallini et al. (US 2005/0003071) in view of Proulx et al. (Iron Bioavailability of Hemoglobin from Soy Root Nodules Using Caco-2 Cell Culture Model”, J. Agricultural and Food Chemistry, 54 (4), (February 2006), pp. 1518-1522 – IDS filed October 30, 2024) and Cammack et al. (“Nitrite and nitrosyl compounds in food preservation”, Biochimica et Biophysica Acta, 1411, (1999), pp. 475-488) as applied to claim 105, and further in view of Yamada (US 4,863,749).
Regarding claim 123, modified Cavallini et al. disclose all of the claim limitations as set forth above. While Cavallini et al. disclose wherein the meat analog is a sausage product (Abstract, [0029], [0042]-[0044]), the reference is silent with respect to a smoked or dehydrated sausage.
Yamada teaches an all-vegetable meat analog that resembles a sausage (C2/L22-26). Yamada teaches a meat analog sausage having the flavor of a smoked sausage (C12/L15-35).
Cavallini et al. and Yamada are combinable because they are concerned with the same field of endeavor, namely vegetable based meat analog compositions. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have made the meat analog sausage of Cavallini et al. smoked flavored because Yamada teaches smoked flavored all vegetable meat analog sausages were known. Moreover, one of ordinary skill in the art could have chosen to flavor the meat analog sausage of Cavallini using any desired flavor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759
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