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 .
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 .
Claim Objections
Claims 6 and 18 are objected to because of the following informalities: claim 6 lists the option “soy milk” twice. In claim 18, the option “oil” is listed twice. 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.
Claims 4, 5, 6, 7, 8, 9 and 14 are 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 claims 5-7, claim 4 recites “dairy product” which implies that the materials following must be dairy. However, claim 6 lists milk beverages that include dairy substitutes, such as soy, almond, goat, sheep and rice milks. Thus, the term “dairy” as used in claim 4 is not entirely clear due to the inconsistency of the options listed in the claims that depend therefrom. Furthermore, it is not clear if foods such as a protein shake, tea and coffee require the presence of dairy or if dairy substitutes are within the scope of the claims. Claims 7-9 are included as they depend from claim 4. For the purpose of examination, the dairy product referenced in claim 4 is considered to also include dairy substitutes consistent with claim 6.
Claim 14 recites the limitation "said candy" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-11, and 14-16 of U.S. Patent No. 11,918,019. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent, specifically claim 5, are drawn to a food or beverage comprising a food component where the food component and the food or beverage of instant claim 1 is identical.
Regarding claims 2-20, claims 6-11 of ‘019 indicate a wide variation of food or beverages including the food component of claim 1 which meet or render obvious the instantly claimed foods or beverages. The ‘019 patent claims include cheese, milk beverages, yoghurt, cream, whipped cream, ice cream, butter, meat analogues, oil in water emulsions, oat milks and almond milks or general plant-based milks. The claims also include fruit as the food or beverage comprising the identical food component. It would have been obvious to form a food comprising any of those listed in the claims of the ‘019 patent or any species thereof based upon the indication in the patent claims that a wide variety of foods and beverages may be formed that comprise the specific bacterial component.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21 and 22 of copending Application No. 18/422,021 in view of US 2019/0069575 (Shigeta).
Instant claim 1 and claim 1 of ‘021 are essentially the same scope but for the limitation of wherein at least 50wt% of the cells of the at least one bacterium of the food or beverage are intact cells. Shigeta discloses a food product comprising a single-cell organism that may be bacterial in origin. The unicellular organism may be non-processed such that the cell membrane/wall are intact [0038-0039]. The whole cell product may contain greater than or equal to about 40%, 50%, 60%, 70%, 80%, 90%, or more whole cells by weight [0080]. It would have been obvious to modify the food of the claims of the ‘021 application to provide the cells as whole cells in amounts up to 90wt% as taught by Shigeta as Shigeta clearly teaches that the cells may be lysed or whole, thus indicating that either alternative is useful for addition to food products and would have been obvious to one of ordinary skill to use.
This is a provisional nonstatutory double patenting rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0352672 (Fruchtl).
Fruchtl discloses a protein-rich supplement with useful application for intake by animals and humans (abstract). In Example 4, Clostridium ljungdahlii was grown in a bioreactor with syngas. Cell culture was centrifuged at 4,000 RPM to remove culture medium. Pellets were collected and allowed to dry in an oven at 100 C overnight. 100 grams of crushed, dried pellet was sent for analysis using the same tests for carbohydrates and protein as described in Example 3. Table 6 indicates that up to 80% of cell mass is protein. Heating at 100C overnight would be expected to kill the cells, thus resulting in at least 50% of a total number of cells are dead cells. The proteins are grown and centrifuged, which is not expected to lyse any of the cells, thus at least 50wt% of the cells are reasonably expected to be intact. As noted in the footnote of Table 6, the samples contained no more than 3% nucleic acid [0231, Table 6].
Regarding claim 2, Fruchtl gives examples of foods such as consumable goods, including baked goods, soups, prepackaged meals, smart food and diet foods [217].
Claim(s) 1-9, and 15-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2024/0057652 (Hwang) (relying on provisional priority date of 10/07/2019).
Regarding claims 1, 17, 19 and 20, Hwang discloses food compositions for humans comprising a Methylococcus capsulatus protein isolate or whole cell product, wherein the Methylococcus capsulatus protein isolate or whole cell product is composed of at least 70% crude protein. Methylococcus capsulatus protein isolates or whole cell products provided herein are useful for the manufacture of meat substitutes as well as other food compositions, such as protein bars, nutritional beverages, protein supplement powders, frozen non-dairy desserts, and baked goods. (abstract). The term “whole cell product,” “whole cell ingredient,” “whole cell protein,” “whole cell proteins,” “whole cell preparation” or the like as used herein refers to a product made from Methylococcus capsulatus biomass without undergoing a step of separating soluble proteins from other components of the biomass, especially solid components such as cell debris and/or cell wall [0147]. Thus, the whole cell material is considered to be 100% intact. Hwang discloses that the protein isolate is composed of at least 70wt% protein [0005] and the food product may contain 0.1-35wt% of the protein isolate [0017]. The comparison to a food without the bacterium cells is considered met by the disclosure of the amounts of the protein that are added to the food.
Example 16 [0256-0257] disclosed whole cell products that are heated at 90C and agaun at 60C which will inactive the cells (considered to provide 100% dead cells). The whole cell product was 3.6-4.7wt% of the total weight of the whole cell product.
Regarding claims 2-9, 15-16 and 18, the food composition is a sauce, dip, dressing, soup, vinaigrette, dairy substitute, protein shake, nutritional beverage, protein gel, or protein supplement powder. The food composition is a meat-substitute, fish/seafood-substitute, extruded snack, pudding, baked good, pasta, or chip. In yet further embodiments, the food composition is stable as an emulsion during storage at room temperature for at least 24 hours, and the food composition is a sauce, dip, dressing, soup, vinaigrette, protein shake, nutritional beverage, or dairy substitute. In yet further embodiments, the food composition has a foam overrun of at least 200%, and the food composition is a meat substitute, chip, egg replacement, or baked good. In yet further embodiments, the food composition has a solubility of at least 75% (such as at least 76%, 77%, 78%, 79% or 80%) at neutral pH, and the food composition is a sauce, dip, dressing, soup, vinaigrette, dairy substitute, protein shake, nutritional beverage, protein gel, or protein supplement powder. Examples of dairy substitutes include a non-dairy milk, non-dairy creamer, non-dairy cream, non-dairy yogurt, non-dairy whipped topping, or non-dairy ice cream. Examples of meat substitutes include a patty, meatball, crumble, sausage, jerky, loaf, filet, bacon, hot dog, or nugget [0015]. Examples of dairy substitutes include a non-dairy milk, non-dairy creamer, non-dairy cream, non-dairy yogurt, non-dairy whipped topping, or non-dairy ice cream. Examples of meat substitutes include a patty, meatball, crumble, sausage, jerky, loaf, filet, bacon, hot dog, or nugget and ready for consumption food compositions [0051-0055]. Exemplary food compositions where solubility is desirable include sauces, dips, dressings, soups, spreads, protein shakes, nutrition beverages, protein gels, dairy-free products (e.g., creamer, ice cream, milk), and protein powders [0146]. Examples of food compositions that Methylococcus capsulatus protein isolate can be used in preparation of include meat substitutes (e.g., patty, meatball, crumble, sausage, jerky, loaf, filet, bacon, hot dog, or nugget), fish/seafood substitutes (e.g., surimi, paste, fish, filet), dairy substitutes (e.g., non-dairy milk, non-dairy creamer, non-dairy cream, non-dairy yogurt, non-dairy whipped topping, and non-dairy ice cream), baked goods (e.g., meringue, crackers, cake (e.g., angel food cake), pies, pastries, cookies brownies, buns, bread, and quick bread), sauces (e.g., Hollandaise sauce), dressings, dips, spreads, mayonnaise, vinaigrettes, creamy sauces, creamy soups, butter, margarine, protein bars, extruded protein crisps, protein shakes, protein gels, and nutrition beverages. Methylococcus capsulatus protein isolate can be used in protein fortified foods (e.g., protein fortified snacks, chips, crackers, puffs, and pasta) [0151]. In certain embodiments, the Methylococcus capsulatus protein isolate or whole cell product is combined with an additional protein source, including animal-based protein, plant-based protein, and microorganism-based protein. Examples of plant-based proteins include soy, pea, rapeseed, beans (e.g., kidney, pinto, black, lentils), nuts, milk, whey, rice, wheat, and oat. Plant based proteins include hydrated and dehydrated plant-based proteins. In certain embodiments, a plant-based protein is a textured vegetable protein, such as textured soy protein. Examples of animal-based proteins include meat, egg, and milk [0188]. Addition to a strawberry puree is disclosed in [0164].
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.
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 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0352672 (Fruchtl) in view of US 2015/0374012 (Klamczynska) OR US 2019/0069575 (Shigeta).
Fruchtl discloses a protein-rich supplement with useful application for intake by animals and humans as discussed above, but does not give specific examples other than consumable goods, including baked goods, soups, prepackaged meals, smart food and diet foods. Klamczynska discloses that biomass formed may be used to provide a diet high in protein recommended to build muscle and/or lose fat [0007]. It would have been obvious to add the protein biomass of Fruchtl to a variety of foods as suggested by Klamznynska to provide the benefit of increased protein to build muscle and/or lose fat. Klamzynska also indicates that protein is added to the food product in amounts of 1-5wt% [0021].
Additionally, Shigeta disclosed a food product comprising single-cell organisms which may be a whole cell (intact) and contain 20-90wt% protein [0039, 0053]. Shigeta discloses that alternative protein sources may greatly reduce the environmental and resource impact of food production [0002]. The cell product may make up 20-90wt% of the food product [0080]. The unicellular organism-containing product may be mixed or combined with one or more flavoring agents to generate the food product. Examples of flavoring agents include yogurt, meat, meat digest, vegetable broth, rice bran, fruit, vegetable, or salt [0095]. The food product may be produced by combining a unicellular organism-containing product with one or more other ingredients [0090-0098]. The one or more other ingredients may include flour, oil, flavoring agents, preservatives, nutritional supplements, dyes, or other edible materials. The food product may contain animal products or may not contain animal products. Animal products may include blood, milk, eggs, connective tissue, fats, oils, proteins, and/or other materials derived from an animal [0084]. It would have been obvious to provide the protein biomass of Klamzynska in a food or beverage as disclosed by Fruchtl or Shigeta to increase the protein amount therein for known benefits (Fruchtl) and to reduce the environmental and resource impact of food production (Shigeta). Both references list several different types of food and it would have been obvious to provide the protein of Klamzynska to any consumable product given the breadth of the variety of foods to which non-animal proteins are added as exemplified by Fruchtl and Shigeta. The amounts of claim 17 are taught by Fruchtl and Shigeta and are considered obvious to one of ordinary skill depending upon the food to which the proteins are added and the desired amount of protein to be delivered to the consumer. The comparison of claims 19 and 20 are considered obviated for the same reason.
Claims 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2024/0057652 (Hwang) (relying on provisional priority date of 10/07/2019).
Hwang discloses food compositions for humans comprising a Methylococcus capsulatus protein isolate or whole cell product as discussed above but does not disclose cornflakes, puffed rice, frosting, or candy as the food product. Hwang discloses the need for new protein sources for human consumption that overcome environmental, ethical health, and nutritional concerns while providing scalable and consistent production. Hwang discloses that the protein isolate or whole cell product may be added to a wide variety of consumables. It would have been obvious to provide the protein biomass of Hwang to any food or beverage as disclosed to provide a non-animal, non-plant protein for known benefits of proteins and to overcome environmental, ethical health, and nutritional concerns while providing scalable and consistent production.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/Primary Examiner, Art Unit 1793