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 .
The amendment filed May 12, 2026 is acknowledged. Claims 1-21 are pending in the application. Claims 20-21 are withdrawn from consideration.
Claim Objections
Claims 2 and 11 are objected to because of the following informalities:
In claim 2 at line 2, it is suggested to insert “or” after “porcine,” and before “fish”.
In claim 11 at line 2, it is suggested to insert “or” after “porcine,” and before “fish”.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al. US 20100021600 (hereinafter “Yagi”) in view of Moore US 20150017129 (hereinafter “Moore”).
With respect to claim 1, Yagi relates to a method of producing beverages comprising collagen (paragraphs [0029] and [0033]-[0036]).
Regarding the recitation “of producing a beverage containing undenatured type II collagen” in the preamble of claim 1, It is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the claim language of comprising combining beverage ingredients and heating in a manner to reduce microbial contamination without denaturing more than 10% of the collagen protein wherein the temperature is at least 50⁰C for a time of at least 2 seconds in claim 1, Yagi teaches combining the ingredients of the collagen beverage and sterilizing the beverage at 110⁰C for 5 minutes in one embodiment (paragraphs [0026], [0028], [0029], [0033]-[0036], and [0047]-[0050]).
However, Yagi does not expressly disclose the collagen is undenatured type II collagen.
Moore relates to undenatured type II collagen. The type II collagen retains its undenatured structure in other processing. The collagen may be blended with other ingredients to prepare drinks (paragraphs [0001], [0027], [0029], [0033], [0055], and [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Moore, to select undenatured type II collagen in the method of Yagi based in its suitability for its intended purpose with the expectation of successfully preparing a functional product without denaturing more than 10% of the collagen protein. One of ordinary skill in the art would have been motivated to do so because Yagi and Moore similarly teach preparing beverages comprising collagen, Yagi is not limited to the particular collagen selected, Moore teaches the undenatured type II collagen is a nutritional supplement, is useful for alleviating symptoms of arthritis, and retains its undenatured structure in other processing (Abstract; and paragraph [0029]), and said modification would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
With respect to claims 2 and 3, modified Yagi is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the claim language of wherein the collagen is avian, bovine, porcine, or fish in claim 2 and wherein the collagen is chicken sternum derived collagen in claim 3, Yagi as modified by Moore teaches this limitation since Moore is relied upon for the teaching of the undenatured type II collagen as addressed above in claim 1, and Moore teaches type II collagen from animals such as cows, pigs, poultry, fish, and chicken sternal cartilage may be used (paragraphs [0010], [0012], [0015], and [0028]).
With respect to claims 4 and 5, modified Yagi is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the collagen is treated at a temperature of at least 70⁰C in claim 4 and wherein the collagen is treated at a temperature of at least 90⁰C in claim 5, modified Yagi teaches this limitation since Yagi teaches the collagen beverage is sterilized at 110⁰C in one embodiment (paragraphs [0047]-[0050]).
With respect to claim 6, modified Yagi is relied upon for the teaching of the method of claim 5 as addressed above.
Regarding the recitation of wherein the collagen is treated at a temperature of at least 120⁰C in claim 6, modified Yagi teaches this limitation since Yagi teaches the heat treating temperatures may be 30⁰C or more and encompasses the presently claimed range (paragraphs [0022] and [0033]-[0036]).As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claims 7 and 8, modified Yagi is relied upon for the teaching of the method of claim 1 as addressed above.
Regarding the recitation of wherein the collagen is treated for at least 2 seconds in claim 7 and wherein the collagen is treated for at least 60 seconds in claim 8, modified Yagi teaches this limitation since Yagi teaches sterilization of the collagen beverage is performed for 5 minutes in one embodiment (paragraphs [0047]-[0050]).
With respect to claim 9, modified Yagi is relied upon for the teaching of the method of claim 8 as addressed above.
Regarding the recitation of wherein the collagen is treated for at least 15 minutes in claim 9, modified Yagi teaches this limitation since Yagi teaches heat treatment may be performed for 30 minutes or more and overlaps with the presently claimed range paragraphs [0022] and [0033]-[0036]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 10, Yagi relates to a method of producing a sterilized food comprising collagen (paragraphs [0033]-[0036]).
Regarding the recitation “of producing pasteurized food items or oral delivery formulations containing undenatured type II collagen” in the preamble of claim 10, It is noted that this recitation is a statement of intended use or field of use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, then the preamble is not considered a limitation and is of no significance to the claim construction. See MPEP 2111.02.
Regarding the recitation of comprising combining food or oral delivery formulation ingredients and heating in a manner to reduce microbial contamination without denaturing more than 10% of the collagen protein wherein the temperature is at least 50⁰C for a time of at least 2 seconds in claim 10, Yagi teaches combining the ingredients of the collagen containing food and sterilizing the food at 110⁰C for 5 minutes in one embodiment (paragraphs [0026], [0028], [0029], [0033]-[0036], and [0047]-[0050]).
However, Yagi does not expressly disclose the collagen is undenatured type II collagen.
Moore relates to undenatured type II collagen. The type II collagen retains its undenatured structure in other processing. The collagen may be blended with other ingredients to prepare compositions for consumption (paragraphs [0001], [0029], [0033], [0055], and [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, given the teachings of Moore, to select undenatured type II collagen in the method of Yagi based in its suitability for its intended purpose with the expectation of successfully preparing a functional product without denaturing more than 10% of the collagen protein. One of ordinary skill in the art would have been motivated to do so because Yagi and Moore similarly teach preparing foodstuff comprising collagen, Yagi is not limited to the particular collagen selected, Moore teaches the undenatured type II collagen is a nutritional supplement, is useful for alleviating symptoms of arthritis, and retains its undenatured structure in other processing (Abstract; and paragraph [0029]), and said modification would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. There would have been a reasonable expectation of success with said modification. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. (“Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle.” Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) See also In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious)) (MPEP 2144.07).
With respect to claims 11 and 12, modified Yagi is relied upon for the teaching of the method of claim 10 as addressed above.
Regarding the claim language of wherein the collagen is avian, bovine, porcine, or fish in claim 11 and wherein the collagen is chicken sternum derived collagen in claim 12, Yagi as modified by Moore teaches this limitation since Moore is relied upon for the teaching of the undenatured type II collagen as addressed above in claim 10, and Moore teaches type II collagen from animals such as cows, pigs, poultry, fish, and chicken sternal cartilage may be used (paragraphs [0010], [0012], [0015], and [0028]).
With respect to claims 13 and 14, modified Yagi is relied upon for the teaching of the method of claim 10 as addressed above.
Regarding the recitation of wherein the collagen is treated at a temperature of at least 70⁰C in claim 13 and wherein the collagen is treated at a temperature of at least 90⁰C in claim 14, modified Yagi teaches this limitation since Yagi teaches the collagen containing food is sterilized at 110⁰C in one embodiment (paragraphs [0033]-[0036] and [0047]-[0050]).
With respect to claim 15, modified Yagi is relied upon for the teaching of the method of claim 14 as addressed above.
Regarding the recitation of wherein the collagen is treated at a temperature of at least 120⁰C in claim 15, modified Yagi teaches this limitation since Yagi teaches the heat treating temperatures may be 30⁰C or more and encompasses the presently claimed range (paragraphs [0022] and [0033]-[0036]).As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claims 16 and 17, modified Yagi is relied upon for the teaching of the method of claim 10 as addressed above.
Regarding the recitation of wherein the collagen is treated for at least 2 seconds in claim 16 and wherein the collagen is treated for at least 60 seconds in claim 17, modified Yagi teaches this limitation since Yagi teaches sterilization of the collagen containing food is performed for 5 minutes in one embodiment (paragraphs [0033]-[0036] and [0047]-[0050]).
With respect to claim 18, modified Yagi is relied upon for the teaching of the method of claim 17 as addressed above.
Regarding the recitation of wherein the collagen is treated for at least 15 minutes in claim 18, modified Yagi teaches this limitation since Yagi teaches heat treatment may be performed for 30 minutes or more and overlaps with the presently claimed range paragraphs [0022] and [0033]-[0036]). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With respect to claim 19, modified Yagi is relied upon for the teaching of the method of claim 10 as addressed above.
Regarding the recitation of wherein the pasteurized food items are selected from the group consisting of dairy products, chocolates, candies and nutrition bars and the oral delivery formulations are selected from the group consisting of gummies, quick dissolve oral strips and chews in claim 19, modified Yagi teaches the limitation since Yagi teaches the produced sterilized food comprising collagen may include dairy products, chocolate, confectionary, and gummy (paragraphs [0029], [0030], and [0033]-[0036]).
Response to Arguments
Applicant’s remarks filed May 12, 2026 are acknowledged.
Due to the amendments to the claims, the 35 USC 112 rejection in the previous Office Action have been withdrawn (P5).
Applicant’s arguments have been fully considered, but they are unpersuasive.
Applicant argues Yagi does not teach the use of undenatured collagen. Yagi is directed to a collagen beverage which is pasteurized and there is nothing in Yagi to suggest that the collagen is undenatured, or that the collagen retains its undenatured state after pasteurization. The collagen used in Yagi appears to be hydrolyzed collagen or collagen peptides and fails to disclose or suggest undenatured collagen. Moore fails to make up the deficiencies of Yagi. Moore does nothing to suggest that drying temperatures above 50⁰C can be used to dry undenatured Type-II collagen and fails to addy anything to Yagi. While Moore does teach undenatured collagen it clearly teaches not to exceed 37⁰C in processing undenatured collagen. Therefore, one would not have placed the undenatured collagen of Moore in the process of making a beverage of Yagi, since Yagi uses 110⁰C to sterilize the beverage. For these reasons, the combination of Moore with Yagi would not be contemplated by one skilled in the art, since Moore clearly state to avoid high temperatures, since high temperatures denature undenatured collagen. Therefore, one skilled in the art would avoid using the Moore undenatured collagen in the Yagi process of making a beverage (P5-P7).
Examiner disagrees. The claimed invention is obvious in view of modified Yagi, and a prima facie case of obviousness has been established. Applicant is reminded that if a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc).
Additionally, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine the references is found within the references themselves as well as within the knowledge generally available to one of ordinary skill in the art.
As previously addressed, Yagi relates to a method of producing beverages comprising collagen (paragraphs [0029] and [0033]-[0036]). Although Yagi does not expressly disclose the collagen is undenatured type II collagen, Moore is relied upon for this teaching since Moore teaches undenatured type II collagen may be blended with other ingredients to prepare drinks (paragraphs [0001], [0027], [0029], [0033], [0055], and [0071]). One of ordinary skill in the art would have been motivated to select undenatured type II collagen in the method of Yagi based in its suitability for its intended purpose with the expectation of successfully preparing a functional product without denaturing more than 10% of the collagen protein because Yagi and Moore similarly teach preparing beverages comprising collagen, Yagi is not limited to the particular collagen selected and teaches sterilizing the beverage at 110⁰C for 5 minutes which falls within the claimed temperature and duration (paragraphs [0029], [0035], [0047]-[0050]), Moore teaches the undenatured type II collagen is a nutritional supplement, is useful for alleviating symptoms of arthritis, and retains its undenatured structure in other processing (Abstract; and paragraph [0029]), and said modification would amount to the use of a known element for its intended use in a known environment to accomplish entirely expected result. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant is also reminded as stated in MPEP 2145 III., “[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references.” In re Keller, 642 F.2d 413, 425 (CCPA 1981). See also In re Sneed 710 F.2d 1544, 1550 (Fed. Cir. 1983) (“[I]I is not necessarily that the inventions of the references be physically combinable to render obvious the invention under review.”); and In re Nievelt, 482 F.2d 965, 968 (CCPA 1973) (“Combining the teachings of references does not involve the ability to combine their specific structures.”).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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