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 October 31, 2025 is acknowledged. Claims 1-21 are pending in the application. Claims 20-21 are withdrawn from consideration.
Election/Restrictions
Applicant’s election of Group I, claims 1-19, in the reply filed on October 31, 2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 1-19 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.
Independent claim 1 recites “the beverage ingredients” at line 2 of the claim. However, this recitation lacks antecedent basis as there is no previous recitation of beverage ingredients in the claim. Therefore, the scope of claim 1 is indefinite. For the purpose of the examination, the recitation of “the beverage ingredients” at line 2 of claim 1 (emphasis added) is interpreted as “beverage ingredients”.
Claim 2 recites “other animal derived collagens” at line 2. It is unclear what is intended by this recitation. More specifically, the phrase includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). For the purpose of the examination, the recitation of “other animal derived collagens” at line 2 of claim 2 (emphasis added) is interpreted as “animal derived collagens”.
Claims 3-9 are not specifically discussed but are rejected due to their dependence on claim 1.
Independent claim 10 recites “the food or oral delivery formulation ingredients” at lines 2-3 of the claim. However, this recitation lacks antecedent basis as there is no previous recitation of food or oral delivery formulation ingredients in the claim. Therefore, the scope of claim 10 is indefinite. For the purpose of the examination, the recitation of “the food or oral delivery formulation ingredients” at lines 2-3 of claim 10 (emphasis added) is interpreted as “food or oral delivery formulation ingredients”.
Claim 11 recites “other animal derived collagens” at line 2. It is unclear what is intended by this recitation. More specifically, the phrase includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). For the purpose of the examination, the recitation of “other animal derived collagens” at line 2 of claim 11 (emphasis added) is interpreted as “animal derived collagens”.
Claims 12-19 are not specifically discussed but are rejected due to their dependence on claim 10.
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, fish or animal derived collagens 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, fish or animal derived collagens 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]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TYNESHA L. MCCLAIN whose telephone number is (571)270-1153. The examiner can normally be reached Monday-Friday 10 AM - 6:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at 571-272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.L.M/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793