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 .
Response to Non-final office action filed on January 16, 2026 is acknowledged.
Claims 1-20 are pending in this application.
Applicant elected without traverse of Group 1 (claims 1-12) and food as the species from food or beverage, 85% or more of the undenatured type II collagen recovered after processing as the species of %, 37C or greater as the species of temperature, and flavoring as the species of additional component in the reply filed on July 10, 2025. Restriction was deemed to be proper and made FINAL in the previous office action. Claims 13-20 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Claim 2 remains withdrawn from further consideration as being drawn to nonelected species. Claims 1 and 3-12 are examined on the merits in this office action.
This application contains claims 13-20, drawn to an invention nonelected without traverse in the paper of 7/10/2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
Withdrawn Objections
Objection to claims 3-12 is hereby withdrawn in view of Applicant’s amendment to the claims.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Maintained Rejections
35 U.S.C. 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 1 and 3-12 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. Claim(s) 1 and 3-12 recite(s):
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. The undenatured type II collagen is a natural component of chicken cartilage and plants as evidenced by Schilling et al (US Patent No. 7083820) and Moore et al (US 2019/0208770, filed with IDS). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “wherein the processed food and/or beverage composition is processed at a temperature of about 37°C or greater” only serves to limit how the collagen is obtained and provides no evidence that the obtained product is structurally different from its natural counterpart. Furthermore, dependent claims 4 and 6-11 only further limit the process by which it is made and do not structurally change the product into something markedly different from what is found in nature. Additionally, dependent claim 3 further define the product by its intended use; however, these limitations do not further transform the natural product into something significantly more. Claims 5 and 12 recite additional components such as native type II collagen, collagen peptides; however, these components are naturally found in the chicken cartilage and plant material that are source of the type II undenatured collagen and are not sufficient to transform the nature based product into something that is significantly more than its natural counterpart.
The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s “2014 Interim Eligibility Guidance” as set forth on December 16, 2014, Revised Guidance set forth on May 2016, and 2019 Revised patent Subject Matter Eligibility Guidance set forth on January 7, 2019 (Please see MPEP 2106).
Step 1: Is the claim to a process, machine, manufacture or composition of matter? The instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea? The claims are directed to a natural phenomenon, specifically a natural-based product limitation.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application? This judicial exception is not integrated into a practical application because the peptide being claimed is naturally occurring.
As evidenced by Schilling et al (US Patent No. 7083820) and Moore et al (US 2019/0208770, filed with IDS), the undenatured type II collagen is a natural component of chicken cartilage. Although one of ordinary skill in the art would construe the limitations “composition” to mean isolated or purified or having additional components, this does not render the claim markedly different from what exists in nature, because the other components may also be naturally occurring, such as water. Myriad clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman' s art”).
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product(s).
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 1 and 3-12 do not qualify as eligible subject matter.
Please see MPEP 2106.
Response to Applicant’s Arguments
8. Applicant argues that “…the claims, when interpreted in light of the specification, recite a processed food and/or beverage composition having markedly different characteristics from naturally occurring undenatured type II collagen, and therefore are not directed to a judicial exception under Step 2A of the USPTO’s 101 guidance.” Applicant further argues that “…one of ordinary skill in the art would understand that “undenatured collage is sensitive to high temperatures and changes in pH,” and therefore that previously it was ‘believed that undenatured collagen would denature when exposed to acidic conditions, and was therefore included in compositions having a pH of greater than 7. Therefore, currently available undenatured collagen products include powders and capsules, that can be optionally incorporated into final products that do not require heating or acidic conditions, or instead, directly consumed.” Applicant further argues that “Notably, the present disclosure teaches that “an undenatured collagen that has been carefully formed to preserve the epitopes on the undenatured strands can be used to form processed food and/or beverage, even when the processed food and/or beverage requires high temperature processing, high pressure processing, or low pH levels for production and/or storage.”
9. Applicant’s arguments have been fully considered but are not found persuasive. Each step analysis of each prong clearly and explicitly indicates the following:
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon (Product of nature), or an abstract idea?
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Step 2b: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Therefore, even though the specification may describe the “markedly different characteristics” of Applicant’s invention, those different characteristics are not recited in the instant claims. Additionally, instant claims are drawn to a product invention comprising the naturally occurring undenatured type II collagen. Therefore, as described in the rejection above, instant claims are directed to a statutory patent-eligible subject matter category, a composition of matter, because claims are directed to a natural phenomenon, a natural-based product limitation of undenatured type II collagen. The claim do not recite additional elements that integrate the judicial exception into a practical application.
As evidenced by Schilling et al (US Patent No. 7083820, cited in the previous office action) and Moore et al (US 2019/0208770, filed with IDS), the undenatured type II collagen is a natural component of chicken cartilage. Although one of ordinary skill in the art would construe the limitations “composition” to mean isolated or purified or having additional components, this does not render the claim markedly different from what exists in nature, because the other components may also be naturally occurring, such as water. Myriad clarified that not every change to a product will result in a marked difference, and that the mere recitation of particular words (e.g., “isolated”) in the claims does not automatically confer eligibility. Id. at 2119. See also Mayo, 132 S. Ct. at 1294 (eligibility does not “depend simply on the draftsman' s art”).
The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to the natural product(s).
For these reasons, it is deemed that the rejection is proper. Therefore, the rejection is maintained herein.
35 U.S.C. 102
10. 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.
11. 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.
12. Claim(s) 1 and 3-12 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Yosef (US 2013/0052175).
13. Ben Yosef reference teaches a processed animal food and/or treat composition comprising an undenatured type II collagen (see abstract, paragraphs [0042]-[0044], and claim 17, for example), meeting the limitation of instant claims 1 and 3. With respect to claims 5 and 12, Ben Yosef reference teaches the composition wherein the animal food and/or treat includes one or more of a protein source, a flavoring, or a coloring (see paragraphs [0010]-[0015] and claim 14, for example). With respect to claim 4, Ben Yosef reference teaches a processed animal food and/or treat composition comprising an undenatured type II collagen, which is interpreted as a processed animal meal given that the composition is intended for consumption (see abstract, paragraphs [0042]-[0044]). Additionally, with respect to “wherein the processed food and/or beverage composition is processed at a temperature of about 37°C or greater (claim 1); wherein the undenatured type II collagen is incorporated into the processed food and/or beverage… (claim 4); wherein an amount of undenatured type II collagen is incorporated into the composition prior to processing… (claim 6); wherein 45% or more of the undenatured type II collagen is recovered after processing (claim 7); wherein 60% or more of the undenatured type II collagen is recovered after processing (claim 8); wherein 85% or more of the undenatured type II collagen is recovered after processing (claim 9); wherein the processed food and/or beverage undergoes processing that includes a temperature of about 40°C or greater (claim 10); wherein the processing lasts from 6 seconds to about 2 hours (claim 11)” according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses;
(B) “wherein” clauses; and
(C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. <”. In the instant case, it is not deemed that the “wherein” clause limits the claim to particular structural features.
Furthermore, instant claims 1, 4 and 6-11 recite product by process. The MPEP states the following: “[E]ven 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...The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product" (see MPEP 2113 [R-1]).
Since Ben Yosef reference teaches ALL of the active components, i.e., undenatured type II collagen, one or more different types of protein/peptides, and flavoring and coloring compounds, the reference anticipates instant claims 1 and 3-12.
Response to Applicant’s Arguments
14. Applicant argues that, “one of ordinary skill in the art would understand that the claims, when read in light of the specification, would required the structure of the undenatured type II collagen to demonstrate markedly different characteristics from naturally occurring undenatured type II collagen as detailed above in order to be included in the processed food and/or beverage composition as required by the presently pending claims.” Applicant argues that “[t]he structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product (MPEP 2113 citing In re Garnero, 412 F. 2d 276, 279, 162 USPQ221, 223 (CCPA 1979) (holding “interbonded by interfusion” to limit structure of the claimed composite and noting that terms such as “welded,” “intermixed,” “ground in place,” “press fitted,” and “etched” are capable of construction as structural limitations)…” Applicant argues that “manufacturing process steps as required by the presently pending claims would be expected to impart distinctive structural characteristics to the final product…”
15. Applicant’s arguments have been fully considered but are not found persuasive.
Instant claims are drawn to a processed food and/or beverage composition comprising undenatured type II collagen. Ben Yosef reference explicitly teaches a processed animal food and/or treat composition. Ben Yosef reference teaches a processed animal food and/or treat composition comprising an undenatured type II collagen. Ben Yosef reference teaches the composition wherein the animal food and/or treat includes one or more of a protein source, a flavoring, or a coloring. Ben Yosef reference teaches a processed animal food and/or treat composition comprising an undenatured type II collagen, which is interpreted as a processed animal meal given that the composition is intended for consumption. Instant claims do not recite any structural differences, any functional differences or any component differences. The claims recite a process food and/or beverage comprising the same undenatured type II collagen as taught by Ben Yosef. Therefore, the product processed food composition of Ben Yosef reference is exactly the same as the process food/beverage composition.
Since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to provide evidence that the instant claimed processed food comprising undenatured type II collagen is markedly different from the processed food comprising undenatured type II collagen of Ben Yosef. In the instant case, Applicant fails to provide any direct evidence that there is a structural difference between the claimed processed food and/or beverage composition comprising an undenatured type II collagen and the processed animal food and/or treat composition comprising an undenatured type II collagen of Ben Yosef reference.
Therefore, the rejection is deemed to be proper and is maintained herein.
DOUBLE PATENTING
16. 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.
17. Claims 1 and 3-12 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No18/009359 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant application, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18. Instant claims are drawn to:
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19. Copending claims are drawn to:
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20. The scope of instant claims and the copending claims are similar in that copending claims recite a supplement for improving one or more of endurance, lipid metabolism, and antioxidant status in a mammal, the supplement comprising: type II collagen composition, the type II collagen composition comprising undenatured collagen, hydrolyzed collagen, or a combination thereof. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Response to Applicant’s Arguments
21. Applicant argues that “…nowhere in the claims of copending Application No. 18009359 does it require, either expressly or inherently, a processed food and/or beverage composition comprising an undenatured type II collagen, wherein the processed food and/or beverage composition is processed at a temperature of about 37C or greater.
22. Applicant’s arguments have been fully considered but are not persuasive. Instant claims are drawn to a processed food and/or beverage composition comprising: an undenatured type II collagen. Copending claims are drawn to a supplement for improving one or more of endurance, lipid metabolism, and antioxidant status in a mammal, the supplement comprising: a type II collagen composition, the type II collagen composition comprising undenatured collagen, hydrolyzed collagen, or a combination thereof. Both instant claims and copending claims recite a composition comprising a undenatured type II collagen. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims and vice versa.
23. Claims 1 and 3-12 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No17/908007 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because if one of ordinary skill in the art practiced the claimed invention of instant application, one would necessarily achieve the claimed invention of copending claims, and vice versa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
24. Instant claims are drawn to:
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25. Copending claims are drawn to:
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26. The scope of instant claims and the copending claims are similar in that copending claims recite a processed animal food and/or treat composition comprising an undenatured type II collagen. Therefore, if one of ordinary skill in the art practiced the claimed invention of instant claims, one would necessarily achieve the claimed invention of copending claims, and vice versa.
Response to Applicant’s Arguments
27. Applicant argues that “Applicant respectfully requests to hold the present nonstatutory double patenting rejection in abeyance until an indication of allowable subject matter is received by the Applicant.”
28. Applicant’s arguments have been fully considered but are not found persuasive. While a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP 714.02). Until a proper Terminal Disclaimer is filed and approved by the Office, the rejection is maintained.
CONCLUSION
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
2/26/2026