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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 1, 2026 has been entered.
Claims 1-20 are pending in this application.
Applicant elected without traverse 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 was made FINAL in the previous office action. Claims 2 and 13-20 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claim. Claims 1 and 3-12 are examined on the merits in this office action.
Withdrawn Objections and Rejections
Rejection of claims 1 and 3-12 under 35 U.S.C. 101, is hereby withdrawn in view of Applicant’s amendment to the claims.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
U.S.C. 102
6. 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.
7. 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.
8. Claim(s) 1 and 3-12 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Yosef reference (US 2013/0052175, cited in the previous office action).
9. 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 40C or greater…wherein an amount of the undenatured type II collagen is incorporated into the composition prior to the processing…(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 45C 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 suggest 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 limitation 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 Crop., 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 “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 an 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 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 produce 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
10. Applicant argues that “…the presently pending claims require (i) incorporation of an undenatured type II collagen into a composition prior to processing, and (ii) recovery of at least about 30% or more of the undenatured type II collagen after processing. Ben Yosef fails to teach or suggest either limitation.” Applicant further argues that “…Applicant respectfully submits that the requirement of at least about 30% recovery of undenatured type II collagen is not a mere product-by-process limitation, but rather a functional and structural characteristic of the final composition itself…”
11. 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 processed 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.
In regard to Applicant’s argument “the requirement of at least about 30% recovery of undenatured type II collagen is not a mere product-by-process limitation, but rather a functional and structural characteristic of the final composition itself” it is unclear how the claim has a “structural characteristic”. Claim 1 has been amended to recite:
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. The newly added limitation “wherein an amount of the undenatured type II collagen is incorporated into the composition prior to processing…about 30% or more of the undenatured type II collagen is recovered after processing.” This newly added limitation only recites method steps. There is structural limitation that is recited in the claim.
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
12. 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.
13. 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.
14. Instant claims are drawn to:
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15. Copending claims are drawn to:
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16. 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.
17. 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.
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 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
21. Applicant argues “Applicant respectfully requests to hold the present nonstatutory double patenting rejections in abeyance until an indication of allowable subject matter is received by the Applicant.”
22. 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 rejections are maintained.
New Rejections
U.S.C. 112(b)
23. 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.
24. Claims 1 and 3-12 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.
25. Claim 1 recites, “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 40C or greater, wherein an amount of the undenatured type II collagen is incorporated into the composition prior to processing and at least about 30% or more of the undenatured type II collagen is recovered after processing.”. Claim 1 recites both a product and a method. A claim can only recite one invention. The preamble recites a processed food and/or beverage composition. Therefore, claim 1 has been interpreted as a product invention. Because claims 3-12 depend from indefinite claim 1 without clarifying the point of confusion, these claims are also rejected under 35 U.S.C. 112(b).
CONCLUSION
No claim is allowed.
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
10/08/2026
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