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 .
Amendments Received
Amendments to the claims were received and entered on 11/21/2025.
Election/Restrictions
Applicant's election with traverse of Group II (drawn to a complex containing undenatured type II collagen and chitosan oligosaccharide) in the reply filed on 11/21/2025 is acknowledged. The traversal is on the ground(s) that “it should be no undue burden on the Examiner to consider all claims in the single application”. This is not found persuasive because the method of preparing the complex (Group I) and the complex per se (Group II) are distinct inventions, requiring examination of different statutory classes and different fields of search. Examination of both groups would have imposed an undue burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
Status of Claims
Claims 1-10 are currently pending.
Claims 8-10 are currently pending, as claims 1-7 are withdrawn.
Priority
The present application is a continuation of PCT/CN2021/134442 filed on November 30, 2021 and claims priority to Chinese application CN202110114882.4 filed on January 28, 2021. Acknowledgment is made of applicant' s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of 01/28/2021. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejections
In view of Applicant’s amendments, rejection of claim 8 under 35 USC § 102 by Zhou et al. is hereby withdrawn.
In view of Applicant’s amendments, rejections of claim 8-10 under 35 USC § 103 over Zhou et al. are hereby withdrawn.
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.
Claim 8 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et al. (CN105725190 A, cited in the IDS, English translation relied upon, cited in a previous office action).
Claim 8 is drawn to “a complex containing undenatured type II collagen and chitosan oligosaccharide prepared by a preparation method that uses an activating agent, and a wherein clause specifying that “the activating agent increases a density of positive charges on a surface of the undenatured type II collagen to immobilize the chitosan oligosaccharide thereon to form the complex containing undenatured type II collagen and chitosan oligosaccharide.” As such, claim 8 is directed to a product that is defined, at least in part, by the process by which it is made and is thus treated as a product‑by‑process claim, wherein determination of patentability is based on the product itself and not on its method of production. However, although claim 8 is in product-by-process form, the “wherein” clause is reasonably construed as reciting a functional property of the resulting complex—namely that, due to the presence of the activating agent, the surface of the undenatured type II collagen exhibits an increased positive charge density sufficient to immobilize chitosan oligosaccharide.
Fang et al. discloses a composition, comprising, in parts by weight, type II collagen (including undenatured type II collagen), chitosan oligosaccharide, grape seed extract, and other ingredients (Specification, pg. 2 and Example 1). Fang et al. further teaches that the grape‑seed extract is prepared to contain a high proanthocyanidin content of at least 97% (pg. 2). It is noted that the instant specification identifies polyphenols, flavones, anthocyanidins, and plant extracts containing such components as examples of “activating agents.” Accordingly, the grape‑seed extract of Fang et al. constitutes an activating agent within the meaning of the present application. The instant specification further teaches that addition of an activating agent increases the density of positive charges on the surface of the undenatured type II collagen and thereby immobilizes chitosan oligosaccharide on that surface. In view of this teaching, when Fang’s activating agent (i.e., grape‑seed extract rich in proanthocyanidins) is combined with undenatured type II collagen and chitosan oligosaccharide as disclosed, the resulting collagen–chitosan complex results in the same increased surface positive charge and charge‑mediated immobilization property recited in claim 8. A property or characteristic is inherent in a prior‑art composition if it is necessarily present or the natural result of the disclosed composition, even if not explicitly recognized. Once a prior‑art composition appears substantially identical to that claimed, the properties of the claimed composition are presumed to be inherent in the prior‑art composition, and the burden shifts to applicant to show that the prior‑art composition does not possess the recited property (see MPEP 2112). Accordingly, Fang et al. discloses a composition comprising undenatured type II collagen and chitosan oligosaccharide, according to claim 8, and therefore anticipates claim 8 under 35 U.S.C. 102.
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 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fang et al., as it applies to claim 8, and further in view of Zhou et al. (CN110214947 A, cited in the IDS, English translation relied upon, cited in a previous office action).
The teachings of Fang et al. as they apply to claim 8 have already been discussed above. Briefly, Fang et al. discloses a composition comprising undenatured type II collagen, chitosan oligosaccharide and grape seed extract, thereby resulting in a collagen–chitosan complex with increased surface positive charge.
Regarding claim 9, Zhou et al. teaches that type II collagen contains a large amount of chondroitin sulfate and that chitosan oligosaccharide is a “positively charged cationic basic amino oligosaccharide” capable of forming complexes with other components (“has certain complexation of metal ions”) (Specification, pg. 1, Summary of the invention). One of ordinary skill in the art would understand that chondroitin sulfate, which contains negatively charged groups, combined with positively charged chitosan oligosaccharides would result in a chemically bonded complex through ionic interactions. Although neither Fang et al. nor Zhou et al. explicitly use the term “chemically bonded”, the teachings, together with well-known chemical principles regarding the interactions of oppositely charged components, would have suggested to a person of ordinary skill in the art that the type II collagen in the composition of Fang et al. is chemically bonded with the chitosan oligosaccharide present in the composition, with a reasonable expectation of success.
Regarding claim 10, Fang et al. discloses an exemplary preparation of a composition comprising undenatured type II collagen and chitosan oligosaccharide, wherein the mass ratio of the type II collagen to chitosan oligosaccharide is 4:1 (20 parts type II collagen and 5 parts chitosan oligosaccharide), which falls within the recited claimed range (Specification, pg. 2).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Fang et al. discloses a composition comprising undenatured type II collagen and chitosan oligosaccharide, and the teachings of Zhou et al. teaches that type II collagen contains a large amount of chondroitin sulfate, which possess negatively charged groups, and that chitosan oligosaccharide is a positively charged cationic saccharide capable of forming complexes with other components. A person of ordinary skill in the art would have been motivated to combine the teachings of Fang and Zhou because Zhou teaches complementary chemical properties of collagen and chitosan oligosaccharide, relevant to Fang. Given that Zhou et al. demonstrates the ability of collagen and chitosan oligosaccharides to form a complex, it would have been obvious to a person of ordinary skill in the art to arrive at the claimed composition comprising type II collagen (inherently comprising chondroitin sulfate) and chitosan oligosaccharide in a chemically bonded form through ionic interactions, and to do so with a reasonable expectation of success. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 11/21/2025, Applicant argues that the compositions disclosed by Fang and Zhou are prepared by the conventional method of mixing various ingredients to obtain products, and do not include an activating agent to adjust the positive charge density on the surface of the type II collagen to immobilize the chitosan oligosaccharide on the surface of the collagen. Applicant’s arguments have been considered in full, and have been found to be persuasive with respect to Zhou et al., when considered alone, as Zhou et al. does not expressly disclose inclusion of an activating agent as defined by the instant specification. However, the arguments are not persuasive with respect to Fang et al.
Fang et al. expressly discloses a composition comprising undenatured type II collagen, chitosan oligosaccharide, and an grape seed extract rich in proanthocyanidins (i.e., an activating agent). The instant specification identifies polyphenolic plant extract as activating agents. As such, Fang et al. discloses an activating agent within the meaning of the present application. Therefore, rejections over Fang et al., and Fang et al., further in view of Zhou et al., are maintained.
Conclusion
No claim is in condition for allowance.
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 NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652