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 .
Priority
This application is a 371 of PCT/CN2022/082557 (filed on 3/23/2022), which claims priority to CHINA 2021 10308583 (filed on 03/23/2021). There is no certified translation of the foreign priority application on record.
Election/Restrictions
Applicant’s election without traverse of Group I in reply filed on 03/11/2026 is acknowledge. Claims 1-4,13-15, and 18 read on the elected group.
Claims Status
Claims 1-19 are pending.
Claims 5-12,16-17, and 19 are withdrawn per election (03/11/2026).
Claims 1-4,13-15, and 18 have been considered on the merits.
Claim Objections
Claims 1-4, 13,15, and 18 are objected to because of the following informalities:
Claims 1-4,15, and 18 are missing the word ‘the’ between “with” and “effect” in the preamble found in the first line of each claim. Should read as, “…cartilage extract with the effect of…”.
Claim 3 has the word ‘ratio’ misspelled in the second line of the claim. Currently reads “ration”, should read ‘ratio’.
Claim 13 is missing the article ‘a’ between “to” and “subject in the second line of the claim. Should read as, “..administering to a subject…”.
Claim 15 has the word ‘claim’ misspelled in the second line of the claim. Currently reads “clam 2”, should read ‘claim 2’. The word ‘ratio’ is also misspelled in the second line of the claim. Currently reads “ration”, should read ‘ratio’.
Appropriate correction is required.
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.
Claims 1-4, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (CN106617102A; citations to the translation) and in view of Liu et al (CN106916870A; as cited in IDS filed on 9/21/2025;citations to the translation), further in view by Kim et al (Journal of exercise rehabilitation, 2018).
Regarding claim 1, Zhang et al disclosed a method of preparing collagen nutrient powder with parts by weight of fish collagen, sodium hyaluronate, and vitamin C, for enhancing immunity, promoting cell growth and to resist aging (See, Abstract). This reads on, A [composition]…with effect of improving immune response.
Zhang et al disclosed a collagen powder prepared with raw materials in parts by weight in 75-85 parts fish collagen, 5-15 parts sodium hyaluronate, 3-13 parts of vitamin C, 0.01-1 parts antioxidant, and 0.5-5 parts synergist (See, ¶ 0012). Zhang et al disclosed that the synergist can be lentinan, pullulan, kelp polysaccharide or mixture thereof (See, ¶0015). Thus, giving a ratio of sodium hyaluronate to lentinan a range of (5:0.5) - (15:5), equivalent to (1:0.1) – (3:1). It would have been prima facie obvious for one of ordinary skill in the art to have selected the overlapping portion of the range for the methods of Zhang et al. As such, containing an effective amount of collagen… supplemented with sodium hyaluronate and lentinan with mass ratio of 4:1-1:1, is rendered obvious by Zhang et al (See, MPEP 2144.05).
Zhang et al does not disclose that the collagen is a cartilage extract or that it contains an effective amount of non-denatured type II collagen.
Liu et al disclosed a method for preparing a cartilage extract containing non-denatured type II collagen. Liu et al disclosed that the method yields cartilage extracts that are high in purity, easy to preserve and rich in non-denatured type II collagen (See, ¶0011). Example 1 of Liu et al, they used raw material cartilage from chicken, duck, or beef for collagen extraction (See, ¶0036-0040). Liu et al disclosed that in Examples 1-6, the non-denatured type II collagen content was tested and quantified; the non-denatured type II collagen ranged from 3.9-12.6% (See, ¶45,55,65,75,85,95). In summary, Liu et al disclosed a method of extracting non-denatured collagen type II from raw material cartilage.
It would have been prima facie obvious to a person having ordinary skill in the art to have modified the method disclosed by Zhang et al such that the collagen used is the non-denatured collagen type II provided from the method disclosed in Liu et al. One would have been motivated to make this modification because it would have been advantageous to use collagen type II due to its known effect of increasing immune response in rats with deteriorating immunity, as evidence by Kim et al (See, Abstract and p734 Figures 1-4). Therefore, the product of claim 1, wherein a cartilage extract with…an effective amount of non-denatured type of II collagen for improving the immune response, characterized in that the cartilage extract is supplemented with sodium hyaluronate and lentinan,…ratio of sodium of 4:1-1:1 is rendered obvious over Zhang et al in view Liu et al and evidenced by Kim et al.
Regarding claim 2, following the discussion above, Liu et al disclosed that the cartilage extracted non-denatured collagen type II has a content ranged from 3.9-12.6% (See, ¶45,55,65,75,85,95) based on the exemplified extractions.
It would have been prima facie obvious for one of ordinary skill in the art to have selected the overlapping portion of the range for the methods of Zhang et al. As such, the cartilage extract, characterized in that said cartilage extract contains from 2 to 20% by mass of non-denatured type II collagen, is rendered obvious by Zhang et al in view of Liu et al (See, MPEP 2144.05).
Regarding claim 3 and 15, following the discussion above, Zhang et al disclosed a ratio of sodium hyaluronate to lentinan can range from (5:0.5) - (15:5), equivalent to (1:0.1) – (3:1). It would have been prima facie obvious for one of ordinary skill in the art to have selected the overlapping portion of the range for the methods of Zhang et al. As such, the cartilage extract, characterized in that the mass ratio of said sodium hyaluronate to lentinan is 4:1-2:1 is rendered obvious by Zhang et al in view of Liu et al (see, MPEP 2144.05).
Regarding claim 4 and 18, following the discussion above, Zhang et al disclosed a collagen powder prepared with raw materials in parts by weight in 75-85 parts fish collagen, 5-15 parts sodium hyaluronate, 3-13 parts of vitamin C, 0.01-1 parts antioxidant, and 0.5-5 parts synergist (See, ¶ 0012). Zhang et al disclosed that the synergist can be lentinan, pullulan, or kelp polysaccharide or mixture thereof (See, ¶0015). Thus, giving a ratio of collagen to sodium hyaluronate to lentinan can range from (75:5:0.5) - (85:15:5), equivalent to (15:1:0.1) – (17:3:1).
Zhang et al does not teach that the cartilage is made from raw material or that the total amount of added sodium hyaluronate and lentinan is a percentage from 10 to 60% or 20 to 30% by the mass on the total mass of the cartilage which is used as raw material.
As above, the collagen type II is from the method of Liu et al. Liu et al disclosed in example 1 that 3.5 kg of chicken breast cartilage was used for the extraction method (See, ¶0037) and the non-denatured collagen type II content was 11.3% for the extraction (See, ¶0045). Therefore, the cartilage extract is extracted from raw material.
Zhang et al nor Liu et al disclosed the percentage of sodium hyaluronate and lentinan to be added to the collagen mixture. However, the percentage of sodium hyaluronate and lentinan are considered prima facie obvious, as the instant claim requires 10 to 60% by mass based on the total mass of the cartilage for extraction, and Liu et al disclosed the mass of the raw material used for cartilage extract extraction, (i.e. 3.5 kg) (See, ¶0037) and Zhang et al disclosed a ratio of the raw materials in parts by weight (See, ¶0012). One of ordinary skill in the art could calculate from these amounts and ratios to determine the amount necessary to have 10 to 60% or 20 to 30% of sodium hyaluronate and lentinan. As such, determining the total amount of raw material needed to for these limitations would have been a matter of routine optimization (See, MPEP 2144.05).
Therefore, claims 1-4,15, and 18 are rendered obvious over Zhang et al in view of Liu et all, evidenced by Kim et al.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (CN106617102A; citations to the translation) and Liu et al (CN106916870A; as cited in IDS filed on 9/21/2025;citations to the translation) as applied to claims 1-4,14-15, and 18 above, and further in view of Becker et al ( International journal of toxicology, 2009), Hazama et al (Anticancer research, 2009), and Tong et al (Inflammation research, 2009), evidenced by LG Chem Life Sciences Fact sheet (https://innovation.lgchem.com/resource/assets/web/images/pdf/LG%20Chem%20Life%20Sciences%20Factsheet.pdf) and JC Lifescience (https://jclifesci.com/product_detail/42.html)
The teachings of Zhang et al and Liu et al are set forth above.
Regarding claim 13, following the discussion above about claim 1, Zhang et al and Liu et al disclosed a method for improving immune response but do not teach improving the immune response in a subject or administering an effective amount of the cartilage extract of claim 1 to a subject.
Tong et al teaches a method to treat collagen induced arthritis (CIA) with chicken type II collagen (CCII) and demonstrates the effects of CCII on T cells in rats (See, Abstract).
Tong et al teaches the administration of CCII to rats at varying doses for 7 days (See, Abstract). Tong et al concludes that the administration of CCII suppressed secondary inflammatory reactions and it has therapeutic effects on CIA, related to decreasing the production of pro-inflammatory mediators (IL-2,IL-17) and increasing production of anti-inflammatory mediators (IL-4, TGF-β); thus, CCII plays a role in regulating immune balance of Th1/Th2 and Th17/Treg in rats with CIA (See, Abstract, Figures 5-9).
Becker et al teaches about the functions of sodium hyaluronate and hyaluronic acid, their widespread clinical applications, and assess their safety for cosmetic use (See, Abstract).
Becker et al teaches that that sodium hyaluronate is the sodium salt of hyaluronic acid and is also technically known as hyaluronic acid (See, p6 col 1 paragraph 4).
Becker et al teaches that hyaluronic acid has been used to stimulate neutrophil activity in patients susceptible to bacterial infections (See, p13 col 1, paragraph 2 | reference has a typo but cited references for section have it correct). Becker also teaches that hyaluronic acid has been shown to stimulate polymorphonuclear leukocytes when subjects were injected with 5 to 10 mg (See, 42 col 2 paragraph 5).
Hazama et al teaches that lentinan (LNT) is an immune adjuvant that has been used for advanced gastric cancer. Hazama et al tested the efficacy of superfine dispersed lentinan (SDL) in 80 patients with colorectal cancer (See, Abstract). Hazama et al used a composition with 15 mg of SDL and it was stable at room temperature for 18 months. Hazama et al administered 15 mg LNT daily for 12 weeks.
Given that Tong et al, Becker et al, and Hazama et al teach methods of administering to a subject, collagen type II, sodium hyaluronate, and lentinan respectively. The individual components of the cartilage extract described in claim 1 have been administered to subjects in effective amounts and resulted in immune response such as regulating Th1 and Tregs, stimulate neutrophils, and enhance immune response as an adjuvant, therefore there is reasonable expectation that combining these components would further improve immune response when administered. Each of the reference, Tong et al , Becker et al , and Hazama et al provide motivations to have and increase efficacy to treat or mitigate disease or illness. This conclusion of obviousness is based on teaching suggestion motivation rationale. One would have had a reasonable expectation of success combining collagen type II, sodium hyaluronate, and lentinan with the teachings of Zhang et al and Liu et al to administer to a subject.
Regarding claim 14, following the discussion above, Zhang et al disclosed the method of combining components of collagen, sodium hyaluronate, and lentinan to create cartilage extract of claim 1 and Liu et al disclosed non-denatured collagen type II to be used in Zhang et al to create the cartilage extract of claim 1.
Zhang et al nor Liu et al teach the shelf life of the cartilage extract at room temperature.
Zhang et al nor Liu et al teach the storage period of nondenatured collagen type II but commercially available non-denatured collagen type II has a shelf life of 36 months at room temperature, as evidenced by JC Lifescience (See, product information). Similarly, Zhang et al and Liu et al are silent on their storage ability of sodium hyaluronate, but commercially available medications for administration in subjects of sodium hyaluronate have a room temperature of 24 months, evidence by LG Chem Life Sciences Factsheet (See, p10 composition and shelf life). Zhang et al and Liu et al are also silent on the shelf life of lentinan but Hazama et al used a composition with 15 mg of superfine dispersed lentinan (SDL) and it was stable at room temperature for 18 months.
Given that Zhang et al disclosed a method of producing the cartilage extract that is the same process of making the product of the current application, a case of prima facie case of obviousness has been established (See MPEP 2112.01(II)). Due to this it is inherent that the cartilage extract will have a “long storage period (not less than 36 months) (See, Application Spec p7 lines 8-12).
Therefore claims 13-14 are rejected as being rendered obvious over Zhang et al and Liu et al in further view of Becker et al, Tong et al, and Hazama et al.
Conclusion
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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