DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on March 4, 2026, has been received and entered.
Claim Disposition
3. Claim 21 has been cancelled. Claims 1-20 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on February 6, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Claim objection
5. Claims 1-20 are objected to for the following informalities:
For clarity it is suggested that claim 1 is amended to delete the numbering of 1-4 and instead use (a)-(d) or (i)-(iv) . The dependent claims hereto are also included.
For clarity and precision of claim language it is suggested that claim 2 is amended to recite “….quantitative analysis of collagen [[on the solution ]] in the solution to be……”.
For clarity it is suggested that the kit includes ‘instructions’ in claim 17. The dependent claims hereto are included
Appropriate correction is required.
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.
6. 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.
7. Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 111748030 (Oct. 2020, of record in the application) in view of CN101213308 (December 21, 2011, of record in the application), CN 111588651 (Aug. 2020, of record in the application) and CN 109627326 (April 2019, of record in the application).
The claimed invention is directed to a pre-treatment method for detection of a non-denatured type II collagen/a method for detecting a non-denatured type II collagen/a kit using a collagen product or cartilage raw material.
The primary reference discloses a method for preparing and detecting a soluble undenatured type II collagen, which method comprises: 1) thawing cartilage, draining same, adding same to water, and homogenizing same to obtain a homogenate; 2) adding NaCl, KCl and NaOH to the homogenate of step1), uniformly mixing same, and then performing ultrasonic treatment to obtain a dispersion; 3) centrifuging the dispersion of step 2), taking the precipitate, adding same to a hydrochloric acid solution, uniformly mixing same, performing acids welling treatment to obtain a mixed solution, and adjusting the pH value of the mixed solution to 1.0-5.0; and 4) adding a protease and an enzymolysis aid to the mixed solution of step 3), and performing enzymolysis treatment to obtain an enzymolysis solution, wherein the protease is one or more of pepsin, papain and bromelain; and analyzing the obtained undenatured type II collagen by means of electrophoresis, spectrographical identification, a scanning electron microscope and a DSC method (see claims and 6, and description, paragraphs 28 and 30). The differences between the claimed invention and the primary reference lie in that 1) collagen is precipitated and extracted using guanidine hydrochloride; 2) accelerated swelling is performed using ultrasound; and 3) the type of the enzyme also comprises an elastase. On the basis of the above-mentioned distinguishing technical features, the technical problem actually to be solved by the present invention is to improve the acids welling property of a undenatured collagen by means of ultrasonic treatment.
The secondary reference teaches a collagen treatment method identical to the collagen treatment methods in the invention (specifically adding a buffer solution containing a neutral salt or guanidine hydrochloride to a sample of an animal raw material to be tested, followed by centrifugation to obtain a precipitate the components of which are identical to those of the guanidine hydrochloride containing buffer solution added in step 4 of the reference; resuspending the precipitate obtained in the first step with acid, performing ultrasonication for immediate swelling, and centrifuging to obtain a supernatant. The use of ultrasonication for accelerating dissolution is also a technology applied in claim 1 and 4 of the reference. Adding pepsin to the supernatant obtained in step 2 for enzymatic hydrolysis, and the identical protease is disclosed in claims 1 and 4 of the reference. Adding elastase to the enzymatically hydrolyzed solution obtained in step 3 for enzymatic hydrolysis, centrifuging, and retaining the supernatant as a test solution, this can be easily ascertained from the description in paragraph [004] of the secondary reference. Further qualitative and/or quantitative analysis of collagen in the test solution obtained in step 4 FIG 1 of the secondary reference (merely a routine detection of the content of specific collagen, which can be accomplished through routine laboratory experiments). Purification is also disclosed and the pretreatment method for detection of non-denatured Type II collagen in animal cartilage raw materials is obvious (see paragraph 2).
The tertiary reference discloses collagen is soaked with an acid solution, and slight ultrasound can accelerate the dissolution thereof, thereby preparing an aqueous collagen solution (see description, paragraph 7). Moreover, the fourth reference discloses a method for extracting a undenatured collagen, comprising: placing the collagen in a guanidine hydrochloride solution, stirring same, and centrifuging same to remove the supernatant to obtain a purified collagen (see claim 3). In addition, the tertiary reference discloses that the solubility of collagen in an acid solution can be promoted by means of ultrasound; and the fourth reference discloses that collagen is precipitated and extracted using guanidine hydrochloride. In addition, for a person skilled in the art, pepsin, papain, bromelain and elastase are all common enzymes for treating collagen in the art, which is common general knowledge in the art. In order to promote the solubility of a soluble undenatured type II collagen in an acid solution, it would have been obvious to a person skilled in the art to perform ultrasonic treatment in the acids welling treatment step of the primary reference, and to adjust the specific enzyme in combination with common general knowledge in the art. Therefore, claim 1 is obvious. Furthermore, the primary reference also discloses analyzing the obtained undenatured type I collagen by means of electrophoresis, spectrographical identification, a scanning electron microscope and a DSC method (see description, para. 28 & 30), thus claim 2 is obvious. One of ordinary skill in the art, adjusting the concentration of a buffer solution, ultrasonic parameters and enzymolysis parameters according to protein precipitation, re-dissolution and enzymolysis conditions is also a common technical means in the art. Using detection reagent components in a kit is a common technical means in the art. Therefore, claims 3-20 are obvious over the combined teaching of the references.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references renders the claims as obvious.
It would be obvious to one of ordinary skill in the art to modify the primary reference to include the teaching of the secondary and tertiary references as routine and conventional in the art and would have more beneficial effects. In addition, the references are considered to be analogous art, another motivation to combine.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 103 remains for the reasons stated above and herein and has been modified to reflect changes made to the claims. Applicant traverses the rejection stating that the invention is not merely directed to applying multiple enzymes. Rather, it addresses a specific technical problem not recognized in the prior art: the persistence of pepsin-resistant crosslinked components limiting extraction efficiency of non-denatured type II collagen (the claimed invention provides a coordinated sequential enzymatic protocol designed to overcome this problem. Applicant’s arguments are not persuasive because the method ‘comprises steps’ which means there maybe other steps not spelled out in the method and the language is therefore not closed. Note claim 12 for example that provides a ‘further limitation’ to step 4 in the method of claim 1. The art cited discloses the steps which would necessarily produce the same results even if the reasoning is different. However, note that the cited references provides a similar method to pretreat and detect non-denatured type II collagen, thus applicant’s arguments are not persuasive. Applicant argues that none of the references discloses or suggests the selective retention mechanism created by guanidine hydrochloride pretreatment. This argument is not persuasive because the references utilizes the same compound thus would produce the same effect whether discussed in the reference expressly or not. In addition, at least the secondary references provides such a disclosure, thus this argument is not persuasive. Applicant also cites KSR, however, KSR as indicated about makes room for inferences. In the instant case, inferences are not needed because the combined teaching of the references renders the claimed invention as obvious (CN101213308 teaches a method for separating collagen from animal tissues, preparing collagen solution from animal tissues, treating the collagen solution as outlined above). Note that rejection has been modified to incorporate the CN101213308 reference provided on the newly submitted IDS which provides for any discrepancy outlined by applicant, thus applicant’s arguments are not persuasive. According to the MPEP
“where information is submitted in an information disclosure statement during the period set forth in 37CFR 1.97 (c) with a fee, the examiner may use the information submitted, e.g., a printed publication or evidence of public use, and make the next Office action final whether or not the claims have been amended, provided that no other new ground of rejection which was not necessitated by amendment to the claims is introduced by the examiner. See MPEP609.04 (b)". Thus, this action is made final.
Conclusion
9. No claims are presently allowable.
10. Accordingly, THIS ACTION IS MADE FINAL. See MPEP ' 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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