DETAILED ACTION
Status of Application
Claims 1-21 are pending
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant’s election without traverse of Group I, claims 1-16, drawn to purified insoluble type II collagen fibers, as submitted in communication filed on 05/21/2026 is acknowledged.
Claims 17-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026.
Claims 1-16 are at issue and will be examined to the extent they encompass the elected invention.
Priority
Acknowledgment is made of applicant’s claim for domestic priority under 35 U.S.C. 119 (e) to provisional Application No. 63582686 filed on 09/14/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/10/2025 is acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 10 is objected to due to the recitation of “comprising less than 1% (w/w) of collagens”. It should be amended to recite “comprising less than 1% (w/w) of the collagens”. Appropriate correction is required.
Claim 11 is objected to due to the recitation of “comprising less than 0.5% (w/w) of collagens”. It should be amended to recite “comprising less than 0.5% (w/w) of the collagens”. Appropriate correction is required.
Claim 16 is objected to due to the recitation of “a hydrothermal shrinkage temperature of from 50°C to 70°C”. It should be amended to recite “a hydrothermal shrinkage temperature of 50°C to 70°C”. Appropriate correction is required.
Claim Rejections - USC § 112(d) or Fourth Paragraph (pre-AIA )
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7-9 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 7-9, dependent on claim 1, broaden the range of hydroxyproline due to the recitation of “comprising more than 13% (w/w) of the hydroxyproline”, “comprising more than 14% (w/w) of the hydroxyproline”, and “comprising more than 15% (w/w) of the hydroxyproline”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a) or First Paragraph (pre-AIA )
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 12 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated in MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow.
Claims 12 are directed in part to purified insoluble type II collagen fibers, wherein the collagen fibers are isolated from cartilage tissues of any animal cartilage and any type of animal, or any human cartilage.
Claim 15 is directed in part to purified insoluble type II collagen fibers, wherein the collagen fibers are isolated by any type genetic engineering technologies.
Claim 12 encompasses collagen fibers from any animal and from any human cartilage. The specification only discloses isolation from tissues that are knee joint articular cartilages and chicken sternum. Claim 15 encompasses a purified insoluble fiber isolated by any genetic engineering technology. The specification only discloses the isolation and purification of the intact type II collagen fibers for engineering ECM of the articular cartilage.
Due to the fact that the specification only discloses a limited amount of animal and human cartilage isolation, and a limited amount of genetic engineering technology, one of ordinary skill in the art would not recognize from the disclosure that Applicant was in possession of the claimed invention.
Claims 12 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the isolation of tissues that are knee joint articular cartilages and chicken sternums and the isolation and purification of the intact type II collagen fibers for engineering ECM of the articular cartilage, the specification does not reasonably provide enablement for (a) isolation from cartilage tissues of any animal cartilage or any human cartilage, or (b) isolation and purification of type II collagen fibers using any engineering technology. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2nd 1400 (Fed. Cir. 1988)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breadth of the claims. The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The breadth of the claims. Claims 12 and 15 broadly encompass a large genus of type II collagen fibers from any animal and from any human cartilage, and a purified insoluble fiber isolated by any genetic engineering technology. The enablement provided is not commensurate in scope with the claims due to the lack of knowledge regarding the (a) structure/identity of any collagen, and the (b) common features of the genetic engineering technologies, needed to be in scope of the claimed invention. In the instant case, the specification enables (a) isolation from tissues that are knee joint articular cartilages and chicken sternums and (b) the isolation and purification of the intact type II collagen fibers for engineering ECM of the articular cartilage.
The amount of direction or guidance presented and the existence of working examples. The specification discloses (a) isolation from tissues that are knee joint articular cartilages and chicken sternums and (b) the isolation and purification of the intact type II collagen fibers for engineering ECM of the articular cartilage. However, the specification fails to provide any clue as to the structural elements required in any animal species, any animal collagen, or any human collagen. Furthermore, specification fails to provide any clue as to the methodological elements required in any genetic engineering method.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art. The type of collagen determines its structural properties, functional properties, and purity. While the art discloses a limited number of purified insoluble type II collagen fibers with high purity neither the specification nor the art provides a correlation between structure, function, and purity such that one of skill in the art can envision any type of animal and collagen location for isolation using any type of genetic engineering. Accordingly, one of ordinary skill in the art would not be able to predict which source of tissues, animal species, or genetic engineering would yield the claimed invention.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While methods of determining agents’ ability to inhibit proteins activity were known in the art at the time of the invention, it was not routine in the art to screen by a trial and error process for an essentially infinite number of animals, animal/human cartilage, and genetic engineering technologies to prepare the type II collagen with the desired characteristics. In the absence of (i) a rational and predictable scheme for selecting those animals and animal/human cartilage, most likely to have the desired characteristics, (ii) a rational and predictable scheme for selecting genetic engineering technologies, one of skill in the art would have to test an infinite number of number of animals, animal/human cartilages, and genetic engineering technologies.
Therefore, taking into consideration the extremely broad scope of the claim, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between animal/human cartilages types, and the desired characteristics, and the high degree of unpredictability, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, Applicant has not provided sufficient guidance to enable one of ordinary skill in the art to make and use the invention in a manner reasonably correlated with the scope of the claims.
Claim Rejections - 35 USC § 103 (AIA )
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.
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.
Claims 1-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over GANSU TIANJI BIOTECHNOLOGY CO., LTD (CN113527466 published 10/22/2021; hereby "GTB"), in view of MARINE BIOMEDICAL RES INSTITUTE OF QINGDAO (CN113185603A published 07/30/2021; hereby “QINGDAO”) and INST FOOD SCIENCE & TECH CAAS; DELISI GROUP LTD (CN111004320 published 04/14/2020; hereby “Delisi”), and evidenced by Cundy et al (Clinical Biochemistry: Metabolic and Clinical Aspects (Third Edition), 2014, Pages 604-635, Chapter 31-Metabolic bone disease).
GTB teaches a method of preparing purified type II collagen (Page 2, line 5-10). GTB teaches that the type II collagen has a purity of 99.90% (Table 3). It is noted that the collagen taught by GTB has a purity level of 99.90%, meaning that any other component of the collagen is an amount less than 0.1%.GTB does not teach of purified insoluble type II collagen fibers comprising less than 50 ng/mg of nucleic acid molecules and hydroxyproline between 12.5% (w/w) to 15.5% (w/w).
QINGDAO teaches that low immunogenic, medical grade collagen has less than 300 ng/mg of DNA (Page 2, line 23-24). Delisi teaches an extraction method of type II collagen in chicken sternum cartilage (Figure 1). Delisi teaches that the extraction method had hydroxyproline content of 142.74 residues / 1000 amino acid residues (Table 2). Hydroxyproline is a major component of fibrillar collagen of all types, comprising ~14% of the total amino acid content as evidenced by Cundy (Page 14, last paragraph).
Claims 1-12 and 14 are directed in part to purified insoluble type II collagen fibers, comprising: less than 0.6%, less than 0.3%, or less than 0.1% of (w/w) uronic acid, less than 50 ng/mg, less than 30 ng/mg, or less than 10 ng/mg of DNA and/or RNA, from 12.5% (w/w) to 15.5% (w/w) of hydroxyproline, more than 97% (w/w) of type II collagen, and less than 1%, or less than 0.5% (w/w) of collagens other than type II collagen and glycosaminoglycans (GAGs); wherein the collagen fibers are isolated from cartilage tissues of animals or humans; wherein the tissues are chicken sternum. It is noted that the term “less than…” is anything under the recited amount, including an amount of 0.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare purified insoluble type II collagen fibers from chicken sternum, having the recited ranges of DNA molecules and the recited range of hydroxyproline. A person of ordinary skill in the art is motivated to isolate collagen from chicken sternum because Delisi teaches that chicken sternum cartilage is a known source of type II collagen. A person of ordinary skill in the art is motivated to further purify the type II collagen of GTB because lower DNA content will reduce the immunogenicity of collagen. One of ordinary skill in the art has a reasonable expectation of success at arriving at purified insoluble type II collagen fibers having the claimed characteristics because all that is required is preparing the collagen taught by GTB with the residual DNA content taught by QINGDO and using a common collagen source. It is noted that contaminant levels can be optimized through routine experimentation. 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.
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over GANSU TIANJI BIOTECHNOLOGY CO., LTD (CN113527466 published 10/22/2021; hereby "GTB"), MARINE BIOMEDICAL RES INSTITUTE OF QINGDAO (CN113185603A published 07/30/2021; hereby “QINGDAO”) and INST FOOD SCIENCE & TECH CAAS; DELISI GROUP LTD (CN111004320 published 04/14/2020; hereby “Delisi”) as applied to claims 1 and 12 above, and further in view of Collagen Matrix, Inc. (US20220105239A1 published 04/07/2022; hereby “CMI”).
The teaching of GTB, QINGDAO, and Cundy have been discussed above. GTB, QINGDAO, and Cundy do not teach that the tissues are from knee joint articular cartilages. GTB, QINGDAO, and Delisi do not teach that the collagen fibers have stability as measured by a hydrothermal shrinkage temperature of from 50°C to 70°C.
CMI teaches a method for producing collagen fibers from the meniscus (Page 1, [0009]). CMI teaches a hydrothermal temperature of 56.9°C (Table 2).
Claim 13 is directed in part to the type II collagen fibers of claim 12, wherein the tissues are knee joint articular cartilages. Claim 16 is directed in part to the type II collagen fibers of claim 1, wherein the collagen fibers have stability as measured by a hydrothermal shrinkage temperature of 50°C to 70°C.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the purified type II collagen fibers of GTB, as modified by QINGDAO and Delisi, from knee joint articular cartilage and obtain collagen fibers having a hydrothermal shrinkage temperature within the recited range. A person of ordinary skill in the art is motivated to utilize knee joint articular cartilage because CMI teaches that meniscus tissue is a known source of collagen fibers. One of ordinary skill in the art has a reasonable expectation of success at arriving at preparing purified type II collagen fibers from the meniscus because that that is required is selecting a known cartilage source for type II collagen. Regrading claim 16, one of ordinary skill in the art has a reasonable expectation of success at arriving at a hydrothermal shrinkage temperature of 50°C to 70°C because CMI teaches a hydrothermal shrinkage temperature within the range. 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over GANSU TIANJI BIOTECHNOLOGY CO., LTD (CN113527466 published 10/22/2021; hereby "GTB"), MARINE BIOMEDICAL RES INSTITUTE OF QINGDAO (CN113185603A published 07/30/2021; hereby “QINGDAO”) and INST FOOD SCIENCE & TECH CAAS; DELISI GROUP LTD (CN111004320 published 04/14/2020; hereby “Delisi”) as applied to claim 1 above, and further in view of Collagen Protein Wuhan Biotechnology (CN115819557 published 03/21/2023; hereby “CPWB”).
The teaching of GTB, QINGDAO, and Cundy have been discussed above. GTB, QINGDAO, and Delisi do not teach that the collagen fibers are isolated by genetic engineering technologies.
CPWB teaches the gene engineering of triple helix recombinant humanized II type collagen, preparation method and application thereof (Page 1, Technical Field). CPWB teaches the gene engineering bacteria expression system of triple helix recombinant humanized II type collagen is simple and convenient; it is easy to realize scale production (Page 2, lines 48-52). CPWB teaches that high biological activity of triple helix recombinant humanized II type collagen protein can be widely applied to artificial bone, artificial cartilage, artificial eye cornea vitreous body, medical appliance, healthcare product and so on (Page 1, lines 27-30).
Claim 15 is directed in part to the type II collagen fibers of claim 1, wherein the collagen fibers are isolated by genetic engineering technologies.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the purified type II collagen fibers of GTB, as modified by QINGDAO and Delisi, using genetic engineering technologies as taught by CPWB. A person of ordinary skill in the art is motivated to utilize the genetic engineering technologies because CPWB teaches that genetic engineering facilitates scale production of collagen. One of ordinary skill in the art has a reasonable expectation of success at arriving at utilize the genetic engineering technologies to isolate collagen because all that is required is incorporating the genetic engineering technology taught by CPWB to prepare the purified type II collagen fibers of GTB. 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.
Conclusion
No claim is in condition for allowance.
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/S.L.S./ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652
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