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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 12/19/2025 in response to the Non-Final Rejection mailed on 9/19/2025 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1, 3-11 are pending.
Claims 7-9 are withdrawn from consideration pursuant to 37 CFR 1.142(b).
Claims 2, 12 is cancelled.
Claims 1, 3-6, 10-11 are pending.
Applicant’s remarks filed on 12/19/2025 in response to the Non-Final Rejection mailed on 9/19/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Rejections
The rejection of claim 3 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of Applicant’s amendment of claim 3 to recite ‘wherein the optional substance is at least one selected from the group consisting of Ca2+, Na+, Cl-, calcium carbonate (CaCO3), and fibroblast growth factor (bFGF).’
The rejection of claims 1, 3-6, 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Morimoto et al (WO2015167003A1, Date Published: 2015-11-05, cited on IDS filed 9/9/2021) {herein Morimoto} as evidenced by Hao et al (2025, Reactive and Functional Polymers 209, cited on PTO-892 dated 9/19/2025) {herein Hao} is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘wherein said collagen solid is a freeze dried collagen solid.’
The rejection of claims 12 under 35 U.S.C. 103 as being unpatentable over Morimoto et al (WO2015167003A1, Date Published: 2015-11-05, cited on IDS filed 9/9/2021) {herein Morimoto} as applied to claims 1, 3-6, 10-11 in view of Varley et al (2016, Acta Biomaterialia, cited on PTO-892 dated 9/19/2025) {herein Varley} as evidenced by Hao et al (2025, Reactive and Functional Polymers 209, cited on PTO-892 dated 9/19/2025) {herein Hao} is withdrawn in view of cancellation of claim 12.
New 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-6, 10-11 are newly rejected under 35 U.S.C. 103 as being unpatentable over Morimoto et al (WO2015167003A1, Date Published: 2015-11-05, cited on IDS filed 9/9/2021) {herein Morimoto} in view of Varley et al (2016, Acta Biomaterialia, cited on PTO-892 dated 9/19/2025) {herein Varley} as evidenced by Hao et al (2025, Reactive and Functional Polymers 209, cited on PTO-892 dated 9/19/2025) {herein Hao}. The new rejection is necessitated by Applicant’s amendment of claim 1 to recite ‘wherein said collagen solid is a freeze dried collagen solid’ and cancellation of claim 12.
As amended, claims 1, 3-6, 10-11 are drawn to a collagen solid, comprising a collagen-cysteine protease degradation product or an atelocollagen-cysteine protease degradation product, wherein: said collagen solid has a density of 50 mg/cm3 or more; each of the collagen-cysteine protease degradation product and the atelocollagen-cysteine protease degradation product includes a triple helical domain of collagen; the triple helical domain includes at least 100 amino acid sequences represented by Gly-X-Y (where each of X and Y is any amino acid); in each of the collagen-cysteine protease degradation product and the atelocollagen-cysteine protease degradation product, three polypeptide chains form a helical structure; and said collagen solid has a tangent modulus of 90 kPa or more, wherein said collagen solid is a freeze dried collagen solid.
With respect to claims 1, 4, 11, Morimoto teaches a cysteine protease that cleaves collagen at a site within its helical domain, thereby producing a collagen comprising a collagen-cysteine protease degradation product (page 2, para 5 and para 11). The collagen of the invention is obtained from biological tissue such as dermis, tendons, bones or fascia of mammals or birds, skin or scales of fish (page 11, para 9). It is well-known in the art that said tissues are biomaterial as they are comprised of organic matter. Morimoto further teaches the collagen and atecollagen degradation products are comprised on triple helical domains (page 2, para 6). Morimoto further teaches the triple helical domain is comprised of at least 100 amino acids sequences represented by consecutive Gly-X-Y (page 1, para 5). One collagen molecule is composed of three polypeptide chains, of which form helical structures (page 1, para 4).
With respect to claim 3, Morimoto teaches the addition of sodium chloride to the degradation product obtained by treating collagen or atelocollagen with protease (page 1, para 8). The specific structure of the salt is not particularly limited, but chloride is preferably used (page 10, para 7).
With respect to claim 5, Morimoto teaches collagen used in the present invention include animal dermis, tendons, bones, and fascia such a mammals such as cattle, pigs, and rabbits, birds such as chicken, etc (page 3, para 5). Absent evidence otherwise, it is the Examiner’s position that collagen from animal dermis, tendons, bones, and fascia such as mammals such as cattle, pigs, and rabbits, birds as ex vivo material since said collagen is tissue taken from living organisms to be studied in a controlled laboratory environment, outside of the body.
With respect to claim 6, Morimoto teaches collagen decomposition product with human mesenchymal stem cells (page 19, para 10). Absent evidence otherwise, it is the Examiner’s position that the stem cells as being bone regeneration material as it is known by those of ordinary skill in that art that stem cells can differentiate into bone-forming cells.
However, Morimoto does not teach wherein: said collagen solid has a density of 50 mg/cm3 or more; said collagen solid has a tangent modulus of 90 kPa or more, wherein said collagen solid is a freeze dried collagen solid (claim 1). Morimoto does not teach wherein: said collagen solid has a disk shape, a tube shape, a columnar shape, a conical shape, an arrowhead shape, a hexahedral shape, a polyhedral shape, a polygonal column shape, a bellows shape, a screw shape, a male screw shape, a female screw shape, or a shape in which two or more of these shapes are connected to each other, or said collagen solid is in a form of powder (claim 10). Morimoto does not teach wherein said collagen solid has a cube shape (claim 11).
With respect to claim 1, Varley teaches freeze drying collagen to increase the stiffness and permeability of the collagen product (page 174, column 1, para 2).
With respect to claims 1, 10-11, given that Morimoto in view of Varley teaches the claimed structure of a freeze-dried collagen solid comprising a collagen-cysteine protease degradation product and atelocollagen-cysteine protease degradation product, said product would necessarily encompass a density of 50 mg/cm3 or more (claim 1), have a tangent modulus of 90 kPa or more (claim 1), have a cubed shape (claim 11); a disk shape, a tube shape, a columnar shape, a conical shape, an arrowhead shape, a hexahedral shape, a polyhedral shape, a polygonal column shape, a bellows shape, a screw shape, a male screw shape or a female screw shape (claim 10). Furthermore, absent evidence otherwise, it is the Examiner’s position that one skilled in the art, would be able to make products of varying densities, at a tangent modulus and different shapes as the method of Morimoto would not preclude anyone from making these types of products.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Morimoto et al. of a cysteine protease that cleaves collagen at a site within its helical domain, thereby producing a collagen solid comprising a collagen-cysteine protease degradation product (page 2, para 5) or combine the teachings of Varley et al because Varley teaches freeze drying collagen to increase the stiffness and permeability of the collagen product (page 174, column 1, para 2).
One of ordinary skill in the art would be motivated to either use the teachings of Morimoto et al. by itself or combine the teachings of Varley because Varley provides the motivation for Morimoto to freeze-dry the collagen-cysteine protease degradation product as doing so has implications for both the stiffness and permeability of the product (Varley: page 174, column 1, para 2). One of ordinary skill in the art knowing the benefit of collagen based on the teachings Morimoto and Varley would have a reasonable expectation of success to try freeze-dry the collagen solid taught by Morimoto as Varley teaches that freeze-drying collagen increases the permeability of collagen product (page 167, column 1, para 3). It is known by those of ordinary skill in the art that increasing the permeability of collagen allows it to dissolve better in liquids, primarily by enabling faster hydration and allowing water molecules to access the collagen backbone more effectively as collagen is inherently hydrophilic, but its compact molecular structure can cause it to clump when added to liquids, especially cold ones, rather than dissolving smoothly. As such, said freeze-dried collagen product would exhibit a longer shelf-life and be easily dissolved for utilization on the skin, as taught by Morimoto. MPEP 2143.I. E states ‘The rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397.’ Furthermore, Varley teaches freeze-drying is a well-established method (page 166, column 2, para 1). Morimoto would be motivated to freeze-dry the collagen solid as it is known by those of ordinary skill in the art that freeze-drying extends the shelf-life of substances thereby reducing the costs associated with having to generate additional collagen solid due to spoilage or contamination.
One of skill in the art would have a reasonable expectation of success to make and use the claimed collagen solid because Morimoto provides the basic collagen solid and its uses and methods of making it. Reference of Varley provides the teachings for freeze-drying collagen to increase the strength and permeability of collagen product (page 166, column 2, para 1). Therefore there would be a reasonable expectation of success to arrive at the above invention. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
RESPONSE TO REMARKS: Beginning on p. 6 of Applicant’s remarks, Applicant contends that the rejection has been addressed by amendment. In summary, Applicant contends that patent Literature 3 (Morimoto) does not disclose a concept of concentrating the degradation product into a highly dense solid.
This argument is found to be not persuasive. Examiner contends that ‘a highly dense solid’ is subjective and not defined by Applicant. As such, said limitation is not a requirement of the claims within the instant application.
Applicant contends that Patent Literature 3 (Morimoto) does not disclose a tangent modulus of the solid... Applicant contends that Morimoto does not provide any guidance as to how to achieve any type of collagen solid, let alone a freeze dried collagen solid having both a density of 50 mg/cm3 or more and a tangent modulus of 90 kPa or more, as presently claimed.
This argument is found to be not persuasive. Examiner contends that given that Morimoto in view of Varley teaches the claimed structure of a freeze-dried collagen solid comprising a collagen-cysteine protease degradation product and atelocollagen-cysteine protease degradation product, said product would necessarily encompass a density of 50 mg/cm3 or more, have a tangent modulus of 90 kPa or more, have a cubed shape; a disk shape, a tube shape, a columnar shape, a conical shape, an arrowhead shape, a hexahedral shape, a polyhedral shape, a polygonal column shape, a bellows shape, a screw shape, a male screw shape or a female screw shape.
Applicant contends that the specific selection of insoluble type I collagen and GAGs, as well as the specific selection of fabrication conditions, is important to the intended purpose of Varley for generating scaffolds with improved permeability to support cell growth. In contrast, the intended purpose of Morimoto is to generate liquid collagen compositions for application to human skin.
This argument is found to be not persuasive. Examiner contends that Morimoto teaching the collagen degradation product in a liquid form does not render the claims nonobvious. Especially since Applicant amended claim 1 to ‘wherein said collagen solid is a freeze dried collagen solid.’ As such, said ‘solid collagen’ is not in a solid form until it is freeze dried, upon which Examiner relied upon Varley to teach.
Applicant contends that given that the liquid compositions of Morimoto and the scaffolds of Varley are structurally and functionally completely different in nature, one skilled in the art would not be motivated to apply the teachings of one to the other, let alone with a reasonable expectation of success.
This argument is found to be not persuasive. Examiner contends that Varley provides Morimoto the motivation to freeze dry the collagen degradation product especially since Varley teaches freeze-drying is a well-established method (page 166, column 2, para 1). Additionally, Varley teaches freeze drying collagen has implications for both the stiffness and permeability of the product (Varley: page 174, column 1, para 2). Increasing the permeability of collagen allows it to dissolve better in liquids, primarily by enabling faster hydration and allowing water molecules to access the collagen backbone more effectively. As such, Morimoto would be motivated to try freeze drying the collagen of the invention as one of ordinary skill in the art would expect it to improve both the stiffness and permeability of the product to allow for long term storage and easier solubility as collagen is inherently hydrophilic, but its compact molecular structure can cause it to clump when added to liquids, especially cold ones, rather than dissolving smoothly.
Applicant contends that Morimoto is completely silent and further fails to provide any guidance or suggestion as to how to make and use a scaffold with insoluble type I collagen and GAGs.
This argument is found to be not persuasive. Examiner contends that Applicant is not claiming how to make and use a scaffold with insoluble type I collagen and GAGs. As such, said limitation is not a requirement of the instant application.
Applicant contends that Varley teaches, e.g., at page 167, that "Young's moduli of freeze-dried (wet and dry) scaffolds tends to be very low - typically - 1-40 kPa, with values usually towards the lower end of the range when wet." As such, one of skill in the art would generally appreciate that the strength of a collagen product is reduced by freeze-drying. one of skill in the art would not likely look to the methods of Varley when seeking to improve the strength of a collagen product, and would certainly not be motivated to perform the freeze-drying disclosed in Varley on the collagen degradation product of Morimoto, let alone with a reasonable expectation of success in achieving a freeze dried collagen solid having both a density of 50 mg/cm3 or more and a tangent modulus of 90 kPa or more, as presently claimed.
This argument is found to be not persuasive. Examiner contends that freeze-drying is a well-established method (Varley: page 166, column 2, para 1). Examiner contends that based on Applicant’s own admission, freeze-drying collagen does provide additional strength with the recitation of ‘"Young's moduli of freeze-dried (wet and dry) scaffolds tends to be very low - typically - 1-40 kPa, with values usually towards the lower end of the range when wet." As such, Morimoto would be motivated to freeze dry the collagen degradation product of the invention as, based on ‘Young’s moduli’ and the teaching of Varley, one of ordinary skill in the art would expect the strength of the freeze-dried collagen to be improved since based on Young’s moduli the kPa value is higher when the collagen degradation product is dry, as opposed to wet.
Applicant contends that even if one skilled in the art were to consider the teachings of Varley in looking to modify the teachings of Morimoto, it is unclear why one skilled in the art would seek to perform freeze- drying on the liquid compositions of Morimoto, particularly where Morimoto teaches the importance of maintaining a liquid format for applications to human skin. Applicant contends that given that the liquid compositions of Morimoto and the scaffolds of Varley are structurally and functionally completely different in nature, one skilled in the art would not be motivated to apply the teachings of one to the other, let alone with a reasonable expectation of success.
This argument is found to be not persuasive. Examiner contends that Morimoto would be motivated to try freeze drying the collagen product as doing so strengthens the product and would increase its shelf-life (Varley: page 174, column 1, para 2). Examiner contends that the collagen product being a liquid, as taught by Morimoto, does not render the freeze drying of said product to be unobvious. Especially since it is known by those of ordinary skill in the art that freeze drying of liquid products is routinely done in the art.
Conclusion
Status of Claims
Claims 1, 3-6, 10-11 are pending.
Claims 7-9 are withdrawn from consideration pursuant to 37 CFR 1.142(b).
Claims 2, 12 is cancelled.
Claims 1, 3-6, 10-11 are rejected.
No claims are in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 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 ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656