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 .
Claim Status
Claims 1-6, 8-9, 11-12, 14, and 16-20 are pending.
Claim 1 is currently amended.
Claims 7. 10, 13, 15, and 21-22 are canceled.
Claims 14 and 16-20 are withdrawn as being directed to a non-elected invention, the election having been made on 12/21/2022.
Claims 1-6, 8-9, 11-12 have been examined.
Priority
This application claims foreign priority of SINGAPORE 10202003504W filed on 04/16/2020.
Withdrawn Rejection
The rejection of claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn because claim 22 has been cancelled.
New Ground of Rejection
Claim Rejections - 35 USC § 112
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 1-6, 8-9, 11-12 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is NEW ATTER rejection.
The amendment to claim 1 includes a limitation “wherein a limitation of the crosslinked polymer matrix is free of a separate non-collagen scaffold” is not support by the original specification of record. Claims 2-6, 8-9, 11-12 are rejected as depending on claim 1.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 608.04(a).
Modified Rejection
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.
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.
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.
1. Claims 1-6 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (CN 106075576A, previously cited 1/31/2023) in view of Wang et al. (J Mater Sci: Mater Med (2016) 27:45, previously cited 9/8/2023).
Claim 1 is drawn to a polymeric material comprising
a cross-linked non-mammalian type I collagen;
wherein-1, the non-mammalian collagen derived from bullfrog skin has a denaturation temperature that is higher than human body temperature and is derived from bullfrog skin,
Wherein-2, the polymeric material forms a wound dressing,
Wherein-3, the non-mammalian collagen has a fiber diameter of 20 nm to 25 nm, and
wherein-4, either crosslinked polymer matrix is free of non-collagen scaffold
scaffold.
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Yan et al. teach a collagen sponge as biomedical materials (p11, Technical field) for promoting wound healing and tissue repair (p11, para 3). Yan et al. teach the collogen is purified from mammalian skin (p13, para 2). Yan et al. teach the polymer material of collagen sponge further comprising carboxymethyl cellulose as a scaffold or filler (not scaffold) to prevent the material from collapsing after absorption and provide an expansion support effect (p11, last para/Summary of invention), reading on a polymer for cross-linking to collagen without a non-collagen scaffold. Yan et al. further teach the crosslinking agent as glutaraldehyde or an epoxy compound crosslinking agent of 1,4- butane Alcohol di(de)hydroglycidyl ether as follows (p12, para 6).
Yan et al. did not teach a collagen as a type I collagen derived from bullfrog skin.
Similarly, Wang et al. teach collagen has wide applications in tissue engineering either on its own, or in combination with other biomaterials for wound dressings known in the art (p2, col 1, para 3), consistent with Yang et al. Thus, one of ordinary skill in the art would have found it obvious to either cross-link collagen on its own (without other non-collagen scaffold) or cross-link collagen with additional biomaterials (e.g., filler instead scaffold) to make a wound dressing. Wang et al. teach commercial collagen from bovine or porcine contain infectious agents including bovine spongiform encephalopathy (BSE), transmissible spongiform encephalopathy (TSE) and foot and mouth disease (FMD) (p2, col 1, para 3). Wang et al. further suggest beneficial use of non-mammalian collagen source from bullfrog skin-derived collagen (BFCOL) to replace mammalian collagen and prevent the risk of contaminated infectious agents in biomedical materials (p2, col 1, para 3). Wang et al. teach the collagen purified from bullfrog skin are fibrous type I collagen (p6, col 2, Results 3.1 Characterisation and confirmation of extraction of Type I collagen). Wang et al. further show the denaturation temperature of fibrous
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type I collagen of bullfrog skin-derived collagen (BFCOL) purified by acid solubilization method (p3, col 1, Sec 2.2 Isolation and purification of collagen from fish scales and bullfrog skin) has a skin denaturation temperature that is at about 40ºC and is inherently higher than human body temperature of 37ºC shown above (Supplementary Data, Fig S4), reading on the limitation (i) and wherein-1.
With respect to the wherein-2, Wang et al. teach collagen has wide applications in tissue engineering either on its own, or in combination with other biomaterials for making wound dressings and other common use known in the art (p2, col 1, para 3),
With respect to the wherein-3, Wang et al. teach the collagen isolated from bullfrog skin is fibrous type I collagen (p6, col 2, 3.1 Characterisation and confirmation of extraction of Type I collagen) purified via acid solubilization method instead of pepsin solubilized treatment to prevent the conversion of collagen into monomeric subunits by pepsin (p2, col 2, para 2), demonstrating Wang’s purified type I collagen of bullfrog is naturally-occurring skin-derived bullfrog collagen. The specification disclosed naturally-occurring skin-derived bullfrog collagen has significant smaller fibre diameter at approximately 20-25 nm [0062]. Applicant further admitted that the diameter of an individual fiber as recited in the claim will not change by crosslinking of collagen in the Remarks (p7, claim rejection – 35 USC § 112, para 3, dated 1/13/2025). Therefore, Wang’s purified naturally-occurring type I collagen from bullfrog inherently has a fiber diameter of 20 nm to 25 nm as claimed.
With respect to the wherein-4, Wang et al. teach collagen has wide applications in tissue engineering on its own for wound dressings (p2, col 1, para 3), reading on crosslinked polymer matrix is free of non-collagen scaffold.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to replace collagen source of Yan’s cross-linked collagen sponge complex with Wang’s non-mammalian bullfrog skin-derived collagen (BFCOL) because Wang et al. teach commercial collagen from bovine or porcine contain infectious agents including bovine spongiform encephalopathy (BSE), transmissible spongiform encephalopathy (TSE) and foot and mouth disease (FMD) (p2, col 1, para 3) and further suggest beneficial use of non-mammalian collagen source from bullfrog skin-derived collagen (BFCOL) to replace mammalian collagen and prevent the risk of contaminated infectious agents in biomedical materials (p2, col 1, para 3). The combination would have reasonable expectation of success because Wang et al. teach collagen has wide applications in tissue engineering on its own for wound dressings known in the art (p2, col 1, para 3).
With respect to claims 2-5, Yan et al. further teach the pharmaceutically acceptable crosslinking agent as glutaraldehyde or an epoxy compound crosslinking agent of 1,4- butane Alcohol di(de)hydroglycidyl ether (p12, para 6).
With respect to claim 6, Yan et al. teach the mass ratio of a crosslinking agent may be 0.05% to 5% (p12, para 6).
With respect to claims 11-12, Yan et al. teach a collagen sponge as the polymer material (p11, Technical field).
Applicant’s Arguments
The amendment to claim 1 overcomes the rejection of record for the reasons as follows: (i) Yan et al. does not teach a collagen as a type I collagen derived from bullfrog skin (Remarks, p11, para 3-4)
Wang et al. at most teaches that both fish and bullfrog with no preference to either one and there is no teaching or suggestion in Wang et al. on the superior wound re-epithelialization and granulation properties associated with the presently claimed invention (Remarks, p11, last para to p12, para 1).
Wang's purified naturally occurring type I collagen from bullfrog inherently has a fiber diameter of 20 nm to 25 nm as claimed. Applicant respectfully submits that this feature is not merely arbitrary - it is the nanofibrillar (tropocollagen) assembly that confers the superior advantages demonstrated to the claimed invention (Remarks, p12, para 3).
Example 1 of Yan et al. discloses a collagen sponge comprising a polymer matrix formed by crosslinking collagen with 1,4-butanediol glycidyl ether while Examples 1 and 2 disclose collagen sponges comprising a sodium carboxymethyl cellulose scaffold. Thus, it is clear that Yan et al. teaches away from the currently claimed polymeric matrix free of a non-collagen scaffold.
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive for the reasons as follows.
Applicant’s argument (i) is not persuasive because the rejection is based on Yan et al. in view of Wang et al. not a single reference of Yan et al. as argued by applicant. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). See MPEP 2145(IV).
Applicant’s argument (ii) is not persuasive because (a) Wang et al. explicitly teach collagen isolated from bullfrog; thus, it would be obvious to select bullfrog collagen from a finite number of identified non-mammalian collagen. Wang et al. further suggest beneficial use of non-mammalian collagen source from bullfrog skin-derived collagen (BFCOL) to replace mammalian collagen and prevent the risk of contaminated infectious agents in biomedical materials (p2, col 1, para 3). It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144(IV).
Applicant’s argument (iii) is not persuasive because Wang et al. teach the collagen isolated from bullfrog skin is fibrous type I collagen (p6, col 2, 3.1 Characterisation and confirmation of extraction of Type I collagen) purified via acid solubilization method instead of pepsin solubilized treatment to prevent the conversion of collagen into monomeric subunits by pepsin (p2, col 2, para 2), demonstrating Wang’s purified type I collagen of bullfrog is naturally-occurring skin-derived bullfrog collagen. The specification disclosed naturally-occurring skin-derived bullfrog collagen has significant smaller fibre diameter at approximately 20-25 nm [0062]. Applicant further admitted that the diameter of an individual fiber as recited in the claim will not change by crosslinking of collagen in the Remarks (p7, claim rejection – 35 USC § 112, para 3, dated 1/13/2025). Therefore, Wang’s purified naturally-occurring type I collagen from bullfrog inherently has a fiber diameter of 20 nm to 25 nm as claimed. “Prima Facie Obviousness Is Not Rebutted by Merely Recognizing Additional Advantages or Latent Properties Present But Not Recognized in the Prior Art”. See MPEP 2145(II).
Applicant’s argument (iv) is not persuasive because Yan et al. did not teach a crosslinked collagen “must” contain non-collagen scaffold materials and Yan’s teachings are not limited to the enabled examples as argued by applicant. In particular, Yan et al. suggest collagen sponge further comprising filler (not scaffold) to prevent the material from collapsing after absorption and provide an expansion support effect (p11, last para/Summary of invention). Similarly, Wang et al. teach collagen has wide applications in tissue engineering either on its own, or in combination with other biomaterials for wound dressings known in the art (p2, col 1, para 3), consistent with Yang et al. Since collagen can be used on its own without a non-collagen scaffold and collagen can further include filler for another embodiment, the examiner does not find any evidence of Yan et al. teaching away this invention.
2. Claims 1-6, 8-9, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. in view of Wang et al. as applied to claims 1-6, 11-12 and further in view of Cardoso et al. (Journal of Nanobiotechnology 2014, 12:36, previously cited 1/31/2023).
Claims 8-9 are directed to the polymeric material further comprising an antibacterial compound of silver nanoparticles.
Yan et al. in view of Wang et al. suggest a cross-linked non-mammalian type I collagen polymer matrix used for drug delivery (Yang et al. p12, para 3-4; Wang et al. p2, col 1, para 3).
Yan et al. in view of Wang et al. do not teach the collagen polymer matrix further comprising an antibacterial compound.
Cardoso et al. teach “Collagen-based silver nanoparticles for biological applications: synthesis and characterization” (Title). Cardoso et al. teach synthesis of silver nanoparticles (AgNPs) stabilized with type I collagen (AgNPcol) to build a nanomaterial with biological utility (Abstract-Background). Cardoso et al. teach the ability of AgNPs to control bacterial activity relies on the interactions with three major structural components of the bacteria: namely peptidoglycan in the cell wall, DNA, and proteins, by mainly affecting the enzymes involved in the electron transport chain (p2, col 1, para 4-5). Cardoso et al. further teach AgNPcol (1:6 molar ratio) for inhibiting the growth of bacteria was comparable to that of AgNO3 (p5, col 1, para 2) shown in Table 2 as follows (p5, Table 2), reading on claims 8-9.
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One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Yan et al. in view of Wang et al. with Cardoso’s silver nanoparticles because (a) Yan et al. in view of Wang et al. suggest the use of a crosslinked bullfrog type I collagen polymer matrix for drug delivery (Yang et al. p12, para 3-4; Wang et al. p2, col 1, para 3) and (b) Cardoso et al. teach silver nanoparticles (AgNPs) beneficially stabilized by type I collagen (AgNPcol) to build a nanomaterial with anti-bacterial activity (Abstract-Background; p5, col 1, para 2; p5, Table 2). The combination would have reasonable expectation of success because the references teach a collagen scaffold for drug delivery.
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive. See Response to arguments above.
Conclusion
No claim is allowed.
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.
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/J.L/Examiner, Art Unit 1658
31-July-2026
/Melissa L Fisher/
Supervisory Patent Examiner, Art Unit 1658
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