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 .
This communication responds to the application and amended claim set filed April 17, 2023. Claims 1-10 are currently pending.
Priority
This application claims priority to TW111141222, filed October 28,2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Reyes et al. (Mediterranean Journal of Basic and Applied Sciences (MJBAS) Volume 4, Issue 2, Pages 93-104, April-June 2020) in view of Huang et al. (TW 202229419 A as listed on the IDS dated 7/14/2023, US2024/0398958 A1 is being used as English Translation herewith).
Regarding claim 1, Reyes et al. teach a crosslinked collagen polymer, wherein type I collagen is chemically crosslinked using an aqueous polyurethane dispersion synthesized by reacting polyethylene glycol and hexamethylenediisocyanate or isophoronadiisocyanate, thereby forming carbamate linkages between the collagen and polyether components (section 2, p.94 -95). Reyes et al. further teach the chemical crosslinking of collagen with polyurethane results in hydrogels with controlled degradation (3rd paragraph, p.94), which implies the hydrogels are suitable for wound treatment applications.
Reyes et al. are silent on the carboxymethylcellulose, sodium chloride, humectant and antimicrobial agents.
However, Huang et al. teach chemically crosslinked gelatin-based hydrogels for soft
tissue sealing and wound healing (abstract). It is noted that gelatin is natural polymer derived from collagen through hydrolysis. Huang et al. further teach the hydrogel composition comprises one or more excipients including water of hydration, carboxymethyl celluloses, sodium carboxymethylcellulose, sodium chloride [0186], antibacterial agents such as polyhexamethylene biguanide hydrochloride (which correspond to the antimicrobial agent) [0192] and polyols such as glycerol, propylene glycol [0184] (which corresponds to the humectant). Given that Reyes et al. teach hydrogels with controlled degradation, then the hydrogels would have been recognized as suitable for wound treatment applications (wound dressings). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the conventional wound-care additives as taught by Huang et al. into the hydrogel of Reyes et al. with the predictable result of improved moisture retention, antimicrobial protection and optimize handling and viscosity.
Regarding claim 2, Reyes et al. teach the hydrophilic polyether is polyethylene glycol (last paragraph, p.94), as required by the instant claims.
Regarding claim 3, the present claim is product by process claim reciting the steps of forming the dicarbamate group. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." (MPEP § 2113 (quoting In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).). If the prior art teaches the same product as the product formed by the process recited in the claims at issue, the claims are unpatentable. However, if the process of the claims at issue results in a product that is different from the product taught by the prior art, then the prior art does not teach the invention recited in the claims at issue.
Regarding claim 4, Reyes et al. teach the hydrogel composition, wherein the collagen is Type I collagen (Section 2.1, p.94), as required by the instant claim.
Regarding claim 5, Reyes et al. in view of Huang et al. are silent on the molar ratio of the collagen to the hydrophilic polyether.
However, Reyes et al teach the degree of crosslinking controls degradation (third paragraph, p.94). Increasing collagen content would increase the degradation. Increasing carbamate/polyether content would slower degradation. Thus, the molar ratio of the collagen to the hydrophilic polyether would be considered a result- effective variable by one of ordinary skill in the art before the effective filing date of the claimed invention that influences degradation (Section 2.1, p.94) and mechanical properties. As such, without showing unexpected results, the claimed molar ratio of collagen to the hydrophilic polyether cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the molar ratio of the collagen to the hydrophilic carbamate /polyether present in the hydrogel of Reyes et al. in view of Huang to reach the desired degradation and mechanical properties, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (See MPEP 2144.05(b).)
Regarding claim 6, Reyes et al. teach a hydrogel composition, wherein the collagen is present at approximately 0.6 wt.% of the total weight of the hydrogel composition (Table 1), as required by the instant claim.
Regarding claim 7, Reyes et al. in view of Huang et al. does not teach the claimed ranges for crosslinked collagen polymer as recited in the instant claim.
However, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05(II)(A).) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).) In this case, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized through routine experimentation the amount of crosslinked collagen to produce a hydrogel composition with the desired degradation and mechanical properties.
Regarding claim 9, Reyes et al. are silent on the amount of carboxymethylcellulose.
However, Huang et al. teach a hydrogel composition for wound treatment applications comprising carboxymethyl cellulose, wherein the hydrogel composition comprises polymer contents above 1 wt.% for wound healing applications, including excipients such as carboxymethyl cellulose ([0181], [0186]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the amount of carboxymethyl cellulose as taught by Huang et al. into the hydrogel composition of Reyes et al. to produce a hydrogel composition with the desire moisture and improve the tissue adherence and flexibility properties (see Hazzi , US 6,706,279 B1 col.3:4-10).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Reyes et al. (MJBAS, Volume 4, Issue 2, Pages 93-104, April-June 2020) in view of Huang et al. (TW 202229419 A, US2024/0398958 A1 is being used as English Translation herewith) as set forth above for claims 1-7, and further in view of Kirwood et al.(US2004/0241214 A1).
Regarding claim 8, Reyes et al. in view of Huang et al. teach the composition according to claim 1 as set forth above and incorporated herein by reference.
Reyes et al. in view of Huang et al. are silent on the amount of humectant.
However, Kirwood et al. teach a wound dressing formed from a water -swellable hydrogel composition (claim 8), wherein the composition comprises 5-50 wt.% of an humectant such as glycerol to help create a moist wound healing environment. It would have been obvious to one of ordinary skill to use the amount of humectant taught by Kirwood et al. into the hydrogel composition of Reyes et al. in view of Huang et al. to produce a hydrogel composition with the desired moisture retention. Further, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the overlapping portion of the range taught by Reyes et al in view of Kirwood et al.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Reyes et al. (MJBAS, Volume 4, Issue 2, Pages 93-104, April-June 2020) in view of Huang et al. (TW 202229419 A, US2024/0398958 A1 is being used as English Translation herewith) as set forth above for claims 1-7, and further in view of Hazzi (US 6,706,279 B1).
Regarding claim 10, Reyes et al. in view of Huang et al. teach the composition according to claim 1 as set forth above and incorporated herein by reference.
Reyes et al. in view of Huang et al. are silent on the concentration of aqueous sodium chloride solution.
However, Hazzi teaches a hydrogel matrix used as a wound dressing composition comprising a hydrocolloid component such as carboxymethylcellulose which retains moisture in the hydrogel and gives the hydrogel tissue adherence qualities; a salt component absorbed in the hydrogel such as sodium chloride at concentrations including 0.9 wt.% (col.1, 50-67, col.3:5-15, col.3:26). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the concentration of the sodium chloride salt as taught by Hazzi into the hydrogel composition of Reyes et al. in view of Huang et al. to produce a hydrogel composition with the desire antibacterial and wound healing properties (col.3:18-22).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA L. DONAHUE whose telephone number is (571)270-1152. The examiner can normally be reached M-F 8:00-5:00.
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/OLGA LUCIA DONAHUE/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763