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 .
Priority
The instant application was filed 28 June 2024 and is the national stage entry of PCT/CN2022/097924 filed 09 June 2022. The Applicant claims priority to foreign application CN201111669589.0 filed 31 December 2021. An English copy of the foreign document has not been provided. Therefore, the effective filing date of the instant application is 09 June 2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “Poloxamer F68” as well as other poloxamer compounds. It is not clear if the Applicant meant Pluronic F68, which is synonymous with Poloxamer 188. The metes and bounds of the limitation cannot be determined. The claim is herein interpreted as Pluronic and Poloxamer as interchangeable terms. The Applicant is advised to clarify the correct “Poloxamer” compound.
Claim 9 contains the trademark/trade names Baymedix ®FP504, VORANATE™ T-80, and WanCURE TP611. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a type of polyurethane prepolymer and, accordingly, the identification/description is indefinite.
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.
Claim(s) 1-5, 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sessions (WO 03097727 A1; cited in IDS).
Regarding claim 1, Sessions teaches a polyurethane foam composition (abs, entire teaching, para. 14) comprising polyurethane prepolymer (Ingredient B) (para. 17), silver metal oxide (antibacterial agent) (para. 40), methylcellulose (suspending agent) (para. 37), polyethylene glycol (wetting agent) (para. 47), Pluronic 68 or L-62 (stabilizer) (para. 52), and water (abs). The components are added and mixed together (para. 64) before foaming occurs (para. 61). The amount of prepolymer may be about 20-60% (para. 32), the amount of silver metal oxide is about 20 wt% (para. 43), the amount of wetting agent may be 1-10% (para. 52), the amounts of adjuvants may be 5-30% (para. 51), and the amount of water may be 14-18% (Table 1).
Regarding claim 2, the antibacterial agent may be silver metal oxide (para. 40).
Regarding claim 3, the composition may comprise silver metal oxide (para. 40).
Regarding claim 4, the composition may comprise methyl cellulose (para. 37).
Regarding claim 5, the composition may comprise methyl cellulose (para. 37) or chitosan (para. 37).
Regarding claim 8, Sessions teaches examples of polyurethane polymers with a viscosity of 12,000 cps (12,000 mPa.s) (para. 75).
Sessions does not teach an exact combination of polyurethane prepolymer, antibacterial agent, suspending agent, wetting agent, stabilizer, and water in claim 1. Sessions does not teach the exact amount ranges for the components or ratio recited in claim 1.
In regards to selecting the combination of polyurethane prepolymer, antibacterial agent, suspending agent, wetting agent, stabilizer, and water in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Sessions teaches polyurethane prepolymer (Ingredient B) (para. 17), silver metal oxide (antibacterial agent) (para. 40), methylcellulose (suspending agent) (para. 37), polyethylene glycol (wetting agent) (para. 47), Pluronic 68 or L-62 (stabilizer) (para. 52), and water (abs), whereas the claimed invention is directed towards an antibacterial polyurethane sponge comprising an antibacterial agent, suspending agent, wetting agent, stabilizer, water, and a polyurethane prepolymer. Since Sessions teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the amounts of components and ratio in claim 1, The components are added and mixed together (para. 64) before foaming occurs (para. 61). The amount of prepolymer may be about 20-60% (para. 32), the amount of silver metal oxide is about 20 wt% (para. 43), the amount of wetting agent may be 1-10% (para. 52), the amounts of adjuvants may be 5-30% (para. 51), and the amount of water may be 14-18% (Table 1). Regarding a 1:1 ratio of Ingredient A:Ingredient B, if the amount of metal oxide is about 20%, amount of wetting agent is around 1%, amounts of adjuvants (suspending agent and stabilizer) may be 5% each, and amount of water is around 14%, it is interpreted that Ingredient A may be around 45%, which falls in the 20-60% amount of prepolymer. That being said and in lieu of objective evidence of unexpected results, the amounts and ratios can be viewed as a variable that achieves the recognized result of successfully making the polyurethane foam composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Sessions. The optimum or workable range of amounts and ratio can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts and ratio of components as nonobvious.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sessions, as applied to claims 1-5, and 8 above, in view of Atamanchemicals.com.
In regards to claim(s) 1-5, and 8, Sessions, as applied supra, is herein applied in its entirety for its teachings of a polyurethane foam composition.
Sessions does not teach PEG-4000 in claim 6.
Atamanchemicals.com teaches that PEG-4000 is non-immunogenic, biocompatible, and flexible, which makes it suitable for dressing material in wound healing (pg. 5).
Since Sessions does not teach PEG-4000 in claim 6, one of ordinary skill in the art would have been motivated to use Atamanchemicals.com’s teaching of PEG-4000. A skilled artisan would have been led to combine the teachings since Sessions teaches compositions used for wound dressing (para. 3) and Atamanchemicals.com teaches that PEG-4000 is particularly useful and suitable for dressing material in wound healing. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sessions in view of Atamanchemicals.com, as applied to claims 1-6, and 8 above, and further in view of Rancan et al. (Screening of Surfactants for Improved Delivery of Antimicrobials and Poly-Lactic-co-Glycolic Acid Particles in Wound Tissue, pharmaceutics, 2021).
In regards to claim(s) 1-6, and 8, Sessions and Atamanchemicals.com, as applied supra, is herein applied in its entirety for its teachings of a polyurethane foam composition.
Sessions does not teach Poloxamer F68 in claim 7.
Rancan teaches that poloxamers, such as Pluronic F68, are commonly used in wound care for their safety in the wound-healing process (pg. 2). “Poloxamer F68” recited in instant claim 7 is interpreted the same as Pluronic F68.
Since Sessions does not teach Poloxamer F68 in claim 7, one of ordinary skill in the art would have been motivated to use Rancan’s teaching of Pluronic F68. A skilled artisan would have been led to combine the teachings since Sessions teaches compositions used for wound dressing (para. 3) and Rancan teaches that Pluronic F68 is widely used in wound care for their safety. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sessions in view of Atamanchemicals.com and Rancan et al. (Screening of Surfactants for Improved Delivery of Antimicrobials and Poly-Lactic-co-Glycolic Acid Particles in Wound Tissue, pharmaceutics, 2021), as applied to claims 1-8 above, and further in view of dow.com.
In regards to claim(s) 1-8, Sessions, Atamanchemicals.com, and Rancan, as applied supra, is herein applied in its entirety for its teachings of a polyurethane foam composition.
Sessions does not teach Voranate T-80 in claim 9.
Dow.com teaches that Voranate T-80 is widely used in flexible foam applications and reactive intermediates in prepolymer applications (pg. 1).
Since Sessions does not teach Voranate T-80 in claim 9, one of ordinary skill in the art would have been motivated to use Dow.com’s teaching of Voranate T-80. A skilled artisan would have been led to combine the teachings since Sessions teaches flexible polyurethane foam compositions (para. 14) and Dow.com teaches that Voranate T-80 is widely used in flexible foam applications and reactive intermediates in prepolymer applications (pg. 1). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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