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 .
Claims Status
Claims 1-20 are pending.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 1-13 are under current examination to the extent of the species elections: collagen dressing; PHMB hydrochloride, magnesium chloride and zinc chloride.
Applicants' arguments filed 06/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
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.
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.
Claims 1-6 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Frank DiCosmo (United States Patent Publication 20200338229) in view of Kevin Powers (United States Patent Publication 9,254,260).
DiCosmo teaches wound dressings having an antimicrobial layer, see paragraphs [0008] and [0017]. The antimicrobial is inclusive of polyhexamethylene biguanide hydrochloride, see paragraph [0017] and [0030]. The polyhexamethylene biguanide hydrochloride (PHMB hydrochloride) can comprise from 0.1-1% by weight, see paragraph [0065]-[0066]. The PHMB can be combined with additional metal active agents including zinc, see paragraph [0120]. The composition can be used with any substrate used for medical dressings including collagen substrates, see paragraph [0016].
DiCosmo does not teach the amount of zinc or that the zinc is zinc chloride. DiCosmo does not teach including an amount of magnesium chloride in the dressing composition.
Powers teaches enhancing wound healing by applying a composition comprising zinc and magnesium, see abstract. The zinc includes zinc chloride and the magnesium includes magnesium chloride, see column 10, lines 60-68; column 15, lines 19-20 and 55-60; column 16, lines 36-38; and column 17, lines 42-50. Magnesium chloride can comprise 0.007-1.14 w/v, while zinc chloride can comprise 0.0000057-2.12 w/v which is equivalent to w/w because the carrier is water, see claim 1, column 15, lines 20-22, column 15, lines 55-58 and column 16, lines 40-44. In an alternative embodiment, the magnesium chloride an comprise a 0.001-2.3% w/v (equivalent to 0.001-2.3% w/w with water carrier), see column 15, lines 19-35 .
The composition provides enhanced wound healing, see column 6, lines 37-45, lines 64-66, column 11, lines 50-51 and column 28, lines 12-13 and column 37, lines 15-58.
It would have been prima facie obvious to provide the zinc of DiCosmo as zinc chloride present from 0.0000057-2.12 percent by weight and to include magnesium chloride in amounts of 0.007-1.14 percent by weight or 0.001-2.3% by weight to the wound dressing antimicrobial composition of DiCosmo.
One of ordinary skill in the art would have been motivated do so because a composition comprising magnesium and zinc ions is taught by Powers to provide enhanced wound healing in a subject.
There would have been a reasonable expectation of success because the dressing of DiCosmo is taught to be applied to wounds and can comprise a mixture of antimicrobial agents including zinc and PHMB hydrochloride.
The modification of DiCosmo to comprise the zinc chloride and magnesium chloride concentrations of Powers overlaps a mass ratio of 0.02-1 of PHMB hydrochloride, 0.1-0.5 of zinc chloride and 1 to 5 of magnesium chloride claimed because the PHMB hydrochloride suggested by DiCosmo can be inclusive of at 0.5% by weight, and the zinc chloride taught in Powers is inclusive of 0.5% by weight, and the magnesium chloride at about 1.14% or 2.3% by weight . 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) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997). In addition, Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Regarding instant claim 8, as DiCosmo in view of Powers teaches a dressing comprising collagen substrate which is the same material used by applicants for the dressing substrate, with zinc chloride and magnesium chloride in overlapping mass percent ratios, the absorbance value of supernatant measured at 450 mm in a cell viability test would be the natural result of applying a collagen based dressing comprising the claimed antimicrobial coating. Regarding the bacteriostatic circle test when placing antibacterial dressing into culture medium against E. Coli and Staphylococcus aureus, since DiCosmo in view of Powers renders obvious a dressing comprising zinc chloride, magnesium chloride and PHMB hydrochloride in overlapping amounts with a collagen dressing, the properties of bacteriostatic circle testing would necessarily follow. Regarding instant claim 12 in that the dressing is capable of allowing fibroblast of long spindle shape to be cultured thereon, since DiCosmo teaches wound dressings which comprise collagen, the dressing would necessarily be capable of allowing fibroblasts to be cultured thereon. Furthermore the limitation in claim 12 characterizes the intended use of the antibacterial dressing claimed for fibroblast culturing on the dressing. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the prior art structure is capable of meeting the intended use because DiCosmo in view of Powers renders obvious antimicrobial collagen dressings which comprise zinc chloride, magnesium chloride and PHMB hydrochloride. Regarding instant claim 13, the wound dressing of DiCosmo comprises antimicrobial agent and treats wounds, thus the dressing is part of a material or medicament for promoting wound healing.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Frank DiCosmo (United States Patent Publication 20200338229) and Kevin Powers (United States Patent Publication 9,254,260) as applied to all claims 1-6 and 8-13 above and further in view of Yu-Bing et al. (TW201620962).
The teachings of DiCosmo in view of Powers are discussed above.
Neither DiCosmo or Powers teaches a water absorption ratio for the collagen dressing, however DiCosmo teaches collagen dressings.
Yu-Bing et al. teach collagen dressings which comprise a water absorption ratio of 1-15, see pages 2-5, 8, and claims 7 and 11. Collagen has a long fiber length and the composite material can comprise a multi layered structure resulting in high water absorption, see pages 2 and 4. Good water absorption is taught to promote wound healing see page 4.
It would have been prima facie obvious to provide the water absorption ratio of the collagen dressings of the modified DiCosmo with values between 1 to 15 as taught by Yu-Bing et al. with the motivation of promoting wound healing.
There would have bene a reasonable expectation of success because both DiCosmo and Yu-Bing et al. teach dressings which can comprise collagen.
Response to Remarks
Applicants argue that biguanide has cytotoxicity as shown in Table 1, however the specific combination of PHMB, zinc chloride, and magnesium chloride satisfying the claimed ratio provided high cell viability and significant inhibition of E. soli and S. aureus and P. aeruginosa (at examples 1-6).Applicants argue that thus the antibacterial dressing according to claim 1 satisfying the claimed ratio can improve cell viability while maintaining robust antimicrobial activity.
Examiner respectfully submits that Applicants argument is considered unpersuasive because the instant claims are not limited to a PHMB, zinc chloride, and magnesium chloride in the recited ratios. PHMB is not even required to be present in claim 1. Per MPEP 716.02(d), the unexpected results must commensurate in scope with the claimed invention. Here, the claims do not require the components in Table 1 or examples 1-6 as claim 1 is to any zinc containing compound, any magnesium containing compound and any biguanide compound. Examiner notes that it appears that it is the combination of zinc chloride, PHMB, magnesium chloride that provide the improved effects on bacteria and reduced toxicity of PHMB at Table 1.
Applicants further argue that there is no motivation to combine the teachings of DiCosmo and Powers as they are aimed at different purposes. DiCosmo is solid cured antimicrobial silicone dressings whereas Powers is an isotonic liquid solution for topical application. Furthermore the solution of ions for magnesium chloride is taken from solution 4 of Powers which has no zinc.
Examiner respectfully disagrees that there would be no reasonable expectation of success because both DiCosmo and Powers utilize compositions which treat wounds. The solid wound dressing of DiCosmo is made by mixing and curing a stable solution in liquid form, see paragraph [0118] and allowing the mixture to cure. In addition to the PHMB and EDTA an additional antimicrobial can be added as suggested by DiCosmo (paragraph [0120]). One of ordinary skill in the art would have been motivated do so because a composition comprising magnesium and zinc ions is taught by Powers to provide enhanced wound healing in a subject. Regarding the magnesium chloride concentration, Powers makes it clear that the concentration is inclusive of a range of from 0.007-1.14w/v (column 15, lines 19-35). Although Example 4 does not explicitly contain zinc it is clear that the suitable concentration of magnesium ions can comprise this concentration form the teachings of Powers as a whole at column 15 and solution 4. Column 15 discloses that Magnesium chloride, typically MgCl2.6H2O, is present in the composition such that the magnesium concentration [Mg2+] is in the range of about 0.007-1.14% (w/v), including all units in between to the thousandth of a percent.
Applicants argue that the amounts disclosed by the references cannot be directly translated to the claimed ratio of claim 1. Applicants argue that the ratio in claim 1 is a dry mass ratio while DiCosmo is a percentage by weight of the final dressing which includes the substrate and adhesive layer. Applicant argue that the zinc and magnesium ions in Powers are a percent by weight volume of liquid solution. Applicants argue that the claimed ratio has the unexpected property of reduced toxicity and enhanced antibacterial activity. Applicants argue that Powers does not disclose the mass range of the zinc compound relative to the mass of PHMB with specificity. With respect to magnesium chloride, powers discloses a broad range of 0.007-1.14% w/v however Powers does not disclose the amount of magnesium chloride with sufficient specificity in relation to PHMB.
Examiner notes that the mass ratio of the biguanide, zinc, and magnesium in claim 1 is not limited to just these components, rather the mass ratio of each can be in relation to a total composition which comprises the zinc, magnesium and biguanide. As noted above, the amounts disclosed in Powers can be converted to a weight percent given the carrier is water. Applicants argue that the claimed ratio has unexpected results, however the claims are not commensurate with the unexpected results to PHMB, magnesium chloride and zinc chloride. Magnesium chloride can comprise 0.007-1.14 w/v, while zinc chloride can comprise 0.0000057-2.12 w/v which is equivalent to w/w because the carrier is water. In an alternative embodiment, the magnesium chloride an comprise a 0.001-2.3% w/v (equivalent to 0.001-2.3% w/w with water carrier). DiCosmo already teaches that PHMB hydrochloride can comprise from 0.1-1% by weight thus when taken together these concentrations render obvious the mass ratios claimed. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). While Applicants have indicated the criticality with PHMB, zinc chloride and magnesium chloride, such a composition does not commensurate in scope with the breadth of claim 1 currently.
Applicants argue that adding Zn alone or Mg alone to the antibacterial layer did not alleviate the cytotoxicity of PHBM only when zinc chloride and magnesium chloride are combined with PHMB the beneficial effects are noticed.
Examiner respectfully notes that claim 1 does not require PHMB, zinc chloride nor magnesium chloride to be present, so while the alleged unexpected results are noted they presently do not commensurate in scope with the claims.
Applicants argue that Liou Yu-Bing is silent regarding the ratio of biguanide zinc compound sand magnesium compound.
Examiner respectfully submits that it Liou was cited to render it obvious to provide the recited water absorption ratio of the dressings as good water absorption promotes healing. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
Currently, claims 1-13 are rejected and no claims are allowed.
Applicant’s arguments/remarks are considered unpersuasive. 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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