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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claims Status
Applicant's election with traverse of Group I, claims 1-13 with the species of zinc chloride, magnesium chloride and polyhexamethylene biguanide hydrochloride (PHMB hydrochloride) and a collagen substrate in the reply filed on 11/12/2025 is acknowledged.
The traversal is on the ground(s) that any claims in Group II and Group III that correspond to allowable Group I claims be reinstated for examination and to the extent that a generic claim is allowed the non-elected species be reinstated.
Examiner acknowledges that should an elected generic claim be found allowable and the presently withdrawn claims require all the limitations of an allowable claim, that the withdrawn claims may be considered for rejoinder at the time of allowance. To be eligible for rejoinder, the withdrawn claims must require all of the limitations of the elected composition.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/12/2025.
Claims 1-13 are under current examination to the extent of the species elections: collagen dressing; PHMB hydrochloride, magnesium chloride and zinc chloride.
Claim Rejections - 35 USC § 112-indefinite
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.
Claim 9 is 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 9 recites the limitation "the absorbance value”. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not require any absorbance values for the dressing. It is believed that Applicants meant to depend from claim 8 which introduces an absorbance value.
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.
Conclusion
Currently, claims 1-13 are rejected and no claims are allowed.
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