DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without specifying traverse of Group I in the reply filed on 6/09/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL.
Claims 17-19 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The elected invention read upon claims 1-16, 20-23 and 25.
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.
Claims 1, 6, 15-16, 21-23 and 25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 is drawn to a bandage comprising “a porous mesh comprising a wound-facing side coated with an adhesive for adhering the porous mesh to the skin, the porous mesh being configured for application of a polymerizable adhesive such that after application the polymerized adhesive and the porous mesh together form a barrier covering the wound”.
The claim is indefinite because it is unclear whether the porous mesh is “coated with an adhesive” or merely “configured for application of a[n]… adhesive”. Yet another possibility is that the porous mesh is coated with an adhesive and further configured for application of an additional adhesive.
Claims 15-16 further add to the uncertainty of claim 1. Claims 15-16 are drawn to a kit comprising “a dressing according to claim 1, and a liquid polymerizable adhesive for application to the dressing” (claim 15), more specifically wherein the adhesive is cyanoacrylate (claim 16). Again, it is unclear whether the dressing of claim 1 comprises adhesive, does not comprise adhesive but is “configured for application of a[n]… adhesive”, or comprises one adhesive and is further configured for application of an additional adhesive which is cyanoacrylate.
For all the foregoing reasons, claims 1 and 15-16 are rejected as indefinite.
Claim 4 is drawn to a dressing “wherein the porous mesh or the absorbent patch comprises a medicament”.
Claim 6 is drawn to the dressing of claim 4, wherein “the medicament is present in the adhesive in a range of between 0 ppm and about 5000 ppm, preferably between about 200 ppm and about 1000 ppm”.
At the outset, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Additionally, the recitation in claim 6 “wherein the medicament is present in the adhesive” lacks antecedent basis in claim 4.
As such, claim 6 is also rejected as indefinite.
Claims 21-23 are drawn to the dressing of claim 4, “wherein the adhesive and/or the absorbent patch comprises an antimicrobial”, more specifically silver (claim 22) and, even more specifically, a silver alginate foam (claim 23).
In the case where the medicament (as recited by claim 4) is contained in the absorbent patch, and the antimicrobial (as recited by claims 21-23) is contained in the absorbent patch, it is unclear whether said antimicrobial is further limiting the medicament recited by claim 4 or whether the antimicrobial is an additional medicament contained in the absorbent patch.
As such, claims 21-23 are also rejected as indefinite.
Claims 25 depend from the dressing of claim 4 “wherein the medicament is dissolved in the adhesive”.
The recitation in claim 25 “wherein the medicament is dissolved in the adhesive” lacks antecedent basis in claim 4.
Accordingly, claim 25 is also rejected as indefinite.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
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 1-5, 9-13, 15 and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by – or, in the alternative, under 35 U.S.C. 103(a) as being unpatentable over – Moghe et al (US 2012/0310186).
Claim 1 is drawn to a dressing for application onto a wound, the dressing comprising:
a porous mesh comprising a wound-facing side coated with an adhesive for adhering the porous mesh to the skin, the porous mesh being configured for application of a polymerizable adhesive such that after application the polymerized adhesive and the porous mesh together form a barrier covering the wound; and
an absorbent patch disposed on the wound-facing side of the porous mesh and arranged to overlie the wound during use.
Moghe et al teach an “[a]dhesive bandage 10… compris[ing] a backing substrate 20 affixed to an absorbent pad 40 via an adhesive 30” (Paragraph 0048) as follows (Figure 2):
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wherein:
“[t]he backing substrate can comprise or consist essentially of a woven fabric” (Paragraph 0007; see also Paragraphs 0029 and 0030: “[t]he backing material or substrate may be made from any suitable material for covering wounds. Non-limiting examples of the backing substrate include polymeric films, paper substrates, woven fabrics, and non-woven fabrics” (Paragraph 0029) and “may be formed using any suitable method. For example… extruded, molded, solvent cast, woven, or braided”);
“the adhesive material can comprise or consist essentially of an acrylic” (Paragraph 0007; see also Paragraph 0044: “[s]uitable adhesives also include acrylic based, dextrin based, and urethane based adhesives” and so on) wherein the “adhesive material or layer may be used to adhere the absorbent pad to the backing material and, in some cases, to secure the dressing or adhesive bandage to the skin of the user” (Paragraph 0044); and
“[t]he absorbent pad can comprise a fiber selected from the group consisting of cellulosic fibers… and polymeric fibers… as well as combinations thereof” (Paragraph 0007; see also Paragraph 0032: “absorbent pads may be made from natural materials, synthetic materials, or combinations thereof including, for example, natural fibers, such as, but not limited to, cotton and wood pulp fibers, and synthetic fibers, such as, but not limited to, polyester, polyamide, and polyolefin fibers” wherein “any of the materials described herein may be placed into a solution and lyophilized or freeze-dried to form a foam”).
Accordingly, claim 1 is anticipated.
Alternatively, recognizing that Moghe et al does not disclose any specific embodiments of a dressing wherein, for example, the backing substrate is a woven fabric and the adhesive is an acrylic, and further assuming arguendo that Moghe et al does not provide sufficient guidance to select this specific combination of variables so as to give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251 (Fed. Circ. 1989)), as indicated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[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”. Accordingly, when considering the obviousness of a combination of known elements, the operative question is “whether the improvement is more than the predictable use of prior art elements according to their established functions”. Significantly, the 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 [but, instead] can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”, emphasizing that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.”
Consistent with this reasoning, it would have been prima facie obvious to select various features from within Moghe et al to arrive at the instantly claimed dressing “yielding no more than one would expect from such an arrangement”.
As such, in the alternative, claim 1 is rejected as prima facie obvious.
Claims 2-3 and 20 are drawn to the dressing of claim 1, wherein the absorbent patch comprises a gel-forming material (claim 2), more specifically wherein the gel-forming material comprises a foam (claim 20), and/or wherein the absorbent patch comprises a foam (claim 3).
As discussed above, Moghe et al teach that the “absorbent pads may be made from natural materials, synthetic materials, or combinations” wherein “any of the materials described herein may be placed into a solution and lyophilized or freeze-dried to form a foam” (Paragraph 0032).
Accordingly, claims 2-3 and 20 are also anticipated or, in the alternative, rejected as prima facie obvious.
Claims 4-5 and 21-22 are drawn to the dressing of claim 1, wherein the porous mesh or the absorbent patch comprises a medicament (claim 4), more specifically a medicament for infection control (claim 5) and/or wherein the adhesive and/or the absorbent patch comprises an antimicrobial (claim 21), wherein the antimicrobial comprises silver (claim 22).
Moghe et al teach that a “therapeutic agent may be applied to and/or incorporated into the pad, or any other part of the dressing or adhesive bandage described herein” (Paragraph 0038); see also Paragraph 0042: “suitable therapeutic agents… may be included in… the backing layer or substrate, the absorbent pad [and/or] the adhesive layer”), wherein “[e]xamples of therapeutic agents… include… antibacterial agents” (Paragraph 0039), wherein “[s]uitable antimicrobial agents… include… silver and silver salts or complexes thereof” (Paragraph 0040).
Accordingly, claims 4-5 and 21-22 are also anticipated or, in the alternative, rejected as prima facie obvious.
Claims 9-10 are drawn to the dressing of claim 1, wherein the porous mesh extends beyond an outer perimeter of the absorbent patch (claim 9), more specifically wherein the porous mesh circumscribes the absorbent patch (claim 10).
Moghe et al teach “[a]s exemplarily illustrated in FIGS. 5 and 6, adhesive bandage 200 may be an island dressing and/or circular configuration with absorbent pad 240 affixed to a generally central portion of backing substrate 220” (Paragraph 0050).
Accordingly, claims 9-10 are also anticipated or, in the alternative, rejected as prima facie obvious.
Claim 11 is drawn to the bandage of claim 10, wherein the porous mesh extends beyond the outer perimeter of the absorbent patch by at least 1 cm.
Moghe et al teach that “[t]he size of the dressing or bandage will depend on the shape of the dressing or bandage and the size of the wound meant to be covered by the dressing or bandage” wherein, for example, “[a] square bandage may range in size from about 2 cm x 2 cm to about 15 cm x 15 cm” (Paragraph 0046).
In view of the foregoing, it is evident that the “island dressing” which is “exemplarily illustrated in FIGS. 5 and 6” entails the porous mesh extending beyond the outer perimeter of the absorbent patch by at least 1 cm.
Accordingly, claims 11 is also anticipated or, in the alternative, rejected as prima facie obvious.
Claims 12-13 are drawn to the dressing of claim 1, further comprising a releasable liner attached to the wound-facing side of the porous mesh and covering the absorbent patch (claim 12), more specifically comprising a central portion overlaying the absorbent patch and at least a portion of the porous mesh, and at least one peripheral portion separable from the central portion (claim 13).
Moghe et al teach that “[r]elease strips, such as siliconized paper, can optionally be placed over the exposed portions of adhesive-applied regions as well as on the non-stick film” of the absorbent pad (Paragraph 0051)
Considering that Moghe et al teach release strips (i.e., in the plural), claims 12-13 are also anticipated or, in the alternative, rejected as prima facie obvious.
Claim 15 is drawn to a kit comprising a dressing according to claim 1, and a liquid polymerizable adhesive for application to the dressing.
Moghe et al teach that “[a]n adhesive material or layer may be used to adhere the absorbent pad to the backing material and, in some cases, to secure the dressing or adhesive bandage to the skin of the user” wherein “[s]uitable adhesives… include acrylic based, dextrin based, and urethane based adhesives” and so on, “and blends thereof” (Paragraph 0044), wherein “[t]he adhesive can be applied in any desired manner such as by spraying, screen printing, or slot die coating” (Paragraph 0045).
At minimum, the step of applying adhesive to the bandage as taught by Moghe et al necessitates bringing into combination the dressing and the liquid polymerizable adhesive to be applied, thereby teaching the instantly claimed kit comprising the dressing and a liquid polymerizable adhesive for application to the dressing.
As such, claim 15 is also anticipated or, in the alternative, rejected as prima facie obvious.
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.
Claims 7-8 are rejected under 35 U.S.C. 103(a) as being unpatentable over Moghe et al (US 2012/0310186) as applied to 1-5, 9-13, 15 and 20-22 above, in further view of Duncan et al (US 3,871,378).
Claims 7-8 are drawn to the dressing of claim 1, wherein the absorbent patch comprises a liner portion and an absorbent portion, wherein the liner portion is directed towards the porous mesh such that the absorbent portion faces the wound after application (claim 7), more specifically wherein the liner portion is substantially impermeable.
As discussed above, Moghe et al teach a dressing of claim 1. However, Moghe et al do not teach the inclusion of a substantially impermeable liner as recited by claims 7-8.
Duncan et al teach “[a]n absorbent bandage” (Abstract) which “prevent[s] strike-through of body exudate from the lowermost side… by providing a waterproof backing sheet essentially coextensive with the lowermost layer of absorbent core material” (Column 4, Lines 16-21)
It would have been prima facie obvious, based further on Duncan et al, to modify the dressing of Moghe et al so as to comprise a substantially impermeable strike-through liner between the absorbent pad and the porous mesh. It would have been obvious to do so in order to prevent strike-through of body exudate with a reasonably expectation of success.
As such, claims 7-8 are rejected as prima facie obvious.
Claim 14 is rejected under 35 U.S.C. 103(a) as being unpatentable over Moghe et al (US 2012/0310186) as applied to 1-5, 9-13, 15 and 20-22 above, in further view of Lang et al (US 4,753,231).
Claim 14 is drawn to the dressing of claim 1, wherein the absorbent patch comprises polyurethane.
As discussed above, Moghe et al teach a dressing of claim 1. However, Moghe et al do not teach the absorbent patch comprising polyurethane as recited by claim 14.
Lang et al teach related “wound dressings… which comprise (a) a comfortable backing layer which has an adhesive… and (b) a low wound adherency absorbent pad positioned on the adhesive side of the backing layer” (Abstract), more specifically the “absorbent pad strip consisting of a laminate of wound facing layer of an elastomer polyurethane net and an absorbent layer of an open cell hydrophilic polyurethane foam” (Column 7, Lines 9-13).
It would have been prima facie obvious, based further on Lang et al, to utilize polyurethane as the absorbent patch in the dressing of Moghe et al. The simple substitution of one known absorbent patch useful in dressings for another known absorbent patch useful in dressings is prima facie obvious.
As such, claim 14 is also rejected as prima facie obvious.
Claim 16 is rejected under 35 U.S.C. 103(a) as being unpatentable over Moghe et al (US 2012/0310186) as applied to 1-5, 9-13, 15 and 20-22 above, in further view of Martin et al (US 2016/0128873).
Claim 16 is drawn to the kit of claim 15, wherein the liquid polymerizable adhesive for application to the dressing is cyanoacrylate.
As discussed above, Moghe et al teach a kit of claim 15. However, Moghe et al teach “[s]uitable adhesives… include acrylic based… adhesives” (Paragraph 0044) but do not specifically name cyanoacrylate as said adhesive, as recited by claim 16.
Martin et al teach related dressings comprising as “the basic structural elements of the bandage 100… a backing layer 101, a film layer 102, and an absorbent layer 103” (Paragraph 0028) wherein “[i]n one or more embodiments, an adhesive layer 108 can be disposed along the second major face 105 of the backing layer 101” (Paragraph 0038) wherein the adhesive can be “cynoacrolate”, which is understood as cyanoacrylate (Paragraph 0039).
It would have been prima facie obvious, based further on Martin et al, to utilize cyanoacrylate as the acrylic based adhesive in the dressing of Moghe et al. The simple substitution of one known adhesive useful in dressings for another known adhesive useful in dressings is prima facie obvious.
As such, claim 16 is also rejected as prima facie obvious.
Claim 23 is rejected under 35 U.S.C. 103(a) as being unpatentable over Moghe et al (US 2012/0310186) as applied to 1-5, 9-13, 15 and 20-22 above, in further view of Scherr (US 2003/0021832).
Claim 23 is drawn to the dressing of claim 22, wherein antimicrobial comprising silver comprises a silver alginate foam.
As discussed above, Moghe et al teach a dressing of claim 22. However, Moghe et al teach that “[e]xamples of therapeutic agents… include… antibacterial agents” (Paragraph 0039), wherein “[s]uitable antimicrobial agents… include… silver and silver salts or complexes thereof” (Paragraph 0040), but do not specifically name silver alginate foam, as recited by claim 23.
Scherr teaches “silver alginate foam compositions” (Title) “for use in the preparation of medical… dressings for the treatment of burns, wounds, ulcerated lesions, and related pathological states” (Abstract) which “acts to immediately provide an… antimicrobial action” (Paragraph 0020).
It would have been prima facie obvious, based further on Scherr, to utilize silver alginate foam as the silver antimicrobial in the dressing of Moghe et al. The simple substitution of one known silver-based antimicrobial useful in dressings for another known silver-based antimicrobial useful in dressings is prima facie obvious.
Accordingly, claim 23 is also rejected as prima facie obvious.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611