DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14/128,735, filed on 12/23/2013.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: antecedent basis for claims 9 and 13-15 is required.
Claim Objections
Claims 1, 4-8, and 12-13 are objected to because of the following informalities:
“a tubular bandage which extends” in claim 1, line 1 should be amended to recite --a tubular bandage comprising: a tube which extends--
“along a longitudinal axis” in claim 1, line 1 should be amended to recite --along a longitudinal axis in a longitudinal direction--
“wound-protective material, characterized, in that said outer layer” in claim 1, line 5 should be amended to recite --wound-protective material, and said outer layer--
“material, and in that, at every point” in claim 1, line 6 should be amended to recite --material, such that, at every point--
“over a distance” in claim 1, lines 7-8 should be amended to recite --by a distance--
“the combination” in claim 1, line 8 should be amended to recite --a combination--
“the latter” in claim 1, line 9 should be amended to recite --the outer layer--
“touches the body part” in claim 1, line 9 should be amended to recite --is configured to touch the body part-- to most clearly avoid claiming a human organism
“the environment” in claim 1, line 10 should be amended to recite --an environment--
“at one radial ending” in claim 4, line 2 should be amended to recite --at one ending--
“is made of a” in claim 5, line 1 should be amended to recite --is a--
“is made as a” in claim 6, line 1 should be amended to recite --is a--
“is made as a” in claim 7, line 1 should be amended to recite --is a--
“the longitudinal and transversal direction” in claim 8, line 2 should be amended to recite --the longitudinal direction and a transversal direction--
“the manufacture” in claim 12, line 1 should be amended to recite --a manufacture--
“a tubular outer layer with two open endings” in claim 12, line 3 should be amended to recite --the radial outer layer with the two open endings--
--the outward-- in claim 12, line 6 should be amended to recite --an outward--
“the rotating axis” in claim 12, line 6 should be amended to recite --a rotating axis of the rotatable shaft--
“an inner layer” in claim 12, line 7 should be amended to recite --the inner layer--
“0,5 mm” in claim 12, line 9 should be amended to recite --0.5 mm--
“tubular outer layer” in claim 13, line 3 should be amended to recite --radial outer layer--
Appropriate correction is required.
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 3, 8, 10, and 11 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.
Regarding claim 3, the claim recites the limitation “more than 1 mm, preferably about 2 mm” in lines 1-2. The scope of this claim is indefinite, because it is not clear whether “about 2 mm” is a limitation. According to MPEP 2173.05(c), “A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. The Examiner should analyze whether the metes and bounds of the claim are clearly set forth. Examples of claim language which have been held to be indefinite are (A) "a temperature of between 45 and 78 degrees Celsius, preferably between 50 and 60 degrees Celsius".
Further, the term “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 8, term “substantial” in line 2 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 10, the claim recites the limitation “preferably less than 25 mm, more preferably less than 20 mm” in lines 1-2. The scope of this claim is indefinite, because it is not clear whether “less than 25 mm” and “less than 20 mm” is a limitation. According to MPEP 2173.05(c), “A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made. The Examiner should analyze whether the metes and bounds of the claim are clearly set forth. Examples of claim language which have been held to be indefinite are (A) "a temperature of between 45 and 78 degrees Celsius, preferably between 50 and 60 degrees Celsius".
Regarding claim 11, the claim is rejected under 35 U.S.C. 112, second paragraph, by virtue of its dependence on claim 10.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-6, 8, 10, and 11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kane 2010/0100025 A1 in view of Jackson GB 191319869 A further in view of Anderson et al. 6,605,172 B1 and Mullane et al. 4,324,246.
Regarding claim 1, Kane discloses a tubular bandage 10 (fig. 1 and [0001], tourniquet dressing sleeve) which extends along a longitudinal axis and which is open at two endings (fig. 3, tube 12 being elongated along a longitudinal axis extending from left to right, and having two open endings on opposite ends), wherein said tube 12 comprises a radial outer layer 16 which is connected to a radial inner layer 14 (figs. 1 and 2 show the cylindrical/radial nature of the layers 14/16, and [0014], exterior material 16 and inner material 14), and wherein the outer layer 16 has a diameter and an elasticity such that the bandage 10 can be clamped adhesive-free around a body part to be treated ([0014], exterior woven material stretchable surface 16; the stretchability and diameter of outer layer 16 is capable of allowing the bandage to be clamped around a body part depending on the circumference of the body part; the exterior material 16 is not disclosed as being adhered to the skin), and wherein the inner layer 14 is made of an elastic wound-protective material ([0010], inner layer is fabrifoam polymeric stretchable material, which is capable of protecting the wound by covering it).
Kane is silent on wherein at every point at the open endings, said outer layer extends in the longitudinal direction over the inner layer over a distance such that by the combination of distance, diameter and elasticity of the outer layer, the latter touches the body part to be treated with its endings when applied, in order to close off the inner layer from the environment.
However, Jackson teaches a tubular bandage (fig. 3 and p.1, line 4) also having an outer layer 1 that is made such that at every point at the open endings, the outer layer 1 extends in the longitudinal direction over the inner layer over a distance (fig. 3 and p. 2, lines 41-43, the outer piece 1 extending past the inner pad inside the recess 4 in both directions along the longitudinal/axial axis) such that by the combination of distance, diameter and elasticity of the outer layer 1, the latter 1 touches the body part to be treated with its endings when applied, in order to close off the inner layer from the environment (fig. 3 and p. 2, lines 38-40, where since the elasticity of the tube 1 renders it taut enough to maintain the bandage on the finger, it is also capable of closing off the inner layer/pad from the environment depending on the diameter of the finger, since the inner layer is placed at a distance from both openings of the outer layer 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the tubular bandage of Kane so that the outer layer is made such that at every point at the open endings, the outer layer extends in the longitudinal direction over the inner layer over a distance such that by the combination of distance, diameter and elasticity of the outer layer, the outer layer touches the body part to be treated with its endings when applied, in order to close off the inner layer from the environment, as taught by Jackson, to seal off the inner layer of the bandage and prevent seepage of exudate or blood from the sides of the bandage.
Kane in view of Jackson is silent on said outer layer being made of an air-permeable and water-repellent material.
However, Anderson teaches a material for use in wound dressings (col. 4, lines 30-31) being made of an air-permeable and water-repellent material (col. 3, line 18, breathable (i.e., air-permeable) and liquid impermeable (i.e., liquid (which includes water) repellent)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said outer layer of Kane in view of Jackson to be made of an air-permeable and water-repellent material, as taught by Anderson, to form a breathable yet liquid impervious backsheet to allow passage of moisture vapor and air (yet prevent seepage of exudate or blood through the major plane of the sheet), which increases the comfort of the wearer by reducing humidity (col. 21, lines 29-34; please note that though this embodiment refers to a diaper, this motivation would still apply to a dressing worn on the body, since humidity can be trapped underneath the dressing for liquid impervious materials).
Kane in view of Jackson further in view of Anderson is silent on said distance being more than 0.5 mm.
However, Mullane teaches an analogous bandage 10 (col. 2, lines 23-26) with an analogous outer layer 14 extending over an analogous inner/absorbent layer 16 by a distance of more than 0.5 mm (fig. 2 and col. 2, line 56-col. 3, line 17, border 29 formed by layer 14 extending past layer 16 can have a width of about 0.318 cm or 3.18 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said distance of Kane in view of Jackson further in view of Anderson to be more than 0.5 mm, as taught by Mullane, since the thickness of this border would further prevent discharged liquid which is not absorbed by the absorbent layer from soiling garments, clothing, bedding, etc. (col. 3, lines 6-9).
Regarding claim 2, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane is silent on that part of said outer layer of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive.
However, Jackson further teaches that part of said outer layer 1 of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive (fig. 3 and p. 2, lines 38-40, the elasticity of the tube renders it taught enough to maintain position on the finger, and the disclosure does not describe adhesive being used to adhere the tube to the finger).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the tubular bandage of Kane in view of Jackson further in view of Anderson and Mullane so that that part of said outer layer of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive, as taught by Jackson, since the lack of adhesive on the ends would allow easier removal of the bandage when necessary.
Regarding claim 3, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Mullane further teaches said distance being more than 1 mm, preferably about 2 mm (col. 3, lines 15-17, about 0.318 cm or 3.18 mm, and about 3.18 mm can be considered about 2 mm), since the thickness of this border would further prevent discharged liquid which is not absorbed by the absorbent layer from soiling garments, clothing, bedding, etc. (col. 3, lines 6-9).
Regarding claim 4, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane is silent on said outer layer completely closing off the inner layer at least at one radial ending thereof.
However, Jackson further teaches said outer layer 1 completely closing off the inner layer at least at one radial ending thereof (p. 2, lines 38-40, where since the elasticity of the tube renders it taut enough to maintain the bandage on the finger, it is also capable of closing off the inner layer from the environment at the ends of the tube, especially depending on the circumference of the finger).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said outer layer of Kane in view of Jackson further in view of Anderson and Mullane to completely close off the inner layer at least at one radial ending thereof, as taught by Jackson, to seal off the inner layer of the bandage and prevent seepage of exudate or blood from the sides of the bandage.
Regarding claim 5, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane is silent on said outer layer being made of a thermoplastic elastomer.
However, Anderson further teaches the material for use in wound dressings (col. 4, lines 30-31) being made of a thermoplastic elastomer (col. 13, lines 46-49, suitable materials for the film include thermoplastic elastomers).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said outer layer of Kane in view of Jackson further in view of Anderson and Mullane to be made of a thermoplastic elastomer, as taught by Anderson, to increase the comfort of the wearer.
Regarding claim 6, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane further discloses said inner layer 14 being made as a compress ([0014], layer 14 is a fabric like polymer foam 14; [0015], fabrifoam provides compression and treats injuries).
Regarding claim 8, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane further discloses said inner layer 14 exhibiting a substantial elasticity in both the longitudinal and transversal direction ([0010], inner layer is fabrifoam polymeric stretchable material; as evidenced by North Coast Medical & Rehabilitation Products, fabrifoam has four-way stretch).
Regarding claim 10, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane is silent on said tube having a length which is less than 30 mm, preferably less than 25 mm, more preferably less than 20 mm.
However, Kane further discloses said tube 12 having any length ([0016], the tube/sleeve 12 may be cut to individual lengths for various digits for all sizes of patients, meaning they can be cut to any size).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have specified the tube of Kane in view of Jackson further in view of Anderson and Mullane to have a length which is less than 30 mm, preferably less than 25 mm, more preferably less than 20 mm, as disclosed by Kane, to be fit for a specific digit for a specifically sized patient ([0016], "[s]leeves may be cut to individual lengths for various digits for all sizes of patients", and a length less than 30 mm may be desirable to fit a certain patient).
Regarding claim 11, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane further discloses the tubular bandage 12 being in the form of a finger bandage or toe bandage ([0017], tourniquet for use on toes or fingers).
Claims 7 and 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kane 2010/0100025 A1 in view of Jackson GB 191319869 A further in view of Anderson et al. 6,605,172 B1, Mullane et al. 4,324,246, and Buglino et al. 6,011,194.
Regarding claim 7, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane in view of Jackson further in view of Anderson and Mullane is silent on said inner layer being made as a viscoelastic gel.
However, Buglino teaches a wound dressing (fig. 1 and col. 1, lines 8-9) also comprising an inner layer 14 that is a visco-elastic gel (col. 4, lines 61-66, hydrocolloid absorbents; according to the specification of Applicant’s disclosure, p. 7, lines 10-12 state that a hydrocolloid is a visco-elastic gel).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the inner layer of Kane in view of Jackson further in view of Anderson and Mullane to be a visco-elastic gel, as taught by Buglino, which is prima facie obvious due to the selection of a known material based on its suitability for its intended use (please see MPEP 2144.07, In reLeshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960)); furthermore, since hydrocolloids are known absorbents, they are an obvious alternative material for absorbing the exudates and blood during use of Kane's dressing; lastly, there is no statement or evidence of criticality of the choice of material in the instant specification.
Regarding claim 9, Kane in view of Jackson further in view of Anderson and Mullane discloses the claimed invention as discussed above.
Kane in view of Jackson further in view of Anderson and Mullane is silent on said inner layer having a thickness between 0.4 mm and 2 mm.
However, Buglino teaches all of the components of the analogous dressing being of any suitable thickness as would be known to those in the art (col. 6, lines 35-36, in other words, the inner layer 14 can be any thickness, which would include a thickness between 0.4 mm and 2 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have specified the inner layer of Kane in view of Jackson further in view of Anderson and Mullane to have a thickness between 0.4 mm and 2 mm, as taught by Buglino, to form the dressing of a suitable thickness according to the purpose of a dressing as known to those in the art (col. 6, lines 35-36).
Allowable Subject Matter
Claims 12-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 12-15 recite allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding dependent claim(s) 12, the prior art of record when applied alone or in combination neither anticipates nor renders obvious a method for the manufacture of a tubular bandage according to claim 1, the method comprising: manufacturing a tubular outer layer with two open endings; sliding the outer layer thus manufactured over a rotatable shaft; rotating the rotatable shaft provided with the outer layer; and moving from the outward in radial direction towards the rotating axis an inner layer applicator to apply an inner layer to the outer layer, wherein the inner layer applicator is provided to stay clear from the endings of the outer layer for at least 0.5 mm in the longitudinal direction. Kane US 2010/0100025 A1 is the closest prior art of record and discloses a tubular bandage as described in claim 1 (please see above detailed rejection, which will not be repeated here for brevity). Kane discloses in [0016] that the inner and outer layer are adhered together adhesively and then folded over and sewn to form a sleeve. Thus, Kane is silent on a method for manufacture comprising sliding the outer layer thus manufactured over a rotatable shaft; rotating the rotatable shaft provided with the outer layer; and moving from the outward in radial direction towards the rotating axis an inner layer applicator to apply an inner layer to the outer layer, wherein the inner layer applicator is provided to stay clear from the endings of the outer layer for at least 0.5 mm in the longitudinal direction. Furthermore, no other reference to date has been found in the prior art that would be able to properly modify Kane to address its deficiencies. Martin US 2008/0262403 A1 also discloses a tubular sleeve for body protection (fig. 5) that is made by fixing an inner layer onto an outer fabric layer and folding and providing a seam to fix the two together ([0022]-[0024]). Martin, similar to Kane, is silent on the claimed method for manufacture. Dependent claims 13-15 would be allowable by virtue of their dependence on claim(s) 12.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, and 12-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. US 12,201,500 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claims in the instant application.
Regarding claim 1, claim 1 of the patent anticipates the entirety of the claim.
Regarding claim 2, claim 1 of the patent anticipates the entirety of the claim.
Regarding claim 12, claim 1 of the patent anticipates the entirety of the claim.
Regarding claim 13, claim 2 of the patent anticipates the entirety of the claim.
Regarding claim 14, claim 3 of the patent anticipates the entirety of the claim.
Regarding claim 15, claim 4 of the patent anticipates the entirety of the claim.
Claims 2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,500 B2 in view of Jackson GB 191319869 A.
Regarding claim 2, the patent claims the claimed invention as discussed above.
The patent is silent on that part of said outer layer of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive.
However, Jackson teaches a tubular bandage (fig. 3 and p.1, line 4) wherein that part of said outer layer 1 of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive (fig. 3 and p. 2, lines 41-43, the outer piece 1 extending past the inner pad inside the recess 4 in both directions along the longitudinal/axial axis; fig. 3 and p. 2, lines 38-40, the elasticity of the tube renders it taught enough to maintain position on the finger, and the disclosure does not describe adhesive being used to adhere the tube to the finger).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the tubular bandage of the patent so that that part of said outer layer of which the endings extend in the longitudinal direction over the inner layer, does not comprise an adhesive, as taught by Jackson, since the lack of adhesive on the ends would allow easier removal of the bandage when necessary.
Regarding claim 4, the patent claims the claimed invention as discussed above.
The patent is silent on said outer layer completely closing off the inner layer at least at one radial ending thereof.
However, Jackson teaches a tubular bandage (fig. 3 and p.1, line 4) with said outer layer 1 completely closing off the inner layer at least at one radial ending thereof (fig. 3 and p. 2, lines 41-43, the outer piece 1 extending past the inner pad inside the recess 4 in both directions along the longitudinal/axial axis; p. 2, lines 38-40, where since the elasticity of the tube renders it taut enough to maintain the bandage on the finger, it is also capable of closing off the inner layer from the environment at the ends of the tube, especially depending on the circumference of the finger).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said outer layer of the patent to completely close off the inner layer at least at one radial ending thereof, as taught by Jackson, to seal off the inner layer of the bandage and prevent seepage of exudate or blood from the sides of the bandage.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,500 B2 in view of Mullane et al. 4,324,246.
Regarding claim 3, the patent claims the claimed invention as discussed above.
The patent is silent on said distance being more than 1 mm, preferably about 2 mm.
However, Mullane teaches an analogous bandage 10 (col. 2, lines 23-26) with an analogous outer layer 14 extending over an analogous inner/absorbent layer 16 by a distance of more than 1 mm, preferably about 2 mm (fig. 2 and col. 2, line 56-col. 3, line 17, border 29 formed by layer 14 extending past layer 16 can have a width of about 0.318 cm or 3.18 mm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the distance of the patent to be more than 1 mm, preferably about 2 mm, as taught by Mullane, since the thickness of this border would further prevent discharged liquid which is not absorbed by the absorbent layer from soiling garments, clothing, bedding, etc. (col. 3, lines 6-9).
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,500 B2 in view of Anderson et al. 6,605,172 B1.
Regarding claim 5, the patent claims the claimed invention as discussed above.
The patent is silent on said outer layer being made of a thermoplastic elastomer.
However, Anderson teaches a material for use in wound dressings (col. 4, lines 30-31) being made of a thermoplastic elastomer (col. 13, lines 46-49, suitable materials for the film include thermoplastic elastomers).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified said outer layer of the patent to be made of a thermoplastic elastomer, as taught by Anderson, to increase the comfort of the wearer.
Claims 6, 8, 10, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,500 B2 in view of Kane 2010/0100025 A1.
Regarding claim 6, the patent claims the claimed invention as discussed above.
The patent is silent on said inner layer being made as a compress.
However, Kane teaches a tubular bandage 10 (fig. 1 and [0001], tourniquet dressing sleeve) with said inner layer 14 being made as a compress ([0014], layer 14 is a fabric like polymer foam 14; [0015], fabrifoam provides compression and treats injuries).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified said inner layer of the patent to be made as a compress, as taught by Kane, to protect and pad the wound.
Regarding claim 8, the patent claims the claimed invention as discussed above.
The patent is silent on said inner layer exhibiting a substantial elasticity in both the longitudinal and transversal direction.
However, Kane teaches a tubular bandage 10 (fig. 1 and [0001], tourniquet dressing sleeve) with said inner layer 14 exhibiting a substantial elasticity in both the longitudinal and transversal direction ([0010], inner layer is fabrifoam polymeric stretchable material; as evidenced by North Coast Medical & Rehabilitation Products, fabrifoam has four-way stretch).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified said inner layer of the patent to exhibit a substantial elasticity in both the longitudinal and transversal direction, as taught by Kane, to be comfortable to wear during movement.
Regarding claim 10, the patent claims the claimed invention as discussed above.
The patent is silent on said tube having a length which is less than 30 mm, preferably less than 25 mm, more preferably less than 20 mm.
However, Kane teaches a tubular bandage 10 (fig. 1 and [0001], tourniquet dressing sleeve) having a tube 12 with any length ([0016], the tube/sleeve 12 may be cut to individual lengths for various digits for all sizes of patients, meaning they can be cut to any size).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have specified the tube of the patent to have a length which is less than 30 mm, preferably less than 25 mm, more preferably less than 20 mm, as taught by Kane, to be fit for a specific digit for a specifically sized patient ([0016], "[s]leeves may be cut to individual lengths for various digits for all sizes of patients", and a length less than 30 mm may be desirable to fit a certain patient).
Regarding claim 11, the patent claims the claimed invention as discussed above.
The patent is silent on a finger bandage or a toe bandage comprising a tubular bandage according to claim 10.
However, Kane teaches a tubular bandage 10 (fig. 1 and [0001], tourniquet dressing sleeve) in the form of a finger bandage or toe bandage ([0017], tourniquet for use on toes or fingers).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the tubular bandage of the patent to be a finger bandage or a toe bandage, as taught by Kane, to enable protection of finger or toe wounds.
Claims 7 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,201,500 B2 in view of Buglino et al. 6,011,194.
Regarding claim 7, the patent claims the claimed invention as discussed above.
The patent is silent on said inner layer being made as a viscoelastic gel.
However, Buglino teaches a wound dressing (fig. 1 and col. 1, lines 8-9) also comprising an inner layer 14 that is a visco-elastic gel (col. 4, lines 61-66, hydrocolloid absorbents; according to the specification of Applicant’s disclosure, p. 7, lines 10-12 state that a hydrocolloid is a visco-elastic gel).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the inner layer of the patent to be a visco-elastic gel, as taught by Buglino, which is prima facie obvious due to the selection of a known material based on its suitability for its intended use (please see MPEP 2144.07, In reLeshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960)); furthermore, since hydrocolloids are known absorbents, they are an obvious alternative material for absorbing the exudates and blood during use of Kane's dressing; lastly, there is no statement or evidence of criticality of the choice of material in the instant specification.
Regarding claim 9, the patent discloses the claimed invention as discussed above.
The patent is silent on said inner layer having a thickness between 0.4 mm and 2 mm.
However, Buglino teaches all of the components of the analogous dressing being of any suitable thickness as would be known to those in the art (col. 6, lines 35-36, in other words, the inner layer 14 can be any thickness, which would include a thickness between 0.4 mm and 2 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have specified the inner layer of the patent to have a thickness between 0.4 mm and 2 mm, as taught by Buglino, to form the dressing of a suitable thickness according to the purpose of a dressing as known to those in the art (col. 6, lines 35-36).
Conclusion
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786