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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the top and bottom side of the non-woven backing, top and bottom side of the first plastic film layer, top and bottom side of the adhesive silicone gel layer, top and bottom side of the protection layer, and a top and bottom side of the second plastic film layer must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities: “the top side of the first film layer” should be “the top side of the first plastic film layer” in lines 3-4. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “the bottom side of the backing layer” should be “the bottom side of the non-woven backing layer” in line 4. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “the top side of the silicone gel layer” should be “the top side of the adhesive silicone gel layer” in lines 5-6. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “the bottom side of the first film layer” should be “the bottom side of the first plastic film layer” in line 6. Appropriate correction is required.
Claim 1 objected to because of the following informalities: “the bottom side of the silicone gel layer” should be “the bottom side of the of the adhesive silicone gel layer” in line 8. Appropriate correction is required.
Claim 2 objected to because of the following informalities: “the article” should be “the medical article” in line 1. Appropriate correction is required.
Claim 3 objected to because of the following informalities: “the article” should be “the medical article” in line 1. Appropriate correction is required.
Claim 4 objected to because of the following informalities: “the article” should be “the medical article” in line 2. Appropriate correction is required.
Claim 5 objected to because of the following informalities: “the article” should be “the medical article” in line 2. Appropriate correction is required.
Claim 6 objected to because of the following informalities: “the article” should be “the medical article” in line 2. Appropriate correction is required.
Claim 7 objected to because of the following informalities: “the article” should be “the medical article” in line 2. Appropriate correction is required.
Claim 8 objected to because of the following informalities: “first film layer” should be “first plastic film layer” in line 2. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “first film layer” should be “first plastic film layer” in line 2. Appropriate correction is required.
Claim 10 objected to because of the following informalities: “silicone gel layer” should be “adhesive silicone gel layer” in line 2. Appropriate correction is required.
Claim 11 objected to because of the following informalities: “first film layer” should be “first plastic film layer” in line 2. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “silicone gel layer” should be “adhesive silicone gel layer” in line 2. Appropriate correction is required.
Claim 13 objected to because of the following informalities: “first film layer” should be “first plastic film layer” in line 2. Appropriate correction is required.
Claim 17 objected to because of the following informalities: “the article” should be “the medical article” in line 1. Appropriate correction is required.
Claim 18 objected to because of the following informalities: “the article” should be “the medical article” in line 1. Appropriate correction is required.
Claim 19 objected to because of the following informalities: “the article” should be “the medical article” in line 1. Appropriate correction is required.
Claim 20 objected to because of the following informalities: “the second film layer” should be “the second plastic film layer” in lines 1-2. Appropriate correction is required.
Claim 20 objected to because of the following informalities: “the tape” should be “the colored tape” in lines 1-2. Appropriate correction is required.
Claim 20 objected to because of the following informalities: “the cut line” should be “the single wave-shaped cut line” in lines 2-3. Appropriate correction is required.
Claim 21 objected to because of the following informalities: “first film layer” should be “first plastic film layer” in line 1. 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 4, 11-12, 14, and 17 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 4 recites the term “about” in line 3, which renders the claim indefinite because the claim does not clearly set forth the metes and bounds of the patent protection desired. Additionally, the term “about” was not defined in the specification.
Claim 11 recites the term “about” in line 2, which renders the claim indefinite because the claim does not clearly set forth the metes and bounds of the patent protection desired. Additionally, the term “about” was not defined in the specification.
Claim 12 recites the term “about” in line 2, which renders the claim indefinite because the claim does not clearly set forth the metes and bounds of the patent protection desired. Additionally, the term “about” was not defined in the specification.
Claim 14 recites the term "wavelike", which does not positively recite the "wave" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "wave-shaped" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim 17 recites the term “about” in line 2, which renders the claim indefinite because the claim does not clearly set forth the metes and bounds of the patent protection desired. Additionally, the term “about” was not defined in the specification.
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.
Claims 1-3, 8-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1).
Regarding claim 1, Embodiment A of Hanson et al. discloses a medical article (10 – figure 1, adhesive article: page 2, lines 28-30) for fixation of a wound dressing (the adhesive article [10] is a part of a medical article such as medical dressings; the medical article [10] is an adhesive that adheres to the user’s skin: page 3, lines 3-10), comprising a non-woven backing layer (16 – figure 1, a backing layer that can be nonwoven fibrous webs, knit, films, fabrics, foams, polymeric films, or a combination thereof: page 10, lines 2-5) with a top side (16a – figure 1, first major surface of the non-woven backing layer: page 2, lines 30-32) and a bottom side (16b – figure 1, a second major surface of the non-woven backing layer: page 2, lines 30-32), a first plastic film layer (12 – figure 1, a tie layer that includes a segmented copolymer: page 3, lines 13-15) with a top side (12a – figure 1, first major surface of the first plastic film layer: page 2, lines 30-32) and a bottom side (12b – figure 1, second major surface of the first plastic film layer: page 2, lines 30-32), wherein the top side of the first film layer (12a) is attached to the bottom side of the backing layer (16b) (figure 1, the top side of the first film layer [12a] is anchored to the bottom side of the backing layer [16b]: page 4, lines 22-35), an adhesive silicone gel layer (14 – figure 1, silicone adhesive: page 2, lines 28-30/page 7, lines 23-28) with a top side (14a – figure 1, first major surface of the adhesive silicone gel layer: page 2, lines 30-32) and a bottom side (14b – figure 1, a second major surface of the adhesive silicone gel layer: page 2, lines 30-32), wherein the top side of the silicone gel layer (14a) is attached to the bottom side of the first film layer (12b) (figure 1, the top side of the silicone gel layer [14a] is bonded to the bottom side of the first film layer [12b]: page 4, lines 22-35).
However, Embodiment A of Hanson et al. fails to disclose a protection layer with a top side and a bottom side, wherein the top side of the protection layer is releasably attached to the bottom side of the silicone gel layer.
Embodiment B of Hanson et al. teaches a protection layer (22 – figure 2, a releasable liner: page 13, lines 17-18) with a top side (A – see annotated figure 1, top side of the protection layer) and a bottom side (B – see annotated figure 1, bottom side of the protection layer), wherein the top side of the protection layer (A) is releasably attached to an analogous bottom side of the silicone gel layer (14b – figure 2, second major surface of the silicone gel layer: page 2, lines 30-32) (figure 2, the top side of the protection layer [A] is releasably attached to the bottom side of the silicone gel layer [14b] via absorbent material [20]; the protection layer [22] can cover all or a portion of the silicone gel layer [14]: page 13, lines 17-18).
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Annotated figure 1: medical article of Embodiment B of Hanson et al.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the bottom side of the silicone gel layer of Embodiment A of Hanson et al. with a protection layer as taught by Embodiment B of Hanson et al. in order to provide a medical article that has an improved silicone gel layer to prevent contamination of the silicone adhesive (Embodiment B of Hanson et al., page 13, lines 17-18).
Regarding claim 2, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the article (10) is provided in the form of a roll (the medical article [10] is provided in a roll form: page 12, lines 11-14).
Regarding claim 3, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the article (10) does not comprise separation lines (the medical article does not comprise separation lines).
Regarding claim 8, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the first film layer (12) comprises of polyurethane (the first film layer [12] can include polyurethane: page 3, lines 30-35).
Regarding claim 9, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the first film layer (12) is a coating (the first film layer [12] is a tie layer film that is semi-crystalline state, which means it can show minor melting and crystallization that allows a bond to the silicone gel layer [14] and is extruded onto the non-woven backing layer [16] for bonding: page 4, lines 7-21/page 13, lines 29-35).
Regarding claim 10, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the silicone gel layer (14) is a coating (the silicone gel layer [14] is a pressure sensitive adhesive that exhibits requisite viscoelastic properties that results balanced tack, peel adhesion, and shear strength; it is a thin layer of silicone gel layer [14] coated onto the first film layer [12]: page 9, lines 25-28/page 13, lines 29-35/page 14, lines 1-21).
Regarding claim 11, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the first film layer has a coating weight of from about 10 g/m2 to about 15 g/m2.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the coating weight of first film layer to be 10 g/m2 to 15 g/m2 to ensure that there is sufficient bond strength between the first film layer and silicone adhesive gel layer to maintain structural integrity during use (Embodiment A of Hanson et al., page 4, lines 7-35), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, applicant places no criticality on the range claimed, indicating simply that the coating weight of the first film layer “may be” within the claimed ranges (written specification: page 5, lines 22-23).
Regarding claim 12, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the silicone gel layer has a coating weight of from about 70 g/m2 to about 90 g/m2.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the coating weight of the silicone gel layer to be 70 g/m2 to 90 g/m2 to ensure that there is sufficient bond strength between the first film layer and silicone adhesive gel layer to maintain structural integrity during use (Embodiment A of Hanson et al., page 4, lines 7-35/page 14, lines 7-9), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, applicant places no criticality on the range claimed, indicating simply that the coating weight of the silicone gel layer “may be” within the claimed ranges (written specification: page 5, lines 23-24).
Regarding claim 13, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses wherein the first film layer (12) is formed using a liquid coating solution of a polyurethane (the first film layer [12] is formed from a resin comprising of polyurethane: page 13, lines 29-35/page 14, lines 1-3).
Regarding claim 15, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses a method of fixing a wound dressing comprising applying the medical article of claim 1 (see rejection above in claim 1 regarding the medical article) on a body of a patient in need of a wound dressing (the medical article [10] can be used as part of a bandage construction that is applied to the user’s skin: page 3, lines 3-10/page 12, lines 34-35/page 13, lines 1-6).
Regarding claim 16, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson et al. further discloses a method of manufacturing a medical article according to claim 1 (see rejection in claim 1 regarding the medical article), comprising the steps of: i. providing a non-woven backing layer (16 – figure 1, a backing layer that can be nonwoven fibrous webs, knit, films, fabrics, foams, polymeric films, or a combination thereof: page 10, lines 2-5) with a top side (16a – figure 1, first major surface of the non-woven backing layer: page 2, lines 30-32) and a bottom side (16b – figure 1, a second major surface of the non-woven backing layer: page 2, lines 30-32), ii. coating the bottom side of the backing layer (16b) with a first composition forming a first plastic film layer (12 – figure 1, a tie layer that includes a segmented copolymer: page 3, lines 13-15) (the first film layer [12] is a tie layer film that is semi-crystalline state, which means it can show minor melting and crystallization that bonds to the silicone gel layer [14] and is extruded onto the bottom side of the non-woven backing layer [16b] for bonding: page 4, lines 7-21/page 13, lines 29-35), said first plastic film layer (12) having a top side (12a – figure 1, first major surface of the first plastic film layer: page 2, lines 30-32) and a bottom side (12b – figure 1, second major surface of the first plastic film layer: page 2, lines 30-32), wherein the top side of the first plastic film layer (12a) is attached to the bottom side of the backing layer (16b) (figure 1, the top side of the first film layer [12a] is anchored to the bottom side of the backing layer [16b]: page 4, lines 22-35), iii. coating the bottom side of the first plastic film layer (12b) with a second composition forming an adhesive silicone gel layer (14 – figure 1, silicone adhesive: page 2, lines 28-30/page 7, lines 23-28) (the silicone gel layer [14] is a pressure sensitive adhesive that exhibits requisite viscoelastic properties that results balanced tack, peel adhesion, and shear strength; it is a thin layer of silicone gel layer [14] coated onto the first film layer [12]: page 9, lines 25-28/page 13, lines 29-35/page 14, lines 1-21), said adhesive silicone gel layer (14) having a top side (14a – figure 1, first major surface of the adhesive silicone gel layer: page 2, lines 30-32) and a bottom side (14b – figure 1, a second major surface of the adhesive silicone gel layer: page 2, lines 30-32), wherein the top side of the adhesive silicone gel layer (14a) is attached to the bottom side of the first plastic film layer (12b) (figure 1, the top side of the silicone gel layer [14a] is bonded to the bottom side of the first film layer [12b]: page 4, lines 22-35), Embodiment B of Hanson et al. further teaches iv. optionally, providing a protection layer (22 – figure 2, a releasable liner: page 13, lines 17-18) with a top side (A – see annotated figure 1, top side of the protection layer) and a bottom side (B – see annotated figure 1, bottom side of the protection layer), and v. optionally, covering the bottom side of the silicone gel layer (14b) with the protection layer (22), wherein the top side of the protection layer (A) is releasably attached to the bottom side of the silicone gel layer (14b) (figure 2, the top side of the protection layer [A] is releasably attached to the bottom side of the silicone gel layer [14b] via absorbent material [20]; the protection layer [22] can cover all or a portion of the silicone gel layer [14]: page 13, lines 17-18).
Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Cros et al. (US 11090406 B1).
Regarding claim 4, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a peel adhesion at 180° on Bristol paper, determined according to FINAT No. 1, of from about 1.3 N/25 mm to about 2.1 N/25 mm.
Cros et al. teaches wherein an analogous article (an adhesive article made of silicone gels that is a part of a dressing: column 1, lines 13-38) has a peel adhesion at 180° on Bristol paper, determined according to FINAT No. 1, of from about 2.625 N/25 mm to about 3.125 N/25 mm (in a preferred embodiment to an item that adheres to the skin, the silicone gel has an adhesive power of between 1.05 N/cm and 1.250 N/cm [2.625 N/25 mm and 3.125 N/25 mm] via testing of FINAT No. 1 with Bristol paper: column 3, lines 34-48/column 6, lines 33-60).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the peel adhesion from 2.625 N/25 mm and 3.125 N/25 mm to 1.3 N/25 mm-2.1 N/25 mm to ensure that rubbing of garments or other high stresses do not peel of the adhesive article from the user’s skin (Cros et al., column 3, lines 49-57), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, applicant places no criticality on the range claimed, indicating simply that the peel adhesion is “preferably” within the claimed ranges (written specification: page 4, lines 8-11).
Regarding claim 17, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 4.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a peel adhesion at 180° on Bristol paper, determined according to FINAT No. 1, of from about 1.3 N/25 mm to about 1.6 N/25 mm.
Cros et al. teaches wherein an analogous article (an adhesive article made of silicone gels that is a part of a dressing: column 1, lines 13-38) has a peel adhesion at 180° on Bristol paper, determined according to FINAT No. 1, of from about 2.625 N/25 mm to about 3.125 N/25 mm (in a preferred embodiment to an item that adheres to the skin, the silicone gel has an adhesive power of between 1.05 N/cm and 1.250 N/cm [2.625 N/25 mm and 3.125 N/25 mm] via testing of FINAT No. 1 with Bristol paper: column 3, lines 34-48/column 6, lines 33-60).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have optimized the peel adhesion from 2.625 N/25 mm and 3.125 N/25 mm to 1.3 N/25 mm-1.6 N/25 mm to ensure that rubbing of garments or other high stresses do not peel of the adhesive article from the user’s skin (Cros et al., column 3, lines 49-57), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Further, applicant places no criticality on the range claimed, indicating simply that the peel adhesion is “preferably” within the claimed ranges (written specification: page 4, lines 8-11).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Ragg (US 20170065459 A1).
Regarding claim 5, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 500g/m2/24h.
Ragg teaches wherein an analogous article (figure 1, an adhesive compression film bandage: paragraph 0038-0038) has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 500g/m2/24h (the article [figure 1] has a moisture vapor transmission rate of 500-1000g/m2/24h [determined by EN 13726-2 {chapter 3.2}], which falls within the claimed range: paragraph 0083).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the medical article of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. with a moisture vapor transmission rate of at least 500g/m2/24h as taught by Ragg in order to provide an improved medical article that prevents accumulation of moisture or sweat, which could lead to adhesive debonding, skin macerations, and bacterial infections (Ragg, paragraph 0080).
Regarding claim 18, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 5.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of at least 680g/m2/24h.
Ragg teaches wherein an analogous article (figure 1, an adhesive compression film bandage: paragraph 0038-0038) has a moisture vapor transmission rate, determined according to EN 13726-2 (chapter 3.2), of 500-1000g/m2/24h (the article [figure 1] has a moisture vapor transmission rate of 500-1000g/m2/24h [determined by EN 13726-2 {chapter 3.2}], which falls within the claimed range: paragraph 0083).
It would have been prima facie obvious to one of ordinary skills in the art before the filing date to have modified the moisture vapor transmission rate from 500-1000g/m2/24h to 680g/m2/24h in order to prevent accumulation of moisture or sweat, which could lead to adhesive debonding, skin macerations, and bacterial infections (Ragg, paragraph 0080). Additionally, the claimed value lies within the range disclosed by the prior art (please see MPEP 2144.05 I., “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 reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976)”). Further, applicant places no criticality on the range claimed, indicating simply that the moisture vapor transmission rate “may” be within the claimed ranges (written specification: page 4, lines 17-19).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Hamerslagh et al. (US 20200188183 A1).
Regarding claim 6, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a waterproofness, determined according to EN ISO 13726-3:2002, of at most 300s.
Hamerslagh et al. teaches wherein an analogous article (figure 4, a wound dressing: paragraph 0134) has a waterproofness, determined according to EN ISO 13726-3:2002, of at most 300s (the article [figure 4] is waterproof as determined by the EN ISO 13726-3:2003; the article [figure 4] was able to withstand the hydrostatic head of 500mm of water for 5 minutes [300 seconds]: paragraph 0181).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medical article of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. to be waterproof as taught by Hamerslagh et al. in order to provide an improved medical article that prevents ingress of water or leakage of wound fluids from the medical article (Hamerslagh et al., paragraph 0043/table 3).
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Dennis et al. (WO 2021249890 A1).
Regarding claim 7, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 2.8.
Dennis et al. teaches wherein an analogous article (1/2/3 - figure 3, a textile structure with a polymer layer [1], nonwoven layer [3], and uniaxially oriented material [2] in between: page 11, lines 12-22) has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 2.8 (the article [1/2/3] has a resistance to microbial penetration in the wet state of at least 6: page 14, lines 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the medical article of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. with a resistance to wet bacterial penetration of at least 2.8 as taught by Dennis et al. in order to provide an improved medical article to protect against exposure with aqueous liquids such as blood, body fluids, aerosols, airborne particles, organic and inorganic chemicals, and toxins (Dennis et al., page 2, lines 16-19).
Regarding claim 19, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 7.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the article has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 5.
Dennis et al. teaches wherein an analogous article (1/2/3 - figure 3, a textile structure with a polymer layer [1], nonwoven layer [3], and uniaxially oriented material [2] in between: page 11, lines 12-22) has a resistance to wet bacterial penetration, determined according to EN ISO 22610:2006, of at least 5 (the article [1/2/3] has a resistance to microbial penetration in the wet state of at least 6: page 14, lines 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the medical article of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. with a resistance to wet bacterial penetration of at least 5 as taught by Dennis et al. in order to provide an improved medical article to protect against exposure with aqueous liquids such as blood, body fluids, aerosols, airborne particles, organic and inorganic chemicals, and toxins (Dennis et al., page 2, lines 16-19).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Iwao et al. (US 20130006203 A1).
Regarding claim 14, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1. Embodiment A of Hanson further discloses wherein the protection layer (22) comprises a second plastic film layer (the protection layer [22] can be made of polyethylene, polypropylene, or polyester: page 13, lines 20-23) with a top side (A) and a bottom side (B).
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose a second plastic film layer with a single wavelike cut line along its length extension.
Iwao et al. teaches an analogous second plastic film layer (8 – figure 2a, a release liner made of polyester: paragraph 0136) with a single wavelike cut line (5 – figure 1, a wavy split part: paragraph 0046/0133) along its length extension (figure 1, the single wavelike cut line [5] extends along the length of the second plastic film layer [8]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the second plastic film layer of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. with a single wavelike cut line along its length extension as taught by Iwao et al. in order to provide a medical article that has an improved second plastic film layer so that it can be easily and readily removed before use of the medical article (Iwao et al., paragraph 0046).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) in view of Iwao et al. (US 20130006203 A1) and in further view Tsuruta et al. (US 20120253255 A1), with extrinsic evidenced provided by “PMC” for the rejection of claim 20.
Regarding claim 20, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. and in further view of Iwao et al. discloses the invention as discussed in claim 14. Iwao et al. further teaches wherein the second film layer (8) is transparent (the second film layer [8] can be transparent since it can be made from polyethylene terephthalate: paragraph 0068; polyethylene terephthalate is transparent, as evidenced by PMC).
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. and in further view of Iwao et al. fails to disclose a colored tape is attached to the bottom side of the second film layer along the cut line, wherein the cut line also penetrates the tape.
Tsuruta et al. teaches a colored tape (18– figure 5, a colored pinching piece forming sheet: paragraph 0082) is attached to an analogous bottom side of the second film layer (C – annotated figure 2, a release sheet [16] made of a polymer: paragraph 0070) along an analogous cut line (20 – figure 5, a perforated line in which perforations penetrate through the colored tape [18]: paragraph 0083) (figure 5, the colored tape [18] is attached to the bottom side of the second film layer, wherein the cut line also penetrates the tape (18) (figure 5, the cut line [20] penetrates the colored tape [18]: paragraph 0083).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the bottom side of the second film layer of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. and in further view of Iwao et al. with a colored tape as taught by Tsuruta et al. in order to provide an improved medical article that allows users to distinguish where to pinch and pull the release sheet from the adhesive layer (Tsuruta et al., paragraph 0024/0082).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Stephen (GB 2460149 A).
Regarding claim 21, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 1.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the first film layer consist of polyurethane.
Stephen teaches wherein an analogous first film layer (2 – figure 1, a structural layer made of a thin film of synthetic plastics: page 8, lines 1-7/page 13, lines 20-26) consist of polyurethane (the first film layer [2] consist of only melt blown polyurethane: page 8, lines 1-7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first film layer of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. to consist of polyurethane as taught by Stephen in order to provide a medical article that has an improved first film layer to enhance breathability of the medical article (Stephen, page 8, lines 22-26).
Claims 22-24 is rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Hanson et al. (WO 2020188438 A1) in view of Embodiment B of Hanson et al. (WO 2020188438 A1) and in further view of Guillermin et al. (US 9827206 B2).
Regarding claim 22, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 9.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the coating is a transfer coating.
Guillermin et al. teaches wherein an analogous coating is a transfer coating (figure 2, a silicone gel [2] is coated onto a temporary anti-adherent process liner [3] and passes through a corona treatment unit [14]; once it passes through, a substrate [4], such as a polyurethane film, is coated onto the silicone gel [2]. At the end of the method, the anti-adherent process liner [3] is removed: column 4, lines 15-40/column 5, lines 8-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating method of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. to be a transfer coating as taught by Guillermin et al. in order to provide a medical article that has an improved coating to allow the coating (thin layers) to be treated with corona treatment to generate strong and lasting adhesion between layers (Guillermin et al., column 5, lines 18-28).
Regarding claim 23, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 10.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the coating is a transfer coating.
Guillermin et al. teaches wherein an analogous coating is a transfer coating (figure 2, a silicone gel [2] is coated onto a temporary anti-adherent process liner [3] and passes through a corona treatment unit [14]; once it passes through, a substrate [4], such as a polyurethane film, is coated onto the silicone gel [2]. At the end of the method, the anti-adherent process liner [3] is removed: column 4, lines 15-40/column 5, lines 8-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating method of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. to be a transfer coating as taught by Guillermin et al. in order to provide a medical article that has an improved coating to allow the coating (thin layers) to be treated with corona treatment to generate strong and lasting adhesion between layers (Guillermin et al., column 5, lines 18-28).
Regarding claim 24, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. discloses the invention as discussed in claim 6.
However, Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. fails to disclose wherein the coating step is a transfer coating step.
Guillermin et al. teaches wherein an analogous coating step is a transfer coating step (figure 2, a silicone gel [2] is coated onto a temporary anti-adherent process liner [3] and passes through a corona treatment unit [14]; once it passes through, a substrate [4], such as a polyurethane film, is coated onto the silicone gel [2]. At the end of the method, the anti-adherent process liner [3] is removed: column 4, lines 15-40/column 5, lines 8-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coating method of Embodiment A of Hanson et al. in view of Embodiment B of Hanson et al. to be a transfer coating as taught by Guillermin et al. in order to provide a medical article that has an improved coating to allow the coating (thin layers) to be treated with corona treatment to generate strong and lasting adhesion between layers (Guillermin et al., column 5, lines 18-28).
Conclusion
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786