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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/2025 has been entered.
Response to Amendment
The amendments filed on 11/25/2025 has been entered. Claims 1 and 22 have been amended; claims 10-11, 15-17, 23, and 25 have been cancelled; claims 26-27 have been added. Accordingly, claims 1-9, 12-14, 18-22, 24, and 26-27 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed on 11/25/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hansen et al. US 2015/0359656 A1 (previously cited), as cited in the IDS, in view of Leise, JR et al. US 2004/0106908 A1 (previously cited), as cited in the IDS, Clok et al. US 6,685,683 B1 (previously cited), and Israelson et al. WO 2017032381 A1 (previously cited).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-9, 12-14, 18-20, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. US 2015/0359656 A1 (previously cited, hereinafter Hansen), as cited in the IDS, in view of Leise, JR et al. US 2004/0106908 A1 (previously cited, hereinafter Leise), as cited in the IDS, Clok et al. US 6,685,683 B1 (previously cited, hereinafter Clok), and Israelson et al. WO 2017032381 A1 (previously cited, hereinafter Israelson).
Regarding claim 1, Hansen discloses a barrier ring 1 (Fig. 6 – base plate 1) adapted for placement around a stoma 4 (Fig. 6 – stoma 4) of a user (Fig. 6, and Abstract – “a base plate (1)… for attaching the base plate to the skin of a user”), the barrier ring 1 (Fig. 6) comprising:
a first layer 11 (Fig. 5-6 – adhesive wafer 11) of a first adhesive material 8 (Fig. 5-6 – top film 8, and Par. 42 – “The top film is relatively flexible and may be… one or more polyethylene (PE) materials”, which in consistent with Applicant’s disclosure of a first adhesive material, i.e. polyethylene materials in Par. 44 of PG-PUB), the first layer 11 (Fig. 5-6) having a proximal surface (Fig. 5-6 – the surface being in contact with adhesive 9) and a distal surface (Fig. 5-6 – the surface being in contact with convex element 10), and the distal surface of the first layer 11 (Fig. 5-6 – the surface being in contact with convex element 10) forms a distal surface of the barrier ring 1 (Fig. 5) that is separate from and attachable to a proximal surface of an ostomy base plate (Fig. 5-6, and Par. 81 – “FIG. 5 shows a base plate 1 of a one-piece or two-piece ostomy appliance (collecting bag not shown)”, the surface being in contact with convex element is distinct from a proximal surface of a collecting bag’s plate which is not shown and is fully capable of attaching to said structure);
a second layer 9 (Fig. 5-6 – adhesive 9) of a second adhesive material (Fig. 5-6, and Par.81 – “a first skin-friendly adhesive 9”), the second layer 9 (Fig. 5-6) disposed on at least the proximal surface of the first layer 8 (Fig. 6, and Par. 81 – “The adhesive wafer 11 comprises a top film 8 having at least a first skin-friendly adhesive 9 disposed on the proximal surface thereof”) to form a proximal surface of the barrier ring 1 (Fig. 6) that is adhesively attachable to skin 7 (Fig. 6 – skin recess 7) of the user (Par. 82 – “the invention positioned in place in a use situation in a skin recess 7 surrounding a stoma 4 on the skin surface of a user”), such that the second layer 9 (Fig. 5-6) directly overlays the first layer 11 (Fig. 5-6); and
a stoma-receiving opening 5 (Fig. 5 – through-going hole 5) extending through a central portion (see annotated Fig. 5 below) of the first layer 11 (Fig. 5) and the second layer 9 (Fig. 5) of the barrier ring 1 (Fig. 5).
However, Hansen does not disclose wherein the first layer comprises a bulk portion located in the central portion of the barrier ring, and a flange portion extending radially inwards from an outer peripheral edge of the barrier ring and transitioning into the bulk portion, where a thickness of the bulk portion is greater than a thickness of the flange portion to form a convex surface present on the proximal surface of the barrier ring, where the convex surface present on the proximal surface of the barrier ring is adapted to fit into a skin fold around the stoma; wherein the first adhesive material of the first layer has a tangent delta (tan δ) below 0.6 at 1.0 Hz and a IG*| below 1 MPa in a frequency range of 0.03 - 1.0 Hz with tangent delta at 0.03 Hz being above tangent delta at 1.0 Hz; wherein the second adhesive material of the second layer has a tangent delta (tan δ) above 0.6 and a IG*| below 1 MPa in a frequency range of 0.03 - 1.0 Hz with tangent delta at 0.03 Hz being below tangent delta at 1.0 Hz.
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Annotated Fig. 5 of Hansen
Leise, in the same field of endeavor of ostomy appliance (Par. 3), teaches wherein the first layer 2 (Fig. 4 – adhesive layer 2) comprises a bulk portion 10 (Fig. 6 – thick central portion 10) located in the central portion (see annotated Fig. 6 below, and Par. 83 – “the adhesive layer 2 comprises… a relatively thick central portion 10”) of the barrier ring 1 (Fig. 4 – wafer 1), and a flange portion 9 (Fig. 6 – thin peripheral portion 9) extending radially inwards from an outer peripheral edge (see annotated Fig. 6 below – portion 9 extends radially inwards and meets portion 10) of the barrier ring 1 (Fig. 6) and transitioning into the bulk portion 10 (Fig. 6 – portion 9 extends radially inwards and meets portion 10), where a thickness t1 (Fig. 6 – thickness t1) of the bulk portion 10 (Par. 84 – “The central portion 10 has a substantially uniform thickness t1”) is greater than a thickness t2 (Fig. 6 – thickness t2) of the flange portion 9 (Fig. 6, and Par. 84 – “The central portion 10 has a substantially uniform thickness t1 which is at least 2.5 mm larger than the thickness t2 of the peripheral portion”) to form a convex surface 10 (Fig. 4, Fig, 6, and Abstract – “a soft convex adhesive wafer“) present on the proximal surface of the barrier ring 1 (see annotated Fig. 6 below), where the convex surface 10 (Fig. 4 and Fig. 6) present on the proximal surface of the barrier ring 1 (see annotated Fig. 6 below) is adapted to fit into a skin fold around the stoma (Par. 88 – “combination of degree of fit of the annular central portion 10 to a moat or groove in the tissue surrounding the stoma”).
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Annotated Fig. 6 of Leise
Clok, in the same field of endeavor of ostomy appliance with adhesive (Abstract), teaches wherein the first adhesive material ∆ (see annotated Graph below – denotated as ∆; refer to Table 1 for composition of adhesive ∆) has a |G*| below 1 MPA in a frequency range of 0.03 – 1.0 Hz (see annotated Graph below, left axis – adhesive ∆ has a |G*| below 106 Pa, or 1 MPa, from 0.03 – 1.0 Hz);
wherein the second adhesive material X (see annotated Graph below – denoted as X; refer to Table 1 for composition of adhesive X) has a tangent delta (tan δ) above 0.6 (see annotated Graph below, right axis – adhesive X has a tan δ above 0.6 from 0.03 – 1.0 Hz) and a |G*| below 1 MPa in a frequency range of 0.03 – 1.0 Hz (see annotated Graph below, left axis – adhesive X has a |G*| below 106 Pa, or 1 MPa, from 0.03 – 1.0 Hz) with tangent delta at 0.03 Hz being below tangent delta at 1.0 Hz (see annotated Graph below – tan δ of adhesive X at 0.03 Hz is less than that at 1.0 Hz). Examiner notes that Examiner is interpreting the four upward trendlines to be tangent delta, and the other four downward trendlines to be |G*|.
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Annotated Graph of Clok
Israelson, in the same field of endeavor of skin adhesive composition (Abstract), teaches the first adhesive material has a tangent delta (tan δ) below 0.6 at 1.0 Hz (Page 6, line 3-4 in the provided document – tan(delta) at 1 Hz is in the range 0.5-3).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first layer of Hansen’s device to have a bulk and flange portion as taught by Leise, in order to provide a wafer of the type indicated that may fit into a moat or groove in the peristomal skin surface surrounding a stoma (Par. 15 of Leise). This allows the device to accommodate more irregular moat configurations (Par. 23 of Leise).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first layer and the second layer of Hansen in view of Leise and substituted their respective adhesive material that allows for formation of a barrier ring and attachment to the skin, for the first and second adhesive material with the claimed properties as taught by Clok, since these adhesive mechanisms perform the same function of attaching a layer onto the skin surface of a user. Simply substituting one adhesive means for another would yield the predicable result of allowing skin barrier component to be affixed to the skin surface. See MPEP 2143. Therefore, one of ordinary skill in the art would have been motivated to substituted the first and second adhesive materials for ones that exhibit the claimed properties of tan(delta) and |G*|, in order to implement adhesive, barrier properties, and also moisture absorbing properties (Col. 3, line 49-57 of Clok).
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first layer of the combination to further have a first adhesive material whose tan(delta) is below 0.6 at 1.0 Hz as taught by Israelson, in order to exhibit mouldability of the composition and its ability to retain its shape after deformation (Page 6, line 13-25 in the provided document of Israelson).
Furthermore, while Israelson does not teach that the tangent delta at 0.03 Hz being above tangent delta at 1.0 Hz, Israelson does, however, teach that tan(delta) values at various frequencies result in an adhesive composition with a balance of elastic and plastic properties (Page 6, line 13-14 of Israelson). Therefore, the tan(delta) and frequency are recognized as a result-effective variable, i.e. a variable which achieves a recognized result. In this case, the recognized result is that with an increased/decreased frequency, the resultant value of tan(delta) will reflect if the adhesive is elastic or plastic, which will determine the mouldability of the adhesive. Therefore, since the general conditions of the claim, i.e. that the tan(delta) of the adhesive is below 0.6 at 1.0 Hz, was disclosed in the prior art by Israelson, it is not inventive to discover the optimum workable range by routine experimentation, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have experimented routinely and ultimately provided a first adhesive with tangent delta at 0.03 Hz being above tangent delta at 1.0 Hz. See MPEP 2144.05 II. Thus, the limitation “tangent delta at 0.03 Hz being above tangent delta at 1.0 Hz” is met.
Regarding claim 3, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses the convex surface 10 (Fig. 6 of Leise) present on the proximal surface of the barrier ring 1 (Fig. 1 of Hansen) describes a curve approximating an S-shape (Fig. 4 of Leise – convex surface of portion 10 forming an S-shape), when seen in a cross-sectional view through the barrier ring 1 (Fig. 1 of Hansen; see annotated Fig. 6 of Leise above – cross-section of wafer 1 shows the convex surface of portion 10).
Regarding claim 4, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses the flange portion 9 (Fig. 6 of Leise) of the first layer 11 (Fig. 5 of Hansen, after modification by Fig. 6 of Leise) lies in a first plane (Fig. 6 of Leise – thin peripheral portion 9 exists on the bottom-most plane that is the annotated distal surface DS of layer 2), and a proximal-most portion 13 (Fig. 6 of Leise – bodyside surface 13 of the central portion 10) of the bulk portion 10 (Fig. 6 of Leise) of the first layer 11 (Fig. 5 of Hansen, after modification by Fig. 6 of Leise) lies in a second plane (Fig. 6 of Leise – second plane being the surface 13 of bulk portion 10), and wherein the second plane is parallel to the first plane (see annotated Fig. 6 of Leise above – surface 13 is parallel to the distal surface DS).
Regarding claim 5, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 4. The combination further discloses a linear distance t1 (Fig. 6 of Leise) between the first plane (see annotated Fig. 6 of Leise above – distal surface DS) and the second plane 13 (Fig. 6 of Leise) measured along a line normal to the first plane (see annotated Fig. 6 of Leise above – t1 is measured as the perpendicular distance from the annotated distal surface DS to surface 13) is in the range of 5-20 mm (Par. 91 of Leise – t1 dimensions are listed as 5.85 mm).
Regarding claim 6, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the second layer 9 (Fig. 5-6 of Hansen) of the barrier ring 1 (Fig. 5-6 of Hansen) has a substantially constant thickness (Fig. 5-6 of Hansen, and Par. 49 of Hansen) measured in an axial direction of the barrier ring 1 (Fig. 5-6 of Hansen).
Regarding claim 7, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 6. The combination further discloses wherein the substantially constant thickness of the second layer 9 (Fig. 5 of Hansen – skin-friendly adhesive 9) is in a range of 0.3 – 1.5 mm (Par. 49 – “an overall average thickness of the skin-friendly adhesive disposed on the top film may be in a range of approximately 0.3-1.5 mm…”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the second layer of the combination, from between 0.3 and 1.5 mm to 0.5 and 10.0 mm as applicant appears to have placed no criticality on the claimed range (Page 15, line 22-29 of Applicant’s specification), and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the second adhesive of the combination would not operate differently with the claimed range, and since the claimed range still overlaps with the working range as taught by Hansen. Thus, one of ordinary skill in the art would have been motivated to expand the thickness range of the second layer, in order to provide a cushioning effect of the barrier ring.
Regarding claim 8, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses a thickness t2 (Fig. 6 of Leise) of the flange portion 9 (Fig. 6 of Leise) of the first layer 11 (Fig. 5-6 of Hansen after modification by Fig. 6 of Leise) measured in an axial direction of the barrier ring 1 (Fig. 5-6 of Hansen) is in a range of 0.2 – 3.0 mm (Par. 90 of Leise – “the thickness t2 is 0.85 mm”).
Regarding claim 9, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein a maximum thickness t1 (Fig. 6 of Leise) of the bulk portion 10 (Fig. 6 of Leise) of the first layer 11 (Fig. 5-6 of Hansen after modification by Fig. 6 of Leise) measured in an axial direction of the barrier ring 1 (Fig. 5-6 of Hansen) is in a range of 3 - 12 mm (Par. 91 of Leise – the maximum thickness t1 from table 1 is 5.85 mm).
Regarding claim 12, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. However, the combination does not disclose |G*| of the second adhesive material is less than the |G*| of the first adhesive material in the frequency range of 0.03 Hz – 1.0 Hz. Currently, the |G*| of the second adhesive material is more than the |G*| of the first adhesive material in the frequency range of 0.03 Hz – 1.0 Hz.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to have optimized the |G*| values between first and second adhesive of the combination to have the one greater than the other, since "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation", where Clok teaches the general conditions of the claim in the prior art, i.e. different adhesives exhibit different |G*| values (result-effective variables) at certain frequency encompassing from 0.03 Hz to 1.0 Hz (Graph 1 of Clok), including the substantially similar composition in all other respects and identical experimental data. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.A. Therefore, one of ordinary skill in the art would have been motivated to experimented routinely and ultimately provided two adhesives whose |G*| values differ as claimed between 0.03 Hz and 1.0 Hz, in order to demonstrate an adhesive that is more prone to deformation than the other to exhibit degrees of elasticity/plasticity (page 6. Line 13-14 of Israelson).
Regarding claim 13, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. However, the combination does not disclose a difference in the respective |G*| of the first adhesive material and the second adhesive material at a frequency of 0.03 Hz is at least 10 kPa and wherein a difference of the respective |G*| of the first adhesive material and the second adhesive material at a frequency of 1.0 Hz is at least 100 kPa.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to have optimized the difference in |G*| values of the combination, since "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation", where Clok teaches the general conditions of the claim in the prior art, i.e. different adhesives exhibit different |G*| values (result-effective variables) at certain frequency encompassing 0.03 Hz and 1.0 Hz (Graph 1 of Clok), including the substantially similar composition in all other respects and identical experimental data. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.A. Therefore, one of ordinary skill in the art would have been motivated to experimented routinely and ultimately provided two adhesives whose |G*| values differ as claimed at 0.03 Hz and 1.0 Hz, in order to demonstrate an adhesive that is more prone to deformation than the other to exhibit degrees of elasticity/plasticity (page 6. Line 13-14 of Israelson).
Regarding claim 14, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. However, the combination does not disclose wherein the first adhesive material 11 (Fig. 5-6 of Hansen) configured to support a pressure applied around the stoma 4 (Fig. 6 of Hansen) of the user to force the stoma 4 (Fig. 6 of Hansen) to protrude from skin of the user (Par. 86 of Hansen – “to provide a convex ostomy product that is able to maintain adequate pressure on the peristomal skin while being hole-size customizable”).
However, the combination does not disclose wherein the first adhesive material is harder than the second adhesive material.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to have optimized the |G*| values between first and second adhesive of the combination to have the one greater than the other, since "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation", where Clok teaches the general conditions of the claim in the prior art, i.e. different adhesives exhibit different |G*| values (result-effective variables) at certain frequency encompassing from 0.03 Hz to 1.0 Hz (Graph 1 of Clok), including the substantially similar composition in all other respects and identical experimental data. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.A. Furthermore, Applicant’s Par. 72 in the PG-Pub also discusses that the complex shear modulus |G*| indicates the moulding characteristics of the adhesive material, i.e. how easy it is to shape and manipulate it with for example your fingers. Therefore, one of ordinary skill in the art would have been motivated to experimented routinely and ultimately provided two adhesives whose |G*| values differ as claimed between 0.03 Hz and 1.0 Hz, in order to demonstrate an adhesive that is more prone to deformation than the other to exhibit degrees of elasticity/plasticity (page 6. Line 13-14 of Israelson).
Regarding claim 18, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the second layer 9 (Fig. 5-6 of Hansen) is displaced radially outward relative to the stoma-receiving opening 5 (Fig. 5-6 of Hansen – adhesive 9 spans outward with respect through-going hole 5) in response to the applied pressure (Par. 44 of Hansen – “One example of at least one skin-friendly adhesive material that may be used for the adhesive wafer according to the invention is a pressure sensitive adhesive”).
Regarding claim 19, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the second layer 9 (Fig. 5-6 of Hansen) forms a localized bulge of increased thickness (Examiner notes that once the modification is made as discussed in claim 1 above, layer 11 of Hansen will have a bulge portion as taught by numerical character 10 of Leise. Therefore, second layer 9 of Hansen overlaying over the central portion 10 of Leise will create a localized bulge where the portion 10 of Leise is, while the overlay over the thin peripheral portion 9 of Leise will remain thin and flat; thus, the limitation is met) relative to a remainder of the second layer 9 (Fig. 5-6 of Hansen).
Regarding claim 20, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein a perimeter of barrier ring 1 (Fig. 5-6 of Hansen) is radially compressible in response to pressure applied at the flange portion 9 (Fig. 6 of Leise; Par. 75 of Leise – “an adhesive layer 2 of moldable skin barrier material, and Par. 44 of Hansen – “One example of at least one skin-friendly adhesive material that may be used for the adhesive wafer according to the invention is a pressure sensitive adhesive”; Examiner notes that since both the materials of the combined barrier ring is moldable and pliable, the perimeter, including the flange portion, of the device is also moldable and pliable).
Regarding claim 26, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the first layer 11 (Fig. 5-6 of Hansen after modification by Fig. 6 of Leise) and second layers 9 (Fig. 5-6 of Hansen) being co-deformable in response to an applied pressure (Par. 42 of Hansen – “The top film is relatively flexible and may be… one or more polyethylene (PE) materials”, and Par. 44 of Hansen – “One example of at least one skin-friendly adhesive material that may be used for the adhesive wafer according to the invention is a pressure sensitive adhesive composition”).
Regarding claim 27, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the first layer 11 (Fig. 5-6 of Hansen after modification by Fig. 6 of Leise) is configured to provide structure to the barrier ring 1 (Fig. 5-6 of Hansen – the adhesive wafer 11 is capable of providing structure) and the second layer 9 (Fig. 5-6 of Hansen) is configured to flow and seal to the skin 7 (Fig. 5-6 of Hansen, and Par. 84 of Hansen – “contact with the peristomal skin surface 3”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Leise in view of Clok in view of Israelson as applied to claim 1 above, and further in view of Nyberg US 2015/0297389 A1 (previously cited, hereinafter Nyberg).
Regarding claim 2, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. However, the combination does not disclose the second layer disposed on an entirety of an inner peripheral surface of the barrier ring defined by the stoma-receiving opening.
Nyberg, in the same field of endeavor of ostomy base plate (Abstract), teaches the second layer 30 (Fig. 1b and Par. 70 – planar flange 30 with coupling means; “coupling means” in Par. 64 of Nyberg’s disclosure can be adhesive-type coupling means) disposed on an entirety of an inner peripheral surface (Fig. 1b – planar flange 30 forms an annular ring and defines the stoma-receiving through-going hole 4) of the barrier ring 10 (Fig. 1b and Fig. 7 – base plate 10) defined by the stoma-receiving opening 4 (Fig. 1b – stoma-receiving through-going hole 4).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second layer of the combination to have the inner peripheral surface at the stoma-receiving opening formed by the second layer as taught by Nyberg, in order to provide a complete seal around the stoma thanks to the annular ring configuration of the second adhesive material at the stoma-receiving opening. Having the adhesive conforms to the non-flat surfaces around the stoma promotes sanitation and leakproof liquid transfer for users.
Claims 21, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Leise in view of Clok in view of Israelson as applied to claim 1 above, and further in view of St. Michael’s Hospital, “Understating Barrier Accessories” (previously cited, hereinafter St. Michael).
Regarding claim 21, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 1. The combination further discloses wherein the barrier ring 1 (Fig. 5-6 of Hansen) is configured to stretch from a first configuration to a second configuration (Par. 44 of Hansen –“One example of at least one skin-friendly adhesive material that may be used for the adhesive wafer according to the invention is a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base”, and Par. 75 of Leise – “an adhesive layer 2 of moldable skin barrier material“; Examiner notes that since both the materials of the combined barrier ring is moldable and pliable, the barrier ring is fully capable of being molded from a first configuration to a second configuration upon pressure on different location of the materials).
However, the combination does not disclose in response to an applied finger pressure at an inner diameter of the stoma-receiving opening.
St Michael, in the same field of endeavor of barrier accessories for ostomy pouching systems (Description of the Youtube video), teaches configurations (see Figs @9:00 and @9:15 – pre-stretch configuration and post-stretch configuration) in response to an applied finger pressure at an inner diameter of the stoma-receiving opening (see Fig. @9:15 below – the finger apply pressure to the diameter of the stoma opening).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further allow configuration change upon pressure as taught by St Michael, in order to provide a desired shape and size that the user wants (transcript @9:04-9:13 of St Michael).
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Regarding claim 22, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 21. The combination further discloses wherein the inner diameter of the stoma-receiving opening is increased in the second configuration (see Fig. @9:15 of St. Michael above) relative to the first configuration (see Fig. @9:00 of St. Michael above – the diameter of the stoma opening is increased in the pull direction).
Examiner notes that once the modification is made as discussed in claim 21, the first and second configuration by finger pressure of St. Michael will be incorporated in the combined device, including the increased inner diameter.
Regarding claim 24, Hansen in view of Leise in view of Clok in view of Israelson suggests the invention of claim 21. However, the combination does not disclose wherein a perimeter of the barrier ring is substantially circular in the first configuration and the perimeter of the barrier ring is substantially elliptical in the second configuration.
St. Michael, in the same field of endeavor of barrier accessories for ostomy pouching systems (Description of the Youtube video), teaches wherein a perimeter of the barrier ring is substantially circular in the first configuration (see annotated Fig. @9:00 above) and the perimeter of the barrier ring is substantially elliptical in the second configuration (see annotated Fig. 9:15 above).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device’s perimeter in the first configuration to a substantially circular as taught by St. Michael, since it is a matter of engineering design to configure the edge of a barrier ring in different ways, where the change in form or shape, without any new or unexpected results, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04). Furthermore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combined device to have an elliptical perimeter in the second configuration as taught by St. Michael, in order to provide a desired shape and size that the user wants, such as an oval-shaped stoma (transcript @9:04-9:31 of St Michael).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hunt et al. US 20170156920 A1
Voto US 7540861 B1
Holmberg US 5496296 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781