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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/23/2025 has been entered.
Response to Amendment
Applicant’s amendments to claim 1 and the cancellation of claim 7 filed on 10/23/2025 are acknowledged by the examiner.
Claims 3-4, 12-13, and 19-21 remain cancelled.
Claims 1-2, 5-6, 8-11, 14-18, 22-28 are currently pending, and claims 1-2, 5-6, 8, and 28 are currently under examination.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of the amendments to the claims, the office action has been updated, and new teaching references are disclosed to cure the deficiencies of Etchells in view of Ruman. See below.
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.
Claim(s) 1-2 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etchells et al. (referred to as “Etchells”) (US 2020/0155357 A1) in view of Ruman et al. (referred to as “Ruman”) (US 9,018,434 B2) in view of Bishop et al. (referred to as “Bishop”) (US 2005/0182347 A1) further in view of Anderson et al. (referred to as “Anderson”) (US 2018/0369462 A1).
Regarding claim 1, Etchells discloses an indicator (400) for detecting a fluid status of a wound dressing (see Fig. 4 and Abstract, [0134]; moisture indicating article 400 is a reversible moisture indicating article), the indicator (400) comprising:
a lower layer (101a) (see Fig. 4; moisture indicating layer 101a is a lower layer as it is arranged on the bottom);
a marking (102) printed along the lower layer (101a), the marking (102) being printed with at least one of an ink or a dye (see Fig. 4 and [0039]; pigmented layer 102 is a marking as it is a specific color/pigment to mark or signal a wound dressing needs to be changed, see [0024]-[0025], [0028], and the pigment of the pigmented layer may be printed onto the surface of the pigmented layer via ink jet printing, and thus is printed via an ink, see [0039], and so the pigment of the pigmented layer 102 is printed along the moisture indicating layer 101a; also although Etchells discloses the printed ink marking, the marking “being printed” is a product by process limitation, absent evidence that an ink marking made by printing would be structurally different from an ink marking made by another process); and
a top layer (101b) formed from a porous, hydrophilic structure defined by a plurality of fibers (see Fig. 4 and [0134], [0035], [0037]-[0038], [0044]-[0045]; the masking layer or the moisture indicating layer 101b may be a fabric of a plurality of fibers that can absorb water and are superabsorbent, and thus are a hydrophilic structure, and are porous as fabric, such as cotton, is inherently porous); wherein a first state, the marking (102) is blocked by the top layer (101b) and not visible to a user under ambient or natural light and the plurality of fibers have a first refractive index (see [0044]-[0045] and Fig. 4, and [0134]; in a first state, the pigmented layer 102 is blocked or masked by the moisture indicating layer 101b that lies on top of pigmented layer 102, and thus pigmented layer 102 is not visible to a user under ambient or natural light, as the moisture indicating layer 101b when dry, or in a first state, reflects all light to an observer, meaning the layer 101b is opaque and does not show the pigmented layer 102, the fibers of the material inherently having a first refractive index);
wherein in a second state, the marking (102) is visible through the top layer (101b) under ambient or natural light and the plurality of fibers have a second refractive index that is greater than the first refractive index (see [0044]-[0045] and Fig. 4, and [0134]; in a second state, when the moisture indicating layer 101b is wet, the fibers absorb the water causing the fibers to swell, thereby diminishing the reflective surfaces, and thus the moisture indicator layer 101b becomes transparent, making the pigment layer 102 visible through the moisture indicating layer 101b under ambient or natural light, and thus the fibers have a second refractive index which is greater than the first refractive index as the fibers go from opaque to transparent); and
wherein in a third state, the marking (102) is blocked by the top layer (101b) and not visible to the user under ambient or natural light, the third state occurring at a point in time subsequent to the second state (see Fig. 4 and [0044]-[0045], [0050], and [0134]; the moisture indicating article 400 is a reversible moisture indicating article, and thus the moisture indicating layer 101b may regain its opacity, and thus is a third state, after being wet, which was the second state, and thus the third state occurs at a point in time subsequent to the second state).
Etchells is silent on the top layer including an outline corresponding to the marking; and an attachment layer disposed between the lower layer and the top layer; wherein the outline overlies the marking and is visible in each of the first state, the second state, and the third state; and wherein the attachment layer is configured to evaporate fluids at a rate equal to a rate of evaporation of the lower layer to enable the wound dressing to transition from the second state to the third state.
However, Ruman teaches an analogous marking (104) (see Fig. 18), and an analogous top layer (12) including an outline (102) corresponding to the marking (104) (see Fig. 18 and Col. 19 lines 62-67 et seq. Col. 20 lines 1-3; the outer cover 12 is an analogous top layer as it is the exterior layer that is directly seen by a user, and the outer cover 12 includes framing device 102 which is an outline that corresponds to gauge element 104, which is an analogous marking as gauge element 104 is an active graphic that may change color when contacted with a liquid, see Col. 19 lines 7-21), wherein the outline (102) is visible in each of the first state, the second state, and the third state (see Fig. 18. and Col. 19 lines 62-27 et seq. Col. 20 lines 1-3, and Col. 19 lines 7-21; framing device 102 is a permanent graphic, meaning the framing device 102 does not change its degree of visibility when subject to liquid like an active graphic like gauge element 104, and thus framing device 102 is visible in each of a first state, a second state, and a third state, see claim 1 and see Col. 3 lines 10-13, as the framing device 102 focuses one’s attention on the gauge element 104 for better discerning when the wetness indicator has been wetted, see Col. 19 lines 19-21), providing to focus one’s attention on the active graphic for better discerning when the wetness indicator has been wetted (see Col. 19 lines 19-21 of Ruman).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the top layer (101b) of Etchells to include an outline (102) corresponding to the marking such that the outline (102) is visible in each of the first state, the second state, and the third state as taught by Ruman, as Etchells also contemplates the pigmented layer to be in the form of a geometric shape, like a circle, see [0025], [0031] of Etchells, to have provided an improved indicator that provides to focus one’s attention on the active graphic for better discerning when the wetness indicator has been wetted (see Col. 19 lines 19-21 of Ruman). Therefore, the combination of Etchells in view of Ruman results in wherein the outline (102 of Ruman) overlies the marking (102 of Etchells) (as previously modified above, the moisture indicating layer 101b or the top layer of Etchells is modified to include framing device 102 of Ruman, and thus overlies the pigment layer 102 of Etchells as pigment layer 102 of Etchells is below the moisture indicating layer 101b of Etchells; see Fig. 4 of Etchells and [0134] of Etchells).
Etchells in view of Ruman discloses the invention as discussed above.
Etchells in view of Ruman is silent on an attachment layer disposed between the lower layer and the top layer; and wherein the attachment layer is configured to evaporate fluids at a rate equal to a rate of evaporation of the lower layer to enable the wound dressing to transition from the second state to the third state.
However, Bishop teaches an analogous lower layer (2) and an analogous top layer (8) (see Figs. 1-2; transmission layer 2 is an analogous lower layer as it is arranged on the bottom of the wound contacting layer 8, and wound contacting layer 8 is an analogous top layer as it is arranged on top of the transmission layer 2), and an attachment layer (4) disposed between the lower layer (2) and the top layer (8) (see Figs. 1-2 and [0077]; adhesive layer 4 is disposed or arranged in between the transmission layer 2 and the wound contacting layer 8, and is an attachment layer as it is an adhesive material to attach the layers together), providing an adhesive layer that attaches the top and lower layers so that they are held in place.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided in between the lower layer (101a of Etchells) and the top layer (101b of Etchells) an attachment layer (14) as taught by Bishop to have provided an improved indicator that has an adhesive layer that attaches the top and lower layers so that they are held in place.
Etchells in view of Ruman further in view of Bishop discloses the invention as discussed above.
Etchells in view of Ruman further in view of Bishop is silent on wherein the attachment layer is configured to evaporate fluids at a rate equal to a rate of evaporation of the lower layer to enable the wound dressing to transition from the second state to the third state.
However, Anderson teaches analogous adjacent layers (see Fig. 7 and [0107] which discusses how dressing layer 102 has an adhesive coated over the entire lower surface 108 and thus this adhesive is also an adhesive layer, and thus the dressing layer 102 and adhesive layer are adjacent layers), and wherein the analogous adjacent layers are configured to evaporate fluids at an equal rate (see Fig. 7 and [0102] which discusses how the adhesive layer coated over the entire lower surface 108 of dressing layer 102 exhibits a moisture vapor transmission rate equal to the film material of the dressing layer 102, and thus evaporates fluids at a rate equal to each other), providing uniform evaporation such that a user’s is more comfortable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the attachment layer (14 of Bishop) and the lower layer (101a of Etchells) in the device of Etchells in view of Ruman further in view of Bishop to evaporate fluids at an equal rate as taught by Anderson to have provided an improved indicator device that provides uniform evaporation such that a user’s is more comfortable. Therefore, the combination of Etchells in view of Ruman in view of Bishop further in view of Anderson results in wherein the attachment layer (14 of Bishop) is configured to evaporate fluids at a rate equal to a rate of evaporation of the lower layer (101a of Etchells) to enable the wound dressing to transition from the second state to the third state (as previously modified above, the adhesive layer 14 of Bishop and moisture indicating layer 101a of Etchells have been modified to evaporate fluids at an equal rate, and thus this equal rate of evaporation allows or enables the wound dressing to transition from the second state to the third state, as the moisture indicating article 400 of Etchells is reversible and thus regains its opacity after being wet as evaporation of fluids occurs, see [0050], [0134] of Etchells).
Regarding claim 2, Etchells in view of Ruman in view of Bishop further in view of Anderson discloses the invention as discussed in claim 1. Etchells in view of Ruman in view of Bishop further in view of Anderson further discloses wherein the first state is representative of an absence of absorbed wound fluid (see [0044] of Etchells; the first state is when the moisture indicating layer 101b of Etchells is dry and thus is representative of an absence of wound fluid), the second state is representative of a presence of absorbed wound fluid (see [0044] of Etchells and [0049] of Etchells; the second state is when the moisture indicating layer 101b of Etchells is wet and thus is representative of a presence of absorbed wound fluid, as the moisture indicating article 400 of Etchells may be incorporated into a wound dressing), and the third state is representative of a reduction of evaporation of the wound fluid present in the second state (see [0050] of Etchells; the third state is when the moisture indicating layer 101b of Etchells has regained its opacity, meaning it is dry, and thus is representative of a reduction of evaporation of the wound fluid present in the second state).
Regarding claim 8, Etchells in view of Ruman in view of Bishop further in view of Anderson discloses the invention as discussed in claim 1. Etchells in view of Ruman in view of Bishop further in view of Anderson further discloses wherein the marking (102 of Etchells) is configured to stay fixed relative to the lower layer (101a of Etchells) when the lower layer (101a of Etchells) is exposed to a fluid (see Fig. 4 and [0048] of Etchells; the pigmented layer 102 of Etchells may be attached to the moisture indicating layer 101a of Etchells via stitching, and thus stays fixed when the moisture indicating layer 101a of Etchells is exposed to a fluid).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etchells in view of Ruman in view of Bishop in view of Anderson further in view of Yano et al. (referred to as “Yano”) (US 2008/0038537 A1).
Regarding claim 5, Etchells in view of Ruman in view of Bishop further in view of Anderson discloses the invention as discussed in claim 1. Etchells further discloses wherein, in the second state, the indicator (400 of Etchells) is exposed to a fluid (see Figs. 4 of Etchells and [0134], [0044]-[0045] of Etchells; the moisture indicating article 400 of Etchells is exposed to a fluid in the second state, as the second state is when the moisture indicating article 400 of Etchells is saturated with fluid).
Etchells in view of Ruman in view of Bishop further in view of Anderson is silent on material from which the fibers are formed being selected such that, when exposed to the fluid, the second refractive index of the fibers is the same as the refractive index of the fluid.
However, Yano teaches an analogous indicator (see [0003]; the printed pattern is an analogous indicator as it becomes visible when exposed to fluid) and the material from the fibers are formed being selected such that, when exposed to the fluid, the second refractive index of the fibers is the same as a refractive index of the fluid (see [0003]; the white fine particles are an analogous material that are formed and selected such that when exposed to fluid (water), the second refractive index of the white fine particles is the same as the refractive index of the fluid (water), as the white fine particles have a refractive index of water when the white fine particles are soaked in water as the white fine particles become transparent), providing to increase transparency when the material is soaked in water (see [0003] of Yano), so that the marking is clearly visible to a user.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second refractive index of the fibers of the top layer (101b of Etchells) in the device of Etchells in view of Ruman in view of Bishop further in view of Anderson to be the same as the refractive index of the fluid as taught by Yano to have provided an improved indicator device that increases transparency when the material is soaked in water (see [0003] of Yano), so that the marking is clearly visible to a user. Therefore, the combination of Etchells in view of Ruman in view of Bishop in view of Anderson further in view of Yano results in material from which the fibers are formed being selected such that, when exposed to the fluid, the second refractive index of the fibers is the same as a refractive index of the fluid (as previously modified above, the fibers of the moisture indicating layer 101b of Etchells is the same as the refractive index of the fluid, as the fibers become transparent).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etchells in view of Ruman in view of Bishop in view of Anderson in view of Yano further in view of LONG et al. (referred to as “LONG”) (US 2022/0304863 A1).
Regarding claim 6, Etchells in view of Ruman in view of Bishop in view of Anderson further in view of Yano discloses the invention as discussed in claim 5.
Etchells in view of Ruman in view of Bishop in view of Anderson further in view of Yano is silent on wherein the second refractive index of the fibers is between 1.30 and 1.35.
However, LONG teaches an analogous top layer (20) that is transparent (see [0064]; barrier layer 20 becomes transparent when in contact with fluid), and wherein the second refractive index of the material is between 1.30 and 1.35 (see Fig. 1 and [0064]-[0065]; the barrier layer 20 becomes transparent when in contact with fluid and can have a refractive index of 1.33 which is in between 1.30 and 1.35), providing to maximize the transparency effect between the fluid and the top layer (see [0065] of LONG).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second refractive index of the fibers of the top layer (101b of Etchells) in the device of Etchells in view of Ruman in view of Bishop in view of Anderson further in view of Yano to be between 1.30 and 1.35 as taught by LONG to have provided an improved indicator device that is able to maximize the transparency effect between the fluid and the top layer (see [0065] of LONG) so that a user is able to clearly see the marking better when fluid is absorbed. Therefore, the combination of Etchell in view of Ruman in view of Bishop in view of Anderson in view of Yano further in view of LONG results in the second refractive index of the fibers to be between 1.30 and 1.35 (as previously modified above, the second refractive index of the fibers of the moisture indicating layer 101b of Etchells is in the range of 1.30 to 1.35).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Etchells in view of Ruman in view of Bishop further in view of Anderson.
Regarding claim 28, Etchelles in view of Ruman in view of Bishop further in view of Anderson discloses the invention as discussed in claim 1.
Etchells in view of Ruman in view of Bishop further in view of Anderson further discloses in another embodiment, wherein the indicator further comprises a cover layer configured to prevent at least a portion of the indicator from transitioning between the first state, the second state, and the third state (see [0049] of Etchells; one application for the moisture indicating articles may be a wound dressing, such as in Figs. 6-7 and 9-10 of Etchells, wherein the moisture indicating article is sandwiched between the surface contacting a wound and a water and occlusive dirt proof transparent outer layer, which is interpreted as a cover layer, as it covers the moisture indicating article, and is water and dirt proof and thus is configured to prevent at least a portion of the indicator from transitioning between the first state, the second state, and the third state, as this outer layer is configured to prevent the moisture indicating article 600 from exposure to fluids that causes the transitions from states), providing a water and occlusive dirt proof transparent outer layer (see [0049] of Etchells) such that the moisture indicating article does not prematurely become exposed to fluids.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the top layer (101b of Etchells) of Etchells in view of Ruman in view of Bishop further in view of Anderson with a cover layer that is configured to prevent at least a portion of the indicator from transitioning between the first state, the second state, and the third state as taught by another embodiment of Etchells to have provided an improved indicator that has a water and occlusive dirt proof transparent outer layer (see [0049] of Etchells) such that the moisture indicating article does not prematurely become exposed to fluids.
Conclusion
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/ROBIN HAN/Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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