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 .
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.
Claim 11 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 11 recites the limitation "the carrier" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the first occurrence of “the carrier” will be interpreted as –a carrier--.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Sherman (US 2022/0226161) .
Regarding claim 1, Cotton discloses a medical dressing (2) ([0048]), comprising: a backing layer (24) ([0051]; Fig. 3) comprising a first major surface and a second major surface opposite the first major surface (Fig. 3, top of layer 24 is a first major surface and bottom of layer 24 is a second major surface); an adhesive (25) on the second major surface of the backing layer (Fig. 3, bottom of backing layer); a release liner ([0038], releasable liner); and a thermochromic indicator ([0048] to [0051], pattern of dots that are thermochromic are applied to the upper surface of the backing layer) having a color-change sensitivity at a temperature ([0046], thermochromic ink changes from a strong visible color to colorless at a more elevated temperature) in a range between about 20 degrees C and to about 45 degrees C ([0015], thermochromic indicator changes color at a temperature between 33 and 39 degrees C which falls within the claimed range).
Cotton does not disclose a support material secured to the backing layer, wherein the support material is less elastic than the backing layer.
Sherman teaches an analogous medical dressing (10’’) ([0073]) having an analogous backing layer (20”) and comprising a support material (42’’) (stiffening elements, [0073]) secured to the backing layer (Fig. 3B, [0073), wherein the support material is less elastic than the backing layer ([0007], the stiffening elements exhibit less elasticity than the backing layer).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide to the dressing of Cotton a support material secured to the backing layer, wherein the support material is less elastic than the backing layer, as taught by Sherman, in order to provide an improved medical dressing that facilitates supporting the backing layer such that the backing layer is less likely to bend, fold or droop (Sherman, [0008]).
Regarding claim 2, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton further discloses wherein the thermochromic indicator is selected from the group consisting of a dye, a colorant, an ink, and a pigment ([0017], ink and dyes; NOTE: ink and dyes are a colorant and a pigment).
Regarding claim 3, Cotton in view of Sherman discloses the invention as described above with regard to claim 2.
Cotton further discloses wherein the thermochromic indicator is a dye ([0017]).
Regarding claim 10, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton further discloses wherein the thermochromic indicator is incorporated in or located on at least one of the backing layer, the adhesive, the release liner, or the support material ([0048] to [0051], the patterns of dots that are printed in thermochromic ink may be applied to the upper surface of the backing layer).
Regarding claim 12, Cotton in view of Sherman discloses the invention as described above with regard to claim 10.
Cotton further discloses where the thermochromic indicator is printed on the medical dressing ([0023], the thermochromic ink is preferably applied by a printing process).
Claim(s) 4, 8-9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Sherman (US 2022/0226161), as applied to claim 1 above, and further in view of Beran (US 2022/0323721).
Regarding claim 4, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton in view of Sherman does not explicitly disclose wherein the medical dressing is an IV site dressing.
Beran teaches an analogous medical dressing comprising an analogous backing layer (106); an analogous thermochromic indicator (106) ([0073], liquid crystal sheet) wherein the medical dressing is an IV site dressing ([0074], for placement at a catheter insertion site).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton in view of Sherman, is an IV site dressing, as taught by Beran, by providing a sliding opening and a central opening in the dressing, in order to provide an improved dressing that facilitates detection of infection around an insertion site (Beran, [0005]).
Regarding claim 8, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton in view of Sherman does not disclose an antimicrobial agent.
Beran teaches an analogous medical dressing ([0006]) having an analogous backing (1) ([0058]) and an analogous thermochromic indicator (2) ([0058], liquid crystal sensitive film) further comprising an antimicrobial agent ([0058]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton in view of Sherman is further comprising an antimicrobial agent as taught by Beran, in order to provide an improved medical dressing that facilitates treating detected infections ([0005]) and that has antimicrobial properties ([0058]).
Regarding claim 9, Cotton in view of Sherman and in further view of Beran discloses the invention as described above with regard to claim 8.
Beran further teaches wherein the antimicrobial agent is selected from the group consisting of parachlorometaxylenol; triclosan; chlorhexidine and salts thereof; poly hexamethylene biguanide and salts thereof; iodine; idodophors; silver oxide; silver and its salts; octenidine; Olanexidine; peroxides; antibiotics; and combinations of the foregoing ([0006], chlorhexidine gluconate).
Regarding claim 13, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton further discloses wherein the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative infection ([0012]).
Cotton in view of Sherman does not disclose that the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration.
Beran teaches an analogous medical dressing comprising an analogous backing layer (106); an analogous thermochromic indicator (106) ([0073], liquid crystal sheet) wherein the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration ([0005], a device that aids in early detection at a catheter insertion site; [0050], device displays changes in skin temperature around catheter insertion site for early detection of local infection; [0074], dressing for placement at a catheter insertion site; NOTE: it is implied that as the device detects temperature change around a catheter insertion site to determine local infection that it is capable of determining IV fluid infiltration by microbes/infection).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the thermochromic indicator of the medical dressing of Cotton in view of Sherman indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration, as taught by Beran, in order to provide an improved medical dressing that facilitates early detection of a local infection at a catheter insertion site (Beran, [0050]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Sherman (US 2022/0226161), as applied to claim 1 above, and further in view of Swaniker (US 2007/0179210).
Regarding claim 6, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton further discloses an island pad (21) proximate the second major surface of the backing (see annotated Fig. 3 below)
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Cotton in view of Sherman does not disclose a hydrogel island pad proximate the backing.
Swaniker teaches an analogous medical dressing ([0063], [0097]) that is comprising an analogous island pad ([0063], island of foam on a backing layer), the island pad a hydrogel island pad ([0097], a coating is applied to a medical dressing including a foam pad, such coatings may be biocompatible hydrogels).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the island pad of the medical dressing of Cotton in view of Sherman is a hydrogel island pad, as taught by Swaniker, by applying a hydrogel coating to the island pad of Cotton, in order to provide an improved dressing that is biocompatible and that is a super soft pad (Swaniker, [0097]).
Claim(s) 7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Sherman (US 2022/0226161), as applied to claim 1 and claim 10 respectively above, and further in view of Hughen (US 5614333).
Regarding claim 7, Cotton in view of Sherman discloses the invention as described above with regard to claim 1.
Cotton in view of Sherman does not disclose a carrier releasably attached to the first major surface of the backing layer.
Hughen teaches an analogous backing layer (10) (Fig. 8B) having an analogous first major surface (upper surface of 10, Fig. 8B) and an analogous thermochromic indicator (12, 15, 40) (Fi. 8A, Fig. 8B; col. 9, lines 1-32, thermochromic coating 12) and a carrier (18) releasably attached (col. 9, lines 1-22, releasable web) to the first major surface of the backing layer (10) (col. 3, lines 20-35, backing 10 may be a base film and an upper surface is the first major surface; col. 9, lines 14-22, thermochromic coating 12 is pressed onto coating 12 of substructure 9 [which includes backing 10] and the web [carrier] is then peeled away, thus it is releasably attached to the first major surface of the backing layer).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton in view of Sherman is further comprising a carrier releasably attached to the first major surface of the backing layer, as taught by Hughen, in order to provide an improved medical dressing on which thermochromic indicator is disposed by a method that avoids the need to cure the backing thereby eliminating deformation (Hughen, col. 2, lines 36-44, col. 9, lines 58-67) and a feasible manufacturing method (col. 2, lines 4-7).
Regarding claim 11, Cotton in view of Sherman discloses the invention as described above with regard to claim 10.
Cotton in view of Sherman does not disclose wherein the thermochromic indicator is transferred from the carrier to the backing layer upon removal of the carrier.
Hughen teaches an analogous backing layer (10) having an analogous first major surface (upper surface of 10, Fig. 8B) and an analogous thermochromic indicator (12, 15, 40) (col. 9, lines 1-32, thermochromic coating 12) and a carrier (18), wherein the thermochromic indicator is transferred from the carrier to the backing layer upon removal of the carrier (col. 9, lines 14-22, thermochromic coating 12 is pressed onto substructure 9 which includes backing 10 and the web [carrier] is then peeled away, thus thermochromic indicator is transferred from the carrier [web] to the backing layer upon removal of the carrier).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the thermochromic indicator of the medical dressing of Cotton in view of Sherman is transferred from the carrier to the backing layer upon removal of the carrier, as taught by Hughen, in order to provide an improved medical dressing on which thermochromic indicator is disposed by a method that avoids the need to cure the backing thereby eliminating deformation (Hughen, col. 2, lines 36-44, col. 9, lines 58-67) and a feasible manufacturing method (col. 2, lines 4-7).
Claim(s) 17-18 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Hughen (US 5614333).
Regarding claim 17, Cotton discloses a medical dressing (2) ([0048]) comprising: a backing layer (24) ([0051]; Fig. 3) comprising a first major surface and a second major surface opposite the first major surface (Fig. 3, top of layer 24 is a first major surface and bottom of layer 24 is a second major surface); an adhesive (25) on the second major surface of the backing layer (Fig. 3, bottom of backing layer); a release liner ([0038], releasable liner); and a thermochromic indicator ([0048] to [0051], pattern of dots that are thermochromic are applied to the upper surface of the backing layer) having a color-change sensitivity at a temperature in a range between 20 degrees C and 45 degrees C ([0015], thermochromic indicator changes color at a temperature between 33 and 39 degrees C which falls within the claimed range).
Cotton does not disclose a carrier releasably attached to the first major surface of the backing layer.
Hughen teaches an analogous backing layer (10) (Fig, 8B) having an analogous first major surface (upper surface of 10, Fig. 8B) and an analogous thermochromic indicator (12, 15, 40) (col. 9, lines 1-32, thermochromic coating 12) and a carrier (18) releasably attached (col. 9, lines 1-22, releasable web) to the first major surface of the backing layer (36, 10) (col. 3, lines 20-35, backing 10 may be a base film and an upper surface is the first major surface; col. 9, lines 14-22, thermochromic coating 12 is pressed onto substructure 9 [which includes backing 10] and the web [carrier] is then peeled away, thus it is releasably attached to the first major surface of the backing layer).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton is comprising a carrier releasably attached to the first major surface of the backing layer, as taught by Hughen, in order to provide an improved medical dressing on which thermochromic indicator is disposed by a method that avoids the need to cure the backing thereby eliminating deformation (Hughen, col. 2, lines 36-44, col. 9, lines 58-67) and a feasible manufacturing method (col. 2, lines 4-7).
Regarding claim 18, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Cotton further discloses wherein the thermochromic indicator is selected from the group consisting of a dye, a colorant, an ink, and a pigment ([0017], ink and dyes; NOTE: ink and dyes are a colorant and a pigment).
Regarding claim 22, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Hughen further teaches wherein the thermochromic indicator is transferred from the carrier to the backing layer upon removal of the carrier (col. 9, lines 14-22, thermochromic coating 12 is pressed onto substructure 9 which includes backing 10 and the web [carrier] is then peeled away, thus thermochromic indicator is transferred from the carrier [web] to the backing layer upon removal of the carrier).
Regarding claim 23, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Cotton further discloses where the thermochromic indicator is printed on the medical dressing ([0023], the thermochromic ink is preferably applied by a printing process).
Claim(s) 19, 21 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Hughen (US 5614333), as applied to claim 17 above, and further in view of Beran (US 2022/0323721).
Regarding claim 19, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Cotton does not explicitly disclose wherein the medical dressing is an IV site dressing.
Beran teaches an analogous medical dressing comprising an analogous backing layer (106); an analogous thermochromic indicator (106) ([0073], liquid crystal sheet) wherein the medical dressing is an IV site dressing ([0074], for placement at a catheter insertion site).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton is an IV site dressing, as taught by Beran, by providing a sliding opening and a central opening in the dressing, in order to provide an improved dressing that facilitates detection of infection around an insertion site (Beran, [0005]).
Regarding claim 21, Cotton in view of Hughen discloses the invention as applied to claim 17 above.
Cotton in view of Hughen does not disclose an antimicrobial agent.
Beran teaches an analogous medical dressing ([0006]) having an analogous backing (1) ([0058]) and an analogous thermochromic indicator (2) ([0058], liquid crystal sensitive film) further comprising an antimicrobial agent ([0058]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the medical dressing of Cotton in view of Hughen is further comprising an antimicrobial agent as taught by Beran, in order to provide an improved medical dressing that facilitates treating detected infections ([0005]) and that has antimicrobial properties ([0058]).
Regarding claim 24, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Cotton further discloses wherein the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative infection ([0012]).
Cotton in view of Hughen does not disclose that the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration.
Beran teaches an analogous medical dressing comprising an analogous backing layer (106); an analogous thermochromic indicator (106) ([0073], liquid crystal sheet) wherein the thermochromic indicator indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration ([0005], a device that aids in early detection at a catheter insertion site; [0050], device displays changes in skin temperature around catheter insertion site for early detection of local infection; [0074], dressing for placement at a catheter insertion site; NOTE: it is implied that as the device detects temperature change around a catheter insertion site to determine local infection that it is capable of determining IV fluid infiltration by microbes/infection).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the thermochromic indicator of the medical dressing of Cotton in view of Hughen indicates a change in temperature from a first temperature indicative of a normal skin to a second temperature indicative of IV fluid infiltration, as taught by Beran, in order to provide an improved medical dressing that facilitates early detection of a local infection at a catheter insertion site (Beran, [0050]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cotton (US 2016/0067102) in view of Hughen (US 5614333), as applied to claim 17 above, and further in view of Swaniker (US 2007/0179210).
Regarding claim 20, Cotton in view of Hughen discloses the invention as described above with regard to claim 17.
Cotton further discloses an island pad (21) proximate the second major surface of the backing (see annotated Fig. 3 above with regard to the claim 6 rejection).
Cotton in view of Hughen does not disclose a hydrogel island pad proximate the backing.
Swaniker teaches an analogous medical dressing ([0063], [0097]) that is comprising an analogous island pad ([0063], island of foam on a backing layer), the island pad a hydrogel island pad ([0097], a coating is applied to a medical dressing including a foam pad, such coatings may be biocompatible hydrogels).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the island pad of the medical dressing of Cotton in view of Hughen is a hydrogel island pad, as taught by Swaniker, by applying a hydrogel coating to the island pad of Cotton in view of Hughen, in order to provide an improved dressing that is biocompatible and that is a super soft pad (Swaniker, [0097]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Smith (US 2022/0112391) teaches thermal transfer printing that uses a thermal transfer ribbon to apply ink from the ribbon to the substrate.
Flam (US 5181905) discloses a dressing (Fig. 5) with a backing layer (33), adhesive (32) and a thermochroic indicator (11).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA MCCARTHY whose telephone number is (408)918-7594. The examiner can normally be reached Monday - Friday, 7:00-3:30 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.M./ Examiner, Art Unit 3786
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786
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