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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Response to Amendment
The amendment to the claims filed 03/31/2026 is acknowledged. In the claims, claims 1, 6-7 and 13 is amended. Claims 1-20 are pending.
The amendment to claims 6-7 and 13 overcome the 112b rejections with regard to those claims.
Response to Arguments
Applicant’s arguments, see page 6 and page 9, filed 03/31/2026, with respect to the rejection(s) of claim(s) 1 under 103 (in view of Cureton/Kudo/Kolte) 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 Therefore, the rejection has been withdrawn.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 previously cited Cureton (US 2013/0096478), in view of previously cited Kudo (US 2020/0115539) and in further view of newly cited Levin (US 2003/0199800).
Applicant’s arguments, see page 6 and page 9, filed 03/31/2026, with respect to the rejection(s) of claim(s) 1 and 13 under 103 (in view of Perez-Foullerat/Kudo/Kolte) 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 Therefore, the rejection has been withdrawn.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 previously cited Cureton (US 2013/0096478), in view of previously cited Kudo (US 2020/0115539) and in further view of newly cited Levin (US 2003/0199800).
Applicant’s arguments, see page 11, filed 03/31/2026, with respect to the provisional double patenting rejection(s) of claim(s) 1-20 have been fully considered and are persuasive. As the scope of the claims of the reference application no. 18/891,036 (now patent no. 12636197) has changed, the claims of the instant application are no longer rejected over claims of application no. 18/891,036 or the corresponding patent. Therefore, the provisional double patenting rejection has been withdrawn.
Applicant’s arguments, see page 11, filed 03/31/2026, with respect to the rejection(s) of claim(s) 1-20 under double patenting have been fully considered and are persuasive. As the scope of the current claims of the instant application has changed, the previous double patenting rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over reference claims of previously cited U.S. Patent 12251293 in view of newly cited Levin (US 2003/0199800) as appears below.
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, as recited in claim 1, each aperture of the plurality of apertures is a void space that extends that extend through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface. wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad, wherein the gel of the gel pad has a second area. and wherein the second area of the gel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad 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.
Specification
The disclosure is objected to because of the following informalities: The Brief Description of the Figures should provide a description for each subpart of the Figures 5 and 8 to 14. For example, “Figure 8” should recite --Figures 8a to 8c illustrate--, or --Figure 8a illustrates the tensile curve for five different types of anisotropic layers in the second (y) direction-- and, separately, --Figure 8b illustrates the tensile curves for five different types of anisotropic layers in the first direction (x)—.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the gel pad has a second area” without having introduced a first area. If appropriate, the claim could be amended to recite --wherein the first surface of the gel pad has an outer periphery surrounding a first area that is a total area of the gel pad--. Appropriate correction is required.
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, 6, 10-13, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) and in further view of Levin (US 2003/0199800).
Regarding claim 1, Cureton discloses a medical dressing (500) ([0049]; Fig. 6; Fig. 7) comprising a backing layer (510) (annotated Fig. 7 below),
PNG
media_image1.png
625
748
media_image1.png
Greyscale
an adhesive body contact layer (506), and a gel pad (508) (hydrogel layer 508, [0052]; a pad is defined as a thin flat mat or cushion, merriamwebster.com; NOTE: as layer 508 is thin and flat and it is a hydrogel, it is a thin flat mat or cushion and is thus a pad) comprising a gel ([0052], hydrogel comprises a gel) arranged between the backing layer (510) ([0049]; NOTE: structural layer 510 is disposed at a back of the hydrogel layer 508 [gel pad] and is thus a backing layer) and the adhesive body contact layer (506) ([0052]; NOTE: layer 506 may be placeable in contact with the skin and is thus an adhesive body contact layer), wherein a gel of the gel pad has a compressive strength (NOTE: it is implied that the hydrogel pad gel has some level of compressive strength), wherein the gel pad has a first surface and a second surface spaced by a thickness (Fig. 7, the top surface of the gel pad is a first surface and a second surface is a bottom surface and they are spaced by a thickness).
Cureton does not disclose wherein the gel has a compressive strength of from 5 to 60 kPa at a strain of 50%, as measured according to a compression test, wherein the gel pad comprises regions of removed gel to form a plurality of apertures, wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface. wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad, wherein the gel of the gel pad has a second area. and wherein the second area of the gel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad.
Kudo teaches an analogous hydrogel for use in analogous wound dressings ([0085]) wherein the gel has a compressive strength of from 5 to 60 kPa at a strain of 50%, as measured according to a compression test ([0037], [0089]; see annotated Kudo Fig. 1 below where at a strain of 50% the hydrogel has a compressive strength of less than 10 kPa and greater than 5 kPa as extrapolated from the table and which range values falls within the claimed range).
PNG
media_image2.png
689
1018
media_image2.png
Greyscale
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 gel of the medical dressing of Cureton has a compressive strength of from 5 to 60 kPa at a strain of 50%, as measured according to a compression test, as taught by Kudo, in order to provide an improved medical dressing that has a gel with a self-supporting property (Kudo, [0039]); high stretchability, (Kudo,[0082]) and/or that can be used as a soft material in medical care (Kudo, [0082]).
Further, 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 gel of the medical dressing of Cureton in view of Kudo has a compressive strength of from 5 to 60 kPa at a strain of 50%, as measured according to a compression test, as Applicant appears to have placed no criticality on the claimed range (Applicant’s priority document specification recites at page 12, fourth to fifth paragraph, that in embodiments, the gel has a compressive strength from 5 to 60kPA, preferably from 5 to 40 kPa at a strain of 50%, most preferably the compressive strength of the gel is less than 25 kPa at a strain of 50%, suitably the compressive strength is from 2 to 12kPa or from 2 to 8kPa at a strain of 25%) and since it has been held that “[i]n cases 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 order to provide an improved medical dressing that has a gel with a self-supporting property (Kudo, [0039]); high stretchability, (Kudo,[0082]) and/or that can be used as a soft material in medical care (Kudo, [0039]).
Cureton in view of Kudo discloses the invention as described above.
Cureton in view of Kudo does not disclose wherein the gel pad comprises regions of removed gel to form a plurality of apertures, wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface, wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad, wherein the gel of the gel pad has a second area, and wherein the second area of the gel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad.
Levin teaches an analogous dressing (20) comprising an analogous body contact layer (36) ([0022], low friction wrap of plastic film whose periphery includes a biocompatible adhesive surface 40 that is applied to the skin 32) and an analogous gel pad (22) ([0023], gel-type material) having an analogous first surface and an analogous second surface (annotated Fig. 3 below),
PNG
media_image3.png
637
999
media_image3.png
Greyscale
wherein the gel pad comprises regions of removed gel to form a plurality of apertures (24) ([0023], apertures in the gel-type material 22) (As to claim 1, the limitation, “wherein the gel pad comprises regions of removed gel to form a plurality of apertures” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Levin may be silent as to the process used to form the plurality of apertures, the apparatus disclosed i.e. a gel pad having a plurality of apertures is the same as claimed), wherein each aperture of the plurality of apertures is a void space (Fig. 3, [0022]; [0023]) that extends through the gel pad an entirety of the thickness of the gel pad (annotated Fig. 3 above) from the first surface to the second surface (annotated Fig. 3 above), wherein each aperture of the plurality of apertures has a respective aperture area (Fig. 3, see perforations 24 each have a respective aperture area), wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad, (annotated Fig. 2 below, top surface area of pad)
PNG
media_image4.png
766
888
media_image4.png
Greyscale
wherein the gel of the gel pad has a second area (annotated Fig. 3, the area on the sides), and wherein the second area of the gel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad (annotated Fig. 2, annotated Fig. 3; NOTEL the area of the pad on the sides without apertures and a more central area with apertures cooperate to form the total area).
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 gel pad of the medical dressing of Cureton in view of Kudo comprises regions of removed gel to form a plurality of apertures, wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface. wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad. wherein the gel of the gel pad has a second area. and wherein the second area of the eel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad, as taught by Levin, in order to provide an improved medical dressing that facilitates absorption of fluid by an absorption layer of the dressing and that prevents the accumulation of sweat and wound fluids beneath the gel pad (Levin, [0022], [0023]).
Regarding claim 6, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton further discloses wherein the gel pad, the backing layer, and the adhesive body contact layer are transparent (The method may further include monitoring the wound dressing, which may include observing the skin through the wound dressing, [0022]; claim 20, [0009]; [0049]; NOTE: as the skin/wound is observed through the wound dressing it is implicit that the wound dressing [and thus its layers including the gel pad, the backing layer, and the adhesive body contact layer are transparent; Also NOTE: [0060] recites a transparent wound dressing).
Regarding claim 10, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Kudo further teaches wherein the gel pad has an opacity of less than 25% as measured by the opacity test described in the specification (The hydrogel of the present application has high transparency. The term “high transparency” specifically refers to a transmittance % of 80% or more [more preferably 90% or more] at 400 nm to 800 nm, [0061]; as indicated in Applicant’s specification where the gel has an opacity of 100% the gel pad has no transparency, page 13, lines 26-31; thus it follows where the gel has an transmittance of 80% or more it has an opacity of 20% or less which includes values less than 25% opacity).
Regarding claim 11, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Kudo further teaches wherein the gel has a compressive strength from 1 to 14 kPa at a strain of 25%, as measured according to the compression test described in the specification (see annotated Kudo, Fig. 1 below where at a strain of 25% the hydrogel has a compressive strength of greater than 1kPA and less than 14 kPA as extrapolated from the table at 25% which range values fall with the range of 1 to 14kPa; the stress value is greater than 1/20 of the length of the Fig. 1 and is thus at least 1 kPA as shown by the arrow labeled “Greater than 1”).
PNG
media_image5.png
693
1018
media_image5.png
Greyscale
Further, 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 gel of the medical dressing of Cureton in view of Kudo and in further view of Levin has a compressive strength from 1 to 14 kPa at a strain of 25%, as measured according to the compression test, as Applicant appears to have placed no criticality on the claimed range (Applicant’s priority document specification at page 12, fourth to fifth paragraph recites that in embodiments, the gel has a compressive strength from 5 to 60kPA, preferably from 5 to 40 kPa at a strain of 50%, most preferably the compressive strength of the gel is less than 25 kPa at a strain of 50%, suitably the compressive strength is from 2 to 12kPa or from 2 to 8kPa at a strain of 25%) and since it has been held that “[i]n cases 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 order to provide an improved medical dressing that has a gel with a self-supporting property (Kudo, [0039]), high stretchability, (Kudo, [0082]) and/or that can be used as a soft material in medical care Kudo, [0082]).
Regarding claim 12, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Kudo further teaches the gel has a compressive strength of from 5 to 40 kPa at a strain of 50%, as measured according to a compression test (see annotated Kudo Fig. 1 above with regard to the rejection to claim 1 where at a strain of 50% the hydrogel has a compressive strength of less than 10 kPa and greater than 5 kPa as extrapolated from the table at 50% which range values falls with the range of 5 to 40 kPa).
Further, 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 gel of the medical dressing of Cooke in view of Kudo has a compressive strength of from 5 to 40 kPa at a strain of 50%, as measured according to the compression test, as Applicant appears to have placed no criticality on the claimed range (Applicant’s priority document specification recites at page 12, fourth to fifth paragraph that in embodiments, the gel has a compressive strength from 5 to 60kPA, preferably from 5 to 40 kPa at a strain of 50%, most preferably the compressive strength of the gel is less than 25 kPa at a strain of 50%, suitably the compressive strength is from 2 to 12kPa or from 2 to 8kPa at a strain of 25%) and since it has been held that“[i]n cases 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 order to provide an improved medical dressing that has a gel with a self-supporting property (Kudo, [0039]), high stretchability, (Kudo, [0082]) and/or that can be used as a soft material in medical care Kudo, [0039]).
Regarding claim 13, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton further discloses wherein at least the backing layer extends beyond a periphery of the gel pad (as seen in Fig. 6 and Fig. 2, a border 502 is connected to each of the layers including the backing layer 510 thus the backing extends beyond a periphery of the gel in the form of border 502 to which it is connected) to define a border portion (502) around a contour of the pad (annotated Fig. 3 below).
PNG
media_image6.png
648
648
media_image6.png
Greyscale
Regarding claim 18, Cureton in view of Kolte and in further view of Levin discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the medical dressing is divided into three separate zones along the longitudinal (y) extension of the medical dressing: one central zone and two lateral zones (In the combination the gel pad of Cureton is amended to include the apertures of Levin and as described above with regard to Levin in the rejection to claim 1, a central portion of the gel pad has apertures while the side areas as seen in annotated Fig. 3 above and labeled as second area has no apertures thus the pad can be divided in three zones a central zone with apertures and two side areas without apertures), wherein the gel pad in at least the central zone comprises the apertures that extend through the gel pad (see explanation for this claim rejection immediately above with regard to Levin having a central zone with apertures, annotated Fig. 3 of Levin above with regard to the claim 1 rejection).
Regarding claim 20, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton further discloses wherein the medical dressing comprises at least one gripping tab 120 (ventilations channel tabs 120, [0035]; capable of intended use of gripping).
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) and in further view of Levin (US 2003/0199800), as applied to claim 1 above, and further in view of McDowall (US 5700254).
Regarding claim 2, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton in view of Kudo and in further view of Levin does not disclose wherein the medical dressing further comprises an anisotropic layer.
McDowall teaches an analogous medical dressing 10 (absorbent article 10, col. 4, lines 1-46; Fig. 1) having an analogous backing layer (18) (backing layer 18, col. 4, lines 1-46; Fig. 1), an analogous body contact layer (12) (liquid permeable facing layer 12, col. 4, lines 1-46; Fig. 1) and an analogous gel pad (16) (absorbent core 16 may be fabricated from any highly absorbent liquid material known in the art including …synthetic hydrogel polymers, col. 4, lines 1-46) arranged between the back layer and the adhesive body contact layer, wherein the medical dressing further comprises an anisotropic layer (14) (liquid distribution layer 14, col. 4, lines 1-46; col. 3, lines 24-32; NOTE: the distribution layer is an anisotropic nonwoven fiber web of microfibers).
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 Cureton in view of Kudo and in further view of Levin further comprises an anisotropic layer as taught by McDowell in order to provide an improved medical dressing provides higher dimensional stability and physical integrity and highly improved liquid distribution properties (McDowell, col. 3, lines 53-67) and that accommodates different designs of functional criteria (McDowall, col. 4, lines 12-19).
Regarding claim 3, Cureton in view of Kudo, in view of Levin and in further view of McDowall discloses the invention as described above with regard to claim 2.
McDowall further teaches wherein the anisotropic layer has apertures that extend through the anisotropic layer (col. 9, lines 17-66; NOTE: pore structures of the web are apertures that extend through the anisotropic layer [the web]).
Regarding claim 4, Cureton in view of Kudo, in view of Levin and in further view of McDowall discloses the invention as described above with regard to claim 2.
McDowall further teaches wherein the anisotropic layer is arranged between the analogous gel pad and the analogous body contact layer (Fig. 1; col. 4, lines 1-46; col. 4, lines 12-19; NOTE: Fig. 1 shows the anisotropic layer 14 in between the analogous gel pad 16 and the analogous body contact layer 12).
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 anisotropic layer of the medical dressing of Cureton, Kudo, Levin and McDowall is arranged between the gel pad and the adhesive body contact layer, as taught by McDowall, in order to provide an improved medical dressing that that provides higher dimensional stability and physical integrity (McDowell, col. 3, lines 53-67) and that accommodates different designs of functional criteria (McDowall, col. 4, lines 12-19).
Regarding claim 5, Cureton in view of Kudo, in view of Levin and in further view of McDowall discloses the invention as described above with regard to claim 2.
McDowall further teaches wherein the anisotropic layer is arranged between the analogous gel pad and the analogous backing layer (Fig. 1; col. 4, lines 1-46; col. 4, lines 12-19; NOTE: as layer 14 may be placed under the absorbent core [analogous pad] it follows that it would be arranged between the analogous gel pad and the analogous backing layer 18).
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 anisotropic layer of the medical dressing of Cureton, Kudo, Levin and McDowall is arranged between the gel pad and the backing layer as taught by McDowall in order to provide an improved medical dressing that that provides higher dimensional stability and physical integrity and highly improved liquid distribution properties (McDowell, col. 3, lines 53-67) and that accommodates different designs of functional criteria (McDowall, col. 4, lines 12-19).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) and in further view of Levin (US 2003/0199800), as applied to claim 6 above, and further in view of McDowall (US 5700254) and Beese (US 2006/0265005).
Regarding claim 7, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 6.
Cureton in view of Kudo and in further view of Levin does not disclose where the medical dressing further comprises a transparent anisotropic layer.
McDowall teaches an analogous medical dressing 10 (absorbent article 10, col. 4, lines 1-46; Fig. 1) having an analogous backing layer (18) (backing layer 18, col. 4, lines 1-46; Fig. 1), an analogous body contact layer (12) (liquid permeable facing layer 12, col. 4, lines 1-46; Fig. 1) and an analogous gel pad (16) (absorbent core 16 may be fabricated from any highly absorbent liquid material known in the art including …synthetic hydrogel polymers, col. 4, lines 1-46) arranged between the back layer and the adhesive body contact layer, wherein the medical dressing further comprises an anisotropic layer (14) (liquid distribution layer 14, col. 4, lines 1-46; col. 3, lines 24-32; NOTE: the distribution layer is an anisotropic nonwoven fiber web of microfibers).
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 Cureton in view of Kudo and in further view of Levin further comprises an anisotropic layer as taught by McDowell in order to provide an improved medical dressing that provides higher dimensional stability and physical integrity (McDowell, col. 3, lines 53-67).
Cureton in view of Kudo, in view of Levin and in further view of McDowell discloses the invention as described above.
Cureton in view of Kudo, in view of Levin and in further view of McDowell does not disclose a substantially transparent anisotropic layer.
Beese teaches an analogous medical dressing (10) ([0021]; NOTE: the kit includes support layers and adhesive for closing a wound and is thus analogous to a dressing) having an analogous anisotropic layer (12) ([0024]; NOTE: layer 24 is analogous to an anisotropic layer in that it is non-woven material is the assembly of textile fibers held together by mechanical interlocking in a random web or mat, for example by fusing thermoplastic fibers to each other as in McDowell) wherein the analogous anisotropic layer is transparent ([0024]; NOTE: support layer 12 is transparent).
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 anisotropic layer of the medical dressing of Cureton in view of Kudo, in view of Levin and in further view of McDowell is transparent, as taught by Beese, in order to provide an improved dressing that facilitates examination of a healthcare provider and positioning of the dressing (Beese, [0033]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) and in further view of Levin (US 2003/0199800), as applied to claim 1 above, and further in view of Llinas (US 10080555).
Regarding claim 8, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton in view of Kudo and in further view of Levin does not disclose wherein the adhesive body contact layer comprises a silicone based adhesive.
Llinas teaches an analogous medical dressing (Fig. 2B) having an analogous gel pad 20 (stress distributing layer 20, col. 7, lines 5-52; suitable stress distributing layers include hydrogels, col. 12, lines 20-31), an analogous backing layer 22 (col. 7, lines 5-18, Fig. 2b) and an adhesive body contact laver 24 (pressure sensitive adhesive 24, col. 7, lines 5-18), wherein the adhesive body contact layer comprises a silicon based adhesive (Examples of pressure sensitive adhesive compositions useful in the present invention include, for example, those based on natural rubbers, synthetic rubbers, styrene block copolymers including but not limited to Styrene-Isoprene-Styrene (SIS), styrene-butadiene, styrene-isoprene and derivatives thereof such as those available from Kraton Polymers under the KRATON tradename, polyvinyl ethers, poly (meth)acrylates (including both acrylates and methacrylates), polyolefins such as polyalpha olefins, silicones, and blends or mixtures thereof., col. 9, lines 32-62; NOTE: pressure sensitive adhesives include silicone) and wherein the gel pad, the backing layer and the adhesive body contact layer are substantially transparent (col. 18, lines 8-19) .
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 adhesive body contact layer of the medical dressing of Cureton in view of Kudo and in further view of Levin comprises a silicon based adhesive, as taught by Llinas, in order to provide an improved medical dressing that is skin compatible (Llinas, col. 9, lines 32-62).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539), in view of Levin (US 2003/0199800), and in further view of Llinas (US 10080555) as applied to claim 8 above, and further in view of Tsai (US 2010/0211029).
Regarding claim 9, Cureton in view of Kudo, in view of Levin and in further view of Llinas discloses the invention as described above with regard to claim 8.
Cureton in view of Kudo, in view of Levin and in further view of Llinas does not disclose wherein the adhesive body contact layer is perforated.
Tsai teaches an analogous dressing 14 ([0018]) having an analogous adhesive body contact layer 26 (adhesive pad 26, [0018]; The adhesive pad 26 is made of a skin friendly adhesive. Examples of suitable adhesives include pressure-sensitive adhesives that may be any of hydrocolloid, polyurethane, acrylic, thermoplastic elastomer (TPE), hydrogel, or silicone-based, [0018]) wherein the adhesive body contact layer is perforated ([0018]).
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 adhesive body contact layer of Cureton in view of Kudo, in view of Levin and in further view of Llinas is perforated, as taught by Tsai, in order to provide an improved medical dressing that permits passage of exudate from the wound site into the dressing (Tsai, [0018]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) in view of Levin (US 2003/0199800), and in further view of McDowall (US 5700254) as applied to claim 2 above, and further in view of Parsons (US 2020/0255992).
Regarding claim 14, Cureton in view of Kudo, in view of Levin and in further view of McDowall discloses the invention as described above with regard to claim 2.
McDowall further implicitly teaches wherein a tensile force at 15% strain of the anisotropic layer is higher in the second direction (y) than in the first direction (x), when measured according to a tensile test (Applicant’s specification provides “In exemplary embodiments, the anisotropic layer is an oriented fibrous non woven layer having more than 50% of the fibers oriented in the longitudinal (y) direction”, page 21, lines 4-7; Also the specification recites at page 19, first paragraph that “Examples of suitable polymers for user in the nonwoven are polyethylene, polyesters, polypropylene and other polyolefin polymers and copolymers.”; McDowall, col. 10, lines 6-46; NOTE: McDowall teaches that the liquid distribution layer of the present invention is fabricated polyolefins, polyamides, polyesters as recited in the specification. McDowall teaches at col. 3, lines 24-67 that the distribution layer is an anisotropic nonwoven fiber web of substantially continuous microfibers produced from a fiber forming polymer, in which the fibers of the nonwoven web are hydrophilically modified and substantially aligned along one desired direction of the web, e.g. in the machine direction (MD) or cross-machine direction (CD) of the web; the level of fiber alignment of a nonwoven web is measured by the fiber alignment ratio, which is defined as the relative fibers alignment in the MD or CD over the relative fiber alignment in the other direction. Desirably, suitable microfiber web of the prevent liquid distribution layers have a fiber alignment ratio of at least 4:1, more desirably at least 10:1, most desirably at least 30:1, having the fibers prominently oriented in either the MD or the CD; NOTE: the machine direction may be considered the (y) direction and the cross direction may be considered the (x) direction and as there is for example fiber alignment ratio of MD/CD it would be that the fiber alignment is where the ratio is for example 4:1, a percentage of alignment in the machine direction [y direction] of 80% ; also NOTE: 80% alignment of fibers meets the criteria of the specification which recites preferably at least 50% alignment of fibers; NOTE: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985). Applicant’s specification recites provides “In exemplary embodiments, the anisotropic layer is an oriented fibrous non woven layer having more than 50% of the fibers oriented in the longitudinal (y) direction”, page 21, lines 4-7 of priority document; McDowall implicitly teaches a tensile forces higher in the second (y) direction at 15% strain; since the materials and structures of the anisotropic layers are equivalent e.g. both the prior art and Applicant’s specification disclose alignment of non woven fibers in one direction of at least 50% thus it is inherent that wherein a tensile force at 15% strain of the anisotropic layer is higher in the second direction (y) than the first direction (x), when measured according to a tensile test).
Cureton in view of Kudo, in view of Kolte and in further view of McDowall discloses the invention as described above.
Cureton in view of Kudo, in view of Levin and in further view of McDowall does not explicitly disclose wherein a tensile force at 15% strain of the anisotropic layer is higher in the second direction (y) than in the first direction (x), when measured according to a tensile test.
Parsons teaches an analogous anisotropic layer (material that has liquid acquisition, retention and storage functions and that can be used in baby diapers, adult incontinence products, sanitary napkins and the like ([0112]; [0013]) wherein the tensile force at 15% strain of the anisotropic layer is higher in the second direction (y) than in the first direction (x) (the nonwoven materials can have a machine wet tensile strength of from about 100 gli to 1000 gli, [0113]; the nonwoven materials can have a cross-direction wet tensile strength of from about 100gli to 1500 gli, [0113]; NOTE: where for example the machine [y direction] gli is 1000 and the cross-direction [x direction] gli is 100, the tensile force is greater in the y direction than the x; the nonwoven materials can have a cross-direction wet elongation at peak load of from about 15% to about 25%, [0113]; additionally, the nonwoven materials can have a cross-direction wet elongation at peak load of from about 15% to about 30%, [00113];thus elongation is disclosed as at 15% ).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide wherein the tensile force of the medical dressing of the combination of in view of Cureton in view of Kudo, in view of Levin and in further view of McDowall at 15% strain of the of the anisotropic layer is higher in the second direction (y) than in the first direction (x), when measured according to the tensile test, as taught by Parsons, in order to provide an improved medical dressing that has improved fluid acquisition characteristics (Parsons, [0114]).
Regarding claim 15, Cureton in view of Kudo, in view of Levin, in view of McDowall and in further view of Parsons discloses the invention as described above with regard to claim 14.
Parsons further teaches wherein the tensile force at 15% strain of the anisotropic layer in the second direction (y) is at least 6 times higher, than in the first direction (x), when measured according to the tensile test (where, for example, the wet tensile strength of the cross direction is 100 gli and the wet tensile strength of the material in the machine direction is 1500 gli, Parsons, [0113]; in this example the tensile force in the machine direction [y] direction is at least 6 times higher than in the first [x] direction).
Further, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide wherein the tensile force at 15% strain of the anisotropic layer of the medical dressing of Cureton in view of Kudo, in view of Levin, in view of McDowall and in further view of Parsons in the second direction (y) is at least 6 times higher than in the first direction (x) when measured according to the tensile test as Applicant appears to have placed no criticality on the claimed range (Applicant’s specification recites at page 7, third paragraph recites, “the anisotropic layer has a tensile force at 15% strain that is at least 6 times higher, preferably at least 10 times higher in the second direction (y) than in the first direction (x)”) and since it has been held that “[i]n cases 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 order to provide an improved wound dressing that that has improved fluid acquisition characteristics (Parsons, [0114]).
Claim(s) 16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539) and in further view of Levin (US 2003/0199800), as applied to claim 1 above, and further in view of Kolte (US 2004/0049146).
Regarding claim 16, Cureton in view of Kudo and in further view of Levin discloses the invention as described above with regard to claim 1.
Cureton further discloses wherein the medical dressing has a lateral (x) extension and a longitudinal Atlanta #3165821 v14ATTORNEY DOCKET NO. 13302.0100U1 APPLICATION NO. Not Yet Assigned(y) extension (see Fig. 1; the dressing extends along an (x) and (y) extensions).
The combination does not disclose wherein the medical dressing has a lateral (x) extension and a longitudinal (y) extension; the gel pad being symmetric about a longitudinal center line and the medical dressing comprising a first lobed portion on one side of the longitudinal center line and a second lobed portion on the other side of the longitudinal center line.
Kolte teaches an analogous medical dressing (Fig. 2, [0070]; [0071]) having an analogous pad (11) (absorbent element 11, [0070]; [0047]), wherein the medical dressing has an analogous lateral (x) extension and an analogous longitudinal (y) extension; the gel pad being symmetric about a longitudinal center line (annotated Fig. 2 below)
PNG
media_image7.png
696
892
media_image7.png
Greyscale
and the medical dressing comprising a first lobed portion (9) (ear part 9, [0071]; annotated Fig. 2 above) on one side of the longitudinal center line and a second lobed portion (9) (second ear part 9, [0071]) on the other side of the longitudinal center line (annotated Fig. 2 above).
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 gel pad of the dressing of Cureton in view of Kudo and in further view of Levin symmetric is being about a longitudinal center line and the medical dressing comprising a first lobed portion on one side of the longitudinal center line and a second lobed portion on the other side of the longitudinal center line, as taught by Kolte, in order to provide an improved medical dressing that may be applied to the heel (Kolte, [0072]).
Regarding claim 19, Cureton in view of Kudo, in view of Levin and in further view of Kolte discloses the invention as described above with regard to claim 16.
The combination further discloses wherein the medical dressing is divided into three separate zones along the longitudinal (y) extension of the dressing: one central zone and two lateral zones (see annotated Kolte Fig. 2 above with regard to claim 16; NOTE: applicant’s specification in Fig. 7 shows 3 similar zones), wherein a compressive strength of the gel of the gel pad in the central zone is lower than in the lateral zones (The absorbent element may comprise slits or indentations in order to enhance the flexibility of the dressing, [0048] NOTE; the absorbent area is in the central zone and has slits or indentations that enhance the flexibility and as it is more flexible that the lateral zones it follows that the compressive strength in the central area including the pad is lower than the lateral zones which are less flexible and would thus have greater compressive strength).
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 Cureton in view of Kudo in view of Levin and in further view of Kolte is divided into three separate zones along the longitudinal (y) extension of the dressing: one central zone and two lateral zones, wherein a compressive strength of the gel of the gel pad in the central zone is lower than in the lateral zones, as taught by Kolte, in order to provide an improved medical dressing that has enhanced flexibility (Kolte, [0048]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cureton (US 2013/0096478) in view of Kudo (US 2020/0115539), in view of Levin (US 2003/0199800), and in further view of Kolte (US 2004/0049146), as applied to claim 16 above, and further in view of McDowall (US 5700254).
Regarding claim 17, Cureton in view of Kudo, in view of Levin and in further view of Kolte discloses the invention as described above with regard to claim 16.
Cureton in view of Kudo, in view of Levin and in further of Kolte does not disclose wherein an anisotropic layer is arranged such that a first direction (x) of the anisotropic layer corresponds to the lateral (x) extension of the dressing, and a second direction (y) of the anisotropic layer corresponds to the longitudinal extension of the dressing.
McDowall teaches an analogous medical dressing 10 (absorbent article 10, col. 4, lines 1-46; Fig. 1) having an analogous backing layer (18) (backing layer 18, col. 4, lines 1-46; Fig. 1), an analogous body contact layer 12 (liquid permeable facing layer 12, col. 4, lines 1-46) , the medical dressing comprising an analogous gel pad 16 (absorbent core 16 may be fabricated from any highly absorbent liquid material known in the art including …synthetic hydrogel polymers, col. 4, lines 1-46), wherein the medical dressing comprises an anisotropic layer 14 (liquid distribution layer 14, col. 4, lines 1-46; col. 3, lines 24-32) arranged such that a first direction (x) of the anisotropic layer corresponds to the lateral (x) extension of the dressing (Fig. 1), and a second direction (y) of the anisotropic layer corresponds to the longitudinal extension of the dressing (Fig. 1; Although Fig. 1 illustrates the placement of the liquid distribution layer as being placed on the absorbent core 12, the liquid distribution layer may alternatively be placed on both the top and the bottom of the absorbent core, or placed between two layer of an absorbent material in order to accommodate different designs and function criteria of absorbent articles, col. 4, lines 1-46; NOTE: thus the x and y directions of the anisotropic layer correspond to the x and y directions of the dressing as it is placed on the top or bottom of the absorbent core which has x and y directions which the anisotropic layer also has the same x and y directions).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide wherein an anisotropic layer of the dressing of Cureton, in view of Kudo, in view of Levin and in further view of Kolte is arranged such that a first direction (x) of the anisotropic layer corresponds to the lateral (x) extension of the dressing, and a second direction (y) of the anisotropic layer corresponds to the longitudinal extension, as taught by McDowall, in order to provide an improved medical dressing that provides higher dimensional stability and physical integrity and highly improved liquid distribution properties (McDowell col. 3, lines 53-67).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-2, 4, 6, and 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-12 and 14 of U.S. Patent No. 12251293 (reference patent) in view of Levin (US 2003/0199800).
Regarding claim 1, the limitations therein are recited in claim 1 of the reference patent including a medical dressing comprising a backing layer, an adhesive body contact layer, and a gel pad arranged between the backing layer and the adhesive body contact layer, wherein a gel of the gel pad has a compressive strength of from 5 to 60 kPa at a strain of 50%, as measured according to a compression test.
Claim 1 of the reference patent does not disclose wherein the gel pad has a first surface and a second surface spaced by a thickness, wherein the gel pad comprises regions of removed gel to form a plurality of apertures, wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface. wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad. wherein the gel of the gel pad has a second area. and wherein the second area of the eel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad.
Levin teaches an analogous dressing (20) comprising an analogous body contact layer (36) ([0022], low friction wrap of plastic film whose periphery includes a biocompatible adhesive surface 40 that is applied to the skin 32) and an analogous gel pad (22) ([0023], gel-type material) having first surface and a second surface spaced by a thickness (annotated Fig. 3 above with regard to the claim 1 rejection), wherein the gel pad comprises regions of removed gel to form a plurality of apertures (24) ([0023], apertures in the gel-type material 22) (As to claim 1, the limitation, “wherein the gel pad comprises regions of removed gel to form a plurality of apertures” is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Levin may be silent as to the process used to form the plurality of apertures, the apparatus disclosed i.e. a gel pad having a plurality of apertures is the same as claimed), wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad (annotated Fig. 3 above) from the first surface to the second surface (annotated Fig. 3 above), wherein each aperture of the plurality of apertures has a respective aperture area (Fig. 3, see perforations 24 each have a respective aperture area), wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad, (annotated Fig. 2 above with regard to the claim 1 rejection, top surface area of pad) wherein the gel of the gel pad has a second area (annotated Fig. 3), and wherein the second area of the gel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad (annotated Fig. 2, annotated Fig. 3).
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 gel pad of the medical dressing of reference claim 1 of the reference patent has a first surface and a second surface spaced by a thickness, where the gel pad comprises regions of removed gel to form a plurality of apertures, wherein each aperture of the plurality of apertures is a void space that extends through the gel pad an entirety of the thickness of the gel pad from the first surface to the second surface. wherein each aperture of the plurality of apertures has a respective aperture area, wherein the first surface of the gel pad has an outer periphery surrounding a total area of the gel pad. wherein the gel of the gel pad has a second area. and wherein the second area of the eel and the respective aperture areas of the plurality of apertures cooperate to form the total area of the gel pad, as taught by Levin, in order to provide an improved medical dressing that facilitates absorption of fluid by an absorption layer of the dressing and that prevents the accumulation of sweat and wound fluids beneath the gel pad (Levin, [0022], [0023]).
Regarding claim 2, the limitations therein are substantially recited in claim 3 of the reference patent.
Regarding claim 4, the limitations therein are substantially recited in claim 3 of the reference patent.
Regarding claim 6, the limitations are substantially recited in claim 1 of the reference patent.
Regarding claim 8, the limitations are substantially recited in claim 1 of the reference patent.
Regarding claim 9, the limitations are substantially recited in claim 14 of the reference patent.
Regarding claim 10, the limitations are substantially recited in claim 9 of the reference patent.
Regarding claim 11, the limitations are substantially recited in claim 6 of the reference patent.
Regarding claim 12, the limitations are substantially recited in claim 7 of the reference patent.
Regarding claim 13, the limitations are substantially recited in claim 1 of the reference patent.
Regarding claim 14, the limitations are substantially recited in patent claim 10.
Regarding claim 15, the limitations are substantially recited in patent claim 11.
Regarding claim 16, the limitations are substantially recited in patent claim 2.
Regarding claim 17, the limitation are substantially recited in patent claim 3.
Regarding claim 18, the limitations are substantially recited in patent claim 4.
Regarding claim 19, the limitations are substantially recited in patent claim 5.
Regarding claim 20, the limitations are substantially recited in patent claim 12
Claims 3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 12251293 in view of Levin (US 2003/0199800) as applied to claim 2 above, and in further view of McDowall (US 5700254).
Regarding claim 3, patent claim 3 in view of Levin discloses the invention as described above with regard to application claim 2.
Patent claim 3 in view of Levin does not disclose wherein the anisotropic layer has apertures that extend through the anisotropic layer.
McDowall teaches an analogous medical dressing having an analogous anisotropic layer wherein the anisotropic layer has apertures that extend through the anisotropic layer (col. 9, lines 17-66; NOTE: pore structures of the web are apertures that extend through the anisotropic layer [the web]).
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 anisotropic layer of the medical dressing of patent claim 3 in view of Levin has apertures that extend through the anisotropic layer as taught by McDowall in order to provide an improved medical dressing that that provides higher dimensional stability and physical integrity and highly improved liquid distribution properties (McDowell col. 3, lines 53-67).
Regarding claim 5, patent claim 3 in view of Levin discloses the invention as described above with regard to claim 2.
Patent claim 3 in view of Levin does not disclose wherein the anisotropic layer is arranged between the gel pad and the backing layer.
McDowall teaches wherein the anisotropic layer is arranged between the analogous gel pad and the analogous backing layer (Fig. 1; col. 4, lines 1-46; col. 4, lines 12-19; NOTE: as layer 14 may be placed under the absorbent core [analogous pad] it follows that it would be arranged between the analogous gel pad and the analogous backing layer 18).
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 anisotropic layer of the medical dressing of patent claim 3 in view of Levin is arranged between the gel pad and the backing layer as taught by McDowall in order to provide an improved medical dressing that that provides higher dimensional stability and physical integrity and highly improved liquid distribution properties (McDowell, col. 3, lines 53-67) and that accommodates different designs of functional criteria (McDowall, col. 4, lines 12-19).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12251293 in view of Levin (US 2003/0199800) as applied to claim 6 above, and in further view of McDowall (US 5700254) and Beese (US 2006/0265005).
Regarding claim 7, patent claim 1 in view of Levin discloses the invention as described above with regard to application claim 6.
Patent claim 1 in view of Levin does not disclose wherein the medical dressing further comprises a substantially transparent anisotropic layer.
McDowall teaches an analogous medical dressing 10 (absorbent article 10, col. 4, lines 1-46; Fig. 1) having an analogous backing layer (18) (backing layer 18, col. 4, lines 1-46; Fig. 1), an analogous body contact layer (12) (liquid permeable facing layer 12, col. 4, lines 1-46; Fig. 1) and an analogous gel pad (16) (absorbent core 16 may be fabricated from any highly absorbent liquid material known in the art including …synthetic hydrogel polymers, col. 4, lines 1-46) arranged between the back layer and the adhesive body contact layer, wherein the medical dressing further comprises an anisotropic layer (14) (liquid distribution layer 14, col. 4, lines 1-46; col. 3, lines 24-32; NOTE: the distribution layer is an anisotropic nonwoven fiber web of microfibers).
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 patent claim 1 in view of Levin further comprises an anisotropic layer as taught by McDowell in order to provide an improved medical dressing that provides higher dimensional stability and physical integrity (McDowell, col. 3, lines 53-67).
Patent claim 1 in view of Levin and in further view of McDowall discloses the invention as described above.
Patent claim 1 in view of Levin and in further view of McDowell does not disclose a substantially transparent anisotropic layer.
Beese teaches an analogous medical dressing (10) ([0021]; NOTE: the kit includes support layers and adhesive for closing a wound and is thus analogous to a dressing) having an analogous anisotropic layer (12) ([0024]; NOTE: layer 24 is analogous to an anisotropic layer in that it is non-woven material is the assembly of textile fibers held together by mechanical interlocking in a random web or mat, for example by fusing thermoplastic fibers to each other as in McDowell) wherein the analogous anisotropic layer is substantially transparent ([0024]; NOTE: support layer 12 is transparent).
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 anisotropic layer of the medical dressing of patent claim 1 in view of Levin and in further view of McDowell is transparent, as taught by Beese, in order to provide an improved dressing that facilitates examination of a healthcare provider and positioning of the dressing (Beese, [0033]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Da Silva Macedo (US 2009/0112142) discloses a medical dressing (1) comprising a backing layer (2), an adhesive body contact layer (4,5) and a gel pad (3) arranged between the backing layer and the adhesive body contact layer (Fig. 4).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.M./ Examiner, Art Unit 3786
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786
Prosecution Insights