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 .
Response to Amendment
1. The amendment filed 06/22/2026 has been entered. Currently, claims 20-25 remain pending in the application. New claims 20-25 were amended to include further narrowing limitations without the addition of new matter. Additionally, claim 1-19 were cancelled overcoming previous claim objections, 35 USC 112(B) rejections, and double patenting rejections that were set forth in the Non-Final Office Action mailed 03/19/2026. Lastly, a new 35 USC 112(B) rejection is recited below.
Response to Arguments
2. Applicant’s amendment of new claims 20-25 is sufficient to overcome the previous 35 USC § 103 rejection of claims recited in the Non-Final Office Action mailed 03/19/2026.
Applicant’s arguments, see Remarks on Pages 5-8, filed 06/22/2026, with respect to the rejection under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, the amended claims have changed the scope of the claims and upon further consideration, a new grounds of rejection is made in view of new and current prior art of the record: Munro (U.S. Patent Pub. No. 20190000677), Ward (WO 9725012 A1), Furumori (U.S. Patent Pub. No. 20070212520), Riesinger (U.S. Patent Pub. No. 20160000610), and Langen et al. (U.S. Patent No. 4944958).
3. Overall, Overall, Examiner notes that Applicant may amend the claims to overcome the prior art of record by reciting positive limitations such as in Applicant’s Page 16, Paragraph 3 and Page 18, Paragraph 1, describing the non-perforation zones as 2-5 mm along both the width and length; 3-5mm channel spacing center to center distance; aggregate surface areas of 11-12% and 4-5%. Furthermore, any negative limitation such as –not—or –without— to teach away from the prior art. Lastly, transitional phrases such as –consisting— or –consisting essentially of-- in the preamble or body of the claim to prevent prior art combinations.
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 25 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.
The term “about” in claim 25, is a relative term which renders the claim indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, “about” is defined as encompassing the claimed diameter as well as values of +/- 10um above and below the claimed ranges.
Claim Rejections - 35 USC § 103
6. 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.
7. Claims 20-25, as best understood given by the 35 USC 112(B) above, are rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Munro (U.S. Patent Pub. No. 20190000677) and in further view of Langen et al. (U.S. Patent No. 4944958) and Riesinger (U.S. Patent Pub. No. 20160000610) and Ward (WO 9725012 A1).
Regarding claim 20, Furomori discloses a dressing (Paragraphs 55-57, pressure-sensitive adhesive tape comprising a non-woven substrate sheet and a pressure sensitive adhesive layer disposed on at least one side of the substrate to treat wound on skin) comprising a sheet and an adhesive, wherein: a. the adhesive is a pressure-sensitive adhesive and is adhered (Paragraph 57) to the sheet, b. the sheet (i) comprises sheet material (Paragraph 56, nonwoven fabric is a sheet material), wherein the sheet material is a fibrous non-woven sheet material (Paragraph 157, substrate nonwoven fabric is rayon); (ii) has a proximal side (Paragraph 57, proximal side of 33substrate where the adhesive layer is attached has a surface area) comprising a surface area, and a distal side comprising a surface area; (ii) has a plurality of channels zones (Paragraph 58, penetrating pores penetrate substrate and adhesive layer forming parallel channel zones) each of the plurality of channel zones having a plurality of channels that: transverse the sheet from the proximal side to the distal side; are disposed with a center-to-center channel spacing and disposed in a plurality of rows of channels; are disposed with a channel angle from 20 degrees to 90 degrees Paragraphs 58 and 111, penetrating pores penetrate substrate and adhesive layer, thereby traverse from proximal side of substrate to distal side of substrate. Pores are aligned in a width direction and spaced apart in a longitudinal direction such that they are positioned at an angle of approximately 90 degrees relative to the substrate) relative to the sheet; have a diameter of 25 um to about 10 mm (Paragraphs 110 and 154, pores are a circular shape and thereby has a diameter, wherein the pore has an area of 0.09 to 3 mm2 such that the diameter is in the range of 0.33 mm to 1.95 mm; See MPEP 2144.05(I) prima facie case of obviousness as the disclosed range falls within and is narrower than the claimed range); and are a number per cm2 of the distal surface area of the respective channel zone (Paragraphs 63, 101, and 110-11, The size of the penetrating pore is in the range of 0.09 to 3 mm2. The distance between one penetrating pore and another penetrating pore adjacent thereto is 0.3 mm or more and 3 mm or less for the distance between non-cut sections in a cross direction and is 1 mm or more and 10 mm or less for the distance between non-cut sections in a longitudinal direction. Thereby, these factors may be selected to derive a number per cm2 of surface area); (iv) has a plurality of non-perforation zones (Figure 1A, non-perforation zone with no channels adjacent the periphery margin edges of sheet) running parallel to a periphery of the sheet; and (v) is air-permeable, liquid-permeable, and moisture-vapor permeable in a portion of the sheet without the channels; andc. the dressing, the adhesive, and the sheet are dermatologically acceptable (Paragraph 11, the pressure-sensitive adhesive tape causes less skin irritation so as to be used for a medical use);d. the sheet has a length and a width and wherein the length is (this part of “or” statement is not being examined) greater (Paragraph 219, the pressure-sensitive adhesive sheet was cut to give a pressure-sensitive adhesive sheet having the size of about 50 cm in length and about 25 mm in width)in length than the width.
However, Furumori fails to explicitly disclose (1) (c.ii) wherein the channels are 1 to 160000 in number per cm2 distal surface area; (2) wherein a non-perforation zone of the plurality of non-perforation zones is located between channel zones of the plurality of channel zones, and wherein each of the non-perforation zones has a width that is greater than the center-to-center channel spacing of the channels of each of the plurality of channel zones; (3) (v) is air-permeable in a portion of the sheet without the channels; (4) (v) is liquid-permeable in a portion of the sheet without the channels; (5) (v) is moisture vapor-permeable in a portion of the sheet without the channels.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to optimize the channel number per cm2 of the distal surface area of Furumori, so that the channel number per cm2 of the distal surface area is 1 to 160000, for the purpose of providing an improved dressing that provides a desirable amount of dressing permeability, as given by the surface area amount of the channel (Furumori, Paragraphs 110-111). Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 17, Paragraph 107 indicating the range is simply selected “depending upon intended usage” and “optionally”). Lastly, Examiner notes that the claim value of 1 to 160000 of the channel surface area is given by selecting the number of holes and dimension of each hole of Furumori as discussed above, and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233, see MPEP 2144.05(I)
However, Furumori as modified fails to explicitly disclose (2) wherein a non-perforation zone of the plurality of non-perforation zones is located between channel zones of the plurality of channel zones, and wherein each of the non-perforation zones has a width that is greater than the center-to-center channel spacing of the channels of each of the plurality of channel zones; (3) (v) is air-permeable in a portion of the sheet without the channels; (4) (v) is liquid-permeable in a portion of the sheet without the channels; (5) (v) is moisture vapor-permeable in a portion of the sheet without the channels.
Munro teaches an analogous dressing (Paragraphs 75-78, 133-134 and Figure 1C, wound dressing with apertures and non-aperture zones along periphery as well as centrally of the dressing) wherein a non-perforation zone (Figure 1C, central non-perforation zone) of the analogous plurality of non-perforation zones (Paragraphs 76-78 and Figure 1C) is located between analogous channel zones of the analogous plurality of channel zones, and wherein each of the analogous non-perforation zones has a width that is greater than the analogous center-to-center channel (Paragraph 76-77, 143 and Figure 1K, spacing of non-perforation zone X1 is greater than 6mm. Meanwhile spacing between apertures X2 is 2mm and each aperture diameter is 2.8mm such that the center to center distance is 4.8mm. Thereby, 6mm is greater than 4.8mm; see MPEP 2144.05(I) prima facie obviousness) spacing of the analogous channels of each of the analogous plurality of channel zones.
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It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the non-perforation zones at the margin periphery of Furumori, so that there is also a non-perforation zone of the plurality of non-perforation zones is located between channel zones of the plurality of channel zones, and wherein each of the non-perforation zones has a width that is greater than the center-to-center channel spacing of the channels of each of the plurality of channel zones, as taught by Munro, in order to provide an improved dressing with enhanced channel and non-channel zones allowing for different areas lacking apertures providing desirable material properties (Munro, Paragraphs 75-78, 133-134). Thereby, permeability and strength can be optimized according to the amount of non-perforation zones.
However, the combination of Furumori as modified in view of Munro fails to explicitly disclose; (3) (v) is air-permeable in a portion of the sheet without the channels; (4) (v) is liquid-permeable in a portion of the sheet without the channels; (5) (v) is moisture vapor-permeable in a portion of the sheet without the channels.
Langen teaches (i) the analogous sheet material 10 (Col. 10, lines 30-40 and Figure 1, wound sheet dressing material 10) without the analogous channels (Col. 8, lines 29-59, Table II, Col. 10, lines 30-40 and Figure 1, dressing area without any 25 um to 10mm channels has air permeability of 80 cm3/s/cm2; see MPEP 2144.05(I) prima facie obviousness wherein a value of at least 80 cm3/s/cm2 overlaps and is narrower than the claimed range of 0.01 to 1000 cm3/s/cm2) has air permeability of at least 0.01 cm3/s/cm2.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the sheet material without the channels of Furumori as modified in view of Munro, so there is an air permeability at an area without the channels, as taught by Langen, in order to provide an improved dressing with an enhanced sheet material that allows for air to be transferred at an area away from the channels for providing a healing effect to the wound (Langen, Col. 8, lines 29-59 and Col. 10, lines 30-40).
However, the combination of Furumori as modified in view of Munro in view of Langen fails to explicitly disclose; (4) (v) is liquid-permeable in a portion of the sheet without the channels; (5) (v) is moisture vapor-permeable in a portion of the sheet without the channels.
Riesinger teaches an analogous dressing (Paragraph 9, dressing is fluid permeable because of porosity of material as opposed to punched perforations) is liquid-permeable in a portion of the sheet without the channels.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the sheet material without the channels of Furumori as modified in view of Munro, so there is liquid permeability at an area without the channels, as taught by Riesinger, in order to provide an improved dressing with an enhanced sheet material that allows for fluid and exudate to be transferred at an area away from the channels for providing a healing effect to the wound (Riesinger, Paragraphs 9 and 69).
However, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger fails to explicitly disclose (5) (v) is moisture vapor-permeable in a portion of the sheet without the channels.
Ward teaches (v) the analogous dressing (Page 2, lines 8-25 and Figures 1-2, dressing has moisture vapor permeability of at least 1000gms/m2/day; see MPEP 2144.05(I) prima facie obviousness wherein a value of at least 1000 gms/m2/24hr overlaps with the claimed range of 2500-6,000 gms/m2/24 hours) has a moisture vapor permeability of at least 1000 gms/m2/24 hours in an area without analogous channels (Page 2, lines 8-25 and Figures 1-2, dressing area without any 25 um to 10mm channels), when measured at 37°C and 100% to 10% relative humidity.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the sheet material without the channels of Furumori as modified in view of Munro in view of Langen in view of Riesinger, so there is moisture vapor permeability at an area without the channels, as taught by Ward, in order to provide an improved dressing with a desirable moisture permeability to allow the wound under the dressing in an area without the channels to heal in a moist condition without softening the skin surrounding the wound (Ward, Page 2, lines 8-25).
Regarding claim 21, the combination Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward discloses the invention as described above. Furumori further discloses wherein the sheet material is rayon (Paragraph 157, substrate nonwoven fabric is rayon).
Regarding claim 22, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward discloses the invention as described above. Furumori further discloses wherein the channels are 0.25 to 1.95 mm in diameter (Furumori, Paragraphs 110 and 154, pores are a circular shape and thereby has a diameter, wherein the pore has an area of 0.09 to 3 mm2 such that the diameter is in the range of 0.33 mm to 1.95 mm; See MPEP 2144.05(I) prima facie case of obviousness as the disclosed range overlaps with the claimed range), wherein the channels are the number per cm2 distal surface area (Furumori, Paragraphs 63, 101, and 110-11, The size of the penetrating pore is in the range of 0.09 to 3 mm2. The distance between one penetrating pore and another penetrating pore adjacent thereto is 0.3 mm or more and 3 mm or less for the distance between non-cut sections in a cross direction and is 1 mm or more and 10 mm or less for the distance between non-cut sections in a longitudinal direction. Thereby, these factors may be selected to derive a number per cm2 of surface area) of the respective channel zones; the dressing further comprises a protective layer (Furumori, Paragraph 181, release liner on a surface of the pressure-sensitive adhesive layer proximal side before the use to prevent contamination on a surface of the pressure-sensitive adhesive layer) releasably secured on the proximal side of the sheet.
However, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward fails to explicitly disclose (1) the channels are 0.25 to 1.5 mm in diameter; (2) wherein the channels are 5 to 25 per cm2 distal surface area.
It would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the channel diameter of 0.25 to 1.95 mm of Furumori as modified in view of Langen in view of Rawlings, so that the diameter is 0.25 to 1.5 mm, as taught by Furumori, in order to provide an improved dressing that provides a desirable amount of dressing permeability, as given by the surface area amount of the channel (Furumori, Paragraphs 110-111). Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 3, Paragraph 12 indicating the range is simply selected in a range comprising a relative term “about”). Lastly, Examiner notes that since the claim value of 0.25 to 1.5 mm of the channel diameter is given by Furumori as discussed above, it has been held that a prior art reference that discloses a range encompassing an overlapping claimed range is sufficient to establish a prima facie case of obviousness; see MPEP 2144.05(I).
Additionally, it would have been obvious for a person having ordinary level of skill in the art before the effective filing date of the claimed invention to modify the channel number per cm2 of the distal surface area of Furumori as modified in view of Langen in view of Rawlings, so that the channel number per cm2 of the distal surface area is 5 to 25, as taught by Furumori, in order to provide an improved dressing that provides a desirable amount of dressing permeability, as given by the surface area amount of the channel (Furumori, Paragraphs 110-111). Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 17, Paragraph 107 indicating the range is simply selected “depending upon intended usage” and “optionally”). Lastly, Examiner notes that since the claim value of 5 to 25 of the channel surface area is given by selecting the number of holes and dimension of each hole of Furumori as discussed above, it has been held that a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness; see MPEP 2144.05(I).
Regarding claim 23, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward discloses the invention as described above and further discloses wherein the moisture vapor-permeability in the portion of the sheet without the channels when measured at 37°C and 100% to 10% relative humidity is at least 100 gms/m2/24 hours (Ward, Page 2, lines 8-25 and Figures 1-2, dressing area without any 25 um to 10mm channels has moisture vapor permeability of at least 1000gms/m2/day; see MPEP 2144.05(I) prima facie obviousness wherein a value of at least 1000 gms/m2/24hr is narrower and falls within the claimed range of at least 100 gms/m2/24 hours).
Regarding claim 24, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward discloses the invention as described above and further discloses wherein the air-permeability in the portion of the sheet without the channels is at least 0.01 cm3/s/cm2 (Langen, Col. 8, lines 29-59, Table II, Col. 10, lines 30-40 and Figure 1, dressing area without any 25 um to 10mm channels has air permeability of 80 cm3/s/cm2; see MPEP 2144.05(I) prima facie obviousness wherein a value of at least 80 cm3/s/cm2 overlaps and is narrower than the claimed range of at least 0.01 cm3/s/cm2).
Regarding claim 25, the combination of Furumori as modified in view of Munro in view of Langen in view of Riesinger in view of Ward discloses the invention as described above and further discloses wherein two non-perforation zones of the plurality of non-perforation zones are within 2 mm (Munro, Paragraph 76-77, 143 and Figure 1K, spacing of non-perforation zone X1 is greater than 6mm and falls within 2mm of the perimeter of the sheet; see MPEP 2144.05(I) prima facie obviousness) of the periphery of the sheet.
Conclusion
8. 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Milo whose telephone number is (571)272-6476. The examiner can normally be reached on Mon-Fri 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached on +1(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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/MICHAEL MILO/
Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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