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 Objections
Claim 8 and 15 are objected to because of the following informalities:
In claim 8, line 2, rephrase “channels a second” to read --channels of a second--.
In claim 15, line 1, rephrase “a dressing” to read --the dressing--.
In claim 16 rephrase "the step" in line 1 to read --a step--. Although steps are inherent of method claims, for improved clarity introduce the limitation first.
Appropriate correction is required.
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.
Claims 1-19 are 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 1, line 10; claim 3, line 2; and claim 8, lines 3 and 5, 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 4, line 2; claim 6, line 3; claim 7, line 3; claim13, line 2; and claim 19, line 2, recite the term “optionally” which renders the claims indefinite because it is unclear if the dressing actually include those optional feature or not. For examination purposes, remove the term “optionally” from the claim to positively recite the feature.
Claim 4, line 3 and claim 18, line 4, recite the limitation "the periphery" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims. Rephrase “the periphery” to read --a periphery--.
Claim 10 recites the limitation "the aperture" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Rephrase “the aperture” to read --apertures--.
Claim 10 recites the limitation "the total surface" in line 2. There is insufficient antecedent basis for this limitation in the claim. Rephrase “the total surface” to read --a total surface--.
Claim 11 recites the limitation "the moisture vapor" in line 1. There is insufficient antecedent basis for this limitation in the claim. Rephrase “the moisture vapor” to read --a moisture vapor--.
Claim 11, lines 2-3 and claim 18, line 3 recites the limitation "the area". There is insufficient antecedent basis for this limitation in the claim. Rephrase “the area” to read --an area—.
Claim 18, line 5 recites the limitation "the wound area". There is insufficient antecedent basis for this limitation in the claim. Rephrase “the wound area” to read --a wound area--.
Claims 2, 5, 9, 12, 14-17 and 19 are rejected for being dependent on an indefinite claim.
Double Patenting
7. 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.
Claims 1-2, 5, 9, and 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9-10, 12-13, and 16 of U.S. Patent No. 12232934.
Regarding claim 1 of this child instant application, the parent U.S. Patent No. 12232934 claim s 1 and 16 disclose “A dressing comprising a sheet and an adhesive, wherein:a. the adhesive is a pressure-sensitive adhesive and is adhered to the sheet,b. the sheet (i) comprises sheet material, (ii) has channels forming a channel zone; (iii) has a proximal side comprising a surface area, and a distal side comprising a surface area, and (iv) the sheet material demonstrates at least water permeability;c. the channels (i) traverse the sheet from the proximal side to the distal side at an angle; (ii) are 1 to 160,000 in number per cm2 of the distal surface area; and (iii) have a diameter of 25 pm to about 10 mm;d. the adhesive, the sheet, and the dressing are dermatologically acceptable;e. the channel angle is from 20 degrees to 90 degrees relative to the sheet;f. the sheet has a length and a width and wherein the length is longer than the width,g. the adhesive is adhered to the proximal side of the sheet;h. the sheet material is rayon; andi. the sheet material without the channels has air permeability of at least 0.01 cm3/s/cm2.”.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between claim 1 of the current application and claims 1 and 16 of patent 12232934 lies in the fact that the patented claims include many more elements and is thus much more specific. Thus, the invention of claims 1 and 16 of patent 12232934 in effect a “species” of the “generic” invention of current application claim 1. It has been held that the generic invention is “anticipated” by the “species". See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claim 1 of the current application is anticipated by claims 1 and 16 of patent 12232934, it is not patentably distinct from claim 1 and 16 of patent 12232934.
All of the limitations of claim 2 can be found in claim 9 of U.S. Patent No. 12232934.
All of the limitations of claim 5 can be found in claim 1 of U.S. Patent No. 12232934.
All of the limitations of claim 9 can be found in claim 10 of U.S. Patent No. 12232934.
All of the limitations of claim 12 can be found in claim 12 of U.S. Patent No. 12232934.
All of the limitations of claim 13 can be found in claim 13 of U.S. Patent No. 12232934.
All of the limitations of claim 14 can be found in claim 7 of U.S. Patent No. 12232934.
All of the limitations of claim 15 can be found in claim 2 of U.S. Patent No. 12232934.
All of the limitations of claim 16 can be found in claim 2 of U.S. Patent No. 12232934.
All of the limitations of claim 17 can be found in claim 2 of U.S. Patent No. 12232934.
All of the limitations of claim 18 can be found in claim 7 of U.S. Patent No. 12232934.
All of the limitations of claim 18 can be found in claim 7 of U.S. Patent No. 12232934.
This is a nonstatutory double patenting rejection.
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.
Claims 1-3, 10, 15, are rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958).
Regarding claim 1, 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), (ii) has channels (Paragraph 58, penetrating pores penetrate substrate and adhesive layer forming parallel channel zones) forming a channel zone; (iii) 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, and (iv) the sheet material demonstrates at least water permeability; c. the channels (i) traverse(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) the sheet from the proximal side to the distal side at an angle; (ii) are a number per cm2 of the distal surface area (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); and (iii) 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); d. the adhesive, the sheet, and the dressing are dermatologically acceptable (Paragraph 11, the pressure-sensitive adhesive tape causes less skin irritation so as to be used for a medical use); e. the channel angle is 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;f. the sheet has a length and a width (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)and wherein the length is longer than the width, g. the adhesive is adhered (Paragraph 57, proximal side of substrate where the adhesive layer is attached) to the proximal side of the sheet; h. the sheet material is rayon (Paragraph 157, substrate nonwoven fabric is rayon).
However, Furumori fails to explicitly disclose (1) (c.ii) wherein the channels are 1 to 160000 in number per cm2 distal surface area; (2) (i) the sheet material without the channels 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 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) (i) the sheet material without the channels has air permeability of at least 0.01 cm3/s/cm2.
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, so there is an air permeability at an area without the channels of at least 0.01 cm3/s/cm2, 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).
Regarding claim 2, the combination Furumori as modified in view of Langen discloses the invention as described above and further discloses wherein the sheet material is nonwoven rayon (Furumori, Paragraph 157, substrate nonwoven fabric is rayon).
Regarding claim 3, the combination Furumori as modified in view of Langen discloses the invention as described above and further discloses wherein the channels are the number per cm2 of the distal surface area (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); wherein the channels have a diameter of 25 um to 2.5 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 as is narrower than the claimed range).
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose the channels are 1 to 1000 in number per cm2 of the 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 number per cm2 of the distal surface area of Furumori in view of Langen, so that the channel number per cm2 of the distal surface area is 1 to 1,000, 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 1 to 1,000 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 10, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furumori further discloses wherein a sum of surface areas defined by the apertures of the channels is a number of a total 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 surface area of the pores relative to the substrate) defined by the sheet.
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose a sum of surface areas defined by the apertures of the channels is a number between 0.01% and 10% of a total 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 % of total surface area of Furumori as modified in view of Langen, so that the channel % of total surface area is 0.01 % and 10%, 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 108 indicating the range is simply selected “optionally”). Lastly, Examiner notes that since the claim value of 0.01 % and 10% of the channel total 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 15, with respect to the method step claimed, the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will obviously perform the method steps as claimed. Furthermore, it has been held that 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); MPEP 2112.01(1), as such, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furumori further discloses a method of treating a wound comprising applying (Furumori, Paragraphs 55-57, pressure-sensitive adhesive tape applied on wound) the dressing.
Claims 4-8, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 1, and in further view of Rawlings et al. (U.S. Patent No. 5010883).
Regarding claim 4, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furumori further discloses a plurality of channel zones (Furumori, Paragraphs 58 and 111, penetrating pores penetrate substrate and adhesive layer forming parallel channel zones) and a plurality of non-perforation zones (Furumori, Paragraph 111, there is 1 mm or more and 10 mm or less for the distance between non-cut sections in a longitudinal direction that are parallel to periphery edges of the tape; See MPEP 2144.05(I) prima facie case of obviousness as the disclosed range falls within and is narrower than the claimed range) of at least 0.5 cm width.
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose the non-perforation zone is at least 0.5 cm in width and localized along a periphery of the width of the sheet.
Rawlings teaches an analogous dressing sheet 11 (Col. 12, lines 6-10 and Figure 3, dressing 11 with first layer 13 extending beyond the periphery of the continuous film 12) has a non-perforation zone (Col. 6, lines 66-68 and Col. 7, lines 1-3, the first layer 13 will extend beyond the periphery of the continuous film 12. The seal may therefore be formed around the edge of the continuous film 12 so leaving a margin of the first layer 13 which is arranged to be unperforated) without analogous channels 18 (Col. 12, line 14, holes 18) and wherein the non-perforation zone is at least 0.5 cm in width (Col. 7, lines 21-23, margin will be from 2 to 4 cm wide; see MPEP 2144.05 regarding prima facia obviousness of overlapping ranges as the taught range of 2 to 4 cm falls within the claimed range of greater than 0.5 cm) and localized along a periphery (Col. 7, lines 25-26, This margin may be present in all four edges of the dressing) of the analogous width of the analogous sheet 11.
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 periphery of the sheet of the dressing of Furumori in view of Langen, so that there is also a non-perforation zone at the periphery that is at least 0.5cm in width, as taught by the second embodiment of Rawlings, in order to provide an improved dressing with an enhanced sheet having a periphery that is unperforated for providing increased support and decreased exudate transport around the perimeter of the dressing (Rawlings, Col. 7, lines 1-3 and 21-23).
Regarding claim 5, the combination of Furumori as modified in in view of Langen in view of Rawlings discloses the invention as described above and further discloses wherein the dressing has a plurality of channel zones (Furumori, Paragraphs 58 and 111, penetrating pores penetrate substrate and adhesive layer forming parallel channel zones) and a plurality of non-perforation zones (Furumori, Paragraph 111, there is 1 mm or more and 10 mm or less for the distance between non-cut sections in a longitudinal direction that are parallel to periphery edges of the tape; See MPEP 2144.05(I) prima facie case of obviousness as the disclosed range falls within and is narrower than the claimed range) of at least 0.5 cm width running parallel to the periphery measured along the width of the dressing wherein at least one of the non-perforation zones is interspersed between (Furumori, Paragraph 111, space of 1 mm or more and 10 mm or less interspersed between channel zones) at least one of the channel zones.
Regarding claim 6, the combination of Furumori as modified in view of Langen in view of Rawlings discloses the invention as described above and 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); 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 Langen in view of Rawlings 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 7, the combination of Furumori as modified in view of Langen in view of Rawlings discloses the invention as described above and 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); the dressing further comprises a liner (Furumori, Paragraph 181, release liner on a surface of the pressure-sensitive adhesive layer before the use to prevent contamination on a surface of the pressure-sensitive adhesive layer).
However, the combination of Furumori as modified in view of Langen in view of Rawlings 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 8, the combination Furumori as modified in view of Langen discloses the invention as described above and further discloses wherein the channels comprise channels of a first channel type, wherein each of the channels of the first channel type have a diameter of 25 um to about 2,500 um (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).
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose channels of a second channel type and each of the channels of the second channel type have a diameter of about 250 um to about 10 mm and wherein the channels of the first channel type are different than the channels of the second channel type with respect to one or more of diameter, shape, and channel angle.
Rawlings teaches an analogous dressing (Col. 6, lines 40-50, dressing placed on top of skin) with analogous channels (Col. 6, lines 40-50, first layer with slits defining the channels) of a second channel type have a diameter of 250 um to 10 mm (Col. 6, line 43, diameter length of 0.35cm to 1cm; ; see MPEP 2144.05 regarding prima facia obviousness of overlapping ranges as the taught range of 0.35 to 1 cm falls within the claimed range of 0.25 to 10 mm).
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 channels of Furumori as modified in view of Langen, so that there channels of a second channel type that have a diameter of 250 um to 10 mm, as taught by Rawlings, in order to provide an improved dressing with enhanced channel having multiple different configurations of the perforations (Rawlings, Col. 6, lines 40-50), resulting in varying permeability properties.
Therefore, the combination of Furumori as modified in view of Langen in view of Rawlings discloses wherein the channels of the first channel type (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) are different than the channels of the second channel type (Rawlings, Col. 6, line 43, channels with diameter length of 0.35cm to 1cm) with respect to one or more of diameter (Furumori, Paragraphs 110 and 154, pores have diameter in the range of 0.33 mm to 1.95 mm; Rawlings, slits have diameter length of 0.35cm to 1cm), shape (Paragraphs 110 and 154, pores are a circular shape; Rawlings, Col. 6, line 46, straight slits), and channel angle (Furumori, Paragraphs 110-111, channels aligned with one another with angle of 90 degrees relative to tape; Rawlings, Col. 6, line 46-47, channel type in the form of two slits at right angles).
Regarding claim 13, the combination of Furumori as modified in view of Langen discloses the invention as described above but fails to explicitly disclose one or more topical agents, wherein the one or more topical agents are selected from the group consisting of an anti-itch compound, an anti- inflammatory agent, an antibiotic, an anti-fungal agent, an anti-cancer agent, an antiviral agent, a natural marine extract, a natural biologic agent, and a mixture thereof.
Rawlings teaches an analogous dressing (Col. 7, lines 35-36, dressing placed on top of skin) with one or more topical agents (Rawlings, Col. 7, lines 35-36, antibacterial incorporated into adhesive 4), wherein the one or more topical agents is an antibiotic.
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 of the dressing of Furumori as modified in view of Langen, so that there is an antibiotic topical agent, as taught by Rawlings, in order to provide an improved dressing with an enhanced sheet having antibacterial properties for ensuring sterility and minimizing pathogens (Rawlings, Col. 7, lines 35-36).
Regarding claim 18, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furomori further discloses an adhesive solution (Paragraph 57, pressure sensitive adhesive layer is an adhesive solution).
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose a topical agent wherein the topical agent and the adhesive solution are admixed and wherein the admixture is applied to the wound in an area to come in contact with a periphery of the dressing thereby reducing the dressing becoming unattached to a wound area at the periphery.
Rawlings teaches an analogous dressing (Col. 7, lines 30-40, dressing placed on top of skin) with a topical agent (Col. 7, lines 35-36, antibacterial agent) wherein the topical agent and the analogous adhesive solution 4 (Col. 7, lines 35-36, adhesive 4 is an adhesive solution) are admixed (Rawlings, Col. 7, lines 35-36, adhesive 4 admixed with antibacterial agent) and wherein the admixture is applied to the wound in an area to come in contact with a periphery (Rawlings, Col. 7, lines 35-36 and Col. 13, lines 32-38, admixture of the adhesive and antibacterial contacts wound with the periphery of the dressing, such that the dressing is adhered around the wound to prevent unattachment) of the dressing thereby reducing the dressing becoming unattached to a wound area at the periphery.
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 adhesive solution of Furumori as modified in view of Langen, so that there is a topical agent admixed with the adhesive solution, as taught by Rawlings, in order to provide an improved dressing with an enhanced adhesive solution having a topical agent that promotes healing and sterility of the wound (Rawlings, Col. 7, lines 35-36).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 1, and in further view of Rolf (U.S. Patent Pub. No. 20070026056).
Regarding claim 9, the combination of Furumori as modified in view of Langen discloses the invention as described above but fails to explicitly disclose an extract of one or more of jatropha, kelp, and hemp.
Rolf teaches an analogous dressing 1 (Paragraph 58, and Figure 1, antiviral adhesive patch 1) comprising an extract 21 (Paragraph 120, 127, and Figure 1, extract of essential hemp oil 21) of hemp.
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 dressing of Furumori as modified in view of Langen, so that there is an extract of hemp, as taught by Rolf, in order to provide an improved dressing having an extract of hemp essential oil yielding therapeutic properties and distinct fragrance (Rolf, Paragraph 120).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 1, and in further view of Ward (WO 9725012 A1).
Regarding claim 11, the combination of Furumori as modified in view of Langen discloses the invention as described above and further discloses a moisture vapor permeability (Furumori, Paragraphs 161 and 170, chemical binding-treated nonwoven fabric exhibits moisture permeability and the adhesive agent used for forming the pressure-sensitive adhesive layer has moisture permeability; Langen, Col. 8, lines 29-59, Table II, Col. 10, lines 30-40 and Figure 1, air permeability also provided moisture vapor permeability at areas of dressing with no perforated channels) of the dressing, and an area (Furumori, Paragraphs 58 and 111, Pores are spaced apart in a longitudinal direction such that they form an area without channels) without channels.
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose the moisture vapor permeability of the dressing when measured at 37°C and 100% to 10% relative humidity is at least 500 gms/ m2/24 hours.
Ward teaches (j) 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 optimize a moisture vapor permeability value of the dressing of Furumori in view of Langen, so that the value is at least 1000 gms/ m2/24 hours, 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).
However, the combination of Furumori in view of Langen in view of Ward fails to explicitly disclose (4) (j) the dressing has a moisture vapor permeability of 2,500-6,000 gms/m2/24 hours in an area without channels, when measured at 37°C and 100% to 10% relative humidity; (5) (k) the sheet has a non-perforation zone without the channels, wherein the non-perforation zone is at least 0.5 cm in width and localized along a periphery of the width of the sheet.
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 moisture vapor permeability from at least 1000 gms/ m2/24 hours of Furumori in view of Langen in view of Ward, so that the moisture vapor permeability is of 2,500-6,000 gms/ m2/24 hours, in order to provide an improved dressing that provides a desirable amount of dressing moisture permeability, as given by the material and thickness of the dressing. Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 15, Paragraph 97 indicating the range is simply selected “preferably”). Lastly, Examiner notes that since the claim value of 2,500-6,000 gms/ m2/24 hours is given by selecting the thickness and material with a value of at least 1000 gms/ m2/24 hours as taught by Ward, in which a value of 2500-6000 is included in Ward’s range, 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 1, and in further view of Rawlings et al. (U.S. Patent No. 5010883) and Keener et al. (U.S. Patent Pub. No. 20110195625).
Regarding claim 12, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furumori further discloses wherein the sheet has a thickness (Furumori, Paragraph 169, thickness of the nonwoven fabric).
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose (1) the thickness is between 0.05 and 0.25 mm (2) a tensile strength at break of 5 lbs per inch width (89 kg/meter width) and wherein the dressing is elongatable in a range of 20% to 30%.
Rawlings teaches an analogous dressing (Col. 6, lines 14-15 and Figure 2, dressing placed on top of skin) wherein the analogous sheet 3 (Col. 6, lines 14-15 and Figure 2, first layer 3) has a thickness between 0.015 and 0.25 mm (Rawlings, Col. 6, lines 14-15, first layer 3 has thickness of 0.015 to 0.1 mm; see MPEP 2144.05 regarding prima facia obviousness of overlapping ranges as the taught range of 0.015 to 0.1 mm falls within the claimed range of .05 and 0.25 mm).
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 thickness of the sheet of Furumori as modified in view of Langen, so that the thickness is between 0.015 and 0.25 mm, as taught by Rawlings, in order to provide an improved dressing with an enhanced sheet having a thickness that provides desirable skin support (Rawlings, Col. 6, lines 14-15).
However the combination of Furumori as modified in view of Langen in view of Rawlings fails to explicitly disclose (1) the thickness is between 0.05 and 0.25 mm; (2) a tensile strength at break of 5 lbs per inch width (89 kg/meter width) and wherein the dressing is elongatable in a range of 20% to 30%.
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 thickness of Furumori as modified in view of Langen in view of Rawlings, so that the thickness is between 0.05 and 0.25 mm, as taught by Furumori and Rawlings, in order to provide an improved dressing that provides a desirable amount structural support and rigidity. Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 7, Paragraph 47 indicating the range is “can be” selected). Lastly, Examiner notes that since the claim value of 0.05 and 0.25 mm is given by selecting the thickness with a value of 0.015 to 0.1 mm as taught by Rawlings, such that it has been held that a prior art reference that discloses an overlapping range is sufficient to establish a prima facie case of obviousness; see MPEP 2144.05(I).
However the combination of Furumori as modified in view of Langen in view of Rawlings as modified fails to explicitly disclose (2) a tensile strength at break of 5 lbs per inch width (89 kg/meter width) and wherein the dressing is elongatable in a range of 20% to 30%.
Keener teaches an analogous dressing 10 (Paragraphs 2, 6 and Figure 1, tape 10 having a fabric 100 and adhesive 200) comprising a tensile strength at break of 5 lbs per inch width (89 kg/meter width) (Paragraph 9, the fabric 100 has a tensile strength of 5 lbs/inch; see MPEP 2144.05 regarding prima facia obviousness of overlapping ranges as the taught amount of 5lbs/inch is claimed value of 5lbs/inch) and wherein the dressing 10 is elongatable in a range of 15% to 30% (Paragraph 10, the warp yarns have an elongation at break of about 15% to 30%).
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 tensile strength and elongation of the dressing of Furumori as modified in view of Langen in view of Rawlings as modified, so that there is a tensile strength of 5 lbs per inch width and elongation range of 15% to 30%, as taught by Keener, in order to provide an improved dressing having desirable tensile and elongation tear characteristics that allows for increased conformability and application when applied to a user’s skin (Keener, Paragraphs 6 and 9-10).
However the combination of Furumori as modified in view of Langen in view of Rawlings in view of Keener fails to explicitly disclose (2) the dressing is elongatable in a range of 20% to 30%.
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 elongation of 15% to 30% of Furumori as modified in view of Langen in view of Rawlings in view of Keener, so that the elongation is 20% to 30%, as taught by Keener, in order to provide an improved dressing that provides a desirable amount of stretch. Also, Applicant appears to have placed no criticality on the claimed range (see Specification, Page 6, Paragraph 37 indicating the range is “about” the claimed value). Lastly, Examiner notes that since the claim value of 20% to 30% is given by a value of 15% to 30% as taught by Keener in the combination of Furumori as modified in view of Langen in view of Rawlings in view of Keener, such that it has been held that a prior art reference that discloses an overlapping range is sufficient to establish a prima facie case of obviousness; see MPEP 2144.05(I).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 15, and in further view of Rosenberg (CN 102223858 A).
Regarding claim 16, the combination of Furumori as modified in view of Langen discloses the invention as described above but fails to explicitly disclose adding a topical agent to the distal side of the dressing.
Rosenberg teaches an analogous dressing 1 (Paragraph 118 and Figure 1, wound dressing 1) with adding a topical agent (Paragraph 202, antibacterial agent or an antibiotic solution or cream applied to the upper surface of the wound dressing, penetrating to the wound surface) to the analogous distal side (Paragraph 202, upper surface) of the analogous dressing 1.
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 distal side of the dressing of Furumori as modified in view of Langen, so that there is a topical agent applied to the distal side of the dressing, as taught by Rosenberg, in order to provide an improved dressing with an antibacterial agent applied onto the top surface of the wound dressing which penetrates through the wound dressing to reach the wound surface to combat infection (Rosenberg, Paragraph 202), without having to remove the entire dressing.
Regarding claim 17, the combination of Furumori as modified in view of Langen in view of Rosenberg discloses the invention as described above but fails to explicitly disclose wherein the dressing is not removed from the wound for at least 10 days.
Rosenberg further discloses wherein the analogous dressing 1 (Paragraph 118 and Figure 1) is not removed from the wound for at least 10 days (Paragraph 207, dressing on burn wound after 13 days provides healing).
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 an application of the dressing of Furumori as modified in view of Langen in view of Rosenberg, so that the dressing is not removed from the wound for at least 10 days, as taught by Rosenberg, in order to provide an improved dressing that promotes healing of the wound after 10 days of application (Rosenberg, Paragraph 207).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Furumori (U.S. Patent Pub. No. 20070212520) in view of Langen et al. (U.S. Patent No. 4944958), as applied to claim 1, and in further view of Stenton (U.S. Patent Pub. No. 20030032980).
Regarding claim 19, the combination of Furumori as modified in view of Langen discloses the invention as described above. Furumori further disclose a kit comprising the dressing (Furumori, Paragraphs 55-57, pressure-sensitive adhesive tape).
However, the combination of Furumori as modified in view of Langen fails to explicitly disclose a container of a topical agent and an adhesive solution.
Stenton teaches an analogous kit 10 (Paragraphs 19, 29, 31, and Figure 1, kit comprising applicator 10) comprising a container 20 (Paragraph 29 and Figure 1, anti-microbial butyl cyanoacrylate formulation containing a soluble poloxamer based iodophor. The cyanoacrylate adhesive formulation is enclosed in a crushable glass ampoule that is itself enclosed in a flexible butyrate tube body 20) of a topical agent (Paragraph 31, the cyanoacrylate prepolymer can include therapeutic agents such as analgesics, anti-inflammatory agents, antimicrobial agents) and an adhesive solution (Paragraph 29, cyanoacrylate adhesive solution within the flexible butyrate tube body 20).
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 kit of Furumori as modified in view of Langen, to include a container of a topical agent and an adhesive solution, as taught by Stenton in order to provide an improved kit with a container of topical agent and adhesive solution for a user to desirably treat a wound area, (Stenton, Paragraph 29) prior and during application of the dressing onto the wound.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sessions (US 6794554 B2) teaches a dressing with channels.
Conclusion
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.
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 on +1(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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL MILO/
Art Unit 3786
/ALIREZA NIA/ Supervisory Patent Examiner, Art Unit 3786