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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1,4-12,35,37,40,69-73 have been considered but are not persuasive.
Applicant argues that the examiner uses one structure (fluid restrictions 420) to reject two separate elements of the claim. While the examiner does not disagree, the prior art (para. 0059) as previously cited teaches that the restrictions may comprise both slits and slot thus providing two distinct structures and thus is not “one element having two separate functions” as the slit and slots are distinct from one another. The examiner notes that if the restrictions only were disclosed as slits and the examiner used that disclosure to reject both restrictions and perforations the argument would be persuasive in view of arguments. Applicant argues further that Robinson943 makes no distinction between slits and slots and that said distinction is only made by the examiner. The examiner disagrees in that the term “combination of slit and slots” indicates that the slits and slots are at least different from one another such that the layer can include both structures. If they were the same a term such as “or” would portray this, but per the examiner’s interpretation “and” provides a clear statement that the slits and slots are different. Applicant further provides the definition of slot, which includes the term slit, however, this is not the only definition for slot provided (includes notch, narrow opening), and for the above reason, it is interpreted that the slit and slots forming the restrictions of the prior art are distinct from one another.
The arguments with regard to the newly amended limitations are considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The examiner notes that with respect to the newly amended limitations, Robinson943, as previously presented reads to the claimed limitation. The examiner notes that paragraph 0059 was previously cited to teach that the restrictions are elastic that deform in response to pressure where said deformation includes opening further/constricting further. While this may be interpreted to function as a valve, the examiner notes that per the same cited section of Robinson943, “one or more of the fluid restrictions (420) may be an elastomeric valve”. As such Robinson943 reads to this claim amendment. Further, claim 1 was amended to require that each of the perforations comprises a circular opening. The rejection of claim 1 has been updated to include both of these limitations.
Examiner’s Comment
The examiner would like to note that a different between the prior art and instant application is recognized. The prior art, as per the description of para. 0059, or as seen in figure 8 and 9 (further detailed under the rejection of claim 1 below) depicts the defined restrictions and perforations. The difference is that in the disclosure of Robinson943, the defined restrictions and perforations are always seen to be connected to, overlaid, or touching one another. While this is the case for some of the restrictions and perforations of the instant application, other restrictions (See figure 5 of the instant application) are not connected to any perforation. Therefore as some of the restrictions do not connect with any perforations in the instant application, this is a distinction over the prior art. The examiner suggests amending the claims to include this difference and providing arguments as to why the prior art does not teach this nor would be obvious to modify to meet this difference.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12,26,35-37,39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. US 2019/0231943, hereafter Robinson943 previously provided in office actions.
Regarding claim 1, Robinson943 discloses
A dressing for treating a tissue site with negative pressure (abstract), the dressing comprising (Figure 4): a first layer comprising a first side and a second and a thickness extending from the first side to the second side (first layer 405, where per the figure, the first side is the upward facing side, and the second side is the downward facing side, where the thickness can be seen connecting said first and second side); a plurality of through-holes extending through the first layer from the first side to the second side to form walls parallel to the thickness of the first layer ([415] para. 0050, where the perforations in said layer extend through the layer per para. 0108. The examiner notes walls formed by the through hole are interpreted to be the walls parallel to the thickness see figure 12 (walls 1215)).
Robinson943 further discloses a second layer configured to be positioned adjacent the second side of the first layer (second layer 410); a plurality of fluid restrictions disposed in the second layer (restrictions 420); and a plurality of perforations disposed in the second layer (para. 0060, where the restrictions in the second layer may comprise a combination of slit and slots where the slots are disclosed to be not completely closed/sealed and are thus interpreted as perforations) and configured to be aligned with the plurality of through-holes (figure 12, where the passages in second layer 410 can be seem to be aligned with the through-holes (415) of the first layer. See also para. 0008). The examiner notes that as seen in figure 4, and as detailed under paragraph 0060, the restrictions may comprise of perforations and/or slots. As the holes of both layers are seen to be substantially aligned it is interpreted that the holes in both layers are corresponding and the centers of said holes in the two layers are aligned. Therefore it is interpreted that the centers of the perforations of layer (215) align with the centers of through-holes on layer (205).
Robinson943 further discloses wherein at least a periphery of each of the plurality of perforations is configured to extend into the plurality of through-holes in response to a pressure gradient across the second layer. The examiner notes that Robinson943 discloses (para. 0054), that the defined second layer is elastic and that said restrictions in the layer are elastic in response to a pressure gradient (para. 0059). It is therefore interpreted that as the perforations are elastic and deform in response to pressure (interpreted to be negative pressure as the device is a suction device), that said elastic movement would cause extension into the through holes, due to the proximity of the layers. However, should applicant disagree, the examiner notes that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Robinson943 teaches a first layer comprising through holes directly adjacent to and corresponding to a second layer comprising perforations, where said perforations are elastic in response to pressure gradients, and the extension of said perforations through the through hole is interpreted as function language, Robinson943 reads to the claimed limitation.
The examiner notes that while the first layer’s perforations (415) are disclosed to be positioned at the edge of the layer (see figures 14-16, para. 0113) as a means to reduce the disruption of keratinocyte migration and enhance re-epithelialization with negative-pressure therapy. However, there is no disclosure of the second layer having said structure. The examiner notes that as detailed in the same rejection of claim 1, as seen in figure 12 the perforations of the second layer align with the through holes of the first layer such that the first layer holes overlay the second layer holes. Therefore, as the through holes of the first layer may extend on an edge of the first layer (thus forming a partial hole) as a means to enhance re-epithelialization with negative-pressure therapy, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have corresponding perforations on the edge of the second layer to align with the edge through-holes of the first layer, as it is interpreted (per figure 12) the through-holes of the first layer correspond and to and overlay perforations in the second layer and said edge through holes are an accepted shape of the device to allow for enhanced re-epithelialization.
Regarding the amendments filed 03/16/2026, the examiner notes that the previously cited paragraph of Robinson943 (para. 0059) discloses that the restrictions may be an elastomeric valve. Further although it is disclosed that the second layer may comprise both slits and slot, where above, the slots were interpreted to be an perforation in the second layer, there is no specific disclosure that each of the perforations (slots) comprise a circular opening. The examiner notes that per MPEP section 2144.04 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). The examiner notes that per applicant’s specification (para. 0078), the perforations may have many shapes, including circular, square, elliptical, polygonal, and amorphous, thus demonstrating a lack of criticality in the circular shape. As such, it would have been obvious to one having ordinary skill in the art prior to the instant application to modify the interpreted perforations of the prior to be circular as an obviousness change in shape rationale.
The examiner notes that should applicant disagree with the above, a secondary rejection in view of Robinson is provided. The examiner notes that Robinson943 teaches that a third layer (See figure 9) may comprise both apertures and slits (As seen in figure 9, see para. 0105), where should valves and apertures both be provided on said layer, the second layer as detailed above, may be omitted (thus making this third layer the “second layer” interfacing directly with the first layer and the wound). The apertures on the third layer are disclosed to be circular (para. 0085). Therefore as Robinson943 teaches that a layer comprising restrictions in the form of elastomeric valves and circular apertures may be used instead of the previously defined second layer (As in the second layer may be omitted if this third layer comprises the valve structure), it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the layer (interpreted as the second layer since it is stated that with the valve structure the “defined” second layer may be omitted) as the second layer per the claimed limitation as a matter of simple substitution, and thus a prima facie case of obviousness exists. Doing so would provide the dressing with a second layer, comprising both elastomeric valve restrictions and circular apertures and thus the claim limitations are read to.
Regarding claim 4, Robinson943 discloses
The dressing of claim 1, wherein the periphery of each of the plurality of perforations completely covers the side walls. The examiner notes that as detailed under the rejection of claim 1, and seen in figure 12 of Robinson943, the perforations in the second layer align with the through-holes and thus walls of the first layer. As such it is interpreted that perforations completely cover the side walls. See also figure 4, where the first and second layer are seen to correspond to one another.
Regarding claim 5, Robinson943 discloses
The dressing of claim 1,wherein each of the plurality of through-holes has an effective diameter between about 5 millimeters and about 20 millimeters (para. 0008, where through-holes are 2-10mm thus overlapping with the claimed range). As such it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention since it has been held that “[i]n the case 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).
Regarding claim 6, Robinson943 discloses
The dressing of claim 1,wherein the plurality of through-holes comprise a first row of through-holes and a second row of through-holes along a longitudinal length of the first layer. The examiner notes that as seen in figure 4 of Robinson943, the through holes of layer 405 can be seen to be arranged in rows.
Regarding claim 7, Robinson943 discloses
The dressing of claim 6, but fails to specifically teach wherein one or more of the through-holes in the first row of through-holes are offset from the second row of through-holes. While Robinson943 discloses that the fluid restrictions in the second layer may be in rows where said rows are aligned or offset (para. 0064), there is no disclosure of the through holes in the first layer being offset. The examiner notes that per MPEP section 2144.04 IV. C, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. Therefore, as Robinson943 teaches that other layers may have their fluid passages aligned in rows or in offset rows, and a person of ordinary skill in the art would have found obvious said change of shape (aligned rows to offset rows) as the alignment of the rows is not found to be significant, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the aligned rows of the through holes of the first layer to be offset.
Regarding claim 8, Robinson943 discloses
The dressing of claim 1, wherein the plurality of through-holes are spaced between about 2 millimeters and about 10 millimeters on center. Per para. 0008 the through holes are spaced apart by about 2-10mm on center.
Regarding claim 9, Robinson943 discloses
The dressing of claim 1, wherein a portion of the plurality of fluid restrictions are registered with a portion of the plurality of through-holes (para. 0008 where the through holes may be registered with at least some of the fluid restrictions)
Regarding claim 10, Robinson943 discloses
The dressing of claim 1, wherein each of the plurality of perforations are smaller than each of the plurality of through-holes. Per Robinson943 the through holes are 2-10mm in diameter (para. 0008 of Robinson943). And the restrictions (per the rejection of claim 1 having both a slit and slot where the slot is interpreted as a perforation) as seen in figure 5 have a length of less than 3mm (para. 0064). Therefore, as the size of the through holes of the first layer and perforations in the second layer are variable, it would have been obvious to one of ordinary skill in the art to select a through hole diameter from the disclosed range with a size greater than the perforations of the second layer.
The examiner notes that per MPEP Section 2144.04 IV. A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Additionally the examiner notes that the size of the holes in the instant application lacks criticality as the holes may be all be the same size, or the size of the first layer holes may be greater than the second layer, and the function of the device remains the same. Therefore, as the size of both the through holes of the first layer and perforations in the second layer are variable, and change of size was found to be an obviousness rationale (detailed directly above) it would have been obvious to one of ordinary skill in the art to select a through hole diameter with a size greater than the perforations of the second layer.
Regarding claim 11, Robinson943 discloses
The dressing of claim 1, wherein each of the plurality of perforations are the same size as each of the plurality of through-holes. Per Robinson943 the through holes are 2-10mm in diameter (para. 0008 of Robinson943). And the restrictions (per the rejection of claim 1 having both a slit and slot where the slot is interpreted as a perforation) as seen in figure 5 have a length of less than 3mm (para. 0064). Therefore, as the size of the through holes of the first layer and perforations in the second layer are variable, it would have been obvious to one of ordinary skill in the art to select a through hole diameter from the disclosed range with a size equal than the perforations of the second layer (for example 2mm). Therefore, as the size of both the through holes of the first layer and perforations in the second layer are variable, it would have been obvious to one of ordinary skill in the art to select a through hole diameter with a size equal to the size of both perforations of the second layer.
The examiner notes that per MPEP Section 2144.04 IV. A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Additionally the examiner notes that the size of the holes in the instant application lacks criticality as the holes may be all be the same size, or the size of the first layer holes may be greater than the second layer, and the function of the device remains the same. Therefore, as the size of both the through holes of the first layer and perforations in the second layer are variable, and change of size was found to be an obviousness rationale (detailed directly above) it would have been obvious to one of ordinary skill in the art to select a through hole diameter with a size equal to the size of both perforations of the second layer.
Regarding claim 12, Robinson943 discloses
The dressing of claim 1, wherein each of the plurality of perforations has an effective diameter less than the effective diameter of each of the plurality of through-holes. Per Robinson943 the through holes are 2-10mm in diameter (para. 0008 of Robinson943). And the restrictions (per the rejection of claim 1 having both a slit and slot where the slot is interpreted as a perforation) as seen in figure 5 have a length of less than 3mm (para. 0064). Therefore, as the size of the through holes of the first layer and perforations in the second layer are variable, it would have been obvious to one of ordinary skill in the art to select a through hole diameter from the disclosed range with a size greater than the perforations of the second layer.
The examiner notes that per MPEP Section 2144.04 IV. A In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Additionally the examiner notes that the size of the holes in the instant application lacks criticality as the holes may be all be the same size, or the size of the first layer holes may be greater than the second layer, and the function of the device remains the same. Therefore, as the size of both the through holes of the first layer and perforations in the second layer are variable, and change of size was found to be an obviousness rationale (detailed directly above) it would have been obvious to one of ordinary skill in the art to select a through hole diameter with a size greater than the perforations of the second layer.
Regarding claim 35, Robinson943 discloses
The dressing of claim 1, wherein the plurality of fluid restrictions comprise a plurality of slots, each of the slots having a length less than about 6 millimeters (Robinson figure 5, para. 0064, where the restrictions have a length of less than 3mm)
Regarding claim 37, Robinson943 discloses
The dressing of claim 1,wherein the plurality of fluid restrictions comprise a plurality of fenestrations or a plurality of slits in the second layer (para. 0060, where the restrictions in the second layer may comprise slits, slots, or a combination of slit and slots, where figure 5 shows a plurality of slits).
Regarding claim 40, Robinson943 discloses
The dressing of claim 1,wherein the second layer is coupled to the second side of the first layer (para. 0049,0067).
Regarding claim 69, Robinson943 discloses
The dressing of claim 1, wherein each through-hole of the plurality of through-holes extends through the first layer from the first side to the second side to form a respective wall of the walls parallel to the thickness of the first layer (figure 12, walls 1205).
Regarding claim 70, Robinson943 discloses
The dressing of claim 69, wherein each wall is perpendicular to the first side and the second side of the first layer (figure 4, 12, where said walls are seen to run through the device [vertically] where the first and second side are horizontal planes [or vice versa]). As such it is interpreted that the walls run perpendicular to the first and second side.
Regarding claim 71, Robinson943 discloses
The dressing of claim 1, wherein the first layer comprises a porous material, the through-holes extending through the porous material (para. 0051).
Regarding claim 72, Robinson943 discloses
The dressing of claim 1, wherein the second layer comprises a liquid-impermeable material (para. 0054).
Regarding claim 73, Robinson943 discloses
The dressing of claim 1, wherein at least one through-hole of the plurality of through- holes being positioned at an edge of the first layer, exposing the wall of the at least one through hole. The examiner notes that while the first layer’s perforations (415) are disclosed to be positioned at the edge of the layer (see figures 14-16, para. 0113) as a means to reduce the disruption of keratinocyte migration and enhance re-epithelialization with negative-pressure therapy. The examiner notes that the hole on the edge would thus expose the corresponding wall.
Conclusion
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 Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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