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 filed February 18, 2026, with respect to the rejection(s) of claim(s) 56 have been fully considered and are not persuasive.
Response to Arguments
Applicant's arguments filed February 18, 2026, have been fully considered but they are not persuasive.
Applicant argues that the combination of Svedman and Ambrosio is improper because the while the dressings both use a manifold, cover and tissue interface with a negative pressure system the tissue interface of Ambrosio is left in the wound bed and the tissue interface of Svedman is removed resulting in per Applicant the “ ‘proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification.’ MPEP 2143.01 (V)”.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case we are simply adding the teaching from Ambrosio to add holes to the dressing layers to achieve a known advantage- improving negative pressure distribution which is clearly taught by Ambrosio in [0053-54] which disclose the tissue contact layer 223 has a first flow channel 234.
In summary the Examiner relied upon a specific fact that holes in the layers provide improve negative pressure distribution rather than adding the holes for the ingrowth of tissue. Ambrosio teaches a dual benefit for the holes. It must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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.
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.
Claim(s) 56- 69 are rejected under 35 U.S.C. 103 as being unpatentable over Svedman US 2011/0015619 A1 and in view of Ambrosio et al. US 2007/0185426 A1.
Regarding claims 56, Svedman discloses system for treating a tissues site comprising (abstract) :a manifold (or substrate 50, formed from reticulated foam [0045] more specifically per [0066] “which can be a polyurethane foam, polyvinyl alcohol foam, gauze, felt or other suitable material” which is the same material (“cellular foam, open-cell foam, reticulated foam, porous tissue collections, and other porous material such as gauze or felted mat”) the instant application uses for the manifold as noted applicant’s specification [0043]) adapted to deliver negative pressure to the tissue site ([0055] notes the use of negative pressure with the wound dressing);
a cover (or membrane 52, fig 6, [0055]) adapted to form a sealed space over the manifold and the tissue site for receiving a negative pressure from a negative-pressure source ([0055]); and
a tissue interface (or more parts 11A-C) adapted to be positioned between the manifold and the tissue site (see figure 6). Applicant discloses the tissue interface maybe formed from multiple materials such as: hydrophilic foam such as “a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam®” or “Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. The tissue interface 107 may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface 107 to promote cell-growth. A scaffold is generally a substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials” in paragraphs [0044-45]. Svedman discloses the material for part 11A-C might be “hydrophilic, water-blown, open-cell, nonreticulated, polyurethane foam in [0045].
Svedman fails to disclose the manifold has a first firmness factor, the tissue interface has a second firmness factor and that the second firmness factor is greater than the first firmness factor; however, since Sevdman appears to be using the same materials as applicant suggest for the manifold and tissue interface it is understood that the materials will have the same firmness factor and the burden of proof shifts to applicant for showing they are not, MPEP 2112.01, I.
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Svedman fails to disclose the tissue interface has a plurality of holes separated from each other by walls.
Ambrosio teaches a multi-layer negative pressure wound dressing (abstract) there by being in a related field of endeavor as the instant application and Svedmen. The wound dressing has a plurality of flow channels formed in the layers to allow for the distribution of negative pressure (abstract and [0053]). These channels maybe inherent or mechanically formed [0053]. Additionally, Ambrosio uses PLA/PGA [0054] for the scaffold or tissue interface layer which is one or the materials disclosed by applicant in the specification as noted above. Of note how the firmness factor related to non-foam materials is unclear since the firmness factor is the “a firmness factor (FF) that is defined as a ratio of the density of a foam in a compressed state to the density of the same foam in an uncompressed state” Applicant’s specification [0059]. Applicant does note the firmness factor can be used for a non-foam material. PLA/PGA are not always a foam; it is not clear if Applicant and or Ambrosio are referring to foam PLA/PGA. Ambrosio also uses GranuFoam® for the manifold which is also the same as applicant as such Ambrosio also appears to read on the instant claims; however, Ambrosio also fails to teach a firmness factor, and the firmness factor appears to be primarily foam specific.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have added the holes to the tissue interface of Svedmen as taught by Ambrosio to improve the flow and delivery of negative pressure within the wound dressing.
Regarding claims 57, Svedman as modified by Ambrosio, Ambrosio further discloses wherein the holes have a perforation shape factor (by virtue of being a hole the hole will have a shape- Ambrosio [0053]) and a strut angle arranging the holes in a pattern on the tissue interface (Ambrosio [0053] and figs 4-6 show different patterns thereby creating a strut angle between the holes).
Regarding claims 58 and 59, Svedman as modified by Ambrosio fails to disclose wherein the strut angle is about 90 degrees per claim 58 and less than one per claim 59.
Ambrosio teaches the holes are used for tissue in grow and or negative pressure distribution [0053-54]. Since the shape and size of the holes effect the strut angle, the strut angle of the holes is disclosed to be a result effective variable in that changing the strut angle of the holes (which would change based on sizing of the holes) changes the amount of tissue in-growth in the dressing. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Freedman to have the strut angle within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Svedman and Ambrosio by making the strut angle of the holes to be about 90°, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 60, Svedman as modified by Ambrosio fails to disclose wherein the perforation shape factor of each hole is less than about 1.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Svedman as modified by Ambrosio to have a perforation shape factor of the holes to be less than about 1, since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the system of Svedman as modified by Ambrosio would not operate differently with the claimed perforation shape factor of the holes, and since the holes/pores in the system of Svedman as modified by Ambrosio have a shape and orientation to encourage the flow and distribution of negative pressure within the dressing (Ambrosio [0053]), the system would function appropriately having the claimed perforation shape factor. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the perforation shape factor “may” be within the claimed range (para. [0072] of published application).
Regarding claims 61, Svedman discloses further comprising a fluid source adapted to be fluidly coupled to the sealed space to provide fluid to the sealed space (abstract).
Regarding claim 62, Svedman as modified by Ambrosio fails to disclose wherein the plurality of holes have an average effective diameter of about 5 mm.
Ambrosio teaches the holes are used for tissue in grow and or negative pressure distribution [0053-54]. Therefore, the diameter of the holes is disclosed to be a result effective variable in that changing the diameter of the holes (which would change based on sizing of the holes) changes the amount of tissue in-growth in the dressing. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Svedman as modified by Ambrosio to have the effective diameter of the holes within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Svedman as modified by Ambrosio by making the diameter of the holes to be about 5 mm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 63, Svedman as modified by Ambrosio, Ambrosio discloses wherein the plurality of holes are formed in two or more parallel rows (fig 4-6).
Regarding claims 64, Svedman as modified by Ambrosio fails to disclose wherein a thickness of the tissue interface is about 15 mm.
Svedman discloses the dressing (11a-11c) can be 1-3inches to accommodate different wound thickness [0054]. Therefore, the thickness of the layered dressing is disclosed to be a result effective variable in that changing the thickness of the layered dressing changes the functionality of the dressing and success of wound approximation, by changing the pliability and collapsibility of the dressing. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the system of Svedman as modified by Ambrosio to have a thickness within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Svedman as modified by Ambrosio by making the thickness of the layered dressing to be about 15 mm, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 65 and 66, Svedman as modified by Ambrosio fails to disclose wherein the second firmness factor is about 5 per claim 65 and wherein the second firmness factor is about 3 per claim 66.
However, since Sevdman and Ambrosio appear to be using the same materials as applicant suggest for the tissue interface it is understood that the materials will have the same firmness factor and the burden of proof shifts to applicant for showing they are not, MPEP 2112.01, I.
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
Claim(s) 67-69 are rejected under 35 U.S.C. 103 as being unpatentable over Svedman US 2011/0015619 A1 and in view of Ambrosio et al. US 2007/0185426 A1 and in further view of Dunn US 2015/0190288 A1.
Regarding claim 67-69, Svedman as modified by Ambrosio discloses the system of claim 56.
However, Svedman as modified by Ambrosio fails to disclose wherein a shape of each through-hole of the plurality of perforations is hexagonal or elliptical or circular.
Dunn teaches (para. [0155]; figs. 21a-e), in the same field of endeavor, a negative pressure wound closure system (abstract) comprising a debridement tool (stabilizing structure 2100, para. [0154]) having a plurality of holes (cells 2102), wherein a shape of each of the holes is hexagonal oval or lozenge-shaped (para. [0155]), in place of cells having four walls (para. [0155]).
The substitution of one known element (holes formed in a hexagonal, oval or lozenge-shaped shape) for another (holes formed in a square shape or having four walls, para. [0155] of Dunn, fig. 4-6 of Ambrosio would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the holes formed in a hexagonal, oval or lozenge-shaped shape as taught by Dunn, would have yielded predictable results, specifically, providing the ability to distribute or allow for negative pressure to flow (Ambrosio [0053]).
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/GABRIELLA E BURNETTE/Examiner, Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781