DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). A certified copy of Application No. 1108229.4, filed in The United Kingdom on 17 May 2011 has been received in parent Application No. 14118202.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 09 October 2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 41-46, 48-54 and 56-60 are rejected under 35 U.S.C. 103 as being unpatentable over MacMeccan; Robert M. et al. (US 20100030178 A1) with incorporation of Egler; Vernon C (US 3459618 A) and SSPM823 (Specialty Silicone Products 2014) in view of Ha; Phong Van Thanh et al. (US 20100318052 A1) with incorporation of Potter; William D. et al. (US 4595001 A).
Regarding claim 41, MacMeccan discloses an apparatus (¶ [0006], [0017], FIG. 1A, the composite article 100);
for promoting scar-free healing at a tissue site (¶ [0004], Insufficient moisture at the wound site can cause scab or eschar formation and the generation of scar tissue; ¶ [0005], provide an environment that is sufficiently moist to promote the formation of granulation tissue);
the apparatus comprising: a tissue contact layer comprising silicone and configured to overlap a wounded area beneath the tissue contact layer (¶ [0017], hydrophobic layer 102; ¶ [0029], the hydrophobic layer can be a polymer film (e.g., an apertured polymer film) … a hydrophobic, pressure sensitive adhesive coating … a silicone coating … silicone-based pressure sensitive adhesives, such as the DOW 7800 platinum catalyzed silicone air-cure adhesives (e.g., Uro-bond.RTM. III brush-on adhesive from Urocare Products, Inc.), and adhesive silicone films, such as Bioflex Rx1267 silicone gel adhesive from Scapa North America. Silicones suitable for use in making the silicone coating include, but are not limited to, silicone films, such as the 1-50 mil knifecoated silicone films available from Specialty Silicone Fabricators; ¶ [0058], When used as a wound dressing, the composite article typically is positioned so that the hydrophobic layer is adjacent to the skin of the patient); and
a plurality of perforations (¶ [0032], the hydrophobic layer 102 preferably comprises a plurality of discrete discontinuities 104).
MacMeccan is silent regarding a combined open area of the perforations. MacMeccan incorporates Egler by reference (¶ [0034], The discontinuities can also be formed by embossing … U.S. Pat. No. 3,459,618). Egler discloses a method of making an absorbent dressing (col. 1, lines 15-20); including a layer having a plurality of perforations (col. 2, lines 15-20, an absorbent dressing of this invention in which the numeral 1 designates the film covering a pad 2 of absorbent material; col. 4, lines 5-15, As the boss 11 travels downwardly, as viewed in FIG. 3 … forms an opening 6);
the combined open area of the perforations comprising around 20% or less of the total area of a single side of the layer (col. 2, lines 5-10, The total open area of the film at least in the portion thereof directly overlying the wound site should be from about 0.25 to 25% of the film area).
MacMeccan teaches the invention substantially as claimed by Applicant but is silent regarding the MVTR of the silicone in the tissue contact layer.
Ha discloses a medical dressing (¶ [0006], [0010], [0056], FIG. 1 … medical dressing 10);
comprising a tissue contact layer comprising silicone (¶ [0057] FIG. 2 … The backing layer 14 comprises an adhesive layer 17 on all or a portion of the surface of the backing layer 14 that faces the wound during use; ¶ [0069], The adhesive 17 may cover all or part of the interior surface 41 in a continuous and/or pattern coated fashion);
the silicone in the tissue contact layer comprising a moisture vapor transmission rate of between about 350 to 410 gm-2/24 hrs (¶ [0113] The pressure sensitive adhesives may, in some embodiments, transmit moisture vapor at a rate greater to or equal to that of human skin; ¶ [0114] Preferably, the film/adhesive composite should transmit moisture vapor at a rate equal to or greater than human skin … at a rate of at least 300 g/m2/24 hrs/37 C./100-10% RH, more preferably at least 700 g/m2/24 hrs/37 C/100-10% RH);
a source of negative pressure connectable to the tissue site and configured to apply negative pressure through the tissue contact layer (¶ [0068] The dressing 10 may include a valve (not shown) on opening 28 in self supporting substrate 12 (as shown in FIG. 7) … may be used to provide negative pressure therapy to a wound over which the dressing 10 is placed as described herein).
Regarding the MVTR of an unperforated silicone material, Ha incorporates Potter by reference (¶ [0114] Issued U.S. Pat. Nos. 3,645,835 and 4,595,001, the disclosures of which are hereby incorporated by reference, describe methods of making such films and methods for testing their permeability). Potter discloses a method that tests a continuous film’s MVTR (col. 2, lines 35-40, The film employed will be a continuous film, that is it will be free of holes; col. 8, lines 1-10, "Dry" MVP Determination. Discs of the material under test are clamped over Payne Permeability Cups (flanged metal cups) using sealing rings and screw clamps; col. 8, lines 20-25, "Wet" MVP determination. The method described above is employed except that the Payne Cups are inverted in the oven so that the water within the cups is in contact with the test material). Potter’s test method implies that the material is tested without perforations.
Ha selects a range of MVTR that mimics the transpiration rate of skin (¶ [0111]-[0113]). A skilled artisan would have been able to modify MacMeccan with Ha’s high-MVTR silicone material by constructing MacMeccan’s silicone tissue contact layer comprising Ha’s materials. One would be motivated to modify MacMeccan with Ha’s MVTR range to regulate a moisture level at the wound surface and thereby reduce scarring, as called for by MacMeccan (¶ [0003]). Therefore, it would have been obvious to modify MacMeccan with Ha’s MVTR range in order to regulate transpiration while a wound heals underneath the dressing.
Regarding claim 50, MacMeccan discloses an apparatus (¶ [0006], [0017], FIG. 1A, the composite article 100);
for promoting scar-free healing at a tissue site (¶ [0004], Insufficient moisture at the wound site can cause scab or eschar formation and the generation of scar tissue; ¶ [0005], provide an environment that is sufficiently moist to promote the formation of granulation tissue);
the apparatus comprising: a tissue contact layer comprising silicone and configured to overlap a wounded area beneath the tissue contact layer (¶ [0017], hydrophobic layer 102; ¶ [0029], the hydrophobic layer can be a polymer film (e.g., an apertured polymer film) … a silicone coating applied to the first surface of the fluid transport layer; ¶ [0058], When used as a wound dressing, the composite article typically is positioned so that the hydrophobic layer is adjacent to the skin of the patient); and
a plurality of perforations (¶ [0032], the hydrophobic layer 102 preferably comprises a plurality of discrete discontinuities 104);
individual perforations comprising an average diameter of 0.025 mm to 1.5 mm (¶ [0033], the hydrophobic layer can comprise a plurality of discontinuities having a dimension of from about 7 µm to about 3,000 µm about 50 µm to about 500 µm or about 100 µm to about 300 µm);
wherein the silicone comprises polysiloxane, polyorganosiloxane, or polydimethylsiloxane (¶ [0029], Silicones suitable for use in making the silicone coating include, but are not limited to, silicone films, such as the 1-50 mil knifecoated silicone films available from Specialty Silicone Fabricators).
MacMeccan calls for a silicone membrane from Specialty Silicone Fabricators (¶ [0029]). The SSPM823 data sheet shows that the membrane comprises Polydimethyl Silicone.
MacMeccan is silent regarding the combined open area of the perforations. MacMeccan incorporates Egler by reference (¶ [0034], The discontinuities can also be formed by embossing … U.S. Pat. No. 3,459,618). Egler discloses a method of making an absorbent dressing (col. 1, lines 15-20); including a layer having a plurality of perforations (col. 2, lines 15-20, an absorbent dressing of this invention in which the numeral 1 designates the film covering a pad 2 of absorbent material; col. 4, lines 5-15, As the boss 11 travels downwardly, as viewed in FIG. 3 … forms an opening 6);
the combined open area of the perforations comprising around 20% or less of the total area of a single side of the layer (col. 2, lines 5-10, The total open area of the film at least in the portion thereof directly overlying the wound site should be from about 0.25 to 25% of the film area).
This rejection cites MacMeccan and Egler as teaching all features of claim 50. A skilled artisan would have been able to modify MacMeccan by selecting a suitable porosity range for hydrophobic layer 102 according to Egler. MacMeccan calls for regulating humidity at a wound site (¶ [0003]-[0005]) and Egler provides a way to adjust the moisture permeability of a wound contact layer by selecting a porosity range.
MacMeccan lacks a source of negative pressure. Ha discloses a source of negative pressure connectable to the tissue site and configured to apply negative pressure through the tissue contact layer (¶ [0068] The dressing 10 may include a valve (not shown) on opening 28 in self supporting substrate 12 … may be used to provide negative pressure therapy to a wound over which the dressing 10 is placed).
Ha accelerates healing at a wound site by removing excess fluids (¶ [0082], By releasing absorbed fluids during the removal of fluids from the sealed environment, the ability of the absorbent material to absorb fluids may be regenerated--which may prolong the useful life of the medical dressing); and optionally irrigates the site with fluid (¶ [0137], Alternatively, the sealed cavity could be rinsed with, e.g., saline or another flushing solution before placing the sealed environment in a negative pressure condition, before delivery of a second agent, etc.).
One would be motivated to modify MacMeccan with Ha’s negative pressure source to accelerate wound healing.
Regarding claims 53, 54 and 57, MacMeccan discloses an apparatus (¶ [0006], [0017], FIG. 1A, the composite article 100);
for promoting scar-free healing at a tissue site (¶ [0004], Insufficient moisture at the wound site can cause scab or eschar formation and the generation of scar tissue; ¶ [0005], provide an environment that is sufficiently moist to promote the formation of granulation tissue);
the apparatus comprising: a tissue contact layer comprising silicone and configured to overlap a wounded area beneath the tissue contact layer (¶ [0017], hydrophobic layer 102; ¶ [0029], the hydrophobic layer can be a polymer film (e.g., an apertured polymer film) … a silicone coating applied to the first surface of the fluid transport layer; ¶ [0058], When used as a wound dressing, the composite article typically is positioned so that the hydrophobic layer is adjacent to the skin of the patient); and
a plurality of perforations (¶ [0032], the hydrophobic layer 102 preferably comprises a plurality of discrete discontinuities 104);
a transmission layer positioned over the tissue contact layer, the transmission layer configured to distribute negative pressure (¶ [0017], FIG. 1 and FIG. 1A, the composite article 100 comprises a fluid transport layer 106; ¶ [0021], the fluid transport layer 106 can be a textile material; ¶ [0022], FIG. 2, the fluid transport layer 200 can be a laid-in fabric comprising one or more yarns 202 … yarns 204); and
a cover layer positioned over the transmission layer (¶ [0042], FIG. 5 and FIG. 5A, the composite article 101 can further comprise a moisture vapor permeable film 130).
MacMeccan is silent regarding the combined open area of the perforations. MacMeccan incorporates Egler by reference (¶ [0034], The discontinuities can also be formed by embossing … U.S. Pat. No. 3,459,618). Egler discloses a method of making an absorbent dressing (col. 1, lines 15-20); including a layer having a plurality of perforations (col. 2, lines 15-20, an absorbent dressing of this invention in which the numeral 1 designates the film covering a pad 2 of absorbent material; col. 4, lines 5-15, As the boss 11 travels downwardly, as viewed in FIG. 3 … forms an opening 6);
the combined open area of the perforations comprising around 20% or less of the total area of a single side of the layer (col. 2, lines 5-10, The total open area of the film at least in the portion thereof directly overlying the wound site should be from about 0.25 to 25% of the film area).
MacMeccan does not explicitly promote healing at a site where negative pressure is applied, and also lacks an opening in the cover layer. Ha discloses a dressing (¶ [0006], [0010], [0056], FIG. 1 … medical dressing 10);
including a cover layer (¶ [0058] As shown in FIG. 2, the self supporting substrate 12 generally comprises a first planar surface 11);
comprising an opening, the opening configured to connect to a source of negative pressure (¶ [0068] The dressing 10 may include a valve (not shown) on opening 28 in self supporting substrate 12 … may be used to provide negative pressure therapy to a wound over which the dressing 10 is placed);
Ha accelerates healing at a wound site by removing excess fluids (¶ [0082]); and optionally irrigates the site with fluid (¶ [0137]). One would be motivated to modify MacMeccan with Ha’s cover layer opening and negative pressure interface to more quickly heal a wound. Therefore, it would have been obvious to modify MacMeccan with Ha’s cover layer opening and negative pressure interface in order to prevent infection and heal a wound more rapidly.
Regarding claims 42 and 43, MacMeccan discloses an apparatus further comprising a transmission layer positioned over the tissue contact layer (¶ [0017], FIG. 1 and FIG. 1A, the composite article 100 comprises a fluid transport layer 106; ¶ [0021], the fluid transport layer 106 can be a textile material);
further comprising an absorbent layer configured to absorb wound exudate, the absorbent layer positioned over the transmission layer (¶ [0037], FIGS. 5 and 5A, the composite article 101 of the invention can further comprise a fluid retentive layer 120 … the fluid retentive layer 120 can be a foam, such as an open cell, non-reticulated polymer foam).
Regarding claim 44, MacMeccan does not explicitly disclose that the tissue contact layer comprises a basis weight of about 130 gsm when unperforated. The tissue contact layer’s basis weight is interpreted as a result-effective variable, subject to experimentation and testing. A result-effective variable is a parameter which achieves a recognized result. These results are obtained by the determination of optimum or workable ranges of said variable through routine experimentation. The contact layer’s basis weight affects its permeability and the dressing’s overall thickness through routine experimentation. For example, a higher basis weight will reduce the permeability and increase the dressing’s thickness, while a lower basis weight will increase the permeability and decrease the dressing’s thickness. Therefore, it would have been obvious to adjust the basis weight in order to obtain a desired permeability. See MPEP 2144.05(II)(A,B). Also see in re Boesch and Slaney, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 45, MacMeccan does not explicitly disclose a tissue contact layer having a MVTR of about 380 g*m-2/24 h when unperforated. The MVTR range is interpreted as a result-effective variable. Ha discloses a MVTR range closely approaching 380 g*m-2/24 h (¶ [0114] Preferably, the film/adhesive composite should transmit moisture vapor at a rate equal to or greater than human skin … at a rate of at least 300 g/m2/24 hrs/37 C./100-10% RH, more preferably at least 700 g/m2/24 hrs/37 C/100-10% RH).
A skilled artisan would have been able to select an appropriate MVTR value according to the needs of specific patients. Regarding the rationale and motivation to modify MacMeccan with Ha’s MVTR, see the discussion of claim 41 above.
Regarding claim 46, MacMeccan further discloses a cover layer (¶ [0038], The composite article 101 can also comprise a moisture vapor permeable film 130).
MacMeccan lacks a fluid passage. Ha discloses a cover layer comprising a fluid passage (¶ [0068] The dressing 10 may include a valve (not shown) on opening 28 in self supporting substrate 12 (as shown in FIG. 7).);
Ha provides a route for applying negative pressure to the dressing. One would be motivated to modify MacMeccan with Ha’s fluid passage in order to deliver negative pressure to the dressing while preventing contamination from entering the dressing.
Regarding claims 49, 56 and 60, MacMeccan incorporates Egler by reference (¶ [0034], U.S. Pat. No. 3,459,618). Egler discloses that the combined area of the apertures comprises about 17.5% or less of the total area of a single side of the tissue contact layer (col. 2, lines 5-10, The total open area of the film at least in the portion thereof directly overlying the wound site should be from about 0.25 to 25% of the film area).
Regarding claims 48 and 59, MacMeccan calls for a silicone membrane from Specialty Silicone Fabricators (¶ [0029]). The SSPM823 data sheet shows that the membrane comprises Polydimethyl Silicone.
Regarding claims 51 and 52, MacMeccan discloses an apparatus further comprising a transmission layer positioned over the tissue contact layer (¶ [0017], FIG. 1 and FIG. 1A, the composite article 100 comprises a fluid transport layer 106; ¶ [0021], the fluid transport layer 106 can be a textile material);
further comprising an absorbent layer configured to absorb wound exudate, the absorbent layer positioned over the transmission layer (¶ [0037], FIGS. 5 and 5A, the composite article 101 of the invention can further comprise a fluid retentive layer 120 … the fluid retentive layer 120 can be a foam, such as an open cell, non-reticulated polymer foam).
Regarding claim 58, MacMeccan discloses individual perforations comprising an average diameter of 0.025 mm to 1.5 mm (¶ [0033], the hydrophobic layer can comprise a plurality of discontinuities having a dimension of from about 7 µm to about 3,000 µm about 50 µm to about 500 µm or about 100 µm to about 300 µm).
Response to Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 09 October 2025 is insufficient to overcome the rejection of claims 41-46, 48-54 and 56-60 based upon MacMeccan, Egler, SSPM823, Ha and Potter as set forth in the last Office action.
Declarant submits that it should be noted that the Specialty reference is dated 2014, well after the priority date of this application (Declaration p. 2, ¶ 7). Examiner responds that SSPM823 is cited only to demonstrate the physical properties of the Specialty Silicone Products silicone layer. MacMeccan was published 04 February 2010 and explicitly describes a silicone layer from this company (¶ [0029], silicone films, such as the 1-50 mil knifecoated silicone films available from Specialty Silicone Fabricators).
Declarant asserts that Egler discloses making holes that range from 0.25 - 25% of the film area but provides no discussion of moisture vapor transmission or recognition of the benefits of an open area of perforations below 20% (Declaration p. 2, ¶ 7). Examiner notes that Egler is not cited to demonstrate an MVTR range. Egler is cited as teaching a perforated film having a total open area that overlaps the claimed range (col. 2, lines 5-10). Egler does not elaborate on the reasons for selecting this range. However, Egler’s range provides a suitable numerical range for the perforated area of a silicone layer.
When constructing MacMeccan’s apparatus, a skilled artisan would have needed to select a combined open area of the perforations. Egler answers this need, and MacMeccan explicitly incorporates Egler as an example of how to form discontinuities in a hydrophobic layer (¶ [0034], The discontinuities can also be formed by embossing a pattern in the material forming the hydrophobic layer as described, for example, in U.S. Pat. No. 3,459,618 (Egler); ¶ [0059], All references … are hereby incorporated by reference).
Declarant contends that MacMeccan, in particular, relies upon “surface energy” as a means to draw fluid from a wound … Further, MacMeccan provides extensive discussion of the use of multiple layers within the dressing having first and second surface energies to draw fluid into the dressing (Declaration p. 2, ¶ 8). Examiner replies that passive and active dressings are the two main approaches for treating wounds. In order to remove excess fluid from a wound surface, passive dressings absorb and sequester the fluid into padded or hydrophilic layers. Active dressings extract fluid with negative pressure and store the fluid in a container remote from the wound. A skilled artisan would have understood that both of these options are suitable for extracting excess fluid from a wound surface.
Declarant submits that Ha does mention silicone as a potential pressure sensitive adhesive, although it is listed among many other options and there is no discussion of silicone being particularly beneficial to wound healing (Declaration p. 2-3, ¶ 8). Examiner responds that Ha is not necessarily cited as teaching a specific silicone layer. Instead, MacMeccan is cited as teaching a silicone tissue contact layer (¶ [0017], [0029], [0058]). Ha’s silicone layer is cited only to demonstrate that Ha selects the same material as MacMeccan for a tissue contact layer.
Declarant asserts that as seen in Figure 3 below from Ha, the surface 41 and the adhesive 17 do not overlie the wound, the underside of self-supporting substrate 12 is open … so as to allow negative pressure to be directly applied to the wound once release liner 24 is removed (Declaration p. 3, ¶ 8). Examiner acknowledges that Ha applies vacuum through a large central opening.
Ha is not cited as teaching a perforated silicone layer that directly applies negative pressure to a wound. Instead, MacMeccan is cited as teaching a perforated silicone contact layer. Ha is cited as teaching negative pressure in the context of a wound dressing and also for an MVTR that overlaps the claimed range. Both MacMeccan and Ha describe a silicone tissue layer that directly contacts the patient’s skin. For this reason, MacMeccan can be modified with Ha’s silicone material and its MVTR.
Declarant contends that however, what para. [0068] actually recites is, “the valve (preferably be a one-way valve) may be used to provide negative pressure therapy to a wound over which the dressing 10 is placed as described herein” (Declaration p. 5, ¶ 9). Examiner notes that Ha further describes other modes for applying negative pressure including a pump (¶ [0007], In particular, the controlled fluid access provided by medical dressings described herein may be useful to remove fluids from the wound (as in, e.g., negative or reduced pressure therapies); ¶ [0035], The medical dressing permits a wound therapy, such as negative pressure therapy, to be located against the wound; ¶ [0050], optionally, a pump; ¶ [0086] The pressure differential across the valve may be achieved by, e.g., applying the inlet of a pump (e.g., a vacuum pump) or a fluid conduit (e.g., tube, hose, etc.) leading to the inlet of a pump over the external surface of valve on the external surface 42 of the backing 14). Ha further quantifies the pressure’s magnitude (¶ [0040], such that a negative pressure can be maintained in the sealed environment … a vacuum of 100 mmHg … and perhaps a vacuum as much as 200 mmHg).
Declarant submits that further in para. [0071], it is explained that “adhesive layer 17 is attached to the tissue (e.g. skin) surrounding the wound W” (Declaration p. 5, ¶ 9). Declarant reasons that Therefore, Ha does not teach applying negative pressure through the silicone adhesive to the wound as recited in Claim 41 (Declaration p. 5, ¶ 10). Examiner reiterates that Ha is not cited as teaching a perforated silicone layer that directly applies negative pressure to a wound. Instead, MacMeccan is cited as teaching a perforated silicone contact layer.
Declarant asserts that at the time of the invention in 2011, it was not thought that silicone adhesives would provide a noticeable improvement in fluid handling and wound outcomes, and further many other well-known more suitable non-silicone materials would have been understood at the time to provide better fluid handling (Declaration p. 5, ¶ 10). Examiner responds that this rejection does not modify MacMeccan with a silicone adhesive, but instead directly cites MacMeccan as teaching a silicone adhesive. MacMeccan explicitly discloses a silicone adhesive and names several commercial sources (¶ [0029], silicone-based pressure sensitive adhesives, such as the DOW 7800 platinum catalyzed silicone air-cure adhesives (e.g., Uro-bond.RTM. III brush-on adhesive from Urocare Products, Inc.), and adhesive silicone films, such as Bioflex Rx1267 silicone gel adhesive from Scapa North America … 1-50 mil knifecoated silicone films available from Specialty Silicone Fabricators).
Declarant contends that as further explained below, a device within the scope of pending Claims 41, 50, and 57 demonstrates unexpected results that are highly advantageous to wound healing when compared to traditional negative pressure such as applied by Ha or versus conventional standard care analogous to MacMeccan (Declaration p. 5, ¶ 11). Declarant submits that previously in the art, silicone tissue contact layers were used to prevent adhesion of wound fillers, however, no reports of scar reduction had been reported (Declaration p. 6, ¶ 13). Examiner responds that MacMeccan acknowledges the effect of insufficient moisture on scar formation (¶ [0004] Conversely, insufficient moisture at the wound site can deleteriously affect the wound healing process. Insufficient moisture at the wound site can cause scab or eschar formation and the generation of scar tissue).
Ha also recognizes reduced scarring among the advantages of NPWT therapy (¶ [0047] Among the potential advantages that may be associated with use of the medical dressings of the invention is … improved cosmetic results (reduced scarring)).
In further examples, the following references were cited on IDS forms and also acknowledge how NPWT reduces scarring.
Gross; James R. (US 5549584 A) The benefits of maintaining a moist wound surface are well-known, and include faster re-epithelialization, less pain and better cosmetic results (col. 8, lines 15-20).
Vitaris; Ronald F. (US 20090234306 A1) use of a wound dressing in this manner has been found to promote healing by reducing the probability of infection, stimulating the deposition of granulation tissue and other beneficial processes (¶ [0022]).
Vitaris; Ronald F. et al. (US 20090234309 A1) The use of a wound dressing in this manner has been found to promote healing by reducing the probability of infection, stimulating the deposition of granulation tissue and other beneficial processes (¶ [0028]).
Riesinger; Birgit (US 20100262090 A1) The absorbing structure according to the invention acts against a superfluous granulation of the wound (¶ [0264]).
Jaeb; Jonathan Paul et al. (US 20090227969 A1) In one example, the tissue-facing side of the HME foam 1015 has an uneven surface such that granulation is promoted at the tissue site 108 when reduced pressure is applied through the HME foam 1015 (¶ [0102]).
Ambrosio; Archel et al. (US 7700819 B2) The application of reduced pressure to the tissue site 219 induces new tissue growth … These factors contribute to increasing the development of granulation tissue at the tissue site, which results in new tissue growth (col. 13-14, lines 65-5).
Declarant asserts that therefore, the inhibition of scar formation through the use of a negative pressure wound therapy treatment device utilizing a silicone wound contact layer within the scope of Claims 41, 50, and 57 as demonstrated below is unexpected (Declaration p. 5, ¶ 13). Examiner replies that reduced scarring is a well-known advantage of NPWT, as demonstrated in the examples cited above, and also by MacMeccan and Ha.
A greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP716.02(a)(I).
Declarant contends that as shown below in Figures 3-4 and Table 1, scar quality as measured by the Visual analog scale (VAS) and Patient Observer Scar Assessment Scale (POSAS) scoring systems was shown to be unexpectedly significantly better with the negative pressure wound therapy device within the scope of the claims than using conventional standard of care, both at 42 days and at 90 days (p-val < 0.001) (Declaration p. 6-7, ¶ 15). Declarant submits that this unexpected improvement in wound healing outcomes using a novel negative pressure wound therapy device within the scope of the pending claims is further supported by peer-reviewed, published data authored by applicant Smith & Nephew (Declaration p. 8-9, ¶ 16).
Declarant asserts that likewise, Figures 6A-D, shown below and corresponding to Fig. 3A-D in Wilkinson et al. (2020), illustrate a reduced epidermal damage response with a negative pressure wound therapy device (SNPWT) within the scope of the claims, compared to a traditional negative pressure wound therapy (tNPWT). (Declaration p. 10, ¶ 18). Declarant contends that considering the above, it is my opinion that at the time of the invention, the reduction in starring observed when practicing a negative pressure wound therapy device within the scope of the claims compared to normal standard of care as evidenced by Galiano was unexpected (Declaration p. 15, ¶ 21).
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Examiner responds that Wilkinson tests a pair of dressings designated tNPWT and sNPWT (p. 300, Fig. 1, The birdseye view (B) shows application of traditional negative pressure wound therapy (tNPWT, red) or single-use NPWT (sNPWT, blue)). In Fig. 1B, the blue sNPWT dressing covers a significantly larger area than the red tNPWT dressing.
Wilkinson also discloses a further difference between the tNPWT and sNPWT dressings, namely that only the tNPWT dressing relies on a wound filler (p. 299, ¶ 3, A traditional canister-based NPWT device (tNPWT; RENASYS GO, TJSmith and Nephew Ltd, Hull, UK) was used with wound filler foam. Asmaller, more portable and lightweight single-use NPWT (sNPWT; PICO; TJ Smith and Nephew Ltd) device requiring no canister, was used without filler material). Wilkinson acknowledges that wound filler material is suspected of hindering re-epithelialization (p. 299, ¶ 1, Traditional NPWT has come under recent scrutiny, with suggestion that wound filler can hinder re-epithelialization and cause foreign body reactions).
Wilkinson discloses a minor difference in the negative pressures applied to the tNPWT and sNPWT dressings (p. 299, ¶ 5, tNPWT or sNPWT dressings were applied to the apical surface of the skin, sealed and placed under NPWT (100 and 80 mmHg, respectively)).
Although Wilkinson finds a difference in the efficacy of tNPWT versus sNPWT dressings, these differences may also be attributed to the difference in coverage area, presence of wound filler or pressure magnitude applied to the wounds.
Also, the cited reference MacMeccan lacks a wound filler and instead directly contacts a wound. MacMeccan’s dressing more closely resembles Wilkinson’s sNPWT dressing, since both the sNPWT and MacMeccan lack a wound filler and instead contact a wound with a perforated silicone layer.
Response to Arguments
Applicant’s arguments filed 09 October 2025 regarding the rejection of claims 41-46, 48-54 and 56-60, under 35 USC § 103 over MacMeccan and Ha with incorporation of Egler, SSPM823 and Potter, have been fully considered but are not persuasive. Therefore, the rejections are maintained.
Applicant submits that Ha does not apply negative pressure through the silicone contact layer, because Ha was in the realm of understanding of traditional negative pressure in 2011. Similarly, MacMeccan already discloses a solution for drawing fluid away from the wound by using various layers with different surface energies to ensure that, "excess moisture does not accumulate at or near the interface of fluid transport layer 106 and a fluid exuding surface, such as the skin or an exuding wound." (remarks p. 6-7). Applicant asserts that one of skill in the art would be further unmotivated to combine Ha with MacMeccan because MacMeccan already offers a solution for fluid handling and has no need for negative pressure (remarks p. 7). Examiner responds that passive and active dressings are the two main approaches for treating wounds, and that a skilled artisan would have considered both of these options for extracting excess fluid from a wound surface.
Applicant contends that accordingly, the combination of these five references to apply negative pressure through a silicone adhesive to the wound bed is an example of impermissible hindsight (remarks p. 7). Examiner replies that the rejection combines the teachings from two references MacMeccan and Ha, while Egler, SSPM823 and Potter are incorporated by reference.
To further demonstrate unexpected results versus traditional negative pressure (such as described in Ha) the Declaration describes multiple examples of unexpected results from Wilkinson et. al. (remarks p. 7). Examiner responds that the Declaration and Wilkinson have been evaluated as discussed above. Wilkinson describes a pair of tNPWT and sNPWT dressings, where the sNPWT dressing more closely resembles the combination of MacMeccan and Ha.
Conclusion
All claims are identical to, patentably indistinct from, or have unity of invention with the claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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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/Adam Marcetich/
Primary Examiner, Art Unit 3781