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 .
In light of the amendments filed 06/15/2026 in which claims 1, 14, 31, 36 and 39 were amended and claims 17 and 29 were cancelled, claims 1-2, 5-8, 10-11, 13-14, 16, 18, 20, 25, 28, 31, 36, 38-39, and 41 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/060595 which claims priority to U.S. Provisional Application no. 63/122,341 filed on 12/07/2020.
Claims 1-2, 5-8, 10-11, 13-14, 16, 18, 20, 25, 28, 31, 36, 38-39, and 41 receive priority to the prior-filed application, filed on 12/07/2020.
Response to Arguments
Rejections to the Claims under 35 U.S.C. 112(a)
Applicant's arguments filed 06/15/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claim 14, the applicant asserts on pg. 7-8 that the amendments to the claim have remedied the defects of the claim as noted in the previous written description rejection.
In response to the applicant’s argument, the examiner notes that, as explained below, the amendments to the claim do not remedy the issue of new matter and create further new matter issues. The applicant asserts that the Specification (para. 00111) distinguishes by way of implication between non-porous and porous embodiments by describing additional porous flow channels in a porous material that can communicate fluid in addition to the windows in some embodiments. There are no specific suitable materials for each of the non-porous and porous embodiments of the manifold disclosed in this paragraph of the specification. The applicant’s Specification (para. 00121) discloses examples of suitable porous materials for a manifold that comprise or can be adapted to form fluid pathways such as, “[l]iquids, gels, and other foams [that] may also include or be cured to include apertures and fluid pathways”. As claim 1 requires that the primary manifold be formed of a gel elastomer and as claim 14 requires that the primary manifold be formed from silicone material, this passage in view of the limitations in the claims provides further evidence that the silicone material is not explicitly non-porous.
Rejections to the Claims under 35 U.S.C. 112(b)
Applicant’s arguments, see pg. 8, filed 06/15/2026, with respect to the U.S.C. 112(b) rejection have been fully considered and are persuasive. The rejection of claim 14 has been withdrawn.
In view of the applicant’s arguments, porosity is considered to be a property of the material of the primary manifold.
Rejections of the Claims under 35 U.S.C. 103
Applicant's arguments filed 06/15/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding claim 1, the applicant asserts on pg. 8-9 that the prior art to Wang and Cornet fail to disclose at least “a portion of the first polymer film is in contact with the second polymer film through at least one of the manifold openings”.
In response to the applicant’s argument, the examiner respectfully notes that Wang and Cornet were not utilized in the previous Office Action filed 03/24/2025 to read on said limitation. Locke ‘650, as used previously in the rejection of at least claim 17, is used in the current rejection of claim 1, as explained below.
The amendments to the claims have necessitated new grounds of rejection as explained below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 14 recites the limitation “where the primary manifold is formed of a non-porous, silicone material” in ln. 1-2. The Specification discloses no explicit structure or provision that the primary manifold is non-porous, nor is the term “non-porous” found anywhere in the Specification, thereby failing to describe a negative limitation. See MPEP 2173.05(i). The term “silicone material” does not provide further understanding that the primary manifold is non-porous. The applicant’s Specification (para. 0099) discloses that “the primary manifold 210 comprises a molded or cast polymer, including but not limited to polyurethane or silicone based materials”. For example, US/2018/0353334 A1 to Locke discloses a dressing manifold comprised of any material suitable for removing fluids from a tissue site through a plurality of pores, pathways, or flow channels, such as a cast silicone (para. 0060). Further, the applicant’s Specification (para. 00121) discloses examples of suitable porous materials that comprise or can be adapted to form fluid pathways such as, “[l]iquids, gels, and other foams [that] may also include or be cured to include apertures and fluid pathways”. As claim 1 requires that the primary manifold be formed of a gel elastomer and as claim 14 requires that the primary manifold be formed from silicone material, this passage in view of the limitations in the claims provides further evidence that the silicone material is not explicitly non-porous.
Further, the Specification discloses no explicit structure or provision that the gel elastomer of the primary manifold is a silicone material. The applicant’s specification (para. 0099; 00115; 00183) discloses that the primary manifold may be formed from a silicone based material or may include or may be silicone. This broad recitation of silicone or silicone material does not explicitly read on silicone gel elastomers. The applicant’s specification (para. 0078; para. 00137) discloses other structures of the apparatus that may be silicone gels, such as attachment devices or sealing layers.
The examiner suggests that the applicant delete this material from claim 14.
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.
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Ex. Fig. 1 of Wang Fig. 5
Claims 1-2, 5-8, 10-11, 13, 18, 20, 31, 36, 38-39, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over US/2017/0196735 A1 to Wang in view of US/2011/0270301 A1 to Cornet, and WO/2018/226650 to Locke (hereinafter referred to as Locke ‘650).
Regarding claims 1, 18, 31, 36, 38, 39, and 41, Wang discloses
(Claim 1) an apparatus for treating a tissue site with negative pressure (para. 0014; para. 0037), the apparatus comprising: a primary manifold (Fig. 5, primary manifold 112) configured to move between a retracted state and an extended state (Fig. 5 showing primary manifold 112 in retracted state; Fig. 17 showing primary manifold 112 in extended state), the primary manifold comprising:
a top surface and a bottom surface positioned opposite the top surface and configured to face toward the tissue site (Ex. Fig. 1 showing top and bottom surface of primary manifold 112 opposite one another; Fig. 8(1) showing bottom surface of primary manifold 112 facing toward tissue site 50), and
a plurality of manifold openings through the top surface and the bottom surface (para. 0043, windows 113 may be areas where primary manifold 112 may not be foamed, chemically etched, or formed through sandblasting; Fig. 11-12, windows 112 in primary manifold 112; para. 0040 ln. 9-13, gaps in the foam of primary manifold 112 are used to drain liquid);
a pleat positioned adjacent to an extension zone (Ex. Fig. 1 showing pleats adjacent to extension zones), wherein the extension zone is configured to extend outward from the bottom surface toward the tissue site when the primary manifold is in the extended state (Fig. 17 showing extension zones extending downward to tissue site 50 in extended state);
(Claim 18) a system for treating a tissue site with negative pressure (Fig. 3; para. 0037), comprising: the apparatus of the invention;
a drape configured to be positioned over at least a portion of the apparatus and seal to tissue adjacent to the tissue site to form a sealed environment (Fig. 5, drape 11a positioned over primary manifold 112; para. 0037, adhesive layer 12 on drape 11a adheres to normal skin 80 to form an airtight seal); and
a negative-pressure source configured to provide negative pressure to the sealed environment (para. 0014; para. 0037; Fig. 3, pressure source 40).
Wang differs from the instantly claimed invention in that Wang fails to disclose (Claim 1) wherein the primary manifold is formed of a gel elastomer material.
Cornet teaches a dressing for a negative pressure wound therapy system (Fig. 1) comprising a manifold formed of a porous elastomeric gel material (para. 0022, manifold 144 may be a gel including or cured to include flow channels; para. 0024, suitable materials for manifold 144; para. 0025, elastomeric, pliable, and gel materials are preferred for soft-tissue application), the material being preferred for soft-tissue applications (para. 0025).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the primary manifold of Wang to be formed from a material as taught by Cornet, because Cornet teaches that elastomeric, pliable, and gel materials are preferred for soft-tissue applications (para. 0025).
Further, as Cornet discloses a manifold that may use a gel elastomer, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a gel elastomer as disclosed by Cornet in the apparatus suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Further, Wang differs from the instantly claimed invention in that Wang fails to disclose
(Claim 1) a first polymer film and a second polymer film, the first polymer film positioned adjacent to the bottom surface of the primary manifold and the second polymer film positioned adjacent to the top surface of the primary manifold, wherein at least the first polymer film includes a plurality of fluid passages, and wherein a portion of the first polymer film is in contact with the second polymer film through at least one of the manifold openings;
(Claim 31) wherein: the first polymer film has a first thickness; the second polymer film has a second thickness; and the first thickness is greater than the second thickness;
(Claim 36) wherein the plurality of fluid passages comprise a plurality of slots or slits, each of the slots or slits having a length less than 5 millimeters and a width less than 2 millimeters;
(Claim 38) a secondary manifold configured to be positioned adjacent the apparatus opposite the tissue site;
(Claim 39) wherein the first polymer film is configured to be positioned adjacent to the tissue site, and wherein the secondary manifold is configured to be positioned adjacent to the second polymer film;
(Claim 41) wherein the secondary manifold is configured to be positioned between the drape and the second polymer film.
Locke ‘650 teaches an apparatus for treating a tissue site with negative pressure (Fig. 14), the apparatus comprising:
(Claim 1) a first polymer film and a second polymer film, the first polymer film positioned adjacent to the bottom surface of the primary manifold and the second polymer film positioned adjacent to the top surface of the primary manifold, wherein at least the first polymer film includes a plurality of fluid passages, and wherein a portion of the first polymer film is in contact with the second polymer film through at least one of the manifold openings (Fig. 14, first polymer film 410, second polymer film 1400, primary manifold 1410, fluid passages 220, manifold openings considered places between manifold section 215 as regions without manifold material; para. 0051-0052; para. 0090);
(Claim 31) wherein: the first polymer film has a first thickness; the second polymer film has a second thickness (Fig. 14);
(Claim 36) wherein the plurality of fluid passages comprise a plurality of slots or slits, each of the slots or slits having a length less than 4 millimeters and a width less than 1 millimeters (para. 0052 ln. 1-4);
(Claim 38) a secondary manifold configured to be positioned adjacent the apparatus opposite the tissue site (Fig. 14, secondary manifold 1405; para. 0090);
(Claim 39) wherein the first polymer film is configured to be positioned adjacent to the tissue site, and wherein the secondary manifold is configured to be positioned adjacent to the second polymer film (Fig. 14);
(Claim 41) wherein the secondary manifold is configured to be positioned between the drape and the second polymer film (Fig. 2, cover 116 positioned atop tissue interface 114; Fig. 14).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the apparatus of the cited prior art to comprise polymer films and manifolds as taught by Locke ‘650, because Locke ‘650 teaches that the polymer layer provides means for controlling or managing fluid flow through fluid restrictions (para. 0051; para. 0058; para. 0063), that the contact points of the polymer films provide seams to create separable sections of the manifold for sizing of the manifold without exposing the manifold within the section (para. 0007; para. 0009; para. 0056), and that the manifold can comprise one or two manifolds while maintaining a thin dressing profile and increased flexibility (para. 0050).
Further regarding claim 31, 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 device of the prior art to have the first polymer film with a greater thickness than the second polymer film 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” See MPEP 2144.04. In the instant case, the combined device of the prior art would not operate differently with the claimed thickness and since the plurality of fluid passages are meant to pass through the entire thickness of the polymer films the device would function appropriately having the claimed thickness. Further, it appears that applicant places no criticality on the proportion claimed, indicating simply that the thickness “may” be different (specification pp. [00189]).
Further regarding claim 36, 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 length and width of the fluid passages of the prior art from between less than 4 mm to less than 5 mm and from between less than 1 mm to less than 2 mm, respectively, 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.” See MPEP 2144.05. Further, applicant appears to have placed no criticality on the claimed range (see pp. [0098] indicating the length and width “may” be within the claimed range).
Regarding claim 2, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the bottom surface of the primary manifold is configured to form a convex shape in conformity with the tissue site when the primary manifold is in the extended state (Fig. 17 showing bottom surface of primary manifold 112 forming a convex shape in conformity with tissue site 50 in the extended state).
Regarding claim 5, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the pleat comprises a fold in the material of the primary manifold (Ex. Fig. 1 showing pleats as folds in primary manifold 112).
Regarding claim 6, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein a cross-section of the pleat comprises a fold between a first portion of the primary manifold and a second portion of the primary manifold (Ex. Fig. 1 showing pleat formed as fold between first and second portions of primary manifold 112), wherein at least a portion of the first portion is configured to overlap the second portion when the primary manifold is in the retracted state (Ex. Fig. 1 showing first portion overlapping second portion horizontally in the retracted state), and wherein at least a portion of the first portion is configured to move away from the second portion in the extended state (Fig. 17 showing extended state wherein primary manifold 112 is largely flat such that the first and second portion of the pleats have moved away from each other).
Regarding claim 7, the cited prior art suggests the invention of claim 6. Wang further discloses: wherein the second portion of the primary manifold is positioned between the first portion of the primary manifold and the extension zone (Ex. Fig. 1 showing second portion positioned between first portion and extension zone of primary manifold 112).
Regarding claim 8, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the pleat is positioned around the extension zone (Ex. Fig. 1 showing pleats positioned around extension zones).
Regarding claim 10, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the pleat comprises a plurality of pleats, wherein the extension zone comprises a plurality of extension zones, and wherein one of the extension zones is positioned between two of the pleats across the top surface and the bottom surface of the primary manifold (Ex. Fig. 1 showing plurality of pleats and extension zones such that at least one of the extension zones is positioned between two pleats across the top and bottom surface of primary manifold 112).
Regarding claim 11, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the pleat comprises a plurality of pleats, wherein the extension zone comprises a plurality of extension zones, and wherein the plurality of pleats and the plurality of extension zones are positioned in alternating concentric rings on the top surface and the bottom surface of the primary manifold (Ex. Fig. 1 showing plurality of pleats and plurality of extension zones in alternating arrangement along top and bottom surface of primary manifold 112; Fig. 4 showing concentric rings in drape 11a and primary manifold 112).
Regarding claim 13, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the pleat comprises a plurality of pleats, wherein the extension zone comprises a plurality of extension zones, and wherein one or more of the extension zones extends outward from the bottom surface of the primary manifold farther than another of the extension zones when the primary manifold is in the extended state (Ex. Fig. 1 showing plurality of pleats and plurality of extension zones; Fig. 17 showing extended state of primary manifold 112 in a substantially flat condition such that extension zones further out from the middle extend less than extension zones closer to the middle).
Regarding claim 20, the cited prior art suggests the invention of claim 1 (the apparatus of claim 1). Wang further discloses: a method of treating a tissue site with negative pressure (para. 0037), the method comprising:
positioning the apparatus of the invention proximate to the tissue site (para. 0047);
applying negative pressure to a sealed environment at the tissue site including the apparatus (para. 0047); and
extending one or more extension zones outward from the bottom surface of the primary manifold toward the tissue site (para. 0047; Fig. 17 showing extended state).
Claims 14 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Cornet, and Locke ‘650 as applied above, and further in view of US/2019/0117861 A1 to Locke (hereinafter referred to as Locke ‘861).
Regarding claim 14, the cited prior art suggests the invention of claim 1. Wang further discloses: wherein the manifold openings are configured to provide fluid communication through the top surface and the bottom surface of the primary manifold (para. 0043, windows 113 may be areas where primary manifold 112 may not be foamed, chemically etched, or formed through sandblasting; Fig. 11-12, windows 112 in primary manifold 112; para. 0040 ln. 9-13, gaps in the foam of primary manifold 112 are used to drain liquid).
The cited prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the primary manifold is formed of a non-porous, silicone material.
Locke ‘861 teaches a manifold formed in multiple layers comprising one layer formed from a non-porous silicone material (para. 0067, gels may include or be cured to include apertures and fluid pathways such that the silicone material isn’t required to be porous; para. 00136, perforated silicone gel 1415 of manifold 108; Fig. 14).
As Locke ‘861 discloses a manifold that may use a non-porous silicone material, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a non-porous silicone material as at least one layer of the manifold as disclosed by Locke ‘861 in the apparatus suggested by the prior art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. See MPEP 2144.07.
Regarding claim 25, the cited prior art suggests the invention of claim 14. Wang further discloses: wherein the manifold openings are windows further configured to provide a visual perception of the tissue site through the top surface and the bottom surface of the primary manifold (para. 0043, windows 113 may be areas where primary manifold 112 may not be foamed, chemically etched, or formed through sandblasting; Fig. 11-12, 113 windows in primary manifold 112).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Wang, Cornet, and Locke ‘650 as applied above, and further in view of U.S. Patent no. 8,057,447 B2 to Olson.
Regarding claim 16, the cited prior art suggests the invention of claim 1; however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the primary manifold further comprises a plurality of standoffs extending outward from one or both of the top surface and the bottom surface.
Olson teaches a dressing for a negative pressure wound therapy system (Fig. 1-2) comprising a primary manifold that comprises a plurality of standoffs extending outward from one or both of the top surface and the bottom surface (col. 4 ln. 12-67 and col. 5 ln. 1-8; Fig. 2, distribution manifold 15 comprising backing substrate 41 and plurality of protrusions 51), the stand-offs acting as a barrier to new tissue growth entering pores of the manifold (col. 5 ln. 4-8, 35-47).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the manifold of the prior art to further comprise standoffs as taught by Olson, because Olson teaches that the substrate comprising protrusions may serve as a barrier to new tissue growth entering pores of the manifold (col. 5 ln. 4-8, 35-47) to avoid the attachment of a manifold to a tissue site which may cause tearing of new tissue during removal (col. 1 ln. 51-59).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wang, Cornet, Locke ‘650, Locke ‘861 as applied above, and further in view of U.S. Patent no. 8,057,447 B2 to Olson.
Regarding claim 28, the cited prior art suggests the invention of claim 25. Wang further discloses: wherein the primary manifold includes a plurality of areas that define the windows that may have any configuration (para. 0043); however, the prior art differs from the instantly claimed invention in that the prior art fails to disclose wherein the primary manifold further comprises a plurality of standoffs extending outward from one or both of the top surface and the bottom surface, wherein the primary manifold includes a plurality of primary nodes and a plurality of links that are interconnected to define the windows, and wherein each of the primary nodes comprises at least one of the standoffs.
Olson teaches a dressing for a negative pressure wound therapy system comprising a substrate comprising protrusions attached to the bottom of a manifold (col. 4 ln. 12-67 and col. 5 ln. 1-8; Fig. 2, distribution manifold 15 comprising backing substrate 41 and plurality of protrusions 51), the protrusions acting as a barrier to new tissue growth entering pores of the manifold (col. 5 ln. 4-8, 35-47).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the manifold of the prior art to further comprise standoffs at least each of a primary node as taught by Olson, because Wang discloses that the primary manifold may be provided in any configuration (para. 0043) and that Olson teaches that the substrate comprising protrusions may serve as a barrier to new tissue growth entering pores of the manifold (col. 5 ln. 4-8, 35-47) to avoid the attachment of a manifold to a tissue site which may cause tearing of new tissue during removal (col. 1 ln. 51-59).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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, Sarah Al-Hashimi can be reached on (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799
4 September 2026
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