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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 September 2025 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 30 September 2025. As directed by the amendment: claim 1 has been amended. Claim 13 has been added. Thus, claims 1-5, 7-8, and 10-13 are presently pending and claims 1, 3-4, 7-8, 10-11, and 13 are under examination in this application.
Response to Arguments
Applicant’s arguments filed 30 September 2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made, further citing Hammond et al. (US 20150112311 A1) and Wall (US 20150005678 A1).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20190216991 A1) in view of Cotton (US 20140309574 A1), Hammond et al. (US 20150112311 A1), and Chien et al. (US 20180154052 A1).
Regarding Claim 1, Locke teaches a wound drain ('dressing interface 110', fig.2A and 4A, ¶ 36) for a wound cavity ('tissue site 109', fig.4A, ¶ 89), the drain comprising:
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Annotated Figure 2I of Locke
a dome ('connector body 162', fig.2A, ¶ 72; "The connector body 162 may be a dome-shaped body" or "the connector body 162 may form a hemisphere", ¶ 72) having a chamber wall defining an internal dome chamber with an open bottom (see annotated figure 2I), the dome formed from a pliable material (“semi-rigid material” [0075]);
an integral peripheral flange (' base 160', fig.2A, ¶ 72) extending radially from the dome 162 ("The base 160 may be a disc-shaped body having a diameter at least one order of magnitude larger than a thickness of the base 160. The connector body 162 may be a dome-shaped body coupled to the base 160 and extending away from the base 160 on a first side", ¶ 72);
a port connection ('conduit port 168', fig.2A, ¶ 73) extending from the dome 162 having a passage therethrough in fluid communication with the dome chamber (see annotated fig.2I, where 168 is clearly extending from 162 having a passage therethrough in fluid communication with the chamber of 162).
Locke fails to teach a support structure within the dome chamber, the support structure comprising a plurality of openings for preventing a foreign object within the wound cavity from migrating into the dome chamber while allowing fluid flow from the wound cavity through the dome chamber and passage, and wherein the chamber wall includes an annular lip extending internally into the dome chamber adjacent the flange to form an annular seat within the dome chamber.
Cotton discloses a wound dressing, and teaches a support structure ('absorbent foam pad 66', fig.10, ¶ 143) within the dome chamber 62, the support structure 66 comprising a plurality of openings ("open cell foams", ¶ 22; "smaller pores", ¶ 24) for preventing a foreign object within the wound cavity from migrating into the dome chamber while allowing fluid flow from the wound cavity 109 through the dome chamber and passage ("to transmit wound exudate...used in conjunction with absorbent bodies (e.g. foam or gauze pads) placed on the opposite side of the dressing to the wound", ¶ 80).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke to include a support structure within the dome chamber, the support structure comprising a plurality of openings for preventing a foreign object within the wound cavity from migrating into the dome chamber while allowing fluid flow from the wound cavity through the dome chamber and passage as taught by Cotton, in order to prevent a foreign object from becoming lodged in the dome structure and preventing negative pressure from being achieved, such that suction of exudate that may exit the wound will preserve the health of the wound environment and prevent infection.
Locke/Cotton fail to teach the support structure is formed of a material more rigid than the dome material. Hammond teaches a wound dressing for use in the application of negative pressure (see Abstract) wherein the support structure (“support member 102” & “stainless steel, titanium” [0213]-[0214]) is formed of a material more rigid than the dome material (“drape 106” & “polyurethane, Opsite film, polyester, polyethylene” [0220]; FIG. 3) (“support members 1514 can therefore provide additional support to prevent the cover member or drape 1506 from collapsing vertically into the wound under the application of reduced pressure” [0272]).
Therefore, it would have been obvious to modify the wound dressing of Locke/Cotton such that the support structure is formed of a material more rigid than the dome material, as taught by Hammond, “to define a space between the wound cover and the wound” (see Abstract) and facilitate healing ([0211]).
Locke/Cotton fail to teach the chamber wall includes an annular lip extending internally into the dome chamber adjacent the flange to form an annular seat within the dome chamber. Chien discloses a wound management assembly, and teaches an annular lip ('curved structure 122', fig.3, ¶ 52) extending internally into the chamber adjacent the flange to form an annular seat within the chamber.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke/Cotton such that the chamber wall would include an annular lip extending internally into the dome chamber adjacent the flange to form an annular seat within the dome chamber as taught by Chien, in order that when the wound dressing device is placed on the wound and forms a reduced pressure environment, the function of reduced pressure may be increased by the disposal of the curved structure (Chien ¶ 52).
Regarding Claim 3, Locke fails to teach the support structure is a grate comprising a plurality of apertures. Cotton teaches the support structure is a grate ('textile material 65', fig.11, ¶ 143; NOTE: a grate is "a framework of parallel or crossed bars, typically preventing access through an opening while permitting communication or ventilation" and the textile material is a framework of parallel and crossed bars of a blend of gelling and non-gelling fibres) comprising a plurality of apertures ('array of perforations 89', fig.12, ¶ 152).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke such that the support structure would be a grate comprising a plurality of apertures, as taught by Cotton, in order to prevent a foreign object from becoming lodged in the dome structure and preventing negative pressure from being achieved, such that suction of exudate that may exit the wound will preserve the health of the wound environment and prevent infection.
Regarding Claim 4, Locke fails to teach the apertures comprise a circular shape. Cotton teaches the apertures comprise a circular shape (see fig.12 in which the apertures 89 are clearly circular).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke such that the apertures comprise a circular shape, as taught by Cotton, in order to optimize the suction of exudate that may exit the wound, preserve the health of the wound environment, and prevent infection.
Regarding Claim 7, Locke fails to teach the support structure comprises a flat screen fitted within the seat. Cotton teaches the support structure 66 comprises a flat screen ("sheet of foam", ¶ 17).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke such that the support structure comprises a flat screen, as taught by Cotton, in order to prevent a foreign object from becoming lodged in the dome structure and preventing negative pressure from being achieved, such that suction of exudate that may exit the wound will preserve the health of the wound environment and prevent infection.
Locke/Cotton fail to teach that the support structure comprises a flat screen that is fitted within the seat. Chien teaches the seat ('curved structure 122', fig.3, ¶ 52).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke/Cotton such that the support structure would comprise a flat screen that would be fitted within the seat as taught by Chien, in order to secure the support structure in place so that it is not moved easily/dislodged such that when the wound dressing device is placed on the wound and forms a reduced pressure environment, the function of reduced pressure may be increased by the disposal of the curved structure (Chien ¶ 52).
Regarding Claim 8, Locke fails to teach the support structure comprises a grate having a plurality of apertures fitted within the seat. Cotton teaches the support structure 66 comprises a grate ('textile material 65', fig.11, ¶ 143; NOTE: a grate is "a framework of parallel or crossed bars, typically preventing access through an opening while permitting communication or ventilation" and the textile material is a framework of parallel and crossed bars of a blend of gelling and non-gelling fibres) having a plurality of apertures 89 fitted within the seat.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke such that the support structure would comprise a grate having a plurality of apertures as taught by Cotton, in order to prevent a foreign object from becoming lodged in the dome structure and preventing negative pressure from being achieved, such that suction of exudate that may exit the wound will preserve the health of the wound environment and prevent infection.
Locke/Cotton fail to teach that the support structure comprises a grate having a plurality of apertures fitted within the seat. Chien teaches the seat ('curved structure 122', fig.3, ¶ 52).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wound dressing of Locke/Cotton such that the support structure would comprise a grate having a plurality of apertures fitted within the seat as taught by Chien, in order to secure the support structure in place so that it is not moved easily/dislodged such that when the wound dressing device is placed on the wound and forms a reduced pressure environment, the function of reduced pressure may be increased by the disposal of the curved structure (Chien ¶ 52).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Locke in view of Cotton, Chien, and further in view of Chen (US 20180200418 A1).
Regarding Claim 10, Locke teaches the dome chamber (see annotated figure 2I), but Locke/Cotton/Chien fail to teach a second port connection, the second port connection being in fluid communication with the dome chamber. Chen discloses a suction disc configured for abutting against a dressing covering over a wound, and teaches a second port connection ('second connecting duct 140', fig.1, ¶ 37), the second port connection 140 being in fluid communication with the dome chamber.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to the wound dressing of Locke/Cotton/Chien to include a second port connection, the second port connection being in fluid communication with the dome chamber as taught by Chen, in order to be a conduit for fluid to pass through as it communicates between the wound environment and an external system.
Regarding Claim 11, Locke teaches the dome chamber (see annotated figure 2I), but Locke/Cotton/Chien fail to teach the second port connection is configured to provide a vent and/or injection port for the introduction of fluid or gas into the dome chamber. Chen teaches the second port connection 140 is configured to provide a vent and/or injection port for the introduction of fluid or gas into the dome chamber (NOTE: 140 is configured to provide fluid or gas into the dome by virtue of being a conduit through which fluid or gas can flow into the enclosed space).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to the wound dressing of Locke/Cotton/Chien such that the second port connection would be configured to provide a vent and/or injection port for the introduction of fluid or gas into the dome chamber as taught by Chen, in order to be a conduit for fluid to pass through as it communicates between the wound environment and an external system to prevent infection and promote healing of the wound environment.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (US 20190216991 A1) in view of Cotton (US 20140309574 A1), Hammond et al. (US 20150112311 A1), Chien et al. (US 20180154052 A1), and Wall (US 20150005678 A1).
Regarding Claim 13, Locke/Cotton/Hammond/Chien fail to specify the dome is formed from silicon rubber. However, Wall teaches a “wound dressing 10 includes a wound dome 20” ([0047]; FIG. 1) wherein the dome is formed from silicon rubber (“silicon rubber” [0047]). Therefore, 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 device of Locke/Cotton/Hammond/Chien to incorporate the claimed structure to allow for suitable gas/fluid flow ([0049]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781