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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 102-121) in the reply filed on 11/7/2025 is acknowledged.
Claims 122-123 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/7/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/1/2023, 6/5/2024, and 7/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 102-103, 105-115, 117-120 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamilton (US 2006/0206051).
In regard to claim 102, Hamilton discloses a patient interface (100) for wound treatment or management, the patient interface comprising: an interface body (102, 104) configured to substantially or at least partially surround a wound, the interface body comprising: a gas inlet (122); a first gas flow path (lumen of 102); a second gas flow path (lumen of 204); and a gas outlet (202) at or adjacent to the wound; wherein the first gas flow path (lumen of 102) is arranged in fluid communication with the gas inlet (122) and the second gas flow path (lumen of 204); wherein the interface body is configured to be retractable from a first position to a second retracted position whilst substantially maintaining at least the first gas flow path (see Figs. 1, 5-10; par. [0041], [0050]-[0052], and [0055], the pliable nature of the device means that the device can be retracted between N number of positions while fluid flow is still capable).
In regard to claim 103, Hamilton discloses wherein the wound comprises a surgical incision (functional limitation), and: the first position comprises a first configuration of the interface body configured to substantially or at least partially surround the surgical incision prior to retraction of the surgical incision; and the second retracted position comprises a second configuration of the interface body configured to at least partially surround the surgical incision subsequent to retraction of the surgical incision (functional limitation; see Figs. 1, 5-10; par. [0041], [0050]-[0052], and [0055], the pliable nature of the device means that the device can be retracted between N number of positions while fluid flow is still capable).
In regard to claim 105, Hamilton discloses, wherein the interface body further comprises: a support structure (see par. [0041]), wherein the first gas flow path is defined at least partially through the support structure (see Figure 1); and a diffusing material portion (206), wherein the second gas flow path and the gas outlet is defined at least partially through the diffusing material portion (see par. [0058]).
In regard to claim 106, Hamilton discloses wherein the interface body (102) further comprises an outer membrane (see Fig. 5) and wherein the first gas flow path is at least partially defined between the outer membrane and the diffusing material portion (see Figs. 5-6).
In regard to claim 107, Hamilton discloses, wherein: the support structure is arranged along an outer side of the interface body configured to face away from the wound; and the diffusing material portion (208) is arranged along an inner side of the interface body configured to face toward the wound.
In regard to claim 108, Hamilton discloses wherein the support structure comprises a flexible structure (104) configurable to conform to contours of a body of a patient surrounding a wound site (see par. [0059]-[0066]).
In regard to claim 109, Hamilton discloses wherein the support structure is configured to be elastically deformable under application of at least one of a laterally, vertically, and longitudinally applied force (see par. [0059]-[0066]).
In regard to claim 110, Hamilton discloses wherein the support structure comprises a plurality of interconnected elements arranged in a repeating pattern over a longitudinal axis of the support structure (see par. [0059]-[0066]).
In regard to claim 111, Hamilton discloses wherein the support structure comprises a scaffold or a spring (see par. [0059]-[0066]).
In regard to claim 112, Hamilton discloses wherein the first gas flow path (lumen of 102) is maintained in an open position by the support structure (the lumen is generally always in an open position).
In regard to claim 113, Hamilton discloses wherein the diffusing material portion (206) comprises a stretchable porous material (see par. [0058]).
In regard to claim 114, Hamilton discloses wherein the stretchable porous material comprises an open cell foam (see par. [0058]).
In regard to claim 115, Hamilton discloses, wherein the diffusing material portion (see 812 in Fig. 19) defining the second gas flow path decreases in thickness from the gas inlet to a distal portion (the diameter clearly decreases and “the distal portion” is never defined in the claim).
In regard to claim 117, Hamilton discloses a patient interface (100) for wound treatment or management, the patient interface comprising: an interface body (102) configured to substantially or at least partially surround a surgical incision, the interface body comprising: a gas inlet (122); a support structure (104) positioned along an outside edge of the interface body configured to face away from the surgical incision; and a diffusing material portion (206) positioned along an inside edge of the interface body configured to face toward the surgical incision; wherein the interface body is configured to receive a gas from the gas inlet and deliver the gas through the diffusing material portion toward the surgical incision (see par. [0058]); wherein the interface body is configured to deform between a first position prior to retraction of the surgical incision and a second position subsequent to retraction of the surgical incision (see Figs. 1, 5-10; par. [0041], [0050]-[0052], and [0055], the pliable nature of the device means that the device can be retracted between N number of positions while fluid flow is still capable).
In regard to claim 118, Hamilton discloses wherein the support structure comprises a flexible structure configurable to conform to contours of a body of a patient surrounding a wound site (see par. [0059]-[0066]).
In regard to claim 119, Hamilton discloses wherein the support structure is configured to be elastically deformable under application of at least one of a laterally, vertically, and longitudinally applied force (see par. [0059]-[0066]).
In regard to claim 120, Hamilton discloses wherein the support structure comprises a plurality of interconnected elements arranged in a repeating pattern over a longitudinal axis of the support structure (see par. [0059]-[0066]).
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) 104, 116, and 121 are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton in view of Argenta et al. (US 5,636,643; hereafter Argenta).
In regard to claims 104, 116, and 121, Hamilton fails to disclose the recited adhesive in these claims.
In a similar art, Argenta teaches an adhesive seal (68) for attaching a mask interface (58) to a target site.
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 device of Hamilton with the adhesive of Argenta in order to provide an art-recognized equivalent for securing an interface to a target site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783