DETAILED ACTION
Response to Amendment
Claim Objections
Claim 102 is objected to because of the following informalities:
On line 10 of claim 102, “a gas outlet at or adjacent to the wound” should read “a gas outlet configured to be at or adjacent to the wound” to reflect the functional nature of the limitation and to avoid claiming the human body.
Appropriate correction is required.
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, 105-111, 113-115, and 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 support structure (see par. [0041] and [0049]-[0051]), wherein the first gas flow path is defined at least partially through the support structure (see Figure 1); and 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 between a first position and a second retracted position at which the interface body is an expanded configuration whilst substantially maintaining at least the first gas flow path in an open position, wherein the support structure is configured to maintain the first gas flow path in the open position during retraction between the first position and the second retracted position (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- the disclosed support structures keep the lumen of 102 open in N number of positions).
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 diffusing material portion (206), wherein the second gas flow path and the gas outlet are 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 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), wherein the support structure is configured to maintain a gas flow path defined by the support structure in an open position in the first position and the second position (see par. [0061]- “In certain embodiments, the draping sheet 104 at least partially seals about the periphery of a surgical site providing a barrier to escape of a heavier-than-air gas such as carbon dioxide from within the surgical site.”- the sealed environment is a gas flow path and is open in N number of retracted positions.
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.
Allowable Subject Matter
Claim 124 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. While the examiner maintains that the disclosed support structures help keep the gas flow conduit open through a plurality of retracted positions, there is no disclosure of allowing the interface body to bend while maintaining a substantially constant cross-section along the first gas flow path during retraction from the first position to the second retracted position. There is no teaching reference to cure this deficiency.
Response to Arguments
Applicant's arguments filed 4/14/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Hamilton fails to disclose or suggest a gas flow path in an open position during retraction between a first position and a second position nor a support structure to maintain the gas flow path in an open position during retraction as is recited in claim 102, the examiner respectfully disagrees. The applicant argues that the gas conduit 102 of Hamilton is disclosed as being pliable such that it is desirable that the gas conduit 102 is foldable when not in use. Citations are made to par. [0041] and [0050]. This argument is not persuasive. As highlighted in the non-final Office Action, the pliable nature of the device means that the device can be retracted N number of positions while fluid flow is still capable. The amended claims are still broad enough to fall under this interpretation. The device is capable of being in a first position (not retracted at all) to a second position (a small degree of retraction) while fluid flow is still possible. The applicant’s citation to the folded configuration is not persuasive because the folded configuration does not need to be used to map to the claimed limitations. Furthermore, there is no indication in Hamilton that fluid flow is stopped in the folded configuration.
In response to the applicant’s argument that Hamilton fails to disclose a support structure that is configured to maintain a gas flow path defined by the support structure in an open position in the first and second position as is recited in claim 117, the examiner respectfully disagrees. The applicant argues that element 104 is a draping sheet and therefore fails to meet the claimed limitations. This argument is not persuasive. In par. [0061], Hamilton discloses that the draping sheet 104 at least partially seals about the periphery of a surgical site providing a barrier to escape of a heavier-than-air gas such as carbon dioxide from within the surgical site. This sealed environment is a gas flow path that is open in N number of positions.
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 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
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