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 .
Claim Objections
Claim 79 is objected to because of the following informalities:
A comma should be added after “surface region” to correct the grammatical error (Claim 79, Line 3).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 65-87, 89, and 93 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 65 states “a conduit facing surface”, “an opposing patient facing surface”, “a conduit facing surface of the second pad region” and “a patient facing surface of the second pad region” (Lines 7 and 12-13). This statement is indefinite because it is unclear how many conduit facing surfaces and patient facing surfaces are there. It appears the applicant was trying to say the conduit facing surface is part of the pad and the patient facing surface is part of the pad. However, distinguishing different pad regions along with their surfaces creates confusion regarding the number of surfaces involved. It is possible that there are multiple conduit facing surfaces and multiple patient facing surfaces. Therefore, the number of surfaces on the pad or pad regions cannot be determined. For examination purposes, the claim limitation will be interpreted as the conduit facing surface is part of the pad as one surface and the patient facing surface is part of the pad as one surface. Similar rejections are applied to Claim 69 (“the outer surface of the conduit” and “an outer surface of the second outer surface region of the conduit”, Lines 1-2 and 4), Claim 74 (“the outer surface of the conduit”, “a first outer surface of the conduit”, “a second outer surface of the conduit”, Lines 11-13), and Claim 79 (“an outer surface of the second outer surface region”, Lines 3-4).
Claim 76 states “a first outer surface region and a second outer surface region” (Line 2). This statement is indefinite because it is unclear if this is the same as the first outer surface and second outer surface mentioned in Claim 74. It appears the applicant was trying to say they’re the same. However, it is possible there are multiple regions involved. Therefore, the number of regions or surfaces involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 79 states “a patient facing surface of the pad” (Line 3). This statement is indefinite because it is unclear if this is the same as the opposing patient facing surface mentioned in Claim 74. It appears the applicant was trying to say they’re the same. However, it is possible multiple surfaces are involved. Therefore, the number of surfaces involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same.
Claim 74 states “at least one of the edges of the pad” (Lines 13-14). This statement is indefinite because it is unclear if these are the same edges as the opposing lateral edges and opposing end edges mentioned earlier. It appears the applicant was trying to say they’re the same. However, multiple other edges of the pad could be involved. Therefore, the number of edges involved cannot be determined. For examination purposes, the claim limitation will be interpreted as they’re the same. Similar rejections are applied to Claim 82 (Line 15), Claim 84 (Lines 2-3), Claim 85 (Line 6), Claim 89 (Line 2), and Claim 93 (Lines 1-2).
Claims 66-73, 75-81, and 83-87 are rejected for being dependent on rejected Claims 65, 74, and 82.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 65-94 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 65 states “a patient facing surface of the second pad region contacts the patient’s head and/or face in use” (Lines 13-14). This statement is directed to a human organism since it requires the patient facing surface to contact a patient’s head and/or face in use. Without the patient’s head and/or face, there is nothing for the patient facing surface to contact with. For examination purposes, the claim limitation will be interpreted as a patient facing surface of the second pad region is configured to contact the patient’s head and/or face in use. Similar rejections are applied to Claim 74 (Lines 9-10), Claim 82 (Lines 9-10), and Claim 88 (Lines 9-10).
Claims 66-73, 75-81, 83-87, and 89-94 are rejected for being dependent on rejected Claims 65, 74, 82, and 88.
Allowable Subject Matter
Claims 65-94 would be allowable if rewritten to overcome the 35 USC 112(b) and 35 USC 101 rejections above.
Claims 65-94 contain allowable subject matter.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 65 discusses a positioning and stabilizing structure configured to hold a seal-forming structure of a patient interface, comprising a conduit with a pad that is claimed to be similar to the conduit depicted in Figs 11A-11C. The pad is described to be folded inward with the conduit.
Claim 74 discusses a similar device to Claim 65 and the conduit with the pad is claimed to be similar to the conduit depicted in Figs 12A-12C. The pad is described to be placed in a notch in the conduit.
Claim 82 discusses a similar device to Claims 65 and 74 and the conduit with the pad is claimed to be similar to the conduit depicted in Figs 10A-10C. The pad is described to match the length of a recess of the conduit.
Claim 88 discusses a similar device to Claims 65, 74, and 82 and the conduit with the pad is claimed to be similar to the conduit depicted in Figs 13A-13B. The pad is described to be concave and the conduit has curved edges surrounding the pad.
Prior art similar to the claimed invention are explained below.
Guney et al. (WO-2021081595-A1) discusses a patient interface. Regarding Claim 65, though Guney teaches a patient interface of similar design to the instant invention including the layer of textile or foam material on the conduit, Guney does not detail much about how the textile or foam material is attached. At most, Guney describes the gas delivery tube having a partial recess or depression and the textile pad being secured in this recess by hook and loop material (Guney: paragraph 0235). Though Guney mentions this, there is no drawings depicting this particular kind of embodiment. It is shown in other embodiments that the textile layer makes up part of the conduit wall (Guney: Figs 5-6) rather than being a textile layer that is placed on top of an existing conduit. The instant invention purposely modifies the conduit shape to accommodate for a textile layer to be placed on top of a recess to avoid sharp edges and improve comfort (Drawings: Fig 11A). This is not found in Guney. Even if one of ordinary skill in the art were to modify the conduit to have this recess or depression, Guney does not mention the specific ways the textile layer is attached to the conduit (first pad region being folded under the second pad region). It would be non-obvious to drastically modify the conduit to be a whole conduit and then add the recess/depression on the existing wall of the conduit to accommodate for a textile layer. One of ordinary skill in the art would not be able to modify the device of Guney to get to the claimed invention due to the lack of details involved in Guney. Other prior art are drawn to layering of straps which is non-analogous to the layering placed on conduits since the instant invention’s patient interface is specific in design. Therefore, Guney fails to disclose Claim 65. Similar arguments are applied to Claims 74, 82, and 88.
Claims 66-73, 75-81, 83-87, and 89-94 contain allowable subject matter due to their dependencies on Claims 65, 74, 82, and 88.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for art cited of interest including:
US-20080047560-A1 discusses a patient interface with a similar mask structure to the claimed invention with conduit cross-sections.
US-20120152255-A1 discusses a PAP system with various cross-sections of the conduit.
US-20210252243-A1 discusses a patient interface with a similar mask structure to the claimed invention with conduit cross-sections.
US-20080060649-A1 discusses a patient interface with a similar mask structure to the claimed invention.
WO-2016043603-A1 discusses a headgear system with various strap cross-sections.
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/BRIAN T KHONG/ Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/ Primary Examiner, Art Unit 3785
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