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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-22, 24-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bearne et al (US 2014/0283842), hereinafter Bearne.
Regarding claim 21, Bearne teaches a patient interface (Figs. 72-78) comprising:
a plenum chamber (Fig. 75, chamber 725) formed from a first material (silicone, paragraph 317) and pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (Paragraph 347 treatment pressures of about 3 to 24 cm H2O), the plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient (paragraph 309, connector 706 connected to base 702 to allow supply of pressurized breathing gases), the plenum chamber including a mounting surface,( Fig. 78: 742)
a seal forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways for sealed delivery of a flow of pressurized air at the therapeutic pressure of at least 6cm H2O above ambient air pressure throughout the patient’s respiratory cycle in use, (Fig. 78, 704, 740, paragraph 317) the seal forming structure comprises:
a first section constructed from the first material, (paragraph 330, section 740 formed from a different material) the first section configured to sealingly engage against a first region of the patient’s face (Fig. 78, seals around a nose area); and
a second section (Fig. 78: 704) constructed from a second material different than the first material, (Paragraph 331) the second section connected to the mounting surface (Paragraph 309, Fig. 78, connected 742), the second section configured to sealingly engage against a second region of the user’s face; (Paragraph 317) and
a positioning and stabilizing structure to provide a force to hold a seal forming structure in a therapeutically effective position on a patient’s head, (Figs 89-91)
wherein the mounting surface is recessed relative to the first section by a first distance so that the first section forms an overhang (paragraph 332, region 742 is recess to help orient. Locate and secure 740), wherein the overhang is connected to the second section (Fig. 78, 740 is connected to 704), and
wherein the second section includes a thickness substantially equal to the first distance so that the second section extends away from the mounting surface along the first distance and the first section and the second section are substantially flush with one another on a common plane parallel to the mounting surface. (See fig. 78, 79)
Regarding claim 22, Bearne teaches the patient interface of claim 21 and further teaches wherein the first material is silicone. (Paragraph 330)
Regarding claim 24, Bearne teaches the patient interface of claim 21 and further teaches wherein the seal forming structure is an oronasal cushion, an ultra-compact full face mask, or a full face mask. (See Fig. 72)
Regarding claim 25, Formica teaches the patient interface of claim 21, wherein the mounting surface is substantially flat and substantially perpendicular to an anterior-posterior direction of the patient’s head in use. (See Fig. 79, cross section of 740 is perpendicular to an anterior-posterior direction of the patient’s head in use.
Regarding claim 26, Bearne teaches the patient interface of claim 21, and further teaches wherein the overhang is oriented substantially perpendicularly with respect to the mounting surface. (Fig. 79)
Regarding claim 27, Bearne teaches the patient interface of claim 21, and further teaches wherein the overhang is configured to contact the patient proximate each nasal ala. (Paragraph 29)
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 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bearne in view of Formica et al (US 2017/0312468), hereinafter Formica.
Regarding claim 23, Bearne teaches the patient interface of claim 21, but does not teach wherein the second material is foam.
However, Formica teaches a patient interface (Figs. 25, 30-1, 30-2) with a seal forming structure (Figs. 30-1, 30-2: 542, 569) comprises:
a first section constructed from the first material, ( 542, paragraphs 251, 374, silicone) and
a second section (569) constructed from a second material different than the first material, (Paragraph 251, 374, made from foam)
It would have been obvious to a person of ordinary skill in the art prior to the filing date of the invention to have modified Bearne so that the second section was constructed from foam as taught by Formica since the courts have held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Bearne.
Regarding claim 28, Bearne teaches the patient interface of claim 21, but does not teach wherein the mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, and wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient’s lip superior so as to leave the patient’s philtrum uncovered by the mounting surface.
However, in another embodiment of Bearne, Bearne teaches wherein the mounting surface is substantially U-shaped or C-shaped and includes a first free end and a second free end, and wherein, in use, the first free end is configured to be spaced apart from the second free end along the patient’s lip superior so as to leave the patient’s philtrum uncovered by the mounting surface. (See Fig. 60 of Bearne, free ends 540, 542 are spaced apart and would leave the patient’s philtrum uncovered)
It would have been obvious to a person of ordinary skill in the art to have modified Bearne to include a first free end and a second free end as taught by the alternative embodiment of Bearne
Regarding claim 30, Bearne teaches the patient interface of claim 21, wherein the overhang is a first overhang the first section further including a second overhang spaced apart from the first overhang by a width approximately equal to a width of a patient’s nose.
However, in another embodiment, Bearne teaches wherein the overhang is a first overhang, the first section further including a second overhang spaced apart from the first overhang by a width approximately equal to a width of a patient’s nose. (See Fig. 60 of Bearne)
Allowable Subject Matter
Claim 29 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.
Regarding claim 29, Bearne teaches the patient interface of claim 21, wherein the overhang includes a first surface configured to contact the patient’s face (Figs. 78-79, top surface contacts patient’s face) and a second surface configured to contact the second section (Figs. 78, bottom surface contacts the second section and front angled portion of 740), wherein the first surface is inclined with respect to the second surface (See fig 78). However, Bearne does not teach wherein a distance between the first surface and the second surface decreases distal to the mounting surface.
Claims 31-41 are allowed.
Regarding claim 31, Bearne teaches a patient interface substantially as claimed with a first section and second section of a different material, a positioning and stabilizing structure to provide a force to hold a seal forming structure to a patient’s face.
However, Bearne does not teach a plenum chamber inlet port having at least one substantially straight surface, a mounting surface including relative to the substantially straight surface, wherein the straight surface is configured to be positioned substantially parallel to the patient’s sagittal plane in use and wherein the positioning and stabilizing structure is configured to provide a greater force to the second section as a result of the position of the straight surface in use as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:00 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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