DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed 11/18/2025. As directed by the amendment, claims 63, 75, 84, 87, 91, 101-104, 111, 118-121, 130, 136, 138, 143, 147, 148, 152 and 158-161 have been amended, claims 114, 116, 117, 140, 145, 146, 163-165, and 167-169 have been cancelled, and claims 171-182 have been added. As such, claims 63-66, 68, 71-77, 79, 82, 84, 85, 87, 89-92, 97-99, 101-104, 109-113, 115, 118-133, 135-139, 142-144, 147, 148, 150-156, 158-162, 166 and 170-182 are pending in the instant application.
Applicant has cancelled claims 164 and 168, rendering the previous rejections under 35 USC 112(a)/first paragraph moot.
Applicant has amended claim 147 to depend from pending claim 120, and cancelled claim 167, addressing or rendering moot the previous rejections under 35 USC 112(d)/fourth paragraph.
Response to Arguments
Applicant's arguments filed 11/18/2025 (hereinafter “Remarks”) with regards to support for the newly-added snap/arcuate protrusion have been fully considered but they are not persuasive.
Applicant argues on pages 19-20 that the non-elected species of Figs. 10-23 describes snap fingers and protrusions, asserting that “there is no basis for the Examiner’s belief that these features are not also present in the preceding example [i.e. the elected species of Figs. 1-5], primarily because these features are indeed shown,” and that “[i]n the example of Figs. 1-9, three snap fingers 1045 are shown on the shroud 1020 and a protrusion 1049(1) is shown on the collar 1049 of the frame 1040.”
The Examiner disagrees that the snap fingers and protrusions of non-elected species 10-23 are shown in the embodiment of Figs. 1-5, because the elected embodiment of Figs. 1-5 does not show the collar crenelations and locking sandwich tabs of non-elected species 10-23, and indeed, the presence of the particular snap fingers and protrusions in the non-elected species was the basis for the election between species. There is nothing in the specification as originally filed that describes the elected species of Figs. 1-5 as having a “snap protrusion configured to releaseably engage a shroud/arcuate protrusion configured to engage a shroud with a snap-fit.” Indeed, e.g. instant paras [0097] and [00186-187] only describe the frame of the embodiment of Figs. 1-5 as connecting to the shroud via an upper retaining mechanism (1048), whereas the description of a lower retaining mechanism including shroud snap fingers and frame/collar protrusions in e.g. paras [00192-195] is in conjunction with the unelected species of Figs. 10-26. Moreover, even if the drawings of the elected species are considered to nominally depict a protrusion 1049(1) around the outer end of the collar 1049 and nubs (1045) extending from the shroud 1020 according to the amendments to the drawings filed 11/18/2025, which is a stretch, as these newly-labeled elements could simply be drawing artifacts, a snap fit between the shroud 1020 and the collar 1049/that the newly-labeled nubs constitute “snap fingers” is not inherent, because these newly-labeled elements could simply be adjacent, non-interacting elements. Therefore, the Examiner has a solid basis for asserting that the snap features of the non-elected embodiment of Figs. 10-13 are not present in the elected embodiment of Figs. 1-5, namely, that the same features are not shown nor described in conjunction with the elected embodiment of Figs. 1-5.
Applicant argues on page 20 of Remarks that “paragraphs 189 and 190 describe taper locks in the context of both examples further demonstrating the contemplated relationship between them.”
The Examiner agrees that the specification supports taper locks in the context of both of the embodiments discussed above, because it clearly discusses and depicts taper locks in conjunction with both embodiments, see e.g. Figs. 2 and 11 and paras [00186-188], which is evidence against Applicant’s insinuation that an element in one embodiment should be inferred to be bodily incorporated in another other embodiment, because, as demonstrated by Applicant, the specification as orinally filed clearly and unambiguously depicts and describes elements that are shared between embodiments, such that the silence regarding any snap-fitting of the shroud 1020 to the collar 1049 (and specifically the snap-fitting depicted in conjunction with the species of Figs. 10-13) is inferred to mean that said snap-fitting is not present, because otherwise it would have been clearly indicated, similar to the taper locks.
Applicant argues on page 20 of Remarks that their boiler plate language in para [0235] contemplates features of one example being applied to others.
If Applicant is asserting that a combination of elements from the elected species and the non-elected species is what supports the instant claims, then Applicant is asserting that the support for the claims is a non-elected species/combination. For purposes of examination, the claims will be examined as if they are descriptive of the elected species, i.e. they are not being withdrawn, but their support cannot be said to be a non-elected species.
Applicant references on page 20 of Remarks “the original PCT claims 41 and 42.”
The Examiner respectfully notes that the original claims 41 and 42 are supported by the non-elected embodiment discussed above; there is no indication that the limitations of the PCT claims 41 and 42 are present in the elected embodiment of Figs. 1-5.
Applicant’s arguments with respect to claim(s) 63 and 120 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument, because D’Souza is an anticipatory reference for the amended protrusion and multiple rejections are not included below for sake of compact prosecution. (See also Lovell (US 6,631,718 B1; Fig. 10A) as another anticipatory reference.) However, it is noted that previously-applied Berthon-Jones in view of Burz would still read on at least the independent amended claims, because the independent claims do not positively recite the shroud, i.e. it (and any “snapping” thereto) is merely intended use, and the claimed protrusion would still read on the protrusion taught at the inner end of the collar in Burz Fig. 15 (which snap-engages with flange 100I because flange 100I is depicted on standard snap fingers in Burz Fig. 14, as would have been readily understood by an artisan at the time of invention) because no location for the protrusion relative to the inner/outer surface of the mask is stipulated in the amended independent claims and the protrusion taught by Burz is fully capable of snapping to a shroud in the same way it interacts with the snap fingers of the elbow as shown in Burz Figs. 14-15. Similarly, without positively reciting the shroud, the independent claims are also taught by e.g. Namey (US 2002/0020416 A1), when combined with the flanged collar taught by Lubke et al. (US 2006/0283461 A1; Fig. 120F), because an unclaimed shroud is fully capable of interfacing with a flanged collar in the same way as a flanged collar interfaces with an elbow.
Specification
The amendment filed 11/18/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the description of a protrusion 1049(1) in para [0097] and associated label in Figs. 1C, 1D, 2 and 4, and the description of snap fingers 1045 on shroud 1020 in para [0097] and associated label in Fig. 4. The specification as originally filed did not identify or discuss these elements, nor did it ascribe to them any functionality, much less snap functionality therebetween, in particular.
Applicant is required to cancel the new matter in the reply to this Office Action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1032” has been used to designate both an opening in the frame 1040 (paras [0099] and [0169]) and an opening in the shroud 1020 (Figs. 3-6). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 63-66, 68, 71-77, 79, 82, 84, 85, 87, 89-92, 97-99, 101-104, 109-113, 115, 118-133, 135-139, 142-144, 147, 148, 150-156, 158-162,166 and 170-182 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 63 and 120 (and thus their dependent claims), the frame of the elected species of Figs. 1-5 was not described in the specification as originally filed as having a “snap protrusion configured to releaseably engage a shroud/protrusion configured to engage a shroud with a snap-fit.” Indeed, e.g. instant paras [0097] and [00186-187] only describe the frame of the embodiment of Figs. 1-5 as connecting to the shroud via an upper retaining mechanism (1048), whereas the description of a lower retaining mechanism including shroud snap fingers and frame/collar protrusions in e.g. paras [00192-195] is in conjunction with the unelected species of Figs. 10-26. Moreover, even if the drawings of the elected species are considered to nominally depict a protrusion around the outer end of the collar 1049 and nubs extending from the shroud 1020, which is a stretch, as these newly-labeled elements could simply be drawing artifacts, a snap fit between the shroud 1020 and the collar 1049 is not inherent, because these newly-labeled elements could simply be adjacent, non-interacting elements. As such, claims 63 and 120 (and thus their dependent claims), considered to read on the elected species for purposes of compact prosecution, contain new matter with regards to a “snap protrusion configured to releaseably engage a shroud/protrusion configured to engage a shroud with a snap-fit.”
Further regarding claims 84, 101, 143 and 158, it is understood that Applicant has directed the amended claims away from the protrusion 1044 on the second end of the collar, see e.g. to the left in Fig. 1D, and towards the protrusion 1049(1), allegedly disclosed on the first end of the collar 1049, see e.g. to the right in amended Fig. 1D. This protrusion, allegedly for engaging the shroud, is not disclosed as “spaced from the first end of the collar;” rather, at best, it is located at the first end of the collar. Therefore, claims 84, 101, 143 and 158 contain new matter as dependent on amended claims 63 and 120.
Further regarding claims 174 and 182, the mere absence of a positive recitation is not basis for an exclusion, see MPEP 2173.05(i). There is nothing in the specification as originally filed that excludes components to secure the frame to the shroud positioned inferior to the collar; as such, claims 174 and 182 contain new matter.
Further regarding claims 176 and 177, aside from the indefiniteness (see 112(b) section below), any protrusion on the disclosed collar of the specification as originally filed is “associated with” an elbow because the disclosed collar is configured to receive an elbow, which must pass through/be positioned in or near (“be associated with”) any radial protrusion of the collar, such that claims 176 and 177 contain new matter.
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 175-178 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.
Regarding claims 175 and 178, it is unclear what is to be considered the scope of a “rigid shell,” since the independent claims already recite that the frame is molded from a relatively rigid material and at least partially forms a breathing chamber and has an outer surface, i.e. meets the definition of “a shell,” i.e. a hard outer case, i.e. it is unclear how claims 175 and 178 are intended to be further limiting. For purposes of examination, any mask frame that meets the limitations of the independent claims comprehends “a rigid shell.”
Regarding claims 176 and 177, it is unclear if the claims are reciting intended use/improper method steps, i.e. “not associated with” is an active prevention step, or the language is intended to apply to an overall system comprising the claimed cushion module, or whether the limitations should be read as structurally applied to the cushion module, e.g. “not associated with” should be read as “does not comprise” or “is not connectable to” (although “not connectable to” is not supported by the specification as originally filed). Since e.g. para [0091] of the specification indicates that a forehead support can be added/associated with the frame, and the collar (and thus any protrusion thereof) is disclosed as being associated with an elbow as discussed in the 112(a) section above, it is unclear that either reading is supported by the specification as originally filed; for purposes of examination and compact prosecution, as best understood, both a method-step interpretation as well as a system that does not comprise a forehead support and a snap protrusion that positively engages with a shroud (with headgear connectors) while not directly contacting an elbow will be considered to read on the instant claims.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 63-66, 68, 75, 76, 82, 85, 87, 89, 91, 92, 102, 103, 111-113, 118-125, 130, 131, 136-139, 142, 147, 148, 150, 152, 153, 159, 160, 171-173 and 175-181 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by D’Souza et al. (WO 2007/041751 A1; hereinafter “D’Souza”).
Regarding claim 63, D’Souza discloses a cushion module (cushion/frame sub-assembly 430) (Figs. 6-7) for a patient interface for treatment of a respiratory disorder in a patient with a supply of air at continuously positive pressure (para [0003]), the cushion module comprising:
a cushion (cushion 416) constructed from a first material (cushion 416 is constructed of liquid silicone rubber, para [0097]), the cushion being shaped and dimensioned to contact and seal against the patient's face in use (Fig. 6; para [0081]); and
a frame (frame 414) molded from a second material that is more rigid than the first material of the cushion (frame 414 is constructed of polycarbonate, para [0098]; wherein “molded” is a product-by-process limitation and the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113; the process of molding produces a frame and D’Souza discloses a frame, thus anticipating the claimed limitation, and see also e.g. D’Souza para [00133], which discusses molding to produce a polycarbonate frame), the frame being connected to the cushion (Fig. 7; para [0099]), and the frame comprising:
a wall having an inner surface (facing down in Fig. 6) configured to at least partially form a breathing chamber in use; and an outer surface (facing up in Fig. 6) opposite the inner surface;
a collar (defining opening 418) that extends from the wall and forms a hole (opening 418) (Fig. 6; para [0098]); and
a snap protrusion (annular wall 440) that extends radially from the collar and is configured to releasably engage a shroud (skeleton frame 412) of the patient interface (Fig. 8; para [00101], wherein the protrusion is considered to be a snap protrusion because it has the same structure as asserted by Applicant, i.e. an annular protrusion that extends from the end of a collar), and the snap protrusion extending from a position on the collar that is, in an axial direction of the collar, spaced from the wall (Fig. 6, where the flange/annular wall is positioned at the upper end of the collar/spaced from the wall by the upright wall of the collar);
wherein the frame (414) does not include a forehead support (Fig. 6);
wherein the frame (414) does not include upper headgear clip receptacles (Fig. 6); and
wherein the frame (414) does not include lower headgear clip receptacles (Fig. 6).
Regarding claim 120, D’souza discloses a cushion module (cushion/frame sub-assembly 430) (Figs. 6-7) for a patient interface for treatment of a respiratory disorder in a patient with a supply of air at continuously positive pressure (para [0003]), the cushion module comprising:
a cushion (cushion 416) constructed from a first material (cushion 416 is constructed of liquid silicone rubber, para [0097]), the cushion being shaped and dimensioned to contact and seal against the patient's face in use (Fig. 6; para [0081]); and
a frame (frame 414) molded from a second material that is more rigid than the first material of the cushion (frame 414 is constructed of polycarbonate, para [0098]; wherein “molded” is a product-by-process limitation and the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113; the process of molding produces a frame and D’Souza discloses a frame, thus anticipating the claimed limitation, and see also e.g. D’Souza para [00133], which discusses molding to produce a polycarbonate frame), the frame being connected to the cushion (Fig. 7; para [0099]), and the frame comprising:
a wall having an inner surface (facing down in Fig. 6) configured to at least partially form a breathing chamber in use; and an outer surface (facing up in Fig. 6) opposite the inner surface;
a collar (defining opening 418) that extends from the wall and forms a hole (opening 418) (Fig. 6; para [0098]); and
an arcuate protrusion (annular wall 440) that is spaced from the wall (Fig. 6, where the flange/annular wall is positioned at the upper end of the collar/spaced from the wall by the upright wall of the collar) and is configured to releasably engage a shroud (skeleton frame 412) of the patient interface with a snap fit (Fig. 8; para [00101], wherein the engagement is considered to be a snap fit because the protrusion has the same structure as asserted by Applicant, i.e. an annular protrusion that extends from the end of a collar, which “snaps” over seal 448, see Figs. 7-8 in view of para [00101]);
wherein the frame (414) does not include a forehead support (Fig. 6);
wherein the frame (414) does not include upper headgear clip receptacles (Fig. 6); and
wherein the frame (414) does not include lower headgear clip receptacles (Fig. 6).
Regarding claims 64 and 122, D’Souza discloses the cushion module of claims 63 and 120, wherein the second material is polycarbonate (frame 414 is constructed of polycarbonate, para [0098]).
Regarding claims 65 and 123, D’Souza discloses the cushion module of claims 64 and 122, wherein the first material is silicone (cushion 416 is constructed of liquid silicone rubber, para [0097]).
Regarding claims 66, 112, 124 and 137, D’Souza discloses the cushion module of claims 63, 65, 120 and 123, consisting of the cushion and the frame (Figs. 6-7, where cushion/frame sub-assembly 430 is constituted solely by 414+416).
Regarding claims 68 and 125, D’Souza discloses the cushion module of claims 63 and 125, wherein the hole of the frame is configured to allow the supply of air at continuously positive pressure into the breathing chamber (Fig. 8; para [0098] in view of paras [0003] and [0081]).
Regarding claims 75, 103, 130 and 160, D’Souza discloses the cushion module of claims 63, 92, 120 and 153, wherein the frame is shaped and dimensioned to limit rotation of a shroud of the patient interface relative to the frame when the frame is connected to the shroud (Figs. 7-8, where the triangular shape of frame 414 and intended positioning of shroud 412 relative to frame 414 prevents rotation of the shroud relative to the frame).
Regarding claims 76 and 131, D’Souza discloses the cushion module of claims 63 and 120, wherein D’Souza further discloses wherein the cushion comprises a membrane configured to contact and seal against the patient's face and an undercushion configured to support the membrane against the patient's face (Fig. 6 in view of e.g. Fig. 5; the cushion 416 includes…a face contacting portion 426…426 has a double wall construction, e.g. membrane and underlying support cushion, para [0097]).
Regarding claims 82 and 142, D’Souza discloses the cushion module of claims 63 and 139, wherein the collar extends from the outer surface of the frame to a first end (upper end, at annular wall 440 in Fig. 6).
Regarding claims 85 and 147, D’Souza discloses the cushion module of claims 63 and 120, wherein an internal surface and an external surface of the collar form concentric circles (Fig. 6, the collar is a circular tube and thus has concentric inner and outer circular surfaces).
Regarding claims 87 and 148, D’Souza discloses the cushion module of claims 63 and 120, wherein the frame has a first surface (the flat lower surface surrounding opening 418) (Fig. 6) configured to be positioned adjacent to and covered by the shroud (412) of the patient interface when connected to the frame (Fig. 8) and a second surface (the surface of the raised area upper immediately below top portion 431) that is positioned radially outward of the first surface and configured to not be covered by the shroud when connected to the frame (Fig. 8), and
wherein the first surface is shaped differently from the second surface (Figs. 6-8, where the first surface is generally trapezoidally shaped and the second surface is generally triangularly shaped).
Regarding claims 89 and 150, D’Souza discloses the cushion module of claims 87 and 148, wherein the first surface is oriented at a first angle relative to an axis of the hole and the second surface is oriented at a second angle relative to the axis of the hole, the first angle being steeper relative to the axis of the hole than the second angle (Fig. 8, where the flat surface is perpendicular to the axis of the hole, and the second surface is oriented at angles less than that).
Regarding claims 91, 102, 152 and 159, D’Souza discloses the cushion module of claims 63, 92, 120 and 153, wherein the collar is configured to releasably and rotatably engage an elbow of the patient interface, because the collar is tubular, the same as the instantly disclosed collar, and there is nothing in the structure of the collar of D’Souza that would preclude this intended use.
Regarding claims 92 and 153, D’Souza discloses the cushion module of claims 63 and 120, wherein:
the first material is silicone (cushion 416 is constructed of liquid silicone rubber, para [0097]), and
the second material is polycarbonate (frame 414 is constructed of polycarbonate, para [0098]).
Regarding claims 111 and 136, D’Souza discloses the cushion module of claims 63 and 120, wherein the frame(, the collar) and the snap/arcuate protrusion are molded from a single piece of the second material (Fig. 6, where the frame/collar/protrusion are a single piece; para [0098] in view of e.g. Fig. 35 and para [00142] and the discussion above regarding the product-by-process of molding).
Regarding claims 113 and 139, D’Souza discloses the cushion module of claims 63 and 120, wherein the hole (418) is circular (Fig. 6).
Regarding claims 118 and 121, D’Souza discloses the cushion module of claims 63 and 120, wherein the snap/arcuate protrusion (440) extends around the entire circumference of the collar (Fig. 6).
Regarding claims 119 and 138, D’Souza discloses the cushion module of claims 63 and 120, wherein the snap/arcuate protrusion (440) forms a circle (Fig. 6).
Regarding claims 171 and 179, D’Souza discloses the cushion module of claims 63 and 120, wherein a portion of the collar extends, in an axial direction of the collar, past at least a portion of the outer surface of the wall (Fig. 6).
Regarding claims 172 and 180, D’Souza discloses the cushion module of claims 63 and 120, wherein a portion of the outer surface of the wall immediately surrounding the hole is configured to be covered by the shroud (412) when the shroud releasably engages the snap/arcuate protrusion (with the snap fit) (Figs. 7-8).
Regarding claims 173 and 181, D’Souza discloses the cushion module of claims 63 and 120, wherein the collar does not extend beyond a forwardmost portion of the outer surface of the wall (Fig. 8).
Regarding claims 175 and 178, D’Souza discloses the cushion module of claims 63 and 120, wherein the frame is a rigid shell (Fig. 6 and see claim 63/120 discussions above).
Regarding claims 176 and 177, D’Souza discloses the cushion module of claim 63 and 120, in one interpretation, D’Souza discloses wherein the frame (414) is not associated with a forehead support because no forehead support is shown/associated with any component in Figs. 6-8, and
wherein the snap protrusion (440) is not associated with an elbow because no elbow is shown/associated with any component in Figs. 6-8 and is configured to connect to a shroud (412) with headgear connectors (headgear clip receptacles 446).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 71, 97, 104, 109, 126, 154, 161 and 162 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Jones et al. (US 2006/0201514 A1; hereinafter “Jones”).
Regarding claims 71, 97, 126, 154, D’Souza discloses the cushion module of claims 63, 92, 120 and 153, but D’Souza is silent regarding wherein the frame includes vent holes. However, Jones teaches that it was known in the respiratory mask art at the time of invention for the dome of a cushion module (shell/cushion 30) to include vent holes (vent orifices 30.9) (Figs. 5 and 7), such that it would have been obvious to an artisan at the time of invention for the domed frame of D’Souza to include vent holes as taught by Jones, in order to provide the predictable result of allowing the venting of expired gases from the mask.
Regarding claims 104 and 161, D’Souza discloses the patient interface system comprising:
the cushion modules of claims 63 and 120 (see discussion of claim 63 above and claim 120 below),
the shroud (skeleton frame 412) configured to be releasably connected to each of the cushion modules (para [0098]); and
headgear (headgear assembly) releasably connected to the shroud and configured to hold the shroud and one of the cushion modules in a therapeutically effective position on the patient's head (para [00101] in view of paras [0003] and [0015]).
D’Souza is silent regarding two or more of the cushion modules, each of the cushion modules being a different size, with the shroud configured to be interchangeably connected to each of cushion module. However, Jones demonstrates that it was well known in the respiratory mask art at the time of invention to provide two or more cushion modules (shell/cushion 30), each of the cushion being a different size ([a] range of shell/cushion 30 sizes, para [0222]), with a component (frame 40) configured to be interchangeably connected to each of cushion module (Fig. 7; para [0182] in view of para [0222]). Therefore, it would have been obvious to an artisan at the time of invention to modify the system of D’Souza to include two or more of the cushion modules, each of the cushion modules being a different size, with the shroud configured to be interchangeably connected to each of cushion module as taught by Jones, in order to provide the predictable result of a system that allows a user to select an appropriately sized cushion and utilize it with interchangeable sub-components for cost savings.
Regarding claims 109 and 162, D’Souza in view of Jones teaches the patient interface system of claims 104 and 161, wherein D’Souza further discloses an elbow configured to be connected to an air delivery tube (para [00100]), but D’Souza is silent regarding wherein the elbow is rotatable relative to the shroud. However, Jones teaches that it was known in the respiratory mask art at the time of invention to provide an elbow (elbow 50) is rotatable relative to the shroud (frame 40) (Figs. 1 and 7; paras [0275-276] and [0297]). Therefore, it would have been obvious to an artisan at the time of invention to modify D’Souza to include wherein the elbow is rotatable relative to the shroud as taught by Jones, in order to predictably allow the elbow to be placed in any desired position (Jones para [0276]) without affecting the shroud/headgear arrangement.
Claims 72-74, 98, 99, 110, 127-129, 135, 155 and 156 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Kwok et al. (US 2002/0005198 A1; hereinafter “Kwok”).
Regarding claims 72, 74, 98, 99, 110, 127, 129, 135, 155 and 156, D’Souza discloses the cushion module of claims 63, 92, 120 and 153, wherein D’Souza further discloses wherein the cushion (416) is an oro-nasal cushion configured to direct the supply of air at continuously positive pressure to the patient's nares and the patient's mouth that forms a single orifice and is shaped and dimensioned to contact and seal against the patient's face around the patient's nose and mouth (Fig. 6; paras [0096-101] in view of paras [0003] and [0081]), but D’Souza does not explicitly state that a lowermost portion of the cushion is shaped and dimensioned to contact and seal against the patient's face above the chin and below the mouth. However, this was a common intended positioning for oro-nasal cushions at the time of invention, as taught by Kwok Fig. 17 and paras [0010] and [0072]. Therefore, it would have been obvious to an artisan at the time of invention for the lowermost portion of the cushion of the oro-nasal mask of D’Souza to be shaped and dimensioned to contact and seal against the patient's face above the chin and below the mouth as taught by Kwok, in order to provide a standard configuration/placement for the oro-nasal mask for effecting the seal around the user’s nose and mouth.
Regarding claims 73 and 128, D’Souza discloses the cushion module of claims 63 and 120, wherein D’Souza further discloses wherein the cushion (416) forms a single orifice (Fig. 6) and is shaped and dimensioned to seal the patient's nose while leaving the patient's mouth uncovered (paras [0096-101] in view of the mask being a nasal mask per [0081]), but D’Souza does not explicitly state that nasal mask cushion is shaped and dimensioned to contact and seal against the patient's face around the patient's nose. However, this was a common intended arrangement for nasal cushions at the time of invention, as taught by Kwok Fig. 4 and para [0060]. Therefore, it would have been obvious to an artisan at the time of invention for the cushion of the nasal mask of D’Souza to be shaped and dimensioned to contact and seal against the patient's face around the patient's nose as taught by Kwok, in order to provide a standard configuration/placement for the nasal mask for effecting the seal around the user’s nose.
Claims 77 and 132 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Ho (US 7,640,933 B1; hereinafter “Ho”).
Regarding claims 77 and 132, D’Souza discloses the cushion module of claims 63 and 120, wherein the first material is silicone (see claim 65 discussion above), but D’Souza is silent regarding wherein the silicone includes at least one polished surface region configured to contact the patient's face and at least one frosted surface region. However, Ho teaches that it was known in the respiratory mask art at the time of invention for a cushion (module) (comprising seal 102) to be constructed from silicone (col. 5, lines 21-22; col. 7, lines 30-32) that includes at least one polished surface region (non-textured/polished area(s)) configured to contact the patient's face and at least one frosted surface region (textured area(s)) (col. 4, line 62-col. 5, line 36; providing the textured area only at select locations on the seal…at the bridge of the nose or at the portion of the seal that underlies the nose, col. 6, lines 29-32). Therefore, it would have been obvious to an artisan at the time of invention for the silicone cushion of D’Souza to include at least one polished surface region configured to contact the patient's face and at least one frosted surface region as taught by Ho, in order to provide the predictable result(s) of reduced skin irritation, greater breathability/comfort, reduced sticky/tacky feeling, more effective sealing and/or enhanced aesthetic appearance (Ho col. 1, line 51-col. 2, line 19).
Claims 79 and 133 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Davidson et al. (WO 2006/074513; hereinafter “Davidson”).
Regarding claims 79 and 133, D’Souza discloses the cushion module of claims 63 and 120, wherein D’Souza further discloses wherein the cushion is connected to the frame at a connection region and has a contacting and sealing surface configured to contact and seal against the patient's face (Fig. 6; paras [0097] and [0081]), and
but D’Souza is silent regarding wherein a portion of the cushion between the connection region and the contacting and sealing surface extends radially outward beyond the connection region. However, Davidson demonstrates that it was well known in the respiratory mask cushion art at the time of invention for a portion of the cushion (comprising external cushion point 39) between the connection region (non-face-contacting portion 12) and the contacting and sealing surface (of membrane 32) to extend radially outward beyond the connection region (e.g. Figs. 30J, 30L-N, 64), such that that it would have been obvious to an artisan at the time of invention for the cushion of D’Souza to comprise a portion of the cushion between the connection region and the contacting and sealing surface that extends radially outward beyond the connection region as taught by Davidson, in order to provide the predictable result of a desired degree of spring for comfort and/or leakage protection (Davidson, paras [0081-83], [0097]).
Claims 84, 101, 115, 143, 144, 158, 166 and 170 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Burz et al. (US 2009/0032024 A1; hereinafter “Burz”).
Regarding claims 84, 101, 143 and 158, D’Souza discloses the cushion module of claims 82, 92, 142 and 152, wherein D’Sousa further discloses wherein the collar extends from the outer surface of the frame to a first end (upper end, at annular wall 440 in Fig. 6), but D’Souza is silent regarding wherein the arcuate protrusion is spaced from the first end of the collar. However, it has been held that rearranging parts of an invention involves only routine skill in the art, see MPEP 2144.04.VI.C, and Burz teaches that it was known in the respiratory mask art at the time of invention to include wherein an external-element-engaging protrusion is spaced from the first end of the collar (see the nubs/inferred circular bead that projects from the external surface of the collar of the mask frame and engages with the elbow in Fig. 45). Therefore, it would have been obvious to an artisan at the time of invention to modify D’Souza to either shift the wall/flange 440 closer to the frame or extend the tubular opening of the collar past the wall/flange 440 such that the arcuate protrusion is spaced from the first end of the collar as taught by Burz, in order to provide the predictable result of an extension of the collar beyond that protrusion, which inserts into the connecting tube/elbow to facilitate a sealed connection therewith.
Regarding claims 115, 144, 166 and 170, D’Souza discloses the cushion module of claims 63, 82, 142 and 120, but D’Souza is silent regarding wherein the collar extends (rearwardly) from the inner surface of the frame (into the breathing chamber past at least a portion of the inner surface of the frame) to a second end opposite the first end. However, Burz teaches that it was known in the respiratory mask art at the time of invention to include wherein the collar (comprising socket 68I) (Fig. 15) extends (rearwardly) from the inner surface of the frame (into the breathing chamber past at least a portion of the inner surface of the frame) to a second end opposite the first end (to the right in Fig. 15). Therefore, it would have been obvious to an artisan at the time of invention to modify D’Souza to include wherein the collar extends (rearwardly) from the inner surface of the frame (into the breathing chamber past at least a portion of the inner surface of the frame) to a second end opposite the first end as taught by Burz, in order to utilize a common mask-elbow connection construction in the art at the time of invention to provide the predictable result of an extension of the collar into the mask for receiving/interlocking the connecting tube/elbow therein to facilitate a sealed connection therewith and delivery of gas directly into the mask.
Claims 90, 151, 174 and 182 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza.
Regarding claims 90 and 151, D’Souza discloses the cushion module of claims 63 and 120, wherein D’Souza further discloses that the cushion (416) and the frame (414) are mechanically interlocked (para [0099]), and that mechanical interlocks were well known to include wherein the cushion and the frame are joined in a tongue and groove arrangement (e.g. Fig. 24), but D’Souza does not explicitly disclose that the mechanical interlock of the embodiment of Figs. 6-8 is particularly a tongue and groove arrangement. However, it would have been obvious to an artisan at the time of invention for the mechanical interlock of the embodiment of D’Souza Figs. 6-8 to include wherein the cushion and the frame are joined in a tongue and groove arrangement as taught by e.g. D’Souza Fig. 24, in order to utilize a standard mechanical interlock to provide the predictable result of a secure and leak-free connection between the cushion and the frame.
Regarding claims 174 and 182, D’Souza discloses the cushion module of claim 63, wherein D’Souza teaches that there can be any number of protrusions 442 (para [0098]) and D’Souza further teaches using only upper/lateral side anchor points (comprising hook 652 in Fig. 10 or comprising clips 852 in Figs. 14-15) for attaching a cushion to a frame, such that D’Souza teaches omitting the lower protrusion 442 in the embodiment of Figs. 6-8 to arrive at wherein the frame does not have any component to secure the frame to the shroud positioned inferior to the collar, in order to provide the predictable result of an easier-to-insert cushion module by virtue of having one fewer tab to have to navigate over the frame members 450 while still maintaining symmetrical securement features.
Claims 176 and 177 are rejected, in the alternative, under pre-AIA 35 U.S.C. 103(a) as being unpatentable over D’Souza in view of Lovell (US 6,631,718 B1; hereinafter “Lovell”).
Regarding claims 176 and 177, D’Souza discloses the cushion module of claim 63 and 120, in an alternative interpretation, as best understood, D’Souza discloses wherein the snap protrusion (440) is not associated with an elbow because the elbow is taught to be associated with the elbow connection seal 448 of the shroud 412 (para [00100]) and is configured to connect to a shroud (412) with headgear connectors (headgear clip receptacles 446),
but D’Souza is silent regarding wherein the frame is not associated with/configured to comprise a forehead support. However, Lovell teaches that it was known in the respiratory mask art at the time of invention for a headgear-connecting shroud (retainer 12/212) to either be associated with/configured to comprise a forehead support (Figs. 9-11) or not (Figs. 1 and 3). Therefore, it would have been obvious to an artisan at the time of invention to modify the headgear-connecting shroud of D’Souza to include wherein the frame is not associated with/configured to comprise a forehead support as taught by Lovell, in order to provide the predictable result of a shroud configured to connect with known headgear that is not configured for attachment to a forehead support.
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 KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHRYN E DITMER/Primary Examiner, Art Unit 3785