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 .
Response to Amendment
Claims 41-55 are previously presented, Claims 56-61 are new, therefore claims 41-61 are pending and currently under examination.
Response to Arguments
Applicant's arguments filed 05/14/2025 have been fully considered but they are not persuasive.
Applicant argues per pages 6-7 [02-04 and 01-03], respectively, with the limitation “flexible nasal seal comprising: a contacting surface comprising an edge, the edge defining a nose-receiving opening into the mask cavity, and the edge being configured to seal around a nose of a user” (with emphasis added), that the office action does not disclose such an arrangement. The examiner respectfully disagrees.
The previous rejection, set forth in the Office Action dated 01/15/2025, cites the elements on pg.3: flexible nasal seal (Fig. 5, ‘10’ and Ho [034]; ‘flexible elastomeric material’), contacting surface (of the flexible nasal seal) ‘87’, (flexible nasal seal comprising) an edge, the edge defining a nose- receiving opening into the mask cavity (Fig. 4, nose opening formed by surface ‘87’), and the edge being configured to seal about the user’s nose (Ho [035]).
Without changing the basic thrust of the rejection, merely further explaining, the Examiner notes additional citations from the prior art that are merely meant to further detail the rejections of record. See accordingly below.
The flexible nasal seal (‘10’) comprising an edge (‘87’), where the edge is a portion of the cushion (‘13’) – Ho Figure 5, an additional citation: (Ho [0033]; the flexible nasal seal (patient interface ‘10’) contains the edge (uppermost portion ‘87’ edge that contacts face seen in Figure 4, hereinafter the edge for simplicity in writing) of the cushion ‘13’ that overlies the nose of the patient). In addition, (Ho [0032]), as seen in Figure 5, the cushion portion ‘13’, forms a tight seal with the face of the patient.
Thereby the flexible nasal seal ‘10’ that contains the cushion ‘13’, that contains an edge ‘87’ of cushion ‘13’ is configured to seal around a nose of a user.
Item ‘29’ is recited in the previous rejection as the under-nose support that is fixedly connected within the flexible nasal seal ‘10’. The ‘seal surface 29’ is the under-nose support of the cushion, as additionally evidenced by Ho [0029]; where the seal surface ‘29’ is configured to conform with a lower portion of the nose and in Figure 5; ‘29’ is depicted as the lower portion (under-nose support) of the cushion ‘13’ that is the flexible nasal seal ‘10’.
Applicant cites towards Ho [051] in the Remarks pg.7 [02-03], for the separate structures of the seal surface ‘29’ (under-nose support) and the patient interface ‘10’ (nasal seal), “separates the function of stabilizing the patient interface from the function of creating a seal between the patient and the patient interface 10”. As cited above, by the Examiner and the Applicant, the nasal seal ‘10’ of Ho and the under-nose support ‘29’ of Ho are different portions of the nasal mask interface assembly.
The seal surface ‘29’ (under-nose support), is not the edge ‘87’ of the flexible nasal seal ‘10’ as both depicted in Figure 5 of Ho and cited previously above, and in the Office Action set forth 01/15/2025. As claimed “the edge being configured to seal around a nose of a user”, is as evidenced provided again: the edge ‘87’ of the cushion ‘13’ that makes up the flexible nasal seal is configured to seal around a user of Ho Figure 5 and through Ho [0032-0033]. Thereby, the seal surface ‘29’ (under-nose support) and the flexible nasal seal ‘10’ (patient interface) having different functions of stabilizing the patient interface vs. creation of a seal between the patient and the flexible nasal seal, does not impede on the fact that the edge ‘87’ of the cushion ‘13’ of the flexible nasal seal ‘10’ is sealed around the nose of a user, as previously explained. The seal surface ‘29’ is configured to provide a seal to the nasal passageway (Ho [0040], evidenced for further explanation), but not ‘around’ the nose, whereas the edge ‘87’ of the cushion ‘13’ (Ho [0032-0033]) is configured to seal around a nose of a user, as previously described above.
Thereby, the edge ‘87’ of Ho Figure 5, is configured to seal around a nose of a user.
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.
Claims 41-44, 55 and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho (US PGPub 2009/0120442).
Regarding claim 41, Ho teaches a nasal mask interface assembly (see Fig. 1) comprising:
a seal housing (Fig. 5, 11); a flexible nasal seal (Fig. 5, 10; see paragraph 34 "flexible" elastomeric material) connectable to the seal housing, the flexible nasal seal at least partially defining a mask cavity (see Fig. 4, cavity is formed in the housing), the flexible nasal seal extending between a face contacting side and an outer side (see Fig. 2; seal contacts the face at one end and extends towards an outer side to connect to a gas source), the flexible nasal seal comprising: a contacting surface (Fig. 4, 87) comprising an edge, the edge defining a nose- receiving opening into the mask cavity (see Fig. 4, nose opening formed by surface 87) and the edge being configured to seal about the user's nose (see paragraph 35); and an under-nose support fixedly connected within the flexible nasal seal (Fig. 4, 29) the under-nose support extending into the mask cavity (see Fig. 4, 29 extends inward) the under-nose support having a contact surface that is oriented to contact at least a portion of the under-nose surface of the user (see paragraph 29)
Headgear comprising a single left side strap and a single right side strap (see fig. 1, single strap going along the face, one on each side), the single left side strap and the single right side strap being capable of extending over a left ear and a right ear of the user respectively (see fig. 1, the straps go over the ears); and
A yoke releasably connectable to the seal housing (fig. 3, yoke 150 connects to seal housing 10), the yoke comprising a pair of opposing distal ends (fig. 3, end with slot 152 on each end of the yoke), each of the pair of opposing distal ends of the yoke being connectable to a corresponding end of one of the single left side strap and the single right side strap such that the headgear is connected to the yoke to define a closed loop headgear system (see fig. 1 and paragraph 30, the ends have slots 152 that connect to the side straps, respectively, and define a closed headgear system).
Regarding claim 42, Ho further teaches wherein the under-nose support comprises an elongate main lateral portion (see fig. 4, elongate main lateral portion 29), the elongate main lateral portion connected to and suspended between opposing sidewall portions of the flexible nasal seal such that the elongate main lateral portion extends laterally within the mask cavity (see figs. 4 and 5, the main lateral portion is suspended between the sidewalls and extends laterally within the mask cavity).
Regarding claim 43, Ho further teaches wherein the under-nose support comprises an elongated strip or band of material (see fig. 4, strip of material 53), the elongated strip or band of material extending laterally across and within the flexible nasal seal between opposing sides of the flexible nasal seal (see fig. 4, strip 53 extends laterally between the opposing sides), the elongated strip or band of material being located rearwardly of the contacting surface (see fig. 5, strip 53 is located rearwardly of contacting surface 13), and the under-nose support being conformable with a sling-like effect to the under-nose surface of the use (see paragraph 47, strip 53 made of elastic material that presses against the under-nose of the user).
Regarding claim 44, Ho further teaches wherein the yoke is substantially elongate (see fig. 3, elongate yoke 150), the yoke comprising a strap connector located at or near each of the pair of opposing distal ends of the yoke such that there are a pair of strap connectors (see fig. 3 and paragraph 30, strap connector cutout 152 on each side of the yoke).
Regarding claim 55, Ho further teaches wherein each of the single left side strap and the single right side strap can extend along sides or cheeks of a face of the user (see fig. 1, the straps extend along the sides/cheeks of the user's face).
Regarding claim 59, Ho further discloses the nasal mask interface assembly of Claim 41, wherein the seal housing comprises a gas inlet, wherein the yoke is connectable to the seal housing at a location spaced from the gas inlet (Ho Figure 5; where ‘11’ is the seal housing, where the yoke ‘150’ is connectable to the seal housing in Figure 11, and in Figure 11; where the yoke ‘150’ is at a location spaced apart from the gas inlet ‘30’ (seen in Ho Figure 6), where the gas inlet is the port for gas to go through the mask and to the patient).
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442) in view of McLaren et al. (WO 2014175752).
Regarding claim 45, Ho teaches all previous elements of the claim as stated above but does not teach wherein each of the pair of strap connectors comprises an end cap to provide a pair of end caps, the pair of end caps located with one of the pair of end caps at each of the pair of opposing distal ends of the yoke, and each of the pair of end caps being non-removably connected to the corresponding one of the pair of opposing ends of the yoke.
However, McLaren teaches an analogous nasal mask interface assembly (abstract and fig. 1) wherein the headgear comprises a pair of strap connectors (fig. 33, connectors 1304 on each end of the yoke) each of the pair of strap connectors comprises an end cap to provide a pair of end caps (see fig. 22, end caps on the end of housing 1304; see paragraph 198 ), the pair of end caps located with one of the pair of end caps at each of the pair of opposing distal ends of the yoke (see fig. 22, located on each end), and each of the pair of end caps being non- removably connected to the corresponding one of the pair of opposing ends of the yoke (see fig. 22 and paragraph 144, the headgear assembly and interface assembly can be integrally formed).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the yoke of Ho to have the attachment
mechanism taught by McLaren comprising end caps so that the headgear can be adjusted using an auto-adjusting mechanism to achieve a "balanced fit" that reduces leaks and improves performance (see paragraph 12 of McLaren).
Claims 46-53 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442) in view of McLaren et al. (WO 2014175752 as applied to claim 45 above, and further in view of Lewis (US 4578843).
Regarding claim 46, Ho, as modified, teaches all previous elements of the claim as stated above but does not teach wherein each of the pair of end caps is over-molded onto a braided element of each of the single left side strap and the single right side strap.
However, Lewis teaches an analogous strap connector (abstract and fig. 1) wherein the end cap is overmolded onto a braided element of the strap (see col. 2, line 67 - col. 3, line 14, the braided strap is molded into end cap 12; see fig. 2).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the straps of Ho to have a braided element as Lewis teaches this is a known material used in straps and to modify the straps of Ho to be overmolded into the end caps, as taught by Lewis, for the purpose of connecting the strap and end cap in a manner that will not disconnect during usage (see Lewis col. 1, lines 28-29).
Regarding claim 47, Ho, as modified, teaches all previous elements of the claim as stated above but does not teach wherein the yoke defines a collector for core elements used in an automatically adjustable headgear.
However, McLaren teaches an analogous nasal mask interface assembly (abstract and fig. 1) wherein the yoke (fig. 22, yoke shown on the front of the mask between attachment points 1304) defines a collector for core elements used in an automatically adjustable headgear (see figs. 21-22 and paragraphs 198-200, the interior of the yoke defines a collector for the core elements 1316 to pass into).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the yoke of Ho to have a collector and the straps of Ho to have core elements collected by the collector, as taught by McLaren, for the purpose of adjusting the fit of the headgear to the user to improve performance (see McLaren paragraph 12).
Regarding claim 48, Ho, as modified, further teaches wherein the core elements extend within the braided element (braided strap material as modified by Lewis; see fig. 22 of McLaren, the core elements 1316 extend within the strap) of each of the single left side strap and the single right side strap (see fig. 1 of Ho, each side of the yoke connects to one strap, the end of the yoke having the attachment mechanism taught by McLaren), and each of the pair of end caps connect the braided element of each of the single left side strap and the single right side strap and headgear to the yoke to define the closed loop headgear system (as modified by McLaren, the end caps are on the ends of the yoke and connect the straps to the yoke to define a closed loop headgear system).
Regarding claim 49, Ho, as modified, further teaches wherein the yoke comprises one or more directional locks that interact with the core elements that extend from each of the single left side strap and the single right side strap of the automatically adjustable headgear (see McLaren figs. 21A-B and paragraphs 198-199, lock 1300 locks the core elements 1316 in place; Ho teaches a strap on each side of the yoke, each strap connects to the yoke through locking mechanism 1300 taught by McLaren within the attachment point to the yoke).
Regarding claim 50, Ho, as modified, further teaches wherein at least one of the one or more directional locks comprises a washer mechanism that frictionally engages with at least one of the core elements during elongation of the automatically adjustable headgear (Fig. 21A-21B, washer mechanism 1308 frictionally engages with core element 1316 as shown in fig. 21B; see paragraphs 198-199), the washer mechanism allowing relatively friction-free movement of the at least one of the core elements during retraction of the automatically adjustable headgear (see fig. 21A and paragraphs 198-199, in the configuration shown in fig. 21A, the core element is able to pass through the washer).
Regarding claim 51, Ho, as modified, further teaches wherein the one or more directional locks are adaptable between a locked configuration and an open configuration (see figs. 21A-21B and paragraphs 198-199 of McLaren).
Regarding claim 52, Ho, as modified, further teaches wherein, in the locked
configuration, a path provided for the core elements through the one or more directional locks is non-linear or tortuous and movement of the core elements is restricted through the directional locks (see McLaren fig. 21B and paragraph 199, the angle of washer 1308 creates a non-linear path for the core element 1316 to apply friction and restrict movement of the core element).
Regarding claim 53, Ho, as modified, further teaches wherein, in the open
configuration, a path is provided for the core elements to be pulled substantially freely though the directional locks (see paragraphs 198-199 and fig. 21A, the core elements can be pulled through the washer in the open configuration).
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442) in view of Salmon et al. (WO 2010/131189).
Regarding claim 54, Ho teaches all previous elements of the claim as stated above but does not teach wherein the seal housing comprises a yoke channel and an exterior surface, the yoke channel extending laterally across the exterior surface of the seal housing, the yoke channel being capable of releasably receiving and retaining the yoke.
However, Salmon teaches an analogous nasal mask interface (see abstract and Fig. 1) comprising a yoke connected or connectable to the seal housing (see Fig. 5A, yoke 501 connects to seal housing at 503) wherein the seal housing comprises a yoke channel and an exterior surface, the yoke channel extending laterally across the exterior surface of the seal housing (see 5A, opening 503 in an exterior of the housing comprised of channel that receive yoke 501, the channel extends laterally), the yoke channel being capable of releasably receiving and retaining the yoke (see fig. 5A and pg. 16, line 25- pg. 17 line 2).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the housing of Ho to include a yoke channel for connecting the yoke to the seal housing, as taught by Salmon, for the purpose of providing a connection between the nasal seal housing and the headgear housing that secures the straps and ensures a proper seal when in use (see page 16, lines 34- page 17 line 2).
Claims 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442).
Regarding claim 56, Ho further teaches the nasal mask interface assembly of Claim 41, wherein the edge of the contacting surface is configured to create a seal around an entire periphery of the edge such that a positive gas pressure can be maintained in the mask cavity (Ho Fig. 4, 87 – contacting surface that contains the edge that contacts the user’s face, the flexible nasal seal (‘10’) comprising an edge (‘87’), where the edge is a portion of the cushion (‘13’) – Ho Figure 5, an additional citation: (Ho [0033]; the flexible nasal seal (patient interface ‘10’) contains the edge (uppermost portion ‘87’ edge that contacts face seen in Figure 4) of the cushion ‘13’ that overlies the nose of the patient). In addition, (Ho [0032]), as seen in Figure 5, the cushion portion ‘13’, forms a tight seal with the face of the patient, Ho [0028]; the system includes the use of a CPAP device – which is positive gas pressure being supplied to the patient through the mask cavity (see Fig. 4, cavity is formed in the housing)).
Although, Ho doesn’t explicitly recite that the positive gas pressure can be maintained in the mask cavity, Ho explicitly discloses the use of a CPAP device with the nasal seal (Ho [0028]), it would have been readily understood by one of ordinary skill in the art that, with the edge sealing around the entire periphery, thereby sealing the face entirely, and with positive gas pressure being supplied through the mask cavity to the patient from the CPAP device, that because the system is fully sealed, the positive gas pressure can be maintained in the mask cavity.
Regarding claim 57, Ho further teaches the nasal mask interface assembly of Claim 56, wherein the under-nose support has a first side that defines the contact surface and a second side opposite the first side, wherein each of the first side and the second side is located within a portion of the mask cavity that is exposed to the positive gas pressure (Ho Figure 4; mask cavity is formed within the housing, Figure 1 below; where the under-nose support ‘29’ has a contact surface (Ho [0029]) and a first and a second side, where the first and second side are opposite of each other and the first side is the contact surface side, where the second side is the portion located within a portion of the mask cavity that is exposed to the positive gas pressure, Ho [0028]; use of positive gas pressure through a CPAP).
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Figure 1: annotated Figure 6 of Ho.
Regarding claim 58, Ho further teaches the nasal mask interface assembly of Claim 57, wherein portions of the contact surface that are uncovered by the under-nose surface of the user are acted upon by the positive gas pressure (Figure 1 above; where the under-nose support ‘29’ contains the contact surface and the portions of the contact surface that don’t contact the user, are instead acted upon by the positive gas pressure because they are on the second side of the under-nose support ‘29’ that gets a positive gas pressure acted upon Ho [0028], Ho [0029]; contact surface).
Claim 60 is rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442) in view of Ging (EP 1360971 A1).
Regarding claim 60, Ho further teaches the nasal mask interface assembly of Claim 59, comprising a seal housing, a yoke, and a gas inlet, wherein the yoke is positioned on the seal housing (see Fig. 10, yoke ‘150’ is positioned on the seal housing ‘11’, (seen in Ho Figure 6) where the gas inlet ‘30’ is the port for gas to go through the mask and to the patient).
Ho fails to teach a gas vent and wherein the yoke is positioned on the seal housing between the gas inlet and the gas vent.
Ging teaches a cushion and mask assembly wherein:
the seal housing comprises a gas vent, wherein the yoke is positioned on the seal housing between the gas inlet and the gas vent (Figures 2 and 3 below; where the seal housing ‘20’ (frame that holds the cushion), is between the gas vent ‘61’ and the gas inlet to the patient, and where the yoke ‘82’ is positioned on the seal housing ‘20’, thereby between the gas inlet and the gas vent because the seal housing is between, where the gas inlet is positioned on the seal housing ‘20’ when the components are connected).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nasal mask interface assembly of Ho to have this configuration of the nasal mask interface as taught by Ging, since, this configuration results in less torque being applied to the mask assembly which results in increased stability, and with increased stability, patient comfort and compliance is increased (Ging [0064]).
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Figure 2: annotated Figure 4 of Ging.
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Figure 3: annotated Figure 6b of Ging.
Claim 61 is rejected under 35 U.S.C. 103 as being unpatentable over Ho (US PGPub 2009/0120442) in view of Scheiner (CN 105377348 A).
Regarding claim 61, Ho further teaches the nasal mask interface assembly of Claim 41, comprising the under-nose support (Figure 1 above; under-nose support ‘29’).
Ho fails to teach the under-nose support comprising an elongate lateral band having opposing end that terminate at respective locations on opposing sidewalls of the flexible nasal seal, wherein a central portion of the under-nose support is positioned lower than the respective locations on the opposing sidewalls.
Scheiner teaches a patient interface wherein:
the under-nose support comprises an elongate lateral band having opposing ends that terminate at respective locations on opposing sidewalls of the flexible nasal seal, wherein a central portion of the under- nose support is positioned lower than the respective locations on the opposing sidewalls (Figure 4 below; where ‘3212’ is an under-nose support that comprises of an elongate lateral band having opposite ends (as labeled) that terminate at their respective locations on opposing sidewalls of the flexible nasal seal ’3100’, where the central portion of the under-nose support ‘3212’ is positioned lower than the respective locations on the opposing sidewalls).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the nasal mask interface assembly of Ho by having the under-nose support be in the shape of an elongate lateral band as taught by Scheiner, since, the shape allows for the under-nose support to abut against the upper lip region for sealing, conforming to the face, to form a seal in the area, and shaped and sized in such a way that an ensured uninterrupted path for pressurized gas flow enters the patient’s airway (Scheiner [0423]).
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Figure 4: annotated Figure 245a of Scheiner.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Boden (US 4288891 A) which discloses a cord lock;
Brambilla et al. (US PGPub 20140276177 A1) which discloses a yoke with end caps;
Dunn (US PGPub 20150290415 A1) which discloses an adjustable headgear.
THIS ACTION IS MADE FINAL. 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 AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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