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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to because Figs. 1, 3-4, 7, and 9 illustrate exploded views, and so must have their separated parts embraced by a bracket (see MPEP 608.02(V)(h)(1)). 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 103
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 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.
Claims 1-5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al. (US 2019/0374737 A1) in view of Nolte (US 2007/0021773 A1) and Guney et al. (US 2009/0044808 A1), or alternatively Collins in view of Ewers et al. (US 2018/0064899 A1), Nolte, and Guney.
Regarding claim 1, Collins discloses a nasal mask (breathing apparatus with nasal respiratory interface) (Figs. 1-2; abstract), comprising:
a frame made of a rigid material (frame 1110 can be made of rigid metal or plastic) (Figs. 1-2, 31, 39; para. [0207]), and including a frame body, a socket which extends through said frame body in a front-rear direction, and a rear surrounding wall which extends rearwardly from said frame body and which surrounds said socket (frame 1110 has a body, an aperture 1113 extending through the body from the front surface 1111 to rear surface 1112; rear surface 1112 has an end wall surrounding the aperture 1113 and which projects rearwardly) (Figs. 1-2, 31-32C, 36A-36B, 39; para. [0205]), said frame body having a surrounding flange which surrounds a front end of said socket (frame 1110 front surface 1111 has a small flange that surrounds a front end of the aperture 1113, as best seen in Fig. 39) (Figs. 1-2, 31-32C, 36A-36B, 39; para. [0205]), said socket having a first inner diameter which is measured on a first sectioned plane that is perpendicular to a left-right direction, and a second inner diameter which is measured on a second sectioned plane that is perpendicular to an up-down direction and which is larger than the first inner diameter (aperture 1113 has a plane with a major axis M larger than a minor axis m on a perpendicular plane) (Figs. 32B, 36B; para. [0208]), the front-rear direction, the left-right direction and the up-down direction being perpendicular to one another (the direction from the front surface 1111 to rear surface 1112, the major axis M, and the minor axis m are all perpendicular to each other) (Figs. 31, 32B-34B, 36B; para. [0208]);
a cushion seal made of a flexible material (nasal pillow 1140 and seal clip 1130; nasal pillow 1140 would be soft and flexible) (Fig. 31; para. [0205]), and removably mounted on said frame (seal for the nasal pillow is removably mounted to frame 1110 via seal clip 1130) (Fig. 31; para. [0205]; para. [0219]), said seal including a seal body which has a front wall and a rear wall that are spaced apart from each other in the front-rear direction to define a chamber therebetween (nasal pillow 1140 and seal clip 1130 have a front wall towards the frame 1110 and a rear wall towards the patient spaced apart from each other; there has to be a chamber of space in-between the walls in order to allow for gas to flow from the aperture 1113 to be delivered to the patient) (Figs. 1-2, 31, 39; para. [0205]), a sleeve hole which is formed in and extends through said front wall in the front-rear direction and which is engaged with said rear surrounding wall (hole in and extending through the front wall of the seal clip 1130 and which engages with the rear wall of frame 1110) (Figs. 31, 39; para. [0205]; para. [0234]), and an intake hole which is formed in and extends through said rear wall in the front-rear direction to be communicated with said sleeve hole through said chamber (a hole in and extending through the rear wall of the nasal pillow 1140 would communicate with the hole in the front wall of the seal clip 1130 in order to be able to allow gas to flow from the aperture 1113 into the chamber of space in the nasal pillow 1140/seal clip 1130 to be delivered to the patient) (Figs. 1-2, 31, 39; para. [0205]); and
a flexible tube made of a flexible material (gas delivery conduit is made out of a material, and all materials would have some degree of flexibility) (Fig. 1; para. [0205]), and in communication with said chamber (gas delivery conduit delivers gas to the space inside the nasal pillow 1140/seal clip 1130) (Fig. 1; para. [0205]), said flexible tube including a tube portion and a connector portion which is connected with said tube portion and which is deformably and pluggably mounted in said socket (a gas delivery conduit portion connected to a conduit connector 1190; conduit connector 1190 is fit into aperture 1113 via a compressible snap-fit) (Figs. 1, 31, 39; paras. [0232-0233]), said connector portion having an outer peripheral wall and a mounting surrounding groove which is formed in said outer peripheral wall (conduit connector 1190 has an outer peripheral wall formed with recesses 1192) (Figs. 31, 39; para. [0232]).
Alternatively, if Collins is not seen as definitely teaching the cushion seal is made of a flexible material and the flexible tube made of a flexible material, Ewers teaches a nasal pillow system (Ewers; abstract) wherein the cushion seal is made of a flexible material (nasal pillow 105 can be made of an elastomeric material that can be stretched; nasal interface structure is thinner for flexibility) (Ewers; Fig. 10a; para. [0148]; para. [0157]) and a flexible tube made of a flexible material (hose is a composite silicon-coated braided tube that has excellent flexibility) (Ewers; para. [0127]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Collins cushion seal to be made of flexible material and the flexible tube to be made of a flexible material, as taught by Ewers, for the purpose of providing a more comfortable and flexible interface with the patient’s nostrils (Ewers; para. [0157]) and for providing a specific material for the hose which is lightweight, has strong crush resistance, and high durability (Ewers; para. [0127]).
Collins does not disclose said mounting surrounding groove having a first groove width which is measured on the first sectioned plane, and a second groove width which is measured on the second sectioned plane, said connector portion being deformable and shifted between a non-mounted state, where said flexible tube is disengaged from said frame, and a mounted state, where said flexible tube is connected with said frame, wherein, when said connector portion is in the non-mounted state, the first groove width is larger than the first inner diameter, and the second groove width is smaller than the second inner diameter, and wherein, when said connector portion is in the mounted state, the first groove width is smaller than the first inner diameter such that said connector portion is deformed and expanded in the left-right direction to permit fitting engagement of said surrounding flange in said mounting surrounding groove.
However, Guney teaches a patient interface for delivering breathable gas (Guney; abstract) wherein the snap fit is a continuous annular snap fit such that said mounting surrounding groove has a first groove width which is measured on the first sectioned plane and a second groove width which is measured on the second sectioned plane (the groove for the continuous annular snap fit is all around the circumference of the elbow 5740, and so has widths measured in two perpendicular planes through the elbow 5740) (Guney; Fig. 18-8-16; para. [0793]; para. [0795]). Moreover, Nolte teaches a breathing device for the nostril (Nolte; abstract; para. [0002]) wherein, when said connector portion is in the non-mounted state, the first width is larger than the first inner diameter, and the second width is smaller than the second inner diameter, and wherein, when said connector portion is in the mounted state, the first width is smaller than the first inner diameter such that said connector portion is deformed and expanded in the left-right direction to permit fitting engagement (body unit 20 is circular when not mounted in the nostril and an oval shape when mounted in the nostril; as such, the body unit 20 has a width in one direction larger than the minor axis of the oval and a width in a second direction smaller than the major axis of the oval when it is unmounted and circular; also, when mounted in the nostril and oval shaped, its width would be smaller than width of the nostril as it fits inside the nostril; body portion 20 attempts to expand back to its circular shape after being deformed into the oval shape when in the nostril, thereby helping it stay in the nostril) (Nolte; Fig. 1; para. [0016]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Collins snap fit to be a continuous annular snap fit such that such that said mounting surrounding groove has a first groove width which is measured on the first sectioned plane and a second groove width which is measured on the second sectioned plane, as taught by Guney, for the purpose of providing a suitable alternative snap fit mechanism to help ensure the assembly does not inadvertently disconnect during use (Guney; para. [0795]). Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Collins connector portion such that wherein, when said connector portion is in the non-mounted state, the first width is larger than the first inner diameter, and the second width is smaller than the second inner diameter, and wherein, when said connector portion is in the mounted state, the first width is smaller than the first inner diameter such that said connector portion is deformed and expanded in the left-right direction to permit fitting engagement, as taught by Nolte, for the purpose of providing a mechanism to help frictionally retain the connector portion in place after insertion (Nolte; para. [0016]).
With this modification, the modified Collins would thus teach said mounting surrounding groove having a first groove width which is measured on the first sectioned plane, and a second groove width which is measured on the second sectioned plane, said connector portion being deformable and shifted between a non-mounted state, where said flexible tube is disengaged from said frame, and a mounted state, where said flexible tube is connected with said frame, wherein, when said connector portion is in the non-mounted state, the first groove width is larger than the first inner diameter, and the second groove width is smaller than the second inner diameter, and wherein, when said connector portion is in the mounted state, the first groove width is smaller than the first inner diameter such that said connector portion is deformed and expanded in the left-right direction to permit fitting engagement of said surrounding flange in said mounting surrounding groove (Collins conduit connector 1190 recesses 1192 modified by Guney to be one continuous annular recess around the conduit connector 1190, and so would change its widths with the rest of the conduit connector 1190; the Collins conduit connector 1190 was modified by Nolte to be compressible from a circular shape when not mounted to an oval shape when mounted and inserted into the Collins oval shaped aperture 1113; as such, when not mounted and circular, the modified Collins conduit connector 1190 has an annular Guney recess with a first width in one direction larger than the minor axis m of the Collins aperture 1113 oval and a second width in a second direction smaller than the major axis M of the Collins aperture 1113 oval; when compressed to be mounted in the Collins aperture 1113 oval, the modified Collins conduit connector 1190 has an annular Guney recess first width smaller than width of the Collins aperture 1113 oval along its major axis M as it fits inside the Collins aperture 1113 oval; the modified Collins conduit connector 1190 would be expanded along the major axis M direction when an oval shape in the Collins aperture 1113 oval and its modified recess 1192 would engage with the corresponding Collins protrusions 1127 in the frame 1110 front surface 1111 flange) (Collins, Figs. 1, 31, 32B, and 39, para. [0208], para. [0232]; Nolte, Fig. 1, para. [0016]; Guney, para. [0016]).
Regarding claim 2, the modified Collins teaches wherein said outer peripheral wall of said connector portion has a surrounding inclined section which is formed at an end thereof opposite to said tube portion (conduit connector 1190 outer peripheral wall has an inclined section at an end opposite the gas delivery conduit portion/conduit connector 1190) (Collins; Figs. 1, 31, 39; paras. [0232-0233]), said surrounding flange of said frame body having a flat end surface section which defines the first inner diameter and the second inner diameter, and a flared end surface section which is connected with and formed forwardly of said flat end surface section (frame 1110 front surface 1111 flange has a flat end surface defining the first and second inner diameters of the oval aperture 1113 and a curved flared end surface connected to and formed forwardly of the flat end surface) (Collins; Fig. 39; para. [0231]).
Regarding claim 3, the modified Collins teaches wherein said surrounding flange of said frame body further has a forward facing surface section connected with said flared end surface section (the frame 1110 small flange around aperture 1113 curved end surface is connected to the front end surface 1111) (Collins; Figs. 32, 39; para. [0205]), and a rearward facing surface section connected with said flat end surface section (the frame 1110 small flange around aperture 1113 flat end surface is connected to the rear end surface 1112) (Collins; Figs. 32, 39; para. [0205]), said outer peripheral wall of said connector portion further having a first connecting section which is connected with and formed forwardly of said surrounding inclined section (conduit connector 1190 outer peripheral wall has a lip section forwardly from the inclined section opposite the gas delivery conduit portion/conduit connector 1190, the lip connecting to the frame 1110) (Collins; Figs. 1, 31, 39; paras. [0232-0233]), a second connecting section which is connected with and formed rearwardly of said tube portion (conduit connector 1190 outer peripheral wall has a bottom section rearwardly connected to the gas delivery conduit portion) (Collins; Figs. 1, 31, 39; para. [0233]), a first abutting section which extends radially and inwardly from said first connecting section (conduit connector 1190 has a top section with material extending radially inwards from the outer peripheral wall to an inner peripheral wall at the lip section) (Collins; Figs. 31, 39; paras. [0232-0233]), a second abutting section which extends radially and inwardly from said second connecting section (conduit connector 1190 has a bottom section with material extending radially inwards from the outer peripheral wall to an inner peripheral wall at the bottom connection to the gas delivery conduit) (Collins; Figs. 1, 31, 39; paras. [0232-0233]), and a third abutting section which interconnects said first abutting section and said second abutting section to cooperatively define said mounting surrounding groove (conduit connector 1190 has a middle section with material extending radially inwards from the outer peripheral wall to an inner peripheral wall at the recess 1192; the middle section of the conduit connector 1190 connects the top and bottom sections and defines the recess 1192) (Collins; Figs. 31, 39; paras. [0232-0233]), said third abutting section having the first groove width on the first sectioned plane, and the second groove width on the second sectioned plane, wherein, when said connector portion is in the mounted state (Collins conduit connector 1190 recesses 1192 modified by Guney to be one continuous annular recess around the conduit connector 1190, and so would change its widths with the rest of the conduit connector 1190; the Collins conduit connector 1190 was modified by Nolte to be compressible from a circular shape when not mounted to an oval shape when mounted and inserted into the Collins oval shaped aperture 1113; as such, when not mounted and circular, the modified Collins conduit connector 1190 has an annular Guney recess with a first width in one plane direction larger than the minor axis m of the Collins aperture 1113 oval and a second width in a second plane direction smaller than the major axis M of the Collins aperture 1113 oval; when compressed to be mounted in the Collins aperture 1113 oval, the modified Collins conduit connector 1190 has an annular Guney recess first width smaller than width of the Collins aperture 1113 oval along its major axis M as it fits inside the Collins aperture 1113 oval) (Collins, Figs. 31, 32B, and 39, para. [0208], para. [0232]; Nolte, Fig. 1, para. [0016]; Guney, para. [0016]), said first abutting section is in abutting engagement with said rearward facing surface section (the conduit connector 1190 top section abuts the flat end surface of the frame 1110 small flange around aperture 1113) (Collins; Figs. 32, 39; para. [0205]; paras. [0232-0233]), said second abutting section is in abutting engagement with said forward facing surface section (conduit connector 1190 bottom section abuts the curved end surface of the frame 1110 small flange around aperture 1113) (Collins; Figs. 1, 31, 39; para. [0205]; paras. [0232-0233]), and said third abutting section is in abutting engagement with said flat end surface section and said flared end surface section (conduit connector 1190 middle section with recess 1192 abuts both the flat end surface and the curved end surface of the frame 1110 small flange around aperture 1113, as they are both inside the recess 1192) (Collins; Figs. 31, 39; para. [0205]; paras. [0232-0233]).
Regarding claim 4, the modified Collins teaches wherein, when said connector portion is in the mounted state, the first groove width is smaller than and approximate to the first inner diameter, and the second groove width is smaller than and approximate to the second inner diameter (Collins conduit connector 1190 recesses 1192 modified by Guney to be one continuous annular recess around the conduit connector 1190, and so would change its widths with the rest of the conduit connector 1190; the Collins conduit connector 1190 was modified by Nolte to be compressible from a circular shape when not mounted to an oval shape when mounted and inserted into the Collins oval shaped aperture 1113; when compressed to be mounted in the Collins aperture 1113 oval, the modified Collins conduit connector 1190 has an annular Guney recess first width just smaller than width of the Collins aperture 1113 oval along its major axis M and second width just smaller than width of the Collins aperture 1113 oval along its minor axis m as it fits inside the Collins aperture 1113 oval) (Collins, Figs. 31, 32B, and 39, para. [0208], para. [0232]; Nolte, Fig. 1, para. [0016]; Guney, para. [0016]).
Regarding claim 5, the modified Collins teaches wherein said frame further includes a plurality of bias flow apertures extending through said frame body in the front-rear direction to provide flow paths from said chamber to ambient surroundings, said bias flow apertures being formed at left and right sides of said socket (frame 1110 with bias flow holes 1201 extending through it in a front to rear direction; the bias flow holes 1201 would provide flow paths to the ambient environment as they are open to the ambient environment; bias flow holes 1201 are on the left and right sides of the aperture 1113) (Collins; Figs. 49A, 51A-51B; para. [0258]).
Regarding claim 7, the modified Collins teaches wherein a ratio of the first inner diameter to the second inner diameter ranges from 0.58 to 0.62 (recall that the first inner diameter is smaller than the second inner diameter as recited in claim 1, and so would the Collins minor axis m corresponds to the first inner diameter while the major axis M corresponds to the second inner diameter; the Collins ratio between the major dimension and the minor dimension is between 1.5 and 2, i.e. major/minor = between 1.5/1 and 2/1, and so the minor/major ratio is between 1/1.5 and 1/2, or in other words between 0.5 and 0.667) (Collins; Fig. 32B; para. [0228]).
Regarding claim 8, the modified Collins is silent on wherein, when said connector portion is in the mounted state, said connector portion is removable from said frame with a first pulling force which is in the front-rear direction and which is at least 2.2 kgf, with a second pulling force which is on the second sectioned plane and intersects the left-right direction by an angle of 45 degrees and which is at least 1.4 kgf, or with a third pulling force which is on the first sectioned plane and intersects the front-rear direction by an angle of 45 degrees and which is at least 0.6 kgf.
However, Guney further teaches the connection of parts is structured to withstand 20 N of pull force at various angles without fracturing or detaching (Guney; para. [0820]), and 20 N is 2.0394 kgf. Thus, it would take more than 20N or 2.0394 kgf to detach the connection. Moreover, MPEP 2144.05(I) recites, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. As 2.0394 kpf is close to 2.2 kgf, one of ordinary skill in the art would be able to optimize the Guney value to the claimed value as a matter of routine experimentation, as the increase would help to further improve the connection by allowing it to withstand a slightly stronger pull force without fracturing or detaching.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Collins connector portion such that when said connector portion is in the mounted state, said connector portion is removable from said frame with a pulling force which is at least 2.2 kgf, as taught by Guney and the MPEP, for the purpose of enabling the connector portion to withstand a specific suitable pull force without fracturing or detaching which one of ordinary skill in the art could feasibly expect to perform reasonably well (Guney, para. [0820]; MPEP 2144.05(I)).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Collins in view of Ewers, Nolte, and Guney as applied to claim 1 above, and further in view of Haibach (US 2020/0197649 A1).
Regarding claim 6, the modified Collins teaches the invention as previously claimed, but does not teach wherein said frame further includes two positioning recesses which are formed in said frame body and at left and right sides of said frame body and which are opened rearwardly, said cushion seal further including two barbs which are formed on left and right sides of said seal body to be extended forwardly and clipped into said positioning recesses, respectively.
However, Haibach teaches a patient interface device (Haibach; abstract) wherein said frame further includes two positioning recesses which are formed in said frame body and at left and right sides of said frame body and which are opened rearwardly (frame 18 has two smaller apertures 60 on its body on left and right sides and which open rearwardly towards the cushion 16) (Haibach; Figs. 1-6; para. [0033]), said cushion seal further including two barbs which are formed on left and right sides of said seal body to be extended forwardly and clipped into said positioning recesses, respectively (cushion 16 has two protruding elements 80 on the left and right sides of its body which extend forwardly into the respective apertures 60) (Haibach; Figs. 1-6; para. [0033]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the Collins frame and cushion seal such that said frame further includes two positioning recesses which are formed in said frame body and at left and right sides of said frame body and which are opened rearwardly, said cushion seal further including two barbs which are formed on left and right sides of said seal body to be extended forwardly and clipped into said positioning recesses, respectively, as taught by Haibach, for the purpose of providing the device with an anti-rotation feature (Haibach; para. [0033]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2019/0030272 A1 by Graham et al. is considered to be relevant as it discloses a respiratory mask system having an oval shaped frame aperture and gas delivery tube.
US 2019/0217036 A1 by Spear et al. is considered to be relevant as it discloses a nasal mask having a conduit frame and conduit which are ovular in shape.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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