DETAILED ACTION
Primary Examiner acknowledges Claims 90-109 are pending in this application, with Claims 90-109 having been newly added, and Claims 1-89 having been cancelled by preliminary amendment on October 11, 2023.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “104” has been used to designate “patient facing side” and “non-patient facing side” (Para 0389). Appropriate correction is required.
Reference character “121” has been used to designate “interfacing feature” and “aperture” (5 instances in Paras 0393 thru 0394). Appropriate correction is required.
Reference character “1301” has been used to designate “mask body” and “deformable structure” (Para 0553). Appropriate correction is required.
Reference character “1304” has been used to designate “patient facing side”, “patient side” (2 instances in Para 0528). Appropriate correction is required.
Reference character “1307” has been used to designate “chin portion”, “first moving portion” (Para 0545). Appropriate correction is required.
Reference character “1421” has been used to designate “interfacing feature”, “mounting mechanism (3 instances Para 0564, 2 instances Para 0565). Appropriate correction is required.
Reference character “1508” has been used to designate “absorbent pad” and “absorbent material” (Para 0577). Appropriate correction is required.
Reference character “1701” has been used to designate “mask body” and “filter body” (Para 0608). Appropriate correction is required.
Reference character “1703” has been used to designate “filter” and “fabric” (Para 0649). Appropriate correction is required.
Reference character “1708” has been used to designate “absorbent pad” (Para 0611) and “absorbent material”. Appropriate correction is required.
Reference character “1821” has been used to designate “interfacing feature” and “aperture” (4 instances Paras 0623-0634). Appropriate correction is required.
Reference character “2003” has been used to designate “fabric” (Para 0667) and “filter”. Appropriate correction is required.
Reference character “2021” has been used to designate “interfacing feature” and “aperture” (several instances Paras 0675-0676). Appropriate correction is required.
Reference character “215c” has been used to designate “two side cushion portions” and “one or both sides” (Para 0417). Appropriate correction is required.
Reference character “2211” has been used to designate “frame”, “transparent visor”, and “frame/visor”. Appropriate correction is required.
Reference character “2321” has been used to designate “interfacing feature” and “dome snap” (several instances Paras 0709-0710). Appropriate correction is required.
Reference character “2421” has been used to designate “interfacing feature” and “clips” (several instances Para 0729-0733). Appropriate correction is required.
Reference character “2501” has been used to designate “mask body” and “mask” (several instances Pars 0756-0757). Appropriate correction is required.
Reference character “2540” has been used to designate “mask headgear” and “headgear”. Appropriate correction is required.
Reference character “2541” has been used to designate “upper headstrap”, “upper headgear connection features”. Appropriate correction is required.
Reference character “2701” has been used to designate “soft mask body”, “mask body”, “interfacing feature”, and “mask”. Appropriate correction is required.
Reference character “2801” has been used to designate “mask body”, and “mask”. Appropriate correction is required.
Reference character “2821” has been used to designate “clip” and “interfacing feature”. Appropriate correction is required.
Reference character “351” has been used to designate “forehead support”, “upper headgear connection features”. Appropriate correction is required.
Reference character “501” has been used to designate “deformable structure” and “mask body”. Appropriate correction is required.
Reference character “533a” has been used to designate “complementary pads”, “first portion”, “pads”, and “second portion”. Appropriate correction is required.
Reference character “533b” has been used to designate “pads” and “second portion”. Appropriate correction is required.
Reference character “711” has been used to designate “frame”, “semi structural frame”, and “mask frame”. Appropriate correction is required.
Reference character “721a” has been used to designate “first mounting structure” and “frame mount”. Appropriate correction is required.
Reference character “801” has been used to designate “deformable structure” and “mask body”. Appropriate correction is required.
Reference characters “1508” and “1708” have been used to designate “absorbent material” and “absorbent pad”. Appropriate correction is required.
Reference characters “2704” and “2821” have been used to designate “clip”. Appropriate correction is required.
Reference characters “1643” and “1841” have been used to designate “mask headstrap”. Appropriate correction is required.
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.
Specification
The disclosure is objected to because of the following informalities:
. Reference character “104” has been used to designate “patient facing side” and “non-patient facing side” (Para 0389). Appropriate correction is required.
Reference character “121” has been used to designate “interfacing feature” and “aperture” (5 instances in Paras 0393 thru 0394). Appropriate correction is required.
Reference character “1301” has been used to designate “mask body” and “deformable structure” (Para 0553). Appropriate correction is required.
Reference character “1304” has been used to designate “patient facing side”, “patient side” (2 instances in Para 0528). Appropriate correction is required.
Reference character “1307” has been used to designate “chin portion”, “first moving portion” (Para 0545). Appropriate correction is required.
Reference character “1421” has been used to designate “interfacing feature”, “mounting mechanism (3 instances Para 0564, 2 instances Para 0565). Appropriate correction is required.
Reference character “1508” has been used to designate “absorbent pad” and “absorbent material” (Para 0577). Appropriate correction is required.
Reference character “1701” has been used to designate “mask body” and “filter body” (Para 0608). Appropriate correction is required.
Reference character “1703” has been used to designate “filter” and “fabric” (Para 0649). Appropriate correction is required.
Reference character “1708” has been used to designate “absorbent pad” (Para 0611) and “absorbent material”. Appropriate correction is required.
Reference character “1821” has been used to designate “interfacing feature” and “aperture” (4 instances Paras 0623-0634). Appropriate correction is required.
Reference character “2003” has been used to designate “fabric” (Para 0667) and “filter”. Appropriate correction is required.
Reference character “2021” has been used to designate “interfacing feature” and “aperture” (several instances Paras 0675-0676). Appropriate correction is required.
Reference character “215c” has been used to designate “two side cushion portions” and “one or both sides” (Para 0417). Appropriate correction is required.
Reference character “2211” has been used to designate “frame”, “transparent visor”, and “frame/visor”. Appropriate correction is required.
Reference character “2321” has been used to designate “interfacing feature” and “dome snap” (several instances Paras 0709-0710). Appropriate correction is required.
Reference character “2421” has been used to designate “interfacing feature” and “clips” (several instances Para 0729-0733). Appropriate correction is required.
Reference character “2501” has been used to designate “mask body” and “mask” (several instances Pars 0756-0757). Appropriate correction is required.
Reference character “2540” has been used to designate “mask headgear” and “headgear”. Appropriate correction is required.
Reference character “2541” has been used to designate “upper headstrap”, “upper headgear connection features”. Appropriate correction is required.
Reference character “2701” has been used to designate “soft mask body”, “mask body”, “interfacing feature”, and “mask”. Appropriate correction is required.
Reference character “2801” has been used to designate “mask body”, and “mask”. Appropriate correction is required.
Reference character “2821” has been used to designate “clip” and “interfacing feature”. Appropriate correction is required.
Reference character “351” has been used to designate “forehead support”, “upper headgear connection features”. Appropriate correction is required.
Reference character “501” has been used to designate “deformable structure” and “mask body”. Appropriate correction is required.
Reference character “533a” has been used to designate “complementary pads”, “first portion”, “pads”, and “second portion”. Appropriate correction is required.
Reference character “533b” has been used to designate “pads” and “second portion”. Appropriate correction is required.
Reference character “711” has been used to designate “frame”, “semi structural frame”, and “mask frame”. Appropriate correction is required.
Reference character “721a” has been used to designate “first mounting structure” and “frame mount”. Appropriate correction is required.
Reference character “801” has been used to designate “deformable structure” and “mask body”. Appropriate correction is required.
Reference characters “1508” and “1708” have been used to designate “absorbent material” and “absorbent pad”. Appropriate correction is required.
Reference characters “2704” and “2821” have been used to designate “clip”. Appropriate correction is required.
Reference characters “1643” and “1841” have been used to designate “mask headstrap”. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 106 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tiwari (2021/0353890, having an effective filing date of May 18, 2020 which is before the effectively filed date of this instant application).
As to Claim 106, Tiwari discloses an interface system (Figures 2 and 3), comprising: a non-sealing patient interface (“The peripheral edge may be formed to include one or more recesses to allow nasal cannula to access the inner-space.” Para 0028) configured to deliver a gases flow to a patient’s airways; and a mask (200, “Referring to FIG. 2, the face mask 200 comprises a mask body 202 defining a cavity configured to be positioned over the mouth and nose of a patient or user, an inlet port 210 for directing a flow of gas to the interior of the face mask 200, a malleable strip 206 to mold the mask around the patient's or user's nose, two side filters 204a and 204b allow the patient to breathe with minimal effort, strap attachments 214a and 214b to secure the mask body to the patient's or user's head, a ribbed tubing 208 designed to connect to a gas sampling tubing for sampling exhaled breath from a user or patient and a luer lock connector 212 attached to the end of ribbed tubing so as to connect the ribbed tubing with the gas sampling tubing.” Para 0026) comprising: a mask body (202, “the face mask 200 comprises a mask body 202 defining a cavity configured to be positioned over the mouth and nose of a patient or user” Para 0026) comprising a patient facing side (defined by the side encompassing the patient’s nose and mouth) and a non-patient facing side (defined by the sided exposed to the ambient environment), the patient facing side (defined by the side encompassing the patient’s nose and mouth) configured to form an interior space (“a mask body 202 defining a cavity configured to be positioned over the mouth and nose of a patient or user” Para 0026) with a patient’s face when the mask is in contact with a patient, the interior space (“a cavity”) configured to accommodate the a portion of the non-sealing patient interface (“nasal cannula” Para 0028); a filter (204a/b, “two side filters 204a and 204b allow the patient to breathe with minimal effort” Para 0026) configured to filter fluid from a patient facing side (defined by the side encompassing the patient’s nose and mouth) of the mask (200) to a non-patient facing side (defined by the sided exposed to the ambient environment), wherein the non-patient facing side (defined by the sided exposed to the ambient environment) faces the ambient environment; and an interfacing feature (“one or more recesses” Para 0028) to interface with the non-sealing patient interface (“nasal cannula” Para 0028).
Claim 106 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chang (2019/0038863, having a publication date of February 7, 2019 - prior to the instant application).
As to Claim 106, Chang discloses an interface system (Figure 8) comprising: a non-sealing patient interface (“FIG. 8 illustrates another embodiment of the oxygen mask of FIG. 7. The re optional recesses 595 formed on the peripheral edge of the mask body 510. The recesses 595 are configured and/or shaped to allow nasal cannula to directly access the nose area of the inner-space while minimizing leakage of the inner-space to the outside environment.” Para 0138) configured to deliver a gases flow to a patient’s airways; and a mask (500, “the oxygen mask 500 includes two recesses 595. The recesses 595 are disposed on opposite sides of the mask body 510.” Para 0138) comprising: a mask body (510, “mask body 510.” Para 0138) comprising a patient facing side (defined by the side encompassing the patient’s nose and mouth) and a non-patient facing side (defined by the sided exposed to the ambient environment), the patient facing side (defined by the side encompassing the patient’s nose and mouth) configured to form an interior space configured to accommodate a portion of the non-sealing patient interface (“nasal cannula” Para 0138); a filter (530, “The vent port(s) 530 may include perforations allowing free flowing of gases.” Para 0132) configured to filter a fluid from a patient facing side (defined by the side encompassing the patient’s nose and mouth) to a non-patient facing side (defined by the sided exposed to the ambient environment), wherein the non-patient facing side (defined by the sided exposed to the ambient environment) faces an ambient environment; and an interfacing feature (“optional recesses 595” Para 0138) configured to interface with the non-sealing patient interface (“nasal cannula” Para 0138).
Claim 109 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Bartos (4,354,488).
As to Claim 109, Bartos discloses a mask (Figures 1 and 2) configured to surround an opening of a patient’s airways (“IG. 1 shows one embodiment of the nose mask of the present invention shown as 11 which comprises a shell 10 having both a front portion 12 and a rear portion 13 and a hollow, gas delivery tube 15.” Column 5, Lines 25-65), the mask (Figures 1 and 2) comprising: a mask body (10, “a shell 10” Column 5, Lines 25-65) having a preformed shape that is configured to deflect fluids form the opening of the patient’s airways in an intended direction (defined by the arrows of Figure 2 leading from 16/17); and wherein either the mask (Figures 1 and 2) further comprises an interfacing feature (14, “A hollow gas supply tube 14 leads to and is received by gas delivery tube 15. The gas delivery tube 15 is attached to the bottom of the shell by a suitable attachment means and extends along the bottom of the shell within an inside region which is the area between the two sides of the front portion of the shell 12 and the area between the lower edge of the wearer's nose and a point just above the wearer's upper lip.” Column 5, Lines 25-65) configured to interface with a patient interface (15, “The gas delivery tube 15 shown in this embodiment contains two distinct sets of gas delivering and dispersing means represented as a row of round gas delivery openings 16 and 17 which extend completely through one wall of the gas delivery tube 15.” Column 5, Lines 25-65) provided on the patient, or the mask is integrally formed with a patient interface (15).
Claim 109 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Muto et al. (4,454,880).
As to Claim 109, Muto discloses a mask (Figures) configured to surround an opening of a patient’s airways (best seen Figures 1 and 3A), the mask (Figures) comprising: a mask body (20, “Nasal hood 20 is preferably formed of soft, pliable, gas impermeable material 27, which may be plastic and translucent and such that it may be sterilized for reuse.” Column 2, Lines 55-65) having a preformed shape that is configured to deflect fluids from the opening of the patient’s airways in an intended direction (defined by the arrows of Figures 1 and 3A leading from 62); and wherein either the mask (Figures) further comprises an interfacing structure (58/59, “Preferably, however, tube 53 is divided at a coupling 55 into two branch supply tubes 56 and 57, each extending along a wing 42 or 43 and each having a terminal end 58 or 59 sleeved into one of the opposite ends of a manifold tube 61.” Column 3, Lines 20-35) configured to interface with a patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface, “The manifold tube 61, preferably includes a pair of spaced nozzles 62 each at an each aperture 54, the nozzles or apertures being located along the bottom of the rear opening 37 and directed toward the inside face 63 of the front wall 34 of open bottom dome 31.” Column 3, Lines 30-40) provided on the patient, or the mask (Figures) is integrally formed with a patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface, “The manifold tube 61, preferably includes a pair of spaced nozzles 62 each at an each aperture 54, the nozzles or apertures being located along the bottom of the rear opening 37 and directed toward the inside face 63 of the front wall 34 of open bottom dome 31.” Column 3, Lines 30-40).
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.
Claims 107 and 108 are rejected under 35 U.S.C. 103 as being unpatentable over either Tiwari (2021/0353890) OR Chang (2019/0038863), as applied to Claim 106, and further in view of Wright (2004/0035431).
As to Claim 107, both Tiwari and Chang disclose an interfacing system (Tiwari: Figures 2 and 3; Chang: Figure 8) for use with a non-sealing patient interface (Tiwari: “nasal cannula” Para 0028; Chang: “nasal cannula” Para 0138).
Yet, neither Tiwari nor Chang expressly disclose “non-sealing patient interface comprising a first retention mechanism configured to retain the non-sealing patient interface on the patient's face in use”.
Wright teaches a non-sealing patient interface (32, “Considering now the nasal cannula assembly 16 in greater detail with reference to FIG. 3, the nasal cannula assembly 16 generally includes a nasal delivery tube or cannula nosepiece 32, a pair of adjustment or extension tubes 40 and 50 respectively, and a pair of ear pieces 44 and 52 respectively. The extension tubes 40 and 50 are slidably mounted to the ear pieces 44 and 52 respectively in such a manner to facilitate supporting the cannula nosepiece 32 from the ear pieces 44 and 52 and to help facilitate adjusting the distance between the nosepiece 32 and individual ones of the ear pieces 44 and 52 so the cannula nosepiece 32 can be properly position relative to the nostrils of the patient P.” Para 0032) having a first retention mechanism (44/52, “pair of ear pieces 44 and 52” Para 0032) configured to retain the non-sealing patient interface (32) on the patient’s face.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the non-sealing patient interface of either Tiwari or Chang include a first retention mechanism as taught by Wright to facilitate the proper placement of the non-sealing patient interface on the patient’s face.
As to Claim 108, please see the rejection of Claim 107, whereby both the modified Tiwari and Chang disclose an interfacing system (Tiwari: Figures 2 and 3; Chang: Figure 8) for use with a non-sealing patient interface (Tiwari: “nasal cannula” Para 0028; Chang: “nasal cannula” Para 0138), and Wright teaches the use of a first retention mechanism (44/52, “pair of ear pieces 44 and 52” Para 0032) configured to retain the non-sealing patient interface (32) on the patient’s face.
Regarding the limitations to the “second retention mechanism”, both the modified Tiwari and Chang, specifically Tiwari and Chang disclose the use of a second retention mechanism to retain the mask on the patient’s face.
Explicitly, the modified Tiwari, specifically Tiwari discloses the mask (200) having “two strap attachments 214a and 214b” (Para 0035) to retain the mask (200) on the patient’s face.
Explicitly, the modified Chang, specifically Chang discloses the mask (500) having “strap attachments 550” (Para 0126) to retain the mask (500) on the patient’s face.
The resultant effect of both the modified Tiwari and Chang is a first retention mechanism (taught by Wright) and a second retention mechanism (disclosed by Tiwari and Chang) that are separate such that the mask is selectively securable to or removable form the patient independent of the non-sealing patient interface.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the non-sealing patient interface having a first retention mechanism to include a second retention mechanism for the mask to secure both the non-sealing patient interface and the mask separately to the patient’s face during use.
Claims 90-92, 94, 98, 99, 104, and 105 are rejected under 35 U.S.C. 103 as being unpatentable over Panzik et al. (4,266,540) in view of Drew et al. (2003/0164170) and Muto et al. (4,454,880).
As to Claim 90, Panzik discloses a mask (Figures 1-3) configured to surround an opening of a patient’s airways (“Referring now to FIG. 1, a nasal oxygen mask according to a preferred embodiment of the present invention will be described.” Column 2, Lines 20-35), the mask (Figures 1-3) comprising: a mask body (10, “Referring now to FIG. 1, a nasal oxygen mask according to a preferred embodiment of the present invention will be described. Mask 10 is attached to patient 12 by flexible strap 14. Mask 10 covers patient's nose 13.” Column 2, Lines 20-35) having a patient facing side (defined by the side which embraces the patient’s nose) of the mask (Figures 1-3) and a non-patient facing side (defined by the side exposed to the ambient) of the mask (Figures 1-3), wherein the non-patient facing side (defined by the side exposed to the ambient) faces an ambient environment, whereby the non-patient facing side (defined by the side exposed to the ambient) of the mask body (10) includes a port (18, “Mask 10 has a port 18 used for exhaling.” Column 2, Lines 20-35) for directing the flow of exhalation gas from the patient facing side (defined by the side which embraces the patient’s nose) to the non-patient facing side (defined by the side exposed to the ambient); and an interfacing feature (defined by the insertion of 20 into the mask body 10) to provide a source of gas to the patient’s airways.
Yet, Panzik does not expressly disclose “a removable filter configured to filter a fluid from a patient facing side of the mask to a non-patient facing side of the mask” nor “a patient interface provided on a patient.”
Regarding the features of the “removable filter”, Drew teaches a similar mask to Panzik suitable for surrounding an opening of the patient’s airways (Figure 6 and 8, “FIG. 6. shows a nasal respiratory mask 80 according to a sixth embodiment of the invention.” Para 0054) for conveying gas to a patient.
In the configuration of Drew, the mask body (12, “In the mask 40 of FIG. 2, the vent is provided in the gas inlet 20, whereas in the mask 80 the vent is provided in the shell 12. More particularly, the mask 80 includes two cylindrical inserts 82 which have an inner opening 26 across which extends the thin air permeable material 28.” Para 0054) includes an port (88, “As best seen in FIG. 8, which is a close-up view of the insert shown in FIG. 6, the insert 82 is comprises a cylindrical portion 86 sized to be a snug fit into a circular orifice 88 provided in the mask shell 12.” Para 0056) suitable for the conveyance of exhalation gases, whereby the port (88) includes an insert (82, “More particularly, the mask 80 includes two cylindrical inserts 82 which have an inner opening 26 across which extends the thin air permeable material 28.” Para 0054) in the form of a removable filter (via 82, “thin air permeable material 28. The thin air permeable material is made from GORE-TEX.RTM. product attached to a polypropylene scrim having an area of 481 mm.sup.2.… Membrane material 100% expanded polytetrafluoroethylene Reference pore size 10-15 micron Bubble Point typical minimum individual 0.02 bar Airflow 0.37 LPM/cm.sup.2 Thickness 0.05 mm Substrate polypropylene scrim” Para 0054) to direct the venting of exhaust gases to the atmosphere (“The mask 10 includes a gas washout vent constituted by an opening 26 in the shell 12 across which extends a thin air permeable membrane 28.” Para 0046; also see: 0007, 0048, 0050, 0061).
Regarding the features of the “patient interface”, Muto teaches a similar mask to Panzik suitable for surrounding an opening of the patient’s airways (Figures 1-6, “As shown in the drawings, the nasal hood 20 of the invention is not a face shield covering the face and is not a cup shaped mask edge sealed against the face of a patient 21.” Column 2, Lines 45-55) for conveying gas to a patient.
In the configuration of Muto, the mask body (20, “Nasal hood 20 is preferably formed of soft, pliable, gas impermeable material 27, which may be plastic and translucent and such that it may be sterilized for reuse.” Column 2, Lines 55-65) includes an interfacing structure (58/59, “Preferably, however, tube 53 is divided at a coupling 55 into two branch supply tubes 56 and 57, each extending along a wing 42 or 43 and each having a terminal end 58 or 59 sleeved into one of the opposite ends of a manifold tube 61.” Column 3, Lines 20-35) to direct the conveyance of gas on the non-patient facing / ambient side of the mask body (20), and further includes an additional internal structure (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface, “The manifold tube 61, preferably includes a pair of spaced nozzles 62 each at an each aperture 54, the nozzles or apertures being located along the bottom of the rear opening 37 and directed toward the inside face 63 of the front wall 34 of open bottom dome 31.” Column 3, Lines 30-40) to provide oxygen to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask body of Panzik to include a removable filter, as taught by Drew to facilitate the exhaustion gases from the interior of the facemask to the ambient environment, and further to include an internal patient interface as taught by Muto to direct oxygen towards the patient’s nose.
As to Claim 91, the modified Panzik, specifically Drew teaches the removable filter (via 82, “thin air permeable material 28. ” Para 0054) comprises a material that is permeable to fluid flow (“The thin air permeable material is made from GORE-TEX.RTM. product attached to a polypropylene scrim having an area of 481 mm.sup.2. … Airflow 0.37 LPM/cm.sup.2 ” Para 0054).
As to Claim 92, the modified Panzik, specifically Drew teaches the removable filter (via 82, “thin air permeable material 28. ” Para 0054) comprises a material that is substantially impermeable to bulk flow of liquid water (“GORE-TEX.RTM. product” Para 0054). As well known, Gore-Tex® is a waterproof, breathable fabric membrane. Thus, the features of impermeability to liquid water is achieved by the waterproof characteristics.
As to Claim 94, the modified Panzik, specifically Muto teaches the patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface) is non-sealing (best seen Figures 1 and 3A).
As to Claim 98, the modified Panzik, specifically Panzik discloses a gases removal port (18) to transmit fluid from the patient facing side (defined by the side which embraces the patient’s nose) of the mask (Figures 1-3) to a remote filter (as taught by Drew via 82, “thin air permeable material 28. ” Para 0054)..
As to Claim 99, the modified Panzik, specifically Panzik discloses a frame (24, “At the point of connection between supply tube 20 and mixing valve 22, there is a support 24 which attaches the mixing valve supply tube connection to strap 14. … Support 24 may be of some light plastic material.” Column 2, Lines 30-45), and wherein the mask body (10) is integral with or releasably coupled to the frame (24). Alternatively, the modified Panzik, specifically Panzik discloses a frame (16, “A flexible deformable clip 16 is mounted on outer bridge of mask 10 at such a position so that the clip may be used to position the mask relative to the bridge of the patient's nose 13. The clip may be made of aluminum or other deformable material.” Column 2, Lines 20-35), wherein the mask body (10) is integral with or releasably coupled to the frame (16).
As to Claim 104, the modified Panzik, specifically Panzik discloses an attachment mechanism (14, “Mask 10 is attached to patient 12 by flexible strap 14.” Column 2, Lines 20-35), the attachment mechanism (14) is releasably attached to the patient’s face.
As to Claim 105, the modified Panzik, specifically Muto teaches the patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface) is a non-sealing nasal cannula (best seen Figures 1 and 3A), wherein the mask body (20) comprises a flexible material (“Nasal hood 20 is preferably formed of soft, pliable, gas impermeable material 27, which may be plastic and translucent and such that it may be sterilized for reuse. The plastic material 27 is relatively thin, flexible and resilient so as to conform to the configuration of the face 28 of a patient and is non-toxic, light in weight, and preferably polyethylene, or the like.” Column 2, Lines 55-65) configured to conform to the non-sealing nasal cannula (best seen Figures 1 and 3A).
Claims 93, 95-97 and 101-103 are rejected under 35 U.S.C. 103 as being unpatentable over Panzik et al. (4,266,540) in view of Drew et al. (2003/0164170) and Muto et al. (4,454,880), as applied to Claim 90, and further in view of Warren (2014/0251323).
As to Claim 93, the modified Panzik discloses a mask having a mask body (20) and an interfacing structure (defined by the insertion of 20 into the mask body 10) and further Muto teaches the patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface) is a non-sealing nasal cannula (best seen Figures 1 and 3A) cooperating within the mask body (20) to facilitate the delivery of oxygen to the patient.
Yet, the modified Panzik does not expressly disclose “an absorbent material to absorb a liquid.”
Warren teaches an additional construction of a mask (best seen Figures 18 – in situ and 19 - ex situ) suitable for surrounding an opening of the patient’s airways (nose and mouth via 266, “In another variant, as illustrated in FIGS. 18 and 19, an air filtration mask 266 is provided. The mask 266 is removably attached to the hollow sleeve 56.” Para 0130 and 0131) for the conveyance of oxygen (via 50 and 56, “ A medical cannula tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 24 to the mouthpiece 14. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the mouthpiece 14 and the tubing assembly 50 and is adapted to attach to an ear 66, a hat (not shown), helmet (not shown) or an eyeglass frame (not shown) of a user 134.” Para 0099) to the patient.
In the configuration of Warren, there is a mask body (266, “an air filtration mask 266” Para 0130 and 0131) and an interfacing structure (defined by the opening which receives 56) configured to interface with a patient interface (146, “A nosepiece 146 is provided that has at least one nose port 26. A medical cannula tubing assembly 50 is provided that is operably attached to the nosepiece, that conceals the medical nasal cannula 146, and the gas delivery pack 34 for delivering a flow of gas from the gas delivery pack 34 to the nosepiece 146. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the nosepiece 146, allowing the medical nasal cannula 50 to protrude through the nosepiece 146, for a snug fit into the nostrils 274.” Para 0111), wherein the patient interface includes at least one prong (26, “at least one nose port 26” Para 0111) that is configured to extend into the patient’s nasal passages, a pair of side arms (118, best seen Figures 6 and 10, “A bracket 118 is provided. The bracket 118 is adapted to support a pair of headphones 122 for use with a portable music system 126. The bracket 118 is attached to the sleeve 56 and locates the headphones 122 in positions suitable for mounting the headphones 122 to ears 66 of a user 134.” Para 0105) that is configured to extend laterally along a patient’s face, and a patient conduit (50, “A tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 34 to the mouthpiece 14. Para 105) configured to connect to a gases source for delivering gases flow to the patient via the at least one prong (26).
Regarding the “absorbent material”, Warren teaches the use of absorbent material (380, “The nose ports 26 are configured to accept Hepa prong filters 380. The Hepa prong filters are configured to fit and seal the nostrils of a user to filter out ambient harmful air from coming into breathing and allows for comfortable exhaling. The bottom 381 is sealed to reduce or prevent the user from drawing ambient air through the bottom of the Hepa prong filters 380. Hepa filters may also provide aroma's and or vitamins in their essential oil state, or may be saturated within the Hepa filters. The Hepa filters may also include medicine for absorption through inhaling thereby avoiding the waste from digestion.” Para 0139) to absorb a liquid (“medicine for absorption”).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the patient interface prongs of the modified Panzik to include the use of an absorbent material, as taught by Warren to permit the administration of medicine to the patient.
As to Claim 95, the modified Panzik, specifically Muto teaches the patient interface (defined by the combination of 61 and 62 - effectively forming a nasal cannula patient interface) is a non sealing (best seen Figures 1 and 3A) nasal cannula.
Yet, the modified Panzik does not expressly disclose “at least one prong that is configured to extend into a patient's nasal passage, a pair of side arms that is configured to extend laterally along a patient's face, and a patient conduit configured to connect to a gases source for delivering a gases flow to the patient via the at least one prong.”
Warren teaches an additional construction of a mask (best seen Figures 18 – in situ and 19 - ex situ) suitable for surrounding an opening of the patient’s airways (nose and mouth via 266, “In another variant, as illustrated in FIGS. 18 and 19, an air filtration mask 266 is provided. The mask 266 is removably attached to the hollow sleeve 56.” Para 0130 and 0131) for the conveyance of oxygen (via 50 and 56, “ A medical cannula tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 24 to the mouthpiece 14. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the mouthpiece 14 and the tubing assembly 50 and is adapted to attach to an ear 66, a hat (not shown), helmet (not shown) or an eyeglass frame (not shown) of a user 134.” Para 0099) to the patient.
In the configuration of Warren, there is a mask body (266, “an air filtration mask 266” Para 0130 and 0131) and an interfacing structure (defined by the opening which receives 56) configured to interface with a patient interface (146, “A nosepiece 146 is provided that has at least one nose port 26. A medical cannula tubing assembly 50 is provided that is operably attached to the nosepiece, that conceals the medical nasal cannula 146, and the gas delivery pack 34 for delivering a flow of gas from the gas delivery pack 34 to the nosepiece 146. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the nosepiece 146, allowing the medical nasal cannula 50 to protrude through the nosepiece 146, for a snug fit into the nostrils 274.” Para 0111), wherein the patient interface includes at least one prong (26, “at least one nose port 26” Para 0111) that is configured to extend into the patient’s nasal passages, a pair of side arms (118, best seen Figures 6 and 10, “A bracket 118 is provided. The bracket 118 is adapted to support a pair of headphones 122 for use with a portable music system 126. The bracket 118 is attached to the sleeve 56 and locates the headphones 122 in positions suitable for mounting the headphones 122 to ears 66 of a user 134.” Para 0105) that is configured to extend laterally along a patient’s face, and a patient conduit (50, “A tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 34 to the mouthpiece 14. Para 105) configured to connect to a gases source for delivering gases flow to the patient via the at least one prong (26).
Therefore it would have been obvious to one having ordinary skill in the art to modify the non-sealing nasal cannula of the modified Panzik to an alternative construction of the nasal cannula as taught by Warren to permit the administration of oxygen with the nasal prongs extending within the nasal passages.
As to Claim 96, the modified Panzik, specifically Panzik discloses the mask is selectively securable to or removable from the face of the patient independently of the patient interface, via an attachment mechanism (14, “Mask 10 is attached to patient 12 by flexible strap 14.” Column 2, Lines 20-35), the attachment mechanism (14) is releasably attached to the patient’s face.
As to Claim 97, the modified Panzik, specifically Panzik discloses the mask; yet, does not expressly disclose the mask “does not comprise a gases supply or gases removal conduit; or does not comprise a connection port for connecting to a gas source or gas removal device; or is not adapted to actively deliver a flow of gases to the patient; or is not adapted to actively remove a flow of gases from the patient.”
Warren teaches an additional construction of a mask (best seen Figures 18 – in situ and 19 - ex situ) suitable for surrounding an opening of the patient’s airways (nose and mouth via 266, “In another variant, as illustrated in FIGS. 18 and 19, an air filtration mask 266 is provided. The mask 266 is removably attached to the hollow sleeve 56.” Para 0130 and 0131) for the conveyance of oxygen (via 50 and 56, “ A medical cannula tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 24 to the mouthpiece 14. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the mouthpiece 14 and the tubing assembly 50 and is adapted to attach to an ear 66, a hat (not shown), helmet (not shown) or an eyeglass frame (not shown) of a user 134.” Para 0099) to the patient.
In the configuration of Warren, there is a mask body (266, “an air filtration mask 266” Para 0130 and 0131) and an interfacing structure (defined by the opening which receives 56) configured to interface with a patient interface (146, “A nosepiece 146 is provided that has at least one nose port 26. A medical cannula tubing assembly 50 is provided that is operably attached to the nosepiece, that conceals the medical nasal cannula 146, and the gas delivery pack 34 for delivering a flow of gas from the gas delivery pack 34 to the nosepiece 146. A single-sided, hollow sleeve 56 is provided. The sleeve 56 at least partially encloses the nosepiece 146, allowing the medical nasal cannula 50 to protrude through the nosepiece 146, for a snug fit into the nostrils 274.” Para 0111), wherein the patient interface includes at least one prong (26, “at least one nose port 26” Para 0111) that is configured to extend into the patient’s nasal passages, a pair of side arms (118, best seen Figures 6 and 10, “A bracket 118 is provided. The bracket 118 is adapted to support a pair of headphones 122 for use with a portable music system 126. The bracket 118 is attached to the sleeve 56 and locates the headphones 122 in positions suitable for mounting the headphones 122 to ears 66 of a user 134.” Para 0105) that is configured to extend laterally along a patient’s face, and a patient conduit (50, “A tubing assembly 50 is provided that is operably attached to the mouthpiece 14 and the gas delivery pack 34 for delivering gas from the gas delivery pack 34 to the mouthpiece 14. Para 105) configured to connect to a gases source for delivering gases flow to the patient via the at least one prong (26).
The mask body (266) of Warren does not comprise a gases supply or gases removal conduit; or does not comprise a connection port for connecting to a gas source or gas removal device; or is not adapted to actively deliver a flow of gases to the patient; or is not adapted to actively remove a flow of gases from the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask body of the modified Panzik to have no gases supply/source or gases removal conduit/devices, as taught by Warren to permit the conveyance of gases solely through the patient interface.
As to Claim 101, please see the rejection of Claim 95. The modified Panzik, specifically Warren teaches the interfacing structure (defined by the opening which receives 56) in the form of an aperture provided in the mask body (266) to allow a portion of the non-sealing nasal cannula (146) to extend therethrough, optionally to allow the patient conduit (50) of the non-sealing cannula (146) to extend through.
As to Claim 102, please see the rejection of Claim 95. The modified Panzik, specifically Warren teaches the mask (Figures 18 and 19) comprising a frame (56) shaped to conform to an external surface of the patient conduit (50) of the non-sealing nasal cannula (146), wherein the interfacing structure (defined by the opening which receives 56) comprises a first mounting structure (opening which receives 56) to releasably couple the frame (56) to the patient conduit (50).
As to Claim 103, please see the rejection of Claim 95. The modified Panzik, specifically Warren teaches the interfacing structure (defined by the opening which receives 56) comprises at least one mounting mechanism (opening which receives 56) to couple the mask (Figures 18 and 19) to the non-sealing nasal cannula (146).
Claim 100 is rejected under 35 U.S.C. 103 as being unpatentable over Panzik et al. (4,266,540) in view of Drew et al. (2003/0164170), Muto et al. (4,454,880), and Warren (2014/0251323), as applied to Claim 95, and further in view of Turnberg (2,663,297).
As to Claim 100, the modified Panzik, specifically Warren teaches mask (Figures 18 and 19) and the interfacing structure (defined by the opening which receives 56) comprising a recess or slot which conforms to an external surface of the non-sealing nasal cannula (146).
Yet, does not expressly disclose the use of “a cushion configured to seal about or against the patient's face … a recess or slot in the cushion … a cushion configured to seal about or against the patient's face, and wherein the interfacing feature comprises a recess or slot in the cushion, wherein the recess or slot conforms to an external surface of the non-sealing nasal cannula such that the cushion substantially seals about the side arms and/or the patient conduit of the non-sealing nasal cannula.”
Turnberg teaches an additional construction of a mask (Figures) suitable for surrounding an opening of the patient’s airways (“Nasal Adapter” Title) for the conveyance of oxygen to the patient.
Regarding the cushion, Turnberg teaches cushions (16 and 32, where 16 – “a padding of foam rubber” and 32 – “A padding of resilient material such as foam rubber” Column 2, Lines 1-35) are provided to the mask body (12) which receives the patient interface (31) having prongs (20/22). As best seen in Figures 4, the cushion (32) appears to wrap around a portion of the diameter of the prongs (20/22) thereby forming a recess in the cushion (32) to provide conformable sealing engagement of the patient conduit (30) of the non-sealing nasal cannula (31). The resultant effect of the cushions (16/32) of Turnburg are to protect the face of the patient when the mask is attached to the patient’s face.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the mask of the modified Panzik to include the use of a cushion as taught by Turnberg to provide protection between the mask and the patient’s face during usage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dietz (5,005,571); Warren (2009/0000618); and Hussain (9,302,064) each disclose additional masks having interfacing structures suitable for receipt of a patient interface. Specifically, Warren discloses the construction of the mask body having a filter medium.
The following IS NOT prior art BUT is considered pertinent to applicant's disclosure.
Salvino (2023/0226300) and Youman (11,918,743) each disclose additional masks having interfacing structures suitable for receipt of a patient interface. Specifically, Salvino discloses the construction of the mask body having a removable filter medium; and Youman discloses the construction of the mask body having a filter medium.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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, Kendra D Carter can be reached at 571-272-9034. 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 inform