DETAILED ACTION
This Office Action is in response to the election/restriction response, filed on January 6, 2026. Primary Examiner acknowledges Claims 21-40 are pending in this application, with Claims 21-40 having been newly added, and Claims 1-20 having been cancelled.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Species 3 in the reply filed on January 6, 2026 is acknowledged. The traversal is on the ground(s) that Applicant asserts “the Restriction Requirement fails to provide any evidence that there would be a serious burden examining all of the claims” (Remarks, Page 7, 2nd Paragraph) . This assertion is not found persuasive.
As outlined in the restriction requirement, mailed on November 6, 2025, on Page 3, 4th and 5th Paragraphs, the serious search and/or examination burden is based on the divergent subject matter claimed within each species. In particular, Species 1 was directed to an “adjustable length headgear with passthrough connection between the first strap and the second strap each connected at a first position and second position respectively”, Species 2 was directed to an “adjustable tension/force headgear with chords attached to an adjustment mechanism mounted on the mask to increase/decrease the tension/force to tighten or loosen the headgear”, and Species 3 was directed to “alignment indicators on each of the mask and the headgear to orient the proper connection of the headgear to the mask”. The claimed structure of each species are separate, distinct, and are not obvious variants of each other as the functionality of each subject matter has a separate status and functionality in the field of headgear systems for patient interfaces. Thus, the requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
Reference character “140” has been used to designate “headgear connectors” and “tabs” (Para 0103 – 2 instances). Appropriate correction is required.
Reference character “324” has been used to designate “back of head portion”, “strap” (Para 0131), and “back of head strap” (Para 0145). Appropriate correction is required.
Reference character “370” has been used to designate “headgear strap”, “headgear” (Para 0141), and “strap” (Para 0142 – 2 instances; and Para 0143). Appropriate correction is required.
Reference character “372” has been used to designate “adjustment indicators”, and “headgear strap” (Para 0143). Appropriate correction is required.
Reference character “402” has been used to designate “chords” and “cords” (Para 0159). Appropriate correction is required.
Reference character “500” has been used to designate “headgear wrap”, “wrap” (Para 0111 – 2 instances), and “headgear straps” (Para 0111). Appropriate correction is required.
Reference character “760” has been used to designate “individual hairs” (Para 0138) and “headgear” (Para 0140). Appropriate correction is required.
Reference character “802” has been used to designate “a first or top strap” (Para 0161), “top strap” (Para 0163), “upper and lower vector members or straps” (Para 0162), and “vector members” (Para 0162). Appropriate correction is required.
Reference character “804” has been used to designate “second or bottom strap” (Para 0161), “bottom strap (Para 0161 and 0163), “upper and lower vector members or straps” (Para 0162), “vector member” (Para 0162). 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 “140” has been used to designate “headgear connectors” and “tabs” (Para 0103 – 2 instances). Appropriate correction is required.
Reference character “324” has been used to designate “back of head portion”, “strap” (Para 0131), and “back of head strap” (Para 0145). Appropriate correction is required.
Reference character “370” has been used to designate “headgear strap”, “headgear” (Para 0141), and “strap” (Para 0142 – 2 instances; and Para 0143). Appropriate correction is required.
Reference character “372” has been used to designate “adjustment indicators”, and “headgear strap” (Para 0143). Appropriate correction is required.
Reference character “402” has been used to designate “chords” and “cords” (Para 0159). Appropriate correction is required.
Reference character “500” has been used to designate “headgear wrap”, “wrap” (Para 0111 – 2 instances), and “headgear straps” (Para 0111). Appropriate correction is required.
Reference character “760” has been used to designate “individual hairs” (Para 0138) and “headgear” (Para 0140). Appropriate correction is required.
Reference character “802” has been used to designate “a first or top strap” (Para 0161), “top strap” (Para 0163), “upper and lower vector members or straps” (Para 0162), and “vector members” (Para 0162). Appropriate correction is required.
Reference character “804” has been used to designate “second or bottom strap” (Para 0161), “bottom strap (Para 0161 and 0163), “upper and lower vector members or straps” (Para 0162), “vector member” (Para 0162). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 24, 25, 31, and 36 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Moore et al. (2003/0196656).
As to Claim 21, Moore discloses a patient interface (Figure 1) configured to deliver breathable gas to a patient, the patient interface (Figure 1) comprising: a sealing portion (40, “As shown in FIGS. 1-4, a nasal mask assembly 10 according to one preferred embodiment of the present invention includes a frame 20 and a cushion 40 that is preferably detachably connected to the frame 20.” Para 0107) with a sealing surface (270 via 205, “The membrane 205 forms a seal forming portion 270 (FIG. 24e) which contacts the patient in the lower nasal bridge region, cheek and lip regions 41-43.” Para 0183), at least a portion of which is configured to seal against an underside of the patient’s nose (“contacts the patient in the lower nasal bridge region, cheek and lip regions 41-43.” Para 0183), a thickness of the sealing surface (270 via 205) being varied (“The sealing element (e.g., membrane) is preferably elastomeric having a thickness in the range of 0.1 and 2.0 mm, preferably 0.35 mm, to allow the membrane to stretch readily over the lower portion of the nasal bridge. The stretch of the membrane may be varied in different regions by varying its thickness, adding stiffening structure such as ribs, or using composites.” Para 0175; also see: “The rim 225 has a thickness that is preferably less than the central portion 215 of the frame 200, but preferably greater than the membrane 205. For example, the membrane 205 has a thickness in the range of between about 0.1-2.0 mm, and preferably 0.35 mm, while the rim 225 has a thickness of between about 0.5 and 2.0 mm, and preferably 1.35 mm. While it is preferable that the membrane 205 be thinner than the rim 225, they could have the same thicknesses.” Para 0183); a support portion (20, “As shown in FIGS. 1-4, a nasal mask assembly 10 according to one preferred embodiment of the present invention includes a frame 20 and a cushion 40 that is preferably detachably connected to the frame 20.” Para 0107) attached to an anterior side of the sealing portion (40); a first connector (one of 20b, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80.” Para 0223; also see: “The frame 20 includes a main body 20a, which is designed to accommodate the cushion 40, and a pair of side frame members 20b that are preferably formed in one piece with the main body 20a of the frame 20.” Para 0109) located on a first lateral end of the support portion (20) and configured to attach to a first connecting member (one of 34 attached to one 20b, “As seen in FIGS. 5c and 6a, the frame 20 includes a locking clip receiver assembly 34 positioned on each side of the frame 20 for connecting to a respective locking clip 82 (FIGS. 9a and 10a) of the headgear assembly 80. Each locking clip receiver assembly 34 includes an engagement face 35 (FIG. 5c), a central support slot 36 and two locking slots 38 positioned on opposite sides of the central support slot 36.” Para 0116; and “As shown in FIG. 10a, the clip 82 can be inserted into releasable engagement with the locking clip engagement receiver 34 of the frame 20.” Para 0125) of the headgear assembly (80, “A swivel elbow assembly 60 and a headgear assembly 80 can be attached to the frame 20.” Para 0107); a second connector (other of 20b, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80.” Para 0223; also see: “The frame 20 includes a main body 20a, which is designed to accommodate the cushion 40, and a pair of side frame members 20b that are preferably formed in one piece with the main body 20a of the frame 20.” Para 0109) located on a second lateral end of the support portion (20), opposite the first lateral end, the second connector (other of 20b) being configured to attach to a second connecting member (other of 34 attached to other 20b, “As seen in FIGS. 5c and 6a, the frame 20 includes a locking clip receiver assembly 34 positioned on each side of the frame 20 for connecting to a respective locking clip 82 (FIGS. 9a and 10a) of the headgear assembly 80. Each locking clip receiver assembly 34 includes an engagement face 35 (FIG. 5c), a central support slot 36 and two locking slots 38 positioned on opposite sides of the central support slot 36.” Para 0116; and “As shown in FIG. 10a, the clip 82 can be inserted into releasable engagement with the locking clip engagement receiver 34 of the frame 20.” Para 0125) of the headgear assembly (80, “A swivel elbow assembly 60 and a headgear assembly 80 can be attached to the frame 20.” Para 0107); and an alignment indicator (one of A1, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80. Specifically, the locking clip 82 of the headgear assembly 80 may include alignment symbols, e.g., diamonds, lines, colors, arrows, etc., on the outer surface thereof that are positioned to align with the alignment symbols A.sub.1 provided on the frame 20 when the locking clip 82 and frame 20 are engaged with one another.” Para 0223) positioned on the support portion (20) adjacent to the first connector (one of 20b) in a location configured to align with a corresponding mark on the first connecting member (one of 34 attached to one 20b) of the headgear assembly (80), wherein the first and second connectors (20b) have the same structure.
As to Claim 24, Moore discloses an orientation indicator (other of A1, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80. Specifically, the locking clip 82 of the headgear assembly 80 may include alignment symbols, e.g., diamonds, lines, colors, arrows, etc., on the outer surface thereof that are positioned to align with the alignment symbols A.sub.1 provided on the frame 20 when the locking clip 82 and frame 20 are engaged with one another.” Para 0223) positioned on the support portion (20) adjacent to the second connector (other of 20b), and wherein the orientation indicator (other of A1) indicates the correct orientation of the patient interface (Figure 1) relative to the patient’s face.
As to Claim 25, Moore discloses the support portion (20) and the sealing portion (40) are formed from the same material (“the mask frame and cushion may be formed from the same material in one piece where the elbow is attached as a separate piece.” Para 0196).
As to Claim 31, Moore discloses a patient interface (Figure 1) configured to deliver breathable gas to a patient, the patient interface (Figure 1) comprising: a sealing portion (40, “As shown in FIGS. 1-4, a nasal mask assembly 10 according to one preferred embodiment of the present invention includes a frame 20 and a cushion 40 that is preferably detachably connected to the frame 20.” Para 0107) configured to seal against a patient’s face (“contacts the patient in the lower nasal bridge region, cheek and lip regions 41-43.” Para 0183), at least part of the sealing portion (40) being configured to seal against an underside of the patient’s nose (“contacts the patient in the lower nasal bridge region, cheek and lip regions 41-43.” Para 0183); a support portion (20, “As shown in FIGS. 1-4, a nasal mask assembly 10 according to one preferred embodiment of the present invention includes a frame 20 and a cushion 40 that is preferably detachably connected to the frame 20.” Para 0107) attached to an anterior side of the sealing portion (40), the support portion (20) being more rigid (“A mask assembly typically includes a rigid shell, a soft face-contacting cushion, a forehead support and headgear for securing the mask to the head.” Para 0005); a first connector (one of 20b, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80.” Para 0223; also see: “The frame 20 includes a main body 20a, which is designed to accommodate the cushion 40, and a pair of side frame members 20b that are preferably formed in one piece with the main body 20a of the frame 20.” Para 0109) located on a first lateral end of the support portion (20) and configured to attach to a first connecting member (one of 34 attached to one 20b, “As seen in FIGS. 5c and 6a, the frame 20 includes a locking clip receiver assembly 34 positioned on each side of the frame 20 for connecting to a respective locking clip 82 (FIGS. 9a and 10a) of the headgear assembly 80. Each locking clip receiver assembly 34 includes an engagement face 35 (FIG. 5c), a central support slot 36 and two locking slots 38 positioned on opposite sides of the central support slot 36.” Para 0116; and “As shown in FIG. 10a, the clip 82 can be inserted into releasable engagement with the locking clip engagement receiver 34 of the frame 20.” Para 0125) of the headgear assembly (80, “A swivel elbow assembly 60 and a headgear assembly 80 can be attached to the frame 20.” Para 0107); a second connector (other of 20b, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80.” Para 0223; also see: “The frame 20 includes a main body 20a, which is designed to accommodate the cushion 40, and a pair of side frame members 20b that are preferably formed in one piece with the main body 20a of the frame 20.” Para 0109) located on a second lateral end of the support portion (20), opposite the first lateral end, the second connector (other of 20b) being configured to attach to a second connecting member (other of 34 attached to other 20b, “As seen in FIGS. 5c and 6a, the frame 20 includes a locking clip receiver assembly 34 positioned on each side of the frame 20 for connecting to a respective locking clip 82 (FIGS. 9a and 10a) of the headgear assembly 80. Each locking clip receiver assembly 34 includes an engagement face 35 (FIG. 5c), a central support slot 36 and two locking slots 38 positioned on opposite sides of the central support slot 36.” Para 0116; and “As shown in FIG. 10a, the clip 82 can be inserted into releasable engagement with the locking clip engagement receiver 34 of the frame 20.” Para 0125) of the headgear assembly (80, “A swivel elbow assembly 60 and a headgear assembly 80 can be attached to the frame 20.” Para 0107); and an alignment indicator (one of A1, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80. Specifically, the locking clip 82 of the headgear assembly 80 may include alignment symbols, e.g., diamonds, lines, colors, arrows, etc., on the outer surface thereof that are positioned to align with the alignment symbols A.sub.1 provided on the frame 20 when the locking clip 82 and frame 20 are engaged with one another.” Para 0223) positioned on the support portion (20) adjacent to the first connector (one of 20b) in a location configured to align with a corresponding mark on the first connecting member (one of 34 attached to one 20b) of the headgear assembly (80), wherein the first and second connectors (20b) have the same structure.
As to Claim 36, Moore discloses the sealing portion (40) comprises a sealing surface (270 via 205, “The membrane 205 forms a seal forming portion 270 (FIG. 24e) which contacts the patient in the lower nasal bridge region, cheek and lip regions 41-43.” Para 0183) with a constant wall thickness (“The rim 225 has a thickness that is preferably less than the central portion 215 of the frame 200, but preferably greater than the membrane 205. For example, the membrane 205 has a thickness in the range of between about 0.1-2.0 mm, and preferably 0.35 mm, while the rim 225 has a thickness of between about 0.5 and 2.0 mm, and preferably 1.35 mm. While it is preferable that the membrane 205 be thinner than the rim 225, they could have the same thicknesses.” Para 0183).
Claims 21, 23, 25, 26, 28-31, 34, 35, and 38-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gunaratnam et al. (2004/0226566).
As to Claim 21, Gunaratnam discloses a patient interface (Figures 108-110) configured to deliver breathable gas to a patient, the patient interface (Figures 108-110) comprising: a sealing portion (617, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) with a sealing surface (defined by the engagement of 617 to the nostrils of the patient), at least a portion of which is configured to seal against an underside of the patient’s nose (via nostrils), a thickness of the sealing portion (617) being varied (“That is, the nozzle assembly and frame may be a one-piece structure with different thicknesses and hardnesses to add rigidity.” Para 0186); a support portion (616, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) attached to an anterior side of the sealing portion (617); a first connector (one of 618, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) located on a first lateral end of the support portion (616) and configured to attach to a first connecting member (one of 614 via 610, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382) of the headgear assembly (608, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382); a second connector (other of 618, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) located on a second lateral end of the support portion (616), opposite the first lateral end, the second connector (other of 618) being configured to attach to a second connecting member (other of 614 via 610, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382) of the headgear assembly (608, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382); and an alignment indicator (611b, “In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) positioned (via 617) on the support portion (616) adjacent to the first connector (one of 618) in a location configured to align with a corresponding mark (via 611a) on the first connector member (one of 614 via 610) of the headgear assembly (608), wherein the first and second connectors (618) have the same structure.
As to Claims 23 and 34, Gunaratnam discloses of the first and second connectors (618) only the first connector (one of 618) is adjacent to the alignment indicator (611b), as best shown in Figure 109.
As to Claim 25, Gunaratnam discloses the support portion (616) and the sealing portion (617) are formed of the same material (“That is, the nozzle assembly and frame may be a one-piece structure with different thicknesses and hardnesses to add rigidity.” Para 0186).
As to Claims 26 and 35, Gunaratnam discloses the sealing portion (617) comprises a nose tip engagement portion (defined by the region between the nostril inserts), configured to engage a tip of the nose of the patient in use; an upper lip engagement portion (defined by the lateral base connecting the nostril inserts) configured to engage an upper lip of the patient in use; and a pair of nostril engagement portions (defined by the nostril inserts) configured to engage the patient’s nostrils. In particular, Gunaratnam discloses “In use, the sealing forces act on more sensitive regions of the patient's face, e.g., nose, and the stability forces act on less sensitive regions of the patient's face, e.g., upper lip, cheeks and back of the patient's head. Moreover, the stability forces tend to be higher than the sealing forces.” (Para 0229).
As to Claims 28 and 38, please see the rejection of Claims 21 and 31, respectively, which addresses the features of the patient interface. Regarding the remaining limitations, Gunaratnam discloses a headgear assembly (608) configured to support the patient interface (Figures 108-110) on the patient’s head, the headgear assembly (608) comprising: the first connecting member (one of 614 via 610) which is configured to connect to the first connector (one of 618) on the support portion (616) and comprising a headgear alignment indicator (611a, “In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) configured to align with the alignment indicator (611b, , “In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) on the support portion (616) when the first connecting member (one of 614 via 610) of the headgear assembly (608) is secured to the first connector (one of 618) on the support member (616); and the second connecting member (other of 614 via 610) which is configured to connect to the second connector (other of 618) on the support member (616), wherein of the first and second connectors (618) only the first connector (one of 618) is adjacent to the alignment indicator (611b), as best shown in Figure 109.
As to Claims 29 and 39, Gunaratnam discloses each of the first and second connectors (618) of the patient interface (Figures 108-110) is configured to connect to either the first and second connecting members (614 via 610) of the headgear assembly (608).
As to Claims 30 and 40, please see the rejection of Claims 28 and 38, respectively, which addresses the features of the patient interface. Regarding the remaining limitations, Gunaratnam discloses a positive airway pressure (PAP) device (via 609, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377 suitable for operating at PAP pressures “The present invention relates to a nasal assembly used for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-invasive Positive Pressure Ventilation (NPPV).” Para 0002) configured to generate the pressurized flow of respiratory gas; and an air delivery tube (606, “An air delivery tube 606 is joined to the swivel elbow 612. The air delivery tube 606 may include a swivel connector 607 and includes an end 609 which also may be provided with a swivel connector. The end 609 is provided with a source of pressurized gas.” Para 0377) configured to convey the pressurized flow of respiratory gas from the PAP device (via 609) to the patient interface assembly (Figures 108-110).
As to Claim 31, Gunaratnam discloses a patient interface (Figures 108-110) configured to deliver breathable gas to a patient, the patient interface (Figures 108-110) comprising: a sealing portion (617, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) configured to seal against a patient’s face (via nostrils), at least part of the sealing portion (617) being configured to seal against an underside of the patient’s nose (via nostrils); a support portion (616, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) attached to an anterior side of the sealing portion (617), the support portion (616) being more rigid (“The nasal assembly generally includes a relatively rigid shell, e.g., a frame, and a pair of nozzles (which may be in the form of nasal pillows, nasal prongs, cannula, or nasal puffs) that are mounted on the rigid shell and structured to be inserted into the nasal passages of the patient.” Para 0004; also see: “the frame 16 is a rigid or semi-rigid structure formed from a polymer material. However, the frame 16 may be semi-rigid to allow flexibility of the frame 16 with respect to the patient's face in use. The frame 16 may also be semi-rigid in certain regions for customized flex in certain regions of the frame 16.” Para 0178) than the sealing portion (617); a support portion (616, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) attached to an anterior side of the sealing portion (617); a first connector (one of 618, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) located on a first lateral end of the support portion (616) and configured to attach to a first connecting member (one of 614 via 610, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382) of the headgear assembly (608, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382); a second connector (other of 618, “In particular, the cushion assembly 604 includes a frame 616 which supports a cushion 617. The frame 616 includes a first connector portion 618 provided to each end of the frame 616 and/or cushion 617. Each first connector portion 618 is provided with or to a seal ring 614” Para 0380) located on a second lateral end of the support portion (616), opposite the first lateral end, the second connector (other of 618) being configured to attach to a second connecting member (other of 614 via 610, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382) of the headgear assembly (608, “As shown in FIG. 110A, each seal ring 614 includes a groove 630 to receive a respective one of the rings 610 of the yoke 608.” Para 0382); and an alignment indicator (611b, “In FIG. 109, the ring 610 of the yoke 608 of the headgear includes an alignment marker 611a and the cushion includes a plurality of alignment markers 611b that can be selectively aligned with marker 611a.” Para 0379) positioned (via 617) on the support portion (616) adjacent to the first connector (one of 618) in a location configured to align with a corresponding mark (via 611a) on the first connector member (one of 614 via 610) of the headgear assembly (608), wherein the first and second connectors (618) have the same structure.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22 and 32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moore et al. (2003/0196656) in view of Schneider (4,971,073).
As to Claims 22 and 32, Moore discloses an alignment indicator (one of A1, best seen Figure 40, “As shown in FIG. 40, the frame 20 may include alignment symbols A.sub.1, e.g., diamonds, lines, colors, arrows, etc., on the side frame members 20b which are structured to facilitate the engagement between the frame 20 and the headgear assembly 80. Specifically, the locking clip 82 of the headgear assembly 80 may include alignment symbols, e.g., diamonds, lines, colors, arrows, etc., on the outer surface thereof that are positioned to align with the alignment symbols A.sub.1 provided on the frame 20 when the locking clip 82 and frame 20 are engaged with one another.” Para 0223).
Yet, does not expressly disclose “the alignment indicator includes information indicating that the patient interface size is large, medium, or small”.
Schneider teaches a patient interface in the form of a restraint jacket that is sized by the health care professional to meet the anatomy of the patient. Schneider teaches the use of indicia in the form of color coding to indicate small, medium, and large sizes so that the patient interface is selected “in size for a particular patient can be quickly selected by a busy health care professional.” (Column 2, Lines 1-10). Such color coding as discussed by Schneider includes “A green-in-collar tab could represent a "small" size jacket; yellow might indicate a "medium" size and a third color might indicate a "large" size, for example.” (Column 5, Line 65 thru Column 6, Line 10). The resultant effect of the color coding provides a fast visual indication to the heath care professional of the size of the patient interface to be selected to best fit the patient in need of the patient interface.
As Moore already considered the use of an alignment indicator to include “color” (Para 0223), the teachings of Schneider reinforce the use of color coordination and coding was known in the claimed configuration for the purpose of enabling the health care professional to quickly select the patient interface consistent with the anatomy of the patient in their care.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the alignment indicator of Moore to further include the use of color coding as taught by Schneider to permit fast visual identification of sizing of the patient interface.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moore et al. (2003/0196656) in view of Correa et al. (6,119,694).
As to Claim 27, Moore discloses the sealing surface (270 via 205) that may be constructed with “varied in different regions by varying its thickness, adding stiffening structure such as ribs, or using composites.” (Para 0175).
Yet, does not expressly disclose “the sealing surface is thicker on lateral sides of the sealing surface than at the central region of the sealing surface”.
Correa teaches an alternative patient interface suitable to deliver breathable gas to a patient (best seen Figures 1-3 and 7) including a sealing portion (B, best seen Figure 7, “As shown in FIGS. 1 and 2, nasal mask assembly B includes flexible nare seal 14 and nare seal support 15.” Column 2, Lines 45-60) for sealing with a sealing surface (14, “flexible nare seal 14” Column 2, Lines 45-60) configured to seal against an underside of the patient’s nose (via 106, “When gas is being provided, nare seal 14 has a second inflated position illustrated by solid lines 106 wherein top surface 56 deflects upward and rearward surface 58 deflects rearwardly against the patient's upper lip to encircle the patient's nares and seal the area surrounding the patient's nares.” Column 4, Lines 40-55), the thickness of the sealing surface (14) being varied (best seen Figure 7, whereby the region of 66 most proximate to 15 appears to be thicker than the region of 66 most proximate to the nares of the patient, “Nare seal 14 also includes left nasal seal side 60, right nasal seal side 62 and nasal seal bottom 64 which in combination with top surface 56 and rearward side surface 58 define nasal seal interior 66.” Column 3, Line 65 thru Column 4, Line 15).
Regarding the remaining limitations of the claims, Correa teaches the sealing surface (14) on the lateral sides (60/62 proximate bottom 64) of the sealing surface (14) is thicker than at the central region (56/58) of the sealing surface (14). The resultant effect of this thicker lateral region as compared to the thinner central region is the ability to secure the sealing portion (B) firmly to the support portion (via 15) of the patient interface (Figures 1-3 and 7) and to permit the pneumatic movement of the seal (14) in response to airflow to provide sealing engagement to the nose of the patient (via operation of 104/106, “As shown in FIGS. 5, 5A and 7, nare seal 14 has a first uninflated position illustrated by broken lines 104 when gas is not being provided to the patient. In the first uninflated position, top surface 56 rests against the bottom of the patient's nose and rearward surface 58 rests against the upper lip of the patient. When gas is being provided, nare seal 14 has a second inflated position illustrated by solid lines 106 wherein top surface 56 deflects upward and rearward surface 58 deflects rearwardly against the patient's upper lip to encircle the patient's nares and seal the area surrounding the patient's nares.” Column 4, Lines 40-55).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the sealing surface of Moore to include a thicker lateral side than the central side as taught by Correa to be a known construction suitable for imparting firm supportive connection to the support portion whilst also permitting pneumatic movement for sealing engagement.
Claim 37 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moore et al. (2003/0196656) in view of Berthon-Jones et al. (2006/0118117).
As to Claim 37, Moore discloses the sealing portion (40); yet, does not expressly disclose “the sealing portion comprises multiple layers of material, wherein each layer has a different thickness”.
Berthon-Jones discloses an alternative patient interface suitable to deliver breathable gas to a patient (best seen Figures 1-3 and 7) including a sealing portion (x00, wherein 400 – “Referring to FIG. 65, a cushion assembly 400 according to a fourth embodiment of the present invention includes a two or three layer structure.” Para 0241; 500 – “Referring to FIG. 66, a cushion assembly 500 according to a fifth embodiment of the invention includes a two or three layer structure.” Para 0243; and 600 – “Referring to FIG. 67, a cushion assembly 600 according to a sixth embodiment of the present invention includes a first layer and a second layer.” Para 0246 and “Although not shown in FIG. 67, it should be appreciated that the cushion assembly 600 may be provided with a third layer, such as a skin.” Para 0249) comprising multiple layers of material (wherein 400 – “The first layer (cushion flange 440) may be a rigid layer of polyurethane elastomer (no foam). The second layer (flexible element 430) may be formed of urethane foam or soft silicone. The third layer (skin 460) may be formed of silicone skin.” Para 0242; 500 – “The first layer (cushion flange 540) may be a rigid polyurethane elastomer (no foam). The second layer (flexible element 530) may be formed of urethane foam or soft silicone. The third layer (skin 560) may be formed of silicone skin with a uniform or varying thickness as described above.” Para 0244; and 600 – “The first layer (cushion flange 640) may be a rigid polyurethane elastomer (no foam). The second layer (flexible element 630) is formed of foam and includes a first portion 631 of relatively low stiffness and a second portion 632 of relatively high stiffness.” Para 0247, and “Although not shown in FIG. 67, it should be appreciated that the cushion assembly 600 may be provided with a third layer, such as a skin.” Para 0249), wherein each layer has a different thickness (as best seen in Figures 65, 66, and 67).
The resultant effect of the varied materials and varied thicknesses is a variation in the conformity and deflection of the cushion upon the face of the patient in order to achieve “the expected degree of deformation” (Para 0242) as desired by the face engagement of the sealing portion to the face of the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the sealing portion of Moore to be constructed with multiple layers of material at different thicknesses as taught by Berthon Jones to be a known design variations suitable for achieving the expected degree of deformation as desired by the face engagement of the sealing portion to the face of the patient.
Claim 33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gunaratnam et al. (2004/0226566).
As to Claim 33, Gunaratnam discloses the alignment indicator (611b) is in the form of a triangle (best seen Figure 109) having vertices; yet, does not expressly disclose the orientation whereby “one of the vertices” of the triangle is configured to be “pointing towards the first connector”.
In light of the importance of the alignment indicators of the headgear to be collinear with the alignment indicators of the patient interface, it would have been obvious to one having ordinary skill in the art to rotate the direction of the alignment indicators of each of the headgear and the patient interface to have a corresponding and collinear shape to confirm proper alignment, since it has been held where the general conditions of a claim are disclosed in the prior art discovering the optimum or workable ranges involves only routine skill in the art. In this particular case, Gunaratnam’s alignment indicators are have a corresponding and collinear shape to the base of the triangle.
Nevertheless, the decision to modify the corresponding and collinear shape of the triangle to be one of the vertices instead of the base of the triangle would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to provide alignment indicators having a corresponding and collinear shape to affirm the proper alignment of the headgear to the patient interface.
Applicant has not asserted the specific configuration of one of the vertices of the triangle “pointing towards the first connector” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of providing a corresponding and collinear shape to confirm proper alignment, thus the use of the specific orientation of the triangles appears to lack criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Gunaratnam, as the orientation would yield the predictable results of providing a corresponding and collinear shape to confirm proper alignment of the corresponding components.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the orientation of the triangle of Gunaratnam, a known result effective variable, in order to provide a corresponding and collinear shape to confirm proper alignment of the corresponding components.
Conclusion
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785