Prosecution Insights
Last updated: April 19, 2026
Application No. 18/456,143

PATIENT INTERFACE

Non-Final OA §102§103§112
Filed
Aug 25, 2023
Examiner
DIXON, ANNETTE FREDRICKA
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
ResMed
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
3y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
889 granted / 1190 resolved
+4.7% vs TC avg
Strong +26% interview lift
Without
With
+25.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
39 currently pending
Career history
1229
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
38.6%
-1.4% vs TC avg
§102
26.0%
-14.0% vs TC avg
§112
18.9%
-21.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1190 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on August 25, 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 “3140” has been used to designate “base ends” and “opening” (Para 0193 – 3 instances). Appropriate correction is required. Reference characters “3140” and “3130” have been used to designate “opening”. Appropriate correction is required. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “channel 3320” as referenced in Para 0216 and recited in independent claim, Claim 15, and its dependents, Claims 16- 20, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Specification The disclosure is objected to because of the following informalities: Reference character “3140” has been used to designate “base ends” and “opening” (Para 0193 – 3 instances). Appropriate correction is required. Reference characters “3140” and “3130” have been used to designate “opening”. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 1-14 , 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Specifically, Claim 1, Line 6 recites “air”; however, this limitation appears to lack antecedent basis in the claims and thus is unclear. The initial recitation of the fluid being transferred through the patient interface was identified as “respiratory gas” in Claim 1, Line 1. However, by the recitation of “air” in Claim 1, Line 6, it is unclear if the “gas” of Line 1 is the same as the “air” of Line 6 or some other feature. Dependent claims, Claims 2-14, incorporate the indefinite subject matter from which they depend. Appropriate correction and clarification is required. Specifically, Claim 2, Line 1; Claim 3, Line 1; Claim 6, Line 1; Claim 7, Lines 2 and 3; and Claim 14, Line 1 recite the limitation “the protrusions”; however, this recitation appears to lack antecedent basis in the claims . In the independent claim, Claim 1, Line 4, Applicant appears to reference “two protrusions”; however, it is unclear whether the recitations of “the protrusions” of Claims 2, 3, 6, 7, and 14 are the same or separate and distinct. Thus, the claims are indefinite. Appropriate correction and clarification is required. Specifically, Claim 4, Lines 1-2 recite “lateral extension portions”; however, it appears this limitation is unclear. By patient convention, new limitations are introduced with the grammatical article of “a”. Thus it appears the recitation should be changed to “a lateral extension portion extending laterally outwards on either side of the two protrusions, wherein each lateral extension portion respectively being …”. Appropriate correction and clarification is required. Specifically, Claim 8, Line 2 recites “a pair of air inlets on opposing lateral sides”; however, this limitation appears to lack antecedent basis in the claims as Applicant has not formerly introduced “a lateral side” of the plenum base. Still further, Primary Examiner is unclear whether the term “lateral side” of Claim 8 is coextensive and/or should depend from the former recitation of “lateral extension portions” in Claim 4, or alternatively if these limitations are separate and distinct. Appropriate correction and clarification is required. Specifically, Claim 11, Line 2 recites “two sealing surfaces”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure what/which “sealing surface(s)” Applicant is attempting to refer . Is Applicant attempting to recite the “seal” of the protrusion as referenced in Claims 2 and 3? Dependent claim, Claim 12, incorporates the indefinite subject matter from which it depends. Appropriate correction and clarification is required. Specifically, Claim 12, Line 2 recites “a mouth seal”; however, there is no reference to a mouth seal in the entire claim listing. Primary Examiner is unsure what structure and relationship of the claimed patient interface would be configured to provide “a mouth seal”. Appropriate correction and clarification is required. Specifically, Claim 19, Line 1 recites “lateral portions”; however, it appears this limitation is unclear. By patient convention, new limitations are introduced with the grammatical article of “a”. Thus it appears the recitation should be changed to “a pair of lateral portions …”. Dependent claim, Claim 20, incorporates the indefinite subject matter from which it depends. Appropriate correction and clarification 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 s 1-8, 10-13, 15-17, 19, and 20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Henry et al. (2016/0296720, which shares a common assignee/inventor with the instant application but has a disclosure date beyond the grace period of this instant application ) . As to Claim 1, Henry discloses a patient interface (best seen Figure 18, “ FIG. 18 is a side view of a patient interface in position on a model patient's head without any positioning and stabilising structure shown. ” Para 0126) configured to deliver a pressurized flow of respiratory gas (via 4180, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456; “ Plenum chamber 3200 in accordance with an aspect of one form of the present technology functions to allow air flow between the two nares and the supply of air from PAP device 4000 via a short tube 4180. The short tube 4180 is typically part of the air circuit 4170 that connects to the frame 3310 via a connection port 3600 and a longer tube (additional gas delivery tube) 4178 connected to the PAP device 4000 . ” Para 0511; “ In the shown example, such breathable gas is provided via the hose or tube 4180 connected to patient interface 3000. The tube 4180 may be connected at its other end (not shown) to a source of breathable gas, such as a blower or ventilator for providing pressurized breathable gas . ” Para 0673) to the patient’s airways (via 3100, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456), the patient interface (best seen Figure 18) comprising: a cradle base ( 3100, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456) configured to cradle the patient’s nose in use; two protrusions (3130, “ In one form of the present technology, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or a pair of nasal pillows 3130 , each nasal putt or nasal pillow being constructed and arranged to form a seal with a respective nares of the nose of a patient, e.g. by forming a seal against a peripheral region of the flares of the patient. ” Para 0462) extending from the cradle base (3100) and being configured to be inserted into the patient’s nose in use, each of the protrusions (3130) having formed therein an opening (defined by the interior perimeter of 3110 as best seen in Figure 9 through which gas flows through to the airways of the patient, “ Referring to FIG. 9, in one form of the present technology, the seal-forming structure 3100 may comprise a sealing flange 3110 and a support flange 3120. ” Para 0460) configured to allow a continuous flow of gas therethrough ; and a plenum base (3310, “ This view also indicates the attachment of the plenum chamber 3200 and seal-forming structure 3100 to the frame 3310 . ” Para 0469; “ Plenum chamber 3200 in accordance with an aspect of one form of the present technology functions to allow air flow between the two nares and the supply of air from PAP device 4000 via a short tube 4180. The short tube 4180 is typically part of the air circuit 4170 that connects to the frame 3310 via a connection port 3600 and a longer tube (additional gas delivery tube) 4178 connected to the PAP device 4000. ” Para 0511) that, together with the cradle base (3100), forms a plenum chamber (3200, “Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200 , a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways.” Para 0456 ; “ This view also indicates the attachment of the plenum chamber 3200 and seal-forming structure 3100 to the frame 3310.” Para 0469 ), wherein the cradle base (3100) is decoupled (via 3236, “ Another aspect of the present technology that may be seen in FIGS. 4, 7, 8, 10 and 11, that the plenum chamber 3200 has a saddle or decoupling region 3236 . As can be seen in FIG. 4, the flexing region 3230 may comprise the decoupling region 3236 , which may be located between the left flexing region 3232 and the right flexing region 3234. The decoupling region 3236 may be concave in shape and may span from the anterior wall 3210 to the posterior wall 3220. By forming the plenum chamber 3200 with the decoupling region 3236 as described, it may be possible to decouple the left flexing region 3232 from the right flexing region 3234 such that movement in one of the flexing regions does not substantially affect the other flexing region. In other words, deformation and/or buckling of the left flexing region 3232 may not cause a disruption to the right flexing region 3234 and vice versa . Advantageously, this may allow the nasal pillow 3130 associated with the undisturbed flexing region to remain in position on the patient's corresponding naris in spite of a disruption to the other flexing region . The decoupling region 3236 , by being recessed between the stalks 3150, may avoid contact with the septum. Also, the decoupling region 3236 may be the thinnest region of the plenum chamber 3200 to allow for the desired amount of flexibility in this region. Alternatively, the decoupling region 3236 may be the thickest region of the plenum chamber 3200. By providing the saddle region 3236 with a deep curvature, septum and/or upper lip contact may be minimised or avoided to improve patient comfort. The saddle region 3236 may be U or V shaped and has a nasolabial angle at its peak of about 70° to about 120°. The saddle region 3236 may be about 0.5 mm to about 2.5 mm in depth for clearance around the patient's septum. ” Para 0519) from the plenum base (3310) . As to Claim 2, Henry discloses the two protrusions (3130) are structured and arranged to seal, in use, with an inner peripheral edge of the respective naris (“ In one form of the present technology, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or a pair of nasal pillows 3130 , each nasal putt or nasal pillow being constructed and arranged to form a seal with a respective nares of the nose of a patient, e.g. by forming a seal against a peripheral region of the flares of the patient . ” Para 0462) . As to Claim 3, Henry discloses the two protrusions (3130) comprise ends (via 3110, “ Referring to FIG. 9, in one form of the present technology, the seal-forming structure 3100 may comprise a sealing flange 3110 and a support flange 3120. ” Para 0460) that, in use, seal with an inner peripheral edge of the respective naris (“ In one form of the present technology, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or a pair of nasal pillows 3130 , each nasal putt or nasal pillow being constructed and arranged to form a seal with a respective nares of the nose of a patient, e.g. by forming a seal against a peripheral region of the flares of the patient . ” Para 0462). As to Claim 4, Henry discloses the cradle base (3100) comprises lateral extension portions ( via 3230/3232/3234, “ In one form of the present technology where the seal-forming structure 3100 comprises respective left and right nasal pillows 3130, th ere is a corresponding respective left flexing region 3232 and tight flexing region 3234 (FIG. 4). Flexing regions 3230, 3232, and 3234 are constructed and arranged to bend and/or flex in response to a force encountered in use of the patient interface 3000 , e.g., a tube drag force, or a movement of the patient's head, e.g., pushing the patient interface 3000 against a bed pillow. Flexing region 3230, left flexing region 3232, and/or right flexing region 3234 may be constructed from a silicone rubber, e.g., with a Type. A indentation hardness in the range of about 35 to about 45. ” Para 0518; “ As can be seen in FIG. 4, the flexing region 3230 may comprise the decoupling region 3236, which may be located between the left flexing region 3232 and the right flexing region 3234 . ” Para 0519) extending laterally outwards on either side of the two protrusions (3130), the lateral extension portions (via 3230/3232/3234) respectively being configured to seal against a lateral or inferior part (via 3140 as shown in Figures 9 and 18, “ Nasal pillows 3130 (FIG. 9) in accordance with an aspect of the present technology include: a frusta-cone 3140 , at least a portion of which forms a seal on an underside of the patient's nose e.g. a frusto -cone portion …” Para 0463; “ Also, the stalk 3150 of the nasal pillow 3130 may be decoupled from the frusto -cone 3140 of the nasal pillow 3130 where at least a portion of which forms a seal on an underside of the patient's nose and within a small portion of the patient's nares . ” Para 0470; “ Proper location of the seal-forming structure 3100 is a significant factor in achieving an effective seal of the frusto -cone 3140 against the patient's nares such that the leaking of pressurized gas is minimized with minimal retention forces. As the frusto -cone 3140 may extend axially from the stalk 3150 of the seal-forming structure 3100, it may be advantageous to allow a degree of flexibility in the orientation of the patient interface 3000 with respect to the patient's nose to achieve an optimal seal. ” Para 0700 ) of each of the patient’s nasal ala in use. As to Claim 5, Henry discloses the cradle base (3100) is configured to be outwardly flexed by the patient’s nose (“ The nasal sling 3213 may also function as a physical tie to prevent the upper and lower portions of the seal-forming structure 3100 from being deflected outwardly due to pneumatic pressure in the gas chamber 3104 . ” Para 0488) when donned by the patient (best seen Figure 18). As to Claim 6, Henry discloses the two protrusions (3130) have a frustoconical shape (“ Nasal pillows 3130 (FIG. 9) in accordance with an aspect of the present technology include: a frusta-cone 3140 , at least a portion of which forms a seal on an underside of the patient's nose e.g. a frusto -cone portion …” Para 0463; “ Also, the stalk 3150 of the nasal pillow 3130 may be decoupled from the frusto -cone 3140 of the nasal pillow 3130 where at least a portion of which forms a seal on an underside of the patient's nose and within a small portion of the patient's nares . ” Para 0470; “ Proper location of the seal-forming structure 3100 is a significant factor in achieving an effective seal of the frusto -cone 3140 against the patient's nares such that the leaking of pressurized gas is minimized with minimal retention forces. As the frusto -cone 3140 may extend axially from the stalk 3150 of the seal-forming structure 3100, it may be advantageous to allow a degree of flexibility in the orientation of the patient interface 3000 with respect to the patient's nose to achieve an optimal seal. ” Para 0700). As to Claim 7, Henry discloses the openings (defined by the interior perimeter of 3110 as best seen in Figure 9 through which gas flows through to the airways of the patient) of the two protrusions (3130) are angled relative to a surface (best seen Figures 4, 7, 8, 11, and 16) of the cradle base (3100) from which the two protrusions (3130) extend. As to Claim 8, Henry discloses the plenum base (3310 ) comprises a pair of air inlets (3400, best seen Figure 32, “ One form of vent 3400 in accordance with the present technology comprises a plurality of very small holes, in other words, a multi-hole vent. Two or more multi-hole vents may be provided on the frame 3310 . ” Para 0833). As to Claim 10, Henry discloses a buffer or damper (via 3242, “ Plenum chamber 3200 may comprise the plenum connection region 3240 (FIG. 6). A retaining structure 3242 of the plenum connection region 3240 has a shape and/or configuration that is complementary to a shape and/or configuration of a corresponding frame connection region 3312 (FIG. 10). … . The shape of the retaining structure 3242 allows a slight degree of flexing but not to the extent that opposite sides of the retaining structure 3242 are able to touch each other if pinched together with finger pressure. ” Para 0531 ) between the cradle base (3100) and the plenum base (3310) is configured to decouple movement of the cradle base (3100) from the plenum base (3310). As to Claim 11, Henry discloses the buffer or damper (via 3242) is not configured to decouple movement between the sealing surfaces of the protrusions (3130). As to Claim 12, Henry discloses the buffer or damper (via 3242) is not configured to decouple movement between a nasal seal of the protrusions (3130) and a mouth seal. It is noted, Henry does not have a mouth seal as shown in Figure 18. Thus, there is no movement between “a mouth seal” in the absence of said “mouth seal”. As to Claim 13, Henry disclose the patient interface (Figure 18) does not comprise a mouth seal (as shown there is no mouth seal). As to Claim 14, Henry discloses a patient interface (Figure 18) configured to deliver a pressurized flow of respiratory gas (via 4180, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456; “ Plenum chamber 3200 in accordance with an aspect of one form of the present technology functions to allow air flow between the two nares and the supply of air from PAP device 4000 via a short tube 4180. The short tube 4180 is typically part of the air circuit 4170 that connects to the frame 3310 via a connection port 3600 and a longer tube (additional gas delivery tube) 4178 connected to the PAP device 4000 . ” Para 0511; “ In the shown example, such breathable gas is provided via the hose or tube 4180 connected to patient interface 3000. The tube 4180 may be connected at its other end (not shown) to a source of breathable gas, such as a blower or ventilator for providing pressurized breathable gas . ” Para 0673) to the patient’s airways (via 3100, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456), the patient interface (best seen Figure 18) comprising: a plenum base (3310, “ This view also indicates the attachment of the plenum chamber 3200 and seal-forming structure 3100 to the frame 3310 . ” Para 0469; “ Plenum chamber 3200 in accordance with an aspect of one form of the present technology functions to allow air flow between the two nares and the supply of air from PAP device 4000 via a short tube 4180. The short tube 4180 is typically part of the air circuit 4170 that connects to the frame 3310 via a connection port 3600 and a longer tube (additional gas delivery tube) 4178 connected to the PAP device 4000. ” Para 0511); a cradle base (3100, “ Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200, a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways . ” Para 0456) attached to the plenum base (3310) and configured to cradle the patient’s nose in use (Figure 18), the plenum base (3310) and the cradle base (3100) together forming a plenum chamber (3200, “Referring to FIG. 166, a non-invasive patient interface 3000 in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100 (see, e.g., FIG. 4), a plenum chamber 3200 , a positioning and stabilising structure 3300 and a connection port 3600 for connection to a short tube 4180 of the air circuit 4170. … In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient 1000 so as to facilitate the supply of air at positive pressure to the airways.” Para 0456 ; “ This view also indicates the attachment of the plenum chamber 3200 and seal-forming structure 3100 to the frame 3310.” Para 0469 ); a channel (3211.1, best seen Figures 16 and 17, “ Plenum connection region 3240 may include a tongue portion 3211 constructed and arranged to be matingly received by a channel portion 3211.1, e.g., a channel portion of a frame 3310 . In this way, the channel portion 3211.1 may form a mating feature for the tongue portion 3211, and vice versa. Also, the tongue portion 3211 and the channel portion 3211.1 may be dimensioned to maximize the sealing surface area in this region. ” Para 0535) in a surface of the plenum base (3310) adjacent to the cradle base (3100), the channel (3211.1) being configured to decouple movement (see section headings “Attachment and Removal of Plenum Chamber from Frame” Paras 0536 thru 0546 and “Plenum Chamber and Frame Attachment and Removal Sequence” Paras 0547 thru Paras 0557) of the cradle base (3100) from the plenum base (3310) , and a pair of projections (3130, “ In one form of the present technology, the seal-forming structure 3100 of the non-invasive patient interface 3000 comprises a pair of nasal puffs, or a pair of nasal pillows 3130 , each nasal putt or nasal pillow being constructed and arranged to form a seal with a respective nares of the nose of a patient, e.g. by forming a seal against a peripheral region of the flares of the patient. ” Para 0462) extending from the cradle base (3100), the pair of projections (3130) being configured to be inserted into the patient’s nares in use (best seen Figure 18), wherein the pair of projections (3130) form a gas flow path from the plenum chamber (3200) to the patient’s airways in use (best seen Figure 18). As to Claim 16, Henry discloses the channel (3211.1) completely surround the cradle base (3100). As to Claim 17, Henry discloses the cradle base (3100) is a U-shaped or V-shaped (at 3236, “ The saddle region 3236 may be U or V shaped and has a nasolabial angle at its peak of about 70° to about 120°. The saddle region 3236 may be about 0.5 mm to about 2.5 mm in depth for clearance around the patient's septum. ” Para 0519). As to Claim 19, Henry discloses lateral portions (via 3230/3232/3234, “ In one form of the present technology where the seal-forming structure 3100 comprises respective left and right nasal pillows 3130, th ere is a corresponding respective left flexing region 3232 and tight flexing region 3234 (FIG. 4). Flexing regions 3230, 3232, and 3234 are constructed and arranged to bend and/or flex in response to a force encountered in use of the patient interface 3000 , e.g., a tube drag force, or a movement of the patient's head, e.g., pushing the patient interface 3000 against a bed pillow. Flexing region 3230, left flexing region 3232, and/or right flexing region 3234 may be constructed from a silicone rubber, e.g., with a Type. A indentation hardness in the range of about 35 to about 45. ” Para 0518; “ As can be seen in FIG. 4, the flexing region 3230 may comprise the decoupling region 3236, which may be located between the left flexing region 3232 and the right flexing region 3234 . ” Para 0519) of the cradle base (3100) are configured to flex towards and away from the plenum base (3130). As to Claim 20, Henry discloses each of the projections (3130) extends with a respective one of the lateral portions (via 3230/3232/3234) of the cradle base (3100). Claim s 1-7 and 9-14 a re rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated Wilkie (2003/0172936) . As to Claim 1, Wilkie discloses a patient interface (best seen Figures 1-6; 12-13A; and 14) configured to deliver a pressurized flow of respiratory gas to a patient’s airways (“ a gas supply element or elements (26) for providing said gas to the nasal airway ” Abstract), the patient interface comprising: a cradle base (72) configured to cradle and form a seal with the patient’s nose in use (“ a flexible shaped bubble made from an elastomeric material having an aperture therein which is adapted to seal 3-dimensionally to the base of a human's nose supplying air to the human's naris without pressurising the exterior of the patient's nose ” Para 0024; also see: Para 0081); two protrusions (74) extending from the cradle base (72) and being configured to be inserted into the patient’s nares in use (“ The nasal prongs 74 and the part of the bubble membrane 72 around the base of the nasal prongs expand under pressure outwardly, to provide a good seal in the patient's nostrils as is illustrated schematically in FIG. 13a. ” Para 0082), each protrusion (74) having formed therein an opening (best seen Figures 13 and 13a) configured to allow a continuous flow of air therethrough; and a plenum base (18) that, together with the cradle base (72), forms a plenum chamber, wherein a flexible interface (defined by the engagement / abutment of the cradle base (72) and the plenum base (18) both made of “flexible elastomeric material” Paras 0068, 0078, 0080 and having a flanged region best seen Figures 10 and 13 undergo expansion - “when air is admitted under pressure into the manifold the bubble expands and will seal three-dimensionally with the base portion 101 of the patient’s nose” (Para 0081) - whereby the flexible bubble membrane of the “cradle base” is retained within the manifold of the “plenum base”, as shown in Figure 9) between the cradle base (72) and the plenum base (18) is configured to decouple movement (replacement - Wilkie clearly states “the upper surface of the manifold are replaced with a flexible shaped ‘bubble’ 62” (Para 0080) and further states “ instead of the membrane 62, a combined membrane 72 and nasal prongs 74 are provided” (Para 0082)) of the cradle base (72) from the plenum base (18). As to Claim 2, Wilkie discloses the protrusions (74) are structured and arranged to seal, in use, with an inner peripheral edge of the respective naris (“ The nasal prongs 74 and the part of the bubble membrane 72 around the base of the nasal prongs expand under pressure outwardly, to provide a good seal in the patient's nostrils as is illustrated schematically in FIG. 13a. ” Para 0082; also see: “ an expanded bubble portion 92 which in use expands and seals within a patient's nostril. Thus the mask seals at the base of the nostril as in the embodiment of FIG. 13 and within the nostril thus providing a double seal . ” Para 0083). As to Claim 3, Wilkie discloses the protrusions (74) comprise ends (defined by the joint upon which 74 meets 72) that, in use, seal with a peripheral edge of respective naris (“ The nasal prongs 74 and the part of the bubble membrane 72 around the base of the nasal prongs expand under pressure outwardly, to provide a good seal in the patient's nostrils as is illustrated schematically in FIG. 13a. ” Para 0082 via the “ relatively thin "bubble" is flexible and when air is admitted under pressure into the manifold the bubble expands and will seal three-dimensionally with the base portion 101 of the patient's nose . ” Para 0081). Also note: an additional construction of the protrusion (74) as seen in Figure 14 includes “ an expanded bubble portion 92 which in use expands and seals within a patient's nostril. Thus the mask seals at the base of the nostril as in the embodiment of FIG. 13 and within the nostril thus providing a double seal . ” (Para 0083). As to Claim 4, Wilkie discloses the cradle base (72) comprises lateral extension portions (76) extending outwards on either side of the two protrusions (best seen Figures 12-14), the lateral extension portions (76) respectively being configured to seal against a lateral or inferior part of each of the patient’s nasal ala in use (best seen Figure 13a). As to Claim 5, Wilkie discloses the cradle base (72) is configured to be outwardly flexed by the patient’s nose when donned by the patient. As seen in Figure 13a, and representative of pressurization, the “ relatively thin "bubble" is flexible and when air is admitted under pressure into the manifold the bubble expands and will seal three-dimensionally with the base portion 101 of the patient's nose . ” (Para 0081). As to Claim 6, Wilkie discloses the protrusions (74) have a frust - conical shape as the construction appears to be tapered toward the interior of the patient’s nose as seen in Figure 13a. Additionally, Paragraph 0015 states the use of “ a pair of generally conical soft synthetic gas delivery elements for insertion into a patient's nares ” was well known. As to Claim 7, Wilkie discloses the opening (best seen Figures 13 and 13a) of the protrusions (74) are angled relative to the surface of the cradle base (72) from which the protrusions (74) extend. As to Claim 9, Wilkie discloses “The manifold [18] is also made from the same flexible elastomeric material as the strap” with respect to the Primary Examiner defined “plenum base” and within Paragraphs 0078 and 0080, Wilkie states “a flexible bubble membrane” (Para 0078), and “The bubble may be made from a flexible elastomeric material (such as silastic)” (Para 0080) are shown to be made of a flexible elastomeric material whereupon each element is secured together to withstand pressurization of gases within the plenum base and the cradle base to release gas to the patient via the nasal prongs. As the act of pressurization effectuates the “ relatively thin "bubble" is flexible and when air is admitted under pressure into the manifold the bubble expands and will seal three-dimensionally with the base portion 101 of the patient's nose . ” (Para 0081), it appears both the plenum base (18) and the cradle base (72) endure inflation from the pressurized gas to seal effectively. As to Claim 10, Wilkie discloses the flexible interface (defined by the engagement / abutment of the cradle base (72) and the plenum base (18) both made of “flexible elastomeric material” Paras 0068, 0078, 0080 and having a flanged region best seen Figures 10 and 13 undergo expansion - “when air is admitted under pressure into the manifold the bubble expands and will seal three-dimensionally with the base portion 101 of the patient’s nose” (Para 0081) - whereby the flexible bubble membrane of the “cradle base” is retained within the manifold of the “plenum base”, as shown in Figure 9) between the cradle base (72) and the plenum base (18) effectively performs as a buffer or damper between the cradle base (72) and the plenum base (18) to decouple movement of the cradle base (72) and the plenum base (18). As to Claim 11, Wilkie discloses the buffer or damper between the cradle base (72), whereby the act of depressurization permits for the decoupling movement between the two sealing surfaces as the neither the bubble or nor the manifold is subject to expansion. Thus, the buffer or damper is not configured to decouple movement but rather the action of depressurization of the plenum chamber. As to Claim 1 2, Wilkie discloses the buffer or damper between the cradle base (72), whereby the construction of Wilkie is absent a mouth seal; thus, the claimed buffer or damper not configured to decouple movement between the nasal seal and the mouth seal is inherent. As to Claim 13, Wilkie discloses the patient interface does not include a mouth seal (best seen Figure 6). As to Claim 14, Wilkie discloses the protrusions (74) do not include stalks - as the construction is uniform and smooth (Figures 13 and 13 a) without the offshoots or teared orientation similar to corn. Claim s 1-7 and 9-14 a re rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated Bordewick (6,431,172) . As to Claim 1, Bordewick discloses a patient interface (Figures 1-6) configured to deliver a pressurized flow of respiratory gas (via 28, “ a gas hose 28 of the type commonly used to convey a breathing gas from a ventilator or respirator . ” Column 3, Lines 40-50) to a patient’s airways (“ In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12. ” Column 4, Lines 1-5), the patient interface comprising: a cradle base (14, “ In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12. ” Column 4, Lines 1-5) configured to cradle and form a seal with the patient’s nose in use; two protrusions (16, “In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12.” Column 4, Lines 1-5) extending from the cradle base (14) and being configured to be inserted into the patient’s nares (“ inserted into the patient's nostrils ”) in use, each of the protrusions (16) having formed therein an opening (best seen Figure 8) configured to allow a continuous flow of air therethrough (“ From plenum chamber 14, the breathing gas flows into the nares elements 16 via outlets 24 in the chamber. The nares elements then direct the breathing gas into the patient's nostrils. To ensure a leak-free fit, the nares elements are preferably snugly positioned within the patient's nostrils . ” Column 4, Lines 40-45); and a plenum base (12, “In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12 .” Column 4, Lines 1-5) that together with the cradle base (14) forms a plenum chamber (best seen Figure 5), wherein a flexible interface (Figure 6 - “ As best seen in FIG. 6, flexible membrane 22 is molded into grooves formed in sidewalls 32 of the support to present a substantially flush outer surface without protruding edges that could irritate a user. It will be appreciated, however, that edges of the flexible membrane could be connected to the sidewalls using an interior or exterior lap joint . ” Column 5, Lines 10-25) between the cradle base (14) and the plenum base (12) is configured to decouple movement of the cradle base (14) from the plenum base (12). As to Claim 2, Bordewick discloses the protrusions (16) are structured and arranged to seal, in use, with an inner peripheral edge of the respective naris. ( “In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12.” Column 4, Lines 1-5 ; also see : “ Nares elements 16 are thus loosely positioned in the user's nostrils without much force. ” Column 4, Lines 20-25; “ From plenum chamber 14, the breathing gas flows into the nares elements 16 via outlets 24 in the chamber. The nares elements then direct the breathing gas into the patient's nostrils. To ensure a leak- free fit, the nares elements are preferably snugly positioned within the patient's nostrils . ” Column 4, Lines 40-45). As to Claim 3, Bordewick discloses the protrusions (16) comprise ends (defined as the proximal portion of 16 for insertion into the nares of the patient) that, in use, seal with an inner peripheral edge of the respective naris. ( “In use, nasal cannula 10 is secured to the head of a patient such that nares elements 16 are inserted into the patient's nostrils and inflatable plenum 14 is disposed underneath the patient's nose between the nares elements and support 12.” Column 4, Lines 1-5 ; also see : “ Nares elements 16 are thus loosely positioned in the user's nostrils without much force. ” Column 4, Lines 20-25; “ From plenum chamber 14, the breathing gas flows into the nares elements 16 via outlets 24 in the chamber. The nares elements then direct the breathing gas into the patient's nostrils. To ensure a leak-free fit, the nares elements are preferably snugly positioned within the patient's nostrils . ” Column 4, Lines 40-45). As to Claim 4, Bordewick discloses the cradle base (14) has lateral extension portions (36) on either side of the two protrusions (16), the lateral extension portions (36) respectively being configured to seal against a lateral or inferior part of each of the patient’s nasal ala in use - this feature is a function of the inflatable nature of the cradle base . As to Claim 5, Bordewick discloses the cradle base (14) is configured to be outwardly flexed by the patient’s nose when donned by the patient - this feature is a function of the inflatable nature of the cradle base. As to Claim 6, Bordewick discloses the protrusions (16) includes a frusto -conical shape (“ These nares elements or inserts are generally frustoconical and mounted on a bellows 20 type corrugated section, with a central air passageway formed therethrough to permit gas flow from plenum chamber 14 into the nose. ” Column 3, Lines 30-35). As to Claim 7, Bordewick discloses the openings (best seen Figure 8) of the protrusions (16) are angled relative to the surface of the cradle base (14) from which the protrusions extend (best seen Figure 4). As to Claim 9, Bordewick discloses the cradle base (14) is inflatable (“ an inflatable plenum chamber 14 ” Column 3, Lines 15-20) and the plenum base (12) is also capable of inflation over higher than normal loads operating loads and pressures (“ Gas inlet tube 20 and support 12 can be formed of any medically acceptable rigid material but are preferably formed of rigid polycarbonate or PVC. The term "rigid" is used in a broad sense to mean subtantially non-deformable and non-inflatable under normal operating loads and pressures . ” Column 3, Lines 45-55). As to Claim 10, Bordewick discloses a flexible interface (Figure 6 - “ As best seen in FIG. 6, flexible membrane 22 is molded into grooves formed in sidewalls 32 of the support to present a substantially flush outer surface without protruding edges that could irritate a user. It will be appreciated, however, that edges of the flexible membrane could be connected to the sidewalls using an interior or exterior lap joint . ” Column 5, Lines 10-25) between the cradle base (14) and the plenum base (12) is configured to decouple movement of the cradle base (14) from the plenum base (12), wherein the features of the flexible interface form a buffer or damper between the cradle base (14) and the plenum base (12) is configured to decouple movement of the cradle base (14) from the plenum base (12). As to Claim 11, Bordewick discloses the buffer or damper is not configured to decouple movement as the presence of an “ interior or exterior lap joint ” determine the sealing surfaces. As to Claim 12, Bordewick discloses the construction of Bordewick is absent a mouth seal; thus, the claimed buffer or damper not configured to decouple movement between the nasal seal and the mouth seal is inherent. As to Claim 13, Bordewick discloses the patient interface does not include a mouth seal (best seen Figures 1-6). As to Claim 14, Bordewick discloses the protrusions (16) do not include stalks - as the construction is uniform and smooth (Figure 8 - “ The nares elements 16 have smoothly sloping walls but could be formed with pleats or folds if desired. ” Column 5, Lines 40-45) without the offshoots or teared orientation similar to corn. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claim s 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (2016/0296720, which shares a common assignee/inventor with the instant application but has a disclosure date beyond the grace period of this instant application ) in view of Bordewick (6,431,172). As to Claims 9 and 18, Henry discloses a plenum base (3310) and a cradle base (3100), wherein the protruding ends (3144, “ The protruding ends 3144 may partially inflate and/or deform to seal in this area. ” Para 0474) of the cradle base (3100) for insertion into the nose of the patient (via 3130) is inflatable. Yet, does not expressly disclose the configuration of BOTH “the plenum base and the cradle base [being] inflatable”. Bordewick teaches a patient interface (Figures 1-3) suitable for the delivery of pressurized flow of a respiratory gas (via 26, “ The optional gas inlet tube 20 is shown in FIGS. 1 and 2 with a fitting 26 at a distal end for receiving a gas hose 28 of the type commonly used to convey a breathing gas from a ventilator or respirator . ” Column 3, Lines 40-70) to a patient’s airways (via 16, “ Nasal cannula 10 includes a rigid support 12 for placement at least partly beneath the nose of a user, an inflatable plenum chamber 14 mounted on the support, and a pair of nares elements 16 mounted on the inflatable plenum chamber . ” Column 3, Lines 10-30) including a plenum base (22B, “ Inflatable plenum chamber 14 includes upper and lower flexible membranes 22A and 22B mounted on opposite sides of support frame to define a chamber therebetween in communication with a gas outlet at the proximal end of gas inlet tube 20. Upper membrane 22A is shown with a pair of laterally spaced gas outlets 24 formed therein for receiving nares elements 16. ” Column 3, Lines 10-30) and a cradle base (22A, “ Inflatable plenum chamber 14 includes upper and lower flexible membranes 22A and 22B mounted on opposite sides of support frame to define a chamber therebetween in communication with a gas outlet at the proximal end of gas inlet tube 20. Upper membrane 22A is shown with a pair of laterally spaced gas outlets 24 formed therein for receiving nares elements 16. ” Column 3, Lines 10-30) with together form a plenum chamber (14, “ Inflatable plenum chamber 14 includes upper and lower flexible membranes 22A and 22B mounted on opposite sides of support frame to define a chamber therebetween in communication with a gas outlet at the proximal end of gas inlet tube 20. Upper membrane 22A is shown with a pair of laterally spaced gas outlets 24 formed therein for receiving nares elements 16. ” Column 3, Lines 10-30) wherein the cradle base (22A) includes two protrusions / projections (16, “ Upper membrane 22A is shown with a pair of laterally spaced gas outlets 24 formed therein for receiving nares elements 16 . ” Column 3, Lines 10-30) for insertion into the nares of the patient. The resultant effect of this configuration utilizing both a plenum base (22B) and a cradle base (22A) that are inflatable is the ability to provide “ greater adjustability and comfort for the patient ” (Column 2, Line 1-5) in that “ added compliance of the inflatable plenum chamber provides additional degrees of freedom for movement of the nares elements while at the same time increasing the range of movement in all directions . This results in improved adjustability of the nares elements, allowing the nasal cannula to accommodate large physical differences between patients . ” Column 4, Lines 40-70). Therefore, it would have been obvious to one having ordinary skill in the art
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Prosecution Timeline

Aug 25, 2023
Application Filed
Mar 11, 2026
Non-Final Rejection — §102, §103, §112 (current)

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