Prosecution Insights
Last updated: October 04, 2026
Application No. 18/262,720

HEADGEAR FOR A RESPIRATORY INTERFACE

Final Rejection §102§103
Filed
Jul 24, 2023
Priority
Feb 09, 2021 — provisional 63/200,012 +1 more
Examiner
HUSSAIN, MISHAL ZAHRA
Art Unit
3785
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Fisher & Paykel Healthcare Limited
OA Round
2 (Final)
67%
Grant Probability
Favorable
3-4
OA Rounds
5m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 67% — above average
67%
Career Allowance Rate
35 granted / 52 resolved
-2.7% vs TC avg
Strong +37% interview lift
Without
With
+37.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
38 currently pending
Career history
79
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
57.1%
+17.1% vs TC avg
§102
23.2%
-16.8% vs TC avg
§112
16.5%
-23.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 52 resolved cases

Office Action

§102 §103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Response to Amendment The following section is in reference to the Applicant’s Amendments, filed June 11, 20226: The Applicant’s cancellation of Claim 8 has been fully considered and acknowledged. The Applicant’s amendments to Claims 1, 4-5, and 9-15 have been fully considered and acknowledged. Applicant’s arguments with respect to Claim 1 and subsequent dependent claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. 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 – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent. (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 1-6 and 9-13 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Capra et al. (US 20150151070 A1, hereinafter “Capra”). Regarding Claim 1, Capra discloses: A headgear for a respiratory interface (Paragraph 0022, Another specific use for the devices is in fitting medical masks to the individual's head. The masks may includes: sleep apnea masks, oxygen masks, gas masks, and the like. As described in greater detail below, the closure devices may aid in easily fitting such masks to the user's head and in comfortably holding the masks tightly to the head), the headgear (Paragraph 0021, the term head restraint/mask as used herein is meant to include any article that is fit about or coupled with a head, or any manner of holding or restraining the head from movement) comprising a positioning web having a height and a length that extends at least partly about a head of a user when the headgear is fitted to the user (Paragraph 0035, Body portion 102 also includes a head cushion 134 that presses against the user's forehead. The restraint member 106 includes a main body portion and a plurality of arm portions 109 that extend towards the body portion 102 and/or head cushion 134. The arm portions 109 and restraint member 106 may be coupled with the head cushion 134 and/or body portion 102 via one or more buckles 110) and the positioning web including: at least one pathway for at least one tension line (Abstract, The closure system includes a tension member, a guide that routes the tension member about the mask and/or the strap, and a tensioning device that is operable to tension the tension member and thereby pull the strap and padded member toward the mask to secure and/or tighten the mask about the user's face), the at least one pathway comprising; a first pathway portion extending along at least part of the length of the positioning web (Paragraph 0036, The lace guides 107 may be coupled with the arm portions 109 (or with body portion 102 or had restrained 134) via buckles 110. In such embodiments, the tubing 120 may be positioned along body portion 102 and/or head cushion 134. Such a configuration allows the reel assembly 104 to simultaneously tension an upper arm portion 109 and a lower arm portion 109 of restraint member 106. For example, the lace 108 may extend from reel assembly 104 to a first lace guide 107 positioned on an upper arm portion 109), and a second pathway portion extending along at least part of the length of the positioning web (Paragraph 0036, The lace 108 may then be guided along the body portion 102 via tubing 120 and to a second lace guide 107 positioned on a lower arm portion 109. The lace 108 may then be directed across a bottom portion of body 102 and to lace guides (not shown) positioned on opposite side of mask 100), wherein the first pathway portion and second pathway portion are spaced apart by a varying distance as they extend along the positioning web (Paragraph 0040, A reel assembly 204 is coupled with the head cushion and may be used to tension lace 208 which is coupled with a restraint member 206 via tubing 222 and/or lace guides); a tension-line length controller comprising a spool, which is operable by the user to control a length of the at least one tension line deployed to the at least one pathway (Paragraph 0037, Reel assembly 104, along with the other reel assemblies described herein, typically includes a knob that may be grasped and rotated by a user to wind lace 108 about a spool that is positioned within a housing of reel assembly 104, or to unwind lace 108 therefrom. As the lace 108 is wound about the spool, the lace 108 is tensioned, which pulls the mask 100 against the user's had and/or face. In some embodiments, the lace 108 may pull on straps or other components of body 102 and/or head cushion 134 to enable tightening of the mask 100. Exemplary embodiments of reel assemblies are described in the following U.S. Patent Applications, the entire disclosures of which are incorporated by reference herein: U.S. patent applications Ser. No. 13/343,658, filed Jan. 4, 2012, entitled "Reel Based Closure System," U.S. patent applications Ser. No. 13/273,060, filed Oct. 13, 2011, entitled "Reel-Based Lacing System," and U.S. patent applications Ser. No. 13/098,276, filed Apr. 29, 2011, entitled "Reel Based Lacing System); wherein the at least one tension line has a pair of ends outside the at least one pathway, each of which are fastened to the spool (Paragraph 0036, The lace may then return to reel assembly 104 and/or terminate on the mask 100. The reel assembly 104 may be operated to tension lace 108 and thereby tightening the mask 100 about the user's face); and wherein the positioning web: maintains a positioning of the at least one pathways about the head of the user (Paragraph 0038, the fit or tightness of the mask 100 is roughly uniform due to the use of lace 108, which is used to tighten both the upper and lower portions of the mask 100 (i.e., the head cushion 134 and body 102). Uniform fit and/or tightness is provided because the tension within the lace 108 is roughly uniform); and is expandable and contractible between an operative configuration when fitted to the user (Paragraph 00404, FIG. 2 shows that the use of the lace 208 allows the mask 200 to be dynamically fit about the user's head) and an expanded configuration to facilitate donning and doffing of the headgear respectively (Paragraph 0038, Another advantage of mask 100 is that a user may adjust the tightness and/or fit of the mask via reel assembly 104 without opening or uncoupling straps of the mask, which is often required with conventional masks. Rather, the user may easily don the mask 100 via the use of buckles 110 and then make all subsequent adjustments via reel assembly 104. Reel assembly 104 additionally allows micro-adjustments (i.e., in mm increments) of the fit or tightness of the mask to be made). Regarding Claim 2, Capra discloses all the limitations of Claim 1. Capra further discloses: wherein the first pathway portion and the second pathway portion are portions of a single pathway (Paragraph 0035, To pull the mask 100 tightly against the user's face, mask 100 includes a reel assembly 104 that is operationally coupled with lace 108 that is in turn coupled with restraint member 106 and arm portions 109. As shown in FIG. 1, restraint member 106 and/or arm portions 109 may include tubing 120 through which the lace 108 is inserted. The tubing 120 may guide the lace 108 along restraint member 106 and/or arm portions 109 between body portion 102 and head cushion 134). Regarding Claim 3, Capra discloses all the limitations of Claim 2. Capra further discloses: wherein the positioning web comprises a first pathway and a second pathway, wherein the first pathway comprises the first pathway portion and the second pathway comprises the second pathway portion (Annotated Figures 1 and 2), (Paragraph 0040, As the restraint member 206 is moved about user's head, the lace 208 moves or shifts within the tubing 220 and/or lace guides to maintain a uniform and/or consistent fit/tightness of the mask 200 about the user's head and face. Further, as the body 202 and/or head cushion shift during use of the mask 200, the lace 208 is able to shift within the tubing and/or lace guides to maintain the uniform and/or consistent fit/tightness of the mask 200 about the user's head. The lace 208 similarly moves or shifts within the tubing 220 and/or lace guides as the reel assembly 204 is operated to tighten the mask 200). PNG media_image1.png 638 640 media_image1.png Greyscale PNG media_image2.png 716 690 media_image2.png Greyscale (Capra, Annotated Figures 1 and 2) Regarding Claim 4, Capra discloses all the limitations of Claim 2. Capra further discloses: wherein the first pathway portion and the second pathway portion intersect (Paragraph 0037, Reel assembly 104, along with the other reel assemblies described herein, typically includes a knob that may be grasped and rotated by a user to wind lace 108 about a spool that is positioned within a housing of reel assembly 104, or to unwind lace 108 therefrom. As the lace 108 is wound about the spool, the lace 108 is tensioned, which pulls the mask 100 against the user's had and/or face. In some embodiments, the lace 108 may pull on straps or other components of body 102 and/or head cushion 134 to enable tightening of the mask 100). The reel assembly serves as a node of intersection for the different pathways of the lace tension line in the headgear system of Capra. If the Applicant is not convinced, Figure 3C also depicts an embodiment in which the lace intersects and overlaps between the upper and lower portion of the mask (Paragraph 0044, Tubing 325 is coupled with the mask 320 and routes the lace 323 between the upper portion 328 and lower portion 327 of mask 320). Regarding Claim 5, Capra discloses all the limitations of Claim 4. Capra further discloses: wherein the first pathway portion and the second pathway portion may intersect at least once at a point where a distance between the first pathway portion and the second pathway portion is zero (Paragraph 0037, Reel assembly 104, along with the other reel assemblies described herein, typically includes a knob that may be grasped and rotated by a user to wind lace 108 about a spool that is positioned within a housing of reel assembly 104, or to unwind lace 108 therefrom. As the lace 108 is wound about the spool, the lace 108 is tensioned, which pulls the mask 100 against the user's had and/or face. In some embodiments, the lace 108 may pull on straps or other components of body 102 and/or head cushion 134 to enable tightening of the mask 100). Regarding Claim 6, Capra discloses all the limitations of Claim 1. Capra further discloses: wherein the positioning web is elastic or inelastic (Paragraph 0034, The airtight fit of the pad 132 may be provided by a restraint member 106 of mask 100, which is typically a large fabric or flexible body that fits or wraps around the rear surface of the user's head), (Paragraph 0027, the mask's components may generally fall into one of two categories: soft good and hard goods. Hard goods typically includes any rigid or firm material, or any components attached thereto, such as the body of the mask, valves, oxygen or gas ports/inlets, cushioning pads, and the like. Soft goods typically includes flexible or soft materials, or any components attached thereto, such as fabrics that wrap around the head, straps, elastic body portions, buckles, and the like) Regarding Claim 9, Capra discloses all the limitations of Claim 1. Capra further discloses: wherein the at least one tension line is operable to hold the positioning web in the operative configuration when the headgear has been donned (Paragraph 0038, An advantage of mask 100 compared with conventional masks is that the single reel assembly 104 may be used to tighten the body 102 and head cushion 134 about the user's head and face. Further, the fit or tightness of the mask 100 is roughly uniform due to the use of lace 108, which is used to tighten both the upper and lower portions of the mask 100 (i.e., the head cushion 134 and body 102). Uniform fit and/or tightness is provided because the tension within the lace 108 is roughly uniform). Regarding Claim 10, Capra discloses all the limitations of Claim 1. Capra further discloses: wherein the at least one tension line comprise a first tension line portion and a second tension line portion and wherein the first tension line portion co-operates with the first pathway portion to extend along the positioning web, and the second tension line portion co-operates with the second pathway portion to extend along the positioning web (Paragraph 0031, The bilateral location of the closure device (i.e., positioning on the front of the mask or the rear surface opposite the mask) allows the laces to wrap around both sides of the head and equalize tension on each side of the head), (Paragraph 0036, In other embodiments, the arm portions 109 may include lace guides 107 that direct and guide the lace 108 along a lace path as described herein. The lace guides 107 may include a channel or lumen within which the lace 108 is positioned. The lace guides 107 may be coupled with the arm portions 109 (or with body portion 102 or had restrained 134) via buckles 110. Such a configuration allows the reel assembly 104 to simultaneously tension an upper arm portion 109 and a lower arm portion 109 of restraint member 106). Regarding Claim 11, Capra discloses all the limitations of Claim 1. Capra (Goodman et al. incorporated by reference, US 20110266384 A1) further discloses: wherein the at least one tension line are less capable of expanding and contracting compared to an expandability and contractibility of the positioning web (Paragraph 0068, The lace 206 can be a highly lubricious cable or fiber having a low modulus of elasticity and a high tensile strength. In some embodiments, the cable can have multiple strands of material woven together. While any suitable lace can be used, some embodiments can utilize a lace formed from extended chain, high modulus polyethylene fibers. One example of a suitable lace material is sold under the trade name SPECTRA™, manufactured by Honeywell of Morris Township, N.J. The extended chain, high modulus polyethylene fibers advantageously have a high strength to weight ratio, are cut resistant, and have very low elasticity. One preferred lace made of this material is tightly woven. The tight weave provides added stiffness to the completed lace). Regarding Claim 12, Capra discloses all the limitations of Claim 1. Capra (Soderberg et al. incorporated by reference, US 20130092780 A1) further discloses: wherein the at least one tension line are less elastic than the positioning web (Paragraph 0053, In some embodiments, the lace 206 can be a highly lubricious cable or fiber having a high modulus of elasticity and a high tensile strength. In some embodiments, the cable can have multiple strands of material woven together. While any suitable lace can be used, some embodiments can utilize a lace formed from extended chain, high modulus polyethylene fibers […] The lace can be made of high modulus fibers that advantageously have a high strength to weight ratio, are cut resistant, and/or have very low elasticity. The lace can be formed of tightly woven fibers to provide added stiffness to the lace). Regarding Claim 13, Capra discloses all the limitations of Claim 1. Capra further discloses: wherein the at least one tension line may be sufficiently elastic to stretch to account for small changes in tension (Paragraph 0038, Reel assembly 104 additionally allows micro-adjustments (i.e., in mm increments) of the fit or tightness of the mask to be made), (Paragraph 0024, The closure devices described herein also provide a dynamic fit for the head masks. For example, using the closure devices described herein, the entire mask may be closed about the user's head simultaneously rather than requiring the closure of individual straps. Further, as the user and/or mask moves, the closure device is able to adjust and compensate for such movement, thereby maintaining the fit and/or tightness of the mask about the user's head), (Goodman et al. incorporated by reference, US 20110266384 A1, Paragraph 0068, The lace 206 can be a highly lubricious cable or fiber having a low modulus of elasticity and a high tensile strength […] The extended chain, high modulus polyethylene fibers advantageously have a high strength to weight ratio, are cut resistant, and have very low elasticity) Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 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. Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Capra (US 20150151070 A1) in view of Amarasinghe et al. (US 20040067333 A1, hereinafter “Amarasinghe”). Regarding Claim 7, Capra discloses all the limitations of Claim 6. Capra further discloses: wherein an elasticity of the positioning web is flexible (Paragraph 0027, the mask's components may generally fall into one of two categories: soft good and hard goods. Hard goods typically includes any rigid or firm material, or any components attached thereto, such as the body of the mask, valves, oxygen or gas ports/inlets, cushioning pads, and the like. Soft goods typically includes flexible or soft materials, or any components attached thereto, such as fabrics that wrap around the head, straps, elastic body portions, buckles, and the like), but does not explicitly disclose that the elasticity is anisotropic. Amarasinghe does disclose: wherein an elasticity of the positioning web is anisotropic (Paragraph 0047, the headgear is constructed from an anisotropic material that is more extensible in a first direction than in a direction at an angle of 90 degrees to the first direction. This enables the headgear to be cut from a single piece of composite material and vet have different extensibilities in different directions, Preferably, the headgear will be more extensible in a vertical direction than in a horizontal direction. Hence the upper and lower straps will be less extensible in a direction along their length than in a direction along their width. This means that the back portion of the headgear can be more extensible in a direction from the base of the skull to the crown, than in a direction at right angles to that direction) Both Capra and Amarasinghe teach headgear assemblies with corded elements and varying stiffness (Amarasinghe, Abstract, A headgear for securing and positioning a mask suitable for the treatment of sleep disordered breathing is constructed from a composite including polyurethane foam. It includes a back portion (40) with upper and lower straps (20, 30) connected to the back portion […] Additional components can be attached to the straps to alter their elasticity and stiffness). It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Amarasinghe to provide a variation in headgear that comfortably accommodates more extension along a base of a user’s skull while maintaining a degree of inelasticity along the retention straps (Amarasinghe, Paragraph 0045, the extensibility of the straps can be altered by attaching lengths of generally inextensible material (62) such as cotton or silk to the straps, as shown in FIG. 6a. The effect of this arrangement is to make the headgear less extensible along the length of the straps than in a vertical direction). Claims 14 and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Capra (US 20150151070 A1) in view of Huddart et al. (US 20160144146 A1, hereinafter “Huddart”). Regarding Claim 14, Capra discloses all the limitations of Claim 1. Capra (Soderberg et al. incorporated by reference, US 20130092780 A1) further discloses: wherein the at least one tension line is substantially inelastic (Paragraph 0053, In some embodiments, the lace 206 can be a highly lubricious cable or fiber having a high modulus of elasticity and a high tensile strength. In some embodiments, the cable can have multiple strands of material woven together. While any suitable lace can be used, some embodiments can utilize a lace formed from extended chain, high modulus polyethylene fibers […] The lace can be made of high modulus fibers that advantageously have a high strength to weight ratio, are cut resistant, and/or have very low elasticity. The lace can be formed of tightly woven fibers to provide added stiffness to the lace). Capra does not explicitly disclose blow-off and tube-pull forces, but does describe retaining and tightening elements for maintaining the seal and overall attachment of the headgear-mask system (Paragraph 0035, The restraint member 106 is configured to pull the mask 100 tightly against the user's face to prevent gaps from developing between the user's face and the pads 132. To pull the mask 100 tightly against the user's face, mask 100 includes a reel assembly 104 that is operationally coupled with lace 108 that is in turn coupled with restraint member 106 and arm portions 109. As shown in FIG. 1, restraint member 106 and/or arm portions 109 may include tubing 120 through which the lace 108 is inserted). Thus, the at least one tension line of Capra is capable of being substantially inelastic at tensions associated with blow-off and tube-pull forces. However, if the Applicant is not convinced, Huddart more explicitly discloses: wherein the at least one tension line (Paragraph 0401, In some configurations, a core member 1620 associated with each of the directional locks 1616 is coupled to the headgear rear portion 1604, extends along or through the adjustment element 1614, through the housing 1618 of the directional lock 1616 and into a collection space 1622) is substantially inelastic at tensions associated with blow-off and tube-pull forces (Paragraph 0271, Therefore, the headgear and/or interface assembly also exhibits an inelastic behavior in response to forces tending to elongate the headgear or increase the perimeter length of the interface assembly. The headgear and/or interface assembly can have a locked mode that can produce a locking force tending to resist expansion, elongation or lengthening of the perimeter length. The locking force can be sufficient to resist elongation, or at least any significant elongation, of the perimeter length in response to blow-off forces. […] In some configurations, the locking force may be selected to resist elongation in response to forces in addition to blow-off forces, such as hose pull forces, for example). Both Capra and Huddart teach headgear assemblies for retaining respiratory interfaces with sufficient seals. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Huddart’s locking mechanism with the system disclosed by Capra, so as to mitigate over-tightening and subsequent patient discomfort when trying to maintain sealed contact with a user’s face (Paragraph 0337, With these prior designs, movement of the mask caused by either hose pull or the interaction of applied respiratory pressure with the mask is likely to occur. Such movement may result in conditions ranging from leaks, loss of therapy, false triggering of breath patterns due to the resulting volume and pressure changes to skin abrasion or potential skin damage. To counteract this movement, a common practice is to over-tighten the headgear (either by providing a high elastic force in elastic systems or manual over-tightening in adjustable inelastic systems), such that the force required to elongate the headgear is greater than that which is produced by either hose pull or that generated via the pressurization of the mask. The application of additional pressure to the user as a result of this excess tightening can result in user discomfort, skin irritation or skin damage) Regarding Claim 15, Capra discloses all the limitations of Claim 1. Capra (Soderberg et al. incorporated by reference, US 20130092780 A1) further discloses: wherein the at least one tension line is substantially inelastic (Paragraph 0053, In some embodiments, the lace 206 can be a highly lubricious cable or fiber having a high modulus of elasticity and a high tensile strength. In some embodiments, the cable can have multiple strands of material woven together. While any suitable lace can be used, some embodiments can utilize a lace formed from extended chain, high modulus polyethylene fibers […] The lace can be made of high modulus fibers that advantageously have a high strength to weight ratio, are cut resistant, and/or have very low elasticity. The lace can be formed of tightly woven fibers to provide added stiffness to the lace) compared to an expandability and contractibility of the positioning web (Paragraph 0034, The airtight fit of the pad 132 may be provided by a restraint member 106 of mask 100, which is typically a large fabric or flexible body that fits or wraps around the rear surface of the user's head). Capra does not explicitly disclose blow-off and tube-pull forces, but does describe retaining and tightening elements for maintaining the seal and overall attachment of the headgear-mask system (Paragraph 0035, The restraint member 106 is configured to pull the mask 100 tightly against the user's face to prevent gaps from developing between the user's face and the pads 132. To pull the mask 100 tightly against the user's face, mask 100 includes a reel assembly 104 that is operationally coupled with lace 108 that is in turn coupled with restraint member 106 and arm portions 109. As shown in FIG. 1, restraint member 106 and/or arm portions 109 may include tubing 120 through which the lace 108 is inserted). Thus, the at least one tension line of Capra is capable of being inelastic compared to an expandability and contractibility of the positioning web for tensions of at least double a blow-off and tube-pull forces However, if the Applicant is not convinced, Huddart more explicitly discloses: wherein the at least one tension line (Paragraph 0401, In some configurations, a core member 1620 associated with each of the directional locks 1616 is coupled to the headgear rear portion 1604, extends along or through the adjustment element 1614, through the housing 1618 of the directional lock 1616 and into a collection space 1622) is inelastic compared to an expandability and contractibility of the positioning web for tensions (Paragraph 0271, The headgear and/or interface assembly can have a locked mode that can produce a locking force tending to resist expansion, elongation or lengthening of the perimeter length. The locking force can be sufficient to resist elongation, or at least any significant elongation, of the perimeter length in response to blow-off forces) of at least double a blow-off and tube-pull forces (Paragraphs 0271-0272, Such additional forces can be referred to collectively herein as “hose pull forces” and such additional resistance to elongation can be referred to herein as a “reserve.” In some configurations, the headgear and/or interface assembly also exhibits a yield force, above which expansion or elongation of the perimeter length is permitted. Preferably, the yield force is greater than the expected blow-off force. In some configurations, the yield force is greater than the expected blow-off force and the hose pull force. Thus, such a headgear and/or interface assembly has a reserve). Both Capra and Huddart teach headgear assemblies for retaining respiratory interfaces with sufficient seals. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Huddart’s locking mechanism with the system disclosed by Capra, so as to mitigate over-tightening and subsequent patient discomfort when trying to maintain sealed contact with a user’s face (Paragraph 0337, With these prior designs, movement of the mask caused by either hose pull or the interaction of applied respiratory pressure with the mask is likely to occur. Such movement may result in conditions ranging from leaks, loss of therapy, false triggering of breath patterns due to the resulting volume and pressure changes to skin abrasion or potential skin damage. To counteract this movement, a common practice is to over-tighten the headgear (either by providing a high elastic force in elastic systems or manual over-tightening in adjustable inelastic systems), such that the force required to elongate the headgear is greater than that which is produced by either hose pull or that generated via the pressurization of the mask. The application of additional pressure to the user as a result of this excess tightening can result in user discomfort, skin irritation or skin damage) Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Chodkowski (WO 2013128309 A1) discloses a respiratory interface device that utilizes tension members and a spool system. Ho et al. (US 9265909 B2) discloses adjustable headgear for a respiratory interface device that incorporate cord-like retention members Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MISHAL HUSSAIN/ Examiner Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Read full office action

Prosecution Timeline

Jul 24, 2023
Application Filed
Feb 11, 2026
Non-Final Rejection mailed — §102, §103
Jun 11, 2026
Response Filed
Aug 25, 2026
Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
67%
Grant Probability
99%
With Interview (+37.0%)
3y 7m (~5m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 52 resolved cases by this examiner. Grant probability derived from career allowance rate.

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