DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18/262720, filed on July 24, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on July 24, 2023 and October 16, 2023 and have been received and considered by the Examiner.
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.
Claims 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huddart et al. (US 20160144146 A1, hereinafter “Huddart”).
Regarding 1, Huddart discloses: A headgear for a respiratory interface (Abstract, A headgear system and/or an interface assembly incorporating a headgear system that, in some configurations, is configured to transform from elasticated or “stretchy” behavior to “inelastic” behavior at least in response to normal or expected forces encountered during the intended therapy. In some configurations, upon fitment to the head of a user, the system automatically adjusts toward or to an appropriate size),
the headgear comprising a positioning web (Figure 57-62, headgear 1600) 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 and the positioning web (Paragraph 0395, The length or circumference adjusting portion 1606 is configured in use to permit a position of the interface coupling portion 1602 to be adjusted relative to the headgear rear portion 1604 such that the headgear assembly 1600 can be adjusted to the head size of a particular user. Thus, the length or circumference adjusting portion 1606 can permit a perimeter length or circumference of the headgear to be adjusted to allow the headgear assembly 1600 to fit the head size of a particular user) including:
at least one pathway for 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), the at least one pathway comprising;
a first pathway portion (Figure 62, upper adjustment elements 1614) extending along at least part of the length of the positioning web (Paragraph 0398, Each pair of the adjustment elements 1614 can couple one side of the headgear rear portion 1604 with one side of the interface coupling portion 1602 […] the upper adjustment elements 1614 are coupled to forward extensions of the headgear rear portion 1604 that extend in a forward direction from a portion of the top strap 1608 at or near a location above the user's ear),
and a second pathway portion (Figure 62, lower adjustment elements 1614) extending along at least part of the length of the positioning web (Paragraph 0398, Each pair of the adjustment elements 1614 can couple one side of the headgear rear portion 1604 with one side of the interface coupling portion 1602 […]The lower adjustment elements 1614 are coupled to ends of the rear strap 1610 of the headgear rear portion 1604),
wherein the first pathway portion and second pathway portion are spaced apart by a varying distance as they extend along the positioning web (Paragraph 0398, Each pair of the adjustment elements 1614 can couple one side of the headgear rear portion 1604 with one side of the interface coupling portion 1602. The pair of adjustment elements 1614 one each side are coupled to the headgear rear portion 1604 at spaced locations); and wherein the positioning web:
maintains a positioning of the at least one pathways about the head of the user (Paragraph 0399, The adjustment elements 1614 are adjustable in length between a retracted length and an extended length. In some configurations, the adjustment elements 1614 cooperate to provide all or substantially all of the adjustment of a circumference of the headgear assembly 1600. Each of the adjustment elements 1614 can also include an elastic element or biasing arrangement that biases the adjustment element 1614 toward one of the retracted or extended lengths. Preferably, the adjustment elements 1614 are biased toward a retracted length, such that the headgear assembly 1600 is biased toward its smallest circumference);
and is expandable and contractible between an operative configuration when fitted to the user and an expanded configuration to facilitate donning and doffing of the headgear respectively (Figures 63-65, Paragraph 0399, Such an arrangement permits the headgear assembly 1600 to be extended and then automatically retract to fit the particular user under the biasing force of the elastic element or other biasing arrangement of the adjustment element(s) 1614).
Regarding Claim 2, Huddart discloses all of the limitations of Claim 1. Huddart further discloses: wherein the first pathway portion and the second pathway portion are portions of a single pathway (Paragraph 0412, the interface coupling portions 1602 couple the adjustment elements 1614 on the same side of the interface assembly 1680 or headgear assembly 1600. That is, each of the pair of interface coupling portions 1602 couple to one another the upper and lower adjustment elements 1614 of one side of the interface assembly 1680 or headgear assembly 1600).
Regarding Claim 3, Huddart discloses all of the limitations of Claim 2. Huddart 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 (Figure 62, Paragraph 0413, In the illustrated arrangement, the interface coupling portions 1602 are generally U-shaped members having an upper end portion 1634 coupled to the upper adjustment element 1614 and a lower end portion 1636 coupled to the lower adjustment element 1614. A curved portion of the interface coupling portion 1602 extends between the upper and lower end portions 1634, 1636).
Regarding Claim 4, Huddart discloses all of the limitations of Claim 2. Huddart further discloses: wherein the first pathway portion and the second pathway portion intersects (Paragraph 0307, Other types of interface assemblies can similarly utilize retention planes between the interface and a rear portion of the headgear. For example, FIG. 11 illustrates a full face mask having two retention planes […] The upper retention plane can be generally horizontal, but can be tilted somewhat in a front-to-back direction. For example, the upper retention plane can be tilted somewhat downward in a front-to-back direction to pass between the user's forehead and a center or rearward-most point on the back of the user's head. A second or lower retention plane extends between a base portion of the mask and a lower location on the rear portion of the headgear. The lower retention plane can extend between a point at about the user's mouth to a point below the user's ear [...] In other configurations, one or both of the upper and lower retention planes can partially or fully overlie an associated strap, can be partially or fully spaced from an associated strap or any combination of the two), (See also, Figures 21-22).
Regarding Claim 5, Huddart discloses all of the limitations of Claim 4. Huddart 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 0307, Other types of interface assemblies can similarly utilize retention planes between the interface and a rear portion of the headgear. For example, FIG. 11 illustrates a full face mask having two retention planes […] The upper retention plane can be generally horizontal, but can be tilted somewhat in a front-to-back direction. For example, the upper retention plane can be tilted somewhat downward in a front-to-back direction to pass between the user's forehead and a center or rearward-most point on the back of the user's head. A second or lower retention plane extends between a base portion of the mask and a lower location on the rear portion of the headgear. The lower retention plane can extend between a point at about the user's mouth to a point below the user's ear [...] In other configurations, one or both of the upper and lower retention planes can partially or fully overlie an associated strap, can be partially or fully spaced from an associated strap or any combination of the two).
Regarding Claim 6, Huddart discloses all of the limitations of Claim 1. Huddart further discloses: wherein the positioning web is elastic (Paragraph 0399, Each of the adjustment elements 1614 can also include an elastic element or biasing arrangement that biases the adjustment element 1614 toward one of the retracted or extended lengths) or inelastic (Paragraph 0342, The overall form of the headgear can be produced by a number of different techniques. For example, the headgear can be cut from a single sheet of at least relatively or substantially inelastic material. In other configurations, the headgear can be injection molded from a single or multiple thermoplastic or thermoset materials. In some configurations, the headgear or head frame is constructed from a single material with variations in cross sectional geometry providing portions of increased or decreased torsional and/or bending stiffness to enable the headgear to smoothly contour to the human head form).
Regarding Claim 8, Huddart discloses all of the limitations of Claim 1. Huddart further discloses: wherein the headgear further comprises one or more tension lines (Figures 57-62, core member 1620) respectively disposed in the at least one or more pathway (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)
Regarding Claim 9, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein each of the one or more tension lines is operable to hold the positioning web in the operative configuration when the headgear has been donned (Figures 63-65, Paragraph 0400, An example of suitable braided elements is described in connection with FIGS. 46-54 of Applicant's patent application no. PCT/NZ2014/000074. However, other suitable constructions or arrangements can also be used. Alternatively, elastic element(s) or biasing element(s) can be located within the interface coupling portion and can interact with the core members to pull the core members into the interface coupling portion), (Paragraph 0462, The directional lock arrangement(s) and biasing arrangement(s) can be the same as or similar to any of those disclosed herein, the same as or similar to any of those disclosed in Applicant's PCT Publication No. WO 2014/175752, published Oct. 30, 2014, entitled AUTOMATICALLY ADJUSTING HEADGEAR FOR PATIENT INTERFACE, the entirety of which is incorporated by reference herein, or can be of any other suitable arrangement).
Regarding Claim 10, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein the one or more tension lines 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 (Figures 57-62), (Paragraph 0400, An example of suitable braided elements is described in connection with FIGS. 46-54 of Applicant's patent application no. PCT/NZ2014/000074. However, other suitable constructions or arrangements can also be used. Alternatively, elastic element(s) or biasing element(s) can be located within the interface coupling portion and can interact with the core members to pull the core members into the interface coupling portion).
Regarding Claim 11, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein the one or more tension lines are less capable of expanding and contracting compared to an expandability and contractibility of the positioning web (Paragraph 0401, The housing 1620 of the directional lock 1616 can comprise one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1618 to selectively allow retraction of the headgear assembly 1600 or lock the headgear assembly 1600 in a particular circumference and inhibit or prevent extension of the headgear at least at forces below the yield force provided by of the directional lock(s). Additional particulars of the operation of the directional locks 1616 are described above and in Applicant's patent application no. PCT/NZ2014/000074).
Regarding Claim 12, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein the one or more tension lines are less elastic than the positioning web (Paragraph 0401, The housing 1620 of the directional lock 1616 can comprise one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1618 to selectively allow retraction of the headgear assembly 1600 or lock the headgear assembly 1600 in a particular circumference and inhibit or prevent extension of the headgear at least at forces below the yield force provided by of the directional lock(s). Additional particulars of the operation of the directional locks 1616 are described above and in Applicant's patent application no. PCT/NZ2014/000074).
Regarding Claim 13, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein the one or more tension lines may be sufficiently elastic to stretch to account for small changes in tension (Paragraph 0272, 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. Preferably, the yield force is set low enough that a user can at least relatively conveniently apply an elongation force to the headgear and/or interface assembly sufficient to exceed the yield force in order to permit the interface assembly to lengthen and to be applied to the user's head. As described above, the contraction force reduces the perimeter length toward a proper head size).
Regarding Claim 14, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein the one or more tension lines is substantially inelastic at tensions associated with blow-off and tube-pull forces (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. In some configurations, the locking force is sufficient to resist elongation in response to the highest blow-off forces expected with a variety of uses or treatments (e.g., Bi-Level or CPAP, NIV, etc.). In some configurations, the locking force may be selected for one or more particular uses/therapies, but may not be suitable for all uses/therapies. 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. 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).
Regarding Claim 15, Huddart discloses all of the limitations of Claim 8. Huddart further discloses: wherein one of the one or more tension lines is inelastic compared to an expandability and contractibility of the positioning web for tensions of at least double a blow-off and tube-pull forces (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. In some configurations, the locking force is sufficient to resist elongation in response to the highest blow-off forces expected with a variety of uses or treatments (e.g., Bi-Level or CPAP, NIV, etc.). In some configurations, the locking force may be selected for one or more particular uses/therapies, but may not be suitable for all uses/therapies. 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. 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).
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 7 is rejected under 35 U.S.C. 103 as being unpatenable over Hudddart (US 20160144146 A1) in view of Amarasinghe et al. (US 20040067333 A1, hereinafter “Amarasinghe”).
Regarding Claim 7, Huddart discloses all of the limitations of Claim 6. Huddart further discloses: wherein an elasticity of the positioning web has variations across a single material (Paragraph 0342, The overall form of the headgear can be produced by a number of different techniques. For example, the headgear can be cut from a single sheet of at least relatively or substantially inelastic material. In other configurations, the headgear can be injection molded from a single or multiple thermoplastic or thermoset materials. In some configurations, the headgear or head frame is constructed from a single material with variations in cross sectional geometry providing portions of increased or decreased torsional and/or bending stiffness to enable the headgear to smoothly contour to the human head form).
This variation could be understood to be in reference to the anisotropic nature of the material. Though not explicitly stated using that terminology, it falls within the recognized definition of the term (Merriam-Webster, “exhibiting properties with different values when measured in different directions”).
However, if the Applicant is not convinced, Amarasinghe more explicitly discloses: 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 Huddart and Amarasinghe teach headgear assemblies with variable elasticity and stiffness, as well embodiments made from a single piece of material with different extensibilities (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. In a preferred embodiment, lengths of cotton are sewn to the straps), (Huddart, Paragraph 0401, The housing 1620 of the directional lock 1616 can comprise one or more members or elements (e.g., lock washers or lock jaws) that interact with the core member 1618 to selectively allow retraction of the headgear assembly 1600 or lock the headgear assembly 1600 in a particular circumference and inhibit or prevent extension of the headgear at least at forces below the yield force provided by of the directional lock(s)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
McLaren et al. (US 20160082217 A1) discloses automatically adjusting headgear for a patient interface
Freestone et al. (US 20210170134 A1) discloses a variety of headgear assemblies to be used in combination with a breathing apparatus
Smith et al. (US 10065010 B2) discloses head gear and adjustment systems for patient interfaces
Huddart et al. (US 20160074614 A1) discloses a substantially inelastic headgear mold
Ho et al. (US 9265909 B2) discloses an adjustable headgear assembly for securing a respiratory interface device
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL Z HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785