DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application as originally filed on April 21, 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 .
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 applicant regards as his invention.
Claim 10 is 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 10, Line 1 recites “said head strap”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if this limitation should read “said facemask retention strap” or some other limitation. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tatkov (10,556,079) in view of Gradon et al. (2002/0005201).
As to Claim 1, Tatkov discloses a closely conforming facemask (Figures 4-6), comprising: a pliable facemask cup (x10, “A user interface according to another embodiment of present invention is illustrated in FIGS. 4-6. The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Column 14, Lines 40-55) that is essentially defined by a nose covering region (defined by the apex of x10 which receives the nose of the patient), a mouth covering region (defined by the base of x10 which receives the mouth of the patient), two cheek covering regions (x25, best shown in Figure 5 as 525 – wherein “The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507.” Column 15, Lines 1-10) and a perimeter (x11, “The user interface 400, 500, 600 includes a seal 411, 511, 611 arranged about a periphery of the mask body 410, 510, 610 to prevent significant leaks around the base of the interface 400, 500, 600 and enable adequate pressure to be developed within the mask.” Column 15, Lines 20-35), the perimeter (x11) essentially defined by a nose bridge rim (defined by the apex of x11 which receives the nose of the patient), two cheek rims (defined by the sides of x11 proximate x25) and a chin rim (defined by the base of x11 which receives the mouth of the patient), the mouth covering region (defined by the base of x10 which receives the mouth of the patient) comprising a mouth center point that is configured to reside directly over and in the center of the lips of the wearer when worn; the nose covering region (defined by the apex of x10 which receives the nose of the patient) comprising a nasal tube (x07, best seen Figure 5 as 507 – wherein “The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507. The conduit 507 couples the cannula 505 to the mask inlet. In the pictured embodiment there is no provision for gases to exit the mask body 500 adjacent the conduit 507 base. However, an auxiliary exit may be provided in the interface 500, either co-axially about the conduit 507 or from another location in the mask body 510, to transport a portion of the expired gases to another breathing system component.” Column 15, Lines 1-20; and “The conduit 507 may include one or more outlets (illustrated in broken lines 520 in FIG. 5) to the mask cavity 510 to flush expired gases toward the venting apertures 530. Preferably, the venting apertures 530 and breathing gas injection ports 520 are positioned at opposed extremities of the mask cavity (as illustrated) to allow the injected gases to flush the entirety of the interface cavity.” Column 15, Lines 25-40) that outwardly extends to a distal tube port (x17, “The user interface 400, 500, 600 incorporates a swivelling mask conduit 417, 517, 617 that permits the angle of the conduit 417, 517, 617 to be adjusted relative to the mask body 410, 510, 610.” Column 14, Lines 55-70), the distal tube port (x17) is in communication with a nasal aperture (x05, best seen Figure 5 as 505 – wherein “The arrangement of the nasal cannula 505 within the mask body 510 is illustrated in FIG. 5. The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507. The conduit 507 couples the cannula 505 to the mask inlet.” Column 15, Lines 1-20) in the nose covering region (defined by the apex of x10 which receives the nose of the patient) configured to confront a human nostril; and a facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) disposed on the face covering cup (x10, as best seen in Figures 4 and 6) proximate the nasal tube (x17).
Yet, Tatkov does not expressly disclose “a facemask retention strap disposed on said face covering cup between the nasal tube and the mouth center point”.
Gradon teaches an alternative closely conforming facemask (best seen Figures 5-7) having a pliable facemask cup (102, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. … The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance.” Para 0039; and “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) a distal tube port (3, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) in communication with a nasal aperture (via 103, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033); and a facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7, wherein 120 – “This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 200 – “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance. As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Paras 0039 and 0040) disposed on the face covering cap (102) proximate the nasal tube (103).
Regarding the concept of the “between the nasal tube and the mouth center point”, the mask of Gradon is explicitly described for nasal only applications as best seen in Figure 4. Consequently, the orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) are located between the nasal tube (103) and the mouth center point, as the mouth center point is beyond and below the pliable facemask cup (102) of Gradon.
Regardless of Gradon’s nasal only facemask cup application, the teachings of Gradon with respect to the placement and orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) remain a feature which would be obvious to modify the facemask of Tatkov, for the purpose of achieving variable pressure points for sealing engagement of the facemask to conform to the face of the user – in order to “allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” (Para 0037) and “to allow pressure from different angles for different face shapes.” (Para 0040).
In light of the teaching of Gradon, the decision to modify the facemask of Tatov to include the facemask retention strap between the nasal tube and along the centerline of the facemask proximate the mouth, would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to vary the sealing pressures applied to Tatov as modified by Gradon to better conform to the anatomical features of the patient wearing the facemask.
Applicant has not asserted this specific orientation “between the nasal tube and the mouth center point” provides a particular advantage, solves a stated problem, or serves a particular purpose different from the ability to effectively seal the facemask to the face of the user; thus, the use of the specific orientation of “between the nasal tube and the mouth center point” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Tatov, as the construction of the facemask retention straps “between the nasal tube and the mouth center point” would yield the predictable results of providing variable pressure points suitable to conform the facemask to seal to the anatomical features of the patient wearing the facemask.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the facemask retention strap of Tatov to extend between the nasal tube and the mouth center point, a known result effective variable and as taught by Gradon to be a known orientation suitable for imparting variable pressure points for sealing engagement of the facemask to conform to the face of the user.
As to Claim 2, the modified Tatov, specifically Gradon teaches at least one anchor (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7, wherein 126/129/130/128/131 – “The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 202 – “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) extending from the facemask (Figures 4-7) that retain the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) between the nasal tube and the mouth center point. As indicated, the anchors (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) provide for a series of placement orientations along the body of the facemask upon which the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) engages to permit variability of pressures for sealing engagement of the facemask to conform to the face of the user.
As to Claim 3, the modified Tatov, specifically Gradon teaches at least one anchor (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) is within 1.25 inches from a facemask midline, which is defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region. As shown in Figure 4 and 5, each of the anchors (126/129/130/128/131 of Figures 4 and 5) extend contiguously in a lateral direction across the facemask midline, whereby the claimed “within 1.25 inches” is an inherent configuration. As shown in Figure 6 and 7, the anchors (202 of Figures 6 and 7) are oriented in a mirrored pattern along the facemask midline, wherein the configuration of the claimed “within 1.25 inches” would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired variability in sealing pressures along the facemask.
As to Claim 4, the modified Tatov, specifically Gradon teaches two anchors (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) extending from the facemask that retain the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) between the nasal tube and the mouth center point, the anchors not located in either of the cheek regions. As shown in Figures 4 and 5, the two anchors 126 and 129 are most proximal to nasal aperture (via 103) at the apex of nose covering region of the facemask at the nasal bridge and would appear to meet the claimed configuration of “not located in either of the cheek regions”. As shown in Figure 6, the two laterally and symmetrically oriented anchors most proximal to the nasal aperture (via 103) at the apex of nose covering region of the facemask at the nasal bridge and would appear to meet the claimed configuration of “not located in either of the cheek regions”.
As to Claim 5, the modified Tatov, specifically Gradon teaches the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) is a closed loop, which together with the headgear 108, best seen Figure 4, encircles the head of the patient to secure the facemask (Figures 4-7) to the head of the patient.
As to Claim 6, the modified Tatov, specifically Tatov discloses the configuration of the facemask (Figures 4-6) oriented to receive both the nose (via 505, as best seen in Figure 5, located within the apex of x10 which receives the nose of the patient) and the mouth/lips (defined by the base of x10 which receives the mouth of the patient) of the wearer, as a function of the tensioning of the facemask retention strap to conform the facemask to the face of the user in a sealing engagement, the resultant effect will be the movement of the face of the patient in closer proximity to facemask cup (x10) wherein the perimeter (x11) which provides the sealing engagement between the facemask cup (x10) and the patient will undergo deflection and will contact the nose and mouth/lips of the wearer. Due to the orientation of the nasal aperture (x05) to be inserted within the nostrils of the patient and abutting with the cheeks (via 525) of the a patient, the anatomical placement of the nasal apertures (x05) within the nose and abutting the cheeks (via 525) would yield the claimed contact “between the nose of the wearer and the lips of the wearer” at the centerline between the nasal apertures (x05) and the cheeks (via 525) – a kin to the anatomical feature known as the philtrum.
As to Claim 7, the modified Tatov, specifically Gradon teaches the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) is configured to go around a head of the wearer when worn, as together with 108, best seen Figure 4, it encircles the head of the patient to secure the facemask (Figures 4-7) to the head of the patient.
As to Claim 8, the modified Tatov, specifically Tatov discloses a series of perforations (x30, “The mask body 410, 510, 610 includes a plurality of venting apertures 430, 530, 630 positioned adjacent a nasal bridge section. The venting apertures 430, 530, 630 are responsible for exhausting expired gases from the user interface 400, 500, 600 directly to the user's surroundings.” Column 14, Line 65 thru Column 15, Line 5) for the purpose of permitting the exhausting of gases from the interior surface of the facemask cup (x10, as seen Figure 5) to the outer surface of the facemask cup (x10, as seen in Figures 4 and 6).
Yet, does not expressly disclose the orientation of the “perforations through said mouth covering region.”
In light of the relationship of the perforations (x30) to permit the venting of expired gases, it would have been obvious to one having ordinary skill in the art to select the location of the perforations to be located “through said mouth covering region” as claimed, since it has been held where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
In consideration of the orientation of the perforations on the facemask cup (x10) of the modified Tatov, the decision to move the perforations from the nasal bridge section to the mouth covering region would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the perforations to permit the venting of expired gases from the user to the ambient environment.
Moreover, Applicant has not asserted the specific location of the perforations “through said mouth covering region” provide a particular advantage, solve a stated problem, or serve a particular purpose; thus, the use of the specific location of the perforations “through said mouth covering region” appears to lack criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Tatov, as the location of the perforations “through said mouth covering region” would yield the predictable result of imparting a pathway upon which expired gases could be excised from the interior surface of the facemask cup to the outer surface of the facemask cup and to the ambient atmosphere.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the perforations on the facemask cup of the modified Tatov to be located “through said mouth covering region”, a known result effective variable, to permit the exhaust of expired gases from the facemask cup to the ambient environment.
As to Claim 9, the modified Tatov, specifically Tatov discloses the tensioning of the facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) disposed on the face covering cup (x10, as best seen in Figures 4 and 6) proximate the nasal tube (x17) to facilitate the sealing engagement of the facemask to the face of the user. In this configuration, the interior surface (best seen Figure 5) of the facemask cup (x10) is placed in explicitly close proximity to the anatomical features of the user’s face, while the nasal tube (x07) extends to the exterior surface (best seen Figures 4 and 6) of the facemask cup (x10) to couple with the distal tube port (x17) located on the exterior surface (best seen Figures 4 and 6) of the facemask cup (x10).
Yet, does not expressly disclose the explicit configuration whereby “no part of an interior surface of said facemask cup is configured to be more than 0.35 inch from the face of the wearer”.
In light of the relationship formed by the tensioning of the facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) to provide sealing engagement on the face of the user, the selection of the specific distance between the interior surface of the facemask cup and the face of the wearer, would have been obvious to ensure efficient directionality in the flow of gases without rebreathing/recirculation to introduce fresh gas from the exterior surface to the interior surface of the facemask cup and to exhale spent gas from the interior surface to the exterior surface of the facemask cup. The resultant effect of rebreathing and recirculation of gases within the interior surface of the facemask cup may yield a hypoxic environment which would preclude the proper oxygen gas exchange to support the life, treatment, and care of the patient. Consequently, the smaller the region available for rebreathing and recirculation of gases within the interior surface of the facemask cup, the more efficient the oxygen exchange can occur to ensure proper life supportive treatment and care to the patient wearing the facemask.
In consideration of the desire to have a smaller region available for rebreathing and recirculation of gases within the interior surface of the facemask cup, the specific value of no “more than 0.35 inch” would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by optimized oxygen exchange to support the life, treatment, and care of the patient wearing the facemask.
Applicant has not asserted the specific value of no “more than 0.35 inch” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of providing a facemask with efficient oxygen exchange to support the life, care, and treatment of the patient; thus, the use of the specific value of no “more than 0.35 inch” lacks criticality in its design.
Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Tatov, in order to yield a facemask having a small region available for rebreathing and recirculation of gases within the interior surface of the facemask cup to provide efficient oxygen exchange to support the life, treatment, and care of the patient wearing the facemask.
Therefore, it would have been obvious to the having ordinary skill in the art to modify the dimensional distance between the facemask cup and the face of the patient of the modified Tatov, to be no “more than 0.35 inch”, a known result effective variable, in order to optimize the efficiency of oxygen exchange to support the life, care, and treatment of the patient wearing the facemask.
As to Claim 10, the modified Tatov, specifically Gradon teaches the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) is a contiguous elastic band, which together with the headgear 108, best seen Figure 4, encircles the head of the patient to secure the facemask (Figures 4-7) to the head of the patient.
As to Claims 11 and 17, Tatkov discloses a facemask (Figures 4-6), comprising: a pliable facemask cup (x10, “A user interface according to another embodiment of present invention is illustrated in FIGS. 4-6. The interface 400, 500, 600 incorporates the features of the nasal interface 2, 200, 300, described previously, applied to a full face mask body 410, 510, 610. The mask body 410, 510, 610 encloses the user's mouth and nose in use.” Column 14, Lines 40-55) defining a perimeter (x11, “The user interface 400, 500, 600 includes a seal 411, 511, 611 arranged about a periphery of the mask body 410, 510, 610 to prevent significant leaks around the base of the interface 400, 500, 600 and enable adequate pressure to be developed within the mask.” Column 15, Lines 20-35), and outer surface (best represented by Figures 4 and 6) and an inner surface (best represented by Figure 5), the inner surface (best represented by Figure 5) configured to confront and cover lips (defined by the base of x10 which receives the mouth of the patient), nostrils and at least part of the nose (defined by the apex of x10 which receives the nose of the patient), and part of a right and left cheek of the wearer (x25, best shown in Figure 5 as 525 – wherein “The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507.” Column 15, Lines 1-10); a nasal tube (x17, “The user interface 400, 500, 600 incorporates a swivelling mask conduit 417, 517, 617 that permits the angle of the conduit 417, 517, 617 to be adjusted relative to the mask body 410, 510, 610.” Column 14, Lines 55-70) extending from the outer surface (best represented by Figures 4 and 6), a distal tube port (x07, best seen Figure 5 as 507 – wherein “The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507. The conduit 507 couples the cannula 505 to the mask inlet. In the pictured embodiment there is no provision for gases to exit the mask body 500 adjacent the conduit 507 base. However, an auxiliary exit may be provided in the interface 500, either co-axially about the conduit 507 or from another location in the mask body 510, to transport a portion of the expired gases to another breathing system component.” Column 15, Lines 1-20; and “The conduit 507 may include one or more outlets (illustrated in broken lines 520 in FIG. 5) to the mask cavity 510 to flush expired gases toward the venting apertures 530. Preferably, the venting apertures 530 and breathing gas injection ports 520 are positioned at opposed extremities of the mask cavity (as illustrated) to allow the injected gases to flush the entirety of the interface cavity.” Column 15, Lines 25-40) of the nasal tube (x17) is in communication with a proximal port (x05, best seen Figure 5 as 505 – wherein “The arrangement of the nasal cannula 505 within the mask body 510 is illustrated in FIG. 5. The nasal cannula 505 may include cheek bearing portions 525 that extend laterally from a central portion of the cannula 505 adjacent the conduit 507. The conduit 507 couples the cannula 505 to the mask inlet.” Column 15, Lines 1-20) in the facemask (Figures 4-6), the proximal port (x05) configured to confront the nostrils; a center point configured to reside between the lips, wherein the center point is defined along a centerline configured to extend between the nostrils and bisecting the lips; a facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) disposed on the face covering cup (x10, as best seen in Figures 4 and 6) proximate the nasal tube (x17), the facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) configured to deflect the pliable facemask cup (x10) between the nasal tube (x17) and the center point toward a philtrum of the wearer (via tensioning of the facemask retention strap to conform the facemask to the face of the user in a sealing engagement).
Yet, Tatkov does not expressly disclose “a facemask retention strap disposed on said face covering cup between the nasal tube and the center point”.
Gradon teaches an alternative closely conforming facemask (best seen Figures 5-7) having a pliable facemask cup (102, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. … The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.” Para 0033; “Referring now to FIGS. 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102.” Para 0035; “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance.” Para 0039; and “As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Para 0040) a distal tube port (3, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033) in communication with a nasal aperture (via 103, “The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3.” Para 0033); and a facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7, wherein 120 – “This is achieved with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102. The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, meaning the headgear 108 can move laterally, independently of the hollow body 102. … Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” Paras 0035 and 0037; and wherein 200 – “In a further embodiment shown in FIGS. 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in FIG. 8 in isolation, is constructed of polyacetal (Delrin 500P NC010) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance. As shown in FIG. 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from FIG. 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.” Paras 0039 and 0040) disposed on the face covering cap (102) proximate the nasal tube (103).
Regarding the concept of the “between the nasal tube and the center point”, the mask of Gradon is explicitly described for nasal only applications as best seen in Figure 4. Consequently, the orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) are located between the nasal tube (103) and the center point, as the center point is beyond and below the pliable facemask cup (102) of Gradon.
Regardless of Gradon’s nasal only facemask cup application, the teachings of Gradon with respect to the placement and orientation of the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) remain a feature which would be obvious to modify the facemask of Tatkov, for the purpose of achieving variable pressure points for sealing engagement of the facemask to conform to the face of the user – in order to “allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.” (Para 0037) and “to allow pressure from different angles for different face shapes.” (Para 0040).
In light of the teaching of Gradon, the decision to modify the facemask of Tatov to include the facemask retention strap between the nasal tube and along the centerline of the facemask proximate the mouth, would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to vary the sealing pressures applied to Tatov as modified by Gradon to better conform to the anatomical features of the patient wearing the facemask.
Applicant has not asserted this specific orientation “between the nasal tube and the center point” provides a particular advantage, solves a stated problem, or serves a particular purpose different from the ability to effectively seal the facemask to the face of the user; thus, the use of the specific orientation of “between the nasal tube and the center point” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Tatov, as the construction of the facemask retention straps “between the nasal tube and the center point” would yield the predictable results of providing variable pressure points suitable to conform the facemask to seal to the anatomical features of the patient wearing the facemask.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the location of the facemask retention strap of Tatov to extend between the nasal tube and the center point, a known result effective variable and as taught by Gradon to be a known orientation suitable for imparting variable pressure points for sealing engagement of the facemask to conform to the face of the user.
As to Claims 12 and 18, the modified Tatov, specifically Gradon teaches two anchors (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) extending from the facemask that retain the facemask retention strap (120 of Figures 4 and 5; 200 of Figures 6 and 7) between the nasal tube and the mouth center point, the anchors not located in either of the cheek regions. As shown in Figures 4 and 5, the two anchors 126 and 129 are most proximal to nasal aperture (via 103) at the apex of nose covering region of the facemask at the nasal bridge and would appear to meet the claimed configuration of “not located in either of the cheek regions”. As shown in Figure 6, the two laterally and symmetrically oriented anchors most proximal to the nasal aperture (via 103) at the apex of nose covering region of the facemask at the nasal bridge and would appear to meet the claimed configuration of “not located in either of the cheek regions”.
As to Claims 13 and 19, the modified Tatov, specifically Gradon teaches at least one anchor (126/129/130/128/131 of Figures 4 and 5; 202 of Figures 6 and 7) is within 1.25 inches from a facemask midline, which is defined as extending along the center of the facemask bisecting the nose covering region and the mouth covering region. As shown in Figure 4 and 5, each of the anchors (126/129/130/128/131 of Figures 4 and 5) extend contiguously in a lateral direction across the facemask midline, whereby the claimed “within 1.25 inches” is an inherent configuration. As shown in Figure 6 and 7, the anchors (202 of Figures 6 and 7) are oriented in a mirrored pattern along the facemask midline, wherein the configuration of the claimed “within 1.25 inches” would be obvious to try choosing from a finite number of identified predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to achieve the desired variability in sealing pressures along the facemask.
As to Claim 15, the modified Tatov, specifically Tatov discloses facemask retention strap (defined by the lateral extensions beyond the face covering cup x10) is configured to deflect the pliable facemask cup (x10) towards the lips (defined by the base of x10 which receives the mouth of the patient) and the nostrils (defined by the apex of x10 which receives the nose of the patient) when worn by the wearer, as a function of the tensioning of the facemask retention strap to conform the facemask to the face of the user in a sealing engagement.
As to Claims 14 and 20, the modified Tatov, specifically Tatov discloses the configuration of the facemask (Figures 4-6) oriented to receive both the nose (via 505, as best seen in Figure 5, located within the apex of x10 which receives the nose of the patient) and the mouth/lips (defined by the base of x10 which receives the mouth of the patient) of the wearer, as a function of the tensioning of the facemask retention strap to conform the facemask to the face of the user in a sealing engagement, the resultant effect will be the movement of the face of the patient in closer proximity to facemask cup (x10) wherein the perimeter (x11) which provides the sealing engagement between the facemask cup (x10) and the patient will undergo deflection and will contact the nose and mouth/lips of the wearer. Due to the orientation of the nasal aperture (x05) to be inserted within the nostrils of the patient and abutting with the cheeks (via 525) of the a patient, the anatomical placement of the nasal apertures (x05) within the nose and abutting the cheeks (via 525) would yield the claimed contact of the “philtrum” at the centerline between the nasal apertures (x05) and the cheeks (via 525) – a kin to the common region located between the nose and lips of the wearer.
As to Claim 16, the modified Tatov, specifically Tatov discloses the facemask (Figures 4-6) has facemask cup (x10) with a material composition to include “sections of breathable material (such as SYMPATEX™ or NAFION™) in direct contact with both the mask cavity 410, 510, 610 and the surrounding environment. … An alternate mask configuration involves integrating a foamed breathable material in the mask body 410, 510, 610. ” (Column 15, Lines 35-60); “the cheek bearing portions are fabricated from a soft pliable material to enable the cannula to be adjusted in an anteroposterior direction.” (Column 4, Lines 45-55; and Column 17, Lines 5-15); “at least a part of the mask, prongs or sealing member is formed of a breathable material.” (Column 4, Lines 1-10); the nasal tube (x17) includes “the conduit includes a malleable spine that extends between the connector and the prongs to support the cannula in position within the mask.” (Column 5, Lines 5-10) wherein “The spine may be fabricated with anisotropic stiffness (by selecting an appropriate shape or material) to bias the prongs toward a preferable orientation in order to minimise the amount of adjustment required.” (Column 13, Lines 30-40). The resultant effect of the variability in material composition along the facemask is to facilitate the conformability of the facemask to seal about the face of the patient, thus meeting the claimed “regions of variable stiffness configured to enhance and target the deflection” as a function of the tensioning of the facemask retention strap to conform the facemask to the face of the user in a sealing engagement.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ogden et al. (5,662,101), Walacavage (2011/0083670), and Jablonski (9,925,349) each disclose a facemask suitable for covering the nose and mouth of the patient, and including a nasal tube which directs the flow of gases to at least the nostrils of the patient, having a facemask retention strap which is symmetrically located along the midsagittal plane of the facemask for securing a headgear in a position anterior to the facemask cup.
Salvino et al. (2023/0270964 – also known as 18/144,688) shares at least one common assignee and/or inventor with the instant application; however, at this time there does not appear to be a double patenting rejection as the subject matter has variations.
For example: Claim 1 of the instant application requires “A close conforming facemask”, “a mouth center point that is configured to reside directly over and in the center of the lips of the wearer when worn”, “a nasal tube that outwardly extends to a distal tube port, the distal tube port is in communication with a nasal aperture”, and the orientation of “a facemask retention strap disposed on said face covering cap between the nasal tube and the mouth center point”. Although the concept of “a head retention strap” is recited in the copending claim, Claim 2, each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For example: Claims 11 and 17 of the instant application requires “the inner surface configured to confront and cover the lips, nostrils, at least part of the nose, and a part of a right and left cheek of the wearer”, the nasal tube “configured to confront the nostrils”, “a center point configured to reside between the lips, wherein the center point is defined along a centerline configured to extend between the nostrils and bisecting the lips”, and the facemask retention strap “configured to deflect the pliable facemask cup between the nasal tube and the center point towards a philtrum of the wearer”. Although the concept of “a head retention strap” is recited in the copending claim, Claim 2, each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
Salvino et al. (2023/0277792 – also known as 18/144,750) shares at least one common assignee and/or inventor with the instant application; however, at this time there does not appear to be a double patenting rejection as the subject matter has variations.
For example: Claim 1 of the instant application requires “A close conforming facemask”, “a mouth center point that is configured to reside directly over and in the center of the lips of the wearer when worn”, “a nasal tube that outwardly extends to a distal tube port, the distal tube port is in communication with a nasal aperture”, and the orientation of “a facemask retention strap disposed on said face covering cap between the nasal tube and the mouth center point”. Although the concept of “a head retention strap” is recited in the copending claims, Claims 2 and 12, each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
For example: Claims 11 and 17 of the instant application requires “the inner surface configured to confront and cover the lips, nostrils, at least part of the nose, and a part of a right and left cheek of the wearer”, the nasal tube “configured to confront the nostrils”, “a center point configured to reside between the lips, wherein the center point is defined along a centerline configured to extend between the nostrils and bisecting the lips”, and the facemask retention strap “configured to deflect the pliable facemask cup between the nasal tube and the center point towards a philtrum of the wearer”. Although the concept of “a head retention strap” is recited in the copending claims, Claims 2 and 12, each of the aforementioned features as underlined are not explicitly recited in the claim listing of the copending application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785