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 .
Election/Restrictions
Applicant's election with traverse of Species I: Figs 1-4 in the reply filed on 09/09/2025 is acknowledged. The traversal is on the ground(s) that the Office failed to explain the reasons for restriction in other words there is no explanation of search burden. This is found to be persuasive as all the components in Species I are the same components that are found within Species II (see Requirement for Restriction/Election filed on 05/09/2025); thus, no search burden would be required. Therefore, the restriction requirement between Species I and Species II have been withdrawn.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the longitudinal axis of the top arm, longitudinal axis of the support strap, and elongated edges must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites that “said headgear device further comprises a fourth lateral arm and wherein a second portion of said support strap is disposed underneath said third lateral arm”. However, claim 6, which claim 7, depends from already discloses that a first portion of said support strap is disposed underneath said third lateral arm. If both the first and second support portion were to be disposed under the third lateral arm, it would be unable to provide support below the head. This makes it unclear which portion of the support strap is supposed to be disposed underneath the third lateral arm and the fourth lateral arm respectively. For purposes of examination, claim 7 is being interpreted as “a second portion of said support strap is disposed underneath said fourth lateral arm”.
The term “about” in claim 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what constitutes as about, in other words, how far the elongated edges of the support strap and top arm can be away from parallel and would still be considered “about parallel”. For purposes of examination, “about parallel” is being considered as at least part of the elongated edge of the support strap being parallel with at least part of the elongated edge.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Doherty (US 20100258136) in view of Correa (US 6119694).
Regarding claim 1, Doherty discloses
An apparatus for stabilizing a mandibular position during CPAP therapy (figs. 1-7; headgear for respiration therapy in treating sleep disordered breathing, in other words used for CPAP therapy; abstract, [0003]), comprising:
a) a first saddle and a second saddle (figs. 28-29; sleeves 817 covers the straps/rigidizers 15, 80 of the headgear; [0219] and [0225]), each comprising
i) a proximal portion having a first headgear fastener (figs. 28-29; side portion 823 of sleeves 817 have plurality of snap fasteners 825; [0219] and [0225]) and
ii) a distal portion having a second headgear fastener (figs. 28-29; side portion 822 of sleeves 817 have plurality of snap fasteners 825; [0219] and [0225]); and
wherein said first saddle is configured to receive a first lateral arm of a headgear device (figs. 1-7 and 28-29; sleeve 817 that covers the right strap/rigidizer 15, 80 of the headgear; [0219] and [0225]) within an opening disposed between said proximal portion and said distal portion of said first saddle (see fig. 29, the side portions 822 and 823 are open creating an opening between the two portions),
wherein said second saddle is configured to receive a second lateral arm of said headgear device (figs. 1-7 and 28-29; sleeve 817 that covers the left strap/rigidizer of the headgear; [0219] and [0225]) within an opening disposed between said proximal portion and said distal portion of said second saddle (see fig. 29, the side portions 822 and 823 are open creating an opening between the two portions),
wherein said first headgear fastener and said second headgear fastener of said first saddle are configured to retain said first lateral arm of said headgear device within said opening (see fig. 28, side portions 822, 823 adapted to be wrapped and fastened around the right strap/rigidizer 15, 80 of the headgear by a plurality of fasteners 825; in other words, the side portions retain 822, 823 the strap/rigidizer 15, 80 using the fasteners 825; [0219] and [0225]), and
wherein said first headgear fastener and said second headgear fastener of said second saddle are configured to retain said second lateral arm of said headgear device within said opening (see fig. 28, side portions 822, 823 adapted to be wrapped and fastened around the left strap/rigidizer 15, 80 of the headgear by a plurality of fasteners 825; in other words, the side portions retain 822, 823 the strap/rigidizer 15, 80 using the fasteners 825; [0219] and [0225]).
Doherty does not disclose a support strap fastener; and a support strap comprising i) a first end having a fastener configured to engage said support strap fastener of said first saddle and ii) a second end having a fastener configured to engage said support strap fastener of said second saddle.
Correa discloses an analogous nasal mask assembly with
a support strap fastener (fig. 1; strap connectors 50 and 52; col. 3, lines 58-65)
b) a support strap (fig. 1; support strap 54; col. 3, lines 58-65) comprising
i) a first end having a fastener (fig. 1; support strap 54 is assembled from a fastening component, col. 3, lines 58-65; therefore, the right end of the support strap 54, that connects to strap connector 52, has a fastening component; col. 3, lines 58-65) configured to engage said support strap fastener (fig. 1; strap connector 52 is a hook fastener which is engaged with the fastening component; col. 3, lines 58-65) and
ii) a second end having a fastener (fig. 1; support strap 54 is assembled from a fastening component, col. 3, lines 58-65; therefore, the left end of the support strap 54, that connects to strap connector 50, has a fastening component; col. 3, lines 58-65) configured to engage said support strap fastener (fig. 1; strap connector 50 is a hook fastener which is engaged with the fastening component; col. 3, lines 58-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the upper side portion of the sleeves and the headgear of Doherty with the strap connectors and the supporting strap with the fastening component of Correa so as to provide support under the chin of the patient and adjust the nasal mask linearly and angularly with respect to the headgear assembly (Correa: abstract and col. 3, lines 58-65).
It directly follows that the resultant sleeves and headgear of Doherty combined with the hook fasteners and support strap with fastening components of Correa would meet the claimed structural limitations of the first and second saddles having a distal end with a support strap fastener (side portions 822 of sleeves 817 of Doherty with the strap connectors of Correa) that is configured to engage with the fasteners of the first and second ends of the support strap (Correa: fig. 1; strap connectors 52, 54 are a hook fasteners which are engaged with the fastening component of the ends of the support strap 54; col. 3, lines 58-65).
Regarding claim 2, Doherty further discloses
the apparatus (headgear for respiration therapy) of claim 1,
wherein a vertical width of said first saddle increases from an anterior end to a posterior end (see fig. 28 below; the sleeve 817 increases in vertical width from the anterior end to the posterior end).
PNG
media_image1.png
573
402
media_image1.png
Greyscale
Regarding claim 5, Doherty discloses
a system for stabilizing a mandibular position during CPAP therapy (figs. 1-7; a system using headgear for respiration therapy in treating sleep disordered breathing, in other words used for CPAP therapy; abstract, [0003]), comprising a mandibular positioning apparatus (figs. 28-29; sleeves 817; [0219] and [0225]) and a headgear device having a first lateral arm and a second lateral arm (figs. 1-7; right and left strap/rigidizer 15, 80 of the headgear; [0219] and [0225]), said apparatus comprising:
a) a first saddle and a second saddle (figs. 28-29; sleeves 817 covers the straps/rigidizers 15, 80 of the headgear; [0219] and [0225]), each comprising
i) a proximal portion (figs. 28-29; side portion 823 of sleeves 817; [0219] and [0225]),
ii) a distal portion (figs. 28-29; side portion 822 of sleeves 817; [0219] and [0225]),
iii) a pair of headgear fasteners (figs. 28-29; plurality of snap fasteners 825; [0219] and [0225]), and
wherein said first lateral arm of said headgear device is retained within an opening (see fig. 29, the side portions 822 and 823 are open creating an opening between the two portions where strap/rigidizer 15, 80 is placed) between said proximal portion and said distal portion of said first saddle (see fig. 28, side portions 822, 823 adapted to be wrapped and fastened around the right strap/rigidizer 15, 80 of the headgear by a plurality of fasteners 825; in other words, the side portions retain 822, 823 the strap/rigidizer 15, 80 in the opening between the side portions using the fasteners 825; [0219] and [0225]), and
wherein said second lateral arm of said headgear device is retained within an opening (see fig. 29, the side portions 822 and 823 are open creating an opening between the two portions where strap/rigidizer 15, 80 is placed) between said proximal portion and said distal portion of said second saddle (see fig. 28, side portions 822, 823 adapted to be wrapped and fastened around the left strap/rigidizer 15, 80 of the headgear by a plurality of fasteners 825; in other words, the side portions retain 822, 823 the strap/rigidizer 15, 80 in the opening between the side portions using the fasteners 825; [0219] and [0225]).
Doherty does not disclose comprising a support strap fastener ; and b) a support strap comprising i) a first end removably engaged with said first saddle and ii) a second end removably engaged with said second saddle.
Correa discloses an analogous nasal mask assembly with
a support strap fastener (fig. 1; strap connectors 50 and 52; col. 3, lines 58-65); and
b) a support strap (fig. 1; support strap 54; col. 3, lines 58-65) comprising
i) a first end removably engaged (fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65);
ii) a second end removably engaged (fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 50, col. 3, lines 58-65) with said second saddle;
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the side portion of the sleeves and the headgear of Doherty with the strap connectors and the supporting strap with the fastening component of Correa so as to provide support under the chin of the patient and adjust the nasal mask linearly and angularly with respect to the headgear assembly (Correa: abstract and col. 3, lines 58-65).
It directly follows that the resultant sleeves and headgear of Doherty combined with the hook fasteners and support strap with fastening components of Correa would meet the claimed structural limitations of a first end removably engaged with said first saddle (Correa: right end of support strap 54 connected to the strap connector 52, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector 52 of Correa) second end removably engaged with said second saddle (Correa: left end of support strap 54 connected to the strap connector 50, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector of Correa).
Regarding claim 8, Doherty further discloses
the system (system using headgear for respiration therapy) of claim 5,
wherein said headgear device further comprises a top arm (figs. 1-7; top straps 20; [0190] and [0191]) extending between said first lateral arm and said second lateral arm (figs. 1-7; top straps 20 extend between each of the straps 15; [0190] and [0191]).
Claims 3, 6, 7, 9-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Doherty (US 20100258136) in view of Correa (US 6119694) and further in view of Newman (US 20110220113).
Regarding claim 3, the modified device of Doherty discloses
the apparatus (Doherty: headgear for respiration therapy; Correa; support strap with a fastening component) of claim 1,
The modified device of Doherty does not explicitly disclose wherein a width of said support strap increases from each of said first end and said second end toward a medial portion of said support strap.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein a width of said support strap increases from each of said first end and said second end toward a medial portion of said support strap (see fig. 25 below; width increases from the ends towards the medial portion of side strap 740 and chip cup 720; [0115], [0117], and [0118]).
PNG
media_image2.png
594
652
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap of the modified device of Doherty with the shape of the chin cup of Newman to provide a chin cup that is preformed to a shape that closely matches a patient’s chin shape which assists in maintaining a patient’s mouth closed while being comfortable (Newman: [0013]-[0019] and [0117]).
Regarding claim 6, the modified device of Doherty discloses
the system (Doherty: system using headgear for respiration therapy; Correa: support strap with a fastening component) of claim 5,
The modified device of Doherty does not disclose wherein said headgear device further comprises a third lateral arm and wherein a first portion of said support strap is disposed underneath said third lateral arm.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein said headgear device further comprises a third lateral arm (fig. 6; headgear 87 includes a plurality of straps including a pair of upper straps 88 and lower headgear straps 89 (third (right) and fourth (left) lateral arm); [0080]) and wherein a first portion of said support strap is disposed underneath said third lateral arm (fig. 6; right side strap 140 of chin cup 120 is positioned underneath right lower headgear strap 89; [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headgear of the modified device of Doherty with the lower headgear straps of Newman to provide further support to the mask system in position on the patient’s face against the patient’s head (Newman: [0023]).
Regarding claim 7, the modified device of Doherty discloses
the system (Doherty: system using headgear for respiration therapy; Correa: support strap with a fastening component) of claim 6,
The modified device of Doherty does not disclose wherein said headgear device further comprises a fourth lateral arm and wherein a second portion of said support strap is disposed underneath said third lateral arm.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein said headgear device further comprises a fourth lateral arm (fig. 6; headgear 87 includes a plurality of straps including a pair of upper straps 88 and lower headgear straps 89 (third (right) and fourth (left) lateral arm); [0080]) and wherein a second portion of said support strap is disposed underneath said third lateral arm (fig. 6; left side strap 140 of chin cup 120 is positioned underneath left lower headgear strap 89; [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headgear of the modified device of Doherty with the lower headgear straps of Newman to provide further support to the mask system in position on the patient’s face against the patient’s head (Newman: [0023]).
Regarding claim 9, the modified device of Doherty discloses
the system (Doherty: system using headgear for respiration therapy; Correa: support strap with a fastening component) of claim 8,
Doherty does not explicitly disclose wherein, near said first saddle, a longitudinal axis of said top arm is aligned with a longitudinal axis of said support strap.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein, a longitudinal axis of said top arm is aligned with a longitudinal axis of said support strap (see fig. 25 below; longitudinal axis of top strap 788(2) is aligned with the longitudinal axis of side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
PNG
media_image3.png
646
772
media_image3.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap, strap connectors, and top straps of the modified device of Doherty to be positioned as disclosed in Newman to provide an arrangement that provides a vertically upwards victor or force component to the patient’s chin or jaw while minimizing an anterior-posterior displacement of the jaw to assist in maintaining the patient’s mouth closed (Newman: [0013]-[0019] and [0024]).
It directly follows that the resultant the support strap, strap connectors, and top straps of the modified device of Doherty combined with the positioning of Newman would meet the claimed structural limitations since:
The modified device combined discloses
wherein, near said first saddle (Doherty: figs. 28, 29; sleeves 817 which covers the rigidizers 80 and lateral straps 15; [0225]; Newman: see fig. 25, longitudinal axis of the side strap of chin cup (support strap) is aligned with the top straps longitudinal axis near the lateral side straps 788 (1); [0115], [0117], and [0118]), a longitudinal axis of said top arm is aligned with a longitudinal axis of said support strap (Newman: see fig. 25 above; longitudinal axis of top strap 788(2) is aligned with the longitudinal axis of side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
Regarding claim 10, the modified device of Doherty discloses
the system (Doherty: system using headgear for respiration therapy; Correa: support strap with a fastening component) of claim 8,
The modified device of Doherty does not disclose wherein an elongated edge of said support strap is about parallel to an elongated edge of said top arm of said headgear device.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein an elongated edge of said support strap is about parallel to an elongated edge of said top arm of said headgear device (see fig. 25(1) below; elongated edge of top strap 788(2) is about parallel with the elongated edge of side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
PNG
media_image4.png
562
788
media_image4.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap, strap connectors, and top straps of the modified device of Doherty to be positioned as disclosed in Newman to provide an arrangement that provides a vertically upwards victor or force component to the patient’s chin or jaw while minimizing an anterior-posterior displacement of the jaw to assist in maintaining the patient’s mouth closed (Newman: [0013]-[0019] and [0024]).
Regarding claim 11, the modified device of Doherty discloses
the system (Doherty: system using headgear for respiration therapy; Correa: support strap with a fastening component) of claim 8,
While the modified device of Doherty does not explicitly disclose wherein said support strap fastener of each saddle is aligned with said top arm of said headgear device.
Newman discloses an analogous headgear for CPAP therapy with a chin strap
wherein said support strap of each saddle is aligned with said top arm of said headgear device (see fig. 25; aligning the top strap 788(1) with the side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap, strap connectors, and top straps of the modified method of Doherty to be positioned as disclosed in Newman to provide an arrangement that provides a vertically upwards victor or force component to the patient’s chin or jaw while minimizing an anterior-posterior displacement of the jaw to assist in maintaining the patient’s mouth closed (Newman: [0013]-[0019] and [0024]).
In other words, it directly follows that the resultant headgear of modifying the positioning of the strap connectors of the modified method of Doherty with the positioning of Newman would meet the claimed limitations of said support strap fastener of each saddle (Correa: fig. 1; support connectors 50, 52 modified on left/right sleeves of Doherty) is aligned (Newman: see fig. 25; aligning the top strap 788(1) with the side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]) with said top arm (Doherty: figs. 1-7; top straps 20; [0190] and [0191]).
Regarding claim 12, Doherty discloses
a method for engaging a mandibular positioning apparatus to a headgear device (figs. 1-7; headgear for respiration therapy in treating sleep disordered breathing, in other words used for CPAP therapy; abstract, [0003]), said device having a plurality of lateral arms (figs. 1-7; right and left strap/rigidizer 15, 80 of the headgear; [0219] and [0225]) and said apparatus comprising a first saddle (figs. 28-29; right sleeve 817 covers the right straps/rigidizers 15, 80 of the headgear; [0219] and [0225]), a second saddle (figs. 28-29; left sleeve 817 covers the left straps/rigidizers 15, 80 of the headgear; [0219] and [0225]),
said method comprising the steps of:
a) separating, along a top edge of each saddle, a proximal portion and a distal portion of each saddle to expose an opening therebetween (see fig. 29; side portions 822, 823 of sleeves 817 are removably attached from each other creating an opening, a top portion of each of the side portions are separated; [0219] and [0225]);
b) positioning a first of said lateral arms of said headgear device within said opening of said first saddle (see fig. 29; right strap/rigidizer 15, 80 is placed within opening created by separated side portions 822, 823 of right sleeve 817; [0219] and [0225]);
c) positioning a second of said lateral arms of said headgear device within said opening of said second saddle (see fig. 29; left strap/rigidizer 15, 80 is placed within opening created by separated side portions 822, 823 of left sleeve 817; [0219] and [0225]);
d) joining, along said top edge of each saddle, said proximal portion and said distal portion of each saddle (see figs. 28 and 29; side portions 822, 823 of sleeves 817 are adapted to fastened to each other by engaging the plurality of fasteners 825 on each of the side portions, top edge of sleeves comprises fasteners for joining; [0219] and [0225])
Doherty does not disclose a support strap, the method comprising the steps of e) positioning a first portion of said support strap underneath a third of said lateral arms of said headgear device; f) positioning a second portion of said support strap underneath a fourth of said lateral arms of said headgear device; g) engaging a first end of said support strap to said first saddle; and h) engaging a second end of said support strap to said second saddle.
Correa discloses an analogous nasal mask assembly with
a support strap (fig. 1; support strap 54; col. 3, lines 58-65)
g) engaging a first end of said support strap (fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65) to said first saddle; and
h) engaging a second end of said support strap (fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 50, col. 3, lines 58-65) to said second saddle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal side portion of the sleeves and the headgear of Doherty with the strap connectors and the supporting strap with the fastening component of Correa so as to provide support under the chin of the patient and adjust the nasal mask linearly and angularly with respect to the headgear assembly (Correa: abstract and col. 3, lines 58-65).
It directly follows that the resultant sleeves and headgear of Doherty combined with the hook fasteners and support strap with fastening components of Correa would meet the claimed structural limitations of g) engaging a first end of said support strap (Correa: fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65) to said first saddle (Correa: right end of support strap 54 connected to the strap connector 52, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector 52 of Correa); h) engaging a second end of said support strap (Correa: fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 50, col. 3, lines 58-65) to said second saddle (Correa: left end of support strap 54 connected to the strap connector 50, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector of Correa).
The modified device of Doherty does not disclose e) positioning a first portion of said support strap underneath a third of said lateral arms of said headgear device; f) positioning a second portion of said support strap underneath a fourth of said lateral arms of said headgear device.
Newman discloses an analogous headgear for CPAP therapy with a chin strap where
e) positioning a first portion of said support strap underneath a third of said lateral arms of said headgear device (fig. 6; right side strap 140 of chin cup 120 is positioned underneath right lower headgear strap 89; [0080]);
f) positioning a second portion of said support strap underneath a fourth of said lateral arms of said headgear device (fig. 6; left side strap 140 of chin cup 120 is positioned underneath left lower headgear strap 89; [0080]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headgear of the modified method of Doherty with the additional lower headgear straps and chin strap positioned beneath as disclosed in Newman to provide further support to the mask system in position on the patient’s face against the patient’s head (Newman: [0023]).
Regarding claim 14, Doherty further discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 12,
wherein said step of separating said proximal portion and said distal portion of each saddle (see fig. 29; side portions 822, 823 of sleeves 817 are removably attached from each other; [0219] and [0225]) comprises disengaging a first headgear fastener on each proximal portion from a second headgear fastener on each distal portion (see figs 28-29; side portion 822 comprises the plurality of fasteners 825 that are removable from the plurality of fasteners 825 of side portion 823; [0219] and [0225]).
Regarding claim 15, Doherty further discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 14,
wherein said step of joining said proximal portion and said distal portion of each saddle (see figs. 28 and 29; side portions 822, 823 of sleeves 817 are adapted to fastened to each other; [0219] and [0225]) comprises attaching said first headgear fastener to said second headgear fastener (see figs. 28 and 29; sleeve 817 is attached by a plurality of fasteners 825 on side portion 822 engaging with plurality of fasteners 825 on side portions 823; [0219] and [0225]).
Regarding claim 16, the modified method of Doherty further discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 12,
wherein said step of engaging said first end of said support strap to said first saddle (Correa: fig. 1; right end of support strap 54 is engaged to the support connector 52, col. 3, lines 58-65, of the modified right sleeve 817 of Doherty) comprises attaching a fastener on said first end to a first support strap fastener (Correa: fig. 1; right end of support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65) on said proximal portion of said first saddle (Correa: fig. 1; the support connector 52, col. 3, lines 58-65, is modified on side portion 822 of right sleeve 817 of Doherty).
Regarding claim 17, the modified method of Doherty discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 16,
wherein said headgear device further comprises a top arm extending between said first of said lateral arms and said second of said lateral arms (Doherty: figs. 1-7; top straps 20 extend between each of the straps 15; [0190] and [0191]) and
wherein said step of positioning said first of said lateral arms of said headgear device within said opening of said first saddle (Doherty: see fig. 29; right strap/rigidizer 15, 80 is placed within opening created by separated side portions 822, 823 of right sleeve 817; [0219] and [0225])
While the modified device of Doherty does not explicitly disclose aligning said first support strap fastener with said top arm.
Newman further discloses a headgear arrangement of aligning the top strap 788(1) with the side strap 740 and chin strap/cup 720 (support strap); see fig. 25; [0115], [0117], and [0118]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap, strap connectors, and top straps of the modified method of Doherty to be positioned as disclosed in Newman to provide an arrangement that provides a vertically upwards victor or force component to the patient’s chin or jaw while minimizing an anterior-posterior displacement of the jaw to assist in maintaining the patient’s mouth closed (Newman: [0013]-[0019] and [0024]).
In other words, it directly follows that the resultant headgear of modifying the positioning of the strap connectors of the modified method of Doherty with the positioning of Newman would meet the claimed limitations of aligning (Newman: see fig. 25; aligning the top strap 788(1) with the side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]) said first support strap fastener (Correa: fig. 1; connector 52) with said top arm (Doherty: figs. 1-7; top straps 20; [0190] and [0191]).
Regarding claim 18, the modified method of Doherty further discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 12
wherein said step of engaging said second end of said support strap (Correa: fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 50, col. 3, lines 58-65) to said second saddle (Correa: left end of support strap 54 connected to the strap connector 50, col. 3, lines 58-65; on side portions 822 of sleeves 817 of Doherty with the strap connector of Correa) comprises attaching a fastener on said second end to a second support strap fastener (Correa: fig. 1; left end of support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 50, col. 3, lines 58-65) on said proximal portion of said second saddle (Correa: fig. 1; the support connector 52, col. 3, lines 58-65, is modified on side portion 822 of left sleeve 817 of Doherty).
Regarding claim 19, the modified method of Doherty discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 18,
wherein said headgear device further comprises a top arm extending between said first of said lateral arms and said second of said lateral arms (Doherty: figs. 1-7; top straps 20 extend between each of the straps 15; [0190] and [0191]) and
wherein said step of engaging said first end of said support strap (Correa: fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65) to said first saddle (Correa: right end of support strap 54 connected to the strap connector 52, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector 52 of Correa).
While the modified device of Doherty does not explicitly disclose aligning said support strap with said top arm.
Newman further discloses a headgear arrangement with a chin strap
aligning said support strap with said top arm (see fig. 25; aligning the top strap 788(1) with the side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap, strap connectors, and top straps of the modified method of Doherty to be positioned as disclosed in Newman to provide an arrangement that provides a vertically upwards victor or force component to the patient’s chin or jaw while minimizing an anterior-posterior displacement of the jaw to assist in maintaining the patient’s mouth closed (Newman: [0013]-[0019] and [0024]).
Regarding claim 20, the modified method of Doherty further discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional straps, strap arrangement, and alignment) of claim 19,
wherein said step of engaging said first end of said support strap (Correa: fig. 1; support strap 54 is assembled from a fastening component which is removably engaged with the fastening hook of the strap connector 52, col. 3, lines 58-65) to said first saddle (Correa: right end of support strap 54 connected to the strap connector 52, col. 3, lines 58-65; side portions 822 of sleeves 817 of Doherty with the strap connector 52 of Correa) comprises aligning a longitudinal axis of said support strap with a longitudinal axis of said top arm (Newman: see fig. 25 below; longitudinal axis of top strap 788(2) is aligned with the longitudinal axis of side strap 740 and chin strap/cup 720 (support strap); [0115], [0117], and [0118]).
PNG
media_image3.png
646
772
media_image3.png
Greyscale
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Doherty (US 20100258136) in view of Correa (US 6119694) and further in view of Formica (US 20110197341).
Regarding claim 4, the modified device of Doherty discloses
the apparatus (Doherty: headgear for respiration therapy; Correa: support strap with a fastening component) of claim 1,
The modified device of Doherty does not disclose wherein said support strap further comprises a plurality of removable partitions at said first end for adjusting a length of said support strap.
Formica discloses an analogous respiratory mask with straps having
a plurality of removable partitions (fig. 26; perforations 6000 provided along the length of the strap (at the end of the strap); [0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap of the modified device of Doherty with the perforations of Formica that may allow the patient to tear or cut segments of the strap off to shorten its length which allows for further adjusting of the strap (Formica: [0129]).
It directly follows that the resultant support strap of Doherty combined with the perforations of Formica would meet the claimed structural limitations since:
wherein said support strap (Correa: fig. 1; support strap 54; col. 3, lines 58-65) further comprises a plurality of removable partitions at said first end (Formica: fig. 26; perforations 6000 provided along the length of the strap (at the end of the strap); [0129]) for adjusting a length of said support strap (Formica: fig. 26; perforations 6000 to tear or cut segments of the strap off to shorten its length adjusting the strap; [0129]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Doherty (US 20100258136) in view of Correa (US 6119694) and further in view of Newman (US 20110220113) and Formica (US 20110197341).
Regarding claim 13, the modified method of Doherty discloses
the method (Doherty: method of using headgear; Correa: method of using/attaching a support strap; Newman: additional strap and strap arrangement) of claim 12,
Doherty does not disclose wherein, before the step of engaging said first end of said support strap to said first saddle, a length of said support strap is adjusted by removing at least one partition from an end of said support strap.
Formica discloses an analogous respiratory mask with straps where
wherein, before the step of engaging said first end of strap (see fig. 26, strap with perforation is not engaged to the respiratory mask)
a length of said support strap is adjusted by removing at least one partition from an end of a strap (fig. 26; perforations 6000 provided along the length of the strap (at the end of the strap) to remove; [0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the support strap of the modified method of Doherty with the adjusting method using perforations of Formica that may allow the patient to tear or cut segments of the strap off to shorten its length which allows for further adjusting of the strap (Formica: [0129]).
It directly follows that the resultant support strap of Doherty combined with the adjusting method using perforations of Formica would meet the claimed structural limitations since:
wherein, before the step of engaging said first end of said support strap (Correa: fig. 1; support strap 54 is engaged to the support connector 52, col. 3, lines 58-65, of the modified right sleeve 817 of Doherty) to said first saddle, a length of said support strap is adjusted by removing at least one partition from an end of said support strap (Formica: fig. 26; perforations 6000 to tear or cut segments of the strap off to shorten its length adjusting the strap; [0129]; Correa: fig. 1; support strap 54).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wade (US 20180008452) – A mouth closing device which provides a chin strap that connects to the upper head gear while is underneath the lower headgear straps.
Ito (JP 6083836) – A headgear assembly with jaw fixation with a top strap, jaw strap, and plurality of lateral straps connected to the respiration mask
Wanderer (WO 2014004418) – A headgear assembly for use with a CPAP mask with a support strap that goes under the chin and a plurality of lateral straps
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYDNEY REYES RUSSELL whose telephone number is (703)756-4567. The examiner can normally be reached M-F 730am -5pm.
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 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.
/S.R.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785