DETAILED ACTION
This is the final rejection based on the 18/345,374 application filed on 06/30/2023 and which claims as amended on 09/26/2025 have been considered in the ensuing 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 .
Response to Amendments
The arguments and amendments to the specification have been sufficient to overcome the drawing objections and the specification objections. The amendments to the claims have been sufficient to overcome the claim objections. The arguments addressing claims 3 and 7 have been persuasive and claims 3 and 7 have been rejoined.
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 1-3, 5-7, and 9-17 are rejected under 35 U.S.C. 103 as being obvious over Kezirian et al (US 10,335,635) in view of Roy (US 4,601,465).
Regarding claim 1:
Kezirian et al discloses a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards a closed position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21); and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the closed position (see Fig. 1A-1D).
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Kezirian et al fails to specifically disclose that the open proximal portion is configured to be disposed to a user’s nose such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user.
Roy teaches a device for stimulating the human respiratory system, specifically, Roy teaches a device having an open proximal portion that can be mouth piece or a mask that covers the nose and mouth of a trainer (“As indicated hereinabove, use can be made of a mouth-piece constructed of flexible material such as rubber. Use may alternatively be made of a mask covering both the nose and mouth of the trainer, thereby forcing him or her to breath exclusively through the device.” See column 3 lines 46-51).
It would have been obvious to a person having ordinary skill in the art to modify the device of Kezirian et al to optionally include a mask that covers the nose and mouth of the trainer instead of the mouth insert, as taught by Roy, to allow for different types of breathing (i.e. forcing the trainer to breath exclusively through the device, as taught by Roy). The Examiner notes that “such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user” is functional language, and the device must only be capable of performing the function, as it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In this instance, Kezirian et al as modified by Roy would allow a user to breathe only through their nose resulting in the movement of the soft palate as claimed.
Regarding claim 2:
Kezirian et al as modified discloses that the threshold pressure is based on at least one of a stiffness of the valve mechanism, a dimension of the valve mechanism, or a dimension of the member (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21).
Regarding claim 3:
Kezirian et al as modified discloses that the valve mechanism is configured such that the threshold pressure is adjustable (see claim 5).
Regarding claim 5:
Kezirian et al discloses a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards an open position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“ In other embodiments, the valve mechanism 118 may open if the pressure in the proximal portion 122 rises above the threshold pressure but then remains open if the pressure in the proximal portion 122 subsequently falls below the threshold pressure. ” see column 3 lines 28-33);and a distal portion (distal portion 124), wherein the proximal portion and distal portion are not fluidly connected when the valve mechanism is not in the open position (see Fig. 1A-1D).
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Kezirian et al fails to specifically disclose that the open proximal portion is configured to be disposed to a user’s nose such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user.
Roy teaches a device for stimulating the human respiratory system, specifically, Roy teaches a device having an open proximal portion that can be mouth piece or a mask that covers the nose and mouth of a trainer (“As indicated hereinabove, use can be made of a mouth-piece constructed of flexible material such as rubber. Use may alternatively be made of a mask covering both the nose and mouth of the trainer, thereby forcing him or her to breath exclusively through the device.” See column 3 lines 46-51).
It would have been obvious to a person having ordinary skill in the art to modify the device of Kezirian et al to optionally include a mask that covers the nose and mouth of the trainer instead of the mouth insert, as taught by Roy, to allow for different types of breathing (i.e. forcing the trainer to breath exclusively through the device, as taught by Roy). The Examiner notes that “such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user” is functional language, and the device must only be capable of performing the function, as it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In this instance, Kezirian et al as modified by Roy would allow a user to breathe only through their nose resulting in the movement of the soft palate as claimed.
Regarding claim 6:
Kezirian et al as modified discloses that the threshold pressure is based on at least one of a stiffness of the valve mechanism, a dimension of the valve mechanism, or a dimension of the member (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21).
Regarding claim 7:
Kezirian et al as modified discloses that the valve mechanism is configured such that the threshold pressure is adjustable (see claim 5).
Regarding claim 9:
Kezirian et al discloses (i) a first apparatus comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards a closed position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21); and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the closed position (see Fig. 1A-1D); (ii) a second apparatus (see claim 11, directed to a method using a first and second apparatus) comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards a closed position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21); and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the closed position (see Fig. 1A-1D).
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Kezirian et al fails to specifically disclose that the open proximal portion is configured to be disposed to a user’s nose such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user.
Roy teaches a device for stimulating the human respiratory system, specifically, Roy teaches a device having an open proximal portion that can be mouth piece or a mask that covers the nose and mouth of a trainer (“As indicated hereinabove, use can be made of a mouth-piece constructed of flexible material such as rubber. Use may alternatively be made of a mask covering both the nose and mouth of the trainer, thereby forcing him or her to breath exclusively through the device.” See column 3 lines 46-51).
It would have been obvious to a person having ordinary skill in the art to modify the device of Kezirian et al to optionally include a mask that covers the nose and mouth of the trainer instead of the mouth insert, as taught by Roy, to allow for different types of breathing (i.e. forcing the trainer to breath exclusively through the device, as taught by Roy). The Examiner notes that “such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user” is functional language, and the device must only be capable of performing the function, as it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In this instance, Kezirian et al as modified by Roy would allow a user to breathe only through their nose resulting in the movement of the soft palate as claimed.
Regarding claim 10:
Kezirian et al as modified disclose that the first apparatus and the second apparatus are characterized by different threshold pressures (see the method of claim 17 stating that the different apparatus can have different threshold absolute pressures).
Regarding claim 11:
Kezirian et al as modified disclose that the first apparatus and the second apparatus define a combined housing (see claim 18).
Regarding claim 12:
Kezirian et al discloses (i) a first apparatus comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards a closed position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“In certain embodiments, the valve mechanism 118 is biased towards the closed position (FIG. 1C) unless it is opened (FIG. 1D) while the positive pressure in the proximal portion 122 is greater than a threshold pressure (e.g., 0.7 pounds per square inch), such threshold pressure to be determined by the properties of the member 114 (e.g., dimensions, etc.) and/or valve mechanism 118 (e.g., stiffness, thickness, etc.) ” see column 3 lines 13-21); and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the closed position (see Fig. 1A-1D); (ii) a second apparatus (see claim 11, directed to a method using a first and second apparatus) comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards a open position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“ In other embodiments, the valve mechanism 118 may open if the pressure in the proximal portion 122 rises above the threshold pressure but then remains open if the pressure in the proximal portion 122 subsequently falls below the threshold pressure. ” see column 3 lines 28-33);and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the open position (see Fig. 1A-1D).
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Kezirian et al fails to specifically disclose that the open proximal portion is configured to be disposed to a user’s nose such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user.
Roy teaches a device for stimulating the human respiratory system, specifically, Roy teaches a device having an open proximal portion that can be mouth piece or a mask that covers the nose and mouth of a trainer (“As indicated hereinabove, use can be made of a mouth-piece constructed of flexible material such as rubber. Use may alternatively be made of a mask covering both the nose and mouth of the trainer, thereby forcing him or her to breath exclusively through the device.” See column 3 lines 46-51).
It would have been obvious to a person having ordinary skill in the art to modify the device of Kezirian et al to optionally include a mask that covers the nose and mouth of the trainer instead of the mouth insert, as taught by Roy, to allow for different types of breathing (i.e. forcing the trainer to breath exclusively through the device, as taught by Roy). The Examiner notes that “such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user” is functional language, and the device must only be capable of performing the function, as it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In this instance, Kezirian et al as modified by Roy would allow a user to breathe only through their nose resulting in the movement of the soft palate as claimed.
Regarding claim 13:
Kezirian et al as modified disclose that the first apparatus and the second apparatus are characterized by different threshold pressures (see the method of claim 17 stating that the different apparatus can have different threshold absolute pressures).
Regarding claim 14:
Kezirian et al as modified disclose that the first apparatus and the second apparatus define a combined housing (see claim 18).
Regarding claim 15:
Kezirian et al discloses (i) a first apparatus comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards an open position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“ In other embodiments, the valve mechanism 118 may open if the pressure in the proximal portion 122 rises above the threshold pressure but then remains open if the pressure in the proximal portion 122 subsequently falls below the threshold pressure. ” see column 3 lines 28-33); and a distal portion (distal portion 124), wherein the proximal portion and distal portion are fluidly connected when the valve mechanism is not in the open position (see Fig. 1A-1D); (ii) a second apparatus (see claim 11, directed to a method using a first and second apparatus) comprising a member (see Fig. 1A-1D) defining an open proximal portion (proximal portion 122) configured to be disposed to a user’s mouth; a valve mechanism (valve mechanism 118) operatively arranged with the member and biased towards an open position unless an absolute pressure in the open proximal portion is greater than a threshold pressure (“ In other embodiments, the valve mechanism 118 may open if the pressure in the proximal portion 122 rises above the threshold pressure but then remains open if the pressure in the proximal portion 122 subsequently falls below the threshold pressure. ” see column 3 lines 28-33);and a distal portion (distal portion 124), wherein the proximal portion and distal portion are not fluidly connected when the valve mechanism is not in the open position (see Fig. 1A-1D).
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Kezirian et al fails to specifically disclose that the open proximal portion is configured to be disposed to a user’s nose such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user.
Roy teaches a device for stimulating the human respiratory system, specifically, Roy teaches a device having an open proximal portion that can be mouth piece or a mask that covers the nose and mouth of a trainer (“As indicated hereinabove, use can be made of a mouth-piece constructed of flexible material such as rubber. Use may alternatively be made of a mask covering both the nose and mouth of the trainer, thereby forcing him or her to breath exclusively through the device.” See column 3 lines 46-51).
It would have been obvious to a person having ordinary skill in the art to modify the device of Kezirian et al to optionally include a mask that covers the nose and mouth of the trainer instead of the mouth insert, as taught by Roy, to allow for different types of breathing (i.e. forcing the trainer to breath exclusively through the device, as taught by Roy). The Examiner notes that “such that nasal breathing by the user through the open proximal portion results in anterior movement of a soft palate of the user to open space in an area of the throat of the user behind the soft palate to create a continuous air pathway from the nose to the lungs of the user” is functional language, and the device must only be capable of performing the function, as it makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. In this instance, Kezirian et al as modified by Roy would allow a user to breathe only through their nose resulting in the movement of the soft palate as claimed.
Regarding claim 16:
Kezirian et al as modified disclose that the first apparatus and the second apparatus are characterized by different threshold pressures (see the method of claim 17 stating that the different apparatus can have different threshold absolute pressures).
Regarding claim 17:
Kezirian et al as modified disclose that the first apparatus and the second apparatus define a combined housing (see claim 18).
Response to Arguments
Applicant's arguments filed 09/26/2025 have been fully considered but they are not persuasive.
Regarding the arguments addressing the movement of the soft palate of the user, the limitation is intended use and the apparatus must only be capable of the intended use. In this instance, a user is capable of only nasal breathing in the modified device above, which would result in the movement of the soft palate as claimed. It makes no difference if the devices of the prior art are used in a different way since a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use
Regarding the arguments addressing the combination of Kezirian et al with a oronasal mask, the Examiner respectfully disagrees. The reference of Kezirian et al does not disclose movement of the soft palate of the user, and does not specifically discuss the function and movements that are being argued. While Kezirian et al does disclose positive or negative pressure in the oral cavity, Kezirian et al specifically states “oral cavity and/or pharynx”. Kezirian et al further discloses that it is known that there are multiple factors in disordered breathing and that the nose, oral cavity and pharynx are all contributing to breathing.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN M ANDERSON whose telephone number is (313)446-6531. The examiner can normally be reached M-TH 6 a.m. -4 p.m. (Arizona).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LoAn Jimenez can be reached at 571-272-4966. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Megan Anderson/Primary Examiner, Art Unit 3784