DETAILED ACTION
This Office Action is in response to the filing of an amendment to the claims on 10/30/2025. As per the amendment, claims 1, 6, 13, 15-16, 18, and 20 have been amended, claims 21 has been added, and claims 11 has been cancelled. Thus, claims 1-10, 12-21 are pending in the application.
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 § 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 1-2, 5, 7, 10, 12-14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Winefordner et al. (US Pat. 5,503,140) in view of Gray (US Pat. 4,090,511) in view of Baragar et al. (US Pat. 5,825,453).
Regarding claim 1, Winefordner discloses a second stage regulator (the disclosed system of Figs. 1-2 and the abstract), comprising: a housing (regulator body 10 in Figs. 1-2); a mouthpiece (mouthpiece 24 in Fig. 2); and a coupler coupled to the housing (see Fig. 2 where a right side of body 10 has a cylindrical opening 12 around hex nut 104 that acts as a coupler to connect to the tube source of air).
Winefordner lacks a detailed description of a first nosepiece coupled to a first lever; a second nosepiece coupled to a second lever; a first spring located in the housing and coupled to the first nosepiece and the first lever; a second spring located in the housing and coupled to the second nosepiece and the second lever; wherein the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other.
However, Gray teaches a similar emergency breathing device, where a first nosepiece coupled to a first lever (see Fig. 1 where there is a first nose clip 25, with a cylindrical extension protruding out as a first lever); a second nosepiece coupled to a second lever (see Fig. 1 where there is a second nose clip 25, with a cylindrical extension protruding out as a second lever); a spring connected to the housing and coupled to the first nosepiece and the first lever (see torsion spring 26 in Fig. 1, connected to a first side of nose clip 25); the spring also coupled to the second nosepiece and the second lever (see torsion spring 26 in Fig. 1, connected to a second side of nose clip 25); wherein the spring biases the first nosepiece and the second nosepiece towards each other (see Fig. 1 and Col. 2 lines 57-62 where a torsion spring 26 is understood to apply a torsion force to the nose clip 25 so as to place the two sides of nose clip 25 under tension to rest on the nares of the user’s nose).
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 patient interface of the regulator of Winefordner to include a spring-held nose clip as taught by Gray, as it would provide a mechanism for holding the user’s nose clamped shut, preventing contaminants or water from entering the nose while the user’s respirates through the regulator.
The modified Winefordner device lacks a detailed description of a first spring located in the housing and coupled to the first nosepiece and the first lever; a second spring located in the housing and coupled to the second nosepiece and the second lever; wherein the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other, wherein the first nosepiece and the first lever rotate about a circumference of the housing to an open position when an actuation force is applied to the first lever.
However, Baragar teaches a worn patient interface device with a nosepiece, where a first spring located in a housing and coupled to the first nosepiece and the first lever (see Figs. 1a-1c where biasing means 60/62 are a first spring located within the U-shaped housing 12, and coupled to a first nosepad 40 and a first lever at leg 14); a second spring located in the housing and coupled to the second nosepiece and the second lever (see Figs. 1a-1c where biasing means 64/66 are a second spring located within the U-shaped housing 12, and coupled to a second nosepad 42 and a second lever at leg 16); wherein the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other (see Col. 5 lines 30-42, where the spring can be adjusted to bias the direction of the nosepads, including and inward bias towards one another that better grips the nose).
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 spring nosepiece of the modified Winefordner device to have a biasing spring associated with each nosepiece as taught by Baragar, as it would allow for more minute adjustments to the shape and direction of the bias applied to the nosepiece, to better fit different shaped noses, while also maintaining a grip against the nose (Baragar; see Col. 5 lines 30-42). It is understood that in the modified Winefordner device, the nose clips and levers as taught by Gray are further modified to be separately biased by first and second springs as taught by Baragar, said springs being located within a housing. Hence, in the modified Winefordner device, there is wherein the first nosepiece and the first lever rotate about a circumference of the housing when an actuation force is applied to the first lever (Baragar; see Col. 5 lines 30-42 where the biasing done by the springs 60/62 and 64/66 rotationally moves the position of the nosepads 40/42, such that the motion is relative to the circumference of the housing of Winefordner in the modified device. Hence, in the modified Winefordner device, the spring nosepiece of Gray is modified so that each respective lever arm has a nose clip on one end, and is connected to and operated by the internal housing spring as taught by Baragar on the other end, for selectively biasing the nose clips in the modified device).
Regarding claim 2, the modified Winefordner device has the first nosepiece and the second nosepiece.
The modified Winefordner device lacks a detailed description of wherein the first nosepiece and the second nosepiece comprise a removable nose pad.
However, Baragar further teaches where the nosepiece can have removably attached nose pads (see Col. 4 lines 32-37 where the nosepads are attachable by removable means)
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 nosepiece of the modified Winefordner device to have removable nose pads as taught by Baragar, as it would allow for easy swapping of nose pads to replace soiled/ damaged pads, as well as allow for the device to be used on other patients.
Regarding claim 5, the modified Winefordner device has wherein the coupler is coupled to a hose (Winefordner; see Fig. 2 where the coupler on the right side of body 10 connects to a hose member).
Regarding claim 7, the modified Winefordner device has wherein the housing further comprises at least one exhaust port allowing exhaled air to leave the second stage regulator (Winefordner; see Figs. 2 and 7 where the exhaust valves 390/392 sit over a pair of exhaust ports at openings 394).
Regarding claim 10, the modified Winefordner device has wherein the exhaust port is located in an exhaust cover coupled to the housing (Winefordner; see Fig. 2 where cover 350 has tabs 358/360 which interface with openings 372 to connect to the body of the regulator, which has the exhaust valves 390/392 located underneath).
Regarding claim 12, the modified Winefordner device has wherein the first nosepiece and the first lever are formed in a unitary component (Gray; see Fig. 1 where the noseclip 25 is made such that the circular pad part that connects the nose is unitary with the cylindrical extension that extends out from it which is the lever).
Regarding claim 13, the modified Winefordner device has wherein the housing comprises a front cover coupled to the housing (Gray; see Figs. 1 and 4 front cover 2), the front cover engages with a portion of the first nosepiece, the first lever, the second nosepiece, and the second lever to maintain the first nosepiece, the first lever, the second nosepiece, and the second lever in engagement with the housing (Gray; see Figs. 1 and 4 where the leaf spring 27 which connects to nose apparatus to the regulator is coupled to the front cover 2, such that in the modified Winefordner device, the nose apparatus (nosepieces and associated levers) are connected to the housing via the front cover).
Regarding claim 14, the modified Winefordner device has wherein the first spring is located in a first spring seat formed in the housing and the second spring is located in a second spring seat in the housing (Baragar; see Figs. 1a-1c where each spring set 60/62 and 64/66 are located in respective spring seats within the U-shaped housing, and where in the modified Winefordner device the spring are attached to and extend from the housing (as taught by Gray) such that the seat that the springs connect to is formed in the housing (Gray; see Figs. 1and 4 where spring 27 connects to the housing via a seat between front cover 2 and screw 28)).
Regarding claim 21, the modified Winefordner device has wherein the second nosepiece and the second lever rotate about a circumference of the housing to an open position independently of the first nosepiece and the first lever when an actuation force is applied to the second lever (Baragar; see Col. 5 lines 30-42 where the biasing done by the springs 60/62 and 64/66 rotationally moves the position of the nosepads 40/42, such that the motion is relative to the circumference of the housing of Winefordner in the modified device. Hence, in the modified Winefordner device, the spring nosepiece of Gray is modified so that each respective lever arm has a nose clip on one end, and is connected to and operated by the internal housing spring as taught by Baragar on the other end, for selectively biasing the nose clips in the modified device).
Claims 3-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Winefordner in view of Gray in view of Baragar as applied to claim 1 above, and further in view of Dague (US Pat. 5,213,095).
Regarding claim 3, the modified Winefordner device has the coupler.
The modified Winefordner device lacks a detailed description of wherein the coupler comprises a threaded coupler.
However, Dague teaches a similar regulator connected to a source of gas via a coupler, where the coupler comprises a threaded coupler (see Figs. 2A-4 where a connection between regulator 14 and hose 12 is done via coupling apparatus 26, and has at least one threaded coupling section at female member 46).
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 coupling between the regulator and tube of the modified Winefordner device to be a threaded coupling as taught by Dague, as it would be a simple substitution of one type of coupling to a tube for another type of coupling to yield the predictable result of coupling the regulator to the tube.
Regarding claim 4, the modified Winefordner device has the coupler.
The modified Winefordner device lacks a detailed description of wherein the coupler comprises a swivel coupler.
However, Dague teaches a similar regulator connected to a source of gas via a coupler, where the coupler comprises a swivel coupler (see Figs. 2A-4 where a connection between regulator 14 and hose 12 is done via coupling apparatus 26, and see Col. 4 lines 27-45 where the engagement between male and female members of the coupling apparatus allow swiveling movement).
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 coupling between the regulator and tube of the modified Winefordner device to be a swivel coupling as taught by Dague, as it would allow the user to more freely rotate their head without substantial resistance from the hose (Dague; see Col. 4 lines 27-45).
Regarding claim 6, the modified Winefordner device has the coupler is coupled to an air source forming a pathway for passing a breathing mix to a user (Winefordner; see Fig. 2 where the shown tube on the right connects to a source of air, through to mouthpiece 24).
The modified Winefordner device lacks a detailed description of wherein the coupler is coupled to an air tank forming a pathway for passing a breathing mix stored in the air tank to a user.
However, Dague teaches a similar regulator connected to a source of gas via a coupler, wherein the coupler is coupled to an air tank and a user can inhale a breathing mix stored in the air tank via a pathway formed the housing and the mouthpiece (see Col. 2 lines 49-58 where the source of air leading to the regulator is an air tank 10; see Figs. 1A-1B as in common in the prior art).
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 source of air of the modified Winefordner device to come from an air tank as taught by Dague, as it would be a simple substitution of one type of air source for breathable air for another source, to yield the predictable result of providing breathable air.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Winefordner in view of Gray in view of Baragar as applied to claim 7 above, and further in view of Furuichi et al. (US Pat. 5,720,279).
Regarding claim 8, the modified Winefordner device has the housing and an exhalation port.
The modified Winefordner device lacks a detailed description of wherein the housing further comprises a check valve preventing exhaled air from entering a pathway allowing a user to inhale a breathing mix.
However, Furuichi teaches a similar respiration device with a regulator, where a check valve is provide between an inhalation air passage and the mouthpiece so that air cannot flow back in the inhalation pathway leading to the user (see Col. 10 lines 1-5).
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 inhalation pathway of the modified Winefordner device to have a check valve as taught by Furuichi, as it would prevent exhaled air from entering the inhalation flow path and mixing with the incoming oxygen (Furuichi; see Col. 10 lines 1-5).
Regarding claim 9, the modified Winefordner device has wherein the pathway comprises a poppet chamber having a poppet (Winefordner; see Fig. 2 where valve 80 includes a poppet assembly 116 in the flowpath of the valve, and existing in a chamber of the valve that holds the poppet).
Claims 15-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Faligant (US Pub. 2004/0035415) in view of Gray (US Pat. 4,090,511) in view of Baragar et al. (US Pat. 5,825,453).
Regarding claim 15, Faligant discloses an emergency breathing system (system of Figs. 1-3 and 5; see abstract), comprising: an air tank (tank 12 in Fig. 1); and a second stage regulator coupled to the air tank (second stage regulator 30 in Figs. 1-3 and 5), the second stage regulator comprising a housing (the housing making up second stage regulator 30 as seen in Figs. 1-3 and 5, most particularly main housing 39).
Faligant lacks a detailed description of a first nosepiece coupled to a first lever, a second nosepiece coupled to a second lever, a first spring located in the housing and coupled to the first nosepiece and the first lever, and a second spring located in the housing and coupled to the second nosepiece and the second lever, where the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other.
However, Gray teaches a similar emergency breathing device, where a first nosepiece coupled to a first lever (see Fig. 1 where there is a first nose clip 25, with a cylindrical extension protruding out as a first lever); a second nosepiece coupled to a second lever (see Fig. 1 where there is a second nose clip 25, with a cylindrical extension protruding out as a second lever); a spring connected to the housing and coupled to the first nosepiece and the first lever (see torsion spring 26 in Fig. 1, connected to a first side of nose clip 25); the spring also coupled to the second nosepiece and the second lever (see torsion spring 26 in Fig. 1, connected to a second side of nose clip 25); wherein the spring biases the first nosepiece and the second nosepiece towards each other (see Fig. 1 and Col. 2 lines 57-62 where a torsion spring 26 is understood to apply a torsion force to the nose clip 25 so as to place the two sides of nose clip 25 under tension to rest on the nares of the user’s nose).
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 patient interface of the regulator of Faligant to include a spring-held nose clip as taught by Gray, as it would provide a mechanism for holding the user’s nose clamped shut, preventing contaminants or water from entering the nose while the user’s respirates through the regulator.
The modified Faligant device lacks a detailed description of a first spring located in the housing and coupled to the first nosepiece and the first lever; a second spring located in the housing and coupled to the second nosepiece and the second lever; wherein the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other, wherein the first nosepiece and the first lever rotate about a circumference of the housing to an open position when an actuation force is applied to the first lever.
However, Baragar teaches a worn patient interface device with a nosepiece, where a first spring located in a housing and coupled to the first nosepiece and the first lever (see Figs. 1a-1c where biasing means 60/62 are a first spring located within the U-shaped housing 12, and coupled to a first nosepad 40 and a first lever at leg 14); a second spring located in the housing and coupled to the second nosepiece and the second lever (see Figs. 1a-1c where biasing means 64/66 are a second spring located within the U-shaped housing 12, and coupled to a second nosepad 42 and a second lever at leg 16); wherein the first spring and the second spring bias the first nosepiece and the second nosepiece towards each other (see Col. 5 lines 30-42, where the spring can be adjusted to bias the direction of the nosepads, including and inward bias towards one another that better grips the nose).
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 spring nosepiece of the modified Faligant device to have a biasing spring associated with each nosepiece as taught by Baragar, as it would allow for more minute adjustments to the shape and direction of the bias applied to the nosepiece, to better fit different shaped noses, while also maintaining a grip against the nose (Baragar; see Col. 5 lines 30-42). It is understood that in the modified Faligant device, the nose clips and levers as taught by Gray are further modified to be separately biased by first and second springs as taught by Baragar, said springs being located within a housing. Hence, in the modified Faligant device, there is wherein the first nosepiece and the first lever rotate about a circumference of the housing when an actuation force is applied to the first lever (Baragar; see Col. 5 lines 30-42 where the biasing done by the springs 60/62 and 64/66 rotationally moves the position of the nosepads 40/42, such that the motion is relative to the circumference of the housing of Faligant in the modified device. Hence, in the modified Faligant device, the spring nosepiece of Gray is modified so that each respective lever arm has a nose clip on one end, and is connected to and operated by the internal housing spring as taught by Baragar on the other end, for selectively biasing the nose clips in the modified device).
Regarding claim 16, the modified Faligant device has further comprising a first stage regulator coupled to the air tank (Faligant; see [0009] where the first stage regulator is secured to a tank), wherein the second stage regulator is coupled to the first stage regulator (Faligant; see [0009]).
Regarding claim 17, the modified Faligant device has further comprising a hose coupled to the first stage regulator, wherein the hose is coupled to the second stage regulator (see [0004] where a hose connects to the first stage regulator and leads to the second stage regulator).
Regarding claim 19, the modified Faligant device has wherein the air tank is formed from a material selected from the group consisting of aluminum and a composite (see [0024] where an air tank can be made of aluminum).
Regarding claim 20, the modified Faligant device has wherein the air tank stores a breathing mix and has a working pressure of approximately 3000 PSI to 4500 PSI (see [0024] where the tank holds pressure at about 3000 PSI).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Faligant in view of Gray in view of Baragar as applied to claim 17 above, and further in view of Merrifield (US Pat. 4,062,356).
Regarding claim 18, the modified Faligant device has wherein: the air tank comprises a first coupler (Faligant; see [0004] where the air tank has some coupling mechanism by which the first stage pressure regulator is mounted to it), the first stage regulator comprises a second coupler (Faligant; see [0004] where the first stage regulator has some coupling mechanism by which it mounts to the air tank), the hose comprises a first swivel coupler (Faligant; see Figs. 2-3 and [0026] where the supply hose 28 has a swivel connection 50, with a first end of the connection being a hose-side coupler), and the second stage regulator comprises a second swivel coupler (Faligant; see Figs. 2-3 and [0026] where the second stage regulator 30 connects to the swivel connection 50, with a second end of the connection being a regulator-side coupler); the air tank is coupled to the first stage regulator by the first coupler and the second coupler (Faligant; see [0004] where the air tank and first stage regulator are coupled by some coupling mechanism); and the hose is coupled to the second stage regulator via the first swivel coupler and the second swivel coupler (Faligant; see Figs. 2-3 where the swivel connection 50 connects the hose 28 to the second stage regulator 30).
The modified Faligant device lacks a detailed description of wherein: the air tank and first stage regulator comprises a first and second threaded coupler that connect them together.
However, Merrifield teaches a similar regulator connected to a source of gas via a coupler, where the air tank and first stage regulator comprises a first and second threaded coupler that connect them together (see Fig. 3 and Col. 5 lines 21-27 where tank 70 is connected to regulator assembly 164 by a threaded connection via manifold interconnect 160, having a male and female threaded portion for the connection).
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 connection between the air tank and first stage regulator of the modified Faligant device to be a threaded connection as taught by Merrifield, as it would be a simple substitution of one type of connection between two pipe-like members for fluid flow for another connection, to yield the predictable result of connecting the first stage regulator and air tank together to create an air flow path.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Applicant argues on page 1 of the remarks that it is unclear how the modified Winefordner prior art device would operate by modifying the nosepiece of Gray in light of the teachings of Baragar as applied. To clarify, Gray teaches that there can be a nosepiece member, with a spring biasing the nosepieces together, but lacks any disclosure about separate springs for each nosepiece. Baragar then teaches where nosepieces can each have their own separate biasing spring in order to provide independent movement and adjustment from one another. In essence, the torsion spring of Gray is modified so that the bottom spring part that connects to the housing (at 27) is modified to instead connect to two internal biasing springs within the housing as taught by Baragar. Thus, each arm of the spring of Gray (the lengthwise section between the nosepieces and the bottom portion of the spring) are now independently connected to a biasing spring as taught by Baragar, for the individual control over each nosepiece.
Applicant argues on pages 11-12 of the remarks that Baragar is not particularly similar to the claimed invention, nor Winefordner, Gray, and Faligant, as it is directed to biased nosepieces for eyeglasses and not any sort of regulator/ breathing device. The argument is not well-taken. A person of ordinary skill in the art would readily recognize that there are a plurality of different well-known arts that employ nose pieces to be attached to the patient (e.g. all sorts of glasses, goggles, masks, and nose clips (e.g. for diving), in addition to regulator devices). A common problem across all these nose clips is the means by which they hold onto the nose, and allow for adjustment for a better and more comfortable fit. Hence, while Baragar is not directed to the same field of endeavor, it aims to solve a similar and well-known problem in nose piece devices, in the holding and adjustment of the nose piece on the nose.
For the reasons above, the rejections hold.
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 MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785