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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pic et al. 2020/0100986
a valve assembly for a medical device (Regulator 40), comprising:
a body (Figure 2, entire body of application device 30) having an inlet that is in fluid communication with a source of fluid (figure 6a, input opening 652, in communication with containment device 2)), and an outlet that is in fluid communication with a delivery conduit of the medical device (figure 2, outlet 34)
and a shuttle (actuator 680) configured to move within the body between a first position and a second position to control delivery of the fluid from the inlet to the outlet (Figure 6a and 6b depicts a transition that allows for fluid delivery to occur, 0163 states “Fluid may then flow between actuator 680 and protrusion 662 to second chamber 660.” From here fluid flows to outlet 34);
wherein, in the first position, the shuttle is configured to maintain the fluid received within the body at a first pressure (the fluid within the body 30 of the device is retained within flow path 48 after a first actuation, and would be at a first pressure in a stagnant state that is maintained when the shuttle is in a position as depicted in figure 6a.) and seal the outlet from the inlet, such that the delivery conduit is isolated from the fluid received from the source at the first pressure (0159 states “FIG. 6A shows regulator 40 in a configuration in which third chamber 666 is sealed, meaning that fluid may not pass through hole 664 and that third chamber 666 is not in fluid communication with second chamber 660 and output opening 654.” When this position occurs, no fluid is flowing through input 652, sealing it from outlet 34.);
and wherein, in the second position, the shuttle is configured to maintain the fluid received within the body at a second pressure (Since the fluid is now moving, the velocity changes, meaning the pressure is now at a second pressure) and fluidly couple the outlet to the inlet, such that the delivery conduit receives the fluid from the source at the second pressure (“FIG. 6B shows regulator 40 in a configuration in which third chamber 666 is not sealed (fluid may pass through hole 664 such that third chamber 666 is in fluid communication with second chamber 660 and output opening 654)” Fluid will now pass from input opening 652,through flow path 48 to outlet 34.), the second pressure being less than the first pressure (Since the velocity of the fluid increases as it begins to move, the pressure would decrease from the stagnant pressure of the fluid as it was maintained within flow path 48, due to Bernoulli’s principle.).
Regarding claim 8, Pic teaches the valve assembly of claim 1, wherein the body is in fluid communication with a regulator assembly configured to convert the fluid from the first pressure to the second pressure (0140 states “A propellant fluid pressure may further be adjusted by a membrane regulator 44 provided in series after regulator 40. The combination of regulator 40 and membrane regulator 44 may reduce the pressure of gas from containment device 20′”).
Regarding claim 9, Pic teaches the valve assembly of claim 1, wherein the shuttle includes a gasket (O-ring 760 acts as a gasket, 0167) positioned about an exterior surface of the shuttle (Figure 6a).
Regarding claim 10, Pic teaches the valve assembly of claim 9, wherein, in a first configuration of the valve assembly: the shuttle is positioned at the first position (Figure 6a); and the gasket is positioned between the inlet and the outlet to fluidly isolate the delivery conduit from the source of fluid (0167 states “ball bearing 750 may press against O-ring 760, forming a seal between ball bearing 750 and O-ring 760. When ball bearing 750 and O-ring 760 are sealed, third chamber 666 may be sealed such that fluid may not move through hole 664 into actuator chamber 684.”).
Regarding claim 11, Pic teaches the valve assembly of claim 10, wherein, in a second configuration of the valve assembly: the shuttle is positioned at the second position (Figure 6b); and the gasket is not positioned between the inlet and the outlet to fluidly couple the delivery conduit to the source of fluid (0162 states “Prong 688 may press in the first direction against ball bearing 750 such that there is a gap between ball bearing 150 and O-ring 160, and third chamber 666 is unsealed/open, so that fluid may pass through hole 664 and third chamber 666 is in fluid communication with second chamber 660 and output opening 654.”).
Regarding claim 12, Pic teaches the valve assembly of claim 9, wherein the body includes a channel configured to receive the shuttle (Figure 6a, channel within inner wall 662A), and a ledge extending radially-inward into the channel (Surface resting against flanged surface 668a); wherein the shuttle includes a flange extending radially-outward from an exterior surface of the shuttle (Flanged surface 668a).
Regarding claim 13, Pic teaches the valve assembly of claim 12, wherein the flange is configured to engage the ledge when the shuttle is in the first position relative to the channel to position the gasket between the inlet and the outlet, thereby fluidly isolating the delivery conduit from the source of fluid (Figure 6a depicts a first position where the flange is engaging a ledge).
Regarding claim 14, Pic teaches the valve assembly of claim 12, but fails to explicitly teach wherein the flange is configured to disengage the ledge when the shuttle is in the second position relative to the channel to position the gasket outside of the inlet and the outlet, thereby fluidly coupling the delivery conduit from the source of fluid. Anderson does teach wherein the flange is configured to disengage the ledge when the shuttle is in the second position relative to the channel (figure 6A depicts bushing 56 with a flange disengaging from the ledge it was on in figure 6) to position the gasket outside of the inlet and the outlet, thereby fluidly coupling the delivery conduit from the source of fluid (The seal at the bottom of bushing 56 is now positioned upwards allowing for fluid flow to occur). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pic with the teachings of Anderson and include the flange disengaging as this allows for a movement of the pierced member to occur.
Regarding claim 15, Pic teaches the valve assembly of claim 1, further comprising a biasing mechanism coupled to the shuttle (First spring 740), the biasing mechanism being configured to move the shuttle from the second position to the first position (Figure 6A to 6B).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Pic in view of Anderson et al. 2014/0020791
Regarding claim 2, Pic teaches the valve assembly of claim 1, further comprising a piercing element (Pierce pin 670) however, it fails to teach the piercing element being configured to move within the shuttle between a retracted position and an extended position to fluidly couple the inlet with the source of fluid. Anderson discloses an analogous fluid delivery device that does teach the piercing element (pierce pin 54) being configured to move within the shuttle (bushing 56) between a retracted position and an extended position to fluidly couple the inlet with the source of fluid (Depicted in figure 6 to figure 6A). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pic with the movable pierce pin as shown in Anderson as it allows for the breaking of a seal on an attached fluid containing device, that will then allow for fluid flow to take place (0003).
Regarding claim 3, Pic in view of Anderson teaches the valve assembly of claim 2, wherein the piercing element includes a needle or a lance having a sharp tip (Claim 8 of Anderson states “a pin having a first end adjacent the extensible piston and a second, sharpened end adjacent the diaphragm”).
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Pic in view of Anderson, further in view of Anderson2 et al. 2014/0124087
Regarding claim 4, Pic in view of Anderson teaches the valve assembly of claim 2, but fails to teach wherein the valve assembly is configured to receive the fluid from the source through the inlet when the shuttle is moved from the first position to the second position, and the piercing element is positioned in the retracted position; and wherein the valve assembly is configured to inhibit delivery of the fluid from the inlet to the outlet when the shuttle is moved from the second position to the first position, and the piercing element is positioned in the extended position. Anderson2 does teach wherein the valve assembly is configured to receive the fluid from the source (vial 78) through the inlet (First passageway 120) when the shuttle (body 100) is moved from the first position to the second position (In figures 2a-2c the shuttle 100 is moved to a second position from a first, figure 2c depicts the valve assembly receiving the fluid), and the piercing element is positioned in the retracted position (needle 122 is in a retracted position in line with passageway 60 in figure 2c); and wherein the valve assembly is configured to inhibit delivery of the fluid from the inlet to the outlet (In figure 2D delivery of the fluid from the inlet is inhibited as the fluid flows through passageway 60) when the shuttle is moved from the second position to the first position (Body 100 is moved back to its original position in figure 2D), and the piercing element is positioned in the extended position (needle 122 is in an extended position above passageway 60). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Pic with the teachings of Anderson2 and include wherein the valve assembly is configured to receive the fluid from the source through the inlet when the shuttle is moved from the first position to the second position, and the piercing element is positioned in the retracted position; and wherein the valve assembly is configured to inhibit delivery of the fluid from the inlet to the outlet when the shuttle is moved from the second position to the first position, and the piercing element is positioned in the extended position as this allows for a controlled delivery of fluid.
Regarding claim 5, Pic in view of Anderson and Anderson2 teaches the valve assembly of claim 4, wherein, in a first configuration of the valve assembly: the shuttle is positioned at the first position (Figure 6 of Anderson depicts bushing 6 at a first position); the piercing element is in the retracted position and separated from the source of fluid (54 is retracted, but in line with the fluid source); and the inlet is not in fluid communication with the outlet such that the fluid is maintained in the source of the fluid at the first pressure (Since at this point the fluid has not been touched it is being maintained at the first pressure).
Regarding claim 6, Pic in view of Anderson and Anderson2 teaches the valve assembly of claim 5, wherein, in a second configuration of the valve assembly: the shuttle is positioned at the second position (Figure 2b of Anderson2 depicts body 100 in a second position); the piercing element is in the retracted position and in contact with the source of fluid (needle 122 is in a retracted position in line with passageway 60); and the inlet is in fluid communication with the outlet such that the fluid is directed to the outlet at the second pressure (Fluid 86 is flowing from passageway 120 to port 20 at a second pressure due to a change in velocity.).
Regarding claim 7, Pic in view of Anderson and Anderson2 teaches the valve assembly of claim 6, wherein, in a third configuration of the valve assembly: the shuttle is positioned at the first position (Figure 2D of Anderson2 has body 100 in the first position); the piercing element is in the extended position and in contact with the source of fluid (Needle 122 is extended, and in contact with the location of the source of fluid) and the inlet is not in fluid communication with the outlet such that the fluid is maintained in the body at the first pressure and the second pressure (The inlet is not in communication with the outlet anymore as fluid 86 is now within body 18, the pressure will get maintained as it travels through passageway 60).
Allowable Subject Matter
Claims 16-20 contain allowable subject matter.
Regarding claim 16, Pic teaches a device for delivering an agent, comprising:
an enclosure configured to store an agent (Container 100, Figure 2);
a pressurized fluid source configured to store a pressurized fluid (Containment device 20);
a valve assembly (Regulator 40), including: a body (Figure 6A) having a first channel (Second chamber 660); a shuttle (actuator 680) configured to move within the first channel between a first position and a second position to fluidly couple the pressurized fluid source to the enclosure (Depicted between figures 6A and 6B), the shuttle having a second channel (Channel that makes up third chamber 666);
Anderson2 does teach a piercing element (needle 122) configured to move within the second channel (channel within body 100 containing passageway 120) between a retracted position and an extended position to fluidly couple the pressurized fluid source to the body (Depicted between figures 2A-2D);
The prior art of record fails to teach, disclose, or render obvious wherein the valve assembly is configured to selectively release the pressurized fluid received from the pressurized fluid source within the body at a first pressure when moving the shuttle to the second position and the piercing element to the retracted position, or release the pressurized fluid received from the pressurized fluid source within the body at a second pressure when moving the shuttle to the first position and the piercing element to the extended position, wherein the second pressure is less than the first pressure. This language makes it clear that the pressurized fluid itself is selectively released at different pressures depending on the positioning of the shuttle. Furthermore, the structure and movement of the piercing element and shuttle member in conjunction is specified as it describes how the movement of both together impact the movement of fluid within the body and how a certain positioning leads to the fluid being at either a first or second pressure. The reference of Anderson2 does not teach the piercing element acting In this fashion with the shuttle, furthermore, a pressure change does not happen within the shuttle of Anderson2.
Claims 17-19 are allowed based on dependency stemming from claim 16.
Claim 20 is allowed for the same reasons as claim 16.
Response to Arguments
Applicant’s arguments with respect to claim 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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