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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/2025 has been entered.
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.
Claims 1-3, 5-6, 9-10, 12-14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKinnon et al. (US 5383851 A).
Regarding claim 1, McKinnon discloses a device (needleless injection device 520, Fig 16) for delivering pressurized fluid (abstract), the device comprising: a handle (housing 524, Fig 17) having a lumen (cavity of housing 524, Fig 16-17) configured to receive a container (cartridge 530, Fig 16) of pressurized fluid (CO2; Col 19, lines 40-45); a cap (cartridge holder 528, Fig 16) configured to close the lumen (cavity of housing 524, Fig 16-17); and an indicator (indicator assembly 540, Fig 16-17) coupled to a post (screw 532 shaft, Fig 16) (shaft of screw knob 532, Fig 16) (indicator 540 comprises pin 588 which moves radially inward and outward depending on the gas pressure from cartridge 530 that is axially movable due to screw 532 in threaded coupling to cap 528; therefore there is a coupling between the shaft of screw knob 532 and pin 588 comprised of the previously mentioned intervening structures, See Fig 7; please note the term couple includes indirect connection by intervening elements), the post is coupled to the cap (528) (cap 528 is coupled to shaft of screw knob 532 by a physical threading connection, Fig 16), the indicator (540) configured to move from a first position (Flush to surface 526, Fig 18) to a second position (protruded from surface 526, Fig 17), wherein the first position (Flush to surface 526, Fig 18) indicates disconnection of the container from a fluid path (path provided for gas flow from that causes movement of indicator pin 588; Col 19, lines 50-57; during the first position the cartridge 530 is disconnected, located at an axial distance from the piercing ring and is not pierced) and the second position (protruded, Fig 17) indicates connection of the container (530) to the fluid path (Col 17, lines 9-19; Fig 17-18; in the second position the cartridge 530 is axially displaced by screw 532 and pierced by the piercing body assembly 538 connecting the container to the path, compress gas flows to the path and push the indicator pin 588 towards the second position, protruding from the bridge 526 as seen in Fig 17).
Regarding claim 2, McKinnon discloses the device according to claim 1, further comprising the container (530), wherein the lumen (cavity of housing 524, Fig 16-17) is outside the fluid path (path provided for gas flow, Fig 17) (Fluid path follow the lumen of the internal components of device 520 as disclosed in Col 19, lines 50-57).
Regarding claim 3, McKinnon discloses the device according to claim 2, further comprising: a pierce pin (piercing body assembly 538, Fig 17) within the handle (524) that is configured to pierce a seal of the container (cartridge seal, Fig 17; (Col 19, lines 47-49).
Regarding claim 5, McKinnon discloses the device according to claim 1, wherein the indicator (540) is connected to the cap (528) via the post (screw 532 shaft, Fig 16), the post including an elongate member (shaft of screw 532 is an elongated member) that is radially offset (1003, Annotated Fig 1) from a longitudinal axis (1000 Annotated, Fig 1) of the handle (524).
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Regarding claim 6, McKinnon discloses the device according to claim 1 wherein the indicator (540) includes an annular (1004, Annotated Fig 2) member that is coupled to the post (screw 532 shaft, Fig 16), and wherein the indicator (540) is configured to move relative to the handle (524) and the container (530) as the indicator (540) moves between the first position (Flush to surface 526, Fig 18) and the second position (protruded from surface 526, Fig 17).
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Regarding claim 9, McKinnon discloses the device according to claim 1, wherein the indicator (540) includes one or more springs (compression spring 590, Fig 18) configured to bias the indicator (540) in the first position (Flush to surface 526, Fig 18) (Col 17, lines 9-11).
Regarding claim 10, McKinnon discloses the device according to claim 9, wherein the pressurized fluid (gas: CO2) is configured to overcome a spring force (bias exerting force) of the one or more springs (590) to move the indicator (540) from the first position (Flush to surface 526, Fig 18) to the second position (protruded from surface 526, Fig 17) (Col 19, lines 61-65).
Regarding claim 12, McKinnon discloses the device according to claim 1, wherein the indicator (540) includes a projection (indicator pin 588) configured to move in a direction radially outward of the handle (524) when the pressurized fluid (CO2) flows through the fluid path (path provided for gas flow, Fig 17) (Col 17, lines 9-19; radial displacement from position first position, flush to surface 526, to the second position, protruded from 526).
Regarding claim 13, McKinnon discloses the device according to claim 12, wherein the indicator (540) is configured to move from the second position (protruded from surface 526, Fig 17)to a third position (position after consumption of gas from previous use), the third position being between the first position (Flush to surface 526, Fig 18) and the second position (protruded from surface 526, Fig 17) to operate the device (520) (Col 17, lines 9-19: (588 protrudes but in between position flush to surface 526, Fig 18 and protruded from surface 526, Fig 17), representative of reduction of gas: CO2 in the container 530, this condition could be considered a subset of position 2 indicative of some use but still enough pressure for an injection)
Regarding claim 14, McKinnon discloses the device according to claim 1, wherein the device further includes an actuator (trigger 544, Fig 17) configured to release the fluid from a downstream end of the device (Col 20, lines 63-68), and wherein the actuator (544) is configured to be actuatable only when the indicator (540) is in the second position (device will actuate if there is sufficient gas pressure for an injection representative of protrusion of indicator pin 588).
Regarding claim 15, McKinnon discloses the device according to claim 1, wherein the indicator (540) is configured to indicate the pressurized fluid (CO2) is flowing from the container (530) at a rate sufficient to operate the device (520) when the indicator (540) is in the second position (protruded from surface 526, Fig 17) (Col 19, lines 61-65).
Regarding claim 20, McKinnon discloses a method for delivering pressurized fluid (gas: CO2) to a device (520, Fig 16), the method comprising: inserting a container (cartridge 530) of pressurized fluid (CO2) into a handle (housing 524) of the device (520), wherein the container (530) is held within the handle (524) by a cap (528) (cartridge 530 is held partially within the handle by cartridge holder 528; Col 19, lines 40-50, see Fig 17); moving an indicator (indicator assembly 540, Fig 16) from a first position (Flush to surface 526, Fig 18) to a second position (protruded from surface 526, Fig 17), wherein the indicator (540) is coupled to a post (shaft of screw knob 532, Fig 16) (indicator 540 comprises pin 588 which moves radially inward and outward depending on the gas pressure from cartridge 530 that is axially movable due to screw 532 in threaded coupling to cap 528; therefore there is a coupling between the shaft of screw knob 532 and pin 588 comprised of the previously mentioned intervening structures, See Fig 7; please note the term couple includes indirect connection by intervening elements) and the post (shaft of screw knob 532, Fig 16) is coupled to the cap (528) (cap 528 is coupled to shaft of screw knob 532 by a physical threading connection, Fig 16 ), wherein the first position (Flush to surface 526, Fig 18) indicates disconnection of the container (530) from a fluid path (path provided for gas flow, Fig 17 ;Col 19, lines 50-57) of the device (520), and the second position (protruded from surface 526, Fig 17) indicates connection of the container (530) to the fluid path (path provided for gas flow, Fig 17) of the device (520); and actuating the device (520) when the indicator (540) is in the second position (protruded from surface 526, Fig 17) (Col 17, lines 9-19; Fig 17-18).
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 4, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable by McKinnon et al. (US 5383851 A) over Holakovsky et al. (US 20130056888 A1).
Regarding claim 4, McKinnon discloses the device according to claim 1. However, McKinnon is silent wherein the indicator includes one or more markings configured to indicate when the container is in the second position, wherein the one or more markings are visible to a user when the container is in the second position and not visible to the user when the container is in the first position.
Holakovsky teaches a device (nebulizer 1, Fig 8) comprising a window (window 49, Fig 6), a container (container 3, Fig 10); an indicator (guidance device 48, Fig 8; [0126]-[0127]) wherein the indicator (48) includes one or more markings (symbols 53, Fig 11) configured to indicate when the container (3) is in the second position (connected), wherein the one or more markings (53) are visible to a user when the container (3) is in the second position (connected) and not visible to the user when the container is in the first position (not connected) ([0164]: “symbol 53, in particular an arrow pointing upwards, indicating that a new container 3 is connected”).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to mark the protruding section of the indicator pin of McKinnon with a symbol similar to the ones disclosed by Holakovsky to provide visual indication to the user that the container is in the second position (connected to the path) to deliver an injection and not be visible to the user when the container is in the first position ([0164]).
Regarding claim 7, McKinnon discloses the device according to claim 6. However, McKinnon is silent wherein an opening in the annular member accommodates the container.
Holakovsky teaches a device (nebulizer 1, Fig 8) comprising a window (window 49, Fig 6), a container (container 3, Fig 10); an indicator (guidance device 48, Fig 8; [0126]-[0127]) wherein the indicator (48) is connected to the cap (lower housing part 18, Fig 10) via a post (counter device 23, Fig 10) the post (23) including an elongate member (shaft 42 of counter device 23, Fig 10) wherein the elongate member (42) is radially offset from a longitudinal axis of the handle (Fig 10; [0116]); wherein the indicator (48) includes an annular member (member 50, Fig 12; [0126]) that is coupled to the post (23) (Fig 8) and wherein the indicator (48) is configured to move relative to the handle (16) and the container (3) as the indicator (48) moves between a first position (before rotation; [0150]) and a second position (after rotation; [0150]).
Holakovsky further teaches wherein an opening (internal space of member 50, Fig 12) in the annular member (50) accommodates the container (3).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of McKinnon to incorporate a similar indicator and associated structural elements as taught by Holakovsky to have visual feedback of the status of the device and accommodate the container and other internal components of the device; the incorporation of these elements would provide the user with additional means for detecting the connection of container to the device ([0150])
Regarding claim 8, McKinnon discloses the device according to claim 1. However, McKinnon is silent wherein a diameter of the indicator is greater than an outer diameter of the container and less than an inner diameter of the handle.
Holakovsky teaches a device (nebulizer 1, Fig 8) wherein a diameter of the indicator is greater than an outer diameter of the container and less than an inner diameter of the handle (Fig 8: ID of handle (16) < Diameter of indicator (48) < OD of container (3))
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the device of McKinnon to incorporate a similar indicator and associated structural elements as taught by Holakovsky, to have visual feedback of the status of the device and accommodate the container and other internal components of the device; the incorporation of these elements would provide the user with additional means for detecting the connection of container to the device ([0150])
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable by McKinnon et al. (US 5383851 A) over Verlaak et al. (US 20190366002 A1).
Regarding claim 11, McKinnon discloses, the device according to claim 1. However, McKinnon is silent wherein the indicator includes a movable member configured to rotate about an axis within a housing based on a pressure of the pressurized fluid flowing into the device from the container.
Verlaak teaches a device (medicament delivery device 10, Fig 2) wherein an indicator (indicator member 23) includes a movable member (rotation member 22, Fig 3B) configured to rotate about an axis (axis of rotation member 22) within a housing (housing 11, Fig 2) based on a pressure of the pressurized fluid flowing into the device from the container (pressurized gas cartridge 14, Fig 2). ([0048]- [0049])
Therefore, it would have been obvious for one of ordinary skill in the art before the effective
filing date of the claim invention to modify the indicator assembly of McKinnon with a similar indicator system as the one taught by Verlaak to detect gas flow ([0049]).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have 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.
In regard to claim 1, applicant submits that McKinnon fails to teach or suggest an indicator coupled to a post, and the post being coupled to a cap. Examiner respectfully disagrees. The claim limitation also includes indirect coupling through intervening elements. McKinnon discloses a structural and functional coupling between the indicator and the post and between the post and the cap. See below the relevant portion of claim 1 rejection for reference:
(…) an indicator (indicator assembly 540, Fig 16-17) coupled to a post (screw 532 shaft, Fig 16) (shaft of screw knob 532, Fig 16) (indicator 540 comprises pin 588 which moves radially inward and outward depending on the gas pressure from cartridge 530 that is axially movable due to screw 532 in threaded coupling to cap 528; therefore there is a coupling between the shaft of screw knob 532 and pin 588 comprised of the previously mentioned intervening structures, See Fig 7; please note the term couple includes indirect connection by intervening elements), the post is coupled to the cap (528) (cap 528 is coupled to shaft of screw knob 532 by a physical threading connection, Fig 16) (…)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/Primary Examiner, Art Unit 3783