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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-6, 8-12, 14,-15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Py US 5,613,957 A (hereinafter Py), as cited in the IDS.
Regarding claim 1, Py discloses a nozzle 20 (Fig. 1 – nozzle 20) for a fluid delivery device 10 (Fig. 1 – apparatus 10), the nozzle 20 (Fig. 1) comprising:
a nozzle head 12 (Fig. 1 – outer body 12) defining an inner head chamber 38 (Fig. 1 – drop cavity 38) for a fluid (Col. 3, line 59-61 – “The drop cavity 38 is preferably dimensioned to hold less than 30 microliters of medicament”), the nozzle head 12 (Fig. 1) having at least one nozzle opening 25 (Fig. 1-2 – interface 25) through which fluid is configured to be selectively delivered from the head chamber 38 (Fig. 1) to a target site during use of the device 10 (Fig. 1 and Col. 3, line 9-23 – “The interface 25 is normally closed, but is opened when medicament of sufficient pressure is forced into the interface to release the medicament through the nozzle 20… Thus, the outer nozzle portion 22 can be flexed relative to the inner nozzle portion 24 to permit the passage of medicament through the interface 25 and out of the nozzle 20”, and Col. 3, line 56-59 – “a drop cavity 38… which is adapted to hold a predetermined volume of medicament for release through the nozzle 20 into the eye”), the nozzle head 12 (Fig. 1) being at least partially formed from a deformable material (Col. 3, line 18-22- “The outer body 12 is preferably molded from a relatively flexible plastic material in comparison to the inner body 14. Thus, the outer nozzle portion 22 can be flexed relative to the inner nozzle portion 24 to permit the passage of medicament”), the nozzle head 12 (Fig. 1) being selectively deflectable between an opened condition (Col. 3, line 16 – “…is opened…”) in which the at least one nozzle opening 25 (Fig. 1) is at least partially open to permit fluid flow therethrough Col. 3, line 15-17 – “The interface 25 is normally closed, but is opened when medicament of sufficient pressure is forced into the interface release the medicament through the nozzle 20 “) and a closed condition in which the at least one nozzle opening 25 (Fig. 1) is at least partially closed (Col. 3, line 15 – “The interface 25 is normally closed”) to restrict fluid flow therethrough (Col. 4, line 17-22 – “Then, once the medicament in the drop cavity 38 is released, the interface 25 returns to its normally closed state (i.e., the inner nozzle portion 24 is maintained in contact with the outer nozzle portion 22) to prevent air or foreign particles from passing through the nozzle and contaminating the remaining medicament within the apparatus”).
Regarding claim 2, Py suggests the invention of claim 1. Py further discloses wherein the nozzle head 12 (Fig. 1) is at least partially formed from a deformable and elastomeric material (Col. 3, line 18-22- “The outer body 12 is preferably molded from a relatively flexible plastic material).
Regarding claim 3, Py suggests the invention of claim 1. Py further discloses wherein the nozzle head 12 (Fig. 1) includes a first head end 32 (Fig. 1 – flange 32), a second head end (see annotated Fig. 1 below), and a head body 22+30 (Fig. 1 – outer nozzle portion 22 and bellows 30) separating and extending longitudinally between the first 32 (Fig. 1) and second head ends (see annotated Fig. 1 below), a portion of the head body 22+30 (Fig. 1) defining a bellows 30 (Fig. 1) configured to be selectively compressed to urge the fluid through the at least one nozzle opening 25 (Fig. 1, Col. 3, line 47-51 – “The bellows 30 is adapted to flex inwardly to permit the piston body 16 and piston 18 to move relative to the outer and inner bodies 12 and 14, respectively, as indicated by the arrows in FIG. 1, to release medicament from the medicament chamber 33 through the nozzle 20”).
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Annotated Fig. 1 of Py
Regarding claim 4, Py suggests the invention of claim 1. Py further discloses wherein, as the nozzle head 12 (Fig. 1) transitions from the opened condition to the closed condition (Fig. 1, and Col. 4, second paragraph), the nozzle head 12 (Fig. 1) becomes at least partially longitudinally compressed (Col. 4, second paragraph, and Col. 4, line 53-55 – after medicament is urged out of the interface 25 upon compression of the bellows, the coil spring 52 drives the piston/bellows back to the normal position, thus the bellows is partially compressed) and the at least one nozzle opening 25 (Fig. 1) is at least partially closed (Col. 4, second paragraph -– once medicament is urged out of the interface 25 upon compression of the bellows, the interface 25 returns to is normally closed state).
Regarding claim 5, Py suggests the invention of claim 1. Py further discloses wherein as the nozzle head 12 (Fig. 1) transitions from the closed condition to the opened condition (Col. 4, second paragraph, Fig. 1 shows the bellows is in approximately the middle of its stroke from a closed position to an opening position of the nozzle head), the nozzle head 12 (Fig. 1) at least partially longitudinally expands to (Col. 4, second paragraph – “the pressurized medicament opens the interface 25 by causing the outer nozzle portion 22 to flex relative to the inner nozzle portion 24 to release the medicament into the eye“) and open the at least one nozzle opening 25 (Fig. 1) at least partially opens (Col. 4, second paragraph – “the pressurized medicament opens the interface 25…”).
Regarding claim 6, Py suggests the invention of claim 1. Py further discloses further comprising a shielding wall (Fig. 1 – phantom lines) encircling at least a portion of the nozzle head 12 (Fig. 1, and Col. 4, line 48-50 – “The outer body 12 is seated against a surface of the ocular treatment apparatus, as indicated in phantom lines in FIG. 1, in order to be maintained in a stationary position”).
Regarding claim 8, Py suggests the invention of claim 6. Py further discloses wherein a moisture chamber (see annotated Fig. 1 above) is defined between an outer surface of the nozzle head 12 (Fig. 1) and an interior surface of the shielding wall (Fig. 1 – perimeter of phantom lines) when the nozzle head 12 (Fig. 1) is in the closed condition (Fig. 1 – when interface 25 is closed).
Regarding claim 9, Py suggests the invention of claim 8. Py further discloses wherein the nozzle head 12 (Fig. 1) includes a first head end 32 (Fig. 1 – flange 32), a second head end (see annotated Fig. 1 above), and a head body 22+30 (Fig. 1 – outer nozzle portion 22 and bellows 30) separating and extending longitudinally between the first 32 (Fig. 1) and second head ends (see annotated Fig. 1 above), the at least one nozzle opening 25 (Fig. 1) being adjacent the second head end (see annotated Fig. 1 above), the nozzle 20 (Fig. 1) further comprising a closure plate 24 (Fig. 1 – inner nozzle portion 24) connected to the second head end (see annotated Fig. 1 above), the closure plate 24 (Fig. 1) engaging the shielding wall (Fig. 1 – phantom lines) when the nozzle head 12 (Fig. 1) is in the closed condition (Fig. 1 – when the interface 25 is closed) to at least partially define the moisture chamber (see annotated Fig. 1 above – the inner nozzle portion 24 in combination with the annotated moisture chamber plug the medication from being exposed to the environment), the closure plate 24 (Fig. 1) being spaced longitudinally from the shielding wall (see annotated Fig. 1 above) when the nozzle head 12 (Fig. 1) is in the opened condition (Fig. 1 – when interface 25 is open, inner nozzle portion 24 is some distance away from the phantom lines).
Regarding claim 10, Py suggests the invention of claim 1. Py further discloses further comprising an adapter 16 (Fig. 1 – piston body 16) for selectively securing the nozzle 20 (Fig. 1) to a fluid-holding container 48 (Fig. 1 – medicament container 48), the adapter 16 (Fig. 1) being connected to the nozzle head 12 (Fig. 1 – piston body 16 is connected to the outer body 12 via the rim 40 and inner body 14).
Regarding claim 11, Py suggests the invention of claim 10. Py further discloses wherein the nozzle head 12 (Fig. 1) includes a first head end 32 (Fig. 1 – flange 32) connected to the adapter 16 (Fig. 1, and Col. 3, line 44-46 – “The piston body 16 includes a lobe 34 which is snapped into a corresponding recess in the flange 32”), a second head end (see annotated Fig. 1 above), and a head body 22+30 (Fig. 1 – outer nozzle portion 22 and bellows 30) separating and extending longitudinally between the first 32 (Fig. 1) and second head ends (see annotated Fig. 1 above), the at least one nozzle opening 25 (Fig. 1) being adjacent the second head end (see annotated Fig. 1 above).
Regarding claim 12, Py suggests the invention of claim 11. Py further discloses further comprising:
a shielding wall (Fig. 1 – phantom lines) longitudinally extending from the adapter 16 (Fig. 1, and Col. 4, line 36-38 – “The apparatus 10 is preferably mounted within an ocular treatment apparatus substantially the same as the apparatus shown and described in U.S. Pat. No. 4,981,479”, thus the perimeter of the phantom lines extends along the longitudinal length of the device 10) and encircling at least a portion of the nozzle head 12 (Fig. 1, and Col. 4, line 48-50 – “The outer body 12 is seated against a surface of the ocular treatment apparatus, as indicated in phantom lines in FIG. 1, in order to be maintained in a stationary position”); and
a closure plate 24 (Fig. 1 – inner nozzle portion 24) connected to the second head end (see annotated Fig. 1 above), the closure plate 24 (Fig. 1) engaging the shielding wall (Fig. 1 – phantom lines) when the nozzle head 12 (Fig. 1) is in the closed condition (Fig. 1 – when the interface 25 is closed) so that the adapter 16 (Fig. 1), shielding wall (Fig. 1 – phantom lines), and closure plate 24 (Fig. 1) collectively define a moisture chamber (see annotated Fig. 1 above – the inner nozzle portion 24 in combination with the annotated moisture chamber plug the medication from being exposed to the environment), the closure plate 24 (Fig. 1) being spaced longitudinally from the shielding wall (see annotated Fig. 1 above) when the nozzle head 12 (Fig. 1) is in the opened condition (Fig. 1 – when interface 25 is open, inner nozzle portion 24 is some distance away from the phantom lines).
Regarding claim 14, Py suggests the invention of claim 1. Py further discloses wherein the fluid is a therapeutic ophthalmic fluid and the target site is a user's eye (Abstract – “apply medicament to an eye”).
Regarding claim 15, Py suggests the invention of claim 1. Py further discloses a fluid delivery device 10 (Fig. 1 – apparatus 10) for delivering fluid to an eye of a user (Col. 1, line 36-37 – “The present invention is directed to an apparatus for applying medicament to an eye”), comprising:
a cartridge 48 (Fig. 1) including a container 48 (Fig. 1 – medicament container 48) and the nozzle 20 (Fig. 1) of claim 1 (See rejection of claim 1 above) coupled to the container 48 (Fig. 1), the container 48 (Fig. 1) having an inner container chamber (Fig. 1 – the space within container 48) configured to accommodate a fluid (Col. 4, line 32-33 – “Medicament… from the container 48”), the head chamber 38 (Fig. 1) being in fluid communication with the container chamber (Fig. 1 – the space within container 48) such that the fluid selectively flows from the container chamber (Fig. 1) to the head chamber 38 (Fig. 1, and Col. 4, line 33-35 – “Medicament is therefore permitted to flow from the container 48… into the drop cavity 38 for release into the eye”); and
an applicator 16 (Fig. 1 – piston body 16) configured to accommodate the cartridge 48 (Fig. 1, and Col. 4, line 30-32 – “The piston body 16 includes several apertures 50 extending through its top wall to couple the container 48 in fluid communication with the medicament”), the applicator 16 (Fig. 1) including an actuator 18 (Fig. 1 – piston 18) for selectively manipulating the nozzle head 12 (Fig. 1) between the opened condition and the closed condition (Col. 4, second paragraph discusses the up position, down position, and middle position of the piston 18 which corresponds to the open and closed state of the interface 25 of the nozzle head 12).
Regarding claim 17, Py suggests the invention of claim 15. Py further discloses wherein actuator 18 (Fig. 1) compresses the nozzle head 12 (Fig. 1) toward the closed condition to cause the fluid to eject from the holding chamber 38 (Fig. 1) via the at least one nozzle opening 25 (Fig. 1, and Col. 4, line 11-13 – “Then, on the downward stroke of the piston 18 (i.e., toward the nozzle 20), the medicament in the drop cavity 38 is forced through the channel 44 and into the interface 25”), the at least one nozzle opening 25 (Fig. 1) at least partially closing as the nozzle head 12 (Fig. 1) is compressed (Col. 4, line 11-13 discusses the downstroke of piston 18 when the interface 25 has not been fully pressurized to open yet).
Regarding claim 18, Py suggests the invention of claim 15. Py further discloses wherein upon actuation of the application, the actuator 18 (Fig. 1):
moves to a loaded position, the nozzle head 12 (Fig. 1) decompressing to the opened condition (Col. 5, line 2-6 – “The pressurized medicament flowing through the channel 44 opens the interface 25 by forcing the flexible outer nozzle portion 22 away from the inner nozzle portion 24 to open the nozzle and release the medicament”) as the actuator 18 (Fig. 1) moves to the loaded position (Col. 5, line 2-6 – the outer nozzle portion 22 of nozzle head 12 expands as the piston is in the downstroke position); and subsequently
moves from the loaded position to a striking position, the nozzle head 12 (Fig. 1) compressing to the closed condition (Col. 5, line 6-9 – “Then, once the medicament is released, the outer nozzle portion 22 returns to its normal position in contact with the inner nozzle portion 24 so as to close the interface 25”) as the actuator 18 (Fig. 1) moves to the striking position (Col. 5, line 6-9 – outer nozzle portion 22 of nozzle head 12 shrinks as the piston 18 is in an up position), the fluid from the head chamber 38 (Fig. 1) being ejected from the head chamber 38 (Fig. 1) as the nozzle head 12 (Fig. 1) compresses (Col. 4, line 58-61 – “when the piston body 16 is located in the up position, medicament is permitted to flow from the medicament chamber 33, through the slots 46, and into the drop cavity 38 to fill the drop cavity”).
Regarding claim 19, Py suggests the invention of claim 15. Py further discloses a method of delivering fluid to a user's eye (Col. 1, line 36-37 – “for applying medicament to an eye”), the method comprising:
providing the fluid delivery device 10 (Fig. 1) of claim 15 (See rejection of claim 15 above);
inserting the cartridge into the applicator 16 (Fig. 1, and Col. 4, line 23-25 – “a medicament container 48 coupled on one end to the piston body 16 for holding medicament”);
aligning an applicator opening 46 (Fig. 1 – slots 46) of the applicator 16 (Fig. 1) with the user's eye (Col. 4, second paragraph – “medicament is permitted to flow… through the slots 46 and into the drop cavity 38… the medicament in the drop cavity 38 is forced… into the interface 25… to release the medicament into the eye”);
activating the actuator 18 (Fig. 1) to manipulate the nozzle head 12 (Fig. 1) from the opened condition to the closed condition (Col. 4, second paragraph, and Col. 4, last paragraph and Col. 5, first paragraph); and
delivering fluid from the head chamber 38 (Fig. 1, and Col. 4, second paragraph), through the nozzle 12 (Fig. 1) and applicator openings 46 (Fig. 1, and Col. 4, second paragraph), and to the user's eye as the nozzle head is manipulated from the opened condition to the closed condition (Col. 4, second paragraph, and Col. 4, last paragraph and Col. 5, first paragraph).
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 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 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Py in view of Fyfe et al. US 2023/0271207 A1 (hereinafter Fyfe).
Regarding claim 7, Py suggests the invention of claim 6. Py further discloses wherein the shielding wall (Fig. 1 – phantom lines) being at least partially longitudinally offset from the at least one nozzle opening 25 (Fig. 1 – the outer surface of the ocular treatment apparatus, which is represented by the phantom lines, is longitudinally offset from the interface 25) when the nozzle head 12 (Fig. 1) is in the opened condition (Fig. 1).
However, Py does not currently disclose wherein a portion of the shielding wall is at least partially longitudinally aligned with the at least one nozzle opening when the nozzle head is in the closed condition.
Fyfe, in the same field of endeavor of dispenser and distributor nozzle (Abstract), teaches wherein a portion of the shielding wall 160 (Fig. 1 – outer nozzle 160) is at least partially longitudinally aligned with the at least one nozzle opening 142 (Fig. 4 – slits 142) when the nozzle head 140 (Fig. 4 – distributer nozzle 140) is in the closed condition (Par. 18 – “In operation, the actuator can be actuated, such as by a user's hand or finger, to place the dispensing system into an active state. In some embodiments, the actuator is twisted clockwise to place the dispensing system into an active state. In some embodiments, when the actuator is twisted in a direction, such as clockwise, the outer nozzle 160 lifts to uncover the hole at the tip of the outer nozzle 160”, which indicates that in an “inactive” state, the shielding wall/outer nozzle 160 aligns and covers the slits 142).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Py to have the shielding wall partially longitudinally aligned with the one nozzle opening as taught by Fyfe, in order to allow the formula to distribute inside the nozzle (Par. 35 of Fyfe) so that it can be urged out of the openings once the nozzle head is in an activate state (Par. 35 of Fyfe).
Regarding claim 13, Py suggests the invention of claim 1. However, Py does not currently disclose wherein the at least one nozzle opening comprises a plurality of nozzle openings.
Fyfe, in the same field of endeavor of dispenser and distributor nozzle (Abstract), teaches wherein the at least one nozzle opening 142 (Fig. 4) comprises a plurality of nozzle openings (Fig. 4 – one or more slits 142).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the nozzle opening of Py to further include a plurality of nozzle openings as taught by Fyfe, in order to dispense formula (Par. 35 of Fyfe).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Py in view of Stowe US 2020/0360180 A1 (hereinafter Stowe).
Regarding claim 16, Py suggests the invention of claim 15. However, Py does not currently disclose wherein the fluid delivery device is a non-gravitational fluid delivery device.
Stowe, in the same field of endeavor of fluid delivery device of ophthalmic application (Title), teaches wherein the fluid delivery device is a non-gravitational fluid delivery device (Par. 3 – “The device allows for the non-gravitational delivery of viscous ophthalmic drugs to the eye using one or more micro-streams”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Py to be a non-gravitational fluid delivery device as taught by Stowe, in order to helps the user efficiently guide eye drops effectively into their eyes without blink interference (Par. 10 of Stowe).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Malviya et al. US 20250099683 A1
Ivri US 20210322210 A1
Py US 5875931 A
Lontrade et al. US 5310085 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781