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 .
Status of Claims
As directed by the amendment filed on 05 January 2026: claim(s) 1, 5-11, and 15-16 have been amended, claims 2-4, 12-14, 17-21 have been cancelled, claims 22-25 have been added. Thus, claims 1, 5-11, 15-16, and 22-25 are presently pending.
Drawings
The replacement drawings were received on 5 January 2026. These drawings are acceptable.
Response to Arguments
Applicant's arguments filed 5 January 2026 have been fully considered but they are not persuasive.
Regarding the argument that "there is no disclosure, nor any suggestion in Collins to provide a "manually energizable pump" that will spray a dosed quantity of the liquid in a single stroke of the piston without the need of an electrical power source. Nor would a skilled person be prompted by Rentsch to configure an eye spray device with such mechanism" on pg. 11 of Remarks, Hughes is relied upon to teach the manually energizable pump. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Regarding the argument that "Rentsch is directed to an inhalation device and, hence, is not involved with an eye spray device that would avoid an eye blinking reaction" on pg. 11, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Rentsch is directed to “a portable device for administering a physiologically active liquid that includes a container for holding the liquid, pressurizing means for applying pressure to the liquid, an atomizer for atomizing the liquid, and an applicator for administering atomized liquid” (see Abstract), which is the same as Collins, Hughes, and the claimed invention. Therefore, the cited references are reasonably pertinent to the particular problem with which the inventor was concerned.
Regarding the argument that "Rentsch does not disclose the size range of the nozzle openings as recited in claims 1 and 11 of the present application" on pg. 11, Collins is relied upon to disclose the claimed limitation as discussed below.
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.
Claim(s) 1, 5-12, and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al. (US 20070119968 A1) in view of Rentsch et al. (US 20220160052 A1) and Hughes (US 20030025002 A1).
Regarding Claim 1, Collins discloses an eye spray device ("ophthalmic fluid delivery device" see Abstract) for delivering a spray of a liquid ("adapted to deliver an ophthalmic fluid in the form of a mist" see Abstract) having a density (ρ) (inherent physical property of any liquid) at a spray length (L) through air to a target ("an optimum distance" [0164]) in an eye of a user ("to an ocular region of a patient" see Abstract),
comprising a container holding said liquid ("reservoir 120" [0109]; FIG. 1), pressurizing means configured for pressurizing a quantity of said liquid to an elevated operating pressure (∆P) ("prime mover 140" [0142]; FIG. 2), and
comprising a spray nozzle member ("nozzle assembly 150" [0110]; FIG. 1) with a plurality (N) of nozzle orifices ("array of openings 1520" [0152]; FIG. 10) extending from an inlet surface to an outlet surface of a nozzle plate ("mesh plate 156" [0148]; FIG. 10), and wherein said nozzle member communicates with said pressurizing means ("mesh plate 156 is biased against the distal end 144 of the prime mover 140" [0151]; FIG. 2),
during operation, exposing said plurality of orifices 1520 at said inlet surface to said quantity of pressurized liquid at said operating pressure and releasing said spray at said outlet surface ([0216]),
wherein said nozzle orifices of said plurality of nozzle orifices are of equal size (Dnozzle) that is between a lower limit (Dmin) and an upper limit (Dmax) ([0152]-[0153]; FIGs. 12A-12D),
wherein said nozzle orifices are of equal size size (Dnozzle) of less than 10 micron ("openings 1520 preferably have diameters in the range of approximately 0.5 to 30 microns" [0152]; FIGs. 12A-12D),
wherein said pressurizing means are configured to pressurize a quantity ∆V of between 5 and 50 microliter of said liquid ("discharging approximately between 2 and 20 microliters per second" [0156]), and wherein said plurality of nozzle orifices discharge said quantity of pressurized liquid over a period of at least 500 microseconds ([0156]).
Collins fails to specify said lower limit being: Dmin ≈
1
/
10
L
λ
∆
P
/
ρ
said upper limit being: Dmax ≈
1
/
10
2
L
λ
∆
P
/
ρ
in which λ≈18 η/ρ, η = 1,8.10-5 kg/ms, representing a viscosity of air, and ρ represents said density of said liquid, wherein .
However, these limitations are not considered distinguishing feature of the claimed invention since the user’s eye, spray length L, air viscosity η, liquid density ρ, and pressure ∆P are not part of the claimed invention. Therefore, prior art does not have to explicitly disclose these limitations in order to anticipate the claimed invention. Furthermore, Collins discloses that the "number, density, size, and shape of the openings 1520 contribute to determining mist parameters such as volume, velocity, and droplet size distribution" ([0152]). Since the number, density, size, and shape of the openings 1520 are result effective variables, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Collins device to have nozzle orifices diameter within the claimed range as it only involves adjusting the dimension of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Collins as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Collins fails to explicitly disclose an operating pressure ∆P of between 5 and 15 bar. However, Rentsch teaches an applicator for administering atomized liquid (Abstract; FIG. 1) with an operating pressure ∆P of between 5 and 15 bar ("13 bar" [0035]). Therefore, it would be obvious to modify the device of Collins as taught by Rentsch “to achieve a droplet size distribution that is as monodisperse as possible” ([0008]).
Collins fails to specify said quantity of liquid is pressurized by means of a manually energizable pump having at least one manually operated piston to pressurize said quantity of liquid, and wherein said quantity of liquid ∆V is pressurized to said operating pressure ∆P in one stroke of said at least one piston. However, Hughes teaches a pressurized fluid spraying apparatus comprising a sprayer and manual piston pump (Abstract; FIG. 1) wherein the pressurizing means comprises a manually energizable pump having at least one manually operated piston to pressurize said quantity of liquid ([0050]), wherein said pump is configured to pressurize said quantity of liquid ∆V to said operating pressure ∆P in a single stroke of said at least one piston ("a single cycle of the pneumatic piston may be sufficient to charge the air sprayer for operation" [0050]). Therefore, it would be obvious to modify the device of Collins as taught by Hughes to easily and efficiently charge the sprayer for operation ([0050]).
Regarding Claim 5, Collins discloses said plurality of nozzle orifices form a cone with a spray cone angle between 5° and 25° ("mist plume diverging with a solid angle of approximately 10-20 degrees" [0156]; FIG. 4).
Regarding Claims 6 and 15, Collins fails to explicitly disclose said spray nozzle member is configured to provide a force of spray impact FSI= ρ.∆V.vL/∆T that is less than 1x10-3 kgm/s2, wherein vL represents an impact velocity at spray length L. However, Collins discloses that the spray impact force is a result effective variable in that "velocity and mass (perhaps in terms of particle size) of the mist contributes to the blink reflex" ([0338]-[0339]) & the "number, density, size, and shape of the openings 1520 contribute to determining mist parameters such as volume, velocity, and droplet size distribution" ([0152]). One of ordinary skill in the art would have had a reasonable expectation of success in modifying the Collins device to have the force of spray impact within the claimed range as it only involves adjusting the physical property of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Collins as a matter of routine optimization to possess the claimed properties since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claims 7 & 16, Collins discloses said spray nozzle member is configured to have a discharge rate less than 50 ul/sec ("discharging approximately between 2 and 20 microliters per second" [0156]), while the spray length (L) is between 5 and 10 cm ("extends about 7.5 to 10 cm" [0156]).
Regarding Claim 8, Collins discloses said orifices have a diameter of between 3 and 6 micron ("openings 1520 preferably have diameters in the range of approximately 0.5 to 30 microns" [0152]), and in that, adjacent said orifices, a thickness of said nozzle plate is smaller than three times a diameter of said orifices ("28 microns" [0270]).
Regarding Claim 9, Collins discloses a first object is provided at a first distance from said outlet surface, wherein a second object is provided at a second distance from said outlet surface, said second distance being larger than said first distance, and in that a second image matches a first image in a common focal plane of the eye of a user when said outlet surface is at said spray length (L) spaced apart from said eye ([0164]-[0167]; FIG. 16).
Regarding Claim 10, Collins discloses an electro-acoustical transducer device ("piezoelectric transducer" [0108]) is provided in a vicinity of said outlet surface ([0313]-[0314]; FIG. 30) that is configured to generate, when energized, a longitudinal soundwave propagating in a direction crossing a propagation direction of said liquid spray and to expose said liquid spray to the longitudinal soundwave ([0339]-[0342]).
Regarding Claim 11, Collins discloses a method for delivering a spray of a liquid ("ophthalmic fluid delivery device" see Abstract) having a density (ρ) through air to a target at a distance (L) ("an optimum distance" [0164]) to an eye of a user ("to an ocular region of a patient" see Abstract), comprising:
- providing a quantity of said liquid having said density (ρ) ([0216]);
- pressurizing said quantity of said liquid to an elevated operating pressure (∆P) ([0216]), and
- forcing said liquid at said elevated pressure (∆P) through a plurality (N) nozzle orifices ([0216]),
- characterized in that nozzle orifices of said plurality (N) of nozzle orifices are of equal size (Dnozzle) that is between a lower limit (Dmin) and an upper limit (Dmax) ([0152]-[0153]; FIGs. 12A-12D),
Collins fails to specify said lower limit being: Dmin ≈
1
/
10
L
λ
∆
P
/
ρ
said upper limit being: Dmax ≈
1
/
10
2
L
λ
∆
P
/
ρ
in which λ≈18 η/ρ, η = 1,8.10-5 kg/ms, representing the viscosity of air, and ρ represents said density of said liquid.
However, these limitations are not considered distinguishing feature of the claimed invention since the user’s eye, spray length L, air viscosity η, liquid density ρ, and pressure ∆P are not part of the claimed invention. Therefore, prior art does not have to explicitly disclose these limitations in order to anticipate the claimed invention. Furthermore, Collins discloses that the "number, density, size, and shape of the openings 1520 contribute to determining mist parameters such as volume, velocity, and droplet size distribution" ([0152]). Since the number, density, size, and shape of the openings 1520 are result effective variables, one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Collins device to have nozzle orifices diameter within the claimed range as it only involves adjusting the dimension of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Collins as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Collins fails to explicitly disclose an operating pressure ∆P of between 5 and 15 bar. However, Rentsch teaches an applicator for administering atomized liquid (Abstract; FIG. 1) with an operating pressure ∆P of between 5 and 15 bar ("13 bar" [0035]). Therefore, it would be obvious to modify the device of Collins as taught by Rentsch “to achieve a droplet size distribution that is as monodisperse as possible” ([0008]).
Collins fails to specify said quantity of liquid is pressurized by means of a manually energizable pump having at least one manually operated piston to pressurize said quantity of liquid, and wherein said quantity of liquid ∆V is pressurized to said operating pressure ∆P in one stroke of said at least one piston. However, Hughes teaches a pressurized fluid spraying apparatus comprising a sprayer and manual piston pump (Abstract; FIG. 1) wherein the pressurizing means comprises a manually energizable pump having at least one manually operated piston to pressurize said quantity of liquid ([0050]), wherein said pump is configured to pressurize said quantity of liquid ∆V to said operating pressure ∆P in a single stroke of said at least one piston ("a single cycle of the pneumatic piston may be sufficient to charge the air sprayer for operation" [0050]). Therefore, it would be obvious to modify the device of Collins as taught by Hughes to easily and efficiently charge the sprayer for operation ([0050]).
Regarding Claims 22 & 23, Collins fails to explicitly disclose said spray nozzle member is operated at/configured to provide a Force of Spray Impact FSI= ρ.∆V.vL/∆T that is less than 2x10-4 kg.m/s2, wherein vL represents an impact velocity at spray length L. However, Collins discloses that the spray impact force is a result effective variable in that "velocity and mass (perhaps in terms of particle size) of the mist contributes to the blink reflex" ([0338]-[0339]) & the "number, density, size, and shape of the openings 1520 contribute to determining mist parameters such as volume, velocity, and droplet size distribution" ([0152]). One of ordinary skill in the art would have had a reasonable expectation of success in modifying the Collins device to have the force of spray impact within the claimed range as it only involves adjusting the physical property of a disclosed component. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Collins as a matter of routine optimization to possess the claimed properties since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 24, Collins discloses said orifices have a diameter of between 3.5 and 5 micron ("openings 1520 preferably have diameters in the range of approximately 0.5 to 30 microns" [0152]).
Regarding Claim 25, Collins discloses the thickness of said nozzle plate is smaller than a diameter of said orifices ("plate having a thickness of approximately 28 microns" would be smaller than a diameter of 30 microns [0152] & [0270]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781