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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/01/2026 has been entered.
Status of the Claims
The claim filed 04/22/2026 has been entered. Claims 1-13, 15 and 17-22 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/01/2026 was filed after the mailing date of the Notice of Allowance on 06/30/2026. The submission 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 § 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.
Claims 1-3, 10-12, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 20180116871 A1) in view of an alternate embodiment of Hunter ([0056] and [0072]).
Regarding claim 1, Hunter substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
A non-gravitational fluid delivery device for delivering fluid to an eye of a user, the device comprising:
a nozzle (figures 1a-k, ejector plate 1632) comprising:
a nozzle wall (figures 1a-k, wall of ejector plate 1632), the nozzle wall having opposing interior and exterior nozzle surfaces (figure 1a, interior surface 1625 adjacent to the fluid 1610 and opposite exterior surface 1622), the exterior nozzle surface having a longitudinal nozzle width (figure 1b, longitudinal length along A-A axis) and a lateral nozzle width (figure 1b, perpendicular lateral width), the longitudinal nozzle width being greater than the lateral nozzle width; and
a plurality of openings (figures 1a and 1b [0059] openings 1626 dispersed along the longitudinal length and lateral width, and the fluid is selectively ejected when piezoelectric actuator 1604 is on) dispersed along the longitudinal nozzle width through which the fluid is configured to be selectively delivered to the eye during use of the device, each opening of the plurality of openings extending through the nozzle wall from a substantially rectangular entry port in the interior nozzle surface to a substantially rectangular exit port in the exterior nozzle surface (figure 1a, and [0061] rectangular openings extending through the ejector plate 1632 comprising rectangular entry port in 1625 and rectangular exit port in opposite 1622) the each opening of the plurality of openings having a longer side ([0061] long side of the rectangular opening) being in the same orientation with a shorter side of the exterior nozzle surface and the each opening of the plurality of openings having a shorter side ([0061] short side of the rectangular opening) being in the same orientation with a longer side of the exterior nozzle surface in a manner that the each opening of the plurality of openings has a longitudinal opening width that is less than a lateral opening length ([0061] the width of the rectangular opening is less than the length of the rectangular opening)
Hunter does not teach the longitudinal nozzle width being greater than the lateral nozzle width;
the each opening of the plurality of openings having a longer side being in the same orientation with a shorter side of the exterior nozzle surface and the each opening of the plurality of openings have a shorter side being in the same orientation with a longer side of the exterior nozzle surface.
However, in an alternate embodiment of Hunter ([0061 and [0072]) teaches rectangular ejector plate ([0061] the ejector plate 1632 can have rectangular shape), which comprises the longitudinal nozzle width being greater than the lateral nozzle width ([0061] The rectangular ejector plate has longer side width being greater than the shorter side length).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter, to incorporate the teachings of the alternate embodiment of Hunter and provide the longitudinal nozzle width being greater than the lateral nozzle width and the each opening of the plurality of openings having a longer side being in the same orientation with a shorter side of the exterior nozzle surface and the each opening of the plurality of openings have a shorter side being in the same orientation with a longer side of the exterior nozzle surface for the purpose of providing optimized droplet stream pattern and flow rate as taught by Hunter ([0064 and 0067]).
Regarding claim 2, modified Hunter teaches the device of claim 1.
Hunter further teaches wherein the longitudinal opening width of the each opening of the plurality of openings inwardly tapers from the entry port to the exit port (figure 1k and [0064] openings inwardly tapers from the entry port to exit port ).
Regarding claim 3, modified Hunter teaches the device of claim 1.
Hunter further teaches wherein the each opening of the plurality of openings includes a substantially truncated pyramid shape as the each opening of the plurality of opening extends through the nozzle wall from the interior nozzle surface to the exterior nozzle surface (figure1i or 1k, the openings has substantially truncated pyramid in side view).
Regarding claim 10, modified Hunter teaches the device of claim 1.
Hunter teaches wherein the nozzle wall has a transverse wall thickness of about 500 micrometers or less ([0063] plate thickness may range from about 50 um to about 500 um).
Regarding claim 11, modified Hunter teaches the device of claim 1.
Hunter does not expressly teach wherein the longitudinal opening width of each opening at the exit port is about 75 to about 90 micrometers, the lateral opening length of each opening at the exit port being about 1 to about 2 millimeters..
However, Hunter teaches the openings could have aspect ratios between 1 and 10, and the dimension and ratio of the openings may result viscosity, droplet properties stream and fluid properties ([0063] and [0065]). Therefore, the opening dimension is a design choice which would lead one of ordinary skill in the art to optimize the opening size through routine experimentation.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter, with a reasonable expectation of success, to provide the longitudinal opening width of each opening at the exit port is about 75 to about 90 micrometers, the lateral opening length of each opening at the exit port being about 1 to about 2 millimeters as a matter of routine optimization since it has been held that “where the general condition 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). In the instant case, one of skill in the art motivated to do so, for the purpose of providing desired viscosity and fluid flow for ophthalmic drug delivery. Furthermore, applicant has not shown unexpected resulting gleaming from having claimed range ([0047]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 12, modified Hunter teaches the device of claim 1.
Hunter further teaches wherein at least the nozzle is formed from at least one of polyethylene and polyethylene ([0073]).
Regarding claim 21, modified Hunter teaches the device of claim 1.
Hunter further teaches wherein the longitudinal opening width of the each of the plurality of openings substantially parallel to the longitudinal nozzle width is less than half of the lateral opening length of the each of the plurality of openings substantially parallel to the lateral nozzle width (Hunter; [0063] the aspect ratio of the opening between 1 and 10 implies the width of the opening is less than half of the length).
Regarding claim 22, Hunter teaches A non-gravitational fluid delivery device for delivering fluid to an eye of a user, the device comprising:
a nozzle (figures 1a-k, ejector plate 1632) comprising:
a nozzle wall (figures 1a-k, wall of ejector plate 1632), the nozzle wall having opposing interior and exterior nozzle surfaces (figure 1a, interior and opposite exterior surfaces 1625 and 1622), the exterior nozzle surface having a longitudinal nozzle width and a lateral nozzle width (figure 1a, longitudinal length along A-A axis and perpendicular lateral width), the longitudinal nozzle width being greater than the lateral nozzle width; and
a plurality of openings (figures 1a and 1b [0059] openings 1626 disposed along the longitudinal length and lateral width) dispersed along the longitudinal nozzle width through which the fluid is configured to be selectively delivered to the eye during use of the device ([0059] fluid selectively ejected when piezoelectric actuator 1604 is on), each opening of the plurality of openings extending through the nozzle wall from a substantially rectangular entry port in the interior nozzle surface to a substantially rectangular exit port in the exterior nozzle surface (figure 1a and [0061] rectangular openings extending through the ejector plate 1632 comprising rectangular entry port in 1625 and rectangular exit ort in opposite 1622), the each opening of the plurality of openings having a longitudinal opening width that is less than a lateral opening length ([0061] shorter side of rectangular opening is less than the longer side);
wherein the each of the plurality of openings has a longitudinal axis substantially perpendicular to a longitudinal axis of the nozzle wall (figures 1a, the longitudinal axis of opening is perpendicular to the longitudinal axis of the nozzle wall).
Hunter does not teach the longitudinal nozzle width being greater than the latera nozzle width.
However, in an alternate embodiment of Hunter ([0061 and [0072]) teaches rectangular ejector plate ([0061] the ejector plate 1632 can have rectangular shape), which comprises the longitudinal nozzle width being greater than the lateral nozzle width ([0061] The rectangular ejector plate has longer side width being greater than the shorter side length).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter, to incorporate the teachings of the alternate embodiment of Hunter and provide the longitudinal nozzle width being greater than the lateral nozzle width for the purpose of providing optimized droplet stream pattern and flow rate as taught by Hunter ([0064 and 0067]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 20180116871 A1) in view of an alternate embodiment of Hunter ([0056] and [0072]), and in further view of Collins (US 20090192443 A1).
Regarding claim 4, modified Hunter teaches the device of claim 1.
Hunter does not teach wherein the nozzle wall is arcuate along the longitudinal nozzle width.
In the same field of endeavor, namely ophthalmic fluid delivery device, Collins teaches wherein the nozzle wall is arcuate along the longitudinal nozzle width (figure 13c [0149] the mesh plate 156g generally convex).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Collins and provide the nozzle wall as claimed, for the purpose of increasing the field of dispersion of the fluid as taught by Collins ([0149]). Specifically, such a modification would enable the device to generate the spray pattern that accommodates the anatomical geometry of the human eye (i.e., the horizontal width of the eye being greater than its vertical height). This allows the complete coverage of the ocular surface without requiring the physical width of the nozzle to match the full width of the eye, thereby maintaining a compact device profile while optimizing the delivery of the drug to the target area.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 20180116871 A1) in view of an alternate embodiment of Hunter ([0056] and [0072]), and in further view of Selby et al (US 20220031975 A1).
Regarding Claim 5, modified Hunter teaches the device of claim 1.
Hunter does not teach wherein the openings are separated into a plurality of opening subgroups, a longitudinal distance between directly adjacent associated exit ports belonging to a single opening subgroup being less than a longitudinal distance between directly adjacent exit ports of two directly adjacent opening subgroups.
In the same field of endeavor, namely an ejector device, Selby teaches a perforated membrane (figure 8, 850) wherein the openings are separated into a plurality of opening subgroups (figure 8 and [0095] apertures in the membrane 850 are separated into arrays 851-853), a longitudinal distance between directly adjacent associated exit ports belonging to a single opening subgroup (figure 8, distance between apertures belong to the subarray 851 is less than the distance among the arrays 851-853) being less than a longitudinal distance between directly adjacent exit ports of two directly adjacent opening subgroups
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunter to incorporate the teachings of Selby and provides the plurality of openings as claimed, and one of skill in the art motivated to do so, for the purpose of generating desired fluid trajectory and fluid droplet distribution as taught by Selby ([0091]-[0094]), for example, closely spaced openings within each subgroup promote coalescence and thereby promote the target delivery of larger droplets ([0050]) without requiring concave nozzle surface.
Regarding claim 6, modified Hunter teaches the device of claim 5.
Hunter further teaches wherein fluid exiting the openings of a corresponding one of the plurality of opening subgroups is configured to coalesce into a single subgroup fluid stream in mid-air prior to contacting the eye (Selby; [0050]-[0051] and [0055]-[0056]).
Regarding claim 7, modified Hunter teaches the device of claim 6.
Hunter further teaches wherein the subgroup fluid stream of each opening subgroup is configured to remain substantially separate from the subgroup fluid stream of another opening subgroup until the subgroup fluid streams reach the eye (subgroup fluid stream of each opening is configured to remain separated from another subgroup opening. As set forth in MPEP 2114, if an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness inherently teaches the functional limitation here. In the instant case, the combination teaches all the structural limitation as claimed in claims 1, 5 and 6, i.e., nozzle wall having plurality openings comprising substantially rectangular ports, the openings are separated into a plurality of opening subgroups, and space between openings in a single subgroup less than adjacent opening subgroups, and as a result the combination inherently teaches and capable of performing claimed function).
Regarding claim 8, modified Hunter teaches the device of claim 5.
Hunter further teaches wherein each opening subgroup of the plurality of opening subgroup has at least two openings (Selby; [0095] and figure 8, at least two openings).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hunter (US 20180116871 A1) in view of an alternate embodiment of Hunter ([0056] and [0072]), and in view of Selby et al (US 20220031975 A1), and in further view of Collins (US 20090192443 A1).
Regarding Claim 9, Hunter, as modified by Shelby, teaches the device of claim 5.
The combination does not teach wherein the nozzle wall is arcuate along the longitudinal nozzle width such that fluid exiting from a longitudinally outermost subgroup coalesces into a subgroup fluid stream in mid-air and travels at a non-perpendicular angle to a longitudinal direction.
In the same field of endeavor, namely ophthalmic fluid delivery device, Collins teaches, wherein the nozzle wall is arcuate along the longitudinal nozzle width (Collins; Collins; figure 13c and [0149], mesh plate 156 is generally convex along both longitudinal and lateral nozzle lengths)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stowe, as modified by Hahn and Selby, to incorporate the teachings of Collins and provide the nozzle wall as claimed, for the purpose of increasing the field of dispersion of the fluid as taught by Collins ([0149]). Specifically, such a modification would enable the device to generate the spray pattern that accommodates the anatomical geometry of the human eye (i.e., the horizontal width of the eye being greater than its vertical height). This allows the complete coverage of the ocular surface without requiring the physical width of the nozzle to match the full width of the eye, thereby maintaining a compact device profile while optimizing the delivery of the drug to the target area.
Consequently, the combination results the fluid exiting from a longitudinally outermost subgroup coalesces into a subgroup fluid stream in mid-air and travels at a non-perpendicular angle to a longitudinal direction (the combination teaches all the structural limitation as claimed in claims 1, 5 and 9, i.e., nozzle wall having plurality openings comprising substantially rectangular ports, the openings are separated into a plurality of opening subgroups, and space between openings in a single subgroup less than adjacent opening subgroups, nozzle was arcuate along the longitudinal nozzle width, the combination is fully capable of performing claimed function).
Claims 13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 20200360180 A1) in view of Selby et al (US 20220031975 A1).
Regarding claim 13, Stowe teaches A nozzle for a fluid delivery device, the nozzle (figure 7, nozzle 37) comprising:
a nozzle wall (figure 7, wall 95) comprising opposing interior and exterior nozzle surfaces (figure 7, internal and external surfaces 105 and 115), the exterior nozzle surface having a longitudinal nozzle width and a lateral nozzle width (figure 7, longitudinal width and lateral width), the longitudinal nozzle width being greater than the lateral nozzle width in a manner that the exterior nozzle surface has a longitudinal axis extending in the same orientation as the longitudinal nozzle width (annotated figure 7, the longitudinal width extend along the longitudinal axis and greater than the lateral width); and
a plurality of openings (figure 7, array of openings 85) dispersed along the longitudinal nozzle width, each opening (figure 7, opening 90) of the plurality of openings extending through the nozzle wall from an entry port (figure 7, 100) in the interior nozzle surface to an exit port (figure 7, 110) in the exterior nozzle surface, the plurality of openings being separated into opening subgroups, each opening subgroup comprising at least one of the plurality of openings, at least one of the opening subgroups comprising at least two of the plurality of openings, the each opening of the plurality of openings being lined up in a row along an axis extending parallel to the longitudinal axis of the exterior nozzle surface (annotated figure 7, the openings 90 are arranged in a row along the longitudinal axis) in a manner that a longitudinal distance along the axis between directly adjacent corresponding exit ports of a corresponding opening subgroup is less than a longitudinal distance along the axis between directly adjacent exit ports of two directly adjacent opening subgroups.
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Stowe does not teach the plurality of openings being separated into opening subgroups, each opening subgroup comprising at least one of the plurality of openings, at least one of the opening subgroups comprising at least two of the plurality of openings, and that a longitudinal distance along the axis between directly adjacent corresponding exit ports of a corresponding opening subgroup is less than a longitudinal distance along the axis between directly adjacent exit ports of two directly adjacent opening subgroups.
In the same field of endeavor, namely an ejector device, Selby teaches a perforated membrane (figure 8, 850) comprising a plurality of openings separated into subgroups, (figure 8 and [0095] openings in arrays 851-853), each opening subgroup comprising at least one of the plurality of openings ([0095] and figure 8, each array comprising at least one opening), at least one of the opening subgroups comprising at least two of the plurality of openings ([0095] and figure 8, each array comprising at least two openings), and that a longitudinal distance along the axis between directly adjacent corresponding exit ports of a corresponding opening subgroup is less than a longitudinal distance along the axis between directly adjacent exit ports of two directly adjacent opening subgroups (Selby; [0095] and figure 8, the distance between adjacent openings within subgroups is less than the distance, including longitudinal and lateral distance, between each subgroups.)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stowe to incorporate the teachings of Selby and provides the plurality of openings as claimed, and one of skill in the art motivated to do so, for the for the purpose of generating desired fluid trajectory and fluid droplet distribution as taught by Selby ([0091]-[0094]), for example, closely spaced openings within each subgroup promote coalescence and thereby promote the target delivery of larger droplets without requiring a concave nozzle surface ([0050]).
Regarding claim 17, Stowe, as modified by Selby, teaches the nozzle of claim 13.
The combination further teaches wherein each of the openings have a longitudinal opening width that inwardly tapers from the entry port to the exit port such that the each openings has a substantially truncated pyramid shape as the each of the openings extends through the nozzle wall from the interior nozzle surface to the exterior nozzle surface (Stowe; as illustrated in the side view of figure 7, each openings 90 inwardly tapers from 100 to 110 and defines a substantially truncated pyramid shape extending from 100 to 110)
Regarding Claim 18, Stowe, as modified by Selby, teaches the nozzle of claim 13.
The combination further teaches wherein fluid exiting the openings of a corresponding opening subgroup is configured to coalesce into a single subgroup fluid stream in mid-air prior to contacting the eye (Selby; [0050]-[0051] and [0055]-[0056], the droplets ejected from a single subgroup configured to coalesce)
Regarding Claim 19, Stowe, as modified by Selby, teaches the nozzle of claim 18.
The combination further teaches wherein the subgroup fluid stream of each opening subgroup is configured to not substantially coalesce with the subgroup fluid stream of another opening subgroup until the subgroup fluid streams reach the eye (Selby; figures 7-9, each arrays are separated from each other such that, the subgroup fluid stream of each opening subgroup is configured to not substantially coalesce).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 20200360180 A1) in view of Selby et al (US 20220031975 A1), and in further view of Hunter et al (US 20180116871 A1)
Regarding claim 15, Stowe, as modified by Selby, teaches the nozzle of claim 13.
The combination does not teach wherein at least one of the openings has a longitudinal opening width that is less than a lateral opening length.
In the same field of endeavor, namely an ejector device, Hunter teaches wherein at least one of the openings has a longitudinal opening width that is less than a lateral opening length ([0063] opening can have aspect ratios between 1 and 10).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stowe, as modified by Selby, to incorporate the teachings of Hunter and provides the openings as claimed, for the purpose of providing droplets of fluids having relatively higher viscosities as taught by Hunter ([0063]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Stowe (US 20200360180 A1) in view of Selby et al (US 20220031975 A1), and in further view of Collins (US 20090192443 A1)
Regarding Claim 20, Stowe, as modified by Selby, teaches the nozzle of claim 13.
The combination does not teach wherein the nozzle wall is arcuate along the longitudinal nozzle width such that fluid exiting from a longitudinally outermost subgroup coalesces into a subgroup fluid stream in mid-air and travels at a non-perpendicular angle to a longitudinal direction.
In the same field of endeavor, namely an ophthalmic fluid delivery device, Collins teaches wherein the nozzle wall is arcuate along the longitudinal nozzle width (Collins; figure 13c and [0149], mesh plate 156 is generally convex along the both longitudinal and lateral nozzle lengths)
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Stowe, as modified by Selby, to incorporate the teachings of Collins and provide the nozzle wall as claimed, for the purpose of increasing the field of dispersion of the fluid as taught by Collins ([0149]). Specifically, such a modification would enable the device to generate the spray pattern that accommodates the anatomical geometry of the human eye (i.e., the horizontal width of the eye being greater than its vertical height). This allows the complete coverage of the ocular surface without requiring the physical width of the nozzle to match the full width of the eye, thereby maintaining a compact device profile while optimizing the delivery of the drug to the target area.
Consequently, the combination results that fluid exiting from a longitudinally outermost subgroup coalesces into a subgroup fluid stream in mid-air and travels at a non-perpendicular angle to a longitudinal direction, as the combination teaches all the structural limitation as claimed in claims 13 and 20, i.e., nozzle wall having plurality openings dispersed along the longitudinal nozzle width, the plurality of openings being separated into opening subgroups, and space between openings in a single subgroup less than adjacent opening subgroups, nozzle was arcuate along the longitudinal nozzle width, the combination is fully capable of performing claimed function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/SETH HAN/Examiner, Art Unit 3781
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