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 § 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 3, 4, 6 and 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tsubota; Kazuo (US 20200229973 A1) in view of Wilkerson; Jonathan Ryan et al. (US 20130299607 A1) in view of Cooper; Guy F. (US 5823434 A).
Regarding claim 1, Tsubota discloses an ophthalmic atomizing delivery system (¶ [0015], [0017], [0027], [0052], a spraying device (1, 31) according to the present invention, as illustrated in FIG. 3 to FIG. 8, is a device that supplies at least a micro liquid to the eye);
comprising: a. a frame configured to rest on a user's face, wherein the frame comprises one or more surfaces configured to form a chamber in front of the user's eyes (¶ [0053] Such a spraying device can be preferably exemplified by an eyeglasses-type spraying device in which the local region 50 is configured by a rim and a temple of the eyeglasses (refer FIG. 3 to FIG. 7), and a cup-type spraying device in which the local region 50 includes an opening (refer to FIG. 8)); and
wherein the chamber comprises an inner surface opposite the user's eyes (¶ [0056] A basic structure of eyeglasses, as illustrated in FIG. 3, is generally configured by a lens 2, a rim 3, a wraparound end piece 4);
b. a disposable pod comprising a nebulizable liquid (¶ [0055], FIG. 3 to FIG. 7 … storing part 11; ¶ [0057], the storing part 11 can be mounted to the temple 6; ¶ [0061], raw material stored in the storing part 11 … into a mist-like substance; ¶ [0066], the storing part 11 that stores a raw material composed of a liquid raw material or a mixture of the liquid raw material and a solid raw material);
wherein the nebulizable liquid can be gravity-fed into a conduit integrated into the frame (¶ [0057], the spraying element 16 and the storing part 11 can be mounted to the temple 6, and thus it is convenient);
d. a nebulizing system integrated into the frame (¶ [0057], the spraying element 16 and the storing part 11 can be mounted to the temple 6; ¶ [0061] The spraying element 16 is an element that turns the raw material … into a mist-like substance and sprays the mist);
wherein the conduit is configured to direct the nebulizable liquid to the nebulizing system (¶ [0061] The spraying element 16 is an element that turns the raw material stored in the storing part 11 described later into a mist-like substance and sprays the mist); and
wherein the nebulizing system is configured to produce a mist from the nebulizable liquid that is directed toward the inner surface of the chamber (¶ [0061] The spraying element 16 is an element that turns the raw material stored in the storing part 11 described later into a mist-like substance and sprays the mist; ¶ [0066] A device capable of adjusting the mode to the “Washing mode,” “Hybrid,” or “Moisture mode” is a device (1, 31) capable of spraying a mist-like substance containing a micro liquid onto the local region 50 around the eye);
wherein the mist has a velocity direction; wherein the inner surface of the chamber is configured to redirect the mist toward the user's eyes and toward an edge of the frame (¶ [0053], the local region 50 is configured by a rim and a temple of the eyeglasses (refer FIG. 3 to FIG. 7); ¶ [0057], a mist-like substance containing a micro liquid is sprayed onto the local region 50 … The local region 50 refers to an enclosed space between the eyeglasses and the eye; ¶ [0061], the raw material may be sprayed by these spraying elements 16 in a mist form as a micro liquid or a micro solid and ultimately turn into at least a micro liquid when reaching the eye; ¶ [0066] A device capable of adjusting the mode … capable of spraying a mist-like substance containing a micro liquid onto the local region 50 around the eye).
Regarding the nebulizable liquid that can be gravity-fed into a conduit integrated into the frame, Tsubota shows that the storing part 11 and spraying element 16 are mounted inside temple 6 (Figs. 3-7). The fluid inside storing part 11 must necessarily travel to spraying element 16 before it can be aerosolized into a mist and sprayed towards the patient’s eyes. Therefore, Tsubota’s frame includes at least one conduit or fluid path that conveys fluid from storing part 11 towards spraying element 16. Tsubota does not disclose any pump or powered conveying system; therefore the fluid appears to flow solely under the influence of gravity.
Tsubota teaches the invention substantially as claimed by Applicant but is silent whether b. the disposable pod comprises a pierceable membrane and c. whether a piercing member is integrated into the frame. Wilkerson discloses devices and methods for ejecting mists, or sprays of micro-droplets for ophthalmic, topical, oral, nasal, or pulmonary use, constituting an ophthalmic atomizing delivery system (¶ [0002], [0007], [0008], [0099], FIG. 1 … ejector device 100);
comprising: b. a disposable pod comprising a pierceable membrane and a nebulizable liquid (¶ [0101] The reservoir or ampoule 102 for use with the ejector device 100 may comprise a flexible, or a hard, non-flexible reservoir … the reservoir comprises a collapsible and flexible reservoir 102 disposed within the top section 200 of the housing 202, and contains or is adapted to receive a volume of fluid. Different types of flexible reservoirs … self-sealing, radio frequency (RF) weld reservoirs as shown in FIG. 1 … a blow-fill-seal technique … in FIG. 3, or a form-fill-seal technique … in FIG. 4; ¶ [0107], FIGS. 6A to 6D … an ampoule having three components, a lidding 601, a container 602, and optionally a stiffening ring 603; ¶ [0113] The sealed combination of lidding 601 and container 602, and optional stiffening ring form an ampoule suitable for holding and storing a fluid for ophthalmic, topical, oral, nasal, or pulmonary use; ¶ [0116], By way of example, in ophthalmic applications, any suitable material for use in pharmaceutical ophthalmic applications may be used, such as polymer materials that do not chemically react with or adsorb fluids to be delivered);
c. a piercing member integrated into a frame and configured to pierce the pierceable membrane (¶ [0167] FIGS. 23-27 … 6 hollow puncture needles 2306 extend from the back surface of the capillary/puncture plate … The needles 2306 are surrounded by a wall 2310 defining a receptacle for a fitment 2312 (shown in FIG. 23E; ¶ [0169] Puncture is accomplished by pressing the puncture plate needles all the way through the gasket 2314 into the fluid filled fitment by forcing the needles through the silicone gasket; ¶ [0171], With reference to FIGS. 23 C and D, the puncture/capillary plate 2304 illustrates a design with 6 needles with an inner diameter (ID) of 650 microns and an outer diameter (OD) of 1 mm. The number of needles can be as small as 1 needle but can also include more needles, e.g., 8 needles); and
enable the nebulizable liquid to be gravity-fed into a conduit integrated into the frame (¶ [0169], The initial transfer of fluid from the reservoir/container through the hollow puncture needles immediately after puncture results from a combination of hydrostatic pressure, fitment retention/reservoir volume, and the fluid reaction force from initial puncture; ¶ [0181] FIG. 29 illustrates how hydrostatic pressure drives fluid from the LTS ampoule into the fitment and through the puncture needles into the fluid reservoir); and
d. a nebulizing system integrated into the frame, wherein the conduit is configured to direct the nebulizable liquid to the nebulizing system (¶ [0133] Referring to FIG. 8, a device of the present disclosure ejects fluid in a direction 804, perpendicular to the direction of gravity 805. In an aspect of the present disclosure, the combination of ampoule 803 and fluid loading plate 802 provide for a consistent flow of fluid to the ejector plate 801 as the attitude angle theta (A) is change; ¶ [0146], the fluid loading plate may be integrated into an ejector device or ejector assembly … in the applications: … 61/591,786 … 61/569,739 … 13/184,484 … each herein incorporated by reference in their entireties; ¶ [0150] FIGS. 15A-15C … ejector mechanism 1504; ¶ [0167], FIGS. 23A and B … ejector mechanism 2300 with 5 rise holes 2302; ¶ [0202], FIGS. 55 A-C, an ejector assembly 5500 may include an ejector mechanism 5501 and a reservoir 5520 … The ejector plate 5502 and generator plate 5532 that can be activated by a piezoelectric actuator 5504 which vibrates to deliver a fluid 5510, contained in the reservoir 5520, in the form of ejected droplets 5512 along a direction 5514); and
wherein the nebulizing system is configured to produce a mist from the nebulizable liquid (¶ [0009], spraying a mist horizontally onto the surface to be treated; ¶ [0016], The average droplet size may be in the range of about 15 microns to over 400 microns; ¶ [0021], the droplets in the directed stream having an average ejecting diameter in the range of … 20-200 microns … 100-200, etc.; ¶ [0143], The ejector mechanism may be configured to eject a stream of droplets having an average ejected droplet diameter greater than 15 microns, with the stream of droplets having low entrained airflow such that the stream of droplets deposits on the eye of the subject during use).
Wilkerson explains how to deliver nebulizable liquid medicine from a disposable pod towards a nebulizing system in an ophthalmic atomizing delivery system. One would be motivated to modify Tsubota with Wilkerson’s pierceable membrane and integrated piercing member since Tsubota calls for a disposable pod but does not provide further details on its structure or how it interfaces with a nebulizing system (Figs. 3-7, storing part 11 and a spraying element 16 are integrated in the spraying device 1). Therefore, it would have been obvious to modify Tsubota with Wilkerson’s pierceable membrane and integrated piercing member in order to construct a disposable pod according to Tsubota’s requirements.
Tsubota and Wilkerson are silent whether the nebulizing system produces a 3-dimensional vortex of mist having a central axis that is not parallel to the velocity direction of the mist. Cooper discloses an aerosol dispensing apparatus (col. 1, lines 5-15; col. 4, lines 50-65, Aerosol dispensing apparatus 20 comprises housing 28; col. 5, lines 30-40, Referring now to FIGS. 2 and 3, there is shown another embodiment … Aerosol dispensing apparatus 50; col. 6, lines 10-20, Referring now to FIGS. 3, 4 and 5, there is shown in FIG. 4 a third embodiment … Aerosol dispensing apparatus 86 comprises housing 88);
comprising: a source of a nebulizable liquid (col. 4, lines 10-15, The inner portion of the housing forms a chamber which contains a medication which may be either in liquid form or powdered form; col. 5, lines 15-20, The inner portion of housing 28 forms a chamber 44 which has contained therein a medication which may be either in liquid form or powdered form; col. 5, lines 55-60, There is attached to the bottom of wall 70 of housing 58 a generally rectangular shaped aerosol generator 72 which provides medicated particles under pressure into lower chamber 62; col. 6, lines 35-40, Medication holding chamber 102 has contained therein a medication which may be either in liquid form or powdered form); and
d. a nebulizing system, wherein the nebulizing system is configured to produce a mist from the nebulizable liquid (col. 5, lines 25-30, There is attached to the bottom of wall 70 of housing 58 a generally rectangular shaped aerosol generator 72 which provides medicated particles under pressure into lower chamber 62; col. 6, lines 1-15, Speaker assembly 66 is connected to a sawtooth waveform generator which generates and then provides the sawtooth waveform signal 38 … This reciprocating motion of the flexible diaphragm of speaker assembly 66 generates the train of ring vortices 52; col. 7, lines 15-20, Each cycle of the sawtooth waveform signal of FIG. 3 generates one ring vortex of the train of ring vortices 130, 132 and 134 respectively from counter flow orifices 108, 110 and 112); and
wherein the mist has a velocity direction; whereby a 3-dimensional vortex of mist is created; and wherein the 3-dimensional vortex of mist has a central axis that is not parallel to the velocity direction of the mist (col. 4, lines 15-25, Each cycle of the sawtooth waveform signal generates one ring vortex of a train of ring vortices with the ring vortex being generated during the vertical portion of the signal when the abrupt forward movement of the flexible diaphragm occurs; col. 9, lines 50-55, The velocity profile of the ring vortex 142 may then be determined by the following equation which is the law of Biot-Savart).
Regarding the 3-dimensional vortex of mist having a central axis that is not parallel to the velocity direction of the mist, Cooper’s ring vortices have a central axis that forms a ring, and a toroidal velocity field which includes velocity vectors that point away from the central ring.
Cooper generates a mist or aerosol comprising small particles and which remains suspended in air for a prolonged time (col. 2, lines 10-15, For example, some metered dose inhalers are relatively inefficient because they produce mainly non-respirable particles that range in size from about 35 micro-meters to about 1 micrometers. Of these particles only about 30 percent, chiefly particles under 5 micrometers, are actually capable of being inhaled; col. 3, lines 55-65, dispensing apparatus which effectively provides medication in a mist or vapor form to the bronchial tubes and the alveolar air sachs of the lungs of a patient without requiring the patient to inhale vigorously). One would be motivated to modify Tsubota and Wilkerson with Cooper’s 3-D vortex nozzle since Tsubota calls for selecting a known nebulizer (¶ [0062] The structural form of the spraying element 16 is not particularly limited, but in an example in which the spraying element 16 is provided to the temple 6 as illustrated in FIG. 3 to FIG. 7, is preferably a size and a shape that allow mounting to the temple 6; ¶ [0064] Further, the spraying element 16 may be a composite of an ultrasonic oscillation element and an atomizing element). Therefore, it would have been obvious to modify Tsubota and Wilkerson with Cooper’s 3-D vortex nozzle in order to construct Tsubota’s system with a known nebulizer or mist generator.
Regarding claims 3 and 4, Tsubota and Wilkerson lack a mist vortex. Cooper discloses an atomizing system wherein the vortex of mist has a central axis that is oriented perpendicular to a horizontal plane or vertical plane (col. 5, lines 25-30, Each cycle of the sawtooth waveform signal of FIG. 3 generates one ring vortex of the train of ring vortices 22 with the ring vortex being generated during vertical portion 42 of signal 38; col. 9, lines 50-55, The velocity profile of the ring vortex 142 may then be determined by the following equation which is the law of Biot-Savart).
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To clarify, Cooper’s vortex rings have a ring-shaped central axis that is perpendicular to both horizontal and vertical planes. For example, a ring that travels outward from the nozzle will travel generally horizontally through the space between the user’s face and lenses. At the ring’s top, a tangent line extends perpendicularly to a vertical plane which extends parallel to the user’s face. At the ring’s side, a tangent line extends perpendicularly to the horizontal plane.
Cooper does not explicitly disclose a frame or the rings’ orientation relative to a frame. This rejection modifies Tsubota and Wilkerson with Cooper’s 3-D vortex nozzle by substituting Tsubota’s nozzle with Cooper’s 3-D vortex nozzle. Tsubota calls for an ultrasonic aerosol generator comprising a plurality of outlets (¶ [0061], Preferable examples of the spraying element 16 include an ultrasonic oscillation element; ¶ [0065] When the spraying element 16 is an ultrasonic oscillation element 17; ¶ [0090], This ultrasonic oscillation plate includes micropores). Likewise, Cooper discloses an embodiment comprising an ultrasonic driver (col. 5, lines 15-20, The sawtooth waveform signal 38 of FIG. 3 may have a frequency of up to 1000 hertz); and a plurality of outlets (col. 6, lines 45-50, counter flow orifices 108, 110 and 112 of aerosol dispensing apparatus 86).
Cooper generates an aerosol that remains suspended for an extended time (col. 2, lines 10-15, particles under 5 micrometers, are actually capable of being inhaled; col. 3, lines 55-65). Regarding the rationale and motivation to modify Tsubota and Wilkerson with Cooper’s 3-D vortex nozzle, see the discussion of claim 1 above.
Regarding claims 6, 8 and 9, Tsubota discloses a system wherein the nebulizing system comprises a piezo and electronic driving system (¶ [0118] FIG. 18 is images showing an example of an embodiment of the eyeglasses-type spraying device … For the electrical system, an input voltage of 5 V from the battery was boosted to ±25 V, and vibration was applied using an ultrasonic piezoelectric transducer (material: lead zirconate titanate) that vibrates at an oscillation frequency of 108 kHz; ¶ [0126], the spraying device … ultrasonically vibrates a piezo element by an inverse piezoelectric effect, and blows the element as water mist (a micro liquid) to humidify the space in front of the eye);
wherein the nebulizable liquid comprises a medication (¶ [0020], The medicinal additive is preferably a substance for spray treatment, and examples include menthol, analgesics, antibiotics, antiallergic agents, steroids, intraocular pressure-lowering agents, and the like; ¶ [0051], Causing a medicinal additive or the like to be contained in a micro liquid is effective as a drug delivery technique for the eye);
wherein the nebulizing system is further configured to produce a heated mist such that a sauna effect is produced in the chamber (¶ [0069], Due to the ease of changing a raw material (a liquid, for example) into a gas (vapor) by heating, the electric resistance element may simultaneously be used as another spraying element 16. Further, the electric resistant element may be a steam fan type with a fan or the like built-in, and the heated vapor could be made to flow in a specific direction by the fan).
Regarding claims 10 and 11, Tsubota lacks a pierceable membrane. Wilkerson discloses a disposable pod including a pierceable membrane (¶ [0101] The reservoir or ampoule 102 … comprises a collapsible and flexible reservoir 102; ¶ [0107], FIGS. 6A to 6D … an ampoule having three components, a lidding 601, a container 602; ¶ [0113] The sealed combination of lidding 601 and container 602). Wilkerson further discloses that the pod comprises a puncture gasket near its bottom surface (¶ [0133] Referring to FIG. 8, a device of the present disclosure ejects fluid in a direction 804, perpendicular to the direction of gravity 805. In an aspect of the present disclosure, the combination of ampoule 803 and fluid loading plate 802 provide for a consistent flow of fluid to the ejector plate 801 as the attitude angle theta (A) is change). In Figs. 8, 26 and 27, the puncture gasket is arranged vertically and is pierced when a horizontally-oriented needle punctures the gasket.
Wilkerson does not explicitly disclose that the pierceable membrane is oriented 90° ± (25° or 15°) in relation to a horizontal plane defined by the two arms. However, this range depends on both the frame’s construction and the orientation of the nebulizing system. Wilkerson discloses an embodiment where both the pierceable membrane and a puncturing element plate are oriented vertically (¶ [0133] Referring to FIG. 8, a device of the present disclosure ejects fluid in a direction 804, perpendicular to the direction of gravity 805. In an aspect of the present disclosure, the combination of ampoule 803 and fluid loading plate 802 provide for a consistent flow of fluid to the ejector plate 801 as the attitude angle theta (A) is change).
A skilled artisan would have been able to adjust Wilkerson’s angle by installing Wilkerson’s pod and membrane in Tsubota’s system according to Wilkerson’s example in Fig. 8. Regarding the rationale and motivation to modify Tsubota with Wilkerson’s pod and membrane, see the discussion of claim 1 above.
Regarding claims 12 and 13, Tsubota discloses an ophthalmic atomizing delivery system (¶ [0015], [0017], [0027], [0052], a spraying device (1, 31) … supplies at least a micro liquid to the eye);
comprising: a. a frame configured to rest on a user's face, wherein the frame comprises one or more surfaces configured to form a chamber in front of the user's eyes (¶ [0053] Such a spraying device can be preferably exemplified by an eyeglasses-type spraying device in which the local region 50 is configured by a rim and a temple of the eyeglasses (refer FIG. 3 to FIG. 7), and a cup-type spraying device in which the local region 50 includes an opening (refer to FIG. 8)); and
wherein the chamber comprises an inner surface opposite the user's eyes (¶ [0056] A basic structure of eyeglasses, as illustrated in FIG. 3, is generally configured by a lens 2, a rim 3, a wraparound end piece 4);
b. a disposable pod comprising a nebulizable liquid (¶ [0055], FIG. 3 to FIG. 7 … storing part 11; ¶ [0057], the storing part 11 can be mounted to the temple 6; ¶ [0061], raw material stored in the storing part 11 … into a mist-like substance; ¶ [0066], the storing part 11 that stores a raw material composed of a liquid raw material or a mixture of the liquid raw material and a solid raw material);
wherein the nebulizable liquid can be gravity-fed into a conduit integrated into the frame (¶ [0057], the spraying element 16 and the storing part 11 can be mounted to the temple 6, and thus it is convenient);
e. a nebulizing system integrated into the frame (¶ [0057], the spraying element 16 and the storing part 11 can be mounted to the temple 6; ¶ [0061] The spraying element 16 is an element that turns the raw material … into a mist-like substance and sprays the mist);
wherein the conduit is configured to direct the nebulizable liquid to the nebulizing system (¶ [0061] The spraying element 16 is an element that turns the raw material stored in the storing part 11 described later into a mist-like substance and sprays the mist); and
wherein the nebulizing system is configured to produce a mist from the nebulizable liquid that is directed toward the inner surface of the chamber (¶ [0061] The spraying element 16 is an element that turns the raw material stored in the storing part 11 described later into a mist-like substance and sprays the mist; ¶ [0066] A device capable of adjusting the mode to the “Washing mode,” “Hybrid,” or “Moisture mode” is a device (1, 31) capable of spraying a mist-like substance containing a micro liquid onto the local region 50 around the eye);
wherein the inner surface of the chamber is configured to redirect the mist toward the user's eyes and toward an edge of the frame (¶ [0057], FIG. 3, preferably the projecting section 3a is provided projecting from the rim 3 in a face direction, or a section between the wraparound end piece 4 and the temple 6 is projected in the face direction, making it possible to cover the face and decrease the likelihood of the occurrence of a gap as a result);
Regarding Tsubota’s gravity-fed liquid and conduit, see the discussion of claim 1 above.
Tsubota does not explicitly disclose a pierceable membrane or piercing members. Wilkerson discloses an ophthalmic atomizing delivery system (¶ [0002], [0007], [0008], [0099], FIG. 1 … ejector device 100);
comprising b. a disposable pod comprising a pierceable membrane vertically oriented in relation to a horizontal plane going through the two arms (Figs. 26 and 27, the puncture gasket is arranged vertically and is pierced when a horizontally-oriented needle punctures the gasket; ¶ [0133] Referring to FIG. 8, a device of the present disclosure ejects fluid in a direction 804, perpendicular to the direction of gravity 805); and
a nebulizable liquid (¶ [0101] The reservoir or ampoule 102 for use with the ejector device 100 may comprise a flexible, or a hard, non-flexible reservoir … the reservoir comprises a collapsible and flexible reservoir 102 disposed within the top section 200 of the housing 202, and contains or is adapted to receive a volume of fluid. Different types of flexible reservoirs … self-sealing, radio frequency (RF) weld reservoirs as shown in FIG. 1 … a blow-fill-seal technique … in FIG. 3, or a form-fill-seal technique … in FIG. 4; ¶ [0107], FIGS. 6A to 6D … an ampoule having three components, a lidding 601, a container 602, and optionally a stiffening ring 603; ¶ [0113] The sealed combination of lidding 601 and container 602, and optional stiffening ring form an ampoule suitable for holding and storing a fluid for ophthalmic, topical, oral, nasal, or pulmonary use; ¶ [0116], By way of example, in ophthalmic applications, any suitable material for use in pharmaceutical ophthalmic applications may be used, such as polymer materials that do not chemically react with or adsorb fluids to be delivered);
c. a piercing member integrated into the frame and configured to pierce the pierceable membrane (¶ [0167] FIGS. 23-27 … 6 hollow puncture needles 2306 extend from the back surface of the capillary/puncture plate … The needles 2306 are surrounded by a wall 2310 defining a receptacle for a fitment 2312 (shown in FIG. 23E; ¶ [0169] Puncture is accomplished by pressing the puncture plate needles all the way through the gasket 2314 into the fluid filled fitment by forcing the needles through the silicone gasket; ¶ [0171], With reference to FIGS. 23 C and D, the puncture/capillary plate 2304 illustrates a design with 6 needles with an inner diameter (ID) of 650 microns and an outer diameter (OD) of 1 mm. The number of needles can be as small as 1 needle but can also include more needles, e.g., 8 needles);
d. a second piercing member integrated into the frame and configured to pierce the pierceable membrane to break a vacuum in the pod (¶ [0167] FIGS. 23-27 … 6 hollow puncture needles 2306 extend from the back surface of the capillary/puncture plate; ¶ [0166], as a capillary/puncture plate fluid delivery system … may utilize one or more of hydrostatic pressure … and air exhaustion; ¶ [0192], an ejector plate of the system may include capillary rise holes to provide additional air pressure relief above the active area (ejector openings). This additional air pressure relief may thereby allow for complete capillary rise of the fluid, which allows the retention/reservoir to be completely filled with fluid).
Regarding the second piercing member, Wilkerson discloses a plurality of piercing members (¶ [0167] FIGS. 23-27 … 6 hollow puncture needles 2306 extend from the back surface of the capillary/puncture plate); and also calls for admitting air pressure through capillary rise holes (¶ [0192], an ejector plate of the system may include capillary rise holes to provide additional air pressure relief above the active area (ejector openings)). Wilkerson appears to designate some of the piercing members as passages that equalize air pressure inside the disposable pod.
Regarding the vertically-oriented pierceable membrane, Wilkerson discloses that the pod comprises a puncture gasket near its bottom surface (¶ [0168], During the initial stage of connection the hollow puncture needles 2302 shown on the back of the puncture plate image in FIG. 23D are partially inserted into the self-sealing silicone puncture gasket or grommet 2314 that rests inside the fitment 2312; ¶ [0171] FIG. 26 illustrates a schematic outlining fluid flow through the puncture plate system after complete puncture through the silicone gasket). In Figs. 26 and 27, the puncture gasket is arranged vertically and is pierced when a horizontally-oriented needle punctures the gasket.
Wilkerson provides details for how to construct a disposable pod for an ophthalmic atomizing delivery system. Regarding the rationale and motivation to modify Tsubota with Wilkerson’s pierceable membrane and piercing members, see the discussion of claim 1 above.
Tsubota and Wilkerson do not explicitly create 3-dimensional vortex of mist. Cooper discloses an aerosol dispensing apparatus (col. 1, lines 5-15; col. 4, lines 50-65, Aerosol dispensing apparatus 20; col. 5, lines 30-40, FIGS. 2 and 3 … Aerosol dispensing apparatus 50; col. 6, lines 10-20, FIGS. 3, 4 and 5, … Aerosol dispensing apparatus 86);
comprising: a source of a nebulizable liquid (col. 4, lines 10-15; col. 5, lines 15-20; col. 5, lines 55-60; col. 6, lines 35-40); and
a nebulizing system configured to produce a mist from the nebulizable liquid that has a velocity direction (col. 5, lines 25-30; col. 6, lines 1-15; col. 7, lines 15-20); and
whereby a 3-dimensional vortex of mist is created, having a central axis that is not parallel to the velocity direction of the mist (col. 4, lines 15-25, Each cycle of the sawtooth waveform signal generates one ring vortex of a train of ring vortices with the ring vortex being generated during the vertical portion of the signal when the abrupt forward movement of the flexible diaphragm occurs; col. 9, lines 50-55, The velocity profile of the ring vortex 142 may then be determined by the following equation which is the law of Biot-Savart).
Cooper generates an aerosol that remains suspended for an extended time (col. 2, lines 10-15, particles under 5 micrometers, are actually capable of being inhaled; col. 3, lines 55-65). Regarding the rationale and motivation to modify Tsubota and Wilkerson with Cooper’s 3-D vortex nozzle, see the discussion of claim 1 above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tsubota, Wilkerson and Cooper in view of Anderson, Daryl E. et al. (US 20050001981 A1).
Regarding claim 7, Tsubota, Wilkerson and Cooper lack an inkjet head. Anderson discloses an ophthalmic atomizing delivery system including a nebulizing system that comprises an inkjet head and electronic driving system (¶ [0040] The illustrated fluid dispensers 14,16 are inkjet-type jet dispensers, such as thermal droplet jet dispensers or piezoelectric droplet jet dispensers, having multiple ejection orifices, or nozzles, (not shown) that dispense small droplets of fluid … such as disclosed in U.S. Pat. No. 5,420,627 to Keefe et al., U.S. Pat. No. 5,278,584 to Keefe et al., U.S. Pat. No. 4,683,481 to Johnson, U.S. Pat. No. 4,992,808 to Bartky et al., U.S. patent No. 6,186,619 to Usui et al., U.S. Pat. No. 6,149,968 to Shimada and U.S. Pat. No. 6,193,343 to Norigoe et al.).
Anderson dispenses an ophthalmic medication with an alternative nozzle. One would be motivated to modify Tsubota, Wilkerson and Cooper with Anderson’s inkjet head since Wilkerson incorporates several examples of spray nozzles or nebulizing systems (¶ [0094], [0146], [0214], [0227], [0281]). Therefore, it would have been obvious to modify Tsubota, Wilkerson and Cooper with Anderson’s inkjet head in order to dispense ophthalmic medication with another known nozzle.
Response to Arguments
The rejections of claims 3, 4 and 11-13 under 35 USC § 112 are withdrawn in view of the amendments filed 22 July 2025.
Applicant’s arguments filed 22 July 2025 regarding the rejection of claims 1, 3, 4 and 6-13 as amended, under 35 USC § 103 over Tsubota, Wilkerson, Hoekman and Anderson, have been fully considered and are persuasive. After further consideration, the amended claims are rejected on new grounds under 35 USC § 103 over Tsubota, Wilkerson, Cooper and Anderson (see above).
Applicant’s arguments regarding Hoekman have been considered but are moot because the reference is no longer cited in the current rejection.
Applicant submits that Hoekman's device creates a vortex of mist with an axis that is longitudinal, or parallel, relative to the nozzle and the direction of the spray exiting the nozzle (remarks p. 7). Applicant reasons that as opposed to Hoekman's device, the vortex of mist is not generated by the configuration of a nozzle and its feeder channels to create a vortex of mist with a central axis that is parallel relative to the nozzle and the direction of the spray exiting the nozzle (remarks p. 7-8). Examiner responds that Hoekman is no longer cited. Cooper is cited in the new grounds of rejection as teaching a mist vortex having a central axis that is not parallel to its velocity direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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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 extension fee 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 date of this final action.
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/Adam Marcetich/
Primary Examiner, Art Unit 3781