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 § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 10 and 19 call for “…wherein the second pathway is hermetically sealed.” Parent claims 1 and 12 call for “… a second end exposed to atmosphere …” which contradicts this meaning. This language is ambiguous because the term “hermetically sealed” is commonly understood to mean a seal that prevents all movement of gas, liquids or any material.
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, 5-7, 9-12, 14-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Quintana; Reynaldo et al. (US 20200281768 A1) in view of Miyoshi, Jun et al. (US 20010029360 A1).
Regarding claim 1, Quintana discloses a handheld device for dispensing a liquid to an eye of a patient (¶ [0002], [0010], [0010], [0021], in some instances the devices are handheld devices; ¶ [0034], FIGS. 1-3 … dispensing device (100) of the present invention; ¶ [0043], Accordingly, FIG. 4 is an enlarged cross section view of a fluid dispenser (400));
the device comprising: a first pathway for directing the liquid from an ampoule to a chamber (¶ [0044], liquid being dispensed is present in reservoir (406) (only partially shown here));
having a) an aperture through which the liquid from the ampoule can be dispensed (¶ [0044] Here (402) is the aperture); and
b) a membrane designed to hydrodynamically excite and dispense the liquid through the aperture (¶ [0044], (408) is a flexible diaphragm);
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an actuator designed to oscillate a rod engaging the membrane so that the membrane can hydrodynamically excite the liquid to open the aperture and dispense the liquid therethrough (¶ [0041] Electromagnetic transducer (100) includes a circuit (100A) which produces alternating current which is fed to the coil (108) to generate a magnetic force which oscillates permanent magnet (109); ¶ [0044], Metal cylinder (412) is composed of a magnetic ferrous alloy so that it can be attracted by the magnetic flux generated by solenoid (410). Member (414) connects (412) to valve member (404)/diaphragm (408). The combination of solenoid (410) and (412) provides an electromagnetic actuator having operating principles as described above); and
a second pathway having a first end in fluid communication with at least one of the first pathway and the ampoule; and a second end exposed to atmosphere (¶ [0028] In some instances, the fluid package may include a vent, e.g., to provide for introduction of gas into the reservoir as fluid is ejected from the fluid package and provide for consistent fluid ejection. The vent may be configured to provide entry of microbial free air into the reservoir from outside of the package … An example of such a vent includes a lumen that extends from an opening in the neck region to a location in the reservoir, such as near the end of the fluid package furthest from the neck region; ¶ [0030] In such instances, the neck region may be mated to the standard ophthalmic bottle, where the neck region includes the aperture, valve member and vent, e.g., as described above).
To clarify, Quintana’s second liquid pathway comprises a vent lumen that extends between the interior of a vial or bottle to the atmosphere (¶ [0028], [0030]).
Quintana teaches the invention substantially as claimed by Applicant but does not explicitly disclose a stop designed to prevent the liquid from escaping. Miyoshi discloses an adapter for transferring a drug solution or solvent from a syringe to a vial, constituting a dispensing device (¶ [0001], [0007], [0023] Referring now to FIGS. 1 to 3, there is illustrated one embodiment of an adapter);
the device comprising: a first pathway for directing the liquid from an ampoule to a chamber (¶ [0024], The puncture needle 2 has a fluid passage 23); and
a second pathway having a first end in fluid communication with at least one of the first pathway and the ampoule (¶ [0029] As illustrated in FIGS. 4 to 6, the puncture needle 2 may be provided with a gas passage 25);
a second end exposed to atmosphere (¶ [0029], vent hole 26); and
a stop designed to prevent the liquid from escaping through the second end of the second pathway (¶ [0029], it is preferred to provide a check valve 28, which allows the gas to flow only in the direction of the gas passage 25, adjacent to the filter 27 in the vent hole 26 on the inside of the filter 27).
Miyoshi excludes contaminants and prevents liquid from leaking out of a container (¶ [0029], provide a check valve 28 … so as to prevent the medical solution from flowing into the vent hole 26 through the gas passage 25 when the vial is reversed). One would be motivated to modify Quintana with Miyoshi’s liquid stop to exclude contaminants since Quintana calls for a filter (¶ [0028], The opening of the lumen in the neck region may be covered, e.g., to prevent ingress from microbial, e.g., bacteria, and other undesired agents into the fluid package). Miyoshi excludes contaminants with a combination of a duckbill valve and filter. Also, Miyoshi’s filter is modular and can fit into any outward-facing opening. A skilled artisan would have been able to modify Quintana with Miyoshi’s liquid-stopping filter and valve by installing Miyoshi’s filter assembly in Quintana’s vent lumen. Therefore, it would have been obvious to modify Quintana with Miyoshi’s filter assembly in order to exclude pathogens with a known filter.
Regarding claim 12, Quintana discloses a handheld device for dispensing a liquid to a site of interest (¶ [0002], [0010], [0010], [0021], [0034], FIGS. 1-3 … dispensing device (100); ¶ [0043] FIG. 4 … fluid dispenser (400));
the device comprising: a first pathway for directing the liquid from an ampoule to a chamber (¶ [0044], liquid being dispensed is present in reservoir (406) (only partially shown here));
having a) a membrane and pin designed to hydrodynamically excite and dispense the liquid (¶ [0044], (408) is a flexible diaphragm to which valve member (404) is affixed … the resulting motions in the fluid dispenser from this actuator are vibration of valve member (404) into and out of engagement with aperture (402), and a vibration of diaphragm (408)); and
b) a sealable aperture through which the liquid from the ampoule can be dispensed (¶ [0044] Here (402) is the aperture);
where the pin is received within the aperture to seal the aperture (¶ [0044], From FIG. 4 it is apparent that the resulting motions in the fluid dispenser from this actuator are vibration of valve member (404) into and out of engagement with aperture (402), and a vibration of diaphragm (408));
an actuator designed to oscillate the membrane and the pin to disengage the pin from the aperture and dispense the liquid therethrough (¶ [0041] Electromagnetic transducer (100) includes a circuit (100A) which produces alternating current which is fed to the coil (108) to generate a magnetic force which oscillates permanent magnet (109); ¶ [0044], Metal cylinder (412) is composed of a magnetic ferrous alloy so that it can be attracted by the magnetic flux generated by solenoid (410). Member (414) connects (412) to valve member (404)/diaphragm (408). The combination of solenoid (410) and (412) provides an electromagnetic actuator having operating principles as described above); and
a second pathway having a first end in fluid communication with at least one of the first pathway and the ampoule, a second end exposed to atmosphere (¶ [0028] In some instances, the fluid package may include a vent, e.g., to provide for introduction of gas into the reservoir as fluid is ejected from the fluid package and provide for consistent fluid ejection. The vent may be configured to provide entry of microbial free air into the reservoir from outside of the package … An example of such a vent includes a lumen that extends from an opening in the neck region to a location in the reservoir, such as near the end of the fluid package furthest from the neck region; ¶ [0030] In such instances, the neck region may be mated to the standard ophthalmic bottle, where the neck region includes the aperture, valve member and vent, e.g., as described above).
Quintana does not explicitly disclose a liquid stop. Miyoshi discloses a stop designed to prevent liquid from escaping through a second end of a second pathway, regardless of orientation of the liquid within an ampoule (¶ [0029], it is preferred to provide a check valve 28, which allows the gas to flow only in the direction of the gas passage 25, adjacent to the filter 27 in the vent hole 26 on the inside of the filter 27).
Miyoshi securely retains a medical solution in an ampoule or bottle while excluding contaminants (¶ [0029]). Regarding the rationale and motivation to modify Quintana with Miyoshi’s filter assembly, see the discussion of claim 1 above.
Regarding claims 2, 3, 5-7, 11, 14-16 and 20, Quintana discloses a device wherein the chamber further comprises: a valve member extending from the membrane, wherein the valve member is engaged within the aperture in a closed configuration and disengaged from the aperture when the actuator oscillates the rod (¶ [0044], From FIG. 4 it is apparent that the resulting motions in the fluid dispenser from this actuator are vibration of valve member (404) into and out of engagement with aperture (402), and a vibration of diaphragm (408));
wherein the valve member and the membrane are a unitary part (¶ [0044], (408) is a flexible diaphragm to which valve member (404) is affixed);
wherein the second pathway further comprises: an air filter designed to sterilize air flowing from the atmosphere into the ampoule as the liquid is dispensed; wherein the air filter is designed to remove particles larger than 0.22 microns; wherein the air filter is designed to remove contaminants and microorganisms from air entering the ampoule; wherein the second pathway is designed to equalize pressure (¶ [0028], The opening of the lumen in the neck region may be covered, e.g., to prevent ingress from microbial, e.g., bacteria, and other undesired agents into the fluid package. In such instances, the covering may have antimicrobial properties, e.g., where covering is a porous membrane having a pore size configured to prevent passage of microbes, e.g., bacteria, such as pore sizes of 0.22 μm or less).
Regarding claims 9 and 18, Quintana lacks a one-way valve. Miyoshi discloses that the stop is a one-way valve designed to prevent the liquid in the ampoule from exiting the pathway (¶ [0029], it is preferred to provide a check valve 28, which allows the gas to flow only in the direction of the gas passage 25, adjacent to the filter 27 in the vent hole 26 on the inside of the filter 27).
Miyoshi blocks contamination and prevents leaks. Regarding the rationale and motivation to modify Quintana with Miyoshi’s one-way valve, see the discussion of claim 1 above.
Regarding claims 10 and 19, Quintana discloses that the second pathway is hermetically sealed (¶ [0028], The opening of the lumen in the neck region may be covered, e.g., to prevent ingress from microbial, e.g., bacteria, and other undesired agents into the fluid package. In such instances, the covering may have antimicrobial properties, e.g., where covering is a porous membrane having a pore size configured to prevent passage of microbes, e.g., bacteria, such as pore sizes of 0.22 μm or less).
These claims are rejected under 112(b) for contradictory language, namely communicating with the atmosphere and also being hermetically sealed. Quintana discloses a passage that communicates with the atmosphere solely through a membrane that excludes pathogens (¶ [0028]). Therefore, Quintana’s second pathway at least excludes pathogens.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Quintana and Miyoshi in view of Syson; Paul et al. (US 20130008923 A1).
Regarding claims 8 and 17, Quintana and Miyoshi do not explicitly disclose that the air filter is a hydrophobic material. Syson discloses a spray dispenser for dispensing sterile fluids (¶ [0001], [0005], [0044] FIG. 1 shows an exploded view of part of a known spray dispenser … The known spray dispenser 1; ¶ [[0046] An example of a dispenser in accordance with the present invention will now be described with reference to FIGS. 2 to 6);
comprising an air filter that is a hydrophobic material such that air filtration and air flow rate into a reservoir are minimally affected by contact between the air filter and the liquid within the reservoir (¶ [0050],The filter (105) is located in a filter housing (116) to facilitate ease of handling. The filter is a membrane of hydrophobic material (Gore(R) membrane, W.L. Gore and Associates, Newark, USA), with 0.2 micron pores therein).
Syson constructs a filter from commercially available materials. A skilled artisan would have been able to modify Quintana and Miyoshi with Syson’s hydrophobic filter material by constructing Quintana’s filter from a hydrophobic Gore(R) membrane. Therefore, it would have been obvious to modify Quintana and Miyoshi with Syson’s hydrophobic filter material in order to assemble a bacterial air filter from a reliable and commercially available material.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Quintana and Miyoshi in view of Yeager; Don F. et al. (US 20110290752 A1).
Regarding claims 4 and 13, Quintana and Miyoshi lack a cap and plug. Yeager discloses a device comprising: a cap designed to cover an aperture, where the cap includes a plug that is designed to enter the aperture to displace liquid in the aperture (¶ [0045] FIGS. 3 and 4B, the closure 68 may also include a first sealing structure and/or a second sealing structure. When the cap 60 is in a closed position on the bottle 20, the first sealing structure seals the interior of the opening 52 of the tip insert 40 and the nozzle 42. The first sealing structure may include a cap pintel 72).
Yeager more effectively seals a dispensing aperture (¶ [0045], The cap pintel 72 may be sized and shaped, such that the cap pintel 72 frictionally fits into the opening 52 on the nozzle 42, thereby effectively closing and sealing the interior of the nozzle 42 when the cap 60 is placed on the bottle 20). One would be motivated to modify Quintana and Miyoshi with Yeager’s cap and plug to keep the dispensing aperture clean and minimize contamination between uses. Therefore, it would have been obvious to modify Quintana and Miyoshi with Yeager’s cap and plug in order to protect the dispensing aperture between uses.
Double Patenting
The following patents are relevant to the claimed invention:
Ivri; Yehuda US 12409063 B2
Ivri; Yehuda US 12290472 B2
Each patent claims a device for dispensing a liquid including an actuator. However, none of these patents claims first and second pathways and a stop designed to prevent the liquid from escaping. Therefore none of these references are cited in a double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clements; Don A. et al. US 5074440 A
Hardy; Michael E. US 5752629 A
Kawashima; Yoichi et al. US 5954233 A
Mbonyumuhire, Pierre et al. US 20050127107 A1
Kubo, Tomohiko et al. US 20050139611 A1
Daly; Paul J. US 20070112323 A1
Helle; Kevin et al. US 20100030181 A1
Reed; Jay et al. US 20100076397 A1
Michels; Stephan et al. US 20180360654 A1
Mansour; George et al. US 20200114071 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights