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 .
Response to Amendment
A preliminary amendment was filed on 05/24/2025. Claims 1-13 have been amended. Currently, claims 1-13 are pending and are being examined on the merits
Claim Rejections - 35 USC § 112
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 9-13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of a fluid having a volume in the order of 5-30 microliters, and the claim also recites a dose of ophthalmic liquid and a volume such as 5-7 microliters, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, the claim will be interpreted as requiring the device to be capable of dispensing an ophthalmic liquid at a volume of 5-7 microliters.
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, 3/1, 5/1, 9, 11/9, and 13/9 are rejected under 35 U.S.C. 103 as being unpatentable over Lim (US 20180338599) in view of Schmid (US 20190275541), and further in view of Cohen (US 5881956).
Regarding claim 1, Lim discloses a device for the delivery of a mist of a dose of an ophthalmic liquid (abstract; while the device is described for the use of a cosmetic container, the device is fully capable of providing a mist dose of ophthalmic liquid), said device comprising:
a housing with:
a holding chamber (61) having a discharge opening (fig. 2, passage 61 with a discharge opening with one of the plurality of through-holes 69A), said holding chamber configured for holding a dose of liquid to be delivered (fig. 2, nozzle passage 61 to serve as a holding chamber, with discharge opening as discharge port 66)
a pump configured for pumping, via a dose supply conduit (see annotated fig. 2 below), said dose of said liquid to said holding chamber (fig. 2, pump contained within piston housing 20 to supply fluid via an annotated dose supply conduit), said pump being connected with a container (C) containing a plurality of said doses (fig. 2, container C for holding doses)
an air flow conduit (26) configured for supplying a flow of air to said holding chamber so as to force said dose delivered by said pump to said holding chamber out through said discharge opening (fig. 2, inlet/outlet holes 26 where external air is introduced, paragraph 0039 describes compressed air being joined with the fluid when discharged)
wherein said pump comprises:
a first part with a base (fig. 2, base as top of cap housing 10), an elongated tubular structure (20) extending from said base (fig. 2, tubular structure as the pump housing 20), a seat configured for securing a neck of said container to said first part with said tubular structure extending inside said neck (fig. 2, cap housing 10, notably the part with threads connecting to the container C, serves as a seat to secure this with the neck of the container C), said tubular structure having a distal end including a one-way valve (22) configured for permitting flow of said liquid from said container into said elongated tubular structure (fig. 2, ball valve 22 as a common one-way valve), said tubular structure defining a pump chamber (fig. 2, piston housing 20 defines a pump chamber inside), said base having an opening leading into said pump chamber at a proximal end of said tubular structure (see annotated fig. 2 below),
a second part movable relative to said first part and including a pump stem (40) extending into said pump chamber through said opening (fig. 2, opening hosts piston 40 that moves with respect to piston housing 20), said pump stem (40) configured for moving relative to said first part inside said pump chamber between a retracted position and an advanced position (see motion between fig. 1 and fig. 2), with a free end of said pump stem closer to said one-way valve in said advanced position (fig. 2, piston 40 closer to ball 22 in advanced position), and elongated flow passage configured for liquid displaced from said pump chamber being defined between said pump stem and the inside of said tubular structure on moving said pump stem to said advanced position (see annotated fig. 2 below)
said dose supply conduit connecting said elongated flow passage with said liquid holding chamber (see annotated fig. 2 below).
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But does not teach a seal surrounding said opening, and wherein the dose supply conduit connecting the elongated flow passage with the liquid holding chamber includes a one-way valve configured for permitting flow of said liquid to said liquid holding chamber.
However, Schmid teaches a dispenser for discharging liquids (abstract) with a seal (45) surrounding said opening (fig. 1, sliding seal 45 with relation to the chamber unit 74, said chamber unit 74 gets moved between fig. 2A and fig. 2B)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that there is a seal surrounding said opening, as taught by Schmid, for the purpose of providing a suitable structure that grants the conventional feature of sealing between components to prevent leakage between them.
Lim does not teach wherein the dose supply conduit includes a one-way valve configured for permitting flow of said liquid to said liquid holding chamber.
However, Cohen teaches an ophthalmic pump (abstract) wherein the dose supply conduit includes a one-way valve (82) configured to permit flow of said liquid to said liquid holding chamber (fig. 2, check valve element 82)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that the dose supply conduit includes a one-way valve configured for permitting flow of said liquid holding chamber, as taught by Cohen, for the purpose of providing a suitable structure that limits flow from the annular flow path (see Cohen, col. 7, lines 33-46)
Regarding claim 3/1, Lim discloses the device further comprising a further chamber (67A) communicating with said single dose chamber via said discharge opening (fig. 2, guide passage 67A in communication with passage 61 via opening 69a), and a further air flow conduit for supplying a second flow of air to said further chamber (fig. 2, separate opening of a plurality of openings 69a to serve as a second air flow conduit, see annotated fig. 2 below), said further chamber having a discharge opening (66) for discharge from said device of said forced out single dose together with said second flow of air (fig. 2, discharge port 66 to release air and fluid, paragraph 0041 and 0046).
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Regarding claim 5/1, Lim discloses wherein said dose supply conduit includes a liquid entry port arranged at a proximal end of said tubular structure adjacent said opening (see annotated fig. 2 below), and appears to show that the dose supply conduit is lateral to the center longitudinal axis of the pump stem (see annotated fig. 2 below) but does not teach a segment of said dose supply conduit extending laterally relative to said pump stem.
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However, Schmid teaches wherein a segment of a dose supply conduit (see annotated fig. 2A below) extends laterally relative to a pump stem (see annotated fig. 2A below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that a segment of said dose supply conduit extends laterally relative to said pump stem, as taught by Schmid, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 9, Lim discloses a pump for the delivery of a liquid (abstract) the pump comprising:
a first part with a base (fig. 2, base as top of cap housing 10), an elongated tubular structure (20) extending from said base (fig. 2, pump housing 20) , a seat configured for securing the neck of said container to said first part with said tubular structure extending inside said neck (fig. 2, cap housing 10, notably the part with threads connecting to the container C, serves as a seat to secure this with the neck of the container C), said tubular structure having a distal end including a one-way valve (22) configured for permitting flow of said liquid from said container into said elongated tubular structure (fig. 2, ball valve 22 as a common one-way valve), said tubular structure defining a pump chamber (fig. 2, piston housing 20 defines a pump chamber inside), said base having an opening leading into said pump chamber at a proximal end of said tubular structure (see annotated fig. 2 below), and
a second part movable relative to said first part and including a pump stem (fig. 2, piston 40 with a pump stem) extending into said pump chamber through said opening (fig. 2, opening hosts piston 40 that moves with respect to piston housing 20), said pump stem configured for discharge of said liquid displaced from said pump chamber (paragraph 0039).
Lim is silent to wherein the pump delivers a liquid having a volume in the order of 5-7 microliters, and a seal surrounding said opening, wherein the pump stem is in sealing engagement with said seal.
However, Cohen teaches wherein a pump dispenses an amount of fluid as small as 5 microliters (col. 1, lines 33-40).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that the pump delivers a liquid having a volume in the order of 5-30 or 5-7 microliters, as taught by Cohen, for the purpose of providing a suitable structure that allows for microdoses for a controlled amount of desired solution (see Cohen, col. 1, lines 34-36), and since applicant appears to have placed no criticality on the claimed range (paragraph 0042 recites a dosage of 6 microliters and 15-20 microliters, and paragraph 0019 recites 5-30 microliters such as 6 microliters), and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Lim fails to teach a seal surrounding said opening, wherein the pump stem is in sealing engagement with said seal.
However, Schmid teaches a dispenser for discharging liquids (abstract) with a seal (45) surrounding said opening (fig. 1, sliding seal 45 with relation to the chamber unit 74, said chamber unit 74 gets moved between fig. 2A and fig. 2B)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that there is a seal surrounding said opening, as taught by Schmid, for the purpose of providing a suitable structure that grants the conventional feature of sealing between components to prevent leakage between them.
Regarding claim 11/9, Lim does not teach wherein a segment of said dose supply conduit includes a normally closed one-way valve.
However, Cohen teaches wherein the dose supply conduit includes a one-way valve (fig. 2, check valve 82) that is normally closed (fig. 2 shows check valve 82 closed when the mechanism is not being activated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that a segment of said dose supply conduit includes a normally closed one-way valve, as taught by Cohen, for the purpose of providing a suitable structure that limits flow from the annular flow path (see Cohen, col. 7, lines 33-46).
Regarding claim 13/9, Lim discloses wherein said dose supply conduit includes a liquid entry port arranged at a proximal end of said tubular structure adjacent said opening (see annotated fig. 2 below), and appears to show that the dose supply conduit is lateral to the center longitudinal axis of the pump stem (see annotated fig. 2 below) but does not teach a segment of said dose supply conduit extending laterally relative to said pump stem.
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However, Schmid teaches wherein a segment of a dose supply conduit (see annotated fig. 2A below) extends laterally relative to a pump stem (see annotated fig. 2A below).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that a segment of said dose supply conduit extends laterally relative to said pump stem, as taught by Schmid, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claims 6 and 7/1 are rejected under 35 U.S.C 103 as being unpatentable over Lim in view of Schmid and Cohen, and further in view of Nielsen (US 20170007449)
Regarding claim 6, Lim does not teach wherein said container is collapsible.
However, Nielsen teaches wherein collapsible containers are well known in the art (fig. 2, reservoir 70 as collapsible, paragraph 0036)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Lim such that the container is collapsible, as taught by Nielsen, for the purpose of providing a suitable structure that guarantees an emptying of the reservoir (see Nielsen, paragraph 0036)
Regarding claim 7/1, Lim discloses the device including an air chamber (30), connected to said air flow conduit (fig. 2, compressing chamber 30 in communication with inlet/outlet holes 26), a displaceable piston configured for driving a volume of air out of said air chamber (fig. 2, piston 40 has a stem as recited in claim 1, and a head at the tip of the piston 40 interpreted as the displaceable piston, paragraph 0049), and a drive (60) for controlling displacement of said piston (fig. 1, pressurizing cap 60 serves as a drive to move the stem of piston 40, and therefore the head of piston 40).
Allowable Subject Matter
Claims 2, 3/2, 4/1, 4/2, 5/2, 7/2, 8, 10, 11/10, 12/9, 12/10, and 13/10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. With respect to the above claims dependent on claim 9, they would be allowable if claim 9 is rewritten to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, and included all the limitations of the base claim and any intervening claims.
Regarding claim 2, Lim does not teach wherein said second part includes a peripheral wall surrounding said first part when in said advanced position of said pump stem.
Such as structure appears to be related to the structure of the instant invention where the pump supplying fluid from the container to be in tandem to a separate air chamber and separate pump.
Nielsen discloses a pump means for supplying fluid into a dispensing chamber, as well as a piston chamber for air, but does not teach the pump stem structure or a second part with a peripheral wall surrounding the first part.
For these reasons, claim 2 is allowable.
Claims that are dependent on claims 1 or 2 would be allowable if dependent on claim 2.
Regarding claims 4/1 and 4/2, Lim does not teach a spring surrounding said first part for controlling said movement of said pump stem inside said pump chamber between said retracted and advanced positions.
Lim teaches a spring that biases a pump stem inside the pump chamber between the retracted and advanced positions, but there does not appear to be a motivation to have a spring surrounding the first part to control the pump stem.
Notably, this structure appears to coincide with the peripheral wall of claim 2, where for a similar reason it would not have been obvious to add the limitations of claim 2, it would not be obvious to add the limitation of claim 4
For these reasons, claims 4/1 and 4/2 are allowable.
Regarding claim 8, Lim does not teach a rotatable handle, said piston including a piston rod and piston head received in said air chamber, wherein rotation of said handle moves said piston to a retracted positioned for drawing in said volume of air into said air chamber, and wherein said rotation of said handle controls said movement of said second part relative to said first part.
The piston involved in compressing the air in Lim includes the piston stem recited in claim 1 and a piston head in the same chamber, but does not teach a separate piston rod and head in the separate air chamber.
Nielsen teaches the above structures of a rotatable handle with a piston rod and piston head received in the air chamber, wherein rotation of the handle moves the piston to a retracted position, but as previously mentioned such a structure does not appear to be obvious to incorporate into the device of Lim without hindsight reasoning and major design changes.
For these reasons, claim 8 is allowable.
Claim 10 is allowable for similar reasons as highlighted in claim 2.
Similarly, claims that are dependent on claims 9 or 10 would be allowable if dependent on claim 10.
Claims 12/9 and 12/10 are allowable for similar rationale with respect to claims 4/1 and 4/2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781