DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 4 and claim 16 are objected to because of the following informalities:
Regarding claim 4, add a comma after “claim 1”
Regarding claim 16, replace “thru” with –through--
Appropriate correction is required.
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 16, 18, 19, 20, 21 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.
Regarding claim 16, the limitation “wherein a line drawn thru a point on the outlet orifice is an equal distance to the central axis of the nozzle” renders the claim indefinite. It is unclear what is meant be an equal distance to the central axis as there is no point of comparison. Further, the examiner notes that a line may be drawn through a point on the outlet orifice in several different planes and a line drawn at an angle through the orifice would have varying distances along the length of the line. For examination purposes the examiner will assume that a line drawn through an axis of the orifice will be an equal distance to the central axis of the nozzle at any point along the line.
Regarding claim 18, the limitations “wherein the angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree” renders the claim indefinite since it is unclear if the plume needs to be all of those angles or if the plume should be those angles at a particular point. For examination purposes the examiner will assume the plume should be 5 degrees or less at any point after exiting the nozzle.
Claim 19 is rejected based on its dependency to claim 18.
Regarding claim 20, the limitation “wherein an impact force delivered by the nozzle is decreased” is indefinite since it is not stated what the impact force is being compared relative to. The examiner will assume a nozzle having the structural shape of claim 15, including multiple channels, will meet the limitations of this claim.
Regarding claim 21, the limitation “wherein a delivery time is reduced” is indefinite since it is unclear what the delivery time is being compared to. For examination purposes a nozzle having multiple channels as disclosed in claim 15 will meet the limitations of the claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-2, 4-5, 14-16, 20-22, and 24 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Kraft et al (US 2008/0230053), hereinafter Kraft.
Regarding claim 1, Kraft teaches a nozzle (Figs. 1A, 3: 70, paragraph 89) comprising:
a drug product inlet configured to receive a mixture of an aerosolized propellant and an intranasal dosage form (paragraph 84, drug emulsion 19 enters the inner microtube 14 of assembly 10 via port 4, is propelled down the fluid microchannel 18 via an appropriate gas), the drug product inlet disposed at a proximal end (Fig. 1A: end with port 4),
a nozzle body defining at least two channels (Fig. 3, multiple channels), the channels having a proximal end and a distal end (see Fig. 1A, end with port 4 and outlet end), the body defining a longitudinal axis (Fig. 1A, Fig. 3), and,
an outlet disposed at the distal end of each channel.(Fig. 1A, Fig. 3, end 71 of nozzles)
Regarding claim 2, Kraft teaches the nozzle of claim 1, and further teaches wherein the channels are disposed parallel to the longitudinal axis. (See fig. 1A)
Regarding claim 4, Kraft teaches the nozzle of claim 1, and further teaches comprising at least five channels. (paragraph 89, ranges from 2 to 12 nozzles))
Regarding claim 5, Kraft teaches the nozzle of claim 1, and further teaches wherein the channels are circular or tubular in shape. (Fig. 3)
Regarding claim 14, Kraft teaches the nozzle of claim 1, and further teaches wherein the channels are a plastic or a metal (Paragraph 90), the body is a plastic or a metal (paragraph 90), and a void is disposed between the channels and the body.(See Fig. 3)
Regarding claim 15, Kraft teaches a nozzle for delivering a compound to an upper olfactory region of a user (Fig. 3, paragraph 89) comprising:
a nozzle body having a central axis (Fig. 3: 72 with axis 75),
a plurality of channels housed within the nozzle body (Fig. 3, paragraph 89, between 2 and 12 channels), the channel having a proximal and a distal end (Fig. 1A, channel has proximal and distal end),
an inlet disposed at the proximal end of the channel (Fig. 1A, port 4),
an outlet orifice disposed at the distal end of the channel (Fig. 1A: end 11, paragraph 85), the outlet orifice arranged parallel to the central axis of the nozzle. (Figs. 1A, 3)
Regarding claim 16, Kraft teaches the nozzle of claim 15, wherein a line drawn through (See 112b rejection) a point on the outlet orifice is an equal distance to the central axis of the nozzle. (Fig. 3 a line drawn through the central axis is parallel to a line drawn through the axis of the nozzle so the lines would be equal distance from each other at any point.
Regarding claim 20, Kraft teaches the nozzle of claim 15, and further teaches wherein an impact force delivered by the nozzle is decreased. (the instant specification teaches that multiple channels result in a decreased impact force (paragraph 69), therefore since Kraft teaches multiple delivery channels the impact force would be reduced. Also see the 112b rejection with respect to the claim)
Regarding claim 21, Kraft teaches the nozzle of claim 15, and further teaches wherein a delivery time for the compound is decreased. (the instant specification teaches that multiple channels result in a decreased delivery time (paragraph 68), therefore since Kraft teaches multiple delivery channels the delivery time would be reduce. Also see the 112b rejection with respect to the claim)
Regarding claim 22, Kraft teaches a nozzle for delivering a compound to an upper olfactory region of a user (Fig. 3, paragraph 89)comprising:
a nozzle body (Fig. 3: 72),
a compound channel housed within the nozzle body (Fig. 3: 74, 76), the compound channel having a proximal end and a distal end (Fig. 1A), the proximal end capable of receiving a compound (Fig. 1A, receives compound at inlet 4), the distal end of the compound channel having an outlet orifice (Fig. 1A: 11), and
a propellant channel (Fig. 1: 12), the propellant channel having a proximal end and a distal end (Fig. 1, paragraph 86), the proximal end capable of receiving a propellant (paragraph 85, carrier gas), the distal end of the propellant channel having an outlet orifice Fig. 1), the compound channel being centered within the propellant channel (Fig. 1, 1A, 1B), wherein the compound and propellant are capable of being emitted from the from the respective outlet orifice.(Figs. 1A, 1B)
Regarding claim 24, Kraft teaches the nozzle of claim 22, wherein the compound is a liquid, a powder, a gas, or combinations thereof. (paragraph 85, a liquid)
Claims 1 and 3 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Djupesland (US Pat. 8,550,073), hereinafter Djupesland.
Regarding claim 1, Djupesland teaches a nozzle (Fig. 49: 345) comprising:
a drug product inlet configured to receive a mixture of an aerosolized propellant and an intranasal dosage form ( Fig. 54, see below, abstract, Col. 1: lines 1-5), the drug product inlet disposed at a proximal end (Fig. 54),
a nozzle body defining at least two channels (Fig. 54: nozzle body 345, see below, channels Col. 22: lines 40-55), the channels having a proximal end and a distal end (Fig. 54: see below), the body defining a longitudinal axis (Fig. 54, longitudinal axis would be center of nozzle body), and,
an outlet disposed at the distal end of each channel.(See Fig. 55)
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Regarding claim 3, Djupesland teaches the nozzle of claim 1, and Djupesland further teaches wherein the channels are disposed at an angle with respect to the longitudinal axis. (See Fig. 55, nozzle channels are at an angle)
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraft.
Regarding claim 6, Kraft the nozzle of claim 1, but does not teach wherein the channels are conical in shape.
However, Kraft teaches that the channels may be of any appropriate shape, providing such shape provides the same advantageous flow rates and particle sizes as illustrated. (paragraph 85)
Therefore, the shape of the tubes is a REV affecting the flow rate and particles sizes.
Therefore, it would have been obvious to one having ordinary skill to have modified Kraft so that the channels are conical in shape as a matter of routine optimization since it has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum conditions.
Claims 7-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraft in view of Collins, JR. (US 2009/0192443), hereinafter Collins.
Regarding claim 7, Kraft teaches the nozzles of claim 1, and further teaches comprising four outlet orifices (paragraph 89, may range from 2 to 12), wherein the outlet orifices are circular (Fig. 3, orifices are circular but does not teach arranged in a square.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft so that the outlet orifices are circular and arranged in a square as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 8, Kraft teaches the nozzle of claim 1, fand further teaches comprising five outlet orifices (paragraph 89), wherein the outlet orifices are circular in shape (Fig. 3) but does not teach arranged in a pentagon.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft so that the outlet orifices are circular and arranged in a pentagon as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 9, Kraft teaches the nozzle of claim 1, and further teaches comprising six outlet orifices (paragraph 89), wherein the outlet orifices are circular in shape (Fig. 3) but does not teach arranged in a hexagon.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft so that the outlet orifices are circular and arranged in a hexagon as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 10, Kraft teaches the nozzle of claim 1, and further comprising six outlet orifices (paragraph 89), but does not teach wherein five of the outlet orifices are configured in a pentagon and one outlet orifice is configured at the center of the pentagon.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft so that five of the outlet orifices are configured in a pentagon and one outlet orifice is configured at the center of the pentagon as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 11, Kraft teaches the nozzle of claim 1, and further teaches comprising four outlet orifices (Paragraph 89), but does not teach the outlet orifices arranged in a line.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft so that five of the outlet orifices are arranged in a line as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 12, Kraft teaches the nozzle of claim 1, further comprising four outlet orifices (paragraph 89), but does not teach wherein the outlet orifices are rectangular in shape and radiate out from the center axis of the nozzle.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft the outlet orifices are rectangular in shape and radiate out from the center axis of the nozzle as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 13, Kraft teaches the nozzle of claim 1, and further teaches further comprising five outlet orifices (paragraph 89), but does not teach wherein the outlet orifices are star shaped and arranged in a pentagon.
However, Collins teaches a fluid atomizer (abstract) and teaches that the number, density and shape of the outlet orifices contribute to parameters such as volume, velocity, and droplet size distribution. As such, the nozzle shape and pattern is a results effective variable.
It would have been obvious to a person of ordinary skill in the art to have modified the device of Kraft the outlet orifices are star shaped and arranged in a pentagon as claimed as a matter of routine optimization since it has been held that where the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Claims 17-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraft in view of Baran (US Pat. No. 6,526,976), hereinafter Baran.
Regarding claim 17, Kraft teaches the nozzle of claim 15, but does not explicitly state wherein the outlet orifices are arranged so that a narrow plume exits the nozzle.
However, Baran teaches a nebulizing system which teaches that the plume size is a factor affecting the rate and efficacy of the delivery of medication. (Col 13: lines 50-60)
Therefore, it would have been obvious to a person of ordinary skill in the art to have provided the nozzle of Kraft with a narrow plume as claimed in order to provide the medication to the desired area.
Regarding claim 18, Kraft teaches the nozzle of claim 17, but does not teach wherein the angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree.
However, Baran teaches a nebulizing system which teaches that the plume size is a factor affecting the rate and efficacy of the delivery of medication. (Col 13: lines 50-60)
Therefore, it would have been obvious to a person of ordinary skill in the art to have provided the nozzle of Kraft with the angle of the plume is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree as claimed in order to provide the medication to the desired area.
Regarding claim 19, the nozzles of claim 18, wherein the angle of the plume is 5 degrees.
However, Baran teaches a nebulizing system which teaches that the plume size is a factor affecting the rate and efficacy of the delivery of medication. (Col 13: lines 50-60)
Therefore, it would have been obvious to a person of ordinary skill in the art to have provided the nozzle of Kraft with an angle of the plume is 5 degrees in order to provide the medication to the desired area.
Claim 23 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraft in view of Minotti (US Pat. No. 7,875,001), hereinafter Minotti.
Regarding claim 23, kraft teaches the nozzle of claim 22, but does not teach further comprising at least a second compound channel, wherein the nozzle is capable of delivering more than one compound at a time.
However, Minotti teaches multiple compounds delivered at a time. (Abstract, Fig. 5, Col. 5: lines 26-35)
It would have been obvious to a person of ordinary skill in the art to have provided the nozzle of Kraft with the ability to delivery multiple compounds as taught by Minotti to allow the use of multiple medicaments without potential interactions or incompatibilities between the medicaments. (Col. 1:lines 55-60)
Claim 25 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kraft in view of Smith (US Pat. No. 5,690,256), hereinafter Smith.
Regarding claim 25, Kraft teaches the nozzle of claim 22, but does not teach further comprising a check shut off valve wherein the check shut off valve prevents propellant from flowing through the compound chamber once the compound is released.
However, Smith teaches an aerosol valve with a ball (Fig. 2: 54) having a diameter smaller than a diameter of the compound channel (Fig. 2: 48 and 40) and configured to block the compound channel. (Fig. 3)
It would have been obvious to a person of ordinary skill in the art to have modified Kraft to include the shut off valve of Smith to control the flow of compound. (Col. 4: lines 1-4)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 12, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 14 of U.S. Patent No. 9,919,117. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent teaches all of the limitations of the claims.
Regarding claim 1, a nozzle (Claim 1, a nozzle) comprising:
a drug product inlet (Claim 1: a drug product inlet) configured to receive a mixture of an aerosolized propellant and an intranasal dosage form (Claim 1 a mixture of a propellant and the intranasal dosage form), the drug product inlet disposed at a proximal end (claim 1, a drug product inlet at the proximal end),
a nozzle body defining at least two channels (Claim 1, 5 channels), the channels having a proximal end and a distal end (Claim 1, a proximal end and a distal end) , the body defining a longitudinal axis (claim 1, defining a longitudinal axis), and,
an outlet disposed at the distal end of each channel. (Claim 1, a circular outlet disposed at the distal end)
Regarding claim 2, the nozzle of claim 1, wherein the channels are disposed parallel to the longitudinal axis. (Claim 2, disposed parallel to the longitudinal axis)
Regarding claim 3, the nozzle of claim 1, wherein the channels are disposed at an angle with respect to the longitudinal axis. (Claim 10, disposed at an angle with respect to the longitudinal axis)
Regarding claim 4, the nozzle of claim 1, further comprising at least five channels. (Claim 1, 5 channels)
Regarding claim 5, the nozzle of claim 1, wherein the channels are circular or tubular in shape. (Claim 1, circular channels)
Regarding claim 8, the nozzle of claim 1, further comprising five outlet orifices, wherein the outlet orifices are circular in shape and arranged in a pentagon. (Claim 1, circular outlets arranged in a pentagon)
Regarding claim 14, the nozzle of claim 1, wherein the channels are a plastic or a metal, the body is a plastic or a metal, and a void is disposed between the channels and the body. (claim 3)
Claims 1, 2, 4, 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, of U.S. Patent No. 10,940,278. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent teaches all of the limitations of the claims.
Regarding claim 1, a nozzle (Claim 1, a nozzle) comprising:
a drug product inlet configured to receive a mixture of an aerosolized propellant and an intranasal dosage form (Claim 1, a drug product inlet configured to receive a mixture of an aerosolized propellant the intranasal dosage form), the drug product inlet disposed at a proximal end (Claim 1, the drug product inlet disposed at a proximal end),
a nozzle body defining at least two channels (Claim 1, a plurality of channels), the channels having a proximal end and a distal end (Claim 1, each channel having a proximal and distal end), the body defining a longitudinal axis (Claim 1, a longitudinal axis), and,
an outlet disposed at the distal end of each channel. (Claim 1, outlet at distal end of the channel)
Regarding claim 2, the nozzle of claim 1, wherein the channels are disposed parallel to the longitudinal axis. (Claim 1)
Regarding claim 4, the nozzle of claim 1, further comprising at least five channels. (Claim 7, between 4 to 11 channels)
Regarding claim 15, a nozzle for delivering a compound to an upper olfactory region of a user (Claim 12 intranasal dosage)comprising:
a nozzle body having a central axis (Claim 12, longitudinal axis),
a plurality of channels housed within the nozzle body (Claim 12, plurality of channels), the channel having a proximal and a distal end (Claim 12 product inlet a first end of the nozzle, outlet at a distal end of the channel)
an inlet disposed at the proximal end of the channel (Claim 12, from the drug product inlet through the channel),
an outlet orifice disposed at the distal end of the channel (Claim 12, outlet orifice at a distal end of the channel), the outlet orifice arranged parallel to the central axis of the nozzle. (claim 12, orifice arranged parallel to the axis)
Regarding claim 16, the nozzle of claim 15, wherein a line drawn through (do claim objection for thru) a point on the outlet orifice is an equal distance to the central axis of the nozzle. (Claim 12, the channels are parallel to the longitudinal axis so if a line was drawn though the center axis of the orifice each point on the line would be the same distance to the central axis of the nozzle)
Regarding claim 17, the nozzle of claim 15, wherein the outlet orifices are arranged so that a narrow plume exits the nozzle. (Claim 12, plume does not exceed 5 degrees)
Regarding claim 18, the nozzle of claim 17, wherein the angle of the plum is about 5 degrees, about 4 degrees, about 3 degrees, about 2 degrees, about 1 degree. (Claim 12, plume does not exceed 5 degrees)
Regarding claim 19, the nozzles of claim 18, wherein the angle of the plume is 5 degrees. (Claim 12, does not exceed 5 degrees)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARGARET M LUARCA whose telephone number is (303)297-4312. The examiner can normally be reached 6:30 am - 3:00 pm MT.
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/MARGARET M LUARCA/ Primary Examiner, Art Unit 3785
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