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
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.
Claim 10 is 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. Claim 10 recites the limitation of “the reservoir is filled with the inhalable composition in an intake volume for 10 to 15 times of puffs”, however describing the volume of the inhalable composition in terms of the number of “puffs” is subjective based on the user and the appropriate dosage, therefore the claim is indefinite. For the purpose of examination, the examiner has taken this limitation to be met as long as the reservoir is capable of holding a volume of inhalable composition.
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Andersson (WO 99/49916).
Regarding claim 1, Andersson discloses an inhaler (inhaler device, Abstract and Figure 1) comprising: a housing having one surface, the other surface opposite to the one surface (casing 6 comprises a front casing part 192 and a rear casing part 190, Figure 4), and a plurality of side surfaces connecting the one surface and the other surface (side wall surfaces 228, 238, 216, 194 connecting the rear and front casing parts, Figure 4); a canister which is mounted interchangeably inside the housing and accommodates an inhalable composition (canister 8 mounted inside housing 22 and comprising a chamber accommodating a medicament, Figure 4 and Abstract); a reservoir which is positioned inside the housing and to which one side of the canister is connected (the valve stem 13 of the cannister 8 is connected to a nozzle block 24 including a tubular bore 72, through which the medicament is directed towards, Figure 5 and Page 8, second paragraph); and a lever having one side forming a portion of the housing (lever arm 132 pivotally connected to drawbar 136, connected to housing 22, Figure 5 and Page 13, second paragraph), and the other side being movable between a bottom surface of the canister and the other surface of the housing (projections 156 of drawbar 136 configured to engage the base end 11 of the cannister, Page 13, second paragraph and Figure 5), wherein, when one side of the lever is pressed, the other side of the lever moves the canister in a direction toward the reservoir and some of the inhalable composition in the canister are stored in the reservoir (in operation, the downward movement of the drawbar 136 through the projections 156 cause the body 10 of the canister 8 to be depressed relative to the valve stem 13 thereof, which relative movement causes the actuation of canister 8 so as to deliver a metered dose of medicament into the tubular section 20 of the mouthpiece 21, Page 13, second paragraph and Figures 5-6).
Regarding claim 2, Andersson further discloses when the lever is pressed, the lever moves in a first direction from one side of the housing toward the canister (in operation, the downward movement of the drawbar 136 through the projections 156 cause the body 10 of the canister 8 to be depressed relative to the valve stem 13 thereof, which relative movement causes the actuation of canister 8 so as to deliver a metered dose of medicament into the tubular section 20 of the mouthpiece 21, Page 13, second paragraph and Figures 5-6).
Regarding claim 3, Andersson further discloses wherein the reservoir (nozzle block 24, Figure 5) is disposed adjacent to the one surface of the housing (see nozzle block 24 disposed adjacent to front casing part, Figure 5), wherein the other side of the canister extends from the one side of the canister to the other surface of the housing (see canister 8 extending towards other surface of housing 22, Figure 5), and wherein, when the lever is pressed, the canister moves in a second direction from the other surface to the one surface of the housing (in operation, the downward movement of the drawbar 136 through the projections 156 cause the body 10 of the canister 8 to be depressed relative to the valve stem 13 therefore moving the canister 8 in a direction from one surface of the housing 22 towards the other, Page 13, second paragraph and Figures 5-6).
Regarding claim 7, Andersson further discloses an accommodation portion which accommodates the inhalable composition (cannister 8 comprises a cylindrical body in which the medicament is held, Figure 5 and Abstract; the Examiner notes this is consistent with the “accommodation portion 210” as shown in Figure 3 of Applicant’s specification and drawings); and an injection hole having one side connected to the reservoir and the other side positioned in the accommodation portion (spray orifice 82 connected to both canister 8 and nozzle block 24, Figure 5), and wherein the injection hole is operated to be opened or closed with respect to the reservoir (an internal metering valve (not illustrated) which is normally biased to a closed position and opened to deliver a metered dose of medicament from the canister 8 when the valve stem 13 and associated lever is depressed, therefore directing medicament to be exit spray orifice 82, Figures 5-6 and Page 6, third paragraph).
Regarding claim 8, Andersson further discloses when the lever is pressed, the injection hole is opened to allow the inhalable composition to move to the reservoir, and when the lever is not pressed, the injection hole is closed (an internal metering valve (not illustrated) which is normally biased to a closed position and opened to deliver a metered dose of medicament from the canister 8 when the valve stem 13 and associated lever is depressed, therefore directing medicament to be exit spray orifice 82, Figures 5-6 and Page 6, third paragraph).
Regarding claim 9, Andersson further discloses further comprising: an elastic member which is provided in the injection hole (biasing element 134, Figures 5-6), wherein the elastic member is compressed when the canister moves in a second direction from the other surface to the one surface of the housing, and returns the canister to its original position when no external force is applied to the canister (the loading mechanism 18 comprises a drawbar assembly 130 which is slidably disposed 20 to the housing 22, a lever arm 132 which is pivotally coupled to the housing 22 and a biasing element 134, in this embodiment a compression spring, which is disposed between the drawbar assembly 130 and the lever arm 132 such as to load the drawbar assembly 130 on acting upon the lever arm 132, Page 11 second paragraph and Figures 5-6).
Regarding claim 10, Andersson further discloses when the lever is pressed, the reservoir is filled with the inhalable composition in an intake volume for 10 to 15 times of puffs (The Examiner notes the 112b rejection presented above; in operation, the downward movement of the drawbar 136 through the projections 156 cause the body 10 of the canister 8 to be depressed relative to the valve stem 13 thereof, which relative movement causes the actuation of canister 8 so as to deliver a metered dose of medicament into the tubular section 20 of the mouthpiece 21, Page 13, second paragraph and Figures 5-6).
Allowable Subject Matter
Claims 4-6 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. Regarding claims 4-6, these limitations are directed towards the involvement of a second lever extending from the first lever towards the canister, wherein the second lever comprises an inclined surface formed in a shape in which a height decreases along a first direction, such that when the first lever member is pressed, the inclined portion of the second lever moves the bottom surface of the canister in a second direction. Although Andersson teaches the use of a lever to move the bottom surface of the canister, Andersson is silent on the involvement of a second lever. As Andersson’s inhaler device functions using only one lever arm, a radical modification of its lever system would be required in order to include a second lever assembly that interacts with the existing lever.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Li et al. (US 2017/0265526 A1) and Raghuprasad (4,576,157).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785