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
This office action is in response to the preliminary amendment filed 3/9/2023. As directed by the amendment, claims 4-6, 8, 9, 11, 15-19 and 22 have been amended, and claims 7, 10 and 14 have been cancelled. As such, claims 1-6, 8, 9, 11-13 and 15-23 are pending in the instant application.
Claim Objections
Claims 1-6, 8, 9, 11-13, 15-21 and 23 are objected to because of the following informalities:
Claim 1, line 4 should read “actuatable” to make it clearer that an active step is not being recited in an apparatus claim
Claim 1, line 9 should read “wherein actuation of the valve by the controller to agitate and actuation of the valve by the controller to release the dose are configured to be” to make it clearer that active steps are not being recited in an apparatus claim and because “a dose” is understood to be referring to that of line 8
The preambles of claims 2-6, 8, 9, 11-13 and 15-19 should be amended to read “The apparatus” for clearer antecedent basis
Claim 3, line 2 should read “the dose” because it is understood to be referring to that of claim 1, line 8
Claim 3, line 3 should read “the reciprocal motion” because it is understood to be referring that of claim 2, line 2
Claim 5, lines 2-3 should read “wherein the actuation of the valve to agitate and the actuation of the valve to release the dose are configured to be” for clearer antecedent basis in conjunction with the amendments recommended above/to make it clearer that active steps are not being recited in an apparatus claim, and because “a dose” is understood to be referring to that of claim 1, line 8
Claim 6, line 2 should read “the actuation” for clearer antecedent basis in conjunction with the amendments recommended above
Claim 8, line 3 should read “is configured to be moved” to make it clearer that the limitation is a required configuration
Claim 8, line 4 should read “the dose” because it is understood to be referring to that of claim 1, line 8
Claim 8, line 5 should read “is configured to be moveed” to make it clearer that an active step is not being recited in an apparatus claim
Claim 11, line 3 should read “the dose” because it is understood to be referring to that of claim 1, line 8
Claim 12, line 3 should read “the dose” because it is understood to be referring to that of claim 1, line 8
Claim 12, line 4 should read “position is configured to be controlled” to make it clearer that an active step is not being recited in an apparatus claim
Claim 16, line 2 should read “the dose” because it is understood to be referring to that of claim 1, line 8
Claim 18, line 2 should read “Pa-s”
Claim 19 is lacking a period at the end thereof
Claim 20, line 8 should read “wherein the actuating…and the actuating…the dose” because they are understood to be referring to that of lines 6-7
Claim 21, line 2 should read “wherein the actuating…and the actuating” because they are understood to be referring to that of claim 20, lines 6-7
Claim 23, line 7 should read “the method further comprises”, since lines 2-6 are also comprised by the method
Claim 23, line 11 should read “wherein the actuating…and the actuating…the dose” because they are understood to be referring to that of lines 8-9
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 12 and 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.
Claim 12 (and thus its dependent claim 13) recites the limitation "the metering chamber" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
Valve actuations that are “discrete” are understood to be valve movements that are separated in time/occur non-concurrently.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a delivery portion” in claim 23.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof: mouthpiece, nosepiece, spacer or attachment adapter per para [0078].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 9, 11, 15, 16 and 20-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rasmussen et al. (US 2010/0043785 A1; hereinafter “Rasmussen”).
Regarding claim 1, Rasmussen discloses a storage and dispensing apparatus for a pressurised metered dose inhaler (Figs. 1, 3a, 4 and 13), the apparatus comprising:
a canister (canister/container 123) containing a mixture of a propellant and a therapeutic agent (e.g. Figs. 1 and 12a; paras [0009], [0028] and [0075]);
an electronically actuated valve (comprising valve rotor 31) (Figs. 3a and 13; para [0097]);
a controller (controller 133) configured to control the valve (Fig. 13; para [0097]);
wherein the controller is further configured to:
actuate the valve to agitate the mixture within the canister (Fig 4, movement from filling position 41 to half-way position 43, wherein the rotational movement of the valve will agitate the mixture to some degree as the leading upper edge of the cavity 32 scoops/passes through the mixture; OR see para [0096], which teaches multiple rotations during a single inhalation, such that repeated rotation/refilling will also agitate the mixture, particularly since the rounded valve displaces a volume of the mixture within the canister in positions 42 and 43); and
actuate the valve to release a dose of the agitated mixture from the canister (Fig. 4, movement from position 43 to dose release position 44);
wherein actuating the valve to agitate and actuating the valve to release a dose are discrete (Fig. 4, where the movement from 41 to 43 occurs, then the movement from 43 to 44 occurs; OR, in the case of the multiple rotations taught by para [0096], the claimed actuating can be considered any subsequent dose delivery actuation after the first rotation).
Regarding claim 9, Rasmussen discloses the apparatus according to claim 1, wherein the valve is a shuttle valve comprising a valve body and an axially moveable valve member (Figs. 12c-d).
Regarding claim 11, Rasmussen discloses the apparatus according to claim 1, wherein the valve is a metering valve configured to release a predetermined volume of the mixture during actuating the valve to release a dose (Fig. 4; paras [0069-70]).
Regarding claim 15, Rasmussen discloses the apparatus according to claim 1, wherein the mixture is a suspension of the therapeutic agent in the propellant (paras [0009], [0017], [0028] and [0075]).
Regarding claim 16, Rasmussen discloses the apparatus according to any preceding claim 1, wherein the controller is configured to only actuate the valve to release a dose within a predetermined time window after the valve has been actuated to agitate the mixture (Fig. 4; paras [0069-70], [0092] and [0096-97], wherein the turning speed dictates the time window from position 43 to 44).
Regarding claim 20, Rasmussen discloses a method of actuating a storage and dispensing apparatus for a pressurised metered dose inhaler (Fig. 4), the apparatus comprising:
a canister (canister/container 123) containing a mixture of a propellant and a therapeutic agent (e.g. Figs. 1 and 12a; paras [0009], [0028] and [0075]); and
a valve (comprising valve rotor 31) (Fig. 3a);
wherein the method comprises:
actuating the valve to agitate the mixture within the canister (Fig 4, movement from filling position 41 to half-way position 43, wherein the rotational movement of the valve will agitate the mixture to some degree as the leading upper edge of the cavity 32 scoops/passes through the mixture OR see para [0096], which teaches multiple rotations during a single inhalation, such that repeated rotation/refilling will also agitate the mixture, particularly since the rounded valve displaces a volume of the mixture within the canister in positions 42 and 43); and
actuating the valve to release a dose of the agitated mixture from the canister (Fig. 4, movement from position 43 to dose release position 44);
wherein actuating the valve to agitate and actuating the valve to release a dose are discrete (Fig. 4, where the movement from 41 to 43 occurs, then the movement from 43 to 44 occurs; OR, in the case of the multiple rotations taught by para [0096], the claimed actuating can be considered any subsequent dose delivery actuation after the first rotation).
Regarding claim 21, Rasmussen discloses the method of actuating according to claim 20, wherein the apparatus comprises an electronic controller (controller 133) (Fig. 13), and wherein actuating the valve to agitate and actuating the valve to release the dose are carried out by the controller (para [0097]).
Regarding claim 22, Rasmussen discloses the method of actuating according to claim 20, wherein the apparatus is according to claim 1 (see claim 1 discussion above).
Regarding claim 23, Rasmussen discloses a method of delivery of a medicament to a human or animal (Figs. 4, 13 and 17; paras [0004], [0011], [0030], [0094-98]) comprising:
providing a pressurised metered dose inhaler (e.g. Fig. 17) having:
a canister (canister/container 123) containing a mixture of a propellant and a therapeutic agent (e.g. Figs. 1 and 12a; paras [0009], [0028] and [0075]); and
a valve (comprising valve rotor 31) (Fig. 3a); and
a delivery portion (mouthpiece 11) for delivering the medicament to a human or animal (Fig. 17; e.g. para [0098]);
wherein the method comprises:
actuating the valve to agitate the mixture within the canister (Fig 4, movement from filling position 41 to half-way position 43, wherein the rotational movement of the valve will agitate the mixture to some degree as the leading upper edge of the cavity 32 scoops/passes through the mixture OR see para [0096], which teaches multiple rotations during a single inhalation, such that repeated rotation/refilling will also agitate the mixture, particularly since the rounded valve displaces a volume of the mixture within the canister in positions 42 and 43); and
actuating the valve to release a dose of the agitated mixture from the canister (Fig. 4, movement from position 43 to dose release position 44);
wherein actuating the valve to agitate and actuating the valve to release a dose are discrete (Fig. 4, where the movement from 41 to 43 occurs, then the movement from 43 to 44 occurs; OR, in the case of the multiple rotations taught by para [0096], the claimed actuating can be considered any subsequent dose delivery actuation after the first rotation).
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 9, 11, 15-17 and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rand (US 7,461,650 B1; hereinafter “Rand) in view of Kominami et al. (US 2022/0242655 A1; hereinafter “Kominami”).
Regarding claim 1, Rand discloses/suggests a storage and dispensing apparatus for a pressurised metered dose inhaler (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-9), the apparatus comprising:
a canister (aerosol can 10) containing a mixture of a propellant and a therapeutic agent (col. 4, lines 12-18);
an electronically actuated valve (metering valve 12) (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-9 and 30-36; and see the discussion below regarding using the electronic cam system to vary a degree with which the valve is depressed/actuated during both agitation and dispensing);
a controller configured to control the valve (driver 42 may be replaced by…battery-driven electric motor, col. 4, lines 30-36; the driver is responsive to a patient-actuatable trigger…comprises a sensor which senses the breath of a patient, col. 3, lines 11-14; where an electric motor driven in response to a sensor infers/suggests/would have rendered obvious to an artisan before the effective filing date of the claimed invention the presence of a controller in order to provide the predictable result of a standard means by which to register breath via a sensor and convey an activation signal to the motor);
wherein the controller is further configured to:
to agitate the mixture within the canister (Fig. 1a; drive 42 is actuated…agitates the contents, col. 4, lines 37-44); and
the apparatus is configured to actuate the valve to release a dose of the agitated mixture from the canister (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39);
wherein agitating and actuating the valve to release [the] dose are discrete (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39).
Rand is silent regarding wherein the controller is configured to actuate the valve to agitate the mixture within the canister, and Rand does not explicitly disclose wherein the (same) controller is configured to process the second trigger/actuate the valve to release a dose of the agitated mixture from the canister. However, Kominami teaches that it was known in the pressurized aerosol container art before the effective filing date of the claimed invention for a controller (discharge apparatus control unit 210) (Fig. 4B) to be configured to actuate the valve (valve mechanism 13, comprising stem 12) (Fig. 2B; paras [0170-173]) to agitate the mixture within the canister (Fig. 7C; the aerosol container is caused to reciprocate within a range where the stroke thereof is shorter than the discharge stroke, whereby the content is vibrated and stirred without being discharged, para [0231]), and wherein the (same) controller is configured to actuate the valve to release a dose of the agitated mixture from the canister (Fig. 7D; at the time of discharge…the discharge unit 30 is controlled…to move the aerosol container by the discharge stroke thereby to perform the discharge operation, para [0232]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Rand to include wherein the controller is configured to actuate the valve to agitate the mixture within the canister, and wherein the (same) controller is configured to actuate the valve to release a dose of the agitated mixture from the canister as taught by Kominami, in order to provide the predictable result of a canister that is held in place at all times within a standard valve block/sump (thus ensuring proper location for dose dispersal) while allowing the canister to be automatically/electronically moved by less than the discharge stroke to agitate the contents and then automatically/electronically moved by the full discharge stroke to release the contents, thus providing discrete, convenient and consistent use of the device, including adequate shaking for sufficient distribution of the contents/consistent discharge quantity (Rand col. 1, lines 56-64 and col. 3, lines 11-39; Kominami paras [0004] and [0048]).
Regarding claim 2, Rand in view of Kominami teaches the apparatus according to claim 1, wherein modified Rand further teaches wherein the controller is further configured to move the valve in a reciprocal motion to actuate the valve to agitate the mixture within the canister (see the arrows in Rand Fig. 1a and Kominami Fig. 7C, and e.g. Kominami para [0231]).
Regarding claim 3, Rand in view of Kominami teaches the apparatus according to claim 2, wherein modified Rand further teaches wherein the controller is further configured to move the valve in a further reciprocal motion to actuate the valve to release [the] dose of the agitated mixture from the canister after the valve has been moved in a reciprocal motion to actuate the valve to agitate the mixture within the canister (e.g. Rand col. 4, line 15 in view of Kominami Figs. 2B and 7D, where the valve is taught to be a typical push-actuated metering valve that returns to the closed position after delivering the desired dose).
Regarding claim 4, Rand in view of Kominami teaches the apparatus according to claim 2, wherein modified Rand further teaches wherein the controller is further configured to move the valve in an oscillatory motion to actuate the valve to agitate the mixture within the canister (see the arrows in Rand Fig. 1a and Kominami Fig. 7C in view of Rand col. 5, lines 1-17, and Kominami paras [0226] and [0231]).
Regarding claim 5, Rand in view of Kominami teaches the apparatus according to claim 1, wherein modified Rand further teaches wherein the valve comprises a moveable valve member (e.g. Rand col. 4, line 15 in view of Kominami Figs. 2B and 7D, where the valve is taught to be a typical push-actuated metering valve), and wherein it would have been obvious to an artisan before the effective filing date of the claimed invention to include wherein actuating the valve to agitate the mixture and actuating the valve to release [the] dose are separated by a dwell period in which the valve member is stationary, in order to provide the predictable result of a delay between the shaking and the dose delivery, to allow the shaking to be performed while the inhaler is not in the user’s mouth for comfort and/or discretion then ensuring a sufficient (but not too long) amount of time for the user to bring the inhaler to their mouth after the shaking for the subsequent delivery actuation.
Regarding claim 9, Rand in view of Kominami teaches the apparatus according to claim 1, wherein modified Rand further teaches wherein the valve is a shuttle valve comprising a valve body and an axially moveable valve member (e.g. Rand col. 4, line 15 in view of Kominami Figs. 2B and 7C-D and paras [0170-173], where the valve is taught to be a typical push-actuated metering valve, i.e. an axially moveable valve stem within a metering body).
Regarding claim 11, Rand in view of Kominami teaches the apparatus according to claim 1, wherein modified Rand further teaches wherein the valve is a metering valve configured to release a predetermined volume of the mixture during actuating the valve to release [the] dose (e.g. Rand col. 4, line 15 in view of Kominami Figs. 2B and 7D, where the valve is taught to be a typical push-actuated metering valve).
Regarding claim 15, Rand in view of Kominami teaches the apparatus according to claim 1, wherein Rand further discloses wherein the mixture is a suspension of the therapeutic agent in the propellant (col. 4, lines 17-18).
Regarding claim 16, Rand in view of Kominami teaches the apparatus according to claim 1, wherein it would have been obvious to an artisan before the effective filing date of the claimed invention to include wherein the controller is configured to only actuate the valve to release [the] dose within a predetermined time window after the valve has been actuated to agitate the mixture, in order to ensure that the agitated contents do not have time to resettle before the dose is released, thus ensuring sufficient distribution of the contents/consistent discharge quantity (Rand col. 1, lines 56-64 and col. 3, lines 11-39; Kominami paras [0004] and [0048]).
Regarding claim 17, Rand in view of Kominami teaches the apparatus according to claim 1, wherein modified Rand further teaches wherein the valve is resiliently biased to a closed condition by the pressure of the mixture within the container (e.g. Rand col. 4, line 15 in view of Kominami Figs. 2B and 7C-D and paras [0170-173], where the valve is taught to be a typical push-actuated metering valve, and see in particular Kominami para [0172]: “stem 12 is urged in a protruding direction by the gas pressure”).
Regarding claim 20, Rand discloses a method of actuating a storage and dispensing apparatus for a pressurised metered dose inhaler (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-9), the apparatus comprising:
a canister (aerosol can 10) containing a mixture of a propellant and a therapeutic agent (col. 4, lines 12-18);
a valve (metering valve 12) (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-9 and 30-36);
wherein the method comprises:
agitating the mixture within the canister (Fig. 1a; drive 42 is actuated…agitates the contents, col. 4, lines 37-44); and
actuating the valve to release a dose of the agitated mixture from the canister (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39; dispenser outlet in the form of a metering valve 12, col. 4, lines 12-15);
wherein agitating and actuating the valve to release [the] dose are discrete (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39).
Rand is silent regarding actuating the valve to agitate the mixture within the canister. However, Kominami teaches that it was known in the pressurized aerosol container art before the effective filing date of the claimed invention to actuate the valve (valve mechanism 13, comprising stem 12) (Fig. 2B; paras [0170-173]) to agitate the mixture within the canister (Fig. 7C; the aerosol container is caused to reciprocate within a range where the stroke thereof is shorter than the discharge stroke, whereby the content is vibrated and stirred without being discharged, para [0231]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Rand to include actuating the valve to agitate the mixture within the canister as taught by Kominami, in order to provide the predictable result of a canister that is held in place at all times within a standard valve block/sump (thus ensuring proper location for dose dispersal) while allowing the canister to be moved by less than the discharge stroke to agitate the contents during shaking for sufficient distribution of the contents/consistent discharge quantity (Rand col. 1, lines 56-64 and col. 3, lines 11-39; Kominami paras [0004] and [0048]).
Regarding claim 21, Rand in view of Kominami teaches the method of actuating according to claim 20, wherein Rand in view of Kominami further teaches wherein the apparatus comprises an electronic controller, and wherein actuating the valve to agitate and actuating the valve to release the dose are carried out by the controller (see claim 1 discussion above), in order to provide the predictable result of automation to allow for discrete and convenient use (Rand col. 1, lines 56-64 and col. 3, lines 11-39).
Regarding claim 22, Rand in view of Kominami teaches the method of actuating according to claim 20, wherein Rand in view of Kominami further teaches wherein the apparatus is according to claim 1 (see claim 1 discussion above), in order to provide the predictable result of automation to allow for discrete and convenient use (Rand col. 1, lines 56-64 and col. 3, lines 11-39).
Regarding claim 23, Rand discloses a method of delivery of a medicament to a human or animal (Rand Figs. 1a-b; col. 1, line 10-col. 2, line 6; col. 3, lines 36-39; col. 4, lines 3-9) comprising:
providing a pressurised metered dose inhaler (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-13) having:
a storage and dispensing apparatus comprising:
a canister (aerosol can 10) containing a mixture of a propellant and a therapeutic agent (col. 4, lines 12-18);
a valve (metering valve 12) (Figs. 1a-b; col. 3, lines 36-39; col. 4, lines 3-9 and 30-36); and
a delivery portion (mouthpiece) for delivering the medicament to a human or animal (col. 6, lines 27-30);
wherein the method [further] comprises:
agitating the mixture within the canister (Fig. 1a; drive 42 is actuated…agitates the contents, col. 4, lines 37-44); and
actuating the valve to release a dose of the agitated mixture from the canister (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39; dispenser outlet in the form of a metering valve 12, col. 4, lines 12-15);
wherein agitating and actuating the valve to release [the] dose are discrete (triggers are coupled such that agitation and dispensing occurs in a sequential fashion, col. 3, lines 36-39).
Rand is silent regarding actuating the valve to agitate the mixture within the canister. However, Kominami teaches that it was known in the pressurized aerosol container art before the effective filing date of the claimed invention to actuate the valve (valve mechanism 13, comprising stem 12) (Fig. 2B; paras [0170-173]) to agitate the mixture within the canister (Fig. 7C; the aerosol container is caused to reciprocate within a range where the stroke thereof is shorter than the discharge stroke, whereby the content is vibrated and stirred without being discharged, para [0231]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for Rand to include actuating the valve to agitate the mixture within the canister as taught by Kominami, in order to provide the predictable result of a canister that is held in place at all times within a standard valve block/sump (thus ensuring proper location for dose dispersal) while allowing the canister to be moved by less than the discharge stroke to agitate the contents during shaking for sufficient distribution of the contents/consistent discharge quantity (Rand col. 1, lines 56-64 and col. 3, lines 11-39; Kominami paras [0004] and [0048]).
Claim(s) 6, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rand in view of Kominami as applied to claim 1 above, and further in view of Burt et al. (US 4,863,073; hereinafter “Burt”).
Regarding claim 6, Rand in view of Kominami teaches the apparatus according to claim 1, but modified Rand is silent regarding wherein a flow restriction is provided between the valve and the canister, such that actuation of the valve to agitate the mixture causes a fluid jet to be created from the restriction into the canister to agitate the contents. However, Burt teaches that it was known in the MDI valve art before the effective filing date of the claimed invention to include wherein a flow restriction (orifice 12) (Fig. 12) is provided between the valve (valve stem 5) and the canister (the container oriented downward in Fig. 2), such that actuation of the valve causes a fluid jet to be created from the restriction into the canister (as the valve stem 5 is actuated/moved downward into extension 2a, some fluid must necessarily be pushed out of the lower extension 2a due to displacement), which will agitate the contents due to the movement of fluid. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Rand to include wherein a flow restriction is provided between the valve and the canister, such that actuation of the valve to agitate the mixture causes a fluid jet to be created from the restriction into the canister to agitate the contents as taught by Burt, in order to utilize a known metered valve construction to predictably provide metered doses, particularly one that provides the benefits touted by Burt (col. 1, lines 4757).
Regarding claim 18, Rand in view of Kominami teaches the apparatus according to claim 1, but modified Rand is silent regarding wherein the viscosity of the contents of the canister is between 1x10-4 and 5x10-4 Pa-s. However, Burt teaches that it was known in the MDI art before the effective filing date of the claimed invention to include wherein the viscosity of the contents of the canister is between 1x10-4 and 5x10-4 Pa-s (viscosity of 0.003 poise, col. 3, line 27; where 1 Pa-s=10 poise, i.e. Burt teaches 3x10-4 Pa-s), and selection of a value of a parameter within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art. MPEP § 2144.05. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Rand to include wherein the viscosity of the contents of the canister is between 1x10-4 and 5x10-4 Pa-s as taught by Burt, in order to provide the predictable result of a known MDI composition for delivery thereof.
Regarding claim 19, Rand in view of Kominami teaches the apparatus according to claim 1, but modified Rand is silent regarding wherein the density ratio of the propellant to the therapeutic agent is between 0.4 and 1.3. However, Burt teaches that it was known in the MDI art before the effective filing date of the claimed invention to include wherein the density ratio of the propellant to the therapeutic agent is between 0.4 and 1.3 (salbutamol (density 1.17x103kg-m-3)…propellant mixture having a density of 1.35 1.17x103kg-m-3, col. 3, lines 23-27; where 1.35/1.17=1.15), and selection of a value of a parameter within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art. MPEP § 2144.05. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Rand to include wherein the density ratio of the propellant to the therapeutic agent is between 0.4 and 1.3 as taught by Burt, in order to provide the predictable result of a known MDI composition for delivery thereof.
Allowable Subject Matter
Claims 8, 12 and 13 would be allowable if rewritten to address the objections thereto as well as to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. It is noted that the independent claims do not exclude the “actuating to agitate” step from also being a valve-filling step and/or a dose-releasing step of its own, nor do the independent method claims require an electronically-controllable valve, such that performing typical priming of standard MDI containers, i.e. either to fill the metering chamber and/or discharge initial pump(s) as waste, see e.g. Paullus et al. (US 3,157,179; Figs. 4-10), Jinks et al. (US 2010/0199983 A1; para [0030]), Bryant (US 5,623,920 and US 5,772,085), Child et al. (US 2010/0326432 A1; para [0041]), Harvey (US 2003/0106550 A1), Van de Laar et al. (US 2018/0100550 A1; para [0003]), would also read on at least claims 20 and 23 because the priming causes agitation by pushing the valve member into the canister, and automating/electronically actuating inhaler valves was well known in the inhaler art before the effective filing date of the claimed invention, see e.g. Fuller et al. (US 2018/0214646 A1), Kulkarni et al. (US 2020/0147328 A1), rending it further obvious to arrive at at least claim 1 from a general “obvious to automate manual activities” standpoint. Additional references regarding means for agitating the contents of pressurized canisters: Genova et al. (US 6,116,234); Barger et al. (US 5,421,492); Fuminori et al. (JP 3919985 B2); Bonney (US 2005/0236434 A1); Rand (US 7,185,648 B1); Spandorfer et al. (US 9,216,267 B2; col. 8, lines 40-45).
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785