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 .
Specification
The amendment filed 04/27/2023 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure given that the effective filing date of the claimed invention is 10/12/2022. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The limitation in lines 7-10 of claim 67, “the narrow section being characterized by a minimum cross-sectional dimension that is at least 10% smaller than a minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane”.
The limitation in lines 10-11 of claim 67, “at least a part of the narrow section being displaced proximally from the mesh membrane by at least 0.5 cm and not more than 6 cm”.
The limitation in lines 1-6 of claim 68, “wherein the at least a part of the narrow section is displaced proximally from the mesh membrane by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm”.
The limitation in lines 1-8 of claim 69, “wherein the narrow section is characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross- sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane”.
The limitation in lines 7-9 of claim 77, “the narrow section being characterized by a minimum cross-sectional dimension that is at least 10% smaller than a minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane”.
The limitation in lines 1-8 of claim 78, “wherein the narrow section is characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross- sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane”.
The limitation in lines 1-7 of claim 82, “wherein the at least a part of the narrow section is displaced proximally from the mesh membrane by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
The “liquid inlet” of claims 71 and 80-81 is taken to mean where a compartment would hold a quantity of a liquid, as it is disclosed in the specification on page 16 lines 13-14.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 67-86 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 67, lines 13-14 positively recites “the mist-exiting location is in direct fluid communication with the user's oropharynx”. It is suggested to amend the language to read -- the mist-exiting location is configured to be in direct fluid communication with the user's oropharynx -- to overcome the rejection.
In claim 67, lines 14-15 positively recites “the mist-exiting location is in direct fluid communication with the user's oropharynx”. It is suggested to amend the language to read -- the mist-exiting location is configured to be in direct fluid communication with the user's oropharynx -- to overcome the rejection.
In claim 76, lines 2-3 positively recites “the mist-generating location is at least 20% deep…”. It is suggested to amend the language to read -- the mist-generating location is configured to be at least 20% deep… -- to overcome the rejection.
In claim 77, lines 14-15 positively recites “the mist-generating location resides distal to the user's teeth within the user's oral cavity”. It is suggested to amend the language to read -- the mist-generating location is configured to reside distal to the user's teeth within the user's oral cavity -- to overcome the rejection.
In claim 86, lines 2-3 positively recites “the mist-generating location is at least 20% deep…”. It is suggested to amend the language to read -- the mist-generating location is configured to be at least 20% deep… -- to overcome the rejection.
Claims 68-75 and 78-85 are rejected based solely on their dependency to the rejected claims.
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 71, 76, and 86 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 71 recites the limitation “the proximal portion” in lines 1, 3, and 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 76 and 86, the term “deep” in lines 3-4 of claims 76 and 86 is a relative term which renders the claim indefinite. The term “deep” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This is due to the lack of clarity regarding the limitation “oral cavity” in lines 4-5 of claims 76 and 86, specifically the lack of a defined starting point (e.g. Lips or teeth). Hence, it is unclear how deep a “percentage deep” actually is.
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 67-86 are rejected under 35 U.S.C. 103 as being unpatentable over Collingwood (EP 3628354 A1) in view of Addington (WO 2014179083 A1) and Dellavecchia (WO 0185240 A1).
Regarding claim 67, Collingwood discloses an electrically-powered inhalation device (FIG. 1 Aerosol delivery system 1 as set forth in [0069]) for delivery of an aerosol to the oropharynx of a user (Medicament is delivered to the lungs as set forth in [0055], which would inherently mean delivery to the oropharynx of the user as the aerosol travels from the device to the lungs), the inhalation device comprising: a distal portion (The distal portion as shown in the annotated figure below) including (i) an aerosol outlet defining a mist-exiting location (FIG. 1 Air outlet 18 as set forth in [0069]) and (ii) a piezo assembly including an ultrasonically vibrable mesh membrane (FIG. 1 Actuation means 30 and perforated membrane 150 as set forth in [0069] and [0071]), for producing, upon electrical activation, droplets of the liquid, the mesh membrane defining a mist-generating location (FIG. 1 The controller 24 generates a drive signal to drive the actuation means 30 to vibrate and induce vibration in the perforate membrane 150, the actuation means 30 comprising suitable actuator 32 having an active component comprising a piezoelectric material, vibration of the perforate membrane 150 causes the liquid formulation to pass through apertures in the perforate membrane 150 and to be ejected as liquid droplets from a second side of the perforate membrane 150 as set forth in [0069] and [0071]); and b. a neck portion (FIG. 1 Mouthpiece 14 as set forth in [0069]) including a narrow section (The Narrow section as shown in the annotated figure below), the narrow section being characterized by a minimum cross-sectional dimension that is smaller than a minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane (D>d as shown in the annotated figure below), and the mist-exiting location is in direct fluid communication with the user's oropharynx (FIG. 1 Vibration of the perforate membrane 150 causes the liquid formulation to pass through apertures in the perforate membrane 150 and to be ejected as liquid droplets from a second side of the perforate membrane 150 as set forth in [0069] and [0071], the liquid droplets of medicament is delivered to the lungs as set forth in [0055], which would inherently mean delivery though fluid communication to the oropharynx of the user as the aerosol travels from the a second side of the perforate membrane 150 to the lungs).
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Collingwood fails to explicitly disclose that the cross-sectional dimension of the narrow section is specifically at least 10% smaller than a minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.
However, though prior art drawings are not interpreted as depicting scale, unless specified, drawings can be relied upon for what they would reasonably teach one of ordinary skill in the art (MPEP 2125). Collingwood clearly depicts the cross-sectional dimension of the narrow section (d) as being smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane (D) as shown in annotated Fig. 1 above. It is clear that (D) is just under three times larger than (d). The cross-sectional dimension of the narrow section (d) is shown to be approximately 66.7% smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane of Collingwood, thus it is clear that any embodiment of the device of Collingwood would clearly show that the cross-sectional dimension of the narrow section is at least 10% smaller than a minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, the narrow section of the mouthpiece allowing for easy engagement with an oral cavity to provide medicament to the lungs of the user.
Collingwood fails to explicitly disclose that at least a part of the narrow section being displaced proximally from the mesh membrane, wherein the inhalation device is shaped such that when the user's lips and/or teeth are transversely engaged with the narrow section, the mist-generating location is configured to reside distal to the user's teeth within the user's oral cavity.
However, Addington teaches a part of the narrow section being displaced proximally from the mesh membrane (Addington: As shown in the annotated FIG. 27 below), wherein the inhalation device is shaped such that when the user's lips are transversely engaged with the narrow section, the mist-generating location resides distal to the user's teeth within the user's oral cavity (Addington: The user’s mouth would inherently engage with mouthpiece , mouthpiece 906 set forth in [0097], meaning the user's lips are engaged with the narrow section, and the nebulizer outlet and mesh are configured to be received within the oral cavity of the patient when the nebulizer is in use as set forth in [0006]).
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Collingwood and Addington are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device configuration of Collingwood to incorporate the teaching regarding the distal portion of Addington and include a part of the narrow section being displaced proximally from the mesh membrane (Addington: As shown in the annotated FIG. 27 below), wherein the inhalation device is shaped such that when the user's lips are transversely engaged with the narrow section, the mist-generating location resides distal to the user's teeth within the user's oral cavity (Addington: The user’s mouth would inherently engage with mouthpiece , mouthpiece 906 set forth in [0097], meaning the user's lips are engaged with the narrow section, and the nebulizer outlet and mesh are configured to be received within the oral cavity of the patient when the nebulizer is in use as set forth in [0006]). Doing so would make it so that the mesh is received within the oral cavity, the mesh location being inside the oral cavity vastly improving the lung-deposition efficiency (Addington: As set forth in [0072]), the fraction of the drug reaching and retained by the lungs.
Collingwood as modified fails to explicitly disclose that at least a part of the narrow section being displaced proximally from the mesh membrane is by at least 0.5 cm and not more than 6 cm.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the length of the part of the narrow section proximal to the mesh membrane a certain length, in this case, at least 0.5 cm and not more than 6 cm, in the device of Collingwood as modified by Addington, because Applicant has not disclosed that the specific length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s length of the part of the narrow section proximal to the mesh membrane, and Applicant’s length of the part of the narrow section proximal to the mesh membrane, to perform equally well because both mechanisms perform the same function of enabling the mesh membrane to be received in the oral cavity of the user.
Therefore, it would have been prima facie obvious to modify Collingwood to obtain the invention as specified in claim 67 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired length of the part of the narrow section proximal to the mesh membrane, and therefore enable the mesh membrane to be located in the cavity of the user, and thus fails to patentably distinguish over the prior art of Collingwood as modified by Addington.
Collingwood fails to explicitly disclose that the droplets of the liquid produced upon electrical activation is a mist. Collingwood does disclose that preferably, the apertures are capable of producing droplets of a size of less than 5 microns (As set forth in [0020]).
However, Dellavecchia teaches an inhalation device producing a mist upon electrical activation, wherein the size of the droplets is between zero and five microns (Dellavecchia: Set forth in paragraph 3 of page 12).
Collingwood and Addington are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the droplets produced by the device of Collingwood can be considered a mist.
Regarding claim 68, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified by Addington fails to explicitly disclose the inhalation device, wherein the at least a part of the narrow section is displaced proximally from the mesh membrane by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the length of the part of the narrow section proximal to the mesh membrane a certain length, in this case, at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm, in the device of Collingwood as modified by Addington, because Applicant has not disclosed that the specific length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s length of the part of the narrow section proximal to the mesh membrane, and Applicant’s length of the part of the narrow section proximal to the mesh membrane, to perform equally well because both mechanisms perform the same function of enabling the mesh membrane to be received in the oral cavity of the user.
Therefore, it would have been prima facie obvious to modify Collingwood to obtain the invention as specified in claim 68 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired length of the part of the narrow section proximal to the mesh membrane, and therefore enable the mesh membrane to be located in the cavity of the user, and thus fails to patentably distinguish over the prior art of Collingwood as modified by Addington.
Regarding claim 69, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified fails to explicitly disclose the inhalation device, wherein the narrow section is characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross- sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, in this case, at least 20%, 30%, 40%, or 50% smaller, in the device of Collingwood as modified, because Applicant has not disclosed that the specific difference provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, and Applicant’s difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, to perform equally well because both mechanisms perform the same function of enabling the narrow section of the device to be received in the oral cavity of the user.
Therefore, it would have been prima facie obvious to modify Collingwood to obtain the invention as specified in claim 69 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, and therefore enable the narrow section of the device to be received in the oral cavity of the user, and thus fails to patentably distinguish over the prior art of Collingwood as modified.
Regarding claim 70, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified further discloses, wherein the minimum cross-sectional dimension of the narrow section and the minimum cross-sectional dimension of the distal portion define vectors that are coplanar (Shown in the annotated figure below).
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Regarding claim 71, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified further discloses the inhalation device, wherein an outlet (FIG. 1 Portion of the fluid reservoir defined by the outer casing 110 as set forth in [0070] where the liquid can exit through perforate membrane 150) of the proximal portion (As shown in the annotated figure below) that includes a liquid inlet (FIG. 1 Where outer casing 110 defining a fluid reservoir containing a liquid as set forth in [0070]) is detachably attachable to the neck portion (FIG. 1 Mouthpiece 14 which is removably coupled to the main housing 12, wherein cartridge 100 is removably received during use as set forth in [0069]) such that an interior volume of the proximal portion that includes a liquid inlet is arranged to be in fluid communication with an interior volume of the neck portion when a pressure-activated one-way valve is activated by pressure from the proximal portion that includes a liquid inlet. (FIG. 1 The fluid reservoir, an interior volume of the proximal portion , is in fluid communication with the interior volume of the neck portion, mouthpiece 14, since perforate membrane 150 is in fluid contact with the liquid formulation in the fluid reservoir and such that a second, opposite side of the perforate membrane 150 is facing the air outlet 18 in the mouthpiece 14 as set forth in [0070], the pressure caused by a user inhaling on the mouthpiece 14 causes air is drawn into the device 10 through the air inlet 16, a pressure-activated one-way valve, which triggers the flow sensor 22 to cause the control to induce vibration of the perforate membrane 150 as set forth in [0071])
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Regarding claim 72, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified fails to explicitly disclose the inhalation device, wherein a center of gravity of the inhalation device is displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state.
However, given that most components of the device (FIG. 1 Main housing 12, cartridge housing 110, a battery 28, and controllers 24 and 25) are located proximally from a distal end of the narrow section, including when the inhalation device is in a liquid-empty state, it would have been prima facie obvious to one of ordinary skill in the art that a center of gravity of the inhalation device would be displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state.
Regarding claim 73, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified further discloses the inhalation device, additionally comprising an inhalation sensor for monitoring a flow in an inhalation flow-path and effective to detect an air pressure in the inhalation-flow path (FIG. 1 The pressure caused by a user inhaling on the mouthpiece 14 causes air is drawn into the device 10 through the air inlet 16, which triggers the flow sensor 22 as set forth in [0071]).
Regarding claim 74, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 73 above.
Collingwood as modified further discloses the inhalation device, comprising control circuitry (FIG. 1 Controller 24 as set forth in [0071]) configured to initiate activation of the mesh membrane in response to a result of the monitoring of the flow in the inhalation flow path (FIG. 1 The trigger the flow sensor 22 sends a signal to the controller 24 which then generates a drive signal to drive the actuation means 30 to vibrate and induce vibration in the perforate membrane 150 as set forth in [0071]).
Regarding claim 75, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified fails to explicitly disclose wherein the distal portion comprises a liquid- retaining compartment in fluid communication with the neck portion, the liquid-retaining compartment being shaped to receive a quantity of the liquid from the neck portion by force of gravity when the inhalation device is in a first orientation, and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation, wherein the retaining is by a wall of the liquid-retaining compartment, the wall being effective to partially block an egress of the retained at least a part of the quantity.
However, Addington teaches wherein the distal portion (Addington: Shown in the annotated figure below) comprises a liquid-retaining compartment (Addington: FIG. 27 Reservoir 920 as set forth in [0097]) in fluid communication with the neck portion (Addington: FIG. 27 mouthpiece 906 as set forth in [0097]; in communication through the mesh 922), the liquid-retaining compartment being shaped to receive a quantity of the liquid from the neck portion (FIG. 27 Medicine flows from the medicine feed lines 934 to the medicine reservoir 920 as set forth in [0098]) by force of gravity when the inhalation device is in a first orientation (Addington: The delivery of medicine through the feed line is partially cause by gravity as set forth in [0063] in reference to figure 13, however, the same should be applied to the medicine feed line 934 of FIG. 27 given they are structurally the same; It is also inherent that gravity would act on the liquid in the puncture tube 932 at an orientation as shown in FIG. 27, and cause the medicine to travel through the fee lines), and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation (Addington: FIG. 27 Reservoir 920 would retain a quantity of medicine despite gravity as shown by the annotated figure below), wherein the retaining is by a wall of the liquid-retaining compartment (Addington: Egress wall as shown in the annotated figure below), the wall being effective to partially block an egress of the retained at least a part of the quantity (Addington: FIG. 27 Reservoir 920 would retain a quantity of medicine despite gravity as shown by the annotated figure below).
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It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device configuration of Collingwood to incorporate the teaching regarding the distal portion of Addington and include a liquid retaining compartment in the distal portion of the device, specifically, wherein the distal portion (Addington: Shown in the annotated figure) comprises a liquid-retaining compartment (Addington: FIG. 27 Reservoir 920 as set forth in [0097]) in fluid communication with the neck portion (Addington: FIG. 27 mouthpiece 906 as set forth in [0097]; in communication through the mesh 922), the liquid-retaining compartment being shaped to receive a quantity of the liquid from the neck portion (FIG. 27 Medicine flows from the medicine feed lines 934 to the medicine reservoir 920 as set forth in [0098]) by force of gravity when the inhalation device is in a first orientation (Addington: The delivery of medicine through the feed line is partially cause by gravity as set forth in [0063] in reference to figure 13, however, the same should be applied to the medicine feed line 934 of FIG. 27 given they are structurally the same; It is also inherent that gravity would act on the liquid in the puncture tube 932 at an orientation as shown in FIG. 27, and cause the medicine to travel through the fee lines), and to retain at least a part of the quantity against the force of gravity when the inhalation device is in a second orientation (Addington: FIG. 27 Reservoir 920 would retain a quantity of medicine despite gravity as shown by the annotated figure), wherein the retaining is by a wall of the liquid-retaining compartment (Addington: Egress wall as shown in the annotated figure), the wall being effective to partially block an egress of the retained at least a part of the quantity (Addington: FIG. 27 Reservoir 920 would retain a quantity of medicine despite gravity as shown by the annotated figure). Doing so would ensure the mesh and a quantity of the liquid medicine or drug remain in contact with the distally located mesh in the oral cavity via the reservoir (Addington: As set forth in [0101]).
Regarding claim 76, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 67 above.
Collingwood as modified fails to explicitly disclose the inhalation device, wherein the inhalation device is shaped such that when the user's lips and/or teeth are transversely engaged with the intermediate portion, the mist-generating location is configured to be at least 20% deep or at least 30% deep or at least 40% deep or at least 50% deep or at least 60% deep or at least 70% deep or at least 80% deep into an oral-cavity volume beneath the user's hard palate.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the mist-generating location a certain percentage deep into an oral cavity, in this case, at least 20%, 30%, 40%, 50%, 60%, 70%, or 80% deep, in the device of Collingwood as modified by Addington, because Applicant has not disclosed that the specific percentage of deepness provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s mist-generating location a certain percentage deep into an oral cavity, and Applicant’s mist-generating location a certain percentage deep into an oral cavity, to perform equally well because both mechanisms perform the same function of enabling the narrow section of the device to be received in the oral cavity of the user in such a way that allows the mesh producing the aerosol to be positioned inside the user’s mouth.
Therefore, it would have been prima facie obvious to modify Collingwood as modified by Addington to obtain the invention as specified in claim 76 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired mist-generating location a certain percentage deep into an oral cavity, and therefore enable the narrow section of the device to be received in the oral cavity of the user in such a way that allows the mesh producing the aerosol to be positioned inside the user’s mouth, and thus fails to patentably distinguish over the prior art of Collingwood as modified.
Regarding claim 77, Collingwood discloses an electrically-powered inhalation device (FIG. 1 Aerosol delivery system 1 as set forth in [0069]) for delivery of an aerosol to the oropharynx of a user (Medicament is delivered to the lungs as set forth in [0055], which would inherently mean delivery to the oropharynx of the user as the aerosol travels from the device to the lungs), the inhalation device comprising: a distal portion (The distal portion as shown in the annotated figure below) including (i) an aerosol outlet defining a mist-exiting location (FIG. 1 Air outlet 18 as set forth in [0069]) and (ii) a piezo assembly including an ultrasonically vibrable mesh membrane (FIG. 1 Actuation means 30 and perforated membrane 150 as set forth in [0069] and [0071]), for producing, upon electrical activation, droplets of the liquid, the mesh membrane defining a mist-generating location (FIG. 1 The controller 24 generates a drive signal to drive the actuation means 30 to vibrate and induce vibration in the perforate membrane 150, the actuation means 30 comprising suitable actuator 32 having an active component comprising a piezoelectric material, vibration of the perforate membrane 150 causes the liquid formulation to pass through apertures in the perforate membrane 150 and to be ejected as liquid droplets from a second side of the perforate membrane 150 as set forth in [0069] and [0071]); and b. a neck portion (FIG. 1 Mouthpiece 14 as set forth in [0069]) including a narrow section (The Narrow section as shown in the annotated figure below), the narrow section being characterized by a minimum cross-sectional dimension that is smaller than a minimum cross-sectional dimension passing through and parallel to the mesh membrane (D>d as shown in the annotated figure below) and that the mist-exiting location is in direct fluid communication with the user's oropharynx (FIG. 1 Vibration of the perforate membrane 150 causes the liquid formulation to pass through apertures in the perforate membrane 150 and to be ejected as liquid droplets from a second side of the perforate membrane 150 as set forth in [0069] and [0071], the liquid droplets of medicament is delivered to the lungs as set forth in [0055], which would inherently mean delivery though fluid communication to the oropharynx of the user as the aerosol travels from the a second side of the perforate membrane 150 to the lungs).
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Collingwood fails to explicitly disclose that a center of gravity of the inhalation device being displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state.
However, given that most components of the device (FIG. 1 Main housing 12, cartridge housing 110, a battery 28, and controllers 24 and 25) are located proximally from a distal end of the narrow section, including when the inhalation device is in a liquid-empty state, it would have been prima facie obvious to one of ordinary skill in the art that a center of gravity of the inhalation device would displaced proximally from a distal end of the narrow section when the inhalation device is in a liquid-empty state.
Collingwood fails to explicitly disclose that the inhalation device is shaped such that when the user's lips and/or teeth are transversely engaged with the narrow section, the mist-generating location resides within the user's oral cavity and the mist-exiting location is in direct fluid communication with the user's oropharynx.
However, Addington teaches an inhalation device shaped such that when the user's lips and/or teeth are transversely engaged with the narrow section, the mist-generating location resides within the user's oral cavity (Addington: The user’s mouth would inherently engage with mouthpiece , mouthpiece 906 set forth in [0097], meaning the user's lips are engaged with the narrow section, and the nebulizer outlet and mesh are configured to be received within the oral cavity of the patient when the nebulizer is in use as set forth in [0006]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device configuration of Collingwood to incorporate the teaching of Addington and include wherein the device shaped such that when the user's lips and/or teeth are transversely engaged with the narrow section, the mist-generating location resides within the user's oral cavity (Addington: The user’s mouth would inherently engage with mouthpiece , mouthpiece 906 set forth in [0097], meaning the user's lips are engaged with the narrow section, and the nebulizer outlet and mesh are configured to be received within the oral cavity of the patient when the nebulizer is in use as set forth in [0006]). Doing so would make it so that the mesh is received within the oral cavity, the mesh location being inside the oral cavity vastly improving the lung-deposition efficiency (Addington: As set forth in [0072]), the fraction of the drug reaching and retained by the lungs.
Collingwood fails to explicitly disclose that the droplets of the liquid produced upon electrical activation is a mist. Collingwood does disclose that preferably, the apertures are capable of producing droplets of a size of less than 5 microns (As set forth in [0020]).
However, Dellavecchia teaches an inhalation device producing a mist upon electrical activation, wherein the size of the droplets is between zero and five microns (Dellavecchia: Set forth in paragraph 3 of page 12).
Collingwood and Addington are both considered to be analogous to the claimed invention because they are in the same field of Nebulizers. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention that the droplets produced by the device of Collingwood can be considered a mist.
Regarding claim 78, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified fails to explicitly disclose the inhalation device, wherein the narrow section is characterized by a minimum cross-sectional dimension that is at least 20% smaller than the minimum cross- sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 30% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 40% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, or at least 50% smaller than the minimum cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, in this case, at least 20%, 30%, 40%, or 50% smaller, in the device of Collingwood as modified, because Applicant has not disclosed that the specific difference provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, and Applicant’s difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, to perform equally well because both mechanisms perform the same function of enabling the narrow section of the device to be received in the oral cavity of the user.
Therefore, it would have been prima facie obvious to modify Collingwood to obtain the invention as specified in claim 78 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired difference between a cross-sectional dimension of the narrow section a certain percentage smaller than the cross-sectional dimension of the distal portion passing through and parallel to the mesh membrane, and therefore enable the narrow section of the device to be received in the oral cavity of the user, and thus fails to patentably distinguish over the prior art of Collingwood as modified.
Regarding claim 79, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified further discloses, wherein the minimum cross-sectional dimension of the narrow section and the minimum cross-sectional dimension of the distal portion define vectors that are coplanar (Shown in the annotated figure below).
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Regarding claim 80, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified further discloses the inhalation device, comprising a first proximal portion (As shown in the annotated figure below) that includes a liquid inlet (FIG. 1 Where outer casing 110 defining a fluid reservoir containing a liquid as set forth in [0070]) and a second proximal portion (As shown in the annotated figure below) that includes a power source for powering the piezo assembly (FIG. 1 Battery 28 supplies electrical power to the actuation means 30 as set forth in [0069]).
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Regarding claim 81, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified further discloses the inhalation device, wherein an outlet (FIG. 1 Portion of the fluid reservoir defined by the outer casing 110 as set forth in [0070] where the liquid can exit through perforate membrane 150) of the proximal portion (As shown in the annotated figure below) that includes a liquid inlet (FIG. 1 Where outer casing 110 defining a fluid reservoir containing a liquid as set forth in [0070]) is detachably attachable to the neck portion (FIG. 1 Mouthpiece 14 which is removably coupled to the main housing 12, wherein cartridge 100 is removably received during use as set forth in [0069]) such that an interior volume of the proximal portion that includes a liquid inlet is arranged to be in fluid communication with an interior volume of the neck portion when a pressure-activated one-way valve is activated by pressure from the proximal portion that includes a liquid inlet. (FIG. 1 The fluid reservoir, an interior volume of the proximal portion , is in fluid communication with the interior volume of the neck portion, mouthpiece 14, since perforate membrane 150 is in fluid contact with the liquid formulation in the fluid reservoir and such that a second, opposite side of the perforate membrane 150 is facing the air outlet 18 in the mouthpiece 14 as set forth in [0070], the pressure caused by a user inhaling on the mouthpiece 14 causes air is drawn into the device 10 through the air inlet 16, a pressure-activated one-way valve, which triggers the flow sensor 22 to cause the control to induce vibration of the perforate membrane 150 as set forth in [0071])
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Regarding claim 82, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified by Addington fails to explicitly disclose the inhalation device, wherein the at least a part of the narrow section is displaced proximally from the mesh membrane by at least 0.5 cm and not more than 6 cm, or by at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the length of the part of the narrow section proximal to the mesh membrane a certain length, in this case, by at least 0.5 cm and not more than 6 cm, or at least 0.5 cm and not more than 5.5 cm, or by at least 0.5 cm and not more than 5 cm, or by at least 0.5 cm and not more than 4.5 cm, or by at least 0.5 cm and not more than 4 cm, or by at least 1 cm and not more than 6 cm, or by at least 1 cm and not more than 5.5 cm, or by at least 1 cm and not more than 5 cm, or by at least 1 cm and not more than 4.5 cm, or by at least 1 cm and not more than 4 cm, in the device of Collingwood as modified by Addington, because Applicant has not disclosed that the specific length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Collingwood as modified’s length of the part of the narrow section proximal to the mesh membrane, and Applicant’s length of the part of the narrow section proximal to the mesh membrane, to perform equally well because both mechanisms perform the same function of enabling the mesh membrane to be received in the oral cavity of the user.
Therefore, it would have been prima facie obvious to modify Collingwood to obtain the invention as specified in claim 82 because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired length of the part of the narrow section proximal to the mesh membrane, and therefore enable the mesh membrane to be located in the cavity of the user, and thus fails to patentably distinguish over the prior art of Collingwood as modified by Addington.
Regarding claim 83, Collingwood as modified discloses the claimed invention substantially as claimed as set forth for claim 77 above.
Collingwood as modified further discloses the inhalation device, additionally comprising an inhalation sensor for monitoring a flow in an inhalation flow-path (FIG. 1 The pressure caused by a user inhaling on the mouthpiece 14 causes air is drawn into the device 10 through the air inlet 16, which triggers the flow sensor 22 as set forth in [0071]), wherein the inhalation sensor is effective to detect a difference between an air pressure in the inhalation flow-path and an ambient air pressure outside the inhalation device (The ability of the sensor to detect flow as a result of a user inhaling through the mouthpie