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 Objections
Claims 1 and 4 are objected to because of the following informalities:
Claims 1 and 4 recite both “center” and “centre”. The Examiner suggests replacing with a single term, to make language consistent throughout the claim.
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 1 and 4, and thus their dependent claims, 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. Claims 1 and 4 both recite the limitation of “one set at each side of the Z-plane”, however the “Z-plane” is not defined by the claims. The Examiner suggests amending the claim with clarifying language to clearly define the structural placement of the Z-plane with respect to structural components of the device.
Additionally, claims 10-14 and 16 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. Claims 10-14 and 16 all recite limitations that further limit the structure of optional limitation(s) from claim 4, as claim 4 only requires “one or more aerosol particle delivery modifiers selected from the group consisting of…”. Therefore, it is unclear what limitations from claims 10-14 and 16 are actually required by the device. As such, these particular claims will not be rejected with prior art as it is unclear what structural components are required by the claims.
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.
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) 1-4, 6, 15-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hale et al. (US 2004/0105819 A1) in view of Taurino (US 2021/0212368 A1).
Regarding claim 1, Hale discloses a medical device for generating a drug condensation aerosol by thermal vaporization of a drug (device 214 comprising an element for heating a respiratory drug composition to form a vapor, forming a condensation aerosol, Figure 2b and Paragraph 0085, Abstract), the medical device comprising:
an airway defined by internal walls (chamber 224 defined by walls 216 and 218, Figure 2b);
an air inlet at one end of the airway (air inlet slots 222 at one end of device 214, Paragraph 0086 and Figure 2b);
an air outlet configured as a mouthpiece, the air outlet located at another end of the airway (tapered end 204 on other side of the device configured to be inserted into a user’s mouth, Figure 2a and Paragraph 0083);
a drug foil substrate having an impermeable surface placed within the airway (substrate associated with film 230, film is deposited on stainless steel substrate foil on a solid support 226, Paragraph 0125 and Figure 2b);
a drug foil substrate support (solid support 226, Figure 2b and Paragraph 0086);
a solid drug film coated on the drug foil substrate (respiratory drug composition film 230, Figure 2b and Paragraph 0087);
an aerosol axis defined by a geometrical center of the solid drug film and a geometrical center of the air outlet, wherein a downstream direction goes from the geometric center of the solid drug film to the geometrical centre of the air outlet and an upstream direction in the opposite direction (see horizontal axis represented by the arrow shown in Figure 2b showing the direction of airflow through the device 214, comprising both an upstream and downstream direction);
a drug foil substrate heating circuit configured to vaporize at least a part of the drug in the solid drug film to produce condensation aerosol particles (device 214 comprises a heating element for heating a respiratory drug composition to form a vapor, an element allowing the vapor to cool, thereby forming a condensation aerosol, Paragraph 0084), wherein the drug foil substrate heating circuit comprises at least one battery (heating element comprising a battery, Paragraph 0084).
Although Hale teaches various aerosol particle delivery modifiers such as a deformable flap to divert air flow (Paragraph 0088) and the presence or absence of structures that produce or restrict turbulence within the chamber (Paragraph 0092), Hales doesn’t explicitly state one or more aerosol particle delivery modifiers selected from the group consisting of:
one or more airflow diverting structures which comprise a structure placed upstream of the drug foil substrate comprising a plurality of channels, wherein the centerlines of the channels define an angle from 100 degrees to 170 degrees, with the ray of the aerosol axis in the upstream direction measured in the sector containing the air inlet;
one or more airflow straightening structures which comprise a structure placed upstream of the drug foil substrate comprising a plurality of channels, wherein the centerlines of the channels define an angle from -10 degrees to 10 degrees with the aerosol axis.
Internal walls comprising two internal opposite walls which define an angle of 5 to 20 degrees in at least 80% of its portion comprised within the projection of the drug foil substrate on the aerosol axis; wherein the vertex of said angle is located in the upstream direction; and
One or more airflow directing structures which comprise a structure placed upstream of the drug foil substrate comprising at least two sets of channels, one set at each side of the Z-plane, wherein the centerlines of each set of the channels define an angle from 5 to 20 degrees with the Z-plane; and wherein the vertex of said angle is located upstream of the drug foil substrate.
However, Taurino teaches a respiratory aerosol generating device (Abstract and Figures 1-4) comprising an aerosol axis (see horizontal arrow shown in Figure 4) and a drug film source (nicotine source 210, Paragraph 0096 and Figure 3), further teaching one or more airflow straightening structures (a plurality of ridges 150 extend longitudinal along the length of the cartridge 100, forming straight air flow channels 160, Paragraphs 0101-0102, Figures 4-5; see also Paragraph 0111 describe the purpose of ridges 150 and channels 160 being to define straight flow paths) comprising a plurality of channels (channels 160, Figure 5 and Paragraph 0102) wherein the centerlines of the channels define an angle from -10 degrees to 10 degrees with the aerosol axis (centerlines of channels 160 parallel with aerosol axis, therefore defining an angle of zero degrees between the two, and therefore within the claimed angle range, Figures 4-5).
The Examiner notes the remaining limitations (sub-elements I, III, and IV are not required by the claim due to the phrase “one or more aerosol particle delivery modifiers selected from the group of…” in the preceding line).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hale’s device with a flow straightening airflow modifier, in the form of a plurality of channels, as taught by Taurino, as providing flow straightening structures within an aerosol delivery device as such structures may aide in the creation of laminar flow throughout the device, reducing areas of flow stagnation within the device.
Regarding claim 2, Hale further discloses wherein the drug foil substrate heating circuit comprises an electric heater (electric heater wire, Paragraph 0084).
Regarding claim 3, Hale further discloses a disposable cartridge and a handheld controller, wherein the disposable cartridge is configured to be connected to the handheld controller, the disposable cartridge comprises features a) to g), and i), and the handheld controller comprises feature h) (see claim 1 analysis discussing the elements of Hale which equate to features a) to g), i) and h).
Regarding claim 4, Hale discloses a disposable cartridge configured to be connected to a handled controller (device 214 comprising an element for heating a respiratory drug composition to form a vapor, forming a condensation aerosol, Figure 2b and Paragraph 0085, Abstract), the handheld controller comprising: an airway defined by internal walls (chamber 224 defined by walls 216 and 218, Figure 2b); an air inlet at one end of the airway (air inlet slots 222 at one end of device 214, Paragraph 0086 and Figure 2b); an air outlet, configured as a mouthpiece, the air outlet located at another end of the airway (tapered end 204 on other side of the device configured to be inserted into a user’s mouth, Figure 2a and Paragraph 0083); a drug foil substrate having an impermeable surface placed within the airway (substrate associated with film 230, film is deposited on stainless steel substrate foil on a solid support 226, Paragraph 0125 and Figure 2b); a drug foil substrate support (solid support 226, Figure 2b and Paragraph 0086);; a solid drug film coated on the drug foil substrate (respiratory drug composition film 230, Figure 2b and Paragraph 0087);; an aerosol axis defined by at a geometrical center of the solid drug film and a geometrical center of the air outlet, wherein a downstream direction goes from the geometric center of the solid drug film to the geometrical centre of the air outlet and an upstream direction in the opposite direction (see horizontal axis represented by the arrow shown in Figure 2b showing the direction of airflow through the device 214, comprising both an upstream and downstream direction).
Although Hale teaches various aerosol particle delivery modifiers such as a deformable flap to divert air flow (Paragraph 0088) and the presence or absence of structures that produce or restrict turbulence within the chamber (Paragraph 0092), Hales doesn’t explicitly state one or more aerosol particle delivery modifiers selected from the group consisting of:
one or more airflow diverting structures which comprise a structure placed upstream of the drug foil substrate comprising a plurality of channels, wherein the centerlines of the channels define an angle from 100 degrees to 170 degrees, with the ray of the aerosol axis in the upstream direction measured in the sector containing the air inlet;
one or more airflow straightening structures which comprise a structure placed upstream of the drug foil substrate comprising a plurality of channels, wherein the centerlines of the channels define an angle from -10 degrees to 10 degrees with the aerosol axis.
Internal walls comprising two internal opposite walls which define an angle of 5 to 20 degrees in at least 80% of its portion comprised within the projection of the drug foil substrate on the aerosol axis; wherein the vertex of said angle is located in the upstream direction; and
One or more airflow directing structures which comprise a structure placed upstream of the drug foil substrate comprising at least two sets of channels, one set at each side of the Z-plane, wherein the centerlines of each set of the channels define an angle from 5 to 20 degrees with the Z-plane; and wherein the vertex of said angle is located upstream of the drug foil substrate.
However, Taurino teaches a respiratory aerosol generating device (Abstract and Figures 1-4) comprising an aerosol axis (see horizontal arrow shown in Figure 4) and a drug film source (nicotine source 210, Paragraph 0096 and Figure 3), further teaching one or more airflow straightening structures (a plurality of ridges 150 extend longitudinal along the length of the cartridge 100, forming straight air flow channels 160, Paragraphs 0101-0102, Figures 4-5; see also Paragraph 0111 describe the purpose of ridges 150 and channels 160 being to define straight flow paths) comprising a plurality of channels (channels 160, Figure 5 and Paragraph 0102) wherein the centerlines of the channels define an angle from -10 degrees to 10 degrees with the aerosol axis (centerlines of channels 160 parallel with aerosol axis, therefore defining an angle of zero degrees between the two, and therefore within the claimed angle range, Figures 4-5).
The Examiner notes the remaining limitations (sub-elements a, c and d are not required by the claim due to the phrase “one or more aerosol particle delivery modifiers selected from the group of…” in the preceding line).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hale’s device with a flow straightening airflow modifier, in the form of a plurality of channels, as taught by Taurino, as providing flow straightening structures within an aerosol delivery device as such structures may aide in the creation of laminar flow throughout the device, reducing areas of flow stagnation within the device.
Regarding claim 6, Taurino again teaches one or more airflow straightening structures (a plurality of ridges 150 extend longitudinal along the length of the cartridge 100, forming straight air flow channels 160, Paragraphs 0101-0102, Figures 4-5; see also Paragraph 0111 describe the purpose of ridges 150 and channels 160 being to define straight flow paths) comprising a plurality of channels (channels 160, Figure 5 and Paragraph 0102) wherein the centerlines of the channels define an angle from -10 degrees to 10 degrees with the aerosol axis (centerlines of channels 160 parallel with aerosol axis, therefore defining an angle of zero degrees between the two, and therefore within the claimed angle range, Figures 4-5).
Regarding claim 15, Hale further teaches wherein the internal opposite walls are straight, convex, or concave (see internal opposing walls of device 214 being convex, Figure 2b).
Regarding claim 16, Taurino further teaches wherein the diverting channels, straightening channels, and/or airflow directing channels have an elliptical shape (the ridges 150 forming the channels 160 may having a sinusoidal profile as opposed to a straight edge, therefore having an elliptical shape, Paragraph 0111).
Regarding claim 18, although Hale teaches the drug in the solid drug film being a variety of different drugs and their placentally acceptable salts (Paragraph 0016), Hale doesn’t explicitly teach the drug being a. loxapine or its pharmaceutically acceptable salts, b. alprazolam, estazolman, c. fentayl, d. zalelon, e. apomorphine, pergolide, ropinirole, pramipexole, f. granisetron, ondansetron, palonestron, g. nicotine, or h. ropinirole, pramipexole, or rotigotine.
However, Taurino teaches a respiratory aerosol generating device (Abstract and Figures 1-4) comprising a solid drug film of nicotine (nicotine source 210, Paragraph 0096 and Figure 3). The Examiner notes due to the presence of the term “or” in claim 18, only one drug from the list of drugs is required by the claim, and therefore the remaining limitations are not required.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hale’s device by having the drug film comprise nicotine, as taught by Taurino, as using nicotine in an inhalation device is an art-recognized drug source commonly used in inhaler devices.
Allowable Subject Matter
Claims 5, 7-9 would be allowable if rewritten 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: Thorens et al. (US 9,420,829 B2) and Cross et al. (US 2005/0268911 A1).
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.
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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
