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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (EP20214452.3) filed on the December 16, 2020.
Claim Objections
Claims 1, 2, 11, and 12 objected to because of the following informalities:
Regarding Claim 1, add “;” after comprising in line 1
Regarding Claim 2, add “,” after “claim 1”
Regarding Claim 11, add “;” after comprising in line 1
Regarding Claim 12, add “,” after “claim 11”
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, pressure sensor must be shown with certain reference numbers in the specification or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7, 10, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 7, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of the Office Action, every limitation after “for example” is not considered.
Regarding claim 10 and 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of the Office Action, every limitation after “such as” is not considered.
Regarding claim 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of the Office Action, every limitation after “preferably” is not considered.
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.
Claim 11 and its dependencies claims 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recites a method; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a method of operating a breath-actuated inhalation device. The claims recite an abstract idea in the form of performing scans in which the membrane is vibrated at a plurality of frequencies, comparing a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation, determining whether liquid is present in the reservoir on the basis of the comparison of the spectra, ceasing to drive the vibrator IF it is determined in step d) that no liquid is present. This represents a mental processes because it can equivalently be done by a person simply by observing and comparing a spectrum obtain during an inhalation and determining whether liquid is present in the reservoir. These are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 11, as a representative example that is applicable to claims 12-15, the abstract idea is defined by the elements of:
A method of operating a breath-actuated inhalation device comprising an aerosol generator having a vibrator and a membrane, and a reservoir for liquid to be aerosolized which is in fluid communication with the membrane,
the method comprising:
a) driving the vibrator intermittently so that the aerosol generator repeatedly undergoes periods of aerosol generation during a patient's inhalations and periods of little or no aerosol generation preceding and/or succeeding the inhalations;
b) performing scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum; wherein the scans are performed during the inhalations and during periods of little or no aerosol generation preceding and/or succeeding the inhalations;
c) comparing a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation;
d) determining whether liquid is present in the reservoir on the basis of the comparison of the spectra; and
e) ceasing to drive the vibrator if it is determined in step
d) that no liquid is present.
The above bolded limitation recite a method of performing scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum, then comparing a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation, then determining whether liquid is present in the reservoir on the basis of the comparison of the spectra, then ceasing the vibrator only if the determined liquid is present, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of performing scans, comparing spectrums, and determining if liquid is present can be carried out in a person’s mind. This is further defining the abstract idea. Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of performing scans, comparing spectrums, and determining if liquid is present through observations. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “vibrator ”, “aerosol generator”, and “reservoir,” does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “aerosol generator” are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). In addition, the use of method of using these aerosol generators has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in US 20050229926 A1 (para. 0031) (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component. Also, “vibrator” is also field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea as it not indictive of integration into a practical application because they are recited at a high -level of generality as shown in US 20030192532 A1 (para. 0002, 0005). This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
A “vibrator ”, “aerosol generator”, and “reservoir,” are filed of use or extra solution activity, are all considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The method recites such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner. The 101 rejection is made because of comparing the scans to determine if liquid is present is the abstract idea, then only IF there is no liquid then something happens but when there is liquid present nothing happens to the abstract idea making it continuous reading.
For step 2B, the independent claim(s) Claim 11 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to carry out the steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a computer without any recitation of details of how to carry out the abstract idea. The rationale set forth for the 2nd prong of the eligibility test above is also applicable to the entirety of the claims. The method can be carried out with processor or control device are generic computer systems and the inhalation devices are drawn to a field of use.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for claim 11 is also applicable to Claim 12-15.
In regards to Claims 12 and 14-15, the applicant is reciting elements that further limit the claims to include a first scan is performed before each inhalation to obtain a first spectrum, a second scan is subsequently performed during each inhalation to obtain a second spectrum, and the first and second spectra are compare and wherein in step c), the spectra are compared by calculating an overlap function and then wherein in step d), it is determined that no liquid is present in the reservoir if the overlap function is above a threshold value, and preferably wherein in step e), driving the vibrator ceases if the overlap function is above the threshold value for a plurality of consecutive inhalation. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 11 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claim 13, the claim recites a new additional element of “a channel” and “pressure sensor” which is routine and conditional using as shown in US 20160366946 A1 (para. 0706; that reaches pressure sensors are used to determine airflow). Also, the applicant is reciting elements that further limit the claims to wherein the inhalation device comprises a channel having an air inlet opening and an aerosol outlet opening and a pressure sensor which is pneumatically connected to the channel, wherein the periods of aerosol generation are initiated in response to inhalation by the patient on the basis of a signal from the pressure sensor. The same rationale set forth for the 2nd prong of the eligibility test above for claim 11 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-8, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb et al. (US 20140352690 A1), hereafter as Kolb, in view of Finke et al. (EP 2883564 A1), hereafter as Finke.
Regarding Claim 1, Kolb discloses a breath-actuated inhalation device (Fig. 5; 1, 2) comprising;
an aerosol generator (Fig. 5; 10, 4, 11, 13) having a vibrator (Fig. 5; 11) and a membrane (Fig. 5; 10),
a reservoir (Fig. 5; 3) for liquid to be aerosolized which is in fluid communication with the membrane (para. 0086), and
a controller (Fig. 5; 9) that provides a driver signal to drive the vibrator so that the membrane vibrates and generates an aerosol (para. 0030, 0042),
wherein the controller is configured (this limitation is functional) to:
drive the vibrator intermittently so that the aerosol generator repeatedly undergoes periods of aerosol generation during a patient's inhalations and periods of little or no aerosol generation preceding and/or succeeding the inhalations (para. 0046; Examiner notes that the generation of aerosol by the nebulizing means could be inhalation triggered);
Kolb does not disclose specifically that the controller is configured to:
perform scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum; wherein the scans are performed during the inhalations and during the periods preceding or succeeding the inhalations;
compare a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation;
determine whether liquid is present in the reservoir on the basis of the comparison of the spectra; and
cease to drive the vibrator if the controller determines that no liquid is present.
However, Finke teaches controller (Fig. 1; 10; para. 0026-0028, 0114, 0116, 0120-0124) configured to:
perform scans in which the membrane is vibrated at a plurality of frequencies (abstract; para. 0120-0124), and in which at least one electrical parameter of the vibrator (Fig. 1; 7) is measured at the plurality of frequencies to provide a spectrum (abstract; para. 0019, 0021, and 0045-0046, 0054, 0122); wherein the scans are performed during an inhalation (para. 0118-120) with a spectrum obtained during the period preceding or succeeding that inhalation (para. 0022-0023; Figs. 2-7B);
compare a spectrum obtained during the inhalation with a spectrum obtained during the periods preceding or succeeding the inhalations (para. 0022-0023, 0028; Examiner notes: the controller is configured to compare these frequencies to adjacent or neighboring detected value detected by the detector meaning the controller is configured to obtain the values of the periods preceding or succeeding the inhalation as the limitation is functional);
determine whether liquid is present in the reservoir on the basis of the comparison of the spectra (para. 0019, 0021); and
cease to drive the vibrator if the controller determines that no liquid is present (para. 124).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device and sensing of the inhalations of Kolb to include the for the controller to perform scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum; wherein the scans are performed during the inhalations and during the periods preceding or succeeding the inhalations; compare a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation; determine whether liquid is present in the reservoir on the basis of the comparison of the spectra; and cease to drive the vibrator if the controller determines that no liquid is present as taught by Finke for the purpose of knowing the presence or absence of fluid in contact with the membrane and/or in the fluid reservoir can be immediately detected upon activation of the aerosol generator. Which in turn the aerosol dosage accuracy is increased, thereby improving the efficiency of the aerosol treatment. Further, by deactivating the vibrator, the power consumption of the aerosol generator can be minimised, e.g., increasing the lifetime of a battery in the aerosol delivery device (para. 0074).
Regarding Claim 2, Modified Kolb discloses the inhalation device according to claim 1,
Modified Kolb does not specifically disclose wherein the controller is configured to perform a first scan before each inhalation to obtain a first spectrum, to subsequently perform a second scan during each inhalation to obtain a second spectrum, and to compare the first and second spectra.
However, Finke teaches the controller (10; Finke) is configured to compare these frequencies to adjacent or neighboring detected value detected by the detector meaning the controller is configured to obtain the values of the periods preceding or succeeding the inhalation (para. 0022-0023, 0028).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device and controller of Modified Kolb to include the perform a first scan before each inhalation to obtain a first spectrum, to subsequently perform a second scan during each inhalation to obtain a second spectrum, and to compare the first and second spectra as taught by Finke for the purpose of allowing for a particularly reliable and efficient detection of the presence of fluid in contact with the membrane and/or in the fluid reservoir (para. 0078, 0081-0082).
Regarding Claim 3, Modified Kolb discloses the inhalation device according to claim 1,
further comprising:
a channel (Fig. 5; 1) having an air inlet opening (at the end of the base unit and “A” in Annotated Fig A below; Fig. 5; 1) and an aerosol outlet opening (at the end of 10 and “B” in Annotated Fig. A below; Fig. 5), and
a pressure sensor (Fig. 5; 8) which is pneumatically connected to the channel (para. 0060),
wherein the controller (10; Finke) is configured to detect inhalation by a patient at the aerosol outlet opening on the basis of a signal from the pressure sensor, and to initiate a period of aerosol generation in response to the inhalation (para. 0060; Kolb; This limitation is functional).
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Figure A: Figure 5 Adapted from Kolb
Regarding Claim 4, Modified Kolb discloses the inhalation device according to claim 3
Modified Kolb does not specifically teach wherein the controller is configured to initiate a period of little or no aerosol generation at a pre-set time after the period of aerosol generation was initiated.
However, Kolb teaches that specific treatment time and/or number of breaths required depend on parameters like the overall condition of the patient, the dose to be administered and the output efficiency of the inhalation device meaning the controller could be able to have a preset time where generation (para. 0046, 0058; Kolb; this limitation is functional).
Therefore, Kolb is considered to be in field of inhalation devices. Due to an absence of the limitations of the controller is configured to initiate a period of little or no aerosol generation at a pre-set time after the period of aerosol generation was initiated, the claimed feature is interpreted under the broadest reasonable interpretation to encompass Modified Kolb’s disclosure of including a certain time period following an aerosol generation, since the reference already teaches controlled administration based on treatment parameters, implementing a temporal restriction on subsequent aerosol generating is known and predictable means of preventing and ensuring adherence to the output efficiency (para. 0058-0059, 0067). The controller is configured to follow certain treatments that would stop the driver.
Regarding Claim 5, Modified Kolb discloses the inhalation device according to claim 1, wherein the aerosol generator (Fig. 5; 10, 4, 11, 13) further comprises
a support member (“A”; in annotated Fig. B below) comprising
a hollow tubular body (Fig. 5; inside of 3) having a flange (“B”; in annotated Fig. B below) at or close to a first end onto which the vibrator (Fig. 5; 11) is attached, and
a second end (“C”; in annotated Fig. B below) into or onto which the membrane is mounted (where 10 is attached), and
wherein the device comprises a filling chamber (“D”; in annotated Fig. B below) above the support member (The circle reference “A” below), so that the filling chamber and the hollow tubular body together form the reservoir (para. 0086; Kolb).
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Figure B: Fig. 5 Adapted from Kolb
Regarding Claim 6, Modified Kolb discloses the inhalation device according to claim 1, wherein the controller (Fig. 1; 10; Finke) is configured to determine the resonant frequency of the aerosol generator from the spectra, and to drive the vibrator at the resonant frequency, or at a frequency related to the resonant frequency, during the periods of aerosol generation other than the scans (para. 0081-0083; 0122-0124; Finke teaches that the detection can be done continuously or at certain time intervals).
Regarding Claim 7, Modified Kolb discloses the inhalation device according to claim 6, Modified Kolb does not specifically teach wherein the plurality of frequencies comprises from about 10 or 15 kHz below the resonant frequency to about 10 or 15 kHz above the resonant frequency (para. 0081-0082, 0123; Finke).
However, Finke teaches wherein the plurality of frequencies comprises from about 10 or 15 kHz below the resonant frequency to about 10 or 15 kHz above the resonant frequency (para. 0081-0082, 0123; Finke).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Modified Kolb to include the wherein the plurality of frequencies comprises from about 10 or 15 kHz below the resonant frequency to about 10 or 15 kHz above the resonant frequency as taught by Finke for the purpose of allowing for a particularly reliable and efficient detection of the presence of fluid in contact with the membrane and/or in the fluid reservoir (para. 0078, 0081-0082).
Regarding Claim 8, Modified Kolb discloses the inhalation device according to claim 1, wherein the controller (10; Finke)
Modified Kolb does not specifically disclose that the controller is configured to compare the spectra by calculating an overlap function.
However, Finke teaches controller may be configured to sequentially operate the vibrator at a plurality of different vibration frequencies so that the difference between one vibration frequency (f1) and the next vibration frequency (f2)(para. 0082; Figs. 2-7b) and also configured to compare the slope or slopes, e.g. the maximum slope or slopes, thus determined with one or more reference values stored in the detector. Based on this comparison, the detector detects or determines the presence of fluid in contact with the membrane (para. 0135).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller of Modified Kolb to include the calculate overlap function as taught by Finke for the purpose of increasing the accuracy of the detection process (para. 0082-0083, 0136).
Regarding Claim 11, Kolb discloses a method of operating a breath-actuated inhalation device comprising:
an aerosol generator (Fig. 5; 10, 4, 11, 13) having a vibrator (Fig. 5; 11) and a membrane(Fig. 5; 10), and a reservoir (Fig. 5; 3) for liquid to be aerosolized which is in fluid communication with the membrane (para. 0086), the method comprising:
a) driving the vibrator intermittently so that the aerosol generator repeatedly undergoes periods of aerosol generation during a patient's inhalations and periods of little or no aerosol generation preceding and/or succeeding the inhalations (para. 0046; Examiner notes that the generation of aerosol by the nebulizing means could be inhalation triggered);
Kolb does not disclose specifically that the method comprising;
b) performing scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum; wherein the scans are performed during the inhalations and during periods of little or no aerosol generation preceding and/or succeeding the inhalations;
c) comparing a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation;
d) determining whether liquid is present in the reservoir on the basis of the comparison of the spectra; and
e) ceasing to drive the vibrator if it is determined in step d) that no liquid is present.
However, Finke teaches controller (10; para. 0026-0028, 0114, 0116, 0120-0124) with a method comprising;
b) performing scans in which the membrane is vibrated at a plurality of frequencies(abstract; para. 0120-0124), and in which at least one electrical parameter of the vibrator (Fig. 1; 7) is measured at the plurality of frequencies to provide a spectrum(abstract; Col. 3-4 para. 0019, 0021, and 0045-0046, 0054, 0122); wherein the scans are performed during the inhalations and during periods of little or no aerosol generation preceding and/or succeeding the inhalations(para. 0022-0023);
c) comparing a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation (para. 0022-0023, 0028; Figs. 2-7b; Examiner notes: the controller is configured to compare these frequencies to adjacent or neighboring detected value detected by the detector meaning the controller is configured to obtain the values of the periods preceding or succeeding the inhalation);
d) determining whether liquid is present in the reservoir on the basis of the comparison of the spectra (para. 0019, 0021, 0123-0124); and
e) ceasing to drive the vibrator if it is determined in step d) that no liquid is present (para. 124).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Kolb to include the for the controller to perform scans in which the membrane is vibrated at a plurality of frequencies, and in which at least one electrical parameter of the vibrator is measured at the plurality of frequencies to provide a spectrum; wherein the scans are performed during the inhalations and during the periods preceding or succeeding the inhalations; compare a spectrum obtained during an inhalation with a spectrum obtained during the period preceding or succeeding that inhalation; determine whether liquid is present in the reservoir on the basis of the comparison of the spectra; and cease to drive the vibrator if the controller determines that no liquid is present as taught by Finke for the purpose of knowing the presence or absence of fluid in contact with the membrane and/or in the fluid reservoir can be immediately detected upon activation of the aerosol generator. Which in turn the aerosol dosage accuracy is increased, thereby improving the efficiency of the aerosol treatment. Further, by deactivating the vibrator, the power consumption of the aerosol generator can be minimised, e.g., increasing the lifetime of a battery in the aerosol delivery device (para. 0074).
Regarding Claim 12, Modified Kolb discloses the method according to claim 11, wherein a first scan is performed before each inhalation to obtain a first spectrum, a second scan is subsequently performed during each inhalation to obtain a second spectrum, and the first and second spectra are compared (para. 0022-0023, 0028; Examiner notes: the controller is configured to compare these frequencies to adjacent or neighboring detected value detected by the detector meaning the controller is configured to obtain the values of the periods preceding or succeeding the inhalation; Finke; Figs. 2-7b; Finke).
Regarding Claim 13, Modified Kolb discloses the method according to claim 11, wherein the inhalation device comprises a channel (Fig. 5; 1) having an air inlet opening (at the end of the base unit and “A” in Annotated Fig A above; Fig. 5; 1) and an aerosol outlet opening (at the end of 10 and “B” in Annotated Fig. A above; Fig. 5) and a pressure sensor (Fig. 5; 8) which is pneumatically connected to the channel (para. 0060),
wherein the periods of aerosol generation are initiated in response to inhalation by the patient on the basis of a signal from the pressure sensor (para. 0060).
Regarding Claim 14, Modified Kolb discloses the method according to claim 11,
Modified Kolb does not specifically disclose wherein in step c), the spectra are compared by calculating an overlap function.
However, Finke teaches controller may be configured to sequentially operate the vibrator at a plurality of different vibration frequencies so that the difference between one vibration frequency (f1) and the next vibration frequency (f2)(para. 0082; Figs. 2-7b) and also configured to compare the slope or slopes, e.g. the maximum slope or slopes, thus determined with one or more reference values stored in the detector. Based on this comparison, the detector detects or determines the presence of fluid in contact with the membrane (para. 0135).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Modified Kolb to include the calculation overlap function as taught by Finke for the purpose of increasing the accuracy of the detection process (para. 0082-0083, 0136).
Claim(s) 9-10, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb and Finke, as applied to claim 8 and 14, in view of Sutton et al. (US 20030005030 A1), hereafter as Sutton.
Regarding Claim 9, Modified Kolb discloses the inhalation device according to claim 8, wherein the controller (Fig. 1; 10; Finke; para. 0028, 0124-0132) is configured to determine that no liquid is present in the reservoir (Fig. 5; 3; Kolb).
Modified Kolb does not specifically disclose controller is able to determine that no liquid is present if the overlap function is above a threshold.
However, Sutton teaches a controller that is able determine if the overlap function is above a threshold (para. 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller that determines no liquid is present in Modified Kolb to include the controller that is able determine if the overlap function is above a threshold as taught by Sutton for the purpose of deciding on future actions of the autonomous device (para. 0061).
Regarding Claim 10, Modified Kolb discloses the inhalation device according to claim 9, wherein the controller (Fig. 1; 10; Finke; 0028, 0124-0132) is configured to cease driving the vibrator (Fig. 5; 3) if the overlap function is above the threshold value (para. 0061; Sutton) for a plurality of consecutive periods of aerosol generation (para. 0028; This limitation is functional Finke taches that is looking at certain periods; Finke).
Regarding Claim 15, Modified Kolb discloses the method according to claim 14, wherein in step d), it is determined that no liquid is present in the reservoir (Fig. 5; 3; Kolb).
Modified Kolb does not specifically disclose controller is able to determine that no liquid is present if the overlap function is above a threshold.
However, Sutton teaches a controller that is able determine if the overlap function is above a threshold (para. 0061).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller that determines no liquid is present in Modified Kolb to include the controller that is able determine if the overlap function is above a threshold as taught by Sutton for the purpose of deciding on future actions of the autonomous device (para. 0061).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KENDRA CARTER can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
