DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. This office action is responsive to the preliminary amendment filed on December 4, 2023. As directed by the amendment: no claims have been amended, claims 1-21 have been cancelled, and no claims have been added. Thus, claims 22-42 are presently pending in this application.
Drawings
3. The drawings are objected to under 37 CFR 1.83(a) because they fail to show any details regarding
an administration element which is interpreted as “a heating element, an ultrasonic nebuliser which vaporises or nebulises liquid using a piezoelectric element, a gas compressor which builds up a gas pressure and thereby nebulises or vaporises liquid through a nozzle, or a nebulising membrane in which liquid is vaporised or nebulised by high-frequency vibration of the membrane” as described in the specification paragraph [0022].
A blocking element which is interpreted as “a latch, a switch or other physical means; alternatively, software control is provided by means of the electronic control apparatus” as described in specification paragraph [0041].
Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
4. The drawings are objected to because figures 2 and 6 include rectangular boxes which should be labelled with short catch word(s) indispensable for understanding. See PCT Rule 11.11(a). 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 Interpretation
5. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
6. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
7. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Administration element in claim 22 lines 6, 7, and 18, claim 29 line 2, claim 30 line 3, claim 31 line 6, claim 32 line 8, claim 33 lines 7, 8, and 21, claim 40 line 6, claim 41 line 8, and claim 42 lines 9, 10, and 21.
Sensor system in claim 22 line 11, claim 33 line 12, and claim 42 line 14.
Flow measuring apparatus in claim 22 lines 11 and 22, claim 33 line 12, and claim 42 lines 14 and 25.
Communication device in claim 23 lines 1-2, claim 24 line 2, claim 25 line 1, claim 26 lines 3-4, claim 27 lines 2-3, claim 32 lines 9-10, claim 34 line 2, claim 35 line 2, claim 36 line 1, claim 37 line 2, claim 38 line 3, and claim 41 lines 9-10.
External deployment source in claim 25 line 2 and claim 36 line 2.
Blocking element in claim 29 lines 1 and 2, claim 30 lines 1 and 2-3, claim 31 line 6, claim 32 line 8, claim 40 line 6, and claim 41 line 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
8. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
9. Claims 29-32 and 40-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification doesn’t provide adequate written description of the following claim limitations:
Regarding claims 29-32 and 40-41, the term “blocking element” in lines 1-2 of claim 29, lines 1-3 of claim 30, line 6 of claim 31, line 8 of claim 32, line 6 of claim 40, and line 8 of claim 41 is not properly described. Paragraph [0041] of the specification states that “the blocking element disables the administration element with a latch, a switch, or other physical means; alternatively, software control is provided by means of the electronic control apparatus to prevent actuation of the administration element.”
In the case of a latch, it is not clear if it is controlled electronically or manually, if the latch includes a motor for actuation if it is controlled electronically, or how a latch can disable an administration element which can be “a heating element, an ultrasonic nebuliser […], a gas compressor […], or a nebulising membrane” as described in paragraph [0022] of the specification.
In the case of a switch, it is not clear if the switch is controlled electronically or manually or if the switch includes a motor for actuation if it is being controlled electronically.
In the case of software control, it is not clear how the software is changing the structure to disable the administration device, is disabling power without some switch, or how software control constitutes the structure of the blocking element if it is being provided by the electronic control apparatus.
10. 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.
11. Claims 22-42 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 claims 22, 33, and 42,
the term “the administration element for mixing the active substant with air flowing in the air channel” in claim 22 lines 7-8, claim 33 lines 8-9, and claim 42 lines 10-11 is unclear how the heating structure for the administration element in specification paragraph [0022] can mix the active substance with the air flow.
The term “a flow measuring apparatus for measuring at least one of a volume flow and a mass flow” in claim 22 lines 11-12, claim 33 lines 12-13, and claim 42 lines 14-15 is unclear in how the flow measuring apparatus can determine volume flow without additional calculation. The claim is interpreted to mean –a flow measuring apparatus for calculating at least one of a volume flow and a mass flow--.
The term “a volume flow and a mass flow of at least one of the air flowing through the air channel and the active substance flowing through the air channel” in claim 22 lines 11-13, claim 33 lines 12-14, and claim 42 lines 14-16 is unclear in the difference between the volume flow and mass flow because specification paragraph [0028] and [0047] reference mass flow interchangeably with volume flow when referring to the air flow.
Regarding claims 22, 24, 26-27, 30, 32-33, 35, 37-39, and 41-42, the term “by means of” in claim 22 line 22, claim 24 line 2, claim 26 line 3, claim 27 line 2, claim 30 line 2, claim 32 line 9, claim 33 lines 19 and 24, claim 35 line 2, claim 37 line 2, claim 38 line 3, claim 39 line 2, claim 41 line 9, and claim 42 line 25 is unclear in what is actually performing the function. The term is interpreted to mean –by--.
Regarding claims 24 and 27, the term “can be” in claim 24 line 1 and claim 27 lines 4 and 5 makes it unclear in what is being claimed. The claim term is interpreted to mean –is--.
Regarding claim 30, the term “the blocking element is configured to disable the administration element” in lines 2-3 is unclear in view of the specification paragraph [0041] which states the blocking element is “a latch, a switch, or other physical means; alternatively, software control is provided” because physical means would not be able to disable the administration element while software control could not disable the delivery of the active substance.
Regarding claims 31-32 and 40-41,
the term “a signaling device comprising the inhaler” in claim 31 line 4, claim 32 line 4, claim 40 line 4, and claim 41 line 4 is unclear how a signal would be emitted from the inhaler to the inhaler.
The term “place and a time stamp” in claim 31 line 8, claim 32 line 12, claim 40 line 8, and claim 41 line 12 is unclear on how the electronic control apparatus could produce a place and a time stamp without some additional structure such as a timer.
Regarding claims 32 and 41, the term “defined deviation” in claim 32 lines 1-2 and 11 and claim 41 lines 1-2 and 11 is unclear in what the defined deviation is and how is it defined.
Claim 32 recites the limitation “the communication device” in lines 9-10. There is insufficient antecedent basis for this limitation in the claim.
Claims 40-41 recite the limitation “the communication device” in line 6 of claim 40 and line 8 of claim 41. There is insufficient antecedent basis for this limitation in the claim.
Claim(s) 23, 25, 28-29, 34, and 36 is/are rejected due to being dependent on a rejected claim.
Claim Rejections - 35 USC § 102
12. 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.
13. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
14. 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.
15. Claim(s) 22-42 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Trzecieski (US 2020/0187560).
Regarding claim 22, Trzecieski reads on an inhaler (figs. 71-73 vaporization device is similar to figs. 12-58, vaporization device 400 according to [0609]) comprising:
a housing having a main body (fig. 12, device body 402), wherein the main body is configured to receive an active substance container (fig. 12, cartridge assembly 500 is similar to cartridge assembly 200 according to [0449] which includes fig. 8, storage compartment 216) containing an active substance (fig. 8, vaporizable material 50), and an air channel (fig. 8, cartridge fluid flow path 278) extending within the housing between at least one air inlet opening (fig. 8, air inlets 138A and 138B) of the housing and an inhalation opening of the housing (fig. 8, cartridge aperture 218 engages with fig. 1, inhalation aperture 112);
an administration element (fig. 8, heating element assembly 210) for nebulising or vaporising the active substance fed from the active substance container to the administration element for mixing the active substance with air flowing in the air channel ([0378]-[0379] states that material 50 is heated to create vapor which flows to the cartridge aperture 218);
an electronic control apparatus (fig. 16, control circuit 420);
an electronic data storage device (fig. 16, memory circuit 420m); and
a sensor system having a flow measuring apparatus (fig. 19, fluid flow sensor 442) for measuring at least one of a volume flow and a mass flow ([0031]-[0035] states the fluid flow sensor can be a volumetric or mass airflow sensor) of at least one of the air flowing through the air channel and the active substance flowing through the air channel for storage as active substance delivery data in the electronic data storage device ([0788] states usage, effectiveness and dosage can be stored as DUFE DATA in memory circuit 420m which is additionally in communication with the cartridge memory module according to [0443]);
wherein:
the electronic control apparatus is configured to convert active substance administration data, provided in the electronic data storage device for administering the active substance by the inhaler ([0783] states that dose settings can be stored in the memory module), into administration data in order to control the mixing, by the administration element, of the active substance with the air flowing in the air channel ([0445] states that the memory module may be read by the control circuit to adjust operation of the heating assembly); and
the electronic control apparatus is configured to calculate a quantity of the active substance delivered from the active substance container based on the active substance delivery data detected by means of the flow measuring apparatus ([0799] states that a dose magnitude is found) and to compare the quantity with the active substance administration data ([0768] states a desired dose is achieved through activation of the heating element which is dependent on the user’s inhalation. [0769] further states that during a quick inhalation a partial dose may be delivered which requires a comparison between the measured amount and the set dosage [0783] states that dose settings can be stored and retrieved).
Regarding claim 23, the inhaler of Trzecieski reads on the limitations of claim 22 and further reads on a communication device to either or both transmit or receive data (fig. 16, wireless communication modules 422, 434, and 426. [0627] states that a smartphone can be wirelessly coupled to the memory module).
Regarding claim 24, the inhaler of Trzecieski reads on the limitations of claim 23 and further reads on data can be provided to the electronic data storage device by means of at least one of the communication device ([0783] states that once a device is connected over Wi-Fi, control parameters can be amended and sent back to the memory module) and a storage unit comprising the active substance container ([0783] states that the memory module includes preset code).
Regarding claim 25, the inhaler of Trzecieski reads on the limitations of claim 23 and further reads on the communication device is configured to communicate with an external deployment source (fig. 16, wireless communication modules 422, 434, and 426. [0627] states that a smartphone can be wirelessly coupled to the memory module) containing the active substance administration data in order to either or both receive the active substance administration data ([0783] states that the connected device can be used to control dose settings) or transmit data ([0797] states that dosage data can be displayed on an associated device screen which requires data to be transmitted to the smartphone, tablet, or laptop).
Regarding claim 26, the inhaler of Trzecieski reads on the limitations of claim 25 and further reads on the external deployment source comprises at least one of an application terminal ([0797] states data can be presented on a laptop computer), a cloud storage ([0798] states that DUFE DATA can be stored in a database), and a mobile application ([0627] states that a smartphone can be wirelessly coupled to the memory module) to either or both receive the active substance administration data by means of the communication device or to transmit data ([0783] states that dose settings can be configured, and [0797] states that dosage information can be transmitted and displayed).
Regarding claim 27, the inhaler of Trzecieski reads on the limitations of claim 26 and further reads on the inhaler is configured to be linked to a mobile application of a communication terminal by means of the communication device ([0781]-[0782] states that the vaporizer device is connected to a smartphone app via control assembly 420) to either or both transmit data or receive data ([0783] states that dose settings can be configured, and [0797] states that dosage information can be transmitted and displayed), wherein the active substance administration data can be received from at least one of the cloud storage and the application terminal via the mobile application ([0783] states that dose settings can be configured via the device with Wi-Fi capabilities) and can be transferred to the electronic data storage device of the inhaler ([0783] states that the amended code is stored in the memory module).
Regarding claim 28, the inhaler of Trzecieski reads on the limitations of claim 22 and further reads on at least one motion sensor ([0789] states that a gravity sensor or accelerometer can be used to determine how the vaporizer device is being held relative to the ground) to detect specific movements of the inhaler at least one of before, during and after delivery of the active substance ([0474] states that the accelerometer detects when the device is picked up to activate the control assembly which inherently occurs before use of the device and after a previous use of the device).
Regarding claim 29, the inhaler of Trzecieski reads on the limitations of claim 22 and further reads on a blocking element ([0610] states that the vaporization device can include an activation lock), wherein the blocking element blocks the administration element to disable the delivery of the active substance from the active substance container ([0610] states that the activation lock can be a switch to disable the heater).
Regarding claim 30, the inhaler of Trzecieski reads on the limitations of claim 29 and further reads on the blocking element is configured to be controlled by means of the electronic control apparatus ([0612] states that keypad 1445 can be used to control the activation lock which is coupled to the control assembly according to [0129]), wherein the blocking element is configured to disable the administration element if the active substance administration data is not available to the electronic control apparatus ([0769] states that users may select a dose size they wish to inhale. [0039] further states that the activation lock is deactivated by default which inherently means the device is only unlocked when the user is ready to inhale which is after a dose size is selected).
Alternatively, even if the administration element being disabled when the active substance administration data is not available, however, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide a program in Trzecieski’s control circuit to only allow activation when the device is ready to be activated to conserve energy as stated in [0475] of Trzeciesk that a low power mode can be used to conserve energy and enable the control circuit for operation.
Regarding claim 31, the inhaler of Trzecieski reads on the limitations of claim 30 and further reads on the active substance delivery data at least substantially matches the active substance administration data, the electronic control apparatus is configured to take an action including at least one of:
emitting a signal to at least one of a signaling device comprising the inhaler, a mobile application, an application terminal, and a cloud storage (fig. 112, is presented on a display of a smartphone according to [0797] which inherently requires a signal to be emitted);
blocking of the administration element by the blocking element ([0762] states that after operation of the heating element it may be disabled for a period of time);
storing of an at least substantial match of the active substance delivery data with the active substance administration data with at least one of a place and a time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application (fig. 112, the dosage and time stamp are recorded and transmitted to be displayed according to [0797]).
Regarding claim 32, the inhaler of Trzecieski reads on the limitations of claim 30 and further reads on in the case of a defined deviation of the active substance delivery data from the active substance administration data, the electronic control apparatus takes an action including at least one of:
emitting a signal to at least one of a signaling device comprising the inhaler, the mobile application, the application terminal, and the cloud storage (fig. 112, is presented on a display of a smartphone according to [0797] which inherently requires a signal to be emitted);
adjusting the administration data for delivering the quantity of the active substance for mixing with the air flowing in the air channel ([0717] states that after each dose an effectiveness value can be provided by the patient to then be used in adjusting dose size);
blocking the administration element with the blocking element ([0762] states that after operation of the heating element it may be disabled for a period of time which inherently means blocking the administration element after a dose exceeds the desired amount);
receiving new active substance administration data by means of the communication device for generating new administration data ([0717] states that after each dose an effectiveness value can be provided by the patient to then be used in adjusting dose size);
storing the defined deviation of the active substance delivery data from the active substance administration data with at least one of a place and time stamp on or in at least one of the electronic data storage device, the application terminal, the cloud storage, and the mobile application (fig. 112, the dosage and time stamp are recorded and transmitted to be displayed according to [0797]).
Regarding claim 33, see the rejection to claim 22 above.
Regarding claim 34, see the rejection to claim 23 above.
Regarding claim 35, see the rejection to claim 24 above.
Regarding claim 36, see the rejection to claim 25 above.
Regarding claim 37, see the rejection to claim 22 above regarding the structure. The method of Trzecieski further reads on the inhaler is linked to a mobile application of a communication terminal by means of the communication device before a first time of either or both of transmitting data or receiving data ([0783] states that once the device is connected, settings can be adjusted which requires transmission and receiving data by the vaporization device).
Regarding claim 38, see the rejection to claim 27 above.
Regarding claim 39, the method of Trzecieski reads on the limitations of claim 38 and further reads on data is transmitted to at least one of the mobile application, the application terminal, and the cloud storage by means of the inhaler (fig. 112, the dosage and time stamp are recorded and transmitted to be displayed according to [0797]).
Regarding claim 40, see the rejection to claim 31 below regarding method steps in addition to the steps of claim 38.
Regarding claim 41, see the rejection to claim 32 below regarding method steps in addition to the steps of claim 38.
Regarding claim 42, see the rejection to claim 26 above.
Conclusion
16. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hadash (WO-2014068504) discloses an inhaler which communicates with a computing device for opening and closing a valve ([0042]). Maharajh et al. (US 2006/0047368) discloses a vapor generator which uses a software to shut off the heater according to programmable threshold ([0068]). Newberry (US 2017/0189629) discloses an atomizer which uses sensors to monitor an intended treatment ([0067]). Jackson et al. (US 2019/0240430) discloses a method for delivering a dose and locking the inhaler after the dose or a preset time (fig. 5). Sexton et al. (US 2005/0166913) discloses an inhalation system with a detection system to determine if a desired particle flux has been achieved (abstract). Barbaric et al. (US 2021/0046261) discloses a system which has electronics to adjust dosage size according to measured pressure within a vaporizer and the environment ([0037]). Ritson et al. (US 5,497,764) discloses a medication cassette which monitors inspiratory flow and, upon a delivery threshold being met, shuts off the medicament delivery (see figs. 6-8 and col. 20, lines 19-28). Burns et al. (US 5,284133) discloses an inhalation device with a shut off mechanism to ensure the proper dosage is provided (col. 10, lines 35-51).
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Thursday (Every other Friday) 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS Z CHANG/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785