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 371 national stage priority based on an application filed in PCT/CN2020/138052 on 12/21/2020. It is noted, however, that applicant has not filed a certified copy of the CN2020/138052 application as required by 37 CFR 1.55.
It is also noted that receipt is acknowledged of national stage priority, however the present application does not properly claim priority to the submitted foreign application (foreign priority is not claimed in the ADS). If this copy is being filed to obtain priority to the foreign filing date under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), applicant must also file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the applicable petition fee under 37 CFR 1.17(m)(1) or (m)(2).
Drawings
The drawings are objected to because the different modules, medical personnel, and patient in fig. 1 (detecting module, expiratory module, inspiratory module, alarm module, and analysis module) do not have reference numbers. Additionally each of the method steps in Fig. 6 do not have reference numbers as well. 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.
Specification
The disclosure is objected to because of the following informalities:
The parts objected to in the drawings above (see drawing objection above) fail to include reference characters in the written description as well. Each part in the drawings/specification, especially the modules, should include a reference character/number.
Appropriate correction is required.
Claim Objections
Claims 6, 8, 11, 12, and 19 are objected to because of the following informalities:
Claim 6, line 5, “a pressure inside the balloon .” should read “a pressure inside the balloon.”
Claim 8, line 4, “the number of respiratory cycles of the patient” should read “a number of respiratory cycles of the patient”
Claim 11, line 1, “the method of claim 10” should read “the ventilation method of the respiratory assembly of claim 10”
Claim 12, line 1, “the method of claim 10” should read “the ventilation method of the respiratory assembly of claim 10”
Claim 19, line 4, “a pressure inside the balloon.” should read “a pressure inside the balloon,”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
Regarding “a detecting module, the detecting module being configured to detect a mouth pressure and an expiratory airway pressure of a patient” in claim 1 (and further in claims 6, 8, and 9).
Uses the term “module” which is a generic placeholder for means
The functional language that modified the “detecting module” is that it is configured to detect a mouth pressure and an expiratory airway pressure (as recited in claim 1) and that it is configured to detect
“detecting module” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, see 112a and 112b sections below.
Regarding “an inspiratory module, the inspiratory module being configured to provide gas to the patient during inspiration” in claim 1 (and further in claim 9).
Uses the term “module” which is a generic placeholder for means
The functional language that modified the “inspiratory module” is that it is configured to provide gas to the patient during inspiration
“inspiratory module” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, the inspiratory module is being interpreted as an inspiratory branch/conduit or other suitable alternative for providing gas to the patient during inspiration as described in the specification and drawings.
Regarding “the regulating member is configured to regulate a difference between the expiratory branch pressure and the mouth pressure” in claim 2 (and further in claims 13, 14, 16, and 17).
Uses the term “member” which is a generic placeholder for means
The functional language that modified the “regulating member” is that it is configured to regulate a difference between the expiratory branch pressure and the mouth pressure
“regulating member” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, the regulating member is being interpreted as a valve such as a PEEP valve or other suitable alternative for regulating a difference between the expiratory branch and mouth/airway pressure as described in the specification and drawings.
Regarding “the alarm module is configured to perform an alarm action when either of the mouth pressure and the expiratory airway pressure is greater than a second predetermined value ” in claim 3 (and further in claim 7).
Uses the term “module” which is a generic placeholder for means
The functional language that modified the “alarm module” is that it is configured perform an alarm action
“alarm module” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, the alarm module is being interpreted as an alarm that can provide a flashing light, sharp sound, or alarm information sent to for example a medical personnel’s smartphone, or other suitable alternative for providing an alarm action as described in the specification and drawings.
Regarding “an analysis module; wherein the analysis module is configured to analyze the expiratory airway pressure (…) to determine whether the patient is exhaling or inhaling and to record the number of respiratory cycles of the patient” in claim 8.
Uses the term “module” which is a generic placeholder for means
The functional language that modified the “analysis module” is that it is configured to analyze the pressures, determine whether the patient is exhaling or inhaling, and record a number of respiratory cycles
“analysis module” in not modified by sufficient structure for performing the claimed functions, therefore 35 U.S.C. 112(f) is invoked.
For purposes of examination, see 112a and 112b sections.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations are 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 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation recites sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation is:
Expiratory airway module in claims 1 and 9 as “expiratory branch” provides further structure to the limitation.
Because this claim limitation is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this limitation 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 to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation does not recite sufficient structure, materials, or acts to perform the claimed function.
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.
The claim limitation “detecting module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification only recites the claimed limitation of the detecting module detecting a mouth pressure and an expiratory airway pressure (see specification paragraphs [0008], [0036]-[0037], [0041], [0045], [0057], [0060]) and the detecting module detecting the pressure inside the balloon ([0050]), without clearly linking the structure for being able to detect mouth pressure, detect expiratory airway pressure, and detect pressure inside the balloon. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
For purposes of examination, the detecting module in claims 1 and 9 as well as detecting a mouth pressure and expiratory pressure in claim 10, are being interpreted as a device or any suitable alternative that is able to detect pressure in an expiratory airway or passage. The detecting module in claim 6 is being interpreted as a device such as a connecting tube with a pressure monitoring system or any suitable alternative that is able to detect pressure in a balloon/cuff.
Claims 2-8 are also rejected due to being dependent off of claim 1, claim 7 is also rejected due to being dependent off of claim 6, and claims 11-19 are also rejected due to being dependent off of claim 10.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The claim limitation “analysis module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification only recites the claimed limitation of the analysis module being configured to analyze expiratory airway pressure and mouth pressure to determine whether the patient is exhaling or inhaling and record the number of respiratory cycles of the patient (see specification paragraphs [0014] and [0045]-[0046]), without clearly linking the structure for being able to perform said structure (i.e. a controller, memory, microprocessor, circuitry, etc.). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
For purposes of examination, the analysis module in claim 8 is being interpreted as a controller or any suitable alternative that analyzes pressure data to detect the exhaling or inhaling and is capable of determining a number of respiratory cycles.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 8 is 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 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 claim discusses the analysis module being configured to analyze expiratory airway pressure and mouth pressure to determine whether the patient is exhaling or inhaling and record the number of respiratory cycles of the patient. However, the specification does not describe what the analysis module is and what structural configurations/components are being used to make these analysis and determinations; it only further recites the claimed limitation of the analysis module being configured to analyze expiratory airway pressure and mouth pressure to determine whether the patient is exhaling or inhaling and record the number of respiratory cycles of the patient (see specification paragraphs [0014], [0036]-[0037], [0045]-[0046]).
Claims 1-19 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 claims contain 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 claims discuss the detecting module configured to detect mouth pressure and expiratory airway pressure as recited in claim 1, the detecting module further configured to detect pressure in the balloon as recited in claim 6, and detecting mouth pressure and expiratory airway pressure as recited in claim 10. However, the specification does not describe what the detecting module is, how the detecting module is detecting each pressure, and what structural configurations/components are being used to detect each pressure; it only further recites the claimed limitation of “the detecting module is configured to detect a mouth pressure and an expiratory airway pressure of a patient” (see specification paragraphs [0008], [0036]-[0037], [0041], [0045], [0057], [0060]) or “the detecting module configured to detect the pressure inside the balloon” ([0050]).
Further, claims 1-19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, 9, and 10, the breadth of the claims is large as the claims simply discloses a detecting module being configured to detect a mouth pressure and an expiratory airway pressure; however, the claim limitation and specification do not explain what the detecting module is, how the detecting module is configured to detect expiratory airway pressure and mouth pressure (or expiratory airway pressure vs mouth pressure), or what structural components are being used. Further, the specification merely only recites that “The detecting module is configured to detect a mouth pressure (Pmouth) and an expiratory airway pressure of a patient” or “the detecting module configured to detect the pressure inside the balloon” with no structural components or configurations of how the components are connected; see [0008], [0036]-[0037], [0041], [0045], [0050], [0057], [0060]). The drawings do not resolve this, as the only figure with a detecting module does not include a reference number and merely shows an arrow drawn from a block labeled ‘patient’ to another block labeled ‘detecting module’, see fig. 1. The other figures (figs. 2-5) are drawn to a trach system/device with an expiratory branch and inspiratory branch and no structural components drawn to a mouth. Therefore, it is unclear how the detecting module is configured to detect mouth pressure and/vs airway pressure or pressure in the balloon.
Claims 1, 9, and 10 state a detecting module is configured to detect a mouth pressure and an expiratory airway pressure or detecting a mouth pressure and an expiratory pressure without providing any supporting interconnecting mechanical elements to get the result. The disclosure lacks any further support of what structural components are used and how those components would be connected.
Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know how the detecting module is configured or what structural elements are being used to get the claimed result of detecting a mouth pressure, expiratory airway pressure, and pressure inside the balloon.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what the detecting module is and how the detecting module is structured, one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine what the detecting module is and what is detecting the mouth pressure and/vs the expiratory airway pressure, or the pressure inside the balloon; therefore, the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention one would have to experiment unduly to reach the claimed result detecting a mouth pressure, an expiratory airway pressure, and a pressure inside the balloon and thus the invention is not enabled.
Claims 2-8 are also rejected due to being dependent off of claim 1, claim 7 is also rejected due to being dependent off of claim 6, and claims 11-19 are also rejected due to being dependent off of claim 10.
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 1-19 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).
Claims 1, 9, and 10 recites “whereby the expiratory airway pressure is caused to rise due to lung contraction” or similar iteration, thus claiming the user’s lungs contracting as part of the claimed invention. An example of claim language that avoid claiming a human organism is “whereby a regulating member is configured to be closed and is configured to trap an exhaled gas in the expiratory branch during exhalation, wherein the expiratory airway pressure is configured to rise due to an increase of the exhaled gas in the expiratory branch”.
Claims 2-8 are also rejected due to being dependent off of claim 1
Claims 11-19 are also rejected due to being dependent off of claim 10.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 4, 5, and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isaza (US 20080060646).
Regarding claim 1, Isaza discloses
a respiratory assembly supporting a vocal function (figs. 1-6; ventilator assembly 14 helps facilitate a patient’s ability to talk; [0012] and [0032]), comprising:
a detecting module, the detecting module being configured to detect a mouth pressure and an expiratory airway pressure of a patient (figs. 1-3; inhalation monitor 54 and exhalation monitor 58 are used to monitor pressure within the passageways and further track the pressure within the patient’s lungs throughout the breathing cycles; [0040] and [0045]);
an inspiratory module (inhalation assembly 42, inhalation valve 46, inhalation passage 36), the inspiratory module being configured to provide gas to the patient during inspiration (figs. 1-3; “inhalation assembly 42 is controlled by controller 52 to cause a flow of gas to pass through the open inhalation valve 46, inhalation passage 36, endotracheal tube 16 into the patient's airway and lungs 28”; [0035]); and
an expiratory module (exhalation assembly 44, exhalation valve 48, exhalation passage 38), the expiratory module comprising an expiratory branch connected to an expiratory airway of the patient (see figs. 1-3; exhalation assembly 44 with exhalation valve 48 is connected to exhalation passage 38 to endotracheal tube assembly 12 through Y-fitting 34; [0029]-[0033]),
said expiratory module being configured to expel gas generated by patient's expiration and to control an expiratory branch pressure to be greater than the mouth pressure according to the mouth pressure detected by the detecting module (figs. 1-3; the controller 52 is able to open exhaust valve 48 during the exhalation phase as in the FIG. 3 non-talking mode as well as close the valve 48 to dynamically control the pressure in conduit assembly 32 in accordance with a desired pressure profile during the exhalation phase using the monitored pressured of the passageway and patient’s lungs to facilitate /enhance the patient’s ability to speak; [0037], [0040], [0042] and [0045]; [0053]),
whereby the expiratory airway pressure is caused to rise due to lung contraction during the patient's expiration, thereby causing gas in the expiratory airway of the patient to flow toward a mouth, and the flowing gas to drive patient's vocal cords to vibrate and vocalize (figs. 1-3; airway pressure increases when closing exhalation valve 48 causing airway pressure to increase during exhalation; thereby, allowing/forcing exhaled gas to flow pass the vocal cords facilitating the patient’s ability to speak; abstract, [0037], [0040], [0042]; [0053]).
Regarding claim 2, Isaza further discloses
the respiratory assembly (ventilator assembly 14) of claim 1, wherein:
the expiratory module comprises a regulating member provided on the expiratory branch (figs. 1-3; “the exhalation assembly 44 includes a controllable exhalation valve 48 that communicates with exhalation passage 36”; [0033]); and
the regulating member is configured to regulate a difference between the expiratory branch pressure and the mouth pressure to a first predetermined value (figs. 1-3; “exhalation valve 48 is controlled by controller 52 to remain in its relatively closed position, or to dynamically control the pressure in conduit assembly 32 in accordance with a desired pressure profile, during the exhalation phase, with the pressure profile being based upon the objective of enhancing the patient's ability to speak”; in other words, a exhalation valve 48 is controlled to regulate the conduit assembly 32 (includes exhalation passage 36) to a desired pressure threshold based on pressure within the patient’s airway and the conduit assembly; [0037], [0042], and [0045]),
wherein the first predetermined value is greater than zero (“ may be desirable to maintain the pressure in conduit assembly 32 above a specified threshold, such as, in one embodiment, 5 centimeters of water”, “to keep pressure within conduit assembly 32 above a certain level to keep the patient's airway open and/or enhance the patient's ability to speak”; [0042]).
Regarding claim 4, Isaza further discloses
the respiratory assembly (ventilator assembly 14) of claim 1,
wherein the expiratory module is further configured to control the expiratory branch pressure to be the same as the mouth pressure to stagnate the gas in the expiratory branch (figs. 1-3; the inhalation and exhalation assembly 42, 44 with the their valves 46, 48 are capable of being controlled to a desired degree using the controller 52 and monitors 54, 58 such that a desired pressure (expiratory branch being the same as the airway pressure) at any point in the breathing cycle based upon talking or non-talking operation; [0040]; in other words, the ventilator assembly 14 is capable of being able to control the valves 46, 48 and flow such that the pressure in the exhalation passage 38 and airway are the same and therefore, creating a breath hold/stagnating the gas in the expiratory passage).
Regarding claim 5, Isaza further discloses
the respiratory assembly (ventilator assembly 14) of claim 1,
wherein the expiratory module is further configured to control the expiratory branch pressure to zero (fig. 3; “if controller 52 actually functioned to open exhaust valve 48 during the exhalation phase as in the FIG. 3 non-talking mode, the pressure in exhalation passage 38 would simply be at atmospheric pressure during the exhalation phase so that exhalation monitor 58 would not be monitoring the patient’s airway pressure during the exhalation phase”; [0051]; in other words, during a non-talking mode, pressure in exhalation passage would be at atmospheric pressure or zero on a pressure gauge).
Regarding claim 8, Isaza further discloses
the respiratory assembly (ventilator assembly 14) of claim 1, further comprising
an analysis module (figs. 1-3; controller 52 comprising a programmable microprocessor uses the data (analyzes the data) relating to the pressure; [0044]-[0045]);
wherein the analysis module is configured to analyze the expiratory airway pressure and the mouth pressure measured by the detecting module (figs. 1-3; controller 52 comprises a programmable microprocessor that uses the data (analyzes the data) relating to the pressure, from the inhalation/exhalation monitors 54, 58, to control operation of the ventilator assembly; [0044]-[0045]) to determine whether the patient is exhaling or inhaling (the output from the monitors can be used to detect the phase of respiration that the patient is in; [0045])and to record the number of respiratory cycles of the patient (controller 52 is for operation in providing repetitive respiration cycles and is able to be used in conjunction with the monitors 54, 58 to detect the phase of respiration that the patient is in; [0044]-[0045]; it would have been readily understood of one of ordinary skill in the art that the controller 52 that tracks/monitors the pressure over multiple respiration cycles and is able to detect the phase of respiration in order to control operation would be capable of recording the number of respiratory cycles of the patient because the control needs to track when the breath starts and ends in order to function).
Regarding claim 9, Isaza discloses
a ventilator (figs. 1-3; ventilating apparatus 10; [0028]), comprising
a respiratory assembly (figs. 1-3; ventilator assembly 14; [0028]) comprising:
a detecting module, the detecting module being configured to detect a mouth pressure and an expiratory airway pressure of a patient (figs. 1-3; inhalation monitor 54 and exhalation monitor 58 are used to monitor pressure within the passageways and further track the pressure within the patient’s lungs throughout the breathing cycles; [0040] and [0045]);
an inspiratory module (inhalation assembly 42, inhalation valve 46, inhalation passage 36), the inspiratory module being configured to provide gas to the patient during inspiration (figs. 1-3; “inhalation assembly 42 is controlled by controller 52 to cause a flow of gas to pass through the open inhalation valve 46, inhalation passage 36, endotracheal tube 16 into the patient's airway and lungs 28”; [0035]); and
an expiratory module (exhalation assembly 44, exhalation valve 48, exhalation passage 38), the expiratory module comprising an expiratory branch connected to an expiratory airway of the patient (see figs. 1-3; exhalation assembly 44 with exhalation valve 48 is connected to exhalation passage 38 to endotracheal tube assembly 12 through Y-fitting 34; [0029]-[0033]);
the expiratory module being configured to expel gas generated by patient's expiration (figs. 1-3; the controller 52 is able to open exhaust valve 48 during the exhalation phase as in the FIG. 3 non-talking mode and is allowed to open/close valve based on desired pressure; [0037], [0040], [0042] and [0045]; [0053]);
the expiratory module being further configured to control an expiratory branch pressure to be greater than the mouth pressure according to the mouth pressure detected by the detecting module (figs. 1-3; the controller 52 is able to open exhaust valve 48 during the exhalation phase to close the valve 48 to dynamically control the pressure in conduit assembly 32 in accordance with a desired pressure profile during the exhalation phase using the monitored pressured of the passageway and patient’s lungs to facilitate /enhance the patient’s ability to speak; [0037], [0040], [0042] and [0045]; [0053]), which causes the expiratory airway pressure to rise due to lung contraction during the patient's expiration, causing gas in the expiratory airway of the patient to flow toward a mouth, and the flowing gas to drive patient's vocal chords to vibrate and vocalize (figs. 1-3; airway pressure increases when closing exhalation valve 48 causing airway pressure to increase during exhalation; thereby, allowing/forcing exhaled gas to flow pass the vocal cords facilitating the patient’s ability to speak; abstract, [0037], [0040], [0042]; [0053]).
Regarding claim 10, Isaza discloses
a ventilation method of a respiratory assembly supporting a voice function (figs. 1-6; a method of using a ventilator assembly 14 helps facilitate a patient’s ability to talk; [0012] and [0032],
wherein the respiratory assembly comprises an expiratory branch connected to an expiratory airway of a patient (see figs. 1-3; ventilator assembly 14 comprises an exhalation assembly 44 with exhalation valve 48 is connected to exhalation passage 38 to endotracheal tube assembly 12 through Y-fitting 34; [0029]-[0033]), and
the ventilation method of the respiratory assembly comprises:
detecting a mouth pressure and an expiratory airway pressure of the patient (figs. 1-3; inhalation monitor 54 and exhalation monitor 58 are used to monitor pressure within the passageways and further track the pressure within the patient’s lungs throughout the breathing cycles; [0040] and [0045]); and
providing gas to the patient during the patient’s inspiration (figs. 1-3; “inhalation assembly 42 is controlled by controller 52 to cause a flow of gas to pass through the open inhalation valve 46, inhalation passage 36, endotracheal tube 16 into the patient's airway and lungs 28”; [0035]); and
causing the expiratory airway pressure to rise due to lung contraction during the patient's expiration, and causing gas in the expiratory airway of the patient to flow toward a mouth, whereby the flowing gas causes the patient's vocal chords to vibrate and vocalize (figs. 1-3; airway pressure increases when closing exhalation valve 48 causing airway pressure to increase during exhalation; thereby, allowing/forcing exhaled gas to flow pass the vocal cords facilitating the patient’s ability to speak; abstract, [0037], [0040], [0042]; [0053]).
Regarding claim 11, Isaza further discloses
the method (method of using ventilating apparatus 10) of claim 10,
in which the step of causing the respiratory airway pressure to rise comprises expelling gas generated by the patient's expiration (it would have been readily understood by one of ordinary skill in the art that the patient exhaling when the exhalation valve 48 is closed would cause an increase in pressure in the airway which would then force air upwards to the vocal cords; [0037], [0040], [0042]; [0053]).
Regarding claim 12, Isaza further discloses
the method (method of using ventilating apparatus 10) of claim 10,
in which the step of causing the respiratory airway pressure to rise comprises controlling the expiratory branch pressure to be greater than the mouth pressure (the exhalation assembly 44 includes a controllable exhalation valve 48 that is controller to be opened/closed based on a desired pressure (increase pressure to a desired pressure) such as keeping pressure within conduit assembly 32 above a certain level to keep the patient's airway open and/or enhance the patient's ability to speak; [0037], [0042], and [0045]; [0053]).
Regarding claim 13, Isaza further discloses
the ventilation method of the respiratory assembly (method of using ventilating apparatus 10) of claim 10,
wherein the respiratory assembly further comprises a regulating member provided on the expiratory branch (figs. 1-3; “the exhalation assembly 44 includes a controllable exhalation valve 48 that communicates with exhalation passage 36”; [0033]),
in which the step of causing the respiratory airway pressure to rise comprises:
regulating, by the regulating member, a difference between the expiratory branch pressure and the mouth pressure to a first predetermined value (figs. 1-3; “exhalation valve 48 is controlled by controller 52 to remain in its relatively closed position, or to dynamically control the pressure in conduit assembly 32 in accordance with a desired pressure profile, during the exhalation phase, with the pressure profile being based upon the objective of enhancing the patient's ability to speak”; in other words, a exhalation valve 48 is controlled to regulate the conduit assembly 32 (includes exhalation passage 36) to a desired pressure threshold based on pressure within the patient’s airway and the conduit assembly; [0037], [0042], and [0045]),
wherein the first predetermined value is greater than zero (“ may be desirable to maintain the pressure in conduit assembly 32 above a specified threshold, such as, in one embodiment, 5 centimeters of water”, “to keep pressure within conduit assembly 32 above a certain level to keep the patient's airway open and/or enhance the patient's ability to speak”; [0042]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The 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.
Claims 3 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Isaza (US 20080060646) in view of Doyle (US 20140000606) as evidenced by Schwartz (US 6457472).
Regarding claim 3, Isaza discloses
the respiratory assembly (ventilator assembly 14) of claim 2, further comprising
Isaza does not disclose an alarm module, wherein the alarm module is configured to perform an alarm action when either of the mouth pressure and the expiratory airway pressure is greater than a second predetermined value.
Doyle discloses an analogous ventilation tubing system with a ventilator
an alarm module, wherein the alarm module is configured to perform an alarm action when either of the mouth pressure and the expiratory airway pressure is greater than a second predetermined value (fig. 1; ventilator 100 may issue an alarm (include any suitable type of notification, such as a visual, an audio, or a vibrational cue) when monitored pressure data gathered by a sensor 107 (which may detect pressure in the lungs) breaches/exceeds a threshold; [0083] and [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventilator assembly of Isaza with the alarm system of Doyle to provide feedback for control and alarm modes when a threshold or other maximum are reached/exceeded to reduce likelihood of injury to the patient (Schwartz: col. 8, lines 9-16, col. 14, lines 53-67 and col. 15, lines 1-3).
Regarding claim 14, Isaza discloses
the ventilation method of the respiratory assembly (method of using ventilating apparatus 10) of claim 13, further comprising:
regulating, by the regulating member, the difference between the expiratory branch pressure and the mouth pressure to the first predetermined value (figs. 1-3; inhalation valve 46 and exhalation valve 48 are controlled by controller 52 to dynamically control the pressure in conduit assembly 32 in accordance with a desired pressure profile, during the inhalation and exhalation phase, with the pressure profile being based upon the objective of enhancing the patient's ability to speak”; in other words, the valves 46, 48 are controlled to regulate the conduit assembly 32 (includes exhalation passage 36) to a desired pressure threshold based on pressure within the patient’s airway and the conduit assembly; [0037], [0042], and [0045]),
Isaza does not explicitly disclose before regulating, performing an alarm action when the mouth pressure or the expiratory airway pressure is greater than a second predetermined value.
Doyle discloses an analogous ventilation tubing system with a ventilator
before regulating (the exhalation valve 105 may be controlled during inspiration to release gases when a pressure overshoot (such as exceeding pressure in the lungs) is detected; [0069]-[0070]), performing an alarm action when the mouth pressure or the expiratory airway pressure is greater than a second predetermined value (fig. 1; ventilator 100 may issue an alarm (include any suitable type of notification, such as a visual, an audio, or a vibrational cue) when monitored pressure data gathered by a sensor 107 (which may detect pressure in the lungs) breaches/exceeds a threshold; [0083] and [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventilator assembly of Isaza with the alarm system of Doyle to provide feedback for control and alarm modes when a threshold or other maximum are reached/exceeded to reduce likelihood of injury to the patient (Schwartz: col. 8, lines 9-16, col. 14, lines 53-67 and col. 15, lines 1-3).
Regarding claim 15, the modified device of Isaza further discloses
the ventilation method of the respiratory assembly (Isaza: method of using ventilating apparatus 10; Doyle: alarm when exceeds threshold (Plimit/max)) of claim 14, further comprising:
before performing the alarm action when the mouth pressure or the expiratory airway pressure is greater than the second predetermined value (Doyle: fig. 1; ventilator 100 may issue an alarm (include any suitable type of notification, such as a visual, an audio, or a vibrational cue) when monitored pressure data gathered by a sensor 107 (which may detect pressure in the lungs) breaches/exceeds a threshold; [0083] and [0085]),
filling the expiratory branch with gas by a plurality of expirations when the patient is at an initial expiration (Isaza: see figs. 1-3; exhalation valve 48 is controlled by controller 52 to remain in its relatively closed position (to prevent exhaled gas from flowing therebeyond), but may be closed only enough to enable a desired pressure to build within the conduit assembly 32 and the patient’s lungs (such as filling the conduit assembly 32/exhalation passage 38 with exhaled gas from the patient) to maintain a pressure profile; [0037]-[0042]).
Regarding claim 16, Isaza further discloses
the ventilation method of the respiratory assembly (Isaza: method of using ventilating apparatus 10; Doyle: alarm when exceeds threshold (Plimit/max)) of claim 15, further comprising:
before filling the expiratory branch with gas by a plurality of expirations when the patient is at an initial expiration (Isaza: see figs. 1-3; exhalation valve 48 is controlled by controller 52 to remain in its relatively closed position (to prevent exhaled gas from flowing therebeyond), but may be closed only enough to enable a desired pressure to build within the conduit assembly 32 and the patient’s lungs (such as filling the conduit assembly 32/exhalation passage 38 with exhaled gas from the patient) to maintain a pressure profile; [0037]-[0042]),
regulating, by the regulating member, the expiratory branch pressure so that the expiratory branch pressure is the same as the mouth pressure (figs. 1-3; the inhalation and exhalation assembly 42, 44 with the their valves 46, 48 are capable of being controlled to a desired degree using the controller 52 and monitors 54, 58 such that a desired pressure (expiratory branch being the same as the airway pressure) at any point in the breathing cycle based upon talking or non-talking operation; [0040]; in other words, the ventilator assembly 14 is capable of being able to control the valves 46, 48 and flow such that the pressure in the exhalation passage 38 and airway are the same; and to later maintain pressure or enable a desired pressure to build up [0039]).
Regarding claim 17, Isaza further discloses
the ventilation method of the respiratory assembly (Isaza: method of using ventilating apparatus 10; Doyle: alarm when exceeds threshold (Plimit/max)) of claim 14, further comprising:
regulating, by the regulating member, the expiratory branch pressure to zero (fig. 3; “if controller 52 actually functioned to open exhaust valve 48 during the exhalation phase as in the FIG. 3 non-talking mode, the pressure in exhalation passage 38 would simply be at atmospheric pressure during the exhalation phase so that exhalation monitor 58 would not be monitoring the patient’s airway pressure”; [0051]; in other words, during a non-talking mode, pressure in exhalation passage would be at atmospheric pressure or zero on a pressure gauge), after the patient has breathed a predetermined number of cycles in a voice ventilation mode (see figs. 1-3; the controller 52 of the ventilator assembly 14 is capable of switching from a talking mode to a non-talking mode where the exhalation valve opens to allow gas to escape from the lungs, where the respiration assembly with the controller 52 is constructed to control operation in providing repetitive respiratory cycles; [0040], [0044], [0048], and [0051]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Isaza (US 20080060646) in view of Doyle (US 20140000606) as evidenced by Schwartz (US 6457472) and further in view of Guo (CN 202666147) and its translation (EspaceNet Translation Guo).
Regarding claim 6, the modified device of Isaza discloses
the respiratory assembly (Isaza: ventilator assembly 14; Doyle: alarm when exceeds threshold (Plimit/max)) of claim 3, further comprising
a cannula (figs. 1-3; endotracheal tube 16; [0029]) and a balloon (figs. 1-3; ventilator assembly 14 is capable of being used with a tracheotomy tube cuff; [0062]), wherein:
the cannula is configured for insertion into the expiratory airway (figs. 1-3; endotracheal tube 16 is inserted into a trachea 18 of the patient 20 in order to communicate with the patient’s airway; [0029]).
However, the modified device of Isaza does not disclose the balloon is provided at a periphery of the cannula, and the detecting module is further configured to measure a pressure inside the balloon.
Guo discloses a pressure monitorable endotracheal tube with a cuff 3 [0022] where
the balloon is provided at a periphery of the cannula (see fig. 1; endotracheal tube 2 is provided with an airbag/cuff 3, at the end (periphery) of the tube as shown in fig. 1; [0022], and the detecting module is further configured to measure a pressure inside the balloon (see fig. 1; an opening on the air bag/cuff 3 for connection to a connecting tube 1, where one end of the connecting tube 1 is connected to the air bag/cuff, and the other end is connected to a pressure sensor, to measure a pressure inside the airbag/cuff 3. The pressure sensor is connected to a display, and the pressure sensor also sends a pressure detection signal to a comparator for comparison with a preset threshold; [0022]-[0023]) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal assembly, controller, monitor, and alarm of the modified device of Isaza with the cuff and pressure system (connecting tube, pressure sensor, comparator, display, and alarm transmitter) of Guo to have inflatable cuff that secures the intubation system to the trachea, thereby preventing dislodgement and a pressure system to monitor pressure, compare the pressure of the cuff with a threshold, and set off an alarm to prompt medical staff to make a timely diagnosis or treatment (Guo: [0004], [0022], and [0025]).
Regarding claim 7, the modified device of Isaza further discloses
the respiratory assembly (Isaza: ventilator assembly 14; Doyle: alarm when exceeds threshold (Plimit/max); Guo: endotracheal tube with cuff and pressure system with comparator and alarm) of claim 6,
wherein the alarm module (Doyle: fig. 1; ventilator 100 may issue an alarm (include any suitable type of notification, such as a visual, an audio, or a vibrational cue); Guo: alarm transmitter; [0023]-[0025]) is further configured to perform an alarm action when the pressure inside the balloon is greater than a third predetermined value (Guo: when the comparator compares the pressure with a threshold and finds that the pressure inside the
airbag 3 is too low or too high, it sends a signal to connect the voice prompt and the alarm
indicator light to prompt medical staff to make a timely diagnosis or treatment; [0023]-[0025]).
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Isaza (US 20080060646) in view of Guo (CN 202666147) and its translation (EspaceNet Translation Guo) and further in view of Hamilton (US 20160001110).
Regarding claim 18, Isaza discloses
the ventilation method of the respiratory assembly (method of using ventilating apparatus 10) of claim 10,
wherein the respiratory assembly further comprises a tracheal cannula (figs. 1-3; endotracheal tube 16; [0029]) and a balloon (figs. 1-3; ventilator assembly 14 is capable of being used with a tracheotomy tube cuff; [0062]),
wherein the tracheal cannula is inserted into the expiratory airway of the patient (figs. 1-3; endotracheal tube 16 is inserted into a trachea 18 of the patient 20 in order to communicate with the patient’s airway; [0029])
However, Isaza does not explicitly disclose the balloon is provided at a periphery of the tracheal cannula and does not disclose the balloon is filled with gas and blocks the expiratory airway when a voice ventilation mode is not turned on; before detecting the mouth pressure and the expiratory airway pressure of the patient, the method further comprising expelling gas from the balloon and turning on the voice ventilation mode to obtain a pressure inside the balloon in real time.
Guo discloses a pressure monitorable endotracheal tube with a cuff 3 [0022] where
the balloon is provided at a periphery of the cannula (see fig. 1; endotracheal tube 2 is provided with an airbag/cuff 3, at the end (periphery) of the tube as shown in fig. 1; [0022])
obtain a pressure inside the balloon in real time (see fig. 1; an opening on the air bag/cuff 3 for connection to a connecting tube 1, where one end of the connecting tube 1 is connected to the air bag/cuff, and the other end is connected to a pressure sensor, to measure a pressure inside the airbag/cuff 3. The pressure sensor is connected to a display, and the pressure sensor also sends a pressure detection signal to a comparator for comparison with a preset threshold; [0022]-[0023]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal assembly, controller, and monitor of the modified method of Isaza with the cuff and pressure system (connecting tube, pressure sensor, comparator, display, and alarm transmitter) of Guo to have inflatable cuff that secures the intubation system to the trachea, thereby preventing dislodgement and a pressure system to monitor pressure, compare the pressure of the cuff with a threshold, and set off an alarm to prompt medical staff to make a timely diagnosis or treatment (Guo: [0004], [0022], and [0025]).
The modified method of Isaza further does not disclose the balloon is filled with gas and blocks the expiratory airway when a voice ventilation mode is not turned on; and before detecting the mouth pressure and the expiratory airway pressure of the patient, expelling gas from the balloon and turning on the voice ventilation mode to obtain a pressure inside the balloon in real time.
Hamilton discloses an analogous speech enhancement system for use with a ventilator with an endotracheal tube 306 and inflatable cuff 310 where the balloon is provided at a periphery of the tracheal cannula (see fig. 3; endotracheal tube 306 ends or terminates at or near an inflatable cuff 310; [0069];
the balloon is filled with gas and blocks the expiratory airway when a voice ventilation mode is not turned on (see figs. 3-4; cuff controller 308 reduces pressure of inflatable cuff 310 when a change in patient breathing associated with vocalization is detected and resumes normal ventilator and cuff operation 414 when not talking or after a preset time; [0069]-[0071], in other words during normal operation (not talking), cuff is inflated and blocks airway);
expelling gas from the balloon and turning on the voice ventilation mode (see figs. 3-4; cuff controller 308 reduces pressure of inflatable cuff 310 when a change in patient breathing associated with vocalization is detected by the sensors; [0069-0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ventilating apparatus, endotracheal system, and pressure monitoring cuff of Isaza with the method of inflating the cuff during non-talking and deflating the cuff when a talking/vocalization mode is turned on as disclosed in Hamilton to permit patient to exhale around cuff and pass air over the vocal cords in order to vocalize and ease the pressure that a patient must fight in order to vocalize (Hamilton: [0069]-[0071]).
It directly follows that the resultant pressure monitoring cuff with the ventilating apparatus of the modified method of Isaza combined with the method of deflating the cuff of Hamilton would meet the claimed structural limitations since:
The combined method of the modified method of Isaza and Hamilton discloses
before detecting the mouth pressure and the expiratory airway pressure of the patient (Isaza: monitoring pressure of lungs with inhalation and exhalation monitors 54, 58; [0037]-[0045]), the method further comprising
expelling gas from the balloon and turning on the voice ventilation mode (Hamilton: see figs. 3-4; cuff controller 308 reduces pressure of inflatable cuff 310 when a change in patient breathing associated with vocalization is detected by the sensors; [0069-0071]) to obtain a pressure inside the balloon in real time (Guo: see fig. 1; an opening on the air bag/cuff 3 for connection to a connecting tube 1, where one end of the connecting tube 1 is connected to the air bag/cuff, and the other end is connected to a pressure sensor, to measure a pressure inside the airbag/cuff 3. The pressure sensor is connected to a display, and the pressure sensor also sends a pressure detection signal to a comparator for comparison with a preset threshold; [0022]-[0023]).
Regarding claim 19, the modified method of Isaza further discloses
the ventilation method of the respiratory assembly (Isaza: method of using ventilating apparatus 10; Guo: pressure-monitoring cuff; Hamilton: deflating cuff based on talking mode) of claim 18, further comprising:
after expelling the gas from the balloon and turning on the voice ventilation mode (Hamilton: see figs. 3-4; cuff controller 308 reduces pressure of inflatable cuff 310 when a change in patient breathing associated with vocalization is detected by the sensors; [0069-0071]) to measure the pressure inside the balloon (Guo: see fig. 1; to measure a pressure inside the airbag/cuff 3; [0022]-[0023]).
performing an alarm action when the pressure inside the balloon is greater than a third predetermined value (Guo: when the comparator compares the pressure with a threshold and finds that the pressure inside the airbag 3 is too low or too high, it sends a signal to connect the voice prompt and the alarm indicator light to prompt medical staff to make a timely diagnosis or treatment; [0023]-[0025]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Latham (US 4280492) – A tracheostomy tube with a pressure monitoring system for the balloon/cuff
Nomori (US 20090025729) – A tracheostomy tube with balloon at the end that is inflated when not talking to block saliva (small pressure exhale does not change cuff inflation) and would deflate slightly by exhaled air (certain pressure would allow for deflation) to allow for vocalization
Kremeir (US 20190231202) – A system for recording breathing efforts that records inspiration and expiration events from monitored respirations/pressure curves
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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