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
Acknowledgement is made to Applicant’s claim to priority to National Stage Application No. PCT/MX2021/050047 filed August 19, 2021 and to foreign priority to Mexican Application No. MX/a/2020/008822 filed August 19, 2020.
Status of Claims
The present office action is in response to the preliminary amendment filed 02/16/2023. As directed by the amendment, claims 1, 3, 5, 7 have been amended, and claims 4 and 6 have been cancelled. Thus, claims 1-3, 5, 7-22 are presenting pending in this application.
Specification
The disclosure is objected to because of the following informalities:
“an oxygen On/Off solenoid valve (61)” in ¶0044 which Examiner suggests amending to read --an oxygen On/Off solenoid valve (60)--
Appropriate correction is required.
Claim Objections
Claims 1, 2-3, 5, and 7-22 are objected to because of the following informalities:
Claim 1 recites, “an On/off air solenoid valve” in ln 4 which Examiner suggests amending to read --an on/off air solenoid valve--.
Further, Examiner suggests amending the limitations, “on/off oxygen solenoid valve” and the “on/off air solenoid valve” in consistent format throughout claims 1-2, 7, 14-15, and claim 20 for clarity.
Claim 1 recites, “a rib at each of its ends” in ln 6 which Examiner suggests amending to read --a rib at each of two opposite ends--
Claim 1 recites, “which in turn is interconnected with” in ln 12-13 which Examiner suggests amending to read --which is interconnected with--
Claim 1 recites, “a microcontroller that, through the parameters sensed by the flow sensor (100) and a differential pressure sensor (130), in each respiratory cycle executes the steps of” in ln 14-15, which Examiner suggests amending to read --a microcontroller configured to executes the followings steps based on parameters sensed by the flow sensor (100) and a differential pressure sensor (130) during each respiratory cycle--
Claim 1 recites, “control” in ln 17, “process” in ln 19, “process and determine” in ln 26, “determine” in ln 29”, “send” in ln 30, “send” in ln 34, and “send” in ln 37 which Examiner suggests amending to read --controlling-- in ln 17, --processing-- in ln 19, --processing and determining-- in ln 26, --determining-- in ln 29”, --sending-- in ln 30, --sending-- in ln 34, and --sending-- in ln 37
Claim 1 recites, “the opening and closing” in 27-28 which Examiner suggests amending to read --an opening and closing--
Claim 2 recites, “characterized in that both” in ln 1-2 which Examiner suggests amending to read --wherein--
Claim 3 recites, “characterized in that it further” in ln 2 which Examiner suggests amending to read --further--
Claim 5 recites, “characterized in that” in ln 2 which Examiner suggests amending to read --wherein--
Claim 7 recites, “characterized in that” in ln 2 which Examiner suggests amending to read --wherein--
Claim 7 recites, “the upper part of a container plate (92) whose position is in turn above the arrangement” in ln 3-4 and “the humidified air” in ln 5 which Examiner suggests amending to read --an upper part of a container plate (92) which is positioned above the arrangement-- in ln 3-4 and --a humidified air--
Claim 8 recites, “characterized in that it also comprises” in ln 1-2 which Examiner suggests amending to read --wherein--
Claims 9-10 recites, “Servomotor” which Examiner suggests amending to read --servomotor--
Claim 9 recites, “characterized in that it further” in ln 1-2 which Examiner suggests amending to read --further--
Claim 10 recites, “characterized in that” in ln 1 which Examiner suggests amending to read --wherein--
Claim 11 recites, “characterized in that” in ln 1 which Examiner suggests amending to read --wherein--
Claim 12 recites, “characterized in that it also comprises a system for collecting, processing data and wired or wireless transfer” in ln 1-2 which Examiner suggests amending to read --further comprises a system configured to collect and process data, and transfer data in a wired or wireless manner-- as described in ¶0081.
Claim 13 recites, “characterized in that the first air connector (8) and the second oxygen connector (12) are arranged in parallel and horizontally” in ln 1-3 which Examiner suggests amending to read --further comprises, a first air connector (8) and a second oxygen connector (12) which are arranged in parallel and horizontally--
Claim 14 recites, “characterized in that it also comprises a hexagonal-shaped connector (11)” in ln 1-2 which Examiner suggests amending to read --further comprises a hexagonal-shaped connector (11)--
Claim 15 recites, “characterized in that it further comprises a hexagonal-shaped connector (61)” in ln 1-2 which Examiner suggests amending to read --further comprises a hexagonal-shaped connector (61)--
Claim 16 recites, “characterized in that it also comprises a computer arrangement that allows it to collect data and transmit it to a cloud” in ln 1-2 which Examiner suggests amending to read -- further comprises a computer arrangement configured to collect and transmit data a cloud--
Claim 17 recites, “characterized in that it also comprises” in ln 1-2 which Examiner suggests amending to read --further comprises--
Claim 18 recites, “characterized in that the normal air channel (8a) and the oxygen channel (9) are fed by air/oxygen supplies (15) that are already in medical units” in ln 1-3 which Examiner suggests amending to read --further comprises a normal air channel (8a) and wherein the normal air channel (8a) and the oxygen channel (9) are fed by air/oxygen supplies (15) which are part of medical units--
Claim 19 recites, “characterized in that it also comprises” in ln 1-2 which Examiner suggests amending to read --further comprises--
Claim 20 recites, “characterized in that it comprises” in ln 2 which Examiner suggests amending to read --comprising--
Claim 20 recites, “control” in ln 3, and “control” in ln 5 which Examiner suggests amending to read --controlling--
Claim 20 recites, “the passage of the oxygen flow” in ln 3 and “the passage of the regulated air” in ln 5 which Examiner suggests amending to read --a passage of an oxygen flow-- and --a passage of a regulated air--
Claim 20 recites, “preset through a plurality of graphical user interfaces displayed by one user interface, values related to tidal volume, positive end-expiratory pressure, trigger pressure, fraction of inspired oxygen, respiratory rate, and inspiration ratio / expiration according to the needs of the patient” in ln 6-9 which Examiner suggests amending to read --receiving preset values related to tidal volume, positive end-expiratory pressure, trigger pressure, fraction of inspired oxygen, respiratory rate, and inspiration ratio / expiration through a plurality of graphical user interfaces displayed by an user interface according to a patient’s needs--
Claim 20 recites, “mix” in ln 10, “humidify and increase” in ln 11, “Sensing” in ln 13 and ln 15, and “regulate” in ln 21” which Examiner suggests amending to read --mix-- in ln 10, --humidifying and increasing-- in ln 11, --sensing-- in ln 13 and ln 15 and --regulating-- in ln 21
Claim 20 recites, “the oxygen and air” in ln 10 which Examiner suggests amending to read --the oxygen flow and the regulated air--
Claim 20 recites, “the temperature of the moisture air/oxygen mixture” in ln 11 and “the moisten mixture” in ln 17 and “the wet mixture” in ln 22-23, and ln 30 which Examiner suggests amending to read --a temperature of a wet mix-- in ln 17 and --the wet mix-- in ln 22-23, and ln 30
Claim 20 recites “the pressure of the inspiration and expiration gases through the input/output differential pressure sensor” in ln 15-16 which Examiner suggests amending to read --a pressure of the inspiration and expiration gases through a differential pressure sensor--
Claim 20 recites, “a patient during the inspiration process” in ln 18 which Examiner suggests amending to read --the patient during an inspiration process--
Claim 20 recites, “the exhaled gases” in ln 19, “the oxygen pressure” in ln 21, “the number of liters of air per minute (volume)” in ln 22 which Examiner suggests amending to read --exhaled gases--, --an oxygen pressure--, and --a volume--
Claim 20 recites, “where the step related to the regulation of oxygen and the number of liters of air per minute comprises the steps of” in ln 24-25 which Examiner suggests amending to read --wherein a method of regulating the oxygen and the volume of the wet mix comprises the steps of--
Claim 20 recites, “control” in ln 26, “process” in ln 29, “process” in ln 33, “process and determine” in ln 35, “determine” in ln 39, “send” in ln 40, “send” in ln 44, and “send” in ln 47 which Examiner suggests amending to read --controlling-- in ln 26, --processing-- in ln 29, --processing-- in ln 33, --processing and determining-- in ln 35, --determining-- in ln 39, --sending-- in ln 40, --sending-- in ln 44, and --sending-- in ln 47
Claim 20 recites, “and pressure” in ln 26, “the positive pressure at the end” in ln 28, “the pressure of the inspiratory and expiratory gases” in ln 29, “said result” in ln 30, “the amount of volume” in ln 33, and “the pressure of the inspiratory and expiratory gases” in ln 34 which Examiner suggests amending to read --and the pressure-- in ln 26, --a positive pressure at an end-- in ln 28, --a pressure of an inspiratory gas and an expiratory gas-- in ln 29, --a result-- in ln 30, --an amount of volume-- in ln 33, and --the pressure of the inspiratory gas and the expiratory gas” in ln 34
Claim 20 recites, “the opening and closing” in ln 36-37 which Examiner suggests amending to read --an opening and closing--
Claim 20 recites, “at least one control signal” in ln 44 and ln 47 which Examiner suggests amending to read --the at least one control signal--
Claim 21 recites, “a point of inspiration” in ln 2 which Examiner suggests amending to read --an inspiration point-- similar to claim 22.
Claim 21 recites, “outlet” in ln 5 which Examiner suggests amending to read --the air/oxygen outlet--
Claim 21 recites, “the lungs” in ln 6 which Examiner suggests amending to read --the patient’s lungs--
Claim 22 recites, “the arrangement of the air On/Off solenoid valve” in ln 2-3 which Examiner suggests amending to read --the on/off air solenoid valve--
Claim 22 recites, “the exhaled air” in ln 4 which Examiner suggests amending to read --the exhaled gases-- similar to claim 20.
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.
Such claim limitation(s) is/are:
“a mix conduction means” and “a CO2 outlet means” in claim 1
“air/oxygen conduction means” in claim 22
The corresponding structure of the “mix conduction means”, the “CO2 outlet means” and the “air/oxygen conduction” means are interpreted as a channel for inspiratory (¶0019) and a channel for expiration process (¶0046)
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.
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(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means of a connection channel”, “means of a connector”, and “means of the air and oxygen solenoid valve” in claim 1
“means of a differential pressure conduit” and “means of a secondary conductor” in claim 8
“means of an oxygen on/off solenoid valve”, “means of an on/off air solenoid valve”, “means of a humidifier”, “means of a flower sensor ”, “means of an exhaled air quality sensor”, “means of the air and oxygen on/off solenoid valves”,
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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/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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
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 16 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(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.
Claim 16 recites, “a database, recombining and combining them by means of algorithms and data science techniques and artificial intelligence” in ln 3-4. The specification fails to provide adequate written description support for the full scope of this limitation.
Although the specification briefly references, “the microprocessor is programmed with control algorithms which a person with expertise in the matter can understand that are not typical of a computer program that runs any conventional computer… Said algorithms were specially designed for the operation of the apparatus of the present invention, to modify in real time said values, which without complicated equations, only decide to increase or decrease the pressures” in ¶0054, it does not describeb how the data within a database is combined and recombined by means of algorithms, data science techniques, and artificial intelligence. Further, the application as filed merely reference that the information to be stored in the cloud where the storage levels are related to the amount of data stored (¶0081-0082); it contains no disclosure of how such data would be combined and recombined nor any indication of data science techniques and the artificial intelligence.
Thus, the specification does not reasonably convey to a person of ordinary skill in the art that the subject matters were in possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2-3, 5, and 7-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation, “determine the values related to the CO2 contained in the exhaled gases to define the opening and closing of a CO2 outlet solenoid valve”, renders claim indefinite. The claim recites a function of analyzing CO2 values without reciting the structure which would provide those values. [See MPEP 2173.05(g)] Examiner suggests amending the claim to include --an exhaled air quality sensor-- as described in ¶0019 and claim 20 for clarity.
Claim 1 recites the limitations, “the parameters sensed” in ln 14, “the pre-established values” in ln 17, “the sensed values related to the pressure” in ln 19, “the real value” in ln 20, “the sensed values related to the volume” in ln 22, “the actual value” in ln 25, “the values related to CO2” in ln 26, “the preset values” in 29 and “the preset value” in 39. There is insufficient antecedent basis for these limitation in the claim.
Claim 1 recites, “compensate at least one difference in pressure between what is programmed and what is sensed in each respiratory cycle….to compensate for at least a difference between the programmed number of liters of air per minute according to the requirements of the patient's condition and what is sensed at each respiratory cycle” in ln 35-37, render claim indefinite. It is unclear whether “what is programmed” is same or different from the preset values and the pre-established values and “what is sensed” is same or different from “the real value” or “the sensed values”. Examiner notes that there is also insufficient antecedent basis within the limitation such as “the requirements”, “event” and etc.
Claims 2-3, 5, 7-19 are rejected by virtue of dependency to claim 1.
Regarding claim 5, claim depends from claim 4 which is canceled. As a result, the metes and bounds of the claimed subject matter is unclear.
Regarding claim 20, the limitations, “the value related to the amount of liters of air per minute (volume)” in ln 13, “the value related to the pressure” in ln 15, “the value of CO2 contained” in ln 19, “the pre-established values related to inspiration, plateau and expiration” in ln 27-28, “the real values of the pressure” in ln 30, and “the actual value” in ln 35 render claim indefinite. There is insufficient antecedent basis for these limitations in the claim.
Further, claim 20 recites, “compensate at least one difference in pressure between what is programmed and what is sensed in each respiratory cycle….to compensate for at least a difference between the programmed number of liters of air per minute according to the requirements of the patient's condition and what is sensed at each respiratory cycle” in ln 41-47, render claim indefinite. It is unclear whether “what is programmed” is same or different from the preset values and the pre-established values and “what is sensed” is same or different from “the real value” or “the sensed values”. Examiner notes that there is also insufficient antecedent basis within the limitation such as “the requirements”, “event” and etc.
Claims 21-22 are rejected by virtue of dependency to claim 20.
Allowable Subject Matter
Claims 1, 2-3, 5, and 7-22 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matter of the independent claims 1 and 20, the closest identified prior art document of the record is Hughey et al. (WO 2021231363 A1), Andrieux et al. (US 20130152923 A1) and Christopher et al. (US 20170128692 A1)
Hughey et al. discloses, the main components of the respiratory assistance device comprising a normal air inlet (a connection of 31, Fig 1), an on/off air solenoid valve (32, Fig 1) an oxygen inlet nozzle (a connection of 33, Fig 1), an on/off oxygen solenoid valve (34, Fig 1), a pressure control valve (24, Fig 1), a CO2 outlet solenoid valve (28, Fig 1), and a PEEP valve (29, Fig 1) and a controller which is a mircroprocessor that receives continuous pressure measurements of the breathing circuit, which is measured by one or more pressure sensor and regulates regulates operation of the charging valve 21, the inspiratory valve 24 and the expiratory valve 28, which is set by a user according to the desirable respiratory rate, inspiratory time while the PEEP valve 29 maintains pressure within said breathing circuit during expiration at approximately between 0-20cm H20(¶0035-0036) , but the prior art fails to teach or suggests an arrangement consisting of a pressure regulator (20), a manometer (21) for the normal air inlet and a pressure control solenoid valve (70) connected to a humidifier (90) by means of a connection channel (91); an air/oxygen outlet (110) interconnected to a mix conduction means (105) which is in turn interconnected with a flow sensor (100), and with a mix outlet (93) of the humidifier (90) by means of a connector (94), and a microcontroller configured to control the CO2 outlet solenoid valve based on CO2 contained in the exhaled gases and send in real time at least one control signal to the CO2 outlet solenoid valve in the event that the value of the remaining volume at the end of expiration sensed is less than the preset value.
Andrieux et al. discloses the main components of the respiratory assistance device as shown in Fig 3 and a control system configured to control the delivery of gas to and/or from patient based on various input, e.g., input received from a user (e.g., via a touch screen and/or other user interfaces provided by ventilation system), data received from one or more sensors, and/or data received from other components or sub-systems of ventilation system and the operation of gas delivery system and the operation of one or more valves in order to control the pressure and/or flow rate of gas delivered (¶0078) and calculate and determine effective pressure values from reading from sensors (¶0083) and controlling the exhalation valve based on the readings of the sensors (¶0071-73), but the prior art fails to teach or suggests an arrangement consisting of a pressure regulator (20), a manometer (21) for the normal air inlet and a pressure control solenoid valve (70) connected to a humidifier (90) by means of a connection channel (91); an air/oxygen outlet (110) interconnected to a mix conduction means (105) which is in turn interconnected with a flow sensor (100), and with a mix outlet (93) of the humidifier (90) by means of a connector (94) and a PEEP valve, and a microcontroller configured to control the CO2 outlet solenoid valve based on CO2 contained in the exhaled gases and send in real time at least one control signal to the CO2 outlet solenoid valve in the event that the value.
Christopher et al. discloses, the general component of the respiratory device as shown in Fig 3 and further disclose the humidifier (26, Fig 3; ¶0074), but the prior art does not suggests or teach the arrangement of the humidifier and the valves and the sensors as indicated in the claim 1 of the instant application.
It is thus found that one of ordinary skills in the art at the time of effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785