Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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:
“an expected pressure” in claims 1 (Line 16), 7 (Lines 14-15), 9 (Lines 18-19), 10 (Lines 20-21), and 18 (Lines 11-12).
“determination result” in claims 1 (Line 1), 7 (Line 21), 9 (Line 4), 10 (Line 6), and 18 (Line 18).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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.
Claim limitation “an expected pressure” 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. This statement is indefinite as it is unclear what the expected pressure value is and how it is calculated. 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 examination purposes, the expected result will be interpreted as the proximal airway pressure.
Claim limitation “determination result” 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. This statement is indefinite as it is unclear what the determination result is and how it is calculated. 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 examination purposes, the claim limitation will be interpreted as a value resulting from the calculation of the difference between the expected pressure and maximum allowable inspiratory pressure.
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.
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.
Claims 7-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
[Step 1]
Regarding claim 7, the claim is a product and is one of the four statutory categories.
[Step 2A, Prong One]
The claim recites the following limitations that recite an abstract idea: determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal; determine the expected pressure based on the flow resistance and based on the first information and/or the second information, and determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or determine the volume flow expected to occur based on the flow resistance and based on the first information and/or the second information, and determine the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure, and determine whether the volume flow expected to occur is higher than the maximum allowable volume flow; provide the determination result corresponding to the determination; and regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded. The above limitations are directed to mental processes that can be done by a person simply observing the outputs of a pressure and/or volume flow sensor and the values inputted into the ventilator by the user, evaluating or comparing the expected inspiratory pressure/flow values to the maximum allowable values, using an equation that can be expressed in decimals, to regulate the pressure and/or volume flow so that the maximum allowable values are not exceeded.
[Step 2A, Prong Two]
Claim 7 recites the additional elements of: a ventilator and a computer program product.
The ventilator is described as “further comprising a computer program product comprising a computer readable storage medium (or media) having non-transitory computer readable program instructions thereon that cause the ventilator to…”. It is essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. The recited abstract process does not improve the functioning of the ventilator, or any other technology or technical field. Nor does the above-identified additional element serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the ventilator, does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). Thus, the abstract idea identified above in Claim 7 is not integrated into a practical application under the 2019 PEG.
[Step B]
The claim does not cite any additional structures that would make it significantly more than the judicial exception. The ventilator consists of a computer program product, and computer readable medium ([0009], [0019-0021], [0033-0035], [0044-0047]). These elements are conventional and well-known in the art.
Computer readable medium and computer program product (The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). It is well-known analysis technique involving an act of evaluating information to a predefined threshold can be practically performed in the human mind.)
Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). The components found in the claim is-well-known to be conventional in the art.
[Step 1]
Regarding claim 9, the claim is a process and is one of the four statutory categories.
[Step 2A, Prong One]
The claim recites the following limitations that recite an abstract idea: determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal; determine the expected pressure based on the flow resistance and based on the first information and/or the second information, and determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or determine the volume flow expected to occur based on the flow resistance and based on the first information and/or the second information, and determine the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure, and determine whether the volume flow expected to occur is higher than the maximum allowable volume flow; provide the determination result corresponding to the determination; and regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded. The above limitations are directed to mental processes that can be done by a person simply observing the outputs of a pressure and/or volume flow sensor and the values inputted into the ventilator by the user, evaluating or comparing the expected inspiratory pressure/flow values to the maximum allowable values, using an equation that can be expressed in decimals, to regulate the pressure and/or volume flow so that the maximum allowable values are not exceeded.
[Step 2A, Prong Two]
Claim 9 recites the additional elements of: a ventilator.
The ventilator is described as “further comprising a computer program product comprising a computer readable storage medium (or media) having non-transitory computer readable program instructions thereon that cause the ventilator to…”. It is essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. The recited abstract process does not improve the functioning of the ventilator, or any other technology or technical field. Nor does the above-identified additional element serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the ventilator, does not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). Thus, the abstract idea identified above in Claim 9 is not integrated into a practical application under the 2019 PEG.
[Step B]
The claim does not cite any additional structures that would make it significantly more than the judicial exception. The ventilator and the process of using a ventilator are conventional and well-known in the art (Schmid et al (US 20240261524 A1), Gray et al (US 20240033456 A1), and Berry Ann et al (US 10293126 B2)).
Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). The components found in the claim is-well-known to be conventional in the art.
Further, dependent claims 10-17 merely include limitation that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
[Step 1]
Regarding claim 18, the claim is a product and is one of the four statutory categories.
[Step 2A, Prong One]
The claim recites the following limitations that recite an abstract idea: determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal; determine an expected pressure based on the flow resistance and based on the first information and/or the second information, and determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or determine a volume flow expected to occur based on the flow resistance and based on the first information and/or the second information, and determine a maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure, and determine whether the volume flow expected to occur is higher than the maximum allowable volume flow; provide a determination result corresponding to the determination; and regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded. The above limitations are directed to mental processes that can be done by a person simply observing the outputs of a pressure and/or volume flow sensor and the values inputted into the ventilator by the user, evaluating or comparing the expected inspiratory pressure/flow values to the maximum allowable values, using an equation that can be expressed in decimals, to regulate the pressure and/or volume flow so that the maximum allowable values are not exceeded.
[Step 2A, Prong Two]
Claim 18 recites the additional elements of: a ventilator, a pressure sensor, and a volume flow sensor, and a computer readable storage medium.
The ventilator is described as performing the aforementioned process steps due to the instructions provided by the computer program product ([0044]). It is essentially acting as a computer element just to execute the program that carries out the abstract method and amounts to merely being the field of use. The recited abstract process does not improve the functioning of the ventilator, or any other technology or technical field. Nor does the above-identified additional element serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The pressure sensor merely measures pressure in the inspiratory line and the volume flow sensor merely measures volume flow in the inspiratory line. It does not use the output in a practical application as it merely outputs the measurements as part of abstract method. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on an electrical structure that is known in the art as the ventilator. The computer readable storage medium merely provides program instructions for the ventilator to perform process steps and calculations. Therefore, the additional elements, do not add a meaningful limitation to the abstract idea because it amounts to simply performing basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). Thus, the abstract idea identified above in Claim 18 is not integrated into a practical application under the 2019 PEG.
[Step B]
The claim does not cite any additional structures that would make it significantly more than the judicial exception. The ventilator consists of various components such as sensors, a breathing gas source, patient interface, inspiratory line, expiratory line, controller, computer program product, and computer readable medium ([0009], [0019-0021], [0033-0035], [0044-0047]). These elements are conventional and well-known in the art.
Ventilator comprising an inspiratory line, expiratory line, controller, patient interface, and breathing gas source (Schmid et al (US 20240261524 A1) [0079-0080], [0085], [0095-0096]).
Sensors (The sensor of the treatment device is recited at a high-level of generality, and merely performs the generic sensing-related computer functions of receiving data, which are insignificant extra-solution activity, or in other words, the steps of the claim. See MPEP 2106.05(b),(f), & (g).);
Computer readable medium and computer program product (The use of a generic processor, memory and/or any other general computer components to store information and perform basic calculations and outputting said results is considered well-understood, routine, conventional computer functions. See MPEP 2106.05(d). It is well-known analysis technique involving an act of evaluating information to a predefined threshold can be practically performed in the human mind.)
Therefore, in addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is-well-understood or conventional. See MPEP 2106.05((g). The components found in the claim is-well-known to be conventional in the art.
[Conclusion]
There needs to be a systemic output from the ventilator i.e. the controller configured to regulate the pressure and/or the volume flow based on the determination result.
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, 7, 8, 11, and 16-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gray et al (US 20240033456 A1).
Regarding Claim 1, Gray discloses a ventilator (high flow respiratory system 10) for ventilating a patient through an inspiratory line (delivery conduit 14), the ventilator comprising:
a breathing gas source (flow source 12) for supplying breathing gas (Fig.1; [0166], [0172]);
a controller (19) which acts as an actuator on the breathing gas source (flow source 12) (Fig.1; [0172]);
a first sensor (18a-d) which is configured to provide a pressure signal which indicates a pressure in the inspiratory line (delivery conduit 14); and (Fig.1; [0172])
a second sensor (18a-d) which is configured to provide a volume flow signal which indicates a volume flow in the inspiratory line (delivery conduit 14) (Fig.1; [0172]),
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
to receive first information indicating a predetermined target volume flow [0207];
to receive second information indicating a predetermined maximum allowable inspiratory pressure [0067,0097-0099],
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
to receive first information indicating a predetermined target volume flow [0207];
wherein the controller (19) is configured to regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (Fig.17; [0276]).
Regarding Claim 2, the ventilator of Gray discloses the ventilator of claim 1, as mentioned above.
The ventilator of Gray also discloses wherein the breathing gas source (flow source 12) is configured as a blower or as a valve (Fig. 1; [0171]).
Regarding Claim 7, Gray discloses a ventilator (high flow respiratory system 10) according to claim 1, further comprising a computer program product comprising a computer readable storage medium (or media) having non-transitory computer readable program instructions thereon that cause the ventilator to ([0240, 0276]):
receive the first information which indicates the predetermined target volume flow [0207];
receive the second information indicating the predetermined maximum allowable inspiratory pressure [0067,0097-0099];
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (“the controller is further configured to control the flow modulator to reduce the flow of respiratory gases to the reduced flow rate in response to the pressure exceeding the pressure threshold values for the corresponding flow rates.” [0080]).
Regarding Claim 8, the ventilator of Gray discloses the ventilator of claim 1, as mentioned above.
The ventilator of Gray also discloses in combination with a patient interface (15) and a tubing system comprising the inspiratory line (delivery conduit 14), wherein the combination forms a system for ventilating a patient (Fig. 1; [0166, 0172]).
Regarding Claim 9, Gray discloses a process for controlling a ventilator (high flow respiratory system 10) for ventilating a patient through an inspiratory line (conduit 14), the process comprising the steps of (Figs.1 and 17; [0169-0179, 0276]):
providing a pressure signal which indicates a pressure in an inspiratory line (delivery conduit 14) (Fig.17; [0276]);
providing a volume flow signal which indicates a volume flow in the inspiratory line (delivery conduit 14) (Fig.17; [0276]);
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (“the controller is further configured to control the flow modulator to reduce the flow of respiratory gases to the reduced flow rate in response to the pressure exceeding the pressure threshold values for the corresponding flow rates.” [0080]).
Regarding Claim 10, Gray discloses a process according to claim 9, wherein the ventilator (high flow respiratory system 10) comprises a breathing gas source (flow source 12) for supplying breathing gas, a controller (19) which acts as an actuator on the breathing gas source (Fig. 1; [0166, 0172]);
a first sensor (18a-d) configured to provide the pressure signal which indicates the pressure in the inspiratory line (delivery conduit 14); and (Fig.1; [0172])
a second sensor (18a-d) which is configured to provide the volume flow signal which indicates the volume flow in the inspiratory line (delivery conduit 14), (Fig.1; [0172])
wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
to receive the first information indicating the predetermined target volume flow [0207];
to receive the second information indicating the predetermined maximum allowable inspiratory pressure [0067, 0097-0099],
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
wherein the controller (19) is configured to regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (Fig.17; [0276]).
Regarding Claim 11, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray also discloses wherein the breathing gas source (flow source 12) is configured as a blower or as a valve [0171].
Regarding Claim 16, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray also discloses wherein the ventilator (high flow respiratory system 10) is in combination with a patient interface and a tubing system comprising the inspiratory line (delivery conduit 14) and the combination forms a system for ventilating a patient (Fig. 1; [0166], [0172]).
Regarding Claim 17, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray also discloses the process further comprising providing a computer program product comprising a computer readable storage medium (or media) having non-transitory computer readable program instructions thereon that cause the ventilator (high flow respiratory system 10) to perform at least some of the process steps ([0240, 0276]).
Regarding Claim 18, Gray discloses a computer program product comprising a computer readable storage medium (or media) having non-transitory computer readable program instructions thereon that cause a ventilator (high flow respiratory system 10) to ([0240, 0276]):
provide a pressure signal which indicates a pressure in an inspiratory line (delivery conduit 14) (Fig.1; [0172]);
provide a volume flow signal which indicates a volume flow in the inspiratory line (delivery conduit 14) (Fig. 1, [0172]);
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
receive first information which indicates a predetermined target volume flow [0207];
to receive the second information indicating the predetermined maximum allowable inspiratory pressure [0067,0097-0099],
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (“the controller is further configured to control the flow modulator to reduce the flow of respiratory gases to the reduced flow rate in response to the pressure exceeding the pressure threshold values for the corresponding flow rates.” [0080]).
wherein the ventilator (high flow respiratory system 10) comprises a breathing gas source (flow source 12) for supplying breathing gas, a controller which acts as an actuator on the breathing gas source (Fig. 1; [0166, 0172]);
a first sensor (18a-d) configured to provide the pressure signal which indicates the pressure in the inspiratory line (delivery conduit 14); and (Fig.1; [0172])
and a second sensor (18a-d) which is configured to provide the volume flow signal which indicates the volume flow in the inspiratory line (delivery conduit 14),
determine a flow resistance of the inspiratory line based on the pressure signal and based on the volume flow signal (“The respiratory system 22 may also determine a real time characterization of resistance in the delivery conduit 30 from the pressure sensors 29 and flow rate sensors 32, compare this to the known resistance to reduce expected variation in the patient pressure.” [0244]);
wherein the ventilator (high flow respiratory system 10) is configured (Fig. 1, [0172]):
to receive the first information indicating the predetermined target volume flow [0207];
to receive the second information indicating the predetermined maximum allowable inspiratory pressure [0067, 0097-0099],
to determine, based on the flow resistance and based on the first information and/or the second information, the expected pressure and to determine whether the expected pressure is higher than the maximum allowable inspiratory pressure, and/or to determine, based on the flow resistance and based on the first information and/or the second information, the expected volume flow that is likely to occur and to determine whether the volume flow that is likely to occur is higher than the maximum allowable volume flow corresponding to the maximum allowable inspiratory pressure; and (“In some embodiments, a safety threshold of about 60 cmH.sub.2O may be preferred, or a safety threshold calculated as a safe margin above the predetermined pressure threshold value for the corresponding flow rate may be used, or calculated as a safe margin above a normal expected region or range of system pressures.” [0243])
to provide the determination result corresponding to the determination (“In some embodiments, the controller 24 may be programmed to apply a further safety threshold being a pressure limit which, when reached at any flow rate, will trigger the controller 24 to substantially reduce or stop operation of the flow modulator 26, for example by turning off the blower 27 and/or closing off of the proportional valve 25.” [0243]).
wherein the controller (19) is configured to regulate the pressure and/or the volume flow based on the determination result such that the maximum allowable inspiratory pressure and/or the maximum allowable volume flow is not exceeded (Fig.17; [0276]).
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 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 1 above, in view of Ringkamp (US 20210322697 A1).
Regarding Claim 3, the modified ventilator of Gray discloses the ventilator of claim 1, as mentioned above.
The modified ventilator of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]).
to provide the first difference as a first input variable for the controller [0057].
The modified ventilator of Gray fails to disclose a ventilator to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow.
However, Ringkamp teaches a ventilator to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow [0052], in order to, determine as least one disturbance variable and remove it from the computation of a respiratory parameter.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ventilator of modified Gray to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow, as taught by Ringkamp, in order to, determine as least one disturbance variable and remove it from the computation of a respiratory parameter [0057].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 9 above, in view of Ringkamp (US 20210322697 A1).
Regarding Claim 12, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]).
to provide the first difference as a first input variable for the controller [0057].
The modified process of Gray fails to disclose a process to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow.
However, Ringkamp teaches a process to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow [0052], in order to, determine as least one disturbance variable and remove it from the computation of a respiratory parameter.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process of Gray to determine a first difference between the predetermined target volume flow and the maximum allowable volume flow, as taught by Ringkamp, in order to, determine as least one disturbance variable and remove it from the computation of a respiratory parameter [0057].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray and Ringkamp, as applied to claim 3 above, further in view of Li et al (US 20230270961 A1).
Regarding Claim 4, the modified ventilator of Gray discloses the ventilator of claim 3, as mentioned above.
The modified ventilator of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
to provide the difference as an input variable for the controller [0057].
The modified ventilator of Gray fails to disclose a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line.
However, Li teaches a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line [0055] because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ventilator of modified Gray to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line, as taught by Li, because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury [0055].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 1 above, in view of Li et al (US 20230270961 A1).
Regarding Claim 5, the ventilator of Gray discloses the ventilator of claim 1, as mentioned above.
The ventilator of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
to provide the difference as an input variable for the controller [0057].
The modified ventilator of Gray fails to disclose a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line.
However, Li teaches a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line [0055] because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ventilator of Gray to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line, as taught by Li, because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury [0055].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray and Ringkamp as applied to claim 12 above, further in view of Li et al (US 20230270961 A1).
Regarding Claim 13, the modified process of Gray discloses the process of claim 12, as mentioned above.
The modified process of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
to provide the difference as an input variable for the controller [0057].
The modified process of Gray fails to disclose a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line.
However, Li teaches a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line [0055] because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process of modified Gray to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line, as taught by Li, because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury [0055].
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 9 above, in view of Li et al (US 20230270961 A1).
Regarding Claim 14, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray further discloses wherein the ventilator (high flow respiratory system 10) is configured (Fig.1; [0166]):
to provide the difference as an input variable for the controller [0057].
The process of Gray fails to disclose a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line.
However, Li teaches a ventilator to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line [0055] because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process of Gray to determine a difference between the maximum allowable inspiratory pressure and the pressure in the inspiratory line, as taught by Li, because large changes in the delivered inspiratory pressure may result in ventilator-induced lung injury [0055].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 1 above, in view of Schmid (US 20240261524 A1).
Regarding Claim 6, the ventilator of Gray discloses the ventilator of claim 1, as mentioned above.
The ventilator of Gray fails to disclose a ventilator comprising an expiratory line, wherein the first sensor is arranged in the expiratory line or is configured to be arranged in the expiratory line.
However, Schmid teaches a process comprising an expiratory line (31), wherein the first sensor (volume flow sensor 11) is arranged in the expiratory line (31) or is configured to be arranged in the expiratory line (31) (Figs.1-2; [0085]) to measure a variable indicative of volume flow through the expiratory line.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ventilator of Gray to comprise an expiratory line, wherein the first sensor is arranged in the expiratory line or is configured to be arranged in the expiratory line, as taught by Schmid, to measure a variable indicative of volume flow through the expiratory line [0085].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable are rejected under 35 U.S.C. 103 as being unpatentable over Gray, as applied to claim 9 above, in view of Schmid (US 20240261524 A1).
Regarding Claim 15, the process of Gray discloses the process of claim 9, as mentioned above.
The process of Gray fails to disclose a process comprising an expiratory line, wherein the first sensor is arranged in the expiratory line or is configured to be arranged in the expiratory line.
However, Schmid teaches a process comprising an expiratory line (31), wherein the first sensor (volume flow sensor 11) is arranged in the expiratory line (31) or is configured to be arranged in the expiratory line (31) (Figs.1-2; [0085]) to measure a variable indicative of volume flow through the expiratory line.
Therefore, it would’ve been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the process of Gray to comprise an expiratory line, wherein the first sensor is arranged in the expiratory line or is configured to be arranged in the expiratory line, as taught by Schmid, to measure a variable indicative of volume flow through the expiratory line [0085].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huang (US 20240173496 A1) is cited for its medical ventilation apparatus.
Modi (US 11383055 B2) is cited for its patient ventilator system and method of using.
Schwaibold (US 20240161903 A1) is cited for its data measurements and calculations for a ventilator.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMIRAH WRIGHT whose telephone number is (571)270-1946. The examiner can normally be reached M-Th: 6:45AM-4:15PM F: 6:45AM-3:15PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMIRAH WRIGHT/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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