DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (PCT/IB2022/050932) filed on the February 03, 2021.
Claim Objections
Claims 7-10, 15-22 objected to because of the following informalities:
Regarding Claims 7-10, "a device minute ventilation" should read as "the device minute ventilation" for consistency.
Regarding Claim 15, "a nasal minute ventilation" should read as "the nasal minute ventilation" for consistency.
Regarding Claim 16, "the nasal minute ventilation, nasal minute ventilation rate of change, and nasal minute ventilation trends" should read as "a nasal minute ventilation, a nasal minute ventilation rate of change, and a nasal minute ventilation trends." for consistency.
Regarding Claims 17-22, "the nasal minute ventilation" should read as "a nasal minute ventilation" for consistency.
Appropriate correction is required.
Specification
The use of the term Bluetooth, WIFI (para. 0012), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
“More details of a thermistor flow rate sensor are described in PCT Application No. PCT/NZ2017/050119, filed September 3, 2017, which is incorporated by reference herein in its entirety.” In para. 0141.
Examiner suggest replacing this paragraph with “More details of a thermistor flow rate sensor are described in PCT Application No. PCT/NZ2017/050119, filed September 3, 2017.”
Similar amendments for para. 0142, 0145, 0183, and 0195, remove “which is incorporated by reference herein in its entirety” in each paragraph.
Examiner notes that the filing date of the PCT is the filing date for the national stage application. Therefore, any amendment that comes in with or after the filing of the national stage application in the US is not part of the original disclosure. Per MPEP 608.01(p)(I)(B) states that to be effective an incorporation by reference statement must be filing at time of filing and cannot
be added after an application’s filing date. Since a 371 application’s filing date is the date the
PCT was filed, an amendment in the 371 application to add an incorporation by reference is not
effective and improper as new matter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 14, 15, and 68-70 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 10, The claim recites determining a device minute ventilation comprises an average of absolute values of a line fitted to the data of the parameter of the flow of gases across a range of time-points within a time range, the limitation of “the average of absolute values” of a line fitted to the data to determine the present device minute ventilation is unclear. In the instant specification does not provide sufficient guidance as how the calculation of line fitted is determine and how the average of the absolute value can come another conclusion of the device minute ventilation. The specification also does not provide a clear definition of underlying fitted line or the mathematical operation being performed. The basis of averaging and how the average absolute value is applied within the context is also unclear, and the absence of details of the claim makes it difficult for ordinary skill of the art to understand reproducing the calculation.
Regarding Claim 14, The claim recites wherein the device minute ventilation is converted to a nasal minute ventilation is unclear. In the instant specification does not provide sufficient guidance as to whether these terms represent distinct measurements, different calculations, or there are different labels for the same parameter. It cannot be understood how one is different from the other in terms of the parameter and what is being obtained from the sensors. Nor does the specification disclose how the conversation is done between a “device minute ventilation” and a “nasal minute ventilation” is performed. Specification describes that the device minute ventilation is obtained first than a constant is used to find the nasal minute ventilation; however, what is the difference between the two in terms of minute ventilation is the parameter is received from the patient respiration efforts. As a result, one in the ordinary skill in the art would not be reasonably able to define the metes and bounds of the claimed subject matter, making this limitation indefinite. Further, the dependent claims 15, 68-70 that further relate on these terms lack clarity because these claims presume the defined relationship between the two parameters that has not been explained in specification.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 and its dependencies claims 7-10, 14-25, and 68-70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim recite a system two of the statutory categories; therefore, the claims pass step 1 of the eligibility analysis. For step 2A, the claim(s) are directed to a device having a controller that is configured to receive data of a parameter of a flow of gases of the respiratory device while the device is in use with an unsealed user interface, the parameter indicative of the patient's respiration, determine a device minute ventilation or a parameter indicative of device minute ventilation, and provide an indication of minute ventilation of a user. The claims recite an abstract idea in the form of receiving data, determine minute ventilation or parameter indicative of minute ventilation, and then providing that indication to the user. This represents a mental processes because it can equivalently be done by a person simply observing the data and determining minute ventilation are actions that a person could do purely in the mind. If a claim recites a limitation, which under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
Using Claim 1, as a representative example that is applicable to claims 7-10, 14-25, and 68-70, the abstract idea is defined by the elements of:
A respiratory device configured to deliver a respiratory therapy to a patient using an unsealed respiratory interface, the device comprising:
a controller, wherein the controller is configured to:
receive data of a parameter of a flow of gases of the respiratory device while the device is in use with an unsealed user interface, the parameter indicative of the patient's respiration,
determine a device minute ventilation or a parameter indicative of device minute ventilation, and
provide an indication of minute ventilation of a user.
The above bolded limitations recite controller receiving data, determine minute ventilation or parameter indicative of minute ventilation, and then providing that indication to the user, that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. The process of receiving data, determine minute ventilation or parameter indicative of minute ventilation, and then providing that indication to the user can be carried out in a person’s mind. This is further defining the abstract idea. Furthermore, this is a process known to be capable of being performed by people mentally, and not limited to be carried out via computer for automation. People (patients or doctor or caregivers) are capable of receiving data, determine minute ventilation or parameter indicative of minute ventilation, and then providing that indication to the user through observations. This is further defining mental process in the form of observations, evaluations, judgments, and opinions. This is considered longstanding practice that is the focus of the (patent ineligible) claimed invention and is further defining the abstract idea. The mere nominal recitation of “respiratory device ”, “data” , “controller”, and “an unsealed user interface,” does not take the claim out of the group of mental processes.
This judicial exception is not integrated into a practical application (2nd prong of eligibility test for step 2A) because the additional elements of the claim amount to the use of “data” which is used for extra solution data gathering. Additionally, the use of “respiratory device” are field of use and/or extra solution activity these are merely being used as a tool to execute the abstract idea, see MPEP 2106.05(f). In addition, the use of “controller” has limitations that are not indicative of integration into a practical application because they are being recited at a high-level of generality as shown in US 20170182267 A1 (para. 0148) (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component. This is indicative of the fact that the claim has not integrated the abstract idea into a practical application and therefore the claim is found to be directed to the abstract idea identified by the examiner.
A “data ”, which is used for extra solution data gathering; “controller” is general purpose computers; and “a respiratory device” is filed of use or extra solution activity, are all considered nothing more than a general link to a technological environment and generic computing devices to perform generic communicating functions such as storing data and instructions, transmitting and receiving data between computers. The “controller” are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of communicating data between users) such that they amount no more than mere instructions to apply the exception using a generic computer component; for example, the additional elements are directed to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, the claim is directed to an abstract idea identified by the examiner.
For step 2B, the independent claim(s) Claim 1 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they do not amount to more than simply instructing one to practice the abstract idea by using a computer to carry out the steps that define the abstract idea. This does not render the claims as being eligible. See MPEP 2106.05(f). The additional elements did not add significantly more to the abstract idea because they were simply applying the abstract idea on a computer without any recitation of details of how to carry out the abstract idea. The rationale set forth for the 2nd prong of the eligibility test above is also applicable to the entirety of the claims. The controller device are generic computer systems and the unsealed user interface and respiratory device are drawn to a field of use.
Likewise, the rationale set forth for the 2nd prong of the eligibility test above for Claim 1 is also applicable to Claims 7-10, 14-25, and 68-70.
In regards to Claims 7-10, the applicant is reciting elements that further limit the claims to include wherein determining a device minute ventilation comprises fitting a plurality of splines to the data of the parameter of the flow of gases, wherein the plurality of splines are fit using the least squares criterion and the device minute ventilation is determined by integrating along the plurality of splines; wherein determining a device minute ventilation comprises determining the integral of the absolute value of the first term of a line fitted to the data of the parameter of the flow of gases; wherein determining a device minute ventilation comprises determining the integral of the absolute value of a line fitted to the data of the parameter of the flow of gases, divided by a time range; and wherein determining a device minute ventilation comprises an average of absolute values of a line fitted to the data of the parameter of the flow of gases across a range of time-points within a time range. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for Claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 14-16 and 68-70, the applicant is reciting elements that further limit the claims to include wherein the device minute ventilation is converted to a nasal minute ventilation; wherein the device minute ventilation is converted to a nasal minute ventilation using a scalar calibration constant. Also, the claims include wherein the controller is further configured to monitor at least one of the nasal minute ventilation, nasal minute ventilation rate of change, and nasal minute ventilation trends. Additionally, the claims further defining the scalar constant to include wherein the scalar calibration constant is determined by inputting patient interface parameters related to the unsealed respiratory interface or current flow rate of the flow of gases, by inputting at least one of the unsealed respiratory interface type, patient size, and naris diameter and/or amount of occlusion of the nares of the patient, or it is calculated by temporarily placing a sealed face mask over the patient's face while the patient is wearing the unsealed respiratory interface to measure at least one flow parameter of the respiratory device. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for Claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 17-19, the claim recites a new additional element of “display” which is routine and conditional using as shown in US 20080295839 A1. Also, the applicant is reciting elements that further limit the claims to include wherein the display is configured to display data relating to the nasal minute ventilation; wherein the display is configured to display data relating to the nasal minute ventilation rate of change; and wherein the display is configured to display data relating to the nasal minute ventilation trends. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 20-22, the claim recites a new additional element of “alarm,” which is routine and conditional using as shown in US 20080287756 A1. Also, the applicant is reciting elements that further limit the claims to include configured to trigger an alarm or notification when the nasal minute ventilation, nasal minute ventilation rate, or nasal minute ventilation trends exceeds or falls below a preset threshold. This is further defining the abstract idea identified by the examiner. No new additional elements were introduced in these claims, therefore, the same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
In regards to Claims 23-25, the claim recites a new additional element of “patient interface”, and “humidifier” which is routine and conditional using. Also, the applicant is reciting elements that further limit the claims to include wherein the respiratory device comprises a patient interface, wherein the patient interface comprises a nasal cannula, configured to deliver a nasal high flow therapy, and a humidifier configured to humidify the gases flow to the patient. The same rationale set forth for the 2nd prong of the eligibility test above for claim 1 can be applied to the following claims. Examiner further considers these claim limitations as pre-solution activity because it is collecting the reference data that is used to make the abstract determination and data gathering is indicative of not amounting to significantly more when considered as a whole. See MPEP 2106(g).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, and 16-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landis et al. (US 20160367779 A1), hereafter as Landis, in view of Freeman et al. (US 20170325695 A1), hereafter as Freeman.
Regarding Claim 1, Landis discloses a respiratory device configured to deliver a respiratory therapy to a patient (para. 0097, 0122-130) using an unsealed respiratory interface (Fig. 17-20), the device comprising:
a controller (Fig. 17; 2060), wherein the controller is configured to (examiner notes; this limitation is functional):
receive data of a parameter of a flow of gases of the respiratory device while the device is in use with an unsealed user interface (from sensors Fig. 17A; 100; Fig. 20, 2120; para. 0097), the parameter indicative of the patient's respiration (para. 0097),
Landis teaches the control determine certain parameters (para. 0130, teaches minute volume) but does not specifically discloses determine a device minute ventilation or a parameter indicative of device minute ventilation, and provide an indication of minute ventilation of a user.
However, Freeman teaches controller determine a device minute ventilation or a parameter indicative of device minute ventilation (Fig. 6A; 650; para. 0018, 0022, 0027-0028, 0083-0084), and provide an indication of minute ventilation of a user (examiner notes: it is displayed on Fig. 6A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the controller of Landis to include the determine a device minute ventilation or a parameter indicative of device minute ventilation, and provide an indication of minute ventilation of a user as taught by Freeman for the purpose of enables accurate volumetric measurement for minute ventilation and tidal volume (para. 0018).
Regarding Claim 16, Modified Landis discloses the respiratory device of claim 1, wherein the controller (Fig. 17; 2060; Landis; Fig. 6A; 650; Freeman) is further configured to monitor at least one of the nasal minute ventilation, nasal minute ventilation rate of change, and nasal minute ventilation trends (Figures 17-20, Landis; Fig. 6A; 650; para. 0018, , 0022, 0027-0028, 0083-0084: Freeman).
Regarding Claim 17, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig. 15-17; 2000; Landis) further comprises a display (Fig. 15-18; 2030; para. 0126, 0137; Landis; Fig. 6A; Freeman), wherein the display is configured to display data relating to the nasal minute ventilation (Fig. 6A; 650-655; Freeman).
Regarding Claim 18, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig. 15-17; 2000; Landis) further comprises a display (Fig. 15-18; 2030; para. 0126, 0137; Landis; Fig. 6A; Freeman), wherein the display is configured to display data relating to the nasal minute ventilation rate of change (Fig. 6A; 650-655; Freeman).
Regarding Claim 19, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig. 15-17; 2000; Landis) further comprises a display (Fig. 15-18; 2030; para. 0126, 0137; Landis; Fig. 6A; Freeman), wherein the display is configured to display data relating to the nasal minute ventilation trends (Fig. 6A; 650-655; Freeman).
Regarding Claim 20, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig.15-17; 2000; Landis) is configured to trigger an alarm (para. 0123, 0131; Landis) or notification when the parameter (para. 0018, 0027; 0083-0084; Freeman) exceeds or falls below a preset threshold.
Modified Landis does not specifically teach the alarm is trigger when nasal minute ventilation exceeds or falls below a preset threshold.
However, Modified device does teach that the device can trigger an alarm when a threshold is reached, even though Landis does not teach nasal minute ventilation parameter is what triggers the alarm, the combined of Landis and Freeman would come to the conclusion the device is configured to the trigger the alarm when the parameter from Freeman is determined to be above or below the threshold of nasal minute ventilation (para. 0123; Landis).
Therefore, Modified Landis is considered to be in field of respiratory devices. Due to an absence of the limitations of alarm is trigger when specifically the parameter of nasal minute ventilation exceeds or goes below a threshold, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “controller” would reasonably encompass the absent limitation of because it is widely well within the ordinary skill in the art that monitoring systems are configured to trigger an alarm when a parameter exceeds or falls below a certain threshold. Accordingly, interpreting the controller including such functionality is consistent and one would be motivated to have the controller being configured to detect nasal minute ventilation going out of the threshold values for the purpose of alerting of deteriorating patient condition (para. 0072; Freeman).
Regarding Claim 21, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig.15-17; 2000; Landis) is configured to trigger an alarm (para. 0123, 0131; Landis) or notification when the parameter (para. 0018, 0027; 0083-0084; Freeman) exceeds or falls below a preset threshold.
Modified Landis does not specifically teach the alarm is trigger when nasal minute ventilation rate exceeds or falls below a preset threshold.
However, Modified device does teach that the device can trigger an alarm when a threshold is reached, even though Landis does not teach nasal minute ventilation parameter is what triggers the alarm, the combined of Landis and Freeman would come to the conclusion the device is configured to the trigger the alarm when the parameter from Freeman is determined to be above or below the threshold of nasal minute ventilation rate (para. 0123; Landis).
Therefore, Modified Landis is considered to be in field of respiratory devices. Due to an absence of the limitations of alarm is trigger when specifically the parameter of nasal minute ventilation rate exceeds or goes below a threshold, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “controller” would reasonably encompass the absent limitation of because it is widely well within the ordinary skill in the art that monitoring systems are configured to trigger an alarm when a parameter exceeds or falls below a certain threshold. Accordingly, interpreting the controller including such functionality is consistent and one would be motivated to have the controller being configured to detect nasal minute ventilation rate going out of the threshold values for the purpose of alerting of deteriorating patient condition (para. 0072; Freeman).
Regarding Claim 22, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig.15-17; 2000; Landis) is configured to trigger an alarm (para. 0123, 0131; Landis) or notification when the parameter (para. 0018, 0027; 0083-0084; Freeman) exceeds or falls below a preset threshold.
Modified Landis does not specifically teach the alarm is trigger when nasal minute ventilation trends exceeds or falls below a preset threshold.
However, Modified device does teach that the device can trigger an alarm when a threshold is reached, even though Landis does not teach nasal minute ventilation parameter is what triggers the alarm, the combined of Landis and Freeman would come to the conclusion the device is configured to the trigger the alarm when the parameter from Freeman is determined to be above or below the threshold of nasal minute ventilation trends (para. 0123; Landis).
Therefore, Modified Landis is considered to be in field of respiratory devices. Due to an absence of the limitations of alarm is trigger when specifically the parameter of nasal minute ventilation trends exceeds or goes below a threshold, it would be obvious to one of ordinary skill in the art, assuming the broadest interpretation of both the prior art and the instant claim, that “controller” would reasonably encompass the absent limitation of because it is widely well within the ordinary skill in the art that monitoring systems are configured to trigger an alarm when a parameter exceeds or falls below a certain threshold. Accordingly, interpreting the controller including such functionality is consistent and one would be motivated to have the controller being configured to detect nasal minute ventilation trends going out of the threshold values for the purpose of alerting of deteriorating patient condition (para. 0072; Freeman).
Regarding Claim 23, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig. 15-17; 2000) comprises a patient interface (Fig. 17-20; 100), wherein the patient interface comprises a nasal cannula (Fig. 17A; 100; para. 0126-0130).
Regarding Claim 24, Modified Landis discloses the respiratory device of claim 1, wherein the respiratory device (Fig. 15-17; 2000) is configured to deliver a nasal high flow therapy (para. 0126-0130).
Regarding Claim 25, Modified Landis discloses the respiratory device of claim 1, further comprising a humidifier (Fig. 17; 2020) configured to humidify the gases flow to the patient (para. 0128-0129).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landis and Freeman, as applied to claim 1, in view of Khan et al. (US 20220301281 A1), hereafter as Khan.
Regarding Claim 7, Modified Landis discloses the respiratory device of claim 1,
Modified Landis does not specifically teach that wherein determining a device minute ventilation comprises fitting a plurality of splines to the data of the parameter of the flow of gases, wherein the plurality of splines are fit using the least squares criterion and the device minute ventilation is determined by integrating along the plurality of splines.
However, Khan teaches a parameter that is determined with fitting plurality of splines to the data using at least square criterion and is determined by integrating along the plurality of splines (para. 0071).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the data of minute ventilation parameter of Modified Landis to be determined by fitting a plurality of splines as taught by Khan for the purpose of providing a more accurate prediction in term of data with rate of change (para. 0057, 0071, 0072).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landis and Freeman, as applied to claim 1, in view of Sakai et al. (US 20060243065 A1), hereafter as Sakai
Regarding Claim 8, Modified Landis discloses the respiratory device of claim 1,
Modified Landis does not disclose specifically wherein determining a device minute ventilation comprises determining the integral of the absolute value of the first term of a line fitted to the data of the parameter of the flow of gases.
However, Sakai teaches that the idea of using the calculation of the integral of the absolute value of the first term of a line fitted to the data of the parameter of the flow of gases (Table 2; Fig. 16; para. 0072-0074).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify determining the parameter of device minute ventilations of Modified Landis to be determined by calculation of the integral of the absolute value of the first term of a line fitted to the data of the parameter of the flow of gases as taught by Sakai for the purpose of providing a flow rate-measuring method and a flow rate-measuring apparatus which give an accurate flow rate, particularly, without a complicated flow rate-measuring system and teach that is known in the art to use these types of equations to determine flow rate. (para. 0006).
Regarding Claim 9, Modified Landis discloses the respiratory device of claim 1,
Modified Landis does not disclose specifically wherein determining a device minute ventilation comprises determining the integral of the absolute value of a line fitted to the data of the parameter of the flow of gases, divided by a time range.
However, Sakai teaches determining the integral of the absolute value of a line fitted to the data of the parameter of the flow of gases, divided by a time range (Table 2; Fig. 16; para. 0072-0074; M/s).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify determining the parameter of device minute ventilations of Modified Landis to be determined by calculation of the integral of the absolute value of a line fitted to the data of the parameter of the flow of gases, divided by a time range as taught by Sakai for the purpose of providing a flow rate-measuring method and a flow rate-measuring apparatus which give an accurate flow rate, particularly, without a complicated flow rate-measuring system and teach that is known in the art to use these types of equations to determine flow rate. (para. 0006).
Examiner Comments
The Examiner notes that no art rejection has been made for claims 10, 14-15, and 68-70 at this time as the prior art of record fails to disclose the claims as written. The Examiner retains the right to make a new art-based rejection on these claims once the 35 U.S.C. 112(b) rejections have been resolved by the Applicant.
Conclusion
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MAAP A. ELLABIB
Examiner
Art Unit 3785
/M.A.E./Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights