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 .
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 1-2, 6-8, 11, 17-18, 34, 38, 41-45, 47, 53 and 101 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recite(s) a method for characterizing a conduit with a respiratory therapy apparatus containing a motor. The steps of receiving data, determining and characterizing are all abstract ideas. This judicial exception is not integrated into a practical application because the generically recited computer respiratory therapy system with a motor does not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on the therapy device that is generically recited. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically recited respiratory therapy system is well-understood, routine, and conventional as evidenced by the prior art of Wickham and Orr set forth below.
Similarly, claims 2, 6-8, 11, 17-18, 34, 38, 41-45, 47 only add more abstract ideas and the respiratory therapy system recited in claim 1 does not add a meaningful limitation to the abstract idea as set forth above. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically respiratory therapy system, user interface with an anti-asphyxia valve (claim 47) are well-understood, routine, and conventional as evidenced by the prior art of Wickham and Orr as set forth below.
Claim 53 recite(s) a system for characterizing a conduit with a respiratory therapy apparatus containing a motor and sensors. The steps of receiving data, determining and characterizing are all abstract ideas. This judicial exception is not integrated into a practical application because the generically recited control system and respiratory therapy system with a motor and sensors does not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on control system/computer that is generically recited. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically recited control system and respiratory therapy apparatus containing a motor and sensors is well-understood, routine, and conventional as evidenced by the prior art of Wickham set forth below.
Claim 101 recite(s) a non-transitory machine readable medium for characterizing a conduit. The steps of receiving data, determining and characterizing are all abstract ideas. This judicial exception is not integrated into a practical application because the generically recited machine executable code is used simply for implementing the abstract idea on control system that is generically recited. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more. The generically recited non-transitory machine readable medium is well-understood, routine, and conventional as evidenced by the prior art of Wickham set forth below.
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 6 and 38 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.
Claim 6 recites “the type of user interface”. There is a lack of antecedent basis for this claimed limitation.
Claim 38 recites “the second airflow”. There is a lack of antecedent basis for this claimed limitation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 18, 53 and 101 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wickham (WO 02/053217 A1)
Regarding claim 1, Wickham discloses: A method for characterizing a conduit (16, page 1, line 21) coupled to a respiratory therapy device (10) in a respiratory therapy system (figure 1), the method comprising:
generating a first airflow from the respiratory therapy device (10) to the conduit (16; the air delivery hose as per page 1, line 21) by operating a motor (page 1, line 22-23) of the respiratory therapy device at a first revolutions per minute (the CPAP apparatus as per page 1, lines 19-24 has a motor and a motor creates different flow by operating at different speeds (revolutions per minute));
receiving a first airflow parameter data (plurality of flow measurements as per page 11, lines 8-11; pressure sensor readings as per page 19, last line to 20 line 5 at first test flow rate) associated with the first airflow (first test flow rate as per page 20 lines 3-4), the first airflow parameter data comprising a first pair of two distinct airflow parameter values (pressure and flow as set forth above),
determining a first relationship between the first airflow parameter data and the conduit (pressure drops and further as described in page 20, lines 11-20); and
characterizing the conduit based on the first relationship (determining mask pressure of mask connected to hose as per page 21 lines 12-14).
Regarding claim 18, Wickham discloses the claimed invention substantially as claimed as set forth for claim 1 above. Wickam further discloses the method comprising:
generating a second airflow (second test flow rate; page 20, lines 3-5) from the respiratory therapy device to the conduit by operating the motor of the respiratory therapy device at a second revolutions per minute (the CPAP apparatus as per page 1, lines 19-24 has a motor and a motor creates different flow by operating at different speeds (revolutions per minute));
receiving a second airflow parameter data (plurality of flow measurements as per page 11, lines 8-11; pressure sensor readings as per page 19, last line to 20 line 5 at first test flow rate) associated with the second airflow (second test flow rate as per page 20 lines 3-4), the second airflow parameter data comprising a second pair of two distinct airflow parameter values (pressure and flow as set forth above); and
determining a second relationship between the second airflow parameter data and the conduit (pressure drops and further as described in page 20, lines 11-20). Page 6, lines 3-6.
Regarding claim 53, Wickham discloses: A system (figure 1) comprising:
a respiratory therapy device (figure 1) configured to supply pressurized air during a sleep session of a user (page 1, lines 7-11);
one or more sensors configured to detect airflow parameter data associated with the supplied pressurized air (plurality of flow measurements as per page 11, lines 8-11; pressure sensor readings as per page 19, last line to 20 line 5); and
a control system including one or more processors (page 7, line 9) configured to execute machine-readable instructions to:
generate a first airflow from the respiratory therapy device (10) to the conduit (16; the air delivery hose as per page 1, line 21) by operating a motor (page 1, line 22-23) of the respiratory therapy device at a first revolutions per minute (the CPAP apparatus as per page 1, lines 19-24 has a motor and a motor creates different flow by operating at different speeds (revolutions per minute));
receive a first airflow parameter data (plurality of flow measurements as per page 11, lines 8-11; pressure sensor readings as per page 19, last line to 20 line 5 at first test flow rate) associated with the first airflow (first test flow rate as per page 20 lines 3-4), the first airflow parameter data comprising a first pair of two distinct airflow parameter values (pressure and flow as set forth above),
determine a first relationship between the first airflow parameter data and the conduit (pressure drops and further as described in page 20, lines 11-20); and
characterize the conduit based on the first relationship (determining mask pressure of mask connected to hose as per page 21 lines 12-14).
Regarding claim 101, Wickham discloses: A non-transitory machine readable medium having stored thereon instructions for performing a method comprising machine executable code which when executed by at least one machine (page 7, lines 12-14), causes the machine (figure 1) to:
generate a first airflow from the respiratory therapy device (10) to the conduit (16; the air delivery hose as per page 1, line 21) by operating a motor (page 1, line 22-23) of the respiratory therapy device at a first revolutions per minute (the CPAP apparatus as per page 1, lines 19-24 has a motor and a motor creates different flow by operating at different speeds (revolutions per minute));
receive a first airflow parameter data (plurality of flow measurements as per page 11, lines 8-11; pressure sensor readings as per page 19, last line to 20 line 5 at first test flow rate) associated with the first airflow (first test flow rate as per page 20 lines 3-4), the first airflow parameter data comprising a first pair of two distinct airflow parameter values (pressure and flow as set forth above),
determine a first relationship between the first airflow parameter data and the conduit (pressure drops and further as described in page 20, lines 11-20); and
characterize the conduit based on the first relationship (determining mask pressure of mask connected to hose as per page 21 lines 12-14).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (WO 02/053217 A1) in view of Boyle et al. (US 2005/0031322 A1).
Regarding claim 44, Wickham does not explicitly disclose wherein the motor of the respiratory therapy device operates between about 3,000 revolutions per minute and about 12,000 revolutions per minute.
However Boyle teaches it is known to ventilators to operate from 0-20,000 RPM [0012].
It would have been obvious to have modified Wickham such that the respiratory device operates from 0-20,000 RPM in order to create the desired flow rate [0012].
While Wickham as modified by Boyle does not explicitly disclose the RPMs being between 3,000 to 12,000 RPM, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the RPMs of the motor from 0-20,000 to 3,000-12,000 as applicant appears to have placed no criticality on the claimed range and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (WO 02/053217 A1) in view of Boyle et al. (US 2005/0031322 A1) in view of Holley et al. (WO 2019/006496 A1).
Regarding claim 47, Wickham as modified as set forth for claim 44 above does not explicitly disclose:
the user interface includes an anti-asphyxia valve; and the first airflow has a flow rate value of less than about 0.4 liters per second.
Holley teaches a user interface which includes an anti-asphyxia valve [0106] and the first airflow has a flow rate value of less than about 0.4 liters per second (see figure 6b, wherein the first flow rate provided is 26 LPM, which equates to 0.433 liters per second which is “less than about 0.4 liters per second”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr such that wherein the first airflow has a flow rate less than about 0.4 liters per second as taught by Holley as this is a known therapeutic level of airflow. Additionally a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (WO 02/053217 A1) in view of Rehman (WO 2018/081245 A1)
Regarding claim 34, Wickham does not explicitly disclose wherein the characterizing the conduit is implemented using a classification-based machine learning algorithm using training data labeled with characterizations of the conduit.
However, Rehman teaches it is known to characterize a component of a respiratory flow system (abstract) wherein the characterizing is implemented using a classification-based machine learning algorithm using training data labeled with characterizations of the conduit (page 8, first paragraph).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified Wickham such that wherein the characterizing the conduit is implemented using a classification-based machine learning algorithm using training data labeled with characterizations of the conduit in order to ensure the classification is correct and evolves over time (page 8, first paragraph).
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (WO 02/053217 A1) in view of Hilbig et al. (WO 2012/114235 A1).
Regarding claim 41, Wickham does not explicitly disclose wherein the first airflow is a laminar flow of air having a Reynolds number of less than about 2300.
However, Hilbig teaches a gas administration apparatus (figure 1) wherein airflow through the conduit (18) is a laminar flow of air having a Reynolds number of less than about 2300 (page 9, lines 19-22).
It would have been obvious to have modified Wickham such that the first airflow is a laminar flow of air having a Reynolds number of less than about 2300 as taught by Hilbig such that turbulences are reduced, allowing for more accurate readings from the sensors in Wickham.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham (WO 02/053217 A1) in view of Flint (US 2009/0266359 A1).
Regarding claim 42, Wickham does not explicitly disclose wherein the first airflow has an associated noise level of no more than about 40 dBA measured at a distance of about one meter from the respiratory therapy device.
However, Flint teaches wherein the first airflow has an associated noise level of no more than about 40 dBA measured at a distance of about one meter from the respiratory therapy device [0003] (best equipment achieves noise levels around 25 dBA).
It would have been obvious to one having ordinary skill in the art to have modified Wickham such that the first airflow has an associated noise level of no more than about 40 dBA measured at a distance of about one meter from the respiratory therapy device for the benefit of not bothering the user with noise levels.
Claim(s) 1-2, 6, 7, 8, 11, 38 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2012/0215125 A1) in view of Holley et al. (WO 2019/006496 A1)
Regarding claim 1, Orr discloses: A method for characterizing a conduit (26) coupled to a respiratory therapy device in a respiratory therapy system, the method comprising:
generating a first airflow from the respiratory therapy device [0020] to the conduit (26);
receiving a first airflow parameter data [0038]-[0039] [0041] associated with the first airflow, the first airflow parameter data comprising a first pair of two distinct airflow parameter values (two pressure readings to calculate a pressure differential [0038]-[0039], flow as per [0041]);
determining a first relationship between the first airflow parameter data and the conduit (the type of pressure fluctuations [0044]); and
characterizing the conduit based on the first relationship (determine a type of interface attached to conduit as per [0044]-[0045].
Orr does not explicitly disclose the first aiflow is generated by operating a motor of the respiratory therapy device at a first revolutions per minute.
However, Holley discloses it is known for a therapy device to be operated via a motor at a first revolutions per minute [0280] (a motor adjusts positive pressure via changing revolutions per minute; [0164]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr such that the first aiflow is generated by operating a motor of the respiratory therapy device at a first revolutions per minute as taught by Holley as this is a known way of creating a positive flow of pressurized air for a patient.
Regarding claim 2, Orr further discloses wherein the characterizing the conduit comprises determining (i) presence or absence of the conduit, (ii) a type of the conduit having a specific inner diameter, (iii) presence or absence of a user interface coupled to the conduit, (iv) determining a type of the user interface coupled to the conduit [0044], or (v) any combination thereof.
Regarding claim 6, Orr does not explicitly disclose wherein the type of user interface is one of (i) a full face mask, (ii) a nasal mask, or (iii) a nasal pillows mask.
However, Holley discloses a full face mask [0072]. The examiner notes that the patient interface in Orr in figure 1 also appears to be a full face mask or a nasal mask.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Orr such that the type of user interface is one of (i) a full face mask, (ii) a nasal mask, or (iii) a nasal pillows mask as these are known interfaces for providing pressurized air to a patient.
Regarding claim 7, Orr further discloses wherein the first airflow parameter data comprises a plurality of first pairs of airflow parameter values associated with the first airflow (fluctuations comprise a plurality of first pairs [0044]).
Regarding claim 8, Orr further discloses wherein the first pair of airflow parameter values includes any two of: (i) a pressure value [0038]-[0039], (ii) a flow rate value [0041], and (iii) an impedance value calculated as a ratio of the pressure value and the flow rate value of the first airflow, (iv) a laminar flow constant, and (v) a turbulent flow constant.
Regarding claim 11, Orr further discloses wherein the determining the first relationship further comprises:
estimating a first measure of central tendency associated with the first airflow parameter data [0046]; and
characterizing the conduit based on the first measure of central tendency associated with the first airflow parameter data satisfying a first condition [0046].
Regarding claim 38, Orr further discloses wherein the flow rate value of the first airflow and the second airflow is generated by a flow sensor communicatively coupled to the respiratory therapy device [0041] and wherein the pressure value of the first airflow and the second airflow is generated by a pressure sensor communicatively coupled to the respiratory therapy device [0038]-[0039].
Regarding claim 43, Orr as modified discloses the claimed invention substantially as set forth for claim 1 above. As currently modified Orr does not disclose wherein the first airflow has a flow rate value of between about 0.1 and 0.8 liters per second.
However, Holley discloses it is known to provide flow rates at this range for therapeutic pressures (see figure 6b, wherein the first flow rate provided is 26 LPM, which equates to 0.433 liters per second and is within applicant’s claimed range).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Orr such that wherein the first airflow has a flow rate value of between about 0.1 and 0.8 liters per second as taught by Holley as this is a known therapeutic level of airflow.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (US 2012/0215125 A1) in view of Holley et al. (WO 2019/006496 A1) in further view of Rydin et al. (US 2002/0020410 A1)
Regarding claim 17, Orr as modified does not explicitly disclose wherein the first airflow is generated for not more than 5 seconds.
However, Rydin teaches an arrangement for providing therapy (abstract) wherein the first airflow is generated for not more than 5 seconds [0020] (figure 3).
It would have been obvious to have modified Orr wherein the first airflow is generated for not more than 5 seconds as taught by Rydin for the purpose of providing a ramped gas flow (figure 3). The description of the article pictured can be relied on, in combination with the drawings, for what they would reasonably teach one of ordinary skill in the art. In re Wright, 569 F.2d 1124, 1127-28, 193 USPQ 332, 335-36 (CCPA 1977). See MPEP 2125. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the time within applicant’s claimed range.
Allowable Subject Matter
Claims 45 and 48 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if the 101 rejection is addressed.
Claim 45 recites: determining, based on characterizing the conduit, a third airflow parameter value for prospective delivery of pressurized airflow to a user, when the user wears the user interface for respiratory therapy, wherein the determining the third airflow parameter value includes determining impedance due to (i) intentional leak through one or more vents in the user interface, (ii) unintentional leak at the user interface or a mouth of the user, or (iii) a combination of both. While prior art such as Foote (WO 2013/040198 A2) discuss impedance and leak [0248], this is not done based on characterizing the conduit as claimed.
Claim 48 recites: wherein the respiratory therapy device includes a waterless humidifier, the method further comprising determining a type of the waterless humidifier based on the first relationship. The prior art does not contemplate determining a type of the waterless humidifier based on the first relationship.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Foote (WO 2013/040198 A2)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA MURPHY whose telephone number is (571)270-7362. The examiner can normally be reached M-F 8:00am-4:00pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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