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 Objections
Claim(s) 135-137, 141 and 173-174 is/are objected to because of the following informalities:
Claim 135, Ln. 2 recites “on measured SpO2 and measured FdO2” which should read “on the measured SpO2 and the measured FdO2” following after claim 134
Claim 136, Ln. 2-3 recites “on measured SpO2 divided by measured FdO2” which should read “on the measured SpO2 divided by the measured FdO2” following after claim 134
Claim 137, Ln. 3 recites “between measured SpO2 of the patient and measured FdO2” which should read “between the measured SpO2 and the measured FdO2” following after claim 134
Claim 141, Ln. 2-3 recites “the change in SpO2 based at least in part on the change in FdO2” which should read “a change in SpO2 based at least in part on a change in FdO2” as it is a first introduction of “changes”
Claims 173 and 174 each recite dependency using the word “claim” in uncapitalized form while all other claims have recited their dependency using “Claim” in capitalized form
Claim 173, Ln. 3-4 recites “a measured oxygen saturation (SpO2)” which should read “the measured SpO2” following after claim 134
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.
Claim(s) 134-148 and 172-174 is/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 pre-AIA the applicant regards as the invention.
Claim 134 recites the limitation “a controller configured to control delivery of gases to the patient using closed loop control” in Ln. 3-4 which deems the claim indefinite. The limitation recites the function of “using closed loop control” but then the body of the claim fails to specifically recite any of the operations of the controller as being part of the closed loop control. It is thus unclear whether the controller’s operating using closed loop control is being positively recited or not. The claim should be amended to clearly detail which parts of the controller’s operation are part of the closed loop control (which appears to be all recited operations of the controller in claim 134). For the purposes of examination the operations recited of the controller in claim 134 will all be read as part of the recited closed loop control.
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(s) 134-148 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) operations of the controller of "deliver[ing] a nasal high flow (NHF) gases flow to the patient; receiv[ing] data from at least one patient sensor indicative of a measured oxygen saturation (SpO2) of the patient; receiv[ing] data indicative of a measured fraction of delivered oxygen (FdO2) of the gases flow; determin[ing] an oxygen efficiency of the patient; and generat[ing] a patient specific model, wherein the patient specific model uses the oxygen efficiency of the patient.” The initial controller operation of “delivering” merely amounts to insignificant pre-solution activity in the context of the claimed invention as none of the subsequent steps of the claim expressly require any consideration of the nasal high flow gases flow recited as delivered by the initial operation (see MPEP 2106.05(g)). The two “receiving” operations of the controller merely amount to the receipt of data, which is an abstract idea. The “determining” operation of the controller is merely a form of mathematical calculation which is not recited by the claim as using any particular data or subsequently being used to effect any change in operation of the respiratory apparatus. The “generating” operation of the controller is merely another form of mathematical calculation which is not recited by the claim as being used to effect any change in operation of the respiratory apparatus. The mere claiming of the performance of abstract idea operations by the structure of a controller fails to define significantly more in the claim than the abstract ideas themselves (see MPEP 2106.04(a)(2)(III)(C)).
This judicial exception is not integrated into a practical application because the claim does not recite any specific treatment or effect based upon performance of the abstract ideas of the claim. For example, while the claim recites generating of a patient specific model the claim fails to recite then using the patient specific model to control the delivery of gases to the patient. Such a further amendment would likely overcome this rejection.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no structure beyond the controller is positively recited by the claim.
Each of dependent claims 135-145 only further detail how the abstract ideas are to be performed while still not reciting any specific treatment or effect based upon performance of the abstract ideas of the claim.
Dependent claims 146 and 148 merely describe the environment of the abstract idea. It is noted that the sensors recited in claims 146 and 148 are not read as positively recited.
Dependent claim 147 recites the structure of a humidifier but does not relate that structure to any other features recited in the claim. Use of a humidifier is common in the respiratory arts and thus this generically, unlinked structure fails to meaningful define beyond the abstract ideas recited in claim 134.
Dependent claims 172 and 173 are not rejected under 35 U.S.C. 101 as they do meaningfully recite integration of the abstract ideas into a practical application.
Allowable Subject Matter
Claims 134-148 and 172-174 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 134, the prior art fails to teach or suggest a respiratory apparatus including all elements and functionality recited by the instant claim. Note is initially made of the above 35 U.S.C. 112(b) rejection of the claim and accompanying interpretation of the operations recited by the controller as all being part of the recited closed loop control. Specifically, the claim is interpreted as performing by a controller within a closed loop control the operations of: delivering a nasal high flow (NHF) gases flow to the patient; determining an oxygen efficiency of the patient; and generating a patient specific model, wherein the patient specific model uses the oxygen efficiency of the patient. The phrasing “oxygen efficiency” is understood in light of the instant specification as referring to a relationship between FdO2 and the patient’s SpO2 (e.g. ¶¶0555-0557). Because the claim is understood as performing the operations of the controller within a closed loop control the generated patient specific model would then need to be used as feedback in control of the delivery of the NHF gases flow to the patient.
The prior art is known to use FiO2 controllers which operate in a closed loop control based on measured patient SpO2. Examples of such prior art are: Claure et al. (U.S. Pub. 2002/0072659; Fig. 2), Baker (U.S. Pub. 2009/0320836; Fig. 2), Lellouche et al. (U.S. Pub. 2011/0067697; Fig. 1), Graboi et al. (U.S. Pub. 2012/0090611; Fig. 1), Kinsky et al. (U.S. Pub. 2018/0099109; Fig. 4) and Lellouche et al. (U.S. Pub. 2018/0280645; Figs. 7-8). Initially, all of those prior art use FiO2 while the claimed invention instead uses FdO2. One of ordinary skill in the art would recognize those two values as measured at different locations. More importantly, none of these prior art teach or suggest generating a patient specific model, using a determined oxygen efficiency of the patient, and applying that patient specific model as feedback in control of the delivery of the NHF gases flow to the patient. All of the closed loop controls of the above cited prior art fail to teach or suggest generating a patient specific model as part of their control loop structure. The instant application discusses the use of a patient specific model as providing the benefit of accounting for individual patient variation in response to FdO2 changes during a therapy session (e.g. ¶0497).
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention, in light of the interpretation applied to the claim in response to the above 35 U.S.C. 112(b) rejection, by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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