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.
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 limitation(s) is/are: “O2 delivery device” in claims 16 – 19 and 21.
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.
Examiner notes that replacing “O2 delivery device” with “O2 delivery patient interface” will overcome the interpretation under 35 USC 112(f).
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 – 5, 8 – 10, 13, 16 – 17, and 19 – 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams (US 20210361899).
1. Williams discloses a method for oxygen titration for a subject (see [0003], closed loop control of oxygen delivery based on SpO2, thereby titrating the optimized oxygen), the method comprising: receiving a target peripheral capillary oxygen saturation (SpO.sub.2) range for the subject [0484]; sensing a subject's SpO.sub.2 level [0438]; calculating an error signal by subtracting the subject’s sensed SpO2 level from the target SpO2 range using a controller (see [0493] and Fig. 10, where [0526] and [0529] explicitly teach that control involves a difference or subtraction between the subject’s level and the target; Fig. 6 gives the general teaching of the illustrated error difference or subtraction, where the (-) or subtracted sign in the top left-most comparator corresponds to the measured SpO2; it is noted that the predicted measured SpO2 may be considered the subject’s SpO2 level in an alternative interpretation); and sending the error signal from the controller (see [0526, 0529], and Fig. 6; the difference/subtraction between target and measured SpO2 error signal is fed from the controller to begin the actuating signal; see also [0493] and Fig. 10) to a valve (see Fig. 10, “oxygen valve”; the valve is a proportional valve whose size of valve opening is relative to the supplied electrical current, see [0494], [0621] and [0627]) coupled to an oxygen (O.sub.2) reservoir (see [0453], [0564] for generic teaching of the reservoir or bottle/tank as the oxygen supply source) to modulate flow of O.sub.2 based on the magnitude of the error signal to deliver O.sub.2 to the subject (see [0493 – 0495], the oxygen valve provides flow to the subject based on the target FdO2, which is determined based on the subtraction between subject and target SpO2; see also [0526], [0529], [0484], the change outside of target SpO2 is used to determine new target FdO2; the magnitude of the error signal and thus magnitude of FdO2 is used to control the oxygen valve by changing the amount of supplied electrical current, see [0494, 0495]; examiner notes that applicant’s specification does not support sending the SpO2 error directly to the servo valve, and feedback for the valve control signal 208 involves incorporation of the O2 sensor signal or FdO2, see [0042, 0046]).
2. Williams discloses the method of claim 1, wherein sensing a subject's SpO.sub.2 level is performed using a pulse oximeter coupled to the subject [0438].
3. Williams discloses the method of claim 1, wherein receiving the target SpO.sub.2 range includes detecting input from a user (see [0484]) via an interface coupled to the controller (see [0485]).
4. Williams discloses the method of claim 1, wherein delivering O.sub.2 to the subject includes flowing O.sub.2 through a high flow nasal cannula (see [0460]).
5. Williams discloses the method of claim 4, wherein the flow rate of O.sub.2 is between about 7 liters per minute and about 60 liters per minute (see [0459]).
8. Williams discloses the method of claim 1, further comprising measuring O.sub.2 concentration prior to delivery to the subject (see [0445], [0494], measured O2 is compared to target O2, and then the controller modulates the O2 valve; see also [0454]).
9. Williams discloses the method of claim 8, further comprising communicating measured O.sub.2 concentration to the controller for use in modulating flow of O.sub.2 (see [0445], [0494], measured O2 is compared to target O2, and then the controller modulates the O2 valve).
10. Williams discloses the method of claim 8, further comprising notifying a user if measured O.sub.2 concentration falls below a threshold value (see [0489, 0491], measured FdO2 is displayed against target limits, thus visually notifying the user when outside the limits).
13. Williams discloses the method of claim 1, further comprising notifying a user if the sensed SpO.sub.2 level falls below a threshold value [0568].
16. Williams discloses a system for oxygen titration for a subject (see [0003], closed loop control of oxygen delivery based on SpO2, thereby titrating the optimized oxygen), the system comprising: a pulse oximeter configured to be coupled to a subject [0438]; an oxygen (O.sub.2) reservoir ([0564] generically teaches a reservoir/bottle as the oxygen supply source; see also [0453], oxygen tank); a valve coupled to the O.sub.2 reservoir (see Fig. 10, “oxygen valve”; the valve is a proportional valve whose size of valve opening is relative to the supplied electrical current, see [0494], [0621] and [0627]); an O.sub.2 delivery device coupled to the O.sub.2 reservoir and configured to deliver O.sub.2 to the subject (patient interface 17, see Fig. 1a); and a controller (see Fig. 10) configured to: receive a target peripheral capillary oxygen saturation (SpO.sub.2) range for the subject [0484]; receive a peripheral capillary oxygen saturation (SpO.sub.2) for the subject from the pulse oximeter [0438]; calculate an error signal by subtracting the SpO2 for the subject from the target SpO2 range (see [0493] and Fig. 10, where [0526] and [0529] explicitly teach that control involves a difference or subtraction between the subject’s level and the target; Fig. 6 gives the general teaching of the illustrated error difference or subtraction, where the (-) or subtracted sign in the top left-most comparator corresponds to the measured SpO2; it is noted that the predicted measured SpO2 may be considered the subject’s SpO2 level in an alternative interpretation); send the error signal to the valve to modulate flow of O.sub.2 from the O.sub.2 reservoir to the O.sub.2 delivery device based on the magnitude of the error signal to deliver O.sub.2 to the subject (see [0493 – 0495], the oxygen valve provides flow to the subject based on the target FdO2, which is determined based on the subtraction between subject and target SpO2; see also [0526], [0529], [0484], the change outside of target SpO2 is used to determine new target FdO2; the magnitude of the error signal and thus magnitude of FdO2 is used to control the oxygen valve by changing the amount of supplied electrical current, see [0494, 0495]; examiner notes that applicant’s specification does not support sending the SpO2 error directly to the servo valve, and feedback for the valve control signal 208 involves incorporation of the O2 sensor signal or FdO2, see [0042, 0046]).
17. Williams discloses the system of claim 16, further comprising an O.sub.2 concentration sensor configured to measure a concentration of oxygen flowing through the O.sub.2 delivery device (see [0445], [0494]; see also [0454]).
19. Williams discloses the system of claim 16, further comprising an interface for receiving input from a user (see [0484, 0485]).
20. Williams discloses the system of claim 16, wherein the O.sub.2 delivery device is a high flow nasal cannula (see [0460]).
21. Williams discloses the system of claim 20, further comprising a humidifier (see [0450], Fig. 1a, 12).
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.
Claim(s) 6, 7, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Chua (US 20140276169).
6. Williams discloses the method of claim 1, wherein delivering O.sub.2 to the subject includes flowing O.sub.2 through a low flow apparatus (see [0653, 0655]). Williams additionally discloses any number of patient interfaces included non-sealed nasal cannulas, see [0451], but does not explicitly disclose a low flow nasal cannula. Nonetheless, Chua discloses a low flow nasal cannula connected to an oxygen supply, see [0007], [00024]. Therefore, according to the teachings of Chua, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Williams to include a low flow nasal cannula for the benefit of improving oxygen efficiency, see [0007].
7. The modified Williams discloses the method of claim 6, wherein the flow rate of O.sub.2 is between about 1 liter per minute and about 6 liters per minute (see Williams, delivery rates between 2 – 5 LPM per [0459]; see Chua [[0039]).
22. Williams discloses the method of claim 16, wherein delivering O.sub.2 to the subject includes flowing O.sub.2 through a low flow apparatus (see [0653, 0655]). Williams additionally discloses any number of patient interfaces included non-sealed nasal cannulas, see [0451], but does not explicitly disclose a low flow nasal cannula. Nonetheless, Chua discloses a low flow nasal cannula connected to an oxygen supply, see [0007], [00024]. Therefore, according to the teachings of Chua, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify Williams to include a low flow nasal cannula for the benefit of improving oxygen efficiency, see [0007].
Claim(s) 11, 12, 14, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Brown (US 20160022952).
11. Williams discloses the method of claim 10, but does not explicitly disclose wherein notifying the user includes actuating any of a visual, haptic, or audio alarm. Nonetheless, Brown discloses a signal and data processer that, upon determining that the patient or system thereof is in a state of a prescribed alarm condition such as persistent desaturation of the patient’s hemoglobin (e.g. low SpO2), or other care provider specified condition, notifies the user including actuating any of a visual, haptic, or audio alarm (see [0016], Fig. 1, 124 – 129). Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the notification(s) of Williams according to the remote alarm of Brown for the benefit of alerting remote caregivers such as at a nurse’s station for a particular hospital unit or area covered by a care provider.
12. Williams discloses the method of claim 10, but does not disclose wherein notifying the user includes interacting with a remotely disposed device through a communications network. Nonetheless, Brown discloses a signal and data processer that, upon determining that the patient or system thereof is in a state of a prescribed alarm condition such as persistent desaturation of the patient’s hemoglobin (e.g. low SpO2), or other care provider specified condition, notifies the user by interacting with a remotely disposed device through a communications network, see [0016]. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to modify the notification(s) of Williams according to the remote notification of Brown for the benefit of alerting remote caregivers such as at a nurse’s station for a particular hospital unit or area covered by a care provider.
14. The modified Williams discloses the method of claim 13, wherein notifying the user includes actuating any of a visual, haptic, or audio alarm (see claim 11 above).
15. The modified Williams discloses the method of claim 13, wherein notifying the user includes interacting with a remotely disposed device through a communications network (see claim 12 above).
18. The modified Williams discloses the system of claim 16, further comprising an alarm configured to produce any of a visual, haptic, or audio notification (see claim 11 above).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to applicant’s arguments concerning the interpretation under 35 USC 112(f), examiner notes that replacing “O2 delivery device” with “O2 delivery patient interface” would overcome the interpretation under 35 USC 112(f).
On page 8, paragraph 2, applicant argues that Williams is silent regarding the calculation of an error signal by subtracting the subject’s sense SpO2 level from the target SpO2 range. The examiner respectfully disagrees. Notably, applicant has omitted the portion of paragraph [0526] stating that “the PID controller would act substantially the same as described earlier”. Thus, the referenced difference (subtraction) is between the measured SpO2 and target SpO2 instead. The examiner has additionally cited paragraph [0529] and Fig. 6, as explained in the action above. Williams discloses sending the error signal to the valve to modulate flow of O2 based on the magnitude of the error signal as explained in the rejection above.
As such, examiner has maintained rejection of claims 1, 16, and dependents therein, as set for the in the action above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY H PHILIPS whose telephone number is (571)270-5180. The examiner can normally be reached 8:00 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy 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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/BRADLEY H PHILIPS/ Primary Examiner, Art Unit 3799
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