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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/351966, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application: claims 4 – 7, 20, and 22 (high/low flow cannula).
As such, claims 1 – 3, 8 – 19, and 21 have an effective filing date of 06/17/2022, and claims 4 – 7, 20, and 22 have an effective filing date of 06/14/2023.
Drawings
The drawings are objected to because Fig. 2 is difficult to read, and would be better illustrated in black and white rather than grayscale. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim Objections
Claim 16 is objected to because of the following informalities: “a pulse oximeter coupled to a subject” should read “a pulse oximeter configured to be coupled to a subject” (emphasis added). Appropriate correction is required.
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]; comparing the subject's SpO.sub.2 level to the target SpO.sub.2 range for the subject using a controller (see [0493] and Fig. 10, where [0526] explicitly teaches that control involves comparison between the subject’s level and the target; it is noted that the predicted measured SpO2 may be considered the subject’s SpO2 level in an alternative interpretation); and actuating a valve coupled to an oxygen (O.sub.2) reservoir to modulate flow of O.sub.2 when the subject's SpO.sub.2 level is outside of the target SpO.sub.2 range to deliver O.sub.2 to the subject (see [0493 – 0495], an oxygen valve provides flow to the subject based on the target FdO2, which is determined based on the comparison between subject and target SpO2; see also [0526], [0484], the change outside of target SpO2 is used to determine new target FdO2; see [0453], [0564] for generic teaching of the reservoir or bottle/tank as the oxygen supply source).
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 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 [0445], [0453]); 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]; actuate the valve to modulate flow of O.sub.2 from the O.sub.2 reservoir to the O.sub.2 delivery device when the subject's SpO.sub.2 level is outside of the target SpO.sub.2 range to deliver O.sub.2 to the subject (see [0493 – 0495], on oxygen valve provides flow to the subject based on the target FdO2, which is determined based on the comparison between subject and target SpO2; see also [0526], [0484], the change outside of target SpO2 is used to determine new target FdO2).
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art is replete with references disclosing SpO2 control of oxygen, including the following references:
US 20240269408 A1
US 20200297960 A1
US 20220339396 A1
US 20010039951 A1
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.
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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