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 .
Response to Amendment
This office action is in response to the amendment filed 5/29/2025. As directed by the amendment, claims 16-18 and 20-24 have been amended. Claims 16-24 are pending in the instant application.
New matter remains in claims 20-22; the rejection under 35 USC 112(a)/first paragraph is maintained below. However, since Applicant has contested the Examiner’s attempt at compact prosecution, the art rejections of claims 20-22 have been withdrawn at this time.
Applicant has amended the claims to address the first previous rejection under 35 USC 112(b)/second paragraph, which is hereby withdrawn, but conflicting method steps are still recited in claims 20-22; therefore, the second previous rejection under 35 USC 112(b)/second paragraph is maintained below.
Response to Arguments
Applicant’s arguments filed 5/29/2025 (hereinafter “Remarks”), see pages 9 and 12 thereof, that the Examiner should not have rejected claims 20-22 in view of prior art based on the specification, but rather based the claims as written (i.e. with their new matter), have been fully considered and are persuasive.
The Examiner concedes, and the prior art rejection of claims 20-22 is withdrawn, because while single upstream regulator valves with multiple downstream individual pulse valves were known in the art before the effective filing date of the claimed invention, see e.g. previously-cited Walker et al. (US 2019/0224505 A1, Fig. 1, which shows upstream regulator 18 and downstream pulse valves 22), Campbell (WO 2015/197542 A1, Figs. 1-2, which show upstream pressure reducer 15 and downstream pulse valves 14), Degenhardt (US 2020/0215358 A1, Fig. 2, which shows upstream pressure reducer valve 2 and downstream pulse valves 8), and the instant specification (instant Fig. 1, which shows upstream valve 13 and downstream pulse valves 17), as were single/shared pulse valves that deliver the same pulses (i.e. not tailored based on respective breath detection) to all downstream masks, see e.g. Neumann et al. (US 2019/0185166 A1; valve 20 and para [0040]), the prior art does not teach [nor does the instant specification disclose] a shared/common pulse valve that delivers individually-tailored demand and safety pulses from the common valve to two different masks according to the instant method. Therefore, art is not applicable to claims 20-22 as they are currently written. [Note: the instant method is also impossible to perform as written, see the 112(b) rejection maintained below, because the two delivering steps recited for each mask cannot occur in the same method because one of the steps requires a breath to be detected in a time frame and the other step requires a breath to not be detected in the same time frame].
Applicant's remaining arguments filed 5/29/2025 (hereinafter “Remarks’) have been fully considered but they are not persuasive.
Applicant requests on pages 9 and 12 of Remarks that “any further Office Action be non-final.”
The Examiner respectfully notes MPEP 706.07(a): “Second or any subsequent actions on the merits shall be final, except where the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).” Since the Examiner has not introduced a new ground of rejection that is neither necessitated by applicant’s amendment of the claims, nor based on information submitted in an information disclosure statement filed as above, Applicant's request cannot be granted.
Regarding the rejection of claims 20-22 under 35 USC 112(a)/first paragraph, Applicant alleges on page 10 of Remarks that “the Office Action concedes that the present application “discloses a regulation valve 13 upstream of the control unit…for delivering oxygen pulses to the respective masks.””
The Examiner contests Applicant’s mischaracterization of the Office Action. Applicant has omitted critical information in their use of ellipses. The full language from the Office Action was: “The specification as originally filed does not disclose a regulation pulse-delivering valve that is shared between masks; rather, it discloses a regulation valve 13 upstream of the control unit 5 and individual controllable valves 17 for each mask within the control unit for delivering oxygen pulses to the respective masks, see instant Fig. 1 and page 4” (emphasis added to highlight the information omitted by Applicant’s ellipses), i.e. it is the individually controllable valves 17 that deliver pulses to the masks under the control of the control unit, not the regulation valve 13. The omitted language is precisely why a new matter rejection was given, because claim 20 as currently written recites a single regulation valve that delivers therefrom individualized demand and safety pulses to two different masks, whereas the instant specification makes it clear that the individualized demand and safety pulses to each mask are delivered from a respective valve 17 that is downstream of the shared regulation valve 13. Therefore, the rejection of claims 20-22 under 35 USC 112(a)/first paragraph is maintained below.
Further regarding the rejection of claims 20-22 under 35 USC 112(a)/first paragraph, on page 10 of Remarks, Applicant argues that their use of “comprising” means that additional structures between the regulation valve and the oxygen masks are not precluded, that the claims “recite that there is a regulation valve common to the first oxygen mask and the second oxygen mask and delivering demand oxygen pulses,” and that Fig. 1 depicts a single regulation valve, concluding that “the presently recited claims are supported by the specification.”
The Examiner agrees that the use of “comprising” does not preclude additional structures, and the Examiner agrees that the specification as originally filed supports a single regulation valve, and if the claims only recited “delivering demand oxygen pulses” and not specifically that the demand oxygen pulses are delivered “from a/the regulation valve” as currently written, there would not be an issue. However, the claims do currently specifically recite that the demand oxygen pulses are delivered “from a/the regulation valve,” which requires the demand oxygen pulses to be delivered from a/the regulation valve, i.e. the demand pulses cannot be provided by an additional, unrecited element in lieu of being provided by the regulation valve. Since the specification as originally filed does not support the demand oxygen pulses to be delivered from a/the regulation valve, but rather discloses that the control unit 5 controls valves 17 according to the instant method, see e.g. instant Fig. 1 and page 4, the rejection of claims 20-22 under 35 USC 112(a)/first paragraph is maintained below.
Regarding the rejection of claims 20-22 under 35 USC 112(b)/second paragraph, Applicant indicates on page 11 of Remarks that they are “unsure how [removing the limitation that the registering/not registering occur within a specified time period] would resolve the Office Action’s concern.”
The Examiner respectfully points out that by removing the requirement that the registering/not registering occur within a specified time period allows for an interpretation where the delivering in response to registering happens outside of a time period while the delivering in response to not registering happens within the time period. This removes the conflict, because, as currently written, both of the delivery/registering steps occur in the same time period, but they cannot, because a breath cannot be both registered and not registered within a given time period.
Further regarding the rejection of claims 20-22 under 35 USC 112(b)/second paragraph, Applicant argues on page 11 of Remarks that claim 20 is not indefinite because the claim “contains a decision point with prescribed responses…to two potential results of the decision.”
The Examiner respectfully notes that the claim positively recites two delivering steps for each mask, and in doing so, positively recites both potential results of the decision. Indeed, the positive recitation of both steps--not within the same time period--see e.g. the amendments made to claim 7 in the claim set filed 3/28/2024, was in response to the Office indicating on pages 6-7 of the Office Action mailed 1/31/2024 that contingent limitations would be interpreted as requiring only one of the conditional steps. If Applicant wishes to revert the claims to conditional limitations, they could recite the delivering steps in the alternative, e.g. with an “or” between them, but it is noted that in doing so, prior art that reads on only one of the potential results of the decision will then be sufficient to reject the method, see MPEP 2111.04.II. Since claim 20 currently positively recites two delivering steps for each mask, and both cannot be performed in accordance with the method because a breath cannot be both registered and not registered within a given time period, the rejection of claims 20-22 under 35 USC 112(b)/second paragraph is maintained below
Regarding the rejections under 35 USC 103, Applicant argues on pages 12-13 of Remarks that there is inadequate motivation to combine Deane with Sasso or Sasaki because Deane notes known differences between aviation and medical applications, alleging that “Deane expressly teaches away from the use or combination of medical oxygen supplies in aviation applications” because Deane states that “[k]nown medical oxygen conservers would also not be well-suited to the general aviation requirement” and “in the context of aviation settings…oxygen deployment systems must be able to operate at various altitudes.”
The Examiner respectfully notes that the rejection is not based on a substitution of the aviation oxygen conservator of Deane with a medical oxygen conservator. Deane already discloses an aviation oxygen conservator that provides a demand pulse when a breath is registered and auto-pulses when no breath is registered and that adjusts the oxygen delivery with altitude; the teachings of Sasso and Sasaki merely supplement the disclosure of Deane to inform “how to register a breath” as claimed and “what frequency/duration to utilize for demand versus safety pulses” as specifically claimed. The Examiner disagrees that Deane’s discussion of the general knowledge of an artisan constitutes “a teaching away” from looking toward medical oxygen conservers when seeking to fill these gaps of Deane. The teachings of Sasso and Sasaki regarding known breath detection methods and known ranges for relative timing/duration of demand versus safety pulses are separate from the altitude corrections taught by the base reference of Deane, and Deane’s discussion of medical oxygen conservators emphasizes that an artisan would have familiar with oxygen conservators of all types, and thus would have been able to readily apply relevant teachings, e.g. breath detection and suitable relative timing/duration for demand versus safety pulses, between the different types. As such, Sasso and Sasaki continue to educate Deane to arrive at the claimed invention as discussed in the art rejections of claims 16-19, 23 and 24 under 35 USC 103 maintained below.
On page 13 of Remarks, Applicant references prior art solutions mentioned in paras [0003] and [0006] of the instant specification.
The Examiner is unclear how these prior art solutions apply to the rejections of record. The prior art of Deane in view of Walker, Sasso and Sasaki teaches all of the claimed limitations as discussed in the art rejections of claims 16-19, 23 and 24 under 35 USC 103 maintained below.
Applicant states on page 13 of Remarks that they are not arguing that the claimed pulses “[are] not dependent on altitude” but that “the ability of the claimed system to both deliver and conserve oxygen is independent of altitude” because the system can deliver demand breaths and safety pulses.
The Examiner does not understand what point Applicant is trying to make. Instant claims 16 and 20 require adjustment “based on at least one of altitude and cabin pressure,” and claims 23 and 24 make no mention of altitude. Deane discloses a system that corrects for oxygen demand based on altitude and delivers demand breaths and safety pulses, which, as best understood, addresses both of the concerns above, and Deane in view of Walker, Sasso and Sasaki teaches all of the claimed limitations as discussed in the art rejections of claims 16-19, 23 and 24 under 35 USC 103 maintained below.
Applicant argues on pages 13-14 of Remarks that “typical emergency oxygen systems for aircraft passengers either conserve oxygen at low altitude by using demand oxygen pulses or allow for continuous air at high altitude” then states “[f]or example, the abstract of Deane specifically notes that, “a mix of gas usage reduction modes can be employed depending on…operating altitude”.
The Examiner fails to see how these arguments apply to the instant claims. While a “typical” emergency oxygen system may use demand pulses and continuous air, the base reference of Deane explicitly discloses an aviation oxygenation system that delivers demand breaths when breath is detected and safety auto-pulses in the absence of breath detection. Moreover, per the remainder of the abstract of Deane, the “mix” taught by Deane is due to allowing separate bolus control to different masks, which is the same functionality as instantly disclosed, and adjustments based on operating altitude are required by instant claims 16 and 20, so the Examiner thanks Applicant for acknowledging Deane’s teachings regarding these limitations. Since Deane in view of Walker, Sasso and Sasaki teaches all of the claimed limitations as discussed in the art rejections maintained below, the art rejections of claims 16-19, 23 and 24 under 35 USC 103 are maintained.
Applicant asserts on page 14 that “a solution as recited in the present claims, that allows for the conservation of oxygen by using demand pulses at all altitudes by also incorporating safety oxygen pulses is not disclosed or contemplated by a permissible combination of Deane, Walker, Sasso or Sasaki.”
The Examiner disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the claimed inventions “allow for the conservation of oxygen by using demand pulses at all altitudes”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, in as far as the Examiner understands Applicant to be asserting that the provision of safety pulses provides the claimed functionality, the base reference of Deane explicitly discloses, and Sasso also teaches, demand pulses when breath is detected and safety auto-pulses when breath is not detected; therefore, Deane/modified Deane possesses/teaches the asserted functionality.
Applicant argues on page 14 of Remarks that Deane’s statement of “absence of breath detection” could mean either “absence of when a breath is expected or absence of the detection ability itself,” and that Deane does not describe “how a correct minute volume” would be determined or provided,” asserting that “the Office Action broadly interprets these phrases without sufficient support for the interpretation” and that Deane does not disclose or contemplate “registering no draw of breath within the first time window” or “delivery of first safety pulses at…intervals.”
First, the Examiner disagrees that Deane’s statement of “absence of breath detection” could mean “absence of the detection ability itself,” because Deane para [0018] explicitly recites a breath sensor 4, i.e., the detection ability itself is not absent in Deane. Second, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The Office Action interprets Deane in light of the general knowledge of an artisan before the effective filing date of the claimed invention, where minute volume was/is an established parameter and the use of the phase “adaptive auto-pulse...in the absence of breath detection” in Deane para [0027] would have inferred to an artisan that the adaptation of applying auto-pulse is in response to a failure of the breath detection used for the demand delivery of Deane paras [0017-18], because an artisan before the effective filing date of the claimed invention would have been familiar the concept of supplying regular auto-pulses to provide a minimum level of oxygen if a breath is not detected, as demonstrated by Sasso (see the discussion of Sasso in the rejections maintained below). Therefore, the combination of references renders the instant claims obvious as discussed in the rejections of claims 16-19, 23 and 24 under 35 USC 103 maintained below.
Applicant states on page 15 of Remarks that “the Office Action concedes that “Sasso teaches a personalized time period” yet asserts that it would be common sense to de-personalize the personalized time period.”
The Examiner affirms that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). It would have been within the general knowledge/common sense of an artisan before the effective filing date of the claimed invention to assess an absence of breathing [as taught by the primary reference of Deane] by waiting some time period in which a normal breath (based on standard or user-specific rates) should have been taken. An artisan would have recognized when integrating a breath detection strategy such as that taught by Sasso into the emergency system of Deane that there would not be the luxury of pre-determining a personalized breathing rate due to the emergency conditions/immediate deployment requirements, and thus it would have been obvious to an artisan before the effective filing date of the claimed invention to rely on a standardized breath rate for setting a time period for assessing an absence of breath, as taught by Sasaski (paras [0047-48] and paras [0047] and [0057-60]), as discussed in the rejections of claims 16-19, 23 and 24 under 35 USC 103 maintained below.
Applicant argues on page 15 of Remarks that “the Office Action does not actually provide a reference that discloses safety pulse delivery at all in the constraints of an aviation application, or delivery of safety pulses after a predetermined window as opposed to user-specific window.”
The Examiner disagrees on the first count; the Office Action does actually provide a reference that discloses safety pulse delivery in the constraints of an aviation application: the base reference of Deane is an aviation application and discloses safety pulse delivery, see para [0027] thereof. Regarding the second count, the Examiner reminds the Applicant that 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 see MPEP 2141. The Examiner has provided a rejection under 35 USC 103 with sufficient motivation/reasoning regarding the obviousness to an artisan at the time of invention to combine the prior art references to arrive at the instantly claimed invention, which establishes a prima facie case for obviousness; therefore, the burden is shifted to Applicant to provide additional evidence of nonobviousness. MPEP 2142. (emphasis added). Regarding the delivery of safety pulses after a predetermined window as opposed to user-specific window, the Examiner reiterates that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Deane discloses safety pulse delivery in the absence of breath detection, Sasso teaches the delivery of safety pulses after a time window for assessing an absence of breath detection, and Sasaki teaches using a predetermined time window for assessing an absence of breath detection based on standard breathing rates. Therefore, it is the combination of references, along with the general knowledge and common sense in the art, that renders claims 16-19, 23 and 24 under 35 USC 103 maintained as below.
Applicant asserts on page 15 that the Office Action “makes an impermissible broad reading of Deane individually, Sasso individually, and combines the impermissible broad reading of Deane and Sasso despite an explicit teaching in Deane not to rely on the medical oxygen delivery systems in aviation settings.”
The Examiner disagrees that any of the readings are impermissibly broad or that Deane teaches away from the combination. Deane para [0027] teaches the use of safety pulses in the absence of breath detection in an aviation oxygen conservator system, and Deane also teaches that an artisan would be aware of medical oxygen conservators, Sasso teaches the use of regular safety pulses after a period of time to assess an absence of breath, and Sasaki teaches a predetermined period of time to assess an absence of breath based on standardized breathings rates and suitable relative pulse timings/durations. The combination does not replace the aviation conservator Deane with a medical oxygen delivery system, nor do the proposed modifications render the device of Deane unsuitable for aviation purposes. Sasso and Sasaki merely educate Deane regarding specifics (e.g. known means of breath detection and known relative timing/durations for demand and safety pulses) for the implementation of auto-pulsing in the absence of breath detection disclosed by Deane. As such, claims 16-19, 23 and 24 remain rejected under 35 USC 103 as maintained below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 20 (and thus its dependent claims 21-22) recites delivering oxygen pulses from a single regulation valve to the first mask AND to the second mask (“first demand oxygen pulse from a regulation valve to the first oxygen mask…first safety oxygen pulses from the regulation valve…second demand oxygen pulse from the regulation valve to the second oxygen mask…second safety oxygen pulses from the regulation valve”). The specification as originally filed does not disclose a regulation valve that is also a common/shared pulse-delivering valve; rather, it discloses a regulation valve 13 upstream of the control unit 5 and individual controllable valves 17 for each mask within the control unit for delivering oxygen pulses to the respective masks, see instant Fig. 1 and page 4. Applicant could address this rejection by amending claim 20 to read “first demand oxygen pulse from a first valve to the first oxygen mask…first safety oxygen pulses from the first valve…second demand oxygen pulse from a second valve to the second oxygen mask…second safety oxygen pulses from the second valve”.
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 20-22 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.
Regarding claim 20 (and thus its dependent claims 21-22), claim 20 recites the step of “registering whether a first/second draw of breath is detected within the time window” but then positively recites each of the conflicting steps of “delivering, in response to registering the first/second draw of breath” and “delivering, in response to registering no draw of breath.” Either a breath is registered within the time period or a breath is not registered within the time period; it cannot be both, in the same method, as currently recited. To address this rejection, Applicant could amend the claim to read “registering whether a first/second draw of breath is detected
Claim Interpretation
The scope of the term “typical frequency” recited in the independent claims is understood in light of the last paragraph on page 5 of the instant specification: “approx. 10 seconds is…larger than the typical period duration of the demand oxygen pulses,” and Fig. 2 of the instant specification, which depicts demand oxygen pulses that are ~6-7 seconds apart, for a frequency of ~8.5-10 breaths per minute.
Note: the specification as originally filed attributes no particular criticality to the frequency of the safety oxygen pulses being at least five times a typical frequency of the demand oxygen pulse[s] or to the pulse duration of the safety oxygen pulses being less than half a pulse duration of the demand oxygen pulses.
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.
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) 16-19, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Deane et al. (US 2008/0072907 A1; hereinafter “Deane”) in view of Walker et al. (US 2019/0224505 A1; hereinafter “Walker”), Sasso, Jr. (US 5,603,315; hereinafter “Sasso”) and Sasaki et al. (US 2019/0388644 A1; hereinafter “Sasaki”).
Regarding claim 16, Deane discloses/suggests an emergency oxygen system for an aircraft passenger (Figs. 1-2; paras [0002] and [0018]), comprising:
a first oxygen port (e.g. passenger port 1) (Fig. 2; para [0018]);
a second oxygen port (e.g. passenger port 2) (Fig. 2; para [0018]);
a controllable oxygen feed (oxygen supply 1) for the first oxygen port and the second oxygen port (Figs. 1-2; para [0018]);
a control unit (controller/CPU 2) for controlling the controllable oxygen feed to the first oxygen port and the second oxygen port (para [0018]);
wherein the control unit is configured to:
register whether a first draw of breath is detected in the first oxygen port (para [0018] in view of para [0004]);
command, in response to registering the first draw of breath, delivery of a first demand oxygen pulse (bolus) to the first oxygen port (para [0018] in view of para [0004]);
command, in response to registering no draw of breath, delivery of first safety oxygen pulses (auto-pulses) at intervals to the first oxygen port (adapted auto-pulse…to deliver the correct minute volume of oxygen in the absence of breath detection, para [0027]; where it would have been suggested to/inferred by an artisan before the effective filing date of the claimed invention that multiple pulses, which would necessarily have some interval therebetween, would be fed if breath detection remained absent);
register whether a second draw of breath is detected in the second oxygen port (para [0018] in view of para [0004]);
command, in response to registering the second draw of breath, delivery of a second demand oxygen pulse (bolus) to the second oxygen port (para [0018] in view of para [0004]);
command, in response to registering no draw of breath, delivery of second safety oxygen pulses (auto-pulses) at the intervals to the second oxygen port (see para [0027] and discussion above); and
adjust at least one of a period of the first demand oxygen pulse, the second demand oxygen pulse, or an oxygen quantity per first demand oxygen pulse and per second demand oxygen pulse based on at least one of an altitude and a cabin pressure (control of the valve timing determines the bolus volume…the bolus delivery timing…adjusted to maintain proper oxygen volume delivery even as the source pressure varies with altitude, para [0018]).
Deane is silent regarding a first and second oxygen mask, a first tube coupling the first oxygen mask to the control unit; a second tube coupling the second oxygen mask to the control unit; a third tube coupling the control unit to a regulation valve. However, these were standard components of emergency oxygen systems for aircraft passengers before the effective filing date of the claimed invention, as demonstrated by Walter, which teaches a first and second oxygen mask (any two of masks 30) (Fig. 1), a first tube (the delivery tube 34 associated with a selected first mask) coupling the first oxygen mask to the control unit (controller 8); a second tube (the delivery tube 34 associated with a selected second mask) coupling the second oxygen mask to the control unit (Fig. 1); a third tube (tubing 4) coupling the control unit to a regulation valve (regulator 18, which would have been well understood by an artisan before the effective filing date of the claimed invention to comprise a valve as a standard component of gas pressure regulators). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the system of Deane to include a first and second oxygen mask, a first tube coupling the first oxygen mask to the control unit; a second tube coupling the second oxygen mask to the control unit; a third tube coupling the control unit to a regulation valve as taught by Walker, in order to provide standard components for facilitating the operation of the system of Deane (Walker paras [0083-84]).
Deane is silent regarding the safety pulses being regular and because Deane does not describe how “the absence of breath detection” in para [0027] is to be assessed, Deane is silent regarding the control unit configured to set, in response to activation of the emergency oxygen system, a first time window corresponding to the first oxygen mask; set, in response to activation of the emergency oxygen system, a second time window corresponding to the second oxygen mask, the first time window and the second time window having a predefined length common to the first oxygen mask and the second mask and the first and second drawings of breath being within the first and second time window, respectively. However, it would have been within the general knowledge/common sense of an artisan before the effective filing date of the claimed invention to assess an absence of breathing by waiting a time period for each mask in which a normal breath (i.e. a breath based on a standard/expected breathing rate) should have been taken, which would indicate a predefined length common to each mask because each length would be based on the same standard rate, and for automated pulses to be regular for simplicity, as evidenced by Sasso, which teaches that it was known in the oxygen conservator art before the effective filing date of the claimed invention to deliver regular safety oxygen pulses (forced pulses of oxygen) to a person if a draw of breath is not registered within a time window, the time window having a predefined length (predetermined time period DL2) (Sasso Fig. 18; [i]f an inhalation is not sensed within the duration of a different predetermined period (DL2), micro-controller 8 may…force a pulse of oxygen to the patient…[p]ulses of oxygen may thus be continuously forced to the patient, col. 8, lines 44-67; oxygen pulses every “n” seconds, col. 12, lines 29-31), with Sasaki further teaching that it was known in the respiratory oxygen delivery art before the effective filing date of the claimed invention to set, in response to activation of a system, a time window (predetermined period of time) (para [0047]), the time window having a predefined length (e.g. 15 sec) (Fig. 5; (t.sub.up, n.sub.up)=(15, 1), para [0048]), and for a registering of no draw of breath (less than 1 is 0) within the time window (paras [0047] and [0057-60]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Deane to include regular safety pulse intervals and the control unit configured to set, in response to activation of the emergency oxygen system, a first time window corresponding to the first oxygen mask; set, in response to activation of the emergency oxygen system, a second time window corresponding to the second oxygen mask, the first time window and the second time window having a predefined length common to the first oxygen mask and the second mask and draw of breath to be within the first and second time windows as taught by Sasso and Sasaki, in order to provide the predictable results of a known control means (i.e. a pre-programmed/predetermined time amount of time for each mask to wait in which a breath would be reasonably expected to occur, e.g. 15 sec, and for no breath being detected in that time period to be registered as an absence of breath) for assessing the absence of breath detection disclosed by Deane (in each mask, and using the same time period in each mask in order to utilize a standard time based on a normal breath in each mask for standardization and/or simplicity/ease of programming), and in order to provide sufficient oxygen in the event that the breath detector has failed and/or is not properly registering inhalations for a given mask (Sasso para [0061]; Sasaki paras [0057-60]).
Modified Deane is silent regarding the regular intervals having a frequency at least five times a typical demand oxygen pulse frequency, and a pulse duration of the first safety oxygen pulses being less than half a demand oxygen pulse duration. However, the safety oxygen pulses taught by modified Deane must have some frequency and duration, and optimization/determination of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05. Sasso teaches only a short delay between forced/safety oxygen pulses, and preselecting the frequency of the forced/safety oxygen pulses (only a short delay in between each pulse, col. 8, lines 53-65; every “n” seconds…being a preselected value, col. 12, lines 29-31), Sasaki teaches that it was known in the pulsed oxygen delivery art before the effective filing date of the claimed invention that a respiratory rate (corresponding to a frequency for demand oxygen pulses) can be 8 bpm (a respiratory rate of the patients is usually about 8 to 48 bpm, para [0041]) and that a frequency of safety oxygen pulses (auto-pulse), which are delivered when a draw of breath is not detected within a certain time window, can be 50 bpm (paras [0058-60]), which arrives at/suggests a frequency that is at least five times a typical demand oxygen pulse frequency (50/8=6.25), and Sasaki further teaches that it was known in the respiratory oxygen delivery art before the effective filing date of the claimed invention that auto-pulsing oxygen when no breath draw has been detected indicates that the oxygen may not be used by the patient because it may be delivered out of synch with the patient’s respiratory pattern (para [0061]). Walker teaches/suggests that it was known in the pulsed oxygen delivery art before the effective filing date of the claimed invention to utilize a pulse duration (time period tP) of safety oxygen pulses (anti-blocking pulses P) of less than half a demand oxygen pulse duration (dose D) (Fig. 3; higher volume [dose D]…preferably 5 times or more [than P], para [0054]; flow FP of the anti-blocking pulses P…is shown lower…time period tP is very short…doses D and anti-blocking pulses P may be produced by the same delivery valve, paras [0096-97]; where the same valve being opened for a shorter duration results in the smaller volume pulses P, as depicted by Fig. 3) in order to reduce the risk of respiration detection failure and to reduce oxygen usage during the safety pulses (para [0054]). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for modified Deane to include wherein the regular frequency of the safety oxygen pulses (for all masks) is at least five times a typical demand oxygen pulse frequency through routine experimentation and as suggested by Sasaki, and for a pulse duration of the safety oxygen pulses (for all masks, although the instant claims only require it for the first mask) to be less than half a pulse demand oxygen pulse duration through routine experimentation and as taught by Walker and in view of the teachings of Sasaki, in order to provide the predictable results of a suitably short time between safety oxygen pulses to ensure that the user is presented with oxygen frequently enough to sustain some degree of oxygenation even in the event that the breath detector has failed and/or is not properly registering inhalations (Sasaki para [0061]), while still conserving oxygen (i.e. not converting to a continuous flow when breathing is not detected) and providing the “correct” minute volume of oxygen (which would require using smaller duration/volume pulses because the safety pulses occur more frequently), and where the use of smaller duration/volume safety pulses would also predictably enhance the ability to detect breaths in the event that the breath detector resumes functioning and/or the user starts breathing again (Walker para [0054]).
Deane is silent regarding the control unit configured to reset, in response to registering the first/second draw of breath, the time window with respect to the first/second oxygen mask. However, Sasso and Sasaki further demonstrate that it was known/would have been obvious in the art of delivering safety oxygen pulses before the effective filing date of the claimed invention for modified Deane to include the control unit configured to reset, in response to registering the first/second draw of breath, the time window for assessing an absence of breath in each mask (Sasso Figs. 6, 10 and 18; col. 8, lines 44-64; col. 12, lines 13-37; Sasaki para [0060]: “cancels an auto-pulsative supply when inspiration sensing point G is detected again” in view of para [0061]: “the condition for switching to…auto-pulse…is satisfied five times,” which would have inferred/suggested to an artisan before the effective filing date of the claimed invention that the breath assessment involving the e.g. 15 sec time window is repeated, which requires another/reset of the 15 sec), in order to provide the predictable result of configuring the system to reiterate the absence of breath detection process (i.e. re-establishing a time period e.g. 15 sec to wait for a breath) after (each/a) detected breath with respect to each mask.
Modified Deane is silent regarding wherein the control unit is configured to adjust at least one of a period of the first safety oxygen pulses, the second safety oxygen pulses, or an oxygen quantity per first safety oxygen pulse and per second safety oxygen pulse based on at least one of an altitude and a cabin pressure. However, Deane teaches adjusting the periods/quantities of the demand pulses based on at least one of an altitude and a cabin pressure as discussed above (control of the valve timing determines the bolus volume…the bolus delivery timing…adjusted to maintain proper oxygen volume delivery even as the source pressure varies with altitude, para [0018]), such that it would have been obvious to an artisan before the effective filing date of the claimed invention for the safety pulses to be similarly corrected for altitude/cabin pressure, in order to predictably ensure that the intended amount of oxygen is being delivered as appropriate for the altitude.
Regarding claim 17, Deane in view of Walker, Sasso and Sasaki teaches the emergency oxygen system according to claim 16, wherein Sasso further educates modified Deane to include wherein the control unit is further configured to:
deliver, in response to registering no draw of breath within the first time window at the first oxygen mask, the first safety oxygen pulses until the first draw of breath is detected; and
deliver, in response to registering no draw of breath within the second time window at the second oxygen mask, the second safety oxygen pulses until the second draw of breath is detected ([i]f an inhalation is not sensed within the duration of a different predetermined period (DL2), micro-controller 8 may…force a pulse of oxygen to the patient…[p]ulses of oxygen may thus be continuously forced to the patient…checks to see if the patient has resumed breathing and if so it discontinues the forced pulses, Sasso col. 8, lines 44-67; see also Sasso col. 12, lines 13-37), in order to provide the predictable results of providing sufficient oxygen upon detection of absence of breathing in the event that the breath detector has failed and/or is not properly registering inhalations for as long as inhalations are not detected, and to provide for resumption of demand breaths if breath detection is reestablished in order to minimize oxygen waste.
Regarding claim 18, Deane in view of Walker, Sasso and Sasaki teaches the emergency oxygen system according to claim 17, wherein Sasso further educates modified Deane to include wherein the predetermined length is longer than each of the period of the first safety oxygen pulses and the period of the second safety oxygen pulses (DL2…a lapse of time equal to several breaths…pulses of oxygen…with only a short delay in between each pulse, Sasso col. 8, lines 53-65; oxygen pulses every “n” seconds, Sasso col. 12, lines 29-31), in order to provide the predictable results of providing sufficient oxygen upon detection of absence of breathing in the event that the breath detector has failed and/or is not properly registering inhalations while still conserving oxygen in the event that the user is not actually breathing by limiting the duration of the safety oxygen pulses to e.g. those sufficient for one breath, and/or to provide for resumption of demand breaths/interruption of safety pulses when breath detection is reestablished in a period shorter than the time window.
Regarding claim 19, Deane in view of Walker, Sasso and Sasaki teaches the emergency oxygen system according to claim 18, wherein modified Deane teaches wherein each of the first demand oxygen pulse and the second demand oxygen pulse comprises a greater oxygen quantity than each of the first safety oxygen pulses and the second safety oxygen pulses, respectively (see discussion in claim 16 above and Walker Fig. 3, where the longer demand pulses comprise greater oxygen quantity/volume).
Regarding claim 23, Deane discloses/suggests an emergency oxygen system for an aircraft passenger (Figs. 1-2; paras [0002] and [0018]), comprising:
a first oxygen port (e.g. passenger port 1) (Fig. 2; para [0018]);
a second oxygen port (e.g. passenger port 2) (Fig. 2; para [0018]);
a controllable oxygen feed (oxygen supply 1) for the first oxygen port and the second oxygen port (Figs. 1-2; para [0018]);
a control unit (controller/CPU 2) for controlling the controllable oxygen feed to the first oxygen port and the second oxygen port (para [0018]);
wherein the control unit is configured to:
register whether a first draw of breath is detected in the first oxygen port (para [0018] in view of para [0004]);
deliver, in response to registering the first draw of breath, a first demand oxygen pulse (bolus) to the first oxygen port (para [0018] in view of para [0004]);
deliver, in response to registering no draw of breath, first safety oxygen pulses (auto-pulses) at intervals to the first oxygen port (adapted auto-pulse…to deliver the correct minute volume of oxygen in the absence of breath detection, para [0027]; where it would have been suggested to/inferred by an artisan before the effective filing date of the claimed invention that multiple pulses, which would necessarily have some interval therebetween, would be fed if breath detection remained absent);
register whether a second draw of breath is detected in the second oxygen port (para [0018] in view of para [0004]);
deliver, in response to registering the second draw of breath, a second demand oxygen pulse (bolus) to the second oxygen port (para [0018] in view of para [0004]);
deliver, in response to registering no draw of breath, second safety oxygen pulses (auto-pulses) at the intervals to the second oxygen port (see para [0027] and discussion above).
Deane is silent regarding a first and second oxygen mask, a first tube coupling the first oxygen mask to the control unit; a second tube coupling the second oxygen mask to the control unit; a third tube coupling the control unit to a regulation valve. However, these were standard components of emergency oxygen systems for aircraft passengers before the effective filing date of the claimed invention, as demonstrated by Walter, which teaches a first and second oxygen mask (any two of masks 30) (Fig. 1), a first tube (the delivery tube 34 ass