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 .
Drawings
The drawings are objected to because Fig. 3 contains improper shading for the features at reference numerals 12, 18, and 28 (see MPEP 608.02(V)(m)) and an unlabeled text box 40 which should be provided with a descriptive text label (e.g. box 40 could have the label --sensor signals--) (see MPEP 608.02(d)(a)). 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 Objections
Claims 3, 5, 16, and 18-19 are objected to because of the following informalities:
Claim 3 recites “IR sensor signals” in lines 3-4, and is suggested to read --infrared (IR) sensor signals-- in order to clarify the acronym.
Claim 5 recites “a CPAP mask” in line 2, and is suggested to read --a continuous positive airway pressure (CPAP) mask-- in order to clarify the acronym.
Claim 16 recites “the threshold number” in line 5, and is suggested to read --the threshold number of unconscious mask removal detections-- in order to more clearly reference how the limitation was originally claimed.
Claim 18 recites “the mask removal detection module” in line 5, and is suggested to read --the unconscious mask removal module-- in order to more clearly reference how the limitation was originally claimed.
Claim 19 recites “the unconscious mask removal detection module” in lines 1-2, and is suggested to read --the unconscious mask removal module-- in order to more clearly reference how the limitation was originally claimed.
Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations use 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 limitations are: “an unconscious mask removal detection module” in claim 1 line 4, “a wake-up alert decision module” in claim 1 line 7, “an adaptive alert module” in claim 1 line 12, “a sleep-onset detection module” in claim 2 line 2, and “a mask removal detection module” in claim 2 lines 2-3.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the Applicant’s specification para. [0031], the modules of “an unconscious mask removal detection module” in claim 1 line 4, “a wake-up alert decision module” in claim 1 line 7, “an adaptive alert module” in claim 1 line 12, “a sleep-onset detection module” in claim 2 line 2, and “a mask removal detection module” in claim 2 lines 2-3 are being interpreted as one or more of an integrated circuit, discrete analogue or digital circuit components, hardware, software, firmware, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the user" in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitation “other than unconscious removal mask-off” in line 6 is confusing, as it is unclear as to what circumstances are being claimed as “other than unconscious” and thus the claim is indefinite. It is suggested to use claim language such as --conscious-- instead in order to avoid such indefiniteness. Furthermore, the limitation “can” in line 17 is confusing, as it is unclear whether the following limitations are required or optional for the claimed invention.
Regarding claim 4, the limitation “outputs” in line 1 is confusing, as this is a method step while the claim is directed towards an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness.
Regarding claim 5, the limitation “outputs” in line 1 is confusing, as this is a method step while the claim is directed towards an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitations “a mask-off status” in line 2 and “a mask-on status” in lines 2-3 are confusing, as it is unclear whether these limitations are meant to be the same as, different from, or a part of “a status of the mask” in claim 2. Furthermore, the limitation “a CPAP mask” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a mask” in claim 1.
Regarding claim 6, the limitation “outputs” in line 2 is confusing, as this is a method step while the claim is directed towards an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness. Moreover, the limitations “the indication” in line 2, "the in-sleep status" in line 4, “the mask-on status” in lines 4-5, “the non-sleep status” in line 5, “the mask-on status” in line 6, “the non-sleep status” in line 8, and “the mask-off status” in lines 8-9 are recited, and there is insufficient antecedent basis for these limitations in the claim. Furthermore, the limitations “the mask-on status” in lines 4-5 and “the mask-off status” in lines 8-9 are confusing, as it is unclear whether these limitations are meant to be the same as, different from, or a part of “a status of the mask” in claim 2.
Claim 7 recites the limitation "the cost-benefit analysis result" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the limitations "the expected benefit" in line 2, “the expected cost” in line 2, “the beginning” in line 4, and “the sleep-onset” in line 4 are recited, and there is insufficient antecedent basis for these limitations in the claim.
Regarding claim 10, the limitation “outputs” in line 1 is confusing, as this is a method step while the claim is directed towards an apparatus, and thus the scope of the claim is unclear. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such indefiniteness.
Regarding claim 11, the phrase "other" in line 2 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 12, the phrase "other" in line 3 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 13, the limitations “a most effective alert setting” in lines 1-2 and “a lesser effective alert setting” in line 2 are confusing, as it is unclear as to what setting these limitations are being compared against, and thus the scope of the claim is indefinite. Moreover, the limitation “to wake up” in line 3 is confusing, as this is a method step while the claim is directed towards an apparatus, and thus the scope of the claim is unclear.
Regarding claim 15, the phrase "other" in line 3 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 17, the limitations “a flow of gas” in line 1, “an airway of a patient respiratory system” in lines 1-2, “unconscious mask removal” in line 2, “a mask” in line 6, “alert settings” in line 12, and “an actuator” in line 12 are confusing, as it is unclear whether or not these limitations are meant to be the same as or different from “a flow of gas”, “an airway of a patient respiratory system”, “an unconscious mask removal”, “a mask”, “alert settings”, and “an actuator” in claim 1, respectively. Furthermore, the limitation “can” in line 14 is confusing, as it is unclear whether the following limitations are required or optional for the claimed invention.
Regarding claim 18, the limitation “an unconscious mask removal” in lines 4-5 is confusing, as it is unclear whether or not this limitation is meant to be the same as or different from “unconscious mask removal” in line 1. Moreover, the limitation “other than unconscious removal mask-off” in line 6 is confusing, as it is unclear as to what circumstances are being claimed as “other than unconscious” and thus the claim is indefinite. It is suggested to use claim language such as --conscious-- instead in order to avoid such indefiniteness. Additionally, the limitation "the output" is recited in line 8, and there is insufficient antecedent basis for this limitation in the claim. Furthermore, the limitation “can” in line 16 is confusing, as it is unclear whether the following limitations are required or optional for the claimed invention.
Regarding claim 19, the limitation “a mask removal detection module” in line 3 is confusing, as it is unclear whether or not this limitation is meant to be the same as, different from, or part of “an unconscious mask removal module” in claim 18.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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 13 is rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 13 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 13, the limitation “to wake up the user” in line 3 is directed towards a human organism. It is suggested to use claim language such as --configured to-- or --adapted for-- in order to avoid such positive recitation of a human organism.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Regarding claim 1, the prior art of record does not disclose nor sufficiently teach the system for unconscious mask removal detection and adaptive alerting comprising all the features as essentially recited in claim 1, in particular with regards to a wake-up alert decision module configured to output a decision whether to not activate or activate a wake-up alert based on (ii) a cost-benefit analysis regarding whether to wake up the user having a positive or negative result based on at least a treatment goal and treatment history data.
Regarding claims 2-17, these claims are dependent upon claim 1 which was indicated to have allowable subject matter, and thus would also be considered to have allowable subject matter.
Regarding claim 18, the prior art of record does not disclose nor sufficiently teach the method for unconscious mask removal detection and adaptive alerting comprising all the features as essentially recited in claim 18, in particular with regards to deciding, via a wake-up alert decision module, whether to not activate or activate a wake-up alert based on (ii) a cost-benefit analysis regarding whether to wake up the user having a positive or negative result based on at least a treatment goal and treatment history data.
Regarding claims 19-20, these claims are dependent upon claim 18 which was indicated to have allowable subject matter, and thus would also be considered to have allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0353190 A1 by Browne is considered to be relevant as it discloses a system to monito the correct position of a mask including whether a mask is on or off a sleeping user, and which can be set to suspend a dislodged mask signal if a selected sleep session duration time has passed.
US 2005/0076906 A1 by Johnson is considered to be relevant as it discloses a notification system that monitors for changes in a CPAP device, including when a mask is removed, and can use a vibration signal to wake a patient.
US 6,629,527 B1 by Estes et al. is considered to be relevant as it discloses a sleep apnea apparatus that can detect a user’s presence or absence and turn on/off accordingly.
US 5,503,146 by Froehlich et al. is considered to be relevant as it discloses a CPAP system which can sense when the mask is removed from a patient and subsequently place the system in a standby mode after a predetermined period of time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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