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
Acknowledgment is made of applicant’s claim for priority under 35 U.S.C. § 119(a-d) with reference to Application Number: TR2022/021598 filed on 12/30/2022.
Information Disclosure Statement
The Information Disclosure Statement(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.97, 1.98, and MPEP § 609.
Drawings
The drawing(s) have been reviewed by the examiner and are found to comply with the provisions of 37 CFR 1.81 to 1.85.
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 – 6 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 1, the limitation “[a] system for allowing oronasal mask to enable sleep prone patients to breathe in harmony with the mechanical ventilation device” is unclear. Specifically, it is unclear if the system is purely intended for the oronasal mask, or if rather the oronasal mask is positively claimed and the system involving the oronasal mask allows for sleep prone patients to breathe in harmony. Per p. 4, ll. 4 – 9, the warning system appears to require the mask.
The limitation “[a] system for allowing oronasal mask to enable sleep prone patients to breathe in harmony with the mechanical ventilation device” additionally recites “patients” in the plural. However, the invention is intended per a singular patient or “a patient” as can be seen throughout the specification and figures, rather than a plurality of patients simultaneously. Examiner recommends replacing the phrase with “a sleep prone patient”. The examiner notes that “patients” plural is recited throughout the claims, and applicant is directed to amend the claims to instead recite “a” or “the patient” throughout the claims as appropriate. Examiner will hereby interpret “patients” as referring to the universal patient rather than a plurality of patients throughout the claims.
The limitation “[a] system for allowing oronasal mask to enable sleep prone patients to breathe in harmony with the mechanical ventilation device” additionally lends insufficient antecedent basis for the phrase “the mechanical ventilation device” in the claim.
The limitation “continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) during noninvasive mechanical ventilation (NIMV) treatment with sleep state that occurs with decline in levels of consciousness” is grammatically improper to the point of lacking clarity. Examiner notes that the phrase may instead recite “the patient receiving continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) during noninvasive mechanical ventilation (NIMV) treatment with [[a]] sleep state that occurs with declining in levels of consciousness” (emphasis added), though is ultimately unclear as to the scope of the phrase.
The limitation “during the treatment (approximately 2 hours) instead of a person being with the patient and giving inhale-exhale commands” is grammatically improper to the point of lacking clarity. The limitation recites what the system is intended to replace and is directed to a comparison scenario rather than the system itself. As such, the limitation is unnecessary for appropriate claim construction, and examiner recommends its deletion. In the event applicant wishes to amend the limitation, examiner notes that it is unclear whether the parenthetical phrase “(approximately 2 hours)” positively requires the 2 hour treatment duration.
The limitation “for providing the patients inhalation and exhalation process in an adjustable time period stimulated by sound and vibration,” is grammatically improper to the point of lacking clarity. Examiner notes that the phrase may instead recite “the system providing the patient with adjustable sound and vibration commands for inhalation and exhalation”, though is ultimately unclear as to the scope of the phrase.
The phrase “a commutator”, as first introduced in claim 1, is unclear. A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. See MPEP 2173.03. Based on the specification and drawings, see p. 4, ll. 10 – 11, it appears that the commutator is nothing more than a practitioner interface or display. The examiner will hereby interpret the claims as such.
Regarding claim 2, the claim recites the limitation "the healthcare personnel" and “the vibrating vest”. There is insufficient antecedent basis for these limitations in the claim.
Regarding claims 5 and 6, the claim recites “the voiced warning system” and “the warning”. There is insufficient antecedent basis for these limitations in the claim. Examiner to interpret to the phrase as the system as a whole, rather than the voiced warning module per se. Claim 5 additionally lacks antecedent basis to “the vibration vest”.
Claim Objections
Claim 1 is objected to because of the following informalities: “sleep state” in line 4 should be amended to recite “a sleep state”. 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.
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: “a voiced warning module” and “a communication module” in claim 1.
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 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) 1 - 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hillsman (US 6273088) in view of Russek (US 5395301).
1. Hillsman discloses a system for allowing oronasal mask (see Fig. 6, mask 21) to enable sleep prone patients to breathe in harmony with the mechanical ventilation device (c. 14: 10 – 29), in patients with hypercapnic respiratory failure (the system is fully capable of use with sleep prone patients with hypercapnia), continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) during noninvasive mechanical ventilation (NIMV) treatment (see c. 13: 54 – 59) with sleep state that occurs with decline in levels of consciousness (the system is fully capable of use with sleep prone patients), during the treatment (approximately 2 hours) instead of a person being with the patient and giving inhale-exhale commands (the ventilator provides a treatment per c. 13: 56 – 59, and is fully capable of being used in place of a caregiver giving inhale-exhale commands per c. 14: 26 – 29), for providing the patients inhalation and exhalation process in an adjustable time period (see c. 14: 13 – 23, Fig. 6, as well as c. 13: 12 – 26, Fig. 5b, giving the general teaching of adjusting the time period) stimulated by sound and visual alert (see c. 14: 26 – 29, Fig. 6, as well as general teaching in c. 13: 4 – 6), the system comprising: a commutator (see general teaching, c. 4: 52 – 53, c. 10: 6 - 12, c. 12: 56 – 59, the physician may attempt different settings for the breathing interface/display), a motion sensor that detects chest movement (c. 13: 66 – c. 14: 2, c. 11: 28 – 35), a microcontroller (computer 5, c. 14: 30 – 38), a voiced warning module (see general teaching in c. 13: 4 – 6), and a communication module (visual display communicating instant and historical breathing results as per c. 14: 26 – 29, Fig. 6, see also general teaching c. 12: 38 – 39 and c. 13: 8 – 11).
However, Hillsman does not disclose providing the patients inhalation and exhalation process in an adjustable time period stimulated by vibration, wherein the system incorporates a a vibration motor. Nonetheless, Russek discloses providing the patients inhalation and exhalation process in an adjustable time period stimulated by vibration (see vibration device, Fig. 1, Fig. 2b, c. 4: 41 – 55, where the vibration is provided in synchronization with the ventilation breathing pattern; examiner notes that the device is considered to vibrate back and forth within the device, see provided definition to vibration https://en.wikipedia.org/wiki/Vibration; alternative vibrators are disclosed in c. 5: 28 – 44; the time is adjustable per c. 7: 6 – 15), wherein the system incorporates a vibration motor (motor 46 driving back and forth vibration, see c. 4: 62 – 63; the general teaching of a motor also applies to the vibrating beeper embodiment). 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 system of Hillsman to incorporate an adjustable vibrator as taught in Russek for the benefit of encouraging the patient to breath in accordance with a desired breathing pattern such as the ventilator breathing pattern, see claim 1, c. 2: 13 – 23.
2. Hillsman in view of Russek discloses the system according to claim 1, wherein when the patient is in apnea the process can be managed automatically by the healthcare personnel by warning the patient with the voiced system and the vibrating (see Hillsman, c. 13: 4 - 6, Russek, c. 7: 13). Hillsman as modified by Russek set forth in claim 1 does not incorporate the vest. Nonetheless, Russek teaches that the vibrator is incorporated into a vest, see Fig. 2b, c. 4: 28 – 29, c. 5: 43 – 44. 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 system of Hillsman so that the vibrator of Russek is incorporated into a vest as taught in Russek for the benefit of easy portability of the device.
3. Hillsman discloses the system according to claim 2, wherein the system can warn the patient by voice about breathing with the voiced warning system (c. 13: 4 – 6) depending on the time instruction set by the health worker (c. 13: 12 – 30).
4. Hillsman discloses the system according to claim 1, wherein the system can measure the patient's chest movement through the sensor and send it to the microcontroller (c. 11: 19 – 35).
5. Hillsman as modified by Russek discloses the system according to claim 1, wherein the system follows the compliance of the patient's chest movement measurement results with the voiced warning system, and in case of incompatibility, administers the alarm (see c. 13: 4 – 6, the voiced warning system follows compliance and then is activated when non-compliant). However, Hillsman does not disclose that the voiced alarm upon incompatibility incorporates vibration such that the vibration is provided by the vibration motor to the patient with the vibration vest. Nonetheless, Hillsman teaches an alarm wherein vibration is provided by the vibration motor to the patient with the vibration vest (c. 5: 28 – 44; note also discussion in claim 1 above). 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 incompatibility alarm of Hillsman to incorporate the vest vibrator of Russek for the benefit of further notifying the patient/caregiver upon incompatible breathing, e.g. in the event of deaf patient. Upon providing the modification as disclosed, Hillsman in view of Russek discloses Hillsman does not disclose that the voiced alarm upon incompatibility incorporates vibration such that the vibration is provided by the vibration motor to the patient with the vibration vest.
However, Hillsman in view of Russek does not disclose continuing the warning until the compliance of the chest movement measurement results with the voiced warning is ensured. Nonetheless, Hillsman continuously tracks compliance of the chest movement measurement results throughout the breath, including tracking compliance once the chest measurement results are non-compliant, and until the desired range are then ensured, see Figs. 4a – 5b, lower safety threshold 14. The visual indication also serves as a continuous warning of incompatibility until compliance is ensured, because of the visual safety threshold. 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 sound/vibration alarm of Hillsman in view of Russek to work in conjunction with the continuous incompatibility monitoring and visual alarm of unsafe thresholds as further taught in Hillsman for the benefit of indicating and encouraging the user to regain the safety threshold. Upon providing the modification as provided, Hillsman in view of Russek discloses continuing the vibration warning until the compliance of the chest movement measurement results with the voiced warning is ensured.
6. Hillsman discloses the system according to claim 1, wherein the system can instantly notify and warn the health worker about the compliance and/or incompatibility of the chest movement measurement results with the voiced warning system (see c. 13: 4 – 6) depending on the time instruction set by the health worker with the communication module (c. 4: 52 – 57, c. 13: 20 – 21).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2006106328 – vent synced alarm
US 20120003620 – vent synced alarm
US 9974923 – vent synced alarm
US 20090114216 – chest monitor vest
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
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