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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on May 26, 2026 is acknowledged.
Applicant’s election with traverse of Species 1-5 is acknowledged. The traversal of Species 1-3 is on the grounds that the patient signal types are not independent inventions but merely alternative input sources for the same inventive system and that they are all well-known alternate sensors. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on 03/25/2026 the species are independent and distinct due to their mutually exclusive characteristics. In addition, these species are not obvious variants of each other based on the current record. For these reasons, the Election of Species requirement of Species 1-3 is maintained.
Applicant’s election with traverse of Species 4 is on the grounds that the claimed invention is directed to the diagnostic and control system, not to the therapy apparatus itself as it is only an external element controlled by the inventive system. The arguments were persuasive and the Election of Species requirement of Species 4 is withdrawn.
Applicant’s election with traverse of Species 5 is on the grounds that the classifier types are functionally equivalent and are well-known, standard classifiers that one of ordinary skill in the art could choose from by routine optimization. The arguments were persuasive and the Election of Species requirement of Species 5 is withdrawn.
Applicant’s argument against the source used for the Unity of Invention requirement are acknowledged, however Applicant’s arguments are moot in view of their amendments and an alternative interpretation of the prior art.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is longer than 150 words and is multiple paragraphs.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 7 and 8 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 7 recites the limitation, “the severity signal”, lacks antecedent basis.
Claim 8 recites the limitation, “the severity signal”, lacks antecedent basis.
In re claim 7, the limitation “where it is considered a success if the output control signal leads to a predetermined sufficiently large reduction in the event signal and/or the severity signal” is unclear. Specifically, it is unclear how a “sufficiently large reduction” is being measured. For examination purposes, as best understood, the limitation “sufficiently large reduction” will be interpreted as determining if outputting the control signal causes any reduction in the severity of a patient’s obstruction.
In re claim 8, the limitation “a decision maker will then determine, using a comparison of the first reduction with the second reduction” is unclear. It is unclear what a “decision maker” means or what it is. For examination purposes, as best understood, the limitation “decision maker” will be interpreted as comparing the two reductions and saving the best one for future use.
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.
Claims 1 and 4-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1 and 4-9 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Step 1: Independent claim 1 is directed to a system for detecting respiratory events of a sleeping patient. Thus, they are directed to statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 1 recites the following claim limitations which are directed to (abstract ideas, specifically mental processes) (see MPEP 2106.04(a)(2)):
In re claim 1:
“to recognize when the first patient signal exceeds or falls below a predetermined tolerance range of signal values and to generate a respiratory event signal therefrom which is representative of a respiratory disorder, wherein the predetermined tolerance range of the signal values is representative of sleeping without a respiratory event” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts)
“to recognize therefrom a first obstruction type as a most probable obstruction type from a group of predetermined obstruction types” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts)
“generating therefrom a control signal which can be used to control the therapy apparatus” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts)
These limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, recognizing when a patient signal exceeds or falls below a predetermined tolerance range, recognizing the most probable obstruction type, and generating a signal which can be used to control a therapy apparatus are a matter of observation, evaluation, judgement, and opinion recognized by the courts as mental processes. Additionally, these limitations are drawn to an abstract idea because they are evaluating and then making a decision based on the evaluation.
Step 2A, Prong 2:
Claim 1 recites the following additional elements:
In re claim 1:
“a) a first detector which receives at least one first patient signal being a breathing/snoring sound as an electrical signal via a first signal input” (data gathering)
“is stored in the first detector” (pre-solution activity)
“b) a second detector which receives the first patient signal as the electrical signal and processes it as a classifier so as” (data gathering)
“to output a corresponding obstruction type signal with the first obstruction type” (insignificant extra-solution activity)
“c) a control unit which is adapted to receive the event signal and the obstruction type signal, and to detect the event signal as a positively existing signal and the obstruction type signal with the first obstruction type” (data gathering and insignificant extra-solution activity)
The above limitations do not integrate the exception into a practical application of the exception because the elements are directed to mere data gathering, pre-solution activity, insignificant extra-solution activity, and mere instructions to implement an abstract idea on a generic computer.
The limitations “a first detector which receives…”, “stored in the first detector”, “a second detector which receives…”, and “a control unit which is adapted to receive the event signal” are directed towards pre-solution activity (see MPEP 2106.05(g)) since they’re used to obtain information about the user and store predetermined information (i.e. mere data gathering).
The limitations “to output a corresponding obstruction type” and “to detect the event signal as a positively existing signal and the obstruction type signal with the first obstruction type” is directed to insignificant post-solution activity (see MPEP 2106.05(g)), as it is just outputting the results found from analyzing the data received by the detectors and determining obstruction occurred and identifying the type of obstruction that occurred.
The judicial exception does not integrate the claims as a whole into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The additional elements in the claim amount to no more than mere data gathering, pre-solution activity, and insignificant extra-solution activity. Thus, none of claims 1 and 4-9 amount to significantly more than the abstract idea itself. Accordingly, claims 1 and 4-9 are not patent eligible and are rejected under 35 U.S.C. 101 as being directed to an abstract idea.
In re claim 10, Examiner asserts that claim 10 is not rejected under 35 U.S.C. 101. Specifically, claim 10 recites “the therapy apparatus which is adapted to receive the control signal of the diagnostic and control system and to generate a corresponding stimulus for the patient which is supplied to the patient”, and the recited “generating a corresponding stimulus for the patient which is supplied to the patient” is being interpreted as applying a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP 2106.04(d)).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patangay et al. (US 8,360,983).
In re claim 1, Patangay discloses a diagnostic and control system (col 1, ln 65-67) for continuous detection of respiratory events (col 7, ln 52-54) and their respective causative types of obstruction of the airway of a sleeping patient (col 1, ln 35-41; col 10, 15-19) and for counteracting control of a therapy apparatus (col 2, ln 14-15), comprising:
a) a first detector (fig 1: 105; col 9, ln 60-63) which
receives at least one first patient signal being a breathing/snoring sound (fig 1A: acoustic sensor; col 5, ln 14-16) as an electrical signal via a first signal input (col 2, ln 11-14) and
is designed
to recognize when the first patient signal exceeds or falls below a predetermined tolerance range of signal values (col 10, ln 25-34) and
to generate a respiratory event signal therefrom which is representative of a respiratory disorder (col 10, ln 55-62),
wherein the predetermined tolerance range of the signal values
is representative of sleeping without a respiratory event (col 10, ln 30-34; col 10, ln 44-49; the system determines whether an apnea or hypopnea occurs based on whether the signal is different than normal) and
is stored in the first detector (col 10, ln 25-34);
b) a second detector (fig 1: 115) which
receives the first patient signal as the electrical signal (col 8, ln 9-11) and
processes it as a classifier so as
to recognize therefrom a first obstruction type (fig 6: 604) as a most probable obstruction type from a group of predetermined obstruction types (col 13, ln 9-12) and
to output a corresponding obstruction type signal with the first obstruction type (col 13, ln 9-12);
c) a control unit (col 10, ln 1-6; claim 20: “processor”) which is adapted
to receive the event signal and the obstruction type signal (col 10, ln 1-9), and
to detect
the event signal as a positively existing signal (col 10, ln 25-29) and
the obstruction type signal with the first obstruction type (col 10, ln 8-9),
generating therefrom a control signal which can be used to control the therapy apparatus (fig 10).
In re claim 9, the diagnostic and control system according to Claim 1,
the second detector being adapted to evaluate, for determining the obstruction type signal, the first patient signal within a predetermined time period preceding the respiratory event signal (col 7, ln 49-54)
in order to determine over this preceding time period the obstruction type signal at the time of the respiratory event (col 9, ln 35-39).
In re claim 10, Patangay discloses further comprising
the therapy apparatus (fig 7: 720) which is adapted
to receive the control signal of the diagnostic and control system (col 13, ln 33-38) and
to generate a corresponding stimulus for the patient which is supplied to the patient (col 13, ln 43-46) and which reduces, in case of a first obstruction type of a group of predetermined obstruction types, an obstruction severity of the airway (col 13, ln 48-50).
Claim Rejections - 35 USC § 103
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Patangay et al. (US 8,360,983) in view of Stahmann et al. (US 2005/0039745).
In re claim 4, Patangay discloses, comprising a detector which is supplied with the first patient signal,
- wherein the detector is adapted to evaluate with respect to an amplitude or a time response to detect apnea occurred (col 10, ln 25-27; col 9, ln 35-39),
- wherein the control unit receives the signal that apnea occurred and processes it such that the control signal is a function of receiving the signal that apnea occurred (col 10, ln 1-9; col 13, ln 33-35).
Patangay lacks
a third detector
wherein the third detector is adapted to evaluate with respect to an amplitude or a time response such that it thereby generates a severity signal which is a function of a severity of the respiratory event,
- wherein the control unit receives the severity signal and processes it such that the control signal is a function of the severity signal.
Stahmann teaches a disordered breathing therapy system (abstract) for treating apnea [0004] that uses multiple detectors (fig. 4) and can determine the severity of the type of disordered breathing [0048] and adjusting the therapy based on whether the severity is improving [0081].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Patangay by determining the severity of disordered breathing episodes and adjusting control of the therapy device as taught by Stahmann, as identifying the severity of sleep apnea and controlling the intensity of the therapy would allow less aggressive therapy to be performed when needed which would reduce the risk of waking the patient and avoid unnecessary therapy being performed.
Claim 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Patangay et al. (US 8,360,983) in view of Wolford (US 2010/0191136).
In re claim 5, Patangay discloses
the second detector being adapted to recognize (col 8, ln 23-27), each of
the first obstruction type (col 9, ln 31-33) and
at least one second obstruction type (col 9, ln 31-33)
as the most probable obstruction type from the group of predetermined obstruction types (col 8, ln 51-65), and
to output a corresponding obstruction type signal with the respective first or second obstruction type (col 8, ln 34-43);
the control unit being adapted
to generate the control signal if the first obstruction type is present in the obstruction type signal (col 8, ln 43-50) and
to generate, if the second obstruction type is present in the obstruction type signal, an additional control signal which is provided for controlling a first therapy apparatus (col 8, ln 43-50; Note: depending on the type of apnea distinguished the result can be stored, used to start therapy, or communicated with a third person).
Patangay lacks
to generate, if the second obstruction type is present in the obstruction type signal, an additional control signal which is provided for controlling an additional therapy apparatus
Wolford teaches a system for monitoring a sleeping person to detect apnea (abstract) that uses different control signals for different devices [0033], such as vibration devices [0035] and additionally oscillating devices [0036] or audible alarms to try to wake the patient [0033].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Patangay with including a secondary therapy function or apparatus as taught by Wolford, as if the first therapy function does not work to improve the patients breathing, applying a second type of stimulus or therapy would increase the chances of reducing the patient’s obstruction.
In re claim 6, see above (In re claim 5) and the following limitations (all mapping directed to Patangay):
the control unit being adapted to generate,
if the first obstruction type is present in the obstruction type signal, a control signal of a first variable (col 8, ln 43-50), and
if the second obstruction type is present in the obstruction type signal, to generate a control signal of a second variable (col 8, ln 43-50).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Patangay et al. (US 8,360,983) in view of Morris (US 6,093,158) in view of Stahmann et al. (US 2005/0039745).
In re claim 7, Patangay lacks,
the control unit being adapted so that
an amplitude or intensity of the control signal is generated in dependence on a stored amplification parameter, which is set and stored adaptively by the control unit depending on success or failure after the output of the control signal,
a reduction in the event signal or the severity signal being determined over a time period, where it is considered a success if the output control signal leads to a predetermined sufficiently large reduction in the event signal and/or the severity signal, and
where, if no sufficient reduction in the event signal and/or the severity signal are detected after the control signal is output, the gain parameter is increased in steps.
Morris teaches a system for monitoring undesired behaviors during sleep that can provide a stimulus for reducing the behavior (abstract). The system determines the appropriate stimulus in response to data from the processor which can include vibration amplitude, intensity, duration and more; the data that relates to the success of the stimulus can be stored for future use (col 5, ln 51-67).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Patangay with storing amplitude or intensity of the control signal based on whether that signal was successful or not after it was used as taught by Morris, as storing stimulation settings that were successful would allow for stimulation occurring during sleep apnea to be more individualized and effective for the unique patient.
Stahmann teaches a disordered breathing therapy system (abstract) for treating apnea [0004] that can determine there is a reduction in the severity or frequency of disordered breathing episodes and can control the therapy regimen based on that reduction. The intensity of the therapy can be increased if the original therapy is not effective [0080].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Patangay with determining success by finding that the severity or frequency of disordered reduced based on the therapy provided as taught by Stahmann, as reducing the obstruction caused by sleep apnea would show that the control signal being used to operate the therapy apparatus was working and successful and if it was not successful, the stimulation parameters could be increased.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Patangay et al. (US 8,360,983) in view of Wolford (US 2010/0191136) in view of Stahmann et al. (US 2005/0039745) in view of Morris (US 6,093,158).
In re claim 8, the diagnostic and control system according to Claim 1,
the control unit being designed to alternately activate first the control output (col 13, ln 38-43; the therapy generation circuit can enable or inhibit electrostimulation) and then the second control output, with a reduction of the event signal or the severity signal being determined over time,
the control output being activated first and, using the first and/or the second signal input, a first success being determined with a delay by a reduction of the event signal or severity signal (col 13, ln 48-50); and then
Patangay lacks
where the control unit has, in addition to the control output, a second control output which is intended to be coupled to another therapy apparatus or another therapy function,
the control unit being designed to alternately activate first the control output and then the second control output, with a reduction of the event signal or the severity signal being determined over time
the second control output being activated and a second success being determined with a delay by a reduction of the event signal or severity signal using the first and/or the second signal input;
whereupon a decision maker will then determine, using a comparison of the first reduction with the second reduction,
whether activation of the control output or the second control output has led to greater success,
whereupon the control output whose success was greater will then be enabled for activation and for future respiratory event signals.
Wolford teaches a system for monitoring a sleeping person to detect apnea (abstract) that uses vibration devices to provide stimulation [0035] and can additionally have oscillating devices to provide additional therapy [0036] or audible alarms to try to wake the patient [0033].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Patangay with including a secondary therapy function or apparatus as taught by Wolford, as if the first therapy function does not work to improve the patients breathing, applying a second type of stimulus or therapy would increase the chances of reducing the patient’s obstruction.
Stahmann teaches a disordered breathing therapy system (abstract) for treating apnea [0004] that can use a first therapy (first control output) to terminate the disordered breathing episode and then a second preventative therapy (second control output) to reduce or eliminate further disordered breathing episodes by using the preventative therapy based on the severity, apnea/hypopnea index, threshold of the patient [0072]. The therapy applied can be more or less aggressive based on whether it successfully reduced the disordered breathing [0079].
It would be obvious to one of ordinary skill in the art to modify the system of the proposed combination by using a second control output to further reduce or terminate apnea episodes after the original apnea episode was detected as taught by Stahmann, as activating the second control output to further reduce episodes of disordered breathing would help the patient have less severe disordered breathing episodes which would also show that the therapy was successful.
Given the system of Stahmann discloses using two different therapy regimes that can be adjusted depending on their effectiveness. The Examiner asserts it would have been obvious to one of ordinary skill in the art to try both therapy regimes and determine which was more successful because this would allow the one that produced the most effective results to be stored for future use. As disclosed above, In re claim 7, Morris discloses storing successful stimulation parameters for future uses. It would have been obvious to one of ordinary skill in the art before the instant invention was filed to modify the system of the proposed combination to store the successful parameters as taught by Morris, to allow for more individualized treatment for the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jannott (DE 102019105762) teaches a classification system for detecting types of obstruction in sleep apnea that uses a snoring noise sensor and three different classifiers (abstract).
Hsu et al. (US 7,473,227) teaches a medical device that comprises a stimulation unit, sleep detector unit, an apnea detector unit that are used to detect sleep apnea from a body signal and control a therapy unit to treat the sleep apnea (abstract).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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