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 .
Claim Objections
Claim 10 is objected to because of the following informalities: “providing intervention stimulus” should be “providing an intervention stimulus”.
Claim 11 is objected to because of the following informalities: “generate snoring score” should be “generate a snoring score”.
Claim 19 is objected to because of the following informalities: “proximate to the subject said sleep-state intervention” should be “proximate to the subject, said sleep-state intervention”.
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 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 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: “alert generator” in claim 13; “receiving unit” in claim 15; and “transmission unit” in claim 16.
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. Page 10 of the provided specification defines the alert generation device as “a wearable device [that] can be worn or attached to the body parts of the sleeping person”. Page 9 of the provided specification defines the transmission unit as “A Bluetooth network. However, any other communication network can be used for the purpose, including a Wired LAN, a Wireless LAN, a WiFi Network, a Zigbee Network, a Z-Wave Network or an Ethernet Network”.
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 § 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 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including generating a snoring score for the received snoring sound. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of generating a snoring score for the received snoring sound sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites transmitting an alert and generating a vibration signal, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generation of the vibration signal does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the generated vibration signal, nor does the method use a particular machine to perform the Abstract Idea. A vibration alert device is conventional within the art of diagnostic devices as evidenced by Gray (US 5357696 A) Col. 9 Lines 50-52 , Alt (US 20030220580 A1) [0020], and Ross (US 20040186390 A1) [0157]. Furthermore, it is established that limiting an abstract idea to one field of use or adding token post solution components did not make the concept patentable. (Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978))
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. The claim recites steps of comparing a snoring score with a threshold value which is another Abstract Idea in the form of a mental process. Besides the Abstract Idea, the claim recites additional steps providing a sleep management system, detecting a snoring sound, and processing the snoring sound. Detecting and processing snoring sound signals is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the providing detecting, and processing steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and generating alerts. Claims 3, 6, 8, and 9 all comprise abstract ideas in the form of mental processes/mathematical concepts. While claims 5 and 7 are drawn to insignificant pre and post solutional activities. The gathering and generating steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
The examiner notes that the additional elements recited in claim 10 do amount to more than the abstract idea as the additional elements provide a prophylaxis and reduce the abstract idea to a practical application that is significantly more than the abstract idea. Specifically, the sleep-state intervention device provides an intervention stimulus that has an intensity proportional to the snoring score, which is significantly more than the abstract idea.
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 3, 5-9, and 11-22 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.
Claim 3 recites the limitation "the presence of snoring". There is insufficient antecedent basis for this limitation in the claim. It is recommended the claim be amended to say “a presence of snoring”.
Claim 11 refers to “the snore detected” in line 4. There is a lack of antecedent basis for this limitation in the claim. It is recommended that the claim be amended to read "the at least one snore detector”.
Claim 14 refers to “the snore detector”. There is a lack of antecedent basis for this limitation in the claim. It is recommended that the claim be amended to read "the at least one snore detector’.
Claim 15 refers to “the at least one snore snoring detector”. There is a lack of antecedent basis for this limitation in the claim. It is recommended that the claim be amended to read "the at least one snore detector”.
Claims 15 refers to “the at least one snore monitoring system”. There is a lack of antecedent basis for this limitation in the claim. It is recommended that the claim be amended to read "the at least one monitoring system". The same issue is present in claim 16.
Claim limitation “receiving unit” in claim 15 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The provided specification does not provide a description of the receiving unit or what structure it is referring to. Figure 2 of the provided drawing merely shows it is part of the monitoring system. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
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(s) 1, 3, and 5-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20050065560 A1 – previously cited) in view of Perez (US 20140276227 A1- previously cited).
In regards to claim 1 Lee teaches a method for managing sleep quality of a subject ([0009]), the method comprising:
providing a sleep management system ([0009]);
detecting a snoring sound; processing the snoring sound ([0012]);
generating a snoring score for the snoring sound ([0039).
generating an alert if a snoring score is above a threshold value, wherein generating the alert comprises: ([0053] teaches snoring index is compared to a threshold and if it is above a threshold CPAP pressure can be increased, CPAP is an alert generation device;)
comparing the snoring score with a threshold value ([0053]) ;
and if the snoring score is above a threshold value then ([0053]);
transmitting an alert signal to an alert generation device ([0053] CPAP).
Lee fails to teach the alert generation device generating a vibration signal. Perez teaches a method wherein an alert generation device generates a vibration signal to indicate the presence of the snoring condition (Perez [0029] wearable device imparts vibrations onto the user). It would have been obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the alert generation device of Lee to include the wearable vibration device of Perez in order to indicate the presence of the snoring condition (Perez [0029]).
In regards to claim 3 Lee teaches the method of claim 1 wherein the step of processing the snoring sound comprises:
generating a snoring sound signal from the snoring sound ([0011]);
transmitting the snoring sound signal to a monitoring system ([0050]);
receiving the snoring sound signal by the monitoring system ([0050]);
analyzing the snoring signal ([0037]);
generating a snoring signal fingerprint ([0037]);
recording the snoring signal fingerprint ([0039]);
and verifying the snoring sound signal ([0044 and 0051]).
In regards to claim 5 modified Lee teaches the method of claim 3 further comprising displaying sleep quality indicators on a display unit (Lee [0039]).
In regards to claim 6 modified Lee teaches the method of claim 5 wherein the sleep quality indicators are selected from a group consisting of: the snoring score, inhalation duration, exhalation duration, breath rate, amplitude of snoring sound, frequency of snoring sound, heart rate, blood pressure, body temperature, pulse rate, brain waves, ECG signal, blood oxygen measure and combinations thereof (Lee [0039]).
In regards to claim 7 modified Lee teaches the method of claim 3 wherein the step of detecting the snoring sound comprises receiving acoustic energy from a direction indicative of the subject (Lee [0009, 0012, 0047]).
In regards to claim 8 modified Lee teaches the method of claim 3. Modified Lee fails to teach a method wherein the step of analyzing the snoring signal comprises filtering background noise from the snoring sound. Perez teaches a method wherein the step of analyzing the snoring signal comprises filtering background noise from the snoring sound (Perez [0027]). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Lee to include a step of filtering background noise from the sound signal like the method of Perez. Doing so would merely be combining prior art elements according to known methods in order to yield the predictable result of filtering out non-related sources of noise.
In regards to claim 9 modified Lee teaches the method of claim 3 wherein the step of generating a snoring signal fingerprint comprises identifying sleep quality indicators selected from a group consisting of: the snoring score, inhalation duration, exhalation duration, breath rate, amplitude of snoring sound, frequency of snoring sound, heart rate, blood pressure, body temperature, pulse rate, brain waves, ECG signal, blood oxygen measure and combinations thereof (Lee [0037]).
In regards to claim 10 modified Lee teaches the method of claim 1 wherein the step of generating an alert if the snoring score is above a threshold value comprises: providing a sleep-state intervention device (Lee [0053] CPAP pressure therapy device); determining a required intervention intensity according to the snoring score ( Lee [0053] CPAP therapy pressure may be adjusted as a function of the snore index); and providing intervention stimulus at the intervention intensity (Lee [0042] and [0053]).
In regards to claim 11 modified Lee teaches a system for managing sleep quality of a subject, the system comprising:
at least one snore detector configured and operable to detect snoring sounds and further operable to generate a snoring sound signal (Lee Fig. 1A Snore Sensor 120);
and at least one monitoring system in communication with the snore detected and operable to receive the snoring sound signals from the detector and further operable to generate snoring score (Lee Fig. 1A Snore detector 140, [0050]).
In regards to claim 12 modified Lee teaches the system of claim 11, further comprising a display configured and operable to display the snoring score (Lee [0039]).
In regards to claim 13 modified Lee teaches the system of claim 11, comprising an alert generator configured to generate an alert if a snoring score is above a threshold value (Lee [0053] The control signal that is created to increase CPAP is an alert. The processor that generates that control signal is an alert generator).
In regards to claim 14 modified Lee teaches the system of claim 11, wherein the snore detector comprises a microphone operable to receive acoustic energy and to convert the acoustic energy into an electrical signal (Lee [0012] and [0036] and [0047] snore sensor is a microphone)
In regards to claim 15 modified Lee teaches the system of claim 11 wherein the monitoring system comprises:
a receiving unit configured to receive a snoring sound signal from the snoring detector (Lee [0047] PIMD device);
and a processor in communication with the receiving unit and operable to analyze the snoring sound signal (Lee [0110-0111]); and a memory unit ([0112]).
In regards to claim 16 modified Lee teaches the system of claim 15 wherein the monitoring system further comprises a transmission unit in communication with an alert generator and operable to send an alert signal thereto (Lee [0011] [0028] wireless transmission in [0036] and [0046-0047]).
In regards to claim 17 modified Lee teaches the system of claim 11, further comprising an alert generator configured to generate an alert if the snoring score is above a threshold value wherein said alert generator comprises a wearable device (Perez [0029]).
In regards to claim 18 modified Lee teaches the system of claim 17, wherein the wearable device is selected from a group consisting of wearable collars, neckbands, wristbands, armbands, wrist-watches, items of jewelry and combinations thereof (Perez [0029]).
In regards to claim 19 modified Lee teaches the system of claim 11, further comprising an alert generator (Lee [0053] CPAP) configured to generate an alert if the snoring score is above a threshold value wherein said alert generator comprises a sleep-state intervention device positioned proximate to the subject said sleep-state intervention device operable to stimulate the subject to transition from a first sleep-state to a second sleep-state (Lee [0053] CPAP).
In regards to claim 20 modified Lee teaches the system of claim 19 wherein the sleep-state intervention device is selected from a group consisting of wireless speakers, vibration producing systems, buzzers, beepers, bells, bleepers, chirpers and combinations thereof (Perez [0029]).
In regards to claim 21 modified Lee teaches the system of claim 11 further comprising a movement detector configured to detect movement of the subject (Lee [0044] accelerometer).
In regards to claim 22 modified Lee teaches the system of claim 21 wherein the movement detector is selected from a group consisting of accelerometers, gyroscopes, video cameras and combinations thereof (Lee [0044] accelerometer).
Response to Arguments
Applicant’s arguments, see remarks, filed 11/21/2025, with respect to the 35 U.S.C. 112(b) rejection of claim 1 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection of claim 1 has been withdrawn.
Applicant's arguments filed 11/21/2025, with respect to the 35 U.S.C. 112(b) rejection of claims 3, and 5-22 have been fully considered but they are not persuasive. Claims 3, 11, 14, and 15 were either not amended, or the amendments that were made still lack antecedent basis.
Applicant’s arguments, see remarks, filed 11/21/2025, with respect to the 35 U.S.C. 101 rejection of claims 10-22 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 10-22 have been withdrawn. Upon further examination the prophylaxis of claim 10 which is based directly on the sleep score and it’s the signal is proportional based off of that score, reduces the abstract idea to a practical application. In regards to claim 11 and its dependents, the claimed apparatus does not recite the abstract idea.
Applicant’s arguments, see remarks, filed 11/21/2025, with respect to the 35 U.S.C. 101 rejection of claims 1-9 have been fully considered, but are not persuasive. Generating a vibration alert is merely conventional post solution activity. It is suggested that claim 1 be amended to mention how the intensity of the vibration signal is being used to awaken the user based on the snoring score as that would be effecting a particular change based on the generated vibration signal tied to the abstract idea.
Applicant’s arguments, see remarks, filed 11/21/2025, with respect to the 35 U.S.C 102 rejection(s) of claim(s) 1-3, 5-7, 9-16, 19 and 21-22 under Lee have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lee in view of Perez.
Applicant's arguments filed 11/21/2025, with respect to the 35 U.S.C 103 rejection(s) of claim(s) 4, 8, 17, 18, and 20 under Lee in view of Perez have been fully considered but they are not persuasive. Applicant contends that the invention of Lee discloses providing undisrupted sleep in paragraph [0042], which would make a vibration based alert contradictory to the goal of the invention. Paragraph [0042] of Lee cited by the applicant fails to mention the goal of Lee being to provide undisrupted sleep. The rest of Lee also contains no mention of the goal of the system to be providing undisrupted sleep. Paragraph [0052] teaches an alarm, and it would be obvious to a person of ordinary skill in the art that an alarm would inherently disturb a patient’s sleep much like the vibration alert of Perez.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY EPPERT/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791