DETAILED ACTION
This Office action is based on the reply filed May 11, 2026 for application 19/227,307. Claims 1-19 are currently pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
Terminal Disclaimer
The terminal disclaimer filed on May 11, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 12,350,066, US Patent 12,036,039, US Patent 11,571,166, US Patent 10,638,973, US Patent 9,855,006, US Patent 9,198,615, and US Patent 8,783,264 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments filed May 11, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s argument that “at least a portion of the sleep data” reasonably refers to at least a portion of either or both of the obtained sleep data and/or the further sleep data collectively since the both the “obtained sleep data” and the “further sleep data” which comprises the stored determination of sleep positions are types of sleep data, the examiner disagrees. Although the determination of the sleep positions is based on the “obtained sleep data”, the determination of the sleep positions also comprises the “further sleep data” such that the “further sleep data” does not necessarily encompass the “obtained sleep data”, but rather the determination of sleep positions is both based on the “obtained sleep data” and comprises “further sleep data”. Therefore, it is unclear if the limitation “transferring at least a portion of the sleep data” is referring to only the “obtained sleep data” and not the “further sleep data”, only the “further sleep data” and not the “obtained sleep data”, or either or both of the “obtained sleep data” and/or the “further sleep data” collectively. The rejections of claims 1-8 and 17-19 under 112(b) are maintained.
In response to Applicant’s argument that the limitation “at least one position detector” inherently encompasses “one or more position detectors” such that one having ordinary skill in the art would understand these phrases refer to the same element, and similarly the phrases “a wearable device” and “a device, wearable by the user” are the same, the examiner disagrees. Although colloquially these phrases might be interpreted as synonymous with each other, it is not clear that the intent of the claim language intends for only this interpretation to clearly define the scope of the claimed invention. Further, since the limitation “a wearable device” recited in line 10 of claim 17 is introduced using the article “a” rather than “the”, it is still unclear if claim 17 attempting to introduce a new element separate from the previously recited “a device, wearable by the user” in line 2. Therefore, the rejections of claims 17-19 under 112(b) are maintained.
In response to Applicant’s argument that Mumford does not disclose or suggest a method or system “for monitoring the sleeping position of a user” as required by claims 1, 9, and 17, the examiner disagrees. Although Mumford is concerned with the occurrence of respiratory events and the position sensor is optional, Mumford still discloses that position sensors were known in the art and can be used to detect the position of the user’s head which indicate whether the user is lying on his or her back (¶ 0085). Mumford further teaches that the method includes determining time spent in a body position (¶ 0026 & 0227) such that the method and system disclosed by Mumford inherently monitor the sleeping position of the user.
In response to Applicant’s argument that Mumford does not disclose “based on the sleep data, determining positions of a user over time” as required by claims 1 and 9 or “based on the sleep data, determining sleep positions of the user over time” as required by claim 17, the examiner disagrees. Mumford discloses that for the split-night study, a duration of a first portion of a designated period may be determined by a minimum or maximum time spent in a given body position (¶ 0027), wherein the body position of the user is determined with the use of a body position sensor (¶ 0085). Therefore, in order for the minimum or maximum time spent in a given body position to be determined, sleep data regarding a user’s body position must be provided by the position sensor over time.
In response to Applicant’s argument that Mumford does not disclose “the computer system generating a report using the transferred sleep data” where the report is based on sleep position data as claimed, the examiner disagrees. Mumford discloses generating sleep profile information based on the physiological information provided by the sensors (¶ 0059), wherein the sensors can include a body position sensor (¶ 0085). Although the body position sensor is optional, when included as disclosed by Mumford, the body position sleep data provided by the body position sensor will be used to generate the sleep profile information.
In response to Applicant’s argument that the proposed combination of Mumford and Walker would not render the claims obvious since the system disclosed by Walker is fundamentally different from the claimed invention, the examiner disagrees. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Walker was relied upon to teach generating feedback to influence a user the change to one or more non-target positions when it is determined that the user is in the target position, wherein the combined teachings with Mumford would have reasonably suggested to one having ordinary skill in the art to include generating feedback to influence a user to change positions when treating a sleep disorder of the user. Further, if Applicant is implying that Walker is nonanalogous art because of the differences, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Walker is in the field of treating sleep disorders which is the same as Applicant’s.
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 1-8 and 17-19 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 “transferring at least a portion of the sleep data” in line 8; however, since claim 1 previously recites both “obtained sleep data” in line 4 and “further sleep data” in line 7, it is unclear if “the sleep data” recited in line 8 is referring to only the original “obtained sleep data”, the “further sleep data”, or all of the sleep data collectively. Claims 7 and 8 also recite the limitation “the sleep data”.
Claims 2-8 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 1.
Claim 17 recites the limitation “obtain sleep data comprising positional data from the one or more position detectors” in lines 9-10; however, since claim 17 previously recites the limitation “at least one position detector which generates positional data” in line 3, it is unclear if the “positional data” recited in line 9 is the same as the previously recited positional data from line 3 or additional positional data.
Claim 17 recites the limitation “the one or more position detectors” in lines 9-10; however, there is insufficient antecedent basis for this limitation in the claim since claim 17 instead previously recites “at least one position detector” in line 3.
Claim 17 recites the limitation “a wearable device” in line 10; however, since claim 17 previous introduces “a device, wearable by the user” in line 2, it is unclear if the “wearable device” in line 10 is intended to refer to the same previously recited device or introduce another wearable device.
Claim 17 recites the limitation “transferring at least a portion of the sleep data” in line 16; however, since claim 17 previously recites both “obtained sleep data” in line 11 and “further sleep data” in lines 14-15, it is unclear if “the sleep data” recited in line 16 is referring to only the original “obtained sleep data”, the “further sleep data”, or all of the sleep data collectively.
Claims 18 and 19 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4, 9-12, and 17-19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mumford et al. (US 2007/0208269).
Regarding claims 1 and 9, Mumford discloses a method for monitoring a sleep position of a user, the method comprising:
obtaining sleep data of the user comprising positional data from one or more position detectors (body position sensor 32/318) of a wearable device (mask assembly 12/212/412) being worn by the user over time (Figs. 1 & 4-5; ¶ 0058 & 0085);
storing the obtained sleep/positional data (¶ 0086 & 0090);
based on the sleep/positional data, determining sleep positions of the user over time (¶ 0227);
storing the determination of the sleep positions of the user, wherein the stored determination of the sleep positions of the user comprises further sleep data (provided by other sensors 314, 316) (¶ 0086 & 0090);
transferring at least a portion of the obtained sleep data, the further sleep data, and sleep positions to a computer system (monitoring unit 16 + sleep efficacy module 36) (Fig. 1; ¶ 0055, 0059, & 0086); and
the computer system (16+36) generating a report (sleep profile) using the transferred data (¶ 0059 & 0091-0092).
Regarding claims 2 and 10, Mumford discloses that the report includes an indication of time spent in a target position and one or more non-target positions (¶ 0026, 0227, & 0240).
Regarding claims 3 and 11, Mumford discloses determining one or more indications of obstructive sleep apnea based on time spent in a target position and one or more non-target positions and at least one additional measure (¶ 0218-0221, 0227, & 0240).
Regarding claims 4 and 12, Mumford discloses that the at least one additional measure comprises interruptions in a sleep pattern (arousals) of the user (¶ 0219-0223).
Regarding claim 17, Mumford discloses a system for monitoring a sleeping position of a user, the system comprising:
a device (mask assembly 12/212/412), wearable by the user (Figs. 1 & 4-5), the device comprising:
at least one position detector (body position sensor 32/318) which generates positional data of the user while the user is wearing the device (Figs. 1 & 4-5; ¶ 0058 & 0085);
a memory (memory unit 432) (¶ 0086 & 0090);
a data transfer interface (cable 34) in communication with the memory (432) (¶ 0086); and
at least one processor (remote processing unit 414) communicatively coupled to the at least one position detector (32/318) and the data transfer interface (34) (¶ 0086), the at least one processor (414) configured to:
obtain sleep date comprising the positional data from the at least one position detector (32/318) of the device (12/212/412) being worn by the user over time (¶ 0086);
store the obtained sleep data in the memory (432) (¶ 0086 & 0090);
based on the sleep data, determining sleep positions of the user over time (¶ 0227);
storing the determination of the sleep positions of the user in the memory (342), wherein the stored determination of the sleep positions of the user comprises further sleep data (provided by other sensors 314, 316) (¶ 0086 & 0090); and
transferring at least a portion of the obtained sleep data and the further sleep data to a computer system (monitoring unit 16 + sleep efficacy module 36) via the data interface (34) (Fig. 1; ¶ 0055, 0059, & 0086).
Regarding claim 18, Mumford discloses that the computer system (16+36) is configured to generate a report (sleep profile) using the transferred data (¶ 0059 & 0091-0092).
Regarding claim 19, Mumford discloses that the report includes an indication of time spent in a target position and one or more non-target positions (¶ 0026, 0227, & 0240).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5, 6, 13 and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mumford as applied to claims 1 and 9 above, in view of Walker (US 2008/0264426).
Mumford discloses the method substantially as claimed, as described above, and further discloses based on the positional data, determining whether the user is in a target (supine) position or one or more non-target positions (¶ 0085).
However, Mumford fails to teach that when it is determined that the user is in a target position, generating feedback to influence the user the change to one or more non-target positions.
Walker discloses a method for monitoring a sleeping position of a user comprising obtaining positional data from one or more position detectors (accelerometer) of a wearable device (position monitor) being worn by the user over time, based on the positional data, determining whether the user is in a target (supine) position or one or more non-target (non-supine) positions, and when it is determined that the user is in the target position, generating feedback (stimulus) to influence the user the change to one or more non-target positions (¶ 0002 & 0013-0017).
Therefore, it would have been obvious to one having ordinary skill in the art, at the time of the invention, to modify the method taught by Mumford to include generating feedback to influence the user the change to one or more non-target positions when it is determined that the user is in the target position as taught by Walker for the purpose of training or conditioning the user to sleep in a non-supine position to help reduce obstructive sleep apnea.
Allowable Subject Matter
Claims 7 and 8 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 15 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 7 and 15 are indicated has having allowable subject matter since the prior art fails to teach that on one or more nights the feedback is withheld and the sleep data/position of the user is stored base line data and subsequently on one or more further nights feedback is not withheld in combination with the other claimed limitations.
Claims 8 and 16 are indicated allowable based on their dependence from allowable claims 7 and 15.
Conclusion
THIS ACTION IS MADE FINAL. 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 Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 7/15/2026
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