DETAILED ACTION
This Office Action is responsive to the Amendment filed 16 March 2026. Claims
1-10 and 14-19 are now pending. The Examiner acknowledges the amendments to
claims 1, 2, 6-9 and 14, as well as the cancellation of claims 11-13 and the addition of
claims 17-19.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
2. The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1206.
3. The drawings are objected to because Fig. 12A recites “micro hope” which should apparently read –microphone--.
4. The drawings are objected to because replacement Fig. 12B appears to show more than one bed attachment 1206; more than one bed attachment of which is not supported by the disclosure as originally filed.
5. The drawings are objected to under 37 CFR 1.83(a) because they fail to show “a bed attachment” as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
6. Claims 2, 3 and 10 are objected to because of the following informalities: with respect to claim 2, either claim 1 or claim 2 should clarify if “the frequency” is referencing “20 Hz” in claim 1; “60 Hz” in claim 1; or a frequency of the claimed “non-invasive stimulus” as recited at line 10 of claim 1. With respect to claim 3, either claim 1 or claim 3 should clarify if “the frequency” is referencing “20 Hz” in claim 1; “60 Hz” in claim 1; or a frequency of the claimed “non-invasive stimulus” as recited at line 10 of claim 1.
7. At line 2 of claim 10, “a subject” should apparently read --the subject--. Appropriate correction is required.
Claim Interpretation
8. 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.
9. 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.
10. 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: “stimulus-emitting component” in claim 1, the equivalent structures thereof enumerated at multiple instances throughout the specification at, for example, paragraphs [0283], [0336], [0339], and [0346] of the instant publication.
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 § 112
11. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. Claims 1-10 and 14-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “the device comprising: (a) a bed attachment comprising (i) an audio source; and (ii) a transducer…”. The specification, as originally filed, does not provide support for “a bed attachment”. The figures do not show the structure and the specification does not provide definition of what constitutes such. One of ordinary skill in the art would expect an example of what would constitute “a bed attachment”, or at least a definition of the bed attachment as a bed attachment could read on a variety of articles such as a mattress pad or simply a Velcro strip, for example.
13. 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.
14. Claims 1-10 and 14-19 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.
15. Claim 1 at line 12 recites the limitation “said subject in need thereof”. There is insufficient antecedent basis for this limitation in the claim. A suggested amendment to line 12 is –said subject--.
16. Claim 2 recites “the frequency is from 35 Hz to 45 Hz”. It is unclear based on the recitation, what the intended language is of the claim; in light of the specification, it appears that the frequency is within a range from “35 Hz to 45 Hz” and will be construed as such for purposes of interpretation of the claim.
17. Claim 9 recite the limitation "reducing the duration of nighttime active periods" There is insufficient antecedent basis for this limitation in the claim.
18. Claim 9 at line 2 recites “the duration of active periods”. It is unclear if this limitation lacks antecedent basis or if it refers back to “the duration of nighttime active periods” recited at line 1.
Claim Rejections - 35 USC § 103
19. 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.
20. 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.
21. Claims 1-10 and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (U.S. Pub. No. 2020/0246579) in view of Aharonovitch et al. (U.S. Pub. No. 2020/0139112). Regarding claim 1, Cohen teaches a device for improving a parameter of sleep quality experienced by a subject, the device comprising: (a) a bed attachment (“Support apparatus 16 may be, for example, a chair, a couch, a table, a bed, a pad, or a combination of pads” [0052]); see Figs. 1-3 and [0053]-[0054]) comprising (i) an audio source (CD player; mp3 device; iPod; cell phone) 18 (as shown in Fig. 1; [0052]; [0174]); and (ii) a transducer (Fig. 7) comprising a stimulus-emitting component capable of providing a non-invasive stimulus to said subject ([0055]-[0062], [0069] and Figs. 6-7);
(b) one or more processors operatively coupled to the bed attachment ([0011], [0173]-[0174]), wherein the one or more processors are individually or collectively programmed to execute a set of instructions comprising:
(i) using the transducer to convert an electrical signal from the audio source into a non-invasive stimulus ([0011]; [0056], [0060], [0062], [0129]-[0131]) from about 20 Hz to about 60 Hz [0056];
(ii) instructing said stimulus-emitting component to emit said non-invasive stimulus to said subject in need thereof ([0011], [0142] and [0130]-[0131]);
(iii) receiving an indication of a physiological, cognitive, neural, or physical assessment of said subject from a feedback sensor configured to receive the indication of said physiological, cognitive, neural, or physical assessment of said subject [0184]; and
(iv) instructing said stimulus-emitting component, based on said indication, to adjust a parameter associated with said non-invasive stimulus ([0184] and [0011]),
thereby improving the parameter of sleep quality experienced by the subject ([0142], [0079], [0106]);
and
(d) said feedback sensor [0184]. However, Cohen fails to disclose explicitly a memory device configured to store said set of instructions. Aharonovitch et al. (hereinafter Aharonovitch) teaches an external device for stimulation of a user via various mechanisms such as vibration, in order to improve sleep and other cognitive disorders/conditions (see Abstract), wherein a cognitive assessment is made following stimulation, followed by stimulation parameters being changed based on the assessment, and storing the stimulation parameters if the results of desired brain response is achieved [0030]. The storing step is performed on the memory of an external device such as a cell phone, tablet, or cloud-based device ([0033], [0016] and [0056]-[0060], [0106]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a processing device as taught by Cohen, to store a set of instructions as suggested by Aharonovitch, as Cohen recognizes the need to regulate parameters of the applied vibration/stimulation to achieve a desired response ([0011] and [0184]), and Aharonovitch teaches that a processing device configured to store instructions enables the storing of stimulation parameters for protocol establishment and future stimulation sessions [0106].
Regarding claims 2 and 3, the frequency is from 35 Hz to 45 Hz, or “about 40 hz” ([0056] of Cohen – “…transducer is capable of producing vibrational frequencies from approximately 0.5 Hz to approximately 1,000 Hz, and has a crossover frequency of approximately 14 Hz to 75 Hz. The transducer is also capable of producing sound frequencies from approximately 20 Hz to approximately 8,000 Hz”).
Regarding claim 4, the non-invasive stimulus comprises an acoustic stimulus ([0055] – [0062] of Cohen).
Regarding claim 5, the device of Cohen is capable of reducing a sleep fragmentation/disturbances in the subject ([0142] of Cohen).
Regarding claim 6, the device is capable of reducing a duration of nighttime active periods/disturbances experienced during sleep ([0142] of Cohen).
Regarding claim 7, the device is capable of reducing a number of nighttime active periods/disturbances experienced during sleep ([0142] of Cohen).
Regarding claim 8, the device is capable of increasing a duration of slow wave sleep or a duration of rapid eye movement sleep experienced by the subject (“lucid dreaming” as described by Cohen [0155]).
Regarding claim 9, the device is capable of reducing the duration of nighttime active periods by at least half ([0142] and [0155]) of Cohen).
Regarding claim 10, the device is capable of improving a reduction in snoring of a subject as the device reduces sleep disturbances/fragmentation ([0142] of Cohen).
Regarding claim 14, the device is capable of adjusting the stimulus which results in a reduction in sleep fragmentation in the subject ([0142], [0079], [0106]) of Cohen).
Regarding claim 15, while Cohen teaches the incorporation of sensors for monitoring patient movement for periodically adjusting stimulation [0184], in addition to physiological parameters such as heart rate and blood pressure being indicative of conditions of the body affecting sleep/anxiety [0091]-[0101]), Cohen does not disclose explicitly that the one or more processors are individually or collectively programmed to execute a set of instructions to monitor the heart rate of the subject. Aharonovitch teaches an external device for stimulation of a user via various mechanisms such as vibration, in order to improve sleep and other cognitive disorders/conditions (see Abstract), wherein an assessment is made following stimulation, of the heart rate of the individual, to determine the efficacy of the stimulation [0208].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a processing device as taught by Cohen, to monitor heart rate of a patient as suggested by Aharonovitch, as Cohen recognizes the need to regulate parameters of the applied vibration/stimulation to achieve a desired response ([0011] and [0184]), and Aharonovitch teaches that a processing device configured to monitor and assess physiological parameters such as heart rate enables enhancement of the efficacy of the stimulation protocol/treatment for improving sleep [0209].
Regarding claim 16, the non-invasive stimulus comprises a vibration ([0011]; [0056], [0060], [0062], [0129]-[0131] of Cohen).
Regarding claim 17, at least one of the one or more processors comprises a processor of a mobile device ([0011], [0173]-[0174] of Cohen).
Regarding claim 18, while Cohen teaches that at least one of the one or more processors comprises a processor of an external controller ([0011], [0173]-[0174]), Cohen fails to disclose explicitly that the controller is a cloud server. Aharonovitch teaches that the one or more processors comprises an external device such as a cloud-based storing device for storing stimulation parameters found to be efficacious in treatment of patients ([0016], [0027], and [0133]-[0134]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure at least one of the one or more processors as taught by Cohen, of a cloud server as suggested by Aharonovitch, as Cohen recognizes the use of remote, external devices for controlling and adjusting the parameters of the stimulation ([0011], [0173]-[0174]), and Aharonovitch teaches that data sent to a cloud server enables larger-scale processing of data in order to suggest future treatment protocol/recommendations ([0133]-[0134]).
Regarding claim 19, at least one of the one or more processors comprises a processor of a controller ([0011], [0173]-[0174] of Cohen).
Response to Arguments
22. Applicant’s arguments filed 16 March 2026 with respect to the objection to the Drawings have been fully considered. While the inclusion of a “bed attachment” is acknowledged, the incorporation of such a “bed attachment” in the manner presented is objected to for the reasons noted above.
23. Applicant’s arguments filed 16 March 2026 with respect to the rejection of claims 1-16 under 35 U.S.C. 112(a) have been fully considered and are not persuasive. Applicant contends that paragraph [0070] provides a description of devices by which the non-invasive signal is delivered to the user’s environment, such as a through a bed attachment, and taken with claim 1, the “the instant specification describes substantive structural limitations to establish a structure-function relationship with respect to a bed attachment comprising an audio source, a transducer, and a stimulus emitting component”. However, this argument is not persuasive. While Applicant’s remark, coupled with the specification and the claim language could establish “a structure-function relationship” with respect to a device comprising an audio source, a transducer, and a stimulus emitting component, this would not cover a bed attachment comprising an audio source, a transducer, and a stimulus emitting component as a bed attachment could read on a variety of articles such as a mattress pad or simply a Velcro strip, or a bracket, for example, each of which are very different types of “attachments,” yet the specification is silent as to any type of such structure. Additionally, the figures do not show the structure, aside from a black box indicating its presence, and the specification does not provide definition of what constitutes such. One of ordinary skill in the art would expect an example of what would constitute “a bed attachment”, or at least a definition of the bed attachment. In view of the foregoing, the rejection of claims 1-16 under 35 U.S.C. 112(a) has been maintained.
24. Applicant’s arguments filed 16 March 2026 with respect to the rejection of claims 2, 6-9 and 16 under 35 U.S.C. 112(b) have been fully considered, however new grounds of rejection are presented above in light of the amendments.
25. Applicant’s arguments filed 16 March 2026 with respect to the rejection of claims 1-10 and 16 under 35 U.S.C. 102(a)(1) citing Karkkainen (‘995) have been fully considered and are persuasive, however new grounds of rejection are presented above in light of the amendments.
26. Applicant’s arguments filed 16 March 2026 with respect to the rejection of claims 11-15 under 35 U.S.C. 103 citing Karkkainen (‘995) in view of Weiss (‘202) have been fully considered and are persuasive, however new grounds of rejection are presented above in light of the amendments.
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 CHRISTINE HOPKINS MATTHEWS whose telephone number is (571)272-9058. The examiner can normally be reached Monday - Friday, 7:30 am - 4:00 pm.
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, Charles A Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
Prosecution Insights