Prosecution Insights
Last updated: April 19, 2026
Application No. 18/261,693

SYSTEM AND METHOD FOR SOOTHING INFANTS

Non-Final OA §101§102§112
Filed
Jul 17, 2023
Examiner
COX, THADDEUS B
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
The Regents of the University of California
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
2y 10m
To Grant
95%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allow Rate
859 granted / 1112 resolved
+7.2% vs TC avg
Strong +18% interview lift
Without
With
+18.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
74 currently pending
Career history
1186
Total Applications
across all art units

Statute-Specific Performance

§101
5.8%
-34.2% vs TC avg
§103
32.3%
-7.7% vs TC avg
§102
21.1%
-18.9% vs TC avg
§112
31.2%
-8.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1112 resolved cases

Office Action

§101 §102 §112
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 Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 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: FILLIN "Identify each claim limitation." \d "[ 1 ]" a processing device and a sound output device in claim 1. The processing device is taught to be, for example, a mobile phone, a tablet, or a remote computer/server, while the sound output device may be, for example, a speaker or baby monitor. 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 § 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. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “a wearable device disposed on a person” in line 2, which positively recites the human body. Suggested language would be -- a wearable device configured to be disposed on a person --. 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 appl icant regards as his invention. Claims 6, 7, 17, and 18 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. Claims 6 and 17 each recite the limitation “ wherein the sounds generated by physiological activity of the person include vascular sounds, respiratory sounds, digestion sounds, movement sounds, and miscellaneous sounds .” It is not clear if this is intended to recite that all of these sounds must be included, if only at least one of these sounds must be included, or if these sounds are merely exemplary. Further, the metes and bounds of “ miscellaneous sounds ” are not clear. Claims 7 and 18 are rejected by virtue of their dependence upon claims 6 and 17, respectively. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 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)(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, 2, 6-13, and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hannula et al. (U.S. Pub. No. 2022/0167930 A1; hereinafter known as “Hannula”) . Regarding claim 1, Hannula discloses a system for generating infant-soothing sounds (Abstract; Figs. 2, 3) , the system comprising: a wearable device disposed on a person, the wearable device including a plurality of sensors 16/17/18/19 , each of which is configured to output a sound waveform in response to sounds generated by physiological activity of the person [0053]-[0054]; [0068]-[0069]) ; a processing device 202 coupled to the plurality of sensors and configured to process and store the sound waveforms as sound files ([0091]; [0097]) ; and a sound output device 103/ 105/ 107 coupled to the processing device, the sound output device is configured to output the sound files to mimic in utero sounds ([0025]; [0053]-[0054]; [0047]; [0077]) . Regarding claim 2 , Hannula discloses that the sound output device is configured to detect infant activity and the processing device is configured to indicate a level of infant activity ([0068]; [0074] -[ 0075]; [0081]-[0082]; [0092]) . Regarding claim 6 , Hannula discloses that the sounds generated by physiological activity of the person include vascular sounds, respiratory sounds, digestion sounds, movement sounds, and miscellaneous sounds ([0068] -[ 0069]; [0089]) . Regarding claim 7 , Hannula discloses that the processing device is configured to categorize the sounds generated by physiological activity of the person and to store the sound files in corresponding storage banks ( [0068] -[ 0069]; [0089] ; [0097]) . Regarding claim s 8 and 9 , Hannula discloses that the sound output device includes a microphone 111 and is configured to monitor a level of agitation of an infant based on sounds generated by the infant ([0075]; [0081]; [0099]) , wherein the sound output device is further configured to output at least one of the sound files based on the level of agitation of the infant ([0028]; [0043]; [0099]; [0104]-[0105]) . Regarding claims 10 and 11 , Hannula discloses that the processing device further includes a user input device configured to display a graphical user interface, wherein the graphical user interface is configured to enable selection of at least one of the sound files for output through the sound output device ([0116]) . Regarding claim 12 , Hannula discloses that the processing device is further configured to mix the sound waveforms ([0098]; [0103]) . Regarding claim 1 3 , Hannula discloses a method for generating infant-soothing sounds (Abstract; Figs. 2, 3) , the method comprising: placing a wearable device on a person, the wearable device including a plurality of sensors 16/17/18/19 , generating a sound waveform at each sensor of the plurality of sensors in response to sounds generated by physiological activity of the person [0053]-[0054]; [0068]-[0069] ; [0098] ) ; processing at a processing device 202 the sound waveforms and storing the sound waveforms as sound files ([0091]; [0097]) ; and output ting the sound files to mimic in utero sounds at a sound output device 103/ 105/ 107 coupled to the processing device ([0025]; [0053]-[0054]; [0047]; [0077]) . Regarding claim 17 , Hannula discloses that the sounds generated by physiological activity of the person include vascular sounds, respiratory sounds, digestion sounds, movement sounds, and miscellaneous sounds ([0068] -[ 0069]; [0089]) . Regarding claim 18 , Hannula discloses categoriz ing the sounds generated by physiological activity of the person and stor ing the sound files in corresponding storage banks ([0068] -[ 0069]; [0089]; [0097]) . Regarding claims 19 and 20 , Hannula discloses monitor ing a level of agitation of an infant based on sounds generated by the infant through a microphone 111 disposed in the sound output device ([0075]; [0081]; [0099]) and output ting at least one of the sound files based on the level of agitation of the infant ([0028]; [0043]; [0099]; [0104]-[0105]) . Allowable Subject Matter Claims 3-5 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 101 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claims 14-16 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: the prior art teaches generating infant-soothing sounds by, for example, imitating the noise of blood flow turbulence through the uterine and umbilical arteries (e.g., Karp et al., cited in the IDS filed 25 February 2026; Fornell , U.S. Pub. No. 2020/0384239 A1). Recording heartbeat and respiratory sounds of the mother is also well-known in the prior art. Lu (CN 104800951 A) teaches a baby soothing device that reproduces audio, wherein a data collecting unit includes a microphone and an elastic band with a sensor. However, none of the prior art of record teaches or reasonably suggests such a wearable device that includes a band formed from an elastic material that is configured to induce arterial stenosis to increase blood flow turbulence, in combination with the recited system and method. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT THADDEUS B COX whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5132 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9am-6pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jason M. Sims can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-7540 . 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. /THADDEUS B COX/ Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Jul 17, 2023
Application Filed
Feb 25, 2026
Non-Final Rejection — §101, §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
77%
Grant Probability
95%
With Interview (+18.2%)
2y 10m
Median Time to Grant
Low
PTA Risk
Based on 1112 resolved cases by this examiner. Grant probability derived from career allow rate.

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