Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed on 1/28/2026. Currently claims 24-36 are pending.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 1/28/2026, with respect to the previous objection of claim 24 have been fully considered and are persuasive. The previous objection of claim 24 has been withdrawn.
Applicant’s arguments, see pg. 6, filed 1/28/2026, with respect to the previous rejection of claims 24-36 under 35 USC 112(a) and 35 USC 112(b) for claim 24’s previous limitation of “a wearable device configured to include a flexible sleeve encircling an ankle or foot of the infant” have been fully considered and are persuasive based on the amendments. The previous rejections of claims 24-36 under 35 USC 112(a) and 112(b) have been withdrawn.
Applicant's arguments, see pg. 6, filed 1/28/2025 with respect to the previous rejection of claims 24-36 under 35 USC 112(b) with respect “about” in the limitation “lower than about five percent (5%) less than an established oxygen level of said infant” in claim 24 have been fully considered but they are not persuasive.
Applicant states following with respect to this limitation:
“For purposes of claim 24 of this application only, the term "about" should be interpreted as+/- 1 % so "about 5%" is interpreted as 4-6%.” [see pg. 6 of applicant’s arguments received 1/28/2026].
While “about 5%” being equal to 4-6% percent is a similar interpretation taken in the previous office action (non-final mailed on 7/28/2025… see pg. 6 of that office action), it overlooks that this was arbitrary boundary taken by the examiner absent any clear boundary provided by the specification. In applicant’s arguments, applicant doesn’t provide why one of ordinary skill in light of the specification would interpret 4-6% as being the boundary. For example, a narrower interpretation of “about 5%” meaning 4.5%-5.5% or a broader interpretation of “about 5%” meaning 3-7% or an even broader interpretation of “about 5%” meaning 2-8% would also be reasonable interpretations as well given the lack of clarity as to what exactly “about” means. This is the reason, an interpretation of “about 5%” being equal to 4-6% being taken for examination which was taken to help with patent prosecution, but the claim was still deemed indefinite (i.e. rejected under 35 USC 112(b)) in the previous office action as it is not clear where the boundary for “about” is. Without any explanation such as where the interpretation stated in the arguments for what “about 5%” is supported in applicant’s disclosure or why one of ordinary skill in the art would agree with this interpretation (as applicant clearly states in their arguments that this interpretation is for this application only) the boundaries for the limitation of “about 5%” are indefinite and thus the claim(s) that recite this limitation (including those through dependency) are not clear. Thus, raising an indefiniteness issue under 35 USC 112(b). Therefore, this rejection under 35 USC 112(b) for claims 24-36 has been maintained.
Applicant's arguments, see pg. 6, filed 1/28/2025 with respect to the previous rejection of claims 24-36 under 35 USC 101 have been fully considered but they are not persuasive.
Applicant merely argues that the rejection of claims 24-36 under 35 USC 101 is improper and applicant merely alleges the claims as amended overcome the 101 rejection without addressing how/ why they believe the analysis which established these claims as amended being directed to abstract idea without substantially more is wrong.
As applicant argues:
“The Examiner rejected claims 24-36 under 35 U.S.C. Section 101 as being directed to an abstract idea.
The applicant respectfully suggests that the rejection under Section 101 is improper and that the amended claims have overcome the Section 101 rejection.” [see pg. 6 of applicant’s arguments received 1/28/2026].
In response, these arguments are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. With respect to the previous rejection of claims 24-36 under 35 USC 101, applicant, has not pointed out the supposed errors in the examiner’s actions as to why the 101 rejection is improper. Without any rational provided, these arguments are not persuasive. Therefore, absent any rational as to why the claims as amended overcomes the 101 rejection or any rational as to why claims 24-36 are directed to something more than an abstract idea without significantly more, the previous rejection of claims 24-36 under 35 USC 101 has been maintained. Therefore, while the 35 USC 101 rejection has been updated to account for language changes made in the recent amendment the grounds of rejection of claims 24-36 under 35 USC 101 has substantially been maintained.
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 24-36 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.
The term “about” in the limitation “lower than about five percent (5%) less than an established oxygen level of said infant” in claim 24 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For this examination “about” is interpreted as +/- 1% so “about 5%” is interpreted as 4-6%. Regardless, applicant should clarify what is being claimed here. Claims 25-36 are under 112(b) as well based on dependency to claim 24 for similar reasons as claim 24.
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 24-36 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (specifically a mental process) without significantly more.
The claim(s) 24 recite(s):
“a processor configured with a preset predetermined oxygen level and configured to establish a set oxygen level, where said preset predetermined oxygen level is configured independently of said indication of the infant’ s said oxygen level, where said set oxygen level is configured independently of said indication of the infant’s said oxygen level;
said processor configured with a preset predetermined heart rate and configured to establish a set heart rate, where said preset predetermined heart rate is configured independently of said indication of the infant’s said heart rate, where said set heart rate is configured independently of said indication of the infant’s said heart rate;
said processor configured to determine values for both the infant’s said oxygen level and the infant’s said heart rate;
said processor further configured for comparing the infant’s said determined oxygen level value and the infant’s said determined heart rate value to (1) the predetermined oxygen level and the established set oxygen level and (2) the predetermined heart rate and the established set heart rate, respectively;
wherein each of the predetermined oxygen level and the established set oxygen level has at least one lower oxygen level threshold; and
wherein the respective at least one lower oxygen level threshold of the predetermined oxygen level and the established set oxygen level is lower than about five percent (5%) less than an established oxygen level of said infant;
wherein each of the at least one of the predetermined heart rate and the established set heart rate has an upper heart rate threshold and a lower heart rate threshold;”
This is a mental process because the human mind is fully capable of comparing if a measured value is greater than or less than a specific value. This judicial exception is not integrated into a practical application because the only additional steps consist of data collection, transferring of data and providing an alert. The additional steps of data collection and transferring of data are directed to the mental process of comparing. While, the alert is merely insignificant extra-solution activity (i.e. specifically it is merely outputting the result which is insignificant “post-solution” activity). And, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional consists of a wearable device with a pulse oximeter, a bracelet, and a transmitter, receivers, and an identifier that form an alarm system. As discussed in Wagner et al (US 20220054086) here after known as Wagner [see Figs. 2A-2C and para 7… “Another conventional wearable monitoring device is illustrated in FIGS. 2A-2C. The monitoring device 200 includes a housing 210 having a screen 220 attached to a band B that is configured to be secured around an appendage of a subject. The housing 210 includes a portion 210a with a biometric sensor 212 that is wearably positionable adjacent the skin of a subject. The biometric sensor 212 includes one or more optical emitters 214 and one or more optical detectors 216 (FIG. 2B).” and para 142… “If the emitter is an optical emitter, the emitter may be configured to generate optical wavelengths within a certain band of frequencies, affording analysis such as pulse oximetry (SpO.sub.2) monitoring or skin or blood analyte monitoring, using methods understood by those skilled in the art.”] a wearable device bracelet and optical sensors that measure oxygen saturation (i.e. pulse oximeters) are well known structures within the field of physiological diagnostics. Also as discussed by Jackson et al (US 6047201) here after known as Jackson, the use of physiological sensors including heart rate sensors, respiration parameters (i.e. oxygen saturation), motion sensors, and/or pulse oximeters connected to sound alarm systems (i.e. transmitters, receivers and identifiers) are well-known and convention [see Col. 1 lines 29-41… “A number of systems have been proposed to alert a parent or other caregiver of physiological changes that may be characteristic of the beginning of a SIDS episode in infants. It is believed if parents have warning of respiratory distress, they can intervene before an episode becomes irreversible. For example, alarm systems have been designed to detect if an infant has stopped breathing or if the infant's heart rate has slowed significantly. These apnea/bradycardia alarm systems have been available for home use since the late 1970's. These alarm systems use electrodes attached to the infant's skin. They provide an audible alarm if the infant stops breathing for a predetermined period or if the heart rate drops below a designated level.” and Col. 2 lines 1-18… “One system has been proposed that uses a combination of pulse oximeter, motion detector, and video camera (see Kim, U.S. Pat. No. 5,505,199). This proposes a motion sensor, video camera and pulse oximeter all be placed in the infant's room and connected to a central unit in the monitoring room, usually the parent's room. The Kim '199 patent states claims that the use of a motion detector with a pulse oximeter and with a video monitor is successful in reducing the number of false alarms.”]. Thus, because the additional structures are well known and convention these structures don’t amount to significantly more than the judicial exception. Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 24 is rejected under 101.
Regarding dependent claim 25, claim 25 includes different types of alarms including audible alarms see rejection to claim 24 above which discloses sound alarms (i.e. audible alarm) as being a well-known convention feature. Thus, claim 25 is rejected under 101 for similar reasons as independent claim 24.
Regarding dependent claim 26, claim 26 additionally includes motion detection. As discussed above a motion sensor (i.e. a device for detecting motion) is a well-known convention feature. Thus, claim 26 is rejected under 101 for similar reasons as independent claim 24.
Regarding dependent claims 27-36, these claims only further describe the mental process and do not further define any of the insignificant post solution activity described above or add any additional structures. Thus, claims 27-36 are rejected under 101 for similar reasons as independent claim 24.
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.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792