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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/09/2025, 08/11/2025. 10/23/2025, 12/03/2025, 03/24/2026, and 05/04/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 is objected to because of the following informalities: the phrase “A non-transitory computer-readable medium having stored a computer program adapted to be executed by a processor of a processing device configured to process physiological information of a subject, the computer program being configured to, when executed, the processing device to:” is repetitive as “executed” is repeated twice and incoherent as to what is being “configured” to be done. 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 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:
“the predictor is configured to output prediction data” in claims 1 and 5. Examiner notes that the instant specification fails to recite structure for the phrase “predictor”. Examiner interprets the predictor to be a processor capable of calculating a probability.
“the reception interface configured to receive waveform data” in claims 1 and 5. Examiner notes that the instant specification fails to recite structure associated with the reception interface. Examiner interprets the reception interface as some structure that receives sensor data from a sensor.
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
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.
Claims 1-5 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.
For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases). See MPEP 2161.01.
Claim 1 and 5 recites the terms “the predictor” and “the reception interface” fail to disclose sufficient structure enough detail for one skilled in the art to have possession of the claimed invention. The claims and specification fail to disclose what the predictor may be, as the function appears to require a processor since the prediction of a probability is a computer implemented function. However, the specification fails to disclose that the predictor is a processor and fails to disclose any structure associated with the predictor. The structure of the “reception interface” is not disclosed as the function of receiving waveform may appear to be a communication module, Bluetooth, or an antenna. However, no structure is disclosed for the reception interface. Therefore, claims 1-5 do not provide sufficient detail for a person skilled in the art to have been in possession of the “predictor” and “reception interface” as claimed.
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 1-5 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 limitation “the predictor” and “reception interface” 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.
If the specification does not provide a disclosure of sufficient corresponding structure, materials, or acts that perform the entire claimed function of a means- (or step-) plus- function limitation in a claim under 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C. 112, "the applicant has in effect failed to particularly point out and distinctly claim the invention" as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA 35 U.S.C. 112]. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc).
The term “predictor” and “reception interface” do not have sufficient structure. It is unknown what structure implements the prediction of a probability and what receives waveform data. Therefore, the applicant has in effect failed to particularly point out and distinctly claim the invention as it is unknown what is implementing the computer implemented function.
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 2-4 are rejected due to their dependency on rejected claim 1.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claims 1 and 5 are directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 6 is directed to a tangible non-transitory computer-readable medium (i.e. a product), and
thus, meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1 and 5-6, the following step is an abstract idea:
“predict, based on the waveform data, a probability that the physiological parameter is erroneously calculated”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. A human can predict whether or not the physiological parameter is erroneously calculated by doing a probability calculation, which is an evaluation done by the human mind.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1 and 5-6, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “reception interface”, “predictor”, and “processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “waveform”, “probability”, “alarm”, “physiological alarm”, “waveform data”, “measured waveform”, “value”, “condition”, “physiological parameter”, “threshold value”, and “notifier/alarm” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “reception interface”, “predictor”, and “processor” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “sensor” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “waveform”, “probability”, “physiological alarm”, “waveform data”, “measured waveform”, “value”, “condition”, “physiological parameter”, “threshold value”, and “notifier/alarm” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1 and 5-6, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, processor and reception interface, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The pulse oximetry sensor are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Baker et al (US 20140309507) teaches the use of pulse oximetry sensors to collect SpO2 or pulse rate signals (Abstract).
Dependent claims 2-4 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to extra-solution activity and generic gathering structure (claims 2-4), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-6 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 4-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker (US 20140309507)(Hereinafter Baker).
Regarding claims 1, and 5-6, Baker teaches A physiological information acquisition device/processing device/non-transitory computer readable medium (Abstract “systems and methods for reducing nuisance alarms using probability and/or accuracy of a measured physiological parameter.” Fig. 9(908 and 914)), comprising:
a reception interface configured to receive waveform data corresponding to a measured waveform of a physiological parameter of a subject from a sensor ([0094] “The oxygen saturation module 912 generates a current oxygen saturation measurement from the data generated by the sensor.”);
a notifier configured to output an alarm indicating an abnormality of at least one of a value and the measured waveform of the physiological parameter (Fig. 9 (910) [0024] “the monitor 14 [notifier] also includes a speaker 22 to provide an audible alarm” [0006] “generating an alarm indicating that a physiological parameter has exceeded a predetermined threshold [abnormality]”);
a processor configured to cause the notifier to output the alarm based on the waveform data (Fig. 9 (908) [0006] “generating an alarm indicating that a physiological parameter has exceeded a predetermined threshold”); and
a predictor configured to predict, based on the waveform data, a probability that the physiological parameter is erroneously calculated (Fig. 9 (918 and 920) Fig. 7(706 and 712) [0069] “this operation 706 calculates a probability distribution of the actual value of the physiological parameter based on the data received. As discussed above, the calculate distribution operation 706 may include calculating an accuracy of the estimated value.” [0072] “the predetermined threshold may be provided in terms of an estimated value threshold and the adjustment operation 710 includes calculating an adjusted estimated value threshold based on the probability distribution,” [0073] “For example, in an embodiment the predetermined threshold may be a lower threshold limit of SpO.sub.2=85% oxygen saturation. Due to an increased amount of noise (e.g., resulting an accuracy of +/-4 as described above) that changes the probability distribution of the estimated SpO.sub.2 values, the predetermined threshold may be lowered to generate an adjusted threshold of SpO.sub.2=81.7%. This results in an adjusted threshold for SpO.sub.2 that maintains the .ltoreq.5% probability of a false alarm at the decreased accuracy.” Examiner interprets “erroneously calculated” as a lower accuracy of the physiological parameter. In the instant case, the probability is adjusted based on the lower accuracy of the physiological parameter that is determined.);
wherein the processor is configured to control an output of the alarm in a case where the probability exceeds a threshold value ([0075] “the generate alarm operation 712 may compare the adjusted threshold to the appropriate parameter to determine if the parameter exceeds the adjusted threshold (i.e., is outside of the acceptable range). If so, the alarm is generated.”).
Regarding claim 2, Baker teaches wherein the notifier is configured to notify an index corresponding to the probability ([0057] “Confidence levels [index] received by the system from a user through such an interface may be stored in memory on the system and also may be displayed on the display GUI as described in greater detail below.”).
Regarding claim 4, Baker teaches wherein the processor is configured to control the alarm so as to provide an additional notification corresponding to a fact that the probability exceeds the threshold value while maintaining an urgency of the alarm ([0026] “the multi-parameter patient monitor 26 may emit a visible [additional notification] or audible alarm via the display 28 or a speaker 30, respectively, if the patient's physiological parameters are found to be outside of the normal range.” [0074] “A generate alarm operation 712 is then performed in which the adjusted threshold is used to determine if an alarm should be generated (i.e., an audio alarm should be sounded, a visual alarm should displayed, an alarm notification should be sent, etc.).” Examiner notes that the urgency of the alarm is maintained because the audio alarm is also ringing while the visible alarm can be seen on the screen.).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 20140309507)(Hereinafter Baker) in view of Gilham et al. (US 20170281276) (Hereinafter Gilham).
Regarding claim 3, Baker teaches the invention of claim 1. Baker teaches wherein the alarm includes a visual alarm and an audible alarm ([0074] “A generate alarm operation 712 is then performed in which the adjusted threshold is used to determine if an alarm should be generated (i.e., an audio alarm should be sounded, a visual alarm should displayed, an alarm notification should be sent, etc.).”).
However, Baker does not teach the processor is configured to control the alarm so as to lower an urgency of at least one of the visual alarm and the audible alarm. Gilham, in the same field of endeavor, teaches sensors for detecting physiological parameters and issuing alarms (Abstract), and further teaches wherein the processor is configured to control the alarm so as to lower an urgency of at least one of the visual alarm and the audible alarm ([0042] “because the simultaneous IBP waveform 201 clearly shows continuing pulse with very regular rhythm and amplitude 210, this high priority alarm is demoted to a low priority alarm indicating “Noisy ECG”.”) to provide a higher accuracy of suppression and promotion of the alarm ([0049]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Baker, with the processor is configured to control the alarm so as to lower an urgency of at least one of the visual alarm and the audible alarm of Gilham, because such a modification would allow to provide a higher accuracy of suppression and promotion of the alarm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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