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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Specification
The abstract of the disclosure is objected to because the term “Fig. 3” at the end of the abstract should be deleted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 26, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on April 26, 2024 are accepted.
Claim Objections
Claims 9 and 11 are objected to because of the following informalities:
In claim 9, lines 4-5: “the desired breathing rate for the breathing cycle of the individual” should be corrected to –the desired breathing rate of each segment of each of the plurality of further breathing cycle of the individual--.
In claim 11, line 3: “the method” should be corrected to –the computer-implemented method--.
Appropriate correction is required.
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.
Claim 11 is rejected under 35 U.S.C. 101 as the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 1 is directed to a computer program product that is a non-statutory subject matter. A program is known and defined in the art as software that is a collection of instructions that performs a specific task when executed by a computer. Therefore, the program is a software that is data per se, which does not fall within one of the four statutory categories.
In the specification, PG Pub US 2024/0416069 A1, [0032] discloses that a computer program product comprising computer program code means which, when executed on a computing device having a control system, cause the control system to perform all of the steps of any herein disclosed method. Hence, the computer program product is merely a program code that is a transitory form. Transitory forms of program elements are not statutory (In re Nuijten, 84 USPQ2d 1495).
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 1-12 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 in lines 8-12 “determining, for a further breathing cycle of the individual, for at least one of the at least two different segments, a target length by processing the recorded length for said segment, the desired breathing rate for the individual, and the sample breathing rate for the individual, wherein the target length for said segment is proportional to the recorded length for said segment” , and in lines 15-23 “wherein, for the further breathing cycle: a ratio between the target length of the inhalation segment and the recorded length of the inhalation segment is greater than a ratio between the target length of said breath holding segment and the recorded length of said breath holding segment; and/or a ratio between the target length of the exhalation segment and the recorded length of the exhalation segment is greater than a ratio between the target length of said breath holding segment and the recorded length of said breath holding segment”. These limitation are computer/processor-implemented functional claim limitations as it is directed to a computer-implemented method steps. Yet the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., how is the target length recited in line 9 determined such that it would fulfill the ratio conditions recited in lines 15-23 such that the ratio associated with an inhalation and exhalation segment is larger than that of a breath holding segment, in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. Note that in the specification, PG Pub US 2024/0416049 A1 discloses in [0015] and [0024] the claim language verbatim. There is no further disclosure to elaborate how the target length is determined to fulfill these conditions.
Further in regard to the computer-implemented step of “determining, for a further breathing cycle of the individual, for at least one of the at least two different segments, a target length by processing the recorded length for said segment, the desired breathing rate for the individual, and the sample breathing rate for the individual”, the specification does not disclose the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed functions, i.e., to derive “the target length of the inhalation segment”, “the recorded length of the inhalation segment”, “the target length of said breath holding segment”, “the recorded length of said breath holding segment”, “the target length of the exhalation segment”, and “the recorded length of the exhalation segment”.
It is not enough to disclose that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). As the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, these claims are rejected for lack of written description. For more information regarding the written description requirement, see MPEP §§ 2161, 2162-2163.07(b).
The dependent claims of the above rejection claim 1 are rejected due to their dependency.
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 1-12 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 pre-AIA the applicant regards as the invention.
Claim 1 recites in lines 15-16: “wherein the at least two different segments comprise an inhalation segment, an exhalation segment and at least one breath holding segment” that renders the scope of the claim indefinite. “At least two different segments” includes two segments, yet the segments as recited in the above identified limitations requires at least three types of segments: “…comprise an inhalation segment, an exhalation segment and at least one breath holding segment”. It hence is unclear how two segments may comprise three segments.
Claim 1 recites in lines 18-23 that a ratio between the target/recorded length of the inhalation/exhalation segment greater than a ratio between the target/recorded length of the breath hold segment. It is unclear whether this ratio condition recited as a wherein clause is a result of the determination of the target length, or it is a requirement when determining the target length. Each of the inhalation segment, the exhalation segment, and the breath holding segment has its own segment length, and the segment length varies by individuals, by the respiratory condition of the individuals, and often times they may vary from breath to breath. Hence it is unclear whether the target length is determined such that these ratio conditions are met, or these ratio conditions are taking into account when determining the target length.
The following terms in lines 18-23 lack proper antecedent basis:
the target length of the inhalation segment
the recorded length of the inhalation segment
the target length of said breath holding segment
the recorded length of said breath holding segment
the target length of the exhalation segment
the recorded length of the exhalation segment
Claim 8 recites “the sum” that lacks proper antecedent basis.
Claim 8 recites “determining a target length for all segments…wherein the sum of all target lengths…” that renders the scope of the claim indefinite. It is unclear if “all segments” has any association with “at least two segments” recited in claim 1. Further, it is unclear whether it is a single target length determined for all of the segments, and it is unclear what “all target lengths” refers to. For examination purpose, it is interpreted such that a target length is determined for each of the at least two segments, which results in target lengths, and the sum of the target lengths refers to the sum of each target length of each of the at least two segments.
Claim 12 depends on claim 1. The following terms that have identical terms recited in claim 1 hence lacks proper antecedent basis:
paced breathing guidance
an individual
an output device
user-perceptible outputs
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 103
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kremer et al., US 2019/0030278 A1, hereinafter Kremer.
Claims 1, 11 and 12. Kremer in FIG.1 teaches a computer-implemented method, a computer program product comprising computer program code means which, when executed on a computing device having a control system, cause the control system to perform all fo the steps of the method, and a system for providing paced breathing guidance to an individual, the system comprising an output device for providing user-perceptible outputs to an individual and a control system (Abstract: systems and methods are provided that provide respiration entrainment cues to a user; and [0051]: FIG.1 illustrates an example system 100…includes a processing unit 110…may be coupled to various other components such as audio output components; and [0052]: the memory 114 may store various program instructions…the system 100 may include a user interface 140) configured to perform the computer-implemented method for controlling an output device to provide paced breathing guidance to an individual ([0005]: systems and method that produce user-discernible cues (such as audio sounds, visible indicators, or haptic cues) having a rhythmic component to which a user is intended to match his or her breathing, by respiration rate and/or architecture), the computer-implemented method comprising:
obtaining a recorded length for each of at least two different segments in a sample breathing cycle of the individual, each recorded length being the length of a respective segment in the sample breathing cycle ([0119]: An optimal respiration architecture may be based on information about a person’s natural inhale/exhale, and potentially hold, ratios…entrainment cues may have portions corresponding to such phases of the respiration cycle) - the inhale, exhale and hole are the different segments of a respiratory cycle;
obtaining a sample breathing rate of the individual; obtaining a desired breathing rate for the individual ([0119]: entrainment cues may have portions corresponding to such phases of the respiration cycle, such that the user can match not only the respiration rate per minute of the entrainment cue but can also match the breath architecture) – the entrainment cue and the architecture comprises a desired breathing rate for the user to follow and match; and
determining, for a further breathing cycle of the individual ([0119]: the system 100 may dynamically adjust ratios based on a user’s response during the entire experience), for at least one of the at least two different segments, a target length by processing the recorded length for said segment, the desired breathing rate for the individual, and the sample breathing rate for the individual ([0119]: An optimal respiration architecture may be based on information about a person’s natural inhale/exhale, and potentially hold, ratios…entrainment cues may have portions corresponding to such phases of the respiration cycle) – each phase of a respiratory cycle has a length that is the target length. To adjust dynamically is to determine the parameters for the further breathing cycle based on the condition of the current or previous cycle, wherein
the target length for said segment is proportional to the recorded length for said segment ([0119]: An optimal respiration architecture may be based on information about a person’s natural inhale/exhale, and potentially hold, ratios…entrainment cues may have portions corresponding to such phases of the respiration cycle) – a ratio is a proportionality; and
generating a control signal for the output device to provide a user-perceptible output for guiding the individual to breathe in accordance with the target length ([0119]: entrainment cues may have portions corresponding to such phases of the respiration cycle, such that the user can match not only the respiration rate per minute of the entrainment cue but can also match the breath architecture. In various examples, the system 100 may measure a user’s breath architecture during operation), wherein
the at least two different segments comprise an inhalation segment, an exhalation segment and at least one breath holding segment ([0119]: An optimal respiration architecture may be based on information about a person’s natural inhale/exhale, and potentially hold, ratios).
In regard to the feature of “a ratio between the target length of the inhalation segment and the recorded length of the inhalation segment is greater than a ratio between the target length of said breath holding segment and the recorded length of said breath holding segment; and/or a ratio between the target length of the exhalation segment and the recorded length of the exhalation segment is greater than a ratio between the target length of said breath holding segment and the recorded length of said breath holding segment” for the further breathing cycle, This feature is considered among various common practices that normally requires only ordinary skill in the art and hence are considered routine expedients. Such an alternate configuration is considered merely changes in size/proportion, which the court has held normally require only ordinary skill in the art and hence is considered routine expedients. It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to arrive such a configuration through routine experimentation with reasonable expectation of success. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.).
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. MPEP 2144.04.IV.A.
Claim 2. Kremer further teaches that
the at least one breath holding segment comprises at least one of a post-inhalation breath holding segment and a post-exhalation breath holding segment ([0119]: An optimal respiration architecture may be based on information about a person’s natural inhale/exhale, and potentially hold, ratios).
A respiration cycle refers to the process of inhaling and exhaling, and a breath holding refers to an act of stopping breathing for a period of time, breath holding would occur either post inhalation or post exhalation. In other words, a post-inhalation breath holding and a post-exhalation breath holding are the only two possible breath holding conditions. Hence it is obvious that the at least one breath holding segment would comprise at least one of a post-inhalation breath holding segment and a post exhalation breathing holding segment.
Claims 3, 5 and 7. Kremer further teaches that
for each breath holding segment, the target length is the same as the recorded length for said segment of the sample breathing cycle (claim 3); the target length is proportional to the recorded length for said segment multiplied by a ratio of the sample breathing rate and the desired breathing rate (claim 5); for the inhalation segment and the exhalation segment, the target lengths are proportional to the recorded length for said segment multiplied by a ratio of the sample breathing rate and the desired breathing rate (claim 7) ([0119]: entrainment cues may have portions corresponding to such phases of the respiration cycle, such that the user can match not only the respiration rate per minute of the entrainment cue but can also match the breath architecture)
In regard to claim 3: to match the breath architecture is to have the target length to be the same as the recorded length.
In regard to claims 5 and 7, respiration rate is matched, the ratio of the sample breathing rate and the desired breathing rate is 1. when the target length and the recorded length are the same, they are proportional. The above condition of “the target length is proportional to the recorded length for said segment multiplied by a ratio of the sample breathing rate and the desired breathing rate” is one times one that remains to be one.
Claim 4. Kremer further teaches that for each breath holding segment,
the difference between the target length and the recorded length is non-zero ([0005]: If the user matches the entrainment cue (e.g., to within a threshold), the systems and methods may slow the rhythmic component to establish a new target respiration rate) – either “within a threshold” or slowing the rhythms component after the matching indicate that there is a non-zero difference.
Allowable Subject Matter
Claims 6, 9 and 10 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.
Claim 8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 limitation recited in claim 6 in regard to the features of “the target length is proportional to a weight that changes responsive to the sampled breathing rate", in combination with the other claimed elements, is not taught or disclosed in the prior arts.
The limitation recited in claim 8 in regard to the features of “the sum of all target lengths, when defined in seconds, is equal to 60 times the reciprocal of the desired breathing rate, when defined in breaths per minute", in combination with the other claimed elements, is not taught or disclosed in the prior arts.
The limitation recited in claim 9 in regard to the features of “the step of determining a target length for each segment comprises processing the recorded length for said segment, the desired breathing rate for each segment of each of the plurality of further breathing cycles of the individual, and the sample breathing rate for the individual ", in combination with the other claimed elements, is not taught or disclosed in the prior arts. Note that this allowable feature reflects the suggested amendment to claim 9 in the claim objection section.
Dependent claim 10 is allowed only by virtue of their respective dependency upon the allowable claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Panteleon et al., US 2022/0248978 A1. This reference discloses applications, treatment-monitoring systems, computing devices and methods configured to aid used monitoring of disordered-breathing and treatment. The methods comprise receiving patient-breathing data, visually rendering the patient-breathing data including the periodic breathing data as a percentage, and display the report to the patient.
Perera et al., US 2021/0330910 A1. This reference discloses systems or apparatus that may be configured with methods for hyperarousal disorder for determining settings that control respiratory therapy for slowing a patients breathing. They may be configured to compute, a parameter set for generating a variable treatment pressure waveform based on target inspiratory/expiratory times. They may be configured to generate feedback to provide information or promote slowing of breathing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408)918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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