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) dated 02/09/2024 has been received and considered.
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 1-5 and 9-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1 and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed toward a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1 and 9 are directed toward a process and thus falls into at least one of the four statutory categories of invention deemed to be appropriate subject matter of a patent (step 1). However, the claim is also directed toward an abstract idea (step 2A, prong one), since calculating a plurality of airflow metrics, calculating an efficacy score, and calculating a total score are steps that, under the broadest reasonable interpretation, covers performance of these limitations in the human mind. The method steps themselves can reasonably carried out in the mind and/or by pen and paper by a clinician: a) calculating a plurality of airflow metrics of a first and second therapy based on airflow data, b) calculating an efficacy score based on a comparison of the first and second therapy, and c) calculating a total score of the second therapy based on a combination of the efficacy and comfort scores, which under BRI standard also covers “mathematical concepts” grouping of abstract ideas. See MPEP 2106.04(a)(2)(I). Thus, these limitations fall within “mental processing” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III). Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application (step 2A, prong two). Claims 1 and 9 do not additionally provide an inventive concept as an additional element integrates the abstract ideas into a practical application that impose a meaningful limit on the judicial exception. Subjecting volunteers to a first and second high-frequency chest wall oscillation (HFCWO) treatment in this case amounts to an extra-solution activity (MPEP 2106.05(g)), as this is well-known in the art (see for example Mitchell et al. US 2016/0113839 A1). These additional elements do not apply, rely on, or use the judicial exception in a manner that precludes the mental performance of the abstract ideas since subjecting patients to two treatments of HFCWO is well known in the art.
Even in combination, the additional elements are routine, conventional, and well known in the art (step 2B). See Mitchell et al. ([0009]). The claim as a whole does not amount to more than the judicial exceptions themselves; thus, the claim lacks inventive concept. As written, the claim is merely outlining mental processes and mathematical calculations that may at most be implemented on or otherwise linked to generic computer hardware components that are well-known, routine and conventional for data acquisition and processing.
For these reasons, there is no inventive concept in the claim, thus it is ineligible under 35 U.S.C. 101.
It is suggested to incorporate the abstract ideas of claims 1 and 9 into a practical application, such as that described in specification [0054] to use the total score to adjust a patient’s baseline pressure therapy, or specification [0055] to generate and display a recommended input into the HFCWO device for patient therapy.
Dependent claims 2-5 further limit parent claims 1, but do not add substantially more as none appear to integrate the claims into a practical application, and only further define the airflow metrics and the basis of the comfort level. Similarly, claims 10-18 do not add substantially more to parent claim 8 than additional abstract ideas, being directed toward further defining the airflow metrics and comfort level.
Claims 6-8 do include subject matter that adds substantially more by further defining the method of parent claim 1, since these claims amount to more than extra-solution activity. Claims 19-22 likewise incorporate the abstract ideas of parent claim 9 into a practical application, since each of these claims implements an effect on the device and/or patient.
Allowable Subject Matter
Claims 1 and 9 are objected to as being rejected under 35 U.S.C. 101 above, but would be allowable if rewritten to overcome the rejection as suggested above.
The following is a statement of reasons for the indication of allowable subject matter.
There does not appear to be prior art of record which discloses, alone or in combination, all of the elements of claim 1 or claim 9, but in particular, calculating a total score based on a combination of the efficacy score of each of the plurality of airflow metrics, and a comfort level of the second therapy.
The prior art of record discloses certain components of claim 1 as follows:
Lee (US 2019/0142686 A1) discloses subjecting users to a first and second high-frequency chest wall oscillation treatment (fig. 3, [0054]) which also individualizes therapy based on the efficacy of the treatment and the comfort of the user ([0054]); however, there is no “score” or equivalent metric assigned to each of the comfort and efficacy, nor is the efficacy based from an airflow; rather, the efficacy is determined from detection of lung sounds [0053]).
Birnkrant et al. (US 2021/0008309) allows the user to select treatment based on preference, including comfort and effectiveness ([0134]), but does not use a plurality of airflow metrics to calculate an efficacy score or a total score.
Libbus et al. (US 2005/0288728 A1) discloses a disordered breathing therapy controller which adjusts therapy to improve side effects and enhance efficacy based on patient metrics ([0124], [0241] [0247]), but does not calculate an efficacy score or a comfort level.
Casse et al. (US 2020/0090485 A1) discloses both efficacy metrics ([0148]) and patient compliance [0139] which is related to comfort, but does not disclose calculating a total score from efficacy and comfort.
Sun et al (US 2005/0188991 A1) discloses an airway pressure therapy system which collects information on compliance and efficacy ([0020] [0027])
Francois et al (US 2014/0142652 A1) discloses a breathing treatment system which selects parameters to optimize comfort and efficacy for a particular patient ([0027])
Hansen et al (US 2011/0125068 A1) discloses a HFCC which evaluates a patient’s breath flow and selects therapy frequencies that result in the highest flow [0028]
Lee et al (US 2005/0061320) [0052] efficacy of sleep disordered therapy breathing may be based on an index based on the respiration signal
Bobey et al (US 2018/0049939) A1 percussion therapy vest [0052] an apnea/hypopnea index may be used to determine the effectiveness of the therapy; see also [0057] that the therapy pressure may be adjusted to maintain effectiveness while minimizing the impact on the patient.
(US 2022/0031564 A1) [0048] discloses a system which determines efficacy of the treatment, then a second therapy applied after modification [0049]
Shouldice et al. (US 2024/0091476 A1) discloses a system for estimating a subjective comfort level of a patient of a respiratory therapy system (abstract) by using a comfort score.
Tangen (“Optimization of Secretion Clearance with HFCC Triangle Waveform” RT Magazine, Feb. 2016) discloses varying frequency and pressure combinations to improve efficacy and patient comfort (page 25), but does not disclose an efficacy score or a total score.
Nicolini et al. (“Effectiveness of treatment with high-frequency chest wall oscillation in patients with bronchiectasis” BMC Pulmonary Medicine, 2013) discloses comparing HFCWO versus traditional chest physiotherapy (abstract).
Anderson et al. (“Evaluation of the safety of high-frequency chest wall oscillation (HFCWO) therapy in blunt thoracic trauma patients” J. of Trauma Management & Outcomes, 2008) discloses evaluating a HFCWO device for efficacy and comfort (page 4)
Osman et al. (“Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis” 2010) discloses perceived efficacy and comfort (page 197).
There does not appear to be any motivation in the prior art for combining the above references to teach the claimed elements of claims 1 or 9.
Claims 1 and 9 would be allowed over the prior art, if rewritten to overcome the 101 rejection detailed above using the suggested amendments.
Claims 2-8 and 10-22 would also be allowed as depending from otherwise allowable claims.
Conclusion
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/SARA K TOICH/ Examiner, Art Unit 3785
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
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