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 .
Response to Amendment
The Amendment filed February 27, 2026 has been entered. Claims 1, 34, 37-38, 42-43, 47, 49, 55, 57, 59, 61, 63, 65, 67, 70-71, 74 and 77-78 remain pending in the application.
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 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 34, 38, 42-43, 47, 49, 55, 57, 59, 61, 63, 65, 67, 70-71, 74 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Hocking et al. (WO 2019/217778 A1) (“Hocking”) in view of Meger et al. (US 2011/0112442 A1) (“Meger”).
Regarding claims 1, 34 and 77, Hocking discloses A system comprising (Abstract and entire document and [0032]):
one or more processors (FIG. 1 and [0036], “The computing device 100 includes one or more processors 102”);
a user interface (FIG. 1 and [0036], user interface 108);
a sensor (FIG. 1 and [0036], sensor 112); and
a computer readable medium storing instructions that, when executed by the one or more processors, cause the system to perform functions comprising (FIG. 1 and [0036] and [0038]):
generating, via the sensor, a signal representing vibrations originating from a blood vessel of a patient (generating, via a sensor of a computing device, a signal representing vibrations originating from a blood vessel of a subject, para.0047);
generating an intensity spectrum of the signal that indicates intensities of the vibrations with respect to oscillation frequencies of the vibrations (obtaining an intensity spectrum of the one or more first intrinsic oscillatory modes over a range of frequencies. The one or more first intrinsic oscillatory modes of the signal representing the lower frequency vibrations originating from the blood vessel, para.0061);
identifying a first peak of the intensity spectrum that corresponds to a respiratory frequency of the patient and a second peak of the intensity spectrum that corresponds to a heart rate of the patient (Frequencies of interest such as a subject's respiratory rate, a pulse rate, and harmonics or multiples of the pulse rate may take the form of "peaks" [i.e. including first peak and second peak] within the obtained intensity spectrum [peak representing respiratory rate is interpreted as peak corresponding to respiratory frequency]. Such peaks may take the form of local (or global) maxima of signal intensity with respect to signal frequency, para.0061; Peak 16 corresponds to the heart rate of the subject, peak 17 corresponds to the first higher order harmonic (e.g, double the heart rate), and peak 18 corresponds to the second higher order harmonic (e.g, triple the heart rate), and so on, para.0097, Fig.12; the ratio of a peak corresponding to the subject's heart rate and a peak corresponding to a frequency that is double the subject's heart rate can be useful in determining blood volume status, para.0063);
Hocking fails to explicitly disclose performing a comparison of a first intensity of the first peak with a second intensity of the second peak;
generating, via the user interface, output indicative of the comparison; and
commencing, adjusting, or ceasing a treatment for the patient based on the comparison.
However, in the same field of endeavor, Meger teaches performing a comparison of a first intensity of the first peak with a second intensity of the second peak ([0129], “In an embodiment of the present invention, for each of the filtered signals, a power spectrum is calculated and a largest peak is identified. A ratio of the heart rate-related peak to the respiration-related peak is calculated.”);
generating, via the user interface, output indicative of the comparison ([0129], plotted, [0098]); and
commencing, adjusting, or ceasing a treatment for the patient based on the comparison ([0208], “The bed is motorized and is able to provide, for example, the following interventions: change the backrest angle, rotate the patient, and/or provide vibration and percussion treatment. System 10 activates one of these interventions in response to the clinical parameters measured.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Hocking to include performing a comparison of a first intensity of the first peak with a second intensity of the second peak; generating, via the user interface, output indicative of the comparison; commencing, adjusting, or ceasing a treatment for the patient based on the comparison. as taught by Meger to provide feedback and control of efficacy ([0113]).
Regarding claim 38, Hocking as modified discloses The method of claim 34, wherein the blood vessel comprises a peripheral vein (Hocking [0048]).
Regarding claim 42, Hocking as modified discloses The method of claim 34, wherein generating the intensity spectrum comprises performing a Fast Fourier transform (FFT) upon the signal (Hocking [0061]).
Regarding claim 43, Hocking as modified discloses The method of claim 34, wherein identifying the first peak comprises identifying the first peak as being a most intense peak of any peaks within a range of 0.1 Hz to 0.5 Hz by determining that the first peak represents a greatest amount of energy of any peaks within the range of 0.1 Hz to 0.5 Hz (Hocking [0061] discussing the range of frequencies and the peaks within those frequencies).
Regarding claim 47, Hocking as modified discloses The method of claim 34, wherein identifying the second peak comprises identifying the second peak as being a most intense peak of any peaks within a range of 0.5 Hz to 3.5 Hz by determining that the second peak represents a greatest amount of energy of any peaks within the range of 0.5 Hz to 3.5 Hz (Hocking [0061] discussing the range of frequencies and the peaks within those frequencies).
Regarding claim 49, Hocking as modified discloses The method of claim 34, further comprising receiving an input identifying the second peak, wherein identifying the second peak comprises identifying the second peak based on the input (Hocking Frequencies of interest such as a subject's respiratory rate, a pulse rate, and harmonics or multiples of the pulse rate may take the form of "peaks" [i.e. including first peak and second peak] within the obtained intensity spectrum. Such peaks may take the form of local (or global) maxima of signal intensity with respect to signal frequency, para.0061; comparing an intensity corresponding to a frequency of the subject's heart rate to an intensity corresponding to a frequency that is double the subject's heart rate, claim 14; the ratio of a peak corresponding to the subject's heart rate and a peak corresponding to a frequency that is double the subject's heart rate can be useful in determining blood volume status. For example, the computing device 100 can use the obtained intensity spectrum to generate a numerical score that represents the blood volume status or any of the subject metrics discussed above, para.0061).
Regarding claim 55, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, a diffusing capacity of the patient's lung for carbon monoxide (DLCO) (Hocking Page 11 describing various values obtained).
Regarding claim 57, Hocking as modified discloses The method of claim 34, further comprising determining based on the comparison, a diffusing capacity of the patient's lung for carbon monoxide divided by an alveolar volume (DLCO/VA) (Hocking Page 11 describing various values obtained).
Regarding claim 59, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, an inspiratory reserve volume (IRV) for the patient's lung (Hocking Page 11 describing various values obtained).
Regarding claim 61, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, an inspiratory capacity (IC) for the patient's lung (Hocking Page 11 describing various values obtained).
Regarding claim 63, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, a maximum rate of oxygen consumption (VO2 max) (Hocking Page 11 describing various values obtained).
Regarding claim 65, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, a work of breathing for the patient (Hocking Page 11 describing various values obtained).
Regarding claim 67, Hocking as modified discloses The method of claim 34, further comprising determining, based on the comparison, a pleural pressure for the patient's lung (Hocking Page 11 describing various values obtained).
Regarding claim 70, Hocking as modified discloses The method of claim 34, wherein commencing, adjusting, or ceasing the treatment comprises adjusting a dosage, frequency, or duration of an oxygen treatment for the patient (Hocking Page 11 discussing changes to or the effectiveness of treatment).
Regarding claim 71, Hocking as modified discloses The method of claim 34, wherein commencing, adjusting, or ceasing the treatment comprises commencing, adjusting, or ceasing a continuous positive airway pressure (CPAP) treatment for the patient (Hocking Page 11 discussing changes to or the effectiveness of treatment).
Regarding claim 74, Hocking as modified discloses The method of claim 34, wherein generating the signal comprises generating the signal such that the signal represents the vibrations that are generated via retrograde transmission of a negative pressure exerted on the patient's a venous system of the patient by inspiratory pressures (Hocking generating, via a sensor of a computing device, a signal representing vibrations originating from a blood vessel of a subject, para.0047).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Hocking in view of Meger in further view of Amano (US 6432060 B1) (“Amano”).
Regarding claim 37, Hocking as modified discloses The method of claim 34, Hocking further discloses further comprising pressing the sensor to a wrist, an ankle, an ear canal, an eye, or a neck of the patient while generating the signal (the sensor 112 may be secured (e.g, via a Velcro strap) to the subject's skin [i.e. pressing sensor to the skin via a Velcro strap] above or near the blood vessel, para.0048; the sensor 112 takes the form of a wearable wristband that is worn by a human subject, para.0044; the sensor 112 as being incorporated into a wrist band 4 that is worn on a human wrist, para.0045).
Hocking as modified fails to disclose pressing the sensor with a pressure ranging from 10 mmHg to 60 mmHg
However, in the same field of endeavor, Amano teaches pressing the sensor with a pressure ranging from 10 mmHg to 60 mmHg (Column 19 lines 50 -67, “Next, the pressure applied by the artery pressing section 14 located on the radial artery 94 is changed to various values by the control section 18 within the range slightly exceeding the commonly encountered blood pressure values, for example, in the range from 200 to 30 mmHg, whereupon a pressure enabling the pulse wave sensor 46 to detect an optimum waveform pattern is selected.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Hocking as modified to include pressing the sensor with a pressure ranging from 10 mmHg to 60 mmHg as taught by Amano to optimize the waveforms (Col. 19 lines 65-67).
Claim 78 is rejected under 35 U.S.C. 103 as being unpatentable over Hocking in view of Meger in further view of Arai et al. (US 4832038 A) (“Arai”).
Regarding claim 78, Hocking as modified discloses The method of claim 34, Hocking as modified fails to disclose wherein the treatment comprises supplemental oxygen therapy.
However, in the same field of endeavor, Arai teaches wherein the treatment comprises supplemental oxygen therapy (Col. 28, “a patient with moderate to severe pulmonary disease resulting in hypoxemia and/or hypercarbia who requires bronchodialator and/or supplementary oxygen and/or mechanical ventilation (e.g. a patient who exhibits a marked decrease in LFP/RFP ratio secondary to myocardial failure due to a profound imbalance between myocardial ventricular output and oxygen demand), may be treated by adjustments in bronchodialator drugs, diuretics, and/or ventilator adjustments.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Hocking as modified to include wherein the treatment comprises supplemental oxygen therapy as taught by Arai to help efficacy and efficiency (Col. 28).
Response to Arguments
Applicant’s arguments, see Remarks, filed February 27, 2026, with respect to the section 101 rejections have been fully considered and are persuasive. The section 101 rejection has been withdrawn.
Applicant’s arguments with respect to claims 1, 34, 37-38, 42-43, 47, 49, 55, 57, 59, 61, 63, 65, 67, 70-71, 74 and 77-78 have been considered but are moot because the new ground of rejection does not rely solely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed February 27, 2026 have been fully considered but they are not persuasive. With respect to the arguments regarding Claim 37 and Amano, the arguments are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., retrograde vibrations) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim recites pressing the sensor on the wrist at 10-60 mmHg, the cited references teaches the limitation. However, the arguments state that the pressure is too great. The pressure is within the claimed range. Thus, the arguments are not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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