DETAILED ACTION
Election/Restrictions
Claims 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/26/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,832,928 (hereinafter, ‘928). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘928 read on instant claims 2-18 as follows:
Claim 2 is disclosed by Claim(s) 1, 3, 4, 5, 9, 16, 17 and 18 of ‘928;
Claim 3 is disclosed by Claim(s) 1 and 2 of ‘928;
Claim 4 is disclosed by Claim(s) 1 and 2 of ‘928;
Claim 5 is disclosed by Claim(s) 1 and 3 of ‘928;
Claim 6 is disclosed by Claim(s) 3 and 4 of ‘928;
Claim 7 is disclosed by Claim(s) 3 and 5 of ‘928;
Claim 8 is disclosed by Claim(s) 3 and 6 of ‘928;
Claim 9 is disclosed by Claim(s) 1 and 7 of ‘928;
Claim 10 is disclosed by Claim(s) 1 and 8 of ‘928;
Claim 11 is disclosed by Claim(s) 1 and 9 of ‘928;
Claim 12 is disclosed by Claim(s) 1 and 10 of ‘928;
Claim 13 is disclosed by Claim(s) 1 and 11 of ‘928;
Claim 14 is disclosed by Claim(s) 1 and 12 of ‘928;
Claim 15 is disclosed by Claim(s) 12 and 13 of ‘928;
Claim 16 is disclosed by Claim(s) 1 and 16 of ‘928;
Claim 17 is disclosed by Claim(s) 16 and 17 of ‘928; and
Claim 18 is disclosed by Claim(s) 16 and 18 of ‘928.
Claim Rejections - 35 USC § 102
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 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) 2-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20090143663 A1 to Chetham.
Regarding Claim 2, Chetham discloses a system for determining a heart failure indicator indicative of a heart failure disease state in a biological subject, the system including inter alia:
a) at least one signal generator (signal generator 11) coupled to first electrodes (electrodes 13, 14) provided in electrical contact with the subject in use ([0338] “… electrodes 13, 14… provided on a subject S, via leads L…”), the at least one signal generator being adapted to generate a drive signal ([0339] “…the signal generator 11… generate[s] one or more alternating signals, such as voltage or current signals, which can be applied to a subject S, via the electrodes 13, 14…”);
b) at least one sensor (sensor 12) coupled to second electrodes (electrodes 15, 16)) ([0338] “…the sensor 12… [is] coupled to respective electrodes… 15, 16…”) provided in electrical contact with the subject in use ([0338] “… electrodes… 15, 16… provided on a subject S, via leads L…”), the at least one sensor being adapted to measure a response signal ([0339] “The sensor 12 then determines the voltage across or current through the subject S using the electrodes 15, 16…”); and
c) at least one processing device (processing system 2) that:
i) at least in part controls the at least one signal generator ([0339] “…he processing system 2 is adapted to generate control signals, which cause the signal generator 11 to generate one or more alternating signals, such as voltage or current signals…”) and receives an indication of a measured response signal from the at least one sensor, allowing at least one impedance measurement to be performed ([0339] “The sensor 12 then determines the voltage across or current through the subject S using the electrodes 15, 16 and transfers appropriate signals to the processing system 2.”);
ii) determines a fluid level indicator using at least one impedance value obtained by performing the at least one impedance measurement ([0012] “…b) for each body segment, and using the measured impedance values, determining an index…”) ([0014] “Typically the index is of a ratio of the extra-cellular to intracellular fluid.”); and
iii) determines a heart failure indicator using the fluid level indicator ([0013] “…c) determining the presence, absence or degree of pulmonary oedema using the determined indices.”) ([0004] “…congestive heart failure is the development of pulmonary oedema…”).
Regarding Claim 3, Chetham discloses the system of claim 2, wherein the fluid level indicator is at least partially indicative of at least one of:
a) intracellular fluid levels in a body segment (intracellular fluid, [0429]);
b) extracellular fluid levels in a body segment (extracellular fluid [0429];
h) a ratio of extracellular to intracellular fluid levels in a body segment (Ri/Re [0442]; or
i) a ratio of intracellular to extracellular fluid levels in a body segment (Ri/Re [0442].
Regarding Claim 4, Chetham discloses the system of claim 3, wherein the body segment includes at least one of:
a) a limb of the subject (limb [0049]);
b) a torso of the subject (toros [0537]) ([0503] “…are the level of the xiphoid process…”);
c) a leg of the subject (leg [0414]); or
d) a left leg of the subject (contra-lateral limbs [0420]).
Regarding Claim 5, Chetham discloses the system of claim 2, wherein the at least one processing device:
a) determines a first fluid level indicator using at least one first impedance value obtained by performing at least one impedance measurement at a first time ([0461] “…the processing system 10 can compare the index ratio IR to previously determined index ratios IRprev measured for the same subject, on the same body segments…”);
b) determines a second fluid level indicator using at least one second impedance value obtained by performing at least one impedance measurement at a second time ([0463] “…the processing system 10 assesses whether the current index ratio IR value is different to the previous index ratio IRprev determined for the same limb.”); and
c) determines the heart failure indicator using the first and second fluid level indicators by at least one of:
i) determining a fluid level change using a difference in the first and second fluid level indicators and determining the heart failure indicator using the fluid level change ([0463] “…the magnitude of the change being used to indicate a degree of change…”);
ii) determining a rate of change of the fluid level change and determining the heart failure indicator using the rate of change ([0444] “…as a plot of the index against time, or comparison of the index to other references, can disclose the onset and rate of advance of oedema.”);
iii) comparing a rate of change to at least one threshold and determining heart failure indicator in accordance with result of the comparison ()
iv) comparing a fluid level change to at least one threshold and determining the heart failure indicator in accordance with results of the comparison ([0457] “… if the index ratio IR falls outside the predetermined range, then this is used by the processing system 10 determine that pulmonary oedema is present…”); or
v) determining a fluid level gradient using the first and second fluid level indicators and the first and second times and determining the heart failure indicator using the fluid level gradient [0444] “…monitoring oedema over time as a plot of the index against time, or comparison of the index to other references, can disclose the onset and rate of advance of oedema.”).
Regarding Claim 6, Chetham discloses the system of claim 5, wherein the at least one threshold is based on at least one of: a) a threshold or variance established for a sample reference population ([0456] “…the range is therefore typically set to take into account the difference in index ratio IR between the thoracic cavity and the limbs in a number of different subjects. This range can therefore be set based on data collected from a number of healthy subjects.”).
Regarding Claim 7, Chetham discloses the system of claim 5, wherein the at least one processing device: a) compares the fluid level change to at least one absolute reference ([0456 “…the index ratio IR can be compared to a predetermined range.”]); b) compares the rate of change to at least one rate of change reference ([0444] “…monitoring oedema over time as a plot of the index against time, or comparison of the index to other references, can disclose the onset and rate of advance of oedema.”); and c) determines the heart failure indicator in accordance with results of the comparisons ([0457] “…if the index ratio IR falls outside the predetermined range, then this is used by the processing system 10 determine that pulmonary oedema…”).
Regarding Claim 8, Chetham discloses the system of claim 5, wherein the at least one processing device: a) determines a baseline using the first fluid level indicator ([0461] “… the previously determined index ratios IRprev are preferably determined prior to the onset of pulmonary oedema…”) ([0471] “The measured index ratio IR can then be used to form the reference value of the index ratio IRprev allowing subsequent measurements to be compared thereto.”); b) determines a plurality of second fluid level indicators by performing multiple impedance measurements at subsequent times ([0461] “…the processing system 10 can compare the index ratio IR to previously determined index ratios IRprev measured for the same subject, on the same body segments.”) ([0463] “…the processing system 10 assesses whether the current index ratio IR value is different to the previous index ratio IRprev determined for the same limb. If there is a change in the value, then the direction in change in value can indicate either increasing or decreasing levels of pulmonary oedema, with the magnitude of the change being used to indicate a degree of change…”); c) determines a plurality of fluid level changes using a difference in the baseline and each of the plurality of second fluid level indicators; and d) determines the heart failure indicator using the plurality of fluid level changes ([0444] “This approach [e.g., paragraph [0043]] has particular application to monitoring oedema over time as a plot of the index against time, or comparison of the index to other references, can disclose the onset and rate of advance of oedema.”).
Regarding Claim 9, Chetham discloses the system of claim 2, wherein the at least one processing device determines at least one of a degree and a severity of heart failure in accordance with the heart failure indicator ([0458] “…a number of value ranges can be defined, with each range corresponding to a different degree of oedema.”).
Regarding Claim 10, Chetham discloses the system of claim 2, wherein the system includes a display, and the at least one processing device: a) generates a representation using at least one of the fluid level indicator and the heart failure indicator; and b) displays the representation on the display ([0069]-[0072]).
Regarding Claim 11, Chetham discloses the system of claim 2, wherein the at least one processing device: a) determines at least one impedance parameter value using at least one of: i) an impedance value obtained by performing impedance measurements at a single frequency ([0028] “a) determining a plurality of measured impedance values for each body segment, each measured impedance value being measured at a corresponding measurement frequency” where a plurality of frequencies contain a single frequency); or ii) a plurality of impedance values obtained by performing impedance measurements at a plurality of frequencies ([0028] “a) determining a plurality of measured impedance values for each body segment, each measured impedance value being measured at a corresponding measurement frequency”); and, b) determines the fluid level indicator using the at least one impedance parameter value ([0442] “…the processing system 10 operates to determine an index I… the index used is given by Ri/Re and is indicative of the ratio of extracellular fluid to intracellular fluid)”.
Regarding Claim 12, Chetham discloses the system of claim 2, wherein the at least one processing device: a) uses the fluid level indicator to identify a plurality of possible disease states ([0458] “… an assessment of the value of the index ratio IR can be used in assessing the degree of pulmonary oedema.”); b) identifies further analysis to be performed in accordance with the identified possible disease states (); and c) performs the further analysis to thereby distinguish between the possible disease states and heart failure ([0458] “…a number of value ranges can be defined, with each range corresponding to a different degree of oedema… the processing system 10 can determine within which range the index ratio IR falls, and uses this to generate an indication of the likely degree of pulmonary oedema.”).
Regarding Claim 13, Chetham discloses the system of claim 2, wherein the at least one processing device: a) determines a signature using at least one of the fluid level indicator and the at least one impedance measurement ([0458] “… an assessment of the value of the index ratio IR can be used in assessing the degree of pulmonary oedema.”); and b) compares the signature to at least one of: i) a reference signature derived from a reference population ([0452] “If it is determined that oedema is present in any of the limbs at step 860, the process moves on to step 865 with the processing system 10…”); or ii) a previous signature for the subject ([0461] “…the processing system 10 can compare the index ratio IR to previously determined index ratios IRprev measured for the same subject, on the same body segments.”); and c) determines the heart failure indicator in accordance with results of the comparison ([0457] “…if the index ratio IR falls outside the predetermined range, then this is used by the processing system 10 determine that pulmonary oedema is present …”).
Regarding Claim 14, Chetham discloses the system of claim 2, wherein the at least one processing device determines the heart failure indicator at least in part using at least one body parameter value measured for one or more other body parameters of the subject ([0460] “The index ratio IR may also depend on a number of factors, such as the subject's age, weight, sex and height, and again a respective range can be selected based on these factors.”).
Regarding Claim 15, Chetham discloses the system of claim 14, wherein the at least one other subject body parameter value is indicative of at least one of: a) a vital signs indicator (see b, c, i); b) a cardiac parameter value (ECG signals [0396]); c) a respiratory parameter value (respiration cycle [0519]-[0020]; i) a weight (weight [0347].
Regarding Claim 16, Chetham discloses the system of claim 2, wherein the system includes a measuring unit including: a) the at least one signal generator coupled to the first electrodes provided in electrical contact with the subject in use ([0338] “… the apparatus includes a measuring device 1 including a processing system 2 coupled to a signal generator 11 and a sensor 12.”); b) the at least one sensor coupled to the second electrodes provided in electrical contact with the subject in use ([0338] “In use the signal generator 11 and the sensor 12 are coupled to respective electrodes 13, 14, 15, 16, provided on a subject S, via leads L…”); and c) a measuring device processor that at least in part controls the at least one signal generator and receives an indication of a measured response signal from the at least one sensor, allowing the at least one impedance measurement to be performed ([0339] “…the processing system 2 is adapted to generate control signals, which cause the signal generator 11 to generate one or more alternating signals, such as voltage or current signals, which can be applied to a subject S, via the electrodes 13, 14. The sensor 12 then determines the voltage across or current through the subject S using the electrodes 15, 16 and transfers appropriate signals to the processing system 2.”).
Regarding Claim 17, Chetham discloses the system of claim 16, wherein the system includes: a) a first housing including first and second electrodes configured to allow the subject to position their hands in contact with the first and second electrodes; and b) a second housing including first and second electrodes configured to allow the subject to position their feet in contact with the first and second electrodes ([0518] “In this instance, or when an entire electrode band is used, it is also possible to provide multiple electrode bands spaced along the length of the thoracic cavity, thereby further enhancing the resolution of the detection process.” where the multiple bands are housings and are capable of being positioned on hands or feet).
Regarding Claim 18, Chetham discloses the system of claim 16, wherein the system includes a processing system in communication with the measuring unit, the processing system including the at least one processing device and being configured to: a) cause impedance measurements to be performed by the measuring unit; b) receive an indication of at least one impedance value from the measuring unit, the at least one impedance value being indicative of a measured impedance; and c) calculate the heart failure indicator ([0341] “The processing system 2 may therefore be a suitably programmed computer system, such as a laptop, desktop, PDA, smart phone or the like.”) ([0342] “…the signal generator 11 and the sensor 12 may be provided in a unit near, or worn by the subject S, whilst the processing system 12 is situated remotely to the subject.”).
Conclusion
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791