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 Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5-18 have been considered but are moot because the new ground of rejection does not rely on the previous combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In view of the amendments made to the claims, an updated search was conducted resulting in the modified 103 Rejection set forth below.
In view of the amendments, the 103 Rejections with respect to claim 19 and 20 are withdrawn.
In view of the amendments, the 112(a) Rejection with respect to claim 19 is withdrawn.
In view of the amendments, the 112(b) Rejection with respect to claim 19 is withdrawn. However, a modified 112(b) Rejection is set forth below (with suggestions) with respect to Independent claims 1, 19, and the corresponding dependent claims.
Claim Rejections - 35 USC § 112
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 1-3, 5-19 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 1 includes the “blood pressure device”. However, claim 1 does not specify how the blood pressure device is incorporated relative to the wearable ultrasound device. It is not clear if the blood pressure device is part of the fastener (as set forth in claim 20 where the blood pressure device is located on the first section of the fastener) or is the blood pressure device is a separate device from the fastener or cuff or strap.
According to the specification, “the wearable ultrasound device 301 can include a strap (or cuff) having sufficient width to include multiple sections. FIG. 4 illustrates some embodiments of a wearable ultrasound device with a strap, or cuff. Referring to FIG. 4, wearable ultrasound device 401 is on a patient's arm 410 and includes a cuff section 420” [0031].
Therefore, it is suggested claim 1 provide further clarification with respect to the location of the blood pressure device relative to the strap or cuff or fastener (as per the specification).
The dependent claims 2, 3, and 5-18 do not provide clarification and therefore stand rejected under 112(b).
Claim 19 includes the elements of the ultrasound device as worn by the operator relative to the patient’s arm to transmit ultrasound signals and receive the reflected ultrasound from the patient anatomy while the operator hand grips the patient and a processor generates a visual representation describing the anatomy. However, it is not clear from the claim language, the type of patient data being considered. Independent claims 1 and 20 explicitly recite measuring or monitoring or controlling blood pressure based on the patient data but claim 19 appears to only transmit ultrasound signals and receive reflected ultrasound from the patient and seems to lack clarity with respect to the “patient data” or “visual representation” that is being processed and what the processed data is being used for.
According to specification, “the wearable ultrasound device 101 can include a display device 103 that can display any suitable data, such as an ultrasound image, guidance on how to move the interventional instrument, an indication of an insertion point for the interventional instrument 102, an indication that the instrument 102 and wearable ultrasound device 101 are properly positioned for the procedure (e.g., a “proceed with the procedure” icon), patient data (e.g., biometric data other than ultrasound data), etc.” [0027].
It is suggested claim 19 provide further clarity with respect to the processed data that is being generated and what is used for in terms of “guidance on how to move the interventional instrument, an indication of an insertion point for the interventional instrument 102, an indication that the instrument 102 and wearable ultrasound device 101 are properly positioned for the procedure” (as set forth in the specification).
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) 1-3, 5, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (2023/0099288) in view of Burton (2021/0169417).
With respect to claim 1, Wang et al. teach of a wearable ultrasound device such as a smartwatch 700 (fig. 7) comprising an array of ultrasound transducers 730 and array 732 configured to transmit ultrasound signals and receive reflected ultrasound based on the ultrasound signals [0050] or array 732 configured to transmit waves towards and receive waves from the exterior of the band 714 or fastener coupled to the array of transducers 730, 732 and configured to secure the wearable ultrasound device or smartwatch proximate to a procedure site where the band 714 is wrapped around the wrist of the user [0050, fig. 7]. Wang et al. teach of monitoring the blood pressure through this device 700 [0052] with the processing of the patient data such as monitoring dimensions of one or more blood vessels [0052] or detect physiological signals including heart-rate variability along with blood pressure and dimensions of the blood vessels [0062]. Wang et al. also teach of processing velocity of blood flow to provide indications of blood pressure association with the blood vessel or the dimensions of one or more blood vessels in a region can be imaged [0067, 0068]. Wang et al. teach of a display device implemented to display a visual representation of the patient data or where the device 700 can be a smartwatch device including a touch and/or display circuitry where the transducer array 732 is on the fastener or band 714 to face a patient body part and the display device is on the fastener above the array of transducers (fig. 7, as shown below with the display on top and the transducer on the fastener).
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With respect to claim 1, Wang et al. teach of blood pressure monitoring but do not explicitly teach of controlling inflation of the blood pressure device. In a similar field of endeavor Burton teaches a mobile wearable monitoring system that may integrated with a smartwatch [0418, 0720]. Burton teaches of the use of doppler blood flow sensor capable of monitoring vascular blood flow and measure blood pressure [1512, 1513] with the incorporation of a inflatable wrist sensor device that can be part of a watch band or watch buckle capable of generating pressure in order to appropriately use biofeedback to precisely determine pressure by ensuring vessel is flattened but not occluded based on monitoring pulse and pressure variations at the point where the vessel is flattened but not occluded to safely apply pressure against the artery [1521, 1782, 1795]. Burton therefore teaches of incorporating one or more pressure-sensitive measurement sensors to be applied in a manner where a spring-loaded mechanical probe or other inflatable part applies a suitable pressure to allow and measure pulsations to enable detection of vessel movement [1795, 1804-1806]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Burton to modify Wang et al. to provide feedback to ensure obtaining optimal pressure measurement.
With respect to claim 2, Wang et al. in view of Burton teach of the smartwatch 1000 being proximate to the procedure site of the patient body part where the transducer arrays 1030A-D can be stimulated to produce one or more ultrasonic waves from the surface of the watch band that reflect off an object 1052 such as the hand near the device 1000 and can propagate towards the plurality of transducer arrays 1030 [0061, fig. 10]. Wang et al. further teach of using the ultrasonic waves near the procedure site to detect changes in the position of the hand [0061]. Under broadest reasonable interpretation, the arrays may be on an operator that is proximate to the patient’s hand for ultrasound wave transmission and reception.
With respect to claim 3, Wang et al. in view of Burton therefore teach of the fastener or band 714 implemented to secure the wearable ultrasound device or smartwatch to the patient body part that is proximate to the procedure site [0050, fig. 7].
With respect to claims 5 and 17, Wang et al. in view of Burton teach of the display device implemented to display the visual representation such as patient data including blood pressure data, heart-rate variability data, and/or indications of blood vessel dimensions [0062] and therefore able to display visual representation without displaying an ultrasound image.
Claim(s) 6-10, 12-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Burton and further in view of McGrath et al.
With respect to claims 6-9, the Wang et al. does not teach of marking the patient for a procedure site. McGrath et al. teach of marking 5013 a suggested puncture site 5008 for initial insertion of the needle or cannula into the skin where a light or mechanical aiming device may be included to assist the user in locating the best puncture site on the patient’s skin [0229, fig. 67B]. McGrath et al. additionally teach of determining surgical margin or boundaries [0344]. McGrath et al. therefore teach of marking the puncture site with light which indicates an insertion point for an interventional instrument such as a needle or cannula and determining a virtual boundary. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous references to assist the user in locating the best puncture site on the patient’s skin. [McGrath, 0229].
With respect to claim 10, Wang et al. do not teach of the patient data to include flow rate. McGrath et al. teach of the patient data to include flow rate of fluid delivered by the injection [0425]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous references to effectively monitor vessel parameters with appropriate feedback to the automated system to make appropriate adjustments to the fluidic flow [McGrath, 0425].
With respect to claim 12, Wang et al. do not teach of directing heat to the anatomy at the procedure site. McGrath et al. teach of applying heat from a heat source to the anatomy of the procedure site or applying heat to a target area injection site through an integrated heating element [0423]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to the previous references to apply heat to the target are injection site to increase vein dilation to measure vascular properties [McGrath, 0423].
With respect to claim 13, Wang et al. teach of detecting the blood pressure [0062, 0067, 0068] but do not teach of a applying pressure to a vessel for cannulation of the vessel. McGrath et al. teach of applying pressure to a blood vessel for cannulation of the vessel [0222, 0223]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify Wang et al. to increase the size of the lumen and stimulate vessel to be more optimal, dilated and easier target for needle insertion [McGrath, 0199].
With respect to claim 14, Wang et al. do not teach of the removing the device to the procedure site. McGrath et al. teach of adjustment of the position of transducer array with respect to the procedure site [0182, 0183, 0186, fig. 3A] and would be capable of being removed from the procedure site prior to a procedure being performed at the procedure site. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous references to allow device to have freedom of access to the skin surface at the procedure site and proximal to the puncture site [McGrath, 0182, 0183].
With respect to claim 15, Wang et al. do not teach of transmitting/receiving reflected ultrasound concurrently with procedure at the site. McGrath et al. teach of allowing surgeon to simultaneously conduct a procedure while viewing real-time 3D images of the anatomical structure and therefore transmitting/receiving reflected ultrasound signals currently with the procedure [0317, 0321, 0405]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous references to allow surgeon to simultaneously conduct a procedure while viewing the 3D images of the anatomy for accurate positioning [McGrath, 0317].
With respect to claim 16, Wang et al. do not teach of a guide for an insertion procedure. McGrath et al. teach of puncture site guides for the interventional instrument for insertion at the procedure site [0259] or needle actuation system 150 to guide the needle 301 to the correct location on the patient [0343]. would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous references to guide the needle or insertion instrument to the correct location on the patient [McGrath, 0343].
With respect to claim 18, Wang et al. teach of device implemented to display the visual representation such as blood pressure, heart-rate variability, and/or indications of blood vessel dimensions [0062]. McGrath et al. teach of display device implemented to display guidance for a procedure at the procedure site [0259, 0260]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by McGrath et al. to modify the previous teaching to perform the insertion of the instrument with the aid of navigation system and allow more precise control of needle motion and insertion [McGrath, 0344].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. in view of Burton and further in view of Tran. Wang et al. do not explicitly teach of the patient data indicating medication ingestion. In a similar field of endeavor Tran teaches of a wearable ultrasound device (fig. 6A, 0310) comprising an ultrasound transducer 84 configured to transmit ultrasound signals and receive reflected ultrasound based on the ultrasound signals [0302, 0303, 0452]. Tran teaches of a fastener of wrist band 1374 which can be an expansion band or wristwatch strap of plastic, leather or woven material [0300, 0301]. Tran teaches of a processor or where the analog signal representative of the Doppler frequency of the echo is received by the transducer and converted to a digital representation by the ADC and suppled to the CPU for signal processing and the CPU applies the vital model to the corresponding blood flow velocity to produce the estimated blood pressure value [0304]. Tran therefore is configured to generate based on the reflected ultrasound patient data such as a blood pressure device with the processor implemented to generate patient blood pressure values [0304-0306, 0407, 0408, 0411]. Tran additionally teaches of a display device 1382 implemented to display a visual representation of the patient data [0310]. Tran teaches of the patient data to indicate medication records [Tran, 0043, 0044, 0046 0448]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Tran to modify Wang et al. to ensure better disease management, recovery, and patient medication management [Tran, 0022].
Allowable Subject Matter
In view of the amendments, claim 20 is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797