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 .
The Reply of 6/23/26 has been entered. Claims 12-17, and 19-20 are pending.
Response to Arguments
Applicant's arguments filed 6/23/26 have been fully considered but they are not persuasive.
First, it is noted that the scope of the claims has changed, by the deletion of “coupled” and the addition of “, enabling the at least one sensor to detect a physiological parameter” in Claim 1. The amendments have further changed the scope of Claims 17 and effectively added Claim 20, which previously depended on Claim 1. Nevertheless, the references of Akins and DiCarlo still meet the claims.
Applicant argues that: “with regard to wireless power, DiCarlo merely teaches that an induction coil can be used such that “[w]hen RF current is passed through the transmitter coil, a RF current can be generated in the heating element[.]” (DiCarlo, ¶ [0066]). In paragraph [0069], DiCarlo describes using “the heating element to degrade a biofilm positioned on an outer surface of the catheter without damaging adjacent tissue.” Thus, the wireless power described by DiCarlo is one of a simple heating of a resistant element through inductive power, not providing power to a sensor that is configured to detect a physiological parameter of a patient.”
This is not convincing, because in addition to the more general teaching of wireless transmission of power from an external device to a medical device, which would more than suffice to phosita to bridge the gap between Akins and Claim 1, DiCarlo also specifically teaches wireless transmission of power from the external device to power a sensor in the catheter (e.g. ¶ 58: “In still another embodiment, the catheter can include a sensor to allow feedback. The sensor, for example, a temperature sensor, can provide the processor with temperature data and allow the processor to adjust the current delivered to the heating element. The temperature sensor (not illustrated) can be located at a variety of locations along, within, and/or on the catheter to allow the processor to determine a temperature profile. In addition, temperature data can be used by the processor to ensure that the temperature of blood or tissue surrounding the catheter does not exceed a maximum temperature and/or that the temperature does not rise to a level that could damage the catheter.”; ¶65: “In addition, the current generated in the receiver could power a sensor, such as, for example, a temperature sensor. Thus, when activated, the inductive current can power the heating element and a sensor, which allows feedback control of the heating element. In addition, or alternatively, the current generated by the receiver can supply power to a battery mated with the catheter.”; and ¶64: the wireless power transmission can be a coil-to-coil transmission). The catheter and the physiological sensors thereof, as well as an external device in wireless communication with the medical device and the sensor, are already taught by Akins in his PICC system. Atkins also teaches powering the catheter wirelessly (¶118). The only part missing is explicitly wirelessly powering the sensor itself. This is remedied by the teachings stemming from DiCarlo (and Akins), as would be understood by phosita, and discussed in further detail below.
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.
Claims 12-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0204818 by Akins in view of US 2009/0131854 by DiCarlo.
Regarding Claim 12, Akins discloses a system comprising:
a medical device (e.g. abstract: catheter assembly) comprising:
a flexible, elongated member configured for insertion within a body such that a distal end may be positioned near a cavoatrial junction of a patient, the flexible, elongated member having a proximal end, and a lumen extending along a length of the flexible, elongated member (e.g. abstract, ¶¶ 4,14,57-58,61,124, and 133, and Fig. 1, 11, 24-25: vascular access catheter assembly 10 with lumens 14 of a flexible catheter 12, which is advanceable near the CAJ as clearly see in Fig. 25, and monitors said advancement past the junction);
one sensor coupled disposed at the distal end of the flexible, elongated member (e.g. abstract, ¶¶ 18,54,58-59, Fig. 16-18, 24: multiple sensors disposed at the distal end of the tube 12. As one example, see sensors 32/200/210 at the distal end 13 of the catheter in ¶¶ 18, 91-93, Fig. 16-18. As another example, see ¶¶ 91,116, and Fig. 16-18, and 24: multiple temperature sensors 100a/100b are placed and integrated along the length of the distal end 13 of the catheter 12);
an external device in wireless communication with the medical device and configured to receive data from the sensor (e.g. ¶¶ 48,60,67,77,107,118, and Fig. 11, and 24: wireless communication between the catheter assembly 10 and its sensors, and an external device, such as console 2402),
wherein the medical device provides power to the sensor, enabling the sensor to detect a physiological parameter (e.g. ¶66,68-70,79,91: power is provided to the sensors to operate, the sensors detecting physiological parameters, including temperature, pressure, ECG; Also see ¶56,58-59)
Akins does not explicitly disclose wherein the external device provides wireless power to the sensor.
However, Akins does teach that the catheter assembly 10 receives power remotely (¶66,118). Moreover, DiCarlo teaches an analogous intravascular catheter with physiological monitoring, wherein the sensors of the catheter are powered wirelessly by an external device (e.g. abstract, ¶¶ 2,15,21,58,65). Thus, in addition to the general teaching of wirelessly powering a sensor of a medical device, which alone would suffice to a person having ordinary skill in the art, DiCarlo also specifically teaches wireless transmission of power from the external device to a sensor in the catheter (e.g. ¶ 58: “In still another embodiment, the catheter can include a sensor to allow feedback. The sensor, for example, a temperature sensor, can provide the processor with temperature data and allow the processor to adjust the current delivered to the heating element. The temperature sensor (not illustrated) can be located at a variety of locations along, within, and/or on the catheter to allow the processor to determine a temperature profile. In addition, temperature data can be used by the processor to ensure that the temperature of blood or tissue surrounding the catheter does not exceed a maximum temperature and/or that the temperature does not rise to a level that could damage the catheter.”; ¶65: “In addition, the current generated in the receiver could power a sensor, such as, for example, a temperature sensor. Thus, when activated, the inductive current can power the heating element and a sensor, which allows feedback control of the heating element. In addition, or alternatively, the current generated by the receiver can supply power to a battery mated with the catheter.”; and ¶64: the wireless power transmission can be a coil-to-coil transmission).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate wirelessly powering the sensors of the catheter, to operate as intended by Akins, with the external device according to the teachings of Akins, as taught by DiCarlo, as this would only amount to an equivalent mechanism of predictably powering the sensors, and furthermore, this would obviate the need for wires or intermediary powering devices.
Regarding Claim 13, Akins discloses the system of claim 12, wherein the sensor includes a pressure sensor (e.g. ¶ 91, Fig. 16: any of the sensors disclosed are included in sensor array 200, such as a pressure sensor; ¶92: glucose sensor)
Regarding Claim 14, Akins discloses the system of claim 12, wherein the sensor includes a first temperature sensor and a second temperature sensor disposed a known distance from the first temperature sensor (e.g. ¶ 91 places all sensors 30 at the distal end, which would include the multiple temperature sensors 100a and 100b used to detect temperature at different locations along the length of catheter 12, and ¶ 116 places said multiple temperature sensors at the distal end; Also see ¶¶ 113, and Fig. 16-18, and 24).
Regarding Claim 15, Akins discloses the system of claim 12, wherein the flexible, elongated member is configured as a peripherally inserted central catheter (¶ 57: PICC).
Regarding Claim 16, Akins discloses the system of claim 12, wherein the flexible, elongated member is configured as a central venous catheter (¶ 57: CVC).
Regarding Claim 17, Akins discloses the system of claim 14, wherein the sensor further comprises a pressure sensor (e.g. ¶91, Fig. 16: pressure sensor 32 as part of sensor assembly 30 at the distal end of the catheter).
Regarding Claim 19, Akins discloses the system of claim 12, further comprising a volume of fluid in communication with lumen of the elongated, flexible member (See MPEP 2115: Material worked upon does not limit apparatus claims. The device of Akins includes catheter 12 with lumens 14, and such lumens are capable of receiving fluids, see e.g. ¶4).
Regarding Claim 20, Akins discloses the system of claim 12, wherein the sensor includes one sensor of a first type and one sensor of a second type (e.g. ¶91, Fig. 16: pressure and temperature sensors).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-13, 15-16, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,268,525 in view of Akins.
Regarding Claim 12, Claim 7 of the issued patent teaches a system comprising: a medical device comprising: a flexible elongated member configured for insertion within a body; the flexible, elongated member having a proximal end, and at least one lumen extending along a length of the flexible, elongated member; at least one sensor coupled disposed at the distal end of the flexible, elongated member (Claim 1: a peripherally inserted central catheter having an elongated tube structure comprising a proximal end, a distal end, and a lumen extending therethrough; a set of sensors coupled to a distal section of the tube structure, the set of sensors comprising at least one pressure sensor and at least one imaging sensor); an external device in wireless communication with the medical device and configured to receive data from the at least one sensor, wherein the external device provides wireless power to the sensor (Claim 1: wherein the power and data coupling device is configured to wirelessly communicate with one or more external devices; Claim 7: the power and/or data signals comprise both power signals sent to the set of sensors and data signals sent from the set of sensors).
Claim 7 of the issued patent does not explicitly disclose the capability of the elongate member such that a distal end may be positioned at or near a cavoatrial junction of a patient. However, Akins discloses an analogous flexible PICC which can be advanced near the CAJ (e.g. abstract, ¶¶ 4,14,57-58,61,124, and 133, and Fig. 1, 11, 24-25: vascular access catheter assembly 10 with lumens 14 of a flexible catheter 12, which is advanceable near the CAJ as clearly see in Fig. 25, and monitors said advancement past the junction). Therefore, it would have been obvious to a person having ordinary skill in the art to size a catheter according to Claim 7 of the issued patent such that it is advanceable near the CAJ, as taught by Akins, as: a) it has been held that a change in the shape or proportion of a prior art device is a design consideration within the skill of the art (See MPEP 2144.04.IV.A), and b) in order to predictably acquire hemodynamic measurements, such as CVP.
Claim 7 does not explicitly disclose powering that enables the sensor to detect a physiological parameter.
However, Akins teaches an analogous PICC with sensors powered to detect physiological signals (e.g. ¶66,68-70,79,91: power is provided to the sensors to operate, the sensors detecting physiological parameters, including temperature, pressure, ECG; Also see ¶56,58-59). Therefore, it would have been obvious to a person having ordinary skill in the art to incorporate physiological monitoring with powered sensors operating on the wireless power already powering the device, as taught by Akins, in order to predictably monitor physiological parameters within a vessel.
Regarding Claim 13, Claim 7 of the issued patent as modified in Claim 12 teaches the system of claim 12, wherein the at least one sensor includes a pressure sensor (Claim 1: pressure sensor; ¶91 of Akins: pressure sensor 32 is incorporated in the modification of Claim 7).
Regarding Claims 15-16, 19, Claim 7 of the issued patent as modified in Claim 12 teaches the system of claim 12, wherein the flexible, elongated member is configured as a peripherally inserted central catheter and as a central venous catheter, further comprising a volume of fluid in communication with lumen of the elongated, flexible member (Claim 1: PICC; Also see MPEP 2115: Material worked upon does not limit apparatus claims).
Regarding Claim 20, Claim 7 of the issued patent as modified in Claim 12, teaches the system of Claim 12, wherein the sensor includes one sensor of a first type and one sensor of a second type (Claim 1: pressure and imaging sensors).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796
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