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 .
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 17-18 and 34-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Helwa (US 20220265175 A1).
For claim(s) 17, Helwa teaches A cut-to-length lactate-sensing catheter, comprising:
a catheter hub; [102]
a catheter tube [104] having a proximal-end portion inserted into a bore of a distal portion of the catheter hub;
a plurality of lactate sensors disposed in or on a surface of the catheter tube along an initial length thereof, each lactate sensor of the plurality of lactate sensors independently electronically addressed with corresponding lactate-sensor electrical leads leading thereto; [Fig(s). 2-4]
a plurality of temperature sensors disposed in or on the surface of the catheter tube along the initial length thereof, each temperature sensor of the plurality of temperature sensors independently electronically addressed with corresponding temperature-sensor electrical leads leading thereto, [Fig(s). 2-4]
wherein: the plurality of temperature sensors and the plurality of lactate sensors are respectively paired along the initial length of the catheter tube, thereby enabling enzyme activity and, thus, lactate concentration, associated with any lactate sensor of the plurality of lactate sensors to be normalized by way of local-temperature compensation with a paired temperature sensor; [Fig(s). 2-4]
and independent electronic addressing enables both a lactate-sensing capability and a temperature-sensing capability of the sensing catheter to be maintained despite excising any one or more sensors selected from the plurality of lactate sensors and the plurality of temperature sensors with a distal length of the catheter tube upon cutting the catheter tube from the initial length to a working length; [Fig(s). 2-4]
and one or more extension legs, each extension leg of the one-or-more extension legs having a distal-end portion inserted into a proximal portion of the catheter hub. [under BRI, a proximal portion of 104 is at least some form of an extension leg, see also branching of Fig. 4, see also jointed tubing of embodiments of Fig. 5]
For claim(s) 18, Helwa teaches The sensing catheter of claim 17,
wherein each lactate sensor of the plurality of lactate sensors includes either a three-electrode sensor or a two-electrode sensor, the three-electrode sensor including a working electrode, a reference electrode, and a counter electrode, and the two-electrode sensor including the working electrode and the reference electrode. [¶¶86-88, ¶¶147-157]
For claim(s) 34, Helwa teaches
wherein the surface of the catheter tube independently includes an abluminal surface or a luminal surface of the catheter tube. [Figs. 2-3]
For claim(s) 35, Helwa teaches
an electrical connector configured to connect a console with sensor electronics of the sensing catheter and relay electrical signals to the sensing catheter, relay electrical signals from the sensing catheter, or both. [Fig. 1]
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1, 12-15, and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwa in view of Selkee (US 20100063478 A1).
For claim(s) 1, Helwa teaches A cut-to-length temperature-sensing catheter, comprising:
a catheter hub; [102]
a catheter tube [104] having a proximal-end portion inserted into a bore of a distal portion of the catheter hub;
a plurality of temperature / lactate sensors disposed in or on a surface of the catheter tube [Figs. 2-3] along an initial length thereof, [¶¶79-84, ¶¶127-128]
each temperature / lactate sensor of the plurality of temperature sensors independently electronically addressed with corresponding temperature-sensor electrical leads leading thereto, thereby enabling a temperature / lactate sensing capability of the sensing catheter to be maintained despite excising any one or more sensors of the plurality of sensors with a distal length of the catheter tube upon cutting the catheter tube from the initial length to a working length; [Figs. 2-4]
and one or more extension legs, each extension leg of the one-or-more extension legs having a distal-end portion inserted into a proximal portion of the catheter hub. [under BRI, a proximal portion of 104 is at least some form of an extension leg, see also branching of Fig. 4, see also jointed tubing of embodiments of Fig. 5]
For claim(s) 1, 12-13, and 30-33 Helwa fails to teach a plurality of strain sensors on the catheter.
Selkee teaches a catheter comprising strain sensors [490] each independently electrically addressed to a lead, paired with temperature sensors [¶¶63-67], with patterned strain elements of silver or gold. [¶52]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the catheter of Helwa to incorporate the strain sensors of Selkee in order to aid in determining catheter position for effective treatment. As motivated by Selkee ¶¶10-11.
For claim(s) 14, Helwa teaches
wherein the surface of the catheter tube independently includes an abluminal surface or a luminal surface of the catheter tube. [Figs. 2-3]
For claim(s) 15, Helwa teaches
an electrical connector configured to connect a console with sensor electronics of the sensing catheter and relay electrical signals to the sensing catheter, relay electrical signals from the sensing catheter, or both. [Fig. 1]
Claim(s) 2-5 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwa in view of Tegg (US 20180092688 A1).
For claim(s) 2-5 and 22-25, Helwa fails to teach the temperature sensors being thermocouples. For claim(s) 2-5 and 22-25, Tegg teaches
wherein the plurality of temperature sensors is a plurality of nested thermocouples. [68]
wherein each thermocouple of the plurality of thermocouples includes a longitudinal loop formed between two conducting lines of dissimilar thermocouple conductors having distal portions disposed in or on the surface of the catheter tube, the two conducting lines distally terminating in a hot junction in or on the surface of the catheter tube. [Fig. 29B in ¶118]
wherein the two conducting lines have proximal portions disposed in or on an outer surface of the catheter hub, the two conducting lines proximally terminating in a cold junction on a printed circuit board assembly of the catheter hub. [Fig. 29B in ¶118]
wherein the proximal portions of the two conducting lines extend from the outer surface of the catheter hub into the bore of the catheter hub, [Fig. 15]
the proximal portions of the two conducting lines within the bore of the hub forming an electrical junction with the distal portions of the two conducting lines where the proximal-end portion of the catheter tube is inserted into the bore of the catheter hub. [Fig. 15]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the temperature sensors of Helwa to be thermocouples as taught by Tegg in order to enable fast and accurate temperature sensing. As motivated by Tegg ¶¶7-10.
Claim(s) 6 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwa in view of Tegg and Sutermeister (US 20150297292 A1).
For claim(s) 6 and 26, Helwa in view of Tegg is silent regarding the conductors being polymers. Sutermeister teaches a thermistor structure [Fig. 2A] where the conductors are conducting polymers. [¶88]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the conductors of Helwa and Tegg to incorporate the conducting polymer of Sutermeister in order to make more efficient and economical the temperature monitoring. As motivated by Sutermeister ¶¶9-10.
Claim(s) 7-9 and 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwa in view of Olson (US 20210022803 A1).
For claim(s) 7 and 27, Helwa fails to teach the temperature sensors being RTDs. Olson teaches a sensing catheter with RTDs. [Fig. 10, Fig. 12, Fig. 13, ¶107, ¶113, ¶115]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the temperature sensors of Helwa to be formed as the RTDs of Olson in order to ensure robust and efficient temperature sensing. As motivated by Olson ¶¶92-98.
For claim(s) 8 and 28, Olson teaches (in the motivated combination of claim(s) 7)
wherein each RTD of the plurality of RTDs includes a temperature-sensing element of an RTD conductor formed in or on the surface of the catheter tube with a known temperature vs. resistance relationship, thereby enabling any measured electrical resistance across the temperature-sensing element to be converted to a temperature. [¶¶92-98]
For claim(s) 9 and 29, Olson teaches (in the motivated combination of claim(s) 7)
wherein the RTD conductor is nanoscale-structured silver or gold. [¶¶92-98]
Claim(s) 16 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Helwa in view of Leach (US 20090124964 A1).
For claim(s) 16 and 36, Helwa fails to teach the catheter being a veinous catheter. However, Helwa does generally suggest the catheter being used for a broad range of surgical monitoring and patient condition assessment and the importance of both in ¶¶13-33.
Leach teaches a patient condition monitoring catheter that is a veinous catheter [abstract, ¶73]. It would have been obvious to one of ordinary skill at the time the invention was filed to modify the catheter of Helwa to be a veinous catheter as taught by Leach in order to increase ease of monitoring of critical patient parameters (e.g., cardiovascular condition and circulatory parameters). As motivated by Leach ¶¶3-4.
Response to Arguments
Applicant's 12/10/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 10 that Helwa fails to teach a plurality of temperature sensors paired with lactate sensors. Examiner respectfully disagrees. Helwa teaches numerous embodiments with coordinated electrode layouts to measure biomarkers as in Helwa Fig(s). 2 and 6 where the biomarkers include temperature and lactate per Helwa ¶¶127-128.
Applicant argues in remarks p. 10 that Helwa fails to teach extension legs having a distal portion inserted into a proximal portion of the catheter hub. Examiner respectfully disagrees. The terms ‘legs’ and ‘portion’ encompass sufficiently broad BRI that even a rear amount of the length of the catheter can suffice to teach at least some form of a ‘leg’ which is inserted into a ‘portion’ of the hub, such as DAQ system 102. The proximal portion of catheter 104 can have a distal half which is inserted via a proximal end into hub 104 thus not requiring any type of unworkable ‘closed loop’ as asserted by Applicant. Examiner suggests amending the claim(s) to further limit the tangible structure of the extension ‘leg(s)’ such that they are more than a ‘leg’ of a structure inserted into a ‘portion’ of another structure which may permit interpretations not intended by the disclosed structure of this application under BRI.
Applicant argues in remarks p. 12 that Selkee fails to teach temperature sensors paired with individual strain sensors. Examiner respectfully disagrees. Selkee ¶65 specifically details that a strain sensor may have an RTD and/or an integrated temperature sensor to aid in strain sensor operation and function. Accordingly, Selkee teaches at least some form of pairing of temperature sensors with strain sensors on an individual functional level. Selkee ¶53 further details this arrangement specifying the temperature sensor assigned to the individual strain gauge.
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).
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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