DETAILED ACTION
1. This office action is in response to the communicated dated 13 August 2026 concerning application number 18/792,147 effectively filed on 01 August 2024.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of Claims
3. Claims 1-3 and 8-22 are pending, of which claims 1, 8, 10, and 17 have been amended; claims 21-22 have been added; claims 4-7 have been canceled; and claims 1-3 and 8-22 are under consideration for patentability.
Response to Arguments
4. Applicant’s arguments dated 18 August 2026, referred to herein as “the Arguments”, have been fully considered, but they are not persuasive.
Applicant argues that Harlev does not explicitly teach the amended limitation of claim 1 that recites a first crease in the flexible sheet, and wherein the plurality of temperature sensors are not located over the first crease. Specifically, Applicant emphasizes that Harlev places fold lines in the balloon body 132 and describes thermistors 149 positioned relative to the flexible printed circuit 154, but does not disclose a crease in the circuit 154 or the sensors (thermistors 149) to be placed off a crease in that circuit (page 6-7 of the Arguments). The Examiner respectfully submits that Harlev was not relied upon for teaching the limitation that recites a first crease in the flexible sheet, and wherein the plurality of temperature sensors are not located over the first crease. Instead, D’Angelo was relied upon for teaching the limitation that recites wherein the flexible sheet has a first crease, and wherein the plurality of temperature sensor elements are not located over the first crease. For example, D’Angelo teaches sensing elements 1704 (e.g., temperature sensors) coupled to a stretchable electronic sheet (e.g., flexible substrate) that is disposed about the inflatable body (e.g., balloon) ([0155, 0159, 0245-0246, 0251]). Furthermore, the stretchable electronic sheet of the inflatable body may include creases or ridges 1702 to facilitate folding of the inflatable body ([0246, 0251]). The Examiner further submits that the sensing elements 1704 are strategically and selectively disposed between the creases or ridges 1702 at areas of minimal curvature in the deflated state, to minimize applied strain on the sensing elements 1704 ([0246, 0251]). In this case, the sensing elements 1704 are not located on the creases or ridges 1702, but are rather located between the creases or ridges 1702 ([0246)]. This configuration is beneficial, as it minimizes the strain on the sensing elements 1704 ([0246, 0251]). Thus, the Examiner respectfully maintains that Harlev in view of D’Angelo suggests the limitation that recites a first crease in the flexible sheet, and wherein the plurality of temperature sensors are not located over the first crease.
Applicant argued that Harlev’s balloon does not collapse to produce the claimed circuit structure (page 7 of the Arguments). 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., claimed circuit structure or “circuit”) 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 Examiner respectfully submits that claims do not recite a circuit. Instead, the claims recite temperature sensor elements disposed on a flexible sheet. Furthermore, the flexible sheet is not explicitly recited to be a circuit.
Applicant argues that neither Harlev, D’Angelo, or Mahajan do not explicitly teach a temperature sensor unit located around at least part of an expansion member (page 7 of the Arguments). The Examiner disagrees, as Harlev teaches the temperature sensors or thermistors 149 being disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 ([0107, 0116, 0122-0123, 0126, FIGS. 5-6, FIG. 17]). Similarly, D’Angelo also teaches sensing elements 1704 (e.g., temperature sensors) coupled to a stretchable electronic sheet (e.g., flexible substrate) that is disposed about the inflatable body (e.g., balloon) ([0155, 0159, 0245-0246, 0251]). Thus, the Examiner respectfully submits that both Harlev and D’Angelo provide respective teachings for the limitation that recites the temperature sensor unit located around at least part of an expansion member.
Claim Objections
5. Claim 17 is objected to because of the following informality.
Claim 17 contains a minor typographical error.
Claim 17, lines 8-9: The Examiner suggests changing “is not orthogonal to an extending direction of the tube” to “is not orthogonal to the extending direction of the tube”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
Claim 17 is 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 17 recites the limitation "the first direction is not parallel to the extending direction of the tube" in line 8. There is insufficient antecedent basis for this limitation in the claim. The Examiner respectfully submits that the extending direction of the tube is not recited in claim 1.
Claim Rejections - 35 USC § 103
7. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
8. Claims 1-3, 8-10, 12-16, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (US 2020/0205890 A1) in view of D’Angelo et al. (US 2013/0150693 A1).
Regarding claim 1, Harlev teaches a temperature measurement device comprising (the catheter device 104 comprises a balloon 122 that is coupled to thermistors 149 [0095, 0122-0123, 0126, FIG. 2]) comprises:
a tube (the catheter device 104 comprises a tube or introducer sheath 160 [0137]); and
a temperature sensor unit within the tube (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the balloon 122 may be retracted within the tube or introducer sheath 160 [0137]. This would result in the thermistors being contained within the introducer sheath 160, as the thermistors 149 are attached to the body 132 of the balloon 122 [0116, 0122, 0126, 0137]), wherein the temperature sensor unit includes a flexible sheet and a plurality of temperature sensor elements on the flexible sheet (the plurality of thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIGS. 5-6, FIG. 17]);
an expansion member in the tube (the expansion member or balloon 122 is configured to be retracted within the tube or introducer sheath 160 [0137]. Furthermore, the balloon 122 may be advance or deployed outside of the introducer sheath 160 [0137]), wherein the expansion member is constructed to expand radially outwardly so as to expand the temperature sensor unit (as stated previously above, the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the body 132 of the balloon 122 is configured to expand radially outward which would result in thermistors 149 expanding outward with the balloon [0126, 0136-0138]); and
wherein the temperature sensor unit is located around at least part of the expansion member (as stated previously above, the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIGS. 5-6, FIG. 17]).
Harlev does not explicitly teach wherein the flexible sheet has a first crease, and the plurality of temperature sensor elements are not located over the first crease.
The prior art by D’Angelo is analogous to Harlev, as they both teach a balloon comprising a flexible substrate that includes temperature sensors ([0155, 0159, 0245-0246, 0251]).
D’Angelo teaches wherein the flexible sheet has a first crease, and the plurality of temperature sensor elements are not located over the first crease (the sensing elements 1704 (e.g., temperature sensors) are coupled to a stretchable electronic sheet (e.g., flexible substrate) that disposed about the inflatable body (e.g., balloon) [0155, 0159, 0245-0246, 0251]. Specifically, stretchable electronic sheet of the inflatable body may include creases or ridges 1702 to facilitate folding of the inflatable body [0246, 0251]. Furthermore, the sensing elements 1704 are strategically and selectively disposed between the creases or ridges 1702 at areas of minimal curvature in the deflated state, to minimize applied strain on the sensing elements 1704 [0246, 0251]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Harlev’s flexible sheet to include a crease and the temperatures sensors not being located over the crease, as taught by D’Angelo. This modification is beneficial, as the creases (e.g., ridges) of the flexible sheet (e.g., stretchable electronic sheet) will facilitate better folding of the expansion member (e.g., inflatable body or balloon). Furthermore, the temperature sensors not being placed on the creases (e.g., ridges) will help minimize strain on the temperature sensors (see paragraphs [0155, 0245-0246, 0251] by D’Angelo).
Regarding claim 2, Harlev teaches wherein the temperature sensor unit is constructed to transition between a stored state in which the temperature sensor unit is stored in the tube (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the balloon 122 may be retracted within the tube or introducer sheath 160 [0137]. This would result in the thermistors 149 being contained within the introducer sheath 160, as the thermistors 149 are attached to the body 132 of the balloon 122 [0116, 0122, 0126, 0137]) and a deployed state in which the temperature sensor unit is deployed outside the tube (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the balloon 122 may be advanced or deployed outside of the introducer sheath 160 [0137]. This would result in the thermistors 149 being deployed outside of the introducer sheath 160, as the thermistors 149 are attached to the body 132 of the balloon 122 [0116, 0122, 0126, 0137]).
Regarding claim 3, Harlev teaches wherein the tube has a distal end and a proximal end (figure 7 illustrate the tube or introducer sheath 160 having a proximal and distal end [0136-0137, FIG. 7]), the temperature measurement device further includes a guide member that moves the temperature sensor unit from an inside of the tube to an outside of the tube through the distal end (the guide member or insertion sheath 139 is configured to guide the balloon 122 through the distal end of the introducer sheath 160 [0136-0138]. As stated previously above, the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]).
Regarding claim 8, Harlev teaches wherein the expansion member is a balloon (the balloon 122 [0126, 0136-0138, FIG. 17]).
Regarding claim 9, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 1. Harlev teaches wherein the balloon has a second crease and is constructed to be in stored in the tube when folded along the second crease (the body 132 of the balloon 122 includes fold lines which allows the balloon 122 to be collapsed and stored in the sheath 160 [0137, 0170-0171]), and the temperature sensor unit is in contact with the balloon ([0126]).
Harlev does not explicitly teach wherein the plurality of temperature sensor elements are located not to overlap the second crease.
However, D’Angelo teaches wherein the plurality of temperature sensor elements are located not to overlap the second crease (the sensing elements 1704 (e.g., temperature sensors) are coupled to a stretchable electronic sheet (e.g., flexible substrate) that disposed about the inflatable body (e.g., balloon) [0155, 0159, 0245-0246, 0251]. Specifically, stretchable electronic sheet of the inflatable body may include creases or ridges 1702 to facilitate folding of the inflatable body for storage within a sheath [0241, 0246, 0251, 0279]. Furthermore, the sensing elements 1704 are strategically and selectively disposed between the creases or ridges 1702 at areas of minimal curvature in the deflated state, to minimize applied strain on the sensing elements 1704 [0246, 0251]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the temperatures sensors suggested by Harlev in view of D’Angelo to not overlap over the second crease, as taught by D’Angelo. This modification is beneficial, as the temperature sensors not being placed on the creases (e.g., ridges) will help minimize strain on the temperature sensors (see paragraphs [0155, 0241, 0245-0246, 0251] by D’Angelo).
Regarding claim 10, Harlev teaches wherein the expansion member includes a plurality of wires each extending in a direction from a first end toward a second end of the tube and constructed to curve and protrude in a direction from an inside toward an outside of the tube in a cross-sectional view in a direction intersecting the direction from the first end toward the second end of the tube (as stated previously in claim 4, the balloon 122 may be advance or deployed outside of the introducer sheath 160 [0137]. Specifically, figure 17 illustrates a cross-sectional view of the electrical wires extending through the sheath and curving in different directions to couple with the thermistors 149 on the balloon 122 [FIG. 17, 0099, 0143]).
Regarding claim 12, Harlev teaches wherein the temperature sensor unit includes a thermistor ([0126]).
Regarding claim 13, Harlev teaches a protective layer covering the temperature sensor unit (Applicant states in claim 14 that the protective layer is a metal which covers the temperature sensor. Similarly, Harley provides an illustration in figure 6 showing the flexible printed circuit 154 having a metallized layer which covers the thermistor 149 [0123, FIG. 6]).
Regarding claim 14, Harlev teaches wherein the protective layer contains a metal (Harley provides an illustration in figure 6 showing the flexible printed circuit 154 having a metallized layer which covers the thermistor 149 [0123, FIG. 6]).
Regarding claim 15, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 1. Harlev teaches wherein the temperature sensor unit is constructed to transition to a deployed state in which the temperature sensor unit is deployed outside the tube (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the balloon 122 may be advanced or deployed outside of the introducer sheath 160 [0137]. This would result in the thermistors 149 being deployed outside of the introducer sheath 160, as the thermistors 149 are attached to the body 132 of the balloon 122 [0116, 0122, 0126, 0137]).
Harlev and D’Angelo do not explicitly teach wherein the plurality of temperature sensor elements are located such that a distance between adjacent temperature sensor elements of the plurality of temperature sensor elements is smaller than or equal to a specified value in the deployed state.
The Examiner respectfully submits, as Harlev teaches the use of temperature sensors in the deployed state (see the explanation above), configuring the exact arrangement or distance between the temperature sensors as recited in claimed limitation would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 16, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 1. Harlev teaches wherein the temperature sensor unit includes four or more temperature sensor elements (figure 17 illustrates the plurality of thermistors 149 having at least four thermistors [FIG. 17, 0122, 0126]), the temperature sensor unit is constructed to transition to a deployed state in which the temperature sensor unit is deployed outside the tube (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]. Furthermore, the balloon 122 may be advanced or deployed outside of the introducer sheath 160 [0137]. This would result in the thermistors 149 being deployed outside of the introducer sheath 160, as the thermistors 149 are attached to the body 132 of the balloon 122 [0116, 0122, 0126, 0137]).
Harlev and D’Angelo do not explicitly teach wherein the four or more temperature sensor elements in the deployed state compose row sensor-element sets and column sensor-element sets each including two or more of the temperature sensor elements aligned in a row direction and a column direction, respectively, on the temperature sensor unit, the row direction and the column direction intersecting each other, the two or more of the temperature sensor elements in each row sensor-element set in the deployed state are aligned at intervals of a first distance in a direction from a first end toward a second end of the tube, the two or more of the temperature sensor elements in each column sensor-element set in the deployed state are aligned at intervals of a second distance in a direction intersecting a direction from an inside toward an outside of the tube in a cross-sectional view in a direction intersecting the direction from the first end toward the second end of the tube, and the first distance is shorter than the second distance.
The Examiner respectfully submits, as Harlev teaches the use of temperature sensors in the deployed state (see the explanation above), configuring the exact arrangement and/or distances of the temperature sensors as recited in claimed limitation would be a matter of rearranging the known elements without producing a new and unexpected result, with such matters having been held by the courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 20, Harlev teaches a treatment device comprising the temperature measurement device according to claim 1 (the treatment system 100 comprises the catheter device 104 having a balloon 122 that is coupled to thermistors 149 [0095, 0122-0123, 0126, FIG. 2]).
Regarding claim 21, Harlev teaches wherein the flexible sheet is a member separate from the expansion member (the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIGS. 5-6, FIG. 17]. Specifically, the flexible printed circuit 154 is a separate element that can be attached to the body 132 of the balloon 122 via mechanical retaining features (e.g., tabs and mating holes) [0107, 0116, 0122-0123, 0126]).
Regarding claim 22, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 2. D’Angelo teaches wherein, in the stored state, the flexible sheet is folded along the first crease (the sensing elements 1704 (e.g., temperature sensors) are coupled to a stretchable electronic sheet (e.g., flexible substrate) that disposed about the inflatable body (e.g., balloon) [0155, 0159, 0245-0246, 0251]. Specifically, stretchable electronic sheet of the inflatable body may include creases or ridges 1702 to facilitate folding of the inflatable body for storage within the tube or sheath [0241, 0246, 0251, 0279, FIGS. 17A-17B]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the flexible sheet suggested by Harlev in view of D’Angelo to be folded along the first crease in a stored state, as further taught by D’Angelo. This modification is beneficial, as the creases (e.g., ridges) of the flexible sheet (e.g., stretchable electronic sheet) will facilitate better folding of the expansion member (e.g. inflatable body or balloon) for storage within the sheath (see paragraphs [0241, 0246, 0279] by D’Angelo). Furthermore, the folded configuration of the inflatable body may help minimize strain on the temperature sensors (see paragraphs [0155, 0245-0246, 0251] by D’Angelo).
9. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. in view D’Angelo et al., further in view of Mahajan et al. (US 2008/0175299 A1).
Regarding claim 11, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 1. Harlev and D’Angelo do not explicitly teach wherein a surface of the temperature sensor unit includes hydrophilic portions that are hydrophilic and water-repellent portions that are water-repellent.
The prior art by Mahajan is analogous to Harlev, as they both teach ablation systems comprising temperature sensors and a catheter ([0034, 0039]).
Mahajan teaches a surface of the temperature sensor unit includes hydrophilic portions that are hydrophilic and water-repellent portions that are water-repellent (the sensor 320 include may be coated with a waterproof epoxy layer which inherently includes surface portions that are water repellant [0068]. Furthermore, the sensor 320 may be also coated with a hydrophilic layer which inherently includes surface portions that are hydrophilic [0068]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the temperature sensor suggested by Harlev in view of D’Angelo to include hydrophilic and water-repellant portions, as taught by Mahajan. This modification is beneficial, as the water repellant portions will protect the sensor and the hydrophilic portions will increase the biocompatibility of the sensor (see paragraph [0068] by Mahajan).
Allowable Subject Matter
10. Claims 17-19 are 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, and if the 112(b) rejection noted above was overcome.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 17, Harlev in view of D’Angelo suggests the temperature measurement device according to claim 1. Harlev teaches wherein the flexible sheet is located on the expansion member (as stated previously, the thermistors 149 are disposed on a flexible printed circuit 154 that is attached to the body 132 of the balloon 122 [0107, 0116, 0122-0123, 0126, FIG. 5]). Similarly, D’Angelo also teaches wherein the flexible sheet is located on the expansion member (the sensing elements 1704 (e.g., temperature sensors) are coupled to a stretchable electronic sheet (e.g., flexible substrate) that disposed about the inflatable body (e.g., balloon) [0155, 0159, 0245-0246, 0251]).
However, Harlev and D’Angelo do not explicitly teach wherein at least part of the flexible sheet is line-shaped and extends in a first direction, and the first direction is not parallel to the extending direction of the tube and is not orthogonal to the extending direction of the tube, which is a direction from a first end toward a second end of the tube. The Examiner respectfully submits that a person having ordinary skill in the art would not find it obvious to change the shape of the flexible sheet and rearrange the flexible sheet to arrive at the claimed limitation. Specifically, such modifications would interfere with the current arrangement of the creases or ridges 1702 on D’Angelo’s flexible sheet (e.g., stretchable electronic sheet) which are critical for facilitating better folding of the inflatable body ([0155, 0246, 0251]). The Examiner further submits that such modifications will also interfere with the current placement of D’Angelo’s temperature sensors on the flexible sheet (e.g., stretchable electronic sheet) which are strategically placed to minimize strain on the temperature sensors while the inflatable body is being inflated ([0155, 0246, 0251]). Based on the critical arrangement of the sensors and creases on the flexible sheet, a person having ordinary skill in the art would not be motivated to alter the structure of D’Angelo’s flexible sheet to arrive at the claimed limitation.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 18-19 are considered to include allowable subject matter, as claims 18-19 depend upon claim 17.
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. The prior art by Jung, JR. (US 2019/0350634 A1) is pertinent to Applicant’s disclosure, as Jung teaches a balloon having a crease and a plurality of temperature sensors or thermocouples ([0070, 0073, 0078-0079]).
12. THIS ACTION IS MADE FINAL. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792