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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Claims 8 and 12 recite a “guide wire.” The term “guide wire” is not provided with a reference number in the figures. Examiner notes that the terms “first depth indicator wire 20” and “second depth indicator wire 44” are provided with reference numbers. Examiner requests clarification if a guide wire as recited in claims 8 and 12 is intended to read instead as a “first depth indicator wire 20.” Examiner further notes that claims 8 and 12 only recite a “depth indicator wire;” however, no reference number is given in the figures the term “depth indicator wire” as compared to first and second depth indicator wires.
Therefore, the identified feature of a “guide wire” and “depth indicator wire” as recited in claims 8 and 12 must be shown with clear reference numbers in the figures or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities:
“causing the guide wire to move proximally exposing depth indicator markers” should read instead as “causing the guide wire to move proximally, exposing depth indicator markers.”
Appropriate correction is required.
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, 5, 8, 11, 12, and dependent claims thereof 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.
Re. Claims 1, 5, 8, and 12: Each of claims 1, 5, 8, and 12 recites “measuring a density of a clot within a vessel of a patient.” Density is defined as mass per unit volume. It is unclear how Applicant’s claimed invention produces a measurement of density (kg/m3) since each independent claim appears to measure only force (N/m) and displacement (m). When looking to Applicant’s Specification understand how such a determination is derivable from such measurements, Paragraph 0033 recites “density of clot 50 can be determined, based on a number of depth indicator markers 56 extending beyond the proximal end of chamber 26,” but produces no further steps as to how such determination is carried out.
Re. Claim 8: Claim 8 recites “causing the guide wire to meet resistance from the clot and to move distally depending upon a density of the clot.” It is unclear how a guidewire moves distally (i.e., forward) when meeting resistance. As best understood, a guidewire meeting resistance at its distal end would move apply a force towards the proximal direction (i.e., against an advancing, or proximally-directed, motion of the guidewire).
Re. Claim 11: Claim 11 recites the limitation "the second depth indicator wire.” There is insufficient antecedent basis for this limitation in the claim.
Re. Claim 12: Claim 12 recites the limitation "the depth indicator wire.” There is insufficient antecedent basis for this limitation in the claim.
Additionally claim 12 also recites “the proximal end of the guide wire proximal end of the depth indicator wire.” Notwithstanding antecedent basis issues, it is unclear what component or part thereof is identified by such this phrase.
Additionally, and similarly to claim 8, claim 12 also recites “causing the guide wire to meet resistance from the clot and to move distally depending upon a density of the clot.” It is unclear how a guidewire moves distally (i.e., forward) when meeting resistance. As best understood, a guidewire meeting resistance at its distal end would move apply a force towards the proximal direction (i.e., against an advancing, or proximally-directed, motion of the guidewire).
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 1, 2, 4, 8, 9, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over:
Balmforth et al. (US 20230047610 A1) (hereinafter – Balmforth) in view of
“Push/pull spring scale, 1 kg.” Flinn Scientific. Available at: https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/ (Accessed: 23 February 2026); archived at Wayback Machine (https://web.archive.org/web/20230610020813/https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/); citing a capture dated 10 June 2023 (hereinafter – Flinn Scientific) in further view of
Ferrarresi et al. (US 20240268686 A1) (hereinafter – Ferrarresi).
Re. Claim 1: Balmforth teaches a tool for measuring a density of a clot within a vessel of a patient (Paragraph 0112: force detection on rod 137; intended use; see citations below regarding mechanical requirements of the claim),
the tool comprising:
a flexible catheter having a first proximal end and a second distal end, the catheter having a lumen extending from the first proximal end to the second distal end (Fig. 3: device catheter body 44; Paragraph 0062: “… the device catheter body may be manufactured from a flexible material so as to enable the device to follow the natural curvature of the lumen of the vessel through which it is travelling”);
a first depth indicator wire having a first proximal end and a second distal end, the first depth indicator wire being disposed in the lumen of the flexible catheter (Figs. 15-16: rod 137),
the second end of the first depth indicator wire extending distally beyond the second distal end of the catheter (Figs. 15, 16: rod 137 extending past introducer sheath 46 of catheter body 44 shown in Fig. 3);
a chamber having a proximal end and a distal end (Figs. 15, 16: see portion of handle 142 containing rod 137, whereby rod 137 is moveably disposed within along the handle as described in Paragraph 0111: “… rod 137 extends through the catheter shaft 48 to the handle 142, where it can be controlled using a thumb button 143. The thumb button 143 is configured for reciprocal translation under manual control along the handle 142 to move the rod 137 back and forth and in so doing move the tip 53 back and forth longitudinally relative to the catheter shaft 48”);
While Balmforth discusses methods of measuring force using a spring force gauge located in handle 142 connected to the catheter 144 (Figs. 15, 16; Paragraphs 0111-0112), Balmforth does not appear to explicitly teach particular structural aspects of Applicant’s Fig. 1, as highlighted below:
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The structure highlighted above is known as a push-pull spring force gauge, commercially available from Flinn Scientific, who teaches analogous art in the technology of force sensing. Flinn Scientific teaches a force measurement device comprising:
the chamber having a piston disposed within the chamber, the piston having a proximal side and a distal side (see annotated figure below);
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the proximal end of the first depth indicator wire being connected to the distal side of the piston
(Examiner notes that the rod 137 of Balmforth would be akin to the following portion, see annotated figure below);
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a spring being disposed within the chamber, the spring having a proximal end and a distal end, the spring being disposed between the proximal end of the chamber and the proximal side of the piston
(see annotated figure below);
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a second depth indicator wire having a proximal end and a distal end, the distal end of the second depth indicator wire being connected to the proximal side of the piston, a proximal end of the second depth indicator wire extending proximally beyond the proximal end of the chamber (see annotated figure below),
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It would have been obvious to one having skill in the art before the effective filing date to have modified the non-descript spring gauge connected to the catheter of Balmforth to instead utilize the push-pull spring scale as taught by Flinn Scientific, the motivation being that both devices require a spring force gauge, and replacing one known spring force gauge for another to utilize another for the same purpose to produce a predictable result (i.e., measuring force) can be viewed as an obvious matter of simple substitution of old prior art elements.
Balmforth as modified by Flinn Scientific teaches a spring force gauge having a component which reads on the claimed function of a second depth indicator wire extending proximally beyond a distal end of a chamber. However, the plurality of depth indicator markers of this component are not located on an exterior surface thereof; rather, the body of the chamber of the spring scale taught in Balmforth shows indicator markers to show depth and displacement.
Ferrarresi teaches analogous art in the technology of force sensing probes (Abstract). Ferrarresi further teaches the invention wherein a tubular component which moves in response to force in a spring-loaded chamber possesses a plurality of indicator markers on an exterior surface thereof (Fig. 4: visual scale 60 provided on portion extending beyond spring-loaded chamber).
It would have been obvious to one having skill in the art before the effective filing date to have modified the spring gauge of Balmforth as modified by Flinn Scientific to instead place markers on the component similar to the claimed second depth indicator (i.e., Ferrarresi’s inner tube 45) as taught by Ferrarresi, the motivation being that such placement of depth indicator markers does not require the chamber itself to be translucent as required by the spring scale taught by Flinn Scientific, and allows a reading by noting how much of a visual scale is exposed from the second depth indicator wire.
Regarding the limitation:
“wherein the distal end of the first depth indicator wire is configured to be moved within a clot within a vessel thereby causing the first depth indicator wire to meet resistance from the clot and to move proximally depending upon a density of the clot,
the proximal end of the first depth indicator wire configured to apply a force to the piston and thereby cause the piston to move distally and causing the second depth indicator wire to move proximally exposing depth indicator markers beyond the proximal end of the chamber:”
This action necessarily occurs in how the resultant combination of Balmforth, Flinn Scientific, and Ferrarresi in operation of the device.
Re. Claim 2: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 1. Ferrarresi further teaches details of the modification including wherein the plurality of depth indicator markers are disposed on the proximal end of the second depth indicator wire (Fig. 4).
Re. Claim 4: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 1. Flinn Scientific further teaches details of the modification including wherein the spring is a coil spring, wherein a portion of the second depth indicator wire disposed within the chamber is disposed within the coil spring (see annotated figures of rejection of claim 1).
Re. Claim 8: Claim 8 recites limitations of claim 1, with the following minor differences:
“guide wire” replaces the term “first depth indicator wire” utilized in claim 1.
“depth indicator wire” replace the term “second depth indicator wire” in claim 1.”
Such title changes do not substantively differentiate such structures from what is encompassed by prior art teachings used in the rejection of claim 1. Thus, the citations of the rejection of claim 1 teach each limitation of claim 8.
Examiner additionally notes that claim 8 differently recites “causing the guide wire to meet resistance from the clot and to move distally depending upon a density of the clot;” however, this is interpreted as a typo and is interpreted as “move proximally” as recited in claim 1, particularly, in light of the rejection of claim 8 under 35 U.S.C. 112(b), meeting resistance at a distal end of a guide wire does not cause further distal movement.
Re. Claim 9: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 8. Ferrarresi further teaches details of the modification including wherein the plurality of depth indicator markers are disposed on the proximal end of the depth indicator wire (Fig. 4).
Re. Claim 11: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 8. Flinn Scientific further teaches details of the modification including wherein the spring is a coil spring, wherein a portion of the second depth indicator wire disposed within the chamber is disposed within the coil spring (see annotated figures of rejection of claim 1).
Re. Claim 12: Balmforth as modified by Flinn Scientific teaches each of the following limitations (see citations of rejection of claim 1):
A tool for measuring a density of a clot within a vessel of a patient, the tool comprising:
a guide wire having a first proximal end and a second distal end;
a chamber having a proximal end and a distal end;
the proximal end of the guide wire slidingly connected to the distal end of the chamber;
the chamber having a piston disposed within the chamber;
the piston having a proximal side and a distal side;
the proximal end of the guide wire connected to the distal side of the piston;
a spring being disposed within the chamber, the spring having a proximal end and a distal end, the spring being disposed between the proximal end of the chamber and the proximal side of the piston.
Regarding the limitations:
wherein, the proximal end of the guide wire proximal end of the depth indicator wire extending distally beyond the distal end of the chamber,
a portion of the depth indicator wire extending distally beyond the distal end of the chamber…
Claim 12 recites features of Applicant’s Fig. 5 rather than features of Fig. 4. Differences are annotated in figures below:
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Flinn Scientific also teaches, as best understood, a proximal end of a guide wire or depth indicator wire which extends distally:
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The spring gauge of Flinn Scientific does not teach indicator markers on an exterior surface of the depth indicator wire; however, the teachings of Ferrarresi utilized in claim 1 apply analogously to modify Balmforth as modified by Flinn Scientific. Either end of the spring gauge portions which move in response to a force applied to the distal end of the device of Flinn Scientific may be reasonable to the skilled artisan to apply the indicator markers taught by Ferrarresi.
Claim 12 further recites:
wherein the distal end of the guide wire is configured to be moved within a clot within a vessel thereby causing the guide wire to meet resistance from the clot and to move distally depending upon a density of the clot,
the proximal end of the guidewire configure to apply a force to the piston and thereby cause the piston to move proximally and causing the guide wire to move proximally exposing depth indicator markers beyond the distal end of the chamber.
Similarly to claim 8, claim 12 differently recites “causing the guide wire to meet resistance from the clot and to move distally depending upon a density of the clot;” however, this is interpreted as a typo and is interpreted as “move proximally” as recited in claim 1, particularly, in light of the rejection of claim 12 under 35 U.S.C. 112(b), meeting resistance at a distal end of a guide wire does not cause further distal movement.
Thus, each citation of Balmforth as modified by Flinn Scientific and Ferrarresi above and previously utilized teaches the invention according to claim 12.
Re. Claim 14: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 12. Flinn Scientific further teaches details of the modification including wherein the spring is a coil spring (see annotated figures of rejection of claim 1).
Claims 3, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over:
Balmforth et al. (US 20230047610 A1) (hereinafter – Balmforth) in view of
“Push/pull spring scale, 1 kg.” Flinn Scientific. Available at: https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/ (Accessed: 23 February 2026); archived at Wayback Machine (https://web.archive.org/web/20230610020813/https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/); citing a capture dated 10 June 2023 (hereinafter – Flinn Scientific) in further view of
Ferrarresi et al. (US 20240268686 A1) (hereinafter – Ferrarresi) in further view of
Ninni et al. (US 20250134603 A1) (hereinafter – Ninni).
Re. Claim 3: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 1, but does not teach the invention further comprising:
a sensor and a display,
the sensor being configured to determine the number of depth indicator markers extending beyond the proximal end of the chamber and to send a signal to the display indicative of the number of depth indicator markers extending beyond the proximal end of the chamber,
the display including a screen configured to receive input from the sensor and to provide a visual output to the user of the number of depth indicator markers extending beyond the proximal end of the chamber.
Ninni teaches analogous art in the technology of catheter navigation systems (Abstract). Ninni further teaches the invention comprising:
a sensor (Paragraph 0043: “…the strain sensor outputs a signal 305 corresponding to the amount of compressive or tensile force (an amount of strain) being applied to each drive wire 210 during actuation of the steerable catheter 100. The sensors 304 can output a signal 305 corresponding to an amount of movement (distance of displacement) for each actuated drive wire 210. A sensor 304 that measures the amount of displacement of the drive wire can also be implemented by a Hall-effect sensor. The sensor 304 can also be part of a tracking system implemented by an electromagnetic (EM) sensor configured to measure and/or detected the position and orientation (pose) of the catheter tip 120. The signals 305 from the sensors 304 (strain sensor, displacement sensor, and/or pose or position sensor) for one or more drive wires 210 are sent to the controller 320 and/or computer 400 to provide real-time feedback and create closed-loop control for each motor or actuator”) and
a display (Paragraph 0044: “…, the computer 400 and actuator system 300 can provide a surgeon or other operator with a graphical user interface (GUI) and navigation information through the display screen 420 to operate the steerable catheter 100”),
the sensor being configured to determine the number of depth indicator markers extending beyond the proximal end of the chamber and to send a signal to the display indicative of the number of depth indicator markers extending beyond the proximal end of the chamber (see citation of Paragraph 0043 above; Examiner notes that determination of a degree of displacement of a drive wire as taught by Ninni, when modifying the combination of Balmforth, Flinn Scientific, and Ferrarresi, would provide a determination of a number of depth indicator markings),
the display including a screen configured to receive input from the sensor and to provide a visual output to the user of the number of depth indicator markers extending beyond the proximal end of the chamber (see citation of Paragraph 0044, in light of modification described).
It would have been obvious to one having skill in the art before the effective filing date to have modified Balmforth, Flinn Scientific, and Ferrarresi to include a sensor and display to output an indication of the displacement/force exerted on a sensing wire, the motivation being that doing so enables another operator to easily view measurements and provide feedback during navigation of the device (Paragraph 0043) as opposed to having to view measurements on exposed depth indicator markers.
Re. Claim 10: Claim 10 recites limitations mutatis mutandis identical to those of claim 3, with the term “depth indicator wire” replacing the term “second depth indicator wire” utilized in claim 3. Thus, the citations of the rejection of claim 3 teach each limitation of claim 10, in view of the rejection of claim 8.
Re. Claim 13: Balmforth as modified by Flinn Scientific and Ferrarresi teaches the invention according to claim 12, but do not teach:
a sensor and a display,
the sensor being configured to determine the number of depth indicator markers extending beyond the distal end of the chamber and to send a signal to the display indicative of the number of depth indicator markers extending beyond the distal end of the chamber,
the display including a screen configured to receive input from the sensor and to provide a visual output to the user of the number of depth indicator markers extending beyond the distal end of the chamber.
Such limitations are taught by citations of Ninni in the rejection of claim 3, in light of modifications recited in claim 12.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over:
Balmforth et al. (US 20230047610 A1) (hereinafter – Balmforth) in view of
“Push/pull spring scale, 1 kg.” Flinn Scientific. Available at: https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/ (Accessed: 23 February 2026); archived at Wayback Machine (https://web.archive.org/web/20230610020813/https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/); citing a capture dated 10 June 2023 (hereinafter – Flinn Scientific) in further view of
Ferrarresi et al. (US 20240268686 A1) (hereinafter – Ferrarresi) in further view of
Gad et al. (US 20250161641 A1) (hereinafter – Gad).
Re. Claim 5: Balmforth as modified by Flinn Scientific and Ferrarresi teaches each limitation of claim (see citations of rejection of claim 1), with the exception of the following limitations:
“the piston having a proximal side, a distal side and an outer circumferential surface in sealing contact with an inner wall surface of the chamber…
a compressible gas being disposed within the chamber between the proximal end of the chamber and the proximal side of the piston…
an outer circumferential surface of the second depth indicator wire in sealing contact with an opening in a proximal end wall of the chamber;”
Balmforth as modified by Flinn Scientific and Ferrarresi teaches the use of a coil spring piston, and thus does not teach the above sealing and gas elements. What is required by claim 5 are structural features inherent to a gas spring piston.
A gas spring system is known from Gad (Paragraph 0091: “According to a possible implementation of the first aspect, wherein a resilient element is positioned between the lockable member of the device and the sealing element sealing radially in the syringe barrel, the resilient element preferably comprising one or more of: a metal spring, a polymer spring, a gas spring or a spring comprising a resilient material;” Figs. 32-35). Gad teaches analogous art in the technology of catheters (Abstract; Title).
Switching a coil spring system to a gas spring system is an obvious matter of simple substitution of old prior art elements, each performing the same function as it had prior to the combination.
Re. Claim 6: Balmforth as modified by Flinn Scientific, Ferrarresi, and Gad teaches the invention according to claim 5. Ferrarresi further teaches details of the modification including wherein the plurality of depth indicator markers are disposed on the proximal end of the second depth indicator wire (Fig. 4).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over:
Balmforth et al. (US 20230047610 A1) (hereinafter – Balmforth) in view of
“Push/pull spring scale, 1 kg.” Flinn Scientific. Available at: https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/ (Accessed: 23 February 2026); archived at Wayback Machine (https://web.archive.org/web/20230610020813/https://www.flinnsci.com/pushpull-spring-scale-500-g/ap7338/); citing a capture dated 10 June 2023 (hereinafter – Flinn Scientific) in further view of
Ferrarresi et al. (US 20240268686 A1) (hereinafter – Ferrarresi) in further view of
Gad et al. (US 20250161641 A1) (hereinafter – Gad) in further view of
Ninni et al. (US 20250134603 A1) (hereinafter – Ninni).
Re. Claim 7: Balmforth as modified by Flinn Scientific, Ferrarresi, and Gad teaches the invention according to claim 5. Claim 7 recites limitations analogous to those of claim 3. Thus, the citations of the rejection of claim 3 teach each limitation of claim 7, in view of the rejection of claim 5.
Balmforth as modified by Flinn Scientific, Ferrarresi, Gad, and Ninni thus teach the invention according to claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791