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 Amendment
The amendment filed May 27, 2026 has been entered. Examiner acknowledges Applicant’s addition of new claims 15-18 reciting essentially identical subject matter, differing by dependency on respective independent claims.
Applicant’s amendments partially overcome the objection to the Drawings. Claim 8 still recites the term “guide wire,” which is not provided with a reference number in the figures.
Applicant’s amendments partially overcome the claim objection of claim 12, but necessitate new claim objections to claims 12 and 15-18.
Applicant’s amendments do not address each ground of rejection of the claims under 35 U.S.C. 112(b), and further necessitate new grounds of rejection under 35 U.S.C. 112(b).
Applicant’s arguments are persuasive to overcome the current prior art of record.
Response to Arguments
Applicant’s arguments, see Remarks pages 9-15, filed May 27, 2026, with respect to the claims have been fully considered and are persuasive. Each prior art rejection of the claims has been withdrawn.
Applicant’s argument that the force detected by the spring gauge of Balmforth is used to identify radial force rather than a clot density is persuasive. As shown in Balmforth’s Figs. 15-16, the rod 137 acts on pulling the atraumatic tip 53 proximally towards the handle, expanding splines 135 to compress against an occlusion 12. The force on the rod 137 is thus understood to be an axial force applied to radially expand against the lumen 10 to remove occlusion 12.
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.
Claim 8 recites “the 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.
Claim 8 also recites 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 claim 8 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:
“first depth indicator wire configure to apply a force” should read as “first depth indicator wire configured to apply a force”
Claims 15-18 are objected to because of the following informalities:
In each of claims 15-18, “the distal end of the first depth indicator wire” should read instead as “the second distal end of the first depth indicator wire”
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 relative 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.
Additionally, it is unclear what density is being used as a reference to be compared to a density measured by the invention in order to establish a “relative” density. No quantity of density is measured by the invention itself, but rather a force on a spring. What may be identified by the invention is therefore the force required to displace a spring by a certain length. Density cannot be attained by identification of a difference in force since there exists materials with significant density, but requiring insubstantial force to penetrate (e.g., mercury in its liquid state). Examiner recommends amendment to have each claim recite the correct physical quantity being measured by the invention.
Re. Claim 8: Claim 8 recites “causing the first depth indicator 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., in the direction of advancement) when meeting resistance. As best understood, a first depth wire meeting resistance at its distal end would move apply a force towards the proximal direction (i.e., against an advancing motion of the guidewire).
Additionally, claim 8 continues to recite the term “the guidewire,” (which possesses insufficient antecedent basis) at lines 4 and 7.
Additionally, claim 8 recites “the depth indicator wire” at lines 11-12. It is unclear whether this term possesses antecedent basis in “a first depth indicator wire” or “a second depth indicator wire.”
Re. Claim 9: Claim 9 recites “the depth indicator wire;” it is unknown which of the first depth indicator wire or the second depth indicator wire this phrase intends to refer to.
Re. Claim 12: 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., in the direction of advancement) 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 motion of the guidewire).
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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