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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1-19 and 21 in the reply filed on 08/13/2026 is acknowledged.
Response to Amendment
This office action is responsive to the amendment filed on 08/13/2026. As directed by the amendment: claims 4, 9, 10 and 20 have been cancelled.
Thus, claims 1-3, 5-8, 10-19 & 21-24 are pending in this application with 1-3, 5-8 and 22-24 being withdrawn.
Specification
The disclosure is objected to because of the following informalities:
Para 0023, lines 1-2 “provide dat or near” should read “provided at or near”.
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 11-19 and 21 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.
Regarding claim 11 and 21, the claim language “a stylet tube” renders the claim indefinite because examiner is unsure whether if the limitation is describing the stylet tube as a “tube of a stylet” OR a “tube/lumen configured for the passage of a stylet.” Clarification is required because a standard stylet does not have lumen, it is usually a solid or semi-solid rod placed inside a lumen of a tube. For purpose of examination, examiner is interpreting “a stylet tube” as a stylet placed inside the aspiration lumen to provide rigidity.
Regarding claim 11, the limitation “a stylet tube extending along the aspiration lumen” is indefinite. The applicant is required to clarify whether this limitation describes “a stylet (having a tube) within a tube,” “a stylet (having a tube) extending longitudinally next to a tube,” “a tube within a tube” OR “a tube extending longitudinally next to a tube.” For purpose of examination, examiner is interpreting this limitation as a stylet passing through the aspiration lumen.
Claim 17 recites the limitation "the stylet" in line 1. There is insufficient antecedent basis for this limitation in the claim.
By virtue of dependency, claims 12-19 are also rejected.
Allowable Subject Matter
Claims 11 and 21 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The closest prior art are Charron et al (US 20150190558 A1) and Chiu et al (US 20090005733 A1).
Regarding claim 11, Charron et al disclose a catheter assembly (30) comprising a distal shaft (41) having an infusion lumen (40); a proximal shaft (34) connected to the distal shaft (fig 1), the proximal shaft defining an aspiration lumen opening (45) at or near the distal shaft (fig 1), and an inflating lumen (42); an inflatable member (36) at a distal end of the inflating lumen (figs 1-2), the inflatable member configured to inflate upon receiving a fluid from the inflating lumen (para 0046); a stylet tube extending along the aspiration lumen (para 0061); wherein the catheter assembly is configured to be displaced percutaneously in an artery by the guide lumen moving along a guide wire (para 0017 and 0042).
Charron et al fail to teach said distal shaft comprises a guide lumen but teach a passage used for both a guide wire and an infusion lumen (para 0045).
However, Chiu et al disclose a catheter (300) comprising a distal shaft (306) having a guide lumen (313) and an infusion lumen (319).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the distal shaft of Charron et al to have a guide wire and an infusion lumen as taught by Chiu et al. This would provide the benefit of having separate lumens to ensure the guidewire remains safely in position during infusion (para 0120).
Charron et al in view of Chiu et al fail to teach/disclose or render obvious “said stylet tube being in fluid communication with the infusion lumen and the stylet tube configured to supply the infusion lumen with a pharmacologic agent” in addition to other limitation.
Regarding claim 21, Charron et al disclose a catheter assembly (30) configured to be delivered percutaneously in an artery (para 0017 and 0042) comprising a distal portion (41) having an infusion lumen (40); a proximal portion (34) having an aspiration lumen opening (45) and an occluder (36), the occluder being configured to occlude the artery (para 0058) and; a stylet tube slidable along the aspiration lumen (para 0061).
Charron et al fail to teach/disclose or render obvious “said stylet tube being in fluid communication with the infusion lumen and the stylet tube configured to supply the infusion lumen with a pharmacologic agent” in addition to other limitation.
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 10/15/2026
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