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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/03/25 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/15/25 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
The amendment filed 10/23/25 has been entered. Claims 1 and 21 have been amended. Claims 4-5 and 22-23 are in the original/ previously presented form. Claims 6-20 remain withdrawn. Claims 2-3 are cancelled. Thus, claims 1, 4-5, and 21-23 remain pending in the application. Applicant’s amendments to the Claims have overcome some of the 112(b) rejections previously set forth in the Final Office Action mailed 08/26/25, hereinafter FOA (see 112(b) rejection below).
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, 4-5, and 21-23 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.
Claim 1 recites the limitation "the looped portion" in line 14 (previously line 13 as originally set forth in the FOA page 3). There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets line 14 to read “the single looped portion” to align with the amendment filed by Applicant on 05/21/25 and to provide proper antecedent basis for the limitation.
Due to claim dependency from claim 1, claims 4-5 and 21-23 are subsequently rejected under 112b.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuroda et al. (U.S. PGPUB No. 2015/0032119), hereinafter Kuroda.
Regarding claim 1, Kuroda discloses a vascular access instrument (21, see FIG. 27) configured to be inserted through a vascular access device (500, see FIG. 1 and [0102]: jaws 11/12 house members 21/22), the vascular access instrument consisting essentially of:
a single wire (wire 25 forming top loop 21, see FIG.27 and [0171-0172]: shape memory alloy wire forming 2D spiral shape), comprising:
a proximal end (31 is proximal end of 21 extending through endoscope device to be actuated by member 131, see FIG.2 for visual clarity and [0106-0107]: 131 for retreating and advancing member 21. See also FIG. 2 for visual clarity of wire 21 forming also the proximal end 31);
a straight middle portion (see ‘Modified FIG. 27’ below)
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aligned with (straight portion extends in parallel with longitudinal axis as labeled and therefore is “aligned” with the longitudinal axis) a longitudinal axis of the vascular access device (longitudinal axis through endoscopic device as seen in ‘Modified FIG. 27’ above); and
a distal end (see ‘Modified FIG. 27’ above) opposite the proximal end (see FIG. 1: distal end with wire 21 opposite the proximal end with actuating portions such as 131 disposed on 100), the straight middle portion (see ‘Modified FIG. 27’ above) extending from the proximal end (31, see FIG. 2 for visual clarity of full extension from proximal to distal end) to the distal end (21), wherein the distal end (21) consists essentially of a bent shape having a single looped portion (see ‘Modified FIG. 27’ above, aligning with Applicant disclosure of the distal end comprises bent shape/ single looped portion in replacement sheet FIG. 2A filed 09/19/23 and [0042]), wherein the single looped portion extends parallel with the longitudinal axis of the vascular access device (see ‘Modified FIG. 27’ above. Single looped portion parallel with longitudinal axis) and comprises a center axis (see ‘Modified FIG. 27i’ below)
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defining a plane that is oriented in a perpendicular direction with respect to a longitudinal axis of the vascular access device (see ‘Modified FIG. 27i’ above, aligning with Applicant disclosure of the center axis in replacement sheet FIG. 2A filed 09/19/23 and [0043]), wherein a cross-sectional area of the single looped portion remains substantially constant (see [0171]: wire 25 may be 2D shape without “swelling”== “substantially” constant cross-sectional area. Further, the cross-sectional area is controlled by the user, see [0173] and [0106-0107], via the advancement/ retreating mechanism. Therefore, the cross-sectional area remains constant unless purposefully changed by the user during operation) during use (use directed by user and is substantially constant unless purposefully altered) of the vascular access instrument (see FIG. 27) and the single looped portion (see ‘Modified FIG. 27’ above) is configured to grab or snare an occlusion within a vasculature and/or to facilitate removal of the occlusion (“configured to ‘ is functional language. see FIG.19 and [0142] & [0144]: wire 21 in use grasps necrotic tissue for removal and therefore is ‘configured to’ or capable of grabbing an occlusion within vasculature to facilitate removal. See [0174]: wire contacts tissue and therefore is “configured to grab/snare/facilitate removal of” an occlusion).
Regarding claim 4, Kuroda discloses the vascular access instrument of claim 1, and Kuroda further discloses wherein the plane of the center axis of the single-looped portion is oriented in a perpendicular direction with respect to the middle portion (middle portion is parallel to longitudinal axis—see ‘Modified FIG. 27’ above. The plane of the center axis is perpendicular to longitudinal axis—see ‘ Modified FIG. 27i’ above. Therefore, the plane of the center axis MUST also be perpendicular to the middle portion).
Regarding claim 5, Kuroda discloses the vascular access instrument of claim 1, and Kuroda further discloses wherein a distal tip of the distal end is pointed in a proximal direction (see ‘Modified FIG. 27ii’ below).
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Regarding claim 21, Kuroda discloses the vascular access instrument of claim 1, and Kuroda further discloses wherein the single looped portion comprises a single loop or a plurality of concentric loops (see ‘Modified FIG. 27iii’ below)
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and wherein the single loop or each of the plurality of concentric loops comprises the center axis defining a plane that is oriented in the perpendicular direction with respect to the longitudinal axis of the vascular access device (see ‘Modified FIG. 27i’ above: each of the plurality of concentric loops as labeled in ‘Modified FIG. 27iii’ are retained within the center axis and plane shown in ‘Modified FIG. 27i’. The structures are labeled on separate modified figures to minimize overcrowding of the modified figure for visual clarity).
Regarding claim 22, Kuroda discloses the vascular access instrument of claim 1, and Kuroda further discloses wherein the single looped portion is measured (see ‘Modified FIG. 27iv” below)
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from a first point of alignment (see ‘Modified FIG. 27iv’ above where STRAIGHT alignment of straight middle portion==a “first point of alignment” changes to curved shape of single looped portion/ a second alignment) or contact traveling distally along the vascular access instrument from the proximal end of the vascular access device and wherein the single looped portion is positioned above or below the longitudinal axis of the vascular access device (see ‘Modified FIG. 27iv’ above).
Regarding claim 23, Kuroda discloses the vascular access device of claim 1, and Kuroda discloses further comprising an advancement tab (131, see FIG. 10 and FIG. 2 showing handle 100 with advancement tab 131 coupled to entire endoscope device) coupled to the proximal end (31, see FIG.10) of the single wire (25 forming loop 21, see FIG. 27), wherein the tab (131, see FIG. 10) extends through a slot (see FIG.10 and [0120-0121]: 131 extends from outside of device housing 3 to inside of device housing within the lumen. Therefore there must be a slot/ opening in the side of the housing to allow 131 into lumen) in a housing (3) of the vascular access device to facilitate advancement and retraction of the single wire through the vascular access device (see [0106-0107] and [0120-0123]: open/close by 130, advance/retract by 131, and expand/contract by 132. Therefore tab 131 specifically for advancing and retracting the wire.).
Response to Arguments
Applicant’s arguments with respect to the 35 U.S.C. § 102 claim rejections of claims 1, 4, and 5 under McLaren have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. All claims have now been rejected under Kuroda.
Applicant's arguments filed 10/23/25 in relation to Kuroda have been fully considered but they are not persuasive.
On page 9, Applicant submits that Kuroda’s vascular access instrument requires the presence of the two jaws (11/12, see FIG. 27) and the secondary wire (22) to remove an occlusion. However, the examiner disagrees with this characterization of the rejection.
First, the examiner has set forth that the jaws are part of the vascular access device where the vascular access instrument is “configured to be inserted” (see claim 1 rejection above). Therefore, the jaws, as argued by Applicant, cannot reasonably be considered a part of the vascular access instrument. Thus, the vascular access instrument does not require the jaws to perform the function of removing an occlusion.
Next, the examiner has set forth that the vascular instrument is the single wire (wire 25 forming top loop 21) forming the single looped portion (see ‘Modified FIG. 27’ in the rejection of claim 1 above for reference). Therefore, the secondary wire (wire 25 forming lower loop 22 as shown in FIG. 27) cannot reasonably be considered part of the vascular access instrument. Thus, the vascular access instrument does not require the secondary wire to perform the function of removing an occlusion.
Thus, Applicant has failed to meet the burden of showing that the introduction of additional components (i.e.: the jaws and/or the secondary wire) would materially change the characteristics of the invention (see MPEP § 2111.03.III). Subsequently, the examiner was not persuaded by Applicant’s submission that the Kuroda’s vascular access instrument requires the jaws and secondary wire.
To explain further, Kuroda’s vascular access instrument, as cited by the examiner, is formed of a single wire (wire 25 forming top loop 21) in a spiral 2D shape (see [0171]), is formed of shape memory alloy (see [0172]), and comes into direct contact with tissue (see [0174]). Therefore, regardless of any other system components, Kuroda’s single wire itself would have the same shape (the 2D spiral), the same stiffness (from the selected shape memory alloy material), and same capability for contacting tissue/ an occlusion within a vasculature. Thus, Kuroda’s single wire (25 forming top loop 21) could be deployed through any vascular access device (such as the vascular access device of the current Application) and would still maintain functionality of the single wire vascular access instrument. Therefore, the examiner maintains that Kuroda’s vascular access instrument as set forth in the rejection meets all claim limitations. Again, Applicant has failed to meet the burden of showing that the introduction of additional components (i.e.: the jaws and/or the secondary wire) would materially change the characteristics of the invention (see MPEP § 2111.03.III: “consisting essentially of”).
Applicant is encouraged to amend the claim language to recite further structural elements that distinguish the current invention from the prior art in order to overcome the current rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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