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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 in the reply filed on 06/29/2026 is acknowledged. Claims 11-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/17/2025, 04/15/2025, 07/15/2025, 10/13/2025, 01/23/2026, 04/23/2026, and 07/02/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Figure 1A, reference numbers (15) and (101).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Paragraph [0055], refers to the following features with respect to Figures 2A-2G: advancement mechanism (60), guidewire lumen (85), and one or more inflation lumens (70). None of these reference numbers are shown in the Figures 2A-2G embodiment.
Paragraph [0060], refers to the following features with respect to Figures 3A-3C: guidewire lumen (85) and inflatable members (65). Both of these reference numbers are not shown in the Figures 3A-3C embodiment.
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. 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.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc.
The abstract of the disclosure is objected to because:
It includes the following phrases, “The present technology relates to…” and “…the present technology is directed to…,” both phrases are phrases that can be implied. The abstract should avoid using phrases which can be implied.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Under the section, “Claim of Priority and Related Application” in paragraph [0001], Applicant states that the current application claims priority to the provisional application 63/365,376, however, the Application Data Sheet of the current application states/documents that the current application claims 371 priority to application PCT/US2023/067551 filed on 05/26/2023 and the PCT claims priority to the provisional application 63/365,376 filed on 05/26/2022. Paragraph [0001] should be amended to reflect this accurately.
Paragraph [001] should be amended to the following, “In another aspect, the system includes an expandable funnel disposed near a proximal end of the compliant shaft. In another aspect, the system comprises an aspiration lumen disposed in the compliant shaft. In some aspects, the system includes one or more fluid ports disposed in the compliant shaft and configured to direct two or more fluid streams into the expandable funnel.”
Paragraph [0055] should be amended to the following, “In some embodiments, the ports are formed to direct the fluid flow along a selected path. In some embodiments, at least two ports are arranged to produce (e.g., respective) fluid streams that intersect at an intersection region of the thrombus removal system. An intersection region can be a region of increased fluid momentum and/or energy transfer, which increase is with respect to individual fluid streams that are not directed to combine at the intersection. The increased fluid momentum and/or energy transfer at an intersection may advantageously fragment thrombus more efficiently and/or quickly. In some embodiments, an intersection region can be formed from at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, or at least 10 fluid streams. An intersection region can be generally near a central axis of the thrombus removal system, or away from the central axis. In some embodiments, at least two intersection regions are formed. In some embodiments, one or more are arranged to direct a fluid stream along an oblique angle with respect to the central axis of the thrombus removal system. An operating pressure of the fluid delivery mechanism may be selected to approach a targeted fluid velocity for a fluid stream that is delivered from a port. In some embodiments, at least two ports are adapted for delivery of respective fluid streams at different fluid velocities, for a given pressure of the fluid delivery mechanism. In some embodiments, at least two ports are adapted to delivery respective fluid streams at the substantially the same fluid velocities, for a given pressure of the fluid delivery mechanism. In some embodiments, angular momentum is imparted to a thrombus by application of a) at least one fluid stream that is directed at an oblique angle from a port, and/or b) at least two fluid streams that have different fluid velocities. Advantageously, angular momentum produced in a thrombus may impart a (e.g., centrifugal) force that assists in fragmentation and removal of the thrombus. Advantageously, an increased cross-sectional area of the fluid lumen reduces a required operating pressure of the fluid delivery mechanism to achieve a targeted fluid velocity of the fluid streams.”
Appropriate correction is required.
Claim Objections
Claims 1-2, 8, and 10 are objected to because of the following informalities:
Claim 1 is missing an “and” after “a compliant shaft;” and “a lumen configured to receive a guidewire;” such that they become, “a compliant shaft; and” and “a lumen configured to receive a guidewire; and”
Claim 2 is missing a comma and should be amended to the following, “The system of claim 1, wherein the plurality of inflatable members comprise inflatable walls of a plurality of inflation lumens.”
Claim 8 states, “an expandable funnel disposed near a proximal end of the compliant shaft,” this appears to be a typographical error. The specification consistently describes the expandable funnel at the distal end (see, e.g., Paragraph [0050] and Figures 1-1A). For purposes of examination will be interpreted as “The system of claim 1, further comprising an expandable funnel disposed near a distal end of the compliant shaft.” Examiner notes, Applicant may have to amend paragraph [0011] of the specification which also misidentifies the end versus Figures 1-1A and paragraph [0050].
Claim 10 should be amended to the following to fix a minor grammatical error, “The system of claim 9, further comprising one or more fluid ports disposed in the compliant shaft and configured to direct two or more fluid streams into the expandable funnel.”
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 1-10 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, “A medical system, comprising: a compliant shaft; a guidewire system coupled to the compliant shaft, the guidewire system including: a lumen configured to receive a guidewire; and a plurality of inflatable members disposed along the lumen, the plurality of inflatable members being configured to be inflated sequentially to engage with the guidewire and decrease a length of the lumen to cause the guidewire system and compliant shaft to advance along the guidewire.” It is unclear what structure constitutes “the lumen” whose length is decreased. The guidewire-receiving lumen is generally a through-lumen of substantially fixed internal geometry. The specification describes axial shortening of the guidewire system/advancement mechanism section (or the compliant shaft) via a bellows/accordion effect when the inflatable members are inflated (see Paragraphs [0056]-[0059] and Figures. 2A-2G). The claim language mixes these concepts, rendering the metes and bounds unclear. For purposes of examination, claim 1 will be interpreted as attempting to claim the inchworm-style advancement mechanism described in the specification (sequential inflation/deflation of annular or H-shaped members that grip a guidewire and axially shorten the device). Similarly, claim 3 recites, “to decrease the length of the lumen.” Thus, because of the imprecise language, the claim fails the Nautilus “reasonable certainty” standard. Prior art will be applied using the specification’s disclosed structures.
Claims 2-10 are rejected by virtue of their dependency on claim 1. Also, claim 4 is rejected by virtue of its dependency on claim 3.
Claim 2 recites, “wherein the plurality of inflatable members comprise inflatable walls of a plurality of inflation lumens.” This language is confusing and unclear. It is not apparent whether the inflatable members are separate structures or merely expanded wall portions of the inflation lumens. While the specification provides some support (Paragraphs [0006] & [0055]), the claim fails to clearly define the relationship. For purposes of examination, claim 2 is interpreted as the deformable-wall embodiment shown in FIGS. 2A–2B. The claim will be examined accordingly but remains indefinite.
Claim 9 recites, “further comprising an aspiration lumen disposed in the compliant shaft.” The introduction of “an aspiration lumen disposed in the compliant shaft” highlights the antecedent and structural ambiguity in Claim 1’s “lumen.” It is unclear whether Claim 1’s lumen is the same as, or different from, the aspiration lumen.
Claim 10 is rejected by virtue of its dependency on claim 9.
Claim 10 recites, “further comprising one or more fluid ports disposed in the compliant shaft and configured to direct two or more fluid streams into the expandable funnel.” The limitation, “configured to direct two or more fluid streams into the expandable funnel” is unclear in scope. The specification primarily describes jets directed toward thrombus engaged with or near the funnel, not necessarily streams directed into the interior volume of the funnel.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hassidov (US 2010/0022947 A1).
Regarding claim 1, as best understood in view of the 112(b) rejection above, Hassidov discloses, a medical system (Figures 1 and 10A-10G, tip-propelled catheter device (15); Paragraphs [0079] & [0104]), comprising:
a compliant shaft (Figures 10A-10G, shaft forming working channel (71) and having tip (73); Paragraphs [0104]-[0105]); and
a guidewire system (Figures 8A & 10A-10G, balloons (78A, 78B, & 78C), balloon wall (79A), separator sections (70A, 70B, & 70C), flow delaying orifices (75), supply line/pipe (76), & walls (5) forming internal channel (6); Paragraphs [0097] & [0105]) coupled to the compliant shaft (Figures 10A-10G; Paragraphs [0104]-[0106]), the guidewire system including:
a lumen (Figures 10A-10G, working channel (71)) configured to receive a guidewire (Figures 8A and 10A-10G, the wire/shaft formed by walls (5) and having internal channel (6) is considered as the guidewire and as clearly seen is received within working channel (71); Paragraphs [0097] & [0105]-[106]; Further, Paragraph [0096] states, “…the embodiments of FIGS. 7A-7B show a guidewire running axially through the center of the device, it is to be understood that this arrangement could equally be applicable for an embodiment with a channel running through the device. It is to be understood that this comment, and its reverse, is applicable for all of the embodiments shown in the application having axially running elements. Such elements can generally be guide wires or channels…” As such, it is completely reasonable for one of ordinary skill in the art to consider the wire/shaft formed by walls (5) and having internal channel (6) as a guidewire); and
a plurality of inflatable members (Figures 10A-10G, balloons (78A, 78B, & 78C)) disposed along the lumen (working channel (71)) (Figures 10A-10G; Paragraph [0105]), the plurality of inflatable members (balloons (78A, 78B, & 78C)) being configured to be inflated sequentially (Paragraphs [0090], [0101], & [0138]) to engage with the guidewire (shaft/wire formed by walls (5)) and decrease a length of the lumen (working channel (71)) to cause the guidewire system and compliant shaft to advance along the guidewire (Paragraph [0080]-[0081]).
Regarding claim 2, as best understood in view of the 112(b) rejection above, Hassidov further discloses, wherein the plurality of inflatable members (balloons (78A, 78B, & 78C)) comprise inflatable walls (Figures 10A-10G, balloon wall (79A)) of a plurality of inflation lumens (Figures 10A-10G, supply pipe (76) & orifices (75)) (Paragraph [0105]).
Regarding claim 5, Hassidov further discloses, wherein the plurality of inflatable members (balloons (78A, 78B, & 78C)) are annular balloons (Paragraph [0097]).
Regarding claim 7, Hassidov further discloses, wherein the compliant shaft (shaft forming working channel (71) and having tip (73)) comprises a thrombectomy device (Intended use limitation; Paragraph [0104] discloses, “At the very tip of the device 74, endoscopic surveillance can be conducted and/or therapeutic tools can be applied to the inside of the passageway.” Further support is found in paragraphs [0098] and [0120]; Paragraph [0001] discloses, that the present invention is intended for vascular use; Thus, coupling the vascular use disclosure with the introduction of therapeutic tools through the Figures 10A-10G embodiment, vascular applicability is inherent (capable of including/having/comprising a thrombectomy device); Figure 21B & Paragraph [0136], disclosing/illustrating incorporate a therapeutic, steerable device for performing surgical procedures within the lumen).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Figures 10A-10G of Hassidov, in view of the embodiment of Figures 14A-14B of Hassidov.
Regarding claim 3, as best understood in view of the 112(b) rejection above, the embodiment of Figures 10A-10G of Hassidov teaches, wherein the plurality of inflatable members (balloons (78A, 78B, & 78C)) are configured to be inflated sequentially from a proximal-most inflatable member to a distal-most inflatable member to decrease the length of the lumen (Figures 10A-10D; Paragraphs [0080]-[0083], [0101], & [0106]).
The embodiment of Figures 10A-10G of Hassidov fails to teach, wherein the plurality of inflatable members are configured to be inflated sequentially from a distal-most inflatable member to a proximal-most inflatable member to decrease the length of the lumen.
The embodiment of Figures 14A-14B of Hassidov teaches, wherein the plurality of inflatable members (Figures 14A-14B, balloons (112A-112D)) are configured to be inflated sequentially from a distal-most inflatable member (Figures 14A-14B, distal balloon (112D)) to a proximal-most inflatable member (Figures 14A-14B, proximal balloon (112A)) to decrease the length of the lumen (Paragraphs [0112]-[0114]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the embodiment of Figures 10A-10G of Hassidov such that the plurality of inflatable members are configured to be inflated sequentially from a distal-most inflatable member to a proximal-most inflatable member to decrease the length of the lumen as taught by the embodiment of Figures 14A-14B of Hassidov, as both embodiments of Hassidov and the claimed invention are directed to balloon-assisted catheter locomotion/inchworm catheters. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embodiment of Figures 10A-10G of Hassidov such that the plurality of inflatable members are configured to be inflated sequentially from a distal-most inflatable member to a proximal-most inflatable member to decrease the length of the lumen as taught by the embodiment of Figures 14A-14B of Hassidov, as such a modification would have been predictable, namely, enable backward or forward motion of the catheter and anchoring the catheter/device at the intended working point in the body lumen (Paragraphs [0112]-[0114] of Hassidov).
Regarding claim 4, the modified embodiment of Figures 10A-10G of Hassidov teaches, wherein inflation of the distal-most inflatable member is configured to anchor the guidewire system to the guidewire (Paragraphs [0080] & [0114]; balloons, including a distal balloon anchors/locks against the guidewire (Figures 10A-10G) while proximal portions advance or reset).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassidov, in view of Laby (US 2018/0071492 A1).
Regarding claim 6, Hassidov teaches, wherein the plurality of inflatable members (balloons (78A, 78B, & 78C)) are annular balloons (Paragraph [0097]).
Hassidov does not explicitly teach, the plurality of inflatable members are H-shaped annular balloons.
Laby discloses, a catheter with a balloon array articulation and propulsion system. Laby teaches, a plurality of inflatable members are H-shaped annular balloons.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to shape the annular balloons of Hassidov in any desired shape, such as H-shapes, as taught by Laby, as both references and the claimed invention are directed to catheters with a balloon array articulation and propulsion system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to shape the annular balloons of Hassidov in any desired shape, such as H-shapes, as taught by Laby, as such a modification would have been predictable, namely, to better control the articulation and propulsion of the catheter.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassidov, in view of Culhane (US 2017/0136158 A1).
Regarding claim 8, Hassidov teaches, tip (73) at the distal end of the compliant shaft (Figures 10A-10G; Paragraph [0104]).
Hassidov fails to teach, further comprising an expandable funnel disposed near a distal end of the compliant shaft.
Culhane discloses, a catheter system for use in the vasculature. Culhane teaches, an expandable funnel (Figures 2A-2H, funnel (20)) disposed near a distal end (Figure 2A, distal end (11)) of the compliant shaft (Figures 1-2H, cannula (10)) (Paragraphs [0054]-[0055] and [0057]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to substitute the tip at the distal end of the compliant shaft of Hassidov for the expandable funnel taught by Culhane, as both references and the claimed invention are directed to catheter systems that require guidance/propulsion to an intervention site. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the tip at the distal end of the compliant shaft of Hassidov for the expandable funnel taught by Culhane, as such a modification would have been predictable, namely, to better engage and capture the undesirable material substantially en bloc and without significant fragmentation (Paragraph [0057] of Culhane).
Regarding claim 9, as best understood in view of the 112(b) rejection above, Hassidov teaches, the lumen (working channel (71)).
Hassidov does not explicitly teach, further comprising an aspiration lumen disposed in the compliant shaft.
Culhane teaches, an aspiration lumen (Figures 1-2H, pathway (12)) disposed in the compliant shaft (cannula (10)) (Paragraph [0054]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to configure the lumen of Hassidov for aspiration as taught by Culhane, as both references and the claimed invention are directed to catheter systems that require guidance/propulsion to an intervention site. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the lumen of Hassidov for aspiration as taught by Culhane, as such a modification would have been predictable, namely, provide a passage along which the captured material and circulatory fluid, such as blood, that may be captured may be transported and directed away from the site of interest (Paragraph [0054] of Culhane).
Regarding claim 10, as best understood in view of the 112(b) rejection above, Hassidov teaches, the compliant shaft (shaft forming working channel (71) and having tip (73)).
Hassidov fails to teach, further comprising one or more fluid ports disposed in the compliant shaft and configured to direct two or more fluid streams into the expandable funnel.
Culhane teaches, one or more fluid ports disposed in the compliant shaft (cannula (10)) and configured to direct two or more fluid streams into the expandable funnel (funnel (20)) (Paragraphs [0016] and [0127], describing rheolytic thrombectomy at the distal end/funneled end, which involves a minimally invasive procedure that uses high-pressure saline jets and the Venturi (Bernoulli) effect to fragment and vacuum blood clots out of arteries and veins, inherently requiring one or more fluid ports to direct two or more fluid streams).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/substitute the compliant shaft of Hassidov for expandable shaft taught by Culhane, such that at the distal end the shaft has the expandable funnel and includes one or more fluid ports to direct two or more fluid streams into the expandable funnel, as both references and the claimed invention are directed to catheter systems that require guidance/propulsion to an intervention site. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify/substitute the compliant shaft of Hassidov for expandable shaft taught by Culhane, such that at the distal end of the shaft has the expandable funnel and includes one or more fluid ports to direct two or more fluid streams into the expandable funnel, as such a modification would have been predictable, namely, more distal clot can be targeted for removal through a combination therapy of suction removal augmented by clot dissolution, dislodgement and/or maceration treatment (Paragraph [0127] of Culhane).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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