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 Group I in the reply filed on 03/30/2026 is acknowledged.
Claim 27 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Drawings
The drawings have been received on 09/16/2024 and these drawings have been objected to under 37 CFR 1.84 for the following reasons: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures (see specifically poor shading in figs. 7a-e and 9a-11 and pixelation in most figures). New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the reasons stated above. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 17 and 22 are objected to because of the following informalities:
In claim 17, the term “reducing” should recite “reduce”.
In claim 22, the phrase “radially extending struts” should read “the radially and/or circumferentially extending struts” or similar language, to distinguish the struts and the plurality of axially extending spines previously introduced.
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 6-8, 11-16, 18-21, 23-24 and 26 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 6, the claim recites “the distal flare” in line 2. It is unclear whether the phrase is referring to the distal flared portion previously introduced, or introducing a new, separate structure. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a distal flare in the distal flared portion, which appears consistent with para. [0128] of the published application (see also figs. 7a-b).
Regarding claim 11, the claim recites “the funnel frame” in line 1. There is insufficient antecedent basis for this limitation in the claim, since a funnel frame has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a funnel frame.
Further, the claim recites “adjacent spines”. It is unclear if the phrase is referring to adjacent spines of the plurality of axially extending spines previously introduced, or introducing new, separate spines. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to adjacent spines of the plurality of axially extending spines.
Regarding claim 12, the claim recites “the proximal flare” in line 1. It is unclear whether the phrase is referring to the proximal flared portion previously introduced, or introducing a new, separate structure. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a proximal flare in the proximal flared portion, which appears consistent with para. [0128] of the published application (see also figs. 7a-b).
Further, the claim recites “each of the plurality of axially extending spines”. There is insufficient antecedent basis for this limitation in the claim, since a plurality of axially extending spines has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of a plurality of axially extending spines.
Regarding claim 13, the claim recites “the distal flare” in line 1. It is unclear whether the phrase is referring to the distal flared portion previously introduced, or introducing a new, separate structure. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a distal flare in the distal flared portion, which appears consistent with para. [0128] of the published application (see also figs. 7a-b).
Further, the claim recites “each of the plurality of radially and/or circumferentially extending struts”. There is insufficient antecedent basis for this limitation in the claim, since a plurality of radially and/or circumferentially extending struts has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of a plurality of radially and/or circumferentially extending struts.
Regarding claim 14, the claim recites “each of the plurality of radially and/or circumferentially extending struts”. It is unclear whether the phrase is referring to the struts previously introduced, or introducing new, separate struts, since a plurality of radially and/or circumferentially extending struts has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 15, the claim recites “a first hinge” in line 1. It is unclear whether the phrase is referring to a first hinge of the at least one hinge previously introduced, or introducing a new, separate hinge. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a first hinge of the at least one hinge previously introduced.
Further, the claim recites “each of the plurality of radially and/or circumferentially extending struts”. It is unclear whether the phrase is referring to the struts previously introduced, or introducing new, separate struts. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 16, the claim recites “a second hinge” in line 1. It is unclear whether the phrase is referring to a second hinge of the at least one hinge previously introduced, or introducing a new, separate hinge. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a second hinge of the at least one hinge previously introduced.
Further, the claim recites “the plurality of radially extending struts” in line 2. It is unclear whether the phrase is referring to the struts previously introduced, or introducing a new, separate plurality of struts. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 18, the claim recites “the plurality of radially and/or circumferentially extending struts”. It is unclear whether the phrase is referring to the struts previously introduced, or introducing a new, separate plurality of struts. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 19, the claim recites “the plurality of radially and/or circumferentially extending struts”. It is unclear whether the phrase is referring to the struts previously introduced, or introducing a new, separate plurality of struts. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 20, the claim recites “the plurality of radially and/or circumferentially extending struts”. It is unclear whether the phrase is referring to the struts previously introduced, or introducing a new, separate plurality of struts. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to each of the struts previously introduced.
Regarding claim 21, the claim recites “two layers of radially extending struts”. It is unclear whether the phrase is referring to the one or more layers of the struts previously introduced, or introducing new, separate layers. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to two layers of the one or more layers of struts previously introduced.
Regarding claim 23, the claim recites “wherein petals in a proximal layer… petals in a distal layer”. It is unclear whether the term “petals” is referring to the plurality of petals previously introduced, or introducing new, separate petals. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least one petal of the plurality of petals for each “petal” term.
Further, the claim recites “a proximal layer” and “a distal layer”. It is unclear whether the phrase is referring to a proximal layer and a distal layer of the one or more layers previously introduced, or introducing new, separate layers. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a proximal layer and a distal layer of the one or more layers previously introduced.
Regarding claim 24, the claim recites “at least six petals”. It is unclear whether the phrase is referring to at least six petals of the plurality of petals previously introduced, or introducing new, separate petals. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to at least six petals of the plurality of petals.
Regarding claim 26, the claim recites “wherein a distal-most portion of the expandable funnel comprises only compliant material with no funnel frame”. It is unclear what is being claimed, because the claim is contradictory. Claim 11, which claim 26 is dependent on, recites “the funnel frame”, such that it is unclear how no funnel frame is present when a funnel frame is previously claimed. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the expandable funnel comprising compliant material as meeting the claimed limitation.
Claims 7-8 are indefinite due to their dependency on indefinite base claim 6.
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.
Claim(s) 1 and 4-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kassab (US 2021/0186547 A1).
Regarding claim 1, Kassab discloses (see abstract; paras. [0072]-[0104]; figs. 1-66) a thrombus removal device (figs. 21-23), comprising:
an elongate catheter (1810, para. [0072]) having an aspiration lumen (vacuum lumen of 1810, abstract, para. [0091]; figs. 21-23 and 42-43) configured to be coupled to an aspiration source (external vacuum source, para. [0091]), and defining a longitudinal axis (figs. 21-23);
an expandable funnel (1830) coupled to the aspiration lumen and the elongate catheter (figs. 21-23), the expandable funnel including a proximal flared portion near the aspiration lumen (proximal portion of 1830, considered to be flared via shape of funnel) and a distal flared portion near a distal end of the expandable funnel (distal portion of 1830, considered to be flared via shape of funnel); and
one or more fluid ports (port of lumen, para. [0084]) disposed near or within the expandable funnel defining a fluid region (considered to define a fluid region, figs. 21-23).
Regarding claim 4, Kassab discloses the device of claim 1. Kassab further discloses wherein the proximal flared portion is configured to facilitate advancement of clots into the fluid region (vanes provide rigidity so cup 1830 can engage tissue of interest under suction/vacuum, proximal portion of 1830 considered to facilitate advancement of tissue into region including vanes, para. [0072]).
Regarding claim 5, Kassab discloses the device of claim 1. Kassab further discloses wherein the distal end of the expandable funnel is directed radially outwards (figs. 21-23).
Regarding claim 9, Kassab discloses the device of claim 1. Kassab further discloses wherein the expandable funnel further comprises a funnel frame (frame considered to be formed by structural vanes, figs. 21-23).
Regarding claim 10, Kassab discloses the device of claim 9. Kassab further discloses wherein the funnel frame comprises a shape memory material (nitinol suction cup which forms vanes, para. [0086]).
Regarding claim 11, Kassab discloses the device of claim 1. Kassab further discloses wherein the funnel frame comprises a plurality of axially extending spines (annotated fig. 22) and one or more layers of radially and/or circumferentially extending struts between adjacent spines (annotated fig. 22).
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Annotated Figure 22 of Kassab
Regarding claim 12, Kassab discloses the device of claim 1. Kassab further discloses wherein the proximal flare (entire cup 1830 considered to be flared, such that cup is considered to have a proximal flare in proximal flared region, figs. 21-23) is formed as a result of a bend in each of the plurality of axially extending spines (spines considered to be bent due to extending circumferentially around suction cup 1830, figs. 21-23).
Regarding claim 13, Kassab discloses the device of claim 1. Kassab further discloses wherein the distal flare (entire cup 1830 considered to be flared, such that cup is considered to have a distal flare in distal flared region, figs. 21-23) is formed as a result of a bend in each of the plurality of radially and/or circumferentially extending struts (struts considered to be bent due to circumferentially extending around cup 1830, figs. 21-23).
Regarding claim 14, Kassab discloses the device of claim 11. Kassab further discloses further comprising at least one hinge (considered to be deflection point of struts, para. [0127] of published application, annotated fig. 22 of Kassab) in each of the plurality of radially and/or circumferentially extending struts (figs. 21-23).
Regarding claim 15, Kassab discloses the device of claim 14. Kassab further discloses wherein a first hinge is disposed at a distal most portion of each of the plurality of radially and/or circumferentially extending struts (annotated fig. 21).
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Annotated Figure 21 of Kassab
Regarding claim 16, Kassab discloses the device of claim 15. Kassab further discloses wherein a second hinge is disposed at a junction between one of the plurality of radially extending struts and one of the plurality of axially extending spines (annotated fig. 21).
Regarding claim 17, Kassab discloses the device of claim 14. Kassab further discloses wherein the at least one hinge is configured to reducing a sheathing force of the expandable funnel (considered to reduce sheathing force by aiding in transition to collapsed configuration, para. [0086]; figs. 21-23).
Regarding claim 18, Kassab discloses the device of claim 14. Kassab further discloses wherein the at least one hinge is integral to the plurality of radially and/or circumferentially extending struts (figs. 21-23).
Regarding claim 19, Kassab discloses the device of claim 11. Kassab further discloses wherein the plurality of axially extending spines are stiffer than the plurality of radially and/or circumferentially extending struts (due to having a greater thickness, para. [0086]; figs. 21-23).
Regarding claim 20, Kassab discloses the device of claim 11. Kassab further discloses wherein the plurality of axially extending spines have a thickness greater than that of the plurality of radially and/or circumferentially extending struts (para. [0086]).
Regarding claim 21, Kassab discloses the device of claim 11. Kassab further discloses wherein the funnel frame comprises two layers of radially extending struts (considered to at least have two sets of struts, which appears consistent with para. [0126] of the published application describing layers as sets, figs. 21-23 of Kassab).
Regarding claim 25, Kassab discloses the device of claim 9. Kassab further discloses further comprising a compliant material attached to the funnel frame (nitinol considered to be a compliant material, para. [0086]).
Regarding claim 1, Kassab discloses (see abstract; paras. [0072]-[0104]; figs. 1-66), under an alternative interpretation with respect to the device, a thrombus removal device (figs. 32-33), comprising:
an elongate catheter (1810, para. [0088]) having an aspiration lumen (vacuum lumen of 1810, abstract, para. [0091]; figs. 42-43) configured to be coupled to an aspiration source (external vacuum source, para. [0091]), and defining a longitudinal axis (figs. 32-33);
an expandable funnel (1830) coupled to the aspiration lumen and the elongate catheter (figs. 32-33), the expandable funnel including a proximal flared portion near the aspiration lumen (proximal portion of 1830, considered to be flared via shape of funnel) and a distal flared portion near a distal end of the expandable funnel (distal portion of 1830, considered to be flared via shape of funnel); and
one or more fluid ports (port of lumen, para. [0084]) disposed near or within the expandable funnel defining a fluid region (considered to define a fluid region, figs. 32-33).
Regarding claim 6, Kassab discloses the device of claim 1. Kassab further discloses wherein the distal end of the expandable funnel curves proximally back towards the distal flare (via inversion, para. [0088]).
Regarding claim 7, Kassab discloses the device of claim 6. Kassab further discloses wherein the distal end is not bonded to the distal flare (portion of distal end considered to have a gap around crease when cup is inverted, i.e., portion distal of crease is not bonded to portion proximal of crease, para. [0088]; fig. 33).
Regarding claim 8, Kassab discloses the device of claim 6. Kassab further discloses wherein the distal end is bonded to the distal flare (materials of cup bonded together, paras. [0072] and [0084]).
Regarding claim 1, Kassab discloses (see abstract; paras. [0072]-[0104]; figs. 1-66), under an alternative interpretation with respect to the device, a thrombus removal device (fig. 3), comprising:
an elongate catheter (1810, para. [0072]) having an aspiration lumen (vacuum lumen of 1810, abstract, para. [0091]; fig. 3 and 42-43) configured to be coupled to an aspiration source (external vacuum source, para. [0091]), and defining a longitudinal axis (fig. 3);
an expandable funnel (1830) coupled to the aspiration lumen and the elongate catheter (fig. 3), the expandable funnel including a proximal flared portion near the aspiration lumen (proximal portion of 1830, considered to be flared via shape of funnel) and a distal flared portion near a distal end of the expandable funnel (distal portion of 1830, considered to be flared via shape of funnel); and
one or more fluid ports (port of lumen, para. [0084]) disposed near or within the expandable funnel defining a fluid region (considered to define a fluid region, fig. 3).
Regarding claim 11, Kassab discloses the device of claim 1. Kassab further discloses wherein the funnel frame comprises a plurality of axially extending spines (annotated fig. 3) and one or more layers of radially and/or circumferentially extending struts between adjacent spines (annotated fig. 3).
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Annotated Figure 3 of Kassab
Regarding claim 22, Kassab discloses the device of claim 11. Kassab further discloses wherein the plurality of axially extending spines and radially extending struts collectively form a plurality of petals in each of the one or more layers (area of suction cup between spines and struts considered to be petals, annotated fig. 3).
Regarding claim 23, Kassab discloses the device of claim 22. Kassab further discloses wherein petals in a proximal layer of the funnel frame are smaller than petals in a distal layer of the funnel frame (via distal portion of cup 1830 being larger than proximal portion, fig. 3).
Regarding claim 24, Kassab discloses the device of claim 22. Kassab further discloses further comprising at least six petals in each of the one or more layers (six petals/areas between spines and struts depicted in fig. 3).
Regarding claim 26, Kassab discloses the device of claim 24. Kassab further discloses wherein a distal-most portion of the expandable funnel comprises only compliant material with no funnel frame (material of cup considered to be compliant, frame as depicted in annotated fig. 3 is considered to not include vane 6010 along perimeter of distal end of cup, paras. [0072] and [0084]).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kassab.
Regarding claim 2, Kassab discloses the device of claim 1.
Kassab further discloses the distal end of the suction cup having a larger circumference than a proximal end of the suction cup (para. [0072]).
However, Kassab fails to explicitly disclose wherein a first diameter of the expandable funnel at the proximal flared portion is within 10% of a second diameter of the expandable funnel at the distal flared portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kassab to have a diameter of the proximal flared portion within 10% of a diameter of the distal flared portion, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kassab would not operate differently with the claimed diameter and since the shape of the suction cup is intended to be a funnel to move tissue into the cup for suctioning, the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter is “optionally” within the claimed range (para. [0134] of the published application).
Regarding claim 3, Kassab discloses the device of claim 1.
Kassab further discloses the distal end of the suction cup having a larger circumference than a proximal end of the suction cup (para. [0072]).
However, Kassab fails to disclose wherein a first diameter of the expandable funnel at the proximal flared portion is within 20% of a second diameter of the expandable funnel at the distal flared portion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kassab to have a diameter of the proximal flared portion within 20% of a diameter of the distal flared portion, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Kassab would not operate differently with the claimed diameter and since the shape of the suction cup is intended to be a funnel to move tissue into the cup for suctioning, the device would function appropriately having the claimed diameter. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the diameter is “optionally” within the claimed range (para. [0134] of the published application).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0103974 A1 to Osborne, disclosing a thrombectomy catheter.
US 2021/0196292 A1 to Vale, disclosing an intravascular catheter.
US 2020/0281611 A1 to Kelly, disclosing a retrieval catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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