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 4/23/26 has been entered. Claims 13 and 20 are amended. Claim 19 is canceled. Claims 1- 18 and 20 are being addressed by this Action.
Response to Arguments
1. It is noted Amended Claim 13 changed the scope of dependent claims 14- 18 and 20.
2. Claim 9 recites “The thrombectomy system of claim 1, wherein the at least one debulking element is at least one self-expanding debulking basket and comprises:
a fenestrated structure extending between a proximal collar and a distal collar, the fenestrated structure defining a plurality of openings permitting fluid flow through the debulking element while capturing solid material within the self-expanding debulking basket;
wherein the proximal collar is fixedly attached to the inner catheter and the distal collar is slidably attached to the inner catheter, wherein the distal collar slides distally along the inner catheter when the self-expanding debulking basket is radially constrained to collapse the self- expanding debulking basket and slides proximally along the inner catheter to expand the self- expanding debulking basket.”
Since claim 1 recites “at least one debulking element positioned on the outer catheter proximal to the adjustable basket” in lines 9- 10, there is no drawing reflecting the proximal at least one debulking element that is attached to the inner catheter. As such, the drawing objection and specification objection relating to claim 9 is reiterated below.
3. Claim 15 recites “ The thrombectomy system of claim 13, further comprising:
an adjustable basket having a fenestrated structure extending between an additional proximal collar and an additional distal collar;
wherein:
the additional proximal collar is attached to a distal end of the outer catheter and the additional distal collar is attached to a distal end of the inner catheter;
the expandable brush element is distal to the adjustable basket;
the fenestrated structure comprises a body portion having a plurality of struts for engaging clot material and defining flow openings permitting fluid flow through the fenestrated structure; and
the body portion defines a mouth at a proximal end of the body portion and a closed distal end tapering to the distal collar.
Since claim 13 recites “an expandable brush element positioned between a proximal collar and a distal collar, wherein the proximal collar is attached to a distal end of the outer catheter and the distal collar is attached to a distal end of the inner catheter” in lines 5- 7, there is no drawing reflecting an adjustable basket that is proximal to the expandable brush element AND having the additional proximal collar is attached to a distal end of the outer catheter and the additional distal collar is attached to a distal end of the inner catheter. That is to say, there is no drawing showing an opening in the outer catheter allowing the distal collar of the proximal adjustable basket to reach the inner catheter location. As such, the drawing objection and specification objection relating to claim 15 is reiterated below.
4. The drawings were received on 4/23/26. The drawing objection made in regards to claims 19 and 20 have been obviated by the corrected drawings. As such, the drawing objection made in regards to claims 19 and 20 have been withdrawn.
5. Applicant’s argument against a 112(f) interpretation of debulking element in claim 1 is not persuasive. As cited on pp. 10- 11 of applicant’s Remarks, the debulking element is described as “debulking element (e.g. basket) 10.” It is well known that the definition of “e.g.” (exempli gratia in Latin) is “for example.” That is to say, “element” is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function of debulking and a basket, for example, is a structural term for performing the claimed function of debulking. As such, the claim interpretation under 35 U.S.C. 112(f) is reiterated below.
6. Applicant’s arguments, see pp. 11- 12 of applicant’s Remarks, filed 4/23/26, with respect to the rejection of claims 13- 14, 16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konya et al. (US Pat. No. 6,146,396) have been fully considered and are persuasive. The rejection of claims 13- 14, 16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konya et al. (US Pat. No. 6,146,396) have been withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: debulking element in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Debulking element is interpreted as a debulking basket, basket or functional equivalents, optionally expanded within the clot material to separately mobilize portions of the clot material proximal to the coring basket (See applicant’s Specification at p. 2, l. 30- p. 3, l. 1 and p. 3, l. 11- 12).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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. Therefore, the:
9. The thrombectomy system of claim 1, wherein the at least one debulking element is at least one self-expanding debulking basket and comprises:
a fenestrated structure extending between a proximal collar and a distal collar, the fenestrated structure defining a plurality of openings permitting fluid flow through the debulking element while capturing solid material within the self-expanding debulking basket;
wherein the proximal collar is fixedly attached to the inner catheter and the distal collar is slidably attached to the inner catheter, wherein the distal collar slides distally along the inner catheter when the self-expanding debulking basket is radially constrained to collapse the self-expanding debulking basket and slides proximally along the inner catheter to expand the self-expanding debulking basket.
15. The thrombectomy system of claim 13, further comprising:
an adjustable basket having a fenestrated structure extending between an additional proximal collar and an additional distal collar;
wherein:
the additional proximal collar is attached to a distal end of the outer catheter and the additional distal collar is attached to a distal end of the inner catheter;
the expandable brush element is distal to the adjustable basket;
the fenestrated structure comprises a body portion having a plurality of struts for engaging clot material and defining flow openings permitting fluid flow through the fenestrated structure; and
the body portion defines a mouth at a proximal end of the body portion and a closed distal end tapering to the distal collar.
must be shown 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
9. The thrombectomy system of claim 1, wherein the at least one debulking element is at least one self-expanding debulking basket and comprises:
a fenestrated structure extending between a proximal collar and a distal collar, the fenestrated structure defining a plurality of openings permitting fluid flow through the debulking element while capturing solid material within the self-expanding debulking basket;
wherein the proximal collar is fixedly attached to the inner catheter and the distal collar is slidably attached to the inner catheter, wherein the distal collar slides distally along the inner catheter when the self-expanding debulking basket is radially constrained to collapse the self-expanding debulking basket and slides proximally along the inner catheter to expand the self-expanding debulking basket.
15. The thrombectomy system of claim 13, further comprising:
an adjustable basket having a fenestrated structure extending between an additional proximal collar and an additional distal collar;
wherein:
the additional proximal collar is attached to a distal end of the outer catheter and the additional distal collar is attached to a distal end of the inner catheter;
the expandable brush element is distal to the adjustable basket;
the fenestrated structure comprises a body portion having a plurality of struts for engaging clot material and defining flow openings permitting fluid flow through the fenestrated structure; and
the body portion defines a mouth at a proximal end of the body portion and a closed distal end tapering to the distal collar.
Claim Objections
Claim 4 is objected to because of the following informalities: it is noted “wherein the second direction is a distal direction and the fenestrated structure of the adjustable basket is radially contract in response to the handle assembly axially advancing the inner catheter in the distal direction” includes a typographical error and to correct it, the claim could be amended to - - wherein the second direction is a distal direction and the fenestrated structure of the adjustable basket is radially contracted in response to the handle assembly axially advancing the inner catheter in the distal direction - - or it could be amended to - - wherein the second direction is a distal direction and the fenestrated structure of the adjustable basket is radially collapsed in response to the handle assembly axially advancing the inner catheter in the distal direction - - to maintain consistent claim terminology. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: line 4 - - “the body portion proximate opposed sides of the mouth” should be amended to - - [[the]] a body portion proximate opposed sides of the mouth - - since it is clear that the mouth has a body portion proximate thereto, amending the claim would provide proper antecedent basis. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: line 8- 9 – “sliding the inner catheter in a proximal direction relative to the outer catheter enlarges at least the proximal end of body portion and an effective diameter of the mouth” should be amended to - - sliding the inner catheter in the first direction relative to the outer catheter enlarges at least the proximal end of body portion and an effective diameter of the mouth - - to maintain claim consistency. It is noted claim 3 recites “wherein the first direction is a proximal direction” in lines 1- 2. Alternatively, the dependency of claim 7, from which claim 8 depends, could be amended to be dependent off claim 3 in order to maintain consistent claim terminology. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: “The thrombectomy system of claim 1, wherein the at least one debulking element is at least one self-expanding debulking basket and comprises: a fenestrated structure extending between a proximal collar and a distal collar, the fenestrated structure defining a plurality of openings permitting fluid flow through the debulking element while capturing solid material within the self-expanding debulking basket; wherein the proximal collar is fixedly attached to the inner catheter and the distal collar is slidably attached to the inner catheter, wherein the distal collar slides distally along the inner catheter when the self-expanding debulking basket is radially constrained to collapse the self- expanding debulking basket and slides proximally along the inner catheter to expand the self- expanding debulking basket” should be amended to - - The thrombectomy system of claim 1, wherein the at least one debulking element is at least one self-expanding debulking basket and comprises: a fenestrated structure extending between a proximal collar and a distal collar, the fenestrated structure defining a plurality of openings permitting fluid flow through the debulking element while capturing solid material within the self-expanding debulking basket; wherein the proximal collar is fixedly attached to the [[inner]] outer catheter and the distal collar is slidably attached to the [[inner]] outer catheter, wherein the distal collar slides distally along the [[inner]] outer catheter when the self-expanding debulking basket is radially constrained to collapse the self- expanding debulking basket and slides proximally along the inner catheter to expand the self- expanding debulking basket - - to be consistent with Figs. 2- 4 showing the debulking elements (e.g., baskets) 10a, 10b are positioned on the outer catheter 12 proximal to the coring basket 8 at a predetermined distance. Appropriate correction is required.
Claim 10 is objected to because it depends off claim 9.
Claim 15 is objected to because of the following informalities: “The thrombectomy system of claim 13, further comprising: an adjustable basket having a fenestrated structure extending between an additional proximal collar and an additional distal collar; wherein: the additional proximal collar is attached to a distal end of the outer catheter and the additional distal collar is attached to a distal end of the inner catheter; the expandable brush element is distal to the adjustable basket; the fenestrated structure comprises a body portion having a plurality of struts for engaging clot material and defining flow openings permitting fluid flow through the fenestrated structure; and the body portion defines a mouth at a proximal end of the body portion and a closed distal end tapering to the distal collar” should be amended to - - The thrombectomy system of claim 13, further comprising: an adjustable basket having a fenestrated structure extending between an additional proximal collar and an additional distal collar; wherein: the additional proximal collar is attached to the outer catheter and the additional distal collar is attached to the outer catheter; the expandable brush element is distal to the adjustable basket; the fenestrated structure comprises a body portion having a plurality of struts for engaging clot material and defining flow openings permitting fluid flow through the fenestrated structure; and the body portion defines a mouth at a proximal end of the body portion and a closed distal end tapering to the distal collar - - to be consistent with Figs. 2- 4 showing the debulking elements (e.g., baskets) 10a, 10b are positioned on the outer catheter 12 proximal to the coring basket 8 at a predetermined distance. Appropriate correction is required.
Allowable Subject Matter
Claims 4, 8- 10 and 15 would be allowable if rewritten to overcome the applicable drawing and claim informalities, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
Claims 1- 3, 5- 7, 11 - 14, 16- 18 and 20 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 1, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, an adjustable basket having a fenestrated structure extending between a proximal collar and a distal collar, wherein the proximal collar is attached to a distal end of the outer catheter and the distal collar is attached to a distal end of the inner catheter; at least one debulking element positioned on the outer catheter proximal to the adjustable basket; and wherein the fenestrated structure is radially expanded by sliding the inner catheter in a first direction relative to the outer catheter and is radially collapsed by sliding the inner catheter in a second direction opposite the first direction relative to the outer catheter.
Regarding claim 13, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the expandable brush element includes: a first radially projecting disc having a first outer diameter; a second radially projecting disc having a second outer diameter; and wherein the first outer diameter is different from the second outer diameter; and wherein the expandable brush element is radially expanded by sliding the inner catheter in a proximal direction relative to the outer catheter and is radially collapsed by sliding the inner catheter in a distal direction relative to the outer catheter.
The closest prior art references include:
Wijeratne (US Pub. No. 2008/0147110 A1) teaches an inner catheter (320) (Figs. 4A- 4D) and an outer catheter (310) (Figs. 4A- 4D), but since the inner catheter (320) extends from proximal collar 130 to distal collar 134 (P. [0040]), Wijeratne does not teach or suggest, alone or in combination, wherein the inner catheter is slidably received within the outer catheter lumen such that the inner catheter is slidable relative to the outer catheter.
Bonnette et al. (US Pub. No. 2010/0268264 A1 - -cited in the IDS filed 8/07/24) teaches a guidewire (22) (Figs. 1- 2, 4- 48); an outer catheter (12) (Figs. 1- 2, 4- 48) defining an outer catheter lumen, wherein the guidewire is slidably received within the outer catheter lumen such that the guidewire is slidable relative to the outer catheter, but Bonnette does not teach or suggest, alone or in combination, an inner catheter; an outer catheter defining an outer catheter lumen, wherein the inner catheter is slidably received within the outer catheter lumen such that the inner catheter is slidable relative to the outer catheter; an adjustable basket having a fenestrated structure extending between a proximal collar and a distal collar, wherein the proximal collar is attached to a distal end of the outer catheter and the distal collar is attached to a distal end of the inner catheter.
Besselink (US Pub. No. 2019/0223995 A1) teaches a reverse-type device placed on the distal side of the operator such that the filter is placed in a direction where the blood flows towards the operator such that when a filter is placed upstream, it is moved in a direction against the blood flow (Abstract) including: an inner catheter (195) (Figs. 8a, 8d); an outer catheter (197) (Figs. 8a- 8c) defining an outer catheter lumen, wherein the inner catheter (195) is slidably received within the outer catheter lumen such that the inner catheter (195) is slidable relative to the outer catheter (197); an adjustable basket (181) (Figs. 8a, 8b) having a fenestrated structure extending between a proximal collar (191) (Figs. 8a, 8b) and a distal collar (192) (Figs. 8a, 8b), wherein the proximal collar (191) is attached to a distal end of the outer catheter (197) and the distal collar (192) is attached to a distal end of the inner catheter (195) (Ps. [0067], [0068] - - Mounting the filter on a single filter holder tube has one disadvantage. Upon collapsing, the conical filter membrane, the frame itself and the retrieval wires all will get a larger axial length and therefore the membrane will get creased somehow; Therefore a slightly different design is showed in FIGS. 8a-e, where rings 192 and 191 are not mounted on the same filter holder tube. Ring 192 still connects the retrieval wires to the distal end of a smaller filter holder tube 195, but ring 191 connects the tip of the filter membrane 190 directly to an additional outer tube 197 that can move back and forth over the surface of the filter holder tube 195. Both tubes 195 and 197 have proximal manipulator rings 198 and 196, respectively. The operator can pull the two rings 198 and 196 close to each other to stretch the filter and make withdrawal into the sheath 130 easier and prevent creasing of the membrane). Besselink does not teach or suggest, alone or in combination, at least one debulking element positioned on the outer catheter proximal to the adjustable basket; and wherein the fenestrated structure is radially expanded by sliding the inner catheter in a first direction relative to the outer catheter and is radially collapsed by sliding the inner catheter in a second direction opposite the first direction relative to the outer catheter.
Ganske et al. (US Pub. No. 2023/0063821 A1 - - cited in the IDS filed 8/07/24) teaches a catheter shaft (134) defining a catheter shaft lumen (136); an adjustable basket (126A) having a fenestrated structure extending between a proximal collar (132) and a distal collar (128); at least one debulking element (126B) positioned proximal to the adjustable basket (126) (P. [0074] - - the filter assembly 124 can comprise at least two component filter baskets 126A, 126B connected by an intermediate collar 132. In at least one embodiment, the filter baskets 126A, 126B and intermediate collar 132 include a unitary fenestrated body, such as a laser cut hypotube. The intermediate collar 132 is, in one example, movably coupled along the catheter shaft 134), but Ganske does not teach or suggest, alone or in combination, an inner catheter; an outer catheter defining an outer catheter lumen, wherein the inner catheter is slidably received within the outer catheter lumen such that the inner catheter is slidable relative to the outer catheter.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Tuesday and Wednesday 9:00a- 5:00p PST.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771
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