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 .
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.
19. The thrombectomy system of claim 13, wherein the expandable brush element comprises: a first radially projecting disc having a first outer diameter; and a second radially projecting disc having a second outer diameter; wherein the first outer diameter is different from the second outer diameter.
20. The thrombectomy system of claim 19, wherein: the first outer diameter is about 12 to 14 mm and the second outer diameter is about 8 to 12 mm; and the expandable brush element is expandable to an outer diameter of about 16 mm
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 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) 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). Konya is cited in the IDS filed 8/07/24.
Regarding claim 13, Konya discloses a thrombectomy system for mechanically engaging clot, comprising:
an inner catheter (14) (Figs. 1- 9B);
an outer catheter (12) (Figs. 1- 7, 9A- 9B) defining an outer lumen, wherein the inner catheter (14) is slidably received within the outer lumen such that the inner catheter (14) is slidable relative to the outer catheter (12);
an expandable brush element (16) (Fig. 5) positioned between a proximal collar (22) and a distal collar (24), wherein the proximal collar (22) is attached to a distal end of the outer catheter (12) and the distal collar (24) is attached to a distal end of the inner catheter (14); and
wherein the expandable brush element (16) is radially expanded by sliding the inner catheter (14) in a proximal direction relative to the outer catheter (12) and is radially collapsed by sliding the inner catheter (14) in a distal direction relative to the outer catheter (12) (Col. 11, l. 10- 11, Col. 9, l. 7- 22 - - Turning now to FIG. 5, there is shown a declotting apparatus 10 similar in design to the apparatus shown in FIG. 4; Turning now to FIG. 4, there is shown a declotting apparatus 10 that includes a catheter 12, a member 14, a plurality of deformable members 30, a proximal portion 22, a distal portion 24, a guidewire 15 having an angled portion 17, and a pair of clips 32. The operation of the embodiment illustrated in FIG. 4 is similar to that of the embodiments illustrated in FIG. 1, FIG. 2 and FIG. 3 in that the distance between proximal portion 22 and distal portion 24 may be modified so as to expand or contract the plurality of deformable members 30. More particularly, the distance may be modified to bow the plurality of deformable members 30 as the distance is reduced, and to compress the plurality of deformable members 30 as the distance is increased. The distance between proximal portion 22 and distal portion 24 may be changed by sliding catheter 12 relative to member 14 (or vice versa)).
Regarding claim 14, Konya further discloses further comprising a handle assembly (40) (Figs. 7- 10) operably connected to the inner catheter (14) to slide the inner catheter (14) in the proximal direction and the distal direction (Col. 6, l. 67- Col. 7, l. 3, Co. 11, 62- 65 - - It is to be understood that in other embodiments, member 14 may be moved relative to catheter 12 so as to achieve a similar effect upon deformable jacket 16; The embodiment of FIG. 7 is similar to the embodiments described previously, but in FIG. 7 it is demonstrated that a sliding agent 40 may be designed so as to slide catheter 12 relative to member 14; it is noted that Konya discloses an embodiment in which member 14 may be moved relative to catheter 12 in a similar manner as the sliding of catheter 12).
Regarding claim 16, Konya further discloses further comprising: a procedural guidewire (15) (Figs. 4- 6, 9A- 9B);
wherein the inner catheter (14) further defines an inner lumen for slidably receiving the procedural guidewire (15) (See Fig. 5).
Regarding claim 18, Konya further discloses wherein the expandable brush element (16) comprises a braided body having at least one radially projecting disc (See Fig. 5) (Col. 8, l. 42- 52 - - deformable jacket 16 may be made from a braided mesh stainless steel … the deformable jacket 16 may be constructed from nitinol, or suitable plastic materials (e.g., nylon) In one embodiment, deformable jacket 16 may be meshed to facilitate the maceration of clots. In one embodiment, the relative rough outer surface of the braided stainless steel mesh makes the apparatus especially suitable for clot maceration and hemodialysis graft applications).
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.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Konya et al. (US Pat. No. 6,146,396) in view of Clark (US Pub. No. 2020/0323547 A1).
Regarding claim 17, Konya discloses the apparatus of claim 13, Konya further disclosing wherein the inner catheter (14) comprises: a tip (32) positioned on the distal end of the inner catheter (14), but Konya does not explicitly disclose
(claim 17) a tapered dilator tip as claimed.
However, Clark teaches a thrombectomy system for mechanically engaging a clot in the same field of endeavor (P. [0087])
(claim 17) a tapered dilator tip (21b) positioned on the distal end of the elongate wire (10);
wherein the dilator tip (21b) tapers radially from a larger diameter proximal end of the dilator (21b) to a smaller diameter distal end of the dilator (21b) (Ps. [0074], [0079] - - As shown in the figures, according to some implementations the distal collar 21 includes a curved/rounded atraumatic end 21b ; the outer surface of the distal end 21b of the distal collar is curved to minimize tissue injury when the retriever 20 is maneuvered through the vasculature of the patient).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the distal collar of the inner catheter associated with Konya wherein the distal collar is a tapered dilator tip positioned on the distal end of the inner catheter and wherein the dilator tip tapers radially from a larger diameter proximal end of the dilator to a smaller diameter distal end of the dilator according to the teachings of Clark because it would allow the device associated with Konya to be maneuvered through the vasculature of the patient with minimal tissue injury (Clark - - Ps. [0074], [0079]).
Reasons for Allowance
Claims 1- 8, 10 and 11- 12 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.
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
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 Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771