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 .
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 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 24, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, “a proximal inflatable member affixed to the inner tubular member and a distal inflatable member affixed to the outer tubular member” (claim 3); and “a distal inflatable member affixed to the outer tubular member” (claim 18) 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.
Abstract
The abstract of the disclosure is objected to because the abstract exceeds 150 words. 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).
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 4-6 and 9-10 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 4 recites “wherein at least one of the one or more perforations” comprises perforations having a first shape and perforations having a second shape. Claim 4 is unclear as to how only one perforation can include perforations of different shapes, thus rendering the claim indefinite. For examination purposes, claim 4 is interpreted as reading - - wherein the one or more perforations” includes perforations having the first shape and perforations having the second shape.
Claims 5 and 6 are rejected as being dependent upon claim 4 and failing to remedy the indefiniteness issue.
Claim 9 recites the limitation “the relaxed state” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because the claim lacks a prior reference to a relaxed state.
Claim 10 recites the limitation “the extended state” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because the claim lacks a prior reference to an extended state.
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.
Claims 1, 8-11, 14-16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferrera et al. (U.S. Patent No. 10413310; hereinafter “Ferrera”)
Regarding claim 1, Ferrera discloses a microcatheter system (1100) for removing an occlusion from a patient's vasculature (col. 13, ln. 30 – col. 14, ln. 3)), comprising:
an outer tubular member (annotated Figs. 29A-29B) having an outer surface, a proximal end, a distal end, and a central lumen extending from the proximal end toward the distal end (col. 15, ll. 23-47), wherein the central lumen and the outer surface cooperate to define a side wall radially therebetween (Figs. 29A-29B);
one or more perforations (1112) formed in the side wall of the outer tubular member near the distal end thereof, the one or more perforations being in fluid communication with the central lumen of the outer tubular member (col. 16, ll. 10-23);
an inner tubular member (1120; col. 15, ll. 35-40) slidably positioned within the central lumen of the outer tubular member, the inner tubular member having a distal end extending distally from a distal opening in the outer tubular member (col. 15, ll. 48-49); and,
an extensible member (1110) having a proximal end affixed to the outer tubular member (Figs. 29A-29B) and a distal end affixed to the inner tubular member (col. 15, ll. 48-49), wherein the inner tubular member is advanceable distally relative to the outer tubular member to expand the extensible member (col. 15, ll. 48-60).
Regarding claim 8, Ferrera discloses wherein the central lumen is open at both the proximal and distal ends of the outer tubular member (e.g., to allow a guidewire and/or therapeutic agents to be passed through the central lumen of the microcatheter; col. 14, ll. 30-37).
Regarding claim 9, Ferrera discloses wherein when the outer tubular member is in the relaxed state (Fig. 29A), at least one of the one or more of the one or more perforations are in a relaxed configuration (e.g., ports (1112) are in an open, relaxed configuration while the outer tubular member holds activation segment (1110) in an unexpanded state; col. 15, ll. 48-60).
Regarding claim 10, Ferrera discloses wherein when the outer tubular member is in the extended state (Fig. 29B), at least one of the one or more of the one or more perforations are in an open configuration (e.g., ports (1112) are in an open configuration while the outer tubular member holds activation segment (1110) in an expanded state; col. 15, ll. 48-60).
Regarding claim 11, Ferrera discloses wherein the extensible member is a coil superimposed over at least a portion of the outer tubular member proximate the one or more perforations (Figs. 29A-29B), wherein the extensible member is advanceable along the outer surface of the outer tubular member between a collapsed configuration in which individual loops of the coil are spaced a first distance from one another (Fig. 29A) and an extended configuration in which individual loops of the coil are spaced a second distance from one another, and wherein the second distance is greater than the first distance (Fig. 29B).
Regarding claim 14, Ferrera discloses wherein the extensible member is an expandable stent (e.g., coil (1110) constitutes a stent because it has, its activated state, a diameter capable of supporting a vascular wall structure; Fig. 29B; col. 16, ll. 49-67).
Regarding claim 15, Ferrera discloses wherein the proximal end of the expandable stent is affixed to an inner surface of the central lumen of the outer tubular member (e.g., via connection with the sidewall of microcatheter (1100); Figs. 29A-29B).
Regarding claim 16, Ferrera discloses wherein the inner tubular member is a guidewire (e.g., activation member (1120) constitutes a guidewire because it is dimensioned and shaped to guide the microcatheter within a patient’s vasculature; col. 15, ll. 31-39).
Regarding claim 20, Ferrera discloses wherein the extensible member is in spaced relation to the outer surface of the outer tubular member (Fig. 29A).
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.
Claims 2-3, 7, 12-13, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Solar et al. (U.S. Patent No. 9028442; hereinafter “Solar”).
Regarding claim 2, the device of Ferrera discloses the invention substantially as claimed, except for at least one inflatable member affixed to the inner tubular member.
Solar, a reference in the vascular occlusion device field of endeavor, teaches providing a catheter system with at least one inflatable member (328, 329) affixed to an inner tubular member (322) near the distal end thereof (Figs. 14A-14C; col. .5, ln. 43 – col. 7, ln. 67) to prevent therapeutic material from flowing outside of a treatment zone during a procedure (col. 7, ll. 12-18).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the microcatheter system of Ferrera with at least one inflatable member affixed to the inner tubular member near the distal end thereof, as taught by Solar, in order to prevent therapeutic material delivered by the microcatheter system from leaving a treatment area to allow the material to elicit a desired affect within a patient.
Regarding claim 3, the modified device discloses wherein the at least one inflatable member comprises a proximal inflatable member (329) affixed to the inner tubular member (322) and a distal inflatable member (328) affixed to the outer tubular member (320) and wherein the at least one or more perforations (344) are disposed therebetween (Solar Fig. 14C).
Regarding claim 7, the modified device disclose the invention substantially as claimed, except for a source of suction. However, Solar teaches providing a system with a source of suction in fluid communication with the central lumen of the outer tubular member near the proximal end thereof to allow for withdrawal of material from a patient during a procedure (col. 14, ll. 1-3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the modified system with a source of suction in fluid communication with the central lumen of the outer tubular member near the proximal end thereof, in view of Solar, in order to remove material from a treatment site as required during a procedure.
Regarding claims 12-13, the modified device is not explicitly disclosed with the inner tubular member including one or more perforations in a sidewall thereof.
Solar teaches providing an inner tubular member (22) with one or more perforations (24) in a sidewall thereof and in fluid communication with a central lumen of the inner tubular member (Figs. 5A-5C; col. 17, ll. 22-53) to deliver blood to a desired location during a procedure (col. 17, ll. 48-53).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the inner tubular member with one or more perforations formed in a sidewall thereof and a central lumen, and wherein the one or more perforations are in fluid communication with the central lumen, in view of Solar, in order to deliver blood to a desired location during a procedure.
Regarding claim 17, the modified device discloses wherein the at least one inflatable member has a preselected profile (Solar Figs. 14A, 14C).
Regarding claim 18, the modified device discloses wherein the at least one inflatable member comprises a proximal inflatable member (328) affixed to the outer tubular member (320) and a distal inflatable member (329) affixed to the outer tubular member and wherein the at least one or more perforations are disposed therebetween (Solar Fig. 14C).
Regarding claim 19, the modified device discloses wherein the extensible member extends between the proximal inflatable member and the distal inflatable member (e.g., as Fig. 29A of Ferrera discloses the extensible member (1110) positioned between outlets (1112) and Fig. 14C of Solar discloses the proximal inflatable member (328) positioned proximal of outlets (344) and the distal inflatable member (329) positioned distal of the outlets).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ferrera in view of Wasicek (U.S. Patent No. 5989218).
Regarding claim 4, the device of Ferrera discloses the invention substantially as claimed, except for the one or more perforations (1112) having the same shape to allow material to flow into and/or out of the catheter system (col. 15, ll. 23-30; col. 16, ll. 10-23) instead of the at least one of the one or more perforations comprises one or more perforations having a first shape and one or more perforations having a second shape.
Wasicek, a reference in the vascular occlusion device field of endeavor, teaches that at least one of the one or more perforations comprises one or more perforations having a first shape (elongated perfusion port; col. 4, ll. 30-47) and one or more perforations having a second shape (circular; Fig. 9) is an equivalent structure known in the art for allowing material to flow into and/or out of a catheter system.
Therefore, because these two at least one perforation configurations were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute at least one of the one or more perforations comprises one or more perforations having a first shape and one or more perforations having a second shape, as taught by Wasicek, for the perforations of Ferrera in order to achieve the predictable result of flowing material into and/or out of the catheter system during a procedure and since the substitution of one known element for another yields predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Regarding claim 5, Wasicek disclose wherein the first shape of the one or more perforations is a slit (elongated perfusion port; col. 4, ll. 30-47).
Regarding claim 6, Wasicek discloses wherein the second shape of the one or more perforations is a substantially circular shape (Fig. 9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rocha-Singh et al. (U.S. Patent Application Publication No. 20180078243) disclosing a bone marrow harvesting device with apertures within a braided cage (Figs. 19A-19C);
Constantz et al. (U.S. Patent No. 8500683) disclosing a catheter system with infusion ports positioned between proximal and distal balloons (Fig. 3B);
Imran (U.S. Patent No. 5947985) disclosing a helical coil and openings between proximal and distal balloons (Figs. 1-3); and
Merk et al. (U.S. Patent No. 10182834) disclosing a thrombus retrieval device (Figs. 1-3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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