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 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.
No claim limitation has been interpreted under 35 U.S.C. 112(f) because each term (e.g., ‘front-facing cutting head’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 8 is objected to because of the following informalities: please change “wall rotates” to “wall is configured to rotate”. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: please change “wall being stationary” to “wall is configured to be stationary”. Appropriate correction is required.
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, 2, 6-8, 12-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeroni et al. (US 2015/0150590A1, “Zeroni”).
Regarding claims 1, 13 and 18, Zeroni discloses an atherectomy device including an outer catheter body (5;Fig. 2), an inner catheter body (3; Fig. 3) extending through an outer catheter lumen of the outer cathe3ter body, a front-facing cutting head (4; [0035) having a portion rotatably connected to a distal end of the inner catheter body [0035], and a rotatable screw member (6; [0032, 0040]) is capable of carrying away material from the front-facing cutting head as the rotatable screw member rotates. A space between the outer catheter body and the inner catheter body defines a flushing lumen and the rotatable screw member having a guidewire lumen (Fig. 15; lumen through which GW extends) that extends coaxially with the outer catheter lumen and the inner catheter lumen. A driver (10; [0032]) is coupled to the front-facing cutting head to rotate the front-facing cutting head. The atherectomy device is advanced and the front-facing cutting head is rotated [0046].
Regarding claims 2 and 14, Zeroni discloses that one of the outer catheter body and the inner catheter body is movable in an axial direction of the atherectomy device relative to the other between extended and retracted positions [0030-0031].
Regarding claim 6, Zeroni discloses that the inner catheter lumen defines an aspiration lumen (12) wherein material is carried away using the rotatable screw member [0033-0034, 0049].
Regarding claim 7, Zeroni discloses that the cutting head includes one or more blades in the form of a cutting edge [0035].
Regarding claim 8, Zeroni discloses that the front-facing cutting head includes a peripheral wall and that the one or more blades are coupled to the peripheral wall such that the peripheral wall is capable of rotating with the one or more blades [0035].
Regarding claim 12, Zeroni discloses that the guidewire lumen extends through the front-facing cutting head (Fig. 15).
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) 3-5 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni in view of Veca et al. (US 6,053,923, “Veca”).
Regarding claims 3-5 and 15-17, Zeroni discloses that the outer catheter is capable of extending and retracting with respect to the inner catheter. Zeroni does not disclose a lateral opening at a distal end portion of the inner catheter body in fluid communication with the inner catheter lumen.
In the same field of endeavor, tissue removal, Veca teaches an inner catheter (66) that includes lateral openings (96; Fig. 4) at a distal end portion, proximal of the cutter assembly. The suction ports are in fluid communication with the inner catheter lumen. Therefore, it would have been obvious to one of ordinary skill in the art to have provided the distal end portion of the inner catheter body of Zeroni with a lateral opening, as taught by Veca, to provide means for aspirating debris through the device. With this modification, the combination of Zeroni and Veca is capable of extending and retracting with respect to the inner catheter to cover and uncover the lateral opening.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zeroni in view of Escudero et al. (US 2009/0018567A1, “Escudero”).
Regarding claim 10, Zeroni does not disclose that the one or more blades are serrated.
In the same field of endeavor, tissue removal, Escudera teaches a cutting surface (113) that includes a blade in the form of an edge that may be serrated [0165]. Therefore, it would have been obvious to one of ordinary skill in the art to have formed the blade of Zeroni to be serrated, as taught by Escudera, to provide the benefit of a more accurate and cleaner removal of tissue and minimal or reduced tissue trauma.
Allowable Subject Matter
Claims 9, 11, 19 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. To et al. (US 2017/0014153A1) discloses an atherectomy device including a rotatable screw member within an inner catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
