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., ‘cutter head’) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.
Claim Objections
Claim 11 is objected to because of the following informalities: In line 7, please change “a control assembly” to “the control assembly”. 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 12-14 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 12 recites the limitation "the other side" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stad et al. (US 2008/0086157A1, “Stad”).
Regarding claims 1 and 5, Stad discloses a resection apparatus including a catheter (112; Fig. 2), a handle body (138) and a cutter head assembly (119) disposed at a distal end of the catheter. A steering assembly includes a first steering point is disposed on catheter distal to joint (128; [0037, 0038]). A second steering point is disposed on the catheter proximal to the joint within the lumens through which pull wires enter (Fig. 2). A steering connector (pull wires; 130, 132) is capable of connecting the first steering point and the second steering point. A control assembly [0038] is disposed on the handle body and is capable of controlling the steering assembly. A torque shaft (actuation member; [0037]) is connected to the cutter head assembly via the catheter end cap (122) and a driving mechanism (140) on the handle body is capable of rotating the torque shaft [0039].
Regarding claim 2, Stad discloses that the steering connector is fixedly connected to the first steering point and movably connected to the second steering point. The distance between the first steering point and the distal end of the catheter is smaller than that between the second steering point and the distal end of the catheter. The first steering point is disposed on the other side opposite to the second steering point. Please see annotated figure below.
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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) 1, 2, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stad et al. (US 2008/0086157A1, “Stad”) in view of Ando et al. (US 2024/0024636A1, “Ando”).
Regarding claim 1, Stad discloses a resection apparatus including a catheter (12; Fig. 1) and a cutter head assembly (19) disposed at a distal end of the catheter. A steering assembly includes a first steering point is disposed on end cap (22; [0036]) of the cutter head assembly. However, Stad does not disclose a handle body, a second steering point, a steering connector and a control assembly.
In the same field of endeavor, steering catheters, Ando teaches a catheter (1; [0034]) in communication with a handle body (7; Fig. 2), a first steering point disposed on the catheter (1L; [0034]; Fig. 2), a second steering point disposed on the catheter in the form of shuttle pieces (13; [0034]). A steering connector (pull wires, 11; [0034]) connects the first and second steering points. A control assembly (9; [0034]) is capable of controlling the steering connector and is disposed on the handle body. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the steering mechanism of the device of Stad with the handle body, the second steering point, steering connector and control assembly, as taught by Ando, as this modification involves the simple substitution of one steering mechanism for another for the predictable result of providing a user with means to facilitate the movement of the cutter head assembly.
Regarding claim 2, the combination of Stad and Ando discloses that the steering connector is fixedly connected to the first steering point and movably connected to the second steering point. The distance between the first steering point and the distal end of the catheter is smaller than that between the second steering point and the distal end of the catheter. The first steering point is disposed on the other side opposite to the second steering point (Fig. 1, Stad, Fig. 2, Ando).
Regarding claims 11 and 12, Stad discloses a resection apparatus including a handle body (138) communicating with a catheter (112; Fig. 2) and a cutter head assembly (119) disposed at a distal end of the catheter. A steering assembly includes a reset fixing piece is disposed on a proximal end of the cutter head assembly wherein pull wires/steering connector (130, 132) are connected thereto (Fig. 2).
However, Stad does not disclose a steering fixing piece disposed on the catheter and a control assembly capable of controlling the steering connector and disposed on the handle body.
In the same field of endeavor, steering catheters, Ando teaches a catheter (1; [0034]) in communication with a handle body (7; Fig. 2), steering fixing piece disposed on the catheter (1L; [0034]; Fig. 2), a reset fixing piece disposed on the catheter in the form of shuttle pieces (13; [0034]). A steering connector (pull wires, 11; [0034]) connects the steering fixing piece and the reset fixing piece. A control assembly (9; [0034]) is capable of controlling the steering connector and is disposed on the handle body. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the steering mechanism of the device of Stad with the handle body, the steering fixing piece, steering connector and control assembly, as taught by Ando, as this modification involves the simple substitution of one steering mechanism for another for the predictable result of providing a user with means to facilitate the movement of the cutter head assembly. With this modification, the reset fixing piece is disposed at a proximal end of the cutter head assembly, the steering fixing piece is disposed on the other end of the catheter, opposite to the reset fixing piece .
Regarding claim 13, the combination of Stad and Ando discloses that the steering connector includes a steering connecting wire (11R) and a reset connecting wire (11L), a steering wire cavity (45R) through which the steering connecting wire extends and a reset wire cavity (45L) through which the reset connecting wire extends are disposed on the catheter. The steering connecting wire is used for connecting the control assembly and the steering fixing piece. The reset connecting wire is used to connect the control assembly and the reset fixing piece ([0034]; Fig. 2, Ando).
Allowable Subject Matter
Claims 3,4, 6-10, and 14-20 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. Sevensma (US 2014/0276612A1) discloses a steering catheter including a steering connector, handle body and a 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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