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 connotes sufficient structure to a person of ordinary skill in the art. See MPEP 2181. If applicant contends otherwise, please point to supporting disclosure.
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.
Claim(s) 19 is 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 19 recites the limitation "the incision member" in line 5. There is insufficient antecedent basis for this limitation in the claim. Please replace “incision member” with “incision portion” and clarify the movement direction of the coupling member.
Claim Objections
Claim 4 is objected to because of the following informalities: please change “width smaller or equal to a circumference….divided by pi” to “width less than or equal to an outer diameter of the elongated body.” This reduces risk of misinterpretation. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: please change “one or more of flexible rods, wires, or inflatables” to “one or more of flexible rods, wires, and inflatables” or “selected from the group consisting of…” in line 3. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: please change “inflatables” to “ inflatable members” in line 3. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: please change “the coupling member reversibly translatable” to “the coupling member “is” reversibly translatable” in lines 1-2. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: please change “the incision portion” to “ the at least one incision portion” in line 1. Appropriate correction is required. Changing the “incision portion” to “the at least one incision portion” improves antecedent consistency with claim 17.
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) 1-3, 5-6, 8-9 and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul, JR. et al. (US 2005/0192606A1, “Paul”).
Regarding claim 1, Paul discloses a device capable of being used to transect pericardial tissue [0040, 0056]. The device includes an elongated body (22; Fig. 1A; [0047]) extending along a longitudinal axis between proximal and distal ends. The elongated body includes a U-shaped notch (18;[0047]; Fig. 1A) defined in the elongated body. The U-shaped notch includes a wall surface (Fig. 1A) extending from a surface of the elongated body and an upper extension (please see annotated figure below) extending from the wall surface substantially parallel (Fig. 1A) with the longitudinal axis of the elongated body. An incision member (16; [0039, 0048]) is located in the U-shaped notch and extends from the elongated body toward the extension of the U-shaped notch at an angle (26;[0049]) wherein the incision member is structured to receive and to cut pericardial tissue passing through the U-shaped notch.
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Regarding claim 2, Paul discloses that the elongated body has an outer diameter of 0.086inch (2.1844mm) [0097] which is within the claimed range of between about 6Fr to about 30Fr (0.079inch/2mm to about 0.39inch/31.42mm).
Regarding claim 3, Paul discloses that the wall surface extends substantially perpendicular to the longitudinal axis of the elongated body (Fig. 1A). Please see annotated figure above.
Regarding claim 5, Paul discloses that the incision member extends from at least a portion of the wall surface of the U-shaped notch (Fig. 1A).
Regarding claim 6, Paul discloses that the incision member extends from the elongated body toward the extension at an acute angle [0049] between 0 degrees and 30 degrees.
Regarding claim 8, Paul discloses that at least a portion of the incision member is a sharpened edge [0039, 0048].
Regarding claim 9, Paul discloses a retractable sheath covering the extension [0014, 0017, 0061; Fig. 5].
Regarding claim 12, Paul discloses an atraumatic tip adjacent the distal end of the elongated body ([0051]; 30; Fig. 1A).
Regarding claim 14, Paul discloses that the surface of the elongated body is a tapered portion adjacent the wall surface of the U-shaped notch (Fig. 1A).
Regarding claim 15, Paul discloses that the distal end of the upper extension tapers to a blunt tip (Fig. 1A).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stad et al. (US 2008/0086157A1, “Stad”).
Regarding claim 17, Stad discloses an elongated body (12’ [0028]; Fig. 1) with proximal and distal ends and a longitudinal axis. A plurality of elongated members (20; [0030]) extend from a circumference of the distal end and coupled to a circumference of a coupling member (22; [0035]; Fig. 1C). At least one of the plurality of elongated members include at least one incision portion (at least one sharpened edge;[0034]). A first configuration (Fig. 1D) where the plurality of elongated members extend substantially parallel with the longitudinal axis and a second configuration (Fig. 1C) where at least one of the plurality of elongated members includes the at least one incision portion extending laterally from the elongated body.
Regarding claim 18, Stad discloses that the coupling member is reversibly translatable from the distal end along the longitudinal axis causing the plurality of elongate members including at least one incision portion to extend laterally [0035].
Regarding claim 19, Stad discloses an actuator member (14; [0035]) extending from a center of the distal end and coupled to a center of the coupling member (Fig. 1C; [0035]) such that translation of the actuator member translates the coupling member proximally to the distal end of the elongated body causing the at least one incision portion to extend laterally beyond an outer diameter of the elongated body. The incision member is configured to receive and to cut pericardial tissue [0034]. At least one of the plurality of elongated members extend beyond an outer diameter of the elongated body and is capable of engaging pericardial tissue (Fig. 1C).
Regarding claim 20, Stad discloses the incision portion extends laterally beyond an outer diameter of the elongated body and at least one of the plurality of elongated members extend beyond an outer diameter of the elongated body providing stabilization of the elongated body (Fig. 1C; [0034]).
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) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Paul.
Regarding claim 4, Paul discloses that the outer diameter of the elongated body is 0.086inch (2.1844mm). The extension is separated from the surface of the elongated body by a distance of between 1mm and 8mm. The height of the extension is horizontally aligned with the diameter of the elongated body, thus the distance the extension is separated from the elongated body is 0.086inch (2.1844mm) which is within the claimed range of between 1mm to 8mm. As seen in Paul, the wall surface height and width are disclosed to be a result effective variable in that changing the height and width of the wall surface changes the angle of the U-shaped notch and ease of engaging tissue. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Paul to have a wall surface height and width in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. It is further noted that the angle (26) can be selected to optimize the ease of engagement of tissue [0049]. Modifying wall surface height and the width of the wall surface alters the notch and tissue capture angle or engagement performance. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Paul by making wall surface height between 1mm and 8mm and the width smaller or equal to a circumference of the elongated body divided by pi as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Paul in view of Johnson (US 6,030,400).
Regarding claim 13, Paul does not disclose that the elongated body includes a lumen capable of receiving a guide wire. In the same field of endeavor, tissue cutting device with U-shaped notch, Johnson teaches an elongated body (10; Fig. 1) having a lumen (28) through which a guide wire is capable of sliding relative to the elongated body. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided the elongated body of Paul with a lumen, as taught by Johnson, for the predictable result of providing means to guide the device to a procedure site, enhanced control and support for maneuverability and steerability, and a guide for delivering other devices and diagnostic capabilities. Although Johnson is directed to harvesting, it is reasonably pertinent to the problem of guiding the elongated body to a procedure site and engaging tissue using the U-shaped notch which are problems shared with tissue transection devices.
Allowable Subject Matter
Claim(s) 7, 10 and 11 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.
Claim(s) 16 is allowed. The prior art does not disclose or suggest a pericardial tissue transection device including an incision member located in a U-shaped notch of an elongated body at an angle, an upper extension extending from a wall surface substantially parallel with the longitudinal axis of the elongated body and stabilizing members structured to reversibly extend laterally from the elongated body, wherein the stabilizing members are located on an opposite side of the elongated body from the U-shaped notch, in combination with the other claimed limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. LeMaitre et al. (US 2012/0046678A1) discloses stabilizing members. Schnepp-Pesch et al. (US 5,158,564) discloses stabilizing members and cutting forceps disposed on an opposite end. No motivation or reasonable combination thereof, could be found to disclose or suggest the stabilizing members and U-shaped notch on opposing ends of an elongated body.
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