DETAILED ACTION
This Office Action is in response to the Amendment filed 15 May 2026. Claim(s) 2-10 and 12-20 are currently pending. The Examiner acknowledges the amendments to claim(s) 2-10,12-15, and 17-20, cancelled claim(s) 1 and 11.
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., ‘incision member’ and ‘stabilizing members) connotes sufficient structure to a POSITA. See MPEP § 2181. If applicant contends otherwise, please point to supporting disclosure.”
Claim Rejections - 35 USC § 103
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 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) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Steele et al. (US 2018/0263654A1, “Steele”) in view of Stad et al. (US 2008/0086157A1, “Stad”).
Regarding claims 17-20, Steele discloses an elongated body (12; [0014]; Fig. 2) with proximal and distal ends and a longitudinal axis. A plurality of elongated members (26; [0015]; Fig. 2) extend from a circumference of the distal end and coupled to a circumference of a coupling member (34; Fig. 2). A first configuration (Fig. 1D) where the plurality of elongated members extend substantially parallel with the longitudinal axis and a second configuration wherein the elongated members extend laterally from the elongated body (Fig. 4). An inflatable member (39; [0017]; Fig. 4) is positioned within the elongated members and is capable of moving the elongated member laterally away from the first configuration to the second configuration when inflated. However, Steele does not disclose that at least one of the plurality of elongated members include at least one incision portion.
In the same field of endeavor, tissue removal devices, 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 or cutting element; [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. 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 provided at least one of the plurality of elongated members of Steele with at least one incision portion, as taught by Stad, to provide means for selecting incision portion geometry most advantageous dependent on the type of cutting motion desired.
Regarding claim 18, the combination of Steele and 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; Stad, Fig. 4; Steele].
Regarding claim 19, the combination of Steele and Stad discloses an actuator member (14; [0035]; Stad) 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 at least one 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, the combination of Steele and Stad discloses the at least one 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]; Stad, Fig. 4, Steele).
Allowable Subject Matter
Claims 2-10 and 12-16 are allowed.
Regarding claim 7, the prior art of record does not disclose or suggest an elongated body including a U-shaped notch that includes a wall surface extending from a surface of the elongated body and an upper extension extending from the wall surface, an incision member located in the U-shaped notch and extending from the elongated body toward an extension of the U-shaped notch at an angle, the incision member is generally planar and extends from a center of a width of the wall surface, at least a portion of the wall surface tapers away from at least one side of the incision member, in combination with the other claimed limitations.
Regarding claim 16, the prior art of record does not disclose or suggest an elongated body including a U-shaped notch that includes a wall surface extending from a surface of the elongated body and an upper extension extending from the wall surface, an incision member located in the U-shaped notch and extending from the elongated body toward an extension of the U-shaped notch at an angle, the incision member is generally planar and extends from a center of a width of the wall surface, at least a portion of the wall surface tapers away from at least one side of the incision member, and stabilizing members located on an opposite side of the elongated body from the U-shaped notch, in combination with the other claimed limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-10 and 12-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McPeak (US 10,478,213) disclose a device capable of transecting tissue, the device including a plurality of elongated members at the end of an elongated body.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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