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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
The limitation ‘expandable element’ in claim 14 is construed under 35 U.S.C. 112(f).
Claim 14 function: to thermally isolate the septal wall between the left atrium and the right atrium.
Corresponding structure: [0021, 0079], balloon lobes (84a, b; Fig. 9).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Majercak et al. (US 2016/0374714A1, “Majercak”).
Regarding claim 1, Majercak discloses a cutting tool including an elongate body (106; Fig. 8) having proximal and distal portions (Fig. 1). An inner shaft (102; [0025]) extends within the distal portion of the elongate body and has proximal and distal ends. A hub (119c) is coupled to the distal end of the inner shaft and a cutting element (108;[0025, 0026, 0027]), wherein movement of the hub transitions the cutting element between a collapsed position and an expanded position (Fig. 8; [0038]).
Regarding claim 2, Majercak discloses a sheath (outer sheath; [0038]) that is movable along the elongate body and sized to cover the cutting element.
Regarding claim 3, Majercak discloses that the hub is rotatably movable within the distal portion via actuation of the inner shaft [0038]. Rotation of the hub transitions the cutting element between the collapsed position and the expanded position [0038; Fig. 8].
Claim(s) 1, 3 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Majercak et al. (US 2016/0374714A1, “Majercak”).
Regarding claim 1, Majercak discloses a cutting tool including an elongate body (outer sheath; Fig. 8) having proximal and distal portions (Fig. 1). An inner shaft (102; [0025]) extends within the distal portion of the elongate body and has proximal and distal ends. A hub (119c) is coupled to the distal end of the inner shaft and a cutting element (108;[0025, 0026, 0027]), wherein movement of the hub transitions the cutting element between a collapsed position and an expanded position (Fig. 8; [0038]).
Regarding claim 3, Majercak discloses that the hub is rotatably movable within the distal portion via actuation of the inner shaft [0038]. Rotation of the hub transitions the cutting element between the collapsed position and the expanded position [0038; Fig. 8].
Regarding claim 4, Majercak discloses that the distal portion of the elongate body includes at least opening (distal outlet of sheath) through which a guidewire or saline may pass through (Fig. 8). The cutting element is sized and capable of passing through the at least one opening when transitioned between the collapsed position and the expanded position [0038].
Allowable Subject Matter
Claim 5-9 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.
Claims 10-20 are allowed.
Regarding claim 10, the prior art does not disclose or suggest a method of creating a shunt between two chambers of a mammalian heart including a cutting tool having an elongate body and a plurality of blades coupled to a hub, puncturing a septal wall with a distal end of the cutting tool to form an aperture, advancing the cutting tool through the aperture with the plurality of blades in an expanded configuration, rotating the hub in a first direction to form a shunt within the septal wall, in combination with the other claimed limitations.
Regarding claim 20, the prior art does not disclose or suggest a method of creating a shunt between two chambers of a mammalian heart including a cutting tool having an elongate body and a plurality of blades coupled to a hub, puncturing a septal wall with a distal end of the cutting tool to form an aperture, advancing the cutting tool through the aperture with the plurality of blades in an expanded configuration, rotating the hub in a first radial direction to transition the plurality of blades from a collapsed position to an expanded position, the transitioning of the plurality of blades cutting the septal wall to form a shunt, rotating the hub in a second radial direction to transition the plurality of blades from the expanded position to the collapsed position, 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. Vardi et al. (US 2020/0170662A1), Yang et al. (US 2022/0370120A1) and Burbank et al. (US 6,331,166) disclose a cutting tool including an elongate body, inner shaft with a hub coupled to the distal end, and a cutting element coupled to the hub.
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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