DETAILED ACTION
This Office Action is in response to the Amendment filed 2 September 2026. Claim(s) 1-20 are currently pending. The Examiner acknowledges the amendments to claim(s) 1.
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, 2, 4 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al. (US 2018/0000509A1, “Wilson”).
Regarding claim 1, Wilson discloses a cutting tool including an elongate body (212; Fig. 2) having proximal and distal portions (Fig. 2). An inner shaft (213; [0044]) extends within the distal portion of the elongate body and has proximal and distal ends. A hub (pin connecting cutting elements (230a; [0044])) is coupled to the distal end of the inner shaft. A cutting element (230;[0044]) having an axial length. The hub is capable of transitioning the cutting element between a collapsed position and an expanded position while maintaining the axial length of the cutting element (Fig. 8; [0038]).
Regarding claim 2, Wilson discloses a sheath (introducer sheath or delivery device; [0036]) that is movable along the elongate body and sized to cover the cutting element.
Regarding claim 4, Wilson discloses that the distal portion of the elongate body includes at least opening (219; [0046]). 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 [0046; Fig. 2].
Regarding claim 5, Wilson discloses at least one stopper (250) disposed within the distal portion of the elongate body. The stopper defines an aperture sized and capable of receiving a portion of one of the inner shaft and the hub and prevents displacement of the hub in a lateral and vertical direction within the distal portion (Fig. 2).
Allowable Subject Matter
Claims 3 and 6-9 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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. Spencer et al. (US 2013/0041391A1) discloses a cutting element formed of a plurality of blades but does not disclose that the cutting element is rotatably coupled to a hub at a distal end of the inner shaft such that the hub is configured to transition the cutting element between a collapsed position and expanded position via actuation of the inner shaft.
THIS ACTION IS MADE FINAL. 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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