DETAILED ACTION
This Office Action is in response to the Amendment filed 1 May 2026. Claim(s) 1-2, 4, 17, 19-21, 24-26 are currently pending. The Examiner acknowledges the amendments to claim(s) 1, 17, 20, 21, cancelled claim(s) 3, 5-16, 18, 22-23 and new claim (s) 26.
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., ‘elongate member,’ ‘puncture member,’ ‘septum penetrator”, “therapeutic device”) 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) 1, 2, 4 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gammie et al. (US 2020/0246046A1, “Gammie”) in view of Khairkhahan et al. (US 2002/0169377A1, “Khairkhahan”).
Regarding claims 1 and 26, Gammie discloses an apparatus including a guide (3430; Fig. 70; [0292]) defining a lumen and capable of being transitioned between a delivery configuration and a deployed configuration. An elongate member (3460) is removably and slidably disposable within the lumen of the guide and is capable of extending distally relative to the distal end of the guide. The elongate member defines a lumen. A puncture member (3470; Fig. 70A; [0292]) is slidably disposable within the lumen of the elongate member and capable of extending distally relative to a distal end of the elongate member. The puncture member is capable of puncturing tissue of a patient [0271]. The guide is capable of having the elongate member and puncture member removed from the lumen of the guide and to receive a therapeutic device (e.g. gw) in the lumen of the guide [0105, 0124], the therapeutic device being maneuverable within the guide by translating, rotating or deflecting the guide. It is noted that the therapeutic device is not positively recited. The puncture member is capable of being electrified with radiofrequency (RF) energy [0106]. However, Gammie does not disclose a dilator slidably disposable within the elongate member and about the puncture member, the dilator distally extendable from the elongate member to dispose a distal end of the dilator in the left atrium.
In the same field of endeavor, dilators used to facilitate access to left atrium, Khairkhahan teaches a dilator disposed within an elongate member (74; Fig. 4; [0090]) and over a puncture member (42). The needle extends into the left atrium from the right atrium (Fig. 8) dilator is positioned within the left atrium. The dilator is advanced through the opening formed by the puncture member [0052], thereby enlarging the opening formed by the puncture member [0060]. 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 the apparatus of Gammie with a dilator between the elongate member and puncture member, as taught by Khairkhahan, to provide means for enlarging the opening formed by the puncture member such that a therapeutic device may easily be disposed therein [0052].
Regarding claim 2, the combination of Gammie and Khairkhahan discloses an end effector (362; Gammie) disposed about the elongate member. The end effector has a cross-sectional area greater than a cross-sectional area of the elongate member, and is removably and slidable disposable within the lumen of the guide. The guide is capable of having the end effector removed from the lumen of the guide with the elongate member and the puncture member [0152-0153, 0292; Fig. 6; Gammie].
Regarding claim 4, the combination of Gammie and Khairkhahan discloses that the puncture member defines a lumen that is capable of slidably receiving a guide wire [0155, 0299; Gammie].
Allowable Subject Matter
Claims 17, 19-21, 24 and 25 are allowed.
Regarding claim 17, the prior art of record does not disclose or suggest a method including inserting a distal end of a guide into a right atrium of the heart, extending an elongate member within the guide towards the septum, extending a septum penetrator within the elongate member such that the septum penetrator pierces the septum and enters a left atrium of the heart, extending a dilator disposed within the elongate member and about the septum penetrator thereby dilating the puncture, removing the elongate member, dilator, and the septum penetrator through the guide, inserting a therapeutic device into the guide and in the left atrium, maneuvering the therapeutic device within the left atrium by at least one of the translating, rotating, or deflecting the guide, in combination with the other claimed limitations.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4, 17, 19-21, 24-26 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. Stokes et al. (US 2017/0014159A1) discloses a transseptal puncture device including a septum penetrator and an elongate member..
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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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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