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.
Claim Objections
Claim(s) 11 is/are objected to because of the following informalities: Please change “a guide coupler” to “the guide coupler” in line 3. Appropriate correction is required.
Claim(s) 12 is/are objected to because of the following informalities: Please change “a guide coupler” to “the guide coupler” in line 1. Appropriate correction is required.
Claim(s) 17 is/are objected to because of the following informalities: Please change “the right atrium” to “a right atrium”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) (1, 2, 6), 4, 5, 7, 3, (1, 2), 4 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 3, 6, 8, 16, 17 of U.S. Patent No. 11,154,325 in view of Gammie et al. (US 2020/0246046A1). U.S. Patent No. 11,154,325 does not expressly disclose that the guide is capable of having the elongate member and puncture member removed from the lumen and receiving a therapeutic device in the lumen to be angularly deflected relative to the shaft while the therapeutic device is disposed in the lumen of the guide. Gammie et al. teaches a guide coupled to a shaft via a guide coupler [0259, 293], an elongate member and a puncture member are capable of being withdrawn/removed from the lumen of the guide [0105, 0124]. The guide coupler is a hinge [0089]. A therapeutic device in the form of a guidewire (gw2) is capable of being received within the guide lumen and angularly deflected relative to the shaft while disposed in the lumen of the guide (Fig. 13D). 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 guide of U.S. Patent No. 11,154,325 with the capability of removing the elongate member and puncture member and receiving a therapeutic device, as taught by Gammie et al., to provide pathways to and from a treatment site. It is further noted that guidewires may include lumens through which treatment fluid may flow.
Claim(s) 1 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,045,224 in view of Gammie et al. (US 2020/0246046A1). U.S. Patent No. 11,045,224 does not expressly disclose that the guide is capable of having the elongate member and puncture member removed from the lumen and receiving a therapeutic device in the lumen to be angularly deflected relative to the shaft while the therapeutic device is disposed in the lumen of the guide. Gammie et al. teaches an elongate member and a puncture member that are capable of being withdrawn/removed from the lumen of the guide [0105, 0124]. A therapeutic device in the form of a guidewire (gw2) is capable of being received within the guide lumen and angularly deflected relative to the shaft while disposed in the lumen of the guide (Fig. 13D). 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 guide of U.S. Patent No. 11,045,224 with the capability of removing the elongate member and puncture member and receiving a therapeutic device, as taught by Gammie et al., to provide pathways to and from a treatment site. It is further noted that guidewires may include lumens through which treatment fluid may flow.
Claim(s) 17, 24, 25 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3, 4, 5 of U.S. Patent No. 11,172,690 in view of Chanduszko et al. (US 2005/0101984A1, “Chanduszko”). U.S. Patent No. 11,172,690 does not expressly disclose that the elongate member and septum penetrator are proximally withdrawn and removed through the guide, a therapeutic device is inserted and delivered distally through the guide to disposed a distal end of the therapeutic device in the left atrium. Chanduszko teaches the removal of inner and outer tubes (12, 14; [0058]) and the delivery of a therapeutic device into the left atrium. 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 method of U.S. Patent No. 11,172,690 with the step of removing the elongate member and septum penetrator and delivering a therapeutic device to the left atrium, as taught by Chanduszko, for the predictable result of providing means for completing a septal puncture procedure through closure of the puncture [0058].
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gammie et al. (US 2020/0246046A1, “Gammie”).
Regarding claim 1, Gammie discloses an apparatus including a guide (3430) coupled and angularly deflectable relative to a shaft (3420; Fig. 70; [0292]) via a guide coupler (3440). The guide is capable of being transitioned between a delivery configuration and a deployed configuration in which a distal end of the guide points away from a centerline of the shaft when transitioned from its delivery configuration to its deployed configuration. The guide defines a lumen. 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]. It is noted that the therapeutic device is not positively recited. The guide is capable of being angularly deflected relative to the shaft while the therapeutic device is disposed in the lumen of the guide [0111].
Regarding claim 2, Gammie discloses an end effector (362) 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].
Regarding claim 3, Gammie discloses that the guide is capable of being transitioned between its delivery configuration and its deployed configuration in response to relative movement between a portion of the guide disposed proximal to the guide coupler and the shaft (Fig. 70).
Regarding claim 4, Gammie discloses that the puncture member defines a lumen that is capable of slidably receiving a guide wire [0155, 0299].
Regarding claim 5, Gammie discloses that the guide coupler allows rotational movement of the guide relative to the shaft and limits relative linear movement between the guide coupler and the guide [0293].
Regarding claim 6, Gammie discloses that the guide coupler is a hinge [0089].
Regarding claim 7, Gammie discloses that the guide coupler is spaced proximally from a distal end of the shaft (Fig. 70).
Regarding claim 8, Gammie discloses that the guide includes a lumen capable of receiving a sheath and the therapeutic device therein, and to be angularly deflected relative to the shaft while the sheath the therapeutic device is disposed in the lumen of the guide. It is noted that the sheath and therapeutic device are not positively recited.
Regarding claim 9, Gammie discloses that the distal end of the guide is capable of being angularly deflected when transitioned from its delivery configuration to its deployed configuration such that a central axis defined by the distal end of the guide is about perpendicular relative to a central axis of the shaft (Fig. 70).
Regarding claim 10, Gammie discloses an apparatus including a guide (3430) coupled and angularly deflectable relative to a shaft (3420; Fig. 70) via a guide coupler (3440). The guide is capable of being transitioned between a delivery configuration and a deployed configuration in which a distal end of the guide points away from a centerline of the shaft when transitioned from its delivery configuration to its deployed configuration. The guide defines a lumen. A therapeutic device (3470, septum penetrator; Fig. 70A; [0292]) is disposed in the lumen of the guide. A distal end of the therapeutic device extends from the distal end of the guide. The position of the therapeutic device is controllable by one or more of angular deflection of the guide, translation of the shaft and rotation of the shaft.
Regarding claim 11, Gammie discloses a handle (380; [0146]) that is operably coupled to the shaft and the guide. The shaft and guide extend distally form the handle (Fig. 4). A length of the guide disposed between a distal end of the handle and the guide couple increases in response to the guide being transitioned from its delivery configuration to its deployed configuration (Fig. 4,70).
Regarding claim 12, Gammie discloses that the guide coupler allows rotational movement of the guide relative to the shaft and limits relative linear movement between the guide coupler and the guide [0293].
Regarding claim 13, Gammie discloses that the guide is coupled to the shaft via a guide coupler that is a hinge [0089].
Regarding claim 14, Gammie discloses that the guide coupler is spaced proximally from a distal end of the shaft (Fig. 70).
Regarding claim 15, Gammie discloses a sheath (3460) disposed in the lumen of the guide with a distal end of the sheath extending from the distal end of the guide (Fig. 70). The therapeutic device is disposed in a lumen of the sheath and the distal end of the therapeutic device extends from the distal end of the sheath (Fig. 70).
Regarding claim 16, Gammie discloses that the distal end of the guide is capable of being angularly deflected when transitioned from its delivery configuration to its deployed configuration such that a central axis defined by the distal end of the guide is about perpendicular relative to a central axis of the shaft (Fig. 70).
Allowable Subject Matter
Claim(s) 18-23 is/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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gutfinger et al. (US 7,976,551) discloses a guide that is angularly deflectable and a coupler (324).
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