DETAILED ACTION
This Office Action is in response to the Amendment filed 19 March 2026. Claim(s) 1-17, 19 and 20 are currently pending. The Examiner acknowledges the amendments to claim(s) 1-17, 19 and 20, cancelled claim(s) 18.
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 1 is objected to because of the following informalities: Please change claim 1, line 19, “deflects a distal length” to “configured to deflect a distal length”. Appropriate correction is required.
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, 4, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hartley et al. (US 2005/0065507A1, “Hartley”).
Regarding claim 1, Hartley discloses an apparatus for engaging a tissue, the apparatus including an elongated introducer assembly (300; Fig. 5) that is capable of being maneuvered toward a positioned proximate to a first biological wall of the patient. The elongated introducer assembly is capable of slidably receiving an elongated guidewire assembly [0037]. The elongated guidewire assembly has a distal portion (604) with a flexible preset-spatial geometry [0038] capable of being selectively maneuvered along the elongated introducer assembly. The distal portion is capable of adopting a straightened state [0037] when inside the elongated introducer assembly and adopting a preset spatial geometry when maneuvered out of the elongated introducer assembly [0037]. The elongated guidewire assembly has an elongated shaft section (602; Fig. 6) and a distal tip (608) that is capable of forming at least in part a puncture hole extending through a first biological wall [0038]. The preset spatial geometry has a distal deflective portion (610) that begins at a minimum length range of 4mm from the distal tip [0038; (610) begins 1cm (10mm) proximal to (608) which is within the claimed range of a minimum length of 4mm] and is capable of deflecting a distal length away from a myocardium at an angle that directs the distal tip generally parallel to a surface of the myocardium (Figs. 2, 5; [0052]). It is noted that the elongated guidewire assembly may be used to create a perforation in the atrial septum but may also be used in other locations within the heart, in other medical applications where a perforation is required and through organs in order to gain access to other areas in the body [0052].
Regarding claim 3, Hartley discloses that the distal portion includes an elastic material, e.g. nitinol [0038].
Regarding claim 4, Hartley discloses that the distal tip is capable of piercing the first biological wall to form at least in part the puncture hole [0011, 0038].
Regarding claim 11, Hartley discloses that the elongated introducer includes a proximal hub (Fig. 3).
Claim Rejections - 35 USC § 103
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Urbanski et al. (US 2020/0060710A1, “Urbanski”).
Regarding claim 2, Hartley does not disclose a stylet of the elongated introducer assembly. In the same field of endeavor, tissue puncturing devices, Urbanski teaches an apparatus including a guidewire (10) and a stylet (60) that are disposed within an introducer assembly (20; [0177]; Fig. 3, 4). Urbanski teaches that the device may be used with or without a stylet [0178]. 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 introducer assembly with means to slidably receive a stylet, as taught by Urbanski, to impart a desired stiffness and curvature when in use with the assembly [0105]. It would have been obvious since one of ordinary skill in the art has good reason to pursue the known options within their technical grasp with the reasonable expectation that at least one would be successful.
Claim(s) 5, 6, 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Kurth et al. (US 2009/0105654A1, “Kurth”).
Regarding claim 5, Hartley does not disclose that the distal portion is in a flattened configuration with a height between 0.003 inches and 0.005 inches.
In the same field of endeavor, transseptal guidewires, Kurth teaches a distal portion (26; Fig. 3) having a flattened configuration. 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 formed the distal tip of Hartley to have a flattened configuration, as taught by Kurth, to retain radiopaque bands by providing an outer perimeter close to the outer perimeter of radiopaque bands and to promote increased flexibility in at least one direction [0074]. There is no evidence that changing the height of the flattened configuration to between 0.003 inches and 0.005 inches would result in a difference in function of the device of the combination of Hartley and Kurth. Further a person having ordinary skill in the art, being faced with modifying the distal portion of the combination of Hartley and Kurth, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed diameters. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the diameter may be within the claimed range [0008] and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the atraumatic tip of the combination of Hartley and Kurth to have a diameter of between 0.003 inches and 0.005 inches as an obvious matter of design choice within the skill of the art.
Regarding claim 6, Hartley does not disclose that the distal length includes a first distal length section and a second distal length section wherein the second distal length section contains the distal tip that is deflected from the first distal length section and generally opposite the distal deflective portion.
In the same field of endeavor, transseptal guidewires, Kurth teaches a distal section (228) having a distal curve oriented in a direction generally opposite of the proximal curve (226a; [0089, 0092]; Fig. 10, 12). 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 formed the distal tip of Hartley with a deflective portion, as taught by Kurth, to minimize contact of the perforating tip against a surface of a lumen of the introducer [0099].
Regarding claims 8 and 9, Hartley does not disclose that the elongated guidewire assembly includes a detectable marker capable of being detected by a medical imaging system. In the same field of endeavor, transseptal guidewires, Kurth teaches a transseptal guidewire (20; [0057]) that includes radiopaque markers (25a-e) that are capable of being detected by a medical imaging system. The detectable marker may further include a metal coil [0102] positioned over the elongated shaft section or distal portion. 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 guidewire assembly with a detectable marker formed of a metal coil positioned over the elongated shaft section, as taught by Kurth, to confirm successful perforation of the septum [0058].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Feng et al. (US 2014/0094836A1, “Feng”).
Regarding claim 7, Hartley does not disclose that the distal tip has a width of no greater than 0.001 inch. Hartley discloses that the outer diameter of functional tip (108) is 0.059” [0045], wherein a diameter is interpreted as the widest width a circle. The width of the distal tip is the maximum transverse dimension at the extreme distal end and reducing the width predictably yields the claimed functional outcome, e.g. controlled puncture without tearing, reduced tissue trauma and precise perforation under limited force. In the same field of endeavor, guidewires, Feng teaches a curved distal section, extending from proximal end of the sharp tip structure to the proximal end of the guide wire, having a width of 0.007inch (0.2mm; [0015]). The proximal end of the sharp tip to the distal tip tapers to a sharp point (Fig. 5), thus the width of the distal tip is smaller than 0.007inch. The tip is used to puncture pericardium tissue. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Hartley to have a width in the claimed range, as taught by Feng, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hartley by making the width of the guidewire distal tip within the claimed range of no greater than 0.001 inch, for the predictable result of performing a controlled puncture without tearing, reducing tissue trauma and performing a precise perforation under limited force.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Roeder et al. (US 2020/0114128A1, “Roeder”).
Regarding claim 10, Hartley does not disclose that guidewire assembly includes a detectable marker detectable by a medical imaging system, where the marker includes grooves, etchings, cuts or roughened regions in the elongated shaft section or the distal portion. In the same field of endeavor, guidewires, Roeder teaches a guidewire including etched marks of the elongated shaft section [0026]. 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 guidewire assembly with a detectable marker in the form of etchings, as taught by Roeder, to provide means to determine the location of the guidewire during use.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Lenker et al. (US 2016/0100860A1, “Lenker”).
Regarding claims 12 and 13, Hartley does not disclose that the proximal hub includes a female luer connector and hemostasis valve. In the same field of endeavor, transseptal devices, Lenker teaches a proximal hub having a female luer connector and a hemostasis valve [0215]. 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 proximal hub of the elongated introducer assembly of Hartley with a female luer connector and a hemostasis valve, as taught by Lenker, to provide means for injecting or withdrawing fluids and a fluid tight connection.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hartley in view of Kick et al. (US 2006/0135962A1, “Kick”).
Regarding claims 14 and 15, Hartley does not disclose an ultrasonically visible marker is positioned at a distal section of the elongated introducer assembly. In the same field of endeavor, transseptal devices, Kick teaches an elongated introducer assembly (sheath) that includes radiopaque marker bands at or near the distal end of the sheath. The radiopaque marker bands are formed of platinum or gold [0027, 0020]. 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 distal section of the elongated introducer assembly of Hartley with an ultrasonically visible marker, as taught by Kick, to provide means to guide and monitor the device during use.
Allowable Subject Matter
Claim(s) 16, 17, 19 and 20 are allowed.
Regarding claim 16, the prior art of record does not disclose or suggest a method for engaging a tissue of a patient including advancing an elongated introducer assembly towards a first biological wall, slidably inserting an elongated guidewire assembly, creating a puncture hole in the first biological wall with a distal tip located on the elongated guidewire assembly, deflecting a distal length of the distal tip, removing the elongated introducer assembly while the guidewire assembly remains in position traversing the first biological wall, slidably receiving the elongated guidewire assembly via a distal exit portal of an elongated catheter apparatus, in combination with the other claimed limitations.
Response to Arguments
Applicant's arguments filed 19 March 2026 have been fully considered but they are not persuasive. The Applicant contends that the Hartley does not disclose a distal deflective portion of a guidewire that deflects a distal length away from the myocardium at an angle configured to direct the distal tip generally parallel to a surface of the myocardium. The Applicant contends that Hartley is directed to a transseptal device as opposed to a pericardiocentesis apparatus and that the functional tip of Hartley is designed to curl within the left atrium chamber after a puncture. The Applicant contends that the purpose and geometry of the curve of the functional tip of Hartley is different from the claimed distal deflective portion and is configured to form a loop of 270 degrees to curl within a heart chamber and not to deflect at an angle such that it is generally parallel to a tissue.
Respectfully, Hartley discloses that the elongated guidewire assembly may be used to create a perforation in the atrial septum but may also be used in other locations within the heart, in other medical applications where a perforation is required and through organs in order to gain access to other areas in the body [0052]. Thus, the assembly of Hartley may be used as a pericardiocentesis apparatus. It is noted that although Hartley’s curve is designed to curl within the left atrium, it is capable of being navigated to be parallel to a tissue surface within the pericardial space. Since claim 1 is a device claim, the prior art must only be capable of performing the intended use and functional language limitations which Hartley has shown and disclosed. The 270 degree curve is capable of providing a configuration wherein the distal tip of the guidewire assembly is generally parallel to a tissue surface within the pericardial space as shown in Figs. 2 and 5. It is noted that the curvature of the guidewire assembly in Figs. 2 and 5 are similar to curvature of the guidewire assembly in Fig. 16 of the instant specification.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fung et al. (US 2012/0095434A1) discloses a device used for pericardial access but the needle does not deflect and the guidewire wire does not puncture.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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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