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 .
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 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 1, 2025 and April 29, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 depends from claim 12 and recites “the visualization catheter” in line 1. There is insufficient antecedent basis for this limitation because it is the first reference to a visualization catheter in the claim, thus rendering the claim indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryan et al (U.S. Patent No. 11052225; hereinafter “Ryan”).
Regarding claim 1, Ryan discloses a medical device assembly (Figs. 1a-1b), comprising:
a first elongate member (10; Fig. 1a) adapted to be advanced through a puncture site formed within a body structure (e.g., as guidewire (10) is sized and shaped for passage through a patient’s vasculature (col. 4, ll. 54-64), it is structured to be capable of advancement through a puncture site having a size larger than the catheter of Ryan), the first elongate member including:
a first elongate shaft (10a); and
a ferrous material (12; col. 8, ll. 13-25; col. 3, ll. 1-3) within the first elongate shaft at a position intended to remain at a first side of the puncture site (Fig. 1a; the position of the magnetically responsive element (12) is capable of remaining at a first side of a puncture site); and
a second elongate member (20; Fig. 1b) adapted to be advanced through the puncture site adjacent the first elongate member (e.g., as catheter (20) is sized and shaped for passage through a patient’s vasculature along guidewire (10; col. 5, ll. 1-19), it is structured to be capable of advancement through a puncture site having a size larger than the catheter), the second elongate member including:
a second elongate shaft (20a); and
one or more magnets (22) secured to the second elongate shaft, the one or more magnets adapted to be attracted to the ferrous material of the first elongate member in order to guide the second elongate member towards the first elongate member (col. 5, ll. 25-64) and through the puncture site (the catheter and its magnets are structured to be capable of advancement through a puncture site having a size larger than the catheter).
Regarding claim 2, Ryan discloses wherein the ferrous material within the first elongate shaft comprises an additional magnet secured to the first elongate shaft (col. 3, ll. 66-67).
Regarding claim 3, Ryan discloses wherein the body structure comprises an atrial septum, and the puncture site is formed in the atrial septum (as guidewire (10) and catheter (20) are sized and shaped for passage through a patient’s vasculature (col. 4, ln. 54 – col. 5, ln. 19), each is structured to be capable of advancement through a puncture site formed in the atrial septum having a size larger than the catheter).
Regarding claim 4, Ryan discloses wherein the additional magnet secured to the first elongate shaft comprises an elongate magnet (12) extending along the first elongate shaft (Fig. 1a).
Regarding claim 6, Ryan discloses wherein the additional magnet comprises a magnet disposed within the first elongate shaft (col. 8, ll. 26-38).
Regarding claim 7, Ryan discloses wherein the additional magnet comprises one or more magnets secured to the first elongate shaft (col. 8, ll. 50-55).
Regarding claim 8, Ryan discloses wherein the one or more magnets comprise one or more electromagnets (col. 8, ll. 29-31).
Regarding claim 9, Ryan discloses wherein the first elongate member comprises a guidewire (col. 4, ln. 21).
Regarding claim 10, Ryan discloses wherein the second elongate member comprises a visualization catheter (e.g., catheter (20) constitutes a visualization catheter because it is structured to be capable of visualization, such as by visual observation of the catheter, by detection of the catheter magnet, and/or passing an observable fluid within or around the catheter) .
Regarding claim 12, Ryan discloses wherein the second elongate member comprises a guidewire (e.g., catheter (20) constitutes a guidewire because it is structured to be capable guiding the passage of another device by allowing the passage that device over the catheter body).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Mesallum (U.S. Patent Application Publication No. 20150297869).
Regarding claim 5, Ryan discloses the invention substantially as claimed, except for the first elongate shaft including a coiled elongate shaft and the additional magnet being coiled within the coiled elongate shaft.
Mesallum, a reference in the intravascular delivery device field of endeavor, teaches configuring an elongate shaft (guidewire) to include a coiled elongate shaft (276; Fig. 2C; para. [0044]) and an additional coiled magnet (152; Fig. 1B; para. [0040]). Mesallum further discloses that the coils can be “combined, overlap, and/or be interleaved” (para. [0040]) to generate a magnetic field to propel or fix another device relative to the guidewire (paras. [0040]-[0041]; [0045]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the first elongate shaft to comprise a coiled elongate shaft and an additional magnet that is coiled within the coiled elongate shaft, in view of Mesallum, in order to generate a magnetic field to precisely position the catheter relative to the guidewire during a procedure.
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Maniam (U.S. Patent Application Publication No. 2022/0354457).
Regarding claim 11, Ryan discloses the invention substantially as claimed, except for the second elongate member being an intracardiac echocardiographic (ICE) catheter.
Maniam, a reference in the visualization medical device field of endeavor, teaches an ICE catheter configured for delivery over a guidewire (para. 0048]). Maniam also teaches that ICE catheters are generally used for imaging to guide and facilitate medical procedures (para. [0003]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the second elongate member to comprise an intracardiac echocardiographic (ICE) catheter, in view of Maniam, in order to facilitate accurate positioning of the ICE catheter via the magnetic guidewire for accurate imaging of a treatment area during a medical procedure.
Regarding claim 17, Ryan discloses the invention substantially as claimed, except for the visualization catheter comprising an intracardiac echocardiographic (ICE) catheter.
Maniam, a reference in the visualization medical device field of endeavor, teaches an ICE catheter configured for delivery over a guidewire (para. 0048]). Maniam also teaches that ICE catheters are generally used for imaging to guide and facilitate medical procedures (para. [0003]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the visualization catheter to comprise an intracardiac echocardiographic (ICE) catheter, in view of Maniam, in order to facilitate accurate positioning of the ICE catheter via the magnetic guidewire for accurate imaging of a treatment area during a medical procedure.
Claims 13-16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Maniam.
Regarding claim 13, Ryan discloses an assembly for accessing a treatment area within a patient’s vasculature, the assembly comprising
a guidewire (10; Fig. 1a) including:
a guidewire shaft (10a) adapted to extend through a puncture formed in the patient's atrial septum (e.g., as guidewire (10) is sized and shaped for passage through a patient’s vasculature (col. 4, ll. 54-64), it is structured to be capable of advancement through a puncture site having a size larger than the catheter of Ryan); and
a guidewire magnet (12) secured to the guidewire shaft at a position intended to remain at a first side of the puncture (Fig. 1a; the position of the magnetically responsive element (12) is capable of remaining at a first side of a puncture site); and
a catheter (20; Fig. 1b) adapted to be advanced through the puncture adjacent the guidewire (e.g., as catheter (20) is sized and shaped for passage through a patient’s vasculature along guidewire (10; col. 5, ll. 1-19), it is structured to be capable of advancement through a puncture site having a size larger than the catheter), the catheter including:
an elongate shaft (20a); and
one or more catheter magnets (22) secured to the elongate shaft, the one or more catheter magnets adapted to be attracted to the guidewire magnet (col. 5, ll. 25-64) in order to guide the catheter towards the guidewire and through the puncture (e.g., the catheter and its magnets are structured to be capable of advancement through a puncture site having a size larger than the catheter).
Ryan discloses the invention substantially as claimed, except for the assembly being for accessing and visualizing a patient’s left atrium.
Maniam, a reference in the visualization medical device field of endeavor, teaches an ICE catheter configured for delivery over a guidewire (para. 0048]). Maniam also teaches that ICE catheters are generally used for imaging to guide and facilitate medical procedures, such as transseptal lumen punctures and left atrial appendage closures (para. [0003]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the catheter as an intracardiac echocardiographic (ICE) catheter for accessing and visualizing a patient’s left atrium, in view of Maniam, in order to facilitate accurate positioning of the ICE catheter via the magnetic guidewire for accurate imaging of a treatment area during a transseptal lumen puncture and/or left atrial appendage closure procedures.
Regarding claim 14, Ryan discloses wherein the guidewire magnet comprises an elongate magnet (12) extending along the guidewire shaft (Fig. 1a).
Regarding claim 15, Ryan discloses wherein the guidewire magnet comprises a single magnet (12) secured to the guidewire shaft (Fig. 1a).
Regarding claim 16, Ryan discloses wherein the guidewire magnet comprises a plurality of magnets secured relative to the guidewire shaft (col. 8, ll. 50-55).
Regarding claim 18, Ryan discloses a kit for accessing and treating an area within a patient’s vasculature, the kit comprising
a guidewire (10;l Fig. 1a) having a guidewire magnet (12) secured to the guidewire at a position intended to remain at a first side of a puncture formed in the atrial septum (Fig. 1a; the position of the magnetically responsive element (12) is capable of remaining at a first side of a puncture site); and
a catheter (20; Fig. 1b) adapted to be advanced through the puncture adjacent the guidewire (e.g., as catheter (20) is sized and shaped for passage through a patient’s vasculature along guidewire (10; col. 5, ll. 1-19), it is structured to be capable of advancement through a puncture site having a size larger than the catheter), the catheter including an elongate shaft (20a) and one or more catheter magnets (22) secured to the elongate shaft, the one or more catheter magnets adapted to be attracted to the guidewire magnet in order to guide the catheter towards the guidewire (col. 5, ll. 25-64) and through the puncture (e.g., the catheter and its magnets are structured to be capable of advancement through a puncture site having a size larger than the catheter).
Ryan discloses the invention substantially as claimed, except for the assembly being for accessing and visualizing a patient’s left atrium.
Maniam, a reference in the visualization medical device field of endeavor, teaches an ICE catheter configured for delivery over a guidewire (para. 0048]). Maniam also teaches that ICE catheters are generally used for imaging to guide and facilitate medical procedures, such as transseptal lumen punctures and left atrial appendage closures (para. [0003]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the catheter as an intracardiac echocardiographic (ICE) catheter for accessing and visualizing a patient’s left atrium, in view of Maniam, in order to facilitate accurate positioning of the ICE catheter via the magnetic guidewire for accurate imaging of a treatment area during a transseptal lumen puncture and/or left atrial appendage closure procedures.
Regarding claim 19, the modified device discloses wherein the one or more visualization catheter magnets comprise electromagnets (Ryan col. 8, ll. 29-31).
Regarding claim 20, the modified device discloses wherein the visualization catheter comprises an intracardiac echocardiographic (ICE) catheter (Maniam para. [0048]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Higgins (U.S. Patent No. 12697483) disclosing a system including a guidewire and a catheter magnetically attracted to each other for positioning within a patient’s vasculature (Figs. 4A-5B);
Barbagli et al. (U.S. Patent Application Publication No. 20080119727) disclosing an ICE catheter visualizing a procedure in a patient’s atrium (Fig. 4A);
Garibaldi et al. (U.S. Patent No. 7066924) disclosing a magnetic guide wire and catheter configured for positioning within a patient;
Fung et al (U.S. Patent No. 9486281) disclosing a magnetic system for delivering treatment devices to a patient’s heart (Figs. 2A-6B);
Kane et al (U.S. Patent No. 6985776) disclosing a magnetic catheter and guidewire system for accessing a patient’s heart (Figs. 5-10)..
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
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