DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15 & 19-20) & Species A (Fig. 2A-B) in the reply filed on 6/5/2026 is acknowledged.
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/5/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/519769 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 8/15/2023.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the center” to -a center- in ll. 12. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “EAM” to -electroanatomical mapping (EAM)- in ll. 2. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: amend “RF” to -radiofrequency (RF)- in ll. 9. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “the center” to -a center- in ll. 8. Appropriate correction is required.
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.
(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) 1-2, 4-6, 8-9 & 14-15 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Stewart et al. (6,702,811).
Concerning claim 1, as illustrated in at last Fig. 1 & 8-9A, Stewart et al. disclose a medical system for performing a procedure within a heart of a patient (catheter assembly 220; Col. 15, ll. 37-44), the system comprising:
an elongate member having a proximal portion and a pre-formed distal portion (catheter body 222 comprises intermediate portion 230 and distal portion 232 that forms loop 234 via shape memory characteristic; Col. 15, ll. 45-58), the pre-formed distal portion being configured to contact a portion of a fossa ovalis of the heart (distal portion 232 is capable of contacting a portion of a fossa ovalis of the heart), a plurality of electrodes located along the pre-formed distal portion (electrodes 224 are band electrodes disposed along loop 234; Col. 16, ll. 1-4), and a lumen extending from the proximal portion to a location proximal of the pre-formed distal portion (catheter body 222 inherently comprises a lumen through which locating device 228 is extended/retracted within; Col. 16, ll. 5-13); and
a perforating device having a proximal portion and a distal portion including a puncturing tip (locating device 228 has a proximal portion and a distal portion with a tip electrode capable of puncturing tissue when connected to an appropriate power source; Col. 5-13), the perforating device being configured to translate within the lumen (catheter body 222 inherently comprises a lumen through which locating device 228 is extended/retracted within; Col. 16, ll. 5-13);
wherein the puncturing tip is located substantially in the center of the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovalis (locating device 228 is located substantially in the center of the pre-formed distal loop 234, and can be located there when the loop 234 is in contact with the fossa ovalis; Fig. 9A).
Concerning claim 2, Stewart et al. disclose the pre-formed distal portion (232) includes a loop (234), arch (234), or spiral (204) (Col. 15, ll. 45-58; Fig. 8-9A).
Concerning claim 4, Stewart et al. disclose the plurality of electrodes (196) are configured to electrically couple with an EAM system for mapping a tissue surface or locating a tissue surface when connected to the appropriate EAM system (Col. 14-15, ll. 64-25).
Concerning claim 5, Stewart et al. disclose the plurality of electrodes (196) are spaced uniformly along the pre-formed distal portion (204) (Fig. 8-9A).
Concerning claim 6, Stewart et al. disclose the plurality of electrodes (196) are positioned in pairs along the pre-formed distal portion (204/234) (Col. 25, ll. 44-57; Fig. 8-9A).
Concerning claim 8, Stewart et al. disclose the pre-formed distal portion (232) remains substantially linear (relatively straight) in a constrained state, and forms a loop (234), arch (234), or spiral (204) in an unconstrained state (Col. 15, ll. 45-58; Fig. 8-9A).
Concerning claim 9, Stewart et al. disclose the puncturing tip is a RF electrode (electrode 210 is capable of being connected to an RF power source).
Concerning claim 13, Stewart et al. disclose the perforating device (228) distal portion (238) includes a curve (Fig. 8-9A).
Concerning claim 14, Stewart et al. disclose the plurality of electrodes (196) are configured to identify the fossa ovalis when connected to an appropriate mapping and/or locating system (Col. 14-15, ll. 64-25).
Concerning claim 15, Stewart et al. disclose the pre-formed distal portion (232) forms a loop (234), arch (234), or spiral in an unconstrainted state that is in a single plane (Col. 15, ll. 45-58; Fig. 9A).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (6,702,811), as applied to claim 1, in further view of Schwartz (2004/0220461).
Concerning claims 3 & 7¸Stewart et al. fail to disclose the elongate member proximal portion includes a magnetic sensor configured to electrically couple with an EAM system. However, Schwartz discloses a medical system for performing a procedure within a heart of a patient where an elongate member (120) comprises a magnetic sensor (128) configured to electrically coupled with an EAM system. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Stewart et al. such that the elongate member includes a magnetic sensor configured to electrically couple with an EAM system in order to provide the benefit sensing the instantaneous position of the distal end of the elongate member as taught by Schwartz. ([0043]; Fig. 4A-B)
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (6,702,811), as applied to claim 1.
Concerning claim 12, Stewart et al. fail to specifically disclose an outer hollow member configured to constrain the pre-formed distal portion of the elongate member for the embodiment of Fig. 9A-B. However, Stewart et al. disclose in an outer hollow member (sheath) configured to constrain a pre-formed distal portion (34) of an elongate member (22) (Fig. 1A). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of the embodiment of Fig. 9A-B of Stewart et al. to further comprise an outer hollow member configured to constrain the pre-formed distal portion of the elongate member in order to provide the benefit of facilitating guiding of the distal portion to the heart as taught by Stewart et al. (Col. 6, ll. 53-62, Col. 7-8, ll. 58-6; Fig. 1A)
Claim(s) 1-2, 4-6, 8-10 & 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (2014/0309678) in view of Davies (WO2022/153082).
Concerning claim 1, as illustrated in at last Fig. 1 & 8-10, Maisano et al. disclose a medical system for performing a procedure within a heart of a patient (apparatus 34 for puncturing a fossa ovalis of a heart; [0452]), the system comprising:
an elongate member having a proximal portion and a pre-formed distal portion (catheter 38 comprises a proximal portion and a distal portion 54 having pre-formed probing element 92 (e.g., mesh 94, plurality 96 of flexible longitudinal members 98, or spring 104) typically held in a constrained state by sheath 12, where probing element 92 comprises a shape-memory material configured to facilitate the deployment of the probing element; [0452], [0460]), the pre-formed distal portion being configured to contact a portion of a fossa ovalis of the heart (probing element 92 is deployed from distal portion 54 of the catheter from a constrained form to an unconstrained form to contact the fossa ovalis 18; [0452], [0460]), and a lumen extending from the proximal portion to a location proximal of the pre-formed distal portion (catheter 38 comprises a central lumen for dilator 49 having dilator tip 16 // or // catheter 38 comprises a lumen parallel to the central lumen through which probing element 92 is deployed; [0433] [0452]); and
a perforating device having a proximal portion and a distal portion including a puncturing tip, the perforating device being configured to translate within the lumen (puncturing element 32, having a proximal and distal portion including a puncture tip, is advanced through the opening at the distal end of dilator tip 16 and through fossa ovalis 18, thus puncturing a hole 40 in fossa ovalis 18; [0418], [0452]);
wherein the puncturing tip is located substantially in the center of the pre-formed distal portion when the pre-formed distal portion is in contact with the fossa ovalis (puncturing element 32 is substantially centered within distal portion 54 and probing element 92 when in contact with the fossa ovalis; Fig. 8-10).
While Maisano et al. disclose locating the fossa ovalis with the pre-formed distal portion ([0452]), Maisano et al. fail to disclose the pre-formed distal portion comprising a plurality of electrodes located along the pre-formed distal portion. However, Davies et al. disclose a medical system for performing a procedure within a heart of a patient comprising an elongate member with a distal portion comprising a plurality of electrodes (748a-b or 748c-e). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the distal portion 54 of Maisano et al. such that the pre-formed distal portion comprises a plurality of electrodes located along the pre-formed distal portion in order to provide the benefit of allowing for EAM location data to be determined as taught by Davies et al. ([0080]; Fig. 7)
Concerning claim 2, Maisano et al. disclose the pre-formed distal portion (92) includes a loop (94), arch (98), or spiral (104) (Fig. 8-10).
Concerning claim 4, Davies et al. disclose the plurality of electrodes (748) are configured to electrically couple with an EAM system for mapping a tissue surface or locating a tissue surface ([0080]; Fig. 7).
Concerning claim 5, Davies et al. further disclose the plurality of electrodes (748) are spaced uniformly along the pre-formed distal portion (204) (Fig. 7).
Concerning claim 6, Davies et al. disclose the plurality of electrodes (748) are positioned in pairs along the pre-formed distal portion (Fig. 7).
Concerning claim 7, Davies et al. disclose the elongate member proximal portion configured to connect with an EAM system ([0080]).
Concerning claim 8, Maisano et al. disclose the pre-formed distal portion (54, 94) remains substantially linear (“squashed configuration”) in a constrained state, and forms a loop, arch, or spiral in an unconstrained state ([0452; Fig. 8A-B).
Concerning claim 9, Maisano et al. fail to disclose the puncturing tip (32) is a RF electrode. However, Davies et al. further disclose a puncturing tip (712) is a RF electrode (748f) and/or a mechanical puncture device. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Maisano et al. such that the puncturing tip is a RF electrode since Maisano teaches a mechanical and a RF perforation device to be equivalents in the art to provide the predictable result of perforating the atrial septum ([0054], [0056]; Fig. 7).
Concerning claim 10¸ Maisano et al. disclose a dilator (49) including a dilator proximal portion, a tapered distal portion (16), and a dilator lumen extending between the dilator proximal portion and the tapered distal portion ([0433]; Fig. 8-10).
Concerning claim 12¸ Maisano et al. disclose an outer hollow member (12) configured to constrain the pre-formed distal portion of the elongate member (94) ([0452]).
Concerning claim 14, the modified invention of Maisano et al. in view of Davies et al. disclose the plurality of electrodes (748) are configured identify the fossa ovalis when connected to an appropriate mapping and/or locating system (see rejection of claim 1).
Concerning claim 15, Maisano et al. disclose the pre-formed distal portion (92) forms a loop (94), arch (234), or spiral (104) in an unconstrainted state that is in a single plane (loop is formed in a plane) (Fig. 8-10).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (2014/0309678) in view of Davies (WO2022/153082), as applied to claim 1, in further view of Schwartz (2004/0220461).
Concerning claim 3¸Maisano et al. in view of Davies et al. fail to disclose the elongate member proximal portion includes a magnetic sensor configured to electrically couple with an EAM system. However, Schwartz discloses a medical system for performing a procedure within a heart of a patient where an elongate member (120) comprises a magnetic sensor (128) configured to electrically coupled with an EAM system. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Maisano et al. in view of Davies et al. such that the elongate member includes a magnetic sensor configured to electrically couple with an EAM system in order to provide the benefit sensing the instantaneous position of the distal end of the elongate member as taught by Schwartz. ([0043]; Fig. 4A-B)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (2014/0309678) in view of Davies (WO2022/153082), as applied to claim 10, in further view of Kuhn et al. (2021/00457773).
Concerning claim 11, Maisano et al. in view of Davies fail to disclose the dilator lumen is configured to constrain the pre-formed distal portion of the elongate member. However, Kuhn et al. disclose a medical system for puncturing the fossa ovalis comprising a puncturing element (1000/1112) and an elongate member (902/1106) having a pre-formed distal portion (910/1110) that serves to stabilize the system against the tissue to advance the puncturing element, where the elongate member (902)/pre-formed distal portion (910) is disposed on an exterior of a dilating transeptal sheath (904) or the elongate member (1102)/pre-formed distal portion (1110) is disposed within an interior lumen of a dilating transeptal sheath (1104). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of to modify the invention of Maisano et al. such that the dilator lumen is configured to constrain the pre-formed distal portion of the elongate member since Kuhn et al. teach the locating the elongate member and pre-formed distal portion on the exterior or interior of the transeptal dilator to be equivalents in the art for the purposes of stabilizing the septum. ([0113-0116]; Fig. 3A-4B).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (2014/0309678) in view of Kuhn et al. (2021/00457773).
Concerning claim 19, as illustrated in at last Fig. 1 & 8-10, Maisano et al. disclose a medical system for performing a procedure within a heart of a patient (apparatus 34 for puncturing a fossa ovalis of a heart; [0452]), the system comprising:
an elongate member having a proximal portion, a pre-formed distal portion (catheter 38 comprises a proximal portion and a distal portion 54 having pre-formed probing element 92 (e.g., mesh 94, plurality 96 of flexible longitudinal members 98, or spring 104) typically held in a constrained state by sheath 12, where probing element 92 comprises a shape-memory material configured to facilitate the deployment of the probing element; [0452], [0460]), and a puncturing tip (puncturing element 32, having a proximal and distal portion including a puncture tip, is advanced through the opening at the distal end of dilator tip 16 and through fossa ovalis 18, thus puncturing a hole 40 in fossa ovalis 18; [0418], [0452]), the pre-formed distal portion being configured to form a loop, arch, or spiral and to contact a portion of a fossa ovalis of the heart (probing element 92 forms a loop (94), arch (98) or spiral (104) is deployed from distal portion 54 of the catheter from a constrained form to an unconstrained form to contact the fossa ovalis 18; [0452], [0460]); and
a dilator including a dilator proximal portion, a tapered distal portion, and a lumen extending between the dilator proximal portion and the tapered distal portion (dilator 50 has a tapered dilator tip 16 and a central lumen through which puncturing element 32 is deployed; [0433]; Fig. 8-10).
Maisano et al. fail to disclose the dilator lumen is configured to constrain the pre-formed distal portion of the elongate member. However, Kuhn et al. disclose a medical system for puncturing the fossa ovalis comprising a puncturing element (1000/1112) and an elongate member (902/1106) having a pre-formed distal portion (910/1110) that serves to stabilize the system against the tissue to advance the puncturing element, where the elongate member (902)/pre-formed distal portion (910) is disposed on an exterior of a dilating transeptal sheath (904) or the elongate member (1102)/pre-formed distal portion (1110) is disposed within an interior lumen of a dilating transeptal sheath (1104). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of to modify the invention of Maisano et al. such that the dilator lumen is configured to constrain the pre-formed distal portion of the elongate member since Kuhn et al. teach the locating the elongate member and pre-formed distal portion on the exterior or interior of the transeptal dilator to be equivalents in the art for the purposes of stabilizing the septum. ([0113-0116]; Fig. 3A-4B).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. (2014/0309678) in view of Kuhn et al. (2021/00457773), as applied to claim 19, in further view of Davies (WO2022/153082).
Claim 20 is rejected upon the same rationale as applied to claim 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Maguire et al. (6,966,908) teach a pre-formed distal portion and a guidewire device (Fig. 17).
Moriyama et al. (2021/0275246) teach an EAM system ([0267]).
Bowe et al. (6,771,996) teach a pre-formed distal portion (80) extending from a lumen of an elongate member (82) (Fig. 8).
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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