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 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) 1-4, 7-11, 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davies (WO 2022/153082) in view of Sun et al. (US 20230064082).
Regarding claim 1, Davies discloses a medical system, comprising:
a sheath 110 including an elongate body having a proximal portion (area around element 132 in fig. 1,) and a distal portion (area of 112/113 in Fig. 1,), and a lumen (section 0016, dilator fully inserted into the sheath) extending from the proximal portion area to the distal portion (Fig 1, section 0057); and
a dilator 102 movable within the lumen (section 0016, dilator fully inserted into the sheath), the dilator including an elongate body 118 having a proximal portion 120, pre-formed distal portion 122, a tapered distal tip 134 (Fig. 2), and a lumen 130 extending from the proximal portion to the tapered distal tip (Fig. 3A-C, section 0072 states electrical conductor extends from tip sidewall 142 into the lumen 130 and goes through the lumen to the proximal end 120);
one or more electroanatomical mapping electrodes 148 located on the distal portion (Fig. 2, section 0055, 0065), the one or more electroanatomical mapping electrodes 148 being configured to electrically couple 152 with an electroanatomical mapping system 104 (Fig. 1, 3C, section 0070);
However, Davies does not specfically disclose dilator including a preformed distal portion, wherein the pre-formed distal portion has a substantially linear configuration when confined in the sheath, and an arcuate configuration when unconfined. Sun discloses dilator 130 including a preformed distal portion 134, wherein the pre-formed distal portion 132 has a substantially linear configuration when confined in the sheath 110 (Fig. 5, 6A), and an arcuate configuration 134 when unconfined (Figs. 3, A, section 0026). This allows for the operator to easily position the system during insertion to the targeted position of the heart and remove the sheath for the dilator to deploy. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Davies by adding dilator 130 including a preformed distal portion 134, wherein the pre-formed distal portion has a substantially linear configuration when confined in the sheath, and an arcuate configuration when unconfined as taught by Sun in order to facilitate the operator to easily position the system during insertion to the targeted position of the heart and remove the sheath for the dilator to deploy.
Regarding claim 2, Davies in view of Sun, specfically Davies discloses The system of claim 1, wherein
the sheath 110 or the dilator 102 includes a steering mechanism 800 (Fig 8-9).
Regarding claim 3, Davies in view of Sun, specfically Sun discloses The system of claim 1, wherein
the pre-formed distal portion 134 includes a first curve (Fig. 3a, side where D1 labeled), a second curve (Fig. 3a, side opposite the d1 label), and a medial segment (area where 134 labeled in Fig. 3a) between the first curve and the second curve, and wherein an axis of the tapered distal tip 132 is offset from an axis of the medial segment when the pre-formed distal portion is in the arcuate configuration (Fig. 3A).
Regarding claim 4, Davies in view of Sun, specfically Sun discloses The system of claim 1, wherein
the pre-formed distal portion 134 and the tapered distal tip 132 are located in the same plane when the pre-formed distal portion is in the arcuate configuration (Fig. 3A).
Regarding claim 7, Davies in view of Sun, specfically Davies discloses The system of claim 1, further comprising
a guiding member 800 configured to be inserted into the lumen of the dilator (Fig. 9, section 0086).
Regarding claim 8, Davies in view of Sun, specfically Davies discloses The system of claim 1, further comprising
a piercing member 112 configured to be inserted into the lumen 130 of the dilator (section 0057).
Regarding claim 9, Davies in view of Sun, specfically Davies discloses The system of claim 8, wherein
the piercing member 112 is RF perforation device or a needle (Section 0057).
Regarding claim 10, Davies in view of Sun, specfically Davies discloses The system of claim 1, wherein
one or more conductor 152 extends from the one or more electroanatomical mapping electrodes 148 to the proximal portion 120 of the dilator elongate body (Fig. 3A-C, section 0072 states electrical conductor extends from tip sidewall 142 into the lumen 130 and goes through the lumen to the proximal end 120).
Regarding claim 11, Davies in view of Sun, specfically Sun discloses The system of claim 1, wherein
the tapered distal tip tapers from an outer diameter of approximately 0.111” to approximately 0.060” over a length of approximately 10 mm (Section 0029)
Regarding claim 12, Davies in view of Sun, specfically Sun discloses The system of claim 1, wherein
the dilator is formed of one or more low density polyethylene, high density polyethylene (Section 0058), shape memory polymer, or shape memory metal.
Regarding claim 13, Davies in view of Sun, specfically Davies discloses The system of claim 1, further comprising
a proximal electrode 748b located proximal of the pre-formed distal portion 702 that is configured to identify a stem of the dilator on the electroanatomical mapping system (Fig. 7, section 0080).
Regarding claim 14, Davies in view of Sun, specfically Davies discloses The system of claim 1, wherein
the electroanatomical mapping system 104 comprises a display 106, 114 for displaying one or more anatomical images, parameters (RF frequency), and positioning information (Fig. 1, section 0056).
Regarding claim 15, Davies in view of Sun, specfically Davies discloses The system of claim 1, wherein
the one or more electroanatomical mapping electrodes includes three electrodes 748A-F (Fig. 7, section 0080).
Regarding claim 16 Davies discloses a medical system, comprising:
a sheath 110 including an elongate body having a proximal portion (area around element 132 in fig. 1) and a distal portion (area of 112/113 in Fig. 1), and a lumen (section 0016, dilator fully inserted into the sheath) extending from the proximal portion to the distal portion (Fig 1, section 0057); and
a dilator 102 movable within the lumen (section 0016, dilator fully inserted into the sheath), the dilator including an elongate body 118 having a proximal portion 120, a distal portion 122, and a distal tip 134 (Fig. 2);
a plurality of electroanatomical mapping electrodes 148, 748a,b located on the distal portion 122, 734 (Fig. 2, 7, section 0055, 0065), the plurality of electroanatomical mapping electrodes 148, 748a,b being configured to electrically couple 152 with an electroanatomical mapping system (Fig. 1, 3C, section 0070);
However, Davies does not specfically disclose dilator including a preformed distal portion, wherein the pre-formed distal portion has a substantially linear configuration when confined in the sheath, and an arcuate configuration when unconfined. Sun discloses dilator 130 including a preformed distal portion 134, wherein the pre-formed distal portion 132 has a substantially linear configuration when confined in the sheath 110 (Fig. 5, 6A), and an arcuate configuration 134 when unconfined (Figs. 3, A, section 0026). This allows for the operator to easily position the system during insertion to the targeted position of the heart and remove the sheath for the dilator to deploy. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify the device of Davies by adding dilator 130 including a preformed distal portion 134, wherein the pre-formed distal portion has a substantially linear configuration when confined in the sheath, and an arcuate configuration when unconfined as taught by Sun in order to facilitate the operator to easily position the system during insertion to the targeted position of the heart and remove the sheath for the dilator to deploy.
Regarding claim 17, Davies in view of Sun, specfically Sun discloses The system of claim 16, wherein
the pre-formed distal portion 134 includes a first curve (Fig. 3a, side where D1 labeled), a second curve (Fig. 3a, side opposite the d1 label), and a medial segment (area where 134 labeled in Fig. 3a) between the first curve and the second curve, and wherein an axis of the tapered distal tip 132 is offset from an axis of the medial segment when the pre-formed distal portion is in the arcuate configuration (Fig. 3A).
Regarding claim 18, Davies in view of Sun, specfically Sun discloses The system of claim 16, wherein
the pre-formed distal portion 134 and the tapered distal tip 132 are located in the same plane when the pre-formed distal portion is in the arcuate configuration (Fig. 3A).
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies (WO 2022153082).
Regarding claim 20, Davies discloses a medical method, comprising:
inserting a sheath 110 and dilator 102 into the right atrium (Fig. 10);
advancing the dilator 102 from a distal tip of the sheath into a mapping configuration (Fig. 10, section 0019);
moving the dilator around the right atrium to generate an electroanatomical map of the right atrium (Fig. 10, section 0019-0020);
retracting the dilator into the sheath to adopt a transseptal crossing configuration (Section 0021);
puncturing the fossa ovalis 806 via a piercing device 112 that is inserted through a hollow lumen of the dilator (Fig. 11, section 0090-0091); and
advancing the sheath 110 and dilator 102 into the left atrium of the heart (Fig. 12).
Allowable Subject Matter
Claim(s) 5-6, 19 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 5 and 19, The prior art is silent on the pre-formed distal portion and the tapered distal tip are located in different planes when the pre-formed distal portion is in the arcuate configuration. Regarding claim 6, The prior art is silent on the sheath has a rigidity greater than a rigidity of the pre-formed distal portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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