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 (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.
Claim Objections
Claim 3 objected to because of the following informalities:
“the flexible sections” in line 3 should be written “the plurality of flexible sections”
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
“the flexible sections” in line 4 should be written “the plurality of flexible sections”
Appropriate correction is required.
Claim 9 objected to because of the following informalities:
“the flexible sections” in line 6 should be written “the plurality of flexible sections”
Appropriate correction is required.
Claim 14 objected to because of the following informalities:
“the flexible sections” in line 1 should be written “the plurality of flexible sections”
Appropriate correction is required.
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.
Claims 7 and 9-10 are 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 7 recites the limitation "the longitudinal rib" in line 2. It is unclear whether this limitation is referring to the first longitudinal rib in claim 1 or the second longitudinal rib recited earlier in claim 7.
Claim 9 recites the limitations "a first polymer material" in line 5 and “a second polymer material” in line 7. It is unclear whether this limitation is referring to the at least one polymer material recited in claim 1 or a different polymer material.
Claim 10 is rejected as being dependent upon a rejected base claim.
Allowable Subject Matter
Claims 1-20 are found to be allowable.
The following is a statement of reasons for the indication of allowable subject matter:
This application contains the same allowable subject matter as application nos. 16/452,223 (‘223 application) and 17/857,229 (‘229 application), of which this application is a continuation, with the addition of language reciting a middle layer radially disposed between the outer surface of the inner layer and the outer layer, wherein the longitudinal rib extends through the middle layer so that C-shaped sections of the middle layer are circumferentially positioned on both sides of the longitudinal rib. As such, the reasons for allowance are the same as those for the ‘223 and ‘229 applications, as explained below.
During the search of the prior arts, Cohen et al., (US 20040215139; hereinafter Cohen), Otten et al. (US 5752937; hereinafter Otten), and Leeflang et al., (US 9937319; hereinafter Leeflang) were found to be pertinent to the claimed invention. However, it is the Examiner’s position that Cohen, Otten, and Leeflang fail to disclose, teach, or suggest the claimed invention.
Regarding independent claim 1, Cohen teaches a delivery device for delivering a pacing lead to the His bundle of a patient's heart, the delivery device comprising: a sheath that is elongated and defines a lumen configured to receive the lead therethrough ([0034] teaches the catheter extending from a steerable hub or handle; [0051]-[0052] teaches a catheter extending from a handle; Fig 1 element 15 teaches a handle; [0131] teaches a proximal end 150 and a distal end 148; Fig 1 illustrates a an elongated sheath 12 having a proximal end and a distal end, the proximal end extending from a handle 14; Fig 10 illustrates a proximal end of a sheath extending from a hub to a distal portion), a distal portion of the sheath having a plurality of flexible sections spaced from one another along a length of the sheath ([0034]-[0035] teaches the distal end of the catheter having controls for changing the points of deflection and bends of the distal end of the catheter; [0055]-[0056] teaches controlling the curvature of an intermediate and distal segments; [0115]; [0136]; Fig 1 illustrates the distal portion of the sheath being flexible; Fig 10 illustrates distal portion 148 being flexible); a pull wire having a distal end connected to the sheath distally of the flexible sections and extending to a proximal end ([0034] teaches a steering or pull wire controlled by the handle; [0052]-[0053] teaches a pull wire; [0055] teaches the steering or pull wire connected to the handle or hub; [0136] teaches having a steering or bending wire); and a mapping electrodes positioned at the distal end of the sheath ([0027] teaches the steerable catheter comprising a distal electrode; [0033]; [0040] teaches electrode used for mapping an visualizing during implantation; [0098]; [0117]; [0124] teaches the pair of electrode used to determine lines or areas of conduction block; [0132]; [0138]). However, Cohen fails to teach the inner layer having a longitudinal rib that protrudes radially outward from an outer surface of the inner layer, the longitudinal rib extending along the length of the sheath; a first split line aligned with the longitudinal rib to facilitate splitting of the sheath; an outer layer composed of at least one polymer material; and a middle layer radially disposed between the outer surface of the inner layer and the outer layer, wherein the longitudinal rib extends through the middle layer so that C-shaped sections of the middle layer are circumferentially positioned on both sides of the longitudinal rib.
Otten teaches a delivery device comprising a sheath having a longitudinal rib extending from the proximal end to the distal end and being splittable along a first split line from the proximal end to the distal end, wherein the sheath includes a recess mating with the rib, the first split line aligned with the rib and the recess to facilitate splitting of the sheath (Col 2 lines 1-52 teaches a splittable cannula comprising an embedded or coextruded strengthening wire/strip substantially along the longitudinal length to act as a cutter to split the cannula; Col 3 lines 29-43; Fig 1 element 6 illustrates a longitudinal strengthening strip; Fig 2 element 6 illustrates the strip being within a channel of the wall. Since the strip it taught to be embedded into the material of the cannula, the wall of the cannula would naturally have a recess that the strip is embedded within).
Furthermore, Leeflang teaches a splittable catheter comprising a first layer, a middle layer and an outer layer, wherein the middle layer is a reinforcing layer embedded between one or more base layer ([abs]; Fig 2a-c illustrates a reinforcing layer 42 between an inner lining 40 and an outer layer 44; col 8 lines 30-51). However, both Otten and Leeflang fail to disclose, teach, or suggest the limitations “the inner layer having a longitudinal rib that protrudes radially outward from an outer surface of the inner layer, the longitudinal rib extending along the length of the sheath; a first split line aligned with the longitudinal rib to facilitate splitting of the sheath; an outer layer composed of at least one polymer material; and a middle layer radially disposed between the outer surface of the inner layer and the outer layer, wherein the longitudinal rib extends through the middle layer so that C-shaped sections of the middle layer are circumferentially positioned on both sides of the longitudinal rib” as required by independent claim 1. Therefore, claim 1 is found to be allowable and claims 2-20 are also found to be allowable since they are dependent upon an allowable base claim.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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