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 Objections
Claim 18 is objected to because of the following informalities:
Claim 18 states “wherein the cam slot is curved such that when the rotation of the cutting tip within the outer band causes the guide pin to slide within the cam slot, causing the cutting tip to move longitudinally” but for grammatical correctness should read “wherein the cam slot is curved such that [[when the]] rotation of the cutting tip within the outer band causes the guide pin to slide within the cam slot, causing the cutting tip to move longitudinally.”
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.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grace et al. (US 20140277037 A1) (noted on IDS).
Regarding claim 1, Grace discloses an apparatus, comprising:
a lead removal device configured to be positioned within a blood vessel of a patient (Paragraph 0116) and comprising:
a longitudinal axis (A-A) (Paragraph 0105);
a first flexible elongate sheath (526) extending along the longitudinal axis and comprising a cutting tip (522) configured to cut tissue to separate a medical lead implanted in the tissue (Figure 5A; Paragraph 0117); and
a second flexible elongate sheath (504) extending along the longitudinal axis, wherein the first flexible elongate sheath is positioned inside the second flexible elongate sheath (Figure 5A; Paragraph 0117),
wherein the cutting tip is configured to have movement relative to the second flexible elongate sheath, wherein the movement comprises lateral motion in a plane perpendicular to the longitudinal axis (Paragraph 0117; 0119; 0123) (the cam path is at an angle thus as the pin travels, it would be laterally moving as well as moving longitudinally).
Regarding claim 2, Grace further discloses wherein the movement comprises: rotational motion around the longitudinal axis (Paragraph 0106; 0117; 0119); and longitudinal motion along the longitudinal axis (Paragraph 0117; 0119).
Regarding claim 4, Grace further discloses wherein the lead removal device further comprises a cam pin (510) comprising a first end fixedly coupled to the cutting tip (Figure 5A-B; Paragraph 0117).
Regarding claim 5, Grace further discloses wherein the second flexible elongate sheath comprises a band (600) (Figure 6A-C; Paragraph 0118), wherein the band comprises a cam path (604) such that the cam path is positioned radially outward of the first end of the cam pin (Figure 6A-C; Paragraph 0118), wherein an opposite, second end of the cam pin is configured to travel along the cam path (Paragraph 0117).
Regarding claim 6, Grace discloses no separation between the cam pin and the cam path, thus at least one of the cam path or the second end of the cam pin is sized and shaped to prevent separation between the cam pin and the cam path.
Regarding claim 7, Grace further discloses wherein the cutting tip comprises a lumen configured to receive the tissue after being cut and/or the medical lead after being separated such that the tissue and/or the medical lead that enters the lumen has the lateral motion (Paragraph 0013; 0103).
Regarding claim 8, Grace further discloses wherein the lateral motion of the cutting tip is configured to cause a diameter of the tissue entering the lumen to be smaller than an inner diameter of the cutting tip (Paragraph 0116).
Allowable Subject Matter
Claim 3 is 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 claim 3, the closest prior art of record, Grace (US 20140277037 A1), discloses the apparatus of claim 2, but fails to explicitly disclose wherein the lateral motion of the cutting tip is configured to cause the rotational motion of the cutting tip to be non-concentric relative to the second flexible elongate sheath. Grace discloses rotation and extension along the longitudinal axis but doesn’t explicitly state lateral motion of the cutting tip is configured to cause the rotational motion of the cutting tip to be non-concentric relative to the second flexible elongate sheath. No prior art of record teaches or suggests wherein the lateral motion of the cutting tip is configured to cause the rotational motion of the cutting tip to be non-concentric relative to the second flexible elongate sheath. Moreover, such a modification would not be obvious to one of ordinary skill in the art as it would result in the cutting surface misaligning and could result in inadvertent cutting of tissue or the lead implant
Claims 9-18 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 9, the closest prior art of record, Grace (US 20140277037 A1) discloses a lead removal device, comprising:
a flexible elongate member (526) configured to be positioned within a blood vessel of a patient, wherein the flexible elongate member comprises a proximal portion and a distal portion (Figure 5A-B; Paragraph 0117);
an outer band (504) fixedly positioned at the distal portion of the flexible elongate member and comprising an inner surface having an inner diameter and a cam slot (514) (Figure 5A-B; Paragraph 0117);
a cutting tip (522) positioned at least partially within the outer band and configured to rotate with respect to the outer band (Paragraph 0117), wherein the cutting tip comprises:
a blade (cutting surface 522 constitutes a blade) configured to cut tissue associated with the blood vessel for removal of an electrical lead implanted in the tissue from a body of a patient (Paragraph 0103);
an outer wall surface (exterior surface of 526) defining an outer diameter that is smaller than the inner diameter of the outer band, such that a gap exists between the outer wall surface and the inner surface of the outer band (Figure 5A-B);
an inner wall surface (inner lumen of 526) defining a lumen with an inner diameter, wherein the lumen is configured to receive the electrical lead and the tissue cut by the blade (Figure 5A-B); and
a guide pin (510) fixedly attached to the outer wall surface and configured to slidably engage with the cam slot such that, proximate to the guide pin, the outer wall surface is in contact with the inner surface of the outer band (Figure 5A-B; Paragraph 117),
wherein a cutting edge of the blade is aligned with the inner wall surface (Figure 5A-B), such that a diameter of the tissue cut by the blade and entering the lumen is smaller than the inner diameter (Paragraph 0116).
Grace fails to disclose wherein rotation of the cutting tip within the outer band causes the guide pin to slide within the cam slot, such that a center of rotation of the cutting tip is not aligned with a geometric center of the cutting tip, causing the cutting tip to move laterally as it rotates. According to Grace, the rotation occurs along the longitudinal axis and does not indicate any lateral movement during rotation. Further, no prior art of record teaches or suggests wherein rotation of the cutting tip within the outer band causes the guide pin to slide within the cam slot, such that a center of rotation of the cutting tip is not aligned with a geometric center of the cutting tip, causing the cutting tip to move laterally as it rotates. Moreover, such a modification would not be obvious to one of ordinary skill in the art as it would result in the cutting surface misaligning and could result in inadvertent cutting of tissue or the lead implant.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20080154293 A1; US 5445639 A
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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