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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/8/2025 has been entered.
Claim Objections
Claims 11-13 are objected to because of the following informalities:
Claim 11: Examiner suggests with correction, “Valvulotome according to claim 9…”
Claim 12: Examiner suggests with correction, “Valvulotome according to claim 1…”
Claim 13: Examiner suggests with correction, “Valvulotome according to claim 1…” Appropriate correction is required.
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.
Claims 1, 3, 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190275293 A1 Lenihan et al. (hereinafter Lenihan) in view of US 20130116500 A1 Kohl et al. (hereinafter Kohl).
Regarding claim 1, Lenihan discloses a valvulotome (1300, Fig. 37a-37Nii, paragraph 362-377) comprising a catheter tube (1140, Fig. 35b, paragraph 352-353) and an expandable basket (1302, Fig. 37a) with cutting elements (1312, 1314, Fig. 37a), wherein the catheter tube being designed to accommodate within itself the expandable basket in a non-expanded state (Fig. 35b, paragraph 352, paragraph 363), characterized in that the expandable basket is fixed to a distal end of a wire element (1320, Fig. 37a) extending in the catheter tube and wherein the wire element terminates distally at the expandable basket and the wire element is not guided into and through the expandable basket (Fig. 37a, wire element 1320 terminates at the proximal portion 1308 of the expandable basket 1302 and does not go through the expandable basket) and the wire element is used exclusively for moving the expandable basket (paragraph 363).
Lenihan is silent on wherein the expandable basket is made of a shape memory material and comprises an atraumatically configured resilient tip distally.
However, Kohl teaches a valvulotome (1, Fig. 1) with an expandable basket (5, Fig. 1) that is made of a shape memory material (paragraph 30, 38, 49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lenihan with the teachings of Kohl to achieve wherein the expandable basket is made of a shape memory material in order to provide flexibility to the basket to cause it to automatically spread out when released from the catheter and retract into the catheter when the treatment is complete as disclosed by Kohl (paragraph 30).
Kohl further teaches an atraumatically configured resilient tip (6, Fig. 1, 2, 4, paragraph 39) distally.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lenihan with the teachings of Kohl to achieve an atraumatically configured resilient tip distally in order to prevent the tissue vessel walls from exposure to hazards when in contact with the tip as disclosed by Kohl (paragraph 39).
Regarding claim 3, the combination of Lenihan and Kohl teaches the limitations of claim 1, and Lenihan further discloses the wire element is welded to a proximal end of the expandable basket (paragraph 222, tubes (hypotubes) may be welded to another tube).
Regarding claim 9, the combination of Lenihan and Kohl teaches the limitations of claim 1, and Lenihan further discloses that the expandable basket has three struts (1316, Fig. 37a, 37b) each provided with one or two cutting elements (1312, 1314, Fig. 37a, 37b, paragraph 364-365).
Regarding claim 10, the combination of Lenihan and Kohl teaches the limitations of claim 9, and Kohl further discloses that the three struts are brought together distally to form the atraumatically configured resilient tip (as seen in Fig. 1).
Regarding claim 11, the combination of Lenihan and Kohl teaches the limitations of claim 9, and Lenihan further discloses that the cutting elements have hook-shaped cutters which extend in the plane of the three struts (as seen in Fig. 37a-c). Kohl further discloses that the hook-shaped cutters (9, Fig. 1-4) being flanked by recesses (10a, 10b, Fig. 1-4) of the three struts (5a, 5b, 5b, Fig. 1-4, paragraph 37-47).
Regarding claim 12, the combination of Lenihan and Kohl teaches the limitations of claim 1, and Lenihan further discloses that the wire element is movably guided in the catheter tube (as seen in Fig. 37Ki-37Nii).
Regarding claim 13, the combination of Lenihan and Kohl teaches the limitations of claim 1, and the combination further discloses a radiopaque marker element in the region of the distal end of the catheter tube (paragraph 254 of Lenihan; paragraph 31 of Kohl).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lenihan in view of Kohl and further in view of US 20120046678 A1 LeMaitre et al. (hereinafter LeMaitre).
Regarding claim 2, the combination of Lenihan and Kohl teaches the limitations of claim 1.
The combination is silent on the wire element is a braided steel wire strand.
However, LeMaitre teaches a valvulotome (100, Fig. 1) having a wire element (140, Fig. 1, paragraph 28, 33) that is a braided steel wire strand (paragraph 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Lenihan and Kohl with the teachings of LeMaitre to achieve wherein the wire element is a braided steel wire strand in order to provide strength and pushability as disclosed by LeMaitre (paragraph 33).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lenihan in view of Kohl and further in view of US20170156898A1 Obradovic.
Regarding claim 4, the combination of Lenihan and Kohl teaches the limitations of claim 1.
The combination is silent on the atraumatically configured resilient tip and the expandable basket are formed in one piece.
However, Obradovic teaches a medical implant (1, Fig. 1-3) comprising an expandable basket (10, Fig. 1-3) and a tip (8, Fig. 1-3) that is formed in one piece (paragraph 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Lenihan with Kohl with the teachings of Obradovic to achieve the atraumatically configured resilient tip and expandable basket formed in one piece in order to simplify the manufacturing steps and since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 5, the combination of Lenihan, Kohl and Obradovic teaches the limitations of claim 4, and Obradovic further discloses that the atraumatically configured resilient tip and the expandable basket consist of a shape memory material, preferably nitinol (paragraph 29).
Regarding claim 6, the combination of Lenihan, Kohl and Obradovic teaches the limitations of claim 5, and Lenihan further discloses that the expandable basket are cut from a tube (paragraph 28, 362, 366), and Obradovic further discloses that the atraumatically configured resilient tip is cut from a tube (paragraph 30).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lenihan in view of Kohl, further in view of Obradovic, and further in view of US20160228681A1 di Palma et al. (hereinafter di Palma).
Regarding claim 7, the combination of Lenihan, Kohl and Obradovic teaches the limitations of claim 6.
The combination is silent on the atraumatically configured resilient tip is provided with a circumferentially running spiral incision.
However, di Palma teaches a vascular treatment device 1 with an expandable segment 20 and a leading flexible tip 55 comprising a spring coil 56 in a spiral fashion (Fig. 2c, 3, 4, paragraph 31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the modification of Lenihan with Kohl and Obradovic with the teachings of di Palma to achieve a spiral incision to provide an atraumatically configured resilient tip that behaves in a flexible spring-coil-like fashion to help advance and track the device through the vessel as disclosed by di Palma (paragraph 31, 40).
Regarding claim 8, the combination of Lenihan, Kohl, Obradovic and di Palma teach the limitations of claim 7, and Obradovic further discloses using an interconnected webbing structure 3 (Fig. 1-3, paragraph 41-48).
It is therefore well known in the art and within the ability of one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of Obradovic to the combination of Lenihan, Kohl, Obradovic and di Palma to yield the predictable result of a spiral incision with interconnected webbing structures to universally join and support the spiral incision and to provide an atraumatically configured resilient tip that behaves in a flexible spring-coil-like fashion to help advance and track the device through the vessel as disclosed by di Palma (paragraph 31, 40).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KHOA TAN LE/Examiner, Art Unit 3771
/MOHAMED G GABR/ Primary Examiner, Art Unit 3771