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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 June 2026 has been entered.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2004/0106878 to Skujins et al. (Skujins hereinafter) in view of US Pre-Grant Publication 2021/0322730 to Hayzelden (Hayzelden).
Regarding claim 1, Skujins teaches a medical device comprising a core wire (10) having a proximal shaft portion (14) including a first material (stainless steel, see paragraph 18), and a distal shaft portion (16) including an inner shaft (16) formed from a second material (nitinol, see paragraph 19) and an outer shell (18a, 18c) which may be formed of the first material (stainless steel, see paragraph 34), and a tip member (24). Skujins further teaches that the proximal and distal portions may be welded together by various welding processes (paragraph 39). Skujins does not explicitly teach that the outer shell (18a, 18c) is welded directly to the proximal shaft. Hayzelden teaches another core wire generally, and particularly teaches that an outer shell (74, see Fig. 11) may be directly welded (90) to a first portion (62) in order to permanently attach the elements together. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to weld the outer shell of Skujins directly to the proximal shaft portion in order to permanently attach the two elements together.
Regarding claim 2, Skujins teaches stainless steel (paragraph 18) as the first material.
Regarding claim 3, Skujins teaches nickel titanium alloy (nitinol, paragraph 19).
Regarding claim 4, Skujins teaches super elastic nickel titanium alloy (nitinol, paragraph 19).
Regarding claim 5, Skujins teaches a taper (post grinding at 12, as in Fig. 2, see paragraph 15).
Regarding claim 6, Skujins teaches a taper in the distal shaft portion (16, post grinding, as in Fig. 2, see paragraph 15, or 316 in Fig. 8).
Regarding claim 7, Skujins teaches a taper in the outer shell (18c, as shown in Fig. 2 post grinding).
Regarding claim 8, Skujins teaches a polymer tip (paragraph 53).
Regarding claim 9, Skujins teaches that the tip may include a coil (125, Fig. 4).
Regarding claim 10, Skujins teaches that the inner shaft is tubular (e.g. at 125 in Fig. 4).
Regarding claim 11, Skujin further teaches a rod (26) extending within the inner shaft.
Regarding claim 12, Skujins teaches that the rod may be formed of stainless steel (paragraph 51) and that stainless steel may be cladded with other materials to make it radiopaque (paragraph 34). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a cladded wire as taught by Skujins as the rod (26) in order to increase the visibility of the apparatus in imaging.
Regarding claim 13, Skujins teaches contacting a first end region (at 20) of a first shaft (14) with a second end region (18b) of a second shaft (16, 18b), the first shaft including a first material (stainless steel, paragraph 18) and the second shaft including an inner region (16, or proximal tip thereof) including a second material (nitinol, see paragraph 19). Skujins further teaches thermal bonding (e.g. welding, paragraph 17) of the first shaft to the second and grinding (as in Fig. 2, see paragraph 15) to remove part of an outer shell (18c). Skujins further teaches that the proximal and distal portions may be welded together by various welding processes (paragraph 39). Skujins does not explicitly teach that the outer shell (18a, 18c) is welded directly to the proximal shaft. Hayzelden teaches another core wire generally, and particularly teaches that an outer shell (74, see Fig. 11) may be directly welded (90) to a first portion (62) in order to permanently attach the elements together. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to weld the outer shell of Skujins directly to the proximal shaft portion in order to permanently attach the two elements together.
Regarding claim 14, Skujins teaches stainless steel (paragraph 18).
Regarding claim 15, Skujins teaches nitinol (paragraph 19), which is a nickel-titanium alloy.
Regarding claim 16, Skujins teaches nitinol (paragraph 19), which is a super elastic nickel titanium alloy.
Regarding claim 17, Skujins a third end region (4 as annotated in Fig. 2 of Skujins below) opposite the second end region teaches grinding the second shaft (16) at a location (distal edge of 18c) adjacent to the third end region (4).
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Regarding claim 18, Skujins teaches a core wire (10) having a stainless steel (paragraph 18) proximal shaft (14) and a nitinol (paragraph 19) distal shaft (16) coupled to the proximal shaft, a stainless steel (paragraph 34) outer cladding (18c), and a tip member (24). Skujins further teaches a first region (1, see annotated Fig. 2 above) and second region (2), as well as a third region (3) and a fourth region (4) which is free from the outer shell. Skujins teaches that the first and second regions are unitary and that the second and third regions are at least indirectly attached. Skujins further teaches that the proximal and distal portions may be welded together by various welding processes (paragraph 39). Skujins does not explicitly teach that the outer shell (18a, 18c) is welded directly to the proximal shaft. Hayzelden teaches another core wire generally, and particularly teaches that an outer shell (74, see Fig. 11) may be directly welded (90) to a first portion (62) in order to permanently attach the elements together. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to weld the outer shell of Skujins directly to the proximal shaft portion in order to permanently attach the two elements together.
Regarding claim 19, Skujins teaches at least a taper of the third region (4, see Fig. 2 above).
Regarding claim 20, Skujins teaches a polymer tip (paragraph 53).
Response to Arguments
Applicant’s arguments, see page 6, filed 26 May 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Skujins in view of Hayzelden as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 8 July 2026
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