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 2 objected to because of the following informalities: In line 1, the word “the” should be inserted after the word “inserting”. 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, 3-4, 7-10, 12-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gainor et al. (US 9,528,537 B2) in view of Reynolds et al. (US 2004/0167441 A1).
Claims 1 and 10: Gainor et al. discloses a method of forming a implantable medical device (Col. 1, Lines 15-25) providing a first wire section (12 of Figure 2; Col. 3, Lines 28-44); providing a second wire section (14 of Figure 2); providing a joining section (50 of Figure 2) that comprises a superelastic material and has first and second ends (Col. 3, Lines 28-44); cooling the joining section (Col. 3, Lines 47-49); after cooling the joining section, forcefully inserting the first wire section into the first end of the joining section and forcibly inserting the second wire section into the second end of the joining section (Col. 3, Lines 49-55); after inserting the wire sections, warming the joining section such that it compresses on to both the first and second wire sections thereby joining them together (Col. 3, Lines 49-59).
While Gainor et al. discloses a portion of the limitations recited in claim 1, Gainor et al. fails to disclose that the formed device is medical guidewire, that the first wire section and second wire section are of differing materials.
However, Reynolds et al. teaches a forming a medical guidewire (paragraph [0002]) that includes a first wire section (paragraph [0026]) and second wire section (paragraph [0027]) that are of differing materials.
Therefore, it would have been obvious to one of ordinary skill in the art to substitute the wire materials of Reynolds et al. for the wire materials of Gainor et al. because it is prima facie obvious to substitute one known prior art element for another in order to achieve predictable results (MPEP 2143(B)). In the instant case the predictable results would be that the medical device formed by the method of Gainor et al. would be a guidewire including two wires of differing materials.
Claims 3 and 12: Gainor et al. further discloses that warming the joining section causes the joining section to apply a compressive force on each first and second wire sections (Col. 3, Lines 45-59).
Claims 4 and 13: Reynolds et al. further discloses that the first material comprising one of stainless steel, nickel-chromium alloy, nickel-chromium-iron alloy, and cobalt alloy and wherein the second material comprising nickel-titanium (paragraph [0026]).
Claims 7 and 15: Gainor et al. further discloses that the joining section comprises a Nitinol alloy (Col. 3, Lines 13-27).
Claims 8 and 16: Reynolds et al. further the guidewire has an outer diameter of between 0.005 and about 0.04 inches (paragraph [0031]).
Claims 9 and 17: Neither Gainor et al. nor Reynolds et al., disclose or reasonably suggest that the guidewire has average results for tensile-to-fail testing of connection is at least 3.1 Ibf.
However, Gainor et al. discloses a method of forming a connection having a tensile-to-fail testing of connection of a desired force.
Therefore, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine the characteristics of the joint taught by Gainor et al. that resulted in a tensile-to-fail testing of connection of at least 3.1 Ibf. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Gainor et al. (US 9,528,537 B2) in view of Reynolds et al. (US 2004/0167441 A1) and Moseman (US 4,769,897).
Claims 2 and 11: Gainor et al. fails to explicitly disclose that forcefully inserting the first and second wire sections into the joining section causes a flaring deformation at each of the first and second ends of the joining section.
However, Moseman it is known in the art that inserting a first and second workpiece (22,24 of Figure 3) into a joining section (26 of Figure 3) will cause flaring if the workpieces have a greater outer diameter than the inner diameter of the joining section.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the size of the first and second wire ends and the joining section in order to cause the desired flaring, since such a modification would have involved a mere change in the size of a components. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further, in Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Gainor et al. (US 9,528,537 B2) in view of Reynolds et al. (US 2004/0167441 A1) and Pai, P. Frank. (2007). Highly Flexible Structures - Modeling, Computation, and Experimentation - 8.2.4 Shape Memory Alloys.
Claims 5 and 14: Gainor et al. further discloses cooling the joining section in order to cause a phase transition in the Nitinol joining section (Col. 3, Lines 28-44), but Gainor et al. fails to explicitly disclose that the cooling includes cooling the joining section to a temperature below 32°F and allowing the joining section to warm to room temperature.
However, Frank teaches that Nitinol phase transitions is known to be varied between 0°C and 100°C based on the Nickel content of the Nitinol in order to achieve a desired effect (8.2.4 first paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art to cool the joining section of Gainor et al. below 32°F and to allow the joining section to warm to room temperature in order to cause a phase transition that would allow for the joining of the wire ends with the Nitinol joining section. This modification would have been obvious to and well within the ability of one of ordinary skill in the art to make, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
In this instant case one of ordinary skill of art would have been capable of determining the phase temperature of the Nitinol based on the Nickel content, and would therefore cool the joining section below that temperature in order to achieve the desired effect.
Conclusion
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/JASON L VAUGHAN/Primary Examiner, Art Unit 3726