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 .
Response to Amendment
Applicant’s amendments, filed 1/29/2026, have been fully considered and reviewed by the examiner. The examiner notes the amendment to claim 1 and the addition of new claims 7-9. Claims 1-9 are pending.
Response to Arguments
Applicant's arguments filed 1/29/2026 have been fully considered but are directed to newly added claim requirements and are addressed hereinafter.
Applicant’s arguments with respect to Ouchi, arguing that the voids between the wires disappear in the process of Ouchi and such is directed to preserving the find voids generated during twisting. The examiner notes that the claims as drafted do not require voids to be preserved after twisting and therefore this argument is unclear and not commensurate in scope with the claims as drafted. A fair reading of the claims requires voids to be present and the voids accommodate the deformed displacement during the manufacture/twisting of the stranded wire. The examiner can not locate any evidence that the voids remain or are “preserved” after manufacturing or that this is different then the process of Ouchi, which during manufacturing of the first and second stranded wire, twists the two together and subjects the stranded wire to deformation to reduce/eliminate the voids between the wires.
The examiner can find nothing in the claims that voids are preserved after twisting or that voids remain in the final product, merely indicating that the voids accommodate deformed displacement while manufacturing appears to be in line with the cited prior art. Specifically, Ouchi explicitly discloses using circular element strands, in a 7x7 arrangement, and voids are present during manufacturing (i.e. both based on the presence of circular cross section wires and the twisting nature of such, see e.g. Figure 4, Figure 2). While the examiner does not disagree that Ouchi further processes the stranded wire through a die to compress and deform the wire in an attempt to reduce/eliminate the voids between the element wires, such is not foreclosed by the drafted claims that include comprising language.
Claim Rejections - 35 USC § 103
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.
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 5947979 by Ouchi et al. taken with US Patent 4981756 by Rhandhawa, US Patent Application Publication 20180334741 by Sukadhare et al. and CN 108103465, hereinafter CN 465 as evidenced by KR 20140006499 A.
Ouchi discloses a method for manufacturing a wire for cutting human soft tissue (see e.g. claim 2, see also, see “snare for an endoscope that is used to remove a polyp” at column 3, lines 15-18), the method comprising: a first step of forming a first stranded wire using a plurality of element wires; a second step of forming a second stranded wire using the first stranded wires; wherein the element wire has a thickness of and is made of stainless steel, the first stranded wire is formed by disposing one element wire at a center, disposing six element wires around the element wire disposed at the center, and twisting a total of seven element wires, and the second stranded wire is formed by disposing one first stranded wire at a center, disposing six first stranded wires around the first stranded wire disposed at the center, and twisting a total of seven first stranded wires (see Figure 8 and accompanying text, “composite stranded wire such as that shown in FIG. 8, which is formed by twisting together seven stranded wires 12 each formed from seven strands 11 twisted together”, see also column 3, lines 60-63, stating “One strand 11 is disposed in the center to extend straight, and the other six strands 11 are helically wound around the central strand 11”).
Ouchi explicitly discloses using circular element strands, in a e.g. a 7x7 arrangement, and voids are present during manufacturing (i.e. both based on the presence of circular cross section wires and the twisting nature of such, see e.g. Figure 4, Figure 2). Ouchi discloses the fine voids will accommodate the deformation during the manufacturing of the strands. While the examiner does not disagree that Ouchi further processes the stranded wire through a die to compress and deform the wire in an attempt to reduce/eliminate the voids between the element wires, such is not foreclosed by the drafted claims that include comprising language.
Additionally, Ouchi discloses at Figure 4, deformation via twisting and swagging does not completely eliminate the voids but merely provides such deformation as to provide the wire with the desire to control the resistance to bending direction and therefore twisting the wires will include fine voids and such will accommodate the desired deformation. Finally, Ouchi discloses the twisted wire does not require swagging and twisting together the individual wires to achieve resistance to bending in other direction than in a direction toward the center of the wire (see e.g. column 4, lines 40-56).
As for the thickness of the individual stainless steel wires, Ouchi fails to explicitly disclose the thickness as claimed. However, Ouchi discloses the composite stranded wire and the diameter of such is a result effective variable, directly affecting the bending and mechanical strength of the wire (column 5, lines 45-50) and therefore determining the optimum thickness of the individual wires would have been obvious to one of ordinary skill in the art to provide the composite wire with the desired properties.
Ouchi discloses a stainless steel wire for cutting tissue; however, fails to disclose the TiN coating and precoating steps. However, Rhandhawa, also in the art of surgical instruments and tools, e.g. cutting tools made from stainless steel (column 1, lines 15-25). Rhandhawa discloses TiN coating by cathode arc deposition, including cleaning the substrate, placing the stainless steel into a vacuum chamber and lower the vacuum to remove air and moisture from the system and thereafter coating with TiN to achieve a thin, hard, wear and corrosion resistance surface (column 3 lines 28-60, column 4, line 50-60, column 5, lines 5-10). Rhandhawa discloses the details of the CAPD vacuum arc include a cathode arc source (column 4, lines 1-30). Therefore, taking the references collectively and all that is known to one of ordinary skill in the art, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified Ouchi with Rhandhawa to provide the stainless steel medical instrument of Ouchi with a TiN hard coating by CAPD to reap the benefits as specifically outlined by Rhandhawa, i.e. hard, thin, wear and corrosion resistance surface for the medical instrument.
As for the pressure, the pressure of Rhandhawa is taught as about 1x10-5 and thus fails to explicitly disclose the claimed pressure; however, the pressure of Rhandhawa is set forth is taught as a result effective variable, directly affecting the removal of air and moisture, and therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the optimum pressure through routine experimentation to achieve the desire or maximum removal of water and air from the system.
As for the temperature of deposition, Ouchi with Rhandhawa fails to disclose the claimed substrate temperature. However, Sukadhare, also in the art of forming a cathodic arc TiN coating onto the surface of a surgical instrument (0004, 0012-0014) discloses deposition temperate that overlap the claimed value and therefore makes obvious deposition at 400C (paragraph 0056 stating “The deposition temperature can be about 180, 200, 300, 400, 500, 600, 700, 800, 900, or 1,000° F”). Therefore, it would have been obvious to have used the known and suitable temperature of the cathode arc deposition of TiN.
Ouchi with Rhandhawa and Sukadhare discloses a stainless steel wire for cutting tissue, cleaning and thereafter coating with TiN (see Rhandhawa column 4, lines 45-50); however, fails to disclose the alcohol and acetone. However, CN 465 discloses a stainless steel cutting apparatus, such as those for medical apparatus, same as Ouchi, and discloses the stainless steel substrate is cleaned in acetone and alcohol (see “acetone, alcohol and de-ionized water for ultrasonic cleaning for 10 min ~ 15 min) and thereafter placing in vacuum chamber for TiN deposition and therefore taking the references collectively, it would have been obvious to have washed in acetone/alcohol to achieve the benefits of preparing the stainless steel for TiN deposition.
Claims 2-3: Ouchi discloses the diameter/thickness of the composite wire that has a thickness that is within the range as claimed (see e.g. column 4, lines 20-25, stating 0.276 mm) or is close to and abuts the range as claimed (with respect to claim 3). In the case where the claimed ranges “overlap or lie” inside ranges disclosed by prior art a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257 191 USPQ 90. See MPEP 2144.05.
With respect to claim 3: A prima facie case of obviousness exists where the claimed ranges and prior art do not overlap but are close enough that one in ordinary skill in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 f.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2144.05.
Additionally, with respect to claims 2-3, the thickness of the composite wire would have been recognized as a result effective variable, directly affecting the properties of the wire and it would have been obvious to have determined the optimum thickness for the composite wire to achieve the desired properties for the use as outlined by Ouchi.
Claims 4-6: Ouchi discloses a wire for cutting human soft tissue (see “snare for an endoscope that is used to remove a polyp” at column 3, lines 15-18) and the process is made obvious as set forth above.
Claim 7: Ouchi discloses the element wires are twisted without breakage (see entire reference).
Claim 8: The use of the vacuum will necessarily prevent adhesion of the ultra-fine dust and foreign matter as evidenced by KR20140006499 (“The vacuum chamber 10 prevents foreign matter from flowing in from the outside and maintains a high vacuum state in order to secure the straightness of the deposition material. The vacuum degree of the vacuum chamber 10 is preferably maintained at about 10 E-7 Torr or less”)
Claim 9: Here, the examiner notes that the improved ultrasound visibility is a physical property or latent property of the TiN layer. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). The claims do not require use of wire or the presence of ultrasound but only that it will increase the ultrasound visibility, which will necessarily exist by the presence of the TiN layer (claims are to manufacture of the wire “for” cutting tissue and are not directed to use in a surgical procedure).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ouchi et al. taken with Rhandhawa, Sukadhare et al. and CN 465 as applied above and further with KR 20140006499 A.
While the examiner maintains the position as set forth above, that is that the presence of the vacuum would be expected to prevent the adhesion of dust and foreign matter, the examiner notes that it would have been obvious to have used the vacuum as taught by KR 499 to prevent the foreign matter, including ultrafine dust, from entering the chamber and prevent adhesion of such as KR 499 discloses using a vacuum to achieve this benefit so as to provide a depositing coating without foreign matter and securing the straightness of the coating.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID P TUROCY whose telephone number is (571)272-2940. The examiner can normally be reached Mon, Tues, Thurs, and Friday, 7:00 a.m. to 5:30 p.m.
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/DAVID P TUROCY/Primary Examiner, Art Unit 1718