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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/20/2026 has been entered.
Response to Amendment
Applicant’s amendments, filed 4/20/2026, have been fully considered and reviewed by the examiner. The examiner notes the amendment to claim 1. Claims 1-9 are pending.
Response to Arguments
Applicant's arguments filed 4/20/2026 have been fully considered but are directed to newly added claim requirements and are addressed hereinafter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 includes “where the second strand is maintained without compressive deformation that eliminates the fine voids such that the fine voids remain in a final manufactured wire”; however, a fair review of the specification fails to support this requirement. The specification makes no reference to the absence or presence of the voids in a final manufactured wire nor does the original disclosure support the negative limitation of “without compressive deformation that eliminates the fine voids”. Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). MPEP 2173.05(i).
Claim 1 requires “fine voids permit elastic deformation . . . during reciprocating cutting”, and such a limitation lacks support in the original filed disclosure. Specifically, there is no disclosure that indicates or infers the claimed nexus, specifically, that the fine voids themselves permit elastic deformation of the second stranded wire during reciprocating cutting.
Additionally, the original disclosure makes no reference to claimed method of cutting and thus fails to support “reciprocating cutting”.
Dependent claims do not cure the deficiencies of the claims from which they depend and are similarly rejected.
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 JPH11104146, hereinafter JP 146 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.
JP 146 discloses a method for manufacturing a wire for cutting human soft tissue (see e.g. ” high-frequency snare” at 0024), 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 4).
JP 146 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 1, 4 and 7). JP 146 discloses the fine voids will accommodate the deformation during the manufacturing of the strands (see Figure 1 and accompanying text, Figure 4).
Additionally, JP 146 discloses at Figure 1, fine voids are present between adjacent wires after formation and wherein the composite strand is maintained (no disclosure of compressive deformation in the reference and therefore would reasonably read on without compressive deformation) and fine voids remain in the manufactured wire (see Figure 1 as evidenced by the circular nature of the composite wires and the twisting that illustrates some voids between adjacent wires exists, see e.g. surface voids). JP 146 discloses plastic deformation of the wire (see e.g. Figure 1) and while such is not explicitly attributed to the presence of the fine voids, the fine voids are present as set forth above and therefore the claims are a result of the presence of the voids and thus would necessarily permit some degree of plastic deformation as claimed unless the applicant is performing different process steps that are not specifically required or disclosure.
As for the requirement of “during reciprocating cutting of human soft tissue”, as the claims are directed towards the manufacture of the wire and not the use of the wire, the examiner notes that performing reciprocating cutting is not actually required by the claims and thus this is met by the prior art that discloses plastic deformation. Additionally, JP 146 discloses the snare, a use, is smoothly bent back into a U shape (0025), and thus utilized in motion that can reasonably be considered reciprocating cutting as claimed.
As for the thickness of the individual stainless steel wires, JP 146 fails to explicitly disclose the thickness as claimed. However, JP 146 discloses the wire and the diameter of such is a result effective variable, directly affecting the bending and strength of the wire (0024) 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.
JP 146 discloses a stainless steel wire for cutting tissue (0017) ; 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 JP 146 with Rhandhawa to provide the stainless steel medical instrument of JP 146 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, JP 146 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.
JP 146 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 JP 146, 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: The thickness of the composite wire would have been recognized as a result effective variable, directly affecting the properties of the composite 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 JP 146.
Claims 4-6: JP 146 discloses a wire for cutting human soft tissue (see “snare”, 0022, “when the polyp or the like is tightened during use, it is easy to cut”) and the process is made obvious as set forth above.
Claim 7: JP 146 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 JP 146 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gordon Baldwin can be reached at 571-272-5166. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID P TUROCY/Primary Examiner, Art Unit 1718
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