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 Arguments
Rejections under 35 USC 112
In regards to Applicant’s response filed 01/08/2026, the amended claims have overcome the rejections under 35 USC 112(b) made in the Non-Final Office Action filed 08/29/2025. Claim 7 has been cancelled and the rejections of claims 4 and 6 under 35 USC 112(b) are hereby withdrawn.
Rejections under 35 USC 103
Applicant’s arguments, see pages 7-10 of the Remarks filed 01/08/2026, with respect to the rejection(s) of claim(s) 1-17 under 35 USC 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 Therefore, the rejection has been withdrawn.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 Mashiko et al (US 20060058843 A1) and/or Morales et al (US 20190343540 A1) and Mashiko et al (US 20060058843 A1). New grounds of rejection detailed below.
Election/Restrictions
Newly submitted claim 18 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 18 is directed to a method of manufacture and would have been subject to restriction if originally presented.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 18 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 09/19/2023 and 03/11/2024 have been considered by the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-9, 15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mashiko et al (US 20060058843 A1).
Claim 1 is a product-by-process claim wherein the determination of patentability is based on the product itself and does not depend on its method of production. See MPEP 2113(I). The limitation ‘wherein the at least one structured contact section is low-temperature diffusion hardened near the surface’ recites the process by which the instrument is made. As long as the end product of the prior art is the same as the claimed invention, the process by which the product is made holds no patentable weight. The claimed end product and the end product of the prior art are equivalent as they both teach a medical instrument having at least one longitudinal member with a structured contact section integrated into a support piece including stainless steel, the structured contact section having toothing or corrugation and a hardened surface layer with a depth of 25 um to 50 um.
Regarding claim 1, Mashiko teaches a surgical instrument (F) comprising at least one longitudinal member (31/33) with longitudinal extension between a first end and a second end (see annotated Fig. 8 below), and
a support piece (33) which has at least one structed contact section (31) that is provided with toothing or corrugation (see Mashiko Fig. 8, [0084]; spiral shaped groove in contact portion 31),
wherein the at least one structured contact section (31) is integrated in the support piece (see [0079]; body part 33 secured to shank 32 formed continuously from the work part 31),
wherein the support piece and the at least one structured contact section include a corrosion-resistant stainless steel (see [0033]; material used for the present invention is an austenite stainless steel), and
wherein the at least one structured contact section is low-temperature diffusion hardened near the surface, wherein the depth of the diffusion zone in the structured contact section is 25 um to 50 um (see [0037-0040]; cool pulling work on the austenite stainless steel, the hardness of the surface is achieved by providing a hardened/carburized layer in which the carbon atom is penetrated of a depth of 5 um to 70 um on the parent material surface).
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Regarding claim 2, Mashiko teaches the instrument according to claim 1, wherein the support piece and the at least one structured contact section include a biocompatible metal material (see [0019-0020]; due to austenite stainless steel, rust is not produced, and the body tissue is not adversely affected even when the instrument directly contacts the body tissue).
Regarding claim 3, Mashiko teaches the instrument according to claim 1 wherein the instrument is a medical file (see Fig. 8, [0077]; medical file F).
Regarding claim 4, Mashiko teaches the instrument according to claim 1, wherein at least the support piece and the at least one structured contact section are free of diamond and cubic boron nitride (see [0033]; the material for the medical needle and the like of the present invention is an austenite stainless steel).
Regarding claim 5, Mashiko teaches the instrument according to claim 1, wherein the at least one structured contact section has an increased surface hardness (see [0080]; a hardened layer 34 made of carburized material is formed on the face of the working end 31).
Regarding claim 8, Mashiko teaches the instrument according to claim 1, wherein at least the support piece has a ductile core (see [0079-0080]; the body part 33 and the work part 31 are formed continuously, the center portion is configured by the fiber shape structure obtained by performing cool pulling work on the austenite stainless steel or the granulated austenite structure that is not formed with cool pulling work, it can be appreciated that austenitic stainless steel is considered to be ductile).
Regarding claim 9, Mashiko teaches the instrument according to claim 1, wherein the corrosion-resistant stainless steel is selected from the group consisting of: rustproof, austenitic chrome-nickel steels with low carbon content; rustproof, austenitic chrome-nickel-molybdenum stainless steels with low carbon content; and corrosion-resistant, heat-resistant iron-nickel-chrome alloys (see [0033]; austenite stainless steel containing molybdenum in the range of 1% to 6%, or containing chromium in the range of 13% to 25%).
Regarding claim 15, Mashiko teaches the instrument according to claim 1, wherein the instrument is a surgical file (see Fig. 8, [0074]; file F) wherein the longitudinal member (33) is rod-like wherein the at least one support piece (31) is constructed on a blade (31a) on a first or second end of the longitudinal member, and wherein the blade is provided at least on one side with a structured contact section (see Fig. 8, [0079]; file F having a structured contact portion 31 having a blade 31a on a first side of the longitudinal member 33).
Regarding claim 17, Mashiko teaches a method for producing a surgical or endoscopic instrument (F) comprising:
providing at least one longitudinal member (31/33) extending between a first end and a second end (see annotated Fig. 8 below),
providing a support piece (31) made of a corrosion-resistant steel material (see [0033]; the material is an austenite stainless steel),
wherein the support piece is a section of the at least one longitudinal member or is a part coupled to the longitudinal member (see [0079]; body part 33 secured to shank 32 formed continuously from the work part 31),
creating at least one structured contact section on the support piece, comprising toothing or corrugation (see Mashiko Fig. 8, [0084]; spiral shaped groove in contact portion 31),
hardening the at least one structured contact section by a low temperature diffusion hardening forming a near-surface diffusion zone in the structured contact section to a depth of 25 um to 50 um (see [0037-0040]; cool pulling work on the austenite stainless steel, the hardness of the surface is achieved by providing a hardened/carburized layer in which the carbon atom is penetrated of a depth of 5 um to 70 um on the parent material surface).
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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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 11-14 is/are rejected under 35 U.S.C. 103 as obvious over Morales et al (US 20190343540 A1) in view of Mashiko et al (US 20060058843 A1).
Claim 1 is a product-by-process claim wherein the determination of patentability is based on the product itself and does not depend on its method of production. See MPEP 2113(I). The limitation ‘wherein the at least one structured contact section is low-temperature diffusion hardened near the surface’ recites the process by which the instrument is made. As long as the end product of the prior art is the same as the claimed invention, the process by which the product is made holds no patentable weight. The claimed end product and the end product of the prior art are equivalent as they both teach a medical instrument having at least one longitudinal member with a structured contact section integrated into a support piece including stainless steel, the structured contact section having toothing or corrugation and a hardened surface layer with a depth of 25 um to 50 um.
Regarding claim 1, Morales teaches a surgical or endoscopic instrument comprising at least one longitudinal member (3a, 3b) with longitudinal extension between a first end and a second end (see Fig. 1, [0057]; needle holder 1 having legs 3a and 3b extending between a first and second end) and
a support piece (6a, 6b) which has at least one structed contact section that is provided with toothing or corrugation (see Fig. 1, [0057-0059]; legs 3a and 3b having contact sections 6a and 6b with a corrugated surface),
wherein the support piece and the at least one structured contact section include a corrosion-resistant steel material or a stainless steel (see [0022]; stainless steel is used as elastic material for the legs which includes support structures 3a and 3b and contact sections 6a and 6b).
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Morales is silent regarding wherein the at least one structured contact section is integrated in the support piece, and
wherein the at least one structured contact section is low-temperature diffusion hardened near the surface, wherein the depth of the diffusion zone in the structured contact section is 25 um to 50 um.
Morales is silent regarding the structured contact portion formed integrally with the support piece as one continuous structure (Morales [0059]; the gripping portions 6a and 6b have an insert with wafer-type corrugated surface structure made from wear-resistant hard material), however it can be appreciated that for purposes of use, the corrugated surface structure/structured contact portion is integrated into the support piece and they are articulated as a single piece. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to form the corrugated surface structure and the support piece as one continuous piece, 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. See MPEP 2144.04(V)(B), In re Larson, 144 USPQ 347.
Mashiko teaches a surgical instrument (F) comprising at least one longitudinal member (31/33) having a support piece which has at least one structed contact section (31) that is provided with toothing or corrugation (see Mashiko Fig. 8, [0084]; spiral shaped groove in contact portion 31),
wherein the at least one structured contact section is integrated in the support piece (see Mashiko [0079]; body part 33 secured to shank 32 formed continuously from the work part 31),
wherein the support piece and the at least one structured contact section include a corrosion-resistant stainless steel (see Mashiko [0033]; material used for the present invention is an austenite stainless steel), and
wherein the at least one structured contact section is low-temperature diffusion hardened near the surface, wherein the depth of the diffusion zone in the structured contact section is 25 um to 50 um (see Mashiko [0037-0040]; cool pulling work on the austenite stainless steel, the hardness of the surface is achieved by providing a hardened/carburized layer in which the carbon atom is penetrated of a depth of 5 um to 70 um on the parent material surface).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the surgical instrument having a corrugated contact surface of Morales with the integral, heat treated carburized hardened contact section as taught by Mashiko. One of ordinary skill in the art would have been motivated to make this modification in order to extend the fiber shape of the stainless steel to increase the hardness of the material and decrease bending at the working portion of the instrument thereby reducing the resistance when in contact with body tissue and reducing the risk of introducing rust into the body tissue (Mashiko [0019-0020]).
Regarding claim 11, Morales teaches the instrument of claim 1, wherein the instrument is a jaw head instrument or a needle holder (see Fig. 1, [0057]; needle holder 1), wherein two jaw members (6a, 6b) are provided, which are movable relative to each other (see [0061]; contact portions 6a and 6b are actuated via gripping portions 7a and 7b), wherein each of the two jaw members forms a support piece (3a, 3b) and is provided with a structured contact section (see [0059]; contact sections 6a and 6b have an insert with a corrugated surface made from a wear-resistant hard material) and whereby the structured contact sections of the two jaw members face each other at least in the closed state (see Fig. 3; contact sections 6a and 6b facing each other in a closed configuration). See annotated Fig. 1 below.
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Regarding claim 12, Morales teaches the instrument of claim 1, wherein the longitudinal member is a shaft (3a, 3b) which extends between a proximal end and a distal end, wherein a grip section (7a, 7b) is arranged on the proximal end, and wherein two jaw members are arranged on the distal end, of which at least one jaw member is movable or pivotable, relative to the other jaw member (see [0061-0062]; jaws 6a and 6b are actuated via grippers 7a and 7b moving about joint 8). See annotated Fig. 1 below.
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Regarding claim 13, Morales teaches the instrument of claim 1, wherein an actuating element extends through the shaft and is configured to actuate the at least one movable jaw member (see Fig. 1, [0060-0062]; legs 3a and 3b comprising grippers 7a and 7b which are actuated to control opening and closing of jaw members 6a and 6b via joint 8).
Regarding claim 14, Morales teaches the instrument of claim 1, wherein a ratchet is provided which is operable to ensure a closed state of the two jaw members (see Figs. 1 and 3, [0058]; locking members 4a and 4b which keep the jaws in a closed state).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mashiko et al (US 20060058843 A1) in view of Arunjunai (EP 2543326 A1).
Regarding claim 6, Mashiko teaches the instrument according to claim 1. They are silent regarding wherein the at least one structured contact section has a Vickers surface hardness of 750 HV - 1050 HV 0.05.
Arunjunai teaches a medical tool such as a rasp which is made of austenite stainless steel with a surface hardness of minimum 850 Hv 0.05 (Arunjunai [Claim 1]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the instrument having a hardened contact surface as taught by Mashiko with the surface hardness of at least 850 Hv 0.05 as taught by Arunjunai. One of ordinary skill in the art would have been motivated to make this modification in order to provide sufficient hardness and other mechanical properties for the removal of bone material while preserving the corrosion resistance of the austenitic stainless steel (Arunjunai [0036]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mashiko et al (US 20060058843 A1) in view of Westman (US 4377381 A).
Regarding claim 16, Mashiko teaches the instrument of claim 15. They are silent regarding wherein the rod-like longitudinal member is provided on each of a first end and a second end with a blade having a support piece with a structured contact section.
Westman teaches a medical instrument having a rod-like longitudinal member (see Westman Fig. 1; handle 10) wherein the rod-like longitudinal member is provided on each of a first end and a second end with a blade (see Westman Fig. 1; blades 11 and 12) having a support piece with a contact section. See annotated Fig. 1 below.
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It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the medical file as taught by Mashiko with the double-ended contact portions as taught by Westman. One of ordinary skill in the art would have been motivated to make this modification in order to perform dual medical purposes with the same tool, eliminating the need for multiple instruments.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792