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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/12/2026 has been entered.
Response to Arguments
Election/Restrictions
In the Remarks filed 05/12/2026, Applicant presents new claim 20 which is directed to an independent product-by-process claim, and argues that restriction between claims 1 and 20 would not be proper, because they are directed to the same essential characteristics of a single disclosed embodiment of an invention, and the process does not produce a materially different product, and the product cannot be made by a materially different process that would distinguish the claimed inventions. Applicant’s arguments have been fully considered and are persuasive.
Examiner notes that for the purposes of examination, as long as the end product of the applied prior art is the same as the claimed invention, the process by which the product is made holds no patentable weight as determination of patentability of based on the product itself.
Rejections under 35 USC 102/103
Applicant’s arguments, see Remarks and Amended Claims filed 05/12/2026, with respect to the rejection of claims 1-17 under 35 USC 102/203, have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Saavedra (US 6261308 B1) and Fukui et al (US 20210113370 A1). See 35 USC 103 rejection detailed below.
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 § 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.
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.
Claims 1, 2, 4, 5, 8, 9, 11-14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Saavedra (US 6261308 B1) in view of Fukui et al (US 20210113370 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 two jaw members movable relative to one another, each jaw member comprising a 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, Saavedra teaches a surgical or endoscopic instrument (10) comprising:
two jaw members (12 and 14) movable relative to one another between an open position and a closed position (see [Col 3, lines 49-52]; opening handles 12a and 14a causes jaws 12b and 14b to open, and closing handles 12a and 14a causes jaws 12b and 14b to close),
each jaw member (12 and 14) comprising a longitudinal member extending between a proximal end and a distal end (see annotated Fig. 1 below, [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end), and
a support piece (12b and 14b) arranged at the distal end,
wherein each support piece has at least one structured contact section provided with toothing or corrugation (see Figs. 5-6 wherein jaws 12b and 14b have rows of teeth 40 and 42 disposed on their respective inner surfaces and Figs. 2-4 wherein the tips of jaws 12b and 14b broaden in a perpendicular direction and are provided with rows of teeth 32 and 34 disposed on their respective inner surfaces),
wherein the structured contact sections of the two jaw members are arranged to oppose one another in the closed position for gripping tissue or objects (see Fig. 1 wherein instrument 10 is in a closed position and structured contact sections of jaws 12b and 14b are opposing one another),
wherein the structured contact sections are integrated in the respective support pieces and are free of a separate plate or inserts (see [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end),
wherein the support pieces and the at least one structured contact section comprise a corrosion-resistant stainless steel (see [Col 4, line 63]; employing 420 stainless steel), and
wherein the at least one structured contact section is heat treated (see [Col 4, lines 61-65]; desired properties may be imparted to the handles and jaws by employing 420 stainless steel appropriately heat treated to achieve the desired level of both flexibility and ductility).
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Saavedra is silent regarding wherein the heat treatment of the stainless steel comprises low-temperature diffusion hardening near the surface such that a diffusion zone having a depth of 25 um to 50 um is formed.
Fukui teaches a surgical or endoscopic instrument comprising a longitudinal member (10) having a stainless steel (see Fukui [0044]) support piece (20) that is low-temperature diffusion hardened near the surface forming a diffusion zone (see Fukui [0044-0045]; surface heating treatment to obtain a thick hardened surface layer). The diffusion zone as taught by Fukui has a thickness of up to 18 um, for the extra narrow shaft disclosed, however it can be appreciated that Fukui also teaches a ratio of the cross-sectional area of the diffusion hardened layer to the entire cross-sectional area of the longitudinal member, where the diffusion hardened layer may be between 2% and 20% of the entire cross-sectional area (Fukui [0045]). Therefore, it can be appreciated that the only difference between the hardened surface layer of the prior art and the claimed invention is the relative size of the longitudinal member and resulting thickness of the hardened surface layer with respect to the proportional relationship between the cross-sectional area of the hardened surface layer and the entire cross-sectional area. It has been 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. See MPEP 2144.04(IV), In Gardner v. TEC Syst., Inc., 725 F.2d 1338.
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 Saavedra’s heat-treated stainless steel forceps using low-temperature diffusion hardening as taught by Fukui. One of ordinary skill in the art would have been motivated to make this modification in order to improve elasticity of the longitudinal member which achieves a higher deflection resistance than an untreated longitudinal member without losing its flexibility (Fukui [0045]).
Regarding claim 2, Saavedra in view of Fukui teaches the instrument according to claim 1, wherein the support piece and the structured contact sections include a biocompatible metal material (see Saavedra, Abstract; the forceps are preferably manufactured of 420 stainless steel).
Regarding claim 4, Saavedra in view of Fukui teaches the instrument according to claim 1, wherein at least the support piece and the structured contact sections, are free of diamond and cubic boron nitride (see Saavedra, Abstract; the forceps are preferably manufactured of 420 stainless steel).
Regarding claim 5, Saavedra in view of Fukui teaches the instrument according to claim 1, wherein the structured contact sections have an increased surface hardness (see [Col 4, lines 61-65]; desired properties may be imparted to the handles and jaws by employing 420 stainless steel appropriately heat treated to achieve the desired level of both flexibility and ductility).
Regarding claim 8, Saavedra in view of Fukui teaches the instrument according to claim 1, wherein at least the support piece has a ductile core (see [Col 4, lines 61-65]; desired properties may be imparted to the handles and jaws by employing 420 stainless steel appropriately heat treated to achieve the desired level of both flexibility and ductility).
Regarding claim 9, Saavedra in view of Fukui teaches the instrument according to claim 1 wherein the instrument comprises a corrosion-resistant stainless steel (see Saavedra, Abstract; 420 stainless steel). However, Saavedra is silent regarding 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.
Fukui teaches wherein the corrosion-resistant material is selected from the group consisting of: rustproof, austenitic chrome-nickel steels with low carbon content (see Fukui [0039]; instrument 20 is made of an austenitic chrome-nickel stainless steel with low carbon content).
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 Saavedra’s stainless steel surgical instrument with the rustproof, austenitic chrome-nickel steels with low carbon content as taught by Fukui. One of ordinary skill in the art would have been motivated to make this modification in order to provide an instrument that has the elastic strength necessary for surgical applications and compatibility with surface hardening procedures (Fukui [0046-0049]).
Regarding claim 11, Saavedra in view of Fukui teaches the instrument according to claim 1, wherein the instrument is a jaw head instrument or a needle holder (see Saavedra Fig. 1, Abstract; medical forceps), wherein two jaw members (12b and 14b) are provided, which are movable relative to each other (see [Col 3, lines 49-52]; stems 12 and 14 are interconnected at yoke 16, opening handles 12a and 14a causes jaws 12b and 14b to open, and closing handles 12a and 14a causes jaws 12b and 14b to close),
wherein each of the two jaw members (12b and 14b) forms a support piece and is provided with a structured contact section (see Figs. 5-6 wherein jaws 12b and 14b have rows of teeth 40 and 42 disposed on their respective inner surfaces and Figs. 2-4 wherein the tips of jaws 12b and 14b broaden in a perpendicular direction and are provided with rows of teeth 32 and 34 disposed on their respective inner surfaces), and whereby the structured contact sections of the two jaw members face each other at least in the closed state (see Fig. 1 wherein instrument 10 is in a closed position and structured contact sections of jaws 12b and 14b are opposing one another).
Regarding claim 12, Saavedra in view of Fukui teaches the instrument according to claim 11,
wherein the longitudinal member (12 and 14) is a shaft which extends between a proximal end and a distal end (see annotated Fig. 1 below),
wherein a grip section is arranged on the proximal end (22 and 24), and
wherein two jaw members (12b and 14b) are arranged on the distal end, of which at least one jaw member is movable or pivotable, relative to the other jaw member (see [Col 3, lines 40-52]; stems 12 and 14 are interconnected at yoke 16 via pivot pin 17, wherein opening handles 12a and 14a causes jaws 12b and 14b to open and closing handles 12a and 14a causes jaws 12b and 14b to close, with movement centered about yoke 16).
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Regarding claim 13, Saavedra in view of Fukui teaches the instrument according to claim 11, wherein an actuating element extends through the shaft (12 and 14) and is configured to actuate the at least one movable jaw member (see [Col 3, lines 49-52]; opening handles 12a and 14a of stems 12 and 14 causes jaws 12b and 14b to open, and closing handles 12a and 14a of stems 12 and 14 causes jaws 12b and 14b to close).
Regarding claim 14, Saavedra in view of Fukui teaches the instrument according to claim 11, wherein a ratchet (22 and 24) is provided which is operable to ensure a closed state of the two jaw members (see Fig. 1, [Col 3, lines 1-16]; hands 12a and 14a are provided with locking tabs 22 and 24, respectively provided with ribs 26a and 26b, which releasably lockingly mate at intervals thereby resisting opening and effecting a lock of the position of stems 12 and 14).
Regarding claim 19, Saavedra teaches a method for producing a surgical or endoscopic instrument (10), comprising:
providing two longitudinal members (12 and 14) configured as jaw members (12b and 14b) and extending between proximal ends and distal ends (see annotated Fig. 1 below, [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end), and
forming or providing, at the distal end of each longitudinal member, a support piece (12b and 14b) made of a corrosion-resistant steel material (see [Col 4, line 63]; employing 420 stainless steel), wherein each support piece is an integral section of the respective longitudinal member and is free of a separate plate or inserts (see [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end);
creating on each support piece at least one structured contact section comprising toothing or corrugation (see Figs. 5-6 wherein jaws 12b and 14b have rows of teeth 40 and 42 disposed on their respective inner surfaces and Figs. 2-4 wherein the tips of jaws 12b and 14b broaden in a perpendicular direction and are provided with rows of teeth 32 and 34 disposed on their respective inner surfaces);
hardening the at least one structured contact section by heat treating (see [Col 4, lines 61-65]; desired properties may be imparted to the handles and jaws by employing 420 stainless steel appropriately heat treated to achieve the desired level of both flexibility and ductility); and
configuring the two longitudinal members (12 and 14) as opposing jaw members (12b and 14b) movable relative to one another between an open position and a closed position (see [Col 3, lines 49-52]; opening handles 12a and 14a causes jaws 12b and 14b to open, and closing handles 12a and 14a causes jaws 12b and 14b to close),
such that the structured contact sections oppose one another in the closed position for gripping tissue or objects (see Fig. 1 wherein instrument 10 is in a closed position and structured contact sections of jaws 12b and 14b are opposing one another).
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Saavedra is silent regarding wherein the heat treatment of the stainless steel comprises low-temperature diffusion hardening near the surface such that a diffusion zone having a depth of 25 um to 50 um is formed.
Fukui teaches a surgical or endoscopic instrument comprising a longitudinal member (10) having a stainless steel (see Fukui [0044]) support piece (20) that is low-temperature diffusion hardened near the surface forming a diffusion zone (see Fukui [0044-0045]; surface heating treatment to obtain a thick hardened surface layer). The diffusion zone as taught by Fukui has a thickness of up to 18 um, for the extra narrow shaft disclosed, however it can be appreciated that Fukui also teaches a ratio of the cross-sectional area of the diffusion hardened layer to the entire cross-sectional area of the longitudinal member, where the diffusion hardened layer may be between 2% and 20% of the entire cross-sectional area (Fukui [0045]). Therefore, it can be appreciated that the only difference between the hardened surface layer of the prior art and the claimed invention is the relative size of the longitudinal member and resulting thickness of the hardened surface layer with respect to the proportional relationship between the cross-sectional area of the hardened surface layer and the entire cross-sectional area. It has been 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. See MPEP 2144.04(IV), In Gardner v. TEC Syst., Inc., 725 F.2d 1338.
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 Saavedra’s heat-treated stainless steel forceps using low-temperature diffusion hardening as taught by Fukui. One of ordinary skill in the art would have been motivated to make this modification in order to improve elasticity of the longitudinal member which achieves a higher deflection resistance than an untreated longitudinal member without losing its flexibility (Fukui [0045]).
Claim 20 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 ‘hardening the at least one structured contact section by low-temperature diffusion hardening to form a near-surface diffusion zone’ 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 two jaw members movable relative to one another, each jaw member comprising a 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 20, Saavedra teaches a surgical or endoscopic instrument (10), produced by a method comprising:
providing two longitudinal members (12 and 14) configured as jaw members (12b and 14b) and extending between proximal ends and distal ends (see annotated Fig. 1 below, [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end), and
providing, at the distal end of each longitudinal member, a support piece (12b and 14b) made of a corrosion-resistant steel material (see [Col 4, line 63]; employing 420 stainless steel),
creating on each support piece (12b and 14b) at least one structured contact section formed integrally with the respective support pieces free of a separate plate or inserts (see [Col 2, lines 51-53]; stems 12 and 14 are of one piece construction and each has a handle 12a/14a at proximal end and a jaw 12b/14b at a distal end); and
comprising toothing or corrugation (see Figs. 5-6 wherein jaws 12b and 14b have rows of teeth 40 and 42 disposed on their respective inner surfaces and Figs. 2-4 wherein the tips of jaws 12b and 14b broaden in a perpendicular direction and are provided with rows of teeth 32 and 34 disposed on their respective inner surfaces);
hardening the at least one structured contact section by heat treating (see [Col 4, lines 61-65]; desired properties may be imparted to the handles and jaws by employing 420 stainless steel appropriately heat treated to achieve the desired level of both flexibility and ductility); and
wherein the instrument comprises two opposing jaw members (12b and 14b) movable relative to one another between an open position and a closed position (see [Col 3, lines 49-52]; opening handles 12a and 14a causes jaws 12b and 14b to open, and closing handles 12a and 14a causes jaws 12b and 14b to close), and
wherein the structured contact sections are arranged to oppose one another in the closed position for gripping tissue or objects (see Fig. 1 wherein instrument 10 is in a closed position and structured contact sections of jaws 12b and 14b are opposing one another).
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Saavedra is silent regarding wherein the heat treatment of the stainless steel comprises low-temperature diffusion hardening near the surface such that a diffusion zone having a depth of 25 um to 50 um is formed.
Fukui teaches a surgical or endoscopic instrument comprising a longitudinal member (10) having a stainless steel (see Fukui [0044]) support piece (20) that is low-temperature diffusion hardened near the surface forming a diffusion zone (see Fukui [0044-0045]; surface heating treatment to obtain a thick hardened surface layer). The diffusion zone as taught by Fukui has a thickness of up to 18 um, for the extra narrow shaft disclosed, however it can be appreciated that Fukui also teaches a ratio of the cross-sectional area of the diffusion hardened layer to the entire cross-sectional area of the longitudinal member, where the diffusion hardened layer may be between 2% and 20% of the entire cross-sectional area (Fukui [0045]). Therefore, it can be appreciated that the only difference between the hardened surface layer of the prior art and the claimed invention is the relative size of the longitudinal member and resulting thickness of the hardened surface layer with respect to the proportional relationship between the cross-sectional area of the hardened surface layer and the entire cross-sectional area. It has been 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. See MPEP 2144.04(IV), In Gardner v. TEC Syst., Inc., 725 F.2d 1338.
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 Saavedra’s heat-treated stainless steel forceps using low-temperature diffusion hardening as taught by Fukui. One of ordinary skill in the art would have been motivated to make this modification in order to improve elasticity of the longitudinal member which achieves a higher deflection resistance than an untreated longitudinal member without losing its flexibility (Fukui [0045]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Saavedra (US 6261308 B1) in view of Fukui et al (US 20210113370 A1) and Arunjunai (EP 2543326 A1).
Regarding claim 6, Saavedra in view of Fukui 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 surgical tool 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 Saavedra and the surface hardening procedure of Fukui to result in a 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 desired surgical function while preserving the corrosion resistant properties of the austenitic stainless steel (Arunjunai [0036]).
Conclusion
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.
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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
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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