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
In response to the amendment filed on 11/22/2024, no claims have been cancelled, and Claims 1-10 are pending.
Claim Rejections - 35 USC § 102
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.
Claims 1 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200268430 A1 Takei et al. (hereinafter Takei).
Regarding claim 1, Takei discloses an ultrasonic treatment instrument (Fig. 1, paragraph 75) comprising:
an ultrasonic blade (13, Fig. 1-3, 8, 11-12, paragraph 34) configured to supply ultrasonic vibration and a high frequency current to a living tissue, respectively (paragraph 31, 75);
a jaw (31, Fig. 2-3) configured to open and close with respect to the ultrasonic blade (paragraph 39);
a holder (41, Fig. 2-3) provided in the jaw to be swingable with respect to the jaw (paragraph 39, 41-42, swing unit 33 is swingable with respect to the jaw 31, and swing unit 33 includes holder 41, therefore holder 41 is swingable with respect to the jaw 31);
and an abutment portion (45, Fig. 3) provided in the holder and made of a first resin material (paragraph 42, 45, the holder 41 is made of a resin, and the abutment portion 45 is included in the holder, therefore the abutment portion is also made of a resin) the abutment portion being configured to abut against the ultrasonic blade when the jaw is closed with respect to the ultrasonic blade (paragraph 46),
at least a part of the holder being made of a second resin material (paragraph 42), and
the holder including an electrode (43, Fig. 3) configured to supply the high frequency current on at least a part of a contact surface (18, Fig. 1-3) that is included in the holder, the contact surface being configured to be in contact with the living tissue (paragraph 22, 41, 63).
Regarding claim 2, Takei discloses the limitations to claim 1, and further discloses wherein
the abutment portion (45) is provided at a center portion of the holder (41) in a width direction (as seen in Fig. 3), and
the electrode (43) is provided on at least a part of each of contact surfaces (18) located on both sides of the abutment portion (45) in the width direction (as seen in Fig. 3).
Claim Rejections - 35 USC § 102/103
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.
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 4 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Takei.
Regarding claim 4, Takei discloses the limitations to claim 1, and wherein the electrode is formed by three-dimensional plating processing.
The limitation “wherein the electrode is formed by three-dimensional plating processing” is considered a product by process claim. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Although the reference does not disclose “wherein the electrode is formed by three-dimensional plating processing”, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the electrode is formed by three-dimensional plating processing, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known manufacturing technique for another yields predictable results to one of ordinary skill in the art; In the instant case, the method of 3D printing would impart a 3D structure to the product as claimed.
Claims 1-2, 4, 5-7, 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 20120101493 A1 Masuda et al. (hereinafter Masuda) in view of US 20200268430 A1 Takei et al. (hereinafter Takei).
Regarding claim 1, Masuda discloses an ultrasonic treatment instrument (21, Fig. 1) comprising:
an ultrasonic blade (29, Fig. 1-7, 9, 12-13) configured to supply ultrasonic vibration and a high frequency current to a living tissue, respectively (paragraph 3, 32);
a jaw (47, Fig. 2-3, 5-6) configured to open and close with respect to the ultrasonic blade (paragraph 42);
a holder (48, Fig. 2-6, 9-14) provided in the jaw to be swingable with respect to the jaw (paragraph 43); and
an abutment portion (49, Fig. 4-6), provided in the holder and made of a first resin material (paragraph 44), the abutment portion being configured to abut against the ultrasonic blade when the jaw is closed with respect to the ultrasonic blade (paragraph 44), and
the holder including an electrode (58, Fig. 5-6) configured to supply the high frequency current on at least a part of a contact surface (62, Fig. 5-6) that is included in the holder, the contact surface being configured to be in contact with the living tissue (paragraph 50-51, 104).
Masuda is silent on at least a part of the holder being made of a second resin material.
However, Takei teaches a similar ultrasonic treatment instrument (Fig. 1, paragraph 75) that comprises an abutment portion (45, Fig. 3) provided in a holder (41, Fig. 2-3) and made of a first resin material (paragraph 42, 45, the holder 41 is made of a resin, and the abutment portion 45 is included in the holder, therefore the abutment portion is also made of a resin) and at least a part of the holder (41) being made of a second resin material (paragraph 42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Masuda with the teachings of Takei to have at least a part of the holder being made of a second resin material in order to provide biocompatibility and electrically insulative properties.
Regarding claim 2, the combination of Masuda and Takei teaches the limitations of claim 1, and Masuda further discloses wherein
the abutment portion (49) is provided at a center portion of the holder (48) in a width direction (as seen in Fig. 5-6), and
the electrode (58) is provided on at least a part of each of contact surfaces (62) located on both sides of the abutment portion (49) in the width direction (as seen in Fig. 5-6).
Regarding claim 4, the combination of Masuda and Takei teaches the limitations of claim 1, and wherein the electrode is formed by three-dimensional plating processing.
The limitation “wherein the electrode is formed by three-dimensional plating processing” is considered a product by process claim. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Although the reference does not disclose “wherein the electrode is formed by three-dimensional plating processing”, it is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have wherein the electrode is formed by three-dimensional plating processing, since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known manufacturing technique for another yields predictable results to one of ordinary skill in the art; In the instant case, the method of 3D printing would impart a 3D structure to the product as claimed.
Regarding claim 5, the combination of Masuda and Takei teaches the limitations of claim 1, and Masuda further discloses further comprising:
a cylindrical pin (57, Fig. 2-5) attached to the jaw and swingably supporting the holder (paragraph 43), wherein
the electrode (58) is electrically coupled to the jaw (47) via the pin (paragraph 46, the inner sheath 41i, body member 47 (jaw), and the electrode member 48 (holder) are electrically connected. Therefore, one of ordinary skill in the art would have inferred that the electrode (58) is electrically coupled to the jaw (47) via the pin (57)).
Regarding claim 6, the combination of Masuda and Takei teaches the limitations of claim 5, and Masuda further discloses wherein
the holder is provided with an insertion hole (56, Fig. 2-5) through which the pin is inserted (paragraph 43), and
an inner surface of the insertion hole is provided with a first electrically conductive surface configured to electrically couple the pin and the electrode (paragraph 46, since the inner sheath, jaw and holder are electrically connected, one of ordinary skill in the art would have inferred that the inner surface of the insertion hole would need to have a conductive contact surface which contacts with the pin in order to electrically couple the pin and the electrode).
Regarding claim 7, the combination of Masuda and Takei teaches the limitations of claim 6, and Masuda further discloses wherein
the holder is provided with a second electrically conductive surface (82, Fig. 10, paragraph 71) configured to electrically couple the first electrically conductive surface and the electrode (paragraph 71, 75, 78).
Regarding claim 9, the combination of Masuda and Takei teaches the limitations of claim 6, and the combination further teaches wherein the jaw (31, Fig. 2-3 of Takei) is made of a third resin material (Takei: paragraph 39) and includes a third electrically conductive surface configured to be electrically coupled to the pin (Masuda: paragraph 46, since the inner sheath, jaw and holder are electrically connected, one of ordinary skill in the art would have inferred that the jaw would need to have a conductive contact surface which contacts with the pin in order to electrically couple to the pin).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Takei as applied to claim 1 above, and further in view of US 20220409232 A1 Fagan et al. (hereinafter Fagan).
Regarding claim 8, the combination of Masuda and Takei teaches the limitations of claim 1.
The combination silent on wherein a coating material having non-adhesiveness to the living tissue is provided on the electrode.
However, Fagan teaches an ultrasonic treatment instrument (Fig. 1-2, abstract, paragraph 2, 6) that comprises a blade (162, Fig. 1-2, 4-6) functioning as an electrode (paragraph 45) wherein a coating material having non-adhesiveness to the living tissue is provided on the electrode (paragraph 44-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Masuda with Takei with the teachings of Fagan to have wherein a coating material having non-adhesiveness to the living tissue is provided on the electrode in order to provide non-stick properties to the electrode and prevent the electrode from sticking to tissue.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Takei as applied to claim 1 above, and further in view of US 20210196334 A1 Sarley et al. (hereinafter Sarley).
Regarding claim 3, the combination of Masuda and Takei teaches the limitations of claim 1.
The combination is silent on wherein the second resin material is polyether ether ketone or polyphenyl sulfone.
However, Sarley teaches an ultrasonic treatment instrument (abstract, paragraph 2, 10) that comprises a clamp arm pad (1010, Fig. 6) made of polytetrafluoroethylene (PTFE) or similar synthetic fluoropolymers of tetrafluoroethylene, and gap pads (1006, 1008) made of a polyamide material, polyimide polymer alloy, or PET (Polyethylene Terephthalate), PEEK (Polyether Ether Ketone) (paragraph 386).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the second resin material of the modification of Masuda with Takei using the materials as taught by Sarley, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Masuda in view of Takei as applied to claim 6 above, and further in view of Sarley.
Regarding claim 10, the combination of Masuda and Takei teaches the limitations of claim 6, and Masuda further discloses wherein the first resin material is polytetrafluoroethylene (PTFE) (paragraph 44, the abutment portion (49) is made of an insulating material having biocompatibility such as polytetrafluorethylene).
The combination is silent on wherein the second resin material is polyether ether ketone (PEEK) or polyphenyl sulfone (PPSU), and the third resin material is polyether ether ketone (PEEK) or polyphenyl sulfone (PPSU).
However, Sarley teaches an ultrasonic treatment instrument (abstract, paragraph 2, 10) that comprises a clamp arm pad (1010, Fig. 6) made of polytetrafluoroethylene (PTFE) or similar synthetic fluoropolymers of tetrafluoroethylene, and gap pads (1006, 1008) made of a polyamide material, polyimide polymer alloy, or PET (Polyethylene Terephthalate), PEEK (Polyether Ether Ketone) (paragraph 386).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the second resin material and third resin material of the modification of Masuda with Takei using the materials as taught by Sarley, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). (See MPEP 2144.07).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771