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
The amendment filed 12/05/2025 has been entered. Claims 1-16 are pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. US 12167851 B2. Although the claims at issue are not identical, they are not
patentably distinct from each other because both sets of claims are directed to a treatment instrument/tool having an end effector, an ultrasound vibration transmission portion; a tubular portion coupled to the end effector; a driver coupled to a proximal end of the tubular portion, the driver is configured to actuate the end effector via the tubular portion; and a pusher configured to support a coupling between the tubular portion and the driver in order to prevent a movement of the tubular portion in a longitudinal direction thereof and the driver includes a protruding portion, and wherein the pusher is configured to be attached to the protruding portion.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: “coupling between the tube”. Amended claim 1 recites “a pusher configured to support a coupling between the tube” and removed “and the driver”. What is the other member for “coupling between the tube”? What is the pusher coupling with the tube? The coupling is between the tube and ?? Presumably “and the driver” should not have been removed and the pusher is coupling the tube and the driver.
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 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.
Claim(s) 1-3, 6-11, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan (US 20180080254 A1).
Regarding claim 1, Yuan discloses a medical treatment instrument (figs. 1-2), comprising: an end effector (40) comprising an ultrasonic blade (cylindroid 42 – absent any other structural mechanism/feature i.e. a motor/ transducer to provide ultrasonic vibrations);
a tube (drive shaft 30) coupled to the end effector;
a driver (10) coupled to a proximal end of the tube, the driver is configured to actuate the end effector via the tube (drive shaft 30), wherein the driver includes a protrusion (protruding unnumbered collar and/or 77, see examiner annotation below) protruding toward a distal end of the tube; and a pusher (65) configured to support a coupling between the tube, wherein pusher is configured to prevent a movement of the tube (drive shaft 30) relative to the driver (10) in a longitudinal direction of the tube and
wherein the pusher (65) is located between the tube (30) and the protrusion (protruding unnumbered collar and/or 77, see examiner annotation below) in a radial direction of the tube (30, [0033-0040], figs. 1-7).
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Regarding claims 2-3 and 9-11, Yuan discloses the pusher (65) is formed in a U-shape (U-shaped bend 66, [0040], fig. 2), the tube (30) includes a notch (35, fig. 5) the driver (10) includes a projection (11), the notch (35) is connected with the projection (11), the projection (11) is located inside the notch (35) and is located opposed to the protrusion (see examiner annotation), the tube (30) is located between the projection (11) and the protrusion (30 is connected on shaft 11 and is between the protrusion and the shaft, [0033-0040], figs. 1-7).
Regarding claims 6-8, Yuan discloses the pusher (65) is configured to be adhered to at least one of the driver or the tube (65 is attached to tube 30 and fixing rods 67 are pressed under driver 10), wherein the driver is configured to move along a longitudinal axis of the medical treatment instrument (driver capable of moving along a longitudinal axis of the medical treatment instrument) and the pusher (65) is configured to be attached to the protrusion (pusher capable of being attached to the protrusion, [0033-0040], figs. 1-7).
Regarding claims 15, Yuan discloses the pusher (65) contacts an outer surface of the tube (30, [0033-0040], figs. 1-7).
Claim(s) 1-4, 6-12, and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ETZKORN et al. (US 3161242 A).
Regarding claim 1, ETZKORN et al. discloses medical treatment instrument (10), comprising: an end effector (drill chuck 115) comprising an ultrasonic blade (drill/saw blade, any of drill cutting tools figs. 3-7);
a tube (nose member 38) coupled to the end effector (drill chuck 115);
a driver (117) coupled to a proximal end of the tube, the driver is configured to actuate the end effector via the tube (38), wherein the driver includes a protrusion (protruding portions 117 and/or collar portion forming annular groove 120) protruding toward a distal end of the tube; and a pusher (42) configured to support a coupling between the tube (38), wherein pusher (42) is configured to prevent a movement of the tube (38) relative to the driver (117) in a longitudinal direction of the tube and
wherein the pusher (42) is located between the tube (38) and the protrusion (protruding portions forming annular groove 120) in a radial direction of the tube (38, col. 2, line 13- col. 6, line 47, figs. 1-7)
Regarding claims 2-3 and 9-11, ETZKORN et al. discloses the pusher (42) is formed in a U-shape (figs. 1-7), the tube (nose member 38) includes a notch (internal hexagonal formation 39), the driver (117) includes a projection (117 or 119), the notch (internal hexagonal formation 39) is connected with the projection (117/119), the projection (117/119) is located inside the notch (both 117/119 are inserted through and inside hexagonal formation 39) and is located opposed to the protrusion (protruding portions forming annular groove 120), the tube (38) is located between the projection (119) and the protrusion (protruding portions 117 and collar portion forming annular groove 120 col. 2, line 13- col. 6, line 47, figs. 1-7).
Regarding claims 4, ETZKORN et al. discloses a vibration transmission portion (drive member 32 has impact generation via strike member 48) located inside the tubular portion, wherein the vibration transmission portion is configured to transmit ultrasound vibration (hammering action configured to transmit ultrasound vibration for percussion- type drill bit 85, cold chisel 95, star drill 105, and/or adapter member 125 adapted for combined rotary and hammering action col. 2, line 13- col. 6, line 47, figs. 1-7).
Regarding claims 6-8, ETZKORN et al. discloses the pusher (42) is configured to be adhered to at least one of the driver or the tube (end portions 44 in radial bores 40 of the nose member 38), wherein the driver is configured to move along a longitudinal axis of the medical treatment instrument (driver capable of moving along a longitudinal axis of the medical treatment instrument and will in a hammering mode) and the pusher (42) is configured to be attached to the protrusion (groove 120 abutting protrusion sides, col. 2, line 13- col. 6, line 47, figs. 1-7).
Regarding claim 12, ETZKORN et al. discloses the pusher (42) is located between the projection (119) and the protrusion (collar portion forming annular groove 120 col. 2, line 13- col. 6, line 47, figs. 1-7).
Regarding claims 15-16, ETZKORN et al. discloses the pusher (42) contacts an outer surface of the tube (end portions 44 in radial bores 40 of the nose member 38) and contacts an outer surface (loop portion 45 in groove 120 abutting protrusion sides) of the protrusion, col. 2, line 13- col. 6, line 47, figs. 1-7).
Allowable Subject Matter
Claims 5 and 13-14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims and if a Terminal Disclaimer is filed for US 12167851 B2.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a medical treatment instrument having an end effector tool with a ultrasonic blade comprising all the structural and functional limitations and further comprising, amongst other limitations/features, a tubular portion provided along a longitudinal axis of the end effector tool, the tubular portion having a first end and a second end, the first end being connected to the end effector, the second end being provided with a first engagement portion, wherein the first engagement portion is a notch; a driver, the driver including a second engagement portion configured to engage with the first engagement portion, wherein the second engagement portion is a projection configured to engage with the notch of the first engagement portion; and a pusher configured to connect the tubular portion and the driver to each other by coming into contact with the tubular portion toward a central axis of the tubular portion in a state where the first engagement portion and the second engagement portion have engaged with each other, wherein the pusher prevents movement of the central axis of the tubular portion to restrict movement of the tubular portion so that the notch of the first engagement portion is not disengaged from the projection of the second engagement portion and an ultrasound transducer configured to generate ultrasound vibration, wherein a vibration transmission portion configured to transmit the ultrasound vibration generated by the ultrasound transducer is arranged in the tubular portion and the driver. Though the prior art of record teaches a similar pusher/clamping member that attaches a tubular member to a driver, it would not be obvious to modify the driver and effector to have an ultrasound transducer configured to generate ultrasound vibration, wherein a vibration transmission portion configured to transmit the ultrasound vibration generated by the ultrasound transducer is arranged in the tubular portion and the driver and one of ordinary skill would recognize that an ultrasound transducer configured to generate ultrasound vibration, wherein a vibration transmission portion configured to transmit the ultrasound vibration generated by the ultrasound transducer is arranged in the tubular portion and the driver cannot be added to the tubular portion and driver without having to change function of the stapling device and modify staple driver to be replace with a ultrasound transducer. Having the efficiency and ease of a pusher to attach a driver and tubular member with an ultrasound transducer provides an effective ultrasound treatment tool for treatment of a tissue with the application of ultrasound energy and high frequency energy to the tissue of a surgical area.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered with respect to the nonstatutory double patenting rejection of US 12167851 B2 but they are not persuasive. Since claim 6 recites “driver includes a protruding portion, and wherein the pusher is configured to be attached to the protruding portion” examiner contends the amendment to claim 1 is not patentably distinct from claim 6 US 12167851 B2 because both sets of claims are directed to the driver having the protruding portion and the pusher configured to be attached to the protruding portion.
Applicant’s arguments with respect to claim(s) 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Additional prior art JP 2016097486 A (FIG. 2) & see references cited, form 892.
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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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, SHELLEY SELF can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731