CTNF 19/009,065 CTNF 88243 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Detailed Action This is in response to the amendment filed 01/03/2025. Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: Claim 16 recites wherein the slots of the set of connectors are formed along a proximal edge of the first shaft, wherein the first end is a distal end, and wherein the tabs of the set of connectors extend distally from a planar distal face at the distal end . The Office agrees the art of record fails to teach or suggest these features . Double Patenting 08-33 AIA 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. Claims 1-14, 17, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 16-18, 20 of U.S. Patent No. U.S. Patent Number 12,239,291 (Sharman et al.) Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the application recites “A medical device, comprising: a handle extending between a first end and a second end; a first actuator; a first shaft; and a second shaft extending from the first shaft, the second shaft including a first articulation portion and a second articulation portion,” which is not patentably distinct from “A medical device, comprising: a handle extending between a first end and a second end; a first actuator coupled to the first end of the handle; a first shaft coupled to the second end of the handle; and a second shaft extending from the first shaft, the second shaft including a first articulation section and a second articulation section,” recited in claim 1 of the patent. Claim 1 also recites “wherein an actuation of the first actuator is configured to articulate the first articulation portion, and an actuation of the handle relative to the first shaft is configured to articulate the second articulation portion.”, which is not patentably distinct from “wherein an articulation of the first actuator relative to the handle is configured to articulate the first articulation section, an articulation of the handle relative to the first shaft is configured to articulate the second articulation section”. Claim 2 of the application recites “wherein the first actuator is configured to articulate relative to the handle within only a first plane and the handle is configured to articulate relative to the first shaft within only the first plane.”, which is not patentably distinct from “wherein the first actuator is configured to articulate relative to the handle within only the first plane and the handle is configured to articulate relative to the first shaft within only the first plane” recited in claim 2 of the patent. Claim 3 of the application recites “ wherein the handle, the first actuator, the first shaft, and the second shaft are configured so that they must rotate together about a longitudinal axis of the medical device in unison” which is not patentably distinct from “wherein the handle, the first actuator, the first shaft, and the second shaft are configured so that they must rotate together about a longitudinal axis of the medical device in unison” recited in claim 3 of the patent. Claim 4 of the application recites “wherein the first actuator is pivotably coupled to the first end of the handle so that the first actuator is configured to pivot relative to the handle within only a first plane.” which is not patentably distinct from “wherein the first actuator is pivotably coupled to the first end of the handle so that the first actuator is configured to pivot relative to the handle within only the first plane.”, recited in claim 4. Claim 5 of the application recites “wherein the second end of the handle is pivotably coupled to the first shaft so that the handle is configured to pivot relative to the first shaft within only a first plane” which is not patentably distinct from “wherein the second end of the handle is pivotably coupled to the first shaft so that the handle is configured to pivot relative to the first shaft within only the first plane.”, recited in claim 5 of the patent. Claim 6 of the application recites “wherein the second articulation portion is proximal to the first articulation portion.” which is not patentably distinct from “wherein the second articulation section is proximal to the first articulation section” recited in claim 6 of the patent. Claim 7 of the application recites “wherein the second shaft further includes a non-articulating section adjacent to the second articulation portion, a first articulation coupler coupled to a first end of the first articulation portion, and a second articulation coupler coupling a second end of the first articulation portion to a first end of the second articulation portion” which is not patentably distinct from “wherein the second shaft further includes a non-articulating section adjacent to the second articulation section, a first articulation coupler coupled to a first end of the first articulation section, and a second articulation coupler coupling a second end of the first articulation section to a first end of the second articulation section.” recited in claim 7 of the patent. Claim 8 of the application recites “a first wire, a second wire, a third wire, and a fourth wire, wherein each of the first wire and the second wire includes a first end fixed within the first actuator, and each of the third wire and the fourth wire includes a first end fixed within a portion of the handle, and wherein the first wire and the second wire are configured to articulate the first articulation portion, and the third wire and the fourth wire are configured to articulate the second articulation portion” which is not patentably distinct from “a first wire, a second wire, a third wire, and a fourth wire, wherein each of the first wire and the second wire includes a first end fixed within the first actuator, and each of the third wire and the fourth wire includes a first end fixed within a portion of the handle, and wherein the first wire and the second wire are configured to articulate the first articulation section, and the third wire and the fourth wire are configured to articulate the second articulation section” recited in claim 8 of the patent. Claim 9 of the application recites “wherein each of the first wire and the second wire further includes a second end fixed within the first articulation coupler, and each of the third wire and the fourth wire further includes a second end fixed within the second articulation coupler” which is not patentably distinct from “wherein each of the first wire and the second wire further includes a second end fixed within the first articulation coupler, and each of the third wire and the fourth wire further includes a second end fixed within the second articulation coupler” recited in claim 9 of the patent. Claim 10 of the application recites “wherein longitudinally-extending portions of the second ends of the first wire, the second wire, the third wire, and the fourth wire extend along a shared plane” which is not patentably distinct from “wherein longitudinally-extending portions of the second ends of the first wire, the second wire, the third wire, and the fourth wire extend along a shared plane” recited in claim 10 of the patent Claim 11 of the application recites “comprising an end effector and a second actuator configured to actuate the end effector, wherein the second actuator is coupled to a portion of the handle between the first end and the second end, and the second actuator is slideably coupled to the handle so that the second actuator may translate along the portion of the handle between the first end and the second end” which is not patentably distinct from “an end effector and a second actuator configured to actuate the end effector, wherein the second actuator is coupled to a portion of the handle between the first end and the second end, and the second actuator is slideably coupled to the handle so that the second actuator may translate along the portion of the handle between the first end and the second end” recited in claim 11 of the patent. Claim 12 of the application reties “wherein the first shaft is coupled to the second end of the handle via a ball and socket connection” which is not patentably distinct from “wherein the first shaft is coupled to the second end of the handle via a ball and socket connection” recited in claim 12 of the patent. Claim 13 of the application recites “wherein the first actuator is coupled to the first end of the handle via a ball and socket connection” which is not patentably distinct from “wherein the first actuator is coupled to the first end of the handle via a ball and socket connection” recited in claim 13 of the patent. Claim 14 of the application recites “a medical device comprising: a handle extending between a first end and a second end; a first shaft pivotably coupled to the handle; a second shaft extending from the first shaft, the second shaft including a first articulation portion and a second articulation portion; and a set of connectors between the first shaft and the handle, wherein the set of connectors restricts a pivoting of the first shaft relative to the handle to a pivot axis, wherein pivoting of the handle relative to the first shaft is configured to articulate the second articulation portion” which is not patentably distinct from “A medical device comprising: a handle extending between a first end and a second end; a first actuator pivotably coupled to the first end of the handle; a first shaft pivotably coupled to the second end of the handle; a second shaft extending from the first shaft, the second shaft including a first articulation section and a second articulation section; a first set of connectors between the first actuator and the first end of the handle, wherein said first set restricts a pivoting of the first actuator to a first pivot axis; and a second set of connectors between the first shaft and the second end of the handle, wherein said second set restricts a pivoting of the first shaft to a second pivot axis, wherein the pivoting of the first actuator relative to the handle is configured to articulate the first articulation section and the pivoting of the handle relative to the first shaft is configured to articulate the second articulation section” recited in claim 16 of the patent. Claim 15 of the application recites “wherein the set of connectors includes slots and tabs received by the slots” which is not patentably distinct from “wherein the first set of connectors includes slots and tabs received by the slots” recited in claim 18 of the patent. Claim 17 of the application recites “wherein each of the slots of the set of connectors are co-planar with the pivot axis” which is not patentably distinct from “wherein the first pivot axis and the second pivot axis are co-planar” recited in claim 17 of the patent. Claim 18 of the application recites “A method of positioning a shaft of a medical device, comprising: inserting a distal end of the shaft of the medical device into a body of a subject; moving a first actuator of the medical device relative to a handle of the medical device to articulate the shaft in a first direction; and moving the handle relative to an intermediary shaft of the medical device to articulate the shaft in a second direction” which is not patentably distinct from “A method of positioning a shaft of a medical device, comprising: inserting a distal end of the shaft of the medical device into a body of a subject; articulating a first actuator of the medical device relative to a handle of the medical device to articulate the shaft in a first direction, wherein said articulation is restricted by configuration of the medical device to a single plane; and articulating the handle relative to an intermediary shaft of the medical device to articulate the shaft in a second direction, wherein said articulation is restricted by the medical device to the single plane” recited in claim 20 of the patent Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 1, 3, 4, 6, 11, 14 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by U.S. Patent Publication Number 2021/0267618 (Yamanaka) Regarding claims 1, 3, 4, 6 Yamanaka discloses as shown in Figure 4, a medical device, comprising: a handle (handle 41, see paragraph [0038]) extending between a first end and a second end; a first actuator (operating knob 43, see paragraph [0024]); a first shaft (bending sheath 81, see paragraph [0038]); and a second shaft (shaft 2, see paragraph [0021]) extending from the first shaft, the second shaft including a first articulation portion (joint 31, see paragraph [0023]) and a second articulation portion (first bending section 5, see paragraph [0022]), wherein an actuation of the first actuator is configured to articulate the first articulation portion; see paragraph [0025]; and an actuation of the handle relative to the first shaft is configured to articulate the second articulation portion (articulating the handle by hand would necessarily cause the first bending section 5 to articulate), wherein the handle, the first actuator, the first shaft, and the second shaft are configured so that they must rotate together about a longitudinal axis of the medical device in unison (if all the handle, the first actuator, the first shaft, and the second shaft are held by hand rotated together, they would necessarily rotate together about a longitudinal axis of the medical device in unison), wherein the first actuator is pivotably coupled to the first end of the handle so that the first actuator is configured to pivot relative to the handle within only a first plane (dials are necessarily restricted to one plane), wherein the second articulation portion is proximal to the first articulation portion, wherein the second shaft further includes a non-articulating section (straight portion of shaft 2 shown in Figure 4 ) adjacent to the second articulation portion, a first articulation coupler (one of force transmission members 7a, see paragraph [0025]) coupled to a first end of the first articulation portion, and a second articulation coupler (one of the other force transmission members 7a, see paragraph [0025]) coupling a second end of the first articulation portion to a first end of the second articulation portion. Regarding claim 11, Yamanaka discloses an end effector (treatment section 3, see paragraph [0023]) and a second actuator (trigger 42, see paragraph [0025]) configured to actuate the end effector, wherein the second actuator is coupled to a portion of the handle between the first end and the second end, and the second actuator is slideably coupled to the handle so that the second actuator may translate along the portion of the handle between the first end and the second end. Regarding claim 14, Yamanaka discloses as shown in Figure 4, a medical device comprising: a handle (handle 41, see paragraph [0038]) extending between a first end and a second end; a first shaft (bending sheath 81, see paragraph [0038])) pivotably coupled to the handle; a second shaft (shaft 2, see paragraph [0021]) extending from the first shaft, the second shaft including a first articulation portion (joint 31, see paragraph [0023]) and a second articulation portion (first bending section 5, see paragraph [0022]); and a set of connectors (bending wires 9a, 9b, see paragraph [0026]) between the first shaft and the handle, wherein the set of connectors restricts (thickness of wires provides resistance to bending and thus restricts) a pivoting of the first shaft relative to the handle to a pivot axis, wherein pivoting of the handle relative to the first shaft is configured to articulate the second articulation portion. Regarding claims 18-20 Yamanaka discloses as shown in Figure 4, a method of positioning a shaft of a medical device, comprising: inserting a distal end of the shaft of the medical device into a body of a subject; see paragraph [0030]; moving a first actuator (operating knob 43, see paragraph [0024]) of the medical device relative to a handle (handle 41, see paragraph [0038]) of the medical device to articulate the shaft in a first direction; and moving the handle relative to an intermediary shaft of the medical device to articulate the shaft in a second direction; See paragraph [0031]; rotating an end effector at the distal end of the shaft by rotating the first actuator; See paragraph [0024]; transitioning an end effector at the distal end of the shaft from a closed configuration to an open configuration by sliding a second actuator (trigger 42, see paragraph [0024]) of the medical device along a longitudinal axis of the handle . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2021/0267618 (Yamanaka) Regarding claim 8, Yamanaka discloses a third wire, and a fourth wire (bending wires 9a, 9b, see paragraph [0026]), and each of the third wire and the fourth wire includes a first end fixed within a portion of the handle, and the third wire and the fourth wire are configured to articulate the second articulation portion. See paragraphs [0032], [0033]. Yamanaka fails to disclose a first wire, a second wire, wherein each of the first wire and the second wire includes a first end fixed within the first actuator, and wherein the first wire and the second wire are configured to articulate the first articulation portion. However, Yamanaka already discloses wires (wires 7a) that do this; see paragraph [0025]; and thus it would have been obvious to one of ordinary skill in the art, before the effective a first wire, a second wire, wherein each of the first wire and the second wire includes a first end fixed within the first actuator, and wherein the first wire and the second wire are configured to articulate the first articulation portion because it would only require a duplication of parts without changing how the device operates. See In re Harza , 274 F.2d 669, 124 USPQ 378 (CCPA 1960) Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho at 571-272-4696 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov . Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /RICHARD G LOUIS/ Primary Examiner, Art Unit 3771 Application/Control Number: 19/009,065 Page 2 Art Unit: 3771 Application/Control Number: 19/009,065 Page 3 Art Unit: 3771 Application/Control Number: 19/009,065 Page 4 Art Unit: 3771 Application/Control Number: 19/009,065 Page 5 Art Unit: 3771 Application/Control Number: 19/009,065 Page 6 Art Unit: 3771 Application/Control Number: 19/009,065 Page 7 Art Unit: 3771 Application/Control Number: 19/009,065 Page 8 Art Unit: 3771 Application/Control Number: 19/009,065 Page 9 Art Unit: 3771 Application/Control Number: 19/009,065 Page 10 Art Unit: 3771 Application/Control Number: 19/009,065 Page 11 Art Unit: 3771
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