CTNF 18/429,633 CTNF 97083 DETAILED ACTION 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. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Species A: valve assembly of Fig. 2, 3A-3E and 4 in the reply filed on February 20, 2026 is acknowledged. Specification 07-29 AIA The disclosure is objected to because of the following informalities: Paragraph [0084] contains two instances of mentioning a Fig. 8E, however Fig. 8E does not exist in this application. Paragraph [0087] contains one instance of mentioning a Fig. 8E, however Fig. 8E does not exist in this application . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 7 and 15 are objected to because of the following informalities: Claim 7, line 2 and claim 15, line 13, recites the phrase “to effect movement”. The phrase should be amended to read “to affect movement” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention . Claim 6 recites “wherein the user-engagement element and said shaft together move axially along said actuation axis”. The examiner is unable to find support in the specification or Figs. 2-4 that demonstrate that the user-engagement element 230 and the shaft 220 together move axially along the actuation axis A. Paragraph [0061] of application specification states that a valve shaft 220 and a user-engagement element 230 are operatively coupled together, further stating in the paragraph that the valve shaft 220 and user-engagement element 230 are movable with respect to each other, generally axially as well as rotationally with respect to the actuation axis, however, is explicitly silent is disclosing wherein the user-engagement element 230 and the shaft 220 together move axially along the actuation axis A. Further, based on the Figs. 3A-3E, it appears that the shaft 220 never moves axially and only rotates about the actuation axis A. In Fig. 3A, the user-engagement member 230 is in its most proximal position and in Fig. 3C, the user-engagement member 230 is in its most distal/depressed position, however, based on the axial position of valve shaft port 222, the shaft 220 appears to be in the same axial position in both Figs. 3A and 3C. It appears that claim 6 is directed to the unelected embodiment of Figs. 5, 6A & 6B, as mentioned in paragraph [0072] of applicant’s specification, that the valve shaft 320 and the user-engagement element 330 may be integrally formed, thus highly suggesting that the valve shaft and user-engagement member together move axially along the actuation axis. Additionally, Figs. 6A & 6B support the limitation of claim 6. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-12-aia AIA (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. 07-15 AIA Claim s 15 -17 and 19-21 are rejected under 35 U.S.C. 102( a)(1 ) as being unpatentable by Tobien (US2018/0361034) . Regarding claim 15, Tobien discloses an actuatable member assembly for a valve assembly of a medical instrument (medical push button valve 1 for endoscope [0004] ), said actuatable member assembly comprising: an actuatable member comprising a user-engagement element along a proximal end thereof (Fig. 1a – 8c: medical push button valve 1 comprises pressure element 9 at the upper, proximal end), and a shaft along a distal end thereof (Fig. 1b: valve piston 4 [0047] is at a bottom, distal end) ; and a collar extending circumferentially around said shaft and configured to be operatively engaged with the valve assembly to mount said actuatable member with respect to the valve assembly (Fig. 1b and 2b: collar is comprised of pusher housing 12 and elastic locking ring 19, which circumferentially surround valve piston 4 and forms part of the medical push button valve 1); wherein: said shaft is positionable within a valve well of the valve assembly and shiftable in the valve well along an actuation axis and between an on position in which the valve assembly is in an on configuration, and an off position in which the valve assembly is in an off configuration ( Fig. 1b: valve piston 4 [0047] is at the distal end, and positionable and shiftable within the valve housing 2 along a longitudinal axis 10 between an on position and configuration, as seen in Fig. 2a and 2b, and an off position and on configuration, as seen in Fig. 1a and 1b ); and one of said user-engagement element, said shaft, or said collar includes a cam surface (Fig. 1a-2b: pressure element 9 comprises slotted guide 24 of the pin and slot control 21/bayonet lock 22 [0057]) , and another of said user-engagement element, said shaft, or said collar includes a cam follower configured to engage said cam surface to effect movement of said shaft between the on position and the off position (Fig. 1a-2b: pusher housing 12 comprises locking pin 23 of the pin and slot control 21/bayonet lock 22 [0057]; pin 23 and slotted guide 24 engage to shift valve piston 4 between the on position and the off position). Regarding claim 16 , Tobien discloses the actuatable member assembly of claim 15, further comprising a biasing element positioned to bias said user-engagement element proximally to a neutral position (Fig. 1b & 2b: spring element 13 biases the pressure element proximally into the off position, when the bayonet lock 22 is not engaged [0048]), the neutral position alternating between the on position and the off position upon sequential application and removal of a distal actuation force to said user-engagement element to move said cam follower along said cam surface (neutral position may alternate between the on position and the off position as an actuation force is applied to the pressure element 9 and as the pin 23 moves through the slotted guide 24 and the bend 25 of slotted guide 24 [0068]). Regarding claim 17, Tobien discloses a method of actuating a valve assembly of a medical device, said method comprising: applying an actuation force to an actuatable member of the valve assembly and releasing the actuation force, leaving the valve assembly in one of an on configuration or an off configuration (operator may apply actuation force to depress the pressure element 9 and valve piston 4, and rotate the pressure element 9 to actuate the bayonet lock 22, and remove actuation force, and the valve would remain depressed an in the open/on configuration [0068-0069]) ; and applying an additional actuation force to the actuatable member and releasing the actuation force, leaving the valve assembly in the other of an on configuration or an off configuration (operator may rotate the pressure element 9 until the locking pin 23 disengages from bend 25 and release compressive force from pressure element 9, and the bias of the spring element 13 pushes the pressure element 9 and valve piston into the closed/off configuration [0070]). Regarding claim 19, Tobien discloses method of claim 17, further disclosing wherein the actuatable member is in a neutral position without application of an actuation force thereto, and a biasing element biases the actuatable member back to the neutral position upon release of an actuation force (spring element 13 may bias the pressure element 9 back to a neutral position, which may be the on position or the off position [0048-0049], where actuation force is not applied). Regarding claim 20 , Tobien discloses method of claim 19, further disclosing wherein application of an actuation force to the actuatable member commences shifting of the valve assembly from one of an on configuration or an off configuration to the other of an on configuration or an off configuration (compressive force on the pressure element pushes the pressure element 9 and piston valve 4 distally from a closed, off configuration to an open, on configuration [0062]), and release of the actuation force allows the biasing element to complete shifting of the valve assembly from one of an on configuration or an off configuration to the other of an on configuration or an off configuration (as soon as the operator no longer exerts compressive force on the pressure element 9, the spring element 13 pushes the pressure element 9 and the valve piston 4 proximally from the open, on configuration to the closed, off configuration [0070]) so that the valve assembly remains in the other of an on configuration or an off configuration when the actuatable member returns to its neutral position (valve remains in closed, off configuration when the pressure element 9 and valve returns to neutral position). Regarding claim 21, Tobien discloses the method of claim 17, further disclosing wherein releasing the actuation force allows the valve assembly to shift from one of an on configuration or an off configuration to the other of an on configuration or an off configuration (as soon as the operator no longer exerts compressive force on the pressure element 9, the spring element 13 pushes the pressure element 9 and the valve piston 4 proximally from the open, on configuration to the closed, off configuration [0070]) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ko (US2022/0361734) in view of Tobien . Regarding claim 1 , Ko discloses an actuatable member for a valve assembly of a medical instrument (suction valve for an endoscope [0028]), said actuatable member having a proximal end and a distal end and comprising (Fig. 2: suction valve formed of pressing unit and shaft 300 [0028]) : a user-engagement element along the proximal end thereof (pressing unit comprises cap 500 and spring 600 [0033] at the proximal end) ; and a shaft along the distal end thereof (Fig. 2: shaft 300 is at the distal end) ; wherein: said shaft is positionable within a valve well of the valve assembly (shaft 300 is placed in a conduit of the endoscope, rotation of shaft 300 in the walls of the conduits of endoscope does not cause scraping [0029]) and shiftable in the valve well along an actuation axis and between an on position in which the valve assembly is in an on configuration (shaft 300 can only rotate without up-and-down movement [0029]; Fig. 5: suction is on, or applied, when cap 500 is depressed, and shaft 300 is rotated to a preset angle so that second opening 302 and second conduit 200 communicate [0029]) , and an off position in which the valve assembly is in an off configuration (Fig. 4: cap 500 is not depressed, and shaft 300 is not rotated, thus second opening 302 and second conduit 200 do not communicate, suction is off) . Ko fails to disclose wherein the actuatable member is held in each of the on position and the off position without an actuation force being applied thereto. In the same field of endeavor, Tobien teaches a substantially similar actuatable member for a valve assembly (medical push button valve 1) , the actuatable member having a proximal end and a distal end (Fig. 1b: proximal end near top of the valve or pressure element 9, distal end near bottom of valve or body 15) and comprising: a user-engagement element along the proximal end thereof ; and a (Fig. 1a: pressure element 9 [0047] at the proximal end) shaft along the distal end thereof ; wherein: the shaft is positionable within a valve well of the valve assembly, and shiftable in the valve well along an actuation axis and between an on position in which the valve assembly is in an on configuration, and an off position in which the valve assembly is in an off configuration (Fig. 1b: valve piston 4 [0047] is at the distal end, and positionable and shiftable within the valve housing 2 along a longitudinal axis 10 between an on position and configuration, as seen in Fig. 2a and 2b, and an off position and on configuration, as seen in Fig. 1a and 1b) , further teaching wherein the actuatable member is held in each of the on position and the off position without an actuation force being applied thereto (valve is in the off position without an actuation force because spring element 13 biases the pressure element 9 in the proximal direction [0066]; valve is in the on position without an actuation force when locking the pressure element 9 in the open position [0067-0068] ). In view of Tobien, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the actuatable member is held in each of the on position and the off position without an actuation force being applied thereto, using a lock mechanism such as the bayonet lock (Tobien, Fig. 1a-3b) or the groove and latching lock (Tobien, Fig. 5a-8c) of Tobien, as it is well-known in the endoscope and valve art that valves commonly comprise a locking mechanism to hold the valve in a depressed position to relieve the operator from having continuously press the valve cap or button, also giving the operator a free hand to perform other tasks related to the operation [0067]. Regarding claim 2 , Ko, modified by Tobien, discloses the actuatable member of claim 1. Tobien further teaches wherein said actuatable member is held in each of the on position and the off position by an actuation component on one of said shaft or said user-engagement element (locking mechanism such as the bayonet lock 22, Fig. 1a-3c, or groove and latching lock, Fig. 5a-8c, holds the valve in the on position and the off position). Regarding claim 3, Ko, modified by Tobien, discloses the actuatable member of claim 1. Ko further discloses wherein said user-engagement element is movable with respect to said shaft (pressing assembly, including cap 500, can only move linearly up and down without rotation while shaft 300 can only rotate without up-and-down movement [0029], thus movable with respect to one another). Regarding claim 4, Ko, modified by Tobien, discloses the actuatable member of claim 3. Ko further discloses wherein said user-engagement element and said shaft rotate with respect to each other to shift said shaft between the on position and the off position (pressing assembly, including cap 500, can only move linearly up and down without rotation while shaft 300 can only rotate without up-and-down movement [0029], thus both elements rotate with respect to one another) . Regarding claim 5 , Ko, modified by Tobien, discloses the actuatable member of claim 4. Ko further discloses wherein said user-engagement element moves axially along said actuation axis and with respect to said shaft ( pressing assembly, including cap 500, can only move linearly up and down without rotation while shaft 300 can only rotate without up-and-down movement [0029], thus the pressing assembly/cap 500 moves axially along the actuation axis and with respect to shaft 300 ). Regarding claim 6, Ko, modified by Tobien, discloses the actuatable member of claim 4. Ko fails to disclose wherein said user-engagement element and said shaft together move axially along said actuation axis, however, in the same field of endeavor, Tobien teaches a substantially similar actuatable member, wherein a user-engagement element and a shaft together move axially along an actuation axis (Fig. 1a-2b: pressure element 9 is depressed, which depresses valve piston 4, opening the valve, as seen in Fig. 2a and 2b; when compressive force is released, the pressure element 9 moves upward/proximally due to the bias of the spring element 13, which also moves the valve piston 4 upward/proximally, closing the valve). In view of Tobien, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that axial movement of user-engagement element and shaft together in the valve of Tobien, is an alternative but equivalent valve configuration to the valve configuration of Ko, both of which are suitable valve structure for opening and closing a fluid passage through a medical instrument. Regarding claim 7 , Ko, modified by Tobien, discloses the actuatable member of claim 1. Ko further discloses wherein said shaft includes one of a cam surface or a cam follower (shaft 300 comprises a curved slide rail 304 [0028], seen in Fig. 6) configured to effect movement of said shaft between the on position and the off position upon engagement with the other of a cam surface or a cam follower associated with the valve assembly (pressing unit is provided with sliding ball 501, seen in Fig. 8, the sliding ball 501 at a position in contact with the curved slide rail 304, such that when the cap 500 is depressed, the sliding ball 501 slides along the curved slide rail 304 bringing the shaft 300 to rotate, thus applying suction [0028]). Regarding claim 8, Ko, modified by Tobien, discloses the actuatable member of claim 7. Ko further discloses wherein said shaft includes a proximal cam surface and a distal cam surface each extending circumferentially around said shaft (Fig. 6: curved slide rail 304 extends circumferentially around shaft 300; See annotated Fig. 6: curved slide rail 304 comprises a proximal surface and distal surface, forming the slide rail 304). PNG media_image1.png 194 356 media_image1.png Greyscale Regarding claim 9 , Ko, modified by Tobien, discloses the actuatable member of claim 8. Ko further discloses wherein said user-engagement element includes a radially-inwardly directed cam follower engaging said cam surfaces of said shaft to rotate said shaft between the on position and the off position (pressing unit 500/cap 500 comprises sliding ball 501, seen in Fig. 8, which appears to be protruding radially inwardly; sliding ball 501 contacts and slides within the curved slide rail 304, seen Fig. 6, to rotate the shaft 300 between the on and off position [0028]). Regarding claim 10 , Ko, modified by Tobien, discloses the actuatable member of claim 9. Ko further discloses wherein said cam follower holds said cam surfaces alternately in the on position or the off position (sliding ball 501 contacts the surfaces of curved slide rail 304 alternately in the on position of off position [0028]). Regarding claim 11 , Ko, modified by Tobien, discloses the actuatable member of claim 7. While Ko teaches wherein said shaft includes one of a movable cam follower or a vertically-extending cam surface (Fig. 6: curved slide rail 4 comprises a surface extending radially and vertically [0028]) , Ko fails to teach wherein the cam surface comprises an on rest position for the cam follower in which the cam follower holds said shaft in the on position, and an off position for the cam follower in which the cam follower holds said shaft in the off position. However, in the same field of endeavor, Tobien teaches a substantially similar actuatable member for a valve assembly, wherein a cam surface on a user-engagement element (Fig. 3a: pressure element 9 comprises slotted guide 24 [0057], which comprises a surface) and a cam follower associated with the valve assembly engage such that the movement between cam surface and cam follower affect movement of the shaft between the on position and the off position (Fig. 1a, 2a, 3a: pin 23 moves through slotted guide 24 to place the valve in the on position and the off position [0065]). Tobien further teaches wherein a vertically-extending cam surface comprises an on rest position for the cam follower in which the cam follower holds said shaft in the on position (slotted guide 24 has a right- angled bend 25 at its upper end, which may hold the locking pin 23 in an axial position, preventing the spring element 13 from moving the pressure element proximally [0068]) , and an off position for the cam follower in which the cam follower holds said shaft in the off position (Fig. 1a: slotted guide 24 comprises an off position for the pin 23 which holds the shaft in the closed, off position). In view of Tobien, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the on rest position and off position for the cam follower, as it is well-known in the endoscope and valve art that valves commonly comprise a locking mechanism comprising an on rest position such as the right-angled bend 25 of Tobien, to hold the valve in a depressed position to relieve the operator from having continuously press the valve cap or button, also giving the operator a free hand to perform other tasks related to the operation [0067]. Regarding claim 12 , Ko, modified by Tobien, discloses the actuatable member of claim 1. Ko further discloses wherein said shaft rotates between the on position and the off position (shaft 300 rotates as the sliding ball 501 slides along the curved slide rail 304, shaft 300 rotates between positions where the second slot 302 and the second conduit 200 communicate or do not communicate [0028]). Regarding claim 13 , Ko, modified by Tobien, discloses the actuatable member of claim 1. Ko further discloses wherein said shaft axially shifts between the on position and the off position (shaft 300 axially shifts, through rotation, between the on and off positions, which are determined when the second slot 302 and second conduit 200 communicate [0028]). Regarding claim 14 , Ko, modified by Tobien, discloses the actuatable member of claim 1. Ko discloses the member further comprising a biasing element positioned to bias said user-engagement element proximally to a neutral position (spring 600 biases the cap 500 to its original state by virtue of elasticity of the spring, which facilitates operation [0033], spring biases the cap 500 proximally). Tobien also teaches the member further comprising a biasing element positioned to bias said user- engagement element proximally to a neutral position (spring element 13 [0048-0049] biases the pressure element 9 and valve piston 4 proximally, in the position of closing the flow channel 3 [0048]) , the neutral position alternating between the on position and the off position upon sequential application and removal of a distal actuation force to said user-engagement element (neutral position may alternative between off position, when the spring element 13 biases the pressure element 9 and valve piston 4 proximally and the bayonet lock 22 is not engaged, and an on position, when the pressure element 9 and valve piston 4 is depressed distally against the bias of the spring element 13 and bayonet lock 22 is engaged [0057-0059]) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5. 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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LI-TING SONG/Examiner, Art Unit 3795 /ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 06/16/26 Application/Control Number: 18/429,633 Page 2 Art Unit: 3795 Application/Control Number: 18/429,633 Page 3 Art Unit: 3795 Application/Control Number: 18/429,633 Page 4 Art Unit: 3795 Application/Control Number: 18/429,633 Page 5 Art Unit: 3795 Application/Control Number: 18/429,633 Page 6 Art Unit: 3795 Application/Control Number: 18/429,633 Page 7 Art Unit: 3795 Application/Control Number: 18/429,633 Page 8 Art Unit: 3795 Application/Control Number: 18/429,633 Page 9 Art Unit: 3795 Application/Control Number: 18/429,633 Page 10 Art Unit: 3795 Application/Control Number: 18/429,633 Page 11 Art Unit: 3795 Application/Control Number: 18/429,633 Page 12 Art Unit: 3795 Application/Control Number: 18/429,633 Page 13 Art Unit: 3795
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