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 Arguments
Applicant's arguments filed 08/12/2026 with regards to claims 1-2, 4, 6-8, 10-12 and 15 have been fully considered but they are not persuasive.
In regards to applicant’s argument that the secondary reference Ferm does not teach an actuator configured to rotate a shaft about a longitudinal axis, Examiner respectfully disagrees. Examiner notes that the primary reference NG discloses majority of the claimed features as is rejected below and only lacks the ability of the actuator to rotate about a longitudinal axis, which the secondary reference Ferm does teach. Given how broad the current claim language is, the secondary reference Ferm merely needs to teach an actuator having a first configuration (the button unactuated) and a second configuration (the button actuated and rotated) that is rotated about a longitudinal axis. Hence the initial unactuated position of the button is interpreted as the first configuration of the actuator, and the rotated actuated position of the button is interpreted as the second configuration of the actuator. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Hence the combined teachings of the references do suggest to one of ordinary skill in the art an actuator that is configured to rotate a shaft about a longitudinal axis as is rejected below.
Applicant’s arguments with respect to claim(s) 16-18 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.
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.
Claim(s) 1-2, 4, 6-8, 10-12, 15, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over NG (Pub. No. US 2022/0221069) in view of Ferm (U.S. Patent No. 2,606,736).
Regarding claim 1, NG disclose a medical valve (Figs. 1-10), comprising: a shaft (2) including a first opening (21) on a distal end (Fig. 4) of the shaft (2) and a second opening (22) on a side surface (Fig. 4) of the shaft (2); and an actuator (111 or 114) configured to control the shaft (2) about a longitudinal axis (paragraph 34) of the shaft (2) in order to transition the medical valve to (a) a first configuration (paragraph 34), in which the second opening (22) is aligned (Fig. 8) with a port (at 6) of a valve well (paragraph 27), in order to deliver suction to a working channel of an endoscope (paragraph 27), and (b) a second configuration (paragraph 34) in which the second opening (22) is misaligned (Fig. 7) with the port (at 6) of the valve well (paragraph 27), but lacks disclosure of the actuator configured to rotate the shaft about a longitudinal axis of the shaft.
Ferm teaches a valve (20) comprising an actuator button (40) connected to an inner shaft (22) that is surrounded by an outer shaft (23) within a valve well (20a), the inner shaft (22) has a pin (38) that can slide in a slot (39) of the outer shaft (23) to guide a rotation of the inner shaft (22) when the button (40) is actuated (Column 3 lines 35-50).
It would have been obvious to one of ordinary skill in the art before effective filing date of the claimed invention to modify the actuator of NG with a pin and slot actuator as taught by Ferm since they are considered art recognized equivalents in the art of mechanical actuators that perform the same function of controlling a fluid valve based on the actuation of a push button.
Regarding claim 2, NG disclose the medical valve (Figs. 1-10), wherein the actuator (111) is configured to automatically transition from the first configuration to the second configuration (paragraph 34).
Regarding claim 4, NG disclose the medical valve (Figs. 1-10), wherein the actuator (111) includes a linear actuator (paragraph 34) configured to move in a direction parallel to the longitudinal axis of the shaft (2).
Regarding claim 6, NG disclose the medical valve (Figs. 1-10), wherein the shaft (2) is an inner shaft (Fig. 5) and wherein the medical valve further comprises an outer shaft (1) including a third opening (Fig. 5) on a distal end of the outer shaft (1) and a fourth opening (12) on a side surface (Fig. 5) of the outer shaft (1).
Regarding claim 7, NG disclose the medical valve (Figs. 1-10), wherein, in the first configuration (Fig. 8), the second opening (22) of the inner shaft (2) is aligned with the fourth opening (12) of the outer shaft (1).
Regarding claim 8, NG disclose the medical valve (Figs. 1-10), wherein the fourth opening (12) is aligned with the port (at 6) in the first configuration (Fig. 8) and the second configuration (Fig. 7).
Regarding claim 10, Ferm (modified above) teaches wherein the outer shaft (23) includes a cut or groove (39), and wherein the inner shaft (22) includes a protrusion (38) configured to engage the cut or the groove (39).
Regarding claim 11, Ferm (modified above) teaches wherein the actuator (40) is fixedly (Fig. 3) coupled to the inner shaft (22), such that linear movement of the actuator (40) causes the protrusion (38) of the inner shaft (22) to ride along the cut or the groove (39) in order to rotate the inner shaft (22) relative to the outer shaft (23).
Regarding claim 12, NG disclose the medical valve (Figs. 1-10), wherein the inner shaft (2) includes a fifth opening (top opening), wherein, in the second configuration (Fig. 7), the fifth opening is proximal of a proximal-most end (Fig. 8) of the outer shaft (1) and the valve well (paragraph 27).
Regarding claim 15, NG disclose the medical valve (Figs. 1-10), further comprising an aperture (13 or 14) configured to be closed in the first configuration (Fig. 10) and open in the second configuration (Fig. 9).
Regarding claim 24, NG disclose the medical valve (Figs. 1-10), wherein the actuator (111 or 114) is also configured to move the shaft (2) axially along the longitudinal axis (paragraph 34) of the shaft (2) to transition medical device to the first configuration and the second configuration (paragraph 34).
Claim(s) 16-18, 21-23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ko (Pub. No. US 2022/0361734) in view of Stanton et al. (Pub. No. US 2020/0386330).
Regarding claim 16, Ko discloses a medical valve (Figs. 1-9), comprising: an inner shaft (300); an outer shaft (400), wherein the inner shaft (300) is concentrically received (Fig. 4) within the outer shaft (400); and an actuator (500) configured to rotate (paragraph 30) the inner shaft (300) about a longitudinal axis (Figs. 4-5) of the inner shaft (300) in order to transition the medical valve to (a) a first position (Fig. 5), in which the medical valve is configured to deliver suction to a working channel (200) of an endoscope (paragraph 30), and (b) a second position (Fig. 4), in which the medical valve inhibits delivery of suction to the working channel (200) of the endoscope (paragraph 30), but lacks disclosure of the actuator also configured to move the inner shaft axially along the longitudinal axis.
Stanton et al. teach a medical valve (Figs. 1-3) comprising an inner shaft (104) and an outer shaft (181), wherein the inner shaft (104) is concentrically received (Fig. 1A) within the outer shaft (181); and an actuator (105) configured to rotate (paragraph 28) the inner shaft (104) about a longitudinal axis (Figs. 1A-B) of the inner shaft (104) and move the inner shaft (104) axially (paragraph 28) along the longitudinal axis (Figs. 1A-B) in order to transition the medical valve (100) from a first position to a second position (paragraph 28).
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 actuator of Ko with an actuator as taught by Stanton et al. since they are considered art recognized equivalents in the art of medical valves that perform the same function of actuating a medical valve, and since Stanton et al. discloses that the actuator can have either a axially rotating inner shaft or the rotating inner shaft similar to Ko (paragraph 28).
Regarding claim 17, Ko discloses the medical valve (Figs. 1-9), wherein, in the second position (Fig. 4), a lumen (inner cavity of 300, Fig. 4) of the inner shaft (300) is in fluid communication with an atmosphere (paragraph 38).
Regarding claim 18, Ko discloses the medical valve (Figs. 1-9), wherein the outer shaft (400) includes a cut or groove (groove enabling ridge 303 to rotate within, Figs. 4-5), and wherein the inner shaft (300) includes a protrusion (300) configured to engage (paragraph 30) the cut or the groove (Fig. 4-5).
Regarding claim 21, Ko discloses the medical valve (Figs. 1-9), wherein the inner shaft (300) includes one or more apertures (Fig. 4) at a proximal end of the lumen (Fig. 4).
Regarding claim 22, Ko discloses the medical valve (Figs. 1-9), wherein the one or more apertures (Fig. 4) are open to the atmosphere (paragraph 38) in the second position (Fig. 4) of the medical valve, wherein the one or more apertures (Fig. 4) are closed to the atmosphere (paragraph 38) in the first position (Fig. 5) of the medical valve.
Regarding claim 23, Stanton et al. (modified above) teach wherein the actuator (105) and the inner shaft (104) are monolithic (Fig. 1A).
Regarding claim 25, Ko discloses a medical valve (Figs. 1-9), comprising: an outer shaft (400), an inner shaft (300) received within the outer shaft (400), wherein the inner shaft (300) defines a lumen (Figs. 4-5), and an actuator (500) coupled to the inner shaft (300) and configured to move linearly relative to the outer shaft (400), wherein the linear movement of the actuator (500) causes the inner shaft (300) to rotate about a longitudinal axis (paragraph 30) of the inner shaft (300) in order to transition the medical valve from a first position (Fig. 5), in which the lumen is in fluid communication with a channel (200) of an endoscope (paragraph 30), and a second position (Fig. 4), in which the lumen is in fluid communication with an atmosphere (paragraph 38), but lacks disclosure wherein the outer shaft includes a cut or groove extending axially and circumferentially along the outer shaft, the inner shaft includes a protrusion engaging the cut or the groove, and wherein linear movement of the actuator causes the protrusion to ride along the cut or the groove such that the inner shaft rotates about a longitudinal axis of the inner shaft and translates along the longitudinal axis in order to transition the medical valve from the first position to the second position.
Stanton et al. teach a medical valve (Figs. 1-3) comprising an inner shaft (104) and an outer shaft (181), wherein the inner shaft (104) is concentrically received (Fig. 1A) within the outer shaft (181); wherein the outer shaft (181) includes a cut or groove (182) extending axially and circumferentially (paragraph 28) along the outer shaft (181), the inner shaft (104) includes a protrusion (183) engaging the cut or the groove (paragraph 28); and an actuator (105) configured to rotate (paragraph 28) the inner shaft (104) about a longitudinal axis (Figs. 1A-B) of the inner shaft (104) and move the inner shaft (104) axially (paragraph 28) along the longitudinal axis (Figs. 1A-B), wherein linear movement (paragraph 28) of the actuator (105) causes the protrusion (183) to ride along the cut or the groove (182) in order to transition the medical valve (100) from a first position to a second position (paragraph 28).
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 actuator of Ko with an actuator as taught by Stanton et al. since they are considered art recognized equivalents in the art of medical valves that perform the same function of actuating a medical valve, and since Stanton et al. discloses that the actuator can have either a axially rotating inner shaft or the rotating inner shaft similar to Ko (paragraph 28).
Conclusion
THIS ACTION IS MADE FINAL. 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 Reinaldo Sanchez-Medina, telephone number 571-270-5168, fax number 571-270-6168. The examiner can normally be reached on Monday-Friday (7:30AM-4:00PM EST).
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/REINALDO SANCHEZ-MEDINA/Primary Examiner, Art Unit 3753
