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 amendments to claim 18 overcome the 112(b) rejection of record. The 112(b) rejection of claim 18 is withdrawn.
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Regarding the argument of independent claim 1 where the prior art combination of Bergheim in view of Lubatschowski does not render claim 1 obvious, the argument is unpersuasive. The prior art of Bergheim teaches a flow control device with a static part (inlet section 44; Figure 3) and a moveable element that is moveable relative to the static part (flow controlling means 39 that moves relative to inlet section 44; Figure 3). However, Bergheim does not teach a moveable element that is pivotable with an actuator arrangement that supplies energy. Lubatschowski teaches a moveable element that is pivotable(flap 13’ is pivotable on the static base plate 12; Figure 3A-3B) with an actuator arrangement that supplies energy (actuating arrangement 17’ moves when energy from infrared laser 300 is applied; Paragraph 0048 and 0054).
The applicant states that Lubatschowski does not suggest an “actuator arrangement and/or moveable element are arranged such that the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement. However, Lubatschowski discusses in paragraph 0048, “When the thermomechanical part of the valve cools down to body temperature, pressure relief flap 13 closes automatically due to shape recovery of the attachment area 12′ which serves as a flexure joint and via which pressure relief flap 13 is connected with base plate 12. If the intraocular pressure is less than 20 mBar, pressure relief flap 13 closes completely.”. Similar to the claimed invention, when energy is not supplied to the actuator/moveable element or when energy is not present within the moveable element, the moveable element will remain in a closed position. Therefore, it is not completely understood why the prior art of Lubatschowski does not teach the actuator arrangement of the claimed invention.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. 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). In this case, both Bergheim and Lubatschowski teaches a valve that is used to control flow through the device. Although not specifically teaching an actuator, Bergheim discusses in column 8, lines 49-58 that the flow controlling means can be a check valve, a slit valve, a micropump, a semi-permeable membrane, or the like. Thus, it is known to one of ordinary skill in the art to replace the flow controlling means that can actuate when energy/force is applied, such as a micropump, with the actuator arrangement with the moveable element of Lubatschowski allow for a non-invasive control of the valve by the user on the eye (Lubatschowski; Paragraph 0026 and 0047; see rejection of claim 1 below).
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.
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.
Claim(s) 1-2, 18, 33, 44-46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (Patent No. US 6,638,239 B1) in view of Lubatschowski (Publication No. US 2018/0250166 A1).
Regarding claim 1, Bergheim teaches a flow control device (implant 31; Figure 3; Column 8, lines 24-28) having:
a static part at least partially defining a fluid path (inlet section 44 defining flow 40; Figure 3; Column 8, lines 49-51 and Column 8, line 66 to Column 9, line 10);
a moveable element which is moveable relative to the static part and arranged such that movement of the movable element relative to the static part causes the fluidic resistance of the fluid path to change (flow controlling means 39 that moves relative to the inlet section 44 to change the fluidic resistance of the flow 40; Figure 3; Column 8, lines 49-54); and
wherein the static part includes an aperture (inlet section 44 comprises an inlet end 38; Figure 3).
Bergheim does not teach a moveable element which is pivotable, an actuator arrangement arranged such that when energy is supplied to the actuator arrangement it causes the movable element to move relative to the static part,
the movable element is a closure member which is arranged to obstruct differing proportions of the aperture dependent on the position of the closure member;
wherein the actuator arrangement and/or movable element are arranged such that the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement,
further wherein the actuator arrangement and the movable element are positioned within the fluid path,
wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by a laser to cause the movable element to move relative to the static part, and
wherein the actuator arrangement includes first and second actuators connected to the movable element and arranged such that when energy is supplied to the first actuator it causes the movable element to move in a first direction and when energy is supplied to the second actuator it causes the movable element to move relative to the static part in a second direction which is opposite to said first direction.
However, Lubatschowski teaches a moveable element which is pivotable (pressure relief flap 13’ is pivotable against the static base plate 12; Figure 3A-3B; Paragraph 0054), an actuator arrangement arranged such that when energy is supplied to the actuator arrangement it causes the movable element to move relative to the static part (infrared laser radiation 300 provides laser energy to the thermomechanical area 17/actuating arrangement; Figure 3A-3B; Paragraph 0047 and 0054),
the movable element is a closure member which is arranged to obstruct differing proportions of the aperture dependent on the position of the closure member (flap 13’ is a closure member that obstructs the passageway 3 at different proportions, based on the position of the flap13’; Figure 3A-3B; Paragraph 0054);
wherein the actuator arrangement and/or movable element are arranged such that the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement (flap 13’ does not move relative to the base plate 12 when energy from infrared laser irradiation 300 is not applied; Paragraph 0048 and 0054),
further wherein the actuator arrangement and the movable element are positioned within the fluid path (actuating arrangement 17’ and flap 13’ are in the fluid path; Figure 3A-3B),
wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by a laser to cause the movable element to move relative to the static part (infrared laser irradiation 300 delivers laser to move flap 13’ relative to plate 12; Figure 3A-3B’; Paragraph 0057), and
wherein the actuator arrangement includes a first actuator connected to the movable element (shape memory material 17’ is connected to flap 13’; Figure 3A-3B; Paragraph 0054) and arranged such that when energy is supplied to the first actuator it causes the movable element to move in a first direction (material 17’ moves flap 13’ in a first direction when energy from infrared laser irradiation 300 is applied; Figure 3A-3B; Paragraph 0054 and 0057).
Bergheim and Lubatschowski are considered to be analogous to the claimed invention because they are in the same field of flow actuators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Bergheim to incorporate the teachings of Lubatschowski and have the moveable element and actuator arrangement of Lubatschowski as the moveable element/valve of Bergheim and attached to the static part of Bergheim, as taught by Lubatschowski. This allows for a non-invasive control of the valve by the user onto the eye of the patient (Lubatschowski; Paragraph 0026 and 0047).
The combination of Bergheim in view of Lubatschowski does not teach a second actuator and when energy is supplied to the second actuator it causes the movable element to move relative to the static part in a second direction which is opposite to said first direction.
Since the applicant has not disclosed that placing a second actuator/shape-memory material flipped under the first actuator/shape-memory material does anything more than produce predictable results (i.e. provide additional directional movement of the flap when activated by laser energy), the mere duplication of the actuator/shape-memory material is not considered to have patentable significance. Therefore it would have been obvious to one having ordinary skill in the art at the time the invention was made, to modify Bergheim in view of Lubatschowski to include a second actuator below the first actuator, in order to predictably have an additional movement direction of the flap in the opposing direction. The mere duplication of parts has no patentable significance unless a new and unexpected result is produced. See In re Harza, 124 USPQ 378 (CCPA 1960) (MPEP 2144.04(VI)(B)).
Regarding claim 2, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski further teaches wherein the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement due to friction between the movable element and the static part; and/or
wherein the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement due to hysteretic properties of the actuator arrangement; and/or wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by an electrical current to cause the movable element to move relative to the static part; and/or
wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by a thermal source to cause the movable element to move relative to the static part (Lubatschowski; infrared source 300 transfers heat W to the thermomechanically active material 17’; Paragraph 0057).
Regarding claim 18, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski further teaches wherein the static part is elongate and the fluid path is defined axially along at least a part of the longitudinal extent of the static part (Bergheim; inlet section 44 is elongate and flow 40 is axial along the longitudinal length of the section 44; Figure 3; Column 8, lines 49-58 and Column 8, line 66 to Column 9, line 10), the aperture is formed in the static part (Bergheim; inlet section 44 comprises an inlet end 38; Figure 3), and the movable element is arranged to move rotationally about the longitudinal axis of the static part so as to obstruct different proportions of said aperture (flap 13’ with material 17’ of Lubatschowski is the valve 39 of Bergheim, thus the flap 13’ will rotate about the longitudinal axis of the inlet portion 44 of Bergheim to obstruct proportions of the inlet end 38; Bergheim; Figure 3; Column 8, lines 49-58 and Column 8, line 66 to Column 9, line 10; Lubatschowski; Paragraph 0054 and 0057; Figure 3A-3B; see rejection of claim 1 above).
Regarding claim 33, Bergheim in view of Lubatschowski teaches an implantable medical device comprising a flow control device according to claim 1 (Bergheim; implant 31 is a device that is implanted into the eye; Figure 3; Column 8, lines 24-30; see rejection of claim 1 above).
Regarding claim 44, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski further teaches wherein the movable element does not move relative to the static part when no energy is supplied to the actuator arrangement due to friction between the movable element and the static part (Lubatschowski; flap 13’ is attached to the plate 12 and is touching each other in a closed position – obvious that a frictional force is present which keeps the flap 13’ in place on the plate 12’ when energy is not applied and flap and place is made of silicone; Paragraph 0020, 0048, and 0054).
Regarding claim 45, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski does not teach wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by an electrical current to cause the movable element to move relative to the static part.
However, another embodiment of Lubatschowski teaches wherein the actuator arrangement is arranged such that energy can be supplied to the actuator arrangement by an electrical current to cause the movable element to move relative to the static part (electric current can be additionally applied to the laser energy; Paragraph 0027).
Bergheim and Lubatschowski are considered to be analogous to the claimed invention because they are in the same field of flow actuators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substituted one known element (infrared laser of Lubatschowski) for another (infrared laser with electric current of Lubatschowski) since the substitution of the energy applied would have yielded predictable results, namely, activating the shape-memory material of the flap of Bergheim in view of Lubatschowski. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143(I)B.).
Regarding claim 46, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski further teaches wherein the movable element includes an obstruction element which is deployable in the fluid path and the movable element and/or actuator arrangement are arranged such that, when energy is supplied to the actuator arrangement the position of the obstruction element is changed (Lubatschowski; flap 13’ has a length that obstructs flow in the flow path when energy is applied; Paragraph 0054 and 0057; Figure 3A-3B; see rejection of claim 1 above).
Regarding claim 48, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski further teaches comprising a first energy-receiving region coupled to, or including the first and second actuators (area comprising first and second actuators of Lubatschowski is a first energy-receiving region; see rejection of claim 1 above).
Claim(s) 47 is rejected under 35 U.S.C. 103 as being unpatentable over Bergheim et al. (Patent No. US 6,638,239 B1) in view of Lubatschowski (Publication No. US 2018/0250166 A1), as applied to claim 1 above, and further in view of Mixter et al. (Publication No. WO 2019/018807 A1).
For the purpose of mapping claim elements (e.g. reference numbers and paragraph numbers), please refer to the US equivalent of the WIPO publication, namely, USPUB 2020/0229977 A1.
Regarding claim 47, Bergheim in view of Lubatschowski teaches the device of claim 1. The combination of Bergheim in view of Lubatschowski does not teach further comprising an outer wall, wherein the static part is enclosed by the outer wall.
However, Mixter teaches further comprising an outer wall (plate 1503/assembly 1519; Paragraph 0078; Figure 15A-15B), wherein the static part is enclosed by the outer wall (tube 1512 is enclosed by plate 1503/assembly 1519; Paragraph 0078; Figure 15A-15C).
Bergheim in view of Lubatschowski and Mixter are considered to be analogous to the claimed invention because they are in the same field of flow actuators. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the device of Bergheim in view of Lubatschowski to incorporate the teachings of Mixter and have the static part of Bergheim in view of Lubatschowski be enclosed by the outer cover of Mixter. This allows for the actuating assembly to be a single component that is implantable onto the eye of the patient (Mixter; Paragraph 0079; Figure 15C).
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 KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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