DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed July 2, 2026.
Election/Restrictions
1. Applicant’s election without traverse of invention I, claims 1-14, in the reply filed on July 2, 2026 is acknowledged. Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
1. Claims 1-14 are pending and currently under consideration for patentability.
Priority
2. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on July 3, 2024 and December 10, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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 (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 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.
4. Claim(s) 1-7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hooven (US 4,676,772).
5. With regard to claim 1, Hooven discloses a valve device (Abstract), including: a dial having a dial indicator (thread screw member 31 and permanent magnet 72 or wrench 70, FIG. 2, col 7, ln 9-10: "permanent magnet 72"; col 5, ln 62- col 6, ln 5: "As is best seen in FIGS. 6 and 7, the magnetic wrench 70 is positioned above the screw member 31 such that pins 71a-71d are received within four of the twelve circular recesses 62 in the upper surface of screw member 31. Such engagement of the pins and recesses allows vertical motion of the wrench relative to the screw member, while at the same time assuring that rotation of one results in rotation of the other. Thus, by rotating the magnetic wrench, the vertical position of the screw member, and hence the contact force existing between ball 29 and valve seat shoulder 54, may be continuously adjusted"), the dial and the dial indicator being moveable between a plurality of positions (about shoulder 56 with serrations 78, FIGS. 2, 6, col 6, ln 22-35 "To prevent inadvertent or
unintentional rotation of the magnetic wrench, the valve includes an annular member 77 formed of a magnetic material embedded in shoulder 56 directly beneath the magnetic wrench 70. In the absence of a strong externally applied magnetic field, the magnetic wrench 70 will be pulled downwardly into contact with step 56 by reason of the attraction between magnet 72 to annular member 77 to the position shown in Fig. 6. As illustrated in Fig. 2, the upper surface of step 56 is provided with a plurality of serrations 78 which serve to increase the friction between the lower surface of the wrench and the casing top 30 to prevent inadvertent rotation of the magnetic wrench when in this position"), the dial being configured such that a position of the plurality of positions of the dial is viewable through cross-sectional imaging
of the dial indicator (magnetic imaging of dial indicator 72 allows position of dial/dial indicator to be viewed via tool 80, FIG. 3, col 6, ln 36- 40, "To allow accurate and non-invasive determination of magnetic wrench position, a position sensor 80, constructed in accordance with the invention, is provided and is illustrated in FIGS. 3 and 4"; alternatively, note intended use as dial indicator is a permanent magnet and housing is polymeric (col 3,ln 60-64, col 7, ln 9-10) therefore have different densities that are distinguishable in various medical scans).
6. With regard to claim 2, Hooven discloses a housing encapsulating the dial (housing half members 65/66 and closure cap 33, FIGS. 2, 4, 6) and including a reference indicator (catheters 17/22, FIGS. 3-4), the reference indicator being viewable through cross-sectional imaging of the housing (intended use, col 3, ln 60-64, note: various medical imaging modalities can be utilized to visualize plastics within the body as they have different densities and shapes to human tissue); wherein a position of the dial indicator relative to the reference indicator is indicative of the position of the plurality of positions of the dial (FIG. 3, "In use, the indicator is placed on the patient's head so that implanted catheters 17 and 22 engage alignment tongs 97 and 98 as illustrated in Fig. 3. The position of the needle 82 is then noted to ascertain the relative adjustment setting of the valve").
7. With regard to claim 3, Hooven discloses a flow limiter in operative association with the dial, the flow limiter being operable for limiting a flow of material through a lumen based on the position of the plurality of positions of the dial (ball 29 and valve seat shoulder 54, FIG. 2, col 5, ln 62- col 6, ln 5: "As is best seen in FIGS. 6 and 7, the magnetic wrench 70 is positioned above the screw member 31 such that pins 71a-71d are received within four of the twelve circular recesses 62 in the upper surface of screw member 31. Such engagement of the pins and recesses allows vertical motion of the wrench relative to the screw member, while at the same time assuring that rotation of one results in rotation of the other. Thus, by rotating the magnetic wrench, the vertical position of the screw member, and hence the contact force existing between ball 29 and valve seat shoulder 54, may be continuously adjusted").
8. With regard to claim 4, Hooven discloses that the dial indicator includes a plurality of dial indicator surfaces identifiable through cross-sectional imaging of the dial indicator (FIGS. 2, 5: see main top surface and top surface between notches 107/108: note identifiable through cross-sectional imaging comprises intended use as the dial indicator is made of a permanent magnet material and the rest of casing is made of plastics, col 3, ln 60-64, col 7, ln 9-10), wherein a position of each dial indicator surface of the
plurality of dial indicator surfaces relative to a reference indicator is indicative of the position of the plurality of positions of the dial (see how alignment of surfaces relative to refence indicator of 80, is indicative of the plurality of positions, FIGS. 3, 5).
9. With regards to claim 5, Hooven discloses that each dial indicator surface of the plurality of dial indicator surfaces is identifiable through cross-sectional imaging by a vertical position and/or a cross-sectional shape of the dial indicator surface relative to the reference indicator (see how main surface is rectangular and smaller surface between notches 107/108 is more square, FIGS. 3, 5).
10. With regard to claim 6, Hooven discloses that the dial indicator includes a dial indicator surface identifiable through cross-sectional imaging of the dial indicator (72, FIG. 2-3: note top surface of 72 (orientation thereof) can be identified by indicator 80), wherein a vertical position of the dial indicator surface relative to a reference indicator is indicative of the position of the plurality of positions of the dial (vertical travel of 72 within 62 corresponds to threading rotation of 31 which correspond to the positions of the valve ball 29 in valve seat, FIG. 2, col 5, ln 62- col 6, ln 5: "As is best seen in FIGS, 6 and 7, the magnetic wrench 70 is positioned above the screw member 31 such that pins 71a-71d are received within four of the twelve circular recesses 62 in the upper surface of screw member 31. Such engagement of the pins and recesses allows vertical motion of the wrench relative to the screw member, while at the same time assuring that rotation of one results in rotation of the other. Thus, by rotating the magnetic wrench, the vertical position of the screw member, and hence the contact force existing between ball 29 and valve seat shoulder 54, may be continuously adjusted").
11. With regard to claim 7, Hooven discloses that the dial indicator surface is moveable along a lead screw in association with the dial (FIG. 2, col 5, ln 62- col 6, ln 5: see screw member 31 with external threads 61 which acts as lead screw).
12. With regard to claim 13, Hooven discloses a valve device (Abstract), comprising: a dial (wrench 70, FIG. 2) having a dial indicator (portion between notches 107/108, FIG. 5) and a magnetic-responsive element (pole at end with notches, FIG. 5, col 5, ln 58-60, "the wrench further includes an elongate magnetic portion 72 having North and South poles at opposite ends thereof"), the dial being moveable between a plurality of positions (about shoulder 56 with serrations 78, FIGS. 2, 6, col 6, In 22-35 "To prevent inadvertent or unintentional rotation of the magnetic wrench, the valve includes an annular member 77 formed of a magnetic material embedded in shoulder 56 directly beneath the magnetic wrench 70. In the absence of a strong externally applied magnetic field, the magnetic wrench 70 will be pulled downwardly into contact with step 56 by reason of the attraction between magnet 72 to annular member 77 to the position shown in Fig. 6. As illustrated in Fig. 2, the upper surface of step 56 is provided with a plurality of serrations 78 which serve to increase the friction between the lower surface of the wrench and the casing top 30 to prevent inadvertent rotation of the magnetic wrench when in this position"); a housing (housing half members 65/66 and closure cap 33, FIGS. 2, 4, 6) having a reference indicator (catheters 17/22, FIGS. 3-4); and a locking mechanism defined by the dial and the housing (annular magnetic member 77 magnetically interacting with wrench, FIG. 6, col 6, ln 22-35 "To prevent inadvertent or unintentional rotation of the magnetic wrench, the valve includes an annular member 77 formed of a magnetic material embedded in shoulder 56 directly beneath the magnetic wrench 70. In the absence of a strong externally applied magnetic field, the magnetic wrench 70 will be pulled downwardly into contact with step 56 by reason of the attraction between magnet 72 to annular member 77 to the position shown in Fig. 6. As illustrated in FIG. 2, the upper surface of step 56 is provided with a plurality of serrations 78 which serve to increase the friction between the lower surface of the wrench and the casing top 30 to prevent inadvertent rotation of the magnetic wrench when in this position"); wherein external application of a magnetic force in a vertical direction draws the dial away from the housing to disengage the locking mechanism (FIG. 7, col 6, ln 6-22: "To permit adjustment of the valve after its implantation beneath the scalp, a tool containing a bar magnet 75 having north and south poles at opposite ends may be positioned above the scalp directly above the implanted valve as shown in Fig. 7. When the magnet is positioned directly above the magnetic wrench such that the unlike poles of each are adjacent one another, the magnetic wrench will be drawn upwardly so that pivot point 74 is received in a suitably positioned recess 76 formed in the interior surface of casing closure cap 33"); wherein external application of the magnetic force enables rotation of the dial to a position of the plurality of positions by the magnetic responsive element (FIGS. 2-5, col 6, ln 6-22: "Pivot point 74 thus allows the magnetic wrench to rotate relative to the interior surface of cap 33 in response to rotational motion of magnet 75. Such rotation of the wrench results in rotation of the screw member 31 and a corresponding change in the contact force existing between ball 29 and shoulder 54."); and wherein a position of the dial indicator relative to the reference indicator is observable through cross-sectional imaging and is dependent upon the position of the dial (magnetic imaging of dial indicator 72 allows position of dial/dial indicator to be viewed via tool 80 relative to housing and all parts thereof, FIG. 3, col 6, ln 36-40, "To allow accurate and non-invasive determination of magnetic wrench position, a position sensor 80, constructed in accordance with the invention, is provided and is illustrated in FIGS. 3 and 4"; alternatively, note intended use as dial indicator is a permanent magnet and housing is polymeric (col 3, ln 60-64, col 7, ln 9-10) therefore have different densities that are distinguishable in various medical scans).
13. Claim(s) 1, 3 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harada et al. (US PGPUB 2021/0330947 A1).
14. With regard to claim 1, Harada discloses a valve device (Abstract), including: a dial having a dial indicator (rotor 50 with magnet 61, FIG. 1, [0025], [0027]), the dial and the dial indicator being moveable between a plurality of positions ([0026]), the dial being configured such that a position of the plurality of positions of the dial is viewable through cross-sectional imaging of the dial indicator (intended use due to material density differences, [0022]-[0027]: note an implantable device for long term use is disclosed comprising a magnet and suitable bio-compatible materials for the remainder of the device. Reasonably assuming metallic permanent magnet and common polymeric materials for the housing, the materials have significantly varying densities that allow for imaging with standard equipment).
15. With regard to claim 3, Harada further discloses a flow limiter in operative association with the dial, the flow limiter being operable for limiting a flow of material through a lumen based on the position of the plurality of positions of the dial (sealing ball 32, spring 3 and supporting ball 34 in operative association with cam surface 51 of rotor, FIG. 1, [0024-0025]).
16. With regard to claim 8, Harada discloses that the dial includes a locking mechanism that, when engaged, prevents alteration of the position of the dial (retention housings 15 and associated locking pins 65, FIGS. 1, 3, [0029-0031]).
17. With regard to claim 9, Harada discloses that the dial includes a first magnetic responsive element that, when activated by an external magnetic device, disengages the locking mechanism to enable alteration of the position of the dial (housing of locking member 60 (carrying magnet 61 and pins 65; FIGS. 1, 3, [0032]).
18. With regard to claim 10, Harada discloses that the dial includes a second magnetic responsive element that, when activated by an external magnetic device, enables rotation of the dial in a clockwise direction or a counterclockwise direction to alter the position of the dial (housing of second locking member 60, FIGS. 1, 3, [0033]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
19. Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hooven in view of Moore (US 4,081,635).
20. With regard to claim 11, Hooven is silent in regard to a flow indicator positionable within a lumen distal to the dial, the flow indicator being moveable by flow of material through the lumen and viewable through cross-sectional imaging of the flow indicator.
However, within the same field of endeavor of fluid valves, Moore discloses an electrical switch responsive to predetermined fluid flow (abstract), comprising a flow indicator positionable within a lumen distal to a dial (shuttle 20, FIGS. 1-2, col 2, ln 8-19), the flow indicator being moveable by flow of material through the lumen (col 2, In 12-13; col 2, ln 56- col 3, ln 6) and viewable through cross-
sectional imaging of the flow indicator (intended use, col 3, ln 7-12: notes use of magnets and plastics allows visual distinction via many imaging modalities).
Accordingly, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the valve device disclosed by Hooven to incorporate a flow indicator valve, similar to that disclosed by Moore, in order to enable a lower limit
pressure control so as to prevent too much drainage, as suggested by Moore in column 2, line 56 to column 3, line 6.
21. With regard to claim 12, Hooven, as modified by Moore, discloses the valve device of claim 11. Further, Moore discloses a flow indicator actuator in operative association with the flow indicator that, when actuated, positions the flow indicator within the lumen (spring 22, FIG. 1); and a third magnetic-responsive element that, when activated by an external magnetic device, draws the flow indicator away from the lumen (magnet 25, FIGS, 1-2, col 2, ln 40-55).
22. Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Hooven in view of Harada.
23. With regard to claim 14, while Hooven discloses the return force as being magnetic (FIGS. 2, 6, col 6, ln 22-35 "To prevent inadvertent or unintentional rotation of the magnetic wrench, the valve includes an annular member 77 formed of a magnetic material embedded in shoulder 56 directly beneath the magnetic wrench 70. in the absence of a strong externally applied magnetic field, the magnetic wrench 70 will be pulled downwardly into contact with step 56 by reason of the attraction between magnet 72 to annular member 77 to the position shown in Fig. 6), Hooven is silent in regard to a tensioning element in association with the dial, the housing, and the locking mechanism such that the tensioning element returns the dial to the housing to engage the locking mechanism and prevent rotation of the dial absent the external application of the magnetic force.
However, Harada discloses a similar device (Abstract) and discloses a magnetic lock element that is pulled away from the housing by an external magnetic force to unlock the device (housing of locking member 60 (carrying magnet 61 and pins 65; FIGS. 1, 3, [0032]) and further discloses a tensioning element, a spring, for return of the magnet to the lock position, i.e. a tensioning element in association with the dial, the housing, and the locking mechanism such that the tensioning element returns the dial to the housing to engage the locking mechanism and prevent rotation of the dial absent the external application of the magnetic force (spring 62, FIG. 1, [0028]). It would have been
obvious to one skilled in the art to incorporate any return (tensioning) element, such as a spring as disclosed by HPB, so as to allow flexibility in design and reduce the use of heavier magnets.
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the valve device disclosed by Hooven to incorporate any return tensioning element, such as a spring, similar to that disclosed by Harada, in order to allow flexibility in design and reduce the use of heavier magnets, and provide a biasing force to assist in biasing the valve into a desired operative position, as suggested by Harada in at least [0016].
Conclusion
24. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Wilson (US PGPUB 2015/0258314) discloses methods and tools for an implanted device.
Negre (US PGPUB 2016/0220794) discloses an adjustable drainage valve.
Boden, JR. et al. (US PGPUB 2019/0083763) discloses a programmable drainage valve.
25. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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