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 .
Status of Claims
1. Claims 22-42 are pending and currently under consideration for patentability.
Claims 1-21 are preliminarily canceled, as of the May 24, 2023 claim amendment.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on May 24, 2023, January 8, 2024, March 5, 2024 and August 20, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claim 36 is objected to because of the following informalities:
Lines 6-7 of claim 36 recite the following limitation: “…and reduce a braking torque due to the frictional force to a minimum”, which appears to be missing commas. It is suggested that the limitation be amended to: ---…and reduce a braking torque, due to the frictional force, to a minimum.---
Appropriate correction is required.
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.
5. Claim(s) 22-36 and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barr (US PGPUB 2014/0052045 A1).
6. With regard to claim 22, Barr discloses an adjustable implantable throttle (device for diverting fluid from the ventricles of the brain, 1) for controlling a flow rate in implantable drains for brain water drainage (abstract; Figs. 1-3; [0051]; [0065]), wherein at least one effective length of at least one channel (resistance tubes, 16) is designed to be adjustable ([0014]; [0017]; [0054]; [0066]).
7. With regard to claim 23, Brr discloses that the throttle comprises at least one inlet (2) and one outlet (4; Fig. 1), wherein the inlet (2) and the outlet or the inlet or the outlet each comprises at least one connection point for an implantable tubing system (“to facilitate routing of tubing leading from the outlet 4 to the area of the body selected for discharge of the fluid; [0063]).
8. With regard to claim 24, Barr discloses that the throttle (1; Figs. 1-3) comprises a housing (upper and lower members, 8 and 10), wherein at least one movable part (selection rotor, 40) is arranged in the housing (8, 10), the movable part (40) being designed to be movable from outside the housing (8, 10; [0054]; [0056-0057]; [0059]), so that its movement makes a flow rate variable at constant pressure ratios between the inlet (2) and the outlet (4) of the throttle (1; [0014]; [0017]; [0054]; [0066]).
9. With regard to claim 25, Barr discloses an adjusting disc (selection rotor, 40; Figs. 1-3) with at least one bore (plurality of exit points, 20) is provided for adjusting the effective length of the channel (16), so that an adjustment can be made or closed by means of a connection of the inlet (2) and the outlet (4) depending on a position of the adjusting disc (40; [0051]; [0053-0054]).
10. With regard to claim 26, Barr discloses that the bore in the adjustment disc (40) is located off-center (circumferentially arranged; Fig. 1) on a radius of a circle of the adjustment disc (40; [0054]; [0056-0057]; [0059]).
11. With regard to claim 27, Barr discloses that the adjustment disc (40; Fig. 1) comprises at least one magnet (small marker magnet, 45; [0059]).
12. With regard to claim 28, Barr discloses that at least one spring (spring loaded ratchet, not shown) is provided and the spring presses the adjustment disc (40) against the channel (16; [0033]; [0054]; [0059]).
13. With regard to claim 29, Barr discloses that the bore (20) in the adjustment disc (40) forms a connection forming at least one space on a first side of the adjustment disc (40) with the channel (16) on a second side of the adjustment disc (40; Fig. 1; [0051-0054]; [0057]; [0064]).
14. With regard to claim 30, Barr discloses that a housing wall of the throttle (1) is elastic (“biocompatible composites… for example, High Density Polyethylene (HDPE)”; [0065], where HDPE is known to be moderately elastic).
15. With regard to claim 31, Barr discloses that the adjustment disc (40) is designed to be movable against a force of the spring ([0033]; [0054]; [0059]).
16. With regard to claim 32, Barr discloses that the throttle (1) has at least two states, a passage state (before/after adjustment) and an adjustment state (during adjustment; [0057]), wherein in the passage state the adjustment disc (40) does not contact channel (16) boundaries and in the adjustment state the adjustment disc (40) rests on the channel boundaries ([0031]; [0034]; [0055]; [0059]; [0066]).
17. With regard to claims 33 and 34, Barr discloses that in the adjustment state the channel (16) is partially or completely closed ([0057]); and that wherein in the pass state the channel (16) is open along its length ([0031]; [0034]; [0055]; [0059]; [0066]).
18. With regard to claim 35, Barr discloses that a first state (first position) can be switched to a second state (second position) by applying pressure (via frictional spring-loaded forces and torsional magnetic forces) and to the housing (8, 10; [0057]; [0059]; [0066]).
19. With regard to claim 38, Barr discloses that the adjustment disc (40) interrupts the connection of the inlet (2) and the outlet (4) in at least one position ([0057]; [0072]; [0083]).
20. With regard to claim 39, Barr discloses a sealing surface (of housing, 8) between the adjustment disc (40) and the channel (16) is realized from an implantable plastic (“HDPE or UHMWPE”) with a hardness of 50 Shore to 80 Shore (known Shore D hardness, or 60 to 70 Shore; [0065]).
21. With regard to claim 40, Barr discloses that the channel (16) extends radially (Figs. 1-3; abstract; [0024]; [0051-0053]).
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.
22. Claim(s) 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Barr in view of Hakim et al. (US 4,595,390).
23. With regard to claim 36, Barr discloses that when the adjustment disc (40) is lifted off, frictional forces between the adjustment disc (40), and a housing (8, 10) and channel (16), which impede rotation, act only in the center of rotation (Fig. 1b) and thus counteract a rotational movement between the adjustment disc (40) and the housing (8, 10) and channel (16) only with a spring biasing means, and reduce a braking torque, due to the frictional force, to a minimum ([0032-0034]; [0055]; [0059]; [0061]; [0065]).
While Barr technically discloses counteracting a rotational movement between the adjustment disc (40) and the housing (8, 10) and channel (16) only with a lever arm of zero mm, and Barr suggests that the biasing means may comprise a resilient member rather than a spring ([0033]), Barr fails to explicitly disclose a lever arm of zero to 0.5 mm, at most 2 mm.
However, within the same field of endeavor, Hakim discloses a magnetically-adjustable cerebrospinal fluid shunt valve (abstract; Figs. 17, 18, 19, 20, 23, 27; col. 6, line 45 – col. 7, line 31), wherein when an adjustment disc (cam, 366) is lifted off, frictional forces between the adjustment disc (366), and a housing (104) and channel (through valve, 312), which impede rotation, act only in the center of rotation and thus counteract a rotational movement between the adjustment disc (366) and the housing (104) and channel (through 312) only with a lever arm (central arm, 338) of zero to 0.5 mm, at most 2 mm (0.75 mm range), and reduce a braking torque due to the frictional force to a minimum (col. 7, lines 32-48).
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 spring biasing means disclosed by Barr to be a lever arm of zero to 0.5 mm, at most 2 mm, similar to that disclosed by Hakim, in order to utilize alternative well-known spring biasing means, such as resilient members, as suggested by Barr in paragraph [0033], where the adjustment disc and lever arm of the spring interact to adjust the spring preload by varying a vertical position of the lever arm and establish pressure through the valve, as suggested by Hakim in column 7, lines 32-48.
24. With regard to claim 37, while the adjustment disc (40) disclosed by Barr appears capable of rotation by 3600 in two directions ([0021]; [0034]; [0054-0055]; [0057-0059]), Barr fails to explicitly disclose that the adjustment disc is arranged rotatable by 3600 in two directions.
However, Hakim discloses that the adjustment disc (366) is arranged rotatable by 3600 in two directions (col. 7, lines 32-48; col. 9, line 65 – col. 10, line 10; col. 11, lines 38-58).
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 adjustment disc disclosed by Barr to be explicitly rotatable by 3600 in two directions, similar to that disclosed by Hakim, in order to provide a plurality of incremental steps which utilizes the full 3600 rotation of the adjustment disc in the clockwise and counterclockwise directions to transition between higher and lower pressures through the throttle, as suggested by Hakim in column 11, lines 38-58.
25. Claim(s) 41 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Barr.
26. With regard to claims 41, Barr discloses a channel cross-section is an area of 0.07 mm2 to 0.5 mm2 (mean diameter between 0.3 mm and 0.8 mm; [0029]) when arranged radially (Figs. 1-3) and having a length which can be varied to tailor, and have a direct effect on, the desired resistance, pressure drop and fluid viscosity through the channel ([0065]).
However, Barr fails to explicitly disclose that the channel cross-section is an area of 0.02 mm2 to 0.04 mm2 when arranged radially and having a length of 30 mm to 40 mm.
Nonetheless, 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 channel cross-section area and channel length disclosed by Barr to be between 0.02 mm2 to 0.04 mm2 and between 30 mm to 40 mm, respectively, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In the instant case, one having ordinary skill in the art would be motivated to tailor the channel length and cross-sectional area, in order to tailor the resistance, pressure drop and fluid viscosity through the channel, as desired for the particular use, as suggested by Barr in paragraph [0065].
27. With regard to claims 42, while Figures 1a, 2a and 3a of Barr appear to illustrate a channel cross-section that is rectangular in shape, Barr fails to explicitly disclose that the channel cross-section is rectangular in shape.
Nonetheless, 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 channel cross-section disclosed by Barr to be rectangular in shape, similar to that illustrated in Figures 1a, 2a and 3a of Barr, in order to utilize alternate, well-known, cross-sectional channel shapes, as suggested by Barr in paragraph [0065].
Conclusion
28. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Boyle (US 4,917,687) discloses an apparatus for controlling fluid flow rate.
Miethke (US PGPUB 2015/0182734) discloses an adjustable hydrocephalus valve.
Chappel (US PGPUB 2012/0316492) discloses a micromechanic passive flow regulator.
29. 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..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas Weiss can be reached on (571)270-1775. 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