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 .
Election/Restrictions
Claims 12-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method and apparatus, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 January 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “an inner wall” and “an outer wall” which are already recited in claim 1. It is unclear if these new recitations refer to the previously claimed language in claim 1 or new elements. In an effort to compact prosecution the limitations are interpreted as –the inner wall—and –the outer wall--.
Claim 7 recites “the adjust area” which renders the claim indefinite since there is no previous antecedent basis for this limitation. In an effort to compact prosecution the limitations are interpreted as –the adjustment area--.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand (US 5637083).
Regarding claim 1, Bertrand discloses a shunt system (20, figure 1) configured to be placed in a subject, comprising:
an inlet (22, figure 1, col 5, lines 5-13);
an outlet (24, figure 1, col 5, lines 5-13);
a reservoir (40, col 5, lines 50-55) in a fluid flow path from the inlet to the outlet (col 5, lines 12-17), wherein a fluid is operable to flow in the inlet, through the reservoir, and out the outlet (figure 1); and
a valve mechanism positioned between the inlet and the outlet to control a flow from the inlet to the outlet at a selected threshold pressure, wherein the valve mechanism comprises,
a housing (36) having at least one adjustment area (108) and an internal wall (internal wall of 36 or 108)
an adjustment member (100, col 8, lines 45-67) having (i) a first side (bottom side) and an adjustment portion (134, col 8, lines 50-67) extending from the first side, wherein the adjustment portion is configured to engage the at least one adjustment area (col 8, lines 50-65), (ii) a second side (opposite side, col 8, lines 45-60) that defines a bias member seat (124), wherein the second side is opposite the first side (figure 12), and (iii) an outer (outer wall of 122, figure 11) wall that extends between the first side and the second side,
a seal member (94, figure 14) configured to seal the shunt system when positioned in a seal position (col 9, lines 1-15), and
a biasing member (96, figure 14) configured to bias the seal member in the seal position with a selected biasing force, wherein the biasing force is selected at least in part by the position of the adjustment member relative to the seal position (col 9, lines 15-25).
Bertrand does not disclose the internal wall that defines an internal polygon, wherein the outer wall defines an external polygon that is complementary to the internal polygon.
However, it has been held that a mere change in shape and size is an obvious variant over the prior art of record (see MPEP 2144.04IVB). In this case, making the exterior and interior complimentary shapes polygons rather than circular does not impact the overall functionality and would not require any undue experimentation for the projection and opening to continue to have the desired rotational interaction. Therefore, it would have been obvious to one of ordinary skill in the art at the effective filling date to modify Bertrand to have external polygons instead of circular shape to have desired rotational interactions since the shape change would not have significant functional impact.
Regarding claim 2, Bertrand further discloses wherein the first side and the second side extend continuously from edge to edge of the adjustment member (figures 9-14).
Regarding claim 3, Bertrand discloses the adjustment portion and members are complementary and adjust the flow of the valve (col 9, lines 15-25) but fails to disclose wherein an interaction of the external polygon and the internal polygon are complimentary and are operable to be rotationally fix the adjustment member in a selected position within the housing.
However, it has been held that a mere change in shape and size is an obvious variant over the prior art of record (see MPEP 2144.04IVB). In this case, making the exterior and interior complimentary shapes polygons rather than circular does not impact the overall functionality and would not require any undue experimentation for the projection and opening to continue to have the desired rotational interaction. Therefore, it would have been obvious to one of ordinary skill in the art at the effective filling date to modify Bertrand to have external polygons instead of circular shape to have desired rotational interactions since the shape change would not have significant functional impact. The resulting device would be capable of also be able to rotationally fix the adjustment member in selected positioning with a change in complementary shape.
Regarding claim 4, Bertrand discloses wherein the housing includes the internal wall having a depression (108, figure 7); wherein the adjustment member includes the outer wall and a projection from the outer wall (134);
wherein the projection is configured to be held within the depression to rotationally hold the adjustment member (col 9, lines 30-47).
Regarding claim 5, Bertrand discloses wherein the depression includes a plurality of depressions (multiple 108, figure 7); wherein the projection is configured to be selectively held in each depression of the plurality of depressions (col 9, lines 30-47).
Regarding claim 6, Bertrand discloses wherein the at least one adjustment area includes at least an outer adjustment area (110) and an inner adjustment area (108, figure 8).
Regarding claim 7, Bertrand discloses wherein the adjustment area includes a first portion(multiple steps of 108) and a second portion (multiple steps of 108, the second protruding further inward); wherein the adjustment portion of the adjustment member is configured to engage both the first portion and the second portion; wherein the adjustment member is moved closer to the seal position when engaged on the second position then the first position (col 9, lines 15-25 and lines 30-47).
Regarding claim 8, Bertrand discloses wherein the adjustment area further includes at least a third portion, a fourth portion, and a fifth portion (multiple step array of 108 each with a step, figures 7-8); wherein the adjustment portion of the adjustment member is configured to be positioned to engage at least one of the first portion, the second portion, the third portion, the fourth portion, or the fifth portion to set a distance of the bias member seat relative to the seal position (col 9, lines 15-25).
Regarding claim 9, Bertrand discloses wherein a force to open the seal member from the seal position is set by the relative position of the bias member seat relative to the seal position (col 9, lines 15-25 and lines 30-47).
Regarding claim 10, Bertrand discloses wherein each of the first portion, the second portion, the third portion, the fourth portion, or the fifth portion has a top surface that is distinct distance from the seal position (each step 108 having a unique step, figure 7).
Regarding claim 11, Bertrand discloses further comprising: a top member (top of 36) configured to cover a selected portion of the housing; and a seal portion (92, figure 16) that defines the seal position relative to the top member; wherein the top member defines a valve mechanism inlet (70, figure 16).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Watson (US 5387188) discloses a valve inside a shunt.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781