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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27MAR2026 has been entered.
Response to Arguments
Applicant’s arguments, see p. 9, filed 02MAR2026, with respect to claims 3 and 20 have been fully considered and are persuasive. The claim objection of claims 3 and 20 has been withdrawn.
Applicant’s arguments, see p. 9, filed 02MAR2026, with respect to the Specification have been fully considered and are persuasive. The objection of the Specification has been withdrawn.
Applicant’s arguments, see p. 9, filed 02MAR2026, with respect to Claims 4 and 5 have been fully considered and are persuasive. The 35 U.S.C. § 112 rejection of Claims 4 and 5 has been withdrawn.
Applicant's arguments filed 02MAR2026 have been fully considered but they are not persuasive.
Regarding the initial adjustment member of Bertrand, Applicant’s arguments are not persuasive. The threaded connection of Bertrand would operate in the way claimed as the threads allow for said member to be raised and lowered, thereby resulting in an altered spring force from the biasing member.
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.
Claim 11 is 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 11 recites “the flow limiter assembly [is] adapted to engage the reservoir”, but this relationship is unclear based on the Claims, Specification, and Drawings. The claim is therefore indefinite. The Specification indicates the flow limiting assembly is (138) and the reservoir (108). Based on figures such as Fig. 4, it is unclear exactly how the engagement occurs. As the general construction of Bertrand is similar to the instant device (the reservoir being housed on a base portion which engages with the flow limiter assembly), the teachings of Bertrand are considered to “engage” in the same manner as claimed.
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.
(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.
Claim(s) 1-3, 6-8, 11-13, 18, 19, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130345646 A1 (Bertrand et al.).
Regarding Claim 1, Bertrand teaches a shunt system (20) (Fig. 1) configured to be placed in a subject, comprising:
a housing (41) (Fig. 3) including an inlet (22) having an inlet connection portion (the portion which connects to a catheter [0040]) and a bore therethrough (Fig. 2) and an outlet (24) having an outlet connection portion [0040] and a bore therethrough (Fig. 2), the housing configured to adjustably engage a seal cap (92) (the threading between (92) and (41) providing an adjustable engagement);
a reservoir (60) in a fluid flow path from the inlet connection portion to the outlet (Fig. 2), wherein a fluid is operable to flow into the inlet, through the reservoir, and out the outlet (the flow path described in [0041]);
a valve mechanism (38) positioned between the inlet and the outlet (Fig. 4) to control a flow from the inlet to the outlet at a selected threshold pressure (the valve mechanism of the device may be set to a threshold pressure level at which fluid may be allowed to begin to flow through the valve [0003]), wherein the valve mechanism comprises,
a seal member (94) configured to operably engage a seal seat (the frustoconical portion of seal cap (92)) defined within the seal cap to seal the shunt system (the seal member controlling flow through passageway (90) [0041]); and
an initial adjustment member (98) operably engageable with a biasing member (96), the initial adjustment member configured to seal the seal member within the seal seat of the seal cap [0041] (Fig. 4) under a selectively adjustable initial biasing force upon movement of the initial adjustable member (movement of the initial adjustment member causing the biasing member to alter force applied through compression or extension of the biasing member, said biasing member being a spring);
wherein, upon movement of the seal cap relative to the housing, the biasing member further adjusts the initial biasing force of the seal member against the seal seat without further movement of the initial adjustment member (adjustment resulting in compression or extension of the biasing member and not causing movement of the initial adjustment member).
Regarding Claim 2, Bertrand further teaches the initial adjustment member (98) includes a rotor (100) [0041] and the biasing member (96) includes a spring [0041].
Regarding Claim 3, Bertrand further teaches the initial biasing force is further adjusted at least in part by a free length of the spring (springs necessarily fulfilling this requirement by applying a varied force based on compression).
Regarding Claim 6, Bertrand further teaches the seal member (94) is spherical (being a ball [0041]) and an outer surface of the seal member engages the valve seal portion at the seal position (94) to seal the valve mechanism [0041].
Regarding Claims 7 and 8, Bertrand further teaches the initial adjust adjustment member (98) selectively regulates an inlet for the valve mechanism (upper opening in 90) (the valve controlling flow as described in [0041]) and the combination of the selective adjustment of the seal cap relative to the housing and the adjustable force of the biasing selectively regulates an outlet (50) for the valve mechanism (as actuation of the valve controls flow through inlet and outlet as described for flow “F”, detailed in [0041]); wherein
the inlet for the valve mechanism extends along a first axis (vertical as seen in Fig. 4) and the outlet for the valve mechanism extends along a second axis (horizontal as seen in Fig. 4), wherein an angle is defined between the first axis and the second axis (being a fixed relationship and therefore defined).
Regarding Claim 11, Bertrand further teaches a flow limiter assembly having a flow limiter and a cover (Bertrand Annotated Fig. 3);
the flow limiter assembly adapted to engage the reservoir (being considered to engage when fully assembled); wherein the flow limiter limits a flow rate from the reservoir (the internal dimensions necessarily limiting a flow rate).
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Bertrand Annotated Fig. 3
Regarding Claim 12, Bertrand further teaches an inlet catheter connected to the inlet connection portion (via (22) as detailed in Claim 1) [0040].
Regarding Claim 13, Bertrand further teaches the inlet connection portion (at (22) as previously described) extends along a first axis (roughly horizontal in Fig. 2) and the outlet connection portion (at (24) as described in Claim 1) extends along a second axis (horizontal in Fig. 2), wherein the first axis is aligned with the second axis (said axes considered to be aligned when comparing Bertrand Fig. 2 with instant application Fig. 23).
Regarding Claim 18, Bertrand further teaches the reservoir (60) is in a fluid flow path from an inlet connection portion (at (22)) to an outlet (at (24)),
wherein a fluid is operable to flow into the inlet connection portion, through the reservoir, and out the outlet connection portion (path “F”, seen in Fig. 4);
wherein the flow limiter is configured to limit a siphon away from the reservoir through the valve mechanism (the internal dimensions necessarily limiting a flow rate).
Regarding Claim 19, Bertrand further teaches the biasing member (96) is a coil spring having a selected free length prior to being compressed to a selected compressed length between the bias member seat (92) and the seal member (94) (the spring being configured for operation and therefore having a selected free length prior to being compressed to a selected compressed length between the seal seat and the seal member) [0041].
Regarding Claim 24, Bertrand teaches a device which through use would result in a method of operating a shunt system configured to be placed in a subject, comprising:
controlling a fluid with a valve mechanism (38) as the fluid flows through a fluid path defined in a housing (41), the fluid flowing from an inlet connection portion (22), through a reservoir (60), and to an outlet connection portion (24), the housing configured to engage an adjustable seal cap (92);
selectively adjusting an initial adjustment member (98) (said member being adjusted by movement of rotor (100) [0044]) to operably engage with a biasing member (96) such that the initial adjustment member seals a seal member (94) within a seal seat (the frustoconical portion of seal cap (92)) of the seal cap under an initial, selectively adjustable biasing force upon movement of the initial adjustment member (the biasing member providing variable force based on compression); and
selectively adjusting the seal cap to move relative to the housing (being threaded as seen in Fig. 4) to further adjust the initial biasing force of the seal member without adjusting the initial adjustment member (the biasing member similarly altering force).
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bertrand.
Regarding Claim 5, Bertrand teaches wherein the external thread threadably engages the internal thread and is selectively rotatable in order to select a dimension between the seal position and the bias member seat (rotation of 92 and 40 would result in 92 raising away from 40), but fails to teach the second selective engagement portion includes an external thread configured to operably engage an internal thread disposed within the housing, instead teach the opposite arrangement of threads.
While Bertrand does not disclose the second selective engagement portion includes an external thread configured to operably engage an internal thread disposed within the housing it would have been obvious to one having ordinary skill in the art at the time the invention was made to reverse the threading locations, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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/HANS KALIHER/Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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