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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 24-30, drawn to an adjustable shunting system.
Group II, claim(s) 31-32, drawn to an adjustable shunting system.
Group III, claim(s) 33-37, drawn to an adjustable shunting system.
Group IV, claim(s) 38-42, drawn to a method of adjusting fluid flow.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of a shape memory actuator, a gating element (having two positions), and an aperture, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of US 20040010219 A1 (McCusker et al.). McCusker teaches an adjustable shunting system (50) (Fig. 4) for draining fluid from a first body region to a second body region [0022], the system comprising: a shunting element (at least 54 and 32) [0044, 0047] configured to extend at least partially between the first body region and the second body region [0022]; an aperture (not illustrate; the interior space which connects “an inlet port” to “an outlet port” per [0044]) fluidly connecting an exterior of the shunting element (outside 58, as illustrated in Fig. 5A [0044]) to an interior of the shunting element (the interior of 58, as illustrated in Fig. 5A [0044]); an actuator (32, 80, and 90, Fig. 5A) [0047, 0056] configured to selectively control fluid flow through the aperture, the actuator having a gating element (32) [0047] moveable between a first position (in which bladder 84 is emptied/retracted, as illustrated in Fig. 5B) [0049] in which a first end portion of the gating element (the bottom/right edge of 32 that contacts the right end of 52, as seen in Fig. 5A) [0047] does not interfere with fluid flow through the aperture (as illustrated in Fig. 5A) [0049] and a second position in which the first end portion of the gating element at least partially interferes with fluid flow through the aperture (when bladder 84 is full/extended, as illustrated in Fig. 5B) [0049],
a first shape memory actuation element (90) [0056] configured to move the gating element from the first position to and/or toward the second position when actuated (as illustrated in Fig. 5B)
During a telephone conversation with Jacob Gober on 18FEB2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 24-30. Affirmation of this election must be made by applicant in replying to this Office action. Claims 31-42 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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) 24-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20040010219 A1 (McCusker et al.) in view of US 20200229977 A1 (Mixter et al.).
Regarding Claim 24, McCusker teaches an adjustable shunting system (50) (Fig. 4) for draining fluid from a first body region to a second body region [0022], the system comprising:
a shunting element (at least 54 and 32) [0044, 0047] configured to extend at least partially between the first body region and the second body region [0022];
an aperture (not illustrate; the interior space which connects “an inlet port” to “an outlet port” per [0044]) fluidly connecting an exterior of the shunting element (outside 58, as illustrated in Fig. 5A [0044]) to an interior of the shunting element (the interior of 58, as illustrated in Fig. 5A [0044]);
an actuator (32, 80, and 90, Fig. 5A) [0047, 0056] configured to selectively control fluid flow through the aperture, the actuator having
a gating element (32) [0047] moveable between a first position (in which bladder 84 is emptied/retracted, as illustrated in Fig. 5B) [0049] in which a first end portion of the gating element (the bottom/right edge of 32 that contacts the right end of 52, as seen in Fig. 5A) [0047] does not interfere with fluid flow through the aperture (as illustrated in Fig. 5A) [0049] and a second position in which the first end portion of the gating element at least partially interferes with fluid flow through the aperture (when bladder 84 is full/extended, as illustrated in Fig. 5B) [0049],
a first shape memory actuation element (90) [0056] configured to move the gating element from the first position to and/or toward the second position when actuated (as illustrated in Fig. 5B), and
a frictional element (80) [0047] configured to physically engage the first end portion of the gating element (Fig. 5A),
wherein (a) when the gating element is in the first position, the frictional element biases the gating element toward and/or releasably retains the gating element at the first position (releasably retains the gating element in the first position as seen in Fig. 5A) [0057], and (b) when the gating element is in the second position, the frictional element biases the gating element toward and/or releasably retains the gating element at the second position (releasably retains the gating element in the second position) [0057].
McCusker fails to teach a second shape memory actuation element configured to move the gating element from the second position to and/or toward the first position when actuated.
Mixter teaches an adjustable shunting system (Figs. 13A and 13B) [0066] comprising:
a first shape memory actuation element (1314) [0066] configured to move a gating element (the horizontal span of the bottom of 1316) from a first position to a second position (“expansion” [0070]); and
a second shape memory actuation element (1315) [0066] configured to move the gating element from the second position to the first position (“shrinkage” [0070]).
Mixter teaches including this technical feature to enhance control of an actuator [0063-0064], as well as varying the shapes and lines of actions of opposing actuators (Figs. 12A, 13A, 13E) [0064, 0066, 0071], and applying pressure using bulk inflation [0071]. To have opposed action of action of one actuator’s shape and motion with a similar shape and opposing line of force (i.e., controlling speed in both directions) would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adjustable shunting system taught by McCusker with the actuators of Mixter in order to enhance control of the actuator’s motion, as well as adjusting the speed of actuation.
Regarding Claim 25, McCusker further teaches the frictional element (80) is configured to:
permit movement of the gating element (32) from the first position to and/or toward the second position upon actuation of the first shape memory actuation element (90) [0047, 0054];
inhibit movement of the gating element from the second position toward the first position after actuation of the first shape memory actuation element [0047], and
The combined device of Claim 24 is considered to permit movement of the gating element from the second position to and/or toward the first position upon actuation of the second shape memory actuation element (allowing for movement either up or down the stair-step array) [0027-0028]; and
inhibit movement of the gating element from the first position toward the second position after actuation of the second shape memory actuation element (friction preventing further undesired movement past the “step” selected [0027, 0028, 0047].
Regarding Claim 26, the combined device of Claim 24 is considered to teach the first shape memory actuation element (90) and the second shape memory actuation element are configured to exhibit a recovery motion following actuation ([0056] describing the shape memory of the first element, with Mixter teaching the second element being capable of returning to its original shape [0067]), and wherein the frictional element is configured to reduce and/or prevent any undesirable motion of the gating element following actuation of the first actuation element and following actuation of the second actuation element (80 frictionally engaging and preventing unintentional adjustment [0011].
Regarding Claim 27, McCusker further teaches the first shape memory actuation element (1314) is configured to impart a rotational force on the gating element (32) (moving about 74, Fig. 5A) [0047] toward the second position when actuated (shown in Fig. 5A), and wherein the rotational force is greater than a static frictional force (as illustrated in Fig. 5A; “friction” [0047]); “moved” [0052]) between the gating element and the frictional element such that the gating element slides past the frictional element toward the second position (as seen in Figs. 4-5B [0052]).
Regarding Claim 28, McCusker further teaches the second shape memory actuation element (1315) is configured to impart a rotational force on the gating element (32) (moving about 74, Fig. 5A) [0047] toward the first position when actuated (Fig. 5A), and wherein the rotational force is greater than a static frictional force (as illustrated in Fig. 5A; “friction” [0047]); “moved” [0052]) between the gating element and the frictional element such that the gating element slides past the frictional element toward the first position (as seen in Figs. 4-5B [0052]).
Regarding Claim 29, McCusker is considered to teach the frictional element (80) is integral with the actuator (32, 80, and 90) as it is a constituent element of the actuator.
Regarding Claim 30, McCusker further teaches the frictional element (80) is a tab, nub, projection, or bump (“stair-step” being considered a bump or projection [0047], Fig. 5A).
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HANS KALIHER/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781