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 .
Response to Arguments
Applicant’s arguments, filed 06 April 2026, with respect to the rejection(s) of claim(s) 1-9 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hakim and Degen.
Examiner notes Applicant argues that the prior art does not teach wherein the manual pump is arranged and configured to move the bolus of the fluid in order to inhibit blockages within the shunt when the electronic pump cannot create the bolus of fluid. However, this newly added limitation is a statement of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the disclosure of Hakim and Degen teaches the structure of the two pumps and it appears that the manual pump of Hakim can perform the intended use function of creating bolus without the electronic pump. There does not appear to be structures that hinder the functioning of the Hakim manual pump from moving fluid.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hakim (US 4261341) in view of Degen (US 2018/0056050).
Regarding claim 1, A shunt for draining fluid, comprising:
a first catheter (22, figures 1 and 2);
a manual pump (37, figure 2) fluidly coupled to the first catheter; and
a second catheter (13) fluidly coupled to the manual pump (figure 2),
wherein, during a drainage operation, the shunt arranged and configured such that a fluid is passively pressure-driven through the shunt (col 3, lines 1-20).
Further, the limitation “wherein the manual pump is arranged and configured to move the bolus of the fluid in order to inhibit blockages within the shunt when the electronic pump cannot create the bolus of fluid.” is a statement of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the manual pump of Hakim can perform the intended use function of creating bolus without the electronic pump since Hakim does not appear to have an electronic pump already. There does not appear to be structures that hinder the functioning of the Hakim manual pump from moving fluid.
Hakim does not disclose an electronic pump fluidly coupled to the first catheter and the manual pump fluidly coupled to the electronic pump and the electronic pump is arranged to move a bolus of the fluid through the shunt.
Degen discloses an implantable shunt for moving fluid and teaches an electronic pump (21, [0030]) fluidly coupled to the first catheter (23, figure 1) and the electronic pump is arranged to move a bolus of the fluid through the shunt ([0030], can naturally be able to move bolus of fluid due to the electromechanical nature of the pump). The combined device would have the manual pump fluidly coupled to the electronic pump since the electric pump is on the distal end of the first catheter in Degen and Hakim has a catheter at the opposite end of the manual pump.
Degen provides an electrical pump in order to prevent clogging and more reliably move fluid ([006]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hakim with the electrical pump of Degen in order to prevent clogging and reliably move fluid.
Regarding claim 2, Hakim does not disclose the device with a control unit that operates the electric pump at preselected time intervals.
Degen further discloses a control unit that operates the electric pump at preselected time intervals ([0009]).
Degen provides an electrical pump with control unit to control the movement of fluid ([0009]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hakim with the electrical pump of Degen in order to prevent clogging and reliably move fluid.
Regarding claim 3, Hakim does not disclose wherein the electric pump moves the bolus of fluid as a pressure wave of the fluid flowing through the shunt at a greater pressure than the fluid being pressure-driven through the shunt.
Degen further discloses the electric pump moves the bolus of fluid as a pressure wave of the fluid flowing through the shunt at a greater pressure than the fluid being pressure-driven through the shunt ([0062]).
Degen provides an electrical pump with control unit to control the movement of fluid ([0009]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hakim with the electrical pump of Degen in order to prevent clogging and reliably move fluid.
Regarding claim 4, Hakim further comprising a one-way valve (19) fluidly coupled to the second catheter.
Regarding claim 5, Hakim discloses wherein the first catheter, the manual pump, the second catheter, and the one-way valve are serially arranged to form the shunt (figures 1-2), but does not disclose the electronic pump in serial arrangement.
The combined device would have the manual pump fluidly coupled to the electronic pump since the electric pump is on the distal end of the first catheter in Degen and Hakim has a catheter at the opposite end of the manual pump.
Degen provides an electrical pump in order to prevent clogging and more reliably move fluid ([006]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Hakim with the electrical pump of Degen in order to prevent clogging and reliably move fluid.
Regarding claim 6, the limitation “wherein the first catheter is configured to be arranged within a peritoneal space of a subject in order to drain fluid from the peritoneal space” is treated as a statement of intended use. In this case, the Hakim catheter is capable of being placed in the peritoneal space and thus meets the limitations.
Regarding claim 7, the limitation “wherein the second catheter is configured to be arranged within a bladder of the subject in order to fluidly couple the peritoneal space of the subject with the bladder of the subject” is treated as a statement of intended use. In this case, the Hakim catheter is capable of being placed in the bladder and thus meets the limitations.
Regarding claim 8, Hakim discloses the one way valve (19) and the valve is a one way valve wherein the one-way valve inhibits fluid (col 2, lines 25-35), the limitation “within the bladder from flowing through the shunt” is a statement of intended use. In this case, the Hakim valve is capable of preventing fluid from the bladder to move through the shunt.
Regarding claim 9, Hakim discloses wherein the manual pump is arranged and configured to move a bolus of the fluid through the shunt based on a manual activation (col 3, lines 1-20).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, Rebecca Eisenberg can be reached at (571) 270-5879. 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.
/KAI H WENG/Primary Examiner, Art Unit 3781
Prosecution Insights