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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/20/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/08/2025 and 08/04/2025 were considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 06/20/2025. As directed by the amendment: Claim 1 has been amended, claims 5 and 13 have been cancelled, and no claims have been added. Thus, claims 1-4, 6-12, and 14-32 are presently pending in the application wherein claims 14-30 are withdrawn.
Applicant’s amendments to the claims have overcome the previous 112 rejection and objections previously set forth in the Final Office Action mailed 12/30/2024.
Response to Arguments
Applicant’s arguments, see pages 9-12, filed 06/20/2025, with respect to the rejection of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of DePasqua (US 11278657).
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “A CSF fluid conduit…” that is not defined. Amending claim 1 to recite “A cerebrospinal fluid “CSF” fluid conduit…” would overcome the objection; appropriate correction is required.
Claim 31 is objected to because of the following informalities: Claim 31 recites “an EEPROM” that is not defined. Amending claim 31 to recite “an electrically erasable programmable read-only memory “EEPROM” would overcome the objection; appropriate correction is required.
Claim 32 recites “the fluid conduit” instead of “the conduit body” in line 2. Appropriate correction is required.
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 1-4, 6-12, and 31-32 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 1 recites the limitation "the bore" in lines 10, 16, 22, and 26-27, claim 8 recites “the bore” in line 1, claim 9 recites “the bore” in line 2, and claim 10 recites “the bore” in line 2. There is insufficient antecedent basis for these limitation in the claims; examiner interprets “the bore” to be “the fluid traversing bore” for the purpose of examination.
Claim 1 recites the limitation "the second end" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the first external catheter conduit" in lines 1-2, and claim 4 recites “the first external catheter conduit” in line 2. There is insufficient antecedent basis for this limitation in the claim; examiner interpret “the first external catheter conduit” to be “the first external catheter” for the purpose of examination.
Claim 31 recites “the catheter controller comprises an EEPROM that turns a tag on an external surface of the fluid conduit red when the fluid conduit has reached its full lifetime use” wherein the specification (lines 7-9 on page 16), filed 09/29/2021, discloses that the external surface of the catheter 14 may have a tag that turns red when the EEPROM determines that the catheter reached its full lifetime use. It is unclear if EEPROM is turning the tag on the external surface of the catheter red before determining that the catheter reached its full lifetime use or if the tag on the external surface of the catheter turns red before the EEPROM determines that the catheter reached its full lifetime use. Also, the specification (lines 22-25 on page 15), filed 09/29/2021, discloses that the EEPROM is part of the external catheter 14, so it is not clear if EEPROM is implemented on the external catheter or the catheter controller or if the catheter controller is part/implemented on the external catheter. Examiner interprets the external surface of the catheter to comprise a tag that turns red when the EEPROM on the catheter determines that the catheter has reached its full lifetime use. Clarification is required.
Claims 3, 6-7, and 32 are rejected for depending on claim 1.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-10, 12, and 32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by DePasqua.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, DePasqua discloses a CSF fluid conduit (Figs.15A-C and 18) for directing CSF flow to or from a patient having two first (1530) and second (1505) exterior ports in fluid communication with the patient's subarachnoid space (lines 4-8 and 61-67 in column 42 and line 1 in column 43), the CSF fluid conduit being compatible with a CSF circuit having a pump (1525) for controlling CSF fluid flow, the patient having a first internal catheter (ventricular catheter) fluidly coupled with a prescribed region of the patient's brain (lines 61-67 in column 42 and line 1 in column 43), the patient also having a second internal catheter (lumbar catheter) fluidly coupled to a prescribed lumbar region or a lower abdomen of the subarachnoid space of the patient (lines 4-8 in column 42), the fluid conduit comprising: a conduit body forming a fluid traversing bore (bore within lumbar catheter, ventricular catheter, return catheter 1510b, and upstream conduit 1510a), the conduit body comprising: a first external catheter (1510) having a first end (end at 1530) and a second end (end connected to the cartridge 1515) in fluid communication with the bore, the first end of the first external catheter (1510b) being removably couplable with the first exterior port (1530) of the patient (Fig.15C), the second end of the first external catheter being removably couplable with the pump (via cartridge 1515 as seen in Fig.18), the first exterior port (1530) configured to fluidly couple with the first internal catheter (lines 61-67 in column 42); a second external catheter (1510a) being in fluid communication with the bore, a first end (end at 1505) of the second external catheter(1510a) being removably couplable with the second exterior port (1505) of the patient (lines 4-8 and column 42), the second end (end connected to the cartridge 1515) of the second external catheter (1510a) being removably couplable with the pump (Figs.15A-C) (lines 50-58 in column 44), the second external catheter (1510a) being in communication with both the second exterior port (1505) and the pump (1525) when removably coupled (lines 4-21 in column 42), the second exterior port (1505) configured to fluidly couple with the second internal catheter (lumbar catheter) (lines 4-21 in column 42), the conduit body being configured to form a closed loop CSF channel when removably coupled with the first and second exterior ports (closed loop channel CSF channel comprises the ventricular CSF space, the ventricular catheter, the second location 1530, the return catheter 1510b, the cartridge 1515, the upstream conduit 1510a, the first location 1505, the lumbar catheter, and the lumbar CSF space), the CSF channel and bore being in fluid communication with the patient's subarachnoid space when the conduit body is removably coupled such that the CSF channel comprises a portion of the subarachnoid space (the ventricular and lumbar CSF spaces) positioned between a distal end of the first internal catheter and a distal end of the second internal catheter (lines 58-67 in column 42 and line 1 in column 43); a flow sensor configured to detect flow through the bore of the conduit body (within return conduit 1510b or upstream conduit 1510a) (lines 34-43 in column 43); a pressure sensor configured to detect pressure within the bore of the conduit body (lines 34-43 in column 43); and a catheter controller (sensing devices) having a communication channel with the pump (via controller system 1520) (lines 34-60 in column 43), the catheter controller (volume meter) having a usage meter configured to track use of the CSF fluid conduit (when measuring the volume of the treated volume) (lines 34-60 in column 43), wherein, the flow sensor, the pressure sensor, and the catheter controller are all a part of the conduit body (lines 34-60 in column 43 and Figs.15A-C).
Regarding Claim 2, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein the first end (end at 1530) of the first external catheter (1510) conduit body is configured as a removable coupling to removably couple with the first exterior port (1530) of the patient (Fig.15C).
Regarding Claim 3, DePasqua discloses the CSF fluid conduit as defined by claim 2 and further discloses wherein the removable coupling comprises a Luer lock (Fig.15C) or a removable needle.
Regarding Claim 4, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein the second end (end connected to the cartridge 1515) of the first external catheter (1510) conduit body is configured to removably couple with the pump (via cartridge 1515 as seen in Fig.18).
Regarding Claim 8, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein the bore is configured to receive a therapeutic material mixed with CSF (lines 28-36 and 58-67 in column 42), the catheter controller being configured to control fluid flow as a function of the therapeutic material (the sensing devices send the data to the control system 1520 wherein the control system 1520 controls flow based on comparing the data with an existing condition) (lines 34-60 in column 43).
Regarding Claim 9, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein the flow sensor is configured to detect the rate of fluid flow through the bore (within return conduit 1510b or upstream conduit 1510a) (lines 34-43 in column 43).
Regarding Claim 10, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein the flow sensor is configured to detect the total volume (The total volume is the volume of the removed/untreated fluid and the volume of the returned/treated fluid wherein the removed volume is known and the sensing devices measure the volume of the treated volume) of fluid through the bore (lines 8-14 in column 42 and lines 43-60 in column 43).
Regarding Claim 12, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses comprising a programmable logic element (1520) configured to be programmed to sense or control use of the CSF fluid conduit (lines 43-64 in column 43).
Regarding Claim 32, DePasqua discloses the CSF fluid conduit as defined by claim 1 and further discloses wherein an entirety of the conduit body is removably connectible with the pump (Figs.15A-C).
Claims 6-7, 11, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over DePasqua (US 11278657); in view of Paul (US 2020/0324006).
Regarding Claim 6, DePasqua discloses all the limitations of claim 1.
DePasqua does not appear to disclose the catheter controller is configured to produce indicia indicating total number of uses of the CSF fluid conduit.
Paul teaches it was known in the art to have a catheter tagged with an RFID chip that is scanned with a mobile app to indicate the number of uses of the catheter (parag. [0186]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified DePasqua to incorporate the teachings of Paul to have a catheter controller configured to produce indicia indicating the toral number of uses of the CSF fluid conduit in order to validate the usage information of the catheter (parag. [0186]).
Regarding Claim 7, DePasqua discloses all the limitations of claim 1.
DePasqua does not appear to disclose the catheter controller is configured to indicate catheter sterilization date information.
Paul teaches it was known in the art to have a catheter tagged with an RFID chip that is scanned upon placement into the sterilizer wherein the chip contains information that include time and date of the last sterilization (parag. [0186], lines 6-7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paul to incorporate the teachings of Paul to have a catheter controller is configured to indicate catheter sterilization date information in order to avoid infection (parag. [0184], last sentence).
Regarding Claim 11, DePasqua discloses the CSF fluid conduit as defined by claim 1 and Paul further teaches wherein the catheter controller is configured to permit a maximum time to use (100 uses) the CSF fluid conduit (parags. [0186]-[0187]).
Regarding Claim 31, DePasqua discloses the CSF fluid conduit as defined by claim 1 and Paul further teaches wherein the catheter controller comprises an EEPROM that turns a tag on an external surface of the fluid conduit red when the fluid conduit has reached its full lifetime use (the catheter is tagged with an RFID chip that turns a status indicator red when the catheter reaches its full lifetime use (100 uses) (parags. [0098] and [0201]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TANIA M ISMAIL whose telephone number is (313)446-6625. The examiner can normally be reached Monday-Thursday 8:00-3:30 pm.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783