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 .
Status of Claims
Claims 1-2, 5-7, 11, 15, 22-23, 25, 27-30, 34-38, and 41 are pending and examined on the merits.
Claims 1-2, 5-7, 11, 15, 22-23, 25, 27-30, 36-38, and 41 are currently amended.
Claims 3-4, 8-10, 12-14, 16-21, 24, 26, 31-33, and 39-40 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2023 was filed before the mailing date of the First Office Action on the Merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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)(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.
Claims 1-2, 5-7, 11, 15, 23, 25, 27-30, 34-38, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelly (U.S. Pre Grant Pub. No. 2005/0131332 A1).
Regarding claim 1, Kelly teaches: A blood treatment system (see Fig. 1 and para. [0043]) comprising:
a blood pump for urging blood from an arterial or venous interface through a blood flow path (see Fig. 1 and para. [0089] describing arterial line 44a and venous line 44b);
a dialyser in fluid communication with said blood flow path for ultrafiltering the blood to remove fluid therefrom (see at least para. [0076] teaching that ultrafiltrate is removed from the patient via the arterial dialyzer);
a fluid removal pump in fluid communication with said dialyser for urging ultrafiltered fluid away from said dialyser (see para. [0187]);
a controller in signal communication with said blood pump (see para. [0080]); and
a reversing valve for selectively reversing direction of blood flow in at least a portion of the blood flow path under signal control of said controller (see para. [0121]),
wherein said blood pump is selectively activatable under signal control of said controller (see para. [0080]); and
wherein said system is portable and wearable by a patient undergoing blood treatment (see at least para. [0008]).
Regarding claim 2, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches wherein said dialyser is a first dialyser (see para. [0083] and Fig. 1) and said system further comprises a second dialyser (Id.): and wherein the system comprises at least one flow control element for directing said blood flow path through a selected one of said first dialyser (see venous line clamp/valve 56 in Fig. 1 and para. [0092]) or said second dialyser under signal control of said controller (see para. [0080]).
Regarding claim 5, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches where the portion of the blood flow path comprises the arterial and the venous interface (see venous dialyzer 20 and arterial dialyzer 30 in Fig. 1 and para. [0083], which are in the blood flow path).
Regarding claim 6, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches wherein the reversing valve is positioned upstream of an inlet of the blood pump for selectively flowing blood from one of the arterial or venous interface to the inlet of the blood pump without reversing the blood pump
Regarding claim 7, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches comprising a prime fluid reservoir (see at least para. [0015]); and a plurality of other valves, each under signal control of said controller to effect automated priming of the system by circulating prime fluid urged by said blood pump from said prime fluid reservoir along selected fluid flow paths (see at least para. [0015]).
Regarding claim 11, Kelly teaches the invention as discussed above in claim 7. Additionally, Kelly teaches wherein said selected fluid flow paths includes at least one of: a fluid flow path connecting said prime fluid reservoir and said first dialyser (since Kelly teaches a closed fluid flow system, as seen in at least Fig. 1, the fluid flow paths are interconnected; therefore, a fluid flow path exists between the reservoir and first dialyser); a fluid flow path connecting said prime fluid reservoir and said second dialyser (since Kelly teaches a closed fluid flow system, as seen in at least Fig. 1, the fluid flow paths are interconnected; therefore, a fluid flow path exists between the reservoir and second dialyser); a fluid flow path connecting said prime fluid reservoir and said arterial interface (since Kelly teaches a closed fluid flow system, as seen in at least Fig. 1, the fluid flow paths are interconnected; therefore, a fluid flow path exists between the reservoir and arterial interface);and/or a fluid flow path connecting said prime fluid reservoir and said venous interface (since Kelly teaches a closed fluid flow system, as seen in at least Fig. 1, the fluid flow paths are interconnected; therefore, a fluid flow path exists between the reservoir and venous interface).
Regarding claim 15, Kelly teaches the invention as discussed above in claim 7. Additionally, Kelly teaches wherein said controller is configured to control said other valves to remove said first dialyser from said blood flow path to facilitate replacement of said first dialyser (as described in para. [0009], the priming sequence is automated, therefore, a controller is configured to control the other valves to remove the first dialyser from the blood flow path); or said controller is configured to control said other valves to remove said second dialyser from said blood flow path to facilitate replacement of said second dialyser (as described in para. [0009], the priming sequence is automated, therefore, a controller is configured to control the other valves to remove the second dialyser from the blood flow path).
Regarding claim 23, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches comprising a pressure sensor for measuring pressure of the blood proximate said arterial or venous interface (see pressure sensor 46 in Fig. 1 and para. [0089]); wherein said controller implements logic for disabling said blood pump in response to detection of the pressure of the blood by said pressure sensor in excess of a pre-defined limit (see pressure switch in para. [0089], which necessarily has to be connected to a controller).
Regarding claim 25, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches comprising a blood sensor for sensing blood in the ultrafiltered fluid (see para. [0118]); wherein said controller implements logic for disabling said blood pump in response to detection of blood by said blood sensor (as described in para. [0118], the blood leak detector 66 includes a light source and photo sensor, which necessarily have to be controlled by a controller that implements logic for disabling the blood pump in response to the detection of blood).
Regarding claim 27, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches wherein said fluid removal pump is reversible under signal control of said controller (para. [0121] describes that pump 48 would run in reverse until a sensor detects an absence of blood in the fluid line; since a controller has to necessarily control the sensor, the pump is under signal control of the controller), to urge ultrafiltered fluid into the dialyser to clear fouling from a membrane of the dialyser (see at least para. [0121]).
Regarding claim 28, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches wherein said controller is configured for reversing said fluid removal pump in response to determining a transmembrane pressure of said dialyser (see at least para. [0103 and 0121]).
Regarding claim 29, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches wherein said controller is configured for controlling a pump rate of said blood pump based on a measured fluid removal rate (the controller of Kelly is configured to control the sensors and other electronics, therefore, it is also configured to control the pump rate).
Regarding claim 30, Kelly teaches the invention as discussed above in claim 1. Additionally, Kelly teaches further comprising non-transitory memory for storing data received at said controller; wherein said data includes sensor data (see at least para. [0293]).
Regarding claim 34, Kelly teaches A method for controlling a blood treatment system (see at least Abstract), the method comprising:
causing a blood pump to flow blood through a flow path from one of an arterial or venous interface to a dialyser and to the other of the arterial or venous interface (see Fig. 1 and para. [0089] describing arterial line 44a and venous line 44b); and
causing a reversing valve to reverse the flow of blood through a portion of the flow path (see para. [0121]).
Regarding claim 35, Kelly teaches the method as discussed above in claim 34. Additionally, Kelly teaches wherein causing the reversing valve to reverse the flow of blood through the portion of the flow path comprises causing blood to reverse flow between the arterial and venous interface (see at least para. [0121]).
Regarding claim 36, Kelly teaches the method as discussed above in claim 34. Additionally, Kelly teaches wherein the reversing valve is positioned upstream of an inlet of the blood pump (see Fig. 1), and the method comprises selectively flowing blood from one of the arterial or venous interface to the inlet of the blood pump without reversing the blood pump (see para. [0121]).
Regarding claim 37, Kelly teaches the method as discussed above in claim 34. Additionally, Kelly teaches comprising directing said blood flow path through a selected one of a first dialyser or a second dialyser (see at least para. [0076]).
Regarding claim 38, Kelly teaches the method as discussed above in claim 34. Additionally, Kelly teaches comprising causing a plurality of flow valves to prime a portion of the flow path by circulating prime fluid urged by said blood pump from a prime fluid reservoir along the portion of the flow path; wherein said portion of the flow path is isolated from a second dialyser (see at least para. [0015]).
Regarding claim 41, Kelly teaches the method as discussed above in claim 34. Additionally, Kelly teaches wherein said portion of the flow path includes said prime fluid reservoir and said arterial interface (see at least para. [0015]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly (U.S. Pre Grant Pub. No. 2005/0131332 A1) in view of Grant (U.S. Pre Grant Pub. No. 2009/0105629 A1).
Regarding claim 22, Kelly teaches the invention as discussed above in claim 1. However, Kelly fails to explicitly teach comprising an anticoagulant source in fluid communication with the blood flow path, for adding anticoagulant to the blood flow path, as required by the claim.
Grant teaches an analogous blood treatment system (see Abstract) comprising an anticoagulant connection for engaging with an anticoagulant source and providing anticoagulant into the blood circuit (see at least para. [0014]).
It 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 device of Kelly to incorporate the teachings of Grant by including an anticoagulant connection and source at least because Grant teachings that inclusion of such structures provides anticoagulant into the blood circuit (see para. [0014]) which would prevent coagulation of the blood.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sasaki (U.S. Pre Grant Pub. No. 2010/0191164 A1) – Hemodialysis Apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIHAD DAKKAK whose telephone number is (571)272-0567. The examiner can normally be reached Mon-Fri: 9AM - 5PM ET.
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.
/JIHAD DAKKAK/ Examiner, Art Unit 3781
/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
Prosecution Insights