DETAILED ACTION
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.
(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.
Claim(s) 1 and 3-5 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Babb, US 4316466 (Babb).
Regarding claim 1, Babb discloses a medical fluid drain container (abstract, figs. 1-2) comprising:
A first compartment (REF 10, see “first flow path”, C4/L16) for collecting a fluid;
An inlet (REF 12) connected to the first compartment, the inlet configured to be connected to a fluid line;
A second compartment (REF 18, see “second flow path”, C4/L22-23) containing an acid (see “trisodium citrate in a saline solution”, C2/L8-12 and “the second flow path is called the “additive fluid flow path””, C2/L47-51);
An outlet (REF 24) fluidly connected to the second compartment, the outlet configured to be connected to a drain line (REF 11);
Wherein fluid transfer between the first compartment and the second compartment is prevented in a first state (when REF 34 is not activated) and permitted in a second state (when REF 34 is activated, ¶ 0020).
Elements drawn to “dialysis fluid” and “used dialysis fluid” are not considered to impart structural weight to the claims beyond requiring the container to be capable of holding a fluid since these elements are not positively recited as a structural feature of the claim (see MPEP 2115).
Regarding claim 3, Babb discloses a container wherein the second compartment is a syringe (REF 35, fig. 1).
Regarding claim 4, Babb discloses a container wherein the syringe comprises a plunger (REF 62) that is extended in a first state (fig. 1) and depressed in a second state (fig. 2).
Regarding claim 5, Babb discloses a container wherein the acid comprises citric acid (see “trisodium citrate in a saline solution”, C2/L8-12).
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Furukawa et al., JP 2021-003262 (Furukawa, IDS).
Regarding claim 1, Furukawa discloses a dialysis fluid drain container (abstract, fig. 1) comprising:
A first compartment (REF 6) for collecting used dialysis fluid (see “dialysis waste fluid”, abstract);
An inlet (distal end of REF 5 within REF 6) connected to the first compartment, the inlet configured to be connected to a used dialysis fluid line (via REF 5);
A second compartment (REF 8) containing an acid (see “acid solution storage tank 8”, abstract);
An outlet (REF 13) connected to the second compartment, the outlet configured to be connected to a drain line (REF 14 via REF B);
Wherein fluid transfer between the first compartment and the second compartment is prevented in a first state (when pump “P” is not activated, ¶ 0020) and permitted in a second state (when pump “P” is activated, ¶ 0020).
Regarding claim 5, Furukawa discloses a container wherein the acid comprises acetic acid (see “acetic acid”, ¶ 0017).
Claim Rejections - 35 USC § 103
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babb in view of Friederichs et al., US 2017/0290970 (Friederichs, IDS).
Regarding claim 2, while Babb discloses the use of a valving system (REF 26, 28, 30, 32) for the control of fluid movement from the first compartment to the second compartment, Babb does not disclose a container further comprising a frangible seal between the first compartment and second compartment, the seal being unbroken in the first state and broken in the second state. However, Friederichs discloses a medical fluid storage system (abstract) where valves such as those used in Babb are used interchangeably with clamps or frangible valves (¶ 0106).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the container of Babb to utilize a frangible type valve as described in Friederichs since it has been shown that such valves are routinely used as alternative means for controlling liquid flow between containers.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Babb in view of Brandl et al., US 2012/0310150 (Brandl).
Regarding claim 6, Babb does not disclose the acid being in powder form. However, Babb discloses that the additive is “preferably trisodium citrate in a saline solution”, where trisodium citrate is mixed with the saline solution to form an aqueous citric acid solution for use. Furthermore, Brandl discloses medical fluid containers containing concentrates in powdered form, liquid form, or liquid slurry form (abstract).
At the time of invention, it would have been obvious to one having ordinary skill in the art to modify the container of Babb to utilize the additive in powder form as described in Brandl since it has been shown that additives in powdered, liquid, or semi-liquid form are equally effective for dissolution when mixed with a liquid and the selection of any of these forms provides no more than predictable and reliable results absent a showing to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIRK R BASS whose telephone number is (571)270-7370. The examiner can normally be reached 8-4:30 EST Monday-Friday.
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, Bobby Ramdhanie can be reached at (571) 270-3240. 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.
DIRK R. BASS
Primary Examiner
Art Unit 1779
/DIRK R BASS/ Primary Examiner, Art Unit 1779