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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the blood treatment device with a cassette, control unit, and pumps must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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)(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.
Claims 1-6, 9, 11, and 12 are rejected under pre-AIA 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2015/0335809 to Stuva et al.
In the specification and figures, Stuva discloses the apparatus substantially as claimed by Applicant. With regard to claims 1, 2, and 11, Stuva discloses a blood treatment system 310 comprising machine 360 to be used with a disposable cassette 372, wherein the machine has a coupling region (see pump raceways 366), and a control unit 361 that carries out pressure measurements and evaluations at different times to determine the quality of the connection of the cassette to the machine 360 (see FIG 2, ¶0095, 0107, 0113-114).
With regard to claims 3, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
With regard to claims 4-5, Stuva discloses that the apparatus comprises multiple pumps (such as pump 14) and takes pressure measurements (Ppump) to test the connection between the pump 14 and a valve 90 to measure the decay of a connection to a return line 82 (see ¶0116).
With regard to claims 6 and 12, Stuva discloses that the pressure measurement may be carried out prior to pump operation as well as during pump operation (see ¶0108).
With regard to claim 9, Stuva discloses that the apparatus is configured to store measured values and display results (see ¶0090-0091, 0071).
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.
Claims 7, 8, are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0335809 to Stuva et al in view of US 2005/0118030 to Kline et al.
In the specification and figures, Stuva discloses the apparatus substantially as claimed by Applicant (see rejections above).
With regard to claims 7, 8, and 13-15, Stuva does not disclose pressure measurements for a plurality of pumps and evaluation for coordination or tolerance. However, Kline discloses an extracorporeal blood treatment machine with a cassette and a testing protocol that tests the pressure at multiple pumps and a controller that determines whether the cassette is properly installed based on threshold values and controlled in a coordinated fashion (see Kline ¶0313-0320, 0153-0154). It would have been obvious to a person having ordinary skill in the art to use the wet-test methods on multiple pumps as disclosed by Kline in the apparatus disclosed by Stuva, in order to ensure continuous proper connection between the cassette and the operating pumps, as taught by Kline.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2019/0209766 Thiebaud et al.
Testing proper installation of a cassette in a medical fluid treatment system
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 12 January 2026