DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 2-8 in the reply filed on 05/12/2026 is acknowledged.
Claims 9-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/12/2026.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9,353,021. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of instant claim 2 is suggested in claim 2 of U.S. Patent No. 9,353,021.
Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 9,353,021.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 9,353,021.
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 6 of U.S. Patent No. 9,353,021.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 9,353,021.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 9,353,021.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 9,353,021.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-7 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hacker et al. (US Pat. No.: 6,101,406) in view of Donig et al. (US Pat. No.: 6,743,201).
Regarding claim 2, Hacker discloses (fig. 5-6, 10) a cassette manifold (cassette 12) and thus in the same field of endeavor, comprising: a fluid path (fluid chamber 18) configured to carry fluid (col. 6, ln. 32-37), the fluid path including at least two probes (ion sensor 28 and thermistor assembly, col. 21, ln. 32-40), at least one probe being a thermal well (36) adapted to receive a sensor (thermistor 224) for transmitting temperature (col. 21, ln. 35-40), the two probes permitting conductivity sensing of fluid passing along the fluid path (col. 16, ln. 23-27, ln. 61-67).
Hacker fails to disclose the cassette comprising a plurality of fluidically separate fluid paths, allowing the fluid paths to carry fluids having different compositions or characteristics.
Donig teaches (fig. 1) a cassette manifold (cassette 10) and thus in the same field of endeavor, comprising: a plurality of fluidically separate fluid paths, allowing the fluid paths to carry fluids having different compositions or characteristics (col. 4, ln. 35-63), the cassette manifold configured to deliver dialysis fluids (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cassette manifold of Hacker such that it comprises a plurality of fluidically separate fluid paths, allowing the fluid paths to carry fluids having different compositions or characteristics, as taught by Donig, in order to configure the cassette manifold to deliver dialysis fluids (Doing, abstract).
Regarding claim 3, Hacker discloses wherein the sensor is a thermistor (col. 21, ln. 35-40).
Regarding claim 4, Hacker discloses wherein said thermal well comprises: a hollow housing of a thermally and electrically conductive material (col. 16, ln. 61-64), said housing having an outer surface and an inner surface (fig. 5) said inner surface being of a predetermined shape so as to form a mating relationship with a sensing probe (fig. 5, 10), whereby said mating thermally and electrically couples the inner surface with a sensing probe (col. 21, ln. 30-40; col. 22, ln. 12-20).
Regarding claim 5, Hacker discloses wherein the probes are electrically conductive leads of a conductivity sensor (col. 21, ln. 35-40; col. 32, ln. 65-col. 33, ln. 16).
Regarding claim 6, Hacker discloses wherein the two probes are configured to make contact with fluid in the fluid path (col. 16, ln. 23-28, ln. 65-67).
Regarding claim 7, Hacker discloses wherein one of the probes is sealed to the cassette using an O-ring seal (228), a retaining plage (212) and fastener (coupling 202) (fig. 1, 10).
Hacker in view of Donig fail to disclose wherein the probes are sealed to the cassette using an o-ring seal, a retaining plate and fastener.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the other probe such that it is sealed to the cassette using an O-ring seal, a retaining plage and fastener, in order to configure the probes to be detachable (Hacker col. 21, ln. 20-23).
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, Hacker in view of Donig disclose a cassette comprising the cassette manifold of claim 2 and said probes and sensor, as discussed above. Hacker further discloses wherein the probes and sensors are mounted onto, and electrically connected with a printed circuit board (printed circuit board subassembly 404), the sensor is connected with two wires to transmit temperature signals to the printed circuit board (col. 21, ln. 35-40), the printed circuit board having an edge connector (electrical cable 434) through which sensor information may be transmitted from the sensors to a system controller (430) (col. 32, ln. 25-30).
Regarding the at least one probe being a thermal well adapted to receive a sensor for transmitting temperature, Hacker discloses the two wires to transmit temperature signals but is silent to an additional wire to transmit electrical conductivity signals. Regarding the other probe, the ion sensor 28, Hacker discloses that the sensor emits a light directed through an optical fiber (col. 33, ln. 1-10). Hacker fails to disclose, teach or suggest that the probes are connected to the printed circuit board with one wire to transmit electrical conductivity signals.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schick et al. (Pub. No.: US 2007/0255527 A1) discloses a conductivity sensor. Kelly et al. (Pub. No.: US 2005/0131332 A1) discloses a fluid path including two probes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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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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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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