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 .
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oppenheimer (USPN 5,601,080-Cited by the Applicant).
Oppenheimer discloses a patient monitoring system (figures 1-2), comprising: a housing comprising: a holder configured to releasably receive a portion of a fluid conduit (housing 12 figures 1-2, Col.5 lines 5-45); at least one illumination source configured to illuminate the received portion of the fluid conduit (light sources 26-27 figures 1-2, Col.5 line 20-Col.6 line 50); and at least one optical sensor configured to generate a signal (detector 32, figures 1-2, Col.5 line 20-Col.6 line 50), wherein the holder comprises one or more engagement features (elements 14 and 20 figures 1-2) configured to orient the received portion of the fluid conduit in a predetermined rotational and vertical orientation relative to the at least one illumination source and the at least one optical sensor (figures 1-2, Col.5 line 5-Col.6 line 50, the limitation “in a predetermined rotational and vertical orientation relative to the at least one illumination source and the at least one optical sensor” is directed towards a functional language and does not further limit the positively recited engagement features).Oppenheimer discloses that the housing comprises a light seal (element 18 figures 1-2, Col.5 line 5-Col.6 line 50). Oppenheimer discloses the one or more engagement features is configured to orient the received portion of the fluid conduit by mating with an alignment feature of the received portion of the fluid conduit (figures 1-2). Oppenheimer discloses the one or more engagement features comprises an open slot (figures 1-2). Oppenheimer discloses the at least one illumination source comprises a plurality of illumination sources (figure 1, elements 16, Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources are configured to illuminate in a first illumination direction and a second illumination direction orthogonal to the first illumination direction (figure 1, elements 16, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources are configured to illuminate in a first illumination direction and a second illumination direction opposite the first direction (figure 1, elements 16, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses at least two of the illumination sources are configured to illuminate along a first plane at a first wavelength (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses at least another two of the illumination sources are configured to illuminate along a second plane substantially parallel to the first plane (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources comprise a first illumination source configured to emit light at a first wavelength between about 800 nm and about 900 nm (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources comprise a second illumination source configured to emit light at a second wavelength between about 400 nm and about 450 nm (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources comprise a third illumination source configured to emit light at a third wavelength between about 500 nm and about 550 nm (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the illumination sources comprise a fourth illumination source configured to emit light at a fourth wavelength between about 230 nm and about 290 nm (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the holder defines a longitudinal axis, and wherein the at least one optical sensor comprises a plurality of optical sensors spaced apart parallel to the longitudinal axis (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses one or more of the at least one illumination source and the at least one optical sensor comprises an anti-reflective coating (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the housing comprises a peritoneal dialysis device fluid path (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the fluid conduit is coupled to a peritoneal dialysis tubing set (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the fluid conduit is coupled to a peritoneal dialysis cycler tubing set (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the fluid conduit is coupled to a peritoneal dialysis drain bag connector (figures 1-2, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the fluid conduit comprises: an inlet portion; an outlet portion (figures 1-4, and Col.5 line 5-Col.6 line 40); and an optically transparent measurement portion between the inlet portion and the outlet portion, wherein the measurement portion comprises at least two substantially planar surfaces, a rotational alignment feature, and a depth alignment feature (figures 1-4). Oppenheimer discloses at least one of the rotational alignment feature and the depth alignment feature is configured to mate with the one or more engagement features of the holder (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses a controller configured to generate patient data based at least in part on the signal (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the controller is located remote from the housing, and wherein the system further comprises a communication device configured to transmit data representative of signal to the controller (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the controller is configured to predict an infection score of a patient based at least in part on the signal (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the controller is configured to predict an infection state of a patient in response to any one or more of the following: the infection score exceeding a predetermined threshold during each of one or more successive measurement time periods, the infection score increasing from a patient baseline over time, and the infection score having an increasing rate of change over time (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the infection state comprises a probability of infection (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the fluid conduit is configured to receive a patient fluid and the controller is configured to estimate turbidity of the patient fluid based at least in part on the signal, wherein the infection score is based at least in part on the estimated turbidity (figures 1-4, and Col.5 line 5-Col.6 line 40). Oppenheimer discloses the controller is configured to monitor a trend in infection score predicting infection resolution of the patient (figures 1-4, and Col.5 line 5-Col.6 line 40).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11, 22-24, 26-27, 38-39, 41-42 of copending Application No. 16221361 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of the reference application and the instant application are directed towards the same invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of 10,925,549. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of the reference application and the instant application are directed towards the same invention.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of 11,344,261. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of the reference application and the instant application are directed towards the same invention.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of 11,992,343. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of the reference application and the instant application are directed towards the same invention.
Claims 1-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of 12,507,961. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter of the reference application and the instant application are directed towards the same invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN FARDANESH whose telephone number is (571)270-5508. The examiner can normally be reached on Monday-Friday 9:00-17:00.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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