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) 1-3,5-14,16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barrett et al. (USPN 2012/0154789).
Regarding claims 1 and 13, Barrett et al. discloses a patient monitoring device and method, comprising: a housing configured to releasably engage a fluid conduit (figure 4, housing 34,[0040]); at least one sensor configured to measure at least one characteristic of fluid flowing through the fluid conduit ([0045]); and a controller ([0011],[0025]) configured to: generate patient data comprising a baseline range of the at least one characteristic over the first time period ([0051]-[0052], calibration parameters); and monitor a patient state based at least in part on the baseline range and the measured at least one characteristic over the second time period ([0053]-[0054]).
Regarding claims 2 and 19, Barrett et al. discloses the patient state comprises one or more of an infection state of the patient, patient compliance with a prescribed therapy, therapy efficacy, device maintenance, sensor calibration, and sensor data (sensor calibration and sensor data, [0051]-[0053]).
Regarding claims 3 and 14, Barrett et al. discloses the at least one characteristic comprises one or more of optical scatter, absorption, color, flow rate, conductivity, temperature, pH, lactate concentration, cell count, leukocyte esterase concentration, chemiluminescence, glucose concentration, urea concentration, and creatinine concentration ([0002], [0076]).
Regarding claim 5, Barrett et al. discloses the housing comprises a hinge and the housing is configured to surround at least a portion of the fluid conduit (figure 4).
Regarding claim 6, Barrett et al. discloses one or more portions of the fluid conduit are composed of a material susceptible to bacteria fouling (blood chamber 32 is made of medical grade plycarbonated or other suitable material known within dialyzer that suspectable to bacteria fouling ([0043])).
Regarding claim 7, Barrett et al. discloses the at least one sensor is configured to clamp over a portion of the fluid conduit transparent to at least one of ultraviolet light, visible light, and infrared radiation ([0021], [0043]).
Regarding claim 8, Barrett et al. discloses the at least one sensor is a fluid- contacting sensor (figure 4).
Regarding claim 9, Barrett et al. discloses the at least one sensor is a non-fluid- contact sensor comprising one or more of a pressure sensor, image sensor, accelerometer, gyroscope, temperature sensor, and magnetic field transducer (figure 4).
Regarding claim 10, Barrett et al. discloses a limited-use sensor configured to releasably engage one or more of the fluid conduit and the housing (figure 4).
Regarding claim 11, Barrett et al. discloses the fluid conduit is coupled to one or more of an in-dwelling catheter for peritoneal dialysis, a urinary catheter, hydrocephalus shunt, percutaneous abscess drainage catheter, ascites drainage catheter, insulin pump, feeding tube, central venous line catheter, tunneled catheter, and implanted access port ([0040]-[0041]).
Regarding claim 12, Barrett et al. discloses the controller is configured to open a valve to fill a sample container with the patient fluid upon detecting a positive infection state of the patient ([0044]).
Regarding claim 16, Barrett et al. discloses measuring a set of patient clinical events during the first time period and the second time period after the first time period; estimating a relationship between the set of patient clinical events and the at least one characteristic over the first time period; monitoring a patient state based at least in part on the estimated relationship and the measured characteristic over the second time period ([0051]-[0054]).
Regarding claim 17, Barrett et al. discloses outputting an alert to a predetermined contact when the measured characteristic over the second time period deviates from the baseline range ([0051]-[0054]).
Regarding claim 18, Barrett et al. discloses modifying an alert sensitivity based on one or more of a number of deviations from the baseline range and a number of patient clinical events ([0051]-[0054]).
Regarding claim 20, Barrett et al. discloses establishing a communication channel between the patient and a health care professional in response to the alert corresponding to the patient being in a high-risk condition ([0051]-[0054]).
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.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barrett et al. as applied to claims 1 and 13 above, and further in view of Newberry (USPN 2017/0014035).
While Barrett et al. teaches that the optical sensor clip assembly calculates the hematocrit, oxygen saturation and change in blood volume associated with the blood passing through the blood chamber ([0056]), Barrett et al. fails to disclose that the at least one characteristic comprises leukocyte esterase concentration. Newberry discloses an optical sensor measuring oxygen saturation levels in blood flow, as well as monitoring concentration of white blood cell count (leukocyte). See [0050] and [00145]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made before the effective filing date of the claimed invention (AIA ) to incorporate the teaching of obtaining the concentration of leukocyte (white blood cell) as taught by Newberry into the device of Barrette et al., in order to obtain additional physiological parameter.
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 claims 1-29 of US Patent 11,331,052. 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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10925549. 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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,865,241. 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Oppenheimer (USPN 5,601,080-Cited by the Applicant) teaches all the limitations of claims 1 and 13.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached on (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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