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 Objections
Claim 1 is objected to because of the following informalities:
Claim 1, ln. 8 should read ---and [[assigned]] assigning a score;---
Appropriate correction is required.
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)(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) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sarkar et al. (Pub. No.: US 2025/0262362 A1).
Regarding claim 1, Sarkar discloses (fig. 1-6) a method of managing fluid status in patients having renal insufficiency or renal failure (¶ 0004, ¶ 0042), comprising: Implanting a sensor device (implantable medical device 10) into a subject, wherein the sensor device has sensors operative to monitor a physical parameter (¶ 0033, ¶ 0035);
Sensing the physical parameter using the implanted sensor (100, impedance measurements collected during a current dialysis session ¶ 0082-¶ 0053);
Comparing the physical parameter data to a predetermined range (previous dialysis session data, ¶ 0083) to determine whether the physical parameter is within, above, or below the predetermined range and assigning a score (a mathematical model is implemented to predict fluid volume estimates based on historical and contemporaneous impedance measurements, ¶ 0083);
Applying a weighting factor to the score (the dry impedance estimate is further personalized depending on various factors, ¶ 0086); and
Calculating a total score (a risk assessment is performed, ¶ 0087-¶ 0088); and
Comparing the total score to at least one predetermined threshold to determine a fluid status of the patient (a determination of whether there is an acceptable risk level, ¶ 0092-¶ 0093).
Regarding claim 2, Sarkar discloses iterating continuously the steps of sensing, comparing, applying and calculating from initiation of dialysis (¶ 0008); and
Halting the dialysis when the total score falls within a second predetermined range (¶ 0094, fig. 6).
Regarding claim 3, Sarkar further discloses iterating remotely the steps of sensing, comparing, applying and calculating (¶ 0008);
Comparing the total score to a third predetermined range to predict if the subject will experience complications prior to a previously scheduled dialysis event (¶ 0037); and
Performing dialysis prior to a previously scheduled dialysis event if the prediction is positive for complications (¶ 0094-¶ 0095).
Regarding claim 4, Sarkar discloses wherein the predetermined range, the weighting factor and/or the at least one predetermined threshold are adjusted to improve accuracy of the determination of the fluid status of the subject (¶ 0040).
Regarding claim 5, Sarkar discloses wherein the sensors are selected from the group consisting of: an accelerometer, a trans-thoracic impedance sensor, a heart rate sensor, a lung tidal volume sensor, a respiratory sensor, and any combination thereof (¶ 0035).
Regarding claim 6, Sarkar discloses wherein the physical parameter is selected from the group consisting of: a change in heart sounds, a presence of fluid in the subject’s lungs, a heart rate, a lung tidal volume, breathing rate, airflow, cough frequency, body temperature, carbon dioxide level, and any combination thereof (¶ 0035).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sigg et al. (Pub. No.: US 2016/0331884 A1) discloses a method of managing fluid status. Katra et al. (Pub. No.: US 2012/0035432 A1) discloses a method of managing fluid status.
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.
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.
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.
/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781
Prosecution Insights