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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2008/0064980) in view of Adams (US 2004/0054352).
Regarding claim 1, Lee discloses substantially the same invention as claimed, including a method for monitoring the health of a patient (abstract), the method comprising: obtaining physiological measurements via a sensing element of an implantable device (Figure 3: 78) while the device is implanted within the patient, wherein the sensing element includes an electro-optical sensing element (Paragraph 41); determining at least one physiological parameter based on the physiological measurements, wherein the at least one physiological parameter includes a temperature parameter (Paragraph 39); comparing the temperature parameter to a predetermined temperature threshold (Paragraph 57); and based on the comparison, providing an indication that the patient is septic (Paragraph 57).
Further regarding claim 1, Lee discloses the principles of the invention can be applicable to any implanted device (Paragraph 61), since infections can begin at the pocket area where the device is implanted (Paragraph 4). Lee does not explicitly disclose an implantable vascular access device. However, Adams teaches an implantable vascular access device comprises a housing containing a reservoir, a septum adjacent the reservoir and configured to receive a needle therethrough for delivery of a fluid agent to the reservoir (Figure 1; Paragraph 2), which is implanted at a subcutaneous pocket (abstract; Paragraph 2). Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Lee as taught by Adams to include an implantable vascular access device as recited, since infections can begin at the pocket area where a device is implanted.
Regarding claim 2, Lee discloses sensing elements can be integrated with the housing (Figure 6; Paragraph 39).
Regarding claim 3, Lee discloses PPG (Paragraph 41), which implies a window as recited.
Regarding claim 4, Lee discloses the sensing element can further comprise an accelerometer and an electrode as recited (Paragraphs 33, 36).
Regarding claim 5, Lee discloses body temperature outside of 96-100 degrees F as recited (Paragraph 57).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stewart (US 3,618,592) shows body temperature may be used as an index of sepsis.
Ofek (US 2017/0086746) shows body temperature with other parameters to indicate sepsis.
Ebner (US 2003/0181815) shows body temperature comparison for sepsis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eugene T Wu whose telephone number is (571)270-5053. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eugene T Wu/Primary Examiner, Art Unit 3796
