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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 26-30, 57-62, and 64) in the reply filed on 7/18/25 is acknowledged. Claims 31-34, 54-56, 61, and 65 are withdrawn from consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 57-62 and 64 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 57, it is unclear whether “an interface” in line 2 is the same or different from “an interface” recited in parent claim 26. It is further unclear whether “a user interface” is the same or different from “an interface in line 1 or “an interface” from parent claim 26. For the purposes of examination, it will be interpreted that a single interface could read on all of the combined limitations.
Regarding claim 61, “at least one interface” is indefinite for the same reasons as the limitations articulated above relative to the other “interface” limitations in parent claims 26 and 57, and will be interpreted similarly for the purposes of examination.
Remaining claims rejected under this statute depend from those addressed above and inherit their deficiencies.
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) 26, 29, 30, 57, 59-61, and 64 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterfreund et al. (US 20140303591).
Regarding claim 26, Peterfreund et al. discloses a noninvasive drug level estimator pump (fig. 1A), the pump comprising: a memory (par. 0148) configured to store a drug library (par. 0088), the drug library comprising a drug half-life (par. 0127) and two or more fields selected from the following group: drug name, concentration or container volume, dosing unit, lower limit, upper limit, catch-up dose permission, maximum catch-up dose, drug expiration, and drug source (par. 0088-0090); the memory further configured to track and record pump behavior (par. 0091-0101); a processor (par. 0010-0011) configured to use the drug library and pump behavior to calculate predicted drug levels in the patient without input from in-vivo sensors (par. 0091-0101); and an interface configured to display the predicted drug levels and periodic pump behavior indicators (par. 0013, 0016, 0046).
Regarding claim 29, Peterfreund et al. discloses the pump behavior includes real-time information concerning forward fluid flow and paused fluid flow (par. 0046; par. 0091-0101).
Regarding claim 30, Peterfreund et al. discloses the pump behavior includes total volume infused (par. 0105).
Regarding claim 57, as best understood, Peterfreund et al. discloses an interface configurable for selecting an infusate delivery rate (par. 0013, 0016, 0018, 0046, 0077); a pump mechanism 105a/b/c configured to achieve the selected infusate delivery rates; the memory further configured to store information that associates infusate delivery rates with pump mechanism operation details (par. 0076); the processor configured to accept the selected infusate delivery rate, access the memory, and use pump operation details to calculate expected infusate arrival time (par. 0091-0101); and a user interface configurable to provide a clinician with selected infusate delivery rate and an expected infusate arrival time (par. 0013, 0016, 0018, 0046, 0077).
Regarding claim 59, as best understood, Peterfreund et al. disclosed feedback sensors positioned within the infusion pump, wherein the processor is further configured to accept input from these sensors and account for this input in the expected infusate arrival time provided through the user interface (par. 0047, 0099).
Regarding claim 60, as best understood, Peterfreund et al. discsloses the memory stores information incorporating pharmacodynamic models specific to the type of medication being delivered (par. 0088), and the processor is further configured to account for this input in displaying the predicted drug level through the user interface (par. 0088-0101).
Regarding claim 61, as best understood, Peterfreund et al. discloses at least one interface of the pump is configured to accept set-up details received from at least one of a manual interface and electronically through at least one of an electronic transmission or optical scan, the set-up details comprising properties of connected tubing, the memory stores these set-up details, and the processor is further configured to account for this input in the expected infusate arrival time provided through the user interface (par. 0088-0101).
Regarding claim 64, as best understood, Peterfreund et al. discloses the user interface is further configurable to provide at least one of the following: the present effective expected drug level with respect to a predicted or desired equilibrium level (par. 0091-0101).
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) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund et al. in view of Gannon et al. (US 20110072381).
Regarding claim 27, Peterfreund et al. discloses the pump as claimed, except for the processor is further configured to compare a drug expiration to an expected drug arrival time and the pump is configured to alert a user if the drug will expire before it is predicted to reach the patient. However, Gannon et al. teaches comparing drug expiration to drug expiration and sending a notification when the drug will expire before reaching the patient (par. 0090-0093). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to include sufficient structure and functionality to notify a user when drug will expire prior to delivery, as taught by Gannon et al., for the purpose of preventing the patient from receiving expired drug and/or enabling adjustment to delivery parameters to ensure drug is delivered prior to expiration.
Claim(s) 28, 58, and 62 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund et al. in view of El-Khatib et al. (US 20210016006).
Regarding claim 28, Peterfeund et al. discloses the pump as claimed, except for the memory is further configured to store a patient profile, the patient profile comprising demographic, medical, or identifying data specific to the patient. However, El-Khatib et al. teaches utilizing patient demographic/medical data to generate control algorithms for pump delivery (par. 0230). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to store patient demographic/medical data, as taught by El-Khatib et al., for the purpose of tailoring control algorithm values to the particular patient (par. 0230).
Regarding claim 58, as best understood, Peterfreund et al. discloses the pump as claimed, including the pump is further configured for intermittent mechanical movement having periodic pauses at low selected infusate delivery rates (par. 0036), except for the memory configured to store pump mechanism operation details specifically comprising length and frequency of periodic pump pauses that have actually occurred. However, El-Khatib et al. teaches storing operation details in the form of length and frequency of pump pauses (par. 0175). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to record length and frequency of pump pauses, as taught by El-Khatib et al., for the purpose of providing data beneficial to developing treatment plans for the patient (par. 0086).
Regarding claim 62, as best understood, Peterfreund et al. discloses the pump as claimed, except for the computer memory is further configured to store patient characteristics received from a user interface or a hospital information system, those received characteristics comprise a patient's sensitivity to a particular medication, and the processor is further configured to combine these characteristics with the pharmacodynamic models in calculating and displaying predicted drug levels through the at least one user interface. However, El-Khatib et al. teaches medicament sensitivity levels as a parameter in the tracking of administered therapy (par. 0145). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pump of Peterfreund et al. to utilize patient drug sensitivity its calculations, as taught by El-Khatib et al., since El-Khatib et al. teaches that such a parameter can change over time and have an effect on therapeutic levels (par. 0145).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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, Michael Tsai can be reached at 571-270-5246. 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.
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
Prosecution Insights