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 .
Applicant filed a communication dated 12/5/2024 in which claims 1-20 are pending in the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/5/2025, 6/20/2025 and 12/15/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-20 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.
In claim 1 (and elsewhere, where applicable), the claim does not describe how the server received an indication that an APR failed to activate the medical device. In order for the server to receive an indication, there has to be a device associated with a medical device that is in communication with the server. The claim does not make it clear if the medical device is in direct communication with the server. This renders the claim indefinite.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen, US Patent Application No. 2014/0180711.
Regarding claim 1, Kamen discloses a method of programing a medical device, comprising, at a server:
receiving an indication that an automatic programming request (APR) failed to activate the medical device for delivery of a fluid ([0070], [0101], parameter, [0463], limit violation.. change the infusion intent (e.g., change the medication, care area, clinical use and/or concentration; [1269]);
in response to the indication:
obtaining one or more historical programming records associated with a drug library record and which include one or more historical parameters that have previously activated the medical device ([0070], [0486], parameter value, [0912]);
identifying a parameter associated with the APR that deviates from the one or more historical parameters that have previously activated the medical device ([0115], [0861]);
determining that the identified parameter should be updated based on a magnitude of a deviation between the identified parameters and the one or more historical parameters ([0546], new value, [0929] new parameter value);
updating, based on at least one of the historical parameters, the identified parameter to form an updated APR ([0546], [0929]), and
providing the updated APR to the medical device to activate the medical device for delivery of the fluid, wherein the medical device is activated responsive to the updated APR and the updated parameter to cause the medical device to deliver the fluid to a patient ([0070], [0092], [0101], [0405], [0422], [0546], [0929]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine different disclosure of Kamen. The motivation for combining these references would have been to provide a fluid to the patient.
Regarding claim 2, Kamen discloses wherein determining that the identified parameter should be updated based on the magnitude of the deviation comprises a value of the identified parameter being outside a guardrail value include in the one or more historical programming records ([0311], [1139]).
Regarding claim 3, Kamen discloses before updating the APR parameter of the APR: determining a recommended parameter value for the APR parameter; providing the recommended APR parameter to a user interface for user review; receiving a confirmation of the recommended APR parameter; and updating the APR parameter of the APR with the recommended APR parameter responsive to receiving the confirmation ([0546], new values serve as recommended parameter, [0929]).
Regarding claim 4, Kamen discloses wherein receiving the indication that the APR failed to activate the medication device includes identifying a system generating the APR as a cause of the medical device failing to activate and a parameter value of the identified parameter of the APR as a cause of the medical device failing to activate (Fig. 6, [0101], [0463], [1269]).
Regarding claim 5, Kamen discloses wherein receiving the indication that the APR failed to activate the medication device includes identifying the drug library record as a cause of the medical device failing to activate and a parameter value of the identified parameter of the APR as a cause of the medical device failing to activate (Fig. 6, [0101], parameter, [0463], [1269]).
Regarding claim 6, Kamen discloses providing the updated parameter to a user for review; and updating the drug library record with the updated parameter, wherein the updated APR is updated based on the updated drug library record ([0546], [0912], [0929]).
Regarding claim 7, Kamen discloses wherein receiving the indication that the APR failed to activate the medication device includes identifying a device state as a cause of the medical device failing to activate (Fig. 6, [0101], [0463], [1269]).
Regarding claim 8, Kamen discloses wherein the updated APR parameter of the APR includes a drug type, fluid type, clinical advisory, therapy type, or drug concentration ([0463]).
Regarding claim 9, Kamen discloses wherein the updated parameter of the APR includes a rate, volume to be infused, or a duration ([0463]).
Claims 10-20 are substantially similar to claims 1-7 and hence rejected on similar grounds.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,165,766. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to a method for programming a medical device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure are listed on the attached PTO -892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJESH KHATTAR whose telephone number is (571)272-7981. The examiner can normally be reached M-F 8AM-5PM.
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, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAJESH KHATTAR
Primary Examiner
Art Unit 3684
/RAJESH KHATTAR/Primary Examiner, Art Unit 3684