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 § 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 2-8 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 2, the recitation of “a flow controller” is vague and indefinite because it is unclear of how it relates, e.g. its connections, to other elements.
The dependent claims 3-8 are also rejected because they are, directly or indirectly, depending from rejected claim 2.
Allowable Subject Matter
Claims 1 and 9-12 are allowed.
Claim 2-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The prior art of record, taken alone or in combination, fails to teach or fairly suggest a method of preparing a combination drug delivery device for a patient, the method comprising: preparing a plurality of drug modules, each containing a drug component or diluent, for the patient; affixing a machine-readable code to each of the plurality of drug modules, wherein the machine-readable codes each represent the drug component or diluent contained in the corresponding drug module; with the drug delivery device being in a ready state with the plurality of drug modules being assembled, capturing a digital image of the plurality of drug modules such that all of the machine-readable codes are included in the digital image; especially reading the machine-readable codes in the digital image to generate an activation code based on the contents of the machine-readable codes and the sequence thereof; and, comparing the activation code with a predetermined authentication code to confirm that: i. the drug component or diluent of each of the plurality of drug modules is correct, and ii. The plurality of drug modules is in the correct sequence as recited in claim 1 and further limitations of the dependent claims 2-12.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
References: Scorvo (US 8,818,825); Sigworth (US 2013/0159712); Tsoukalis (US 2019/0001057) and Grabiner (US 2012/0175412) are cited because they are related to system and method for drug verification using machine-readable barcode.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tuyen Kim Vo whose telephone number is (571)270-1657. The examiner can normally be reached Mon-Thurs: 8AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Paik can be reached at 571-272-2404. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TUYEN K VO/Primary Examiner, Art Unit 2876
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