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.
Claim 36-38, 39-42 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.
Claim 36 calls for an electronic system. Claim 36 includes the user interface member according to claim 35. Claim 35 includes the electronic system according to claim 23. Therefore, it is not clear of “an electronic system” recited in claim 36 is the same electronic system recited in claim 35 or an additional system.
Claims 37, 38 inherit the deficiencies of claim 36.
Claim 39 recites “a method of detecting an exposure of a drug delivery device comprising a measurement unit to fluid”. The wording of this phrase is confusing.
Claims 40-42 inherit the deficiencies of claim 39.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 23-36, 38-33, 35-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al (WO 2021/059212 A1) in view of Barber et al (WO 2010/046886 A2).
Regarding claim 23, Harris discloses an electronic system for a drug delivery device, wherein the electronic system is configured to take measurements that are suitable to provide information about a drug delivery device and determine an exposure of the drug delivery device to fluid based on the measurements (page 4, para. 0012).
Claim 23 further calls for the electronic system to compare the measurements taken with a measurement unit with a reference, and determine the exposure of the drug delivery device to fluid based on the result of the comparison. Harris does not specifically disclose that a comparison is used to determine the exposure to fluid. Barber teaches a system for determining contact with fluid including an electronic system the compares a measurement with a reference, wherein the comparison is used to determine exposure to a fluid (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to compare the measurement with a reference value and determine an exposure of the drug delivery device to the fluid based on the comparison as taught by Barber to provide a reliable means for determining fluid ingress into the housing that can be monitored over time.
Regarding claim 24, Barber further teaches that the system is configured to determine an exposure of an electric element (detector wire) of the device to fluid based on the result of the comparison (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to be configured to determine exposure of an electric element of the device to fluid based on the result of the comparison as taught by Barber to allow the presence and location of the fluid to be determined so that the device can take appropriate action.
Regarding claim 25, Barber further teaches that the electronic system is configured to adjust the reference based on previous measurements of the measurement unit taken during a preceding period of time (page 6, para. 0077). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system to be configured to adjust the reference based on previous measurements as taught by Barber to maintain accuracy of the measurements and the comparisons.
Regarding claim 26, Barber further teaches that comparing the measurements with the reference comprises comparing an amplitude of the measurements with an amplitude of the reference (page 6, para. 073).
Regarding claim 28, Harris discloses that the measurements are taken during use of the device (page 4, para. 0012).
Regarding claim 29, Harris discloses that the measurement unit comprises an optical senso(page 45, para. 00155: photosensor).
Regarding claim 30, Harris discloses that the electronic system is further configured to produce an output signal to communicate to a user if an exposure of the drug delivery device to fluid is determined (page 4, para. 0012: indicating to a user the status of the device).
Regarding claim 31, Barber further teaches that a processor receives the measurements and performs the comparison (page 7, para. 082). It would have been obvious to one of ordinary skill in the art to modify the system of Harris to include a processor as taught by Barber to allow the device to determine when a fault condition is present and alert the user.
Regarding claim 32, Harris discloses the measurement unit for taking the measurements, and a communication unit for communicating to a user if an exposure of the drug delivery device to fluid is determined (page 4, para. 0012), and wherein the electronic system is configured to determine an exposure of the drug delivery device to fluid based on the measurements of the measurement unit and measurements of a further measurement unit (page 6, para. 0020).
Regarding claim 33, Harris discloses an electronic system for a drug delivery device, wherein the electronic system is configured to take measurements that are associated with information about a drug delivery device and determine an exposure of the drug delivery device to fluid based on the measurements (page 4, para. 0012).
Claim 33 further calls for the electronic system to compare the measurements taken with a measurement unit with a reference, and determine the exposure of the drug delivery device to fluid based on the result of the comparison. Harris does not specifically disclose that a comparison is used to determine the exposure to fluid. Barber teaches a system for determining contact with fluid including an electronic system the compares a measurement with a reference, wherein the comparison is used to determine exposure to a fluid (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to compare the measurement with a reference value and determine an exposure of the drug delivery device to the fluid based on the comparison as taught by Barber to provide a reliable means for determining fluid ingress into the housing that can be monitored over time.
Regarding claim 35, Harris discloses a user interface member 280 for a drug delivery device, the user interface member comprising the electronic system being configured to be touched by a user in order to operate the user interface member for performing a dose dial and/or a drug delivery process (page 14 para. 0063). Harris in view of Barber teaches the electronic system according to claim 23 as discussed above.
Regarding claim 36, Harris discloses a drug delivery device comprising: a container 230 holder for holding a drug container 210; and an electronic system configured take measurements, wherein the measurements are suitable to provide information about the drug delivery device (page 4, para. 0012), and to determine an exposure of the drug delivery device to fluid based (page 4, para. 0012).
Claim 36 further calls for the electronic system to compare the measurements taken with a measurement unit with a reference, and determine the exposure of the drug delivery device to fluid based on the result of the comparison. Harris does not specifically disclose that a comparison is used to determine the exposure to fluid. Barber teaches a system for determining contact with fluid including an electronic system the compares a measurement with a reference, wherein the comparison is used to determine exposure to a fluid (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to compare the measurement with a reference value and determine an exposure of the drug delivery device to the fluid based on the comparison as taught by Barber to provide a reliable means for determining fluid ingress into the housing that can be monitored over time.
Regarding claim 37, Harris discloses the drug container filled with a drug (page 14, para. 0061).
Regarding claim 38, Harris discloses a method of delivering a drug from a drug delivery device (page 4, para. 0012), the method comprises using the drug delivery device according to claim 37 (see claim 37 above).
Regarding claim 39, Harris discloses a method for detecting an exposure of a drug delivery device comprising a measurement unit to fluid (page 4, para. 0012), the method comprising: receiving measurements taken with the measurement unit (page 4, para. 0012), and determining an exposure of the drug delivery device to fluid (page 4, para. 0012).
Claim 39 further calls for the measurements taken with a measurement unit to be compared with a reference, and determine the exposure of the drug delivery device to fluid based on the result of the comparison. Harris does not specifically disclose that a comparison is used to determine the exposure to fluid. Barber teaches a system for determining contact with fluid including an electronic system the compares a measurement with a reference, wherein the comparison is used to determine exposure to a fluid (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to compare the measurement with a reference value and determine an exposure of the drug delivery device to the fluid based on the comparison as taught by Barber to provide a reliable means for determining fluid ingress into the housing that can be monitored over time.
Regarding claim 40, Harris discloses that the measurements taken with the measurement unit are associated with the information about the drug delivery device (page 4, para. 0012).
Regarding claim 41, Barber further teaches that the system is configured to determine an exposure of an electric element (detector wire) of the device to fluid based on the result of the comparison (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to be configured to determine exposure of an electric element of the device to fluid based on the result of the comparison as taught by Barber to allow the presence and location of the fluid to be determined so that the device can take appropriate action.
Regarding claim 42, Barber teaches a system for determining contact with fluid including an electronic system the compares a measurement with a reference, wherein the comparison is used to determine exposure to a fluid (page 6, para. 073). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Harris to compare the measurement with a reference value and determine an exposure of the drug delivery device to the fluid based on the comparison as taught by Barber to provide a reliable means for determining fluid ingress into the housing that can be monitored over time.
Allowable Subject Matter
Claims 27, 34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 27, the prior art fails to teach or fairly suggest that the drug delivery device is configured to perform several drug delivery processes one after the other, and the electronic system is configured to adjust the reference based on measurements of the measurement unit associated with the last n drug delivery processes, where n > 1, in combination with the features of the invention, substantially as claimed.
Regarding claim 34, the prior art fails to teach or fairly suggest the drug delivery device comprises a movable member and the measurement unit comprises an optical sensor configured to emit radiation and detect a portion of the radiation reflected by the movable member of the drug delivery device, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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