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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1-3, 5, 6, 8, and 11 are objected to because of the following informalities:
Regarding claim 1, the claim should be amended to recite “the at least one electronics unit” in line 10, “the at least one reusable housing module” in line 12, and “the at least one electronics unit” in line 14 to keep claim terminology consistent.
Regarding claim 2, the claim should be amended to recite “the at least one electronics unit” in line 2 to keep claim terminology consistent.
Regarding claims 3 and 5, the claim should be amended to recite “the at least two housing sections” in line 2 to keep claim terminology consistent.
Regarding claim 6, the claim should be amended to recite “the at least one reusable housing module” in line 2 and “the at least two housing sections” in line 2 to keep claim terminology consistent.
Regarding claim 8, the claim should be amended to recite “the at least one reusable housing module” in line 2 to keep claim terminology consistent.
Regarding claim 11, the claim should be amended to recite “the at least one reusable housing module” in line 2 to keep claim terminology consistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-8, and 10-12 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shmilovich (US 20220001105).
Regarding claim 1, Shmilovich discloses a medical flow sensor module assembly as part of an installation for patient monitoring and/or patient care (fig. 7A/B),
- having at least one single-use sensor module (sensor module 17 in fig. 7A; paragraph 62 discloses the module being disposable), comprising:
-- a channel body with at least one flow channel (fluid supply tube/line 17d in fig. 7A),
-- a flow sensor for measuring a fluid flow through the flow channel (see below, top part of electrodes 17h in fig. 11B in contact with the fluid is the “flow sensor”; paragraph 80); and
-- a flow sensor interface which is in signal connection with the flow sensor (see below, bottom surface of electrodes 17h which contact contacts 17i in fig. 11B is the “interface”),
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- having at least one reusable housing module for receiving the sensor module (wearable housing/device 11 in fig. 11A-C), comprising:
- at least one electronics unit (lid circuitries 71g and base circuitries 72g in fig. 11B) and
-- an electronics unit interface via which the electronics unit is in signal connection with the flow sensor interface (see above; paragraph 80),
- wherein the reusable housing module has at least two housing sections which enclose the single-use sensor module in a form-fitting manner (lid 71 and base 72 enclose the sensor module 17 when the lid is closed in fig. 7C),
- wherein the electronics unit comprises at least one data processing and control component for controlling the flow sensor and for receiving, processing and transmitting sensor signals (paragraph 72 discloses a processor 11p).
Regarding claim 2, Shmilovich discloses the electronics unit comprises an interface for signal connection to an external device (paragraph 46 discloses the circuitries incorporate wireless communication methods).
Regarding claim 3, Shmilovich the two housing sections each comprise an electronics unit (fig. 11B shows lid 71 comprises lid circuitry 71g and base 72 comprises base circuitry 72g).
Regarding claim 5, Shmilovich discloses the two housing sections are hingedly connected to one another by means of a swivel joint (see below).
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Regarding claim 6, Shmilovich discloses the housing module is designed such that the two housing sections are fixedly connected to one another in a folded connection position (fig. 7C shows that lid 71 and base 72 are in a folded, or closed, connection position when lid 71 is closed).
Regarding claim 7, Shmilovich discloses at least two sensors (the top portion of electrodes 17h designated above and light detectors 72o in fig. 11B; paragraph 81), one of which is the flow sensor (paragraph 80 discloses the electrodes 17h form a flow sensor).
Regarding claim 8, Shmilovich discloses that one of the sensors is part of the reusable housing module as a reusable sensor (light detector 72o in fig. 11B is part of base 72 and would be reusable).
Regarding claim 10, Fulkerson discloses the channel body is configured to be multi-part such that the flow channel has a plurality of sequential channel sections which are formed by different channel body sections (see below; sections of tube 17d which extend outside sensor module 17 are respective sections and the section which extends inside sensor module 17 is a third section.
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Regarding claim 11, Fulkerson discloses the housing module has an indicator unit (display 71y in fig. 11B).
Regarding claim 12, Fulkerson discloses a reusable pump unit for generating a flow of media through the flow channel (flow control device 41 in fig. 4A; paragraph 61 discloses that an example flow control device is an “infusion pump”).
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.
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shmilovich, as applied to claims 1, 7, and 8 above, and further in view of Robinson (US 20030199803).
Regarding claim 9, Shmilovich discloses all of the claimed limitations set forth in claims 1, 7, and 8, as discussed above, but does not teach or disclose the reusable sensor is designed as an ultrasonic sensor.
Robinson is directed towards a sensor module comprising a reusable housing module comprising two housing sections (front panel 120 and console door 130 in fig. 20) which comprises a reusable sensor embodied as an ultrasonic sensor (ultrasonic sensor 240 in fig. 20; paragraph 105). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the reusable housing module of Shmilovich to comprise an ultrasonic sensor which engages a portion of the tube of Shmilovich, as taught by Robinson, to prevent air from entering the user (paragraph 105).
Allowable Subject Matter
Claim 4 is 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 4, the closest prior art is Shmilovich which does not teach or disclose the at least two electronics units are in signal connection with one another via an electrical plug-in connection between the housing sections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783