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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a trigger structure rotatably arranged on a side edge of an interior of a container shell as mentioned in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-10 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 1, neither the specification nor the claim make clear what is to be considered a “trigger structure”. Clarification is requested as to the structure of the trigger structure. For this examination, any structure/element that allows for another structural element to be moved will be considered a trigger structure.
Regarding claim 2, it is unclear what is meant by a trigger structure “rotatably arranged” on the side edge of the interior of the container shell. Neither a reading of the specification nor a review of either of Figures 1 or 2 provide any guidance as to what is meant by a “trigger structure is rotatably arranged” on the side edge of the interior of the container shell.
Regarding claim 3, the phrase “the outside” lacks proper antecedent basis. For this examination, the phrase is being interpreted as “an outside of the apparatus shell”.
Regarding claim 9, the phrases “the on and off” and “the function of the continuous blood glucose monitoring system” both lack proper antecedent basis. For this examination, the phrases are being interpreted as “an on and off” and “a function of the continuous blood glucose monitoring system”, respectively.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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.
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Antonio et al.’560 (US Pub No. 2021/0378560) in view of Bosua’155 (US Pub No. 2021/0194155).
Regarding claim 1, Figures 2 and 14 of Antonio et al.’560 disclose a continuous blood glucose monitoring system (sections [0054-0055]), the system comprising: a container shell 200, and a spring 202/206, a continuous blood glucose detection apparatus 102 (see Figures 2, 31A, 31B, and 32A) and a trigger structure 244+246+278+279 (sections [0079], [0088]) which are arranged in an interior of the container shell, wherein one end of the spring is connected to an interior of the container shell (see Figure 2), and the other end of the spring is connected to the continuous blood glucose detection apparatus (see Figure 2); the trigger structure is arranged on a side edge of the interior of the container shell (at least elements 244 and 246 are arranged on a side edge of the interior of the container shell), a protruding portion 244 is arranged on the trigger structure, and the protruding portion is unlockably locked with the continuous blood glucose detection apparatus (sections [0079], [0088]); and the continuous blood glucose detection apparatus comprises: an apparatus shell (Figure 3, apparatus shell 106; section [0057]) and a circuit board (Figure 3, circuit board 118; section [0057]) arranged in the apparatus shell, an electronic component being carried on the circuit board (this is inherent of a circuit board; and see section [0069]); and a probe assembly 114a (section [0057]) for penetrating skin (sections [0003], [0066]), the probe assembly being connected to the circuit board (section [0069]).
Antonio et al.’560 discloses all of the elements of the current invention, as discussed above, except for the system comprising a pressure detection sensor connected to the circuit board, the pressure detection sensor being configured to detect a pressure change signal on the apparatus shell. Bosua’155 teaches detecting a pressure change signal on an apparatus shell of a glucose monitor (section [0028]) in order to detect contact of a user’s body with a reading area of the monitor, wherein readings by the monitor are triggered when contact is detected (section [0082]). It is noted that Antonio et al.’560 discloses triggering readings by the continuous glucose monitor using sensor signals from a magnet sensor (section [0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have substituted a pressure detection sensor connected to the circuit board for the magnet sensor connected to the circuit board as it would merely be the substitution of one known measurement triggering mechanism for another to obtain predictable results. The modification to Antonio et al.’560 would result in a system that triggers glucose measurements based on a pressure sensor reading as opposed to a magnet sensor reading.
Regarding claim 3, Figure 4 of Antonio et al.’560 shows that the probe assembly comprises a probe extending to an outside through an opening at one end of the apparatus shell.
Regarding claims 4-7, it is noted that the placement of the pressure detection sensor on the interior of the apparatus shell, on an upper surface of an interior of the apparatus shell, on a lower surface of the interior of the apparatus shell, or on a side edge of the interior of the apparatus shell would not have modified the operation of the device of Antonio et al.’560 in view of Bosua’155. According to section 2144.04 VI. C. of the MPEP, the particular placement of a claimed element is merely an obvious matter of design choice when the placement of the claimed element would not have modified the operation of a device.
Further regarding claims 4-7, it is noted that without a point of reference, prior art that teaches a pressure detection sensor on any surface of an interior of the apparatus shell would read on all of claims 4-7. Rotating a single continuous blood glucose monitoring system having a pressure detection device on a surface of an interior of an apparatus shell 90 degrees clockwise 3 separate times would result in the pressure detection device being on an upper surface, a lower surface, and a side edge of the interior of the apparatus shell.
Regarding claim 8, Antonio et al.’560 discloses that the circuit board is a printed circuit board (sections [0009], [0024], [0057]).
Regarding claim 9, as modified by Bosua’155, the electronic component of the circuit board of Antonio et al.’560 comprises a control unit that controls on and off functions of the continuous blood glucose monitoring system (the control unit turns the continuous blood glucose monitoring system on when the pressure detection sensor detects contact with a user).
Regarding claim 10, Official notice is being taken that the use of a capacitive pressure sensor or a resistive pressure sensor as a pressure detection device is well known in the medical diagnostic art (see, for example: section [0303] of Silver et al.’740 -- US Pub No. 2006/0079740; section [0047] of Manstrom et al.’698 -- US Pub No. 2010/0234698; section [0055] of Hawkins et al.’456 -- US Pub No. 2015/0313456; section [0131] of Shanjani et al.’961 -- US Pub No. 2018/0368961; and section [0032] of Najafi’339 -- US Pub No. 2019/0269339).
Conclusion
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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