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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, option 7, recites “a sensor and a sensor probe and sensor probe includes”; this is grammatically incorrect and should be phrased similarly to “a sensor and a sensor probe, where the sensor probe includes”.
Claim 4, option 8, recites “the sensing device comprises a sensor and a sensor probe and the sensor probe is configured with a planar shape, and includes at least two (2) electrodes”; the placement of the comma renders this clause unclear, as it is now unclear which of the elements includes at least 2 electrodes. It appears this should be amended to move the comma to “a sensor probe, and the sensor probe is configured” such that this more clearly sets forth that these clauses describe the sensor probe.
Appropriate correction is required.
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. See, for example, claims 28-34. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
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 4, 7, 10, 11, 18, 23-34 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 4 presents a list of numerous alternative options; the third option refers to “the sensor” but there is insufficient antecedent basis for this as it stands presented.
Option 4 recites “at least one of a sensor housing and a PCBA also includes” – what does the “also” refer to? Neither has been positively recited as being part of the system in claim 1 such that there is no antecedent basis for either to “also” include components when no initial components have been defined for either element. The same issue is also found in option 5.
Option 6 refers to “the sensor device”; there is insufficient antecedent basis for this limitation in the claim as only a “sensing device” has been defined. For the purposes of examination it will be treated as such.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, option 6 of claim 4 recites the broad recitation “at least one”, and the claim also recites “preferably a plurality” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Option 6 also refers to “the sensor probe”; there is insufficient antecedent basis for this limitation in this alternative configuration in the claim.
Option 7 recites that the “sensor probe includes at least of”; as this does not contain a number defining how many are required, this limitation is entirely indefinite. For the purposes of examination it will be treated as though calling for at least one but correction is required.
Claim 7 recites “the sensor includes at least one of”; there is insufficient antecedent basis for this limitation in the claim, as not all of the alternative options in claim 4 require the presence of a sensor. Claim 7 should clearly define all the components of the system.
Claim 7 further refers to “a/the sensor housing”; it is not permissible to use both articles to identify an element. As above, the claim should clearly set forth which of the options of claim 4 are included as part of the system as not all of the options also include a sensor housing, or define that some option of claim 4 and its components further comprises a sensor housing.
Claim 10 refers to “the sensor probe”; there is insufficient antecedent basis for this limitation in the claim, as not all of the alternative options of claim 4 include a sensor probe, nor does claim 7. The claim should clearly define what components are part of the system as claimed.
Claim 10 requires that the system include all of a sensor, a sensor probe, and a sensor housing; none of the alternative configurations of claim 4 include all of these components. At best, a sensor housing is “optionally” included in claim 7, such that the system of claim 10 requires that the housing not be “optional” in addition to existing only as part of one of the alternative configurations depending from claim 4. Correction is required.
Claim 11 refers to both “the sensor probe” and “the sensor housing”; there is insufficient antecedent basis for both of these limitations in the claim as not all options in claim 4 include one or both of these elements.
Claim 18 refers to “the receiver and the transmitter; there is insufficient antecedent basis for this limitation in the claim, as not all options in claim 4 include both of these elements. Further, none of the alternative configurations defined in claim 4 include all of a sensor probe, sensor housing, receiver, and transmitter as required by claim 18 depending from claim 11, such that it is entirely unclear which of the alternative configurations of claim 4 this might rely upon.
Claim 18 recites that “the receiver and the transmitter comprise a transceiver” – does each of these comprise a transceiver? Or does a singular transceiver perform the functions of both a receiver and a transmitter even though as recited these are separate elements, not functions? Clarification is required.
Claim 23 refers to “the at least two (2) electrodes”; there is insufficient antecedent basis for this limitation in the claim, as not all options in claim 4 include this element. The same issue is found in claims 25 and 26.
Claim 27 refers to “each electrode”; there is insufficient antecedent basis for this limitation in the claim, as not all of the options of claim 4 include any electrodes, and it is not readily apparent that this “each electrode” is the same as “at least two (2) electrodes” found in only one of the alternative configurations in the claim, or the working and/or counter electrodes of another configuration?
Claim 28 further refers to “the sensor probe”; there is insufficient antecedent basis for this limitation in the claim, as not all of the alternative configurations in claim 4 include a sensor probe.
Claim 28 defines “one or more contact pads”; claim 27, from which it depends, already defines that “each electrode” is connected to “a respective contact pad” – are these the same contact pads or additional contact pads? The same issue is found in claim 29. Clarification is required.
Claim 31 refers to “the sensor housing”; there is insufficient antecedent basis for this limitation in the claim, as not all of the alternative configurations of claim 4 include a sensor housing and it does not appear that any of the alternative configurations set forth the combination of elements required for claim 31 as it depends from claims 30, 28, 27.
Claim 32 refers to “the PCBA”; there is insufficient antecedent basis for this limitation in the claim, as not all of the alternative configurations of claim 4 include a PCBA and it does not appear that any of the alternative configurations set forth the combination of elements required for claim 32 as it depends from claims 31, 30, 28, 27.
Regarding claim 32, the phrase ”e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 32 recites “wherein upon the contacts plate being positioned within the sensor housing” – this is an active method step requiring a response to the plate being positioned, which is not possible as part of a system/device claim.
Claim 33 recites that the contacts plate is “folded on a first side at 180 degrees” – does this refer to an amount of folding or to a position on the edge of a circle? Clarification is required.
Claim 34 presents a limitation in parentheses; it is unclear if this is intended to be positively recited as part of the invention as claimed or if this is an attempt to further define the already defined limitations or why this is present. Clarification is required.
Claim 34 refers to “the contacts plates”; there is insufficient antecedent basis for this limitation in the claim. It is unclear if the intent is to define an additional “contacts plate” or if this is a typographical error.
Claim 34 refers to “both contact pads”; there is insufficient antecedent basis for this limitation in the claim.
Claim 34 refers to “the PCBA”; there is insufficient antecedent basis for this limitation in the claim as no claim from which it depends includes a PCBA.
As every claim depending from claim 4 is indefinite due to the inconsistent references to the alternative configurations set forth therein, the Examiner suggests carefully reviewing all components intended to be included in each of the claims to ensure sufficient antecedent basis and definition.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7, 10, 11, 18, 23-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pace (US 2013/0150691).
Regarding claim 1, Pace discloses continuous glucose monitoring system for continuously monitoring glucose levels of a user, the system comprising:
a mounting assembly (paragraph [0080]; elements 206 and 212 “packaged connected together”); and
a sensing device (element 222), wherein at least a portion of the sensing device is housed within the mounting assembly prior to mounting the sensing device on the user (figures 2B-2G, 3, 4).
Regarding claim 2, Pace further discloses that the sensing device includes at least a transmitter configured to transmit signals corresponding to sensed glucose levels of the user (paragraph [0081]).
Regarding claim 3, Pace further discloses that the system further comprises a remote display unit configured with at least with a receiver for receiving the sensed glucose readings from the sensing device via the transmitter (element 226, paragraph [0081]), and
the sensing device (figure 25A) comprises a sensor configured for adhering to the skin of the user (element 2502), and a sensor probe configured for insertion into the subcutaneous tissue of the user (element 2202).
Regarding claims 4 and 7, Pace further discloses that the sensing device comprises a sensor (paragraphs [0126]-[0127]) and a sensor probe configured for insertion into the subcutaneous tissue of the user (element 2202).
Regarding claim 10, Pace further discloses that the sensor probe includes a first portion configured for insertion into subcutaneous tissue and a second portion (figures 22, 23A, 23B) configured for receiving by a sensor housing (figure 25A).
Regarding claims 4 and 11, Pace further discloses that the sensing device comprises a sensor (paragraphs [0126]-[0127]) and a sensor probe configured for insertion into the subcutaneous tissue of the user (element 2202) where the sensor probe includes a first portion configured for insertion into subcutaneous tissue and a second portion (figures 22, 23A, 23B) configured for receiving by a sensor housing (figure 25A).
Regarding claim 18, Pace further discloses a receiver and a transmitter comprising a transceiver (paragraph [0081]).
Regarding claims 4 and 23, Pace further discloses that the sensing device comprises a sensor (paragraph [0140]) and a sensor probe (element 3300), where the sensor probe is configured with a planar shape (figure 33A), and includes at least two (2) electrodes (paragraph [0136]), wherein the at least two (2) electrodes comprises at least a working electrode (paragraph [0136]).
Regarding claim 24, Pace further discloses that the working electrode is configured for positioning on at least one of a first side of the sensor probe and at a distal end thereof (figure 33A, 33B).
Regarding claims 4 and 25, Pace further discloses that the sensing device comprises a sensor (paragraph [0140]) and a sensor probe (element 3300), where the sensor probe is configured with a planar shape (figure 33A), and includes at least two (2) electrodes (paragraph [0136]), wherein the at least two (2) electrodes comprise a counter electrode (paragraph [0136]).
Regarding claims 4 and 26, Pace further discloses that the sensing device comprises a sensor (paragraph [0140]) and a sensor probe (element 3300), where the sensor probe is configured with a planar shape (figure 33A), and includes at least two (2) electrodes (paragraph [0136]), wherein the at least two (2) electrodes comprise at least a working electrode and a counter electrode (paragraph [0136]), wherein the working electrode is configured for positioning on at least one of a first side of the sensor probe and at a distal end thereof, and the counter electrode is configured for arrangement on a side of the sensor probe opposite to the side where the working electrode is positioned on the sensor probe (figures 33A, 33B).
Regarding claims 4 and 27, Pace further discloses that the sensing device comprises a sensor (paragraph [0140]) and a sensor probe (element 3300), where the sensor probe is configured with a planar shape (figure 33A), and includes at least two (2) electrodes (paragraph [0136]), wherein each of the at least two electrodes is connected via electrical conductors to a respective contact pad (paragraph [0138]; figure 33F).
Regarding claim 28, Pace further discloses that the respective contact pads are configured for positioning on at least one side of a contacts plate (paragraph [0140]).
Regarding claim 29, Pace further discloses that the respective contact pads are configured for positioning on each side of a contacts plate (paragraph [0140]; “each side” does not have a frame of reference such that left and right sides of a single plane are still separate “sides”).
Regarding claim 30, Pace further discloses that the contacts plate is positioned approximately perpendicular to the sensor probe (figures 34D, 36).
Regarding claim 31, Pace further discloses that the contacts plate is positioned within a sensor housing (figures 34A-D, 36).
Regarding claim 32, Pace further discloses that, wherein upon the contacts plate being positioned within the sensor housing, at least one (1) contact pad is facing a printed circuit board assembly (PCBA) (figure 37).
Regarding claim 33, Pace further discloses that the contacts plate is folded on a first side such that each contact pad is facing the PCBA (figures 34C, 34D).
Regarding claim 34, Pace further discloses that the sensor probe and the contacts plate are constructed from a “sheet” configured such that the sensor probe is perpendicular to the skin, the contacts plate is perpendicular to the sensor probe, and both contact pads are facing a PCBA (figures 34C, 34D, 37).
Conclusion
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/KAREN E TOTH/Examiner, Art Unit 3791