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 .
Status of Claims
This office action is responsive to the amendment filed 24 April 2023.
Claims 1-7 and 13-20 have been elected to in the provisional election below.
Claims 8-12 are withdrawn.
Claims 1-7 and 13-20 are presently pending in this application.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7 and 13-20, drawn to an electronic device, classified in A61M5/1723.
II. Claim 8-12, drawn to a glucose monitor, classified in A61B5/14532.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different designs and functions. Invention II stores and forwards glucose readings to a wireless transmitter, which is not recited in invention I. Invention I takes corrective action upon receiving indicated excessive compression, which is not recited in invention II. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Kevin Canning on 20 November 2025 a provisional election was made without traverse to examine invention I, claims 1-7 and 13-20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-12 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following reference characters:
"1214" and "1215" have both been used to designate the “adhesive layer” (para. 0044).
"1210" and "1212" have both been used to designate the “force sensitive resistor” (para. 0044).
“300” has been used to designate both “corrective action” and “trigger alerts” (para. 0035).
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. 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.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 19 is 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 19 recites the limitation "the excessive compression" in line 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the excessive compression” to mean –an excessive compression--.
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.
(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.
Claims 1-4, 7 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bohm et al. (US Patent Publication No. 20120078071 A1), hereinafter Bohm.
Regarding claim 1, Bohm teaches an electronic device (Bohm: Fig. 1, continuous analyte sensor system 8) secured to a user (Fig. 1, device is secured to the user; para. 0119-0120), comprising: a medicament delivery unit (device can include an insulin delivery device; para. 0119) for delivering medicament to the user (para. 0119); a biological sensor (Fig. 1, comprising sensor electronics module 12 and analyte sensor 10) for sensing biological data of the user (Fig. 2A, compression, temperature, and blood analyte; para. 0117 and 0125) and generating biological sensor data (para. 0117 and 0125) indicative of the sensed biological data (para. 0117 and 0125); a compression sensor (Fig. 2A, compression sensor 254) for sensing compression of the biological sensor (12 and 10) and/or biological tissue of the user (sensor 254 indicates compression of tissue and force to the sensor module 12; para. 0279) and generating compression sensor data (para. 0279); and a processor (Fig. 2A, processor module 214) configured for receiving the compression sensor data (Fig. 2A, module 214 receives and processes all data; para. 0127) from the compression sensor (254) and taking corrective action (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force during excess compression; para. 0276 and 0279) when the compression sensor data (para. 0279) from the compression sensor (254) indicates excessive compression of the biological sensor (12 and 10) and/or biological tissue of the user (para. 0276 and 0279).
Regarding claim 2, Bohm teaches the device above, wherein the corrective action (para. 0276 and 0279) includes triggering an alarm that indicates to the user (module 12 can initiate an alarm; para. 0279) that there is the excessive compression of the biological sensor (12 and 10) and/or biological tissue of the user (para. 0276 and 0279).
Regarding claim 3, Bohm teaches the device above, wherein the alarm (module 12 can initiate an alarm; para. 0279) is part of the electronic device (8) and the alarm (para. 0279) includes at least one of a vibratory alarm or an audio alarm (module 12 can initiate an alarm that is audible or tactile; para. 0279).
Regarding claim 4, Bohm teaches the device above, wherein the corrective action (para. 0276 and 0279) includes one of modifying an amount of medicament delivered to the user by the medicament delivery unit (para. 0119) to compensate for the excessive compression or adjusting the biological sensor data from the biological sensor (12 and 10) to compensate for the excessive compression (module 12 can modify or apply a different algorithm to measure data and/or modify medication administration based on the level of detected force during excess compression; para. 0276 and 0279).
Regarding claim 7, Bohm teaches the device above, further comprising an adhesive layer (Fig. 2B, adhesive pad 250) having an adhesive (para. 0146) for securing the electronic device (8) to the user (para. 0146).
Regarding claim 13, Bohm teaches a method performed by a processor (214) of an electronic device (8), comprising: receiving sensor data (para. 0279) from a compression sensor (254) of a glucose monitor (Fig. 1, comprising sensor electronics module 12 and analyte sensor 10, which monitors user glucose; para. 0117) for a user; processing the sensor data (para. 0279) from the compression sensor (254) with the processor (214) to determine that the glucose monitor (12 and 10) and/or biological tissue of the user is being compressed (para. 0279); and with the processor (214), triggering corrective action (para. 0279) responsive to the determining that the glucose monitor (12 and 10) and/or biological tissue of the user is being compressed (para. 0279).
Regarding claim 14, Bohm teaches the method above, wherein the compression sensor (254) is an electronic sensor (sensor 254 can be an electric pressure transducer; para. 0280) that senses pressure or magnitude of force (para. 0279).
Regarding claim 15, Bohm teaches the method above, wherein the compression sensor (254) is a mechanical sensor (sensor 254 can be an electric pressure transducer that senses mechanical external pressure upon the sensor system; para. 0280).
Regarding claim 16, Bohm teaches the method above, wherein the compression sensor (254) is secured to a bottom surface of the glucose monitor that faces the user (Fig. 2C, sensor 254 can be in a mounting unit that holds sensor 10 with a compressible portion of the housing. Sensor 10 faces the user; para. 0285).
Regarding claim 17, Bohm teaches the method above, wherein the corrective action (para. 0279) includes initiating one or more alarms (para. 0279) to alert the user of the glucose monitor (12 and 10) and/or the biological tissue of the user is being compressed (para. 0279).
Regarding claim 18, Bohm teaches the method above, wherein the corrective action (para. 0279) comprises adjusting glucose readings from the glucose monitor (12 and 10) to compensate for the compression (modify or apply different algorithm for measuring data; para. 0279).
Regarding claim 19, Bohm teaches the method above, wherein the corrective action (para. 0279) is sending data (para. 0279) to an insulin delivery device (para. 0119) indicative of the excessive compression (para. 0279) of the glucose monitor (12 and 10) and/or the biological tissue of the user (para. 0279).
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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Fujii et al. (US Patent Publication No. 20210244379 A1), hereinafter Fujii.
Regarding claim 5, Bohm teaches the device above, further comprising one or more housings (Fig. 2B, mounting unit 240) for encasing the medicament delivery unit and the biological sensor (Fig. 2B, mounting unit houses the system 8; para. 0286), wherein the one or more housings (240) is a single housing (Fig. 2B, unit 240 is singular).
Bohm does not expressly disclose a compliant layer to which the compression sensor is secured or positioned against, wherein the compliant layer is secured to the housing.
Fujii teaches a compliant layer (Fujii: Fig. 3B, protective layer 27) to which a sensor (Fig. 1, piezoelectric film 20) is secured or positioned against (Fig. 3B, film 20 is secured to material 52 layer 27), wherein the compliant layer (27) is secured to a housing (Fig. 1, layer 27 is secured to film 20, which is secured to the base 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device to comprise a compliant layer to which the compression sensor is secured or positioned against, wherein the compliant layer is secured to the housing as taught by Fujii in order to provide mechanical strength and heat resistance to the sensor (Fujii: para. 0067).
Regarding claim 6, Bohm in view of Fujii discloses the device above.
Bohm does not expressly disclose further comprising an additional compliant layer positioned so that the compression sensor is situated between the compliant layer and the additional compliant layer.
Fujii teaches an additional compliant layer (Fujii: Fig. 3B, protective layer 28) positioned so that the sensor (20) is situated between the compliant layer (27) and the additional compliant layer (Fig. 3B, film 20 is situated between protective layers 27 and 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Bohm to comprise an additional compliant layer positioned so that the compression sensor is situated between the compliant layer and the additional compliant layer as taught by Fujii in order to provide mechanical strength and heat resistance to the sensor (Fujii: para. 0067).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bohm in view of Lintereur et al. (US Patent Publication No. 20200101223 A1), hereinafter Lintereur.
Regarding claim 20, Bohm teaches the method above, wherein the electronic device (8) is an insulin delivery device (para. 0119).
Bohm does not expressly disclose that the insulin delivery device is attached to the user.
Lintereur teaches an insulin delivery device (Lintereur: infusion device 102 injects insulin; para. 0035), wherein the device (102) is attached to the user (device 102 is secured to user; para. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Bohm such that the insulin delivery device is attached to the user as taught by Lintereur in order to simultaneously receive analyte or other sensor data while also delivering infusion (Lintereur: para. 0037-0039).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783