DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on July 23, 2026 were received and fully considered. Claim 12 was amended. Claim 14 was cancelled. Claims 32-34 are new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 23, 2026 have been considered by the examiner.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12, 13, 15-17, and 22-34 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US Patent No. 7946984 B2) (hereinafter “Brister 2”).
With respect to claim 12, Brister 2 teaches a medical sensing device for sensing an analyte (see title “transcutaneous analyte sensor”, the sensing device comprising: a case having a lower major wall adapted to be mounted against a skin of a patient (lower side, towards skin, of mounting unit 412 with base portion 464 and lower base 476 mounted on patient skin; see Figs. 27A-27D; see also col. 71 line 58 – col. 73 line 65 “mounting unit 464… adapted for placement adjacent to the host’s skin”), and an upper opposing major wall (upper side, away from skin, of mounting unit 412 with base portion 464; see Figs. 27A-27D); a sensor extending from the case through an opening in the lower major wall (sensor 416 extends through a slot/opening and groove 480 in lower base 476; see Figs. 27A – 27D), the sensor having a distal end sensitive to the analyte to produce an electrical signal (sensor 416 has a distal end that is sensitive to blood analyte and produces an electrical signal; Figs. 27A – 27D), and a proximal end within the case having electrical contacts (PCB assembly 468, see Figs. 27C – 27D); a T-shaped support mounted within the case having a cross arm extending transversely across the case, and a stem extending towards a second end of the case (needle holder 474 is T-shaped and has a stem for needle 446 to extend through; see Fig. 27D; see also col. 71 line 58 – col. 73 line 65), the stem having a guide channel for through which the sensor extends from the opening in the lower major wall to the proximal end within the case (needle 446 extends through channel in stem portion of T-shape support 474), wherein the upper major wall includes an orifice for entry of a needle (see Figs. 27A-27D), and the T-shaped support extends to the upper major wall at an intersection of the cross arm and the stem and provides a guide for the needle (See Figs. 27A-27D).
Although Brister’s embodiment, as depicted in Figs. 27A – 27D, does not explicitly show a power unit disposed at a first end of the case, further modification to incorporate this feature would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Brister’s cited embodiment utilize PCB 468 and disclose the use of “sensor electronics housed” (col. 71 line 58 – col. 73 line 65). Moreover, other embodiments utilize a battery 144 operably connected to the sensor electronics 132 in order to provide power for the sensor (col. 45, lines 60+). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Brister’s embodiment, as depicted in Figs. 27A-27D, to incorporate a power unit (e.g. battery) disposed at a first end of the case in order to provide power source for the sensor, as suggested in other embodiments (col. 45, lines 60+).
With respect to claim 13, Brister 2 teaches wherein the T- shaped support includes support pads at ends of the cross arm in contact with the upper major wall (see col. 71 line 58 – col. 73 line 65 “side tabs 460a, 460b”; see Fig. 27A).
With respect to claim 15, Brister 2 teaches wherein the lower major wall comprises a printed circuit board assembly supporting the power unit and the T-shaped support, the printed circuit board assembly further having pads connecting to the electrical contacts of the sensor (see col. 71 line 58 – col. 73 line 65 “PCB 468… sensor electronics housed… solder pads and provide for electrical connection between the electrodes and the PCB… connected via a trace”).
With respect to claim 16, Brister 2 teaches wherein the case is made of a flexible material (col. 43, lines 13+ “base 24 of the mounting unit 14 is formed from a flexible material, for example silicone”).
With respect to claim 17, Brister 2 teaches wherein the case is made of silicone or polyurethane (col. 43, lines 13+ “base 24 of the mounting unit 14 is formed from a flexible material, for example silicone”).
With respect to claim 22, Brister 2 teaches a printed circuit board assembly within the case, the printed circuit board assembly being electrically coupled to the sensor through the electrical contacts, and the power unit being electrically coupled to the printed circuit board assembly (see col. 71 line 58 – col. 73 line 65 “PCB 468… sensor electronics housed… solder pads and provide for electrical connection between the electrodes and the PCB… connected via a trace”).
With respect to claim 23, Brister 2 teaches an adhesive patch attached to the lower major wall for mounting the case against the skin of the patient (col. 67, lines 1+).
With respect to claim 24, Brister 2 teaches wherein the upper major wall is connected to the lower major wall in a water tight manner (col. 69, lines 29+).
With respect to claim 25, Brister 2 teaches wherein the sensor is a flexible thin film sensor comprising elongated conductive elements encased between flexible insulative layers (col. 70, lines 13+).
With respect to claim 26, Brister 2 teaches wherein the sensor includes at least two sensor electrodes at the distal end for generating at least one electrical signal representative of the analyte (col. 73, lines 42+).
With respect to claim 27, Brister 2 suggests wherein the power unit comprises a battery disposed at the first end of the case (col. 45, lines 60+). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Brister’s embodiment, as depicted in Figs. 27A-27D, to incorporate a battery disposed at a first end of the case in order to provide alternative power source for the sensor, as suggested in other embodiments (col. 45, lines 60+).
With respect to claim 28, Brister 2 does not expressly teach a battery pull tab adapted to break an electrical coupling of the battery from a printed circuit board assembly within the case prior to use of the sensing device. However, further modification to incorporate a battery pull tab would have been prima facie obvious to PHOSITA when the invention was filed for the following reasons. First, Brister 2 expressly teaches utilizing a battery than be recharged as needed (col. 45, lines 60+). Moreover, it is widely known, across many fields of endeavors, to utilize a pull tab in order to remove and replace a depleted battery. Therefore, PHOSITA would have had predictable success modifying Brister 2 to incorporate a battery pull tab for the purpose of allowing easier ability to remove a depleted battery for purposes of replacing and/or recharging the depleted battery.
With respect to claim 29, Brister 2 teaches a transmitter electrically coupled to a printed circuit board assembly within the case, the transmitter adapted to wirelessly transmit analyte readings sensed by the sensor (col. 73, lines 63+).
With respect to claim 30, Brister 2 teaches an elastomeric connector disposed within the case and biased by one of the major walls to urge the proximal end of the sensor into contact with a printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly (col. 35, lines 29+).
With respect to claim 31, Brister 2 teaches wherein the elastomeric connector comprises alternating conductive layers and non-conductive layers, such that the elastomeric connector is conductive along its width and height but not along its length (col. 35, lines 29+).
With respect to claim 32, Brister 2 suggests a medical sensing device for sensing an analyte, the sensing device comprising: a case having a lower major wall and an upper opposing major wall, the lower major wall defining a first opening and the upper major wall defining a second opening; a T-shaped support mounted within the case, support comprising a cross arm extending transversely across the case and a stem, the T-shaped support extending from the lower major wall to the upper major wall at an intersection of the cross arm and the stem, and the stem having a guide channel; and a sensor extending through the guide channel from the first opening to a proximal end of the sensor disposed within the case, wherein the second opening is aligned with the intersection of the cross arm and the stem such that a needle received through the second opening is guided by the T-shaped support (see rejection of claim 12 above; Brister 2’s embodiments depicted in Figs. 27A-27D).
With respect to claim 33, Brister 2 teaches wherein the T-shaped support includes support pads at ends of the cross arm in contact with the upper major wall (see col. 71 line 58 – col. 73 line 65 “side tabs 460a, 460b”; see Fig. 27A).
With respect to claim 34, Brister 2 teaches wherein the case is made of a flexible material (col. 43, lines 13+ “base 24 of the mounting unit 14 is formed from a flexible material, for example silicone”).
Response to Arguments
Applicant’s arguments with respect to the prior art rejections raised in the previous office action have been considered, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Please see prior art section above for more detail, updated citations (new Brister 2 reference), and updated obviousness rationale.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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