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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 12-17, and new claims 22-31) in the reply filed on April 8, 2026 is acknowledged. Claims 18-21 were also cancelled.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior filed applications (16/943677 filed on 7/30/2020; 15/478110 filed on 4/3/2017; 62/460710 filed on 2/17/2017; 15/357952 filed on 11/21/2016; 15/357925 filed on 11/21/2016; 15/357885 filed on 11/21/2016; 62/402676 filed on 9/30/2016; 62/344847 filed on 6/2/2016; 62/344852 filed on 6/2/2016; and 62/320290 filed on 4/8/2016) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 April 2024; 7 August 2024; 14 November 2024; and 8 April 2026 have been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “the device” in line 1 should be changed to --the medical sensing device--.
Appropriate correction is required.
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 12-17 and 22-31 are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al. (US PG Pub. No. 2006/0016700 A1) (hereinafter “Brister”).
With respect to claim 12, Brister teaches a medical sensing device for sensing an analyte (title “transcutaneous analyte sensor”), the device comprising: a case (mounting unit 14 in Figs. 1-3) having a lower major wall adapted to be mounted against a skin of a patient (adhesive pad 8 and releasable backing layer 9 in Figs. 1-3), and an upper opposing major wall (base 24 and back surface 25 in Figs. 1-3); a sensor extending from the case through an opening in the lower major wall (sensor 32 extends from case 14 through circular opening in lower major wall 8/9, see Fig. 3), the sensor having a distal end sensitive to the analyte to produce an electrical signal (par.0114 “electrical connection between the sensor 32 and the electronics unit 16”; par.0118 “sensor 32 includes a distal portion 42… the in vivo portion”), and a proximal end within the case having electrical contacts (par.0118 “sensor 32 includes… a proximal portion 40… to operably connect to the electronics unit 16 via contacts 28”); a power unit disposed at a first end of the case (electronics unit 16 disposed on top of case 14; see Figs. 1-3);
Although Brister does not explicitly disclose that support 32/37 is T-shaped, this would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed as a mere design choice. Moreover, both the instant application and Brister set forth utilizing support structures (within a sensor case) in a similar manner, i.e., allows for proper sensor insertion at various angles in relation to patient skin while also securing said sensor within the case (see Brister’s Fig. 10 B; see instant application par.0106).
With respect to claim 13, Brister suggests wherein the T- shaped support includes support pads at ends of the cross arm in contact with the upper major wall (Figs. 1-4C).
With respect to claim 14, Brister suggests wherein the upper major wall includes an orifice for entry of a needle, 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 (Figs. 1-4C)
With respect to claim 15, Brister suggests 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 (par.0101).
With respect to claim 16, Brister teaches wherein the case is made of a flexible material (par.0104).
With respect to claim 17, Brister teaches wherein the case is made of silicone or polyurethane (par.0112).
With respect to claim 22, Brister teaches further comprising 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 (par.0101).
With respect to claim 23, Brister teaches further comprising an adhesive patch attached to the lower major wall for mounting the case against the skin of the patient (par.0106).
With respect to claim 24, Brister teaches wherein the upper major wall is connected to the lower major wall in a water tight manner (par.0106).
With respect to claim 25, Brister teaches wherein the sensor is a flexible thin film sensor comprising elongated conductive elements encased between flexible insulative layers (par.0121-122, 0125+).
With respect to claim 26, Brister 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 (par.0118+).
With respect to claim 27, Brister teaches wherein the power unit comprises a battery disposed at the first end of the case (pa.0260).
With respect to claim 28, Brister suggests 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 (par.0260).
With respect to claim 29, Brister 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 (par.0101, 0257+, 0262+, 0265, 0304).
With respect to claim 30, Brister suggests 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 (par.0112, 0115, 0199, 0201, 0248-249).
With respect to claim 31, Brister suggests 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 (par.0112, 0115, 0199, 0201, 0248-249).
Conclusion
No claim is allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights