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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/17/26, 08/18/25, 02/14/25, 07/09/24, 03/19/24, 10/25/23, 04/14/23, and 02/04/22 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on February 17, 2026, claim 23 has been amended.
Response to Arguments
Applicant’s remaining arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Barone reference), and updated obviousness rationale
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 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.
Claims 23 and 27-36, 39, 40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (U.S. Patent Application Publication 2019/0133501) and in further in view of Barone (U.S. Patent Application Publication 2022/0313129) and Baker (U.S. Patent Application Publication 2018/0360493).
Rao was applied in Applicant’s IDS and the previous office action
Baker was applied in the previous office action
Regarding claim 23, Rao teaches an assembly, comprising: (1) an applicator for delivering a sensor control device (par. 6), the applicator comprising:
a housing (fig. 6a, element 702), comprising a sealing lip (fig. 6a, lower aspect of housing 702 that has threads, etc.);
a sensor carrier coupled to the housing (fig. 6a, element 710);
the sensor control device [fig. 1, element 102; par. 77];
a sharp and a spring [fig. 6A, elements 2500, 1104; par. 94];
and a cap threadably coupled with the housing (par. 109, housing threads 1310 secures housing 702 to cap 708 by aligning complimentary cap threads 1708 as seen in fig. 11A and rotating in a clockwise or counterclockwise direction),
wherein the cap includes a cavity (see fig. B, element 4 below; Examiner notes the cavity is the space between elements 2 and 3), wherein the sealing lip of the housing comprises a first axial extension (see fig. A, element 1 below) that is configured to mate with a second axial extension (see fig. B, element 2 below) and a third axial extension (see fig. B, element 2 below) of the cavity to form a gasketless seal interface (par. 109, housing threads 1310 secures housing 702 to cap 708 by aligning complimentary cap threads 1708 as seen in fig. 11 and rotating in a clockwise or counterclockwise direction which is interpreted as the housing threads 1310 mating with a cavity to create a gasketless seal interface), wherein the second axial extension and the third axial extension define the cavity (see fig. 11, element D below);
(2) the sensor control device, comprising:
an in vivo glucose sensor [par. 83, 84];
an electronics housing [par. 83, 84];
wherein the applicator is configured to advance the sensor carrier, the sensor control device, and the sharp from a proximal position entirely within the applicator to a distal position, wherein the spring is configured to automatically retract the sharp from the distal position to a retracted position entirely within the applicator [fig. 20A-20E; par.
PNG
media_image1.png
416
384
media_image1.png
Greyscale
[AltContent: rect][AltContent: textbox (A)]112, 144]
PNG
media_image3.png
394
398
media_image3.png
Greyscale
[AltContent: rect][AltContent: textbox (B)]
PNG
media_image3.png
394
398
media_image3.png
Greyscale
[AltContent: textbox (B)][AltContent: arrow][AltContent: arrow][AltContent: textbox (2)][AltContent: textbox (3)][AltContent: arrow][AltContent: textbox (4)]
Although Rao does not explicitly teach the gasketless seal interface is configured to serve as a moisture barrier, this would be obvious to a person having ordinary skill in the art when the invention was filed, since Rao also suggests when cap 708 is coupled with housing 702 via threads 1708, it can create a sterile or at least dust-free environment during shipping and storage and can protect electronics housing 706 and prevent adhesive layer 105 from becoming dirty [par. 125]. Examiner notes that since the first, second and third axial components of Rao are the same as the present application, this configuration would also serve as a moisture barrier. Therefore, incorporating the gasketless seal interface to be configured to serve as a moisture barrier would involve only routine skill in the art.
Although Rao does not explicitly teach the first axial extension, the second axial extension, and the third axial extension are configured to form two radial seals at a proximal end of the cavity, this would be obvious to a person having ordinary skill in the art when the invention was filed, since Rao also suggests a first, second and third axial extension [fig A, B, elements 1-3]. Examiner notes that although there is no equivalent figure to figures 41A and 41B of the present application, the elements 1-3 in fig A and B above equate to the first, second and third axial extensions and cavity taught in the present application. Therefore, incorporating the first axial extension, the second axial extension, and the third axial extension are configured to form two radial seals at a proximal end of the cavity would involve only routine skill in the art.
However, Rao does not teach wherein the first axial extension is in continuous contact with the third axial extension along an axial length of the first axial extension
Barone teaches wherein the first axial extension is in continuous contact with the third axial extension along an axial length of the first axial extension [fig. 38, elements 207, 237; par. 221]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, to incorporate the first axial extension is in continuous contact with the third axial extension along an axial length of the first axial extension, to prevent the support 200 from sliding vertically relative to the interface, and/or may be held in a position that allows the lower region of the interface 230 to flex, as evidence by Barone [par. 221].
However, Rao does not teach sensor electronics disposed with the electronics housing and coupled with the analyte sensor, and wherein the sensor control device and the sharp are disposed in the housing while the cap is coupled with the housing.
Baker teaches sensor electronics disposed with the electronics housing and coupled with the analyte sensor [fig. 1B, elements 134, 140; par. 135], and wherein the sensor control device and the sharp are disposed in the housing while the cap is coupled with the housing [fig. 1B, elements 134, 140; par. 135]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Rao, to incorporate sensor electronics disposed with the electronics housing and coupled with the analyte sensor, and wherein the sensor control device and the sharp are disposed in the housing while the cap is coupled with the housing, for providing convenient and secure application, as evidence by Baker [par. 136].
Regarding claim 27, Rao further teaches radial seals comprise a redundant sealing configuration configured to accommodate tolerance and thermal variations (par. 125, fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 can create a sterile dust free environment during shipping and storage and can protect electronic housing 706 and prevent adhesive layer 105 from becoming dirty where accommodating tolerance and thermal variations is part of protection during shipping and storage).
Regarding claim 28, Rao further teaches, wherein a diameter of the cavity is sized to receive a diameter of the first axial extension (fig. 7A, element 1310, fig. 11, element 1708, fig. A, element 1 and fig. B element 4 shown above’ par. 110; Examiner notes that when housing threads 1310 are aligned with cap threads 1708, the first axial extension would fit in the cavity).
Regarding claim 29, Rao further teaches wherein the diameter of the first axial extension at a first height corresponds to the diameter of the cavity at the first height, wherein the diameter of the first axial extension at a second height corresponds to the diameter of the cavity at the second height, and wherein the diameter of the first axial extension at the first height is different from the diameter of the first axial extension at the second height (fig. B, element 4 as shown above; Examiner notes the cavity is angled to fit the first axial extension; fig. A, element 1; Examiner notes the first axial extension is angled due to the threads, causing the first axial extension to have different diameters).
Regarding claim 30, Rao further teaches wherein the housing comprises a first plurality of threads, and wherein the cap comprises a second plurality of threads configured to engage with the first plurality of threads (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708).
Regarding claim 31, Rao further teaches wherein the first plurality of threads comprises a first plurality of curved surfaces, and wherein the second plurality of threads comprises a second plurality of curved surfaces corresponding to the first plurality of curved surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708).
Regarding claim 32, Rao further teaches wherein the first plurality of threads further comprises a first plurality of flat surfaces, and wherein the second plurality of threads further comprises a second plurality of flat surfaces corresponding to the first plurality of flat surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 and it is seen that the flat surfaces between grooves establish threads).
Regarding claim 33, Rao further teaches wherein the first plurality of threads comprises a first plurality of angled surfaces, and wherein the second plurality of threads comprises a second plurality of angled surfaces corresponding to the first plurality of angled surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 and it is seen that there are angled surfaces).
Regarding claim 34, Rao further teaches wherein the first plurality of threads further comprises a first plurality of flat surfaces, and wherein the second plurality of threads further comprises a second plurality of flat surfaces corresponding to the first plurality of flat surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 and it is seen that the flat surfaces between grooves establish threads).
Regarding claim 35, Rao further teaches wherein the first plurality of threads comprises a first plurality of chamfered surfaces, and wherein the second plurality of threads comprises a second plurality of chamfered surfaces corresponding to the first plurality of chamfered surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 and it is seen that the threads could also be considered chamfered as they appear beveled).
Regarding claim 36, Rao further teaches wherein the first plurality of threads further comprises a first plurality of flat surfaces, and wherein the second plurality of threads further comprises a second plurality of flat surfaces corresponding to the first plurality of flat surfaces (fig. 7A, element 1310, fig. 11, element 1708; par 125, Fig.11 depicts a perspective cross section of cap 708 which is when it is coupled with housing 702 via threads 1708 and it is seen that the flat surfaces between grooves establish threads).
Regarding claim 39, Rao further teaches wherein the sensor electronics comprise one or more processors (par. 79), memory (par. 78), and wireless communication circuitry (par. 78, multifunctional transceiver 232 which can communication wirelessly with an antenna 234).
Regarding claim 40, Rao further teaches wherein the wireless communication circuitry is configured to transmit data indicative of an in vivo glucose level to a reader device (par. 77, sensor applicator 150 can be used to deliver sensor control device 102 to a monitoring location on a user’s skin where sensor 104 is maintained in position for a period of time by an adhesive patch 105; the sensor device 102 is further described in Fig. 2B and can communicate with reader device 120 via wireless technique which is interpreted as being able to transmit data).
Regarding claim 42, Rao further teaches wherein the cap is configured to hold a desiccant component (fig. 5B; par. 90, desiccant 502 is stationery with respect to tray 810 and sensor module 504 is mounted within tray 810).
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. 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 on 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
/GRACE L ROZANSKI/ /AURELIE H TU/Examiner, Art Unit 3791 Primary Examiner, Art Unit 3791
Prosecution Insights