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 .
Election/Restrictions
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/18/2026.
Claims 1-15 are hereby under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/29/2025 on 06/25/2026 have been considered by the examiner.
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 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 1-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2013/0150691 by Pace et al., hereinafter "Pace" in view of US Patent 6,319,232 by Kashmer hereinafter "Kashmer".
Regarding claim 1, Figs. 4-5 and 10-11 of Pace teaches a cartridge (container 206) for coupling to an applicator housing of a transcutaneous analyte sensor applicator (Figs. 10E-10M show the coupling of container 206 to applicator housing 216), the cartridge comprising:
a transcutaneous analyte sensor (Fig. 10L, [0093]; sensor assembly 410 contains a sensor to be inserted through the skin);
a needle (Fig. 10L, [0093] the sharp is included in the sensor assembly) configured to guide the transcutaneous analyte sensor into skin of an individual (insertion shown in Fig. 11C); and
a body configured to be coupled to the applicator housing (Figs. 10C-D, [0094]; body of container 206 couples to applicator housing through guide sleeve 318) and including a retainer retaining the transcutaneous analyte sensor (Figs. 4-5, [0084]; sensor assembly support 512 holds the sensor assembly 410) and including a wall extending around at least a portion of the transcutaneous analyte sensor (Figs. 5A, [0084-0089]; Platform 408).
Pace is silent regarding: a needle cover configured to cover at least a portion of the needle following the needle guiding the transcutaneous analyte sensor into the skin of the individual.
Fig. 2-3 of Kashmer teaches a needle cover (shield 22) that effectively shields the sharpened distal tip of the needle prior to and after use. The needle cover allows for the user to safely use the needle and provides protection from the sharp in a before the application of the needle and provides final protection after the application and through disposal (Col 1, lines 48-53).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the sharp taught by Pace to include a needle cover to provide increased safety to the user, providing protection before application, after application, and through disposal, as taught by Kashmer (Col 1, lines 48-53). It is noted that the needle cover of Kashmer is mounted on a needle hub, which constitutes the base of the needle. In the combination of Pace and Kashmer, the needle cover would be mounted on the sharp boss 1014 of Pace, as the sharp boss of Pace constitutes the base of the sharp (i.e., needle) and would cover the needle following the application of the sensor unit.
Regarding claim 2, the combination of Pace and Kashmer teaches the cartridge of claim 1, wherein the body includes an upper opening (Pace, Fig. 5B, opening of container 206).
Regarding claim 3, the combination of Pace and Kashmer teaches the cartridge of claim 2, further comprising a removable cover (Pace, Fig. 4, cover 402) covering the upper opening.
Regarding claim 4, the combination of Pace and Kashmer teaches the cartridge of claim 3, wherein the removable cover forms a hermetic seal of the upper opening (Pace, [0084]; “With the cover 402 sealed, the container 206 can be subjected to gamma or radiation (e.g., e-beam) sterilization, an approach compatible with the chemistry of the sensor included in the sensor assembly 410. Like the applicator 212, the container 206 is its own sterile packaging so that no additional packaging, other than the casing 404 and the cover 402, is required to maintain sterility of the interior of the casing.". If the cover can maintain sterility it is considered to be hermetic.).
Regarding claim 5, the combination of Pace and Kashmer teaches the cartridge of claim 3, wherein the removable cover comprises a flap (Pace, Fig 10A, the hermetic seal comprises a flap).
Regarding claim 6, the combination of Pace and Kashmer teaches the cartridge of claim 3, wherein the removable cover comprises a body (the mass of the cover 402) having a height and width (Pace, Fig. 10A; 402 has a height (thickness of the cover) and width (width of the cover)) and covering the needle cover (Pace, Fig. 5B; 402 is positioned over the entire sensor assembly and sharp, which includes the needle cover of Kashmer as applied in claim 1).
Regarding claim 7, the combination of Pace and Kashmer teaches the cartridge of claim 1, but does not teach further comprising a wearable housing for the transcutaneous analyte sensor coupled to the transcutaneous analyte sensor, and wherein the needle cover is coupled to the wearable housing.
Figure 10 of Pace teaches a wearable housing for the transcutaneous analyte sensor and the electronics assembly disposed within the applicator. However, Pace also recites that the container may store the sensor, sharp, and/or the electronics assembly and that the electronics assembly includes a housing adapted for attachment to the skin of the user (i.e., wearable housing) ([0011]). Therefore the container is capable of comprising the wearable housing and electronics assemblies within it.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the combination of Pace and Kashmer to include the wearable housing and electronics assembly in the container, as this rearrangement of parts can allow for a configuration where all elements of the on-body device are in the same container. The courts have held that the particular placement of an element was held to be an obvious matter of design choice. See MPEP 2144.04.VI.C. In this rearranged combination of Pace and Kashmer, the wearable housing for the transcutaneous analyte sensor (housing of on-body device 222 can be seen in Fig 2 of Pace) is coupled to the transcutaneous analyte sensor (as the wearable housing does not need to be advanced to couple the housing to the sensor assembly if both components are initially in the container). In this rearranged combination of Pace and Kashmer, the needle cover (which is mounted on the sharp boss 1014 of Pace) is coupled to the sensor assembly, and therefore the wearable housing.
Regarding claim 8, the combination of Pace and Kashmer teaches the cartridge of claim 7, wherein the wearable housing is configured to couple to an electronics unit (the wearable housing of Pace is coupled to the electronics assembly as shown in Figs 10 E-M, and in the combination of Pace and Kashmer of claim 7, they are coupled within the container.).
Regarding claim 9, the combination of Pace and Kashmer teaches the cartridge of claim 7, wherein the needle cover is configured to be separable from the wearable housing. The sharp retraction assembly of Pace removes the sharp and sharp boss (where the needle cover is mounted) from the wearable housing, electronics assembly and sensor assembly. Therefore, upon the retraction of the sharp, the needle cover is separated from the wearable housing.
Regarding claim 10, the combination of Pace and Kashmer teaches the cartridge of claim 1, wherein the needle cover comprises a sheath (Kashmer, needle shield 22 wraps around most of the needle comprising a sheath (shown in Fig. 2)) configured to extend over at least the portion of the needle (as shown in Kashmer, Fig. 2)).
Regarding claim 11, the combination of Pace and Kashmer teaches the cartridge of claim 1, wherein the needle cover is configured to rotate relative to the needle to extend over at least the portion of the needle. The needle cover taught by Kashmer includes a hinge that pivots (rotates) the needle cover away from the needle for use and over the needle after use (Kashmer, Abstract).
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Annotated Fig. 10F
Regarding claim 12, the combination of Pace and Kashmer teaches the cartridge of claim 1, wherein the wall extends around at least a portion of the needle cover (Pace, platform 408 extends around all of the sensor assembly, as it is situated in 408, below the opening, See Annotated Fig. 10F).
Regarding claim 13, the combination of Pace and Kashmer teaches the cartridge of claim 1, wherein the wall includes an inner surface configured to face inward towards the transcutaneous analyte sensor, and includes an outer surface facing opposite the inner surface and configured to be positioned within the applicator housing (See Annotated Figs. 5A and 10F).
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Annotated Fig. 5A
Regarding claim 15, the combination of Pace and Kashmer teaches the cartridge of claim 13, further comprising a protrusion on the outer surface configured to align the body with the applicator housing (Shown in Annotated Fig. 5A).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pace in view of Kashmer, as applied to claim 13, in view of US Patent Publication 2005/0149090 by Morita et al. (hereinafter “Morita”).
The combination of Pace and Kashmer teaches the cartridge of claim 13, but does not teach wherein the outer surface has an asymmetrical contour.
Figs. 25-26 of Morita teaches a cassette (i.e., cartridge) and a mating wall featuring an asymmetrical shape (i.e., contour) 536. The shape of the cassette and the wall are predetermined to match each other in order to ensure that the cassette can only be inserted in one predefined orientation ([0238-0239]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the outer wall of the combination of Pace and Kashmer to have an asymmetrical contour to ensure the correct insertion orientation, as taught by Morita ([0238-0239]). In this combination of Pace, Kashmer, and Talmadge, the walls of the applicator would also be contoured to match the asymmetrical contour of the outer wall of the contour and define a predetermined insertion direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2008/0194988 by Nakamura et al. teaches a cartridge couplable to an applicator with a needle, biosensor and seal.
US Patent Publication 2020/0178899 by Chae et al. – cited by applicant teaches a cartridge usable with an applicator containing a transcutaneous analyte sensor, needle, and a wearable housing. The container also has an asymmetrical contour to ensure proper alignment.
US Patent Publication 2018/0360493 by Baker et al. discloses an applicator and container with an asymmetrical contour comprising a transcutaneous analyte sensor, needle, and wearable housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/NELSON ALEXANDER GLOVER/
Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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