DETAILED ACTION
Applicant’s arguments, filed on 03/03/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 03/03/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-11 are the current claims hereby under examination, with claims 12-15 being withdrawn.
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 .
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.
Claims 1, 3-4, and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 20120328473) in view of Muller (US 10207016).
Regarding independent claim 1, Thomas teaches a medical system ([0006]: “provided in accordance with the embodiments of the present disclosure are methods and systems for the sterilization of medical devices, including devices for the continuous or automatic monitoring of analytes, such as glucose, in bodily fluid”), comprising:
a housing (Housing 618);
a module received in the housing (Inserter 600 is the module) and comprising:
an analyte sensor configured for detecting an analyte in a body fluid of a user (Analyte sensor 620),
an electronics unit electrically connected to the analyte sensor ([0124]: “medical device assembly for sterilization may include one or more electronic components, an analyte sensor including active sensing agents and/or chemistry and/or biologics related to analyte sensing disposed on the sensor, a sensor delivery unit including a mounting unit, an insertion needle such as a sharp introducer and/or adhesive, or one or more combinations thereof”; [0180]: “The electronic components may include a data transmitter, a microprocessor, or a memory device.”. The electronic components includes the data transmitter and microprocessor which control the sensor, therefore are connected.),
an insertion component configured for inserting the analyte sensor into body tissue of the user ([0090]: “FIG. 6 illustrates an example of a sensor insertion unit, or sensor delivery unit, used in one or more embodiments of the present disclosure”. The carrier 610 is the insertion component.), and
a sterility cap at least partially surrounding the insertion component ([0141]: “a protective component (not shown), such as a cap, may be provided over the open end of the sensor delivery unit 600 of FIG. 6”);
a removable protective cap connected to the housing and covering the module ([0174]: “the container materials may include a thermoformed plastic tray with a sealable, removable cover, e.g., an aluminum foil cover that is adhered to the plastic tray with adhesive”), wherein the protective cap at least partially surrounds the sterility cap ([0173]: “Such an assembly comprising analyte sensor and mounting unit and sensor delivery unit may be positioned inside a container prior to sterilization, where a container may also include one or more materials whose properties may be considered in the sterilization process for example, to achieve the desired sterility assurance level.”; [0174]: “the container materials may include a thermoformed plastic tray with a sealable, removable cover, e.g., an aluminum foil cover that is adhered to the plastic tray with adhesive.”. The container materials (including the cover) contains the sensor delivery unit, which includes the sterility cap.).
However, Thomas does not teach wherein the sterility cap comprises a sterility testing access that has at least one of a septum and a multiple-step sealing; and wherein the sterility testing access is accessible from outside of the protective cap when the protective cap is connected to the housing and covering the module.
Muller teaches a sample preparation container. Specifically, Muller teaches wherein the sterility cap comprises a sterility testing access that has at least one of a septum and a multiple-step sealing; and wherein the sterility testing access is accessible from outside of the protective cap when the protective cap is connected to the housing and covering the module (Column 2, lines 25-34: “the sampling port of the container is closed by the septum a contamination of the sample inside the container can be avoided when a sampling device like a needle or the like is inserted from the outside to get access to the inside space, i.e. to extract fluid from the inside space or to add any fluid to the inside space. The septum also allows repeated access in a sterile manner, especially if the septum has self-sealing properties in general, preferably if the septum is in the form of a block of piercable material that has such a self-sealing property”. The sampling port is the sterility testing access, which is accessible from outside the device while the device is closed, which is analogous to being accessible from outside the protective cap when the cap is closed). Thomas and Muller are analogous art as they are both related to medical devices that are adapted for sterile conditions.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sterility testing access from Muller into the sterility cap from Thomas as it allows the system to test the sterility of the device without removing the cap, which maintains the integrity of the seal, ensuring the device is still sterile before use.
Regarding claim 3, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the sterility testing access is closed by at least one of the septum and a removable stopper (Muller, Column 2, lines 25-34: “the sampling port of the container is closed by the septum a contamination of the sample inside the container can be avoided when a sampling device like a needle or the like is inserted from the outside to get access to the inside space, i.e. to extract fluid from the inside space or to add any fluid to the inside space. The septum also allows repeated access in a sterile manner, especially if the septum has self-sealing properties in general, preferably if the septum is in the form of a block of piercable material that has such a self-sealing property”).
However, the Thomas/Muller combination is silent on the structure of a sidewall surrounding the sterility testing access.
Muller teaches wherein the sterility cap comprises a tubular sidewall surrounding a sterility testing access opening (Column 4, line 33-37: “The sampling port 5 includes a septum 6, preferably in the form of a block of piercable material which has self-sealing properties and which is held in a space 9 defined by a cylindrical wall protruding from the housing wall”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the structure of the sidewall from Muller into the Thomas/Muller combination as the combination is silent on the structure of a sidewall, and Muller discloses a suitable structure in an analogous device.
Regarding claim 4, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the protective cap has an opening that allows access to the sterility testing access (Muller, Column 2, lines 25-34: “the sampling port of the container is closed by the septum a contamination of the sample inside the container can be avoided when a sampling device like a needle or the like is inserted from the outside to get access to the inside space, i.e. to extract fluid from the inside space or to add any fluid to the inside space. The septum also allows repeated access in a sterile manner, especially if the septum has self-sealing properties in general, preferably if the septum is in the form of a block of piercable material that has such a self-sealing property”. The sampling port is the sterility testing access, which is accessible from outside the device while the device is closed, which is analogous to being accessible from outside the protective cap when the cap is closed.) and the opening is sealed by a removable seal (Thomas, [0173]: “Such an assembly comprising analyte sensor and mounting unit and sensor delivery unit may be positioned inside a container prior to sterilization, where a container may also include one or more materials whose properties may be considered in the sterilization process for example, to achieve the desired sterility assurance level.”; [0174]: “the container materials may include a thermoformed plastic tray with a sealable, removable cover, e.g., an aluminum foil cover that is adhered to the plastic tray with adhesive.”. The container materials (including the cover) contains the sensor delivery unit, which includes the sterility cap.).
Regarding claim 7, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the module further comprises a base plate, wherein the sterility cap is connected to the base plate (Thomas, [0178]: “the target surface dose and irradiation time period for a packaging that includes analyte sensor only may differ from a packaging that includes the sensor delivery unit and the analyte sensor pre-loaded in the delivery unit, and further which includes the mounting base for positioning on the user's skin surface during the sensor insertion process”; [0127]: “the mounting unit/base of the medical device assembly discussed above”; [0124]: “a sensor delivery unit including a mounting unit”. The sensor delivery unit is the insertion unit, which is connected to the sterility cap, therefore the mounting unit (the base plate) is connected to the sterility cap.).
Regarding claim 8, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the module further comprises a cover that covers the electronics unit and at least part of the analyte sensor (Thomas, [0164]: “a container including an inner cavity and a seal, the container including an analyte sensor insertion device assembly positioned substantially within the inner cavity, wherein the seal is provided entirely over the cavity on the container”. The seal is the cover, which covers the analyte sensor insertion device, which includes the electronics unit and the sensor.).
Regarding claim 9, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the sterility cap provides a sealed interior space (Thomas, [0175]: “the cover may be sealed to form an enclosed interior space”), wherein the analyte sensor and the insertion component are at least partially located within the sealed interior space (Thomas, [0173]: “Such an assembly comprising analyte sensor and mounting unit and sensor delivery unit may be positioned inside a container prior to sterilization, where a container may also include one or more materials whose properties may be considered in the sterilization process for example”).
Regarding claim 10, the Thomas/Muller combination teaches the medical system according to claim 1, further comprising a driving actuator configured for driving the insertion component into the body tissue of the user (Thomas, [0091]: “Inserter 600 may be provided with an actuator button for releasing barbed fingers 614 from stops 616 as also previously described, allowing drive spring 612 to drive carrier 610 downward with introducer sharp and/or sensor 620 to be inserted into the patient's skin”. The spring 612 is the driving actuator.).
Regarding claim 11, the Thomas/Muller combination teaches the medical system according to claim 1, wherein the module further comprises an electrical energy storage device (Thomas, [0045]: “a power supply 207, such as a battery, may also be provided in the data processing unit 102 to provide the necessary power for the data processing unit 102”).
Claims 2 and 5-6are rejected under 35 U.S.C. 103 as being unpatentable over the Thomas/Muller combination as applied to claim 1 above, and further in view of Walter (EP 3202324).
Regarding claim 2, the Thomas/Muller combination teaches the medical system according to claim 1.
However, the Thomas/Muller combination does not teach wherein the sterility cap comprises the multiple-step sealing and the multiple-step sealing further comprises a plurality of circumferential sealing elements having differing equivalent diameters, the circumferential sealing elements being disposed within an interior space of the sterility cap.
Walter discloses a medical device for detecting an analyte in a body fluid. Specifically, Walter teaches a multiple-step sealing and the multiple-step sealing further comprises a plurality of circumferential sealing elements having equivalent diameters (Column 13, lines 14-20: “the sealing element may comprise at least one sealing lip. As used herein, the term "sealing lip" may refer to a maximum in a cross-sectional profile of the sealing element, which, when the sealing element thereon is pressed on another surface, is the first part of the sealing element to contact the other surface”. The at least one sealing lip (which connotes a plurality of sealing lips is contemplated) are the sealing elements.). Thomas and Walter are analogous arts as they are both related to medical devices used for sensing analytes in a body fluid.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sealing components from Walter including multiple sealing lips into the sterility cap of the Thomas/Muller combination as it provides a suitable sealing step that can allow for a tight seal, ensuring that the sterility cap stays sterile and clean for insertion into the body.
Regarding claim 5, the Thomas/Muller combination teaches the medical system according to claim 1.
However, the Thomas/Muller combination does not teach wherein the sterility cap is engaged with the removable protective cap such that when the protective cap is removed from the housing, the sterility cap is removed from the module.
Walter teaches wherein the sterility cap is engaged with the removable protective cap such that when the protective cap is removed from the housing, the sterility cap is removed from the module ([0051]: “The detachable lower cover may be configured such that a removal of the detachable lower cover removes the detachable lower cap”. With respect to claim 5, the protective cover is considered to be the lower cover and the lower cap is analogous to the sterility cap).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the connection of the caps from Walter into the Thomas/Muller combination as it allows the device to easily remove both caps, which ensures that when the protective cap is opened, the device is in the proper state to begin usage by also removing the sterility cap.
Regarding claim 6, the Thomas/Muller combination teaches the medical system according to claim 1.
However, the Thomas/Muller combination does not teach wherein the sterility cap has at least one side in common with the protective cap.
Walter teaches wherein the sterility cap has at least one side in common with the protective cap (Fig. 5A shows lower cap 164 sharing a side with the lower cover 216, and with respect to claim 5, the protective cover is considered to be the lower cover.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the sterility cap and the protective cap sharing a side as the Thomas/Muller combination is silent on the connection between the two caps, and Walter discloses a suitable connection in an analogous device.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-11 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.
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 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 ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
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, Jason Sims can be reached at 5712727540. 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.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights