DETAILED ACTION
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/4/2026 has been entered.
Claims 1-17 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 10, the limitation “a backing layer” is vague and unclear because there is already a backing layer in claim 1 on which claim 10 depends. Therefore, it is unclear if the two backing layers are the same or different. In order to prosecute the application, Examiner assumes the two backing layers are the same.
Claims 11-17 are rejected for depending on a rejected claim.
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 1-12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over USPGP# 20090257911 of Thomas et al. (henceforth Thomas) in view of USP# 5163557 of Sokolowski (henceforth Sokolowski).
Regarding claim 1, Thomas teaches
A package (top right package shown in fig. 10) for receiving and securing a product (1001,1002), the package comprising:
a product (1001,1002) comprising an implantable continuous glucose sensor (1001, para 0029-0030);
at least one first container (1003) configured to receive and secure the product therein (para 0117);
a second container (1010) configured to receive the at least one first container (para 0117); and
a retainer (slots 1011) configured to secure the at least one first container in a fixed position and fixed orientation within the second container such that movement of the second container does not result in movement of the first container within the second container (para 0117-0118).
Thomas does not explicitly teach
the at least one first container having a backing layer, wherein the backing layer includes a lot number corresponding to sensor manufacturing, and information configured to facilitate calibration of the implantable continuous glucose sensor.
Sokolowski teaches
at least one first container (10, 40) configured to receive and secure a product therein (30); wherein the at least one first container has a backing layer (40), wherein the backing layer includes a lot number (60) corresponding to product manufacturing, and information configured to facilitate usage of the product (64).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first container of Thomas with the addition of a backing layer with printed relevant information, as taught by Sokolowski, in order to securely package the product while preventing ingress of debris and/or particles from contaminating the first container and/or product which improves the sterility and/or shelf life of the product. Additionally, having important information, such as lot number and information configured to facilitate usage of the device (i.e. information configured to facilitate calibration of the implantable continuous glucose sensor), on the backing layer makes it readily available and easy visible. This makes the package more user friendly. Furthermore, it makes it harder for the user to misplace such information (for example compared to the information being printed on a separate sheet/booklet). Additionally, a skilled artisan would have recognized that the modification of Thomas with the teachings of Sokolowski involves no more than the predictable use of prior art elements according to their established functions. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR, 550 U.S. at 416
Regarding claim 2, as shown in claim 1, the combination of Thomas and Sokolowski teaches
wherein the at least one first container comprises a plurality of first containers (Thomas: plurality of 1003 shown in see fig. 10), wherein the retainer comprises a plurality of regions (Thomas: regions for spacing 1003 in retainer 1011) each configured to secure one of the plurality of first containers (Thomas: para 0117-0118).
Regarding claim 3, as shown in claim 2, the combination of Thomas and Sokolowski teaches
wherein the plurality of regions of the retainer are spaced apart at an equal distance such that the plurality of first containers are spaced apart at an equal distance (Thomas: see placement of 1003 in 1011 which correspond to retainer slots 1011 as described in para 0117-0118).
Regarding claim 4, as shown in claim 2, the combination of Thomas and Sokolowski teaches
a plurality of products (Thomas: 1001, 1002 in each of the of the first container 1003), wherein the plurality of products are aligned in a uniform orientation (Thomas: para 0117-0118).
Regarding claim 5, as shown in claim 1, the combination of Thomas and Sokolowski teaches
wherein the retainer is an integral component of the second container (Thomas: see fig. 10).
Regarding claim 6, as shown in claim 1, the combination of Thomas and Sokolowski does not teach
wherein the retainer is an insert releasably attached to the second container.
However, it would have been obvious to one having ordinary skill in the art, before the effective filling date of the invention, to make the retainer separable attached to the second container, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
Regarding claim 7, as shown in claim 6, the combination of Thomas and Sokolowski teaches
wherein a region of the retainer comprises an aperture or pocket shaped to receive and conform to a region of the first container (Thomas: 1011 is a slot for receiving the first container).
Regarding claim 8, as shown in claim 1, the combination of Thomas and Sokolowski teaches
wherein the product further comprises a housing (Thomas: para 0124 incorporates USP# 6,175,752 as the product (analyte sensor) to be packaged. USP# 6,175,752 describes the product 44 (analyte sensor) having a housing 45) configured to receive an electronics unit (c. 29, l. 55-59 of USP# 6,175,752, “The housing 45 typically contains most or all of the electronic components”), wherein the housing comprises an adhesive configured to attach the housing to a host (Thomas: c. 31, l. 63+ to c. 32 l. 1-5 of USP# 6,175,752. “The on-skin sensor control unit 44 is typically attached to the skin 75 of the patient, as illustrated in FIG. 17. The on-skin sensor control unit 44 may be attached by a variety of techniques including, for example, by adhering the on-skin sensor control unit 44 directly to the skin 75 of the patient with an adhesive provided on at least a portion of the housing 45 of the on-skin sensor control unit 44 which contacts the skin 75 or by suturing the on-skin sensor control unit 44 to the skin 75 through suture openings (not shown) in the sensor control unit 44.”).
Regarding claim 9, as shown in claim 8, the combination of Thomas and Sokolowski teaches
wherein the product further comprises an insertion device (Thomas: 1002 of Thomas or insertion device 120 of USP# 6,175,752) configured to insert the implantable continuous glucose sensor into the host (Thomas: c. 27, l. 42-43 of USP# 6,175,752 “An insertion device 120 can be used to subcutaneously insert the sensor 42 into the patient, as illustrated in FIG. 12.”).
Regarding claim 10, as shown in claim 1, the combination of Thomas and Sokolowski teaches
a backing layer (Sokolowski: 40) adhered to the shaped layer (Sokolowski: c. 3, l. 16-19).
The combination of Thomas and Sokolowski, as shown above, does not explicitly teach
wherein the at least one first container comprises a shaped layer.
Sokolowski teaches
at least one first container (10, 40) configured to receive and secure a product therein (30); wherein the at least one first container comprises a shaped layer (10, c. 2, l. 65+ to c. 3, l. 1-15).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first container of the combination of Thomas and Sokolowski, as shown in claim 1, with the addition of a shaped layer, as taught by Sokolowski, in order to provide the predictable result of preventing movement of the products inside the first container. This reduces the chance of damage to the product. Additionally, a skilled artisan would have recognized that the modification of the combination of Thomas and Sokolowski with the teachings of Sokolowski involves no more than the predictable use of prior art elements according to their established functions. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR, 550 U.S. at 416
Regarding claim 11, as shown in claim 10, the combination of Thomas and Sokolowski teaches
wherein the backing layer comprises: a material selected from the group consisting of (Sokolowski: c. 3, l. 24-30, TYVEK), (Sokolowski: c. 3, l. 24-30 TYVEK).
Regarding claim 12, as shown in claim 10, the combination of Thomas and Sokolowski teaches
wherein the shaped layer is a molded part (Sokolowski: see fig. 1, c. 2, l. 65+) with a chamber (Sokolowski: 32a-32e) for receiving the product.
Regarding claim 15, as shown in claim 10, the combination of Thomas and Sokolowski teaches
wherein the shaped layer comprises at least one region (Sokolowski: 32a-e) configured to secure the product in a fixed position and fixed orientation within the at least one first container such that movement of the at least one first container and/or the second container does not result in movement of the product within the at least one first container (Sokolowski: c. 2, l. 65+ to c. 3, l. 1-14 and Thomas: slot 1011, para 0117).
Regarding claim 16, as shown in claim 15, the combination of Thomas and Sokolowski teaches
wherein the at least one region of the shaped layer comprises a plurality of regions (Sokolowski: 32a-e) configured to secure the product in a fixed position and fixed orientation within the at least one first container (Sokolowski: fig. 1-3).
Regarding claim 17, as shown in claim 10, the combination of Thomas and Sokolowski teaches
wherein the shaped layer is shaped and dimensioned to prevent bending of an adhesive patch (Thomas teaches an adhesive patch 77 of USP# 6,175,752. Sokolowski teaches in c. 2, l. 65+ to c. 3, l. 1-14 different compartments for each part of the product to separate and prevent damage. Therefore the combination teaches the shaped layer (of Sokolowski) is shaped and dimensioned to prevent bending (i.e. damage) of the adhesive patch (of Thomas)).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Thomas and Sokolowski in view of USPGP# 20140107579 of Lanigan et al. (henceforth Lanigan).
Regarding claim 13, as shown in claim 10, the combination of Thomas and Sokolowski teaches
wherein the shaped layer is formed of a film (Sokolowski: c. 2, l. 65+ to c. 3, l. 1-14. In accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, the limitation of being formed by has not been given full patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. shaped layer, does not depend on its method of production, i.e. by film. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985)).
Nonetheless, Lanigan teaches
a first container (4070 and cover as described in para 1264) configured to receive and secure a product therein (4072); wherein the first container comprises a shaped layer (4070) and a backing layer adhered to the shaped layer (para 1264, “the cover removably bonds to the housing 4070 and provides a barrier to maintain sterility inside the housing 4070”); wherein the shaped layer is formed of a film (Lanigan: para 1264)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the first container of the combination of Thomas and Sokolowski such that the shaped layer is formed from film, as taught by Lanigan, in order to provide the predictable result of allowing the shaped layer to be formed using commercially available methods and technologies. This reduces manufacturing cost as new methods of forming the shaped layer is not needed. Additionally, a skilled artisan would have recognized that the modification of the shaped layer with the teachings of Lanigan (forming by film) involves no more than the predictable use of prior art elements according to their established functions. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. KSR, 550 U.S. at 416
Regarding claim 14, as shown in claim 13, the combination of Thomas, Sokolowski and Lanigan teaches
wherein the film comprises a polymer selected from the group consisting of (Lanigan: para 1264), .
Response to Arguments
Applicant’s arguments filed on 8/4/2026 have been fully considered:
All drawing objections have been overcome.
Amended claims have overcome all previous 112 (b) or second paragraph rejections. However, new rejections are made in light of the amendments.
Applicant' s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply to the new reference of Sokolowski being used in the current rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
Claims 1-17 can also be rejected with a different interpretation of Thomas (in view of Sokolowski and Lanigan) where Thomas teaches a package (top right package shown in fig. 10) for receiving and securing a product (1001,1002), the package comprising: a product (1001) comprising an implantable continuous glucose sensor (1001, para 0029-0030); at least one first container (1002) configured to receive and secure the product therein (para 0117); a second container (1003) configured to receive the at least one first container (para 0117); a retainer (1010) configured to secure the at least one first container in a fixed position and fixed orientation within the second container such that movement of the second container does not result in movement of the first container within the second container (para 0117-0118).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOBEEN AHMED whose telephone number is (571) 272-0356. The examiner can normally be reached on M-F (8:30 am to 5 pm).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached on 571-270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A./
Examiner, Art Unit 3731
/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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