3DETAILED ACTION
Response to Amendments
The amendment filed on 12/26/2025 has been entered.
Claims 1-19 remain pending in the application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “third container” of claims 18-19 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the original specification does not describe “the at least one first container is sterilized by an electron beam sterilization process prior to the second container receiving the at least one first container” as now claimed in claim 1. Para 0094 and 0097 of PGPub describes material of the first container permits sterilization using electron beam. Para 0103 of PGPub describes single layer packaging in a third container when using electron beam sterilization. Para 0104-105 of PGPub describes using specific memory chips that can withstand election beam sterilization. Para 0110-0111 of PGPub and Fig. 7 describes electron beam sterilization of the second container after the first container is packaged inside the second container. The relevant section do not describe sterilization of the first container using electron beam sterilization prior to being placed into the second container. Claims 2-19 are rejected for depending on claim 1.
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 1-19 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 1, the limitation “the at least one first container is sterilized by an electron beam sterilization process prior to the second container receiving the at least one first container” is vague and unclear because the original specification does not teach electron beam sterilization of first container prior to being placed in the second container. On the contrary, para 0110-0111 and fig. 7 teach electron beam sterilization after the first container is placed inside the second container. Therefore, it is unclear how the invention will work when electron beam sterilization of the first container is performed prior to second container receiving the first container. For example, is there a need for additional electron beam of the second container after the first container is received into the second container.
Any remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-9 and 18-19 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by USPGP# 20090257911 of Thomas et al. (henceforth Thomas).
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), wherein the at least one first container is sterilized by an electron beam sterilization process prior to the second container receiving the at least one first container (para 0145 describes “separate components may be sterilized separately using different or the same sterilization techniques as described above, and assembled and packaged after sterilization” Therefore, Thomas teaches separate components such as first container 1003 can be sterilized prior to being packaged into the second container 1010. See also para 0105-0107 which describe electron beam sterilization for products (analyte sensors) that have been packaged in a primary container 801a/b).
Regarding claim 2, as shown in claim 1, Thomas teaches
wherein the at least one first container comprises a plurality of first containers (plurality of 1003 shown in see fig. 10), wherein the retainer comprises a plurality of regions (regions for spacing 1003 in retainer 1011) each configured to secure one of the plurality of first containers (para 0117-0118).
Regarding claim 3, as shown in claim 2, Thomas 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 (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, Thomas teaches
a plurality of products (1001, 1002 in each of the of the first container 1003), wherein the plurality of products are aligned in a uniform orientation (para 0117-0118).
Regarding claim 5, as shown in claim 1, Thomas teaches
wherein the retainer is an integral component of the second container (see fig. 10).
Regarding claim 8, as shown in claim 1, Thomas teaches
wherein the product further comprises a housing (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 (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, Thomas teaches
wherein the product further comprises an insertion device (1002 of Thomas or insertion device 120 of USP# 6,175,752) configured to insert the implantable continuous glucose sensor into the host (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 18, as shown in claim 1, Thomas teaches
a third container (1020), wherein the third container is dimensioned and configured to receive a plurality of second containers (see fig. 10) and secure the plurality of second containers in a fixed position and fixed orientation (para 0118-0119).
Regarding claim 19, as shown in claim 1, Thomas teaches
a third container (1020), wherein the third container is dimensioned and configured to hold only one level of a plurality of second containers (see fig. 10 and para 0118-0119).
Claims 1-4, 6-9, 18-19 are rejected under 35 U.S.C. 102 (a)(1/2) as being anticipated by an alternate interpretation of Thomas.
Regarding claim 1, alternate interpretation of 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); and
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), wherein the at least one first container is sterilized by an electron beam sterilization process prior to the second container receiving the at least one first container (para 0145 describes “separate components may be sterilized separately using different or the same sterilization techniques as described above, and assembled and packaged after sterilization” Therefore, Thomas teaches separate components such as first containers 1003 can be sterilized prior to being packaged into the second container 1010. See also para 0105-0107 which describe electron beam sterilization of products (analyte sensors) that have been packaged in a primary container 801a/b).
Regarding claim 2, as shown in claim 1, alternate interpretation of Thomas teaches
wherein the at least one first container comprises a plurality of first containers (plurality of 1002 shown in see fig. 10), wherein the retainer comprises a plurality of regions (regions for spacing 1002 in retainer 1011) each configured to secure one of the plurality of first containers (para 0117-0118).
Regarding claim 3, as shown in claim 2, alternate interpretation of Thomas 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 (see placement of 1002/1003 in 1011 which correspond to retainer slots 1011 as described in para 0117-0118).
Regarding claim 4, as shown in claim 2, alternate interpretation of Thomas teaches
a plurality of products (1001 in each of the first containers 1002), wherein the plurality of products are aligned in a uniform orientation (para 0117-0118).
Regarding claim 6, as shown in claim 1, alternate interpretation of Thomas teaches
wherein the retainer is an insert releasably attached to the second container (see fig. 10).
Regarding claim 7, as shown in claim 6, alternate interpretation of Thomas teaches
wherein a region of the retainer comprises an aperture or pocket (1011) shaped to receive and conform to a region of the first container (1011 is a slot for receiving the first container).
Regarding claim 8, as shown in claim 1, alternate interpretation of Thomas teaches
wherein the product further comprises a housing (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 (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, alternate interpretation of Thomas teaches
wherein the product further comprises an insertion device (1002 of Thomas or insertion device 120 of USP# 6,175,752) configured to insert the implantable continuous glucose sensor into the host (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 18, as shown in claim 1, alternate interpretation of Thomas teaches
a third container (1020), wherein the third container is dimensioned and configured to receive a plurality of second containers (see fig. 10) and secure the plurality of second containers in a fixed position and fixed orientation (para 0118-0119).
Regarding claim 19, as shown in claim 1, alternate interpretation of Thomas teaches
a third container (1020), wherein the third container is dimensioned and configured to hold only one level of a plurality of second containers (see fig. 10 and para 0118-0119).
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable in view of Thomas.
Regarding claim 6, as shown in claim 1, Thomas 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, Thomas teaches
wherein a region of the retainer comprises an aperture or pocket shaped to receive and conform to a region of the first container (1011 is a slot for receiving the first container).
Claims 10-17 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas in view of USPGP# 20140107579 of Lanigan et al. (henceforth Lanigan).
Regarding claim 10, as shown in claim 1, Thomas does not explicitly teach
wherein the at least one first container comprises a shaped layer and a backing layer adhered to the shaped layer.
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”).
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 such that it has a shaped layer and a backing layer as taught by Lanigan, 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.
Regarding claim 11, as shown in claim 10, the combination of Thomas and Lanigan teaches
wherein the backing layer comprises: a material selected from the group consisting of (Lanigan: para 1264, TYVEK), (Lanigan: TYVEK, para 1264).
Regarding claim 12, as shown in claim 10, the combination of Thomas and Lanigan teaches
wherein the shaped layer is a molded part (Lanigan: para 1264) with a chamber (4078, 4080) for receiving the product.
Regarding claim 13, as shown in claim 10, the combination of Thomas and Lanigan teaches
wherein the shaped layer is formed of a film (Lanigan: para 1264).
Regarding claim 14, as shown in claim 13, the combination of Thomas and Lanigan teaches
wherein the film comprises a polymer selected from the group consisting of (Lanigan: para 1264),
Regarding claim 15, as shown in claim 10, the combination of Thomas and Lanigan teaches
wherein the shaped layer comprises at least one region (Lanigan: 4078, 4080) 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 (Lanigan: para 1264, Thomas: slot 1011, para 0117).
Regarding claim 16, as shown in claim 15, the combination of Thomas and Lanigan teaches
wherein the at least one region of the shaped layer comprises a plurality of regions (Lanigan: 4078, 4080) configured to secure the product in a fixed position and fixed orientation within the at least one first container (Lanigan: fig. 185B).
Regarding claim 17, as shown in claim 10, the combination of Thomas and Lanigan 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. Lanigan teaches in para 1264 “The housing 4070 may therefore include compartments 4078, 4080 to accommodate the various disposables” to prevent damage to the disposable. Therefore the combination teaches the shaped layer (of Lanigan) is shaped and dimensioned to prevent bending (i.e. damage) of the adhesive patch (of Thomas)).
Response to Arguments
Applicant’s arguments filed on 12/26/2025 have been fully considered:
Amended specification have overcome all previous drawing objection/s. However, new objections are made in light of the amendments.
Amended claims have overcome all previous 112 (b) or second paragraph rejection/s. However, new rejections are made in light of the amendments.
Applicant’s arguments regarding claims 1, have been fully considered but are not persuasive.
Regarding claim 1, Applicant states that Thomas does not teach the amended claim. As shown in the rejection above Thomas teaches the invention as claimed. Specifically, Thomas teaches in para 0145 that electron beam sterilization can be used to sterilize the first container prior to placing the first container into the second container and para 0105-0107 teach how a first container can be sterilized using electron beam sterilization.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 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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