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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a sensor unit defining a particular “sealed” region as being within a cover, second opening, and introducer, where a sensor is configured to include one portion in that region and one portion outside that region as described in the specification. As shown, it appears that there may be a slot in cylindrical member 221 so that sensor 206 can be pushed into place from beyond element 224 up to meeting surface 204, as the areas shaded consistently with 204 are not present on the left side of chamber 220 in figure 2A
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However, figure 2B presents only a partial illustration that does not clearly show what this area looks like. If element 221 is not a solid cylinder, it is not clear how it can distinctly seal off the interior area 220 to create a separate sealed area. However, if element 221 is a solid cylinder, it is not clear how the device could be assembled - is element 206 passed through the apparent opening shown in 2A and then bent into its perpendicular shape? Otherwise, the expanded illustration of figure 2B does not appear to be physically possible to achieve. Further, if 221/224 does have some sort of slot that would allow element 206 to be seated within it, is there some additional component that would close that off that has not been illustrated? Opening 234 appears to have some sort of tab that apparently fits into some opening in the side of element 221? If not, how are these assembled? Is there an additional component that fits into elements 221, 233, 234 providing some aspect of “sealing”? Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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.
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 device having both a “second opening” and an “insertion shaft opening” 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 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, 2, 4-8, 21-24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 defines that the insertion shaft cover and introducer are both sealed against the housing proximate the second opening, but later defines that “the sealed and sterilized region is formed by the insertion shaft cover, an insertion shaft opening, and the introducer”. It is unclear how this “insertion shaft opening” relates to the “second opening”, whether both openings are present in the housing, or even how these three elements could constitute a “sealed” region when the cover and introducer are sealed proximate the second opening, not the insertion shaft opening. Clarification is required.
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.
Claim(s) 1, 2, 4-8, and 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pace (US 2013/0150691).
Regarding claim 1, Pace discloses a sensor assembly for a continuous glucose monitoring system, comprising:
a sensor unit, comprising:
a sensor housing (paragraph [0125]);
a “sealed and sterilized region” (see figure 23B; as noted above regarding the drawings, as the instant invention does not include structural elements defining all boundaries of this region, any region contained in the same area and including some “seals” is thus equally “sealed”; paragraphs [0084], [0085]),
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a conductive member outside of the “sealed and sterilized region” (elements 2204, see figures 22, 23A, 23B);
a sensor (element 2202, see figure 23B) comprising a non-contact portion that is within the “sealed and sterilized region” and wherein the sensor comprises a contact portion that is outside of the “sealed and sterilized region”,
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wherein the conductive member makes electrical contact with the contact portion of the sensor outside of the sealed and sterilized region (see figure 23B);
an insertion shaft cover (element 2212); and
an introducer (element 2206);
wherein the sensor housing comprises:
a bottom member (element 2208);
a top member coupled to the bottom member (element 2210);
a first opening (see figure 23B, where elements 2204 exit the unit);
a second opening laterally displaced from the first opening and extending through the bottom member and through the top member; [[and]]
wherein the conductive member extends through the first opening (elements 2204, see figures 22, 23A, 23B);
wherein the sensor extends at least partially through the second opening (element 2202, see figure 23B);
wherein the insertion shaft cover is sealed against a top surface of the top member proximate the second opening (element 2212, see figure 23B);
wherein the introducer is sealed against a bottom surface of the bottom member proximate the second opening (element 2206, see figures 23A, 23B);
wherein the “sealed and sterilized region” within the sensor unit is formed by the cover, an “insertion shaft opening”, and the introducer (see figure 23B; as noted above, as the instant invention does not include structural elements defining all boundaries of this region, any region contained in the same area which includes some seals is thus equally “sealed”; paragraphs [0084], [0085]);
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a sensor carrier, comprising:
a sensor unit receiving area for receiving the sensor unit (figure 25A); and
an electronics receiving area configured to electrically connect to the conductive member of the sensor unit (figure 24A; paragraph [0126]).
Pace does not disclose the first opening extending through the “bottom member”; Pace does disclose the first opening extending through the “top member” in this embodiment, but in other embodiments discloses the area where the sensor makes contact with the conductive member being on the “bottom member” side of an equivalent sensor unit (see figures 34C, 34D, 47A, 47B), and paragraph [0140] states that “In some embodiments, all the sensor’s electrical contacts 3312, 3314, 3316 can be provided on a single side of the sensor 3300, or, in other embodiments, both sides of the sensor 3300.” As such, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have merely reversed the parts to move the location of first opening from “top” to “bottom”, as this would be an obvious modification given the disclosures of a plurality of potential locations for this connection area. See In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955), and MPEP 2144.05.VI.A.
Regarding claim 2, Pace further discloses that the introducer comprises a handle and an insertion shaft (figure 23A, element 2206), wherein the insertion shaft extends through the “insertion shaft opening” and is within the “sealed and sterilized region” (figure 23B).
Regarding claim 4, Pace further disclose that the sensor unit further comprises:
a spacer pad disposed between the top member and the bottom member (paragraph [0125], the fill),
wherein the second opening extends from the bottom member through the spacer pad and to the top member (see figure 23B, the second opening allows passage of the introducer between “top” and “bottom”, and
wherein the first opening extends from the bottom member to the spacer pad (as modified above with the first opening extending through the bottom member; figure 23B, the “first opening” ends when it meets the “spacer pad”.
Regarding claim 5, Pace further discloses that the sensor unit further comprises a “cylindrical member” extending through the second opening between the “top member” and the “bottom member”, and wherein the sensor is received with in the “cylindrical member” (element 2206, see figures 23A, 23B).
Regarding claim 6, Pace further discloses that the sensor carrier comprises a “first sensor carrier opening” through which the “cylindrical member” passes when the sensor unit is positioned within the sensor unit receiving area (figures 21A-C, 24B, 26).
Regarding claim 7, Pace further discloses that the sensor carrier further comprises a “top carrier member” coupled to a “bottom carrier member” to define the electronics receiving area (figures 24A, 25A; paragraphs [0126], [0127]).
Regarding claim 8, the Examiner notes that “opposite” is a relative term dependent upon the point of reflection such that Pace’s first opening is “opposite” the second opening in the sensor unit.
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Regarding claim 21, Pace further discloses that the sensor carrier further comprises: electronic circuitry (paragraph [0126]), wherein the electronic circuitry comprises a memory configured for receiving information from the sensor (inherently required for the circuitry as disclosed to function).
Regarding claim 22, Pace further discloses that the sensor and the insertion shaft are sterilized within the “sealed and sterilized region” (paragraphs [0084]-[0085]).
Regarding claim 23, Pace further discloses that the conductive member makes electrical contact with the contact portion of the sensor via one or more predefined portions of the conductive member (elements 2204, see figures 22, 23A).
Regarding claim 24, Pace further discloses that the conductive member is configured to allow the sensor to make electrical contact with a substrate (paragraph [0125]).
Response to Arguments
Applicant's arguments filed 10 December 2025 have been fully considered but they are not persuasive.
Regarding the Drawings, the Examiner notes that the amendment to the drawings to identify a particular part of the sensor does not address the issue of how that part of the sensor is assembled with the remainder of the device, particularly in that element 221 is not fully or clearly illustrated and does not show how sensor 206/233 is inserted into element 221 and also whether there is some sealing element on the side of element 221 that would result in the “sealed” region being fully sealed or if “sealed” refers only to that being a region which in some areas is sealed and other areas is not. The Examiner also notes that the amendment to the claims defining an “insertion shaft opening” in addition to the “second opening” has raised additional drawing objections.
Regarding the art rejections, Applicant’s arguments rely upon an application of Pace against a different invention; that invention is not being examined here such that those arguments are moot.
As the instant application does not clearly show or disclose all boundaries of a “sealed” region as having specific structural features that differ from Pace’s equivalent “sealed” region, Pace clearly teaches a region that is “sealed” in the same manner as that of the instant invention where it is a region defined by a cover, opening, and introducer, the cover and introducer sealed to the opening, and which has within a portion of a sensor where the remainder of that sensor is outside that region with no disclosed, drawn, or claimed features limiting how that sensor exits the “sealed” region or what other features might be present as part of defining boundaries of that “sealed” region. Applicant’s remarks asserting that “Pace does not teach or suggest a sensor with a contact portion outside of the sealed and sterilized region and a non-contact portion inside the sealed and sterilized region” is entirely unpersuasive as Pace does teach this when the sealed and sterilized region of Pace is defined using the same boundaries as defined by the disclosure of the instant invention. The claims remain rejected.
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/ Examiner, Art Unit 3791