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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 5/15/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brister et al. (US US 2006/0142651 A1, hereinafter Brister).
For claim 1, Brister discloses an applicator (12) for applying an analyte monitor (14) to a patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]), the applicator comprising inter alia:
a surface (adhesive pad 8) configured to hold at least a base of the analyte monitor for positioning the base against the patient's skin and adhering the base to the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0271-0276]);
a delivery needle (sensor needle 32) configured to advance axially past the surface of the applicator and the base of the analyte monitor when the base is held to the applicator to deliver a portion of a sensor member of the analyte monitor into the patient's skin at an insertion site located laterally within a perimeter of the base (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0299-0321]); and
an actuator (button 22) configured to be actuated to initiate advancement of the delivery needle to the insertion site and into the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0398-0428]);
wherein when the applicator is held against the patient's skin to adhere the base of the analyte monitor to the patient's skin, at least part (60) of the actuator is positioned directly above the insertion site of the delivery needle relative to an axis that is normal to a surface of the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 1), and the actuator is configured to be actuated in a direction parallel to the axis that is normal to the surface of the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 1, wherein button 22 may be actuated in a normal direction to patient’s skin when pressed).
For claim 2, Brister discloses the applicator of claim 1, wherein the surface of the applicator is further configured to hold at least a transmitter (148) of the analyte monitor (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Figs 1,14A).
For claim 3, Brister discloses the applicator of claim 1, wherein the delivery needle is configured to advance linearly past the surface and the base when the actuator is actuated (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B).
For claim 4, Brister discloses the applicator of claim 3, wherein the delivery needle is configured to advance linearly at an acute angle relative to the surface of the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B).
For claim 5, Brister discloses the applicator of claim 1, wherein the delivery needle is configured to advance along a curved trajectory past the surface and the base when the actuator is actuated (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B and [0436-0438] when insertion angle alpha is varied during insertion).
For claim 6, Brister discloses the applicator of claim 1, wherein after the portion of the sensor member is delivered into the patient's skin at the insertion site, the delivery needle is configured to be retracted back above the surface and the base and into the applicator while the portion of the sensor member remains in the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0455,0466-0505]) (especially [0455]).
For claim 7, Brister discloses the applicator of claim 1, wherein the actuator comprises a button or trigger (button 22) (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]).
For claim 8, Brister discloses the applicator of claim 1, wherein a minimum force needed to actuate the actuator corresponds to a desired force to be applied by the actuator to the patient's skin at the insertion site to constrain a region of the patient's skin around the insertion site (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0411]).
For claim 9, Brister discloses an applicator (12) for applying an analyte monitor (14) to a patient's skin, the applicator comprising inter alia:
a surface (adhesive pad 8) configured to hold at least a base of the analyte monitor for positioning the base against the patient's skin and adhering the base to the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0271-0276]);
a delivery needle (sensor needle 32) configured to advance axially past the surface of the applicator and the base of the analyte monitor when the base is held to the applicator to deliver a portion of a sensor member of the analyte monitor into the patient's skin at an insertion site located laterally within a perimeter of the base (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0299-0321]); and
an actuator (button 22) configured to be actuated to initiate advancement of the delivery needle to the insertion site and into the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0398-0428]);
wherein when the surface of the applicator is held against the patient's skin to adhere the base to the patient's skin, the delivery needle is configured to be advanced along an axis that is arranged at an acute angle relative to a surface of the patient's skin to deliver the sensor member under the surface of the patient's skin at the acute angle (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B), while the actuator is configured to be actuated in a direction perpendicular to the surface of the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 1, wherein button 22 may be actuated in a normal direction to patient’s skin when pressed), such that respective axes of movement of the delivery needle and the actuator are angled relative to one another (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B).
For claim 10, Brister discloses the applicator of claim 9, wherein the surface of the applicator is further configured to hold at least a transmitter (148) of the analyte monitor (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Figs 1,14A).
For claim 11, Brister discloses the applicator of claim 9, wherein after the portion of the sensor member is delivered into the patient's skin at the insertion site, the delivery needle is configured to be retracted back above the surface and the base and into the applicator while the portion of the sensor member remains in the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [04555]).
For claim 12, Brister discloses the applicator of claim 9, wherein the actuator comprises a button or trigger (button 22) (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]).
For claim 13, Brister discloses the applicator of claim 9, wherein the acute angle is between 20° and 40° (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B and [0412,0436-0438]).
For claim 14. The applicator of claim 13, wherein the acute angle is approximately 30° (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Fig 10B and [0412,0436-0438]).
For claim 15, Brister discloses a system (10) (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]), comprising inter alia:
an analyte monitor (14) (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) and
an applicator (12) for applying the analyte monitor to a patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]), the applicator comprising inter alia:
a surface (base 24) configured to hold at least a base of the analyte monitor for positioning the base against the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0269-0276]);
a delivery needle (sensor needle 32) configured to advance axially past the surface of the applicator and the base of the analyte monitor when the base is held to the applicator to deliver a portion of a sensor member (26) of the analyte monitor into the patient's skin at an insertion site located laterally within a perimeter of the base (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0299-0321]); and
an actuator (button 22) configured to be actuated to initiate advancement of the delivery needle to the insertion site and into the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0398-0428]);
wherein when the applicator is held against the patient's skin, an adhesive patch (adhesive pad 8) is configured to adhere the base to the patient's skin ((Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0269-0276]), the adhesive patch further configured to constrain a region of the patient's skin surrounding the insertion site (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0269-0276]), and wherein actuation of the actuator in a direction perpendicular to a surface of the patient’s skin is configured to apply direct pressure against a portion of the adhesive patch that surrounds the insertion site and that is closer radially to the insertion site than to an outer perimeter of the base to increase tension of the patient's skin that surrounds the insertion site during advancement of the delivery needle (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0269-0276]).
For claim 16, Brister discloses the system of claim 15, wherein the surface of the applicator is further configured to hold at least a transmitter (148) of the analyte monitor (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially Figs 1,14A).
For claim 17, Brister discloses the system of claim 15, wherein after the portion of the sensor member is delivered into the patient's skin at the insertion site, the delivery needle is configured to be retracted back above the surface and the base and into the applicator while the portion of the sensor member remains in the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0455]).
For claim 18, Brister discloses the system of claim 15, wherein the sensor member is configured to be inserted to a maximum depth of 1.5 mm to 3 mm deep in the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0438]).
For claim 19, Brister discloses the system of claim 18, wherein the sensor member is configured to be inserted to a maximum depth of less than 2.5 mm deep in the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0438]), so as to position sensing regions of the sensor member in the dermis of the patient's skin (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0438]).
For claim 20, Brister discloses the system of claim 15, wherein when the surface of the applicator is held against the patient's skin, a distance between the insertion site and the portion of the adhesive patch that surrounds the insertion site where the direct pressure is applied by the actuator is less than 1 cm (Figs 1-3,10A-10B,14A,15) ([0255-0322,0393-0438,0466-0505]) (especially [0269-0276]).
Response to Arguments
Applicant’s arguments, see page 7, filed 5/15/26, with respect to the amended claim(s) overcoming the 112(b) rejection have been fully considered and are persuasive. The 112(b) rejection of the claim(s) has been withdrawn in lieu of the amendment.
Applicant's arguments, see pages 7-10, filed 5/15/26 have been fully considered but they are not persuasive.
Applicant argues the anticipatory rejection of the claims under Brister, specifically arguing the following:
For claim 1, “Brister does not disclose a device where "at least part of the actuator is positioned directly above the insertion site of the delivery needle," or an arrangement where "the actuator is configured to be actuated in a direction parallel to the axis that is normal to the surface of the patient's skin," as recited in claim 1. The Examiner interprets plunger subassembly 22 as being the actuator in Brister. However, as can best be seen in Figs. 8B-8D of Brister, no part of plunger subassembly 22 is ever "positioned directly above the insertion site" of needle 72. Furthermore, plunger subassembly 22 of Brister is arranged at an acute angle a relative to the surface of the patient's skin, and the applicator of Brister is not adjustable, so that the angle a cannot be increased or decreased. Therefore, plunger subassembly 22 of Brister can only be actuated at the angle a relative to the patient's skin, and not "in a direction parallel to the axis that is normal to the surface of the patient's skin," as further recited in claim 1.”
For claims 9 and 15, “Brister does not disclose an arrangement where "the actuator is configured to be actuated in a direction perpendicular to the surface of the patient's skin," or where "respective axes of movement of the delivery needle and the actuator are angled relative to one another," as recited in claim 9. Similar to the rejection of claim 1, the Examiner interprets plunger subassembly 22 of Bristor as being the actuator. However, similarly as discussed above with respect to claim 1, plunger subassembly 22 of Brister is only movable along an acute angle a relative to the surface of the patient's skin, where the angle a is not adjustable, and therefore plunger subassembly 22 cannot be actuated in a direction perpendicular to the surface of the patient's skin, as recited in claim 9. Furthermore, plunger subassembly 22 of Brister and needle 72 move coaxially (i.e., along the same axis), so the respective axes of movement of the delivery needle and the actuator are not angled relative to one another, as further recited in claim 9.”
The Examiner respectfully disagrees, maintains the rejection as set forth and reiterated hereinabove, and in response notes the following:
Brister’s device, as cited, meets the claim limitations of "at least part of the actuator is positioned directly above the insertion site of the delivery needle," and an arrangement where "the actuator is configured to be actuated in a direction parallel to the axis that is normal to the surface of the patient's skin,".
Brister’s device, as cited, meets the claim limitations where "the actuator is configured to be actuated in a direction perpendicular to the surface of the patient's skin," and where "respective axes of movement of the delivery needle and the actuator are angled relative to one another,".
Figures 1, 8A, and 8B clearly show that when 12, which contains elongate 22, engages 10 to insert 32, that at least a part of the actuator must be situated directly above the insertion site of the delivery needle for insertion to succeed. Not only is a part of the actuator positioned in that fashion, the entirety of 22 is positioned directly above in when considering a direction along the insertion angle. Further, the distalmost portion of 22 may be considered the part positioned directly above the insertion site of the delivery needle in an alternate interpretation.
The examiner agrees that Brister’s actuation of the delivery needle may in one illustrated example be at an acute angle with respect to the patient’s skin. However, Brister’s actuator may be pushed/actuated in a perpendicular direction towards the skin that would engage and insert the hinged needle at an acute angle with respect to the skin while the actuator is perpendicularly engaged with varying angles between the delivery needle and actuator. The user may engage the actuator button from many varying angles of approach. Nonetheless, Brister discloses arranging the actuator perpendicular to or at a variety of other angles relative to the delivery site (as reproduced hereinbelow) and further includes a hinged disposition between the actuator and delivery needle to permit an angle therebetween..
In response to Applicant’s arguments, the Examiner notes Brister explicitly states inter alia:
“[0412] FIG. 8B shows the mounting unit and applicator in the ready position. The sensor system can be shipped in this configuration, or the user can be instructed to mate the applicator 12 with the mounting unit 14 prior to sensor insertion. The insertion angle a is preferably fixed by the mating engagement of the applicator 12. In the illustrated embodiment, the insertion angle a is fixed in the applicator 12 by the angle of the applicator body base 60 with the shaft of the applicator body 18. However, a variety of systems and methods of ensuring proper placement can be implemented. Proper placement ensures that at least a portion of the sensor 32 extends below the dermis of the host upon insertion. In alternative embodiments, the sensor system 10 is designed with a variety of adjustable insertion angles. A variety of insertion angles can be advantageous to accommodate a variety of insertion locations and/or individual dermis configurations (for example, thickness of the dermis). In preferred embodiments, the insertion angle a is from about 0 to about 90 degrees, more preferably from about 30 to about 60 degrees, and even more preferably about 45 degrees.”
“[0427] In some embodiments, the sensor 32 exits the base of the mounting unit 14 at a location distant from an edge of the base. In some embodiments, the sensor 32 exits the base of the mounting unit 14 at a location substantially closer to the center than the edges thereof. While not wishing to be bound by theory, it is believed that by providing an exit port for the sensor 32 located away from the edges, the sensor 32 can be protected from motion between the body and the mounting unit, snagging of the sensor by an external source, and/or environmental contaminants (e.g., microorganisms) that can migrate under the edges of the mounting unit. In some embodiments, the sensor exits the mounting unit away from an outer edge of the device. FIG. 23 shows transcutaneous glucose sensor data and corresponding blood glucose values obtained over approximately seven days in a human, wherein the transcutaneous glucose sensor data was configured with an exit port situated at a location substantially closer to the center than the edges of the base.”
“[0436] FIGS. 10A and 10B are perspective and side cross-sectional views, respectively, of the mounting unit immediately following sensor insertion and release of the applicator from the mounting unit. In one embodiment, such as illustrated in FIGS. 10A and 10B, the contact subassembly 26 is held in its insertion position, substantially at the insertion angle .alpha. of the sensor. Maintaining the contact subassembly 26 at the insertion angle a during insertion enables the sensor 32 to be easily inserted straight through the contact subassembly 26. The contact subassembly 26 further includes a hinge 38 that allows movement of the contact subassembly 26 from an angled to a flat position. The term "hinge," as used herein, is a broad term and is used in its ordinary sense, including, without limitation, a mechanism that allows articulation of two or more parts or portions of a device. The term is broad enough to include a sliding hinge, for example, a ball and detent type hinging mechanism.”
“[0437] Although the illustrated embodiments describe a fixed insertion angle designed into the applicator, alternative embodiments can design the insertion angle into other components of the system. For example, the insertion angle can be designed into the attachment of the applicator with the mounting unit, or the like. In some alternative embodiments, a variety of adjustable insertion angles can be designed into the system to provide for a variety of host dermis configurations.”
Conclusion
THIS ACTION IS MADE FINAL. 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY G. HOEKSTRA/Primary Examiner, Art Unit 3791
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
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