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 2/2/26. The previous ground(s) of objection and/or rejection is/are withdrawn.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.
Response to Amendment
The declaration under 37 CFR 1.130 (a) filed on 2/2/26 is sufficient to overcome the rejection of the claims based on Brister et al. (US 20240156376). The declaration effectively provides evidence of the 35 U.S.C. 102(b)(1) exception provision.
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.
Claim 2 is 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 2 positively recites the limitation "the surface of the applicator in line " in 1. Although “the surface” may inherently find antecedent from “the applicator” of claim 1. The scope of the claim is indeterminate with respect to “the surface” of claim 2 and “a surface configured to hold at least a base of the analyte monitor” of claim 1. These appear to be two different “a surface”(s). In light of the instant Specification, one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention, such that the claim is indefinite.
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 surface of the applicator is held against the patient's skin to adhere the base 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 and the base 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 and the base 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 surface of 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 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]).
Conclusion
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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