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 .
Claim Objections
Claims 1, 9, 16 are objected to because of the following informalities:
In line 1 of claim 1, “delivery of medicament” should read “delivery of a medicament”.
In line 4 of claim 1, “adhesive patch” should read “the adhesive patch”.
In line 1 of claim 9, “delivery of medicament” should read “delivery of a medicament”.
In line 4 of claim 9, “adhesive patch” should read “the adhesive patch”.
In line 1 of claim 16, “delivery of medicament” should read “delivery of a medicament”.
In line 4 of claim 16, “adhesive patch” should read “the adhesive patch”.
Appropriate correction is required.
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 1-20 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 recites the limitation "a user" in line 4. It is unclear if it is referring to the limitation in line 2 of claim 1 or it is referring to new user. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of claim 1, line 2.
Claim 9 recites the limitation "a user" in line 4. It is unclear if it is referring to the limitation in line 2 of claim 9 or it is referring to new user. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of claim 9, line 2.
Claim 9 recites the limitation "the tab" in line 8. It is unclear if it is referring to the limitation “at least one tab” or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of the at least one tab.
Claim 10 recites the limitation "the tab" in line 8. It is unclear if it is referring to the limitation “at least one tab” or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of the at least one tab.
Claim 16 recites the limitation "a user" in line 4. It is unclear if it is referring to the limitation in line 2 of claim 16 or it is referring to new user. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of claim 16, line 2.
Claim 19 recites the limitation "a diameter of the adhesive patch" in line 2. It is unclear if it is referring to the limitation in line 8 of claim 16 or it is referring to new limitation. For the purpose of examination, the examiner will interpret the limitation that it is referring to the limitation of claim 16, line 8.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gyrn (US. 20110152778A1).
Re claim 1, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract), comprising: an adhesive patch having an adhesive on an underside of the patch configured to attach that adhesive patch to a body of a user (1, ¶0036) and an opening (7, Fig. 3, Fig. 7, Fig.9, ¶0046) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b) removably attached to the underside of the patch (¶0036), the patch liner including a continuous spline-shaped liner cut extending across a diameter of the adhesive patch to divide the patch liner into a first portion and a second portion (¶0037, lines that separate a first portion 3a and a second portion 3b, in Fig. 2-9 see an example of Annotated Fig. 6-8 of Gyrn).
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Annotated Fig. 6-8 of Gyrn
Re claim 2, Gyrn discloses wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the adhesive patch (at least in Fig. 7-8, it will not intersect with the middle opening, ¶0038).
Re claim 3, Gyrn discloses wherein the first portion and the second portion of the patch liner each include a tab (6a, 6b) configured to be grasped by the user to pull the corresponding portion off of the adhesive patch, ¶037).
Re claim 4, Gyrn discloses wherein each tab is aligned such that when the user pulls the tab the corresponding portion of the patch liner initially separates from the adhesive patch at a single point on the adhesive patch (Fig. 6-9, ¶0037).
Re claim 5, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width from the single point around a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 6, Gyrn discloses wherein each tab is aligned such that when the user pulls the tab a force removing the corresponding portion of the patch liner is directed generally along a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 7, Gyrn discloses wherein the first portion and second portion of the patch liner each overlap the diameter of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 8, Gyrn discloses wherein at least a portion of each of the first portion and the second portion of the patch liner that overlaps the diameter of the adhesive patch is concentrically aligned with a circumference of the adhesive patch (Fig. 6-9, ¶0037).
Re claim 9, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract ), comprising: an adhesive patch (1, ¶0036) having an adhesive on an underside of the patch (1, ¶0036) configured to attach that adhesive patch to a body of a user ( ¶0046) and an opening (7, Fig. 3, Fig. 7, Fig.9, ¶0046) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b, ¶0036) removably attached to the underside of the patch, wherein the patch liner include at least one tab configured to be grasped by the user to pull the patch liner off of the adhesive patch (¶0037), and wherein the at least one tab (6a, 6b) is oriented such that when the user pulls the tab a force removing the patch liner from the adhesive patch is directed generally along a circumference of the adhesive patch (¶0037, ¶0047).
Re claim 10, Gyrn discloses wherein the at least one tab I (6a, 6b) s aligned such that when the user pulls the tab patch liner initially separates from the adhesive patch at a single point on the adhesive patch (¶0047).
Re claim 11, Gyrn discloses wherein the patch liner includes a separate first portion (3a) and second portion (3b, ¶0047), and the at least one tab (6a, 6b) includes a first tab on the first portion (6a) and a second tab on the second portion (6b, ¶0047).
Re claim 12, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width around a circumference of the adhesive patch (Fig. 7).
Re claim 13, Gyrn discloses wherein the first and second portions are separated by a continuous spline-shaped liner cut extending across a diameter of the adhesive patch (line 4 between 3a and 3b, ¶0047).
Re claim 14, Gyrn discloses wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the adhesive patch (Fig. 7-8, ¶0038).
Re claim 15, Gyrn discloses wherein a body portion of the patch liner connected to the tab overlaps a diameter of the adhesive patch around the circumference of the adhesive patch (Fig. 7-8, ¶0038).
Re claim 16, Gyrn discloses an infusion set configured to facilitate delivery of medicament from an infusion pump to a user (¶0025, ¶0047, Fig. 1-11c, abstract ), comprising: an adhesive patch (1, ¶0036) having an adhesive on an underside of the patch configured to attach that adhesive patch to a body of a user (1, ¶0036) and an opening (7, Fig. 3, Fig. 7, Fig.9, ¶0046) extending through the underside of the adhesive patch through which a cannula is configured to be inserted into the body of the user (9, Fig. 10, ¶0046); and a patch liner (liner 3 has at least two sections 3a-b, ¶0036) removably attached to the underside of the patch (¶0037), wherein the patch liner is divided into a separate first portion (3a) and second portion (3b), wherein each of the first portion and the second portion overlaps a diameter of the adhesive patch around a circumference of the adhesive patch (Fig. 2-9, ¶0037, ¶0047).
Re claim 17, Gyrn discloses wherein at least a portion of each of the first portion and the second portion of the patch liner that overlaps the diameter of the adhesive patch is concentrically aligned with the circumference of the adhesive patch (Fig. 2-9).
Re claim 18, Gyrn discloses wherein the first portion and the second portion of the patch liner increase in width around the circumference of the adhesive patch (Fig. 7-8).
Re claim 19, Gyrn discloses wherein the first and second portions are separated by a continuous spline-shaped liner cut extending across a diameter of the adhesive patch (line 4 between 3a and 3d, Fig. 7-8, ¶0038).
Re claim 20, Gyrn discloses wherein the continuous spline-shaped liner cut does not intersect the opening extending through the underside of the adhesive patch (Fig. 7-8, ¶0038).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAMZA A. DARB whose telephone number is (571)270-1202. The examiner can normally be reached 8:00-5:00 M-F (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAMZA A DARB/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783