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 .
Information Disclosure Statement
The information disclosure statements (IDS) been submitted on 02/10/26, 10/17/25 and 10/11/24 have been considered by the examiner
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Halac (US 2017/0188910)
Halac was applied in Applicant’s IDS submitted on 02/10/26
Regarding claim 1, Halac teaches an applicator assembly comprising:
a medical device comprising a sensor unit [fig. 7, element 134] having a sensor of which at least a portion is to be inserted into skin of a user [fig. 7, element 138] and a base unit [fig. 7, element 128] attached to the skin of the user to be coupled to the sensor unit [fig. 7, element 134; par. 282, 353];
an applicator body [fig. 7, element 152] comprising an applicator body bottom portion [fig. 7, bottom portion of element 152] disposed to face the skin of the user and an applicator body recess formed to the applicator body bottom portion wherein the base unit is disposed [fig. 7, 18, 19, the recess below element 232; par. 282, 354];
and an insertion unit disposed to the applicator body for moving the sensor unit from a first position spaced apart from the base unit to a second position for being coupled to the base unit [fig. 7, element 150; par. 283],
wherein the base unit is disposed to the applicator body recess to protrude from the applicator body bottom portion [par. 283, 284]
Regarding claim 3, Halac further teaches a locking hook that is provided on the applicator body, wherein at least a portion of the locking hook protrudes from the applicator body bottom portion and that is configured to engage with a portion of the base unit, wherein the portion of the base unit protrudes from the applicator body bottom portion [fig. 19, elements 232, 230; par. 354]
Regarding claim 6, Halac teaches an applicator for attaching, to skin of a user, a medical device [fig. 7, element 132] comprising
a sensor unit [fig. 7, element 134] having a sensor of which at least a portion is to be inserted into the skin of the user [fig. 7, element 138] and a base unit [fig. 7, element 128] attached to the skin of the user to be coupled to the sensor unit [fig. 7, element 134; par. 282, 353],
the applicator comprising: an applicator body [fig. 7, element 152] comprising an applicator body bottom portion [fig. 7, bottom portion of element 152] disposed to face the skin of the user and an applicator body recess formed to the applicator body bottom portion wherein the base unit is disposed [fig. 7, 18, 19, the recess below element 232; par. 282, 354];
and an insertion unit disposed to the applicator body for moving the sensor unit from a first position spaced apart from the base unit to a second position for being coupled to the base unit [fig. 7, element 150; par. 283],
wherein a depth of the applicator body recess is smaller than a thickness of the base unit [fig. 7, 18, 19, the recess below element 232; Examiner notes that the edges of the base are thicker than the recess (area between element 232 and bottom of the base 128; par. 282, 354]
wherein the base unit is to protrudes from the applicator body bottom portion when the base unit is disposed to the applicator body recess [par. 283, 284]
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Halac and in further view of Halac (US 2017/0188912), Herein referred to as Halac ‘912
Regarding claim 2, Halac teaches an applicator assembly, as disclosed above.
However, Halac does not teach the applicator body comprises a plurality of floor ribs disposed around the applicator body recess to protrude from the applicator body bottom portion
Halac ‘912 teaches the applicator body comprises a plurality of floor ribs disposed around the applicator body recess to protrude from the applicator body bottom portion [fig. 141, elements 840; par. 680]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Halac, to incorporate the applicator body comprises a plurality of floor ribs disposed around the applicator body recess to protrude from the applicator body bottom portion, for coupling the base to the system, as evidence by Halac ‘912 [par. 680].
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Halac and in further view of Pryor (US 2013/0267811)
Pryor was applied in Applicant’s IDS submitted on 02/10/26
Regarding claim 4, Halac teaches an applicator assembly, as disclosed above.
However, Halac does not teach the sensor is configured to be in contact with an electrical contact part of the base unit when the sensor unit moves to the second position to be coupled to the base unit, and the medical device is configured to be activated as the sensor is in contact with the electrical contact part
Pryor teaches the sensor is configured to be in contact with an electrical contact part of the base unit when the sensor unit moves to the second position to be coupled to the base unit, and the medical device is configured to be activated as the sensor is in contact with the electrical contact part [par. 8, 9]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Halac, to incorporate the sensor is configured to be in contact with an electrical contact part of the base unit when the sensor unit moves to the second position to be coupled to the base unit, and the medical device is configured to be activated as the sensor is in contact with the electrical contact part, for generating and transmitting analyte information, as evidence by Pryor [par. 8, 9].
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Halac and in further view of Rao (US 2018/0235520)
Regarding claim 5, Halac teaches an applicator assembly, as disclosed above.
However, Halac does not teach a protrusion height to which the base unit protrudes from the applicator body bottom portion has a size greater than or equal to a half of a thickness of the base unit
Rao teaches a protrusion height to which the base unit protrudes from the applicator body bottom portion has a size greater than or equal to a half of a thickness of the base unit [fig. 13A, 13B, element 704; Examiner notes element 704 almost fully from element 3704; par. 124]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Halac, to incorporate the sensor is configured to be in contact with an electrical contact part of the base unit when the sensor unit moves to the second position to be coupled to the base unit, and the medical device is configured to be activated as the sensor is in contact with the electrical contact part, for causing the applicator to be “fired” which in turn causes the sharp carrier to advance in the proximal direction, as evidence by Rao [par. 124].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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