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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 February 2026 has been entered.
Response to Amendment
Applicant’s amendment, filed 23 February 2026, is acknowledged. Claim 1 is amended. Claims 92-93 are new. Claims 3, 9, and 19-89 were previously cancelled.
Claims 1, 2, 4-8, 10-18 and 90-93 are pending in the instant application.
Response to Arguments
Regarding Applicants arguments, regarding the 103 rejection of claim 1, Examiner respectfully does not agree that Rao fails to disclose the elongate protector comprises a channel, as Examiner believes Figure 11B, shows a channel. As Rao does not describe, in writing, that the elongate protector comprises a channel and in an effort to move prosecution, Examiner will withdraw the 35 USC 103 rejections in view of Rao (US20180235520A1) and further in view of Matsumoto (US20160008028A9), however, a new ground(s) of rejections for claim 1 is made in view of Rao (US20180235520A1) and further in view of Choi (WO2019045503A1) and in view of Rao (US20180235520A1) and further in view of Nakamura (WO2004002312A1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 4, 6-8, 10-15, 90, and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Choi (WO2019045503A1).
Regarding claim 1, Rao discloses an applicator (Paragraph [0008], Fig. 10C), comprising a housing (Figure 10C, housing “2702”) comprising a distal end configured to be placed against a skin surface (Paragraph [0153]); a sensor module comprising a connector coupled with a sensor (Paragraph [0092]); a sharp module coupled with the sensor module (Paragraph [0092]), the sharp module comprising: a base (Figure 11B, hub push cylinder “2558”); an elongate protector coupled with the base wherein the elongate protector comprises a longitudinal axis (Figure 11B, sharp spacer “2568”); and a sharp coupled with the elongate protector or the base (Figure 11B, hub push cylinder “2552”), wherein a distal portion of the sharp extends past a distal end of the elongate protector at an angle to a longitudinal axis of the elongate protector (Figure 11E); a retraction spring configured to automatically retract the sharp module and the sharp from the skin surface in a proximal direction (Figure 13D, outer spring “1104”, paragraph [0161]); and sensor electronics configured to be advanced from a proximal position in the housing to a distal position (Paragraphs [0159]-[1060]).
Rao does not expressly disclose that the elongate protector comprises a channel, wherein the channel of the elongate protector is configured to receive an intermediate portion of the sensor. Choi discloses an alternative design for a sharp module, with the sharp module comprising an elongate protector (See annotated figure 2 below) wherein the elongate protector comprises a longitudinal axis and a channel (See annotated figure 2 below), wherein the channel of the elongate protector is configured to receive an intermediate portion of the sensor (See annotated figure 2 below), wherein a distal portion of the sensor extends past a distal end of the elongate protector (See annotated figure 2 below); and a sharp coupled with the elongate protector (See annotated figure 2 below), wherein a distal portion of the sharp extends past the distal end of the elongate protector at an angle to a longitudinal axis of the elongate protector (See annotated figure 4A below). As the sharp module of Choi is intended to work with a continuous glucose monitoring system (Page 2), it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by Rao, with the sharp module as taught by Choi, since such a modification would provide the predictable results of providing a sharp module of high strength and flexibility (Page 2), while allowing a smaller diameter needle to be used, reducing a user’s pain (Page 2).
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Regarding claim 2, Rao as modified by Choi, discloses the sharp comprises a proximal portion and a bent portion between the proximal portion and the distal portion (Rao, Figure 11E). While Choi does not disclose a bent sharp, Choi does disclose the sharp and sensor are flexible (Page 2). As inserting an needle at an angle provides greater control over the penetration depth of the needle versus inserting at 90 degrees, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with the sharp comprises a proximal portion and a bent portion between the proximal portion and the distal portion as taught by Rao, since such a modification would provide greater accuracy in achieving the appropriate penetration depth.
Regarding claim 4, Rao as modified by Choi, discloses the channel has a cross-section
shaped like a U (Choi, see Figure 2 above).
Regarding claim 6, Rao as modified by Choi, discloses the proximal portion of the sharp is attached to the elongate protector (Choi, see Figure 2 above).
Regarding claim 7, Rao, as modified in claim 2, further discloses the bent portion comprises a single deflection having an angle formed by the proximal and distal portions of the sharp (Figure 11E), wherein the angle is between about 160° and about 175° (Paragraph [0139] If the distal tip forms an angle with a line parallel to the proximal portion, and that angle is between 5° to 17° then angle between the proximal and distal portions would be between 163° and 175°).
Regarding claim 8, Rao, as modified by Choi, discloses the elongate protector has a first side and a second side, wherein the first side comprises the channel, and the proximal portion of the sharp is attached to the second side of the elongate protector, wherein the second side is a back side of the first side (Choi, see Figure 2 above).
Regarding claim 10, Rao as modified by Choi, discloses channel extends along a distal portion of the elongate protector (Choi, see Figure 2 above).
Regarding claim 11, neither Rao as modified by Choi, nor Choi, disclose the distal portion of the sharp has a length in a range of about 1.0 to about 5.0 mm. Rao does disclose that a sharp may have a length between 1.5 to 25 mm (Paragraph [0147]), wherein the sharp is dimensioned such that the applicator provides for insertion of at least a portion of the dermal sensor into the dermal layer (Paragraph [0146]). Rao future discloses the insertion depth of the sharp in the skin on a subject in those certain embodiments will be limited to the dermal layer, e.g., about 1.5 mm to 4 mm, depending on the skin location (Paragraph [0147]). As the criticality of the length of distal portion of the sharp is not disclosed by specification or claims, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with the length of distal portion of the sharp in a range of about 1.0 to about 5.0 mm since the range could be found through routine optimization of the sharp length to provide penetration limited to the dermal layer, e.g., about 1.5 mm to 4 mm.
Regarding claim 12, Rao, as modified in claim 1, discloses wherein the sharp comprises a solid needle (Choi, see annotated figure 2 above, “Solid” is an extra broad term. It’s a metal needle, therefore it is solid). Choi is silent as to the diameter, but Rao discloses the sharp has a cross-sectional diameter of from 0.1 mm to 0.5 mm (Rao, Paragraph [0146]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by Rao, with a sharp not having a diameter greater than about 0.5 mm as taught by Rao, since such a modification would provide the predictable results of the sharp being dimensioned such that the applicator provides for insertion of at least a portion of the dermal sensor into the dermal layer (Rao, Paragraph [0146]).
Regarding claim 13, Rao, as modified in claim 1, disclose the angle of insertion is between about 5° and about 15°. (Paragraph [0146]). While Choi does not disclose an insertion angle, Choi does disclose the sharp and sensor are flexible (Page 2). As inserting a needle at an angle provides greater control over the penetration depth of the needle versus inserting at 90 degrees, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with an angle of insertion between about 5° and about 15° as taught by Rao, since such a modification would provide greater accuracy in achieving the appropriate penetration depth.
Regarding claim 14, Rao, as modified by Choi, further discloses applicator is configured to advance the sensor electronics in a distal direction (Rao, Paragraphs [0159]-[1060]).
Regarding claim 15, Rao, as modified by Choi, further discloses the sensor further comprises a bump having a traction surface disposed for engagement with the distal end of the elongate protector for transmission of an insertion force along an insertion force vector that is substantially parallel to the longitudinal axis of the elongate protector (Choi, see Figure 2 above, oblique serration protrusion “111”, Page 2).
Regarding claim 90, Rao, as modified by Choi, further discloses the sharp is coupled to the elongate protector (Choi, see Figure 2 above).
Regarding claim 92, Choi is silent as to the length of the sensor extending past that distal end of the elongate protector. Rao discloses the dimensions of the sensor may be selected according to the body site of the subject in which the sensor is to be inserted, as the depth and thickness of the epidermis and dermis exhibit a degree of variability depending on skin location (Paragraph [0149]). As the criticality of to the length of the sensor extending past that distal end of the elongate protector is not disclosed by specification or claims, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with the length of the sensor extending past that distal end of the elongate protector being in the range of 0.5 to 4.0 mm, since the range could be found through routine optimization of the sensor length to provide appropriate penetration.
Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Nakamura (WO2004002312A1).
Regarding claim 1, Rao discloses an applicator (Paragraph [0008], Fig. 10C), comprising a housing (Figure 10C, housing “2702”) comprising a distal end configured to be placed against a skin surface (Paragraph [0153]); a sensor module comprising a connector coupled with a sensor (Paragraph [0092]); a sharp module coupled with the sensor module (Paragraph [0092]), the sharp module comprising: a base (Figure 11B, hub push cylinder “2558”); an elongate protector coupled with the base wherein the elongate protector comprises a longitudinal axis (Figure 11B, sharp spacer “2568”); and a sharp coupled with the elongate protector or the base (Figure 11B, hub push cylinder “2552”), wherein a distal portion of the sharp extends past a distal end of the elongate protector at an angle to a longitudinal axis of the elongate protector (Figure 11E); a retraction spring configured to automatically retract the sharp module and the sharp from the skin surface in a proximal direction (Figure 13D, outer spring “1104”, paragraph [0161]); and sensor electronics configured to be advanced from a proximal position in the housing to a distal position (Paragraphs [0159]-[1060]).
Rao does not expressly disclose that the elongate protector comprises a channel, wherein the channel of the elongate protector is configured to receive an intermediate portion of the sensor. Nakamura a piercing needle-integrated body fluid sampling device (Abstract), wherein the needle spacer (Figure 3, needle storage section, “2”) and the sensor holder (Figure 3, “6”) for a channel (Figure 3, second support portion “82”). The second support section is configured to receive and intermediate portion of the sensor (Figure 3, sensor “5”). As Rao, in Figure 11E, shows a similar channel between the casing located near the protrusion “2251” and the spacer “2586” similar to the second support section of Nakamura, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by Rao, with the second support section as taught by Nakamura, since such a modification would provide the predictable results of supporting the proximal end side of the sensor (Nakamura, page 7).
Regarding claim 5, Rao, as modified by Nakamura in claim 1, further discloses the distal portion of the sharp is not attached to the elongate protector (Figure 11E).
Claims 16 and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Choi (WO2019045503A1), as applied to claim 15 above, and further in view of Estes (US20130245981A1).
Regarding claim 16, Rao as modified in claim 15, does not disclose the bump comprises a sensor chip. Estes discloses a system for continuous analyte analysis (Abstract) comprising a sensor system and applicator (Paragraphs [0182]-[0184]), wherein the sensor system comprises an implantable analyte sensor and a thermistor integral with the analyte sensor that measures temperature at the surface of the skin (Paragraphs [0182]-[0184]). The thermistor, recognized by a POSITA as a sensor chip, provides a comparative value to the analyte sensor so that factors contributing to a change in sensor sensitivity or a change in other sensor properties can then be determined (Paragraph [0278]). As the bump disclosed by modified Rao is not at the distal end of the sensor, therefore it would have been close to the surface of a user’s skin, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with the bump comprising a sensor chip as taught by Estes, since such a modification would provide the predictable results of providing a comparative value to the analyte sensor so that factors contributing to a change in sensor sensitivity or a change in other sensor properties can then be determined (Paragraph [0278]).
Regarding claim 93, Estes previously disclosed in claim 16 supra, the sensor chip is a thermistor (Paragraph [0278]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Choi (WO2019045503A1) and Estes (US20130245981A1) as applied to claim 16 above, and further in view of Simpson (US20140107450A1).
Regarding claim 17, Rao as modified in claim 16, does not disclose sensor chip is encased in a protective membrane. Simpson discloses an applicator for measuring an analyte concentration, wherein the entire sensor body is coated in a hardening agent (Figure 9) to prevent the sensor body from bending or peeling back during insertion (Paragraph [0150]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with the sensor chip being encased in a protective membrane as taught by Simpson, since such a modification would provide the predictable results of preventing the sensor chip from being damaged during insertion of the sensor body (Paragraph [0150]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Choi (WO2019045503A1), as applied to claim 1 above, and further in view of Simpson (US20140107450A1).
Regarding claim 18, Rao, as modified in claim 1, does not disclose the sensor further comprises a stiffener coupled with a distal portion of the sensor. Simpson discloses an applicator for measuring an analyte concentration, wherein the sensor body is coated in a hardening agent (Figure 9) to prevent the sensor body from bending or peeling back during insertion (Paragraph [0150]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, such that the sensor further comprises a stiffener coupled with a distal portion of the sensor as taught by Simpson, since such a modification would provide the predictable results of preventing the sensor body from bending or peeling back during insertion (Paragraph [0150])
Claim 91 is rejected under 35 U.S.C. 103 as being unpatentable over Rao (US20180235520A1) in view of Choi (WO2019045503A1), as applied to claim 1 above, and further in view of Effenhauser (WO03009759A1).
Regarding claim 91, Rao, as modified in claim 1 by Choi, discloses through the sharp module of Choi, that the sharp is attached to the elongate protector (Choi, see annotated figure 2 above), but is silent as how the sharp and elongate protector are connected. Effenhauser discloses a system for collecting small amounts of body fluids (Abstract) and that is known in the art to connect two metallic insertion components via welding (page 4). If POSITA was looking to couple the sharp to the elongate protector it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the applicator as taught by modified Rao, with coupling the sharp to the elongate protector by spot welding as taught by Effenhauser, since such a modification would provide the predictable results of an effective method of coupling that would not interfere with the biocompatibility of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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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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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791