DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Amendment, filed 03 April 2026, the status of the claims is as follows:
Claims 1, 3, 4, 10, and 13 are currently amended;
Claims 5-9, 11, and 12 are as originally filed; and
Claim 2 is cancelled.
3. The rejection of claim 13 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in view of the Amendment, filed 03 April 2026.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 6-7, filed 03 April 2026, with respect to the rejection of claims 1, 2, 4, and 6-13 under 35 U.S.C. 102(a)(1) as being anticipated by Funderburk et al., U.S. Patent Application Publication No. 2004/0133164 A1, have been fully considered, and are persuasive in view of the Amendment, filed 03 April 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claims 1, 4, and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over Funderburk et al., U.S. Patent Application Publication No. 2004/0133164 A1 (“Funderburk”), in view of Curry et al., U.S. Patent Application Publication No. 2011/0288574 A1 (“Curry”).
As to Claim 1, Funderburk teaches the following:
A needle (“introducer sharp”) 340 included in an applicator (“inserter”) 310 for inserting a sensor (“sensor”) 314 for measuring biometric information into skin of a user and configured to be insertable into the skin of the user with the sensor 314 (see figs. 16 and 26A), the needle 340 comprising:
a needle body (“tail”) 424 having a first channel (“U-shaped rails”) 348 accommodating the sensor 314 and to be insertable into the skin of the user (see “Sensor 314 has a main surface 346 slidably mounted between U-shaped rails 348 of introducer sharp 340 and releasably retained there by sensor dimple 350 which engages introducer dimple 352.” in para. [0102]);
a needle head (“main portion of introducer 340”, not labeled) with a thickness greater than the needle body 424 (see “The height of the main portion of introducer 340 is 0.614 inches, and the inside width is 0.513 inches. … The length and width of introducer tail 424 are 0.354 and 0.036 inches, respectively.” in para. [0113]); and
…
wherein the needle body 424 and the needle head (“main portion of introducer 340”) are formed as one integrated piece (integrated as “introducer sharp 340”) by being press-processed from same base material (see “Introducer 340 is made from SUS 301 medical grade stainless steel, 0.004 inches thick, having a surface roughness less than or equal to 0.5 micrometers. The height of the main portion of introducer 340 is 0.614 inches, and the inside width is 0.513 inches. … The length and width of introducer tail 424 are 0.354 and 0.036 inches, respectively.” in para. [0113]).
Funderburk does not teach the following:
a needle neck formed as one integrated piece with the needle body and the needle head to connect the needle body and the needle head, and having a shape in which a thickness of the needle neck gradually decreases from the needle head toward the needle body by forming a sloped surface that continuously connects the needle head and the needle body, …
However, Curry teaches the following:
a needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, and having a shape in which a thickness of the needle neck gradually decreases from the needle head 136 toward the needle body 124 by forming a sloped surface that continuously connects the needle head and the needle body 136 (see “One embodiment of a needle hub for an inserter is illustrated in FIGS. 4-5. Needle hub 136 supports sharp 124, having a sharpened distal portion 160. In some embodiments, as discussed herein, a longitudinal wall opening or gap 162 is provided in at least a portion of the wall of the sharp 124. The length N of the gap 162 is selected to be commensurate with the length of the insertion portion 30 through to the proximal retention portion 48 of the sensor, and in certain embodiments may be about 3 mm to about 50 mm, e.g., about 5 mm, or about 10 mm, or about 15 mm, or about 20 mm.” in para. [0135], and figs. 4-5).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Funderburk’s needle (“introducer sharp”) 340 to have a needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, and having a shape in which a thickness of the needle neck gradually decreases from the needle head 136 toward the needle body 124 by forming a sloped surface that continuously connects the needle head and the needle body 136, as taught by Curry, because it is a mere substitution of one known feature, i.e. Funderburk’s needle (“introducer sharp”) 340, for another, i.e. Curry’s needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, to yield the same predictable result, i.e. transcutaneous insertion of a sensor.
As to Claim 4, Funderburk teaches the following:
wherein:
the needle body 424 comprises a needle body base (not labeled, the portion between the “skin piercing edge 430” and “main portion of introducer 340” in fig. 26A) having a needle tip (“skin piercing edge 430”) 430 at an end of the needle body base,
the needle head (“main portion of introducer 340”, not labeled) comprises a needle head base (not labeled, top portion of main portion of “introducer 270”, shown in fig. 12) disposed on a same plane as the needle body base, and
the needle neck (not labeled, see intermediate portion of “introducer 270” in fig. 12) is formed with a shape of which width gradually decreases from the needle head base toward the needle body base (not labeled, the portion between the “skin piercing edge 430” and “main portion of introducer 340” in fig. 26A) and includes a needle neck base (not labeled, see intermediate portion of “introducer 270” in fig. 12) disposed on a same plane as the needle body base (not labeled, the portion between the “skin piercing edge 430” and “main portion of introducer 340” in fig. 26A) and the needle head base (top portion of main portion of “introducer 270”) to connect the needle body base (not labeled, the portion between the “skin piercing edge 430” and “main portion of introducer 340” in fig. 26A) and the needle head base (see the different portions of “introducer 270” in fig. 12).
As to Claim 6, Funderburk teaches the following:
a needle tail (“skin piercing edge 430”) 430 extended from an end of the needle body base to be disposed on a same plane as the needle body base and having a width narrower than the needle body base (see fig. 26A).
As to Claim 7, Funderburk teaches the following:
wherein the needle head has a locking portion (“dimple 352” and holes in “main portion of introducer 340” in fig. 26A) configured to be engageable with a carrier (“shuttle”) 338 included in the applicator 310 (see “Sensor 314 has a main surface 346 slidably mounted between U-shaped rails 348 of introducer sharp 340 and releasably retained there by sensor dimple 350 which engages introducer dimple 352. Introducer sharp 340 is mounted to face 354 of shuttle 338, such as with adhesive, heat stake or ultrasonic weld. Sensor 314 also has a surface 356 that extends orthogonally from main surface 346 and just beneath a driving surface 358 of shuttle 338 when mounted thereon (details of these features are better shown in FIGS. 19 and 25-27.)” in para. [0102]).
As to Claim 8, Funderburk teaches the following:
wherein the locking portion includes a needle hole (see holes in “main portion of introducer 340” in fig. 26A) penetrating the needle head (“main portion of introducer 340”).
As to Claim 9, Funderburk teaches the following:
wherein the locking portion is formed as one integrated piece with the needle head and includes a hook portion (see rectangular holes in “main portion of introducer 340” in fig. 26A) protruding from the needle head.
As to Claim 10, Funderburk teaches the following:
A needle assembly (not labeled, see the needle assembly shown in fig. 26A) included in an applicator (“inserter”) 310 for inserting a sensor (“sensor”) 314 into skin of a user (see figs. 16 and 26A), the needle assembly comprising:
a needle (“introducer sharp”) 340 comprising
a needle body (“tail”) 424 including a first channel (“U-shaped rails”) 348 accommodating the sensor 314 and configured to be insertable into the skin of the user (see “Sensor 314 has a main surface 346 slidably mounted between U-shaped rails 348 of introducer sharp 340 and releasably retained there by sensor dimple 350 which engages introducer dimple 352.” in para. [0102]),
a needle head (“main portion of introducer 340”, not labeled) having a thickness greater than the needle body 424 (see “The height of the main portion of introducer 340 is 0.614 inches, and the inside width is 0.513 inches. … The length and width of introducer tail 424 are 0.354 and 0.036 inches, respectively.” in para. [0113]),
…
wherein the needle body 424 and the needle head (“main portion of introducer 340”) are formed as one integrated piece (integrated as “introducer sharp 340”) by being press-processed from same base material (see “Introducer 340 is made from SUS 301 medical grade stainless steel, 0.004 inches thick, having a surface roughness less than or equal to 0.5 micrometers. The height of the main portion of introducer 340 is 0.614 inches, and the inside width is 0.513 inches. … The length and width of introducer tail 424 are 0.354 and 0.036 inches, respectively.” in para. [0113]); and
a carrier (“shuttle”) 338 having a clamp portion (“face”) 354 engaged with the needle head (“main portion of introducer 340”), the carrier 338 movably mounted to an applicator body (“inserter base”) 344 of the applicator 310 and coupled with the needle 340 to move with the needle 340 (see para. [0101]-[0103], and fig. 16).
Funderburk does not teach the following:
a needle neck formed as one integrated piece with the needle body and the needle head to connect the needle body and the needle head, and having a shape in which a thickness of the needle neck gradually decreases from the needle head toward the needle body by forming a sloped surface that continuously connects the needle head and the needle body, …
However, Curry teaches the following:
a needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, and having a shape in which a thickness of the needle neck gradually decreases from the needle head 136 toward the needle body 124 by forming a sloped surface that continuously connects the needle head and the needle body 136 (see “One embodiment of a needle hub for an inserter is illustrated in FIGS. 4-5. Needle hub 136 supports sharp 124, having a sharpened distal portion 160. In some embodiments, as discussed herein, a longitudinal wall opening or gap 162 is provided in at least a portion of the wall of the sharp 124. The length N of the gap 162 is selected to be commensurate with the length of the insertion portion 30 through to the proximal retention portion 48 of the sensor, and in certain embodiments may be about 3 mm to about 50 mm, e.g., about 5 mm, or about 10 mm, or about 15 mm, or about 20 mm.” in para. [0135], and figs. 4-5).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Funderburk’s needle (“introducer sharp”) 340 to have a needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, and having a shape in which a thickness of the needle neck gradually decreases from the needle head 136 toward the needle body 124 by forming a sloped surface that continuously connects the needle head and the needle body 136, as taught by Curry, because it is a mere substitution of one known feature, i.e. Funderburk’s needle (“introducer sharp”) 340, for another, i.e. Curry’s needle neck (distal portion, not labeled, of “needle hub 136” in fig. 4) formed as one integrated piece (figs. 4 and 5 show the “needle hub 136” and “sharp 124” as one integrated piece) with the needle body (“sharp”) 124 and the needle head (“needle hub”) 136 to connect the needle body 124 and the needle head 136, to yield the same predictable result, i.e. transcutaneous insertion of a sensor.
As to Claim 11, Funderburk teaches the following:
wherein:
the carrier 338 has an insertion groove (not labeled, see side walls of “face 354” in fig. 27) into which the needle head (“main portion of introducer 340”) is inserted (see fig. 27), and
the clamp portion 354 is disposed in the insertion groove (see side walls of “face 354” in fig. 27).
As to Claim 12, Funderburk teaches the following:
wherein
the needle head (“main portion of introducer 340”) has a needle hole (not labeled, see holes in “main portion of introducer 340” in fig. 26A), and
the clamp portion 354 comprises a hook (not labeled, see rectangular protrusions in “face 354”, shown in fig. 27) inserted into the needle hole (see holes in “main portion of introducer 340” in fig. 26A).
As to Claim 13, Funderburk teaches the following:
wherein the carrier 338 comprises a carrier body (“outer ring”) 362, having the clamp portion 354 and a pair of locking arms (not labeled, side walls of “face 354” in fig. 27) elastically deformably connected to the carrier body 362 to be detachably engageable with both edges of a sensor housing (combination of “sensor 314” and “introducer sharp 340” in figs. 25 and 26A), wherein the sensor 314 is configured to be mounted to the sensor housing (combination of “sensor 314” and “introducer sharp 340” in figs. 25 and 26A).
Allowable Subject Matter
7. Claims 3 and 5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
8. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 3, neither Funderburk nor the prior art of record teaches the needle of base claim 2, including the following, in combination with all other limitations of the base claim:
wherein
the needle head includes a second channel having a width wider than the first channel, and
in the needle neck, a third channel of which width gradually decreases from the second channel to the first channel is provided to be connected to the first channel and the second channel, respectively.
As to Claim 5, neither Funderburk nor the prior art of record teaches the needle of base claim 4, including the following, in combination with all other limitations of the base claim:
wherein:
the needle body comprises a first needle body wing and a second needle body wing bent at both sides of the needle body base to form the first channel with the needle body base,
the needle head comprises a first needle head wing and a second needle head wing bent at both sides of the needle head base to form a second channel with the needle head base, and
the needle neck comprises a first needle neck wing bent at one side of the needle neck base and connecting the first needle body wing and the first needle head wing, and a second needle neck wing bent at an other side of the needle neck base and connecting the second needle body wing and the second needle head wing, and the first needle neck wing and the second needle neck wing with the needle neck base form a third channel connected to the first channel and the second channel, respectively.
Conclusion
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M Sims can be reached at 571-272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 06/03/2026
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