DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/27/26 has been entered.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rao et al. (US 2018/0235520) in view of Shimizu et al. (US 2021/0169518), and further in view of Schoonmaker et al. (US 2017/0112534).
As to claim 1, Rao teaches a continuous glucose measurement apparatus ([0071]) comprising: a body attachable unit (150) configured to be insertedly attachable to a body to periodically measure blood glucose ([0086]); and an applicator (150) configured to insert and attach the body attachable unit to the body according to manipulation of a user ([0096]); wherein the body attachable unit comprises: a housing (the outside of control device 102), a sensor module configured to be insertable into the body (504), wherein a sensing area to react with the blood glucose in the body is formed at one side of the sensor module (2408; [0071]), a guide needle arranged to cover an outside of the sensor module (Fig. 12B - 2552) and configured to, after being inserted into the body together with the sensor module, be extracted and removed from the body (Fig. 12D; [0156]), and wherein the applicator (Fig. 12A-D) comprises: a main case (2702), a plunger body disposed within the main case (710) and configured to move in an outward discharge direction along with the body attachable unit (Fig. 12A-B: see plunger body move in an outward discharge direction along with the body attachable unit (102)
Rao does not specifically teach that the applicator comprises a rack and pinion gear structure configured to move the sensor module in an outward discharge direction relative to the guide needle to insert the sensor module deeper into the body than the guide needle, the rack and pinion gear comprising a housing rack gear formed on an outer side of the housing, a case rack gear formed on an inner side of the main case, and a pinion gear rotably coupled to one side of the plunger body.
Shimizu teaches a sensor insertion device with a rack and pinion gear structure ([0009]) with a housing rack gear formed on an outer side of the housing (34), a case rack gear formed on an inner side of the main case (33), and a pinion gear rotably coupled to one side of the plunger body (30). Shimizu does not necessarily teach that the rack and pinion gear structure is configured to move the sensor module in an outward discharge direction relative to the guide needle to insert the sensor module deeper into the body than the guide needle. Schoonmaker also teaches a sensor insertion device with a rack and pinion gear structure (Fig. 27) and used for sensor and needle insertion ([0248]) and also that this insertion component can be configured such that the needle is deployed to a first depth, and the sensor wire is deployed to a second depth, this second depth being deeper than the first depth ([0019]). It further notes that pushing the sensor to a second depth allows the sensor to extend past the location where trauma from the needle is produced, reducing sensor artifacts and other deleterious signal effects ([0279]).
Accordingly, it would have been obvious to modify Rao with Shimizu to utilize a rack and pinion gear structure for sensor insertion, and further modify with Schoonmaker to utilize said rack and pinion gear structure to move the sensor module deeper into the body than the guide needle to increase the accuracy of the device.
As to claim 2, Rao teaches in a body insertion process, the needle guide is inserted to the body before or at the same time as the sensor module is inserted to the body (Fig. 12B; [0154]).
As to claim 3, Rao teaches the sensor module comprises a sensor probe portion formed to be elongated along a boyd insertion direction so that at least a portion section of the sensor probe portion is insertable into the body (Fig. 12A - 104); and the sensing area is formed at an end part of the sensor probe portion ([0143] of incorporated reference US 2016/0331283 as noted in [0183]).
As to claim 4, Rao teaches the needle guide has a shape of covering an outside of the sensor probe portion (Fig. 12B) and the needle guide is configured to be extracted and removed from the body after being inserted to a shallower depth than the sensor probe portion ([0185] - positioned at different end-depth, with the sharp positioned at a shallower tissue).
As to claim 5, Rao teaches the end of the guide needle is inserted to a depth closer to a skin surface than a maximum depth point of the sensing area ([0185]).
As to claim 6, Rao teaches the end of the guide needle is inserted to a depth closer to the skin surface than an outmost point of the sensing area ([0185]).
As to claim 7, Rao teaches the guide needle comprises an incision portion (2506) formed at a front end of the guide needle to incise skin of the body in a process in which the guide needle is being inserted into the body ([0134]), an insertion support portion (2504) formed to be extended from a back portion of the incision portion and configured to be inserted to the body continuously along the incised portion incised by the incision portion, the incised portion being a wound in the body formed by the incision portion (Fig. 12B), and wherein a “border line/plane” between the insertion support portion and the incision portion is inserted to a depth closer to a surface than a maximum depth point of the sensing area ([0185]).
As to claim 8, Rao teaches the applicator comprises a needle extracting means extracting and removing the guide needle from the body in a state in which the needle guide is inserted to the body ([0164]), and the needle extracting means is configured to extract and remove the guide needle before insertion of the sensor module to the body is completed ([0173] - the sharp can be partially retracted while the sensor is further penetrating the tissue to its final position; [0176] - sharp is retracted while the housing, along with the sensor, is still being deployed downwards; Fig. 16C).
As to claim 9, Rao teaches the applicator is configured to insert the sensor module and the guide needle such that the sensor module is inserted faster than the guide needle after the sensor module and the guide needle are inserted into the body ([0173] - after both are deployed, the guide needle stops and actually starts reversing while the sensor module is still moving downwards, and is thus moving faster than the guide needle, which is actually moving at a negative rate at this point).
As to claim 10, Rao teaches that even after the guide needle is inserted into a preset insertion depth in a state that the sensor module is inserted to the body together with the guide needle, the sensor module is further deeply inserted into the body by the applicator ([0173]; Figs. 16A-C).
Response to Arguments
Applicant’s arguments with respect to the prior art have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 2/19/26