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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 22 January 2026 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2015/0065834 to Al Sahli et al. (Al Sahli hereinafter) in view of U.S. Patent 5,536,249 to Castellano et al. (Castellano).
Regarding claim 1, Al Sahli teaches a glucose testing module (1), comprising a housing (3), a lancet apparatus (2) comprising a solid lancet (see paragraph 36), a glucose sensor (testing meter, see e.g. paragraph 30), and a microcontroller (16) controlling testing operations and providing wireless communication with an external device (35). Al Sahli does not teach an insulin delivery module or calculation of a dose. Castellano teaches an all-in-one insulin pen (200) comprising a handheld housing (14), a glucose testing module (202) for testing a one-time glucose concentration of a patient, an insulin delivery module (20), and a microcontroller (32). Castellano further teaches determination of a dose (col. 7, ln. 15-29) to be administered to the patient. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an insulin delivery module as taught by Castellano to the testing module of Al Sahli in order to simultaneously dose the user after testing.
Al Sahli does not teach formation of a seal with the skin or use of a vacuum pump and chamber. Moerman teaches another glucose sensing device generally, and particularly teaches a vacuum pump (24, see e.g. Fig. 2A) and formation of a seal with skin (see e.g. Fig. 2C, seal implied by raised skin illustrated). Moerman teaches that this allows the skin to be punctured by the lancet for improved sensing (e.g. by drawing blood into the sensor, see discussion of Fig. 8G). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide a vacuum pump as taught by Moerman to the pen of Al Sahli in order to draw blood to the testing sensor.
Regarding claim 2, it has been held that where the difference between the prior art and the claimed invention is only a matter of claimed dimensions (such as those determining volume), a prima facie case of obviousness is present (MPEP 2144.04 IV. A). In this case, the sole limitation of claim 2 relates to dimensions and the examiner finds no evidence of criticality. The examiner concludes therefore that the subject matter of claim 2 is obvious in view of Al Sahli as modified by Castellano and Moerman.
Regarding claim 3, Castellano teaches determination of a dose (col. 7, ln. 15-29) to be administered to the patient.
Regarding claim 4, Castellano teaches providing dose data to an external device (col. 8, ln. 17-22). While Castellano does not specifically teach using a wireless module to do so, it would have been obvious at the time of the effective filing date of the application to use the wireless communication module of Al Sahli to perform this communication more conveniently as is well understood in the art.
Regarding claim 5, the pump of Moerman is a micropump.
Regarding claims 6, 7, and 19, as best understood by the examiner, Moerman teaches (see again Fig. 2C, with implied scale from Fig. 1) increase in skin height of about 10mm.
Regarding claims 8-9, Moerman teaches multiple use sensors (e.g. Fig. 8A+ and col. 8, ln. 44-65) which are configured to release vacuum, establish atmospheric pressure, and then create the vacuum again in approximately the specified timeframe in successive uses of the sensor(s).
Regarding claim 10, Moerman teaches the use of a spring-loaded actuator (see spring 20). Which would have been obvious to provide with the vacuum pump of claim 5 in order to achieve the improved sensing
Regarding claims 11 and 12, Moerman teaches the use of a micromotor (803) for actuating the lancet. Those of ordinary skill in the art would have expected this to be a DC motor due to the common limitations of body worn electronics.
Regarding claim 13, Castellano teaches initialization of at least dosage instructions by the external device (col. 14, ln. 42-48).
Regarding claim 14, Al Sahli teaches the use of single use strips and needles (paragraph 9).
Regarding claim 15, Al Sahli teaches extraction of between 1/3 and 3 microliters (paragraph 4) which overlaps with the claimed range.
Regarding claim 16, Al Sahli as modified in view of Castellano and Moerman teaches the apparatus of claim 16, as discussed with respect to claims 1 and 5 above, and further teaches operably coupling and assembling all elements thereof.
Regarding claims 17 and 18, Al Sahli as modified in view of Castellano and Moerman teaches the apparatus of claim 17, as discussed with respect to claims 1 and 5 above, and further teaches placing the pen against a portion of skin of a user, and while held, operating both the lancet and the insulin dosing module to test and subsequently dose insulin based on the test. The examiner notes that the blood sample is not necessarily obtained from the portion of skin against which the pen is pressed. Accordingly, it would fall into the scope of claim 17 to hold the pen in hand during testing and administration phases and for the continuous contact with the hand (that is, spaced from the testing and dosing sites) to meet the “portion of skin of a user” limitation. This would not be true if the sample and dose were obtained via and administered to the portion of skin.
Regarding claim 20, due to the separate nature of the testing module and insulin delivery module, the structure of the combination is configured to test a first area and administer to a different second area.
Response to Arguments
Applicant’s arguments, see page 6, filed 7 January 2026, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and/or 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Al Sahli in view of Castellano and Moerman as set forth above.
Conclusion
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 6 March 2026