DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is rejected 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.
Claim 7 recites that the time between sensor insertion into the host and the electronics unit securing to the housing is less than about 1 second. Since the electronics unit forms the electrical connection between the unit and the sensor at the factory, this would necessarily indicate that the electronics unit is also secured to the housing at around the same time, prior to the sensor insertion into the host. The examiner notes that while the remarks indicates that claim 7 has been canceled, it remains pending in the submitted form.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, and 22-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over over Moein et al. (US 2012/0323098) in view of Pace et al. (US 2013/0150691), and further in view of Freeman et al. (US 2006/0052810).
As to claim 1, Moein teaches a device for applying an on-skin assembly to skin of a host, the device comprising: a housing configured to receive an electronics unit ([0176]), wherein the electronics unit is configured to generate analyte information based on a signal from a sensor ([0187]), wherein the electronics unit includes conductive polymer contacts to electrically connect the electronics unit to the sensor ([0064]), wherein the electrical connection between the electronics unit and the sensor is formed at a factory ([0175] - sensor electronics unit can be integrated in the sensor; [0176] - the sensor electronics unit includes a housing typically formed as a single integral unit wherein the housing contains most or all of the electronic components of the sensor electronics unit, which is reflective of the connection be made at the factory); a sensor insertion mechanism including a needle configured to insert the sensor into the host (Moein incorporates by reference 13/071,487 - US 2011/0288574 (see [0207]) which teaches the insertion device 200 to be used with the housing to insert the sensor into the host [0147]). Moein does not necessarily teach that the housing includes one or more channels configured to wick moisture to a perimeter of the housing.
Pace teaches an analyte sensor with a housing including one or more channels configured to wick moisture to a perimeter of the housing (Fig. 50C - the channels on the housing). It would have been obvious to modify Moein with Pace to utilize channels on the housing to remove wick away moisture to the perimeter of the housing such that the moisture is less likely to reach the sensor and result in improper and/or inaccurate readings.
The above combination does not teach a silicon barrier disposed proximate the needle, the silicon barrier configured to prevent blood from wicking to the housing. Freeman teaches a tissue penetration device (Fig. 67) for sampling blood in which a membrane made of silicone-based gel (639) is disposed proximate a lancet (637) and seals the cut caused by the piercing lancet to prevent blood from flowing into the housing device ([0307]). It would have been obvious to modify the above combination with Freeman to prevent blood from wicking to the housing, which could otherwise result in contamination of the device.
As to claim 3, Moein teaches the housing is configured such that the electronics unit cannot be removed from the housing while the housing is adhered to the skin of the host ([0176] - as the housing is formed as a single integral unit that contains the electronics unit, it cannot be removed while the housing is adhered to the skin of the host).
As to claims 22-24, Moein teaches that the sensor electronics unit can be integrated in the sensor ([0175]) with the electronics unit being integral to a housing ([0176]), which would make it obvious, if not necessarily inherent, that the sensor is permanently connected to the conductive polymer contacts, which allows for connection between the electronics unit and the sensor. As they are integrally connected, they would necessarily be configured to be disposed together.
Claims 10-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moein et al. (US 2012/0323098), Pace et al. (US 2013/0150691), and Freeman et al. (US 2006/0052810), and further in view of Brauker et al (US 2006/0222566).
Regarding claims 10-11, Brauker teaches the device is configured to disengage from the housing and from the electronics unit in response to the electronics unit being released from a lock; wherein the device is configured to provide one or more tactile, auditory, or visual indications that the electronics unit has been inserted into the housing to the extent permitted by a lock (Figures 8A-D; paragraphs 233-234, safety latch mechanism 84 locks the plunger subassembly 22 in a stationary position such that it cannot be accidentally pushed prior to release of the safety latch mechanism; force-locking mechanism 86 which ensures a proper mate between the electronics unit and the mounting unit; a seal is formed between the two units; paragraph 277-278; elastomeric seal). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a locking mechanism as taught by Brauker because the seal secures the electronics unit to the mounting unit and a locking mechanism prevents accidental insertion.
Regarding claim 12, the above combination does not teach a trigger lock. Brauker teaches a transcutaneous analyte sensor and insertion mechanisms. Brauker teaches a lock configured to prevent accidental activation of the trigger (Figures 8A-D; paragraphs 233-234, safety latch mechanism 84 locks the plunger subassembly 22 in a stationary position such that it cannot be accidentally pushed prior to release of the safety latch mechanism; force-locking mechanism 86 which ensures a proper mate between the electronics unit and the mounting unit; a seal is formed between the two units; paragraph 277-278; elastomeric seal). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a locking mechanism as taught by Brauker because a locking mechanism prevents accidental insertion.
Response to Arguments
Applicant’s arguments 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.
Conclusion
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.
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).
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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.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 3/5/26