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 .
Claim Objections
Claim 1 is objected to because of the following informalities: “the slide element is actuated” should be “the slide element is configured to be actuated” to be clear that the claim is not reciting a positive method step. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 11, 12, and 14-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mann et al. (US 4,808,167).
With regard to claims 1, 5, 6, 11, and 12, Mann et al. teach a single use medical device, comprising: a housing defining an insertion slot (Fig. 2 member 10 slot into which 12 fits); and a lockout mechanism comprising: a biasing mechanism (Fig. 2 82); and a movable slide element positioned adjacent to the insertion slot and the biasing mechanism, the slide element movable between a pre-use configuration, an in-use configuration, and a post-use configuration (Fig. 2 84); wherein the slide element is actuated via an insertion member removably inserted into the insertion slot (Fig. 2 insertion member is the portion of 12 that may be inserted into the slot 12, Col. 8 lines 24-54); wherein the insertion member is fixed to a multi-use device (a use is not define, the inserted portion of 12 is fixed to the battery 22 which may deliver multiple doses providing multiple uses, once removed it may be used for something else).
With regard to claims 2 and 7, see Col. 8 lines 33-34, 84 would be visible.
With regard to claim 3, 84 is always in contract with the housing at the wider diameter end near 82 (Fig. 2).
With regard to claim 4, see Fig. 2, Col. 8 line 40.
With regard to claim 8, one of members 56 and 58 is taken as a start post and one of members 60 and 62 is taken as a start button as it connects the electrical circuit.
With regard to claim 9, the smaller diameter portion of 84 is taken as the tip (Fig. 2).
With regard to claims 14 and 15, see at least 20, 26, and 28 comprising the cassette/fluid plug, 28 is tubing which may not be used again at some point in the future (Fig. 2).
With regard to claims 16 and 17, Mann et al. teach a medical device system, comprising: a multi-use device, comprising: a housing defining a cavity (Fig. 2 member 12, cavity where 30 is); and an insertion member (Fig. 2 portion of 12 inserted into 10 in the area of 84, a use is not define, the inserted portion of 12 is fixed to the battery 22 which may deliver multiple doses providing multiple uses, once removed it may be used for something else); and a single use device configured to be removably coupled with the multi-use device, the single use device, comprising: a housing defining an insertion slot (Fig. 2 member 10 slot into which portion of 12 fits); and a lockout mechanism disposed within the housing of the single use device, the lockout mechanism comprising: a biasing mechanism (Fig. 2 82); and a movable slide element positioned adjacent to the insertion slot and the biasing mechanism, the slide element movable between a pre-use configuration, an in-use configuration, and a post-use configuration (Fig. 2 84); wherein when the slide element is in the post-use configuration, the single use device is prevented from being functionally assembled with the multi-use device (Fig. 2, Col. 8 lines 24-54).
With regard to claims 18 and 19, Mann et al. teach a medical device system, comprising: a multi-use device, comprising: a housing defining a cavity (Fig. 2 member 12, cavity where 30 is); an insertion member (Fig. 2 portion of 12 inserted into 10 in the area of 84, a use is not define, the inserted portion of 12 is fixed to the battery 22 which may deliver multiple doses providing multiple uses, once removed it may be used for something else); and a start button (Fig. 2 one of members 56 and 58); and a single use device configured to be removably coupled with the multi-use device, the single use device, comprising: a housing defining an insertion slot (Fig. 2 member 10 slot into which portion of 12 fits); a start post (Fig. 2 one of members 60 and 62); and a lockout mechanism disposed within the housing of the single use device, the lockout mechanism comprising: a biasing mechanism (Fig. 2 82); and a movable slide element (Fig. 2 84) positioned adjacent to the insertion slot and the biasing mechanism, the slide element movable between a pre-use configuration, an in-use configuration, and a post-use configuration; wherein the slide element is moved from the pre-use configuration to the in-use configuration upon insertion of the insertion member into the insertion slot (Fig. 2, Col. 8 lines 24-54); wherein when the insertion member is inserted into the insertion slot, the insertion member is configured to directly engage the lockout mechanism (Fig. 2); and wherein when the slide element is in the post-use configuration, the single use device is prevented from being functionally assembled with the multi-use device (Col. 8 lines 24-54).
With regard to claim 20, see Fig. 2 member 78 (Col. 7 line 46, Col. 8 lines 17-20).
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mann et al. (US 4,808,167) as applied to claim 9 above, and further in view of Brandl et al. (US 2013/0248629 A1).
With regard to claim 10, Mann et al. teach a device substantially as claimed but does not disclose the tip is configured to disable a component. However, Brandl et al. teaches that when using a single use cartridge, a tip tears an information carrier to prevents re-use as the device cannot be re-filled ([0054], [0055], Fig. 2 88 disables 86). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an information carrier which would be torn by 84 in Mann et al. as in Brandl et al. as this would prevent the fluid cartridge from being re-filled to further prevent re-use.
Allowable Subject Matter
Claim 21 is 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.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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. Citations to Mann et al. have been amended in light of the amendments to the claims. Applicant argues 12 is not a multi-use device and 10 is not a single use device. A use has not been defined. Member 10 is capable of a single use, member 12 may deliver multiple substances over time or multiple doses or may be repurposed for a completely different use once disconnected from 10.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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