DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wall (US 2004/0116847 A1) in view of Gross et al. (US 5,527,288), Hadvary et al. (US 2013/0324884 A1), and Hessel (US 4,769,008).
With regard to claim 1, Wall teaches a medical fluid injection device that may be adhered to the skin of a patient, the device including: a housing including a skin-facing surface and upper and lower housing portions with the lower housing portion including the skin-facing surface (Fig. 1d member 10, the lower housing is taken as the lower half of the housing and the upper housing is the upper half of the housing); a medical fluid reservoir defined by an expandable elastomeric bladder having a fixed proximal end and a distal end where the bladder is elongated between the proximal and distal ends and is expandable upon the pressurized introduction of medical fluid thereinto, the elastomeric bladder solely exerting a uniform pressure force on the medical fluid there within as the distal end of the bladder moves towards the proximal end (Figs. 1b-1d member 60, the proximal end facing the skin is fixed the opposing distal end 61 moves toward the proximal end [0061], the bladder is elongated between the proximal and distal ends as it extends the length between these ends, [0068] details the reservoir can be made of a material which contracts to reduce the volume, [0084] discloses that if a spring is used a constant force is applied for a constant rate which is interpreted as uniform pressure force, [0104] discloses various force means may be used/combined, the bladder is in contract with the fluid and is what is solely transferring pressure); an injection needle including an injection end movable between a retracted position within the housing and an injection position extending through the skin facing surface of the housing for injection into a patient, the needle being in fluid communication with the bladder in the injection position (Figs. 2a and 2e member 40). Wall does not disclose a protrusion surrounded by a remaining portion of the skin-facing surface and including a circumferential base portion tapering away from the remain portion of the skin-facing surface in a direction radially inwards towards the injection needle. However, Gross et al. teach a protrusion as recited (see Reference Figure 1 below), on an adhesively attached surface, which is beneficial for counter-acting the natural resilience of the skin to allow for better penetration (abstract, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a protrusion with a circumferential base in Wall as Gross et al. teach this is beneficial for stretching the skin to aid in penetration. Wall does not disclose the remaining portion of the skin-facing surface includes a circumferential edge that is tapered or curved toward the upper housing. However, Gross et al. teach the remainder of the skin-facing surface may be curved toward the upper housing for counter-acting the natural resilience of the skin to allow for better penetration (Fig. 10, surface 104, Col. 10 lines 42-46). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a curved skin-facing surface in Wall as Gross et al. teach this is beneficial for enhancing penetration. Further, one of ordinary skill would combine both the embodiments of Figs. 10 and 11 since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. This would enhance penetration further by enhancing the stretching. Wall does not disclose an elastomeric needle shield. However, Hadvary et al. teach an elastomeric seal within a skin facing protrusion within which an injection needle is embedded prior to use which would prevent leaking and accidental needle sticks (Fig. 3 member 18, [0046], [0049]). Such a seal would also necessarily enhance sterility. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a shield in Wall as in Hadvary et al. as this would close the end of the needle to prevent leakage and would necessarily enhance sterility. As combined the protrusion extends from the skin-facing surface of the wall, a septum seal as in Hadvary et al. is placed within the opening of the protrusion. The device would still be able to operate to provide delivery. Wall does not disclose an inner plug in the expandable blader with a larger diameter to pre-stress the blader. However, Hessel teaches pressurized fluid dispensing with a bladder which pre-stresses the bladder so that constant pressure is provided during delivery to reliably delivery contents at a substantially constant flow rate (Col. 1 lines 10-26, 48-60, Fig. 2 plug 4 bladder 2). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a pre-stressed bladder in place of the bladder and spring of Wall as Hessel teaches this is beneficial for providing constant pressure for a constant flow rate. This would yield the same predictable result of delivery.
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With regard to claims 2-5, see Fig. 1b and exemplary Fig. 5 releasable member 120, adhesive portions 122 and 127, cover 129, 122 is pierced by the needle and remains on the skin ([0131], [0143], [0144]). This would be placed over the protrusion provided by the combination above.
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.
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