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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/9/23 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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 4 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 4 recites the limitation "said movable support" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claim 8 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.
Claim 14 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. Claim 15 is further objected to based on dependence on claim 14.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-7, 9-13, 16-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAllister et al. (US 2018/0133447) (“McAllister”).
A device and method 500 (Fig. 5)[0082] for introducing microneedles into the skin of a subject said device comprising: a first part 530 comprising at least one carrier 540 having integral or associated therewith a plurality of microneedles 550 wherein said carrier is moveably mounted in a first housing 520 to move with respect to said housing from a retracted to an extended position where, when in said extended position, said microneedles or part thereof project beyond said housing (Fig.5 middle to top figure, horizontal arrow) and further wherein said at least one carrier is also moveably mounted in said housing to move with respect to said housing laterally or at 90° with respect to said movement (Fig.5 top figure, vertical arrow) that produces the afore extension, a second part comprising at least one actuator 510 which is mounted in, or integral with, a second housing (Fig.5) that is adapted to engage with said first housing, wherein said actuator and/or said second housing is movable with respect to said first housing so that said actuator is functionally coupled with said at least one carrier whereby, when the actuator is activated: i) the actuator exerts a force to move said carrier with respect to said first housing from said retracted to said extended position (Fig.5 middle figure) and, when in said extended position, ii) said actuator exerts a force to move on said carrier with respect to said first housing laterally or at 90° with respect to said movement that produces the afore extension, thereby breaking the microneedles to leave parts of same in the skin (Fig.5 top figure).
said at least one carrier 540 is mounted on or in a plate 530 or between a pair of plates.
a plurality of said carriers are mounted on or in a plurality of plates or between pairs of plates (Fig. 5 bottom figure).
a plurality of said carriers or plates are mounted on said movable support 560
said carrier or plate is/are mounted on a movable support to move with respect to said first housing from said retracted to an extended position. (Fig.5 middle to top figure, horizontal arrow)
said carrier or plate is/are mounted on a movable support in said first housing to move with respect to said first housing laterally, or at 90° with respect to said movement that produces the said extension. (Fig.5 top figure, vertical arrow)
movement of said movable support brings about synchronized movement of said carriers or plates whereby said carriers or plates move from said retracted to an extended position in a synchronized fashion. (Fig.5 middle to top figure, horizontal arrow)
said actuator 510 makes contact with at least one of said carrier(s) or plate(s) or movable support(s) Fig. 5.
wherein said actuator, when activated, is adapted to produce a downward stroke that moves said carriers or plates from said retracted to said extended position. (Fig.5 middle to top figure, horizontal arrow)
said actuator, when activated, is adapted to produce a downward stroke that moves said carrier(s) or plate(s) laterally or at 90° with respect to said movement that produces the said extension. (Fig.5 top figure, vertical arrow)
said actuator, when activated, is adapted to produce a downward stroke that after, moving said carriers or plates from said retracted to said extended position, moves said carrier(s) or plate(s) laterally or at 90° with respect to said movement that produces the said extension. (Fig.5 top figure, vertical arrow)
said device comprises a stopping member 570 for limiting the amount of downward motion of at least one of said carrier(s) or plate(s) or movable member(s).
at least one of said housings comprises an indicator [0130] which indicates when the said downward and/or extended and/or lateral movement is complete.
indicator is a marker that becomes visible, or sits in a more visible position, once said afore movement(s) is/are complete. [0130]
microneedle(s) are tapered and further include a neck region or indented region which forms a point of weakness for the breakage of same. [0044] Fig.1A-C
microneedles are semi-circular in cross section and aligned so that, in use, their flat surface faces towards the actuator and their curved surface away from said actuator. Fig.1A-C
microneedles are dissolvable or degradable or substantially dissolvable or degradable. [0093]
microneedles comprise at least one therapeutic, pharmaceutical, cosmetic, or biological agent for delivery into the skin. [0093]
a removable shield 570 or cap adapted to prevent the relative movement of the first part or first housing and second part or second housing.
said actuator is manually operated. [0133]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783