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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, Species A (figures 1-2) and claims 1-2, 5, 8, 11, 14, 17-19, 25, 29, 32, 38-42, and 83 in the reply filed on 1/12/2026 is acknowledged.
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 1 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. The claim limitation of “an interface for an actuator, for actuating a movement” is unclear if the “actuator” is a positively claimed separate structure or is the “interface” the “actuator”. Appropriate correction is required.
Claim 2 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.
Regarding claim, the phrase "not comprising the actuator" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear if the device does not contain the interface as this structure in claim 1 is claim to actuate movement. It is unclear if the interface is included if the actuator is not part of the claimed structures. Appropriate correction is required.
Claim 18 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.
The claimed limitation of:
“…the contact parts move away from each other due to a coupling between a movement of the base-body and the contact parts and parallel in time the platform is moved towards the skin-side end due to a coupling to the movement of the base-body until the patch contacts the skin 3…” is unclear.
The appears to be some grammatical and/or logistical formatting errors as it is unclear the function of the movement being claimed (“in time” and “due to a coupling to the movement”) and also the “skin 3” language. Appropriate correction is required.
Claim 40-41 are 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.
The claims claim dependance on claim 0 however there is no claim 0. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 8, 11, 14, 17-19, 25, 29, 32, 38-42, and 83 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kobayashi et al. (US 2016/0354589 A1).
Kobayashi teaches an applicator (as in figures 81-94 for examples) for applying a microneedle patch (4166) to a skin of a subject, comprising: a base (4144) for positioning onto the skin, the base comprising: a skin-side end (end to 4182 surface side) ;a holder (4157) for holding the microneedle patch in position relative to the skin-side end, and at least two contact parts (each side of 4149) at the skin-side end for contacting the skin, of which at least one is movable over the skin and away from another contact part to stretch the skin at least during penetration of the skin by a microneedle of the patch (see figure 93 for example); the applicator further comprising: an interface (4140) for an actuator, for actuating a movement of the microneedle patch relative to the skin-side end to penetrate at least into the stratum corneum of the epidermis of the skin with the microneedle (see figure 93 for example).
Concerning claim 2 and not comprising the actuator, and wherein the interface comprises a contact surface on which a person can exert pressure to manually push the base towards the skin (see figure 93 and the force applied to interface 4140).
Concerning claim 5 and a coupling (4147) which couples the movement of the patch towards the skin-side end to a movement of the contact part over the skin, for penetrating the skin by the microneedle when the skin is stretched a predetermined amount (see figure 92-94 showing the stretching and penetrating).
Concerning claim 8 and the coupling is arranged to trigger actuation of the movement of the patch when the patch is at a distance from the skin (note the movement of the patch as shown in the transition from figures 92 to figure 93 to figure 94).
Concerning claim 11 and the coupling (4147) couples the contact parts (4149) to the contact surface (near 4141) for actuating movement of the contact parts away from each other as reaction to a force exerted by the hand on the contact surface (shown in figure 93); and wherein the contact parts are coupled to the pressure surface (4140) by a flexing member (4146) connected at one side to the pressure surface and at another side to the contact parts, the flexing member arranged to flex under the pressure exerted on the base by the hand and a counterpressure from the skin, such that the contact parts are moved away in a direction parallel to the skin (as in figure 94).
Concerning claim 14 and the contact parts are separate parts each having a fixed proximal end connected to the base and a distal, free-end with a contact surface for contacting the skin, the free-ends of the contact parts being movable relative to each other in at least a direction parallel to the skin (see contact parts proximal near 4148 and distal near 4149).
Concerning claim 17 and the holder (4157) comprises: a movable platform (4152), movable relative to the skin-side end in a direction towards the skin, for placing the microneedle patch oriented with a skin-adhesive surface (4166) facing the skin-side end, and a base-body (4159) for holding the movable platform in position relative to the base.
Concerning claim 18 and when the actuator engages on the interface (4140) :the base-body (4144) is moved towards the skin-side end, the contact parts move away from each other due to a coupling between a movement of the base-body and the contact parts(4149) and parallel in time the platform is moved towards the skin-side end due to a coupling to the movement of the base-body until the patch contacts the skin 3 (see figure 93).
Concerning claim 19 and the movable platform (4152) is movably attached to the base-body (as in figure 92-93); the coupling of the movement of the patch to the movement of the base is automatically interrupted at a predetermined point, when the patch touches the skin (compare figures 93 and 94); and wherein when after the predetermined point has been reached the base-body is moved further towards the skin, the base-body is moved towards the platform and a distance between the base-body and the platform lessens and a skin-wards pressure is exerted on the platform which causes penetration of the skin by the microneedle (again see figures 92-94).
Concerning claim 25 and the holder (4157) comprises a guide (4159) for guiding the movement of the patch along a predetermined path between a distant position and a skin contacting position.
Concerning claim 29 and the actuator comprises a spring (4137) arranged to be biased, the spring coupled to the holder (4147), for exerting on the holder, when biased, a force towards the skin-side end; and the coupling comprises: a releasable latch (4130) with a latching state in which the latch latches movement of the holder induced by the force and a released state in which the latch allows the movement,and a control engaging on the releasable latch to control the state of the releasable latch to enter into the release state when the contact parts are moved the predetermined distance away from each other (compared figures 92-94 and the latch 4130).
Concerning claim 32 and comprising a latch which latches movement of the holder in a direction away from the base at a predetermined point after movement has started, such as upon or after penetration of the skin (see figure 94 and engagement of latch 4130).
Concerning claim 38 and wherein the base (4147) comprises: a housing (4123) with a bore extending towards the holder and a mass provided in the bore, which mass (4141) is movable towards the holder to generate an impact-force on the holder; a kinetic transducer (4132) for converting a movement of the housing relative to the base into potential energy of the mass;a potential energy storage (4145) for storing the potential energy;a release for releasing the potential energy; anda kinetic transducer (4132) for converting the stored potential energy into kinetic energy of the mass upon release.
Concerning claim 39 and: the holder (4157) is formed by an insert (4154) and the base comprises a space which has a skin-side opening at, and facing, the skin-side end for admitting the insert; the insert piece has a proximal side to be admitted into the space and interlocked with the base, and an exposed, skin-contacting side for contacting the skin provided with the contact parts (see figure 92-93 and 4157).
Concerning claim 40 and the sides of the space are defined by a skirt extending from the base between the opening and the skin-side end (see skirt sides of 4148).
Concerning claim 41 and the contact parts are formed by blocks of a resilient material shaped to contact the skin and deform under a shear stress induced by pushing the base onto the skin, the blocks being placed around the opening (see resilient material of 4147 and flexing in the figures 92-93).
Concerning claim 42 and for penetrating through the stratum corneum further into the epidermis until into, or through, one of the group selected from: the stratum lucidum, the stratum granulosum, the stratum spinonsum, the stratum basale, basement membrane (examiner is of the position that the device of Kobayashi does disclose that it penetrates the skin and this would be including the layers as listed above).
Concerning claim 83 and the applicator is a single use applicator (it is examiners position that this would be capable of single use as to not contaminate a further patient).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783