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 with traverse of Group I, Clm. 1, 2, 5, 6, 8, 9, 16, 19, 20, 27, 29, 31, 32, 34, 40, 44, 69 in the reply filed on 17 March 2026 is acknowledged. The traversal is on the ground(s) that the invention(s) should be subject to rejoinder as required by MPEP 821.04(b). This is not found persuasive because consideration of rejoinder is only provided after the identification of allowable subject matter, wherein rejoinder, in the instant case would be premature. Here there presents overlapping subject matter between the claimed inventions (as detailed in the Restriction Requirement), but this shared subject matter has been demonstrated to lack unity of invention for the reasons provided in the requirement and further affirmed by the below rejection of the invention of Group I provided below. Applicant’s traversal fails to address this lack of unity or explain why the claimed inventions exhibit unity focusing only on rejoinder of the inventions because of shared subject matter. However, until such time that shared subject matter is demonstrated to be a special technical feature which provides unity by making a novel and non-obvious contribution over the prior art rejoinder will not be considered.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim(s) 9 is/are objected to because of the following informalities:
Regarding Claim 9, it is believed that this limitation should read “in contact with the skin”.
Appropriate correction is required.
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(s) 6, 9, 31, 34, 40, and dependents thereof is/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.
Regarding Claim 6, the phrase "such as" 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).
Regarding Claim 9, the instant claim lacks antecedent basis for the claim terminology (re: “predetermined part of the applicator other than the at least two contact parts is in contact [with] the skin after the separation between the at least two contact parts reaching the predetermined distance”). Specifically, the phrase “predetermined part” is not found in the specification nor is the utility of “contact [with] the skin after the separation…” Careful examination of the disclosed species does not appear to resolve any particularly disclosed embodiments where such contact occurs incident to a “coupling which couples the movement of the microneedle patch toward the skin-side end to a movement of a contact part over the skin…wherein the contact part is one of the at least two contact parts”.
It is unclear if Claim 9 is intended to encompass configurations (see e.g. Fig. 1) wherein a total of four identical contact parts (13, 131) are provided with two of the contact parts satisfying the claimed limitations of “the at least two contact parts” and the other two contact parts comprising the “a predetermined part of the applicator other than the at least two contact parts”.
Regarding Claim 31, Applicant recites “to control state of the releasable latch” which appears to be a grammatical error and creates confusion as to what “state” is referenced.
Regarding Claim 34, the phrase "such as" 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).
Regarding Claim 34, Applicant recites “latches movement of the holder in a direction away from the base…” However, this creates confusion as the holder is introduced in Claim 1 as being a constituent part of the base, re: “a base for positioning onto the skin, the base comprising: … a holder for holding the microneedle patch”. It is unclear how, if the holder is part of the base, it can be latched into movement “in a direction away from the base”.
Regarding Claim 40, the instant claim creates confusion inasmuch as it appears to be inconsistent with its differentiation of components from one another. Specifically, the claim requires “a housing with a bore…” and separately a “kinetic transducer for converting a movement of the housing relative to the holder”. However, the specification appears to point to a single component satisfying both of these claimed elements. Specifically, even though different reference numerals are used (re: “transducer 1003” and “housing 1000” as part of “base 10”) these reference numerals appear to point to the same structure, whereas the claim implies that they are distinct structures.
Relatedly, the spring (1004) while storing potential energy does not appear to “release” this potential energy for application by the spring (1006) as kinetic energy. Rather these two stored potential energies appear to be discrete, i.e. compression of the housing/base compresses each spring (1006) and (1004) independently (Fig. 21), wherein the energy is stored in each spring separately (Fig. 22) with the spring (1006) releasing its stored energy independently (see Fig. 24) in an insertion motion of the patch with the spring (1006) later releasing its potential energy (Fig. 25) AFTER the stored potential energy of the spring (1004) has already been released in order to cause expansion of the housing/base arrangement (see Fig. 25, 26). The relationship claimed does not appear to be consistent with the disclosed invention. Specifically, the “potential energy” stored by spring (1004) is separate from the potential energy stored by spring (1006) with the stored energy performing two different functions.
Regarding Claim 40, Applicant recites “… the moveable platform”. However, no such “moveable platform” has been previously introduced in Claim 40 or parent Claim 1. A “movable platform” is recited in other claims (e.g. Clm. 19 and 32), but Claim 40 is not indicated as being dependent upon these claims. The claim is therefore indefinite as it is unclear if this “the movable platform” is intended to reference structure previously introduced in Claims 1 or 40 (e.g. the holder, the microneedle array, the housing…etc.), separately introduce a new “a moveable platform” with no additional structural limitations, or if the claim was intended to depend upon one of Claims 19, 20, or 32 where a “moveable platform” is introduced, inclusive to the additional limitations found therein.
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, 2, 5, 6, 8, 13, 19, 20, 27, 29, 31, 32, 44, and 69 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2019-170870 (“Kinoshita”).
Regarding Claim 1, Kinoshita discloses a re-usable (here the phrase “re-usable” is not understood to be a structural limitation, but an intended use limitation which governs only the capability of the device of Kinoshita to have some portions thereof used multiple times inclusive to any necessary steps required to reprocess the equipment including cleaning/sterilizing, partial or complete disassembly/reassembly, resetting, or providing necessary adjustments to the equipment inclusive to replacement of consumable parts as needed) applicator (10) for applying a microneedle patch (11, 35, 12) to a skin of a subject, comprising:
a base (13) for positioning onto the skin (see generally Fig. 5), the base comprising:
a skin-side end (see generally 13aS);
a holder (13b) for holding the microneedle patch in position relative to the skin-side end (see Fig. 2), and
at least two contact parts (13aS, proper) at the skin-side end for contacting the skin (see Fig. 5), 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 Figs. 2 and 5-8 in sequence);
and the applicator further comprising:
an interface (13c) for an actuator (14) for actuating a movement of the microneedle patch relative to the skin-side end to penetrate at least into stratum corneum of epidermis of the skin with the microneedle (see Fig. 5-8 in sequence – re: “The urging portion 14 is attached to the restriction portion 13 and urges the cylindrical portion 11… Therefore, the speed at which the cylindrical portion 11 is directed toward the skin along the urging direction is increased by the amount of urging by the urging portion 14, and the protrusion 12 is easily punctured into the skin” <<translation>>).
Regarding Claim 2, Kinoshita discloses the actuator is a mechanical actuator (i.e. a spring) connected to the interface (see where 14 adjoins 13c) for actuating the movement of the microneedle patch (see Figs. 2 and 5-8 in series).
Regarding Claim 5, Kinoshita discloses a coupling (see 13b, 11) which couples the movement of the microneedle 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, wherein the contact part is one of the at least two contact parts (see Figs. 2 and 5-8 in sequence).
Regarding Claim 6, Kinoshita discloses the coupling is between the a least two contact parts and the actuator, for triggering actuation of the movement of the microneedle patch when the contact part is moved a predetermined distance away from the other contact part (see Figs. 2 and 5-8 in sequence).
Regarding Claim 8, Kinoshita discloses the coupling is arranged to trigger actuation of the movement of the microneedle patch when the microneedle patch is at a distance from the skin (see Figs. 2 and 5-6 in sequence).
Regarding Claim 13, Kinoshita discloses a contact surface (L, 21) for a hand of the human operator, and wherein the coupling couples the at least two contact parts to the contact surface for actuating movement of the at least two contact parts away from each other as reaction to a force exerted by the hand on the contact surface (see Figs. 2 and 5-8 in series).
Regarding Claim 19, Kinoshita discloses the holder comprises:
a movable platform (i.e. the distal frustum of 11), movable relative to the skin-side end in a direction towards the skin, for placing (see Figs. 5-8 in sequence) the microneedle patch oriented with a skin-adhesive surface (re: the “adhesive layer formed from an adhesive” facing the skin-side end, and a base-body (i.e. the conical section of 11 which adjoins to flat frustrum face to the proximal section upon which the actuating springs engage) for holding the movable platform in position relative to the base.
Regarding Claim 20, Kinoshita discloses the movable platform is admitted with the microneedle patch, when placed on the movable platform, facing the skin-side end, in a space in the base-body, the space having an open-side facing the skin- side end through which the movable platform can pass, to allow the microneedle patch to move from an initial position up to or beyond the skin-side end (see Figs. 2 and 5-8 in sequence).
Regarding Claim 27, Kinoshita discloses the holder comprises a guide for guiding the movement of the microneedle patch along a predetermined path between the distant position and the skin contacting position (i.e. the holder is receivable in cooperative geometry with the interior space of the applicator to constrain radial movement of the holder and direct movement in the proximal to distal direction – see Figs. 6-8 in sequence).
Regarding Claim 29, Kinoshita discloses the actuator is arranged to control the movement of the microneedle patch to have a velocity upon contacting the skin by the microneedle patch sufficient to penetrate the skin by impact (see Figs. 5-8 in sequence – re: “Therefore, the speed at which the cylinder portion 11 is directed toward the skin along the urging direction is increased by the amount of urging by the urging portion 14, and the protrusion 12 is easily punctured into the skin.” <<translation>>).
Regarding Claim 31, Kinoshita discloses the actuator comprises a spring arranged to be biased, the spring coupled to the holder, for exerting on the holder, when biased, a force towards the skin-side end (see Figs. 2 and 5-8 in sequence(; and
the coupling comprises:
a releasable latch (see the ledge formed by 13b which engages with the ledge of 11 to latch the holder within the applicator in a static state) with a latching state (see Fig. 2) in which the latch latches a movement of the holder induced by the force and a released state (see Fig. 5-6 in sequence the coupling become unlatched when the ledge of 13b clears the corresponding ledge of 11) 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 released state when the at least two contact parts are moved the predetermined distance away from each other (see Fig. 5 and 6 in sequence).
Regarding Claim 32, Kinoshita discloses the holder comprises a movable platform (see Fig. 2, i.e. the flat distal frustrum of 11), movable relative to the skin-side end in a direction towards the skin, for placing the microneedle patch oriented with a skin-adhesive surface facing the skin-side end, and
a base-body (i.e. the conical section of 11) for holding the movable platform in position relative to the base; and
the spring is arranged between the movable platform and the base-body to exert a force from the base-body to the movable platform (see Figs. 5-8 in sequence).
Regarding Claim 44, the applicator described by Kinoshita is useful for penetrating through the stratum corneum further into the epidermis, wherein the penetrated layers depend upon the thickness of the skin at the injection site, wherein selection of locations with differing skin thickness between anatomical sites and differing between patient to patient will cause penetration depth to be variable through into or through the various layers of the stratum lucidum, stratum granulosum, stratum spinonsum, stratum basale, and basement membrane depending on how thick the skin is at any particular location for any particular patient, wherein thinner skill will be more deeply penetrated and thicker skin will be more superficially penetrated.
Regarding Claim 69, the microneedle patch of Kinoshita is mounted in the holder (see Fig. 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2019-170870 (“Kinoshita”) as applied above, and further in view of WO 01/93931 (“Palmer”).
Regarding Claim 9, Kinoshita discloses the invention substantially as claimed except that that the coupling is arranged to trigger actuation of the movement of the patch when a predetermined part of the applicator other than the at least two contact parts is in contact the skin after the separation between the at least two contact parts reaching the predetermined distance. Rather, Kinoshita only discloses two parts, i.e. the two contact parts 13aS, which provide contact with the skin. However, Palmer discloses a related applicator which comprises two contact parts (62, 66) equivalent in form and function to those described by Kinoshita, but also discloses two additional, predetermined parts (62, 66 – see Fig. 7) other than the two contact parts which are configured to be provide in apposition with the skin as part of the applicator prior to triggering of the application of the microneedle patch to the skin (see Fig. 9). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Kinoshita to comprise two additional predetermined parts other than the two contact parts, as disclosed by Palmer, in order to ensure that the triggering of the application of the microneedle patch occurs consistently and uniformly by allow the adjustment and release of the microneedle patch via duplication of the essential working parts of an invention thereby allowing the contact parts to spread with less resistance.
Regarding Claim 16, Kinoshita discloses the invention substantially as claimed except that for disclosing that the at least two contact parts are clearly 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. While Kinoshita does use the plural “contact portions 13a” to describe the increase in distance between the two labeled components (see Fig. 2) the supplied figures lack clarity to demonstrate that the two portions are actually separated from one another as claimed. However, as discussed above, Palmer discloses a configuration (see Fig. 7-9) for a microneedle applicator wherein such contact parts are provided as discrete, separate components each having a fixed proximal end connected to the base and a distal, free-end with a contact surface for contacting the skin (see Fig. 7-9). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the contact parts of the invention of Kinoshita to be separated from one another in the manner described by Palmer, in order to ensure consistent separation between the parts during application by providing discrete living hinge sections that allow for consistent displacement.
Claim(s) 1, 34, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2004/009172 (“Clarke”) in view of WO 01/93931 (“Palmer”).
Regarding Claim 1, Clarke disclose a re-usable applicator (140; Fig. 8-10) for applying a microneedle patch to a skin of a subject (Abstract), comprising:
a base (140) for positioning onto the skin, the base comprising:
a skin-side end (see generally at 170);
a holder (160) for holding the microneedle patch in position relative to the skin-side end (see generally Fig. 8), and
the applicator further comprising:
an interface for an actuator (see where 146 is depressed distally for actuating release of 164) for actuating a movement of the microneedle patch relative to the skin-side end to penetrate at least into stratum corneum of epidermis of the skin with the microneedle (see Fig. 8-10 in series).
Clarke discloses the invention substantially as claimed except that that the base comprises at least two contact parts 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. Clarke discloses a singular contact part (170) constructed as a circumferential flange configured to serve as a “pressure collar” to help provide tightness to the skin during operation. However, Palmer discloses a related applicator (10), wherein the base end, skin facing end of the applicator can comprise at least two contact parts (62, 66) 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 (Fig. 6-9) to assist in stretching the skin. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the distal end of the applicator of Clarke to include flexible, displaceable contact parts, as disclosed by Palmer, in order to allow the contact parts to splay outwardly with respect to one another during the application of a distally directed force to thereby help stretch the skin the ensure desirable tightening of the skin in a known and predictable manner to thereby enhance efficacy and reproducibility of the applicator operation.
Regarding Claim 34, Clarke discloses a latch (164, 143) which latches movement of the holder in a direction away from the base at a predetermined point after movement has started (i.e. during retraction of the holder 160 the holder is retracted and withdrawn a predetermined distance to activate the latch and hold the device in a pre-use stored position).
Regarding Claim 40, Clarke discloses the base comprises:
a housing (146) with a bore extending towards the holder (see Fig. 8);
a kinetic transducer (146) for converting a movement of the housing relative to the holder into potential energy;
a potential energy storage for storing the potential energy (see the spring between 146 and 144)
a release (147, 164) for releasing the potential energy; and
a kinetic transducer (150) for converting the stored potential energy into a force on the movable platform upon release (See Fig. 8-10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/22/2026
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