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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/24/2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “connection portion between the separation guide and the tip has a step shape” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Tamaru et al. (USPGPub 2016/0158512) in view of Park et al. (USPGPub 2017/0252546) above, and further in view of Ferguson et al. (USPGPub 2012/0041337).
Re Claim 1, Tamaru teaches a microneedle (Tamaru Figs. 9a-9c), comprising: a needle part (1) comprising a plurality of tips (11, 13) formed from a liquid formulation formed with a medicinal solution (Tamaru ¶ 0120) and configured to penetrate skin (as seen in Tamaru Figs. 9a-9c); and a base (3) for supporting the plurality of tips (11, 13); and a guide part (23) configured to guide the needle part (1) to penetrate the skin (Tamaru ¶ 0152-0163), wherein the base (3) includes a plurality of openings (9b) (Tamaru ¶ 0152), wherein the plurality of tips (11, 13) includes a plurality of coupling grooves (9a) at rear ends of the plurality of tips (11, 13) (as seen in Tamaru Figs. 9a-9c), wherein each of the plurality of coupling grooves (9a) is open through a corresponding opening of the plurality of openings (9b) in the base (3) in a direction opposite to the penetration direction (as seen in Tamaru Figs. 9a-9c), wherein the guide part (23) includes a plurality of pressing protrusions (25) respectively coupled to the plurality of coupling grooves (9a) through the plurality of openings (9b) and a support (23) for supporting the plurality of pressing protrusions (25) (Tamaru ¶ 0096; Fig. 9b), wherein each of the plurality of pressing protrusions (25) has a front end and a rear end extending from the rear end to the front end in the protrusion direction (as seen in Tamaru Fig. 9b), and wherein a size of a cross-sectional area of each of the plurality of pressing protrusions (25) decreases from the rear end toward the front end (as seen in Tamaru Fig. 9b, the pressing protrusions 25 have a stepped configuration that decreases in cross-sectional area from the rear end to the front end in the protrusion direction).
Tamaru fails to expressly teach wherein the needle part, in a state of being coupled with the guide part, penetrates the skin. However, the limitation "wherein the needle part, in a state of being coupled with the guide part, penetrates the skin" is a functional limitation and an inherent characteristic of prior art Tamaru. Nothing in prior art Tamaru prevents the embodiment of Figs. 9a-9c being used in the manner as suggested by applicant where Tamaru possesses all of the structure necessary for carrying out the aforementioned functional limitation (See MPEP 2114-I). Furthermore, a claim limitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (See MPEP 2114-II).
However, Tamaru fails to teach the microneedle comprising a base supporting a plurality of separation guides formed between the plurality of tips and the base; wherein each separation guide of the plurality of separation guides is formed between the base and each tip of the plurality of tips respectively to separate the plurality of tips from the base, wherein each of the plurality of separation guides is provided between a tip of the plurality of tips and the base along only a circumference of a rear end of the tip of the plurality of tips, wherein (i) a thickness of the tip between a side surface of the tip and a curved surface of a coupling groove of the tip among the plurality coupling grooves gradually decreases toward the rear end of the tip and (ii) a thickness of a separation guide coupled to the tip among the plurality of separation guides is relatively greatly reduced compared to the thickness of the tip at the rear end of the tip so that a connection portion between the separation guide and the tip has a step shape and the plurality of tips are easily separated from the base.
Park teaches a microneedle (Park Annotated Fig. 2 below) with needle part (1) comprising a plurality of tips (2) configured to penetrate the skin (Park ¶ 0056-0059), a base (3), and a plurality of separation guides (2-1) formed between the plurality of tips (2) and the base (3); wherein each separation guide of the plurality of separation guides (2-1) is formed between the base (3) and each tip of the plurality of tips (2) respectively to separate the plurality of tips (2) from the base (3), wherein each of the plurality of separation guides (2-1) is provided between a tip of the plurality of tips (2) and the base (3) along only a circumference of a rear end (2-3) of the tip of the plurality of tips (2), wherein (i) a thickness of the tip between a side surface of the tip and a curved surface of a coupling groove (4) of the tip among the plurality of coupling grooves gradually decreases toward the rear end of the tip and (ii) a thickness of a separation guide coupled to the tip among the plurality of separation guides (2-1) is relatively greatly reduced compared to the thickness of the tip at the rear end of the tip so that a connection portion between the separation guide (2-1) and the tip has a step shape and the plurality of tips (2) are easily separated from the base (3) (as seen in Park Annotated Fig. 2 below) for securing the plurality of tips to the base until penetration into the skin, thus shortening an administration time and allowing administration of a fixed amount of medication (Park ¶ 0005-0007, 0011-0013).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the base of Tamaru to support a plurality of separation guides formed between the plurality of tips and the base; wherein each separation guide of the plurality of separation guides is formed between the base and each tip of the plurality of tips respectively to separate the plurality of tips from the base, wherein each of the plurality of separation guides is provided between a tip of the plurality of tips and the base along only a circumference of a rear end of the tip of the plurality of tips, wherein (i) a thickness of the tip between a side surface of the tip and a curved surface of a coupling groove of the tip among the plurality coupling grooves gradually decreases toward the rear end of the tip and (ii) a thickness of a separation guide coupled to the tip among the plurality of separation guides is relatively greatly reduced compared to the thickness of the tip at the rear end of the tip so that a connection portion between the separation guide and the tip has a step shape and the plurality of tips are easily separated from the base, the configuration as disclosed by Park for securing the plurality of tips to the base until penetration into the skin, thus shortening an administration time and allowing administration of a fixed amount of medication (Park ¶ 0005-0007, 0011-0013). In the present case, modification of the plurality of tips of Tamaru to be similar to that of Park would result in the plurality of tips being easily separated from the base due to a physical pressing force by the guide part.
Tamaru also fails to teach wherein each of the plurality of coupling grooves has a hemispherical cavity extending in a penetration direction of the needle part and a curved surface facing the penetration direction. Park teaches a plurality of coupling grooves (4) wherein each coupling groove (4) has a hemispherical cavity extending in a penetration direction of the needle part (1) and a curved surface facing the penetration direction (as seen in Park Annotated Fig. 2 below). It would have been an obvious matter of design choice to modify Tamaru in view of Park to include coupling grooves with a hemispherical cavity and a curved surface extending in a penetration direction since applicant has not disclosed that having coupling grooves with a hemispherical cavity and a curved surface extending in a penetration direction solves a stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of coupling grooves with a hemispherical cavity and a curved surface extending in a penetration direction, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the coupling grooves of Tamaru in view of Park to have a hemispherical cavity extending in a penetration as disclosed by Park wherein such a configuration is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement (as seen in Park Annotated Fig. 2 above). Furthermore, in the Tamaru in view of Park embodiment, the pressing force due to a physical pressing force by the guide part by Tamaru would be placed, respectively, into and coupled to curved surfaces of the plurality of coupling grooves of the plurality of tips though the plurality of openings of the base.
Finally, Tamaru in view of Park fail to teach wherein a size of a cross-sectional area of each of the plurality of pressing protrusions gradually decreases from the rear end toward the front end. Ferguson teaches a microneedle (501) and pressing protrusion (550) (Ferguson Figs. 5A and 5C) wherein a size of a cross-sectional area of the pressing protrusion (550) gradually decreases from the rear end toward the front end (as seen in Ferguson Figs. 5A and 5C) for ease of removing the microneedle (501) from the pressing protrusion (550) (Ferguson ¶ 0049). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the cross-sectional area of each of the plurality of pressing protrusions gradually decrease from the rear end toward the front end as disclosed by Ferguson for ease of removing the microneedle from the pressing protrusion (Ferguson ¶ 0049).
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Re Claim 2, Tamaru in view of Park above, and further in view of Ferguson teach all of the limitations of Claim 1. Tamaru teaches wherein the guide part (23) is integrally formed with the needle part (1) (Tamaru Fig. 9c), and is configured to separate from the plurality of tips (11, 13) after the plurality of tips (11, 13) penetrate the skin (as seen in Tamaru Figs. 9c, the guide part 23 becomes integrally formed with the needle part 1 when the two are connected).
Re Claim 4, Tamaru in view of Park above, and further in view of Ferguson teach all of the limitations of Claim 1. Tamaru teaches wherein the guide part (23) and the base (3) are configured to be separated from the plurality of tips (11, 13) when the plurality of tips (11, 13) penetrate the skin (as seen in Tamaru Fig. 9c).
Response to Arguments
Applicant's arguments filed 03/24/2026 have been fully considered but they are not persuasive. Applicant has amended Claim 1of the present case as described at the bottom of Page 4 of the response. On Page 6 of the response, applicant argues Park (and the combination of cited references) does not teach or suggest "(ii) a thickness of a separation guide coupled to the tip among the plurality of separation guides is relatively greatly reduced compared to the thickness of the tip at the rear end of the tip so that a connection portion between the separation guide and the tip has a step shape" of claim 1. It is unclear in the present case what is being referred to as “a step shape.” The specification is silent with regard to a step with regard to the separation guides. It may be the case that this feature is the grounds upon which the present case can move to allowance. If this feature is supported by the figures, examiner recommends amending the figures to explicitly point to this feature and update the specification to refer to this term as well. Examiner is available to discuss this feature in interview at applicant’s leisure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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