DETAILED CORRESPONDENCE
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 .
Response to Amendment
This office action is responsive to the amendment filed on 6/20/2025. As directed by the amendment: claim(s) 1, 15, 23, and 26 have been amended, and claim(s) 28 has been cancelled. Thus, claims 1, 5-7, 11-27, and 29 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6/20/2025 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding the preceding 112b rejection on page 6-7:
Applicant's present amendment resolves the preceding office actions stated 112b rejection.
Regarding applicant’s argument regarding the independent claims on page 7-9:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"the plunger (20) comprises a plunger element (26) that is located on one end of the plunger (20) such that the plunger element (26) has a cross-sectional width smaller than that of the plunger (20) but substantially equal in cross-sectional width to a width Of the microarray (28)"
Applicant particularly argues that "disclosed in Nagai are identically sized elements as can be seen from the fact that the size of microneedle patch (3) (formed from substrate (3a) and microneedles (3b)) is identical in cross-section width to presser part (41) which has an identically cross-sectionally sized attachment pan (47) to which the microneedle patch (3) is attached (see Figure 6 and Paragraph [0091] of Nagai) ".
However, examiner notes that the cited disclosure does not recite that the presser part 41, patch 3 nor its substrate 3a or microneedles 3b, or attachment part 47 as all having an identical cross-sectional area/width, merely this part of the disclosure pertains to the manner by which attachment part is fixed to base 45 of presser part 41. Rather, paragraph 94 of Nagai recites that the attachment part 47 and patch 3 have the same area, note that this recited shape relationship is not extended to presser part 41.
Examiner notes that the present embodiment of Nagai is silent regarding its plunger element having a cross-sectional width smaller than that of the plunger. However, as noted in examiner's rejection as necessitated by the amendment, below, such a modification would only involve routine skill in the art and wouldn't alter the performance of the prior art for its disclosed function(s).
Regarding applicant’s argument regarding dependent claims on page 9:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1, 5-7, 11-13, 15-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190083769 A1, henceforth written as Nagai.
Regarding Claim 1
Nagai discloses:
An applicator for the application of
(applicator 1; fig 1)
a microarray comprising:
(microneedles 3b; fig 6)
a housing
(main body 5; fig 1)
in which a plunger is arranged for linear displacement therein;
(paragraph 88; main body (not enumerated) of lever 7, constitutes the claimed plunger, spanning from nut 35 to a point on lever 7 above base 45 ; fig 2-6)
a retainer element connected with the housing upon which the microarray is located;
( fig 7 demonstrates the manner by which microneedles 3b on patch 3 are located on pressing portion 41, and fig 7+3 demonstrate the manner by which portion 41 is considered connected to body 5 via other interconnecting elements of the invention such as but not limited to lever 7, hole 33a, and member 37)
a pressure element for the displacement of the plunger in order to act on the microarray received by the retainer element;
(resilient body 9 permits the movement of the main body of lever 7 to bias patch 3 and its microneedles 3b; fig 4)
and an actuation element, wherein the actuation element retains the plunger in an inner position and releases the plunger for displacement actuating the actuation element in an inward direction relative to the housing, wherein when the actuation element cooperates directly with the plunger and the actuation element is connected with the plunger in a form-fitting manner to maintain the plunger in the inner position,
(paragraph 67+70+76-78+81-86; switch 13 retains the position of lever 7 until an operator uses their finger to press down on operator on switch 13, therein actuating switch 13 inwardly into main body 5, to release claw member 25 from protrusion 23 on lever 7 and permit movement of lever 7; fig 1-5; the manner by which switch 13's claw member 25 is shaped by its engaging claw 25a having a flat and inclined surface which are configured to mate with the flat and/or inclined surface of protrusion 23 can be considered to be a form-fitting connection between the claimed actuation element and claimed plunger maintaining the inner position of the plunger)
wherein the actuation element can be displaced to release the plunger, such that the actuation element is moved in a perpendicular direction to a moving direction of the plunger, such displacement of the actuation element releases the form-fitting connection between the actuating element and the plunger in order to release the plunger,
(paragraph 76-78+81-86; switch 13 can be displaced perpendicularly to an injection axis, by being inwardly depressed by an operator, releasing its claimed form fitting connection via its claw member 25, to permit axial translation of the lever 7; fig 2-5)
wherein the plunger comprises a recess or a protrusion which cooperates with the actuation element,
(protrusions 23, and the gaps (not enumerated) formed therebetween constitute claimed recess, which engage with claw member 25 of switch 13; fig 2-5)
and wherein the plunger further comprises a plunger element that is located on one end of the plunger such that the plunger element has a cross-sectional width --substantially equal in cross-sectional width to a width of the microarray,
(paragraph 94; attachment part 47, the claimed plunger element, has the same area, therein the same cross-sectional area and thus width, as patch 3; fig 6-7)
wherein the retainer element comprises a receiving surface having arranged thereon a carrier element connected with the microarray, such that
(surface (not enumerated) of part 47 constitutes the claimed receiving surface, and has a substrate 3a arranged on it retaining the microneedles 3b; fig 6-7)
the receiving surface is shaped in the form of at least a partial ring,
(fig 1+6-7 demonstrate that the surface of part 47 is formed as a ring around screw 51)
wherein the housing has an exit opening for the plunger,
(opening (not enumerated) between inner surface 43a of end part 43; fig 1-7)
and wherein the receiving surface completely surrounds the exit opening.
(fig 1 illustrates where the surface of part 47 surrounds the claimed exit opening)
Nagai discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
the plunger element has a cross-sectional width smaller than that of the plunger
However, MPEP 2144.04(V)(B) where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. Such a modification of making lever 7 some amount wider than its base 45, would not arrive at a modified invention which performs the recited functions of Nagai differently than its disclosed present embodiment.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to widen the lever 7 disclosed by Nagai relative to the base 45 disclosed by Nagai, as such a modification increasing the relative proportion of the claim elements would only involve routine skill in the art , see MPEP 2144.04(IV)(A), and would not alter the performance of the Nagai for its disclosed function(s).
Regarding claim 5, Nagai discloses:
The applicator according to claim 1, wherein the pressure element is pre-stressed and/or compressed in the inner position of the plunger.
(paragraph 65; body 9 is compressed in the claimed position; fig 2-3)
Regarding claim 6, Nagai discloses:
The applicator according to claim 1, wherein the pressure element comprises a spring element.
(paragraph 65; body 9 is a compression coil spring)
Regarding claim 7, Nagai discloses:
The applicator according to claim 1, wherein the pressure element is arranged on a rear side of the plunger opposite the exit opening.
(fig 2-3 demonstrating arrangement of body 9 relative to the main body (not enumerated) of lever 7)
Regarding claim 11, Nagai discloses:
The applicator according to claim 1, wherein the actuation element is arranged in a recess of the housing.
(fig 1-3 illustrate that switch 13 is disposed in a recess (not enumerated) of body 5)
Regarding claim 12, Nagai discloses:
The applicator according to claim 1, wherein the housing comprises a fixation element for fixing the applicator on the skin of a patient.
Examiner notes that the broadest reasonable interpretation of the claim term "fixing" as it is understood by a person of ordinary skill in the art not inconsistent with the specification, is best provided by Merriam-Webster's dictionary definition for fix: "to make firm, stable, or stationary"
(paragraph 31+63+98; contact part 31 sets a stable insertion position for the applicator 1, therein constituting a fixing element)
Regarding claim 13, Nagai discloses:
The applicator according to claim 12, wherein the fixation element comprises a contact surface which surrounds the receiving surface at least in a partial ring shape or a complete ring shape.
(fig 1+6-7 illustrates contact part 31 forming a ring shape around the surface of part 47)
Regarding claim 15, Nagai discloses:
The applicator according to claim 1, wherein the retainer element comprises the receiving surface for arranging thereon the carrier element connected with the microarray, such that the receiving surface is shaped in the form of a complete ring.
(fig 6-7 illustrate that portion 41 receives the surface of part 47, as part of receiving part 47, such that substrate 3a, and its connected microneedles 3b, are arranged on the surface of part 47; fig 1+6-7 demonstrate that the surface of part 47 is formed as a complete ring around screw 51)
Regarding claim 16, Nagai discloses:
The applicator according to claim 15, wherein the receiving surface completely surrounds the plunger and/or the exit opening.
(fig 1 illustrates where the surface of part 47 surrounds the claimed exit opening)
Regarding claim 17, Nagai discloses:
The applicator according to claim 15, wherein the carrier element is a patch.
(paragraph 62; microneedle patch 3, includes substrate 3a)
Regarding claim 18, Nagai discloses:
The applicator according to claim 1, wherein the carrier element is a patch.
(paragraph 62; microneedle patch 3, includes substrate 3a)
Regarding claim 19, Nagai discloses:
The applicator according to claim 1, wherein the actuation element or a protrusion on the actuation element extends into the recess on the plunger.
(paragraph 81-83; protrusions 23, and the gaps (not enumerated) formed between protrusions 23, engage with the protruding claw member 25 of switch 13; fig 2-5+15-16)
Regarding claim 20, Nagai discloses:
The applicator according to claim 19, wherein when the plunger is released from the form-fitting connection, the actuation element is moved inward such that the form-fitting connection is released and the plunger is able to be moved by the pressure element.
(depressing switch 13, therein moving switch 13 and its protrusion 13a inwardly, disengages switch 13 from lever 7; fig 2-5)
Regarding claim 21, Nagai discloses:
The applicator according to claim 1, wherein the retainer element is arranged on the housing.
(fig 1 demonstrates that portion 41 is carried by/sliding within, therein on, body 5)
Regarding claim 22, Nagai discloses:
The applicator according to claim 1, wherein the housing comprises a base element having a planar lower side,
(body 5 has a leading end part 43 with a planar contact part 31; fig 1-6)
the planar lower side having an inner annular region serving as the retainer element
(the annular inner surface 43a extending from contact part 31, serves to radially retain and guide the portion 41, therein constituting part of the claimed retaining element; fig 1-7)
and an annular contact surface surrounding the inner annular region to make contact with the skin of a patient.
(paragraph 31+63+98; annular contact part 31; fig 1)
Regarding claim 23, Nagai discloses:
The applicator according to claim 1, wherein when the plunger is in the inner position the plunger is spaced from the retainer element.
Examiner further notes that the broadest reasonable interpretation of the claim term "spaced" as it is understood by a person of ordinary skill in the art not inconsistent with the specification, can best be briefly described as "not encompassing the same disposition in one, two, or three dimensions"
(fig 2-5+7 demonstrate that the main body (not enumerated) of lever 7, noted above as extending from nut 35 to a point on lever 7 above base 45, and portion 41 do not occupy the same position in an axial dimension and thus can be considered space from eachother when the main body of lever 7 is in the initial inner position illustrated by fig 2-3)
Regarding claim 24, Nagai discloses:
The applicator according to claim 1, wherein the actuation element comprises an opening.
(fig 2-5 demonstrate that there is an opening (not enumerated) between protrusion 13a and claw 25a where the main body (not enumerated) of lever 7 translates within)
Regarding claim 25, Nagai discloses:
The applicator according to claim 24, wherein upon releasing the plunger, the plunger is displaced linearly downward through the opening.
(fig 2-5+15-16 illustrate releasing of main body (not enumerated) of lever 7 resulting in a linear translation through the opening (not enumerated) of switch 13)
Regarding claim 26, Nagai discloses:
The applicator according to claim 24, wherein upon displacing the actuation element, a projection of the actuation element formed by the opening disengages from the recess of the plunger to release the plunger.
(paragraph 81-83; protrusions 23, and the gaps (not enumerated) formed between protrusions 23, engage with the projecting claw member 25 of switch 13; fig 2-5+15-16)
Regarding claim 27, Nagai discloses:
The applicator according to claim 25, wherein upon displacing the actuation element, the projection of the actuation element formed by the opening disengages from the recess of the plunger to release the plunger.
(paragraph 75-83; the projecting claw member 25 of switch 13 disengages from protrusions 23, and the gaps (not enumerated) formed between protrusions 23, to release the main body (not enumerated) of lever 7 ; fig 2-5+15-16)
Regarding claim 29, Nagai discloses:
The applicator according to claim 1, wherein the actuation element is L- shaped.
(fig 2-5 illustrate that switch 13, integral with claw 25, forms an L shape)
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nagai, as applied to claim 13 above, in view of US 20160082242 A1, henceforth written as Burton.
Regarding Claim 14,
Nagai discloses all of the elements of the current invention which the present claim is dependent upon, as described above. However, Nagai is silent regarding:
The applicator according to claim 13, wherein the contact surface comprises an adhesive layer which is provided with a removable protective film.
However, Burton teaches a microneedle injector:
wherein the contact surface comprises an adhesive layer which is provided with a removable protective film.
(paragraph 82-83; base 133 has adhesive 150 disposed on its skin contacting side and a removable release liner 152; fig 5)
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the adhesive and protective film taught by Burton to the contact surface disclosed by Nagai in order to advantageously arrive at an invention with means for adhering to a patient for long term ambulatory use and while providing means for protecting said adhering means during storage and shipment, see paragraph 82-83 of Burton.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (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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/FORREST B DIPERT/Examiner, Art Unit 3783 /MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783