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 I in the reply filed on 10/30/2025 is acknowledged. Claims 12-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Claims 1-11 remain pending and under prosecution.
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, curved surface of Claim 3-4 and 6,
the ridges of Claim 7, and the dividing plane of Claim 9-10 must be shown with reference numbers 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
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.
Claims 4 and 9-10 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.
In regard to Claim 4, the recitation of “at least a part of all surfaces extending from the semi-enclosed internal void space to the third body side are curved” is indefinite because it sounds like the claim allows for an interpretation of some of the surfaces not being curved, which contradicts the limitation “all surfaces…are curved.” Furthermore, as indicated in the Drawing Objection above, since the submitted drawings do not illustrate which portions constitute the curved portion, the is unclear exactly which and how a part of all the surfaces are curved as recited.
In regard to Claims 9 and 10, since the drawings do not illustrate the dividing plane as recited, it is unclear in which manner the dividing plane is not parallel with the substrate plane as well as not parallel with the bevel, other than just being defined as such. See the Drawing Objection above. Clarification is requested.
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.
Claims 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nordon et al (US Pub No. 20170274196) in view of Simmers (US Pub No. 20160166819).
In regard to Claim 1, Nordon et al disclose a microneedle provided on a substrate 160, best seen in Figure 9 (0138), comprising:
an elongated body 110 extending along a longitudinal axis from a top end to a bottom end on the substrate, best seen in Figure 1, wherein:
the elongated body comprises an upper portion 112 and a lower portion 130, best seen in Figure 1;
the lower portion of the elongated body comprises an internal capillary bore hole – defined as the inner most part of channel 140 at said lower portion – extending into the substrate (at the location of reservoir 150), best seen in Figure 1 and 9 – “the open channel 140 of each microneedle 100 extends from the body 110 and the base 130 into the support member 160 to communicate/transfer fluid to and from the reservoir 150 “ (0157), also see (0149, 0120);
the upper portion of the elongated body has a semi-enclosed internal void space 140 with an opening slit extending from the lower portion 130 of the elongated body to the upper end 112, best seen in Figure 1 – “an open channel 140 extending along a side of the body 110 from the first end 112 to the second end 114” (0120);
a sharp tip 120 – pointed tip, best seen in Figure 1 (0120);
the semi-enclosed internal void space of the upper portion of the elongated body opening to the internal capillary bore hole – as defined – of the bottom end of the elongated body (0120, 0149, 0157); and
the bottom end of the elongated body is connected to the substrate 160, best seen in Figure 9 (0138).
However, Nordon et al do not expressly disclose the upper portion formed by at least three body sides whereof two body sides join at a sharp edge and a third body side having the opening slit and the top end of the elongated body is configured as a bevel to create the sharp tip at the top of said edge, said bevel extending to the third body side. Nordon et al shows the sharp tip formed by a curved shape, best seen in Figure 1.
Simmers discloses an analogous microneedle comprising an upper portion 166 formed by at least three body sides – two secondary bevels 145, best seen in Figure 5 (0046) along with bevel face 140, best seen in Figure 4-5 (0041),
whereof two body sides join at a sharp edge 164’ (0043 – “a sharp edge (e.g., for penetrating skin) at the tip 164”) and
a third body side 140 (bevel face) having an opening 172, best seen in Figure 4 (0041), and
the top end of the elongated body is configured as a bevel to create the sharp tip at the top of said edge, said bevel extending to the third body side, best seen in Figure 4, as an effective configuration for the tip of the microneedle comprising an analogous internal void 170 with opening 172 on the bevel face 140, best seen in Figure 4-5 and 8.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the tip of Nordon et al such that the curved tip is replaced by one having the upper portion formed by at least three body sides whereof two body sides join at a sharp edge and a third body side having the opening slit and the top end of the elongated body is configured as a bevel to create the sharp tip at the top of said edge, said bevel extending to the third body side as taught by Simmers, as an equally as effective configuration for the sharp tip of the microneedle that includes the opening slit and semi-enclosed internal void space of Nordon et al, since the opening slit and semi-enclosed internal void space are positioned at the same location as the bevel face of Simmers.
2. Nordon et al in combination with Simmers disclose a microneedle according to claim 1, wherein the opening slit 140 of Nordon et al is positioned at the centre of a flat body side – bevel face 140 – of Simmers when combined, best seen in Figure 1 of Simmers.
3. Simmers disclose a microneedle according to claim 1, wherein at least one surface extending from the semi-enclosed internal void space of Nordon et al when modified by Simmers to the third body side 140 of Simmers is curved, best seen in Figure 4-5 of Simmers – channel 176 is show with curved portion in Figure 4 (0042).
4. Simmers disclose a microneedle according to claim 3, wherein at least a part of all surfaces extending from the semi-enclosed internal void space of Nordon et al when modified by Simmers to the third body side 140 of Simmers are curved, best seen in Figure 4-5 of Simmers. Also see 112 rejection above.
5. Nordon et al in combination with Simmers disclose a microneedle according to claim 1, wherein the elongated body comprises three body sides, best seen in Figure 1 of Simmers as modified above.
6. Simmers disclose a microneedle according to claim 5, wherein the two body sides 145 joined at a sharp edge 164’ are joined to a third body side 140 through curved surfaces (see U shape of bevel face 140), best seen in Figure 4-5.
8. Nordon et al disclose a microneedle according to claim 1, wherein the upper portion 110, 112 is having a first cross-sectional area, and the lower portion 130 is having a second cross-sectional area, wherein the second cross-sectional area is larger than the first cross sectional area, best seen in Figure 13 – “the flared base 130 of the microneedle 100 is almost twice the width of the body 110” (0198).
9. Nordon et al disclose a microneedle according to claim 1, further comprising a dividing plane dividing the upper portion 110, 112 and the lower portion 130, wherein at least a part of the dividing plane is not in parallel with the substrate plane, because the dividing plane can be defined as such. Also see 112 rejection above.
10. Nordon et al disclose a microneedle according to claim 9, wherein the dividing plane between the upper portion 110, 112 and the lower portion 130 is parallel with the bevel, when modified by Simmer et al, because the dividing plane can be defined as such. Also see 112 rejection above.
11. Nordon et al disclose a microneedle according to claim 1, further comprising a curved portion 130 – flared based 130 (0123) – connecting the elongated portion 110 with the substrate 160, best seen in Figure 1 and 9.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nordon et al (US Pub No. 20170274196) in view of Simmers (US Pub No. 20160166819) as applied to Claim 1 above, further in view of Berthier et al (US Pub No. 20140038306).
Nordon et al in combination with Simmers disclose the invention above but do not expressly disclose ridges that extends on an outer surface of the microneedle, where the ridges extends in a direction that is perpendicular to the longitudinal axis.
Berthier et al teach that it is well-known in the art to provide ridges 121 that enhance the capillary action of fluid flow in an analogous microfluidic channel, the ridges positioned perpendicular to a longitudinal axis of reservoir 120 when defined as such, best seen in Figure 12A-C (0169).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the microneedles of Nordon et al as modified by Simmers such that there are ridges that extend on an outer surface of the microneedle, where the ridges extends in a direction that is perpendicular to the longitudinal axis, as taught by Berthier et al, to effectively enhance the capillary action of the fluid flow to the microneedle as desired. Also see Drawing Objections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791