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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/19/25 has been entered.
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 12/19/25. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Claim Objections
Claim 15 is objected to because of the following informalities: the recitation of “and” in line 12 appears grammatically incorrect and/or unnecessary. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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(s) 1-2 and 9-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krieger et al. (11/21/22 IDS NPL citation 5: Krieger et al., "Simple and customizable method for fabrication of high-aspect ratio microneedle molds using low-cost 3D printing," Microsystems & Nanoengineering, September 9, 2019, 14 pages, and hereinafter Krieger) in view of Lamerton et al. (WO 2017/055631, hereinafter Lamerton).
For claim 1, Krieger discloses a skin microbe sampler, comprising inter alia:
a plurality of solid microneedles (microneedles in Fig 6b) extending from a support surface (support surface in Fig 6b),
wherein the microneedles are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer (Figs 3 and 6a) to inherently obtain microbes residing in a stratum corneum of the epidermis layer and in a sweat gland and/or hair follicle of the dermis layer (pg 1, col 2);
wherein the microneedles are configured to be inherently capable of obtaining microbes residing beyond 50% of the depth of the stratum corneum of the epidermis (Figs 3 and 6a show the heights of microneedles required to perform the claimed function such that they are at least the structural if not also functional equivalent);
wherein the microneedles comprise a shape that tapers from a base to a tip (Fig 6b);
wherein the microneedles comprise a cone shape that is devoid of patterning on the surface of said cone shape (Fig 6b);
wherein the microneedles have a needle height in the range of from about 1 mm to about 2.2 mm (Fig 3d);
wherein the microneedles have an aspect ratio in the range of about 0.5 to about 4 (Fig 3d, pg 3); and
wherein the base comprises a width of from 0.5 mm to 1.5 mm (Figs 3b-3c).
For claim 1, Krieger discloses the claimed invention except for expressly disclosing the plurality of solid microneedles are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer to obtain and extract microbes residing in a stratum corneum of the epidermis layer and in a sweat gland and/or a hair follicle of the dermis layer. Krieger is concerned with the design criteria of compound extracting sensing applications (Page 2, first full Paragrapgh).
For claim 1, Lamerton teaches a skin microbe sampler (pages 2-4), comprising inter alia: a plurality of solid microneedles (10) are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer (40) to obtain and extract microbes residing in a stratum corneum of the epidermis layer and in a sweat gland and/or a hair follicle of the dermis layer (pages 2-4), wherein said microneedles taper in width from base to tip (page 3), are cone shaped (page 3) devoid of surface patterning (page 3), and have a height of 1-2mm (page 3).
For claim 1, Kriger and Lamerton are both considered to be analogous to the claimed invention because they are in the same field of microneedle array skin-based biological specimen collection endeavor. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krieger to incorporate the teachings of Lamerton to provide a microneedle array configured to obtain and extract microbes from the staratum corneum of the epidermis and a seat gland and/or hair follicle of the dermis layer. Doing so would aid in achieving the predictable result of skin-based microbe retrieval using an adhering microneedle array (Krieger, page 2 first full paragraph) (Lamerton, bottom of page 3).
For claim 9, Krieger discloses the microbe sampler of claim 1, wherein the microneedles are spaced at a distance of from about 0.5 mm to about 2.0 mm from each other on the support surface (Fig 6b).
For claim 10, Krieger discloses the microbe sampler of claim 1, wherein the microneedles are disposed on the support at an average needle density of about 0.1 needles/mm2 to about 0.6 needles/mm2 (pg 11 left column) (Fig 4).
For claim 11, Krieger discloses the microbe sampler of claim 1, wherein the microneedles are arranged in one or more 8x4 array(s) (pg 11 left column).
For claim 12, Krieger discloses the microbe sampler of claim 1, wherein the microneedles and the support surface form a unibody (Fig 6b).
For claim 13, Krieger discloses the microbe sampler of claim 1, wherein the microbe sampler is inherently collapsible due to material properties of PLA to reduce its original surface area and more than fully capable of fitting into a chamber having an opening that is smaller than its original surface area.
For claim 14, Krieger discloses the microbe sampler of claim 1, wherein the surfaces of the microneedles comprise an adhesion coating on their surfaces for enhancing adhesion of the microbes on the microneedles (pg 11, left column).
For claim 15, Krieger discloses a skin microbe sampler, comprising inter alia:
a plurality of solid microneedles (microneedles in Fig 6b) extending from a support surface (support surface in Fig 6b), wherein the microneedles are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer (Figs 3 and 6a) to inherently obtain and extract microbes residing in the skin (pg 1, col 2);
wherein the microneedles are configured to be inherently capable of obtaining microbes residing beyond 50% of the depth of the stratum corneum of the epidermis (Figs 3 and 6a show the heights of microneedles required to perform the claimed function such that they are at least the structural if not also functional equivalent);
wherein the microneedles comprise a shape that tapers from a base to a tip (Fig 6b);
wherein the microneedles comprise a cone shape that is devoid of patterning on the surface of said cone shape (Fig 6b);
wherein the microneedles have a needle height in the range of from about 1 mm to about 2.2 mm (Fig 3d);
wherein the microneedles have an aspect ratio in the range of about 0.5 to about 4 (Fig 3d, pg 3); and
wherein the microneedles are 3D printed microneedles (Fig 1).
For claim 15, Krieger discloses the claimed invention except for expressly disclosing the plurality of solid microneedles are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer to obtain and extract microbes residing in a stratum corneum of the epidermis layer and in a sweat gland and/or a hair follicle of the dermis layer. Krieger is concerned with the design criteria of compound extracting sensing applications (Page 2, first full Paragrapgh).
For claim 15, Lamerton teaches a skin microbe sampler (pages 2-4), comprising inter alia: a plurality of solid microneedles (10) are dimensioned and configured to be capable of penetrating an epidermis layer of the skin and accessing a dermis layer (40) to obtain and extract microbes residing in a stratum corneum of the epidermis layer and in a sweat gland and/or a hair follicle of the dermis layer (pages 2-4), wherein said microneedles taper in width from base to tip (page 3), are cone shaped (page 3) devoid of surface patterning (page 3), and have a height of 1-2mm (page 3).
For claim 15, Kriger and Lamerton are both considered to be analogous to the claimed invention because they are in the same field of microneedle array skin-based biological specimen collection endeavor. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Krieger to incorporate the teachings of Lamerton to provide a microneedle array configured to obtain and extract microbes from the staratum corneum of the epidermis and a seat gland and/or hair follicle of the dermis layer. Doing so would aid in achieving the predictable result of skin-based microbe retrieval using an adhering microneedle array (Krieger, page 2 first full paragraph) (Lamerton, bottom of page 3).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2 and 9-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights