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 .
DETAILED ACTION
This action is in response to papers filed 3/11/2026.
Claims 1-21 are pending.
The following rejections are newly applied based upon amendments to the claims.
This action is FINAL.
Withdrawn Objections and Rejections
6. The objection to the claims and 35 USC 112b and 35 USC 103 made in the previous office action is withdrawn based upon amendments to the claims.
Claim Rejections - 35 USC § 112
Claim limitation “configured to” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The phrase “configured to” is not recited in the specification. The specification fails to provide the structured for a device “configured to quantify expression” or “patch is “configured to be applied”. In particular the device does not quantify the expression, but rather an expression assay s used. Furthermore, it is not clear the structure required by the patch to perform the detachment. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. 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.
10. Claim(s) 1-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahmood et al. (US Patent 9540684 Jan 10. 2017).
The claims requires (1) a quantifying device. The specification does not explicitly define this term nor dies the claim require any particular structure other than “configured to quantify”.
(2) a micro needle patch comprising a plurality of microneedles wherein each needle is made of biodegradable polymer hyaluronic acid.
The wherein clause are considered intended use. With regard to the wherein clause, this appears to be the intended use of the micro needle patch and device. As the prior art teaches the structures, the product would be capable of the intended use.
With regard to claims 1, 3, 5,7, 9, 11, 13, Mahmood et al. teaches a microneedle device to place on the surface of the skin (para 39). Mahmood et al. teaches a device that can be configures to quantify expression levels of RNA (para 35 and 39 and 88). Mahomood et al. teaches that the patch can be comprises of biodegradable materials including coating with hyaluronic acid (para 43). Although Mahomood et al. taches not teach a kit that comprises both, it would be prima facie to one of ordinary skill in the art at the time of the effective filing date that the known structures can be combined into a “kit” that comprises the recited structures.
With regard to claim 2, the claim appears to limit the intended use, but does not change the structure of claim 1 therefore claim 2 is rejected based upon the rejection of claim 1.
With regard to claim 4, the claim appears to limit the intended use, but does not change the structure of claim 3 therefore claim 4 is rejected based upon the rejection of claim 3.
With regard to claim 6, the claim appears to limit the intended use, but does not change the structure of claim 5 therefore claim 6 is rejected based upon the rejection of claim 5.
With regard to claim 8, the claim appears to limit the intended use, but does not change the structure of claim 7 therefore claim 8 is rejected based upon the rejection of claim 7.
With regard to claim 10, the claim appears to limit the intended use, but does not change the structure of claim 9 therefore claim 10 is rejected based upon the rejection of claim 9.
With regard to claim 11, the claim appears to limit the intended use, but does not change the structure of claim 12 therefore claim 11 is rejected based upon the rejection of claim 12.
With regard to claim 14, the claim appears to limit the intended use, but does not change the structure of claim 13 therefore claim 14 is rejected based upon the rejection of claim 13.
With regard to claims 15-21, teaches devices for RNA extraction form skin (para 21-25).
Conclusion
11. No claims are allowed.
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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