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, claims 1-7 and 11-15, in the reply filed on 08 June 2026 is acknowledged. Claims 16-21, 24, and 25 are hereby withdrawn.
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 2, 3, 7, and 13-15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 2 and 7 each recite broad limitations and a narrower statement of the range/limitation (e.g., claim 2 recites “about 25 to about 1000 MNs” and “about 100 to about 400 MNs” and “about 100 to about 200 MNs”; and claim 7 recites (a) “about 250 µm or 300 µm to about 1000 µm” and “about 450 µm to about 750 µm” and “about 600 µm”, (b) “about 7.5mm x 7.5mm, about 10 mm x 10 mm, or about 7.5-10mm x 7.5-10mm”, and (c) “about 300 µm to about 500 µm” and “about 400 µm”). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 13, the phrase “and a vacuum port in operable connection lateral flow test strip” renders the claim indefinite. For this examination, the phrase is being interpreted as “and a vacuum port in operable connection with the lateral flow test strip”.
Regarding claim 14, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Determan et al.’707 (US Pub No. 2013/0123707).
Regarding claim 1, Figure 2 of Determan et al.’707 discloses a transdermal microneedle array 22 comprising a first microneedle array composed of a plurality of solid microneedles 10 (sections [0256-0258], [0261-0262]).
Regarding claim 2, Figure 2 shows that microneedle array 22 comprises between 25 to 1000 microneedles.
Regarding claim 4, the microneedle array is made of a metallic material (section [0251]).
Regarding claims 5 and 6, the microneedle array is coated with a biocompatible material, the biocompatible material being polyethylene glycol (sections [0010], [0022], [0142-0146]).
Regarding claim 7, the microneedle array microneedles are about 250 µm or 300 µm to about 1000 µm in height (section [0258]).
Claims 1, 2, 4, 5, 7, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wirtanen et al.’444 (US Pub No. 2015/0290444).
Regarding claim 1, Figure 13 of Wirtanen et al.’444 discloses a transdermal microneedle array 107A comprising a first microneedle array composed of a plurality of microneedles 108A (sections [0039-0040], [0068], [0093], [0100], [0138]).
Regarding claim 2, Figure 2 shows that microneedle array 107A comprises between 25 to 1000 microneedles.
Regarding claim 4, the microneedle array is made of a metallic material (section [0103]).
Regarding claim 5, the microneedle array is coated with a biocompatible material (sections [0014], [0093], [0100]: the active agent delivered to the skin is biocompatible).
Regarding claim 7, the microneedle array microneedles are about 250 µm or 300 µm to about 1000 µm in height (section [0118]).
Regarding claim 11, Figures 2, 3, and 5 disclose a kit comprising the transdermal microneedle array of claim 1 (shown as element 106, section [0039]), and a rigid skin patch 102,120,122 with one or more cut outs 114/142 configured to fit the transdermal microneedle array (best seen in Figures 3 and 5: bore 114 fits microneedle array 106, sections [0043], [0049]).
Regarding claim 12, the skin patch is fabricated from a plastic substrate coated on at least one side with an adhesive 150 (sections [0033], [0065], [0084]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Determan et al.’707, as applied to claim 2.
Determan et al.’707 discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the microneedles being arranged in a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 configuration. Section [0262] of Determan et al.’707 discloses that the microneedles may be arranged in any desired pattern. According to MPEP section 2144.04 IV. B., the configuration of a claimed element is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element is significant. While Determan et al.’707 fails to explicitly disclose that the pattern includes a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 arrangement, it would have been an obvious design choice to a person of ordinary skill in the art to have configured the microneedle array as a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 arrangement because Applicant has not disclosed that the feature provides an advantage, is used for a particular purpose, or solves a stated problem.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wirtanen et al.’444, as applied to claim 2.
Wirtanen et al.’444 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the microneedles being arranged in a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 configuration. Section [0138] of Wirtanen et al.’444 discloses that the microneedles may be arranged in any desired pattern. According to MPEP section 2144.04 IV. B., the configuration of a claimed element is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed element is significant. While Wirtanen et al.’444 fails to explicitly disclose that the pattern includes a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 arrangement, it would have been an obvious design choice to a person of ordinary skill in the art to have configured the microneedle array as a 5 x 5, 10 x 10, 15 x 15, 20 x 20, or 30 x 30 arrangement because Applicant has not disclosed that the feature provides an advantage, is used for a particular purpose, or solves a stated problem.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wirtanen et al.’444, as applied to claim 11, in view of Strohmaier et al.’724 (US Pub No. 2024/0081724) further in view of Samproni et al.’857 (US Pub No. 2022/0023857).
Wirtanen et al.’444 discloses all of the elements of the current invention, as discussed in paragraph 7 above, except for the kit comprising a lateral flow test strip and a vacuum port in operable connection with the lateral flow test strip.
Strohmaier et al.’724 teaches using a lateral flow test strip to assess immune activity in a subject. The lateral flow test strip is used in conjunction with a transdermal microneedle patch, wherein a means for pumping fluid obtained from a subject wearing the transdermal microneedle patch is used to transport the fluid through channels of the lateral flow test strip (see ABSTRACT, section [0027]). The microneedle patch and lateral flow test strip are used to analyze a large variety of analytes (section [0029]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the kit of Wirtanen et al.’444 to include a lateral flow test strip. The combination of a transdermal microneedle array, a rigid skin patch, and a lateral flow test strip would allow a large variety of analytes to be analyzed, thus allowing for the assessment of the immune activity of a subject.
Wirtanen et al.’724 in view of Strohmaier et al.’724 discloses all of the elements of the current invention, as discussed above, except for the kit comprising a vacuum port in operable connection with the lateral flow test strip. As noted above, Strohmaier teaches using a means for pumping fluid samples through channels of the lateral flow test strip. Samproni et al.’857 teaches using a vacuum port connected to a lateral flow test strip as a means for transporting fluid through channels of the lateral flow test strip (section [0070]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the kit of Wirtanen et al.’724 in view of Strohmaier et al.’724 to include a vacuum port in operable connection with the lateral flow test strip as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Wirtanen et al.’724 in view of Strohmaier et al.’724 would provide a means by which to transport the fluid sample obtained from the subject through the channels of the lateral flow test strip.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wirtanen et al.’444 in view of Strohmaier et al.’724 further in view of Samproni et al.’857, as applied to claim 13, further in view of Luke’386 (US Pub No. 2016/0320386).
Wirtanen et al.’444 in view of Strohmaier et al.’724 further in view of Samproni et al.’857 discloses all of the elements of the current invention, as discussed in paragraph 11 above, except for the lateral flow test strip comprising a membrane such as a nitrocellulose or cellulose membrane. Luke’386 teaches that lateral flow test strips are frequently made of nitrocellulose (section [0039]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have used a lateral flow test strip comprising a nitrocellulose membrane as Luke’386 teaches that lateral flow test strips are frequently made of nitrocellulose.
In the combination of Wirtanen et al.’444 in view of Strohmaier et al.’724 further in view of Samproni et al.’857 further in view of Luke’386, the lateral flow test strip is connected to the patch by microchannels. The combination fails to explicitly disclose the width of each channel. As Applicant has failed to provide any details or evidence of criticality or unexpected results with regard to the claimed channel width, it would have been obvious, through routine experimentation, to determine the optimum channel width of the microchannels of Wirtanen et al.’444 in view of Strohmaier et al.’724 further in view of Samproni et al.’857 further in view of Luke’386.
Regarding claim 15, Luke’386 discloses including an antigen binding agent disposed on the membrane of a lateral flow test strip to capture, detect, and quantify a particular analyte being tested (sections [0073-0075], [0080-0081]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the lateral flow test strip of Wirtanen et al.’444 in view of Strohmaier et al.’724 further in view of Samproni et al.’857 further in view of Luke’386 to include an antigen binding agent disposed in or on said membrane as it would merely be combining prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kommareddy et al.’245 (US Pub No. 2013/0224245) teaches coating solid microneedles with chitosan (section [0084]).
Gill et al.’461 (US Pub No. 2008/0213461) teaches coating solid microneedles of a microneedle array with polyethylene glycol (sections [0061-0064]).
Manneh et al.’463 (US Pub No. 2017/0176463) teaches moving samples in a lateral flow test strip channel using vacuum or capillary action (section [0044]).
Skoda et al.’386 (US Pub No. 2018/0356386) teaches using a micro-pump vacuum to move samples in a lateral flow test strip channel (section [0102]).
Burton’512 (US Pub No. 2020/0368512) teaches a transdermal microneedle array comprising a first microneedle array composed of a plurality of solid microneedles (section [0023]).
Li et al.’108 (US Pub No. 2017/0212108) teaches using antigen binding agents within a lateral flow test strip to capture an analyte of interest (section [0046]).
Nawana et al.’474 (USPN 11,452,474) teaches using a vacuum to facilitate the flow of a sample through the channel of a lateral flow test strip (col. 13, lines 42-45).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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