CTNF 18/453,116 CTNF 97244 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Election/Restriction 08-08 AIA Restriction to one of the following inventions is required under 35 U.S.C. 121: I. Claim s 1-10 , drawn to an apparatus , classified in B01L 3/5023 . II. Claim s 11-15 , drawn to method of manufacturing the apparatus , classified in B01L 2200/12 . 08-09 AIA III. Claim s 16-20 , drawn to method of using the apparatus , classified in G01N 33/94 . 08-13 AIA The inventions are independent or distinct, each from the other because: 08-18 AIA Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process as claimed can be made to a materially different product such as a barebone multi-layer laminated paper test strip without having reagent predisposed in it . 08-20 AIA Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process of using the product as claimed can be practiced with another materially different product such as a Litmus paper or a Covid test strip . 08-14-01 AIA Inventions II and III are directed to related processes . The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are not capable of use together and have a different mode of operation, function, or effect as one method is directed to manufacturing an analytical device, while the other method is directed to analyzing such device . Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: Group I would require a search and consideration in at least CPC B01L 3/5023, along with a unique text search. Group II would require a search and consideration in at least CPC B01L 2200/12, along with a unique text search. Group III would require a search and consideration in at least CPC G01N 33/94, along with a unique text search. 18-22 AIA Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention . The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. 08-23 AIA During a telephone conversation with Michael Haukaas on March 12, 2026 , a provisional election was made with preservation of traverse to prosecute the invention of Group I , claim s 1-10 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 11-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 08-21-04 AIA The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined. In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 1-10 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. Regarding claim 1, the claim recites one or more laminated strips and air gap barrier between each of the one or more laminated strips disposed on the hydrophobic backing. An embodiment of a single laminated strip would have inadvertently obviated the limitation regarding forming the air gap as a gap is only measurably between at least two quantities of the strips. Examiner recommends applicant amending the claim to be “two or more laminated strips”. Claims 2-10 are also rejected for being for failing to cure the deficiency above. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lieberman 1 (US 20130034908 A1) in view of Lieberman 2 (Paper analytical devices for fast field screening of beta lactam antibiotics and anti-tuberculosis pharmaceuticals, 2014) . Regarding claim 1, Lieberman 1 discloses a paper analytical device (PAD) (Fig. 4) comprising: two or more laminated strips (hydrophilic test lanes A-L, Fig. 4 and 5; … in another embodiment , laminated or layered structures are produced which again increase the PAD depth. para. [0042]) comprising porous hydrophilic substrate ( porous substrate Ahlstrom 319 , para. [0008], [0128], and [0178]), wherein the two or more laminated strips are separated by a hydrophobic barrier between each of the two or more strips (black lanes between test lane A-L; Fig. 4 and 5); one or more assay regions disposed on the two or more strips wherein the one or more assay regions ( The analytical device also contains at least one assay reagent in each of the assay regions . Para. [0047]) comprises one or more reagents for detecting an analyte (… placing 2-8 μL (preferably 4 ul) of each of the following reagents in the designated locations on a paper analytical device that has 12 lanes defined by hydrophobic separators that completely penetrate the thickness of the underlying porous substrate Ahlstrom 319 , para. [0128]; Table 4) (also para. [0178] and Table 6 for another embodiment); and one or more sample deposition areas (swipe line 401 and 501; Fig. 4 and 5) on the one or more laminated strips ( In order to run the test, a tablet is scraped along the “swipe line” on the PAD, most effectively using a piece of metal or plastic screening or sandpaper to help remove powder from the tablet. Para. [0178]) ( In some instances, a solid formulation can be used directly with the PAD, by swiping or rubbing the formulation onto the PAD at a specific location(s). para. [0051]). The limitation of wherein the PAD is activated when one or more solvents travel through both the one or more sample deposition areas and the one or more assay regions due to capillary action is a recitation of intended use as the solvent is not recited as part of the claimed apparatus. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, Lieberman 1 discloses the one or more solvents travel through both the one or more sample deposition areas and the one or more assay regions due to capillary action (… in the preferred embodiment of this application method, the solvent is allowed to contact a part of the assay region and then fill the assay region by capillary action . Para. [0054]; Water runs up the twelve lanes which initiates the chemical tests and produces colors characteristic of specific functional groups present in the targeted analytes . para. [0178]). The specific embodiment of Fig. 4 and 5 in Lieberman 1 does not disclose the laminated strips comprising a first adhesive layer and the laminated strips are disposed on hydrophobic backing, or the air gap barrier is formed between the each of the two or more laminated strips disposed on the hydrophobic backing, wherein the air gap barrier is about 1 mm to about 5 mm in width and extends along an entire length of the two or more laminated strip. The separators/barrier utilized in the embodiments of Lieberman 1 are hydrophobic barrier by wax printing (… separators are formed by the wax printing method . Para. [0128]; … allow the wax to melt through the paper and forth a continuous hydrophobic barrier surrounding the desired assay region . Para. [0045]). However, Lieberman 1 offers an alternative method of manufacturing the device by “cut and paste” (para. [0046]) wherein the lanes are cut from hydrophilic paper medium and adhered to a hydrophobic backing ( relatively strong backing ; para. [0046]) using a first adhesive layer ( hydrophilic paper medium and adhered to a relatively strong backing…using an adhesive ; para. [0046]). Furthermore, the cut and paste method would form one or more air gap between at least two or more laminated strips as Lieberman 1 discloses air gap as a suitable alternative to using hydrophobic barrier ( Typically, a hydrophobic barrier or an air gap defines multiple assay regions with multiple assay reagents or precursors thereof arranged in a defined pattern to facilitate contact with the chemical components to be tested . Para. [0010]; also in claim 3). Regarding the limitation of the width of air gap barrier, Lieberman 2 is an academic disclosure of the device of Lieberman 1 (See Fig. 1 and 2). Lieberman 2 discloses the final width of the hydrophobic barrier (wax lines) was 1.5-2mm (Supplementary Information, Fabrication, Baking the wax layers, page 2), which is within the claimed range of 1 mm and 5 mm. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date to have re-built the device of embodiment 4 and 5 of Lieberman 1 using the cut and paste method as taught by Liberman 1 (while maintaining the dimensions the device based on Liberman 2) to derive the device with one or more air gap between the two or more laminated strip with width of the gap between 1.5-2mm. Building the device using cut and paste method eliminate the chance of hydrophobic agent bleeding over into the hydrophilic lanes ( This method does not require the application of a hydrophobic agent in order to define the hydrophilic reaction areas. As a result, the chance of bleed-over of hydrophobic agent into the lanes is eliminated ; para. [0046]). Regarding the limitation of the air gap barrier extends along an entire length of the two or more laminated strip, Lieberman 1 discloses the length of the rectangular lane of the strips can range from about 1 cm to the full length of the PAD. As the hydrophilic strips can extend to the full length of the PAD, by extension, one of ordinary skill in the art would have extended the air gap barrier to the full length of the PAD as well in order to fully isolate each strip. from one another and prevent fluids/samples/reagents of one strip from bleeding into another strip (para. [0043]). Regarding claims 2-3, Modified Lieberman discloses the claimed invention as discussed above in claim 1. The embodiment of Fig. 4 and 5 of Lieberman 1 does not explicitly discloses the PAD is disposed on a printed card with defined width and length (and by extension having a second adhesive layer laminated on the hydrophobic backing for pasting the hydrophobic backing onto the printed card). Lieberman 1 discloses the PAD has a layer containing information like color standards, text, a QR code, and fiducial markers (Fig. 6). Furthermore, Lieberman 1 offers an alternative method of manufacturing the device by “cut and paste” (para. [0046]) wherein the lanes are cut from hydrophilic paper medium and adhered to a hydrophobic backing ( relatively strong backing ; para. [0046]) using a first adhesive layer ( hydrophilic paper medium and adhered to a relatively strong backing…using an adhesive ; para. [0046]). Lieberman 2 discloses the device comprises three layers, a print card layer ( color laser printer layer, Supplemental Information, Fabrication, Printing, para. 1, page 1) containing color standards, text, a QR code, fiducial markers, and lane loading indicators (Supplemental Information, Fabrication, Printing, para. 1, page 2), a hydrophobic lane/wax layer (Supplemental Information, Fabrication, Printing, para. 2, page 2), and a hydrophilic substrate layer/Ahlstrom 319 (Supplemental Information, Materials, para. 3, page 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have utilize the cut and paste method of Lieberman 1 and adhere/disposed the hydrophobic backing of the PAD onto a print card by a second adhesive or lamination layer similar to the configuration taught by Lieberman 2. Doing so provided the device with a third layer providing essential information such ID tag, color standards (Lieberman 2, Supplemental Information, Fabrication, Printing, para. 1, page 2) and fiducial marker ( Fiducial markers ( 603 , 613 , 604 , 614 ) aid in orienting the captured image so that the image software can correct or transform the captured image . Lieberman 1, Para. [0203]). Regarding claims 4-5, Modified Lieberman discloses the claimed invention as discussed above in claim 1. Lieberman 1 discloses the device further comprises at least one optically readable information area (Fiducial markers ( 603 , 613 , 604 , 614 ), Fig. 6) that provides visual information for detection of analyte, wherein at least one optically readable information area comprises one or more alignment references ( Fiducial markers ( 603 , 613 , 604 , 614 ), Fig. 6) for transforming or correcting a captured images of the PAD to facilitate analysis ( Fiducial markers ( 603 , 613 , 604 , 614 ) aid in orienting the captured image so that the image software can correct or transform the captured image . Para. [0203]), wherein one or more alignment references include a plurality of fiducial markers for orienting a captured image of the PAD (( Fiducial markers ( 603 , 613 , 604 , 614 ) aid in orienting the captured image so that the image software can correct or transform the captured image . Para. [0203]), and the PAD further comprises an identification tag of a two-dimensional barcode ( QR codes (601, 611 ), Fig. 6). Regarding claim 6, Modified Lieberman discloses the claimed invention as discussed above in claim 1. Lieberman 2 teaches the width of the hydrophilic paper lane was 2.5 to 3 mm ( the width of the hydrophilic paper lanes was 2.5-3 mm ; Supplementary Information, Fabrication, Baking the wax layers, page 2), which falls completely within the claimed range of about 2 mm to about 7 mm, and the width of gap barrier to be 1.5 mm-2mm ( The final width of the wax lines was 1.52 mm; Supplementary Information, Fabrication, Baking the wax layers, page 2), which overlaps with the claimed range of 2 mm to about 4.5 mm in width. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness. See MPEP § 2144.05.I. Regarding claim 7, Modified Lieberman discloses the claimed invention as discussed above in claim 1. The limitation regarding the visual information comprises color information caused by an interaction of the analyte and the one or more reagent is a recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, Lieberman 1 discloses the visual information comprises color information caused by an interaction of the analyte and the one or more reagents (… at least one electronically readable information zone which after activation of the device provides color information necessary for identification of the device and analysis or detection of the at least two chemical components . Para. [0008]). Regarding claims 8-9, Modified Lieberman discloses the claimed invention as discussed above in claim 1. Lieberman 1 discloses the analyte comprises amoxicillin and ampicillin (para. [0052], [0130], and [0177]; Table 5 and 6). Regarding claim 10, Modified Lieberman discloses the claimed invention as discussed above in claim 1. The recitation of the analyte comprises a solid powder applied directly to the one or more sample deposition areas is a recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, Lieberman 1 discloses the analyte is a solid powder applied directly to the one or more sample deposition areas ( In order to run the test, a tablet is scraped along the “swipe line” on the PAD, most effectively using a piece of metal or plastic screening or sandpaper to help remove powder from the tablet. Para. [0178]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET. 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, Maris Kessel can be reached at 5712707698. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /M.H./Examiner, Art Unit 1758 /MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758 Application/Control Number: 18/453,116 Page 2 Art Unit: 1758 Application/Control Number: 18/453,116 Page 3 Art Unit: 1758 Application/Control Number: 18/453,116 Page 4 Art Unit: 1758 Application/Control Number: 18/453,116 Page 5 Art Unit: 1758 Application/Control Number: 18/453,116 Page 6 Art Unit: 1758 Application/Control Number: 18/453,116 Page 7 Art Unit: 1758 Application/Control Number: 18/453,116 Page 8 Art Unit: 1758 Application/Control Number: 18/453,116 Page 9 Art Unit: 1758 Application/Control Number: 18/453,116 Page 10 Art Unit: 1758 Application/Control Number: 18/453,116 Page 11 Art Unit: 1758 Application/Control Number: 18/453,116 Page 12 Art Unit: 1758 Application/Control Number: 18/453,116 Page 13 Art Unit: 1758 Application/Control Number: 18/453,116 Page 14 Art Unit: 1758