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 .
Response to Amendment
Applicant’s amendment and remark filed on 06/22/26 have been entered. Claims 1-20 remain pending. Claims 11-20 remain withdrawn. Claims 1-10 are examined herein. Applicant’s amendment and remark have overcome each and every rejection under 112(b) set forth in Office Action mailed on 03/25/26.
Status of Rejection
The 112(b) rejection of claims 1-10 is withdrawn in view of Applicant’s amendment.
The 103 rejection of claims 1-10 over Libermans (US 20130034908 A1) and Paper analytical devices for fast field screening of beta lactam antibiotics and anti-tuberculosis pharmaceuticals, 2014) as cited in previous Office Action is maintained.
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.
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) 1-10 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, wherein the laminated strips are formed by laminating the hydrophilic substrate to the adhesive layer and cutting the resultant laminated structure into strips prior to disposing the laminated strips on the 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]).
Response to Arguments
Applicant's arguments filed 06/22/26 have been fully considered but they are not persuasive.
Regarding applicant’s first argument, applicant argues that the prior arts failed to disclose the claimed invention as the neither Liebermans discloses structure resulted from the manufacturing method of “laminating the hydrophilic substrate to the adhesive layer and cutting the resultant laminated structure into laminated strips prior to disposing the laminated strips on hydrophobic backing” (Page 8-9 of the Remark). Examiner respectfully disagrees.
MPEP 2113, I states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process."
In the claim’s current drafted form, the final product from the process is an adhesive layer on a strip of hydrophilic substrate layer. It is determined that there is no apparent structural difference of the final product from the claimed process or the alleged process of Libermans (i.e. placing an adhesive layer on the strips after the paper is cut into strips or applying an adhesive layer on the backing followed by another layer of paper strips). MPEP 2113, II states: “ONCE A PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS FOUND AND A PRIOR ART REJECTION IS MADE, THE BURDEN SHIFTS TO THE APPLICANT TO SHOW AN NONOBVIOUS DIFFERENCE”. On the contrary of Applicant’s assertion that Lieberman failed to disclose a substrate laminated to an adhesive layer (para. 1, page 9), Lieberman 1 has already disclosed the paper strips can be laminated strips applied with an adhesive layer (in another embodiment, laminated or layered structures are produced which again increase the PAD depth. para. [0042]). As the applicant did not show a nonobvious difference in the remark, the first argument is not deemed convincing.
Regarding applicant’s second argument, applicant alleges Libermans failed to disclose the air gap as claimed by reciting the specific function and structure of the air gap (para. 2-3, page 10). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Current claim simply requires air gap to be a gap/spacing between two laminated strips on a hydrophobic backing.
For the reasons above, the rejection is maintained.
Conclusion
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 MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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