DETAILED ACTION
The communication dated 11/25/2025 has been entered and fully considered.
Claims 1-24 and 40-42 are pending. Claims 25-39 are cancelled.
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 of Group I, claims 1-24, in the reply filed on 11/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Objections
Claim 42 objected to because of the following informalities: “analyte indicator molecules is” should read ‘analyte indicator molecules are”. Appropriate correction is required.
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.
Claim 23 is 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.
Claim 23 recites the limitation "the indicator hydrogel film" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 is similarly rejected being dependent on claim 23.
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.
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, 4-6, 10-11, 14, 19 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, in view of NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI.
Regarding claim 1, PRESLEY teaches: A process (PRESLEY teaches a process [Abstract; Figs. 2a-2b].) comprising: injecting a monomer solution into a mold (PRESLEY teaches the deposition module for forming the material on the substrate may be injection molding [0065; 0083-0084; Fig. 2b]. PRESLEY teaches injection a monomer solution (285) into a mold (227) [0117-0119; Fig. 2o].); polymerizing the monomer solution in the mold to produce an indicator sheet (PRESLEY teaches polymerizing the monomer solution in the mold to produce an indicator sheet [0119; Fig. 2o]. PRESLEY teaches the sheets comprise integrated miniature factories (100, 200, 201), integrated circuit (600) and devices (607, 609, 611), but are not limited and may include an extensive variety of devices such as MEMS sensors, implantable drug delivery systems, DNA chips, microfluidic chips, etc. [0025; 0165].); cutting the indicator sheet . . . (PRESLEY teaches cutting the indicator sheet [0076].); and attaching an indicator film of the one or more indicator films to a product (PRESLEY teaches attached an indicator film to a substrate [0084-0085; Fig. 2b].).
PRESLEY does not explicitly teach cutting the indicator sheet “to product one or more indicator sheets”; however, in the same field of endeavor, indicator sheets, NAKAI, teaches dicing a sheet to form a plurality of individual sheets [0016]. It would have been obvious to one of ordinary skill in the art at to time of the effective filing date of the applicant’s invention to modify PRESLEY, by cutting the sheet to a plurality of films, as suggested by NAKAI, in order to form a plurality of films [0043]. Furthermore, it’s a known method in the art. See KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Regarding claim 4, PRESLEY teaches: further comprising assembling the mold (PRESLEY teaches assembly the mold [Fig. 2o; 0069].).
Regarding claim 5, PRESLEY teaches: wherein injecting the monomer solution into the mold comprises injecting the monomer solution into an injection port of the mold (PRESLEY teaches injecting the monomer solution into an injection port (280b) of the mold (227) [0119; Fig. 2o].).
Regarding claim 6, NAKAI further teaches: wherein cutting the indicator sheet to produce one or more indicator films comprises using a cutting tool to partition the indicator sheet (NAKAI teaches using a cutting tool (cutter knife) to partition the sheet [0462].).
Regarding claim 10, PRESLEY teaches: wherein attaching the indicator sheet to the product comprises using a film attachment tool (PRESLEY teaches attaching substrates to the device with rollers [Fig. 2l; 0108-0109]. PRESLEY also teaches removing the device with a roller that grips the material and rolls the material off of the surface and transports it to an optional module [0082].).
Regarding claim 11, PRESLEY teaches: wherein using the film attachment tool comprises: holding the product in one or more product cradles of the film attachment tool (PRESLEY teaches the device (106a) may be removed from the enclosure (102) from a tray (106b), which the Examiner is interpreting as a cradle [0025; 0103; Fig. 2b].); and using a roller of the film attachment tool to attach the indicator film to the product (PRESLEY teaches attaching substrates to the device with rollers [Fig. 2l; 0108-0109]. PRESLEY also teaches removing the device with a roller that grips the material and rolls the material off of the surface and transports it to an optional module [0082].).
Regarding claim 14, PRESLEY teaches: further comprising determining whether the indicator film passes an inspection before attaching the indicator film to the product (PRESLEY teaches the device is inspected before the final product is finished [0068].).
Regarding claim 19, PRESLEY teaches: further comprising applying a protective material to the indicator film attached to the product (PRESLEY teaches a protective overcoat (628) is on the circuit (600) [0154].).
Regarding claim 41, PRESLEY teaches: wherein the indicator film includes analyte indicator molecules (PRESLEY teaches the device (106a) might include a microfluidics-based device that might be configured for biological analysis such as protein crystallography, polymerase chain reaction (PCR), cell counting and sorting, DNA analysis, assay analysis, and/or other analysis [0070; 0159].).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 1 above, and further in view of Sigrist et al. (U.S. PGPUB 2003/0064405), hereinafter SIGRIST.
Regarding claim 2, PRESLEY and NAKAI teach all of the claimed limitations as stated above, including: wherein the mold comprises first and second plates (PRELSEY teaches a first plate (282) and a second plate (281) [Fig. 2o; 0117-0119].) and wherein the monomer solution is injected between the first and second plates (PRESLEY teaches the monomer solution is injected between the first and second plates [0119].), but are silent as to: one or more clips configured to hold the first and second plates together. In the same field of endeavor, injection molding, SIGRIST teaches clips are used in injection molding to hold two plates together [0046]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having clips hold the plates, as suggested by SIGRIST, in order to ensure a detachable assembly [0046].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, and Sigrist et al. (U.S. PGPUB 2003/0064405), hereinafter SIGRIST, as applied to claim 2 above, and further in view of Taniai et al. (U.S. 4,135,277), hereinafter TANIAI.
Regarding claim 3, PRESLEY, NAKAI and SIGRIST teach all of the claimed limitations as stated above, including: wherein the first plate is a glass plate (PRESLEY teaches the first plate is a glass plate [0120].), the second plate is a stamped plate (PRESLEY teaches the second plate is a stamped plate (281, as it’s a cavity with a shape) [0119]. NAKAI also teaches a second plate that is stamp (22) [Fig. 3c; 0270].), but are silent as to: and the one or more clips are plastic clips. In the same field of endeavor, clips, TANIAI teaches clips that are made of plastic [Col. 2, lines 1-5]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY, NAKAI and SIGRIST, by having the clips be made of plastic, as suggested by TANIAI, in order to have a clip that can be integrally molded easily and inexpensively by injection molding [Col. 2, lines 1-5].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 6 above, and further in view of Freund (U.S. PGPUB 2006/0176180), hereinafter FREUND.
Regarding claim 7, PRESLEY and NAKAI teach all of the claimed limitation as stated above, but are silent as to: wherein using the cutting tool to partition the indicator sheet comprises: providing the indicator sheet between a platform and a cut out sheet of the cutting tool, wherein the platform comprises projections, and the cut out sheet comprises openings that mate with the projections of the platform; and inserting the projections of the platform into the openings of the cut out sheet. In the same field of endeavor, cutting tool, FREUND teaches providing a sheet (20) between a platform (4) and a cutout sheet (10) of the cutting tool (2) [0046; Fig. 4]. FREUND teaches the platform (4) comprises projections (6) [0045; Fig. 4]. FREUND teaches the cut out sheet has openings (12) that mate with the projections (6) [0046]. FREUND teaches inserting the projections (6) of the platform (4) into the openings (12) of the cutout sheet (10) [0046]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having a cutout sheet and platform of the cutting tool that mate with each other, as suggested by FREUND, in order to remove the plurality of articles [0046].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 1 above, and further in view of Schwartau (U.S. PGPUB 2014/0261980), hereinafter SCHWARTAU.
Regarding claim 8, PRESLEY and NAKAI teach all of the claimed limitations as stated above, including: wherein attaching the indicator sheet to the product comprises: applying an adhesive onto the product (PRESLEY teaches applying adhesive on the substrate [0101].), but are silent as to: placing a first edge of the indicator film in the adhesive on the product; and placing a second edge of the indicator film in the adhesive on the product. In the same field of endeavor, adhesive and polymers, SCHWARTAU teaches the concept of placing a first edge of a film on a product and then placing a second end on the product [Figs. 3A, 3C; 5A-5B]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by placing a first edge of the film on the adhesive on the product and then a second edge, as suggested by SCHWARTAU, as it’s a known option in the art. See KSR int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007) ("A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.").
Regarding claim 9, PRESLEY teaches: wherein attaching the indicator sheet to the product comprises rotating the product and pressing the indicator film against the product as the product rotates (PRESLEY teaches an optional robotic transfer mechanism to move the substrate into and out of the enclosure [0059].).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 11 above, and further in view of Schein et al. (U.S. PGPUB 2012/0325695), hereinafter SCHEIN.
Regarding claim 12, PRESLEY and NAKAI teach all of the claimed limitations as stated above, but are silent as to: wherein holding the product in the one or more product cradles comprises using one or more magnets of the film attachment tool to hold the product in the one or more product cradles. In the same field of endeavor, injection molding, SCHEIN teaches the concept of using magnets as fastening mechanisms to for trays [0111; 0119]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having a magnet as a fastening mechanism to hold a tray, as suggested by KIDO, in order to prevent accidental removal or dislodgment of article [0129].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 11 above, and further in view of Schwartau (U.S. PGPUB 2014/0261980), hereinafter SCHWARTAU.
Regarding claim 13, PRESLEY and NAKAI teach all of the claimed limitations as stated above, but are silent as to: wherein using the roller to attach the indicator film to the product comprises rotating the roller 180 degrees in one of the clockwise and counterclockwise directions and then rotating the roller 180 degrees in the other of the clockwise and counterclockwise directions. In the same field of endeavor, rollers, SCHWARTAU teaches a roll (48) may supply material in a first direction and then may be rotated or turned by 180-degrees on a carriage [0054; Figs. 3A-3C]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having the roller turn by 180-degrees, as suggested by SCHWARTAU, in order to change directions and avoid fold or kinks in the material [0054; 0078].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 14 above, and further in view of Leach et al. (U.S. PGPUB 2009/0131769), hereinafter LEACH.
Regarding claim 15, PRESLEY and NAKAI teaches all of the claimed limitations as stated above, but are silent as : wherein determining whether the indicator film passes the inspection comprises determining whether the indicator film includes a threshold amount of analyte indicator molecules. In the same field of endeavor, indicators, LEACH teaches the concept of determining a threshold amount of analyte indicator molecules [0986; 1016]. It would have been obvious to be one of ordinary skill in the art at the time of the effective filing date to modify PRESLEY and NAKAI, by determining a threshold amount of analyte indicator molecules, as suggested by LEACH, in order for the sensor to be considered to be stable [0986].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 1 above, and further in view of Kudrna et al. (U.S. PGPUB 2024/0224424), hereinafter KUDRNA.
Regarding claim 16, PRESLEY and NAKAI teach al of the claimed limitations as stated above, but are silent as to: further comprising determining whether the indicator film attached to the product passes an inspection. In the same field of endeavor, processes, KUDRNA teaches a final inspection of the final product [Fig. 6; 0180]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having a final inspection, as suggested by KUDRNA, in order to pass quality standards [0180].
Regarding claim 17, KUDRNA further teaches: further comprising: determining that the indicator film attached to the product does not pass the inspection (KUDRNA teaches determining components that fail the inspection [0180]); removing all or a portion of the indicator film from the product (KUDRNA teaches removing the failed components [0180].); and attaching another indicator film to the product (KUDRNA teaches attached another component [0180].). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by inspecting failed parts, removing the failed parts and attaching another part, as suggested by KUDRNA, in order to recycle the components [0180].
Claim(s) 18, 20-21, 23-24 and 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 1 above, and further in view of KORI (U.S. PGPUB 2020/0348297).
Regarding claim 18, PRESLEY and NAKAI teach all of the claimed limitation as stated above, but are silent as to: further comprising drying the product including the indicator film attached to the product. In the same field of endeavor, injection processes, KORI teaches drying the substrate after the film is manufactured [0053; 0042]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by drying the product and film, as suggested by KORI, in order to clean the surface and store the substrate [0168; 0181].
Regarding claim 20, PRESLEY and NAKAI teach all of the claimed limitations as stated above, but are silent as to: wherein the protective material is configured to reduce deterioration of analyte indicator molecules of the indicator film. In the same field of endeavor, injection processes, KORI teaches a protective material to reduce deterioration of analyte molecules of the substrate [0060-0062]. It would have been obvious to one of ordinary skill in the art at the time of the effective of the applicant’s invention to modify PRESLEY and NAKAI, by having a protective material to reduce the deterioration of the analyte molecules in the substrate, as suggested by KORI, in order to improve storage stability of the sensor substrate [0062].
Regarding claim 21, KORI further teaches: wherein the protective material is configured to catalyze degradation of reactive oxygen species (ROS) (KORI further teaches a hydroxy group acts in place of a water molecule, even when the sensor substrate is dried [0107].). It would have been obvious to one of ordinary skill in the art at the time of the effective of the applicant’s invention to modify PRESLEY and NAKAI, by having a protective material to catalyze degradation of reactive oxygen species (ROS), as suggested by KORI, in order for the deterioration of the first specific-binding substance due to the drying be suppressed [0107].
Regarding claim 23, PRESLEY teaches: wherein: the indicator film of the one or more indicator films is a first indicator film (PRESLEY teaches the indicator film is a first indicator film. PRESLEY teaches the device (106a) might include a microfluidics-based device that might be configured for biological analysis such as protein crystallography, polymerase chain reaction (PCR), cell counting and sorting, DNA analysis, assay analysis, and/or other analysis [0070; 0159].); the first indicator film is attached to a first portion of the product (PRESLEY teaches the first indicator film (device 106a) is attached to a portion of the substrate [0026].); . . . ; the process further comprises attaching a second indicator film to a second portion of the product (PRESLEY teaches multiple copies of the device (106a) on the substrate (104a) [0026].); . . . ; and the second analyte is different than the first analyte (PRESLEY teaches the devices may perform multiple and different processes [0155].).
PRESLEY and NAKAI are silent as to: the first indicator film includes first analyte indicator molecules configured to reversibly bind a first analyte and emit an amount of first emission light indicative of an amount of the first analyte indicator molecules that have reversibly bound the first analyte and the indicator hydrogel film includes second analyte indicator molecules configured to reversibly bind a second analyte and emit an amount of second emission light indicative of an amount of the second analyte indicator molecules that have reversibly bound the second analyte. In the same field of endeavor, injection processes, KORI teaches the indicator film includes analyte indicator molecules [0144]. KORI further the analyte is detected by irradiating the detection region with excitation light from the light source and detecting the intensity of the fluorescence emitted from the fluorescent substance [0147]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by using fluorescence, as suggested by KORI, in order to detect an amount of analyte [0085].
Regarding claim 24, PRESLEY teaches: wherein the monomer solution is a first monomer solution (PRESLEY teaches the monomer solution is first monomer solution [0121].), the mold is a first mold (PRESLEY teaches the mold is a first mold [Fig. 2b].), . . . , and the process further comprises: injecting a second monomer solution into a second mold (PRESLEY teaches injecting a second monomer solution into a mold [Fig. 2b.; 0121]. PRESLEY also teaches the patterns may be formed by hot or soft embossing techniques wherein patterns may be altered per substrate by selected different molds [0150]. PRESLEY doesn’t explicitly disclose a second mold; however, it would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate a second mold of injection molding, since it have been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motivated to duplicate a mold for the purpose of increase in manufacturing time [0004]. See MPEP 2144.04(VI)(C).), wherein the second monomer solution includes the second analyte indicator molecules (PRESLEY teaches the device (106a) might include a microfluidics-based device that might be configured for biological analysis such as protein crystallography, polymerase chain reaction (PCR), cell counting and sorting, DNA analysis, assay analysis, and/or other analysis [0070; 0159].); polymerizing the second monomer solution in the second mold to produce a second indicator sheet (PRESLEY teaches polymerizing the second monomer solution [0121].); and cutting the second indicator sheet to produce one or more second indicator films, wherein the second indicator film attached to the product is one of the one or more second indicator films (PRESLEY teaches bonding the device to the final product [Fig. 2b].). PRESLEY is silent as to cutting the sheet into a plurality of films. In the same field of endeavor, indicator sheets, NAKAI, teaches dicing a sheet to form a plurality of individual sheets [0016]. It would have been obvious to one of ordinary skill in the art at to time of the effective filing date of the applicant’s invention to modify PRESLEY, by cutting the sheet to a plurality of films, as suggested by NAKAI, in order to form a plurality of films [0043]. Furthermore, it’s a known method in the art. See KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
Regarding claim 40, PRESLEY and NAKAI teach all of the claimed limitation as stated above, but are silent as to: wherein the indicator sheet is a hydrogel sheet, the one or more indicator films are one or more hydrogel films, and the indicator film is a hydrogel film. In the same field of endeavor, sensors, KORI, teaches sensor substrate (10a) and the base material is a hydrogel [0104]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by substituting the material to be hydrogel, as suggested by KORI, in order to easily bound materials to the surface [0104]. Furthermore, it’s a known option in the art. See KSR int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 82 USPQ2d 1385 (2007) ("A person of ordinary skill has good reason to pursue the known option within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.").
Regarding claim 41, PRESLEY and NAKAI teach all of the claimed limitations as stated above. In the alternative, in the same field of endeavor, indicators, KORI teaches: wherein the indicator film includes analyte indicator molecules (KORI teaches an indicator film (10a) [Fig. 1; 0144]. KORI teaches the indicator film includes analyte indicator molecules [0144]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by the indicator film having analyte molecules, as suggested by KORI, in order to create a biosensor [0002].
Regarding claim 42, KORI further teaches: wherein the analyte indicator molecules is configured to reversibly bind an analyte and emit an amount of emission light indicative of an amount of the analyte indicator molecules that have reversibly bound the analyte (KORI further the analyte is detected by irradiating the detection region with excitation light from the light source and detecting the intensity of the fluorescence emitted from the fluorescent substance [0147].). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by using fluorescence, as suggested by KORI, in order to detect an amount of analyte [0085].
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, and KORI (U.S. PGPUB 2020/0348297), as applied to claim 19 above, and further in view of Tehrani et al. (U.S. PGPUB 2023/0012662), hereinafter TEHRANI.
Regarding claim 22, PRESLEY and NAKAY teach all of the claimed limitations as stated above, but are silent as to: further comprising applying a second protective material to the indicator film attached to the product. In the same field of endeavor, indicators, TEHRANI teaches an outer cap (161), a holder or encasement (163) [0064; Fig. 1C]. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by having a second protective material, as suggested by TEHRANI, to house and protect the components [0064].
Claim(s) 41-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Presley et al. (U.S. PGPUB 2009/0056116), hereinafter PRESLEY, and NAKAI et al. (U.S. PGPUB 2022/0009134), hereinafter NAKAI, as applied to claim 1 above, and further in view of Tehrani et al. (U.S. PGPUB 2023/0012662), hereinafter TEHRANI.
Regarding claim 41, PRESLEY and NAKAI teach all of the claimed limitations as stated above. In the alternative, in the same field of endeavor, indicators, TEHRANI teaches: wherein the indicator film includes analyte indicator molecules (TEHRANI teaches an indicator film (111) [Fig. 3; 0100]. TEHRANI teaches the indicator film includes analyte indicator molecules [0188]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by the indicator film having analyte molecules, as suggested by TEHRANI, in order for a wearable non-intrusive microneedle sensor patch [0188].
Regarding claim 42, TEHRANI further teaches: wherein the analyte indicator molecules is configured to reversibly bind an analyte and emit an amount of emission light indicative of an amount of the analyte indicator molecules that have reversibly bound the analyte (TEHRANI further teaches that fluorescence images were used and analyzed [0134].). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the applicant’s invention to modify PRESLEY and NAKAI, by using fluorescence images to show the analyte molecules, as suggested by TEHRNAI, in order to depict the impact of sterilization on each sensor in terms of their sensitivity drop [0170].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLINE BEHA whose telephone number is (571)272-2529. The examiner can normally be reached MONDAY - FRIDAY 9:00 A.M. - 5:00 P.M.
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, ABBAS RASHID can be reached at (571) 270-7457. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.B./Examiner, Art Unit 1748
/Abbas Rashid/Supervisory Patent Examiner, Art Unit 1748