Prosecution Insights
Last updated: April 19, 2026
Application No. 17/636,004

ALL-IN-ONE MOLECULAR DIAGNOSTICS DEVICE

Final Rejection §103
Filed
Feb 16, 2022
Examiner
GERHARD, ALISON CLAIRE
Art Unit
1797
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Gmd Biotech Inc.
OA Round
2 (Final)
10%
Grant Probability
At Risk
3-4
OA Rounds
3y 10m
To Grant
38%
With Interview

Examiner Intelligence

Grants only 10% of cases
10%
Career Allow Rate
2 granted / 21 resolved
-55.5% vs TC avg
Strong +29% interview lift
Without
With
+28.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
46 currently pending
Career history
67
Total Applications
across all art units

Statute-Specific Performance

§101
4.1%
-35.9% vs TC avg
§103
41.5%
+1.5% vs TC avg
§102
25.5%
-14.5% vs TC avg
§112
24.0%
-16.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 21 resolved cases

Office Action

§103
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 Arguments Applicant’s arguments, see Remarks page 6, filed 12 September 2025, with respect to the specification objections have been fully considered and are persuasive in light of the amendments. The objections to the specification have been withdrawn. Applicant’s arguments, see Remarks page 6, filed 12 September 2025, with respect to the rejection(s) of claim(s) 11 – 13 and 17 – 19 under 35 USC 112(b) have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. Applicant’s arguments, see Remarks page 6, filed 12 September 2025, with respect to the rejections of claims 1 – 5, 8, and 9 under 35 USC 102(a) have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Rolland et al in view of Seok et al. Applicant’s argument that Seok teaches a three-layer stacked structure is addressed by the combination of Rolland et al in view of Seok. Rolland et al teaches a binding pad which is used to move reagents to different “zones”, including an amplification zone disposed above a binding pad (See [0081] and Figure 1B). One of ordinary skill in the art would be able to look at the teaching of Rolland et al, including a layer for amplification on top of a binding pad, and arrive at placing the three layered device taught by Seok et al in place of the “amplification zone” taught by Rolland et al. Applicant’s argument that Seok et al does not teach an elution buffer is not convincing in light of the combined references of Rolland et al in view of Seok. As Seok does not teach that the DNA is bound prior to addition to the transfer pad, Seok has no reason to teach the inclusion of an elution buffer. Rolland et al teaches quite clearly that embodiments may require release of captured polynucleotide from a bound state within a membrane, in order to allow interaction with reagents in other regions (see [0026]). While applicant is correct that the embodiments of Rolland et al teach the release of polynucleotides after amplification, one of ordinary skill in the art would recognize that it would be required to release the bound polynucleotides to travel through the transfer pad taught by Seok, to arrive at the amplification region taught by Seok. That is to say, one of ordinary skill in the art would recognize that the technique of bringing bound polynucleotides in contact with a release buffer applies regardless of whether amplification has occurred. This, in view of Seok et al’s teaching of free polynucleotides travelling upwards through the transfer pad, renders the inclusion of a dry elution buffer in the transfer pad of Seok et al obvious, absent an unexpected result of the combination. As such, applicant’s arguments regarding the combination of Rolland et al in view of Seok et al are not convincing, and a rejection of amended independent claim 1 is made in light of 35 USC 103. Status of Claims Applicant’s amendments to the claims, filed 12 September 2025, have been entered. Applicant’s remarks filed 12 September 2025 are acknowledged. Claims 1, 10 – 14, and 16 – 18 are in status “Currently Amended.” Claims 2 – 6, 8, 9, and 15 are in status “Original.” Claims 7 and 19 are in status “Cancelled.” Claim Rejections - 35 USC § 103 The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1 – 5 and 8 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Rolland et al (US 20140295415 A1) in view of Seok et al (Seok Y, Joung H-A, Byun J-Y, Jeon H-S, Shin SJ, Kim S, Shin Y-B, Han HS, Kim M-G. “A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets.” Theranostics. 2017; 7(8): 22202230). With regards to claim 1, Rolland et al teaches: The claimed “a molecular diagnostics device” has been read on the taught, ([0076], "The invention provides molecular diagnostic test devices…"); The claimed “a binding pad specifically binding to a diagnostic target molecule transferred by a washing buffer to extract the diagnostic target molecule” has been read on the taught ([0080], “The sliding strip defines a test zone, labeled as "oligo capture", and is in the middle of a stack of five strips positioned at a first station to receive a filtered blood sample and capture RNA or DNA after lysis.”; The sliding strip which captures RNA or DNA reads on a binding pad.); The claimed “a transfer pad disposed on an upper surface of the binding pad and including an elution buffer in a dry state that separates the diagnostic target molecule from the binding pad” has been read on the taught ([0011], "The device may comprise additional stations, or plural regions within a generic station, to facilitate processes including, but not limited to, application of a wash agent or thermal nucleotide amplification."; [0026], "In such embodiments, it will be necessary to effect release of polynucleotide reagents from the test zone membrane […] by bringing the test zone into fluid communication with a dried reagent capable of effecting polynucleotide release from the membrane comprising the test zone. Commercially available buffers or buffers known in the art to effect polynucleotide release from paper membranes such as Tris-HCl/EDTA (TE) can be employed to achieve release of amplification products from the test zone membrane."; The additional station to facilitate processes including application of a wash agent reads on the transfer pad. The dried reagent capable of effecting polynucleotide release from the test zone reads on an elution buffer in a dry state that separates the diagnostic target molecule from the binding pad.); The claimed “at least one reaction pad”, wherein the reaction pad is capable of “generating an amplification reaction for the diagnostic target molecule” has been read on the taught ([0011], "…a second station comprises a polynucleotide amplification region wherein the test zone and captured polynucleotides are in fluid communication with a buffer inlet and dried amplification reagents."; The second station comprising an amplification region in fluid communication with dried amplification reagents reads on an amplification pad where an amplification reaction occurs.); However, Rolland et al does not explicitly disclose wherein the amplification pad comprises a channel pad disposed on an upper surface of the transfer pad and including at least one molecule passage channel through which the diagnostic target molecule received from the transfer pad passes, wherein the at least one reaction pad is disposed at a position corresponding to the at least one molecule passage channel, and wherein the transfer pad is farmed of a membrane having a structure in which pore sizes decrease in a lower direction. In the analogous art of paper-based devices for performing nucleic acid amplification reactions, Seok et al teaches; “An amplification pad” has been read on the taught (Figure 1a, paper device; Introduction, paragraph 4, "In this study, we describe a paper-based device for performing LAMP…"; Results and Discussion, Basic Concept of the Proposed Device, paragraph 1, "Figure 1 (a) shows the stacking structure of three functional layers, including the transfer pad, fluidic channel pad, and reaction pad used for single-step operation."); The claimed “a transfer pad,” wherein the pad includes “an elution buffer in a dry state that separates the diagnostic molecule from the binding pad” has been read on the taught (Figure 1(a), transfer pad; Results and Discussion, Basic Concept of the Proposed Device, “Figure 1(a) shows the stacking structure of three functional layers, including the transfer pad… When the DNA sample solution is loaded into the sample injection hole, the sample solution moistens the transfer pad...”); The claimed “a channel pad disposed on an upper surface of the transfer pad and including at least one molecule passage channel through which the diagnostic target molecule received from the transfer pad passes” has been read on the taught (Figure 1(a), channel pad; Results and Discussion, Basic Concept of the Proposed Device, “Figure 1 (a) shows the stacking structure of three functional layers, including the […] fluidic channel pad… When the DNA sample solution is loaded into the sample injection hole, the sample solution moistens the transfer pad and then flows […] through the fluidic channel.”); The claimed “at least one reaction pad disposed at a position corresponding to the at least one molecule passage channel and generating an amplification reaction for the diagnostic target molecule” has been read on the taught (Figure 1(a), channel pad; Results and Discussion, Basic Concept of the Proposed Device, “Figure 1(a) shows the stacking structure of three functional layers, including the […] reaction pad… When the DNA sample solution is loaded into the sample injection hole, the sample solution moistens the transfer pad and then flows to the reaction pad through the fluidic channel.”). The claimed “wherein the transfer pad is formed of a membrane having a structure in which pore sizes decrease in a lower direction” has been read on the taught (LAMP assay, Fabrication of paper-based device, paragraph 2, “All paper components were sequentially stacked in the order vivid GF, patterned PES, and glass fiber. The large-pore side of the vivid GF made contact with the patterned PES membrane.”; The vivid GF membrane reads on the transfer pad. As shown in Figure 1A, the patterned PES membrane reads on the channel pad. The large-pore side of the vivid GF being in contact with the channel pad means that the small pore side of the vivid GF is below. Accordingly, Seok et al teaches that the pore size of the transfer pad reads on the pore size decreasing in the lower direction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including multiple, stacked layers defining functional regions as taught by Rolland et al with the amplification pads as taught by Seok et al, in order to create a small and compact amplification pad suitable for point-of-care testing in resource-limited settings (Results and Discussion, Basic Concept of the Proposed Device, paragraph 1 “The device […] is a small and compact structure suitable for POC testing in resource-limited settings.”). The claimed “… a diagnostic target molecule transferred by a washing buffer to extract the diagnostic target molecule” is functional language describing the intended use of the device and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Rolland et al in view of Seok et al teaches all of the structural limitations of the device, this additional limitation does not define the instant application over the prior art. With regards to claim 2, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches: The claimed “wherein the binding pad includes a porous membrane” has been read on the taught ([0116], “A particularly attractive material which claims to accomplish both lysis and capture is the paper FTA® cards available from Whatman®...”; [0143], “In certain embodiments, the device contains a capture layer. The material for the capture layers is selected from, but not limited to: nitrocellulose membrane, nylon membranes such as Immunodyne® and Biodyne® membrane sold by Pall®, paper, chromatography paper, and non-woven polymeric membranes.”; Paper, nitrocellulose membrane, and nylon membranes read on porous membranes). With regards to claim 3, the device of claim 2 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches: The claimed “wherein the porous membrane is at least one selected from the group consisting of glass fiber, silica membrane, cellulose, nitrocellulose, cellulose acetate, cotton, and nylon” has been read on the taught ([0143], “In certain embodiments, the device contains a capture layer. The material for the capture layers is selected from, but not limited to: nitrocellulose membrane, nylon membranes such as Immunodyne® and Biodyne® membrane sold by Pall®, paper, chromatography paper, and non-woven polymeric membranes.”; [0028], “Certain components of the device comprise sheet-like material such as paper, cloth, or polymer film, such as nitrocellulose or cellulose acetate.”; Nitrocellulose membranes read on a porous membrane composed of nitrocellulose.). With regards to claim 4, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches: The claimed “wherein the binding pad further includes a binding material that specifically binds to the diagnostic target molecule” has been read on the taught ([0144], “In preferred embodiments, the capture layer contains a capture antibody which can bind to an antigen present in a given sample.”; The capture antibody reads on a binding material which specifically binds to the diagnostic target molecule.). With regards to claim 5, the device of claim 4 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches: The claimed “wherein the binding material is at least one selected from the group consisting of nucleic acid, aptamer, hapten, locked nucleic acid (LNA), antibody, antigen, DNA or RNA binding protein, single strand binding protein, Rec A protein, polypeptide, Fab fragment small- molecular chemical material, cationic compound, synthetic polymer, and mixtures thereof” has been read on the taught ([0144], “In preferred embodiments, the capture layer contains a capture antibody which can bind to an antigen present in a given sample.”; The capture antibody reads on an antibody.). With regards to claim 8, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches wherein the device of claim 1 further comprises: The claimed “a sample pad in which a sample containing the diagnostic target molecule is accommodated” has been read on the taught ([0011], "The first station comprises a polynucleotide capture region wherein the test zone is disposed in fluid communication with a sample inlet…"; The sample inlet reads on a sample pad in which a sample containing the diagnostic target molecule is accommodated.); The claimed “a loading pad in which a washing buffer carrying the diagnostic target molecule is accommodated” has been read on the taught ([0011], "…a second station comprises a polynucleotide amplification region wherein the test zone and captured polynucleotides are in fluid communication with a buffer inlet."; The buffer inlet reads on a loading pad in which a washing buffer carrying the diagnostic target molecule is accommodated.); The claimed “a wicking pad which absorbs the washing buffer developed into the amplification pad and is positioned downstream of the amplification pad” has been read on the taught ([0025], "In some embodiments, the device may comprise an adsorptive reservoir downstream of or stationed in a layer directly below and in fluid communication with the colorimetric test readout for drawing liquid along the flow path"; [0028], "Adsorbent layers or reservoirs may be exploited to advantage for drawing fluid from or through a hydrophilic region and through the test zone."; The absorptive reservoir reads on a wicking pad.). With regards to claim 9, the molecular diagnostics device of claim 8 is anticipated by Rolland et al. Rolland et al additionally teaches: The claimed “wherein the loading pad, the sample pad, the amplification pad, and the wicking pad are sequentially spaced apart from each other and arranged” has been read on the taught ([0011], "The device comprises at least first, second, and third substantially planar members, one or more of which comprises fluid-impermeable barriers which define boundaries of hydrophilic regions therein which support fluid flow across and therethrough, and are designed to execute various functions as disclosed herein."; The hydrophilic regions with defined boundaries which support fluid across and therethrough reads on the loading pad, the sample pad, the amplification pad, and the wicking pad are sequentially spaced apart from each other and arranged; Additional details on the pads being sequentially spaced apart and arranged can be seen in Figure 1B.). With regards to claim 10, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the washing buffer includes at least one of distilled water (D.W.) and deionized water (D.I water)” has been read on the taught ([0202], "Tris Buffer (400 mM): A solution of 4.8456 g Tris Base (Sigma Aldrich) in 100 mL DI H2O…"; DI H2O reads on D.I water). With regards to claim 11, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the reaction pad includes a dry primer for generating the amplification reaction for the diagnostic target molecule” has been read on the taught ([0037], “The nucleotide amplification reagents may include primers…”; [0036] clarifies that the nucleotide amplification reagents may be dried, reciting, “…a third station comprising dried nucleotide amplification reagents….”). With regards to claim 12, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein at least one of the transfer pad and the reaction pad includes a dry indicator of which fluorescence intensity changes as the amplification reaction occurs” has been read on the taught ([0128], “Oligonucleotide amplification can also be detected via application of reagents that fluoresce at specific wavelengths following intercalation between nucleic acid base pairs.”; Claim 6 teaches that the polynucleotide detection reagents can be dried, “…wherein said test zone and captured polynucleotides are in fluid communication with a buffer inlet and a dried polynucleotide detection reagent.”). With regards to claim 13, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein at least one of the transfer pad and the reaction pad includes a dry amplification reaction enzyme for generating the amplification reaction for the diagnostic target molecule” has been read on the taught (Table 1, on page 11-12 of Rolland et al, teaches amplification techniques including a variety of enzymes such as helicase, recombinase, and polymerase; [0011] teaches that the amplification reagents (which read on enzymes) may be dried, “…a second station comprises a polynucleotide amplification region wherein the test zone and captured polynucleotides are in fluid communication with a buffer inlet and dried amplification reagents."). With regards to claim 14, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the amplification reaction is an isothermal amplification reaction” has been read on the taught ([0118], “The Table below lists a variety of isothermal amplification techniques available for use at the amplification site.”). With regards to claim 15, the device of claim 14 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the isothermal amplification reaction is at least one selected from the group consisting of helicase-dependent amplification (HAD), recombinase polymerase amplification (RPA), rolling circle amplification (RCA), loop mediated isothermal amplification (LAMP), nucleic acid sequence-based amplification (NASBA), transcription mediated amplification (TMA), signal mediated amplification of RNA technology (SMART), strand displacement amplification (SDA), isothermal multiple displacement amplification (IMDA), single primer isothermal amplification (SPIA), and circular helicase dependent amplification (cHDA)” has been read on the taught ([0118], "A particularly attractive technique is Loop-mediated isothermal amplification (LAMP)."; Table 1 teaches LAMP, HAD, RPA, and TMA methods, among others). With regards to claim 16, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the amplification pad or the transfer pad includes an enhancer in a dry state for accelerating the amplification reaction” has been read on the taught ([0144], "The blocking agent may be selected from, but not limited to, the following: casein, bovine serum albumin, mouse Immunoglobulin G, poly(ethylene glycol), Tween®, Pluronic®, or Zwittergent®. or polyvinyl alcohol."; Page 19 of the instant specification supports that bovine serum albumin and neutral surfactants including Tween are enhancers for accelerating the amplification reaction; [0011] teaches that the amplification reagents (which read on enhancers) may be dried, “…a second station comprises a polynucleotide amplification region wherein the test zone and captured polynucleotides are in fluid communication with a buffer inlet and dried amplification reagents."). With regards to claim 17, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the device includes fluorescent detection reagents” has been read on the taught ([0016], “Preferably, the detection reagents comprise a […] a fluorophore […], to permit colorimetric assessment of the presence of amplicons in the test zone.”). Seok et al additionally teaches; The claimed “wherein the at least one reaction pad further includes dry MgSO4 for controlling the fluorescence intensity as the amplification reaction occurs” has been read on the taught (Materials and Methods, LAMP assay, paragraph 1, "The reaction was performed in a final volume of 25 μL with […] 8 mM MgSO4…"; Results and Discussion, Fluorescence of HNB for LAMP detection, paragraph 1, “The color of the HNB solution also changes depending on the concentration of Mg2+ and reflects DNA amplification by chemical bonding between Mg2+ and P2O7 4- . […] The fluorescence intensity increased with the Mg2+ concentration…”; Introduction, paragraph 4 supports the MgSO4 as a dry reagent, reciting, “To the best of our knowledge, this study is the first paper-based LAMP system operated by fully drying reagents.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a fluorophore as taught by Rolland et al in view of Seok et al with dry MgSO4 as taught by Seok et al, in order to measure by-products of DNA synthesis with reagents that are not sensitive to storage conditions (Results and Discussion, Fluorescence of HNB for LAMP Detection, paragraph 1, “In the DNA amplification process, including the LAMP, pyrophosphate ion (P2O7 4- ) were generated as by-products from the consuming process of dNTP for the synthesis of new DNA strands. The color of the HNB solution also changes depending on the concentration of Mg2+ and reflects DNA amplification by chemical bonding between Mg2+ and P2O7 4- .”; Introduction, paragraph 3, “Dry reagents are not sensitive to storage conditions [27], thus preventing problems with temperature-dependent transport or storage.”). With regards to claim 18, the device of claim 1 is obvious over Rolland et al in view of Seok et al. Rolland et al additionally teaches; The claimed “wherein the device includes dried amplification reagents” has been read on the taught ([0011], "…a second station comprises a polynucleotide amplification region wherein the test zone and captured polynucleotides are in fluid communication with a buffer inlet and dried amplification reagents."). Seok et al additionally teaches; The claimed “wherein the reaction includes dry dNTPs for forming a synthesis block of the diagnostic target molecule” has been read on the taught (LAMP assay, LAMP assay in solution, paragraph 1, "The reaction was performed in a final volume of 25 μL with […] 2.8 mM dNTPs…"; Results and Discussion, Fluorescence of HNB for LAMP detection, paragraph 1, "In the DNA amplification process, including the LAMP, pyrophosphate ion (P2O7 4- ) were generated as by-products from the consuming process of dNTP for the synthesis of new DNA strands."; Introduction, paragraph 4 supports the MgSO4 as a dry reagent, reciting, “To the best of our knowledge, this study is the first paper-based LAMP system operated by fully drying reagents.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including dried amplification reagents as taught by Rolland et al in view of Seok et al with the dried dNTPs as taught by Seok et al, in order to allow the amplification reaction to proceed with reagents that are not sensitive to storage conditions (Introduction, paragraph 3, “Dry reagents are not sensitive to storage conditions [27], thus preventing problems with temperature-dependent transport or storage.”; Results and Discussion, Fluorescence of HNB for LAMP detection, paragraph 1, "In the DNA amplification process… the consuming process of dNTP for the synthesis of new DNA strands.”). Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rolland et al (US 20140295415 A1) in view of Seok et al (Seok Y, Joung H-A, Byun J-Y, Jeon H-S, Shin SJ, Kim S, Shin Y-B, Han HS, Kim M-G. “A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets.” Theranostics. 2017; 7(8): 22202230) and further in view of Moon Woo Chul et al (KR 20060022434 A, cited on the IDS submitted 16 February 2022. The relied-upon translation was attached with the action submitted 14 March 2025). With regards to claim 6, the device of claim 5 is obvious over Rolland et al in view of Seok et al. However, Rolland et al in view of Seok et al fails to teach wherein the cationic compound is a cationic lipid or cationic polymer. In the analogous art of DNA analysis in paper-based system, Moon Woo Chul et al teaches: “A paper-based device with a binding material that specifically binds to a diagnostic target molecule” has been read on the taught (Disclosure, Tech-Problem, paragraph 6, “Another object of the present invention is to prepare a paper card-type chitosan-containing material (DNA card) that can store a liquid mixture of chitosan and DNA…”; Disclosure, Tech-Problem, paragraph 1, “When water-soluble chitosan is mixed with DNA, a stable bond is formed…”; The chitosan reads on the binding material. The DNA reads on the diagnostic target molecule.). The claimed “wherein the binding material is a cationic compound” has been read on the taught (Invention Title, Background Art, paragraph 17, “Water soluble chitosan exhibits a strong positive charge…”; The strong positive charge reads the material being a cationic compound.); The claimed “wherein the cationic compound is a cationic polymer” has been read on the taught (Invention Title, Background Art, paragraph 15, “Chitosan generically refers to cationic polymers…”); It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 5 including a binding material as taught by Rolland et al in view of Seok et al with the device including a binding material which is a cationic polymer as taught by Moon Woo Chul et al, in order to use a binding material with excellent stability, biodegradability, and biocompatibility (Moon Woo Chu et al, Invention Title, Background Art, paragraph 14, “Chitosan is a biopolymer that is widely used in medicine because of its excellent stability, biodegradability and biocompatibility.”). 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 ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST. 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, Lyle Alexander can be reached at (571) 272-1254. 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. /ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /MAUREEN WALLENHORST/ Primary Examiner, Art Unit 1797
Read full office action

Prosecution Timeline

Feb 16, 2022
Application Filed
Mar 10, 2025
Non-Final Rejection — §103
Sep 12, 2025
Response Filed
Nov 10, 2025
Final Rejection — §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12427514
PIEZOELECTRIC MICROPIPETTE
2y 5m to grant Granted Sep 30, 2025
Patent 12352766
IMMUNOASSAY METHOD FOR FREE AIM IN BIOLOGICAL SAMPLE, AND METHOD FOR DETECTING NASH IN SUBJECT
2y 5m to grant Granted Jul 08, 2025
Study what changed to get past this examiner. Based on 2 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
10%
Grant Probability
38%
With Interview (+28.6%)
3y 10m
Median Time to Grant
Moderate
PTA Risk
Based on 21 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month