DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendment
1- The amendment filed on 01/19/2026 has been entered and fully considered. Claims 5, 7-12 remain pending in the application, where the independent claim has been amended. New claims 20-30 have been added.
Response to Arguments
2- Examiner has considered Applicants’ proposed amendments and acknowledges they moot/overcome the 35 USC 112(f) claim interpretation of the previously pending claims, as set forth in the non-final office action mailed on 10/22/2025.
3- Moreover, Applicant’s amendments and their corresponding arguments, with respect to the rejection of the pending claims under 35 USC 102 and 103 have been fully considered and are persuasive.
Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground of rejection is made over the prior art used in the previous office action in view of Fuke et al. (JP 2004117048).
Claim Rejections - 35 USC § 103
4- 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
In addition, the functional recitation in the claims (e.g. "configured to" or "adapted to" or the like) that does not limit a claim limitation to a particular structure does not limit the scope of the claim. It has been held that the recitation that an element is "adapted to", "configured to", "designed to", or "operable to" perform a function is not a positive limitation but only requires the ability to so perform and may not constitute a limitation in a patentable sense. In re Hutchinson, 69 USPQ 139. (See MPEP 2111.04); see also In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014).
Also, it should be noted that it has been held that a recitation with respect to the manner in which a claimed device is intended to be employed does not differentiate the claimed device from a prior art apparatus satisfying the claimed structural limitations Ex-parte Masham 2 USPQ2d 1647 1987).
The claimed system in the instant application is capable of performing the claimed functionality, as is the prior art used in the present office action. The Examiner notes that where the patent office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. In re Swinehart and sfiligoj, 169 USPQ 226 (C.C.P.A. 1971).
5- Claims 5, 7, 10-12, 21, 26-30 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Macedo et al. (PGPUB No. 2024/0012005) in view of Fuke et al. (JP 2004117048).
As to amended claims 5, 21, Macedo teaches a method (Abstract and Figs. 1-9), comprising: transporting a solution in which a target molecule is dissolved (solution with antigens capable of binding with antibodies 1.3) through a channel (Figs. 1-2; channels between 2.1, 2.2 and 2.3)
the channel including a first portion without a hydrogel layer (Fig. 1; ¶ 36-38, 42; area 1.10/1.12 and its surrounding; area 1.7, free from hydrogel 1.4) and a second portion with a hydrogel layer (Fig. 1; ¶ 36-38, 42; area 1.10/1.12 and its surrounding; area 1.7, free from hydrogel 1.4; area 1.10 covered with hydrogel 1.4);
measuring by surface plasmon resonance -SPR-, a time function of an SPR angle at the first portion to obtain a first measurement result measuring, a time function of an SPR angle at the second portion to obtain a second measurement result (¶ 20, 26, 40-41, 61-62, 63), the target molecule diffusing through the hydrogel layer to reach a sensing surface (¶ 45 for ex.).
Macedo does not teach expressly the first portion being upstream of the second portion in a direction of transport; measuring during the transporting; the time functions being time changes of an SPR angle at the first portion and at the second portion; evaluating a diffusion rate of the molecules in the hydrogel by comparing the first measurement result with the second measurement result; (claim 21) wherein the time change of the SPR angle at the first portion and the time change of the SPR angle at the second portion are measured simultaneously during the transporting.
However, Macedo’s channel and microfluidic (Figs. 1-2) appear to present an arbitrary direction of the flow inside the microfluid, during the loading stage of the sample/solution, and areas 1.10 and 1.12 appear to be arbitrarily disposed upstream or downstream of each other in the direction of a stream from 2.1 to 2.3. As the optical resonance measurements are known to be faster than any mechanical/fluidic transport, one PHOSITA would find it obvious to use the SPR measurements, in the two portions, simultaneously, and during the transporting step of loading the sample/solution into biosensor 2.3 for a fast diagnostics process in a clinical laboratory (See MPEP § 2143 Sect. I. B-D). Moreover, Macedo suggests tracking the light measurements as functions of time (¶ 61-62 for ex.), in addition to the teachings of Fuke, which in a similar field of endeavor using SPR with/without get (Abstract, Figs. 1-13), teaches how important is the measuring/analyzing of the changes over time of resonance angle using SPR (Figs. 10-12 and ¶ 7), which would suggest to one PHOSITA to track the time change of the SPR signals between the different areas, and the molecular diffusion characteristics with or without gel, such as the vertical diffusion rate towards the gold particles 1.5 (See MPEP § 2143 Sect. I. B-D). These vertical diffusion characteristics need to be contrasted with the transversal dynamic fluid characteristics along the channel surface, which Macedo does not target (¶ 21).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the method of Macedo according to different embodiments and to Fuke’s suggestions so that the first portion being upstream of the second portion in a direction of transport; measuring during the transporting; the time functions being time changes of an SPR angle at the first portion and at the second portion; evaluating a diffusion rate of the molecules in the hydrogel by comparing the first measurement result with the second measurement result; wherein the time change of the SPR angle at the first portion and the time change of the SPR angle at the second portion are measured simultaneously during the transporting, with the advantage of effectively and thoroughly characterizing the molecular vertical diffusion of the target substance into the hydrogen towards the plasmonic gold particles.
Moreover, Macedo teaches:
(claim 7/30) wherein the target molecule is selected from the group consisting of small molecule drugs, biologics, and nucleic acid-based drugs (Abstract and ¶ 20, 39, 42 for ex.; biomarkers, pathogens, antigens for ex. are considered).
As to claims 10/27, 11/28, 12, 29, the combination of Macedo and Fuke teaches the method according to claim 5 and the method according to claim 26.
The combination does not teach expressly wherein the diffusion rate of molecules in the hydrogel is evaluated by comparing a slope of the first measurement result with a slope of the second measurement result; (claim 11/28) wherein the diffusion rate of molecules in the hydrogel is evaluated by comparing a time delay in a rising time of the first measurement result with a time delay in the rising time of the second measurement result, or wherein evaluating the diffusion rate comprises comparing a rising time of the scaled first SPR angle change curve with a rising time of the scaled second SPR angle change curve; (claim 12) further comprising scaling the first measurement result and the second measurement result such that a convergence value of the first measurement result becomes 1; (claim 29) wherein the scaling is performed by linearly scaling the first SPR angle change curve and the second SPR angle change curve.
However, Macedo suggests tracking the light measurements as functions of time (¶ 61-62 for ex.) which would suggest to one PHOSITA to track the time change, and the velocity and fluid characteristics, such as the diffusion rate, of the particles with or without gel, from the slopes or the rising/falling delays of the time measurements (See MPEP 2143 Sect. I. B-D). As to claim 12, Examiner uses here an Official Notice submitting that normalization, linearly or exponentially or else, of experimental measurement data is a routine practice to allow easy comparison between similar and related measurements (See MPEP 2143 Sect. I. B-D).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the method of Macedo and Fuke according to different Macedo’s embodiment suggestions so that the diffusion rate of molecules in the hydrogel is evaluated by comparing a slope of the first measurement result with a slope of the second measurement result; or wherein the diffusion rate of molecules in the hydrogel is evaluated by comparing a time delay in a rising time of the first measurement result with a time delay in the rising time of the second measurement result or wherein evaluating the diffusion rate comprises comparing a rising time of the scaled first SPR angle change curve with a rising time of the scaled second SPR angle change curve; further comprising scaling the first measurement result and the second measurement result such that a convergence value of the first measurement result becomes 1; wherein the scaling is performed by linearly scaling the first SPR angle change curve and the second SPR angle change curve, with the advantage of effectively and thoroughly characterizing the molecular kinetics in the target substance.
As to claim 26, a method for evaluating molecular diffusion in a hydrogel, comprising: transporting a solution containing a target molecule through a channel, wherein the channel includes a first portion without a hydrogel layer and a second portion with a hydrogel layer, and wherein the first portion is upstream of the second portion in a direction of transport; measuring, by surface plasmon resonance during the transporting, a time change of an SPR angle at the first portion as the solution passes through the first portion to obtain a first SPR angle change curve; measuring, by surface plasmon resonance during the transporting, a time change of an SPR angle at the second portion as the target molecule diffuses through the hydrogel layer to reach a sensing surface to obtain a second SPR angle change curve; scaling the first SPR angle change curve and the second SPR angle change curve such that a convergence value of the first SPR angle change curve becomes 1; and evaluating a diffusion rate of the target molecule in the hydrogel by comparing the scaled first SPR angle change curve with the scaled second SPR angle change curve (see rejection of claims 5 and 12).
6- Claim 8 is rejected under AIA 35 U.S.C. 103 as being unpatentable over Macedo and Fuke in view of Finlan (US Patent 5055265)
As to claim 8, the combination of Macedo and Fuke teaches the method according to claim 5.
The combination does not teach expressly wherein the hydrogel is an acrylamide gel.
However, in a similar field of endeavor, Finlan teaches biological sensors (Abstract and Figs. 1-3) wherein the hydrogel is an acrylamide gel (Col/ll. 7/1-7).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the method of Macedo and Fuke according to Finlan’s suggestions so that the hydrogel is an acrylamide gel, with the advantage taught by Finlan of effectively using a protective gel layer (Col/ll. 7/1-7).
7- Claim 9 is rejected under AIA 35 U.S.C. 103 as being unpatentable over Macedo and Fuke in view of Okano (US PGPUB 20070059763)
As to claim 9, the combination of Macedo and Fuke teaches the method according to claim 5.
The combination does not teach expressly wherein the measurement device further includes a negative pressure pump connected to the discharge port of the channel, the negative pressure pump being configured to transport the solution through the channel.
However, in a similar field of endeavor, Okano teaches resonance plasmon based cellomics and sensors (Abstract, ¶ 116, 742 and Figs. 1-155) using a negative pressure pump to circulate the targeted substance within the circuit (¶ 627, 630, 651, 671-673, 692-695).
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the method of Macedo and Fuke according to Okano ’s suggestions so that he measurement device further includes a negative pressure pump connected to the discharge port of the channel, the negative pressure pump being configured to transport the solution through the channel, with the advantage of effectively circulating the targeted substance through the optical sensor.
8- Claim 20 is rejected under AIA 35 U.S.C. 103 as being unpatentable over Macedo and Fuke in view of Vidarsson et al. (US PGPUB 20150323525)
As to claim 20, the combination of Macedo and Fuke teaches the method according to claim 5.
The combination does not teach expressly further comprising: establishing a baseline SPR angle when the channel is filled with a reference solution prior to the transporting; and determining the time change of the SPR angle at the first portion and the second portion relative to the baseline SPR angle.
However, and in a similar field of endeavor, Vidarsson teaches a SPR imaging system and method (Abstract, Figs. 1-13) further comprising: establishing a baseline SPR angle when the channel is filled with a reference solution prior to the transporting (¶ 79, 86). Adapting Macedo’s method accordingly to comprise determining the time change of the SPR angle at the first portion and the second portion relative to the baseline SPR angle appears obvious.
Therefore, it would have been obvious to one with ordinary skills in the art before the effective filing date of the instant application to use the method of Macedo and Fuke according to Vidarsson’s suggestions to comprise: establishing a baseline SPR angle when the channel is filled with a reference solution prior to the transporting; and determining the time change of the SPR angle at the first portion and the second portion relative to the baseline SPR angle, with the advantage of effectively circulating the targeted substance through the optical sensor.
Allowable Subject Matter
9- Claims 22-25 are allowed.
The following is an examiner's statement of reasons for allowance:
As to independent method claim 22, the prior art of record, taken either alone or in combination, fails to disclose or render obvious:
A method for evaluating molecular diffusion in a hydrogel, comprising: providing a channel including a measurement area, wherein the measurement area includes a first portion disposed proximate to an introduction port and having no hydrogel layer, a second portion having a hydrogel layer formed thereon, and a third portion disposed proximate to a discharge port and having no hydrogel layer; transporting a solution containing a target molecule through the channel from the introduction port toward the discharge port; measuring … a time change of an SPR angle at each of the first portion, the second portion, and the third portion; determining an arrival time of the solution at the second portion based on a difference between an arrival time of the solution at the first portion and an arrival time of the solution at the third portion; and evaluating a diffusion rate of the target molecule in the hydrogel based on the time change of the SPR angle at the second portion and the determined arrival time.
in combination with the other limitations.
The closest prior art found that pertains to the invention, with emphasis added, is Macedo, Fuke and Vidarsson. However, the prior art fail to teach, suggest or render obvious the entire invention as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled "Comments on Statement of Reasons for Allowance."
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).
The examiner has pointed out particular references contained in the prior art of record in the body of this action for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. Applicant should consider the entire prior art as applicable as to the limitations of the claims. It is respectfully requested from the applicant, in preparing the response, to consider fully the entire references as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED AMARA whose telephone number is (571)272-7847. The examiner can normally be reached on Monday-Friday: 9:00-17:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tarifur Chowdhury can be reached on (571)272-2287. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Mohamed K AMARA/
Primary Examiner, Art Unit 2877