DETAILED ACTION
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 amendments filed 03/23/2026 have been entered. Applicant amendments overcomes the previous 112(b) rejections set forth in the Office Action mailed 12/22/2025, the previous 112(b) rejections are withdrawn.
Status of Claims
Claims 1-20 remain pending in the application, with claims 1-4 and 20 being examined and claims 5-19 being withdrawn pursuant to the election filed 11/07/2025.
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US-2003/0044801-A1) in view of ThermoFisher Scientific “Biotinylation”, herein ThermoFisher. Please note that ThermoFisher was previously cited in the 892 filed 09/12/2025.
Regarding claim 1, Harvey teaches a biochip (apparatus 10) ([0015], Figure 1), comprising:
a substrate (substrate 12) ([0015], Figure 1), and
at least one spot (attachment points 16) disposed on a surface of the substrate (12) ([0016], Figure 1),
wherein each of the at least one spot (16) comprises a complex of a solid carrier (microsphere 20) modified with a reactive group (streptavidin) and a material (ligand) immobilized on the solid carrier (20) ([0006], [0016], [0033] see ligand 112 can be directly linked to the microsphere 120 or a linker group can be used where the linker group can be an entity that binds to the microsphere and binds to the ligand, where an example provided is streptavidin which would bind to biotinylated ligands, Figures 1-2).
However, Harvey does not teach wherein the ligand (material) is modified with a group reacting with the reactive group via a spacer,
wherein the spacer comprises a carbon chain or polyethylene glycol, and a length of the spacer is from 5 to 150 Å.
In the analogous art of biotinylation, ThermoFisher teaches the incorporation of poly(ethylene glycol) into a spacer arm (ThermoFisher; page 3 Biotinylation Reagent Solubility section, further see the figure provided in this section that shows a PEG4 chain conjugated onto the spacer arm between the reactive moiety (the red portion on the left) and biotin (the blue portion on the right)).
Specifically, ThermoFisher teaches that the ability of avidin to bind to biotin molecules or biotinylated proteins is dependent upon the availability of biotin without steric hinderance from multiple biotins on the same protein, where longer spacer arms can enhance the detection sensitivity of the target protein because more biotin molecules are available for reporter-conjugated avidin binding (ThermoFisher; page 3 Spacer Arm Length section). As further described in the Spacer Arm Length section on page 3, the spacer arm length of a biotinylation reagent can be the difference between strong protein detection/purification and weak or no detection/purification because of the availability or unavailability for binding. As seen in the Figures provided from the Spacer Arm Length section on page 4, spacer arm lengths include 13.5 Å, 22.4 Å, and 30.5 Å.
It would have been obvious to one skilled in the art to modify the biotinylated ligand of Harvey such that there is a spacer arm that is either 13.5 Å, 22.4 Å, 30.5 Å as taught by ThermoFisher because ThermoFisher teaches that a spacer for a biotinylated component enhances detection sensitivity and can be the difference between strong protein detection/purification and weak or no detection/purification (ThermoFisher; page 3 Spacer Arm Length section).
Therefore, the ligand (material) is biotinylated (group reacting with the reactive group, the reactive group being streptavidin) via a PEG spacer.
Regarding claim 2, modified Harvey teaches the biochip according to claim 1. Harvey further teaches wherein the reactive group is selected from the group consisting of avidin or a derivative thereof (Harvey; [0033] where streptavidin is a derivative of avidin).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US-2003/0044801-A1) and ThermoFisher Scientific “Biotinylation”, herein ThermoFisher, and in further view of Gale (US-2007/0231458-A1).
Regarding claim 3, modified Harvey teaches the biochip according to claim 1. Harvey does teach wherein two or more spots are disposed (see Figure 1 with plurality of attachment points 16). [0037]-[0040] of Harvey does describe methods of fabricating an apparatus for detecting analytes, however Harvey does not discuss specifically how the microspheres are placed on each of the attachment points.
In the same problem solving area of forming microassays, biochips, biosensors, and cell cultures, Gale teaches a spotter device (Gale; abstract).
Specifically, Gale teaches a spotter capable of patterning the surface of microarrays with individually addressed high-concentration spots, where the spotter increases the surface density at each spot by directing a flow of the desired substance, such as probes and/or target compounds, over the spot area until a high-density spot has been created (Gale; [0013]). Examples of the probes that can be flowed include ligands, where in one example a microarray has the substances/probes attached to beads (Gale; [0013], [0104]). It is further described by [0017] of Gale that each spot area may be the same size and/or shape.
It would have been obvious to one skilled in the art to modify the array of Harvey such that the microspheres are disposed on the attachment points via the spotter as taught by Gale because Gale teaches that the spotter has the advantage of creating a high-density spot, where each spot area may be the same size and shape (Gale; [0013], [0017]).
While Gale does not address the volume variation coefficient of the complex between the two or more spots is less than 11.8%, because the spots of Gale are the same size and shape the volume variation coefficient will be less than 11.8%.
Further, please note that there has been no established criticality for the claimed volume variation coefficient.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US-2003/0044801-A1) and ThermoFisher Scientific “Biotinylation”, herein ThermoFisher, and in further view of Sheppard (US-2002/0076804-A1).
Regarding claim 4, modified Harvey teaches the biochip according to claim 1. While Harvey does teach where the attachment points can be patterned onto the substrate where the attachment points are capable of retaining one or more microspheres via moieties that are able to chemically bind to the microspheres ([0022], [0040]), Harvey does not teach wherein a surface treatment with a blocking agent is performed on the substrate.
In the analogous art of integrated, affinity-binding based analytical apparatuses for detecting particulates, Sheppard teaches a platform for performing an affinity-binding based assay (Sheppard; [0037]).
Specifically, Sheppard teaches where the platform is provided as a surface or detection chamber treated to comprise a specific binding reagent (Sheppard; [0087]). The binding reagent is applied to the surface or detection chamber of the platform by depositing the reagent on the surface, where it can provide a two-dimensional array or pattern where certain areas are treated with the specific binding reagent and others are not (Sheppard; [0087]). More specifically, Sheppard describes where the surface/detection chamber is provided with transparent portions coated with a specific binding reagents and other portions coated with a reflective material, where in addition the surface of the platform comprising reflective portions are treated with a blocking agent such as BSA to prevent non-specific binding of particulate matter on the surface of the platform (Sheppard; [0087]).
It would have been obvious to one skilled in the art to modify the substrate of Harvey such that the areas between the attachment points are treated with a blocking agent as taught by Sheppard because Sheppard teaches that the blocking agent prevents non-specific binding of particulate matter (Sheppard; [0087]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harvey (US-2003/0044801-A1) and ThermoFisher Scientific “Biotinylation”, herein ThermoFisher, and in further view of Gale (US-2007/0231458-A1) and Sheppard (US-2002/0076804-A1).
Regarding claim 20, modified Harvey teaches the biochip according to claim 1 (see claim 1 supra).
Harvey further teaches wherein the reactive group is selected from the group consisting of avidin or a derivative thereof (Harvey; [0033] see streptavidin);
[0037]-[0040] of Harvey does describe methods of fabricating an apparatus for detecting analytes, however Harvey does not discuss specifically how the microspheres are placed on each of the attachment points.
In the same problem solving area of forming microassays, biochips, biosensors, and cell cultures, Gale teaches a spotter device (Gale; abstract).
Specifically, Gale teaches a spotter capable of patterning the surface of microarrays with individually addressed high-concentration spots, where the spotter increases the surface density at each spot by directing a flow of the desired substance, such as probes and/or target compounds, over the spot area until a high-density spot has been created (Gale; [0013]). Examples of the probes that can be flowed include ligands, where in one example a microarray has the substances/probes attached to beads (Gale; [0013], [0104]). It is further described by [0017] of Gale that each spot area may be the same size and/or shape.
It would have been obvious to one skilled in the art to modify the array of Harvey such that the microparticles are disposed on the attachment points via the spotter as taught by Gale because Gale teaches that the spotter has the advantage of creating a high-density spot, where each spot area may be the same size and shape (Gale; [0013], [0017]).
While Gale does not address the volume variation coefficient of the complex between two or more spots is less than 11.8%, because the spots of Gale are the same size and shape the volume variation coefficient will be less than 11.8%.
Further, please note that there has been no established criticality for the claimed volume variation coefficient.
While Harvey does teach where the attachment points can be patterned onto the substrate ([0040]), Harvey does not teach wherein a surface treatment with a blocking agent is performed on the substrate.
In the analogous art of integrated, affinity-binding based analytical apparatuses for detecting particulates, Sheppard teaches a platform for performing an affinity-binding based assay (Sheppard; [0037]).
Specifically, Sheppard teaches where the platform is provided as a surface or detection chamber treated to comprise a specific binding reagent (Sheppard; [0087]). The binding reagent is applied to the surface or detection chamber of the platform by depositing the reagent on the surface, where it can provide a two-dimensional array or pattern where certain areas are treated with the specific binding reagent and others are not (Sheppard; [0087]). More specifically, Sheppard describes where the surface/detection chamber is provided with transparent portions coated with a specific binding reagents and other portions coated with a reflective material, where in addition the surface of the platform comprising reflective portions are treated with a blocking agent such as BSA to prevent non-specific binding of particulate matter on the surface of the platform (Sheppard; [0087]).
It would have been obvious to one skilled in the art to modify the substrate of Harvey such that the areas between the attachment points are treated with a blocking agent as taught by Sheppard because Sheppard teaches that the blocking agent prevents non-specific binding of particulate matter (Sheppard; [0087]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 8, filed 03/23/2026, with respect to the rejection(s) of claim(s) 1-2 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Harvey (US-2003/0044801-A1) and ThermoFisher Scientific “Biotinylation”. Note ThermoFisher was previously cited in the 892 filed 09/12/2025.
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 (i.e., a biological material) 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).
Claims 1 and 20 only describe a material, not a biological material.
On page 11 applicants argue that in view of the results of the examples, the limitation of the claimed invention – wherein the material to be immobilized is modified with a group that reacts with a reactive group via a spacer – exhibits a remarkable and unexpected effect.
Examiner respectfully disagrees.
First with regards to the examples, applicants have not provided sufficient evidence to show unexpected results. To show unexpected results, applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage, see MPEP 716.02(a).
Additionally, please see ThermoFisher which has been incorporated into the rejection which describes that spacer arms can enhance detection sensitivity due to more biotin molecules being available for reporter-conjugated avidin binding (ThermoFisher; page 3 Spacer Arm Length section).
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.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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