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 .
Applicants’ amendment to the claims filed on 2/9/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-6, 8-10, 19, 24-32, 34 are pending.
Claims 7, 11-18, 20-23, 33 are cancelled.
Claims 19, 24-32, 34 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-6, 8-10 are pending and examined on the merits.
Priority
Acknowledgement is made of applicants’ claimed domestic priority to U.S. provisional application 63/383,779, filed on 11/15/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/25/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 11/14/2023 and 1/4/2024 are acknowledged and accepted by the examiner.
Claim Objections
Claims 2, 8-10 are objected to under 37 CFR 1.75 because of the following informalities: ‘s’ (claims 8-10), ‘()’ and ‘mol’ (claim 2). It is suggested that Applicant spell out the abbreviation ‘s’ and ‘mol’ fully for clarity. Furthermore, it is suggested that Applicant amend claim 2 to recite “wherein the predetermined ratio of mole enzyme and mole protein substrate is about 1:20….”. Appropriate correction is suggested.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2-5, 8-10 are 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.
Regarding claim 2, the phrase " (mol enzyme : mol substrate)" renders the claim indefinite because it is unclear whether the limitation(s) in brackets following the terms are part of the claimed invention. See MPEP § 2173.05(d). It is unclear whether the items inside of the brackets are examples or generic terms. Additionally, the term ‘mol’ is indefinite as it is unclear what said term represents. It is suggested that Applicant spell out the term. Appropriate correction is suggested.
Regarding claim 3 (claim 4 dependent thereof) it is unclear what Applicant is referencing with the recitation 'concentration' as claim 1 refers to only the “predetermined ratio” and does not provide any guidance with respect to concentration. Appropriate correction is suggested.
Claim 5 recites the limitation " the solution" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation of solution in claim 1, upon which claim 5 depends. Appropriate correction is suggested.
Regarding claims 8-10, the term ‘s’ is indefinite as it is unclear what said term represents. It is suggested that Applicant spell out the term. Appropriate correction is suggested.
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.
Claims 1-6, 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Anzai et al (1999, Graduate School of Pharmaceutical Sciences, Examiner cited) {herein Anzai}.
Claims 1-6, 8-10 are drawn to a method of preparing a protein sample in a thin film for a bioprocessing assay, comprising:(a) combining an enzyme and a protein substrate at a predetermined ratio to produce an substrate-enzyme mixture; (b) depositing the mixture of step (a) in a bottom conical or frustoconical surface; and (c) pressing the mixture between the bottom conical or frustoconical surface and a top conical or frustoconical surface by applying a predetermined force between the top conical or frustoconical surface and the bottom conical or frustoconical surface, wherein the top conical or frustoconical surface and bottom conical or frustoconical surface are vertically oriented and configured to produce a nested conical or frustoconical interface; thereby forming a thin film comprising the protein-enzyme mixture in the nested conical interface.
With respect to claim 1, Anzai teaches a method wherein Concanavalin A (Con A), a lectin protein found in Jack bean, is used to form multiplayer thin films composed of 1ng of ConA and 1 mg of mannose-labeled enzymes (mLOx) on the surface of quartz slides (page 2581, column 2, para 2 and page 2852, column 1, para 1). Furthermore, glycoproteins such as glucose oxidase (GOx) and horseradish peroxidase (HRP) were found to be assembled into multilayer thin films (page 2852, column 1, para 1; page 2852, column 1, para 2). Absent evidence otherwise, it is the Examiner’s position that 1ng of ConA and 1 mg of mannose-labeled enzymes are predetermined ratios as recited in the instant application claim 1.
However, Anzai does not teach (b) depositing the mixture of step (a) in a bottom conical or frustoconical surface; and (c) pressing the mixture between the bottom conical or frustoconical surface and a top conical or frustoconical surface by applying a predetermined force between the top conical or frustoconical surface and the bottom conical or frustoconical surface, wherein the top conical or frustoconical surface and bottom conical or frustoconical surface are vertically oriented and configured to produce a nested conical or frustoconical interface; thereby forming a thin film comprising the protein-enzyme mixture in the nested conical interface (claim 1). Anzai does not teach wherein the predetermined ratio of the enzyme and protein substrate is about 1:20, 1:25, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:90, 1:100, 1:110, 1:120, 1:130, 1:140, 1:150, 1:160, 1:170, 1:180, 1:190, or 1:200 (mol enzyme : mol substrate) (claim 2). Anzai does not teach wherein the substrate-enzyme mixture is in a solution at a concentration of 0.1 to 20 mg/mL (claim 3). Anzai does not teach wherein the enzyme mixture is in 10 µL to 100 µL of the solution (claim 4). Anzai does not teach wherein the solution has a viscosity of 0.1 to 2.0 mPa-S (claim 5). Anzai does not teach wherein the predetermined force is between 3 and 20 pounds (claim 6). Anzai does not teach wherein the force is applied for a duration between 3 and 5 s (claim 8). Anzai does not teach wherein the application of force is followed by withdrawal of force for a duration of between 1 s and 2 s (claim 9). Anzai does not teach wherein the application and withdrawal of force is performed over a total duration of 30 s (claim 10).
With respect to claim 5, since Anzai teaches the structure of a method of preparing a protein sample in a thin film for a bioprocessing assay. As such, it is the Examiner’s position that said assay would necessarily have a viscosity of 0.1 to 2.0 mPa-S, as recited in claim 5 of the instant application. Although the reference of Anzai does not explicitly teach the limitations of claim 2 (the predetermined ratio of the enzyme and protein substrate is about 1:20, 1:25, 1:30, 1:40, 1:50, 1:60, 1:70, 1:80, 1:90, 1:100, 1:110, 1:120, 1:130, 1:140, 1:150, 1:160, 1:170, 1:180, 1:190, or 1:200 (mol enzyme : mol substrate), claim 3 (wherein the substrate-enzyme mixture is in a solution at a concentration of 0.1 to 20 mg/mL), claim 4 (the enzyme mixture is in 10 µL to 100 µL of the solution.), claim 5 (the solution has a viscosity of 0.1 to 2.0 mPa-S), MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the ratio of enzyme to substrate, concentration of substrate-enzyme mixture, concentration of enzyme mixture, viscosity depending on the particular application. It would be routine for one to arrive at a ratio of enzyme to substrate, concentration of enzyme mixture, concentration of the enzyme-substrate mixture, viscosity for the application they intend on using the thin film for a bioprocessing assay. Therefore, the above invention would have been prima facie obvious.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method of preparing a protein sample in a thin film for a bioprocessing assay, taught by Anzai, of (b) depositing the mixture of step (a) in a bottom conical or frustoconical surface; and (c) pressing the mixture between the bottom conical or frustoconical surface and a top conical or frustoconical surface by applying a predetermined force between the top conical or frustoconical surface and the bottom conical or frustoconical surface, wherein the top conical or frustoconical surface and bottom conical or frustoconical surface are vertically oriented and configured to produce a nested conical or frustoconical interface because it is known by those of ordinary skill in the art and well-known in the art that depositing mixtures between thin films in a conical shape, pressing thin film between a top conical surface and bottom conical surface in a vertical orientation would provide enhanced performance by managing fluid flow, optimizing storage conditions and providing structural stability. As such, said limitation is not novel or inventive considering it is routinely known and well-understood in the art.
One of ordinary skill in the art would be motivated, have had a reasonable expectation of success, a reasonable level of predictability to deposit the thin film with the mixture in a bottom conical surface and place a top conical surface vertically oriented to produce a nested conical interface, apply pressure and subsequently apply a withdrawal force to form a thin film comprising a protein sample as doing so would reduce the likelihood of protein leaching, optimize storage conditions and maintain structural stability. It would be obvious to one of ordinary skill in the art to modify the invention taught by Anzai by pressing the mixture between the bottom conical surface and a top conical surface by applying a predetermined force between the top conical surface and the bottom conical surface, wherein the top conical surface and bottom conical surface are vertically oriented and configured to produce a nested conical interface; thereby forming a thin film comprising the protein-enzyme mixture in the nested conical interface as Anzai teaches that the multilayer thin films are relatively leaky to the substrates of the enzymes and the reaction products (page 2856, column 2, para 1). Additionally, after 2 months of storage, the catalytic activities of ConA-m-LOx film was less stable (page 2856, column 1, para 2). About a half of the original activity remained after 2 weeks (page 2586, column 1, para 2). As such, Anzai would be motivated to modify the storage conditions of the thin film by pressing the mixture between the bottom conical and a top conical of the test tube and applying a predetermined force between the top conical and bottom conical of the tube as doing so would reduce the likelihood of leaking during storage as the material would be sealed. Additionally, it would reduce the likelihood of premature protein unfolding as the thin film would not be exposed to external environmental factors such as water would could cause protein unfolding due to high surface tension and hydrophobic interactions.
Consequently, although the reference of Anzai does not explicitly teach the limitations: the predetermined force is between 3 and 20 pounds (instant application claim 6), the force is applied for a duration between 3 and 5 s (instant application claim 8), withdrawal of force for a duration of between 1 s and 2 s) (instant application claim 9), the application and withdrawal of force is performed over a total duration of 30 s (instant application claim 10), MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the force and duration of the withdrawal force depending on the particular application. It would be routine for one to arrive at a force and duration of the withdrawal force for the application they intend on using the thin film for a bioprocessing assay. Furthermore, pressing or forming thin films, particularly in specialized containers with conical bottoms, is a routine process in various technical, industrial, and laboratory applications. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of Claims
Claims 1-6, 8-10 are pending.
Claims 7, 11-18, 20-23, 33 are cancelled.
Claims 19, 24-32, 34 stands withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-6, 8-10 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656