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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/16/2025 has been entered.
Status of Claims
Claim 1-30 are pending and under examination.
Response to Amendment
The amendments to the claims, received 12/16/2025, are accepted and the previous claim objections are withdrawn.
New 101 rejection(s) have been set forth.
In view of Applicant’s amended claims and remarks, the previous prior art rejection over Fava has been maintained (see below).
The terminal disclaimer, filed 08/25/2025, and subsequent terminal disclaimer review decision, mailed 09/08/2025, have not overcome the double patenting rejection. Accordingly, the double patenting rejection has been maintained.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Claims 1 and 30 are directed toward a method.
Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas.
Claim 1 recites the abstract idea “developing an assay protocol for a GMP-compliant assay for dupilumab”. Claim 30 recites the abstract ideas “(e) modifying the assay protocol based on the first data collected”, and “repeating step (e) … until the assay protocol has been optimized”. Claims 1 and 30 recite the abstract ideas “generating a GMP-compliant dataset of dupilumab from the collected data…includes an audit trail, identification of location data, and record of changes”.
These abstract ideas are mental processes that could be performed by a human person by pen and paper or by a black box computer. The computer system in claims 1 and 30 are merely a general-purpose computer for which to apply the abstract ideas, but does not preclude the steps from being considered an abstract idea. See MPEP 2106.04(a)(2) subsection (III).
Step 2A, Prong Two: Has the abstract idea been integrated into a particular practical application?
No. Upon developing the assay protocol and generating a dataset, no further action is performed, and therefore is not a particular practical application.
Claims 1 and 30 additionally recite storing the assay protocol and any changes, communicating the assay protocol to a computer, subjecting at least one sample comprising dupilumab to the assay protocol using an automated operation, and collecting data associated with the sample to provide an audit trail and record. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception. Furthermore, receiving, transmitting, or providing data over a network has been recognized as well-understood, routine, and conventional functions when they are claimed in a merely generic manner or as insignificant extra-solution activity to apply an exception. See MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Step 2B: Does the claim recite any elements which are significantly more than the abstract ideas?
Claims 1 and 30 recite the additional elements storing the assay protocol and any changes, communicating the assay protocol to a computer, subjecting at least one sample comprising dupilumab to the assay protocol using an automated operation, and collecting data associated with the sample to provide an audit trail and record. These additional elements do not amount to significantly more as they are well-understood, routine, and conventional (WURC) in the art as evidenced by Fava et al. (US 2002/0147515; – hereinafter “Fava”), and Wang et al. (US 2015/0320022 – hereinafter “Wang”). Fava disclose storing the assay protocol and any changes (Fava; [0044, 0076]), communicating the assay protocol to a computer (Fava; [0044, 0076]), subjecting at least one sample to the assay protocol using an automated operation (Fava; [0044-0045, 0077, 0083]), and collecting data associated with the sample to provide an audit trail and record (Fava; [0044-0045, 0076-0077, 0083]). Wang disclose the additional elements of a dupilumab assay protocol (Wang; [0193]).
Claim 2 further limits the assay to a bioassay. However, these additional elements are interpreted as mere instructions to implement the abstract idea or other exception on a computer, and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception. Accordingly, these elements do not integrate a judicial exception or provide significantly more and cannot integrate the judicial exception into a practical application. See MPEP 2106.05(f), Mere Instructions To Apply An Exception, and MPEP §2106.05(h), Field of Use and Technological Environment.
Claim 3 recites the abstract idea of optimizing the protocol from data collected from the sample subjected to the assay protocol (step 2A prong 1), but does not integrate the exception under 2A prong 2 because data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 4 further limits the protocol as being password protected. However, a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more. See MPEP § 2106.05(b)(III), MPEP § 2106.05(c), Particular Transformation, MPEP § 2106.05(d), Well-understood, Routine, Conventional Activity and MPEP § 2106.05(g), Insignificant Extra-Solution Activity.
Claim 5 further limits the assay protocol as being subject to quality control review. However, these additional elements are do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more that the abstract idea (MPEP § 2106.05(c), Particular Transformation).
Claim 6 recites the first computer system executes the assay protocol using a scheduling software. However, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 7 further limits the scheduling software in claim 6. However, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 8 recites the automated operation includes a robotic arm. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0032, 0059]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 9 further limits the robotic arm as being configured to move in the x, y, z axes. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0032, 0059]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 10 recites the automated operation as comprising a liquid handler and/or reagent dispenser. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0032, 0059]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 11 further limits the liquid handler and/or reagent dispenser dispense between 0.5 and 1000 microliters per channel, monitor air displacement, and comprises dynamic positioning systems, and capacitance and pressure sensors. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Noggle et al. (US 2013/0345094 – hereinafter “Noggle”). Noggle teach a Hamilton STARlet liquid handling robot; [0218]. See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 12 recites the at least one sample is selected from a group consisting of cell culture fluid, harvested cell culture fluid, filtrate, chromatography eluate, drug substance, and drug product. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Wang (Wang; [0193]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 13 recites the collected data comprises subjecting the at least one sample comprising dupilumab to at least one measurement. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 14 further limits the at least one measurement as being selected from a group consisting of spectrophotometry, ultraviolet detection, fluorescence detection, luminescence detection, radioactivity detection, Raman spectroscopy, mass spectrometry, biolayer interferometry, surface plasmon resonance, and absorbance detection. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0034-0037]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 15 further limits the sample as being contained in a microplate. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0032, 0083]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 16 recites the collecting data includes using at least one data analysis software. However, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 17 further limits the data analysis software of claim 16. However, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 18 recites the data includes a unique identifier for the at least one sample. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 19 recites the data includes a unique identifier for a container containing the sample. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 20 recites generating a unique identifier for a container containing the sample. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 21 further limits the unique identifier as a barcode. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0018, 0022, 0083-0085]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 22 recites the barcode is generated using a label printer. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0018, 0022, 0083-0085]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 23 recites the container is labeled with the barcode using a label printer. However, these elements do not effectively transform or reduce the system to a different state or thing beyond such that the claims recite significantly more than well-understood, routine, and conventional activities previously known to the industry as evidenced by Fava (Fava; [0018, 0022, 0083-0085]). See MPEP § 2106.05(c), Particular Transformation and MPEP § 2106.05(d), Well-Understood, Routine, Conventional Activity.
Claim 24 recites scanning the barcode at a critical step of subjecting the sample to the assay protocol to generate location data for the sample. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 25 recites the automated assay is qualified. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 26 recites the computer system and the automated operation of the assay protocol are qualified. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception. Further, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 27 recites the computer system and automated operation of the assay protocol are qualified prior to subjected the sample to the assay protocol. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception. Further, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
Claim 28 recites the automated assay is validated. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception.
Claim 29 recites the dataset subject to the assay protocol is validated prior to generating the dataset. However, data gathering and generally linking the use of a judicial exception to a particular technological environment or field of use in which to apply the judicial exception do not integrate the judicial exception into a particular practical application because data gathering is merely insignificant extra-solution activity. See MPEP § 2106.05(g), Insignificant Extra-Solution Activity and § 2106.05(f), Mere Instructions To Apply an Exception. Further, a general-purpose computer that applies the judicial exception by use of conventional computer functions does not qualify as a particular machine (MPEP § 2106(b)(I)), a machine that is merely an object on which the method operates does not integrate the exception into a practical application or provide significantly more (MPEP § 2106(b)(II)), and the use of a machine that contributes only nominally or insignificantly to the execution of the claimed method would not integrate a judicial exception or provide significantly more (MPEP § 2106.05(b)(III)).
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 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 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 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.
Claims 1-3, 5-10, 12-16 and 18-30 are rejected under 35 U.S.C. 103 as being unpatentable over Fava et al. (US 2002/0147515; already of record – hereinafter “Fava”), where CRS (A255 Robot Arm User Guide; already of record – hereinafter “CRS”) is used as supporting documentation, and further in view of Wang et al. (US 2015/0320022; already of record – hereinafter “Wang”), or alternatively over Fava where CRS is used as supporting documentation, in view of Wang, and further in view of Food and Drug Administration 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals; in effect on 01/01/2022; already of record – hereinafter “FDA 211”).
Regarding claim 1, Fava disclose a method for conducting an automated GMP-compliant assay (Fava; figs. 1-4, [0020, 0032, 0085]), the method comprising:
developing an assay protocol for a GMP-compliant assay (Fava disclose the laboratory automation workcell system may be configured to automate a specific assay or a number of assays, wherein creation of a protocol is performed by a user; [0031, 0037-0039, 0041-0042, 0044, 0073-0077]);
storing the assay protocol to include any changes and record of associated usage data, wherein any change to the protocol is stored and tracked (Fava; [0044, 0076]);
communicating the assay protocol to a first secure computer system in accordance with the assay protocol (Fava; [0044, 0076]);
subjecting at least one sample to the assay protocol executed by the first secure computer system (Fava; [0044-0045, 0077, 0083]), wherein the first secure computer system causes an automated operation of the assay protocol on the at least one sample (Fava; [0017, 0020, 0032-0033, 0037-0039, 0041-0042, 0085]);
collecting data associated with the at least one sample subjected to the assay protocol as part of the automated operation of the assay protocol on the at least one sample (Fava; [0044-0045, 0077, 0083]); and
generating a GMP-compliant dataset from the collected data as part of the automated operation of the assay protocol on the at least one sample, wherein the GMP-compliant dataset includes an audit trail of the GMP-compliant dataset (The Food and Drug Administration 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals; in effect on 01/01/2022 states under § 211.68 Automatic, mechanical, and electronic equipment “(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.”. Fava disclose control over changes in master production and control records or other records are instituted only by authorized personnel; 0044-0045, 0076-0077]). Fava also disclose a backup file of data entered into the computer or related system shall be maintained; [0077, 0083]), identification of location data for the at least one sample throughout execution of the assay protocol (Fava; [0044-0045, 0077, 0083]), and a record of any changes to the assay protocol, software and/or equipment controlled by the first secure computer system (Fava; [0076]).
Fava does not teach the assay is for dupilumab, wherein the at least one sample comprises dupilumab, and the dataset is for dupilumab.
However, Wang disclose the analogous art of conducting an assay, wherein the assay is for dupilumab on at least one sample comprising dupilumab (Wang; [0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automated assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, because Wang teaches assay performed on the at least one sample comprising Dupilumab determines the neutralizing effect against IL-4 (Wang; [0193]). Further, it would have been obvious to make the dupilumab assay of Wang automated as in Fava for the advantage of increased reproducibility, higher throughput, and use of less personal, because automating the dupilumab assay of Wang is merely automating a manual activity which is not considered patentably distinguishable over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.). See MPEP 2144.04(III). The modification resulting in the dataset of Fava being for dupilumab. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Fava and Wang teach performing an assay on at least one sample.
If it is deemed that modified Fava does not teach the method is GMP-compliant for conducting a GMP-compliant assay, or the dataset being GMP-compliant, FDA 211 disclose the analogous art of collecting data associated with at least one sample subjected to an assay protocol (FDA 211, p. 27, “§ 211.194 Laboratory records”, subsection (a)), wherein the data collection is GMP-compliant for conducting a GMP-compliant assay (FDA 211, p. 27, “§ 211.194 Laboratory records”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automated system of modified Fava to be GMP-compliant, as directed by the FDA, because the GMP-compliant guidelines set forth by the Food and Drug Administration are used in drug product commercialization and distribution to humans or animals in which laboratory records of all tests, including assays, are required. The modification therefore comprising a GMP-compliant assay and GMP-compliant dataset. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and FDA 211 both teach collecting data on an assay for a drug product.
Regarding claim 2, modified Fava teach the method of claim 1 above, wherein the GMP-compliant assay for dupilumab is a bioassay (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. The in vitro IgE class-switching assay taught by Wang is a bioassay).
Regarding claim 3, modified Fava teach the method of claim 1 above, wherein the protocol is optimized using data collected from the at least one sample comprising dupilumab subjected to the assay protocol (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Fava disclose optimizing the assay protocol using data from the at least one sample; [0026-0027, 0067, 0071, 0072]).
Regarding claim 5, modified Fava teach the method of claim 1 above, wherein the assay protocol is subjected to quality control review between 1 and 31 times per month, between 1 and 10 times per month, between 1 and 7 times per week, 1 time per week, 2 times per week, or 3 times per week (Fava; [0080]. Additionally, the modification of the method of modified Fava to be GMP-compliant, as directed by the FDA, has previously been discussed in claim 1 above. Sections § 211.22 (a), § 211.100(a), and §211.160(a) of the guidelines direct a quality control unit to “review production records to assure that no errors have occurred … written procedures, including any changes, shall be drafted, review, and approved by the appropriate organizational units and revied and approved by the quality control unit … any specifications, standards, sampling plans, test procedures, or other laboratory control mechanism … shall be … reviewed and approved by the quality control unit”. Accordingly, a quality control review is required for GMP-compliance).
Regarding claim 6, modified Fava teach the method of claim 1 above, wherein the first secure computer system executes the assay protocol using a scheduling software (Fava; [0004, 0026-0027, 0030, 0040, 0043, 0069]).
Regarding claim 7, modified Fava teach the method of claim 6 above, wherein the scheduling software comprises workflow visualization, real-time control, monitoring, and error management on multiple devices in an integrated software platform (Fava; fig. 1, [0015, 0041-0059, 0061-0065, 0073-0084]).
Regarding claim 8, modified Fava teach the method of claim 1 above, wherein the automated operation of the assay protocol includes a robotic arm (Fava; [0032, 0059]).
Regarding claim 9, modified Fava teach the method of claim 8 above, wherein the robotic arm is configured to move in the x, y, and z axes (Fava disclose equipment includes a CRS Robotics A255 articulated robot 13 mounted on a 4.5 meter long Inpecto TR-10/4 air bearing track (a double pair of pincers are designed to transfer Microtiter plates and Tip Racks and Sample Tubes to and from all Resources in the LAWS; [0032, 0059]. CRS part 1, page 1, paragraph 1 and corresponding figure disclose a robotic arm configured to move in the x, y, and z axes).
Regarding claim 10, modified Fava teach the method of claim 1 above, wherein the automated operation of the assay protocol includes at least one liquid handler and/or reagent dispenser (Fava; [0033]).
Regarding claim 12, modified Fava teach the method of claim 1 above, wherein the at least one sample comprising dupilumab is selected from a group consisting of cell culture fluid, harvested cell culture fluid, filtrate, chromatography eluate, drug substance, and drug product (The modification of the assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Dupilumab is a drug substance and a drug product).
Regarding claim 13, modified Fava teach the method of claim 1 above, wherein collecting data comprises subjecting the at least one sample comprising dupilumab to at least one measurement (The modification of the assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Fava; [0023, 0033-0036, 0042, 0084]).
Regarding claim 14, modified Fava teach the method of claim 13 above, wherein the at least one measurement is selected from a group consisting of spectrophotometry, ultraviolet detection, fluorescence detection, luminescence detection, radioactivity detection, Raman spectroscopy, mass spectrometry, biolayer interferometry, surface plasmon resonance, and absorbance detection (Fava; [0034-0037]).
Regarding claim 15, modified Fava teach the method of claim 1 above, wherein the at least one sample comprising dupilumab is contained in a microplate (The modification of the assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Fava; [0032, 0083]).
Regarding claim 16, modified Fava teach the method of claim 1 above, wherein collecting data includes using at least one data analysis software (Fava; [0023, 0027]).
Regarding claim 18, modified Fava teach the method of claim 1 above, wherein the GMP-compliant dataset of dupilumab includes a unique identifier for the at least one sample comprising dupilumab (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Fava; [0018, 0022, 0083-0085]).
Regarding claim 19, modified Fava teach the method of claim 1 above, wherein the GMP-compliant dataset of dupilumab includes a unique identifier for a container containing the at least one sample comprising dupilumab (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Fava; [0018, 0022, 0083-0085]).
Regarding claim 20, modified Fava teach the method of claim 1 above, further comprising generating a unique identifier for a container containing the at least one sample comprising dupilumab (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Fava; [0018, 0022, 0083-0085]).
Regarding claim 21, modified Fava teach the method of claim 20 above, wherein the unique identifier is a barcode (Fava; [0018, 0022, 0083-0085]).
Regarding claim 22, modified Fava teach the method of claim 21 above, wherein the barcode is generated using a label printer (Fava; [0018, 0022, 0083-0085]).
Regarding claim 23, modified Fava teach the method of claim 21 above, wherein the container is labeled with the barcode using a label printer (Fava; [0018, 0022, 0083-0085]).
Regarding claim 24, modified Fava teach the method of claim 21 above, further comprising scanning the barcode at a critical step of subjecting the at least one sample comprising dupilumab to the assay protocol to generate the location data for the at least one sample comprising dupilumab (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, has previously been discussed in claim 1 above. Fava; [0044-0045, 0077]).
Regarding claim 25, modified Fava teach the method of claim 1, wherein the automated GMP-compliant assay for dupilumab is qualified (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Accordingly, the automated assay for dupilumab being a qualified GMP-compliant process).
Regarding claim 26, modified Fava teach the method of claim 1 above, wherein the first secure computer system and the automated operation of the assay protocol is qualified (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Accordingly, the first secure computer system and automated operation of the assay protocol for dupilumab being a qualified GMP-compliant process).
Regarding claim 27, modified Fava teach the method of claim 1 above, wherein the first secure computer system and the automated operation of the assay protocol is qualified prior to the subjecting the at least one sample comprising dupilumab to the assay protocol (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Accordingly, the first secure computer system and automated operation of the assay protocol for dupilumab being a qualified GMP-compliant process prior to subjecting the at least one sample to the assay protocol).
Regarding claim 28, modified Fava teach the method of claim 1 above, wherein the automated GMP-compliant assay for dupilumab is validated (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Accordingly, the automated operation of the assay protocol for dupilumab being a validated GMP-compliant process).
Regarding claim 29, modified Fava teach the method of claim 1 above, wherein the GMP-compliant dataset of dupilumab subjected to the assay protocol is validated prior to generating the GMP-compliant dataset of dupilumab (The modification of the assay performed by Fava with the assay for dupilumab, and the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, and the modification of the automated system of modified Fava to be GMP-compliant, as directed by the FDA, have previously been discussed in claim 1 above. Accordingly, the automated operation of the assay protocol for dupilumab being a validated GMP-compliant process prior to generating the GMP-compliant dataset of dupilumab).
Regarding claim 30, Fava teach a method for conducting an automated GMP-compliant assay (Fava; figs. 1-4, [0020, 0032, 0085]), the method comprising:
(a) providing an assay protocol for a GMP-compliant assay (Fava disclose a laboratory automation workcell system LAWS comprising a process control PC, data manager DM, laboratory information system LIS, Laboratory information system driver U, a graphical user interface GUI, and an automation managing system AMS; figs. 1 & 2, [0015, 0017]);
(b) communicating the assay protocol to a secure computer system in accordance with the assay protocol (Fava; [0017, 0020, 0032-0033, 0037-0039, 0041-0042, 0044, 0076, 0085]);
(c) subjecting at least one sample to the assay protocol executed by the secure computer system (Fava; [0044-0045, 0077, 0083]), wherein the secure computer system causes an automated operation of the assay protocol on the at least one sample (Fava; [0017, 0020, 0032-0033, 0037-0039, 0041-0042, 0085]);
(d) collecting a first data associated with the at least one sample subjected to the assay protocol as part of the automated operation of the assay protocol on the sample (Fava; [0044-0045, 0076-0077, 0083]);
(e) modifying the assay protocol based on the data collected from the at least one sample subjected to the assay protocol (Fava; [0076]);
(f) storing and recording any modifications to the assay protocol (Fava; [0076]);
(g) communicating the modified assay protocol to the secure computer system in accordance with the assay protocol (Fava; [0076]);
(h) subjecting at least one sample to the modified assay protocol executed by the secure computer system, wherein the secure computer system causes an automated operation of the modified assay protocol on the at least one sample (Fava; [0076]);
(i) collecting a second data associated with the at least one sample subjected to the modified assay protocol as part of the automated operation of the modified assay protocol on the sample (Fava; [0076]);
(j) repeating steps (e) to (i) until the assay protocol has been optimized based on the collected data (Fava; [0076]); and
(k) generating a GMP-compliant dataset from the collected data, wherein the dataset includes an audit trail of the GMP-compliant dataset, identification of location data for the at least one sample throughout execution of the assay protocol, and a record of any modifications to the assay protocol, software and/or equipment controlled by the secure computer system (The Food and Drug Administration 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals; in effect on 01/01/2022 states under § 211.68 Automatic, mechanical, and electronic equipment “(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.”. Fava disclose control over changes in master production and control records or other records are instituted only by authorized personnel; 0044-0045, 0076-0077]). Fava also disclose a backup file of data entered into the computer or related system shall be maintained; [0077, 0083]).
Fava does not teach the assay is for dupilumab, wherein the at least one sample comprises dupilumab, and the dataset is of dupilumab.
However, Wang disclose the analogous art of conducting an assay, wherein the assay is for dupilumab on at least one sample comprising dupilumab (Wang; [0193]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, because Wang teaches assay performed on the at least one sample comprising Dupilumab determines the neutralizing effect against IL-4 (Wang; [0193]). Further, it would have been obvious to make the dupilumab assay of Wang automated as in Fava for the advantage of increased reproducibility, higher throughput, and use of less personal, because automating the dupilumab assay of Wang is merely automating a manual activity which is not considered patentably distinguishable over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.). See MPEP 2144.04(III). The modification resulting in the dataset of Fava being for dupilumab. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Fava and Wang teach performing an assay on at least one sample.
If it is deemed that modified Fava does not teach the method is GMP-compliant for conducting a GMP-compliant assay, or the dataset being GMP-compliant, FDA 211 disclose the analogous art of collecting data associated with at least one sample subjected to an assay protocol (FDA 211, p. 27, “§ 211.194 Laboratory records”, subsection (a)), wherein the data collection is GMP-compliant for conducting a GMP-compliant assay (FDA 211, p. 27, “§ 211.194 Laboratory records”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of modified Fava to be GMP-compliant, as directed by the FDA, because the GMP-compliant guidelines set forth by the Food and Drug Administration are used in drug products administered to humans or animals in which laboratory records of all tests, including assays, are required. The modification therefore comprising a GMP-compliant assay and GMP-compliant dataset. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and FDA 211 both teach collecting data on an assay for a drug product.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fava, where CRS is used as supporting documentation, in view of Wang, in view of FDA 211, and further in view of Mishima et al. (US 2006/0190187; already of record – hereinafter “Mishima”).
Regarding claim 4, modified Fava teach the method of claim 1 above, comprising the protocol.
Modified Fava does not teach wherein the protocol is protected by a password.
However, Mishima teach the analogous art of an automated system (Mishima; figs. 1 & 2, [0053-0054]), wherein the automated system is protected by a password (Mishima; figs. 21-23, S2, [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the protocol of modified Fava with the password protected system, as in Mishima, because Mishima teach the password grands access to a user’s confirmation database for the application program stored on the hard disk, and authenticates the user by determining whether or not there is an account recording the logon ID and password, whether or not the account is valid, and whether or not the account expiration time has expired; Mishima; [0110]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and Mishima both teach systems that perform automated assays on samples.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fava, where CRS is used as supporting documentation, in view of Wang, in view of FDA 211, and further in view of Noggle et al. (US 2013/0345094 – hereinafter “Noggle”).
Regarding claim 11, modified Fava teach the method of claim 10, wherein the at least one liquid handler and/or reagent dispenser is configured to dispense (Fava; [0033]).
Modified Fava does not teach wherein the at least one liquid handler and/or reagent dispenser is configured to dispense between 0.5 µL to 1000 µL per channel, monitor air displacement, and comprises dynamic positioning system, and capacitance and pressure sensors.
However, Noggle teach the analogous art of at least one liquid handler and/or reagent dispenser configured to dispense (Noggle; fig. 5A, #100, [0218]), wherein the at least one liquid handler and/or reagent dispenser is configured to dispense between 0.5 µL to 1000 µL per channel, monitor air displacement, and comprises dynamic positioning system, and capacitance and pressure sensors (Noggle teach a Hamilton STARlet liquid handling robot; [0218]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the at least one liquid handler and/or reagent dispenser configured to dispense of modified Fava with the Hamilton STARlet liquid handling robot, as taught by Noggle, because Noggle teach the Hamilton STARlet liquid handling robot can be controlled by programmable software on a PC and is equipped with a modular arm for 4/8/12 channel pipetting (Noggle; [0230]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and Noggle both teach laboratory automation with liquid handlers.
NOTE: When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02. As stated in In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986): Where, as here, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, the PTO can require an applicant to prove that the prior art process does not necessarily or inherently possess the characteristics of his claimed process. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. A review of applicant’s as-filed specification states “In a specific aspect, the at least one liquid handler and/or reagent dispenser is a Hamilton STARlet”, see paragraphs [0015, 0033]. In this case, Noggle disclose an identical product and would necessarily perform the method claimed.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fava, where CRS is used as supporting documentation, in view of Wang, in view of FDA 211, and further in view of XU (US 2021/0011033 – hereinafter “XU”).
Regarding claim 17, modified Fava teach the method of claim 16 above, comprising the at least one data analysis software (Fava; [0023, 0027]).
Modified Fava does not teach wherein the at least one data analysis software comprises pre-configured assay protocols, curve-fitting algorithms, cross-plate analysis, interpolation and automatic calculation metrics, data acquisition and visualization functions.
However, XU teach the analogous art of conducting an assay (XU; [0122]) and using at least one software comprising pre-configured assay protocols, curve-fitting algorithms, cross-plate analysis, interpolation and automatic calculation metrics, data acquisition and visualization functions to analyze data (XU teach using Softmax software to plot the standard curve of assay results; [0122]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the at least one data analysis software of modified Fava with Softmax software, as taught by XU, because XU teach Softmax software can be used to plot the standard curve for an assay (XU; [0122]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and XU both teach data analysis of an assay using software.
NOTE: When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02. As stated in In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986): Where, as here, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, the PTO can require an applicant to prove that the prior art process does not necessarily or inherently possess the characteristics of his claimed process. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. See MPEP 2112. A review of applicant’s as-filed specification states “In a specific aspect, the at least one liquid handler and/or reagent dispenser is a Hamilton STARlet”, see paragraphs [0015, 0033]. A review of applicant’s as-filed specification states “In a specific aspect, the at least one data analysis software is SoftMax”, see paragraphs [0020, 0038]. In this case, XU disclose an identical product and would necessarily perform the method claimed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13-15 of copending Application No. 18/409,065 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 13-15 of copending Application No. 18/409,065 disclose:
Regarding claim 1, 18/409,065 disclose a method for conducting an automated GMP-compliant assay for dupilumab (18/409,065 – Claims 1 and 13-15), the method comprising:
developing an assay protocol for a GMP-compliant assay for dupilumab (18/409,065 – Claims 1 and 13-15);
storing the assay protocol to include any changes and record of associated usage data, wherein any change to the protocol is stored and tracked (18/409,065 – Claims 1 and 13-15);
communicating the assay protocol to a first secure computer system in accordance with the assay protocol (18/409,065 – Claims 1 and 13-15);
subjecting at least one sample comprising dupilumab to the assay protocol executed by the first secure computer system, wherein the first secure computer system causes an automated operation of the assay protocol on the at least one sample comprising dupilumab (18/409,065 – Claims 1 and 13-15);
collecting data associated with the at least one sample comprising dupilumab subjected to the assay protocol as part of the automated operation of the assay protocol on the at least one sample comprising dupilumab (18/409,065 – Claims 1 and 13-15); and
generating a GMP-compliant dataset of dupilumab from the collected data as part of the automated operation of the assay protocol on the at least one sample comprising dupilumab, wherein the GMP-compliant dataset of dupilumab includes an audit trail of the GMP-compliant dataset of dupilumab, identification of location data for the at least one sample comprising dupilumab throughout execution of the assay protocol, and a record of any changes to the assay protocol, software and/or equipment controlled by the first secure computer system (18/409,065 – Claims 1 and 13-15).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 12/16/2025 have been considered but were not found persuasive.
Applicant argues, see pages 7-8 of their remarks, that Fava’s disclosure on the automated system is limited to its ability to save modified protocols with specific identification and version number and maintain the history and status of samples, and saving a modified protocol does not teach or suggest to a person skilled in the art the additional steps and features of automatically generating an audit trail documenting every change to a protocol, and that information regarding the history and status of the samples fails to teach or suggest the method of securely maintaining the data showing the location of samples throughout the execution of the assay protocol. The examiner respectfully disagrees. Fava disclose “The Process Controller acquires the programs to be run, controls the timing with the internal database that maintains the history and status of each plate processed through the system. It communicates with Resource Drivers, while it creates a log file and data export files for the Laboratory Information System. Finally, the Resource Drivers communicate with the Resources in a modular and concurrent way.” (Fava; [0044]), “Actually, each Resource Driver has its own small database in which it keeps track of all plates that it is containing or processing at that moment in time. This allows the Process Controller and the Sample Carrier Device Driver to fully control and check the status of each plate as necessary” (Fava; [0077]), and “While creating the Protocol in this way, a text window is shown in which the script of low-level commands are displayed. It is possible at any moment during the Protocol definition (or when recalling an earlier defined Protocol) to modify, add or delete any line of this script. Protocols are saved, into the protocol Database, with a specific identification and version number so that they can be used in any future moment.” (Fava; [0076]). Accordingly, Fava teach an automated system for conducting an assay which includes storing the assaying protocol to include any changes and record of associated usage data, wherein any change to the protocol is stored and tracked, collecting data associated with the at least one sample subjected to the assay protocol as part of the automated operation of the assay protocol, and generating a dataset from the collected data as part of the automated operation of the assay protocol including an audit trail, identification of location data, and a record of any changes to the assay protocol.
Applicant further argues on pages 8-9 of their remarks towards the combination of Fava in view of Wang that Wang does not provide any indication that the assay is suitable for automated use in a GMP-compliant setting, and cites Example 2 described in Applicant’s specification which evaluates the performance of the automated assay against the manual assay, and that no motivation is provided in Wang for deriving the claimed invention. The examiner respectfully disagrees. First, automating a manual activity is not considered patentably distinguishable over the prior art. In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958) (Appellant argued that claims to a permanent mold casting apparatus for molding trunk pistons were allowable over the prior art because the claimed invention combined "old permanent-mold structures together with a timer and solenoid which automatically actuates the known pressure valve system to release the inner core after a predetermined time has elapsed." The court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.). See MPEP 2144.04(III). Second, Applicant’s Example 2 concludes in paragraph [0152] of their printed publication that “these results demonstrated that the automated assay behaved in a manner consistent with or better than the manual assay.”. Additionally, Fava discloses the automated system is designed for different assays (Fava; [0005, 0042]) and utilizes equivalent laboratory equipment including plates, tip racks, sample carrier devices, a turntable, container handling devices, a barcode reader, plate storage carousels, tip rack storage carousel, a plate sealer, liquid handlers and/or reagent dispensers, robotic arms, a plate shaker, an incubator, a plate washer, and assay devices for detection (Fava; [0032-0033]) for performing assay protocols in an automated manner, which would behave in a manner consistent with or better than the manual method of Wang. That being said, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the assay performed by Fava with the assay for dupilumab, and to modify the at least one sample with the at least one sample comprising dupilumab, as taught by Wang, because Wang teaches assay performed on the at least one sample comprising Dupilumab determines the neutralizing effect against IL-4 (Wang; [0193]).
Applicant argues on pages 9-10 of their remarks towards the combination of Fava in view of FDA 211 that FDA 211 avoids prescribing specific, detailed methods for implementing these standards, and does not specify a specific system or method for generating GMP-compliant assay records. The examiner respectfully disagrees. The Food and Drug Administration 21 CFR Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals; in effect on 01/01/2022 states under § 211.68 Automatic, mechanical, and electronic equipment “(b) Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Input to and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. A backup file of data entered into the computer or related system shall be maintained except where certain data, such as calculations performed in connection with laboratory analysis, are eliminated by computerization or other automated processes. In such instances a written record of the program shall be maintained along with appropriate validation data. Hard copy or alternative systems, such as duplicates, tapes, or microfilm, designed to assure that backup data are exact and complete and that it is secure from alteration, inadvertent erasures, or loss shall be maintained.”. Fava disclose control over changes in master production and control records or other records are instituted only by authorized personnel (Fava; 0044, 0076-0077]). Fava also disclose a backup file of data entered into the computer or related system shall be maintained (Fava; [0077, 0083]).
In short, the system of Fava would satisfy many of the GMP guidelines but is absent to a specific teaching of the term “GMP-Compliant”. That said, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automated system of modified Fava to be GMP-compliant, as directed by the FDA, because the GMP-compliant guidelines set forth by the Food and Drug Administration are used in drug product commercialization and distribution to humans or animals in which laboratory records of all tests, including assays, are required. The modification therefore comprising a GMP-compliant assay and GMP-compliant dataset. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Fava and FDA 211 both teach collecting data on an assay for a drug product.
Applicant’s arguments on pages 10-13 have been fully considered but are moot as the Office Action does not rely on theses references as teaching the argued limitations.
Applicant’s argument on page 13 has been fully considered but was not found persuasive. Applicant argues towards the double patenting rejection that a terminal disclaimer for copending application no. 18/409,065 was filed August 25, 2025 and thus when the claims of copending application no. 18/409,065 have been patented, the rejection has been overcome. The examiner respectfully disagrees. The subsequent terminal disclaimer review decision, mailed 09/08/2025, has not overcome the double patenting rejection as the review decision was “DISAPPROVED” due to the TD signature not originating from the applicant, patentee or attorney or agent of record. 37 CFR 1.321(a) and (b).
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Kochar et al. (US 2022/0365106) disclose methods, devices and systems for associating consumable data with an assay consumable used in a biological assay.
Farrelly et al. (US 2007/0184546) disclose a robotic laboratory automation workcell including equipment that is integrated using a conveyor and controlled by a controller with specialized software to automate the proteomics research process.
Wagner et al. (US 2022/0284574) disclose platforms, systems, and methods including a cell culture system.
Preston et al. (US 2018/0068359) disclose systems and methods for manufacturing control that utilize blockchain technology and smart contracts.
Conclusion
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. 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.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798