DETAILED ACTION
Continued Examination Under 37 CFR 1.114
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/5/2026 has been entered.
Notice to Applicant
This action is in reply to the filed on 6/5/2026.
Claims 1-2, 4, 10-11, 13, 19-20 and 22 have been amended.
Claims 3, 12 and 21 have been cancelled.
Claim 1-2, 4-11, 13-20 and 22-27 currently pending and have been examined.
Response to Amendments
The Applicant’s amendments, and cancellation, of the claims as currently submitted have been noted by the Examiner. Said amendments, and cancellation(s), are not sufficient to overcome the rejections previously set forth under 35 U.S.C. §101. As such, said rejections are herein maintained for reasons set forth below.
Information Disclosure Statement
The Information Disclosure Statements filed on 6/5/2026 has been considered. An initialed copy of Form 1449 is enclosed herewith.
Subject Matter Free of Prior Art
Clark-Joseph (US 2020/0080980) and Shanafelt (US 2012/0297282) teach a computer-implemented method for generating a batch report. Clark-Joseph and Shanafelt do not teach “a graphical user interface, "receiving at least one user input to the graphical user interface for modifying at least one of the analyzed data...", "automatically generating an updated version of the compiled batch report...,” etc. Therefore, the Applicant has successfully overcome the Examiner’s 35 USC 103 rejection and Examiner withdraws his 35 USC 103 rejection.
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.
Human Interactions Organized
Applicant discloses (Applicant’s Specification, [0003]) that review and analysis of batch production records is needed as part of drug development. So a need exists to organize these human interactions through automated data analysis and reporting of pharmaceutical batch production records using the steps of “extracting data, receiving commands, performing statistical analyses, generating and storing figures and tables, identifying discussion boxes, compiling batch requests, saving reports, displaying user interfaces, receiving user inputs, generating updates,” etc. Applicant’s method is therefore a certain method of organizing the human activities as described and disclosed by Applicant.
Rejection
Claim(s) 1-2, 4-11, 13-20 and 22-27 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1, 10 and 19 is/are directed to the abstract idea of “automated data analysis and reporting of pharmaceutical batch production records,” etc. (Applicant’s Specification, Abstract, paragraph(s) [0002]), etc., as explained in detail below, and thus grouped as a certain method of organizing human interactions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Accordingly, claims 1-2, 4-11, 13-20 and 22-27 recite an abstract idea.
Step 2A Prong 1 – The Judicial Exception
The claim(s) recite(s) in part, method for performing the steps of “extracting data, receiving commands, performing statistical analyses, generating and storing figures and tables, identifying discussion boxes, compiling batch requests, saving reports, displaying user interfaces, receiving user inputs, generating updates,” etc., that is “automated data analysis and reporting of pharmaceutical batch production records,” etc. which is a method of managing personal behavior or relationships or interactions between people (social activities, teaching, following rules, instructions) and thus grouped as a certain method of organizing human interactions. Accordingly, claims 1-2, 4-11, 13-20 and 22-27 recite an abstract idea.
Step 2A Prong 2 – Integration of the Judicial Exception into a Practical Application
This judicial exception is not integrated into a practical application because the generically recited additional computer elements (i.e. processors, input devices, communication devices, output devices, memory storage (Applicant’s Specification [0103]-[0105], [0109]-[0114]), etc.) to perform steps of “extracting data, receiving commands, performing statistical analyses, generating and storing figures and tables, identifying discussion boxes, compiling batch requests, saving reports, displaying user interfaces, receiving user inputs, generating updates,” etc. do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and this is nothing more than an attempt to generally link the product of nature to a particular technological environment. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limit on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Insignificant extra-solution activity
Claim(s) 1-2, 4-11, 13-20 and 22-27 recites storing data steps, retrieving data steps, providing data steps, output steps (Bilski v. Kappos, 561 U.S. 593, 610-12 (2010), Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can., 771 F.Supp.2d 1054, 1066 (E.D. Mo. 2011), aff’d, 687 F.3d at 1266), and/or transmitting data step (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014), Apple, Inc. v. Ameranth, Inc., 842 F.3d 1299, 1241-42 (Fed. Cir. 2016)) that is/are insignificant extra-solution activity. Extra-solution activity limitations are insufficient to transform judicially excepted subject matter into a patent-eligible application (MPEP §2106.05(g)).
Step 2B – Search for an Inventive Concept/Significantly More
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above with respect to integration into a practical application, the additional elements (i.e. processors, input devices, communication devices, output devices, memory storage, etc.) are recited at a high level of generality, and the written description indicates that these elements are generic computer components. Using generic computer components to perform abstract ideas does not provide a necessary inventive concept (Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”)). Accordingly, the claims are not patent eligible.
Individually and in Combination
The additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The additional elements amount to no more than generic computer components that serve to merely link the abstract idea to a particular technological environment (i.e. processors, input devices, communication devices, output devices, memory storage, etc.). At paragraph(s) [0103]-[0105], [0109]-[0114], Applicant’s specification describes generic computer hardware for implementing the above described functions including “processors, input devices, communication devices, output devices, memory storage,” etc. to perform the functions of “extracting data, receiving commands, performing statistical analyses, generating and storing figures and tables, identifying discussion boxes, compiling batch requests, saving reports, displaying user interfaces, receiving user inputs, generating updates,” etc. The recited “processors, input devices, communication devices, output devices, memory storage,” etc. does/do not add meaningful limitations to the idea of beyond generally linking the system to a particular technological environment, that is, implementation via computers. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, or improves any other technology, or improves a technical field, or provides a technical improvement to a technical problem. Their collective functions merely provide generic computer implementation. Therefore, claims 1-2, 4-11, 13-20 and 22-27 do not amount to significantly more than the underlying abstract idea of “an idea of itself” (Alice).
Dependent Claims
Dependent claim(s) 2, 4-9, 11, 13-18, 20 and 22-27 include(s) all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein.
Although dependent claims 2, 4-9, 11, 13-18, 20 and 22-27 add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. Dependent claims 2, 4-9, 11, 13-18, 20 and 22-27 merely describe physical structures to implement the abstract idea. These information and physical characteristics do not change the fundamental analogy to the abstract idea grouping of certain method of organizing human interactions, and when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as independent claim(s) 1, 10 and 19.
Response to Arguments
Applicant’s arguments filed 6/5/2026 with respect to claims 1-2, 4-11, 13-20 and 22-27 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed 6/5/2026.
Applicant’s arguments filed on 6/5/2026 with respect to claims 1-2, 4-11, 13-20 and 22-27 have been fully considered but are moot in view of the new ground(s) of rejection.
Applicant argues that (A) the Applicant’s claimed invention is directed to statutory matter.
101 Responses
As per Applicant’s argument (A), Applicant’s remarks with regard to the statutory nature of Applicant’s claimed invention are addressed above in the Office Action.
Rehash
Applicant's remarks and arguments merely rehash issues addressed in the Office Action mailed 12/8/2025 and incorporated herein.
Applicant’s Amendments
Applicant amended claims recite “received from one or more manufacturing devices in real-time as the one or more manufacturing devices are manufacturing a batch of a pharmaceutical product,” “receiving a user command on a user device to automatically generate a batch report in real-time,” “performing one or more statistical analyses on the stored raw batch data in real- time as the one or more manufacturing devices are manufacturing the batch of the pharmaceutical product, wherein performing the one or more statistical analyses comprises identifying at least one outlier data value in the stored raw batch data,” “displaying a graphical user interface comprising the compiled batch report and a real-time alert associated with the at least one outlier data value on the user device.” These are information processing steps that are part of Applicant’s abstract idea and do not move Applicant’s invention into eligible subject matter. Applicant’s argument is not persuasive.
Data Processing Step
Applicant’s amended steps of “received from one or more manufacturing devices in real-time as the one or more manufacturing devices are manufacturing a batch of a pharmaceutical product,” “receiving a user command on a user device to automatically generate a batch report in real-time,” “performing one or more statistical analyses on the stored raw batch data in real- time as the one or more manufacturing devices are manufacturing the batch of the pharmaceutical product, wherein performing the one or more statistical analyses comprises identifying at least one outlier data value in the stored raw batch data,” “displaying a graphical user interface comprising the compiled batch report and a real-time alert associated with the at least one outlier data value on the user device,” are abstract computational steps that are part of Applicant’s abstract idea. (See MPEP 2106.04(a)(2)III.D. Examples of product claims reciting mental processes include:... • A wide-area real-time performance monitoring system for monitoring and assessing dynamic stability of an electric power grid – Electric Power Group, 830 F.3d at 1351 and n.1, 119 USPQ2d at 1740 and n.1...). Further, Applicant appears to be claiming generic computer implementation of a certain method of organsing human interaction. Therefore, Applicant’s argument is not persuasive.
Improvements – Advantageous over previous methods
The test for patent-eligible subject matter is not whether the claims are advantageous over previous methods (e.g. in previous systems, "an outlier value that was attributable to a manufacturing error may have been identified after the entire batch was produced, thus leading to the disposal of that batch, allowing the user to investigate and remedy the cause of outlier data values immediately as such values are identified). Even if Applicant’s claims provide advantages over manual collection of data, Applicant’s claims no technological improvement beyond improvement beyond the use of generic computer components/a generic computer network. Applicant’s argument is not persuasive.
Improvements
Despite recitation of processors, input devices, communication devices, output devices, memory storage, Applicant’s claims are, at bottom, directed to the collection, organization, grouping and storage of data using techniques such as information processing. The processors, input devices, communication devices, output devices, memory storage recited in Applicant’s claims are merely tools used for organizing human activity, and are not an improvement to computer technology. This, the claims do not present any specific improvement in computer capabilities. Applicant’s arguments are nothing more than conclusory statements unmoored from specific claim language. Applicant’s argument is not persuasive.
Applicant claims the improvement of “reducing waste of pharmaceutical products,” “conserving valuable production resources,” “users do not need to wait until the entire batch has been produced to identify and address any manufacturing issues,” etc. It has been held that it is not enough to merely improve a fundamental practices or abstract process by invoking a computer merely as a tool (Affinity Labs. of Texas, LLC v. DIRECTV, LLC, In re TLI Communications LLC Patent Litigation). In Intellectual Ventures I LLC v. Capital One Bank (USA), it was held that “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” was insufficient to render the claims patent eligible. In SAP America, Inc. v InvestPic, LLC it was held that patent directed to “selecting certain information, analyzing it using mathematical techniques, and reporting or displaying results,” are ineligible, and claims focused on an improvement in wholly abstract ideas are ineligible. Further, invocation of “already-available computers that are not themselves plausibly asserted to be in advance…amounts to a recitation of what is well-understood, routine, and conventional” (SAP America, Inc. v InvestPic, LLC). Accordingly, Applicant’s argument is not persuasive.
Step 2A, Prong 2, Abstract Idea Cannot Supply the Inventive Concept
Applicant’s reliance on “reducing waste of pharmaceutical products,” “conserving valuable production resources,” “users do not need to wait until the entire batch has been produced to identify and address any manufacturing issues,” etc. is misplaced because “the abstract idea itself cannot supply the invention concept, no matter how groundbreaking the advance” (Trading Technologies International, Inc. v IBG LLC). Thus, the claims do not integrate the recited abstract idea into a practical application. Accordingly, Applicant’s argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES P. COLEMAN whose telephone number is (571) 270-7788. The examiner can normally be reached on Monday through Thursday 7:30a-5:00p.
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/C. P. C./
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
