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 .
The following is a non-final, first office action on the merits, in response to application filed 11/10/2023. Claims 1-11 have been examined and are currently pending.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on application filed in Japan (JP) on 5/13/2021, and the instant application is a cont. of PCT/JP2022/012559, filed 3/18/2022.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Response to Amendment
The amendment filed on 11/10/2023 cancelled no claim. No claim was previously cancelled. No new claims are added. Claim 11 has been amended. Claims 1-11 are considered and pending.
Specification
Modifications made to the title and [0001], [0076], [0085] in original disclosure are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/23/2024, 11/27/2024, 7/1/2025, 3/6/2026 follows the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 therefore, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Alice Corp. also establishes that the same analysis should be used for all categories of claims, regardless of a system/apparatus, a method, or a product claim.
The claimed invention (Claims 1-11) is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) abstract ideas including “Certain Methods of Organizing Human Activity”, “an idea “of itself”, which have been identified/found by the courts as abstract ideas in new 101 memos of the subject matter eligibility in here (https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility) including 2019 Revised Patent Subject Matter Eligibility Guidance. This judicial exception is not integrated into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because it/they is/are recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications:
Independent claim 1 (Step 2A, Prong I): is directed to multiple abstract ideas including “Certain Methods of Organizing Human Activity”, and “Mental process”.
Claim 1, Steps of,
acquiring time-series data that indicates, in chronological order, a plurality of metabolite data and a culture parameter, the plurality of metabolite data each corresponding to a respective amount of a plurality of metabolites generated by culturing a cell line for producing the antibody, the culture parameter being detected from the cell line in culture;
acquiring a degree of relevance between the culture parameter and each of the plurality of metabolites on the basis of the time-series data; and
generating display data based on the degree of relevance.
fall within “Certain Methods of Organizing Human Activity” grouping of abstract idea because these steps recite “acquiring/receiving data, generating /displaying data”, which are human activities and/or interactions between users/people/devices and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer.
In addition, claim 1, steps mentioned above also falls within the abstract “Mental Processes” grouping of abstract ideas since these limitation covers performance of the limitations in the mind, or by paper and pencil. For example, a human being can observe/receive/acquire information, can observe/generate/display/output/information.
Further, steps of (“acquiring”) are considered as “insignificant extra-solution activity” to the judicial exception since they are merely receiving/collecting/providing data.
Independent claim 1, Step 2A (Prong II): Accordingly, the claim recites an abstract idea(s) as pointed out above. This judicial exception(s) is/are not integrated into a practical application. In particular, the claim recites no additional elements that are significant more than the abstract ideas. There is no hardware or machine which performs the steps. Thus, nothing in the claim element precludes the step from practically being performed in the mind and is simply organized information through human activity or merely mental tasks, and is part of, or a related, judicial exception and does not meaningfully limit the application of the identified judicial exception, and as such does not constitute significantly more.
There is no specificity regarding any technology, just broadly, execute the programming instructions to receive/collect data, generate/display data. The steps are mainly receiving/inputting data, generating data. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, there is neither improvement to another technology or technical field nor improvement to the functioning of the computer itself and does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Independent claim 1, (step 2B):
There are no additional elements recited or recited at a high level of generality, and add nothing of substance to the underlying abstract idea; thus, they are not significantly more than the identified abstract idea. This component is merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic scanner/sensor/computer components recited as performing generic sensing/computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic computer components to receive/send/transmit information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
Dependent claims 2-10, merely add further details of the abstract steps/elements recited in claim 1, without including an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Therefore, dependent claims 2-10 are also non-statutory subject matter.
Independent claim 11: Alice Corp. also establishes that the same analysis should be used for all categories of claims. Therefore, independent product claim 11, are also rejected as ineligible subject matter under 35 U.S.C. 101 for substantially the same reasons as the method claim(s) 1.
Further, the components (i.e., a computer, a recording medium) described in independent claims 11, add nothing of substance to the underlying abstract idea. Similarly, as relates to the computer product claim, the limitations appear to be performed by a generic computing system/device. These components are merely recited at a high level of generality and/or are recited as performing generic computer functions routinely used in the computer applications; thus, they are not significantly more than the identified abstract idea. Generic computer components recited as performing generic sensing/computer functions that are well-understood, routine and convention activities amount to no more than implementing the abstract idea with a computerized system. The use of generic encoder/decoder/computer components to receive/collect/generate/display information over communication network/internet does not impose any meaningful limit on the computer implementation of the abstract idea. At best, the claim(s) are merely providing an environment to implement the abstract idea. (see analysis in claim 1).
According to MPEP 2106.05 (d), elements that the Courts have recognized as well-understood, routine, conventional activity in particular fields are e.g., "Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward
information); Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93” (evidence required by Berkeimer memo). Further, according to Berkheimer memo 04/19/2018, section III.A.1, “A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)”.
Applicant’s Specification, [0020] indicates a general-purpose computer performs the instant steps and demonstrates the well-understood, routine, conventional nature of the information processing device (a processor/a memory/a computer) in any computing implementation. Thus, evidence has been provided to show these additional elements are well-understood, routine, conventional activity according to Berkheimer memo. Therefore, for the above-mentioned reasons, viewed as a whole, even in combination, the above steps do not amount to significantly more/do not provide an inventive concept.
Viewed as a whole, the claims (1-11) do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
Thus, the claims do NOT recite limitations that are “significantly more” than the abstract idea because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of the computer itself, or meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment.
Thus, the claimed invention does not provide 'significantly more' than the abstract idea and is non-statutory subject matter.
Prior Art Rejection
Amended Independent claims 1, 11, recite a combination of limitations that has Not been found as define over prior art of record (the combination of
SCHAUB JOCHEN (WO-2010136515-A1), Shibuya et al. (US 2021/0189452), Namatame et al. (US 2015/0329817), Pla et al. (US 2012/0077213), Pla et al. (US 2014/0234905), Goudar et al. (US 2012/0088679), PLA ITZCOATL A (WO-2008033517-A2), Wu et al. (US 2007/0190057), Corper et al. (US 2015/0307594), Kjaergaard et al. (US 2009/0182127),
and
NPL1--Powers DN, Trunfio N, Velugula-Yellela SR, Angart P, Faustino A, Agarabi C. Multivariate data analysis of growth medium trends affecting antibody glycosylation. Biotechnol Prog. 2020 Jan;36(1):e2903. doi: 10.1002/btpr.2903. Epub 2019 Oct 18. PMID: 31487120; PMCID: PMC7027499. (Year: 2019)
NPL2--Schwedhelm I, Zdzieblo D, Appelt-Menzel A, Berger C, Schmitz T, Schuldt B, Franke A, Müller FJ, Pless O, Schwarz T, Wiedemann P, Walles H, Hansmann J. Automated real-time monitoring of human pluripotent stem cell aggregation in stirred tank reactors. Sci Rep. 2019 Aug 23;9(1):12297. doi: 10.1038/s41598-019-48814-w. NPL3--Erratum in: Sci Rep. 2024 Apr 2;14(1):7773. doi: 10.1038/s41598-024-57467-3. PMID: 31444389; PMCID: PMC6707254.
NPL3--X. Yue et al., "A Real-Time Multi-Channel Monitoring System for Stem Cell Culture Process," in IEEE Transactions on Biomedical Circuits and Systems, vol. 2, no. 2, pp. 66-77, June 2008, doi: 10.1109/TBCAS.2008.925639. (Year: 2008)
All the above fail to teach all the required claimed features as in amended independent claim 1, 11.
Allowable Subject Matter
Claims 1-11 are deemed to be allowed considering the specification, amendments filed on 11/10/2023. As to the prior art rejections, upon further search and consideration, it is found that claims 1-11 are allowable subject to outstanding 101 rejections.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with, and pending remedy to outstanding issues cited above. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
• Corper et al. (US 2015/0307594, teaches the screening of the antibody variants for binding to Her2 or TF antigen targets occurred in two steps: an indirect capture of the antibody variants onto the anti-human Fc antibody surface in the ligand direction followed by the simultaneous injection of 5 concentrations of purified antigen and one buffer blank for double referencing in the analyte direction),
• Kjaergaard et al. (US 2009/0182127, describes the generation of bi-specific antibodies by modifying amino acid residues at the Fc interface and at the CH1:CL interface of light-heavy chain pairs that reduce the ability of the light chain of one pair to interact with the heavy chain of the other pair).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN M LI whose telephone number is (571)270-5489. The examiner can normally be reached on Mon-Thurs, 8:30am--5pm. Fax is 571-270-6489.
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/SUN M LI/Primary Examiner, Art Unit 3685
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