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 .
DETAILED ACTION
This action is in response to the papers filed on July 30, 2024. Claims 1-8 are currently under examination.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/KR2022/017488, filed November 8, 2022, which claims priority to Republic of Korea Application KR10-2022-0147345, filed on November 7, 2022, and Republic of Korea Application KR10-2021-0153238, filed on November 09, 2021, is acknowledged. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is November 09, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/30/2024 and 05/02/2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim objections
Claim 1 should be amended to recite: “A method for obtaining a non fungible token (NFT) cell based image, comprising:” in line 1. Additionally, abbreviations such as NFT should be spelled out at the first encounter in the claims for clarity.
Claim 1 should be amended to recite: “into the NFT image”, in line 6.
Claim 5 is objected to because of because of improper Markush language. A proper Markush-type claim recites alternatives in a format such as “selected from the group consisting of A, B and C.” See Ex parte Markush, 1925 C.D. 126 (Comm’r Pat. 1925).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 and 6-8 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claims 3 and 4 are indefinite in the recitation of the limitation “the step”, in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8 are indefinite in the recitation of “wherein in step”. The ordinary artisan would be unable to reasonably determine the metes and bounds of the claim because it is unclear what step is being referenced. Appropriate correction is required.
Claim 7 is further indefinite in the recitation of “wherein in step, the cell image is an image with sound added.” It is unclear how an image includes sound. The ordinary artisan would not be reasonably apprised of the scope of the invention because images are visual representations, not an audio producing form of data.
Claim Rejections - 35 USC § 103
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lian et al. (Nat Protoc. 2012 Dec 20;8(1):162–175.), in view of Zhou et al. (J Am Soc Nephrol. 2011 Jul;22(7):1221-8. Epub 2011 Jun 2.) and Gross et al. (JMIR Bioinform Biotechnol. 2021 Oct 22;2(1):e29905.).
Regarding claim 1, Lian teaches differentiating human pluripotent stem cells, including iPSCs, into functional cardiomyocytes under defined conditions by temporal modulation of WNT/β-cantein signaling, and further teaches acquiring images of the differentiated cardiomyocytes by immunostaining and microscopy, including expression of cardiac markers such as cTnT, α-actinin, and MLC2a (Abstract; pg. 172, Protocol A.; Table 2; Fig. 4). Lian does not expressly teach separating the starting cells from a biological sample or obtaining the iPSCs from urine-derived cells.
However, Zhou teaches collecting urine cells from urine samples and reprograming those urine cells into induced pluripotent stem cells using exogenous reprogramming factors including Oct4, Sox2, Klf4, and c-Myc, and further teaches that the resulting urinary iPSCs can differentiate into cardiomyocytes and neurons, along with acquiring images (Abstract; pg. 2081, Box 1; Fig. 2 and 3).
The combined teachings of Lian and Zhou do not expressly teach converting the image of the differentiated cell into an NFT image.
However, Gross teaches using blockchain and nonfungible tokens for biospecimens and derived human cellular and tissue-based products. Gross teaches the benefit of NFTs for maintaining provenance of inherently unique digital assets, provide transparency, engagement, accountability, and patient benefit, where NFTs can be used to track biospecimen use through blockchain and smart contracts (Abstract; pg. 2, column 1, para. 1-2; pg. 3, Section: Technological Solutions with Blockchain Technology and NFTs; pg. 4, last para.). Before the effective filing date of the instant application, one of ordinary skill in the art would have been motivated to apply the known NFT/blockchain technique of Gross to the known differentiated-cell imaging methods of Lian and Zhou to yield the predictable result of creating a blockchain/NFT traceable digital asset corresponding to a unique biological cellular image, thereby enhancing provenance, privacy, transparency, engagement, efficiency, and accountability, as taught by Gross.
Regarding claim 2, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Additionally, Zhou teaches the urine biological sample and a method for generating human iPSCs from renal tubular cells present in urine (Abstract; pg. 2080, column 2, last para.).
Regarding claim 3, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Zhou further teaches collecting and culturing urine cells and describes processing urine cells for iPSC generation, including culture, passaging, trypsinization, and seeding of urine cells before reprograming (pg. 2081, Box 1). The ordinary artisan would have found it obvious to perform routine centrifugation, supernatant removal, and resuspension steps when isolating cells from a liquid biological sample such as urine because such steps are standard and predictable sample-preparation techniques for concentrating cells from suspension (pg. 2084-2085, Procedure, Steps 1-32).
Regarding claim 4, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Zhou teaches culturing urine cells and seeding cells on gelatin and Matrigel coated plates for reprograming and mesenchymal cell media (pg. 2081, column 1, para 3.; pg. 2083, column 2, last section; pg. 2084-2086, Procedure; Fig. 3). Lian additionally teaches culturing pluripotent stem cells on coated culture substrates, including Matrigel and gelatin-coated coverslips and plates, and use of defined stem-cell and differentiation media (pg. 163, column 2, para. 2-3; Fig. 1-2).
Regarding claim 5, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Moreover, Zhou teaches reprogramming urine cells using the Sox2 transcription factor (pg. 2082, Box 1; Fig. 2).
Regarding claim 6, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Additionally, Lian teaches acquiring images of differentiated cells using phase contrast, bright-field morphology, immunofluorescence staining, and microscopy to characterize cardiomyocyte differentiation (pg. 165, Section: Equipment; Fig. 1 and 3).
Regarding claim 7, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Lian teaches that differentiated cardiomyocytes exhibit spontaneous beating and contractile motion. Lian teaches the observation of beating cluster of cells. (pg. 164, column 2, para. 1; pg. 170, step (B)(.iv); pg. 174, last para.). Gross teaches tokenization of biospecimens and related biological information as NFTs or digital assets associated with biospecimens, cellular products, and related clinical data.
The ordinary artisan would have found it obvious to include sound with the cell image because sound is a known representation of mechanical vibration or motion, and combing audio and image data with an NFT was a routine and predictable multimedia implementation prior to the effective filing date of the instant application. Before the effective filing date of the instant application, the ordinary artisan would have found it obvious to apply the known NFT multimedia technique, as taught by Gross, including association of biospecimen-related digital assets with blockchain-based NFT records, to the known method of imaging and observing differentiated cardiomyocytes taught by Lian, which exhibit beating and contractile motion, ready for improvement to yield the predictable result of representing additional characteristics of the differentiated cells, including motion or vibration related information, through both visual and audio media within a single NFT based digital asset.
Regarding claim 8, the combined teachings of Lian, Zhou, and Gross render claim 1 obvious. Additionally, Gross teaches using NFTs and blockchain to maintain provenance of biospecimens, tissue, cellular products, and associated clinical data. The ordinary artisan would have found it obvious to combine the cell image with other digital content or metadata in the NFT because Gross teaches associating biospecimen-derived assets with blockchain based provenance and related data to improve transparency, accountability, and patient engagement.
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 1-8 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception, an abstract idea or mental processes, without significantly more.
Specifically, independent claim 1 recites a method comprising the steps of: separating a cell from a biological sample; obtaining a stem cell by treating the cell with a dedifferentiation inducer; differentiating the stem cell; acquiring an image of the differentiated cell; and converting the image of the differentiated cell into an NFT image. The claim is directed to collecting biological image information and converting the information into a blockchain-associated ownership or authentication asset. The “converting” step constitutes an abstract idea because it amounts to mathematically organizing, labeling, storing, authenticating, and commercializing digital information using conventional NFT concepts.
The judicial exceptions are not integrated into a practical application because the additional claim elements merely employ routine and conventional laboratory techniques and generic digital asset concepts to gather and manipulate information. Specifically, the steps of separating cells from a biological sample, culturing cells, generating induced pluripotent stem cels, differentiating stem cells, imaging differentiated cells, and associating the image with NFT ownership information merely generate data that is later subjected to the abstract NFT conversion step. These activities do not impose meaningful limits on the abstract idea itself.
The specification confirms that the recited biological and processing techniques were well-understood and conventional. The specification describes the use of known urine-derived cells, known stem-cell reprograming techniques using factors such as Oct3/4, Sox2, Klf4, L-Myc, and Lin28a, known microscopy imaging techniques, and known NFT concepts involving ownership and blockchain-based digital assets. The specification further defines that NFTs are used for digital ownership, authentication, profile images, avatars, metaverse interactions, and commercialization of digital content ([0003-0008]; [0016]; [0035-0039]; [0041-0060]).
The claims do not recite any technical improvement to stem-cell biology, cell differentiation, microscopy imaging, block chain architecture, NFT minting technology, cryptographic processing, image processing, or computer functionality. Rather, the claims merely apply known NFT concepts to conventional biological image data. The claims also fail to recite any particular blockchain implementation, cryptographic protocol, or technical mechanism for creating the “NFT image”. There is no further step of applying the NFT determination in a technologically meaningful manner, such as improving blockchain operation, improving data storage, digital security, or biological imaging systems. Simply implementing the abstract idea of associating ownership or authenticity metadata with biological images using generic NFT concepts does not constitute a practical application of the abstract idea. The recited biological preparation steps constitute insignificant extra-solution activities because they merely gather biological information to be used in the abstract NFT conversion step. The claims do not recite any transformation of the biological material into a therapeutic product, treatment step, or any technological improvement arising from the NFT conversion process itself.
Enumerated groups of abstract ideas include certain methods of mental processes, mathematical concepts, classification, and information organization, see MPEP 2106.04(a) and 2106.04(a)(2). Limitations that the courts have found not to be enough to quality as 'significantly more' include: Simply appending well-understood, routine, conventional activities, known in the industry, specified at a high level of generality, to the judicial exception, as discussed in Alice Corp., 134 S. Ct. at 2359-60, 110 USPQ2d at 1984; and adding insignificant extra solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea ... so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (MPEP 2106.05 (l)(A)).
Before the effective filing date of the instant application, stem-cell culturing, induced pluripotent stem-cell generation, stem-cell differentiation, microscopy imaging, and NFT tokenization of digital media were well-understood, routine, and conventional activities engaged in by those skilled in the art. The mere physical nature of obtaining and imaging cells does not automatically confer eligibility upon a claim directed to an abstract idea. The claims do not recite any specific technological implementation for NFT conversion, nor do they improve any computer technology or biological technology.
With regard to Step 2A, prong one, the claims are directed to collecting biological image formation, evaluating or associating the information with ownership/authentication metadata, and creating a digital asset representation. These activities constitute abstract information processing and commercial interaction concepts. With regard to Step 2A, prong two, the judicial exception is not integrated into a practical application because the imaging steps merely constitute conventional data-gathering activity, and the NFT conversion step merely labels or associates information with ownership metadata. The claims do not recite any technological improvement to blockchain systems, NFT architectures, imaging processing systems, or biological imaging technique data conversion implementation, see MPEP 2106.05(f).
With regard to Step B, the claims do not include additional elements sufficient to amount the significantly more than the judicial exception. The techniques of isolating urine-derived cells, reprograming cells into induced pluripotent stem cells, differentiating stem cells, microscopy imaging, and associating digital images with NFTs were standard practices in stem-cell biology and blockchain-based digital asset management. The dependent claims similarly fail to recite significantly more than the abstract idea itself. Claim 2 merely specifies urine or oral tissue as biological sources. Claim 3 recites routine centrifugation and cell sediment processing steps. Claim 4 recites conventional culture dishes and media replacement. Claim 5 recites known reprogramming factors. Claim 6 recites standard microscopy techniques. Claim 7 recites adding sound to digital media. Claim 8 recites combining digital content with images. These limitations merely represent routine optimization and conventional digital-media manipulation techniques.
Therefore, the claimed subject matter, as individual elements and as a combination of elements, does not recite 'significantly more' than the judicial exception. The claimed subject matter does not recite patent eligible subject matter under 35 USC § 101.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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