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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/27/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of species: the destruction mode of a cell, lysing agent, NK-92 cell, component specific to cell death, an immunoassay and a chemical moiety in the reply filed on 10/17/2022 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/17/2022.
Claims 1-4, 6-11, 15-19 and 21 are under consideration in the instant Office Action.
Withdrawn Rejections
The rejection of claims 1-11 and 14-22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is moot since the claims have been canceled or amended.
The rejection of claim 20 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, is moot since the claim has been canceled.
The rejection of claims 1-11 and 14-22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the newly amended claims.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3, 8 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Dependent claim 3, depending from claim 1, requires only an agent while independent claim 1 calls for closed group of agents. Therefore, claim 3 broadens the scope and fails to further limit the claims. Dependent claim 8 suffers from the same issue since depends from claim 1 with a closed group for an indicator and claim 8 requires an open group for the indicator and actually broadens the scope of the claims. Claim 19, which depends from claim 1, also broadens the scope rather than narrow by requiring an electrical or magnetic characteristic that is not set forth in the independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejection Necessitated by Amendment
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 1-4, 6-11, 15-19 and 21 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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-4, 6-11, 15-19 and 21 are directed towards a computer assisted method of tracking a biological assay (i.e. a process) which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claim 1 is determined to be directed to an abstract idea because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas without significantly more. The abstract idea recited in independent claim 1 is identified in bold as:
A computer assisted method of tracking a biological assay from sample being run through assay, wherein the assay generates a value, that value is transmitted to a processor and implemented via a digital distributed ledger, and thereby validating the assay, the method comprising:
running a biological sample on an assay;
obtaining, via at least one processor, first identifying digital data for the biological sample, wherein the identifying digital data is subjected to a sample tracking protocol to produce a sample tracking chain data structure stored in at least one computer memory, wherein the sample tracking chain data structure is indexed and reported as digital data;
providing the results from the cell sample assay to a cell user and cell owner via values and a code wherein the verification code comprises a blockchain portion;
wherein the validation is subjected to the sample tracking protocol and thereby added, via the at least one processor, to the sample tracking chain data structure; and
thereby validating the result do an assay, via at least one processor, to the sample tracking chain data structure, wherein the sample tracking chain structure is indexed and confirms the cell destruction.
The identified abstract idea falls within the subject matter grouping of certain methods of organizing human activity and the sub-grouping of managing personal behavior or relationships or interactions between people. The claims recite a method which organizes the human activity of tracking a biological sample, searching ledgers and validating an assay process and, delivering a validated value to an indexed data that shows that the process has been performed via processor and distributed ledger technology. The claims organize the steps lab workers required to perform in order to obtain and determine an action had been successfully performed, which is method of managing personal behavior. For example, similar to In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982), the claims recite a process that a lab technician should follow in order to prove that the destruction of cells has been produced. Accordingly, the claims recite an abstract idea. Additionally, the indexing, searching and validating can also be considered an abstract idea which falls within the subject matter grouping of mental processes as a human with the aid of pen and paper can index data, search data and validate data. Data gathering steps required to perform a mental process, to arrive at a determination of whether the assay was successful in destroying cells, do not add a meaningful limitation as they are insignificant extra-solution activity. Further, the remaining claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims recite a method of cell destruction and have the results recorded and reported by a system (a computer). It is well established that the mere physical or tangible nature of additional elements, such as the obtaining and detecting of steps, does not automatically confer eligibility on a claim directed to a natural phenomenon, here an abstract idea [see, e.g., Alice Corp v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59 (2014)]. There are no additional elements in the combination of elements in the claimed invention that add other meaningful limitations not already present when the elements are considered separately. The method for cell destruction assay and recording and reporting the results based on the measured one or more parameters is recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the abstract idea itself. The courts have found that arranging a hierarchy of groups is to be well-understood, routine, conventional activity when they are claimed at a high level of generality Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1331, 115 USPQ2d 1681, 1699 (Fed. Cir. 2015) (see MPEP 2106.05(d)). Therefore, the step does not relate to the abstract idea in a significant way to impose a meaningful limit on the scope. For all of these reasons, the claims recite the judicial exceptions of an abstract idea.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular assay; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Conversely, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use. These elements are insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below. The additional elements of independent claim 1 are identified as:
A computer assisted (processor) method to assist in tracking the assay (cell destruction assay) where it matches the method of running a medium with dead cells through a system that comprises the assay and processor (computer), wherein the running of an assay generates a value and code to indicate the assay has been run (obtaining, via at least one processor), first identifying digital data for the biological sample, wherein the identifying digital data is subjected to a digital recognition algorithm protocol to produce a sample tracking chain data structure, via a digital distributed ledger (computer memory), wherein the sample tracking chain data structure is indexed and reported as digital data; providing the results from the cell sample assay to a cell user and cell owner via values and a code wherein the verification code comprises a blockchain portion (as instant claims 1, 7-9, 11, 14, 16-18); and thereby validating the result of an assay, via at least one processor, to the sample tracking chain data structure, wherein the sample tracking chain structure is indexed as in instant claims 1,11, 14-22 where the results of the data from the biological sample is tracked and added to the data structure to produce a report.
The computer assisted method, computer memory configured to store data structures, the distributed ledger and the at least one processor configured to obtain data, add data and validate data are considered to be mere instructions to apply an exception under 2106.05(f). The processors, memory and distributed ledger are recited at a high level of generality and used in its ordinary capacity (i.e. processing data and storing data).
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the computer memory configured to store data structures, distributed ledger and the at least one processor configured to obtain data, add data and validate data are considered to be mere instructions to apply an exception under 2106.05(f) and insufficient to amount to significantly more than the judicial exception. The instant claims require the destruction of cells and the observation and reporting of that destruction but does not go beyond mere data gathering. The process of cell destruction and the methods of observed cell destruction that encompass cell apoptosis is well-known in the art as evidenced by Kepp et al., 2011 (9/18/2024 PTO-892), Ramirez et al., 2010 (9/18/2024 PTO-892) and Cate et al., 2015 (9/18/2024 PTO-892). Thus the claims are not patent eligible.
Dependent Claims Steps 2A-2B:
Dependent claims 2-11, 15-22 add additional limitations, but these only serve to further limit the abstract idea, and are therefore also directed towards fundamentally the same abstract idea as independent claim 1, do not integrate the abstract idea into a particular application and/or do not amount to an inventive concept or significantly more. The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. Dependent claims 2 claims 2-11, 15-22 merely discuss what the additives are and what the identifying data is, which is encompassed by the abstract idea. Dependent claims 2-11, 15-22 recite additional abstract human activity steps used for validation of the cell destruction. Furthermore, the distributed network are considered to be mere instructions to apply an exception under 2106.05(f) and insufficient to amount to significantly more than the judicial exception as they are recited at a high level of generality. The instant claims require the destruction of cells and the observation and reporting of that destruction but does not go beyond mere data gathering. The process of cell destruction and the methods of observed cell destruction that encompass cell apoptosis is well-known in the prior art as evidenced by Kepp et al., 2011 (9/18/2024 PTO-892), Ramirez et al., 2010 (9/18/2024 PTO-892) and Cate et al., 2015 (i9/18/2024 PTO-892). Kepp teaches that there are many signals that can be monitored to detect apoptotic cell death, for example see their Figure 1, and teaches that there are many cell death assays to choose from, see page 223. Ramirez teaches different cell assays for viability and teach the use of flow cytometry as method of monitoring or determining cell viability (see pages 224-225). Cate teaches microfluidic assays that include lateral flow immunoassay (see abstract). Cate teaches that these lateral flow assays are used for detection of different assays and using electrochemical sensing and QR codes to gather and store pertinent information about the assay (see page 36, 1st column). Cate also teaches the use of smartphone and cloud-computing for a quantitative readout (see bottom of page 34). Further, the fact that the instant claims are towards a method of automating a human activity via generic tools using a computer does not add anything that would be considered significantly more than an abstract idea and that the steps called for in the instant methods are data gathering steps. Therefore, these claims merely encompass the abstract idea identified above, do not integrate the claims into a practical application using well known assay and methods in the art to gather data and do not amount to significantly more.
Furthermore, 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 amounts to an inventive concept.
Therefore, whether taken individually or as an ordered combination, 1-11 and 14-22 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 5/27/2025 have been fully considered but they are not persuasive. Applicant argues that the instantly claimed method which now recites a physical assay for destroying cells is an active step and no longer reads on an abstract idea. This is not found persuasive because the instant claims are all towards a method of observing and reporting the outcome of a process. The fact that one has to induce cell death in the assay that is required to be performed as now required in amended claims is not found persuasive because the assay steps, under the broadest reasonable interpretation of the claims reads on data gathering. The assay is a routine and conventional assay that is well known in the prior art and therefore, is just a way of obtaining data to observe and report. All of the claim limitations are routine and conventional in the art and do not add anything transformative beyond a mental step of observation and reporting via a generic computer process.
Applicant argues that the instant claims are analogues to the 2018: Eligibility Quick Reference sheet (part I) example that involves claims directed to the methods of detecting JUL-1 in a patient. This refers to the Example 29, Diagnosing and Treating Julitis, Claim 1 in the Subject Matter Eligibility Examples: Life Sciences provide on May 2016. The Julitis claim 1, is eligible (under 101) because it is for a method of detecting JUL-1 in a patient and does not require a diagnosis (the judicial exception which would be a natural correlation). The Julitis Claim 2 failed as an eligible claim because it is directed to diagnosing an abnormal condition by performing clinical tests and thinking about the results and therefore is directed to a judicial exception of a the use of a natural correlation. The analysis of this example claim also teaches that it failed to provide anything in their limitations or the combination of their limitations to ensure the claim amount to significantly more than the exception. The analysis concluded that the active steps of the claim were routine and conventional. Consideration of the additional elements (specifically recited genes) as a combination adds no other meaningful limitations to the exception not already present when the elements are considered separately. The Julitis Claims 3 and 4 are towards a method of diagnosis and are found 101 eligible due to the fact that the antibodies used to perform the method of detection were not routine and conventional in the art to detect the protein in humans. The instant claims are rejected under the 101 abstract idea while the JUL-1 example is an analysis of a potential 101 natural correlation rejection (diagnosis). The considerations are not the same since an abstract idea, as already set forth above, is nothing more than the routine and conventional data gathering steps and making observations and determinations. The newly amended claim 1 is still an abstract idea since all the limitations are recited at a high level of generality and vagueness. It is unclear what is the significant improvement of the technology as argued by the applicant since their claims are vague and broad without an specific indication of what is the improvement, beyond using some “test device” with a computer. Even the new limitation of “test device” does not help the instant claims since there is no clear metes and bounds for what is encompassed by this device and no clear definitions or guidance in the instant specification to help clarify these matters.
Applicant argues that conventional methods of verifying destruction of cells do not include a way to show that cells are actually destroyed or even mixed with an agent to kill the cells. This is not found persuasive because the method still reads on making observations from a performed method and documenting these observations through a computer which still read on an abstract idea. The identified abstract idea falls within the subject matter grouping of certain methods of organizing human activity and the sub-grouping of managing personal behavior or relationships or interactions between people. The claims recite a method which organizes the human activity of tracking a biological sample, searching ledgers and validating an assay process and, delivering a validated value to an indexed data that shows that the process has been performed via processor and distributed ledger technology.
Therefore, the arguments are not found persuasive and the 101 rejection is maintained over the reasons set forth above.
Conclusion
No claims are allowed.
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/AURORA M FONTAINHAS/ Primary Examiner, Art Unit 1675
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