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 .
Status of the Claims
Claims 1-2 and 4-13 are currently pending. Claim 3 is canceled in the Claims filed on April 15, 2026.
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 1-2 and 4-13 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.
Step 1
Claims 1-2 and 4-13 are within the four statutory categories. Claims 1-2 and 4-13 are drawn to a “cell therapy suite,” which, for the purposes of examination is interpreted as a system for cell therapy, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: A cell therapy suite comprising:
one or more processors configured to:
receive information comprising a library of cell therapy protocols for a plurality of combinations of patient indications and genes of interest (GOI);
receive a request for treating a patient with cell therapy based on a combination of the patient's indication and GOI; and
in response to receiving the request for treating a patient with cell therapy, have the cell-processing device perform a step of a respective cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI so that cells are treated with the GOI.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of receiving cell therapy protocols, receiving a request for treating a patient with cell therapy, and performing a step of a cell therapy recite at least following rules or instructions to treat a patient), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2 and 4-13 include other limitations, for example Claim 2 recites a source for the received information, Claim 4 recites that the information includes operating conditions for the device, Claim 5 recites that the request includes operating conditions, Claim 6 recites evaluating the patient’s RNA carrying the GOI, Claim 7 recites a type of RNA, Claim 8 recites receiving modifications to the library of cell therapy protocols, Claim 9 recites types of cell therapy suites, Claim 10 recites an RNA production unit that loads GOIs onto an RNA vehicle, Claim 11 recites receiving a patient’s GOI and loading the identified GOI onto the RNA vehicle, or transmitting the GOI information to a remote server, Claim 12 recites a sequencer to identify the patient’s GOI, and Claim 13 recite an apheresis device, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2 and 4-13 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Hence Claims 1-2 and 4-13 are directed towards the aforementioned abstract idea.
Prong 2 of Step 2A
Claim 1 is not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the one or more processors and the cell-processing device itself) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the one or more processors and the cell-processing device, which amounts to merely invoking a computer or other machinery as a tool to perform the abstract idea, e.g. see [0098] of the as-filed Specification, and see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language of the therapy being a cell therapy, and the recitation of the cell-processing device, which amounts to limiting the abstract idea to the field of healthcare, e.g. see MPEP 2106.05(h).
Additionally, dependent Claims 2 and 4-13 include other limitations, but these limitations also amount to no more than mere instructions to apply an exception (e.g. the types of devices recited in dependent Claims 2 and 10-13), generally linking the abstract idea to a particular technological environment or field of use (e.g. the type of data being processed comprising RNA data recited in dependent Claims 6-7, the type of clean room recited in dependent Claim 9), and/or do not include any additional elements beyond those already recited in independent Claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-2 and 4-13 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the one or more processors and the cell-processing device itself), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally linking the abstract idea to a particular technological environment or field of use, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0098] of the as-filed Specification discloses that the additional elements (i.e. the one or more processors) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the additional elements merely recite the creating and maintaining of a library of cell therapy protocols and associated patient indications and GOI;
Immunizing a patient against a disease, e.g. see Classen Immunotherapies, Inc. v. Biogen IDEC – similarly, the additional elements recite a cell therapy for the patient without specifying a particular treatment, a particular condition. and/or without specifying particularities that are required of the administration;
Dependent Claims 2 and 4-13 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the types of devices recited in dependent Claims 2 and 10-13), generally linking the abstract idea to a particular technological environment or field of use (e.g. the type of data being processed comprising RNA data recited in dependent Claims 6-7, the type of clean room recited in dependent Claim 9), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claim 1, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-2 and 4-13 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-2 and 4-13 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-2, 4-5, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zien (US 2015/0370982) in view of Banna (US 2022/0125656).
Regarding Claim 1, Zien teaches the following: A cell therapy suite comprising:
one or more processors (The system includes a processing unit, e.g. see Zien [0062].) configured to:
receive information comprising a library of cell therapy protocols for a plurality of combinations of patient indications and genes of interest (GOI) (The system retrieves data including identifications of diseases indications of patients, sets of genes or proteins, and molecular profiles of patients and targeted treatments, together with associated target proteins and/or corresponding genes, e.g. see Zien [0062]-[0066].);
receive a request for treating a patient with cell therapy based on a combination of the patient's indication and GOI (The system receives a selection of a treatment (i.e. a request for treating) for a patient, wherein the treatment corresponds to associated target proteins and/or genes and a disease indication of a patient, e.g. see Zien [0067].); and
in response to receiving the request for treating a patient with cell therapy, perform a step of a respective cell therapy protocol from the library of cell therapy protocols that corresponds to the combination of the patient's indication and GOI (The system includes a step of administering the selected treatment to the patient, e.g. see Zien [0012].).
But Zien does not teach and Banna teaches the following:
the cell therapy suite further comprising a cell-processing device (The system includes a cell and/or gene therapy (CGT) medicine manufacturing system (i.e. a cell therapy suite) including at least one CGT manufacturing unit (CMU) (i.e. a cell-processing device), e.g. see Banna [0030], [0035], and [0037], Figs. 1-2, wherein the CMU further comprises a genetic engineering unit (GEU) that extracts cells and/or genes from the patient’s blood and genetically engineers (i.e. processes) the cells and/or genes, e.g. see Banna [0041].);
wherein the cell-processing device performs the step of the respective cell therapy protocol so that cells are treated with the GOI (The GEU performs various processes on the cells and/or genes, e.g. see Banna [0035]-[0041], wherein the GEU may also administer (i.e. perform) treatment (i.e. a cell therapy protocol) to the patient, e.g. see Banna [0041] and [0049]-[0050].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to incorporate the CGT medicine manufacturing system and administering the treatment to the patient from the CGT medicine manufacturing system as taught by Banna in order to enable better control of the process, and/or to expedite process time and/or maximize manufactured cells, e.g. see Banna [0043].
Regarding Claim 2, the combination of Zien and Banna teaches the limitations of Claim 1, and Banna further teaches the following:
The cell therapy suite of claim 1, wherein the received information is from a remote server location outside of the suite (The CGT medicine manufacturing system includes a user interface that enables a user to submit data for customizing a treatment process per patient (i.e. a library of cell therapy protocols), wherein the user interface may communicate with the CGT medicine manufacturing system via the remote server, e.g. see Banna [0036], wherein the system includes a plurality of GEUs to genetically engineer a plurality of different types of cells, e.g. see Banna [0041].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to retrieve data from a remote database as taught by Banna in order to enable the physician to customize the medical treatments and maximize the treatments’ effectiveness, e.g. see Banna [0036] and [0050].
Regarding Claim 4, the combination of Zien and Banna teaches the limitations of Claim 1, and Banna further teaches the following:
The cell therapy suite of claim 1, wherein the information comprising the library of cell therapy protocols comprises a plurality of operating conditions for the cell-processing device for the plurality of combinations of patient indications and GOIs (The system enables a user to customize the treatments and/or change the CGT medicine manufacturing process and/or type, e.g. see Banna [0036].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to enable the user to make changes to the CGT medicine manufacturing process and/or type as taught by Banna in order to enable the physician to customize the medical treatments and maximize the treatments’ effectiveness, e.g. see Banna [0036] and [0050].
Regarding Claim 5, the combination of Zien and Banna teaches the limitations of Claim 4, and Banna further teaches the following:
The cell therapy suite of claim 4, wherein receiving a request for treating a patient with cell therapy based on a combination of the patient's indication and GOI comprises receiving a request for an operating condition of the cell-processing device based on a combination of the patient's indication and GOI (The physician may customize the CGT medicine manufacturing process and/or type considering parameters such as the changing physical condition of the patient (i.e. the patient’s indication and GOI), e.g. see Banna [0036], wherein each patient who is undergoing CGT medicine process is unique in terms of genetics and physical condition, e.g. see Banna [0033].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to enable the user to make changes to the CGT medicine manufacturing process and/or type based on the unique patient data as taught by Banna in order to enable the physician to customize the medical treatments and maximize the treatments’ effectiveness, e.g. see Banna [0036] and [0050].
Regarding Claim 8, the combination of Zien and Banna teaches the limitations of Claim 1, and Banna further teaches the following:
The cell therapy suite of claim 1, wherein the one or more processors are configured to receive modifications to the library of cell therapy protocols for a plurality of combinations of patient indications and GOIs (The system enables a user to customize the treatments and/or change the CGT medicine manufacturing process and/or type, e.g. see Banna [0036].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to enable the user to make changes to the CGT medicine manufacturing process and/or type based on the unique patient data as taught by Banna in order to enable the physician to customize the medical treatments and maximize the treatments’ effectiveness, e.g. see Banna [0036] and [0050].
Regarding Claim 12, the combination of Zien and Banna teaches the limitations of Claim 1, and Zien further teaches the following:
The cell therapy suite of claim 1, further comprising a sequencer to identify the patient's GOI (The system receives a molecular profile of a patient, e.g. see Zien [0062], wherein the molecular profile includes expression levels of genes measured by next generation sequencing, e.g. see Zien [0059].).
Claims 6-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zien and Banna in view of Ko (US 2021/0381005).
Regarding Claim 6, the combination of Zien and Banna teaches the limitations of Claim 5, but does not teach and Ko teaches the following:
The cell therapy suite of claim 5, wherein in response to receiving the request for the operating condition, the one or more processors are configured to process cells of the patient with RNA carrying the GOI in the cell-processing device according to a respective operating condition that corresponds to the combination of the patient's indication and GOI (The system includes treating a cell culture by cloning a GOI into a temperature-sensitive self-replicating RNA (srRNA1ts2) vector, e.g. see Ko [0227]-[0228].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to treat the patient cell culture with RNA carrying the GOI as taught by Ko in order to treat diseases and disorders that can benefit from administration of a temperature sensitive agent and to differentiate human iPS cells into neurons rapidly and efficiently, and the diagnosing of a patient condition, e.g. see Ko [0127] and [0232].
Regarding Claim 7, the combination of Zien, Banna, and Ko teaches the limitations of Claim 6, and Ko further teaches the following:
The cell therapy suite of claim 6, wherein the RNA is c-srRNA (The system includes treating a cell culture by cloning a GOI into a temperature-sensitive self-replicating RNA (srRNA1ts2) vector, e.g. see Ko [0227]-[0228].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to treat the patient cell culture with RNA carrying the GOI as taught by Ko in order to treat diseases and disorders that can benefit from administration of a temperature sensitive agent and to differentiate human iPS cells into neurons rapidly and efficiently, and the diagnosing of a patient condition, e.g. see Ko [0127] and [0232].
Regarding Claim 10, the combination of Zien and Banna teaches the limitations of Claim 1, but does not teach and Ko teaches the following:
The cell therapy suite of claim 1, further comprising an RNA production unit configured to load GOIs onto an RNA vehicle (The system includes treating a cell culture by in vitro transcriptions (i.e. an RNA production unit) cloning a GOI into a temperature-sensitive self-replicating RNA (srRNA1ts2) vector (i.e. an RNA vehicle), e.g. see Ko [0227]-[0228].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to treat the patient cell culture with RNA carrying the GOI as taught by Ko in order to treat diseases and disorders that can benefit from administration of a temperature sensitive agent and to differentiate human iPS cells into neurons rapidly and efficiently, and the diagnosing of a patient condition, e.g. see Ko [0127] and [0232].
Regarding Claim 11, the combination of Zien, Banna, and Ko teaches the limitations of Claim 10, and Zien and Ko further teach the following:
The cell therapy suite of claim 10, wherein the one or more processors are configured to receive a patient's GOI identified by a sequencer (The system receives a molecular profile of a patient, e.g. see Zien [0062], wherein the molecular profile includes expression levels of genes measured by next generation sequencing, e.g. see Zien [0059].) and in response to receiving the patient's identified GOI, load the identified GOI onto an RNA vehicle in the RNA production unit (The system treats a cell culture by in vitro transcriptions (i.e. an RNA production unit) cloning a GOI into a temperature-sensitive self-replicating RNA (srRNA1ts2) vector (i.e. an RNA vehicle), e.g. see Ko [0227]-[0228].) or the one or more processors are configured to transmit the identified GOI information to a remote server location outside of the suite.
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to treat the patient cell culture with RNA carrying the GOI as taught by Ko in order to treat diseases and disorders that can benefit from administration of a temperature sensitive agent and to differentiate human iPS cells into neurons rapidly and efficiently, and the diagnosing of a patient condition, e.g. see Ko [0127] and [0232].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zien and Banna in view of Penn (US 2013/0303597).
Regarding Claim 9, the combination of Zien and Banna teaches the limitations of Claim 1, but does not teach and Penn teaches the following:
The cell therapy suite of claim 1, wherein the cell therapy suite is a clean room that satisfies ISO 5, ISO 7, or ISO 8 (The system includes the manufacturing of a substance to treat a patient, wherein the manufacturing is performed in a clean room facility consisting at least of an anteroom (Class 10,000, ISO 7), e.g. see Penn [0163].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to include manufacturing the treatment substance in a cleanroom satisfying ISO 7 as taught by Penn in order to streamline drug product manufacture using pre-established quality testing services, e.g. see Penn [0163].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zien and Banna in view of Strober (US 2011/0129503).
Regarding Claim 13, the combination of Zien and Banna teaches the limitations of Claim 1, but does not teach and Penn teaches the following:
The cell therapy suite of claim 1, further comprising an apheresis device for extracting the patient's cells (The system includes a method of treating patients including extracting a patient’s cells via apheresis, e.g. see Strober [067]-[0068].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Zien and Banna to include extracting a patient’s cells via apheresis as taught by Strober in order to minimize the risk of infection and rejection of the patient, e.g. see Strober [0068].
Response to Arguments
Applicant’s arguments, see Remarks, filed April 15, 2026, with respect to the rejections of Claims 1-2 and 4-13 under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant initially alleges that the claimed invention is patent eligible because the steps of receiving the cell therapy protocols and the request do not recite a certain method of organizing human activities, e.g. see pgs. 5-6 of Remarks – Examiner disagrees.
Examiner initially notes that, as shown above in accordance with the amendments made to the inventive concept, the abstract idea now incorporates the step of performing a step of the respective cell protocol from the library of cell therapy protocols. Furthermore, Examiner asserts that the steps of receiving the cell therapy protocols and the request and performing a step of the cell therapy protocol, given the broadest reasonable interpretation, are properly interpreted as managing personal behavior, specifically following rules or instructions in order to perform a treatment on a patient. For example, as presently claimed, the language of the one or more processors being configured to “have” the cell-processing device perform a step of the cell therapy protocol may, given the broadest reasonable interpretation, be interpreted as a computer providing instruction to a human user to merely use the cell-processing device to perform the step of the cell therapy protocol. The present claim language does not require, for example, the cell-processing device being controlled by the one or more processors and automatically performing a step of the cell therapy protocol. Additionally, the present claim language does not claim the cell-processing device with any particularity beyond “having” it perform a step of the cell therapy protocol, does not claim any details regarding a patient condition/disease, and further does not claim any details regarding the step of the cell therapy protocol. Hence, Claims 1-2 and 4-13 recite the abstract idea of a certain method of organizing human activities.
For the aforementioned reasons, Claims 1-2 and 4-13 are rejected under 35 U.S.C. 101.
Applicant’s arguments, see Remarks, filed April 15, 2026, with respect to the rejections of Claims 1 and 12 under 35 U.S.C. 102(a)(1) have been fully considered and, in combination with the claim amendments, are persuasive. The rejections of Claims 1 and 12 under 35 U.S.C. 102(a)(1) have been withdrawn. However, for the reasons disclosed above, and as further explained below, Claims 1-2 and 4-13 are nonetheless rejected under 35 U.S.C. 103.
Applicant’s arguments, see Remarks, filed April 15, 2026, regarding the rejections of Claims 1-2 and 4-13 under 35 U.S.C. 103 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection. As shown above, Claim 1 has been amended to now claim that the cell-processing device actually performs a step of the cell therapy protocol so that the cells are treated with the GOI, which is distinguished from the previous language of Claim 3, which merely recited that the suite further comprised a cell-processing device, without reciting any functions/operations of the cell-processing device. Furthermore, as shown above, the aforementioned claim language is taught by the newly cited Banna reference. Hence, any arguments pertaining to these features in view of Zien and Yu are moot. Hence Claims 1-2 and 4-13 are rejected under 35 U.S.C. 103 for the reasons disclosed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN P GO/Primary Examiner, Art Unit 3681
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