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 1-13 are currently pending. Claims 14-22, 33-34, and 44-45 are canceled in the Claims filed on February 11, 2025. Claims 23-32 and 35-43 are withdrawn pursuant to an election made without traverse of Claims 1-13 dated December 8, 2025.
Election/Restrictions
Applicant’s election without traverse of Claims 1-13 in the reply filed on December 8, 2025 is acknowledged.
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 1-13 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 1-13 are within the four statutory categories. Claims 1-13 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, 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 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 and receiving a request for treating a patient with cell therapy are properly interpreted as 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 2-13 include other limitations, for example Claim 2 recites a source for the received information, Claim 3 recites a device, 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 2-13 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Hence Claims 1-13 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 step of performing a step of the cell therapy in response to receiving the request) 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, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see [0098] of the as-filed Specification, and see MPEP 2106.05(f);
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language of treating the patient with cell therapy, which amounts to limiting the abstract idea to the field of healthcare, e.g. see MPEP 2106.05(h); and/or
add insignificant extra-solution activity to the abstract idea – for example, the recitation of performing a step of the cell therapy protocol, which amounts to an insignificant application, e.g. see MPEP 2106.05(g).
Additionally, dependent Claims 2-13 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 2-3 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 1-13 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 step of performing a step of the cell therapy in response to receiving the request), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, 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 performing a step of a respective cell therapy to the patient without specifying a particular treatment, a particular condition. and/or without specifying particularities that are required of the administration;
Cutting hair after first determining the hair style, e.g. see In re Brown – similarly, the additional elements merely recite performing the step of the cell therapy protocol from the library of cell therapy protocols at a high level of generality;
Dependent Claims 2-13 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 2-3 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 1-13 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 1-13 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zien (US 2015/0370982).
Regarding Claim 1, Zien discloses 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].).
Regarding Claim 12, Zien discloses the limitations of Claim 1, and Zien further discloses 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].).
Claim Rejections - 35 USC § 103
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Goltra (US 2014/0288969).
Regarding Claim 2, Zien discloses the limitations of Claim 1, but does not teach and Goltra 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 system includes a database that stores medical information that is located remotely, wherein the system displays the medical data retrieved from the remote database, e.g. see Goltra [0061], [0066], and [0069].).
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 Goltra in order to enable access to more data populations for effective treatment and management of patients, e.g. see Goltra [0002].
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Yu (US 2016/0224730).
Regarding Claim 3, Zien discloses the limitations of Claim 1, but does not teach and Yu teaches the following:
The cell therapy suite of claim 1, wherein the suite comprises a cell-processing device (The system includes a nucleic acid sequencer (i.e. a cell-processing device) coupled with a processor that analyzes a patient biological sample including nucleic acids, e.g. see Yu [0020], [0023], and [0071].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien include a nucleic acid sequencer as taught by Yu in order to improve the performance and accuracy of nucleic acid based testing for diagnosing a patient condition, e.g. see Yu [0020] and [0198].
Regarding Claim 4, the combination of Zien and Yu teaches the limitations of Claim 3, and Yu further teaches the following:
The cell therapy suite of claim 3, 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 includes a cartridge configured to perform at least one of a plurality nucleic acid tests, e.g. see Yu [0096].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien include a nucleic acid sequencer configured to perform nucleic acid testing as taught by Yu in order to improve the diagnosing of a patient condition, e.g. see Yu [0020].
Regarding Claim 5, the combination of Zien and Yu teaches the limitations of Claim 4, and Yu 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 set of nucleic acids to be tested by the cartridge are selected based on the patient symptoms, e.g. see Yu [0102].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to include a nucleic acid sequencer configured to perform nucleic acid testing for selected nucleic acids as taught by Yu in order to improve the diagnosing of a patient condition, e.g. see Yu [0020].
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zien and Yu in view of Ko (US 2021/0381005).
Regarding Claim 6, the combination of Zien and Yu 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 Yu 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, Yu, 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 Yu 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Szeto (US 2021/0142864).
Regarding Claim 8, Zien discloses the limitations of Claim 1, but does not teach and Szeto 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 updates a patient record including an updated treatment plan, e.g. see Szeto [0017] and [0057].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Zien to include the updated treatment as taught by Szeto in order to improve the patient prognosis, e.g. see Szeto [0057].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Penn (US 2013/0303597).
Regarding Claim 9, Zien discloses 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 Zien 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].
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Ko.
Regarding Claim 10, Zien discloses 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 Zien 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 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 Zien 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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zien in view of Strober (US 2011/0129503).
Regarding Claim 13, Zien discloses 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 Zien 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].
Conclusion
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 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN P GO/Examiner, Art Unit 3681