DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of the species Activated CAR cells in the reply filed on 01/04/2026 is acknowledged. The traversal is on the ground(s) that there is no an undue burden placed on the Examiner to search both activated and regular CAR cells. Similar search terms would be used, and the Examiner can easily check both species at the same time. This is not found persuasive. The species are distinct because none is rendered obvious by the others in its group and because the disclosure does not connect them by any design, operation, or effect. In addition, these species are not obvious variants of each other based on the current record. See M.P.E.P. § 806.04(b). A requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious burden on the examiner if restriction is not required. See M.P.E.P. § 808.01(a). In this case, considering enablement, utility, and description issues for each claimed species, as well as conducting a thorough search of the prior art for each and every combination embodied by the present claims, would pose a serious burden to the examiner.
The examiner wishes to point out for the record that an election of species requirement is for search purposes only and does not necessarily narrow the scope of patentable claims, since all nonelected species are rejoined at the time of allowance. See 37 C.F.R. §1.146 and M.P.E.P. § 809.02(c) for a discussion of species election practice. In short, electing one species does not preclude consideration of the nonelected species later in the prosecution, i.e. at the time of allowance. The fact that all of the original claims were generic was the precise reason for the requirement for species election; in the interest of expedient processing of applications, the examiner concentrates on the patentability of the entire invention as it pertains to one species. Once the invention per se is claimed in an allowable manner, all disclosed species are rejoined to the claims.
The requirement is still deemed proper and is therefore made FINAL.
Claims Status
Claims 16 and 18 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-15, 17 and 19-20 have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim recites “not predicted to response”. This is incorrect grammar. Amending the claim to recite “not predicted to respond” would overcome this objection.
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-15, 17 and 19-20 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1: Claim 1b recites “a predetermined threshold” which indicates if said subject is likely to respond to CAR therapy. Step c. of claim 1 requires a prediction based on the predetermined threshold of step b. however a predetermined threshold is not defined by the claim or the instant specification nor is how to determine said threshold common knowledge in the art.
The broadest reasonable interpretation of “a predetermined threshold” is a threshold of any number.
Teachings of the instant specification:
The instant specification teaches measuring CAR-Tc and teaches an association between CAR-Tc numbers in peripheral blood smears and patient outcomes (Example 6 Fig 5A-D). The data appear to support a higher number of cells in a peripheral blood smear at days 1-5 and days 11-15 correlate with a complete response, however the data do not teach a threshold value. Figure 6 teach “large numbers” of activated CAR-Tc in day 14 PBS are correlated with long complete response and negatively correlated with early complete response onset, but do not teach a specific threshold value.
The state of the art:
Caballero et al (Fronters in Immunology (2022) 13;1-19; published 06 July) teach that immunotherapy with CART cells has clinical efficacy with patients that have relapsed/refractory B-cell lymphoma (abstract). However, Caballero also teach more than 50% of treated patients do not benefit from the therapy and understanding of why patients have different responses is needed (Abstract). Caballero teach identification of the subgroup of patients who would certainly benefit from CART19 remains a challenge (p3/4 col 2/1 ¶4/1).
Conclusion
The instant specification provides a single example of a. receiving a peripheral blood smear (PBS) from a subject after CAR therapy, b. determining the number of CAR cells in the PBS (Example 5 p17) and teach that the number of CAR-Tc cells are significantly higher in patients that obtain a complete response at day 30 post infusions (17.1 cells/PBS vs 2.8 cells/PBS) (p18 [079]).
However the instant specification does not provide sufficient guidance or working examples of the species of “predetermined threshold numbers” that one of ordinary skill in the art to identify a threshold number and the art teaches that patients response to CART therapy is unpredictable and why patients have different responses to CART therapy is unknown.
However a small number of example of a species are not sufficient to fulfill the written description requirement for a broad genus in view of unpredictability in how one of ordinary skill would determine “a predetermined threshold”.
MPEP 2163 states “To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention”.
As described above, in the case of the instant claim 1 claimed invention is broad and does not provide sufficient guidance as to how one of ordinary skill in the art would identify a threshold number and the instant specification provides a single example of determining a number of CAR cells which may imply a threshold number, but gives no clear guidance how to determine a value for said threshold.
In view of the unpredictability of predicting patient response to CART therapy as taught by Caballero, and the trial and error necessary for one of ordinary skill in the art to identify a threshold number (which would predict the response of the therapy), the specification fails to support “a predetermined threshold” as claimed such that one skilled in the art can reasonably conclude the inventor had possession of the broad genus of any value of “predetermined threshold” as recited in the instant claim 1.
The gap between the single example in the instant specification, which implies but does not clearly define a threshold number, and the vast number of possible values for “a predetermined threshold” as recited in the instant claim 1 is large. Given this large gap, the specification fails to support the broad genus of “a predetermined threshold” as claimed such that one skilled in the art can reasonably conclude the inventor had possession of the claimed invention.
Note claims 2-15, 17 and 19-20 depend from claim 1 and do not cure the deficiencies.
Claims 14 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claim 14 reads “subject is likely to suffer”. This is indefinite because it is unclear if the subject will or will not suffer, thus one of ordinary skill in the art would not be appraised of the metes and bounds of the claim limitation.
Claim 19 depends from claim 1 and recites “further comprising administering said CAR therapy to said subject”. Claim 1 recites two CAR therapy administration steps; CAR therapy before the PBS blood smear of step a. and a second dose of CAR therapy in step c. It is unclear if claim 19 refers to a third administration of CAR therapy and a second peripheral blood smear (following the steps of claim 1) or if the blood smear is following the second CAR therapy administration of claim 1 step c.
For purposes of compact prosecution the claim is interpreted as referring to the administration step of claim 1 step c. and obtaining peripheral blood from the subject of claim 1 step c. because the second administration of CAR therapy is clearly described as “a second dose of CAR therapy” in claim 1, and thus if a third dose of CAR therapy were required, it would likely be clearly identified as “a third dose of CAR therapy”. Furthermore, the instant specification teaches patients that receive one CAR T cell therapy and are assessed; the patient cohort underwent a scan one month post CAR-Tc infusion (p13 [066]). However the instant specification does not describe a second or third administration of CAR therapy.
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 1-15, 17 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception, i.e. abstract idea without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation.
Step 1: Are the claims directed to a statutory category of invention?
Yes, the claims are drawn to a process (method), which is a statutory category of invention (Step 1: YES).
Step 2A, Prong 1: Do the claims recite a judicial exception (JE)?
Regarding claim 1: The claim recite mental steps. Specifically “predicting subject response” and “determining the number” are considered a mental steps.
MPEP 2106.04(a)(2)III states “The courts consider a mental process (thinking) that ‘can be performed in the human mind, or by a human using a pen and paper’ to be an abstract idea.” Determining the number of CAR cells can be done mentally by observing experimental outputs visually and therefor reads on an abstract idea.
(Step 2A, Prong 1: YES)
Step 2A, Prong 2: Do the claims recite additional elements that integrate the JE into a practical application? The claims are directed to an abstract idea (a mental process; acquiring knowledge, acquiring a value, acquiring a measure, identification, determination).
Regarding claim 1: The claim does not integrate the mental step into a practical application because the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step a. does recite receiving a peripheral blood smear which is required for the “determining”, however this is considered an extra-solution activity which is well known and thus does not impose a meaningful limit on to render the claims more than the judicial exception (MPEP 2106.05(g)).
Step c. of the claim recites additional steps of “administering an alternative therapy or administering a second dose”, however these steps do not require or integrate “determining” because they are conducted based on “said CAR therapy” and do not require or utilize results of the “determining” and furthermore are well understood and conventional.
(Step 2A, Prong 2: NO).
Step 2B: Are there additional elements that add significantly more to the ‘abstract ideas; mental step’ judicial exception’?
Claims 1-20: Claim 1 step a. does recite receiving a peripheral blood smear which is required for the “determining”, however this is considered an extra-solution activity which is well known and thus does not impose a meaningful limit on to render the claims more than the judicial exception (MPEP 2106.05(g)).
Claim 1 step c. of the claim recites additional steps of “administering an alternative therapy or administering a second dose”, however these steps do not require or integrate “determining” because they are conducted based on “said CAR therapy” and do not require or utilize results of the “determining” and furthermore are well understood and conventional.
Claims 2-20 do not further recite elements that add significantly more to the judicial exception, therefore there are no additional elements that add significantly more to the judicial exception.
(Step 2B: NO).
Claims 1-20 are patent ineligible.
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 1-15, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fridberg et al (HemaSphere (2022) 6:S3;1-2; published 06/23/2022) and Gauthier et al (Blood (2021) 137:3;1-13) and as evidenced by NCBI (Complete Response [online] NCBI [retrieved on 06/02/2026]. Retrieved from the Internet: <https://www.cancer.gov/publications/dictionaries/cancer-terms/def/complete-response).
Regarding claim 1-9, 12, 17 and 20: Claim 1 is drawn to a method and recites the intended use statement “of predicting subject response to chimeric antigen receptor (CAR) therapy and treating said subject”.
MPEP (2111.02 II) states “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim”.
The intended use statement in the preamble of claim 1 does not impose active steps or imply a structural limitation to the claimed method and thus is not considered to limit the claim.
The instant claim 1, step (b) recites the wherein clause “wherein a number of CAR cells in said PBS above a predetermined threshold indicates said subject is likely to respond to said CAR therapy” which is dependent on a value above a predetermined threshold. The instant claim 1c. recites two steps of administration in the alternative, dependent on a predetermined threshold.
As discussed above, neither the claims, the instant specification nor the art clearly teach how one of ordinary skill in the art may determine a threshold number. Therefore a predetermined threshold is broadly interpreted to be any value.
Claim 1 step b. is therefore interpreted as “determining the number of CAR cells in said PBS” because any number of CAR cells in a PBS reads on a threshold which can be any value.
Claim 1 step c. is interpreted as “administering an alternative therapy to a subject or administering a second dose of CAR therapy” because a predetermined threshold of any value is not considered limiting.
The instant claim 1 recites the following active steps: “receiving”, “determining” and “administering” which are considered in the following analysis.
Turning to the art, Fridberg teach CAR-T therapy for patients with relapsed and refractory non-Hodgkin’s large B cell lymphomas (LBCL) who failed two or more therapeutic regimens (abstract).
Fridberg teach receiving peripheral blood smears (PBS) from a subject after CAR therapy (PBS samples obtained from DLBCL patients treated with tisagenlecleucel or axicabtagen ciloludel) (p1 methods). As evidenced by Jain, Axicabtagene ciloleucel is an anti-CD19 CAR T therapy for the treatment of relapsed/refractory B-cell non-Hodgkin’s lymphoma (title). Fridberg further teach samples were measured on day 5 post CAR-T-transfusion (p1 results).
Fridberg teach determining the number of CAR cells in the PBS (Detection of CAR-T was superior with the FFM platform (a novel digital microscopy platform with full field analysis); the absolute number of CAR-T cells in the PBS post infusion was higher in patients treated with axicabtagene ciloleucel) (p1 Results). Fridberg also teach the number of activated CAR-T cells (p1 results; p2 figure).
Fridberg do not teach “administering” either an alternative therapy or a second dose of CAR therapy.
Gauthier teach most patients do not achieve complete or durable responses to CD19 CART therapy (p1 col1 ¶1). Gauthier further teach one option for patients that need further therapy is a second infusion of CD19 CART cells (p1 col2 ¶1). Gauthier teach some patients achieve durable responses after a second infusion of CART cells (abstract).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Fridberg drawn to receiving a peripheral blood smear and determining the number of CAR cells by administering a second dose of CAR therapy to a subject in need as taught by Gauthier.
One of ordinary skill in the art would have been motivated to modify the method as taught by Fridberg to include a step of administering a second dose of CAR therapy as taught by Gautheir for the purposes of achieving durable response in some patients who do not achieve a durable response with the first dose of therapy.
One would have had a reasonable expectation of success because Gauthier teach a second infusion of CART cells was well tolerated and more durable responses were achieved in a subset of patients (p2 col1 ¶1).
Regarding claims 10-11, 13-14: Claim 11 recites “complete response”. The instant specification is silent on an explicit definition for the term. As evidenced by NCBI, a complete response (CR) is the disappearance of all sings of cancer in response to treatment (p1).
The claims do not impart active steps on the claimed method.
Regarding claim 15: The claim recites “at least one of” options a. b. and c.. Thus only one of the limitations are required. Option a. does not impart an active step on the claimed method.
Regarding claim 19: The claim is interpreted as obtaining a peripheral blood smear from said subject after administering said CAR therapy a second time (as discussed supra).
Gauthier further teach after the second infusion of CART cells, CAR T cells were detected in the blood by flow cytometry (p7 col2 ¶2). Gauthier do not teach producing smears from peripheral blood of the subject after the second CAR therapy.
As discussed supra, Fridberg teach Wright Giemsa-stained peripheral blood smears from patients during the first month after a first CAR-T-cell infusion are imaged (p2 col2 ¶1).
It would have been obvious to one of ordinary skill in the art to adapt the combined method of Fridberg and Gauthier drawn to administering a second dose of CAR therapy to a subject in need by further obtaining peripheral blood and producing smears from said blood as taught by Fridberg.
One of ordinary skill in the art would have been motivated to modify the combined of method as taught by Fridberg and Gauthier to include a step of further obtaining peripheral blood and producing smears from said blood as taught by Fridberg, after a second dose of CAR therapy, as an alternative method of monitoring the CART cell population in the peripheral blood of the patient. One of ordinary skill in the art would understand that generating peripheral blood smears is technically less challenging than cell analysis by flow cytometry and thus would be motivated to alter the method of Gauthier, which uses flow cytometry to monitor CAR therapy by using the more simple method taught by Fridberg.
One would have had a reasonable expectation of success because Fridberg teaches generating a peripheral blood smear after a first CAR therapy.
Thus the teachings of Fridberg and Gauthier render obvious the invention as claimed.
Claims 1-15, 17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Faude et al (Blood advances (2021) 5:8;1-9; cited in the IDS filed 8/25/2024) and Gauthier et al (Blood (2021) 137:3;1-13).
Regarding claims 1-3, 5-7: Claim 1 is drawn to a method and recites the intended use statement “of predicting subject response to chimeric antigen receptor (CAR) therapy and treating said subject”.
MPEP (2111.02 II) states “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim”.
The intended use statement in the preamble of claim 1 does not impose active steps or imply a structural limitation to the claimed method and thus is not considered to limit the claim.
The instant claim 1b recites the wherein clause “wherein a number of CAR cells in said PBS above a predetermined threshold indicates said subject is likely to respond to said CAR therapy” which is dependent on a value above a predetermined threshold. The instant claim 1c. recites two steps of administration in the alternative, dependent on a predetermined threshold.
As discussed above, neither the claims, the instant specification nor the art clearly teach how one of ordinary skill in the art may determine a threshold number. Therefore a predetermined threshold is broadly interpreted to be any value.
Claim 1 step b. is therefore interpreted as “determining the number of CAR cells in said PBS” because any number of CAR cells in a PBS reads on a threshold which can be any value.
Claim 1 step c. is interpreted as “administering an alternative therapy to a subject or administering a second dose of CAR therapy” because a predetermined threshold of any value is not considered limiting.
The instant claim 1 recites the following active steps: “receiving”, “determining” and “administering” which are considered in the following analysis.
Faude teach methods to follow lymphocyte kinetics and morphology after CD19-directed CAR T-cell infusion in patients with B-ALL who were treated with CAR T-cell therapy (p2 col1 ¶1).
Faude teach Wright Giemsa-stained peripheral blood smears from patients during the first month after CAR-T-cell infusion are imaged (p2 col2 ¶1). This reads on “receiving peripheral blood smears from a subject after CAR therapy” as required by (a) of the instant claim.
Faude teach absolute the lymphocyte count (ALC) at day 0 of infusion is low due to lymphodepleting chemotherapy. Faude further teach ALC peaks at day 10 after infusion with peak ALC counts ranging from 280-69,000 (p3 col1 ¶4; Fig 1A and B). Faude teach that prior studies have established that by the end of the first week after infusion most circulating lymphocytes comprise CAR T cells (p6 col2 ¶3). Thus the ALC counts of Faude comprise CAR T cells and reads on determining the number of CAR cells in the peripheral blood smear, as required by (b).
Faude do not teach “administering” either an alternative therapy or a second dose of CAR therapy.
Gauthier teach most patients do not achieve complete or durable responses to CD19 CART therapy (p1 col1 ¶1). Gauthier further teach one option for patients that need further therapy is a second infusion of CD19 CART cells (p1 col2 ¶1). Gauthier teach some patients achieve durable responses after a second infusion of CART cells (abstract).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Faude drawn to receiving a peripheral blood smear and determining the number of CAR cells by administering a second dose of CAR therapy to a subject in need as taught by Gauthier.
One of ordinary skill in the art would have been motivated to modify the method as taught by Faude to include a step of administering a second dose of CAR therapy as taught by Gautheir for the purposes of achieving durable response in some patients who do not achieve a durable response with the first dose of therapy.
One would have had a reasonable expectation of success because Gauthier teach a second infusion of CART cells was well tolerated and more durable responses were achieved in a subset of patients (p2 col1 ¶1).
Regarding claims 4 and 8-9: The claims do not impart active steps on the claimed method.
Regarding claims 10-11, 13-14: The claims do not impart active steps on the claimed method.
Regarding claim 12: The teachings of Faude are discussed supra. Fig 1a of Faude teach peripheral blood smears at day 5 after CAR therapy.
Regarding claim 15: The claim recites “at least one of” options a. b. and c. Thus only one of the limitations are required. Option a. does not impart an active step on the claimed method.
Regarding claim 19: The claim is interpreted as obtaining a peripheral blood smear from said subject after administering said CAR therapy a second time (as discussed supra).
Gauthier further teach after the second infusion of CART cells, CAR T cells were detected in the blood by flow cytometry (p7 col2 ¶2). Gauthier do not teach producing smears from peripheral blood of the subject after the second CAR therapy.
As discussed supra, Faude teach receiving peripheral blood smears (PBS) from a subject after a first CAR therapy (PBS samples obtained from DLBCL patients treated with tisagenlecleucel or axicabtagen ciloludel) (p1 methods).
It would have been obvious to one of ordinary skill in the art to adapt the method of Faude and Gauthier drawn to administering a second dose of CAR therapy to a subject in need by further obtaining peripheral blood and producing smears from said blood as taught by Faude.
One of ordinary skill in the art would have been motivated to modify the combined of method as taught by Faude and Gauthier to include a step of further obtaining peripheral blood and producing smears from said blood as taught by Faude, after a second dose of CAR therapy as an alternative method of monitoring the CART cell population in the peripheral blood of the patient because one of ordinary skill in the art would understand that generating peripheral blood smears is technically less challenging than cell analysis by flow cytometry and thus would be motivated to alter the method of Gauthier, which uses flow cytometry to monitor CAR therapy by using the more simple method taught by Faude.
One would have had a reasonable expectation of success because Faude teaches generating a peripheral blood smear after a first CAR therapy.
Regarding claim 20: The teachings of Faude are discussed supra. Faude also teach a high proportion of lymphocytes were classified as variant or atypical lymphocytes by automated machine-learning algorithms (Fig 1C; p3 col1 ¶4). This reads on “counting said CAR cells with a digital microscopy platform that employs machine learning to determine cell classes based on morphology” as required by the instant claim because calculating a proportion requires counting, and the microscopy platform is disclosed as CellaVision which uses machine-learning algorithms (Fig 1c; p6 col2 ¶3).
Thus the teachings of Faude and Gauthier render obvious the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA LYNNE MORRIS SPENCER whose telephone number is (571)272-3328. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/TAEYOON KIM/Primary Examiner, Art Unit 1631
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