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 .
Status of Claims
The amended claims filed 02/13/2026 are acknowledged and entered.
Claims 1, 5, 10 and 16-18 have been amended
Claims 8, 9, 19, 21, 23 and 24 are cancelled
Claims 1-7, 10-18, 20 and 22 are pending and examined on their merits.
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claim Rejections - 35 USC § 112 withdrawn
1. The rejections for claims 5 and 16-17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as being indefinite is withdrawn in view of the amendments of claim 5 and 16-17
Claim Rejections - 35 USC § 102 withdrawn
2. The rejections of claims 1-9, 11, 15-18, 20 and 22 under 35 U.S.C. 102(a)(b) as anticipated by Prommersberger (previously cited), are all withdrawn in view of Applicant’s amendments to claim 1.
Rejections Maintained
Claim Rejections - 35 USC § 103 - Maintained
Claims 1-7, 10-18, 20 and 22 remain rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Prommersberger (previously cited) in view of Wolf (previously cited)
Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejections are maintained.
Applicant’s Arguments:
- (a) Prommersberger fails to disclose "culturing the fourth immune cell population to reach a cell density ranging from about 2x106 cells/ml to about 20x106 cells/ml" and "wherein step (b) to step (f) are performed within 5 days" recited in amended claim 1. Rather, Prommersberger teaches 10-24 days, much longer than the claimed time frame.
- (b) Prommersberger teaches isolating peripheral blood mononuclear cells (PBMCs) before the activating step. Specifically, Prommersberger teaches "Day 1, 1/3- Isolation of PBMC from peripheral blood by density gradient centrifugation" (page 3, last section) and "Day 1, 2/3-Immunomagnetic purification of T cells or T cell subsets from PBMC using Miltenyi MicroBeads, MACS columns and separators" (Prommersberger, page 4). In contrast, the claimed methods do not require isolating PBMCs before activating the cells. Rather, the claimed methods can sort a blood sample without PBMC isolation. This technical solution not only simplifies the process, but also effectively achieves high efficiency and high quality of immune cell preparation (see the Examples in the present application). Therefore, the claimed invention is completely different from the traditional PBMC method, including Prommersberger's.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
- (a) As discussed in the Non-Final action dated 11/13/2025, The method taught by Prommersberger can take a minimum of 3 days to about 7 days (page 2 paragraph before Material section) or more (as explained in Claim Rejections - 35 USC § 102). Applicant has not provided any explanation as to why they believe Prommersberger’s method can take 10-24 days. As a matter of fact, Prommersberger’s timeline includes the isolation of PBMCs and applicants have not included this step in their timelines. As discussed in detail in the Non Final action, Wolf teaches the expansion of the number of genetically modified cells in a culture by using a bioreactor with the goal to achieve steady‐state cultures using a perfusion bioreactor run at 20 × 106 cells/ml. This expansion process is not dependent on the cell type and in can be used for the fourth immune cell population culture. In addition, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Whereas Prommersberger teaches the method, Including the timeline, Wolf teaches the number of cells. Applicant has not sufficiently described why there is no prima facie case for obviousness.
- (b) Amended claim 1 recites as step (a) providing a sample containing immune cells. Claim 20 recites: “The method of claim 1, wherein the sample is peripheral blood, cells, fresh apheresis, cryopreserved apheresis, monocyte collections, peripheral blood mononuclear cells (PBMCs),….”. Therefore, the sample can be PBMCs and these PBMCs can only be obtained by being somehow isolated, even if applicant has not included the isolation step in the method, or any step about obtaining or providing the sample. The claim encompass PBMCs. There is no limitation in the instant claims excluding the isolation of PBMCs or the PBMCs being “the sample”, and consequently the teaching of Prommersberger are still applicable. It should be noted also that Applicant’s transitional phrase is open and so a step of PBMC isolation is not excluded from the claims for this reason also. Said another way, Applicant’s arguments over PMBC isolation are not commensurate in scope with the claims.
Regarding both items (a) and (b) above, and as discussed in the Non-Final action in more detail, it would further be obvious that many of the parameters in the claimed method, such as type of cells, number of cells to activate, microbeads to cell ratio, days needed to perform each step of the protocol, the number of cells to inoculate the production medium, perfusion rates etc., are clearly a result effective parameters that a person of ordinary skill in the art would routinely optimize. This routine optimization will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameters are critical.
Applicant argues as set forth above. Thus, for the reasons set forth above and the reasons of record, the rejection is maintained.
Double Patenting- Maintained
Claims 1-6, 9, 11, 15-18, 20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-6, 8-9, 11, 17-18, 20-22 and 31-32 (claims 13 is cancelled and 33 is withdrawn) of copending application No. 18/001,306 are maintained.
Applicant’s Arguments: the amended claims are not made obvious by the reference application claims.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive. For example, the amended limitations of instant claim 1 are found in also in 18/001,306. See comparison below: Underlined text has been incorporated to amend the instant claim.
Amended Claim 1: A method for preparing genetically modified immune cells, the method comprising:(a) providing a sample containing immune cells;(b) sorting the sample to obtain a first immune cell population enriched in immune cells; wherein the sorting comprises positive sorting using anti-CD4 and/or anti-CD8 antibodies or fragments thereof; (reference claims 1, and 31); (c) activating the first immune cell population to obtain a second immune cell population; (d) culturing the second immune cell population to obtain a third immune cell population; (e) genetically modifying the third immune cell population to obtain a fourth immune cell population; and (f) culturing the fourth immune cell population to reach a cell density ranging from about 2x106 cells/ml to about 20x106 cells/ml; wherein step (b) to step (f) are performed within 5 days. (reference claim 18 (the range of cells/ml is included in instant claims 1, 6 and 10 and reference amended claim 1 (time to perform steps)).
It would be obvious that many of the parameters recited in the instant claims, such as number of cells to activate, microbeads to cell ratio, days needed to perform each step of the protocol, etc., are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. (see Double Patenting Rejection in the Non-Final Rejection dated 11/13/2025)
Therefore, the instant application claims are made obvious by the reference application claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues as set forth above. Thus, for the reasons set forth above and the reasons of record, the rejection is maintained.
New Rejections Based on Amendments
Claim Rejections - 35 USC § 112(d)
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 11-14 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.
Claims 11-14 are dependent on claim 1. Claim 1 recites the following timeline limitation “….wherein step (b) to step (f) are performed within 5 days.”. Claim 11 recites the limitation “The method of claim 1, wherein step (b) to step (f) are performed in about 4 days to about 5 days”. Since the term “about” is not defined in the specification, “about” can be interpreted to mean a bit longer than 5 days. Claims 12-14 recite a range of days to perform the individual steps: Claim 12 - step (d) is performed for about 1.5 days to about 3 days; claim 13 - step (e) is performed for about 0.5 days to about 2.5 days; and claim 14 - step (f) is performed for about 1 day to about 3.5 days. If the longer number of day within the ranges are counted together, steps (d) to (f) are performed in about 9 days (step (b) is not included) which is a longer timeline than the “time required for steps (b) to (f) to be performed within 5 days” as recited by claim 1. Claims 11-14 fail to further contain all the limitations of the subject matter of the claim upon which they depend.
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.
Conclusion
No claims are allowed.
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.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671
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