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 .
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.
Claim Status
Applicant's arguments, amendments, and affidavit dated 12/29/25 have been received and entered in the application.
Claims 1-21, 23-27 are currently pending.
Claims 1-12 are withdrawn as directed to non-elected inventions with traverse in the response dated 12/20/24.
Claim 13 is currently amended.
Claims 13-21, 23-27 are elected and examined on the merits.
Claim Interpretation
Claims 13, 16, 22-27 are interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product. For examination purposes, claim 13 is interpreted as comprising: a population of antigen-specific T cells, comprising between about 80% to about 99% CD3+ T cells, < 1% CD14+ monocytes, < 10% CD19+ B cells, and < 2% CD3-CD56+ NK cells, wherein the T cells demonstrate activity against at least one tumor associated antigen and a second antigen. Dependent claims 14-27 are interpreted in accordance with this reading.
With respect to claims 14-15, 17, 24-26, applicant’s invention is interpreted as containing functional language limitations. Claims directed to a product must be distinguished from the prior art in terms of the structure of the product rather than by the function of the product. See MPEP § 2114. Consequently, functional language limitations are considered in a patentability analysis only to the extent that the limitations result in structural changes to the product.
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.
In view of the MPEP § 2106, claims 13-21, 23, 26-27 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.
Subject Matter Eligibility Guidance
A three part inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101 for process claims that involve laws of nature. See Subject Matter Eligibility Guidance. This inquiry comprises answering: 1) Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? 2A) Does the claim recite or involve one or more judicial exceptions? Judicial exceptions include abstract ideas, laws of nature/natural principles, natural phenomena, and natural products. 2B) Does the claim as a whole recite something significantly more than the judicial exception(s)?
Claim Interpretation
With respect to claim 13 applicant’s invention is interpreted as comprising a population of antigen-specific T cells, comprising between about 80% to about 99% CD3+ T cells, < 1% CD14+ monocytes, < 10% CD19+ B cells, and < 2% CD3-CD56+ NK cells wherein the T cells demonstrate activity against at least one tumor associated antigen and a second antigen. With respect to claims 18-21, applicant’s invention is interpreted as comprising a population of antigen-specific T cells containing certain percentages of T cell sub-populations. With respect to claims 16, 22-27 are interpreted as comprising product-by-process limitations which are not considered in the patentability of the claimed composition. With respect to claims 14-15, 17, 24-26, applicant’s invention is interpreted as containing functional language limitations which are considered in the patentability analysis only to the extent that result in structural changes to the composition.
Analysis in View of Claim Interpretation and Subject Matter Eligibility Guidance
1) Statutory Subject Matter
Claims 13-21, 23-27 are directed to a population of cells, which is a composition. Therefore, claims 13-21, 23-27 are directed to statutory subject matter.
2A) Judicial Exception
1) Does the claim recite a judicial exception?
Claims 13-21, 23-27 recite a judicial exception because antigen-presenting T cells are naturally occurring cells, i.e., cells are a product of nature.
2) Does the claim recite additional elements that integrate the judicial exception into a practical application?
Under certain circumstances, purification and/or isolation may result in changes significant enough to qualify as markedly different (See Section 1.A.3 of the Subject Matter Eligibility Guidance dated 16 December 2014: "[i]n accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product’s naturally occurring counterpart”). In example 4.2 of the Nature Based Product Examples, the example clearly demonstrates that the purification process alters the physical structure of the antibiotic to a form which cannot be produced by the bacteria. The change in structure is due to applicant’s purification process, and objective evidence is presented elucidating that structural difference. In the present case, applicant has presented evidence (Figs. 7-9 and associated paragraphs) that claimed product by process limitations and functional language limitations confer some characteristics which differ from cells obtained by different methodologies. However, applicant has not presented any evidence that the claimed product by process limitations or functional language limitations confer characteristics significantly different than a population of naturally occurring cells. Clear evidence that the claimed product by process limitations produce a population of isolated cells which differ from naturally occurring cells may be sufficient to show a marked difference. However, in the absence of evidence to the contrary, the product by process limitations recited by applicants do not result in markedly different characteristics from the naturally occurring, isolated cells. Consequently, claims 13-21, 23-27 recite a judicial exception because antigen-presenting T cells are naturally occurring, i.e., cells are a natural phenomenon.
2B) Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claims only contain limitations directed to a population of cells, nothing else appears in the claims. Thus, there is no apparent difference between applicant's claimed isolated cells and naturally occurring cells.
Summary
On balance the relevant factors weigh against eligibility and claims do not qualify as eligible subject matter under 35 U.S.C. § 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13-21, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Buuren et al., PCT Publication No. WO 2020/227546 (cited on IDS dated 8/15/24, hereinafter Van Buuren).
Regarding claims 13, 16, 23-27, Van Buuren discloses populations of tumor antigen specific T cells and methods of making thereof (Abstract). Van Buuren discloses obtaining a population of peripheral blood mononuclear cells (PBMCs) and depleting CD14+ cells from PBMSCs to produce a population of antigen presenting cells (APCs) and T cells ([0005]-[0008], [0251], claim 1). In some embodiments the population maybe further depleted of CD19+ cells ([0055], [0341]-[0342], [0488], claim 61). The APCs and T cells are incubated in the presence of FLT3L and at least one tumor presenting peptide ([0008], [0300]-[0307], claims 1), 9. In some embodiments, CD3+ cells comprise at least 60% of the total cell population, in particular 90% of the population ([0019], [0206], Fig. 68, claim 25).
Regarding claims 14-15, 17, activation of the T cell may be verified by detecting the release of a cytokine, such as IFNγ ([0424], [0467], [0563], [0596], Fig. 10).
Regarding claims 18-21, the population of CD3+ cells may further comprise central memory (TCM) and effector memory cells T cells (TEM) ([0027]-[0034], [0206], Fig. 68, 71, claims 33-40). Preferably, the percentage of TCM cells is at least 10% of the population ([0030], [0034]). Preferably, the percentage of TEM cells is at least 60% of the population ([0032]). Preferably, the percentage of TEM cells expressing CD45RA is less than 10% of the population ([0033]). Preferably, the percentage of naïve T cells is less than 25% of the population ([0031]).
Van Burren does not explicitly disclose that the population contains less than 10% CD3- CD56+ natural killer (NK) T cells. However, Van Buuren discloses that the antigen specific T cell may comprise at least 95% of the cells contained in the composition ([0425]). Therefore, there is a suggestion present in Van Burren that 5% or less of total cells in the composition may be NK T cells or other cell types. Further, as per MPEP § 2144.05, a prima facie case of obviousness exists in cases where the claimed ranges or amounts “do not overlap with the prior art but are merely close”. Van Buuren discloses embodiments in which at least 95% of the cells are antigen specific T cells, i.e., the composition contains less than 5% of NK T cells. As the claimed range is close to that disclosed by Van Buuren, the claimed range is deemed obvious.
Response to Arguments
Claims 13-21, 23-27 are rejected under 35 U.S.C. 101 as being subject matter ineligible.
Applicant argues that the current claims are similar to claim 5 of Example 30 of the May 4, 2016 Subject Matter Eligibility Examples for Life Sciences (Response p7-8). Applicant argues that depleting CD56+ cells from the claimed population results in the changed property of increased antigen specificity as compared to a naturally occurring population of cells (Response p7-8, Affidavit p3).
With respect to Example 30, there is a change in the structure of the texiol; the natural particle size is altered such that a property of the texiol is changed. In the present case the change in antigen specificity is due to the removal of CD56+ cells, not due to a change in the structure, use, or function of the cells which are present in the composition (i.e., the CD3+ T cells have not changed). As discussed in the previous response, Example 6 of the Nature-Based Product Examples from December 16, 2014 is illustrative in this case. The discovery that a particular combination of naturally occurring components can be mixed with certain effects is an application of a natural principle (e.g., a different combination of cell types will have different antigen specificity). Each of the cell types individually acts in the same manner in which they have always acted. The cells have not acquired a new use, structure, or functional feature that what occurs in nature; “[t]hey serve the ends nature originally provided”. It is not clear that the combination of cells of the invention has any markedly different characteristics than those of naturally occurring cells combined in the same manner.
Claim(s) 13-21, 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Van Buuren.
Applicant argues that the process of Van Buuren results in a different T cell population than that of the claimed invention (Response p9-10). Applicant argues that Van Buurren does not provide any information as to the percentages of the cell types contained in the composition (Response p9-10).
The examiner concedes that the method of Van Buuren is different than the method of the present application. However, the claims as presented are directed to a composition. As noted above, the relevant inquiry is consequently whether the composition of Van Buuren is the same or different than that of the present claims.
Van Buuren explicitly states that the antigen specific T cell may comprise “at least about… 95% of the T cells or total immune cells in the composition” ([0425]). This indicates that, in at least some embodiments, Van Buuren has contemplated compositions which contain less than 5% of all other cell types. As per MPEP § 2144.05, a prima facie case of obviousness exists in cases where the claimed ranges or amounts “do not overlap with the prior art but are merely close”. Therefore, there is both a suggestion present in Van Buuren that other cell types may be minimized, and the claimed range is sufficiently to that explicitly disclosed by Van Buuren that a cell population comprising less than about 2% CD3-CD56+ NK cells is considered obvious.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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