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 .
DETAILED ACTION
Amendment Entry
1. Applicant's amendment / response filed July 27, 2026 is acknowledged and has been entered. Claims 12, 19, 29, and 32 have been amended. Claims 18, 25, 30, 31, 33, and 34 have been cancelled. Claims 1-11 and 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Accordingly, claims 1-17, 19-24, 26-29, and 32 are pending. Claims 12-17, 19-24, 29, and 32 are under examination.
Withdrawn Rejections / Objections
2. Any objection or rejection not reiterated herein, has been withdrawn.
3. The rejections of claim 18, 25, 30, 31, 33, and 34 are moot in light of Applicant's cancellation of the claims.
Priority
4. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Based on the Filing Receipt, the present application claims the benefit of Provisional Application Number 63/297,184 filed 01/06/2022. Accordingly, the effective filing date of the instant application is January 6, 2022 which is the filing date of Provisional Application Number 63/297,184 from which the benefit of domestic priority is claimed.
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.
5. Claims 12-17 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2009/011456 A1) in light of Becton Dickinson (CD Marker Handbook (2011)) in view of Hillhouse et al. (Double Negative T Cell Levels Correlate with Chronic Graft-versus-Host Disease Severity. Biol Blood and Marrow Transplant 25:19-25 (2019)) and Wang et al. (Expression of inducible co-stimulator (ICOS) in peripheral blood T lymphocyte subgroups after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its relation with acute graft-vs-host disease (aGVHD). Zhonghua Xueyexue Zazhi 28 (2): 127-129 (2007)).
Miller et al. disclose a method of predicting (prognosis) and treating a subject in need of treatment at risk of acute graft-versus-host disease (aGVHD) for aGVHD ([0010, 0011, 0024-0024, 0041-0045]; Figure 1A, Figure 1B). The method comprises: (1) measuring a level of CD4+CD8+ double positive T cells (DPT, CD4+CD8β+ T cells) in a biosample isolated from the subject using flow cytometry (Table 3; [0010, 0017-0020, 0022, 0026, 0042, 0044, 0056; 0073, 0076]; Figure 1A, Figure 1B; Figure 2; Figure 3A; Figure 3C; Figure 5); (2) measuring a level of CD45RO+ (cellular activation marker) T cells (memory T cells) in the biosample isolated from the subject ([0037, 0045, 0056, 0076]; Table 2); (3) identifying the subject as being at risk of aGVHD when the level of CD4+CD8+ DPT cells is high/elevated in percentage, proportion data, or cell population abundance in the biosample of the subject relative to control values (Table 3; [0010, 0026, 0031, 0037, 0041, 0042, 0045, 0049-0051, 0053, 0056, 0073, 0076]; Table 2); and (4) administering to the subject an amount of treatment effective to treat aGVHD in the subject ([0010, 0023, 0026, 0031, 0038]; Figure 1B; Figure 6). Smith et al. teach using the method to predict (prognosis) aGVHD in the subject (Abstract; Table 3; [0023, 0074]).
The biosample is bone marrow tissue or autologous whole blood obtained from the subject 7-21 days (encompassed within 5-22 days) after HSC transplant (post transplantation) ([0017-0020]; Figure 3B; Figure 3C). The biosample may be a bone marrow tissue or autologous whole blood obtained from the subject at least 22 days (encompassed within 22-90 days) after HSC transplant [0027]; so that the method can be used to predict aGVHD in the subject [0024, 0027, 0028]. Smith et al. teach that the subject has undergone hematopoietic stem cell (HSC) transplantation (bone marrow transplant) [0017, 0027]. Smith et al. also teach measuring the percentage of Treg cells (CD3, CD4, CD25 expression) in total T cells, CD8β+ T cells in total T cells, and DPT cells; wherein the subject is treated for aGVHD when the Treg cell % in total T cells is high/elevated, the CD8β+ T cell % in total T cells is high/elevated, and/or the DPT cell % is high/elevated in the blood sample of aGVHD subjects [0031, 0037, 0045, 0049, 0050, 0053, 0056, 0073]; Table 2). The treatment as taught by Smith et al. comprises methylprednisolone [0038].
With respect to the CD3+CD4+CD8 β+ T cells as taught by Smith et al., Becton Dickinson teaches and shows that CD3 is a pan biomarker of all T cells; hence CD3 expression is inherent in all T cells (see page 3).
Although Table 2 shows measuring CD45RO+ T cells in the sample, Smith et al. does not teach correlating the amount or percentage of CD4+CD8+ DPT cells relative to a total amount of all CD45RO+ T cells in the sample of an aGVHD subject.
Hillhouse et al. specifically teach measuring a level of CD4+CD45RO+ T cells and CD8+CD45RO+ T cells in biosample isolated from GVHD subjects using flow cytometry; and identifies its correlation to presence of chronic GVHD (cGVHD) (p. 22, right column; Figure 2B; Figure 2C) in comparison to CD4-CD8- DNT cells. Hillhouse et al. also teach specifically using CD4, CD25, and FoxP3 cell surface expression to determine the level of CD4+CD25+FoxP3 T regulatory cells (Tregs) in the biosample of GVHD subjects who show low/reduced levels of Treg cell frequency (p. 20, left col. 2nd full ¶). Hillhouse et al. show using flow cytometry to detect percentages of T cell blasts (cancer cells) in acute lymphocytic leukemia (ALL) subjects (Table 1).
Wang et al. studied the changes of inducible co-stimulator (iCOS) expression in peripheral blood T lymphocyte subgroups from leukemic patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and its relation to acute graft-versus-host disease (aGVHD). Wang et al. specifically teach measuring a level of CD4+ CD45RO+ T cells (T lymphocytes) and CD8+CD45RO+ T cells; hence, determining CD4+CD8+ DPT cell expression and CD45RO+ T cell expression in biosamples isolated from aGVHD subjects. Wang et al. further teach correlating and identifying the subjects as having aGVHD based on the measured amount of CD4+CD8+ DPT cells and CD45RO+ T cells in the biosample (see entire Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have incorporated the teaching of Hillhouse and Wang in correlating the percentage of CD4+CD8+ DPT cells relative to the total of CD45RO+ T cells into the method of diagnosis and treatment of aGVHD as taught by Smith because Hillhouse and Wang show that such combination of biomarker parameters provides additional advantage in correlating T cell population biomarker expressions in the diagnosis, prediction, and treatment regimen specifically of aGVHD. One of ordinary skill would have had reasonable expectation of success in incorporating the teaching of Hillhouse and Wang into the method of Smith because Smith and Wang together teaches analogous art in diagnosis and treatment of aGVHD.
With respect to the recitation of specifically identifying 4% to 6% CD4+CD8+ DPT of all CD45RO+ T cells as showing risk of aGVHD in claims 12 and 19 and identifying <=1% CD4+CD8+ DPT of all CD45RO+ T cells as showing risk of relapse of hematologic malignancy in claim 19; and using the values as a basis for treating aGVHD and also treating relapse of hematologic malignancy; generally, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific percentages or parameters recited in claims 12 and 19 are for any particular purpose or solve any stated problem and the prior art references teach that concentrations often vary according to the cell subpopulations and samples being analyzed; and various matrices, solutions and parameters appear to work equally as well; absent evidence to the contrary, it would have been obvious for one of ordinary skill to have discovered the optimum workable range of the methods disclosed by the prior art by normal optimization procedures.
It is proper for purposes of this obviousness rejection to interpret the combination "CD4+", "CD8+", and "CD45RO+" T cell populations taught by Smith, Hillhouse, and Wang as encompassing the CD4+CD8+ DPT and CD45RO+ T cells in Applicant’s claimed invention because unpatented claims are given the broadest reasonable interpretation consistent with the specification.
New Grounds of Rejection
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.
6. Claims 12-17, and 19-24 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. Based upon an analysis with respect to each of these claims as a whole, these claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims recite a correlation between risk of acute graft-versus-host disease (aGVHD) and the level of CD4+CD8+ double positive T cells (DPT cells) at 4% to 6% of all CD45RO+ T cells in claims 12 and 19; and also risk of a relapse of hematologic malignancy and the level of CD4+CD8+ DPT cells at <= 1% of all CD45RO+ T cells in claim 19. These results are used as a basis to identify patients as manifesting risk of aGVHD and/or manifesting risk of a relapse of hematologic malignancy; and the claims further recite “treating the identified subject for aGVHD or relapse of hematologic malignancy. This judicial exception is not integrated into a practical application because the claimed invention is limited to a correlation being categorized as a law of nature/natural phenomenon or existence in nature apart from any human action without significantly more. The claims do not include additional elements that are sufficient to amount to significantly more because the judicial exception is not integrated into a significant practical application in a manner that imposes a meaningful limit on the judicial exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A Prong One
The claims recite identifying a subject at risk of aGVHD and/or risk of relapse of hematologic malignancy and treating the subject identified as being at risk of aGVHD and/or risk of a relapse of hematologic malignancy on the basis of the measured level of CD4+CD8+ DPT cells at 4% to 6% of all CD45RO+ T cells or hematologic malignancy on the basis of the measured the level of CD4+CD8+ DPT cells at <= 1% of all CD45RO+ T cells. The claimed steps of measuring CD4+CD8+ T cell percentage amongst CD45RO+ T cells in blood and providing indication of risk of aGVHD read on mental processes, such as a physician obtaining data result from a patient, and forming an observation/evaluation/judgment/opinion regarding the subject’s likely diagnosis or prognosis of the disease. See the 2019 Revised Patent Subject Matter Eligibility Guidance (“2019 PEG”), issued on 1/7/2019 and available at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Such steps of correlating measured biomarker levels or measurements between blood cell populations read on mental processes insofar as such correlations could take place wholly in the human mind, or by a human using pen and paper. Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing or correlating known information in Classen, or comparing information regarding a sample or test subject to a target data in Ambry and Myriad CAFC. Such concepts as assessing abnormal results and conditions by performing clinical tests for biomarker expression in T cell populations, determining abnormal elevated concentrations, and thinking about the results have also been characterized by the courts as abstract ideas. Additionally, the correlation between CD4+CD8+ T cell frequency in CD45RO+ cells and risk of aGVHD is also categorized as a law of nature/natural phenomenon; this is a judicial exception as the correlation exists in nature apart from any human action (July 2015 Update, Quick Reference Sheet; see also Univ. of Utah Research Found. v. Ambry Genetics Corp., 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) and In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)).
The claimed step of calculating a percentage ratio of CD4+CD8+ DPT cells to CD45RO+ T cells also recite mathematical processes encompassed in “mathematical concepts” in order to obtain a number or a variable or percentage ratio that is deemed to be representative of specific biomarker relationship that exists in the presence of disease. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number such as in this case a ratio of two associated biomarker levels that provides further mathematical data representative of correlation to a disease. Such step of calculating in order to determine a percentage ratio using mathematical calculation methods or similar mathematical concepts and processes have also been held by the courts to be abstract ideas or mental steps (i.e. performing a resampled statistical analysis to generate a resampled distribution, SAP Am., Inc. v. InvestPic, LLC,20; calculating a number representing an alarm limit value using the mathematical formula ‘‘B1=B0 (1.0–F) + PVL(F),’’ Parker v. Flook;21 and using a formula to convert geospatial coordinates into natural numbers, Burnett v. Panasonic Corp.22). As set forth supra, the judicial exception recited is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application.
Step 2A Prong Two
“Integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception; evaluating whether any additional element is recited beyond the judicial exception; and determining whether the additional element(s) integrate the exception into a practical application of the exception. This new consideration is based on case law including Vanda, for evaluation of particular treatment or prophylaxis limitations.
With respect to claims 12 and 19, this judicial exception is not integrated into a practical application because steps corresponding to mental activity, which could be performed in a practitioner’s head, are insufficient to constitute a practical application. In this case, indicating/ diagnosing the presence or risk of aGVHD, without significantly more, is a judicial exception and not a practical application thereof.
There are no subsequent steps in claims 12 and 19 recited that would be performed depending on the results of the assay. As in Mayo, there is no requirement that a doctor act on the results of the method. Rather, the claims merely inform a relevant audience about the judicial exception, at most amounting to a suggestion that a clinical practitioner should take those laws into account when treating the patient, such as recited in claim 12, step b) and claim 19, step b). With respect to claim 12, step b) and claim 19, step b), the recitation of simply “treating the identified subject for the risk of aGVHD or relapse of hematologic malignancy” encompasses additional steps/ elements that are also insufficient to render the claims patent-eligible because simply appending with a generic treatment by “treating the disease” (i.e. treating …for aGVHD or treating … for relapse of a hematologic malignancy), specified at a high level of generality, has been held not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception.
There are no subsequent steps recited that would practically apply the method depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
It is also noted that the claims do not clearly recite or require any physical or wet steps to be performed, such as performing immunological assays to measure CD4, CD8, and CD45RO biomarker expression in T cells. Steps of measuring CD4+, CD8+ DPT and CD45RO+ and relating their percentage proportions, when given their broadest reasonable interpretation, could read on reading values and percentages off of a chart, which would also constitute mental activity.
Although claims 12 and 19 do invoke an active step of measuring, this is not a practical application of the judicial exception because such steps are merely data gathering steps. The detecting/ measuring steps are recited at a high level of generality and are not tied, for example, to a particular machine or apparatus. Accordingly, even if the claims are interpreted as requiring a wet assay step to detect or measure biomarker expressions in the T cells of claims 12 and 19, such steps are insufficient because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015).
As above, there are no subsequent steps recited in claims 12 and 19 that would practically apply the methods depending on the results of the method, i.e. process steps that integrate the natural principle into the method and assure that it is applied in some practical manner.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
In addition to the judicial exceptions, the claims do recite steps of measuring CD4+ (positive protein expression), CD8+ DPT, and CD45RO+ cells in blood sample of the subject. As noted above, such data gathering steps are recited at a high level of generality and are not limited, for example, to any specific or unconventional testing technique. Limitations that are necessary for all practical applications of a judicial exception, such that everyone practicing the judicial exception would be required to perform those steps or every product embodying that judicial exception would be required to include those features, would not be sufficient to confer patent eligibility. As stated supra, such additional steps/elements are also insufficient to render the claims patent-eligible because simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, has been held not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception.
Although claims 13 and 20 specify a particular testing technique which is flow cytometry, such testing technique was well-known, routine and conventional as evidenced by the instant specification which shows that flow cytometry is well-known and conventionally used in the art” [0048], [0063], [0064], [0078-0081].
In addition to the evidence of the specification, Smith et al. (US 2009/0011456) teach measuring CD4, CD8 and CD45RO positive expression in T cells of peripheral blood samples of subjects using flow cytometry. Zeng et al. (US 2024/0083998) also teach measuring CD4 and CD8 positive expression on infiltrating T cells [0032]. Therefore, prior to the effective filing date of the claimed invention, it was well-understood, routine and conventional to detect and measure cell surface antigens such as CD4, CD8, and CD45RO in T cells of PBMCs using flow cytometry. See also Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015):
Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.
When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or a transformation of a particular article, in such steps that distinguishes them from well-understood, routine, and conventional data gathering activity engaged in by scientists prior to applicant’s invention, and at the time the application was filed, e.g., the routine and conventional techniques of detecting a protein using an antibody to that protein. See also MPEP 2106.05(g). Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
The combination of steps recited in these process claims taken as a whole, including the well-understood, routine, and conventional steps of data acquisition recited with a high level of generality which would substantially foreclose others from using the naturally occurring correlation, or limitations of the use to a particular technological environment (field-of-use) (“Guidance”, I.B.1), are not sufficient to qualify as a patent-eligible practical application of a law of nature or of a naturally occurring correlation, i.e. of a natural principle, as the claims do not amount to significantly more than a statement of the natural principle with generalized directions to apply it to the relevant population. See Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 101 USPQ2d 1961 (2012).
Based upon this analysis of the claims as a whole, the claims do not recite something significantly different than a judicial exception and fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Response to Arguments
7. Applicant's arguments filed July 27, 2026 have been fully considered but they are not persuasive.
A) Applicant argues that Smith et al. teaches measuring CD3+CD4+CD8β T cells and provides no mention of measuring only CD4+CD8+ T cells or DPT cells as the cell population predictive of aGVHD. Applicant specifically contends that the claimed DPT cells encompass Smith’s CD3+CD4+CD8 β T cells and other T cells that do not express CD3 (CD3 negative CD4+, CD8+ DPT) and that there is no teaching in Smith et al. that suggests how CD3 negative DPT correlates with aGVHD.
Applicant’s argument is not persuasive because contrary to Applicant’s argument and as updated in the obviousness rejection supra, Applicant’s claimed T cells including the CD4+CD8+ T cells all inherently express CD3 because CD3 is a pan biomarker of all T cells as taught and shown by Becton Dickinson. Accordingly, Applicant’s argument is not on point in stating that there are “other T cells that do not express CD3 (CD3 negative DPT)” that are encompassed in Applicant’s claimed invention but not taught by Smith et al.
Allowable Subject Matter
8. Claims 29 and 32 are allowed. Claims 29 and 32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
9. 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 GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
October 6, 2026
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