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 the Claims
Claims 68 – 75 and 77 – 86 were pending. Claims 68, 75 and 80 have been amended. No claim has been canceled or added. Claims 68 – 75 and 77 – 86 are pending and are the subject of this Office Action.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 112
Claims 75 – 86 were 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.
In view of the claim amendments in the reply of 03/31/2026, this rejection is withdrawn.
Claim Rejections - 35 USC § 103
Claims 68 – 74 were rejected under 35 U.S.C. 103 as being unpatentable over VOLK (WO 2012/171882 A1, published 12/20/2012; see PTO-892: Notice of References Cited of 12/02/2025) in view of KAARTINEN (Kaartinen, T, et al., Low interleukin-2 concentration favors generation of early memory T cells over effector phenotypes during chimeric antigen receptor T-cell expansion, Cytotherapy, Volume 19, Issue 6, 2017, Pages 689-702; see PTO-892 of 12/02/2025), ZAZA (Zaza G, et al. mTOR inhibition role in cellular mechanisms. Transplantation. 2018 Feb 1;102(2S):S3-16; see PTO-892: of 01/29/2025) , and RAMOS (Ramos, H. J. et al., Reciprocal responsiveness to interleukin-12 and interferon-α specifies human CD8+ effector versus central memory T-cell fates. Blood 2009; 113 (22): 5516–5525; see PTO-892 of 12/02/2025).
In view of the claim amendments in the reply of 03/31/2026, this rejection is withdrawn.
Double Patenting
Claims 68 – 75 and 77 – 86 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10, 13, 17 – 23, 31, and 402 – 406 of copending Application No. 17/984,810 (reference application).
In view of the claim amendments and the terminal disclaimer in the reply of 03/31/2026, this rejection is withdrawn.
NEW REJECTIONS
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 75 and 77 – 79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a composition comprising manufactured T cells, wherein at least of portion of the manufactured T cells have the following property: secretion of low levels of the inflammatory cytokines IFN-y and TNF-a at the end of six days in ex vivo culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation with anti-CD3/anti-CD28 coated magnetic beads at a 3:1 bead-to-T cell ratio. However, the T cells do not require any treatment that alters their structure so that they differ from T cells found in nature.
The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and “as an ordered combination” are considered to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. The second step—known as the “inventive concept”—requires that claims include elements which would render the method both new and useful.
The recent Eligibility Guidance (2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance and 2018 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019) address the subject matter eligibility analysis for all claims (i.e., machine, composition of matter, manufacture and process claims). The analysis is to be used for evaluating whether a claim is drawn to patent-eligible subject matter.
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions). “Directed to” means the exception is recited in the claim, i.e., the claim sets forth or describes the exception.
In Prong One of Step 2A it is determined if the claim recites a judicial exception. If the claim recites a judicial exception, then Prong Two of Step 2A determines whether the claims recites additional elements that integrate the exception into a practical application.
If the answer to Prong Two of Step 2A is no, Step 2B is used to determine whether the claim as a whole amounts to significantly more than the exception by the recitation of additional elements.
The present claims are directed to a product so Step 1 is satisfied.
With respect to Step 2A MPEP 2106.04(c) II(C)(2) teaches:
In Myriad, the Supreme Court made clear that not all changes in characteristics will rise to the level of a marked difference, e.g., the incidental changes resulting from isolation of a gene sequence are not enough to make the isolated gene markedly different. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. The patentee in Myriad had discovered the location of the BRCA1 and BRCA2 genes in the human genome, and isolated them, i.e., separated those specific genes from the rest of the chromosome on which they exist in nature. As a result of their isolation, the isolated genes had a different structural characteristic than the natural genes, i.e., the natural genes had covalent bonds on their ends that connected them to the rest of the chromosome, but the isolated genes lacked these bonds. However, the claimed genes were otherwise structurally identical to the natural genes, e.g., they had the same genetic structure and nucleotide sequence as the BRCA genes in nature. The Supreme Court concluded that these isolated but otherwise unchanged genes were not eligible, because they were not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring BRCA genes. See, e.g., Myriad, 569 U.S. at 585, 106 USPQ2d at 1977 ("Myriad's patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes … But isolation is necessary to conduct genetic testing") and 569 U.S. at 593, 106 USPQ2d at 1980 (describing how would-be infringers could not avoid the scope of Myriad’s claims). In sum, the claimed genes were different, but not markedly different, from their naturally occurring counterparts (the BRCA genes), and thus were product of nature exceptions.
In Ambry Genetics, the court identified claimed DNA fragments known as "primers" as products of nature, because they lacked markedly different characteristics. University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014). The claimed primers were single-stranded pieces of DNA, each of which corresponded to a naturally occurring double-stranded DNA sequence in or near the BRCA genes. The patentee argued that these primers had markedly different structural characteristics from the natural DNA, because the primers were synthetically created and because "single-stranded DNA cannot be found in the human body". The court disagreed, concluding that the primers’ structural characteristics were not markedly different than the corresponding strands of DNA in nature, because the primers and their counterparts had the same genetic structure and nucleotide sequence. 774 F.3d at 760, 113 USPQ2d at 1243-44. The patentee also argued that the primers had a different function than when they are part of the DNA strand because when isolated as a primer, a primer can be used as a starting material for a DNA polymerization process. The court disagreed, because this ability to serve as a starting material is innate to DNA itself, and was not created or altered by the patentee:
In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction--a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here--the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.
Ambry Genetics, 774 F.3d at 760-61, 113 USPQ2d at 1244. In sum, because the characteristics of the claimed primers were innate to naturally occurring DNA, they lacked markedly different characteristics from nature and were thus product of nature exceptions. A similar result was reached in Marden, where the court held a claim to ductile vanadium ineligible, because the "ductility or malleability of vanadium is . . . one of its inherent characteristics and not a characteristic given to it by virtue of a new combination with other materials or which characteristic is brought about by some chemical reaction or agency which changes its inherent characteristics". In re Marden, 47 F.2d 958, 959, 18 CCPA 1057, 1060, 8 USPQ 347, 349 (CCPA 1931).
For Prong One of Step 2A the claims recite a judicial exception, i.e. a natural product which is a natural phenomenon. In particular, the claimed composition comprises T cells are obtained from human patients. Thus, the answer to Prong One of Step 2A is yes, the claims do recite a judicial exception.
For Prong Two of Step 2A the claims do not integrate the exception into a practical application. The judicial exception is not integrated into a practical application because the additional limitation of “wherein at least of portion of the manufactured T cells have the following property: secretion of low levels of the inflammatory cytokines IFN-y and TNF-a at the end of six days in ex vivo culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation with anti-CD3/anti-CD28 coated magnetic beads at a 3:1 bead-to-T cell ratio” of present claim 75 and the properties of the T cells recited in claims 77 – 79 are only suggestive of an intended use that does not change the structure or function of the T cells. Thus, the answer to Prong Two of Step 2A is no.
With respect to Step 2B MPEP 2106.05 (I) teaches that:
The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).
An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
With respect to Step 2B MPEP 2106.05 (d) teaches that:
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry.
If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility. If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
. . .
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were "well known" and, thus, did not amount to a patentable application of the mathematical formula)). In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists "routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
The limitations describing properties of the claimed T cells do not change the structure or function of the T cells. Thus, the claimed T cells do not have a significantly different structure or function from the naturally-occurring human T cells which demonstrates that the recited products are not markedly different from what exists in nature.
REJECTIONS MAINTAINED
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.
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.
Claims 75, 77 – 81, 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over VOLK in view of ZAZA, FENG (Feng, X. et al. Rapamycin is highly effective in murine models of immune-mediated bone marrow failure. Haematologica 2017;102(10):1691-1703;) and BRAHMANDAM (WO 2019/090004 A1, filed 11/01/2018; see PTO-892).
Present independent claim 75 is directed to a composition comprising manufactured T cells, wherein at least of portion of the manufactured T cells have the following property: secretion of low levels of the inflammatory cytokines IFN-γ and TNF-α at the end of six days in culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation at a 3:1 bead-to-T cell ratio.
Present independent claim 80 is directed to a method of treating cancer in a subject in need thereof, comprising: administering to said subject a composition comprising manufactured T cells at a therapeutically effective dose, wherein at least of portion of the manufactured T cells have the following property: secretion of low levels of the inflammatory cytokines IFN-γ and TNF-α at the end of six days in culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation at a 3:1 bead-to-T cell ratio.
FENG is directed to a strategy that involves a combination of immune activation and the immunosuppressive mTOR inhibitor rapamycin. See abstract. FENG teaches how the mTOR inhibitor rapamycin modulates T-cell function (see p. 1695, right column) and that modulation of mTOR activity and its downstream signaling molecules is key to the therapeutic efficacy of rapamycin (see Discussion, first paragraph, p. 1701).
FENG teaches that plasma from mice were treated with rapamycin and analyzed for T-cell-related cytokines, with the results showing IFNγ and TNFα each being less than < 100 pg/ml. See Figure 3E.
Furthermore, FENG teaches that lymph node (LN) cells (2.0 x 106) were cultured, and T cells were stimulated with anti-CD3 (1 µg/ml) and CD28 antibodies (2 µg/ml). See Supplemental Materials and Methods , p. 4, at the end of FENG.
Although FENG does not co-stimulate at exactly 3:1 bead to T-cell ratio, FENG teaches the co-stimulation method and thus, this ratio can be determined by routine optimization. “[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 reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)”. See MPEP 2144.05 (I) and (II).
Because VOLK teaches manufactured T cells by cultured in the presence of temsirolimus or an IL-2 signaling inhibitor (because targeting IL-2 receptor binding or mTor pathway enables superior protective CD4-mediated CD8+ T-cell immunity) for administration to a patient (see p. 7, lines 7 – 8), ZAZA discloses that temsirolimus inhibits the mTOR pathway and leads to cellular growth but suppresses IFN-α, which may be beneficial for effector T cells, and FENG discloses plasma cells treated with mTOR-inhibitor rapamycin with properties of IFN-γ and TNF-α secreted less than < 100 pg/ml, it would have been obvious to arrive to a T-cell composition having the properties of claim 75 and 80 in a method of treating cancer of claim 80. There would have been a reasonable expectation of success given that the inhibition of mTOR is known to lead to T-cells having low levels of IFN-γ and TNF-α and known to be effective in the manufacture of T cells for T-cell therapy as evidenced by the applied prior art.
BRAHMANDAM is directed to a method for producing a composition of engineered cells, the method comprising: (a) incubating, under stimulating conditions, an input composition comprising primary human T cells, said stimulating conditions comprising the presence of (i) a stimulatory reagent capable of activating one or more intracellular signaling domains of one or more components of a TCR complex and/or one or more intracellular signaling domains of one or more costimulatory molecules and (ii) an agent that inhibits mTOR activity. See claim 1. Furthermore, BRAHMANDAM teaches that the agent that inhibits mTOR activity is rapamycin, temsirolimus. See claim 33.
BRAHMANDAN discloses the formulating cells of the output composition for cryopreservation and/or administration to a subject, optionally in the presence of a pharmaceutically acceptable excipient. See claim 74.
Regarding claims 77 and 78, BRAHMANDAM teaches that the portion, percentage, and/or amount of cells that express one or more markers of exhaustion in the output composition is or is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% less than the portion, percentage, and/or amount of cells that express the one or more markers in an output composition produced by the exemplary, alternative process and that the one or more markers of exhaustion is or includes CTLA-4 and PD-1. See paragraph 0317. Thus, an amount of cells that express CTLA-4 or PD-1 in the disclosed output composition is at least 90% less than the amount of cells that express CTLA-4 in an output composition produced by the exemplary, alternative process would be equivalent to 10% or less of T cells expressing CTLA4 of claim 77 or PD1 of claim 78. BRAHMANDAM also teaches that presence of surface expression is detected by flow cytometry. See paragraph 0560.
Regarding claim 79, BRAHMANDAM teaches an agent that inhibits mTOR activity inhibits at least one activity of an mTOR protein, such as, for example, the serine/threonine protein kinase activity on at least one of its substrates, e.g., p70S6 kinase. See paragraph 0328.
Regarding claim 83, BRAHMANDAM teaches that the dose of cells comprises between at or about 2 x 105 of the cells/kg and at or about 2 x 106 of the cells/kg, such as between at or about 4 x 105 of the cells/kg and at or about 1 x 106 of the cells/kg or between at or about 6 x 105 of the cells/kg and at or about 8 x 105 of the cells/kg. See paragraph 0505.
Regarding claim 84, BRAHMANDAM teaches that the disease, disorder or condition is a tumor or a cancer such as multiple myeloma (MM). See paragraphs 0033 and 0486.
Thus, because VOLK and ZAZA teach a method of producing manufactured T cells in a culture medium with temsirolimus and an IL-2 signaling inhibitor and adding IFN-α as discussed above, FENG teaches T cells with a secretion of low levels of the inflammatory cytokines IFN-γ and TNF-α, as defined by < 100 pg/ml per 1 x 106 cells, and BRAHMANDAM teaches the culturing of cells with mTOR inhibitors, it would have been obvious to combine the methods of the cited references to arrive to the inventions of claims 77 – 81, 83 and 84.
Claims 82, 85, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over VOLK in view of ZAZA, FENG and BRAHMANDAM as applied to claims 75, 77 – 81, 83 and 84 above, and further in view of DEISHER and KANE.
The teachings of VOLK, ZAZA, FENG and BRAHMANDAM are discussed above and fully incorporated here.
DEISHER is directed to novel therapeutic compositions and methods that keep cellular immunotherapies in the circulation or at the site of injection for extended periods of time without resorting to the use of cytotoxic preconditioning. See abstract.
KANE is directed to pharmacology, pharmacokinetics, adverse effects, and various dosage regimens of pentostatin. See Abstract: Objective, p. 939.
While VOLK discloses a T cell preparation for use in the prevention or therapy of cancer (see claim 13), VOLK does not disclose that the immune depletion regimen comprises: administering pentostatin to said subject of claim 82 or that the pentostatin is administered to said subject at a dose between 1-4 mg/m2 of claim 85.
Regarding claim 82, DEISHER discloses that prevailing thought has been that preconditioning enhanced adoptive cell transfer or therapy (ACT) effectiveness by eliminating Tregs and that pentostatin and cyclophosphamide are preconditioning agents. See paragraphs [003] and [0052].
Because VOLK in view of ZAZA discloses a T cell preparation for use in the prevention or therapy of cancer and FENG discloses T cells having the property of claim 80 (from which claim 82 depend; as discussed above), and DEISHER teaches that the administration of pentostatin and cyclophosphamide enhances adoptive cell transfer or therapy (ACT) effectiveness, it would have been obvious to one having ordinary skill in the art to modify the administration of VOLK/ZAZA’s T cell preparation to add pentostatin and cyclophosphamide to arrive to the invention of claim 82.
Regarding claim 85, KANE discloses the administration of pentostatin at a dose between 1-4 mg/m2. See Abstract: Data synthesis, p. 939.
Regarding claim 86, DEISHER discloses at paragraph [0083] that cyclophosphamide may be administered at about 200 to about 2100 mg/m2. Considering that the average human is 1.79 m2, DEISHER discloses the claimed range.
Response to Arguments
On p. 8, second paragraph, Applicant argues that “Volk specifically touts manufacturing T cells that have an enhanced cytokine release profile upon stimulation following treatment with mTOR inhibitors. See Volk at p. 9, lines 23-39; FIG. 5 (showing enhanced IFN and TNF secretion following stimulation)”. However, rapamycin does not appear to increase TNF and IFN levels in VLD or LD vs w/o columns in Fig. 5 of VOLK.
On p. 8, third paragraph – p. 9, first paragraph, of the reply, Applicant argues against FENG.
Applicant’s arguments have been fully considered; however, the cited references renders the composition of claim 75 obvious that results in the property of secretion of low levels of the inflammatory cytokines IFN-y and TNF-a at the end of six days in ex vivo culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation with anti-CD3/anti-CD28 coated magnetic beads at a 3:1 bead-to-T cell ratio, and therefore the composition of the cited references would inherently achieve the property recited in claim 75. Alternatively, the recitation of “secretion of low levels of the inflammatory cytokines IFN-y and TNF-a at the end of six days in ex vivo culture, as defined by < 100 pg/ml per 1 x 106 cells per 24 hours contained in a culture supernatant after a co-stimulation with anti-CD3/anti-CD28 coated magnetic beads at a 3:1 bead-to-T cell ratio” in claim 75 is an intended use that does not result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art and thus is not given weight for comparison of the claims with the prior art.
Allowable Subject Matter
Claims 68 – 74 are allowed. The prior art does not teach the method for producing manufactured T cells as recited in present claims 68 – 74.
Conclusion
Claims 75 and 77 – 86 are rejected. Claims 68-74 are allowable.
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/ESTELLA M. GUSTILO/Examiner, Art Unit 1646
/PETER J REDDIG/Primary Examiner, Art Unit 1646
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