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 .
Claim Status
The claim set filed 12/8/25 is acknowledged. Claims 1-20 are cancelled. New claims 21-39 are added.
Claims 21-39 are currently under consideration for patentability under 37 CFR 1.104.
Non-compliant Specification Amendment
The specification amendments filed 12/8/25 is non-compliant and has not been entered. The amendment identifies the paragraphs by the incorrect specification paragraph numbers. Applicant is advised that the specification amendment should be refiled with paragraph numbers that correspond to the paragraph numbers in the specification filed on 4/29/22.
Withdrawn Objections
The objection to the abstract of the disclosure because the abstract contains legal phraseology in the phrase “inter alia” is withdrawn in light of Applicant’s amendments thereto.
The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code in paragraphs [0240] and [0241 is withdrawn in light of Applicant’s amendments thereto.
The objection to the disclosure because it contains the use of the terms AVERTIN, GENTLEMACS, PERCOLL, LIVE/DEAD, TruStain, TOTALSEQ, TWEEN, CHROMIUM, GLUTAMAX, and possibly others, which are trade names or marks used in commerce is withdrawn in light of Applicant’s amendments thereto.
The objections to claims 2-4, 9, and 20 are rendered moot by cancellation of the claims.
Withdrawn Claim Rejections
The rejection of claims 1-10 and 16-20 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 is rendered moot by cancellation of the claims.
The rejection of claims 1-9 and 16-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating metastatic melanoma with the claimed method, does not reasonably provide enablement for treating all types of tumors with the claimed method is rendered moot by cancellation of the claims.
The rejection of claims 1-10 and 16-20 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 is rendered moot by cancellation of the claims is rendered moot by cancellation of the claims.
Maintained Claim Rejections
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30-39 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Wang et al (US 2019/0262399 A1; filed 9/7/17; published 8/29/19).
The rejection of claims 1-5, 7-10, 16-17, and 19-20 is rendered moot by cancellation of the claims.
The instant claims are directed to a method of treating cancer in a patient in need thereof comprising isolating tumor-matching T cells from blood obtained from the patient, expanding the isolated T cells ex vivo to produce expanded tumor-matching T cells, and administering the expanded cells to the patient to treat the cancer. The cells can be CD8+ T cells. The tumor-matching cells can have an increased expression of KLRD1 or KLRK1, an increase expression of CXCR3, CD39, LGAS1, and/or LGALS3. The tumor-matching cells can have a decreased expression of LTB, CCR7, GYPC, and/or FLT3LG. The method can further comprise administering an additional agent such as pembrolizumab. The cancer can be melanoma.
Regarding the limitations of instant claim 30-33, Wang teaches a method of isolating from a biological sample an immune cells or immune cell population, in vitro expanding the immune cell, and administering the expanded immune cell to a subject (see e.g. claim 18, 35, 49, 68, 72; paragraph [0155]). The immune cell can be characterized by a signature, and can be present in a pharmaceutical composition (see e.g. claim 14, 34, 49, 68). The cells obtained can display tumor specificity (i.e. “tumor-matching”, see e.g. paragraph [0183], [0238], [0248], claim 42, 49, and 52). The cell can be used in a method for eliciting an immune response in a subject (see e.g. claim 34, 49, 73; paragraph [0050], [0157]). The cell can comprise an immune cell signature (see e.g. paragraph [0157]. The isolated cell can be used to treat a tumor or cancer (see e.g. paragraph [0067]-[0069], and claim 73, 78, 79). The T cells can be isolated from blood samples (see e.g. paragraph [0162]). The cells can comprise CD8+ T cells (see e.g. claim 41, 52). The cells can be isolated from melanoma (see e.g. paragraph [0830]), and can be administered to subjects with melanoma (see e.g. paragraph [0247] and [0883])
Regarding the limitations of instant claims 30-33, the cells can have altered expression of KLRK1 (see e.g. paragraph [0063], [0197], [0204], claim 49), an altered expression of LGALS1 (see e.g. paragraph [0063], [0197]-[0200], claim 49), and an altered expression of CCR7 (see e.g. paragraph [0054]-[0057], and claim 49)). The term “altered expression” denotes that the modification of the immune cell alters, i.e., changes or modulates, the expression of the recited gene(s) or polypeptides (see e.g. paragraph [0210]). The term “altered expression” encompasses any direction and any extent of said alteration, and specifically encompasses both increase (e.g., activation or stimulation) or decrease (e.g., inhibition) of expression (see e.g. paragraph [0210]). Wang teaches a method of isolating from a biological sample an immune cells or immune cell population, in vitro expanding the immune cell, and administering the expanded immune cell to a subject (see e.g. claim 18, 35, 49, 68, 72; paragraph [0155]). The immune cell can be characterized by a signature, and can be present in a pharmaceutical composition (see e.g. claim 14, 34, 49, 68). The cells obtained can display tumor specificity (i.e. “tumor-matching”, see e.g. paragraph [0183], [0238], [0248], claim 42, 49, and 52). The cell can be used in a method for eliciting an immune response in a subject (see e.g. claim 34, 49, 73; paragraph [0050], [0157]). The cell can comprise an immune cell signature (see e.g. paragraph [0157]. The isolated cell can be used to treat a tumor or cancer (see e.g. paragraph [0067]-[0069], and claim 73, 78, 79). The cells can comprise CD8+ T cells (see e.g. claim 41, 52). The cells can have altered expression of KLRK1 (see e.g. paragraph [0063], [0197], [0204], claim 49), an altered expression of LGALS1 (see e.g. paragraph [0063], [0197]-[0200], claim 49), and an altered expression of CCR7 (see e.g. paragraph [0054]-[0057], and claim 49)). The term “altered expression” denotes that the modification of the immune cell alters, i.e., changes or modulates, the expression of the recited gene(s) or polypeptides (see e.g. paragraph [0210]). The term “altered expression” encompasses any direction and any extent of said alteration, and specifically encompasses both increase (e.g., activation or stimulation) or decrease (e.g., inhibition) of expression (see e.g. paragraph [0210]).
Regarding the limitations of instant claim 34, the cancer can be colon cancer (see e.g. paragraph [0489] and [0883]).
Regarding the limitations of instant claims 35-37, the gene signatures can be measured by protein expression levels, or RNA expression levels (see e.g. paragraph [0149]). The RNA can be mRNA (see e.g. paragraph [0215]).
Regarding the limitations of instant claim 38, comparison can be made with naïve CD8+ cells (see e.g. paragraph [0078], [0779]-[0780], [0825]).
Regarding the limitations of instant claim 39, the method can further comprise administration of an additional agent, such as a chemotherapeutic or biotherapeutic agents (see e.g. paragraphs [0708]-[0709]). The agent can be pembrolizumab (see e.g. paragraph [0709]).
Applicant’s Arguments
Applicant argues:
1. Applicant recite an increased or decreased expression level of certain genes. Wang does not disclose the specific combination of these genes, and does not specify that they are only used for colon cancer or melanoma. The reference does not include all three biomarkers in the same paragraphs. Therefore, the reference does not anticipate the instant claims.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Regarding the “laundry list” argument, the method requires measurement of specific biomarkers, which Applicant concedes are all named in the reference. Applicant even identifies a single claim that references all of the recited biomarkers. Reference claim 49 states that “one or more genes or gene products” are selected, and that these genes or gene products are specifically named as having altered expression. The phrase “one or more gene products” indicates that all possible combinations are anticipated, even those that include subsets of the named genes. The same genes from the instant claims are specifically listed as possible gene products to have altered expression in an isolated immune cell. MPEP 2131.02 states that when the species is clearly named in a reference, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that “the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is ‘described’ as that term is used in 35 U.S.C. § 102(a), in that publication.”). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims were directed to polycarbonate containing cadmium laurate as an additive. The court upheld the Board’s finding that a reference specifically naming cadmium laurate as an additive amongst a list of many suitable salts in polycarbonate resin anticipated the claims. The applicant had argued that cadmium laurate was only disclosed as representative of the salts and was expected to have the same properties as the other salts listed while, as shown in the application, cadmium laurate had unexpected properties. The court held that it did not matter that the salt was not disclosed as being preferred, the reference still anticipated the claims and because the claim was anticipated, the unexpected properties were immaterial.). The elements of the reference are listed in the same manner as the instant claims, with a similar intended purpose. Therefore the claims are anticipated.
New Claim Rejections
Claim Rejections - 35 USC § 112(b)
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.
Claims 21-29 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 21 recites “measuring an expression level of genes on CD8+ T cells” but then the dependent claims recite measurement of expression levels of internal molecules like mRNA. It is unclear if the term “on” requires only surface molecules to be measured, or if the term is inaccurate and is intended to indicate measurement of internal and surface expression for the CD8+ cells.
Claim 23 depends from claim 1, which has been cancelled. Therefore, claim 23 is indefinite.
Claims depending from the rejected claims do not remedy the deficiency and therefore are also rejected.
Conclusion
No claim is 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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/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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