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 .
Priority
This application is a 371 of PCT/US2022/031105, filed 5/26/2022. This application claims benefit to U.S. Provisional Application Serial Number 63/194,051, filed 5/27/2021. Claims 1-52 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statements submitted on 4/3/2024 and 2/19/2025 have been considered by the examiner.
Claim Objections
Claim 34 is objected to because of the following informalities:
Claim 34 recites “The method of any of claim 32...” which should be “The method of . Appropriate correction is required.
Applicant is advised that should claim 22 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, i.e. claim 22 recites a triple co-culture composition wherein: i) when the first cell is a patient derived cancer cell of a certain cancer of the hematological origin selected from leukemia, lymphoma, and myeloma; ii) the second cell is a bone marrow stromal cell; and iii) the third cell is a cancer cell of the certain cancer of the hematological origin whereas claim 23 recites the exact same subject matter wherein the three alternatives are explicitly listed. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Applicant is advised that should claim 24 be found allowable, claim 25 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof, i.e. claim 24 recites a triple co-culture composition wherein: the first cell is a patient derived cancer cell of a certain solid tumor selected from acral lentiginous melanoma, adenocarcinoma, adenoma, anaplastic thyroid cancer, brain tumor, breast cancer, colon cancer, colorectal cancer, cutaneous T-cell lymphoma, epithelioid sarcoma, esophageal cancer, follicular lymphoma, gastrointestinal cancer, head and neck cancer, hepatocellular carcinoma, intraocular melanoma, melanoma, nodular melanoma, nonmelanoma skin cancer, non-small cell lung cancer, ovarian cancer, ovarian epithelial cancer, pancreatic cancer, and uveal melanoma; the second cell is a fibroblast, vascular endothelial cell, pericyte, or adipocyte; and the third cell is a cancer cell of the certain solid tumor whereas claim 25 recites the exact same subject matter wherein the 24 combinations for the alternatives of solid tumor are explicitly listed. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 1-25 and 48-52 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 1 recites the limitation "the patient" in line 5. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously disclose a patient; hence, the limitation does not have antecedent basis; hence, claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 2-25 depend from claim 1; hence, claims 2-25 are also rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 19 recites the limitation "the patient’s cancer microenvironment" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 19 depends from claim 17 which depends from claim 1. None of claims 1, 17 nor 19 recite a patient’s cancer microenvironment; hence, the limitation does not have antecedent basis; therefore, claim 19 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 48 recites the limitation "the formation of the cellular aggregate" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite formation of the cellular aggregate; hence, the limitation does not have antecedent basis; therefore, claim 48 is rejected under 35 U.S.C. 112(b) as being indefinite. Claims 49-52 depend from claim 48; hence, claims 49-52 are also rejected under 35 U.S.C. 112(b) as being indefinite
Claim 49 recites the limitation "the magnetic first cell " in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 49 depends from claim 48. Neither claim 48 nor 49 recite a magnetic first cell; hence, the limitation does not have antecedent basis; therefore, claim 49 is rejected under 35 U.S.C. 112(b) as being indefinite.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 50 recites the broad recitation “applying the first cell, the second cell, and the third cell into a container having a cell-repellent inner surface”, and the claim also recites “optionally, centrifuging the container” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
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.
Claim 23 is 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.
Claim 23 depends from claim 22 which encompasses the same subject matter and scope as claim 23 although worded differently; thus, claim 23 does not further limit the subject matter of claim 22. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
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 26-47 and 53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 26-47 and 53 are drawn to methods comprising a mental step, i.e., a judicial exception.
The first question in the subject matter eligibility determination is “Is the claim to a process, machine, manufacture or composition of matter?” (Step 1)
Yes, claims 26-47 and 53 are drawn to methods, i.e., a process.
The second question (Step 2A, prong 1) in the subject matter eligibility determination asks “Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?"
Yes, the claimed methods of claims 26-47 and 53 are drawn to processes comprising an abstract idea (mental step; judicial exception) and well understood, conventional and routine laboratory steps.
Regarding claims 26-36 and 53, the process is drawn to a method for detecting a response comprising culturing the triple co-culture according to claim 1 in the presence of a test agent, wherein the test agent is an anti-cancer therapeutic or a candidate anti-cancer therapeutic; and detecting the response to the test agent of the first cell, the second cell, and the third cell, i.e., comprising a mental step, which is an abstract idea or intangible relationship, which is a judicial exception, wherein the mental step is detecting a response. The dependent claims, e.g., claims 31-34, make clear that the detecting a response can comprise scoring the cells as sensitive (or non-sensitive) to the test agent - clearly a mental step.
Regarding claims 37-47, the process is drawn to a method of analyzing a set of test agents comprising culturing a set of triple co-cultures, wherein each triple co-culture of the set comprises the triple co-culture according to claim 1, and wherein each triple co-culture in the set comprises the same patient derived cancer cell, and the same second cell and third cell; administering to each triple co-culture of the set a different test agent from the set of test agents or a different concentration of the same test agent; and detecting a response to the test agents of the first cell, the second cell, and the third cell in each triple co-culture, i.e., comprising a mental step, which is an abstract idea or intangible relationship, which is a judicial exception, wherein the mental step is detecting a response. The dependent claims, e.g., claims 42-44, make clear that the detecting a response can comprise scoring the cells as sensitive (or non-sensitive) to the test agent - clearly a mental step.
Step 2A, prong 2 asks “Does the claim recite additional elements that integrate the judicial exception into a practical application?”
Regarding claims 26-47 and 53, no, the claims do not integrate the judicial exception into a practical application because the claims do not recite any practical steps to be taken upon making the mental step of detecting the response or scoring the sensitivity of the cells as sensitive or not.
The final question (Step 2B) in the subject matter eligibility determination to be asked is “Does the claim recite additional elements that amount to significantly more than the judicial exception?”
No, claims 26-47 and 53 do not recite additional elements that amount to significantly more than the judicial exception.
Regarding claims 26-47 and 53, producing and culturing a triple co-culture composition is well-understood, routine and conventional as demonstrated at [0010] and throughout the disclosure of Hamilton et al., US 2019/0119618 (cite A, attached PTO-892; herein “Hamilton”) and at ([0079], [0389]; Fig. 14) of Mcallister et al., US 2015/0212072 (US Patent Application Publications cite 1, IDS, 4/3/2024; herein “Mcallister”).
Regarding claims 26-47 and 53, administering an agent, which can be an anti-cancer agent, to the co-culture and assaying changes in cell growth, cell number, cell size, and/or cell morphology is well-understood, routine and conventional as demonstrated at ([0024], [0028], [0033-34], [0039], [0042], [0089], [0166], [0168], [0225]) of Hamilton and at ([0195], [0212], [0249]) of Mcallister.
Regarding claims 34-36 and 45-47, marking cells with reporters which can be assayed by fluorescence activated cell sorting (FACS) analysis is well-understood, routine and conventional as demonstrated at ([0403], [0433]; Figs. 14, 19) of Mcallister.
These well-understood, routine, conventional activities are not part of a specific transformative method, but rather represent generalized method steps which are executed solely for the production of data for the mental step. Accordingly, claims 26-47 and 53 do not amount to significantly more than the judicial exceptions and are not patent eligible.
Thus, claims 26-47 and 53 are rejected under U.S.C. 101 as not being drawn to patent eligible subject matter.
Allowable Subject Matter
Claims 1-52 are rejected as set forth above. Claims 1-52 comprise allowable subject matter pending resolution of the rejections under 35 U.S.C. §§ 101 and 112 set forth above.
The following is a statement of reasons for the indication of allowable subject matter:
Kitano et al., US2019/0049432 (cite B, attached PTO-892; herein “Kitano”) is considered the closest prior art.
Kitano teaches triple co-culture compositions comprising a patient-derived cancer cell, fibroblasts and vascular endothelial cells, i.e., a first cell, wherein the first cell is a patient-derived cancer cell; a second cell, wherein the second cell is a non-tumor derived cell that supports growth and/or viability of the first cell (Abst.; [0027], [0034], [0048-49], [0257-259]; Examples 2-16, [0101-253]). Kitano teaches methods of determining the response of the cancer cells in the triple co-culture to anticancer agents wherein the response can comprise the number of cells which can be determined with fluorescent reporters by FACS ([0086-87], Examples 2-16, [0101-253]). However, neither Kitano nor any other prior art or combination of prior art suggests for the cultures of Kitano to further comprise a tumor-derived cell that is not derived from the patient and that exhibits sensitivity to at least one anti-cancer drug or drug combination; hence, claim 1 comprises allowable subject matter. Claims 2-53 depend, directly or indirectly, from claim 1 and are enabled for the scope of the claims; hence, claims 1-53 comprise allowable subject matter but are rejected in the current form.
Conclusion
No claims are allowed; claims 1-53 comprise allowable subject matter as detailed above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651