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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/17/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on September 04, 2026.
Claims 1-20 are currently pending, with claim 5, 8, 14-20 withdrawn.
Claims 1-4, 6-7 and 9-13 are under examination. This is the first action on the merits.
Priority
The priority date of the instant claims 1-4, 6-7 and 9-13 is 05/30/2023, filling date of the US provisional application NO. 63/504,816.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-14) in the reply filed September 04, 2026 is acknowledged. The traversal is on the ground that "Groups I and III share the same search" (Remarks, page 5). Applicant then points to claims in the groups that recite overlapping features, including genes and administering /treating steps.
The traversal by the applicant is not found persuasive.
The groups I and III are drawn to distinct inventions because the method in Group I is directed to a gene expression analysis method, whereas the method of Group III is directed to therapeutics. The two groups have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06).
Group III does not require performing the detection method of Group I. Likewise, Group I does not require treatment of a patient having increased gene-expression condition recited in Group III. The inventions are not disclosed as requiring one another and have different modes of operation and effects: Group I focuses on method of determining gene expression; whereas Group III focuses on providing therapeutic treatment.
This restriction is proper because these inventions are independent or distinct for the reasons given above and there would be a serious search and/or examination burden because Group I would require a search in at least G01N 33/5023 along with a unique text search. Group III would not be searched as above and would require a search in at least A61P 43/00 along with a unique text search.
Groups I and III do not "share the same search." Applicant's reliance on overlapping features in certain claims does not establish that the inventions require substantially the same search. Overlap in some limitations is different from showing that the two claimed inventions require identical search. For example, a search for Group I would not have searched a treatment step to a patient having increased gene expression condition required by Group III. A search for Group III would not have searched collecting and analyzing CTCs based on the specific selection criteria as required by Group I.
Therefore, the restriction requirement as initially imposed is properly maintained. The requirement is still deemed proper and is therefore made FINAL 1.
Applicant's election with traverse of the following species in the reply filed September 04, 2026 is acknowledged:
Species of measuring gene expression: A) Detecting RNA expression (claim 1; specification, page 4, line 7);
Species of mammal: C) The mammal is human (claim 1, specification, page 3, line 21);
Species of CTC: E) human Mel-A+ (CD146) (claim 4)2;
Species of gene marker indication: G) the presence or amount is indicative of onset of MBM (claim 7) 3;
Species of treatment: I) treating the mammal with a checkpoint inhibitor (claim 12) 4;
Applicant traverses on the grounds that "a search of all the alleged species could be made by the Examiner without an undue burden, and that the results of any such search would likely bear on all of the alleged species." (Remarks, page 7). However, Applicant provides no evidence to support this conclusory statement.
This is not persuasive.
In this instant case, the requirement for species election is properly made.
As stated in the restriction requirement (mail date 07/07/2026), and reiterated here:
The species are independent or distinct because the different species recite separate characteristics of such species, and there is no disclosure of relationship between species (see MPEP § 806.04(b)). In addition, these species are not obvious variants of each other based on the current record. The species necessitate separate searches, leading to serious search and/or examination burden (see MPEP § 808.01(a)) because the "Species of measuring gene expression" result in search requirements for different means for measuring different analytes; the "Species of mammal" reflect different requirements for the subjects in the method, requiring separate searches in the clinical space or the animal research space; the "Species of CTC" result in search requirements for different cells expressing different protein markers; the "Species of gene marker indication" reflect separate searches for different objectives, and subject qualifying schemes required by the method; the "Species of treatment" result in search requirement for four different treatments.
Additionally, there is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Therefore, these species are directed to independent or patentably distinct inventions, and there would be a serious search and/or examination burden if species election is not required. The requirement is still deemed proper and is therefore made FINAL.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Claims 5, 8, 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-4, 6-7 and 9-13 are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, lines 1-2, it should read "A method to detect in a mammal having or at risk of having melanoma
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 1 recites a method comprising:
a) providing a sample from the mammal having circulating tumor cells (CTCs);
b) detecting the presence or amount of expression of two or more genes in the CTCs from the sample of a); and
c) determining whether the presence or amount in b) is indicative of melanoma brain metastases (MBM).
Under BRI, this method encompasses both diagnostic or prognostic methods that rely on expression of known biomarkers; and methods for discovering new biomarkers.
Specifically, the determining step is broad enough to encompass analyzing the detected gene expression to determine whether the expressed genes include genes indicative of MBM (i.e., biomarker gene signature discovery via bioinformatic pipelines). The determining step is also broad enough to encompass analyzing the detected gene expression to determine whether known marker genes indicative of MBM are expressed in the sample (i.e., diagnosis/prognosis based on expression of a panel of known biomarkers).
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.
Claim 4 is rejected under 35 U.S.C. 112(b), 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.
Regarding claim 4, it recites "wherein the CTCs are human Mel-A+ (CD146)."
This recitation is indefinite because of the parenthetical language "Mel-A+ (CD146)."
Mel-A and CD146 are two different cell surface proteins. The parenthetical language makes it unclear whether Mel-A and CD146 are intended to be interchangeable, such that the CTCs may be expressing Mel-A or CD146, or whether CD146 is optional, or whether CD146 otherwise further defines Mel-A+ CTCs.
The specification does not clearly define or describe a CTC that is Mel-A+ (CD146). Accordingly, the metes and bounds of the claimed subject matter cannot be determined with reasonable certainty.
For the purpose of compact prosecution and applying prior art under 35 USC§ 102 and 103, this phrase is interpreted as encompassing human CTCs that express Mel-A or CD146.
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 1-4, 6-7 and 9-13 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.
Independent claim 1 is drawn to a method comprising detecting gene expression in a sample comprising circulating tumor cells, in order to determine whether the gene expression is indicative of melanoma brain metastases (MBM).
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Step 1 - Whether the Claim is to a Statutory Category: YES. The claims are drawn to a method, therefore to one of the four statutory categories.
Step 2A Prong 1 - Whether the Claim Recite an Abstract idea, Law of Nature, or Natural Phenomenon: Yes.
As stated in MPEP 2106.04(b)(I), laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
Here, the claim recites a judicial exception, namely a law of nature of natural phenomenon. Specifically, the claim recites the natural correlation between a gene expression pattern observed in a sample from a subject, and the subject having a physiological condition (e.g., melanoma brain metastases).
In conclusion, the claims recite laws of nature and natural phenomena.
Step 2A Prong 2 - Whether the Claim Recite Additional Elements that Integrate the Judicial Exception into a Practical Application: No. The claim as a whole do not integrates the exception into a practical application of that exception. The additional element in the claim do not integrate the recited judicial exception into a practical application of the exception.
Claim 1 involves a natural correlation (correlation between a gene expression pattern observed in a sample from a subject, and the subject having a condition), and recites steps of providing CTCs, detecting gene expression, and determine whether the detected gene expression is indicative of melanoma brain metastases. The step of providing CTCs, recited at high-level of generality, reflects extra-solution activities for data gathering. The detecting and determining steps, recited at high level of generality, reflect observation of the naturally occurring correlation, and See MPEP §2106.04(d).
Thus, these method steps merely observe the judicial exception and do not integrate it into a practical application.
Although claims 12-13 further recite "treating the mammal with a checkpoint inhibitor or a kinase inhibitor." This treatment step does not integrate the judicial excepting into a practical application.
The treating step does not depend on the outcome of the determining step and is not recited as applying or using the judicial exception in any meaningful way. Thus, the treatment limitation has no more than a nominal or insignificant relationship to the judicial exception.
Further, as currently written, the claims encompass scenarios in which the mammal is treated first and the gene expression is observed afterward. Accordingly, the treating step is merely ancillary to the overall observation of the judicial exception and represents insignificant extra-solution activity. See MPEP 2106.04(d)(2)
Step 2B- Whether a Claim Amounts to Significantly More: No.
According to MPEP§ 2106.05, 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” 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).
In this instant case, the claims, when considered as a whole, do not recite any inventive concept with additional elements that amount to significantly more than the judicial exception.
Claim 1 recites detecting gene expression in a CTC sample, but does not recite any specific technique or detail for carrying out the detection step. Accordingly, the detection step encompasses any known gene expression detection method in the art. As recognized by the courts, determining the marker expression level through molecular biology techniques such as amplification and sequencing, represents well-understood, routine, conventional activity in the life science arts. See University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014).
The determining step does not provide an inventive concept (significantly more than the judicial exception) because it is classified as an abstract mental process, which is also a judicial exception. Moreover, the steps of “detecting” and “determining,” recited at a high level of generality, are merely data gathering in conjunction with a law of nature. Thus, these steps are insignificant extra-solution activities and do not qualify as “significantly more.” (see MPEP § 2106.05(g))
The dependent claims have been considered but they do not recite additional elements that amount to significantly more than the judicial exception, as they represent mere general linkage of the judicial exception to the additional elements in the claims (MPEP § 2106.05(h)).
As discussed above, the treating step in claims 12-13 do not integrate the judicial exception into a practical application. Claims 12-13 also do not amount to significantly more, because as discussed above, in the absence of a significant relationship to the judicial exception, they represent a general linkage to the judicial exception. Additionally, the recited compositions suitable for treating cancer (e.g., Nivolumab , ipilimumab) were well-known, routine, and commercially available5.
In conclusion, the claims are not patent eligible under 35 U.S.C. 101.
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.
Claims 1-4, 6-7 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bowley 6(Bowley et al., The RPL/RPS gene signature of melanoma CTCs associates with brain metastasis. Cancer Res Commun. 2022 Nov;2(11):1436-1448. doi: 10.1158/2767-9764.crc-22-0337. Epub 2022 Nov 16. PMID: 36407834; PMCID: PMC9668078.; supplementary material included)
Regarding claim 1, Bowley teaches a method to detect in a mammal having or at risk of having melanoma brain metastasis comprising:
a) providing a sample from the mammal having circulating tumor cells (CTCs) (p. 1437, right-hand col, para. 1-2);
b) detecting the presence or amount of expression of two or more genes in the CTCs from the sample of a) (p. 1437, right-hand col, para. 3, RNA sequencing); and
c) determining whether the presence or amount in b) is indicative of melanoma brain metastases (MBM) (p. 1443, right-hand col, The Identification of the CTC RPL/RPS Gene Signature by Multilevel MBM Discrimination).
Regarding claim 2, Bowley teaches wherein the mammal has melanoma (p. 1437, left-hand col, para 4, “Patients diagnosed with primary or metastatic melanoma”).
Regarding claim 3, Bowley teaches wherein the sample is a physiological fluid sample (p. 1437, left-hand col, blood sample).
Regarding claim 4, Bowley teaches wherein the CTCs are human Mel-A+ (p. 1437, right-hand col, line 1).
Regarding claim 6, it recites “wherein the presence or amount is increased relative to a corresponding sample from a corresponding mammal without MBM.”
This limitation is anticipated by Bowley because it does not further distinguish the claimed method from prior art methods comprising all the claimed steps.
Per MPEP 2111.04, a wherein clause can limit a method claim if it contributes meaning and purpose to the manipulative steps.
In this instant case, the "wherein" clause does not introduce any additional steps or modify any existing step. It merely describes a potential outcome of the method of observing gene expression, and does not make a manipulative difference to the claim scope.
Therefore, this descriptive claim language does not distinguish the claimed method from prior art methods that disclose all the claimed steps.
Regarding claim 7, Bowley teaches wherein the presence or amount is indicative of onset of MBM (p. 1444, right-hand col, para 2, lines 10-12, “We demonstrated that transcriptional subtyping of melanoma CTCs resulted in the common CTC RPL/RPS gene signature, possibly responsible for MBM onset and progression” ).
Regarding claim 9, Bowley teaches wherein an increase in expression of at least one of the genes is indicative of MBM (Figure 7D; p. 1443, right-hand col, para 1, “unique CTC genetic signature associated with MBM… mean RPL/RPS values in patients with MBM had 2- to 10-fold increase in the level of ribosomal proteins, compared with patients with No MBM”).
Regarding claim 10, Bowley teaches wherein at least 3, 4, 5, 6, 7, 8, 9, 10 or more genes are detected (Figure 7C-D).
Regarding claim 11, Bowley teaches wherein a plurality of RPL 12, RPL 13, RPL 18A, RPL 19, RPL 23, RPL 26, RPL 35A, RPL 37, RPL 38, RPL 6, RPL 7, RPL 7A, RPS 12, RPS 15A, RPS 18, RPS 24, RPS 26, RPS 28, RPS 5, RPS 7, or RPS A, or any combination thereof, is detected (Table S4).
Regarding claims 12-13, Bowley teaches treating the mammal with nivolumab (p. 1439, right-hand col., para 2, lines 19-21).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-4, 6-7 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bachireddy (US20190300967A1- Compositions and methods for predicting response and resistance to ctla4 blockade in melanoma using a gene expression signature ; Published 2019-10-03), in view of Massague (US20100029748A1- Metastasis Promoting Genes and Proteins; 2010-02-04); as evidenced by
Affymetrix ([HG-U133A] Affymetrix Human Genome U133A Array; Public on Mar 11, 2002; NCBI GEO Database: Platform GPL96; www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GPL96); and
Sprouse (Sprouse et al., PMN-MDSCs Enhance CTC Metastatic Properties through Reciprocal Interactions via ROS/Notch/Nodal Signaling. Int J Mol Sci. 2019 Apr 18;20(8):1916. doi: 10.3390/ijms20081916. PMID: 31003475; PMCID: PMC6514876. ).
A) Bachireddy teaches methods of performing gene expression analysis for predicting treatment response in metastatic melanoma (Abstract; [0003]-[0005]).
Regarding claim 1, Bachireddy teaches a method to detect in a mammal at risk of having melanoma brain metastasis ([0005] patients with metastatic melanoma, which are at risk of brain metastasis, see [0183] “Brain metastases are particularly common in patients with metastatic melanoma”) comprising:
providing a sample from the mammal having circulating tumor cells (CTCs) ([0009] obtaining a test sample from a human subject having melanoma; [0011]; [0032] “sample comprises one or more circulating tumor cells”);
detecting the presence or amount of expression of two or more genes in the CTCs from the sample of a) ([0009]; [0011] “determining the expression level of at least one melanoma-associated gene in the test sample;” ; [00232] lines 18-19, gene expression analysis using Affymetrix GenChip technology; see also [0034] “ the expression level of the melanoma-associated gene is detected via an Affymetrix Gene Array hybridization”).
Bachireddy teaches performing gene expression profiling in a sample, such as circulating tumor cells, from a patient with metastatic melanoma ([0009]; [0011]; [0032]). A skilled artisan would readily understand that a patient with metastatic melanoma is at risk of having brain metastasis because Bachireddy teaches that “brain metastases are particularly common in patients with metastatic melanoma”([0183]).
Although Bachireddy does not explicitly teach determining whether gene expression is indicative of melanoma brain metastases, this feature would have been obvious in view of the knowledge in the art, as shown by Massague.
Massague similarly teaches performing gene expression profiling of circulating tumor cells for differentially expressed gene signatures that can be used for predicting brain metastasis (Abstract; [0040]-[0041]).
Accordingly, a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it prima facie obvious to modify Bachireddy’s gene expression analysis method in metastatic melanoma patients to further consider the expression of brain metastasis signatures, as taught by Massague, in order to further determine the patient’s risk of brain metastasis.
A skilled artisan would have been motivated to make this modification because Bachireddy teaches that brain metastases are particularly common in patients with metastatic melanoma. Therefore, evaluating the risk of brain metastasis would have been useful for understanding the patient’s prognosis and selecting appropriate treatment options.
There would have been a reasonable expectation of success because the references provide technical compatible teachings. Both reference teach overlapping gene expression analysis methods, including use of Affymetrix Gene Array (Bachireddy in [0034]; Massague in [0065]). Thus, a skilled artisan would not have needed to substantially modify Bachireddy’s method, other than considering the gene signature taught by Massague, whose expression would have already been detected by the Affymetrix Gene Array.
B) Regarding claim 2, Bachireddy teaches the mammal has melanoma ([0009] a human subject, with melanoma ).
Regarding claim 3, Bachireddy teaches the sample is a physiological fluid sample ([0032] a blood sample)
Regarding claim 4, it recites “wherein the CTCs are human Mel-A+ (CD146).”
This limitation would have been obvious in view of the combined teachings of Bachireddy and Massague, as evidenced by Sprouse.
Bachireddy teaches analyzing sample comprising CTCs from human subjects having melanoma ([0009] obtaining a test sample from a human subject having melanoma; [0032] the sample comprises one or more circulating tumor cells).
Mel-A is a surface marker for melanoma CTCs, as evidenced by Sprouse (see Figure 1D). Therefore, a skilled artisan would readily understand that the melanoma CTCs disclosed in Bachireddy would have possessed the Mel-A surface marker.
Regarding claim 6, it recites “wherein the presence or amount is increased relative to a corresponding sample from a corresponding mammal without MBM.”
This limitation is obvious in view of the combined teachings of Bachireddy and Massague because it does not further distinguish the claimed method from prior art methods comprising all the claimed steps.
Per MPEP 2111.04, a wherein clause can limit a method claim if it contributes meaning and purpose to the manipulative steps.
In this instant case, the "wherein" clause does not introduce any additional steps or modify any existing step. It merely describes a potential outcome of the method of observing gene expression, and does not make a manipulative difference to the claim scope.
Therefore, this descriptive claim language does not distinguish the claimed method from prior art methods that disclose all the claimed steps.
Regarding claim 7, it recites “wherein the presence or amount is indicative of onset of MBM.”
Massague teaches gene signatures with a significant correlation with brain relapse ([0041]), and can be used in predicting the risk of cancer metastasis to the brain ([0024]). These identified gene expression enables circulating breast cancer cells to penetrate and colonize the brain (0055]).
Therefore, although Massague does not explicitly teach that its gene signatures are indicative of melanoma brain metastasis, it teaches and suggests that the gene signatures are applicable to any cancer brain metastasis (not limited only to breast cancer), because the genes have functions that support the process of brain metastasis itself, not limited to breast cancer, including blood-brain barrier penetration and brain colonization.
Accordingly, a skilled artisan would have understood that the gene signatures taught by Massague would have been relevant to evaluating brain metastasis in other metastatic cancers, including melanoma, which also requires tumor cells to access and colonize the brain.
Regarding claim 9, Massague teaches increase in expression of at least one gene is indicative of brain metastasis (Table 1).
Regarding claim 10, Massague teaches least 3 genes are detected by teaching detecting gene expression level via an Affymetrix HG-U133A gene expression chip ([0065]; [0068]; [0029]; [0053]), as evidenced by Affymetrix.
Affymetrix teaches detection of least 3 genes (p.2, panel comprising over 20, 000 genes).
Regarding claim 11, Massague teaches detecting gene expression level via an Affymetrix HG-U133A gene expression chip ([0065]; [0068]; [0029]; [0053]), which encompasses detecting gene expressions of a plurality of genes comprising RPL 12 (ID# 200809_x_at in Affymetrix); RPL 13 (ID# 208929_x_at in in Affymetrix), RPL 18A (ID# 200869_at in in Affymetrix), as evidenced by Affymetrix.
Regarding claims 12-13, Bachireddy teaches treating the mammal with ipilimumab ([0041]; [0051]).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
The following prior art also teach detecting gene expression in CTC samples:
Klotz et al., Circulating Tumor Cells Exhibit Metastatic Tropism and Reveal Brain Metastasis Drivers. Cancer Discov. 2020 Jan;10(1):86-103. doi: 10.1158/2159-8290.CD-19-0384. Epub 2019 Oct 10. PMID: 31601552; PMCID: PMC6954305;
Aya-Bonilla et al. Detection and prognostic role of heterogeneous populations of melanoma circulating tumour cells. Br J Cancer 122, 1059–1067 (2020).; doi.org/10.1038/s41416-020-0750-9;
Fankhauser et al, Single-Cell Identification of Melanoma Biomarkers in Circulating Tumor Cells. Cancers (Basel). 2022 Oct 8;14(19):4921. doi: 10.3390/cancers14194921. PMID: 36230844; PMCID: PMC9564060;
US20180057889A1 - Digital Analysis of Circulating Tumor Cells in Blood Samples
Conclusion
Claim 1 is objected to; claims 1-4, 6-7 and 9-13 are rejected. No claims are allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIAN NMN YU/Examiner , Art Unit 1681
1 Claims 15-20 are withdrawn as being drawn to non-elected groups II-III.
2 Claim 5 is withdrawn as being drawn to non-elected species F.
3 Claim 8 is withdrawn as being drawn to non-elected species H.
4 Claim 14 is withdrawn as being drawn to non-elected species K-N.
5 See Wikipedia (Checkpoint inhibitor - Wikipedia; Archived Dec 15, 2022 on WaybackMachine)
6 Bowley qualifies as prior art, because its publication date in Nov, 2022 precedes the currently effective filling date on May 30, 2023. Additionally, Bowley includes additional authors other than the inventors in this present application.
