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 17/948,760 filed on 09/20/2022 claims the benefit of provisional U.S. Patent Application No. 63/246,208, filed on 09/20/2021.
The priority date of independent claims 1 and 16, and their dependent claims, is determined to be 09/20/2021, the filing date of provisional U.S. Patent Application No. 63/246,208.
Status of Claims
Applicant’s amendments to claims filed 11/10/2025 in response to the Non-Final Rejection mailed 08/08/2025 are acknowledged.
Claims 1, 3, 4, 6-11, and 13-16 are amended.
Claim 12 has been canceled.
Claims 1-11 and 13-21 are pending and under examination.
Response to Remarks filed 11/10/2025
The amendments and arguments presented in the papers filed 11/10/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 08/08/2025 listed below have been reconsidered as indicated.
a) The objections to the specification regarding the use of trade names or marks are withdrawn in view of the amendments to the specification.
b) The 35 USC 112(b) indefiniteness rejections of claims 7 and 15 have been withdrawn in view of the amendments to claims.
c) The rejection of claims 3,4,6, and 7 under 35 U.S.C. 101 have been withdrawn in view of the amendments to claims.
d) The rejections of claims 1-8 and 10-11 under 35 U.S.C. 102(a)(1) as being anticipated by Han et al. (Lymph Liquid Biopsy for Detection of Cancer Stem Cells. 2020. Cytometry Part A. 99(5): 496-502), are withdrawn in view of the amendments to the claims.
e) The rejections of claims 16-20 under 35 U.S.C. 102(a)(1) as being anticipated by Milasan (Extracellular vesicles are present in mouse lymph and their level differs in atherosclerosis. 2016. J Extracell Vesicles.5:31427 p. 1-10), are withdrawn in view of the amendments to the claims.
f) The rejection of claim 12 under 35 U.S.C. 103 as being unpatentable over Han et al. (Lymph Liquid Biopsy for Detection of Cancer Stem Cells. 2020. Cytometry Part A. 99(5): 496-502) in view of Lassig et al. (Excessive inflammation portends complications: Wound cytokines and head and neck surgery outcomes. 2019. The Laryngoscope, 129: E238-E246), is withdrawn as being moot in view of the cancellation of the claim.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
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 1-2, 5-6, 8, 10, 11, 14, and 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Callaghan et al.(US20190060546A1).
Regarding claim 1, Callaghan teaches a method for diagnosing a medical condition such as cancer (para 27), removing lymphatic fluid from the thoracic duct during a surgical procedure (para 26) on a human (Fig. 5). Callaghan further teaches the method can be used to detect cancer markers (para 110).
Regarding claim 2, Callaghan teaches a cancer cell as a cancer marker (para 110).
Regarding claims 5 and 6, Callaghan teaches comparing parameters of lymphatic fluid with parameters of whole blood from elsewhere in the body, which satisfies the requirements of detecting the presence of the cancer biomarker in a blood sample from the subject. Callaghan further teaches sampling components from blood and lymph to generate a ratio of the concentration of the sampled components in whole blood and lymph (para 123), which satisfies the requirements of measuring a ratio of a quantity of the cancer biomarker in the fluid and the blood sample.
Regarding claim 8, Callaghan teaches the fluid is lymphatic fluid (paras 20, 26).
Regarding claim 10, Callaghan teaches separating lymphatic fluid from other fluid (para 15).
Regarding claim 11, Callaghan teaches detecting cancer biomarkers in lymphatic fluid (para 110).
Regarding claim 14, Callaghan teaches removing lymphatic fluid during a bypass procedure (para 26), i.e. not a cancer-related surgery.
Regarding claim 16, Callaghan teaches a method for diagnosing a medical condition (para 27), removing lymphatic fluid from the thoracic duct during a surgical procedure (para 26) on a human (Fig. 5). Callaghan teaches the lymphatic fluid may be collected in a storage container and analyzed (para 17).
Regarding claim 17, Callaghan teaches detecting antibodies, i.e. not sequencing (para 106).
Regarding claim 18, Callaghan teaches detecting markers to diagnose immunologic conditions (para 106).
Regarding claim 19, Callaghan teaches detecting markers that include white blood cells (para 106), i.e. solid material.
Regarding claim 20, Callaghan teaches removing lymphatic fluid from the thoracic duct
Regarding claim 21, Callaghan teaches removing lymphatic fluid during a surgical procedure (paras 26, 116).
Response to Arguments against Claim Rejection - 35 U.S. C § 102
Claims 1-8 and 10-11 (anticipated by Han); and claims 16-20 (anticipated by Milasan)
The response asserts that Han and Milasan methods are performed specifically for the collection of thoracic duct (TD) lymph from mice, and further that Han and Milasan fail to report obtaining a fluid form a thoracic duct of a human subject as a by-product of surgery (p. 9)
Applicant’s arguments with respect to the rejection(s) of claim(s) 1-8 and 10-11 by Han and claims 16-20 by Milasan have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made of claims1-2, 5-6, 8, 10, 11, 14, and 16-21, in view of Callaghan et al.(US20190060546A1).
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.
Claims 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Callaghan et al. (US20190060546A1) in view of Wang (US20180252722A1) .
These are new rejections necessitated by claim amendments filed on 11/10/2025.
The teachings of Callaghan as they relate to claim 1 are stated in the 102 rejection above in this office action.
Regarding claims 3 and 4, Callaghan teaches detecting and quantifying cancer biomarkers (para 110), but does not teach providing fluorescent labels to the fluid to identify the cancer biomarker (claim 3), or quantifying the cancer biomarker based on the fluorescent labels (claim 4).
Wang teaches methods for enumerating circulating tumor cells in a blood or lymphatic fluid sample, the method comprising: coupling different fluorophores to different sequence-specific reporting probes (para 22).
Wang further teaches counting the number of circulating tumor cells by calculating the amount of tumor-specific cells (para 29).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Callaghan and Wang to arrive at the instantly claimed invention. The modification would have entailed using the fluorophores of Wang to detect and quantify the cancer biomarkers of Callaghan. One of ordinary skill in the art would have been motivated to add the fluorophores detection and quantification of Wang for the benefits of convenience and versatility enabled by the use of fluorophore labels. As Wang states, there are many sequence-specific commercially available probes (para 22). There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Callaghan et al. (US20190060546A1).
This is a new rejection necessitated by claim amendments filed on 11/10/2025.
Regarding claim 7, Callaghan teaches certain cells, proteins, factors, and/or other components of the fluid may be present at a higher concentration than in the patient's whole blood (paras 103, 121) and that, compared to blood, lymphatic fluid contains a much higher concentration of various components (para 103). This higher concentration (of e.g. cell populations) can be useful in diagnosing various diseases (para 103). Callaghan also states that the lymphatic system may be involved in a variety of pathologic states including invasion and spread of malignant cells leading to metastasis. And further that the lymphatic system may contain a higher concentration of malfunctioning cells in various immune system disorders (para 3).
Callaghan does not explicitly teach if the subject is afflicted with cancer, the fluid comprises a greater concentration of the cancer biomarker than blood obtained from the subject.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Callaghan to arrive at the instantly claimed invention. Callaghan states that the lymphatic system is involved in nearly any immune mediated response (para 3). Given the higher concentration of malignant cells found in the lymphatic system, it would have been obvious to one of skill In the art that markers of cancer would be higher in the fluid of a patient with cancer that one without. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 15, Callaghan teaches sampling fluid over time for trending of contents (para 127), but does not specifically teach the fluid is captured within 24 hours of the surgery.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to collect the fluid of Callaghan within 24 hours of surgery. One would have been motivated to do so in order to accurately track changes in levels of contents of the lymphatic fluid in close proximity to the surgery. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Callaghan et al. (US20190060546A1) in view of Strickler et al. (Genomic Landscape of Cell-Free DNA in Patients with Colorectal Cancer. 2018. Cancer Discovery. 8(2):164-173).
This a new rejection necessitated by claim amendments filed on 11/10/2025.
Regarding claim 9, Callaghan does not teach detecting the presence of a cancer biomarker comprises sequencing DNA or RNA from a tumor cell or from cell-free tumor DNA.
Strickler teaches sequencing cell-free DNA fin a liquid biopsy from cancer patients (p. 164, Abstract). Strickler states that cfDNA profiling can generate insights into tumor heterogeneity and therapeutic resistance and identify mutations. (p. 164, Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Callaghan and Strickler to arrive at the instantly claimed invention. The modification would have entailed using the sequencing assay of Strickler on the lymphatic fluid samples of Callaghan. A person with ordinary skill in the art would have been motivated to perform the assay of Strickler on the existing samples of Callaghan to identify characteristics that would aid in disease diagnosis, a stated goal of Callaghan. Further, Strickler is directed towards liquid biopsy analysis and methods would be expected to be compatible with the samples of Callaghan. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Callaghan et al. (US20190060546A1) in view of Nowecki et al. (Molecular and biochemical testing in stage III melanoma: multimarker reverse transcriptase‐polymerase chain reaction assay of lymph fluid after lymph node dissection and preoperative serum lactate dehydrogenase level. 2008. British Journal of Dermatology. 159(3): 597–605).
This a new rejection necessitated by claim amendments filed on 11/10/2025.
Regarding claim 13, Callaghan is silent as to the surgery type.
Nowecki teaches testing lymphatic fluid for melanoma markers, the method comprising collecting lymph fluid after lymphadenectomy (p. p. 598, col. 2). Nowecki states that there is a need for biomarkers to identify patients at risk for disease progression after resection of melanoma regional lymph node metastasis (p. 597, Abstract). Nowecki further states that lymph fluid is routinely collected from patients who had undergone lymphadenectomy and use of lymph fluid as a diagnostic would be very important for diagnostic purposes (p. 603, col. 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Callaghan and Nowecki to arrive at the instantly claimed invention. The modification would have entailed using the method of Nowecki to obtain the lymphatic fluid sample of Callaghan. One would have been motivated by routine accessibility of the surgical lymph fluid of Nowecki. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(I). (i). Claims 1-2, 5-8,10, 11, and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,871 (reference application) in view of Callaghan et al. (US20190060546A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims of '871 are both directed to methods for disease diagnosis comprising steps of collecting fluid from a lymphatic channel and identifying indicia of cancer (i.e. cancer biomarker) in said fluid .
Regarding instant claim 1, copending claim 1 requires collecting fluid from a lymphatic channel of a patient suspected of having cancer; and identifying indicia of cancer (i.e. cancer biomarker) in said fluid.
The teachings of Callaghan as they relate to this claim is given previously in this office action and are fully incorporated here.
Regarding instant claim 2, copending claim 7 requires the indicia of cancer (i.e. cancer biomarker) be a tumor cell.
Regarding instant claim 5, copending claim 9 requires comparing said amounts to amounts identified in blood, which is encompassed by the claim requirement of detecting the cancer biomarker in blood.
Regarding instant claim 6, copending claim 9 requires determining amounts of said indicia and comparing said amounts to amounts identified in blood, i.e. measuring a ratio of the biomarker in thoracic fluid (lymphatic channel) and blood.
Regarding instant claim 7, copending claims do not require if the subject is afflicted with cancer, the fluid comprises a greater concentration of the cancer biomarker than blood obtained from the subject. The teachings of Callaghan as they relate to this claim is given previously in this office action and are fully incorporated here.
Regarding instant claim 8, copending claim 1 requires fluid from a lymphatic channel.
Regarding instant claim 10, copending claim 2 requires extracting lymphatic fluid from said fluid.
Regarding instant claim 11, copending claim 1 requires collecting fluid from a lymphatic channel of a patient suspected of having cancer; and identifying indicia of cancer (i.e. cancer biomarker) in said fluid.
Regarding instant claims 14 and 15, copending claims do not require the surgery is not a cancer-related surgery (claim 14), or the fluid is captured within 24 hours of the surgery. The teachings of Callaghan as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 16, copending claim 1 requires collecting fluid from a lymphatic channel of a patient suspected of having cancer; and identifying indicia of cancer (i.e. marker of a medical condition) in said fluid. Copending claim 7 further requires the indicia can be a protein (i.e. not tumor-associated genetic material).
The teachings of Callaghan as they relate to this claim is given previously in this office action and are fully incorporated here.
Regarding instant claims 17 and 18, copending claims do not require the assaying step does not include sequencing (instant claim 17) or the marker of a medical condition is not a marker of cancer (instant claim 18).
The teachings of Callaghan as they relate to these claims are given previously in this office action and are fully incorporated here.
Regarding instant claim 19, copending claim 7 requires the indicia can be a protein or tumor cell (i.e. solid material).
Regarding instant claim 20, copending claims 1 and 2 require collecting fluid from a lymphatic channel (e.g. thoracic duct) and extracting lymphatic fluid from said fluid.
Regarding instant claim 21, copending claims do not require the fluid is obtained during surgery.
The teachings of Callaghan as they relate to this claim is given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii). Claims 3 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,871 (reference application) in view of Callaghan et al. (US20190060546A1) in view of Wang (US20180252722A1).
Regarding instant claim 3, copending claim 1 requires identifying the indicia of cancer (i.e. cancer biomarker) but copending claims do not require providing fluorescent labels to the fluid to identify the cancer biomarker.
Regarding instant claim 4, copending claim 9 requires determining amounts of said indicia (i.e. cancer biomarker) but does not require quantifying the cancer biomarker based on the fluorescent labels.
The teachings of Callaghan and Wang as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(iii) Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,871 (reference application) in view of Callaghan et al. (US20190060546A1), further in view of Strickler et al. (Genomic Landscape of Cell-Free DNA in Patients with Colorectal Cancer. 2018. Cancer Discovery. 8(2):164-173).
Regarding instant claim 9, copending claims do not require the step of detecting the presence of a cancer biomarker comprises sequencing DNA or RNA from a tumor cell or from cell-free tumor DNA (instant claim 9).
The teachings of Callaghan and Strickler as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(iv). Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,871 (reference application) in view of Callaghan et al.(US20190060546A1) in view of Nowecki et al. (Molecular and biochemical testing in stage III melanoma: multimarker reverse transcriptase‐polymerase chain reaction assay of lymph fluid after lymph node dissection and preoperative serum lactate dehydrogenase level. 2008. British Journal of Dermatology. 159(3): 597–605).
Regarding instant claim 13, copending claims do not require the surgery comprises a resection, dissection, or excision.
The teachings of Callaghan and Nowecki as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(II). (i). Claims 1-2, 5- 6, and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-23 and 29-30 of copending Application No. 17/947,861 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims of '861 are both directed to methods comprising steps of identifying biomarkers in lymphatic fluid. .
Regarding instant claim 1, copending claim 15 requires measuring a biomarker in lymphatic a surgical drain fluid to predict metastatic disease (i.e. cancer).
Regarding instant claim 2, copending claim 19 requires the cancer biomarker is selected from a list including tumor cell.
Regarding instant claim 5, copending claim 16 requires identifying the biomarker in blood.
Regarding instant claim 6, copending claim 29 requires assessing metastatic disease based on relative amounts of said biomarker in the at least two of lymphatic channel fluid, lymph node tissue, and blood, thus satisfying the requirement of measuring a ratio of a quantity of the cancer biomarker in the fluid from the thoracic duct and the blood sample.
Regarding instant claim 11, requires identifying a cancer biomarker in lymphatic channel fluid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii). Claims3 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-23 and 29-30 of copending Application No. 17/947,861 in view of Callaghan et al.(US20190060546A1) in view of Wang (US20180252722A1).
Copending claims do not require the limitations of instant claims 3 or 4.
The teachings of Callaghan and Wang as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(iii). Claims 7-8, 10, 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-23 and 29-30 of copending Application No. 17/947,861 in view of Callaghan et al. (US20190060546A1).
Regarding instant claims 7, 8, 10, and 14-21, copending claims patent do not require limitations of the instant claims. .
The teachings of Callaghan as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(iv). Claim 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,861 in view of Callaghan et al. (US20190060546A1), further in view of Strickler et al. (Genomic Landscape of Cell-Free DNA in Patients with Colorectal Cancer. 2018. Cancer Discovery. 8(2):164-173).
Regarding instant claim 9, copending claims do not require the step of detecting the presence of a cancer biomarker comprises sequencing DNA or RNA from a tumor cell or from cell-free tumor DNA (instant claim 9).
The teachings of Callaghan and Strickler as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(v). Claim 13 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 17/947,861 in view of Callaghan et al. (US20190060546A1), further in view of Nowecki et al. (Molecular and biochemical testing in stage III melanoma: multimarker reverse transcriptase‐polymerase chain reaction assay of lymph fluid after lymph node dissection and preoperative serum lactate dehydrogenase level. 2008. British Journal of Dermatology. 159(3): 597–605).
Regarding instant claim 13, copending claims do not require the surgery comprises a resection, dissection, or excision.
The teachings of Callaghan and Nowecki as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(III). (i). Claims 1-2, 5, 8, 9, 11, 13, 15-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/834,663 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims of '663 application are both directed to methods for detecting disease comprising obtaining a fluid, detecting an analyte indicative of a disease.
Regarding instant claim 1, copending claim 1 requires isolating analytes comprising nucleic acids (biomarkers) from a surgical drainage fluid sample (a genus to the species thoracic fluid and lymphatic fluid),from the surgical site and a blood sample; detecting and quantifying the analytes, and detecting cancer.
Regarding instant claim 2, copending claim 3 requires the analytes comp
Regarding instant claim 5, copending claim 1 requires detecting analytes in a blood sample.
Regarding instant claim 8, copending claim 1 requires a surgical drainage fluid sample (a genus to the species thoracic fluid and lymphatic fluid).
Regarding instant claim 9, copending claim 4 requires whole genome sequencing, next generation DNA sequencing, or next generation RNA sequencing.
Regarding instant claim 11, copending claim 1 requires detecting an analyte indicative of a condition (i.e. cancer biomarker) in a surgical drainage fluid sample (a genus to the species thoracic fluid and lymphatic fluid).
Regarding instant claim 13, copending claim 2 requires the surgery is selected from a resectioning surgery, a dissection surgery, or an excision surgery.
Regarding instant claim 15, copending claim 9 requires capturing the surgical drainage fluid from the drainage tube within about 24 hours of the surgery.
Regarding instant claim 16, copending claim 1 requires obtaining a surgical drainage fluid sample (a genus to the species thoracic fluid and lymphatic fluid), and detecting analytes (a marker) indicative of the at least one systemic condition. Copending claim 2 further requires isolating samples comprising exosomes, i.e. not tumor-associated genetic material.
Regarding instant claim 17, copending claim 14 requires assays comprising Western blot targeted capture (i.e. not sequencing).
Regarding instant claim 18, copending claim 1 requires a marker for immune response.
Regarding instant claim 19, copending claim 3 requires the analytes comprise immune cells or protein (i.e. solid material).
Regarding instant claim 20, copending claim 1 requires a surgical drainage fluid sample (a genus to the species thoracic fluid and lymphatic fluid).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii), Claims 3 and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/834,663 in view of Callaghan et al.(US20190060546A1) and Wang (US20180252722A1).
Regarding instant claim 3, copending claim 1 requires detecting (i.e. identifying) analytes (i.e. cancer biomarker). Copending claims do not require providing fluorescent labels to the fluid to identify the cancer biomarker.
Regarding instant claim 4, copending claim 1 requires quantifying analytes (i.e. cancer biomarker). Copending claims do not require quantifying based on fluorescent labels.
The teachings of Callaghan and Wang as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection.
(iii). Claims 6-7, 10, 14, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-23 and 29-30 of copending Application No. 17/947,861 in view of Callaghan et al. (US20190060546A1).
Regarding instant claims 6-7, 10, 14, and 21, copending claims patent do not require limitations of the instant claims. .
The teachings of Callaghan as they relate to these claims are given previously in this office action and are fully incorporated here.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments against Double Patenting
The response requests that the double patenting rejections be held in abeyance until the allowance of one or more reference application or until the claims of the present application are otherwise allowable (p. 13).
Applicant's arguments have been fully considered but are not persuasive.
No terminal disclaimer has been filed and no argument has been presented
against the double patenting rejections.
The rejections have been updated to reflect amendments to instant and copending claims.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA GRAY whose telephone number is (571)272-0116. The examiner can normally be reached Monday-Friday 8-5 with second Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, WINSTON SHEN can be reached at (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682