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 .
Claims 76-79 and 82-88 are currently pending and under examination. Claims 1-75 and 80-81 are cancelled. Claim 76 is amended.
Response to Amendment
The Amendment filed 12/5/25 has been entered. Claims 76-79 and 82-88 are pending. Applicant’s amendments to the specification and claim 76 have overcome the objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 9/5/25.
Response to Arguments
Applicant’s arguments, see pages 5-7, filed 12/5/25, with respect to the rejections of claims 76-79 and 82-88 under 35 USC 101 have been fully considered and are found unpersuasive, and the 101 rejections documented in the Non-Final mailed 9/5/25 have been revised to address claim amendments filed 12/5/25 in this Final Office Action. More detailed responses to Applicant’s arguments are provided at the end of each maintained rejection.
Applicant’s arguments, see pages 7-9, filed 12/5/25, with respect to the rejections of claims 76-79 and 82-88 under 35 USC 103 and nonstatutory double patenting have been fully considered and are found persuasive. Therefore, the rejections documented in the Non-Final mailed 9/5/25 have been withdrawn. However, upon further consideration, new grounds of rejections necessitated by claim amendments are made in this Final Office Action.
Claim Objections
Claim 76 is objected to because of the following informalities:
line 10 has a typographical error and should read “extracellular vesicle”. Appropriate correction is required.
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 76-79 and 82-88 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims have been evaluated using the 2019 Revised Patent Subject Matter Eligibility Guidance (see Federal Register Vol. 84, No. 4 Monday, January 7, 2019).
This rejection is revised/updated in response to claim amendments filed 12/5/25.
Step 1: The claim is directed to the statutory category of a process.
Step 2A, prong one: The claim recites a judicial exception.
Claim 76 recites active steps of “comparing a level” and “identifying the blood sample”. These limitations are abstract mental processes (see MPEP 2106.04(a)(2)(III)).
Step 2A, prong two: The judicial exception is not integrated into a practical application.
Claim 76 additionally recites an active step of “detecting” that is considered extra-solution and data-gathering, with no specification of a particular treatment or prophylaxis (see MPEP 2106.04(d)(2)). The detecting step using a proximity ligation assay is extra-solution and data-gathering at a high level of generality. Claims 76-79 and 82-88 recite extra-solution and data-gathering limitations for detecting the biomarker signature.
Step 2B: The claim does not provide an inventive concept.
MPEP 2106.05(d)):
The courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S.
at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health
Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir.
2017);
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs.
Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir.
2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115
USPQ2d 1152, 1157 (Fed. Cir. 2015);
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78,
115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123
USPQ2d at 1088 (Fed. Cir. 2017);
iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v.
Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
v. Analyzing DNA to provide sequence information or detect allelic
variants, Genetic Techs. Ltd., 818 F.3d at 1377, 118 USPQ2d at 1546;
vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119
USPQ2d at 1375;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah
Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241,
1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d
at 1247.
The claims are directed to well-understood, routine, and conventional activities in the life science arts recited at a high-level of generality. Determining biomarker signatures within cancer is not inventive (see Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23) and Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23)). Additionally, proximity ligation assays are not inventive (Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23).
For the reasons set forth above, claims 76-79 and 82-88 are not directed to patent eligible subject matter.
Applicant’s Arguments
Applicant argues “Amended claim 76 is directed to a process, which is one of the statutory categories of patent eligible subject matter. See 35 U.S.C. §101. Each step, or "element", of the claimed process is an active step requiring the use, collection, or delivery of tangible objects and materials (e.g., blood sample, detection probes). Claim 76 should next be analyzed to determine whether it is directed to any judicial exception. Claim 76 recites steps of using specific physical probes to generate a ligated template through a reaction that is physically constrained to single- vesicle colocalization. No step of claim 76 recites any judicial exception. Claim 76 is not directed to a judicial exception. Under step 2A of Mayo/Alice test, claim 76 obtains a "no"-not directed to a judicial exception-and is patent eligible. None of the recited steps could be construed as an abstract idea” (Remarks 12/5/25, page 6, last paragraph).
Response to Applicant’s Arguments
The Examiner respectfully disagrees with the assertion that “None of the recited steps could be construed as an abstract idea.” As stated above, claim 76 recites the active steps of “comparing a level” and “identifying the blood sample”. These are processes that are performed within the mind and are thus construed as abstract mental processes. The remaining claim 76 active step of detecting via proximity ligation assay is a data-gathering and extra-solution activity, as that assay generates the input data of the abstract mental process. Additionally, this step is recited at a high level of generality with no particular treatment or prophylaxis for lung cancer. Proximity ligation assays are not considered inventive either, as they have been performed prior to the instant invention (see below 103 rejections).
Thus, claims 76-79 and 82-88 are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
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 76-79, 82, and 84-88 are rejected under 35 U.S.C. 103 as being unpatentable over Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15) in view of Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23; publication of US application 15/769,904 filed on 4/20/18).
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
(i) Halbert et al. teaches limitations relevant to claims 76-79, 82, and 84-88.
Relevant to claim 76, Halbert et al. Abstract teaches "Methods and compositions are provided for specific aptamers and aptamer pools that bind biomarkers of interest such as microvesicle surface antigens or functional fragments of microvesicle surface antigens. In various embodiments, aptamers of the invention are used in diagnostic, prognostic, or theranostic processes to screen a biological sample for the presence or levels of biomarkers such as microvesicles that are determined to provide a diagnostic, prognostic, or theranostic readout. The diagnosis, prognosis, or theranosis may be related to cancer or other diseases and disorders. The invention also provides methods and composition to facilitate aptamer library screening and aptamer detection methods."
Further relevant to claim 76, Halbert et al. teaches "The one or more microvesicle surface antigen can be a biomarker of a disease or disorder, including without limitation those disclosed herein. In some embodiments, the disease comprises a cancer… The cancer can be… lung cancer…" (paragraph 0062).
Further relevant to claim 76, Halbert et al. teaches "The biological sample can be a tissue sample, a cell culture, or a bodily fluid… In some embodiments, the bodily fluid comprises blood, serum or plasma" (paragraph 0029).
Further relevant to claim 76, Halbert et al. teaches "The invention provides methods for identifying binding agents comprising contacting a plurality of extracellular microvesicles with a randomly generated library of binding agents, and identifying a subset of the library of binding agents that have an affinity to one or more components of the extracellular microvesicles. The binding agents can be aptamers and/or antibodies" (paragraph 0063).
Further relevant to claim 76, Halbert et al. teaches "In an embodiment, the target of interest and the one or more confounding target comprise proteins. The target of interest and the one or more confounding target may also comprise a microvesicle. In some embodiments, the target of interest and the one or more confounding target comprise one or more microvesicle surface antigen. The microvesicle surface antigen can be selected from Tables 3, 4 and/or 26" (paragraph 0061).
Further relevant to claim 76, Halbert et al. teaches "Vesicles such as exosomes can be assessed to provide a phenotypic characterization by comparing vesicle characteristics to a reference. In some embodiments, surface antigens on a vesicle are assessed. The surface antigens can provide an indication of the anatomical origin and/or cellular of the vesicles and other phenotypic information, e.g., tumor status" (paragraph 0270).
Relevant to claims 77-78, Halbert et al. teaches "FIGS. 1A-1F illustrate methods of assessing biomarkers such as microvesicle surface antigens. FIG. 1A is a schematic of a planar substrate coated with a capture agent, such as an aptamer or antibody, which captures vesicles expressing the target antigen of the capture agent. The capture agent may bind a protein expressed on the surface of vesicles shed from diseased cells ("disease vesicle"). The detection agent, which may also be an aptamer or antibody, carries a detectable label, here a fluorescent signal. The detection agent binds to the captured vesicle and provides a detectable signal via its fluorescent label. The detection agent can detect an antigen that is generally associated with vesicles, or is associated with a cell-of-origin or a disease, e.g., a cancer" (paragraph 0113).
Relevant to claim 79, Halbert et al. teaches "The invention provides methods for identifying binding agents comprising contacting a plurality of extracellular microvesicles with a randomly generated library of binding agents, and identifying a subset of the library of binding agents that have an affinity to one or more components of the extracellular microvesicles. The binding agents can be aptamers and/or antibodies" (paragraph 0063).
Relevant to claim 82, Halbert et al. teaches "In a non-limiting example, a homogeneous microvesicle population can be obtained from a heterogeneous microvesicle population by subjecting the heterogeneous microvesicle population to affinity isolation or size exclusion methodology" (paragraph 0332).
Relevant to claims 84-87, Halbert et al. teaches "The invention relates generally to the field of aptamers capable of binding to microvesicle surface antigens, which are useful as therapeutics in and diagnostics of cancer and/or other diseases or disorders in which microvesicles implicated. The invention further relates to materials and methods for the administration of aptamers capable of binding to microvesicles. The microvesicles may be derived from cells indicative of cancer" (paragraph 0006).
Further relevant to claims 84-87, Halbert et al. teaches "As described herein, the methods and compositions of the invention can be used in assays to detect the presence or level of one or more biomarker of interest. The biomarker can be any useful biomarker disclosed herein or known to those of skill in the art. In an embodiment, the biomarker comprises a protein or polypeptide. As used herein, 'protein,' 'polypeptide' and 'peptide' are used interchangeably unless stated otherwise. The biomarker can be a nucleic acid, including DNA, RNA, and various subspecies of any thereof as disclosed herein or known in the art.
Further relevant to claims 84-87, Halbert et al. further teaches "A biosignature comprising more than one biomarker can comprise one type of biomarker or multiple types of biomarkers. As a non-limiting example, a biosignature can comprise multiple proteins, multiple nucleic acids, multiple lipids, multiple carbohydrates, multiple biomarker complexes, multiple microvesicles, or a combination of any thereof" (paragraph 0273).
Relevant to claim 88, Halbert et al. teaches "FIGS. 1A-1F illustrate methods of assessing biomarkers such as microvesicle surface antigens. FIG. 1A is a schematic of a planar substrate coated with a capture agent, such as an aptamer or antibody, which captures vesicles expressing the target antigen of the capture agent. The capture agent may bind a protein expressed on the surface of vesicles shed from diseased cells ("disease vesicle"). The detection agent, which may also be an aptamer or antibody, carries a detectable label, here a fluorescent signal. The detection agent binds to the captured vesicle and provides a detectable signal via its fluorescent label. The detection agent can detect an antigen that is generally associated with vesicles, or is associated with a cell-of-origin or a disease, e.g., a cancer" (paragraph 0113).
(ii) Halbert et al. is silent to specifics regarding proximity ligation assays relevant to claim 76. However, these limitations were known in the prior art and taught by Fredriksson et al.
Relevant to claim 76, Fredriksson et al. teaches "The present invention relates to methods for the manufacture of probes (proximity probes) for use in proximity probe based detection assays for an analyte in a sample. In particular, the present invention relates to an improved method for producing a plurality of proximity probe pairs having different target analyte binding specificities, and comprising different nucleic acid domains" (paragraph 0001).
Further relevant to claim 76, Fredriksson et al. teaches "The concept of proximity probing has been developed in recent years and many assays based on this principle are now well known in the art, for instance proximity probe based detection assays include… proximity ligation assays" (paragraph 0003).
Further relevant to claim 76, Fredriksson et al. teaches "Thus, the present invention also provides a pair of proximity probes, said pair comprising a first and a second proximity probe, wherein each proximity probe comprises an analyte binding domain and a partially double-stranded nucleic acid domain and each proximity probe of a pair can simultaneously bind to a target analyte, and wherein the nucleic acid domains of a pair of proximity probes are able to interact directly or indirectly upon binding of the pair of proximity probes to their target analyte, wherein: a. a first said proximity probe comprises a first universal oligonucleotide conjugated to a first analyte binding moiety and a first tag oligonucleotide hybridised to the first universal oligonucleotide, wherein the first tag oligonucleotide comprises a first universal complement domain which is complementary to the first universal oligonucleotide and a first unique domain which is not capable of hybridising to a first or second universal oligonucleotide; and b. a second said proximity probe comprises a second universal oligonucleotide conjugated to a second analyte binding moiety and a second, cognate, tag oligonucleotide hybridised to the second universal oligonucleotide, wherein the first tag oligonucleotide comprises a second universal complement domain which is complementary to the second universal oligonucleotide and a second unique domain which is not capable of hybridising to a first or second universal oligonucleotide, wherein said first and second unique domains are cognate domains capable of mediating an interaction, directly or indirectly, with each other, thereby enabling the nucleic acid domains of the first and second proximity probes to interact when said proximity probes have bound to their target analyte" (paragraphs 0018-0021).
Further relevant to claim 76, Fredriksson et al. teaches "As noted above, the probes of the present invention may also be used in proximity-dependent assays based on ligation (i.e. a proximity ligation assay, or PLA) (i.e. wherein at least first and second proximity probes comprise nucleic acid domains and the interaction between them involves a ligation reaction). Viewed generally, the nucleic acid domains of the probes may mediate (e.g. take part in, directly or indirectly), a ligation reaction. Such a ligation reaction may involve ligation of the nucleic acid domains of the proximity probes, and/or the nucleic acid domain(s) may template a ligation reaction" (paragraph 0065).
(iii) Although Halbert et al. does not explicitly teach the Fredriksson et al. proximity ligation assay, it would have been prima facie obvious to the skilled artisan. Halbert et al. and Fredriksson et al. are analogous disclosures in the instant field of biomarker detection.
The skilled artisan would be motivated to combine the analogous art. Fredriksson et al. teaches “Thus signal generation is dependent on an interaction between the probes (more particularly by the nucleic acid or other functional moieties/domains carried by them) and typically requires the formation of one or more nucleic acid duplexes e.g. by the direct or indirect interaction of the nucleic acid domains, which enables a ligation reaction (either of nucleic acid domains to each other, or wherein the nucleic acid domain(s) template the ligation of one or more separately added oligonucleotides) and/or extension reaction (e.g. of at least one of the nucleic acid domains), thereby to generate a detectable signal. A signal hence only occurs when both (or all) the necessary probes have bound to the analyte, thereby lending improved specificity to the detection system” (paragraph 0003).
Thus, the skilled artisan would have been motivated to include the Fredriksson et al. proximity ligation assay within the Halbert et al. methods of screening a sample in order to take advantage of the improved detection specificity. The skilled artisan would have a reasonable expectation of success based on the disclosures of Halbert et al. in view of Fredriksson et al.
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15) in view of Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23; publication of US application 15/769,904 filed on 4/20/18), as applied to claims 76-79, 82, and 84-88 above, and further in view of Malhotra et al. (2016; NPL citation 5 in IDS filed on 9/13/24; “Risk factors for lung cancer worldwide”; Eur Respir J. 2016 Sep;48(3):889-902. doi: 10.1183/13993003.00359-2016. Epub 2016 May 12).
The teachings of Halbert et al. in view of Fredriksson et al. are applied to instantly rejected claim 83 as they were previously applied to claims 76-79, 82, and 84-88 as rendering obvious a method of screening a sample for indicia of lung cancer.
Halbert et al. in view of Fredriksson et al. is silent to specifics regarding additional methods of screening for lung cancer relevant to claim 83. However, these limitations were known in the prior art and taught by Malhotra et al.
Relevant to claim 83, Malhotra et al. teaches "Genetic risk factors. Family history and high-penetrance genes. A positive family history of lung cancer has been found to be a risk factor in several registry-based studies that have reported a high familial risk for early-onset lung cancer [citation]. Increased relative risks were found even after careful adjustment for smoking [citation]. A linkage analysis of high-risk pedigrees identified a major susceptibility locus to chromosome 6q23-25 [citation]. Lung cancer risk is also increased within the framework of the Li-Fraumeni syndrome, characterised by germline mutation in the tumour-suppresor gene p53 [citation]. Genetic polymorphisms. Recent genome-wide association (GWA) studies have been able to identify multiple genetic polymorphisms underlying lung cancer risk by utilising up to a million tagging single-nucleotide polymorphisms (SNP) to identify common genetic variations. Table 2 summarises the evidence of an association between genetic variants and lung cancer" (page 890, paragraphs 4-5).
Although Halbert et al. in view of Fredriksson et al. does not explicitly teach the Malhotra et al. additional screening methods, it would have been prima facie obvious to the skilled artisan. It is noted that Halbert et al., Fredriksson et al., and Malhotra et al. are all analogous disclosures in the instant field of cancer biology.
The skilled artisan would have been motivated to combine the analogous disclosures. Malhotra et al. teaches the importance of genetics within increased lung cancer risks, and that genome wide associated genetic assays have identified specific genetic variants associated with lung cancer. Thus, the skilled artisan would have been motivated to include the Malhotra et al. genetic assay within the Fredriksson et al.-modified Halbert et al. methods in order to address the well-characterized genetic associations within lung cancer and better identify risks. The skilled artisan would have a reasonable expectation of success based on the disclosures of Halbert et al. in view of Fredriksson et al., and further in view of Malhotra et al.
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.
Claims 76 and 78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 140 of copending Application No. 17/793,382 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15) and Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23; publication of US application 15/769,904 filed on 4/20/18).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claims 76 and 78 are directed to a method for screening a blood sample for indicia of lung cancer using a proximity ligation assay, and capture agents and probes that comprise a target binding moiety, and an oligonucleotide domain capable of hybridizing when probes are bound to the same extracellular vesicle.
Copending claim 140 is directed to “A kit for detection of ovarian cancer” using a “capture agent that binds a polypeptide on an extracellular vesicle surface (EV)” and “at least two probes, each comprising” a “target binding moiety for at least one ovarian cancer biomarker selected from the group comprising a surface protein” and “a single-stranded oligonucleotide, wherein the single-stranded oligonucleotides of the at least two probes are capable of hybridizing to each other when the probes are bound to the same EV”.
MPEP 804(II)(B)(1) section entitled “Construing the Claim Using the Reference Patent or Application Disclosure” references Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010) case law, with pertinent section reproduced below. Although the case law pertains to a compound and use of the compound, the precedent would be applicable to the instant kit and use of the kit.
To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. (Emphasis added.)
Copending application specification paragraphs 60-68 disclose the scope of the reference claim, with paragraph 60 disclosing that “Some aspects provided herein relate to systems and kits for use in provided technologies. In some embodiments, a system or kit may comprise detection agents for a tumor biomarker signature of ovarian cancer (e.g., ones described herein). In some embodiments, such a system or kit may comprise a capture agent for an extracellular vesicle-associated membrane-bound polypeptide present in extracellular vesicles associated with ovarian cancer (e.g., ones used and/or described herein); and (b) at least one or more detection agents directed to one or more target biomarkers of a target biomarker signature of ovarian cancer, which may be or comprise additional surface protein biomarker(s) (e.g., ones as used and/or described herein), intravesicular protein biomarker(s) (e.g., ones as used and/or described herein), and/or intravesicular RNA (e.g., mRNA) biomarker(s)(e.g., ones as used and/or described herein).”
Although the copending claim 140 is directed to a kit for the detection of ovarian cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claims 76 and 78 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of ovarian cancer (Halbert et al. paragraph 0032) and that kits can be provided for “carrying out the methods herein” (Halbert et al. paragraph 0037). Thus, the copending claim’s recitation of a kit and ovarian cancer would be obvious variants to the instant limitations, as viewed by the skilled artisan.
Additionally, it would have been prima facie obvious to the skilled artisan to include the Fredriksson et al. proximity ligation assay, as discussed in the above 103 rejections. Thus, the copending claim’s probes capable of hybridizing to each other would be obvious variants to the instant limitations, as viewed by the skilled artisan.
The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 17/793,382 in view of Halbert et al. and Fredriksson et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of copending Application No. 18/580,444 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for colorectal cancer through detection of “extracellular vesicle-associated surface biomarker[s]”, comparison to reference levels, and identification of colorectal cancer based on the comparison. Copending claim 10 is directed to detection via a capture assay. Copending claim 20 is directed to detection via proximity ligation assay.
Although the copending claim 1 is directed to the detection of colorectal cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of colorectal cancer (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of colorectal cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan.
The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,444 in view of Halbert et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of copending Application No. 18/580,445 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15) and Fredriksson et al. (2018; US 2018/0312901; USPGPub citation 17 in IDS filed on 12/26/23; publication of US application 15/769,904 filed on 4/20/18).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for cancer through detection of extracellular vesicle-associated surface biomarkers, comparison to reference levels, and identification of cancer based on the comparison. Copending claim 19 is directed to a capture assay.
Although the copending claim 1 is directed to the detection of cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of numerous cancers (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan.
Additionally, it would have been prima facie obvious to the skilled artisan to include the Fredriksson et al. proximity ligation assay, as discussed in the above 103 rejections. Thus, the copending claim’s probes capable of co-localization and capture assay would be obvious variants to the instant limitations, as viewed by the skilled artisan.
The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,445 in view of Halbert et al. and Fredriksson et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of copending Application No. 18/580,427 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for breast cancer through detection of “extracellular vesicle-associated surface biomarker[s]”, comparison to reference levels, and identification of breast cancer based on the comparison. Copending claim 10 is directed to detection via a capture assay. Copending claim 20 is directed to detection via proximity ligation assay.
Although the copending claim 1 is directed to the detection of breast cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of breast cancer (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of breast cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan. The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,427 in view of Halbert et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of copending Application No. 18/580,412 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for pancreatic cancer through detection of “extracellular vesicle-associated surface biomarker[s]”, comparison to reference levels, and identification of pancreatic cancer based on the comparison. Copending claim 10 is directed to detection via a capture assay. Copending claim 20 is directed to detection via proximity ligation assay.
Although the copending claim 1 is directed to the detection of pancreatic cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of pancreatic cancer (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of pancreatic cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan. The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,412 in view of Halbert et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of copending Application No. 18/580,442 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for prostate cancer through detection of “extracellular vesicle-associated surface biomarker[s]”, comparison to reference levels, and identification of prostate cancer based on the comparison. Copending claim 10 is directed to detection via a capture assay. Copending claim 20 is directed to detection via proximity ligation assay.
Although the copending claim 1 is directed to the detection of prostate cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of prostate cancer (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of prostate cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan. The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,442 in view of Halbert et al.
Claims 76 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 20 of copending Application No. 18/580,440 (reference application) in view of Halbert et al. (2016; US 2016/0003835; USPGPub citation 8 in IDS filed on 12/26/23; publication of US application 14/438,172 filed on 4/23/15).
This is a provisional nonstatutory double patenting rejection.
This new 103 rejection is necessitated by claim amendments filed 12/5/25.
Instant claim 76 is directed to a method for screening a blood sample for indicia of lung cancer within blood samples through detection of extracellular vesicle biomarkers via proximity ligation assay, comparison to reference levels, and identification of lung cancer based on the comparison. Instant claim 77 is directed to detection via a capture assay.
Copending claim 1 is directed to a method for classifying blood samples for esophageal cancer through detection of “extracellular vesicle-associated surface biomarker[s]”, comparison to reference levels, and identification of esophageal cancer based on the comparison. Copending claim 10 is directed to detection via a capture assay. Copending claim 20 is directed to detection via proximity ligation assay.
Although the copending claim 1 is directed to the detection of esophageal cancer – not the instant lung cancer – this would have been prima facie obvious to the skilled artisan in view of Halbert et al. Halbert et al. teachings obviate instant claim 76 (see above 103 rejections) and further disclose that their detection methods are applicable to detection of esophageal cancer (Halbert et al. paragraph 0032). Thus, the copending claim’s recitation of esophageal cancer would be an obvious variant to the instant limitations, as viewed by the skilled artisan. The skilled artisan would have a reasonable expectation of success based on the disclosures of copending application 18/580,440 in view of Halbert et al.
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.
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682