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 .
This Office Action is in reply to Applicants’ correspondence of 11/12/2025.
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
In the reply filed on 06/11/2025 Applicants elected the particular species that are: (I) cfDNA; and (II) next generation DNA sequencing; and the Examiner has rejoined the particular species that are “RNA” (relevant to election (I) in the requirement of 04/11/2025) and “PCR” (relevant to election (II) in the requirement of 04/11/2025); the claims are examined in so far as they are directed to either the elected cfDNA or the rejoined RNA, and the elected next generation DNA sequencing or PCR (see page 2 of the Office Action of 08/11/2025).
New Claim Rejections - 35 USC § 112 – New Matter
Necessitated by Claim Amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The amendments of the claims contain changes to independent claims 1 and 12 to include performing a plurality of nucleic acid assays “wherein one of the plurality of nucleic acid assays is a surgical margin assay that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease”. The relevant teachings of the application as originally filed, as recited in original claim 5, include providing:
a surgical margin assay module configured to detect and quantify tumor- associated nucleic acids indicative of minimal residual cancer within the surgical site
The teaching of the application as originally filed is directed using some object/device (i.e.: a “module”) that is a “surgical margin assay module”, with the functional limitation of being “configured to detect and quantify tumor- associated nucleic acids indicative of minimal residual cancer within the surgical site”. The application as originally filed is directed to the use of the “surgical margin assay module” in the analysis of “a surgical drainage sample”. This is different than the methods as currently claimed, in which the nucleic acids of a “a surgical drain sample” are detected and quantified “using … a surgical margin assay that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease”. A surgical margin assay, as understood in the related art, is an assay performed on at the edges of tissue (i.e.: the margins) removed during surgery to ensure no cancer cells remain at those edges. Because the assay of the claims is performed using nucleic acids from a surgical drain sample, and not tissue from the margins of a surgical bed, the subject matter of the claims is not supported by the application as originally filed.
Withdrawn Claim Rejections - 35 USC § 112 – Failure to Limit
The rejection of claims 6 and 17 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, as set forth on pages 2-3 of the Office Action of 06/02/2022, are withdrawn in light of the amendments to the claims.
New Claim Rejections - 35 USC § 112 – Indefiniteness
Necessitated by Claim Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-20 are unclear over recitation of the requirement that “one of the plurality of nucleic acid assays is a surgical margin assay that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease” in the methods as claimed which are applied to nucleic acid isolated from a surgical drain sample. As noted above, applying the detection and quantifying to nucleic acids isolated from a surgical drain sample is not a “surgical margin assay” because the method is not performed on any margin tissue (e.g.: margins of a surgical bed). Thus, it is unclear what the methods are intended to require or encompass for the assay as recited in the claims.
Claim 10 is unclear over recitation of the limitation “wherein obtaining the sample from the subject comprises” because there is no antecedent basis for any step of “obtaining the sample from the subject” in either claim 10, or in claim 1 from which claim 10 depends.
Claim 19 is unclear over recitation of the limitation “wherein obtaining the sample from the subject comprises” because there is no antecedent basis for any step of “obtaining the sample from the subject” in either claim 19, or in claim 12 from which claim 19 depends.
Maintained Claim Rejections - 35 USC § 101
Modified as Necessitated by Claim Amendments
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions encompassing abstract ideas and natural phenomena without significantly more.
The claim(s) recite(s) using the results of nucleic acid detecting and quantifying to produce at least one assay result, wherein the at least one assay result is indicative of a condition in the subject (as recited in each of claims 1 and 12). The claims are thus directed to an abstract idea which is a mental process, the evaluation of data or information to make an evaluation or render a judgment or opinion (e.g.: MPEP 2106.04(a)). Furthermore, where the claims are broadly directed to a correlation between nucleic acid presence or levels and some condition in a subject, the claims are directed a natural association (e.g.: between the presence of a nucleic acid and the existence of some condition), and thus are directed to a natural phenomenon (see MPEP 2106.04(b) I).
This judicial exception is not integrated into a practical application because the because the claims do not require any significant practical steps that are performed because of any particular results of the judicial exception(s). For example, the method of independent claim 1 ends with the detection of assay results indicative of a condition (which is an abstract idea, as noted above). Independent claim 12 ends with “selecting” a treatment, but this selecting is itself an abstract idea (e.g.: an identification of suitability of some treatment), and is not a required practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the practical steps of the claims are well understood, routine and convention in the related art (MPEP 2106.05(d). In the instant case the additional elements of the claims are the data gathering steps of the claim, recited at a high level of generality, and thus are properly considered insignificant extra-solution activity (MPEP 2106.05(g)). Here it is noted that while the data gathering steps of the claims include that assay of nucleic acids from surgical drain fluid, that performing nucleic acid assays using nucleic acid isolated form a surgical drain samples was performed in the prior art, for example as taught by Zhang et al (2006) and by Komen et al (2014).
Thus, the claims are properly rejected as being directed to a judicial exception to patentability without significantly more.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 101 as maintained above. Applicants’ arguments (p.7-8 of the Remarks of 11/12/2025) have been fully considered but are not persuasive to withdraw the rejection. Applicants have argued that the claims are not directed to an abstract idea because claim 1 is amended to remove recitation of the limitation related to providing a result to a practitioner. This is not persuasive because, as maintained in the rejection above, the claims recite the production of results that are indicative of a condition, where the correlation of some results to the presence of a condition is an evaluation of data that is an abstract idea. Additionally, the “selecting” of claim 12 is also an abstract idea (as noted in the rejection).
Applicants have argued that the claims require isolating nucleic acid from a surgical drain sample, and the do not recited a natural phenomenon, as they require instrument and reagents, the transformation of matter, and analysis of the results thereof. Initially in this regard it is noted that the analysis of results is an abstract idea (the analysis of data to make observations or evaluations, or render judgments or opinions, is a mental process (MPEP 2106.04(a)(2)III). Additionally, while the claims may include steps of the practical manipulation of samples using laboratory instruments, such steps related to the gathering of data are the use of well understood, routine and conventional methods, and thus are properly considered to be insignificant extra-solution activity (MPEP 2106.05(g)). Similarly, where Applicants argue that the claim integrate the identified judicial exceptions into a practical application because the claims require laboratory assays and the analysis of results, the laboratory assays are the data collection step used produce results that are indicative of a condition. The assays are pre-solution data gathering steps; the results of the assay are not integrated into the data collection because the data collection occurs before the results. While the results are used to indicate a condition, this indicating of a condition is an abstract idea and a natural phenomenon (as detailed above). And while in claim 12 the results are used in the selection of a treatment, as noted above the selection is itself an abstract idea.
Maintained Claim Rejections - 35 USC § 102
Modified as Necessitated by Claim Amendments
In the rejection of claims in view of the prior art, the limitations of the claims are noted. The claims are previously rejected under 35 USC 112(b) as unclear over the requirement of performing “a surgical margin assay” on nucleic acids isolated from a surgical drain sample. In the interested of compact prosecution and customer service, the limitation of the required assay is interpreted as an assay that is capable of detecting and quantifying tumor-associated nucleic acids indicative of minimal residual disease in a surgical margin tissue sample.
Claim(s) 1-4, 7, 10 and 11 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (2006).
Relevant to claim 1, Zhang et al teaches an analysis of nucleic acids isolated from axillary drainage fluid from subjects treated with modified radical mastectomy (which is a resection relevant to claim 2). Zhang et al teaches obtaining a surgical draining sample (e.g.: p.506 - Patient population, collection of axillary drainage fluid, treatment, and follow-up), and isolating RNA (relevant to claim 3) from the sample (including centrifugation relevant to claim 7) (e.g.: p.506. - Real-time quantitative RT-PCR). Zhang et al further teaches performing nucleic acid assays (RT-PCR, relevant to claim 4) to detect and quantify (e.g.: p.506. - Real-time quantitative RT-PCR) both CEA and CK-19 nucleic acids from the samples, and provides the results of the assay (e.g.: p. 507 – Results Fig. 2); the performance of PCR using primer pairs specific for different targets (e.g.: CEA and CK-19), both of which are markers of tumor cells, is considered to be performance of a plurality of assays. Where, Zhang et al teaches that the results of the RT-PCR are indicative of residual tumor cells, and the assay could be similarly performed on a surgical margin tissue sample, the teaching of Zhang et al are sufficient to anticipate the limitations of the claims.
Regarding claims 10 and 11, Zhang et al teaches that axillae were drained postoperatively by closed vacuum drains (Ch-14, Biometrix, Chelmsford, MA) (e.g.: p. 506 - Patient population, collection of axillary drainage fluid, treatment, and follow-up), where “Ch-14” (Charrière scale) indicates the diameter of a drain tube, and that the output of the drain was collected and measured every 24 h, with the presence of CEA, CK-19, and β-actin was assessed in the fluid collected during the second postoperative day.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 102 as anticipated by the teachings of the cited prior art. Applicants’ arguments (p.8-9 of the Remarks of 11/12/2025) have been considered but are not persuasive to withdraw the rejection as maintained above. Applicants have argued that Zhang et al does not provide for the limitations of the claim which require a plurality of assays, and an assay that is a surgical margin assay that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease. These arguments are not persuasive because, as noted in the rejection, where Zhang et al teaches RT-PCR of both CEA and CK-19, the different PCR reactions for each target (e.g.: using different primers) are considered a plurality of assays. Furthermore, where the limitation requiring a “surgical margin assay” that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease has been addressed previously in this Office Action, where Zhang et al teaches that CEA and CK-19 transcripts are diagnostically indicative of residual cancer cells, such an assay is suitable for the analysis of surgical margin tissue to detect minimal residual disease (i.e.: the small number of cancer cells that remain in a patient's body after treatment, which can lead to relapse).
Maintained Claim Rejections - 35 USC § 103
Modified as Necessitated by Claim Amendments
Claim(s) 1-4, 7-15, 18 and 19 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (2006).
Relevant to claims 1 and 12, Zhang et al teaches an analysis of nucleic acids isolated from axillary drainage fluid from subjects treated with modified radical mastectomy (which is a resection relevant to claim 2). Zhang et al teaches obtaining a surgical draining sample (e.g.: p.506 - Patient population, collection of axillary drainage fluid, treatment, and follow-up), and isolating RNA (relevant to claims 3 and 14) from the sample (including centrifugation relevant to claims 7 and 18) (e.g.: p.506. - Real-time quantitative RT-PCR). Zhang et al further teaches performing a nucleic acid assay (RT-PCR, relevant to claims 4 and 15) to detect and quantify (e.g.: p.506. - Real-time quantitative RT-PCR) nucleic acids from the samples, and provides the results of the assay (e.g.: p. 507 – Results Fig. 2).
Regarding claims 10, 11 and relevant to claim 19, Zhang et al teaches that axillae were drained postoperatively by closed vacuum drains (Ch-14, Biometrix, Chelmsford, MA) (e.g.: p. 506 - Patient population, collection of axillary drainage fluid, treatment, and follow-up), where “Ch-14” (Charrière scale) indicates the diameter of a drain tube, and that the output of the drain was collected and measured every 24 h, with the presence of CEA, CK-19, and β-actin was assessed in the fluid collected during the second postoperative day.
Zhang et al does not teach a step of selecting an additional treatment (relevant to claim 8 and the final step of claim 12) such as radiotherapy (relevant to claims 9 and 13). However, Zhang et al does teach that breast cancer patients with higher risk of locoregional recurrence may benefit from postmastectomy radiotherapy (e.g.: p.505). Zhang et al further teaches that the detection of RNA markers in axillary drainage fluid is predictive of locoregional recurrence.
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to performed the analysis of Zhang et al, and selected an additional treatment for the subject based on the results of the analysis. The skilled artisan would have been motivated to select radiotherapy as an additional treatment for a subject that had assay results showing the presence of CEA and CK-19 mRNA in drain fluid based on the expressed teachings of Zhang et al that the presence of CEA and CK-19 mRNA in drain fluid is indicative of the presence of residual cancer cells and an increased likelihood of locoregional recurrence (e.g.: Table 3). The skilled artisan would have been motivated to provide radiotherapy to the subject with CEA and CK-19 mRNA in drain fluid based on the expressed teachings of Zhang et al that patients at risk of locoregional recurrence may benefit from postmastectomy radiotherapy.
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 103 as rendered obvious by the teachings of the cited prior art. Applicants’ arguments (p.9-10 of the Remarks of 11/12/2025) have been considered but are not persuasive to withdraw the rejection as maintained above. Applicants have argued that Zhang et al does not provide for the limitations of the claim which require a plurality of assays, and an assay that is a surgical margin assay that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease. These arguments are not persuasive because, as noted in the rejection, where Zhang et al teaches RT-PCR of both CEA and CK-19, the different PCR reactions for each target (e.g.: using different primers) are considered a plurality of assays. Furthermore, where the limitation requiring a “surgical margin assay” that detects and quantifies tumor-associated nucleic acids indicative of minimal residual disease has been addressed previously in this Office Action, where Zhang et al teaches that CEA and CK-19 transcripts are diagnostically indicative of residual cancer cells, such an assay is suitable for the analysis of surgical margin tissue to detect minimal residual disease (i.e.: the small number of cancer cells that remain in a patient's body after treatment, which can lead to relapse). Applicants haver asserted that “Zhang's assay for tumor cells for LRR is significantly different than the claimed surgical margin assay for tumor nucleic acid as an indicator of MRD”, but the argument does not provide any ways in which that broadly claimed methods are in fact distinct from the teachings of Zhang. As discussed previously in this Office Action, Applicants’ argument that the claims require a “surgical margin assay” performed on surgical drain fluid is not persuasive to withdraw the rejection.
New Claim Rejections - 35 USC § 103
Necessitated by Claim Amendments
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (2006) as applied to claims 1-4, 7-15, 18 and 19 above, and further in view of Rivera-Buendia et al (2019).
Zhang et al teaches the methods of claim 1, from which claim 5 depends, and rendered obvious the methods of claim 12, from which claims 16 depends.
Zhang et al does not teach methods in which the assays performed on surgical drain fluid include an infection assay to detect and quantify infection-associated nucleic acids indicative of an infection within the surgical site.
However, the analysis of nucleic acids related to infection in surgical drain related samples from subjects after breast cancer surgery was known in the prior art and is taught by Rivera-Buendia et al.
Rivera-Buendia et al teaches (e.g.: p.3885 – Microbiology, Statistical Analysis; Supplementary Material) the detection of the bacterial 16S ribosomal gene by quantitative real-time PCR to quantify bacterial load.
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have included the bacterial load detection via quantitative real-time PCR of Rivera-Buendia et al in the surgical drain fluid analysis taught by Zhang et al. The skilled artisan would have been motivated to include the methods of Rivera-Buendia et al based on the expressed teachings of Rivera-Buendia et al that surgical-site infections are a common complication related to breast cancer surgery, and that quantitative real-time PCR 16S gene analysis can provide a precise measurement and detection of bacterial load. The skilled artisan would recognize that detection of bacterial infection would allow for the treatment of infection to alleviate the infection and prevent pathological problems related to surgical site infection.
Claim(s) 6 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (2006) as applied to claims 1-4, 7-15, 18 and 19 above, and further in view of de Carvalho et al (2012) and Lassig et al (2017).
Zhang et al teaches the methods of claim 1, from which claim 6 depends, and rendered obvious the methods of claim 12, from which claims 17 depends.
Zhang et al does not teach methods in which the assays performed on subjects after a neck surgery.
However, the analysis of nucleic acids in surgical margin tissue related to recurrence of head and neck cancer in patients was known in the prior art and is taught by de Carvalho et al.
de Carvalho et al teaches the detection of expression of molecular markers using qRT-PCR in histologically negative surgical margins, and determines a correlation of these tumor-related alterations with clinical and prognostic parameters including the development of second primary tumors rates of local control. The reference teaches that detection of molecular/genetic markers may provide a more sensitive approach to detect the presence of malignant transformed cells in histologically negative surgical margins.
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have applied the teachings of Zhang et al to the detection of nucleic acid biomarkers associated with increased risk of recurrence of neck cancer. The skilled artisan would have been motivated to detect such molecular markers in a neck surgery context based on the expressed teachings of de Carvalho et al that molecular marker can provide and indication of a high risk of local failure and development of second primary tumors. The skilled artisan would recognize that a high risk of local failure and development of second primary tumors may require additional treatment. The skilled artisan would have had a reasonable expectation of success based on the teachings of Lassig et al, which teaches the detection of biomarkers related to cancer pathology in surgical drain fluid from patients treated for squamous cell carcinoma (SCC) of the oral cavity and oropharynx with modified radical neck dissection surgery.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (2006) as applied to claims 1-4, 7-15, 18 and 19 above, and further in view of Jansen et al (2016).
Zhang et al teaches the methods of claim 1, from which claim 20 depends.
Zhang et al does not teach methods in which the assays performed on a sample that comprises cfDNA.
However, the analysis of cfDNA in the detection of cancer cells in breast cancer patients was known in the prior art and is taught by Jansen et al.
Jansen et al teaches the detection of various biomarkers that are mutations in cfDNA from breast cancer patients (e.g.: Fig 1) and teaches that quantities of particular biomarkers are indicative of disease state and response to treatment (Fig 2).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have measured cfDNA related to breast cancer, as taught by Jansen et al, in surgical drain fluid as taught by Zhang et al. The skilled artisan would have been motivated to analyze cfDNA based on the expressed teachings of Jansen et al that detection of cfRNA derived from tumors may be an analyte to detect disease progression at an early stage. The skilled artisan would have a reasonable expectation of success based on the expressed teachings of Jansen et al that cfDNA markers originate from a primary tumor, and sequence analysis of cfDNA can provide sensitive detection and monitoring of specific tumor-derived mutations.
Maintained Double Patenting
Modified as Necessitated by Claim Amendments
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,152,280 in view of Zhang et al (2006), and further in view of: Rivera-Buendia et al (2019) (relevant to the rejection of claims 5 and 16, as they require an assay related to infection infection); de Carvalho et al (2012) and Lassig et al (2017) (relevant to the rejection of claims 6 and 17, as they require a subject with a neck surgery); and Jansen et al (2016) (relevant to the rejection of claim 20, as it requires cfDNA biomarkers).
The conflicting claims are directed to the analysis of RNA collected from surgical drain fluid collected during a surgical procedure. The conflicting claims do not include detecting a condition following a surgery (as recited in claims 1 and 12), or selecting an additional treatment. However such steps in the analysis of drain fluid were known in the prior art and art taught by Zhang et al (further teachings of Zhang et al relevant to the instantly rejected claims are detailed earlier in this Office Action).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have modified the claims of U.S. Patent No. 12,152,280 to perform an analysis of risk in a subject after a surgical procedure. The skilled artisan would have been motivated to perform the methods of U.S. Patent No. 12,152,280 to perform an analysis of risk in a subject after a surgical procedure based on the expressed teachings of Zhang et al that the analysis of post-surgical drain fluid can provide a measure of residual disease and the need for additional treatment.
The rejection of claims in view of: Rivera-Buendia et al (2019); de Carvalho et al (2012) and Lassig et al (2017); and Jansen et al (2016) are made with the same rationales as provided previously in this office action.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-34 and 36-38 of copending Application No. 17/786,473 in view of Zhang et al (2006) and further in view of: Rivera-Buendia et al (2019) (relevant to the rejection of claims 5 and 16, as they require an assay related to infection infection); de Carvalho et al (2012) and Lassig et al (2017) (relevant to the rejection of claims 6 and 17, as they require a subject with a neck surgery); and Jansen et al (2016) (relevant to the rejection of claim 20, as it requires cfDNA biomarkers).
The claims of the conflicting application are directed to methods comprising performing a laboratory analysis of nucleic acids (see conflicting claim 27) from surgical drain fluid to detect a mutation or variant.
The conflicting claims do not include providing an assay result to a practitioner (as recited in instant claim 1), or or selecting an additional treatment (relevant to instant claims 8, 9 and 12). However such steps in the analysis of drain fluid were known in the prior art and art taught by Zhang et al (further teachings of Zhang et al relevant to the instantly rejected claims are detailed earlier in this Office Action).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have modified the claims of copending Application No. 17/786,473 to include presentation of the results, and selection of an additional treatment, as taught by Zhang et al. The skilled artisan would have been motivated to perform the methods of copending Application No. 17/786,473 to include presentation of the results, and selection of an additional treatment based on the exemplifications of Zhang et al (e.g.: providing assay results), and the expressed teachings of Zhang et al that the analysis of post-surgical drain fluid can provide a measure of residual disease and the need for additional treatment.
The rejection of claims in view of: Rivera-Buendia et al (2019); de Carvalho et al (2012) and Lassig et al (2017); and Jansen et al (2016) are made with the same rationales as provided previously in this office action.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 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), and in view of: Rivera-Buendia et al (2019) (relevant to the rejection of claims 5 and 16, as they require an assay related to infection infection); de Carvalho et al (2012) and Lassig et al (2017) (relevant to the rejection of claims 6 and 17, as they require a subject with a neck surgery); and Jansen et al (2016) (relevant to the rejection of claim 20, as it requires cfDNA biomarkers).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the analysis of surgical drain fluid following a surgery, and encompass the analysis of nucleic acids (e.g.: conflicting claims 3, 4, 13 and 14) for the detection of conditions and the selection of additional treatments,
The rejection of claims in view of: Rivera-Buendia et al (2019); de Carvalho et al (2012) and Lassig et al (2017); and Jansen et al (2016) are made with the same rationales as provided previously in this office action.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/435,187 in view of in view of Zhang et al (2006), and further in view of: Rivera-Buendia et al (2019) (relevant to the rejection of claims 5 and 16, as they require an assay related to infection infection); de Carvalho et al (2012) and Lassig et al (2017) (relevant to the rejection of claims 6 and 17, as they require a subject with a neck surgery); and Jansen et al (2016) (relevant to the rejection of claim 20, as it requires cfDNA biomarkers).
The conflicting claims are directed to analyses of nucleic acids (e.g.: conflicting claim 9) collected from surgical drain (e.g.: conflicting claim 7) fluid collected following a surgical procedure (e.g.: conflicting claims 2 and 4) The conflicting claims do not include providing a result (instantly rejected claim 1) or selecting an additional treatment (instantly rejected claims 8, 9 and 12). However such steps in the analysis of drain fluid were known in the prior art and art taught by Zhang et al (further teachings of Zhang et al relevant to the instantly rejected claims are detailed earlier in this Office Action).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have modified the claims of copending Application No. 18/435,187 to perform an analysis of risk in a subject after a surgical procedure including providing results and selecting an additional treatment, as taught by Zhang et al.. The skilled artisan would have been motivated to perform the methods of copending Application No. 18/435,187to perform an analysis of risk in a subject after a surgical procedure based on the expressed teachings of Zhang et al that the analysis of post-surgical drain fluid can provide a measure of residual disease and the need for additional treatment.
The rejection of claims in view of: Rivera-Buendia et al (2019); de Carvalho et al (2012) and Lassig et al (2017); and Jansen et al (2016) are made with the same rationales as provided previously in this office action.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683