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 1-15 are pending and currently under examination.
Priority
The instant application 18/481,306 filed on 10/5/23 is a CON of non-provisional application 16/908,822 filed on 6/23/20, which is a CON of non-provisional application 15/518,392 filed on 4/11/17, which is a 371 US national phase of PCT/IB2015/002046 filed on 10/20/15, and claims foreign priority to EP14306666.0 filed on 10/20/14.
Absent a record of the English translation of the certified copy of EP14306666.0, the priority date is determined to be 10/20/15.
Objections to Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification (Tables 1 and 4) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
The disclosure is objected to because page 23 contains embedded hyperlinks and/or other forms of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 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).
Step 1: The claim is directed to the statutory category of a process.
Step 2A, prong one: The claim recites a judicial exception.
Claim 1 vi) ratio of total concentration of mitochondrial cell free nucleic acids to total concentration of nuclear cell free nucleic acids is lower in cancer compared to healthy subjects is considered as the judicial exception of Laws of Nature and Natural Phenomena (see MPEP 2106.04(b)). Claim 1 iv) active method step of “calculating a ratio” (Mathematical Concept) and claim 1 v) active method step of “comparing the ratio” (Mental Process) are considered as the judicial exceptions of Abstract ideas of Mathematical Concepts and Mental processes (see MPEP 2106.04(a)).
Step 2A, prong two: The judicial exception is not integrated into a practical application.
Claims 1-15 recite insignificant extra-solution activities directed towards mere data gathering at high levels of generality (see MPEP 2106.05(g)).
It is further noted that the claims are not directed to a particular treatment or prophylaxis (see MPEP 2106.04(d)(2)). Although claim 1 recites that the “anticancer treatment is at least one of radiotherapy, chemotherapy, immunotherapy, adjuvant therapy, or surgical resection”, the Specification discloses embodiments of “Therapeutic applications” (pages 27-34) at high levels of generality that are not limited to a particular treatment or prophylaxis.
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 end with the judicial exceptions. Additionally, methods of treating a cancerous subject following characterization of mitochondrial and nuclear cell free nucleic acids are not inventive (Mizumachi et al. 2008. "Increased distributional variance of mitochondrial DNA content associated with prostate cancer cells as compared with normal prostate cells"; Prostate. 2008 Mar 1;68(4):408-17. doi: 10.1002/pros.20697; Zachariah et al. 2008. "Levels of Circulating Cell-Free Nuclear and Mitochondrial DNA in Benign and Malignant Ovarian Tumors"; Obstet Gynecol. 2008 Oct;112(4):843-50. doi: 10.1097/AOG.0b013e3181867bc0).
For the reasons set forth above, claims 1-15 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 1-6 and 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zachariah et al. (2008. "Levels of Circulating Cell-Free Nuclear and Mitochondrial DNA in Benign and Malignant Ovarian Tumors"; Obstet Gynecol. 2008 Oct;112(4):843-50. doi: 10.1097/AOG.0b013e3181867bc0).
Relevant to claim 1 i) - iii), Zachariah et al. teaches "To analyze the levels of circulating cell-free nuclear DNA and circulating cell-free mitochondrial DNA in patients with benign and malignant ovarian tumors using a gold-standard assay and to investigate whether quantitative alterations of the circulating cell-free species have values in the management of the patients" (Objective).
Relevant to claim 1 iv), Zachariah et al. teaches "In the plasma samples, circulating cell-free mitochondrial DNA levels were significantly higher than circulating cell-free nuclear DNA levels" (last sentence of page 845).
Relevant to claim 1 v), Zachariah et al. Table 2 teaches "Levels of Circulating Cell-Free Nuclear DNA and Circulating Cell-Free Mitochondrial DNA in the Four Study Groups", wherein the groups include healthy controls, benign epithelial ovarian tumor, epithelial ovarian cancer, and endometriosis subjects.
Relevant to claim 1 vi), Zachariah et al. Table 2 teachings would enable the skilled artisan to learn that the mean CmCn content ratio in epithelial ovarian cancer in plasma (~459) is lower than the mean CmCn content ratio in control plasma (~885).
Further relevant to claim 1 vi), Zachariah et al. teaches "Our study confirmed the interpretation that although elevated levels of plasma circulating cell-free DNA were observed in ovarian cancer and showed possible diagnostic values to discriminate between epithelial ovarian cancer cases and healthy individuals, the levels of serum circulating cell-free DNA reveal the results without clinical relevance" (page 849, column 1, paragraph 4).
Relevant to claim 1 vii), although the Zachariah et al. "blood samples were taken before any invasive procedures and before any treatments" (page 844, column 2, paragraph 2), the skilled artisan would find it obvious to administer an anti-cancer treatment to the subject because Zachariah et al. teaches that their investigations aimed to determine "whether quantitative alterations of the circulating cell-free species have values in the management of the patients" (Objective), and determined that "From our study, we can conclude that both circulating cell-free nuclear DNA and circulating cell-free mitochondrial DNA in plasma can be potentially useful biomarkers in ovarian cancer" (last sentence of page 849, column 2).
Relevant to claim 2, Zachariah et al. teaches "To analyze the levels of circulating cell-free nuclear DNA and circulating cell-free mitochondrial DNA in patients with benign and malignant ovarian tumors using a gold-standard assay and to investigate whether quantitative alterations of the circulating cell-free species have values in the management of the patients" (Objective).
Relevant to claim 3, Zachariah et al. teaches "Quantification of circulating cell-free DNA using multiplex real-time PCR was performed using the ABI Prism 7000 Sequence Detector" (page 845, last paragraph of column 1).
Relevant to claims 4-6, Zachariah et al. teaches "The amounts of nuclear DNA and mitochondrial DNA were quantified by multiplex real-time PCR for both the glyceraldehype-3-phosphodehydrogenase (GAPDH) gene and the mitochondrial DNA encoded ATPase (MTATP) 8 gene" (page 845, column 1, paragraph 6).
Relevant to claims 11-12, Zachariah et al. mitochondrial target nucleic acid sequence has a length of 79 base pairs, and the nuclear target nucleic acid sequence has a length of 97 base pairs, as seen in the UCSC Genome Browser views of the amplified regions.
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Relevant to claim 13, Zachariah et al. teaches "The primer and probe sequences for GAPDH and MTATP 8 gene are shown as follows: GAPDH (forward): 5' [sequence] 3'; (reverse): 5' [sequence] 3'; ... Mitochondrial DNA (forward): 5' [sequence] 3'; (reverse): 5' [sequence] 3'…" (page 845, column 2, paragraph 7).
Relevant to claims 14-15, Zachariah et al. teaches "Blood samples were processed strictly according to our common experimental protocol described in previous publications" (page 845, column 1, paragraph 4).
Zachariah et al. does not teach a specific embodiment having all the claimed elements. That being said, however, it must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious," the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR at 1741. The Court emphasized that "[a] person of ordinary skill is... a person of ordinary creativity, not an automaton." Id. At 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed elements — including treatments, amplicons, and techniques — for a method, to arrive at compositions "yielding no more than one would expect from such an arrangement."
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zachariah et al. (2008. "Levels of Circulating Cell-Free Nuclear and Mitochondrial DNA in Benign and Malignant Ovarian Tumors"; Obstet Gynecol. 2008 Oct;112(4):843-50. doi: 10.1097/AOG.0b013e3181867bc0), as applied to claims 1-6 and 11-15 above, and further in view of Rothfuss et al. (2010. "Analysis of differential DNA damage in the mitochondrial genome employing a semi-long run real-time PCR approach"; Nucleic Acids Res. 2010 Mar;38(4):e24. doi: 10.1093/nar/gkp1082).
The teachings of Zachariah et al. are applied to instantly rejected claim 7 as they were previously applied to claims 1-6 and 11-15 as rendering obvious a method. Zachariah et al. is silent to specifics regarding non-coding region[s] of the mitochondrial genome. However, this limitation is known in the prior art and taught by Rothfuss et al.
Relevant to claim 7, Rothfuss et al. teaches "The mitochondrial genome is known to be a more fragile target than nuclear DNA for endogenous and exogenous genotoxic insults. Heteroplasmic as well as homoplasmic somatic mtDNA mutations were identified in cells and tissues associated with a broad spectrum of cancer types and age-related diseases (for review see mitomap.org). Interestingly, DNA mutations are localised almost along the entire mitochondrial genome but predominantly in the non-coding regulatory D-Loop suggesting an increased susceptibility for somatic mutations in human cancer [citation]. Employing the SLR rt-PCR method, we were able to show that the D-Loop is indeed more prone to ROS derived DNA damage than other mtDNA loci" (page 8, column 2, paragraph 1).
Although Zachariah et al. does not include the Rothfuss et al. amplification of non-coding regions of the mitochondrial genome, it would have been prima facie obvious to the skilled artisan. Both Zachariah et al. and Rothfuss et al. are analogous disclosures to the instant nucleic acid characterization field.
The skilled artisan would have been motivated to include the Rothfuss et al. amplification of non-coding regions of the mitochondrial genome within the methods rendered obvious by Zachariah et al. Rothfuss et al. teaches that “DNA mutations are localised almost along the entire mitochondrial genome but predominantly in the non-coding regulatory D-Loop suggesting an increased susceptibility for somatic mutations in human cancer”. Thus, the skilled artisan would have been motivated to amplify the Rothfuss et al. non-coding mitochondrial regions within the Zachariah et al. methodology because Rothfuss et al. teaches that the regions have “increased susceptibility for somatic mutations in human cancer”, indicating their importance in cancer pathology.
The skilled artisan would have a reasonable expectation of success based on the disclosures of Zachariah et al., and further in view of Rothfuss et al., as discussed in the preceding paragraphs.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zachariah et al. (2008. "Levels of Circulating Cell-Free Nuclear and Mitochondrial DNA in Benign and Malignant Ovarian Tumors"; Obstet Gynecol. 2008 Oct;112(4):843-50. doi: 10.1097/AOG.0b013e3181867bc0), as applied to claims 1-6 and 11-15 above, and further in view of Mizumachi et al. (2008. "Increased distributional variance of mitochondrial DNA content associated with prostate cancer cells as compared with normal prostate cells"; Prostate. 2008 Mar 1;68(4):408-17. doi: 10.1002/pros.20697).
The teachings of Zachariah et al. are applied to instantly rejected claims 8-9 as they were previously applied to claims 1-6 and 11-15 as rendering obvious a method. Zachariah et al. is silent to specifics regarding mitochondrial target nucleic acid sequence and the target nuclear nucleic acid sequence have about the same length and amplicon length differences. However, these limitations are known in the prior art and taught by Mizumachi et al.
Relevant to claims 8-9, Mizumachi et al. teaches that "For the determination of mtDNA and nDNA, the forward primer 5'-[sequence]-3' and the reverse primer 5'-[sequence]-3' (complementary to the sequences of the human b-globin gene) were used to amplify a 106-bp product. For the analysis of the mtDNA, the forward primer 5'-[sequence]-3' and the reverse primer 5'-[sequence]-3' which are complementary to the sequence of the ND1 gene, were used to amplify a 108-bp PCR product" (page 410, column 1, paragraph 3).
Relevant to claim 9, the ND1 mitochondrial target nucleic acid sequence is approximately 1.89% longer than the b-globin gene nuclear target nucleic acid sequence.
Although Zachariah et al. does not include the Mizumachi et al. amplicon length limitations, it would have been prima facie obvious to the skilled artisan. Both Zachariah et al. and Mizumachi et al. are analogous disclosures to the instant nucleic acid characterization field.
The skilled artisan would have been motivated to include the Mizumachi et al. amplicon length limits within the methods rendered obvious by Zachariah et al. Mizumachi et al. teaches that “Since it has been suggested that there is a large variation in the amount of mtDNA between cells [citation], we investigated whether there is a difference in mtDNA content in cancer cells. We analyzed mtDNA copy number at a single cell level and compared mtDNA copy number between cancer and adjacent normal cells in vitro. We also investigated mtDNA copy number at a single cell level, in which single cells were obtained from cancer and adjacent normal tissue from the same tissue specimen using laser micro-dissection. Our results indicate that there may be an enhancement of distributional variance of mtDNA content associated with cancer initiation and/or progression” (last paragraph of Introduction).
Thus, the skilled artisan would have been motivated to include the Mizumachi et al. amplicon length limits within the Zachariah et al. methodology because Mizumachi et al. teaches that their amplicon analyses led to the successful single-cell resolution of mitochondrial DNA content and association with “cancer initiation and/or progression”. The skilled artisan would have a reasonable expectation of success based on the disclosures of Zachariah et al., and further in view of Mizumachi et al., as discussed in the preceding paragraphs.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zachariah et al. (2008. "Levels of Circulating Cell-Free Nuclear and Mitochondrial DNA in Benign and Malignant Ovarian Tumors"; Obstet Gynecol. 2008 Oct;112(4):843-50. doi: 10.1097/AOG.0b013e3181867bc0), as applied to claims 1-6 and 11-15 above, and further in view of European Pharmaceutical Review. (2009. "Article 3: qPCR Assay Design" Issue 3 2009. https://www.europeanpharmaceuticalreview.com/article/846/article-3-qpcr-assay-design/).
The teachings of Zachariah et al. are applied to instantly rejected claim 10 as they were previously applied to claims 1-6 and 11-15 as rendering obvious a method. Zachariah et al. is silent to specifics regarding the mitochondrial and nuclear target nucleic acid sequences have the same length. However, this limitation is known in the prior art and taught by the European Pharmaceutical Review.
Relevant to claim 10, the European Pharmaceutical Review teaches “When comparing the relative expression of several genes of interest, it is advisable to designs amplicons of approximately equal lengths for comparative DDCq analysis, as this makes it more likely that the qPCR assays will be of similar efficiencies” (page 2, section “2. Consider the amplicon”).
Although Zachariah et al. does not include the European Pharmaceutical Review equivalent amplicon length limitation, it would have been prima facie obvious to the skilled artisan. Both Zachariah et al. and the European Pharmaceutical Review are analogous disclosures to the instant nucleic acid characterization field.
The skilled artisan would have been motivated to include the European Pharmaceutical Review equivalent amplicon length limitation within the methods rendered obvious by Zachariah et al. The European Pharmaceutical Review teaches that “it is advisable to designs amplicons of approximately equal lengths for comparative DDCq analysis, as this makes it more likely that the qPCR assays will be of similar efficiencies”. Thus, the skilled artisan would have been motivated to include the European Pharmaceutical Review equivalent amplicon length limitation because it would enable similar qPCR efficiencies and desirable comparison conditions between genes of interest.
The skilled artisan would have a reasonable expectation of success based on the disclosures of Zachariah et al., and further in view of the European Pharmaceutical Review, as discussed in the preceding paragraphs.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,704,104 B2 (hereafter patent ‘104). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims differ from the claims of patent ‘104 only in the type of cancer characterized. The instantly claimed cancers are obvious variants of the patent ‘104 colorectal cancer. Otherwise, the methods and limitations are identical.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,821,044 B2 (hereafter patent ‘044). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
The instant claims differ from the claims of patent ‘044 only in the type of cancer characterized. The instantly claimed cancers are obvious variants of the patent ‘044 breast cancer. Otherwise, the methods and limitations are identical.
Conclusion
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682