DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 26-42 are pending and currently under consideration.
Claim Rejections - 35 USC § 112
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.
Claim 34 is 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.
Claim 34 is rejected for reciting “…wherein the primers detect a K-ras mutation corresponding to amino acid number 12.” The metes-and-bounds of the claim are unclear because it is unclear which amino acid of what is “amino acid number 12.” In an effort to expedite prosecution, it is noted the following amendment to claim 34 could obviate this rejection: “…wherein the primers detect a K-ras mutation corresponding to amino acid number 12 of the K-ras.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 26, 28, 29, 32, 34-41 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Caldas et al (Cancer Research, 1994, 54: 3568-3573).
Caldas et al teaches a method comprising determining the presence K-ras mutations in a DNA sample obtained from a stool sample from a subject wherein the K-ras mutations are “scored” as 12asp +12val or 12val (Table 2, in particular). The method of Caldas et al amplifies a region of DNA in the sample using primers specific for one or more K-ras mutations (left column on page 3569, in particular). Caldas et al further teaches aid method wherein the DNA sample is obtained from the stool sample using extraction reagents (razor blade, phenol-chloroform, proteinase K, PC8) and DNA stabilization buffer (500 mM Tris-16 mM EDTA-10mM NaCl, pH 9.0) (left column on page 5596, in particular).
Claim Rejections - 35 USC § 102
Claim(s) 26, 29-34, 37, and 42 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kraunz et al (British Journal of Cancer Research, 2005, 93: 949-952; 1/15/25 IDS).
Kraunz et al teaches a method comprising determining a BMP methylation status by treating a DNA sample from a subject with bisulphite reagent and amplifying a region of the treated DNA using primers specific for BMP3 (page 949-950 and Table 1, in particular). Kraunz et al further teaches the method comprising determining presence of a K-ras mutation (Table I, in particular).
Claim Rejections - 35 USC § 102
Claim(s) 26, 27, 29, 30, 32, and 34-39 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mori et al (LabMedicine, 2006, 37(5): 286-289).
Mori et al teaches a method comprising determining the presence of K-ras mutations in a bodily fluid DNA sample from a subject wherein the K-ras mutations are “scored” as AGT, CGT, GAT, GCT, GTT, TGT, or GGT at codon 12 using digital melt curve analysis or amplifying a region of the DNA sample using primers specific for one or more K-ras mutation corresponding to amino acid number 12 of K-ras (page 286-287, Figures 2-3, and Table 3, in particular).
Claim Rejections - 35 USC § 102
Claim(s) 26, 28-32, and 34-41 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shuber et al (US 2004/0043467 A1; 3/4/2004).
Shuber et al teaches a method comprising determining the presence of K-ras mutations in a DNA sample from a subject ([0009], in particular) wherein the K-ras mutations are “scored” as mutations of codon 12 or codon 13 ([0047], in particular) by amplifying a region of the DNA sample by quantitative PCR using primers specific for one or more K-ras mutations ([0068], in particular). Shuber et al further teaches the stool is obtained in a DNA stabilization buffer and is extracted using DNA extraction reagents ([0044], in particular). Regarding instant claim 30 passively reciting “…score is determined using digital melt curve analysis.”, one performing the method of claim 30 is not required to actively determine using digital melt curve analysis.
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 26-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. Abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claims 26-42 are directed to abstract idea and natural phenomenon because the claims recite natural phenomenon and an abstract idea (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: K-ras mutations and BMP methylation are present in DNA samples from subjects. The “abstract idea” is: the step of “determining” a K-ras mutation score (mental process). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to well-understood, routine and conventional limitations of known steps of detecting K-ras mutations and BMP methylation (“Step 2B”). See above anticipation rejections, for example. Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
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);
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ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. 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);
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v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
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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
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viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
Recited active steps of the claims impose no meaningful limit on the scope of the claims, implicate a relevant pre-existing audience, and are recited at a high level of generality such that substantially all methods of detecting a K-ras mutation or detecting BMP methylation in just any DNA sample would conventionally and routinely perform such steps. Further, the specification discloses “standard PCR techniques” can be used to determine methylation and mutations can be detected by known Sanger sequencing ([0041] and [0088], in particular). Here, the claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, the broad instant claims, encompassing detection methods that can be used to diagnose subjects with a disorder that has yet to be shown to correlate with K-ras mutation or BMP methylation, do not relate the judicial exception(s) in a significant way and appear to be a drafting effort designed to monopolize laws of nature in a manner that is antithetical to patent laws. Further, the active method steps are conventional and routine in the art for the reasons stated above and the claims do not amount to significantly more than the judicial exception(s). Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting a mutation or methylation) are routinely performed in the art to obtain data regarding expression any methylation. The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s).
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 26, 28-32, and 34-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, and 8 of U.S. Patent No. 7368233. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to methods encompassed by instant claims. As disclosed by the patent, K-ras mutations of the patent method are “scored” as mutations of codon 12 or codon 13 by amplifying a region of the DNA sample by quantitative PCR using primers specific for one or more K-ras mutations (Example 1, in particular). The patent further teaches the stool is obtained in a DNA stabilization buffer and is extracted using DNA extraction reagents (Example 1, in particular). Regarding instant claim 30 passively reciting “…score is determined using digital melt curve analysis.”, one performing the claimed method is not required to actively determine using digital melt curve analysis.
Claims 26-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-8 of U.S. Patent No. 8673555,
claims 1-2 of U.S. Patent No. 9632093,
claims 1-5 of U.S. Patent No. 9803249,
claims 1-2 of U.S. Patent No. 10590489, and
claims 1-13 of U.S. Patent No. 12043871,
The patent claims are directed to species of the instant claims (the instant application is a continuation of the patents).
Claims 26-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-13 of U.S. Patent No. 9121070,
claims 1-11 of U.S. Patent No. 9399800, and
claims 1-8 of U.S. Patent No. 11530449,
The patent claims are directed to a system that is disclosed as being used to perform methods of the instant claims (the instant application is a continuation of the patents).
Claims 26, 29-32, and 34-41 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 10000817 in view of Mori et al (LabMedicine, 2006, 37(5): 286-289). The patent claims differ from the instant claims in that the patent claims do not recite the K-Ras mutation is any particular K-Ras mutation that provides a K-Ras mutation score or is detected by digital melt curve or quantitative PCR of the mutant allele. However, it would be obvious to perform the claimed method wherein just any known K-Ras mutation is detected (including those of Mori et al) that provides a K-Ras mutation and wherein the K-Ras mutation is detected by any known detection means (including those of Mori et al) because the patent method recited detecting a K-Ras mutation.
Claims 26-32 and 34-42 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10011878 in view of Mori et al (LabMedicine, 2006, 37(5): 286-289). The patent claims differ from the instant claims in that the patent claims do not recite the K-Ras mutation is any particular K-Ras mutation that provides a K-Ras mutation score or is detected by digital melt curve or quantitative PCR of the mutant allele. However, it would be obvious to perform the claimed method wherein just any known K-Ras mutation is detected (including those of Mori et al) that provides a K-Ras mutation and wherein the K-Ras mutation is detected by any known detection means (including those of Mori et al) because the patent method recited detecting a K-Ras mutation.
Claims 26, 27, 29-32 and 34-42 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10435753 in view of Mori et al (LabMedicine, 2006, 37(5): 286-289). The patent claims differ from the instant claims in that the patent claims do not recite the K-Ras mutation is any particular K-Ras mutation that provides a K-Ras mutation score or is detected by digital melt curve or quantitative PCR of the mutant allele. However, it would be obvious to perform the claimed method wherein just any known K-Ras mutation is detected (including those of Mori et al) that provides a K-Ras mutation and wherein the K-Ras mutation is detected by any known detection means (including those of Mori et al) because the patent method recited detecting a K-Ras mutation.
Claims 26-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12416050. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are directed to species of instant claims.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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