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 .
Election/Restrictions
Applicant’s election without traverse of Group I, a method of predicting an outcome of a colorectal cancer subject, in the reply filed on 1/29/26 is acknowledged.
Claims 1-20 are pending. Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/29/26.
Claims 1-10 and 18-20 are currently under examination.
Priority
The instant application 18/271,793 filed on 7/11/23 is a 371 US national phase of PCT/EP2022/050105 filed on 1/5/22, and claims foreign priority to EP21151054.0 filed on 1/12/21. The priority date is determined to be 1/12/21.
Objections to Specification
The disclosure is objected to because pages 1-2 and 45 contain an embedded hyperlink and/or other form 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 Objections
Claims 1, 7, and 18 are objected to because of the following informalities:
claim 1 line 7 should include the changes of “consists of” and “the immune”; claim 7 line 1 has extraneous space in “claim 5 ,”; and
claim 18 line 2 should include the changes of “associated” and should end in a period.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 6 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 6 recites the limitation "the clinical parameters" in line 1. There is insufficient antecedent basis for this limitation in the claim, which is first introduced in claim 5 (not claim 4 as currently dependent upon). For purposes of compact prosecution, claim 6 is interpreted as dependent from claim 5.
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 1-10 and 18-20 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 correlation of gene expression and colorectal cancer is considered as the judicial exception of Laws of Nature and Natural Phenomena (see MPEP 2106.04(b)). Claim 1 preamble “predicting an outcome” and last step of “determining the prediction” are considered as the judicial exception of Abstract ideas of Mental processes (see MPEP 2106.04(a)).
Step 2A, prong two: The judicial exception is not integrated into a practical application.
Claims 1-10 and 18-20 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 claims 9-10 and 20 recite potential therapies, the Specification discloses embodiments of therapies (pages 2 and throughout) 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 predicting an outcome of a colorectal cancer subject are not inventive (Buerki et al. 2014; WO 2014/028884 A2). For the reasons set forth above, claims 1-10 and 18-20 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 1-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Buerki et al. (2014; WO 2014/028884 A2).
Relevant to claim 1, Buerki et al. Abstract teaches "Disclosed herein, in certain instances, are methods, systems and kits for the diagnosis, prognosis and determination of cancer progression of a cancer in a subject. Further disclosed herein, in certain instances, are methods, systems and kits for determining the treatment modality of a cancer in a subject. The methods, systems and kits comprise expression-based analysis of biomarkers. Further disclosed herein, in certain instances, are probe sets for use in assessing a cancer status in a subject."
Further relevant to claim 1, Buerki et al. teaches "the cancer may be a carcinoma… By way of non-limiting example, carcinomas include… colorectal cancer" (paragraph 0338).
Further relevant to claim 1, Buerki et al. teaches "Table 55: 2,040 biomarker library. For each feature, genomic category, associated Affymetrix probeset ID…" (paragraph 0154).
Further relevant to claim 1, Buerki et al. Table 55 teaches two immune defense genes (APOBEC3A, DHX9), two T-Cell receptor signaling genes (CD247, PDE4D), and three PDE4D7 correlated genes (ABCC5, PDE4D, TDRD1).
Further relevant to claim 1, Buerki et al. teaches "The present invention discloses systems and methods for diagnosing, predicting, and/or monitoring the status or outcome of a cancer in a subject using expression-based analysis of a plurality of targets. Generally, the method comprises (a) optionally providing a sample from a subject suffering from a cancer; (b) assaying the expression level for a plurality of targets in the sample; and (c) diagnosing, predicting and/or monitoring the status or outcome of the cancer based on the expression level of the plurality of targets" (paragraph 0165).
As discussed above within rejection of claim 1, and relevant to claim 2, Buerki et al. Table 55 includes the claimed genes.
Relevant to claims 3-4, Buerki et al. paragraphs 0301-0304 teach combination of gene expression and regression functions.
Relevant to claim 5, Buerki et al. paragraphs 0305-0306 teach "Additional Techniques and Tests" that "can be employed in combination with measurements of the target sequence expression."
Relevant to claim 6, Buerki et al. paragraphs 0343-0345 teach the TNM classification system.
The Buerki et al. teachings relevant to above rejections of claims 1-5 read upon the limitations of claim 7.
Relevant to claim 8, Buerki et al. paragraph 0417 teaches an embodiment wherein a biological sample is obtained from the subject before the start of the therapy.
Relevant to claim 9, Buerki et al. paragraphs 0354-0397 teach the claimed therapies.
Relevant to claim 10, Buerki et al. paragraphs 0397-0399 teach embodiments that read upon the limitations of claim 10.
Relevant to claim 18, Buerki et al. paragraphs 0400-0401 teach a patient report that reads upon the limitations of claim 18.
Relevant to claim 19, Buerki et al. Table 55 teaches two immune defense genes (APOBEC3A, DHX9), two T-Cell receptor signaling genes (CD247, PDE4D), and three PDE4D7 correlated genes (ABCC5, PDE4D, TDRD1).
Relevant to claim 20, Buerki et al. paragraph 0354 teaches an adjuvant therapy is chemotherapy and wherein an alternative therapy is immunotherapy.
Buerki 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 genes, clinical parameters, therapies, and techniques — for a method, to arrive at compositions "yielding no more than one would expect from such an arrangement."
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 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-10 of copending Application No. 17/908,279 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘279 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-10, and 25-36 of copending Application No. 18/022,565 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘565 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 18-22 of copending Application No. 18/023,598 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘598 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 18, and 21 of copending Application No. 18/029,748 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘748 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 16-17 of copending Application No. 18/707,820 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘820 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16-19 of copending Application No. 19/118,177 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘177 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 13-16 of copending Application No. 19/111,568 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘568 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10 and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 16-20 of copending Application No. 19/495,585 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are coextensive in scope.
Although the claims at issue are not identical, they are not patentably distinct from each other because the present claims are broad and generic so as to encompass the claims of the ‘585 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682