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 .
Priority
This application is a 371 of PCT/JP2022/014051 filed 03/24/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/18/2023, 10/25/2023, 8/6/2024 and 12/17/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 9/18/2023. These drawings are found acceptable by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
(a) The use of the term “EvaGreen” at paragraphs [0128], [0143], Table 5 and Table 9, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 8-12, 15 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a law of nature/natural phenomenon, and /or an abstract idea without significantly more. The judicial exception is not integrated into a practical application and the claims do not include additional elements without significantly more than the judicial exception for the reasons that follow.
Applicant’s attention is directed to MPEP 2106 “Patent Subject Matter Eligibility” which discusses the Alice/Mayo two-part test for evaluating subject matter eligibility.
Regarding step 1 of the subject matter eligibility test set forth at MPEP 2106III, the claims are directed to the statutory category of a process.
Regarding Step 2A, prone, the claims recite the judicial exception of a law of nature. The claim 1 recite the correlation between identifying bacteria and sepsis. As in Mayo Collaborative Services v. Prometheus, the recited relationship is a natural phenomenon that exists apart from any human action. See also Cleveland Clinic Foundation v. True Health Diagnostic, LLC 2018-1218 (Fed. Circ. 2019) which states that “the re-phrasing of the claims does not make them less directed to a natural law”.
The claim 8 recites oligonucleotide primers and probes specific to the full-length or a partial region of genes of the recited bacteria in the form of a kit. As in Myriad, nucleic acid sequences which embraces genes and fragments thereof are deemed natural products that exists apart from any human action. The Supreme Court stated that, “Myriad did not create or alter any of the genetic information encoded by the BRCA1 and BRCA2 genes in that the location and order of the nucleotides exists in nature before Myriad found them” (page 6, Myriad).
Regarding step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements which integrates the judicial exception into a practical application. Herein, the claims do not recite additional steps or elements that integrates the recited judicial exception into a practical application of the exceptions(s). The present claims do not recite performing any specific transformative steps. The steps of performing PCR to detect the gene regions are well-known and part necessary to observe the judicial exception.
Regarding step 2B, the next question is whether the remaining elements/steps -i.e., he non-patent ineligible elements/ steps – either in isolation or combination, amount to significantly more than the judicial exception. Herein, the claims as whole are not considered to recite any additional steps or elements that amount to significantly more than routine and conventional activity and do not add something “significantly more” so as to render the claims patent-eligible. To reiterate, the steps of performing PCR to detect gene regions of bacteria of sepsis are known in the art as evidence by Blaschke et al (Diagnostic Microbiology and Infectious Disease, (2012), citation made of record on IDS filed 6/6/2024), Lehmusvouri et al (Journal of Microbiological Methods, (2015), citation made of record on IDS filed 9/19/2023, see e.g., Table 2) and Ell-Aziz et al (Journal of Applied Microbiology, 2020, citation made of record on IDS filed 9/18/2023) all teach PCR-based assay for detecting multiple bacteria of Escherichia coli, Staphylococcus aureus, Staphylococcus epidermidis, Klebsiella pneumoniae and Enterococcus spp. in sepsis.
See also MPEP 2106.05(d) II which states that:
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. 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., 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.
In Mayo v. Prometheus, the Supreme Court stated: "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
In view of the foregoing, the recited steps and elements do not provide the inventive concept necessary to render the claims patent eligible. See also Genetic Technologies Ltd. v. Merial L.L.C. 818 F.3d at 1377, 1379 (Fed. Cir. 2016).
For the reasons set forth above, when the claims are considered as a whole, the claims are not considered to recite something significantly more than a judicial exception and thereby are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
11) Claim(s) 1, 6-8, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaschke et al (Diagnostic Microbiology and Infectious Disease, citation made of record on IDS 8/6/2024) and Lehmusvuori et al (Journal of Microbiological methods, citation made of record on IDS in of Beissinger et al (WO 2008077397, July 2008).
Regarding claims 1, 6-8, 13, 14, Blaschke teach method for identifying causative bacteria of sepsis, the method comprising: performing a PCR method using a sample collected from a subject and a combination of sets of primers each specific to the full-length or a partial region of each of gyrB gene of Escherichia coli, nuc gene of Staphylococcus aureus, gyrB gene of Klebsiella pneumoniae and rpoB gene of Enterococcus spp.; and detecting the presence or absence of amplification of the full-length or the partial region of each of the genes by using a combination of probes each specific to DNA of the full-length or the partial region (see entire document, especially Materials and Methods; section 2, and Table 1).
Lehmusvuori et al teach ready-to-use dry reagents, for use in a method similar to that of Blaschke, for identifying causative bacteria of sepsis (Materials and Methods), wherein the method comprises oligonucleotide primers and probe sequences for use in PCR assays to detect several variants of 16SrRNA, gyrB, Lyta from 22 sepsis causing bacteria, wherein the bacteria comprise E.coli, S. aureus and S. pneumoniae and Pseudomonas spp. and broad-range bacteria. Lehmusvuori et al teach the use of a dry reagent PCR assay chip and further comprising the presence of a ;luminescent lanthanide chelate complex which hybridized to the amplified target and is capable of being bound to the support (chip) (see entire document, especially pages 65-68 and Tables 1- 2).
While both Blaschke et al and Lehmusvuori et al teach the bacteria, Staphylococcus epidermidis, they do not expressly teach targeting the variant atIE gene of Staphylococcus epidermidis.
In a general teaching of detecting gram-positive bacteria that may be associated with infection using PCR based assay(s), Beissinger et al teach detection of multiple gene variants of bacteria including the gene variant atIE gene of Staphylococcus epidermidis (see bottom of page 15). Beissinger et al teach that all gram-positive bacteria such as clostridia, bacilli, listeria, staphylococci, lactobacilli, enterococci, aerococci, pediococci, streptococci, mycoplasmas, leuconococcus, streptococci, mycoplasmas, leuconostoc can be bound and thus accumulated, captured, immobilized and thus with the inventive method using the polypeptide constructs according to the invention if necessary. The type of application depends on the type of samples used (page 23).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have been motivated to have combined the teachings of Beissinger with that of Blaschke et al and Lehmusvuori et al. The ordinary artisan would have been motivated to do for the obvious benefit of detecting variant sequences of bacterial species associated with infection and sepsis to improve means of diagnostics and treatment. The combination of the cited prior art is prima facie obvious in the absence of secondary consideration.
Conclusion
12) Claims 1-16 are rejected. The claims 2, 3, 5, 9, 10, 12, 15, and 16 have not been rejected under prior art because while the recited full gene sequences appear to be known in art, no prior art was found teaching the combination of oligonucleotide sequences as primer sets/probe sets for the claimed intended purpose. These claims have been rejected for other reasons.
13) Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681