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 .
FINAL ACTION
Election/Restrictions
Applicant’s species election of the marker combination of Rho GDP dissociation inhibitor beta (ARHGDIB) and cadherin 13 (CDH13) in the reply filed on 5/28/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The Restriction Requirement is still deemed appropriate and is therefore made FINAL.
Claims 13 and 14 have been canceled without prejudice or disclaimer. Claims 2, 3, 5, 6, 7, 8, and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 5/28/26.
Currently, claims 1, 4, 9, 10, 12, 15, and 16 are under consideration.
Rejections and/or objections of record not reiterated herein have been withdrawn.
Priority
6. This application has a priority date of April 28, 2020: The application is a U.S. national stage entry under 35 U.S.C. §371 of PCT International Patent Application No. PCT/EP2021/061085, filed April 28, 2021, which claims priority to European Patent Application No. 20171726.1, filed April 28, 2020.
NEW GROUNDS OF REJECTIONS NECESSITATED BY AMENDMENTS
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.
7. Claims 1, 4, 9, 10, 12, 15, and 16 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.
A. Claims 1, 4, 9, 10, and 16 are vague and indefinite because it is not clear as to what the method will encompass or measure. As recited the claim recites the detection of ARHGDIB and CDH13. However, the specification appears to teach measurements of SEQ ID NO:1 and SEQ ID NO:6 (see page 9 and figure 2).
Additionally, a simply detection does not warrant the measurement of lung cancer because the disclosure shows an upregulation of ARHGDIB in lung cancer compared to healthy subjects and down regulation of CDH13 in lung cancer compared to healthy subjects. The mere measurement of any detection is therefore ambiguous as to what parameters are being evaluated. In order to obviate this rejection, it is suggested that the claims clearly identify that the change is increased or decreased expression in lung cancer as compared to a normal control (healthy subject). Appropriate correction is required.
B. The term “threshold value” in claims 12 and 15 is a relative term which renders the claim indefinite. The term “threshold value” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims recite that the threshold value represents a “known diagnosis of lung cancer”. And the specification teaches that the results were analyzed by a threshold-based approach with a cut off value. See page 50, Discussion. It is not clear as to what will be considered “known” or if a “threshold-based approach” will be utilized in the claims. In order to obviate the rejection it is suggested that the actual cuff off parameters (units of measurement) are recite in the claims. Please clarify.
C. Claims 12 and 15 are vague and indefinite in reciting that the kit will include a threshold value. Does Applicant intend to mean a specific control sample with a known detection parameter is included in the product or is a written pamphlet with known values included? As recited the meets and bounds of the claim cannot be determined. Please clarify the claims.
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.
8. Claims 1, 4, 9, 10, 12, 15, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to a judicial exception or JE (i.e. natural phenomena-measuring biomarkers found in nature and abstract idea-comparison to a reference control/threshold value) without significantly more.
The claim(s) recite(s): Claim 1. (Previously presented) An in vitro method for diagnosing lung cancer in a subject known or suspected to have lung cancer, wherein the method comprises detecting Rho GDP dissociation inhibitor beta (ARHGDIB) and at least one biomarker selected from the group consisting of alpha-tubulin 4A (TUBA4A), glutathione S-transferase omega 1 (GSTO1), filamin A (FLNA), peroxiredoxin 6 (PRDX6) and cadherin 13 (CDH13) in a blood sample from the subject.
Claim 12. (Previously presented) A kit for diagnosing lung cancer, the kit comprising: (a') a binding agent specifically binding to ARHGDIB, wherein said binding agent allows measuring the quantity or expression levels of ARHGDIB in a blood sample from a subject; (a") a binding agent specifically binding to at least one biomarker selected from the group consisting of TUBA4A, GSTO1, FLNA, PRDX6 and CDH13, wherein said binding agent allows measuring the quantity or expression levels of said at least one biomarker in a blood sample from a subject; and (b) a threshold value for each of said at least two biomarkers, wherein said threshold value represents a known diagnosis of lung cancer.
Claim 15. (Previously presented) The method according to claim 1, wherein the detection of ARHGDIB and at least one biomarker selected from the group consisting of TUBA4A, GSTO1, FLNA, PRDX6 and CDH13 is performed using a kit for diagnosing lung cancer, the kit comprising: (a') a binding agent specifically binding to ARHGDIB, wherein said binding agent allows measuring the quantity or expression levels of ARHGDIB in a blood sample from a subject; (a") a binding agent specifically binding to at least one biomarker selected from the group consisting of TUBA4A, GSTO1, FLNA, PRDX6 and CDH13, wherein said binding agent allows measuring the quantity or expression levels of said at least one biomarker in a blood sample from a subject; and (b) a threshold value for each of said at least two biomarkers, wherein said threshold value represents a known diagnosis of lung cancer.
The judicial exception (natural phenomena) is not integrated into a practical application because determining natural biomarkers (ARHGDIB and CDH13) in a biological sample, comparing data (reference/threshold control levels), and diagnosing lung cancer by merely thinking about the results does not practically apply the judicial exception.
In other words, there is no corresponding action with respect to the knowledge provided by the judicial exception. Claim 1 merely detects the biomarkers while claims 12 and 15 compare the measured markers to a threshold (with no corresponding method steps – therein reading on an abstract idea). Accordingly, the claims do not integrate the JE into a practical application.
The steps of “detecting, determining and comparing” in the claims do not actually require an active wet step but encompasses abstract ideas and are insufficient to make an otherwise ineligible claims patent eligible, the claims are ineligible subject matter under 35 U.S.C. 101. (Alice Corporation Pty. Ltd. v. CLS Bank International, et al.).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detecting, determining, and comparing steps do not transform the method into an inventive process. The additional steps do not amount to significantly more than the judicial exception.
Based upon an analysis with respect to the claims as a whole, the claims are determined to be directed to a law of nature/natural principle (natural phenomena). The rationale for this determination is explained below:
A claim that focuses on use of a natural principle (method merely identifying or detecting/determining the natural compositions of (ARHGDIB and CDH13) must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966.
To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968.
Specifically the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, would fail this inquiry. See id. at 1965, 1971.
It is not necessary that every recited element or step integrate or relate to the natural principle as long as it is applied in some practical manner. However, there must be at least one additional element or step that applies, relies on or uses the natural principle so that the claim amounts to significantly more than the natural principle itself.
Along with integration, the additional steps must be sufficient to ensure that the claim amounts to significantly more than the natural principle itself by including one or more elements or steps that limit the scope of the claim and do more than generally describe the natural principle with generalized instructions to “apply it.” See id. at 1965, 1968.
The additional elements or steps must narrow the scope of the claim such that others are not foreclosed from using the natural principle (a basic tool of scientific and technological work) for future innovation.
Elements or steps that are well-understood, purely conventional, and routinely taken by others in order to apply the natural principle, or that only limit the use to a particular technological environment (field-of-use), would not be sufficiently specific. See id. at 1968.
In the present case, the claims are directed to a naturally occurring correlation, namely the natural composition of (ARHGDIB and CDH13); naturally found in an individual; and measuring differential expression in lung cancer. See claims 1, 4, 9, 10, 12, 15, and 16.
The combination of steps recited in the claims, taken as a whole, is not sufficient to qualify as a patent-eligible practical application because the steps are not sufficiently specific to ensure that the claims amount to significantly more than the natural principle itself. Rather, in this case the claims would cover every substantial practical application of the correlation.
In particular, the “detecting, determining, and comparing are recited at a high level of generality and is not sufficient to ensure that the claims amount to significantly more than the naturally occurring correlation itself.
This is because every application of the correlation would require determining; and also because the “detecting/determining and comparing to a reference control do not relate to the natural principle in a significant way to impose a meaningful limit on the claim scope.
Limitations that are necessary for all practical applications of the natural principle, such that everyone practicing the natural principle would be required to perform those steps or every product embodying that natural principle would be required to include those features, would not be sufficient to confer patent eligibility.
In addition, appending conventional steps, specified at a high level of generality, to a natural principle does not make the claim patent-eligible.
Steps that amount to instructions that are well-understood, routine, conventional activity, previously engaged in by those in the field add nothing specific to the natural principle that would render it patent-eligible.
In this case, it was known to measure biomarkers such as (ARHGDIB and CDH13) in lung cancer patients. See for example the reference to Brown et al. (US2016/0041153 A1) which discloses biomarkers for conditions and diseases such as cancer include biological molecules such as proteins, peptides, lipids, RNAs, DNA and variations and modifications thereof. The identification of specific biomarkers, such as DNA, RNA and proteins, can provide biosignatures that are used for the diagnosis, prognosis, or theragnosis of conditions or diseases. The biomarkers can be detected in bodily fluids, including circulating DNA, RNA, proteins, and vesicles. Circulating biomarkers include proteins such as PSA and CA125, and nucleic acids such as SEPT9 DNA and PCA3 messenger RNA (mRNA). Circulating biomarkers can be associated with circulating vesicles. Vesicles are membrane encapsulated structures that are shed from cells and have been found in a number of bodily fluids, including blood, plasma, serum, breast milk, ascites, bronchioalveolar lavage fluid and urine.
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The instantly claimed invention when given its broadest reasonable interpretation (BRI) reads on a method or kit (claims 1, 12, and 15) measuring ARHGDIB and CDH13 in a test sample wherein the detection of lung cancer is or is not measured (i.e. ARHGDIB is not upregulated or CDH13 is not down regulated). The step of detecting/determining is therefore insufficient to render the claim patent eligible, since it represents well-understood, routine, and conventional activity that was previously engaged in by those in the field.
Furthermore, the additional elements set forth in the dependent claims also represent well-understood, routine, conventional activity that was previously engaged in by those in the field.
In other words, ARHGDIB and CDH13 with additional biomarkers are naturally occurring products and the claimed methods identifying them merely amount to routine activity that is not patent eligible.
In summary, the claims do not include additional elements/steps or a combination of elements/steps that are sufficient to ensure that the claims amount to significantly more than a natural principle itself. This is because (1) the claims would cover every substantial practical application of the correlation and (2) the additional steps recited in the claim were previously taken by those in the field.
When the claims are considered as a whole, the steps taken together amount to no more than recognizing the law of nature itself.
A claim setting forth the relationship between naturally occurring ARHGDIB and CDH13 with or without additional biomarkers levels in patients would require additional steps that do significantly more to apply this principle than conventional marker testing or general diagnostic activity based on such testing. Such additional steps could involve, for example, a testing technique or treatment steps that would not be conventional or routine.
Additionally Claim(s) 1, 12, and 15 appear to be directed to abstract ideas wherein the biomarkers are “compared to a threshold value or reference control” (reading on mental processes). Comparing information regarding a sample or test subject to a control or target data reads on “An Idea ‘Of Itself’” as when given its broadest reasonable interpretation, such a comparison would read on a mental process that could be performed in the human mind, or by a human using pen and paper. See July 2015 Update, Quick Reference Guide.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC.
The specific information that is being compared (ARHGDIB and CDH13) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
The analysis to be used for evaluating whether a claim is drawn to patent-eligible subject matter.
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis from Alice Corp. (also called the Mayo test) for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, Prong 1 determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea enumerated in the 2019 PEG (judicial exceptions) and
Step 2A, Prong 2 determine whether the claims recites additionally elements that integrate the exception into a practical application of the exception
If the exception is not integrated into a practical application, then proceed to Step 2B determines whether the claim as a whole amounts to significantly more than the exception.
101 Analysis – Claims 1, 12, and 15
Step 1: – Is the claim to a process, machine, manufacture or composition of matter?
YES. The claims recite a step or act, i.e. method or kit for diagnosing lung cancer by measuring ARHGDIB and CDH13 in a biological sample to determine lung cancer. Thus, the claim is directed to a process and manufacture.
Step 2A Prong 1: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea?
Yes. The claims recite a step of detecting/determining and comparing ARHGDIB and CDH13 biomarkers levels. This reads on comparing or mental activities that are abstract ideas (JE). The steps of comparing (determining presence or level) is recited a high level of generality that merely requires a comparison of two pieces of information and imposes no limits on how the comparison is performed. In Myriad CAFC, the court round this step of comparing to be an abstract idea. When applying the 2014 IEG and interpreting the claim during examination, it is apparent that the step of comparing (determining presence or level) could be performed by a human using mental steps or basic critical thinking.
Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC.
The specific information that is being compared (ARHGDIB and CDH13) merely narrows the abstract idea, which does not make the comparison step less abstract and is not sufficient to provide eligibility on its own.
Thus, the claim is directed to an abstract idea. The claim is drawn to an abstract ideas in what they are directed to a method for collecting and comparing information regarding a sample or test subject to a control or target data (Ambry/Myriad CAFC).
Step 2A Prong 2: Is the JE integrated into a practical application?
No, there is not action on the JE. The method merely requires thinking about the information or results obtained (comparison and possibly administering a treatment) reading on instances wherein the JE is not physically acted on.
Step 2B: Does the claim as a whole amount to significantly more than the judicial exception, i.e. the product of nature, law of nature, natural phenomenon, or abstract idea? Inventive concept
The claim as a whole is analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the abstract idea. The claim recites steps of measuring ARHGDIB and CDH13 biomarkers in blood samples are all well understood, routine and conventional procedures. Accordingly, the claims as a whole do not amount to significantly more than the abstract idea of comparing/determining information (evaluating data). The claim is not patent eligible.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The method and kit of claims 1, 4, 9, 10, 12, 15, and 16 are generally directed to collecting information and comparing the data to determine lung cancer. The use of conventional, well understood, and routine activities previously known to the industry, specified at a high level of generality, had been held NOT to be enough to qualify as “significantly more” when recited in a claim with a judicial exception.
Determining whether ARHGDIB and CDH13 biomarkers are present in a sample merely instructs a scientist to use any detection technique. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or transformation of a particular article, in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientist prior to applicant’s invention, and at the time the application was filed. Further, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and detecting steps does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int’l, 134 S.Ct. 2347, 2358-59 (2014)).
For all of the reasons above, at least claims 1, 12, and 15 fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Claims 4, 9, 10, and 16 are directed to the additional steps of measuring by known routine assay techniques. As such, claims 1, 4, 9, 10, 12, 15, and 16 fail to include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
9. 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.
10. Claim(s) 1, 4, 9, 10, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pastor et al. (Journal of Proteomics, Vol,89, 26 August 2013, pages 227-237) in view of Li et al. (Oncotarget, 2018, Vol.9, No.1, pages881-891) and Toyooka et al. (Cancer Research, Vol.61, pages 4556-4560, June 1,2001).
Pastor et al. disclose the measurement of ARHGD1B in lung cancer. 40 biomarkers were analyzed in figure 1. The researchers performed proteomic analysis of several biomarkers including ARHGD1B and found that ARHGD1B was upregulated in in the disease set. Venn diagrams (figure 2) were used to display the differentially expressed proteins in each pathological subgroup studied. Among patients belonging to the LC group, 6 proteins were found to be up-regulated (CTSD, ALDO A, FBP1, ERZ, AKR1B10, TKT) and 1 down-regulated (SELENBP1) as compared to those in the control group, that were not found to be differentially expressed in patients belonging to the COPD or COPD/LC groups.
On the other hand, the LC and LC/COPD groups shared 5 proteins (ALDH3A1, AKR1C3, PKM2, PYGM and PPIA) that were significantly up-regulated compared to the control group, that were not deregulated in the COPD group. Similarly, the COPD and COPD/LC groups shared 4 up-regulated proteins (CAT, PRDX1, PRDX2 and PRDX5) in contrast with the LC group. Finally, the three pathological groups shared 24 deregulated proteins, 17 of them up-regulated (HSP70, TXN, ENO1, AMY1A, AMY2A, ANXA1, ANXA2, ANXA5, CA1, CRP, TPPP3, C3A, GSR, IDH1, SERPINB1, PEBP4, and ARHGDIB), 5 down-regulated (GSTA1, GSTA2, GSTP, LCN2, and UCHL1), and 2 proteins (CAPS 2 and CFL1) down-regulated in the COPD group and up-regulated in the LC and LC/COPD groups as compared to the control group.
Pastor et al. differ from the instant invention in not specifically teaching the measurement of CDH13 in lung cancer.
However, the prior art has demonstrated that CDH13 is down regulated or depleted in lung cancer blood samples.
Li et al. teach that Cadherin 13 (CDH13, T-cadherin, H-cadherin) has been identified as an anti-oncogene in various cancers. Recent studies have reported that downregulation of H-cadherin in cancers is associated with CDH13 promoter hypermethylation, which could be affected by the single nucleotide polymorphisms (SNPs) near CpG sites in the CDH13 promoter. A total of 454 patients with NSCLC were placed into a NSCLC group and 444 healthy controls were placed into a control group, all participants were recruited to genotype the SNPs using Taqman assay.
The researchers showed that the allelic frequencies of rs11646213 were significantly different between NSCLC and control groups (P = 0.006). Indicating that the rs11646213 and rs7195409 in CDH13 could be associated with NSCLC or its pathologic stages in the Chinese Han population. See abstract and Tables 1-7.
While, Toyoota et al. disclose that CHD13 is significantly reduced in some breast, lung, and ovarian cancers. See page 4559-Discussion. And CDH13 (H-cadherin), located on chromosome 16q24.2–3, may function as a tumor suppressor gene. In human tumors, loss of expression of many tumor suppressor genes occurs by aberrant promoter region methylation. The methylation status of the CDH13 promoter in breast and lung cancers was correlated with mRNA expression using methylation-specific PCR and reverse transcription PCR. Methylation was frequent in primary breast tumors (18 of 55, 33%) and cell lines (7 of 20, 35%). In lung cancers, methylation was present more frequently in non-small cell lung cancer tumors (18 of 42, 43%) and cell lines (15 of 30, 50%) than in small cell lung cancer cell lines (6 of 30, 20%; P 0.03). Only the methylated or unmethylated forms of the gene were present in most (73 of 80, 91%) tumor cell lines.
CDH13 expression was present in 24 of 30 (80%) of nonmethylated tumor lines. All 18 methylated lines tested lacked expression irrespective of whether the unmethylated form was present, confirming biallelic inactivation in methylated lines. The results demonstrate frequent aberrant methylation of CDH13 in breast and lung cancers accompanied by loss of gene expression. See abstract.
Absent evidence to the contrary including known biomarkers such as CDH13 in lung cancer measurements of ARHGDIB is deemed an obvious design choice previously taught by the prior art.
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960); Ryco, Inc. v. Ag-Bag Corp., 857 F.2d 1418, 8 USPQ2d 1323 (Fed. Cir. 1988).
Therefore it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to include the CDH13 biomarker taught by Li et al. and Toyooka et al. in the biomarker analysis exemplified by Pastor et al. as a routine design choice/binding reagent taught the prior art that provided lung cancer detection in immunoassays. Additionally, when biomarkers (such as ARHGDIB and CDH13) are measured in combination, it is noted that synergism has no magic status in rendering otherwise obvious subject matter patentable.
11. Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pastor et al. (Journal of Proteomics, Vol,89, 26 August 2013, pages 227-237) in view of in view of Li et al. (Oncotarget, 2018, Vol.9, No.1, pages881-891) and Toyooka et al. (Cancer Research, Vol.61, pages 4556-4560, June 1,2001) and further in view of Foster et al. (US Patent No. 4,444,879).
Please see Pastor et al. in view of Li et al. (Oncotarget, 2018, Vol.9, No.1, pages881-891) and Toyooka et al. (Cancer Research, Vol.61, pages 4556-4560, June 1,2001) as set forth above.
While Pastor et al. in view of Li et al. (Oncotarget, 2018, Vol.9, No.1, pages881-891) and Toyooka et al. (Cancer Research, Vol.61, pages 4556-4560, June 1,2001) teach the reagents required by the instant claims; it does not specifically claim the reagents in kit configurations. In other words, the references fail to recite the reagents as a kit. However, kits are well known embodiments for assay reagents. Foster et al.
(U.S. Patent #4,444,879) describe one example. In their patent kits including the reactant reagents, a microplate, positive controls, negative controls, standards, and instructions are taught. The reagents are compartmentalized or packaged separately for utility. See figure 6, and column 15, lines 10-34.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the detection reagents exemplified by Pastor et al. in view of Li et al. (Oncotarget, 2018, Vol.9, No.1, pages881-891) and Toyooka et al. (Cancer Research, Vol.61, pages 4556-4560, June 1,2001) and format it into a kit because Foster et al. teach that it is convenient to do so and one can enhance sensitivity of a method by providing reagents as a kit.
Further, the reagents in a kit are available in pre-measured amounts, which eliminates the variability that can occur when performing the assay. Kits are also economically beneficial in reagent distribution.
It is also worth noting that the printed matter on instructions merely teaches the use of an existing product, and thus cannot impart patentability. See In re Ngai, 5/13/04, Michel, Gajarsa, Linn, per curiam. In other words the printed matter on the instructions in a kit cannot serve to define the kit over the prior art. See In re Gulack, 217 USPQ (CAFC 1983).
Response to Arguments
Applicant’s arguments and amendments were found persuasive against the rejection under 35 USC 112(a) enablement. However, prior art rejections are present herein to make the claimed invention obvious.
12. For reasons aforementioned, no claims are allowed.
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lisa V. Cook whose telephone number is (571) 272-0816. The examiner works a flexible Part-Time schedule but can normally be reached on Monday, Thursday, and Friday from 9:00 AM - 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached on (571) 272-0839.
Any inquiry of a general nature or relating to the status of this application should be directed to Group TC 1600 whose telephone number is (571) 272-1600.
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Lisa V. Cook
Hoteling
Art Unit 1641
571-272-0816
/LISA V COOK/Primary Examiner, Art Unit 1641
Prosecution Insights