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 .
Claim Status
Currently, claims 1-19 are pending in the instant application. This action is written in response to applicant' s correspondence submitted 10/24/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Final.
Claims 1-19 are under examination with respect to the entire combination of gene markers in claims 1-3.
Withdrawn Rejections
The rejection of claims 1-19 under 35 USC 112(b) and claims 8-9 under 35 USC 112(d) is withdrawn in view of the amendment to the claims. With regard to claims 8-9, the rejections have been withdrawn in light of the specification that addressed an Aspergillus infection classification can be a subject that does or does not have an Aspergillus infection and includes a healthy subject (see para 89) and pg. 10 of the remarks mailed 10/24/2025.
Declaration
The declaration under 37 CFR 1.132 filed 10/24/2025 is insufficient to overcome the rejection of claims 1-19 based upon 112, 1st enablement as set forth in the last Office action because: the declaration is not commensurate in scope of the instant claims. While the declaration addresses a classifier using human subjects, the declaration does not provide the genes that were used for the classification. As such the declaration is not commensurate in scope of the instant claims and has not been found persuasive to overcome the rejection.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119€ as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/980478, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. ‘478 does not disclose measuring gene expression levels of two or more aspergillus versus reference genes comprising all of the genes listed in instant table 2 and administering an antifungal treatment, selecting a subject classified as having Aspergillus infection based on gene expression of all of the genes listed in instant table 2, or determining presence of Aspergillus infection. While ‘478 disclosed gene expression analysis, ‘478 does not disclose the claimed gene markers of instant table 2 nor does ‘478 disclose measuring expression levels in a subject compared to reference genes. ‘478 discloses a Table 2 however the genes are not the same gene listed in instant table 2 and the analysis is with respect to immunosuppressive effects of conserved gene expression signature (see pg. 47-57) not for analysis of treatment or presence of disease. As such the effective filing date of the instant application is 2/23/2021.
Response to Arguments
The response traverses the rejection on pages 7-9 of the remarks mailed 10/24/2025. The response asserts that every gene listed in table 2 of the instant application and now amended to claim 1 and 3 are listed by the supplemental table 2 of ‘478. This response has been reviewed but not found persuasive. The following two genes, CNPY3 and FLCN are not listed in the supplemental table 2 of ‘478, as such ‘478 does not provide support for the amended claims and the effective filing date is 2/23/2021.
The response asserts that pages 71-72 of ‘478 provide support for administering appropriate treatment regimen. However the disclosure of ‘478 is only 63 pages long.
The response addressed the measured and reference expression and asserts the ‘478 discloses this aspect of the claims on page 12, 21, and 24. None of these pages provide reference genes and comparison to the genes recited in amended claim 1 and claim 3. While ‘478 disclosed gene expression analysis, ‘478 does not disclose the claimed gene markers of instant claims, particularly CNPY3 and FLCN, nor does ‘478 disclose measuring expression levels in a subject compared to reference genes. ‘478 discloses a Table 2 however the genes are not the same gene listed in instant table 2 and the analysis is with respect to immunosuppressive effects of conserved gene expression signature (see pg. 47-57) not for analysis of treatment or presence of disease. For these reasons and reasons of record the effective filing date is 2/23/2021.
Maintained Rejections
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claim(s) recite(s) a law of nature and an abstract idea and the judicial exception is not integrated to a practical application. This rejection was previously presented and has been rewritten to address the amendment to the claims.
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a process.
Step 2A. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application?
Yes, the claims are directed to law of nature/natural phenomenon. Claim 3 recites determining the presence of an Aspergillus infection in a subject by measuring gene expression of the markers in table 2 and identifying the subject as having Aspergillus infection. Claim 10-11 requires the subject is suspected of having Aspergillus infection or fungal infection. The claims recite the law of nature of identifying a subject as having Aspergillus infection based on the amount of gene expression level of gene markers. The recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of natural processes.
The claims also recite the judicial exception of an abstract idea and particularly mental processes. Claim 1-3 recites the abstract idea of a mental process. Claim 1 and 3 recites the step of subject identified as having an Aspergillus infection. Claim 2 recites the step of selecting a subject who has been classified as having an Aspergillus infection. Neither the specification or the claims set forth limiting definition for subject identified or selecting and the claims do not set forth how selecting or identifying is accomplished. The broadest reasonable interpretation of the selecting and identifying is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding expression levels then draws a mental conclusion. Such selecting and identifying thereby encompasses process that may be performed mentally and this is an abstract idea.
Having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application.
The claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
It is noted that claims 1 and 2 recite a step of “administering an effective amount of an antifungal treatment”.
As mentioned above, a claim limitation can integrate a judicial exception by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. When evaluating this consideration one must the following:
(i) the particularity or generality of the treatment or prophylaxis limitation;
(ii) whether the limitations have more than a nominal or insignificant relationship to the exception; and
(iii) whether the limitations are merely extra solution activity or field of use.
The steps of administering to the subject an antifungal treatment is not particular i.e., specifically identified so that it does not encompass all applications of the judicial exception. In other words the claims broadly encompass any and all treatments for Aspergillus and any and all treatments that are considered antifungal treatment. Additionally the treatment limitations do not appear to have a significant relationship to the exception. Administering antifungal treatment only occurs if the subject is identified as having Aspergillus (claim 1) and administering antifungal treatment occurs to any subject (claim 2). In claim 1 if a subject is not identified then treatment does not occur. In claim 2 the treatment step is not tied to selecting a subject. For these reasons the administering step does not integrate the judicial exceptions into a practical application.
In addition to the judicial exceptions the claims recite measuring gene expression levels in a biological sample (claim 1 and 3). Claim 5-7 recites sample types and gene expression assays. Claims 8-9 recite reference samples. Claims 10-19 further classify the subject. These additional steps/elements are not considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No.
Herein the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more than well-understood, routine, and conventional activities in the art and do not add something “significantly more” so as to render the claims patent-eligible. The step of measuring gene expression merely instructs a scientist to use well established, routine and conventional nucleic acid techniques to gather samples for diagnostic analysis. As address in the instant specification methods of expression analysis are well-known in the art (See para 57).
The step of measuring gene expression in a biological sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions.
The additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art. The recited steps and elements do not provide inventive concept necessary to render the claims patient eligible. There is no combination of elements in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
Response to Arguments
The response traverses the rejection on pages 11-16 of the remarks mailed 10/24/2025. The response asserts addresses the law of nature. The response asserts the claims do not stake out a general relationship but instead require human defined comparison to reference expression levels associated with a known infection classification. The response asserts that the expression levels are tied to known classification not statement of natural law. The response asserts that measured values to reference values associated with known classification is not a recitation of a law of nature. The response further asserts that measuring and administering are concrete steps outside this expectation. This response has been reviewed but not found persuasive. The expression levels associated with known infection classification is a natural phenomenon. The expression levels are a consequence of the infection and the change is a result of the infection and do not require a hand of man. As such the expression levels from an infection are a law of nature, the recited relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process. While the measuring and administering are additional steps, these steps do not integrate the law of nature.
The response asserts the claims are not abstract idea. The response asserts the limitations define the identification or selection of the subject by a specific comparison operation tied to measured laboratory values and known classification and do not recite an act of reading a report and forming a mental conclusion. This response has been reviewed but not found persuasive. The claims require selecting and identifying. These steps are mental processes that are performed in the mind. While the selecting and identifying occur based on measuring laboratory values, the analysis of the measured laboratory value to identify or select a subject is a mental process as such the comparison and selecting of a subject or identifying a subject based on expression encompasses mental analysis of reported data from a laboratory to determine the subject as having an infection or not, this is a mental process, this is not occurring on a computer and as such is an abstract idea. It is not the laboratory process that is an abstract idea, it is the step of identifying and selecting a subject which is an abstract idea and mental process.
The response asserts that the claims as a whole integrate the exception into a practical application. The response asserts that the claims are diagnosing and treating Aspergillus infection using defined gene markers with each step grounding in concrete laboratory and clinical procedures. The response asserts the practical application is diagnosis and treatment of a challenging clinical condition and results in concrete, real world action and improves the functioning of the technical field of the infectious disease diagnostic and treatment. The response further addresses claim 1 and claim 2 require administering an antifungal treatment to a subject identified as having Aspergillus infection. The response further asserts that the claims are limited to the use of antifungal treatments and require that treatment be specifically administer to a subject identified as having the infection. This response has been reviewed but not found persuasive. As addressed in the rejection above the treatment limitations do not have a significant relationship to the exception. Administering antifungal treatment only occurs if the subject is identified as having Aspergillus (claim 1) and administering antifungal treatment occurs to any subject that is selected (claim 2). In claim 1 if the subject is not identified then treatment does not occur. In claim 2 the treatment step is not tied to selected a subject, for these reasons the administering step does not integrate the judicial exception into a practical application.
The response further asserts that the combination of limitations recited in the claims produces a particular unconventional solution related to an inventive concept of using expression levels from a specific gene panel to prov ide improved Aspergillus infection and diagnosis. The response addresses Vanda and asserts the claims are directed to a defined set of gene markers and the claims resides not in the mere recognition that some gene is differentially expressed in a disease but the selection and application of a specific constellation of gene markers. The response asserts that the specification demonstrates that this approach provides substantial advantages over the prior art. The response asserts that the office provides no evidence that the specific panel of markers was routine, conventional and well understood at the time of filing. The response asserts the specific combination of election recited here were unconventional and there is no evidence of record to date that two gene selected from the set compared to reference samples to identify an infection and administer an antifungal treatment. This response has been reviewed but not found percussive. The combination of steps to which applicant is relying upon encompass judicial expectations. The comparison of expression values to identify an infection are abstract ideas and cannot integrate a judicial exception nor evidence for unconventional steps when the steps encompass a judicial exception. Regard measuring the expression of the gene set, the claimed genes are found on a commercially available mouse array, as such measuring expression of the gene set was routine and conventional. The recitation of sample types, reference samples and additional steps/elements do not integrate the judicial exception and not are significantly more than the judicial exception because they merely add insignificant extra solution activity, data gathering, to the judicial exception. The instant specification addresses that measuring expression levels of gene was well known in the art, see para 57. Additionally, as addressed above, The step of measuring gene expression in a biological sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers whose level is to be determined however the claims do not require a particular, non-conventional primer or probe consisting of or comprising a specific nucleotide sequence or any other specific reagent that is used to accomplish such determining such that the claims would recite significantly more than the judicial exception. The targets to be detected are part of the judicial exception and thereby the naming of the targets does not add something “significantly more” to the recited judicial exceptions. For these reasons and reasons of record this rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for determining the presence of Aspergillus infection in a mouse and treating an Aspergillus infection in a mouse by measuring gene expression levels of all the gene markers in table 2 to identify a mouse as having Aspergillus and administering to the mouse that has Aspergillus an antifungal treatment, does not reasonably provide enablement for identifying or treating any subject, including humans. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Nature of the Invention and Scope of the Claims:
The claimed methods are drawn to determining presence of Aspergillus and treating Aspergillus infection by measuring gene expression levels of gene markers in table 2.
The claims generically encompass analysis of any subject organism for presence of Aspergillus infection and for treating of an Aspergillus infection.
The claims require the knowledge of a reliable and robust association between measuring gene expression of the gene markers in table 2 with diagnosis of Aspergillus infection and determining treatment by administering an antifungal treatment to a subject identified as having Aspergillus infection.
Direction provided by the Specification and Working examples:
The instant specification provides an example wherein samples from mouse were analyzed to determine gene expression levels. Relevant to the method of the pending claims, the data in the specification (example 5) demonstrates analysis of gene expression data in a mouse infected with Aspergillus compared to mouse not infected with Aspergillus. The gene expression data was determined by microarray analysis using Affymetrix murine 430 microarray and table 2 encompasses the genes that were increased or decreased compared to a reference in a mouse sample. The specification identifies relevant genes in mice in table 2 however the actual expression levels are not described only with respected to increase or decreased expression.
Relevant to the breadth of the claims, there is no analysis of any non-murine subjects. There is no analysis of any gene expression data in a human subject or analysis using a human genechip. While the specification discusses applying the method in the context of humans, no actual human data is presented.
State of the art, Level of skill in the art, and Level of unpredictability
While the state of the art and level of skill in the art with regard to measuring gene expression in biological samples is high, the unpredictability in associating any particular gene expression with a specific phenotype, or species extrapolation of gene expression is even higher. The unpredictability is demonstrated by the related art and the instant specification.
The claims encompass any subject, including humans and therefore encompass identifying a human subject as having Aspergillus infection. It is relevant to point out the unpredictability in extrapolating gene expression results among different species. Applicants own art demonstrates the unpredictability of extrapolating murine expression data to human data. Steinbrink et al. (2020, cited on IDS) demonstrate a murine model for Aspergillus infection and disclose gene expression data for the murine model. Steinbrink teaches the study has several limitations. The gene signatures were developed and validated in a specific murine model and do not account for inter-host genetic difference or fungal strain-specific difference, which may affect direct translatability to human subject. Validation of the signatures in human populations (where biological differences and inter-host variability will be much greater) is a necessary next step. Steinbrink further asserts that the experimental model, which is identical to the instant specification, does not assess how well such as assay performs with differentiating Aspergillus from disease caused by other pathogens, including other molds. Additionally the ability of an Aspergillus classifier to a discriminate between clinically similar disease states due to other etiology will be necessary moving forward. Steinbrink further discusses that microarray technology provides for scientific discovery but is not suitable for clinical purposes. Steinbrink teaches that the type of information gleaned from large scale microarrays once validated and pruned to a reasonable size offers potential for eventual migration to a number of clinical ready PCR based platforms. Thus, Steinbrink teaches the unpredictability of extrapolating the instant specification data to other species and demonstrates more studies are needed.
Therefore, absence evidence of the results being recapitulated in humans, the claimed method is not enabled for use in humans or any other species as acknowledged that differences in mice and human in the context of Aspergillus infection, as taught by Steinbrink.
Additionally as addressed by Steinbrink, it is unpredictably whether the claimed methods can distinguish Aspergillus from any other infection as other infections can cause the same differences in expression of the claimed genes. In particular, it is unpredictable whether other fungal infections could be distinguished as addressed by Steinbrink.
Quantity of Experimentation:
For the reasons discussed above, it would have required undue, unpredictable
experimentation of a trial- and-error nature to practice the recited methods in the full,
broad scope encompassed by the rejected claims. The type of experimentation required
is not routine and the subsequent data analysis is sophisticated. Furthermore, the outcome of the tasks is entirely unpredictable based on the limited data and analysis provided in the instant specification.
Conclusions:
Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed.
Response to Arguments
The response traverses the rejection on page 16-18 of the remarks mailed 10/24/2025. The response asserts the claims are commensurate in scope with the supporting disclosure and experimental data and the specification and declaration together provide a skilled artisan with all necessary instruction to practice the claimed metho without undue experimentation. The response asserts the declaration provides new human data and enables the amended claims and addresses the classifier built from mapped human orthologs of the claimed gene panel achieved an area under the ROC curve of .763. The response further asserts that all the steps can be reasonably performed by those of ordinary skill in the art without requiring undue experimentation. The response asserts the declaration demonstrates the success of translating the finding across species. This traversal has been thoroughly reviewed but not found persuasive. The declaration by Steinbeck does not provide the panel of genes used in the study. The declaration of Steinbeck asserts assessing the panel of genes from the application (see para 6) however there are many different panel of genes within the application. There is no indication in the declaration of which genes were used for the classification and identification of Aspergillus infection. Steinbeck further addresses exhibit A, experiments measuring host gene expression in blood compared to reference expression profile from subject with known Aspergillus infection status to identify new patients. Para 7 addresses the expression level of the set of genes listed in the claims were quantified, however the claims recite two or more genes and the declaration does not clearly demonstrate the entire combination of genes of claims 1-3 is predictably associated with identifying Aspergillus infection. Additionally as addressed in the rejection, the claims encompass any level of expression to be measured to identify an infection and treat an infection, this would require undue experimentation to determine which genes and expression levels are predictably associated with an infection and therapy. The exhibit addresses that mouse signature genes were mapped to their human equivalents and any gene that mapped and were retained after filtering were used in subsequence analysis, however the declaration does not demonstrate which genes were used for analysis.
As addressed in the rejection, while methods of measuring gene expression does not require undue experimentation, the extrapolation of mouse genes to human genes and disease association encompasses undue experimentation. For these reasons and reasons of record the rejection is maintained.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 3-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinbrink (2020, cited on IDS).
Steinbrink teaches mice were separated into six experimental groups. Steinbrink teaches healthy mice, mice exposed to corticosteroids, cyclophosphamide (claims 15-19). Steinbrink teaches exposing the mice to Aspergillus fumigatus (see material and methods and figure 1). Steinbrink teaches measuring gene expression by microarray analysis of blood samples (see RNA preparation and expression analysis, pg. 3) (claims 5-7). Steinbrink teaches expression analysis of all gene markers in table 2 because the microarray analysis of Steinbrink is the same analysis of the instant specification. Both Steinbrink and the instant specification encompass analysis of blood samples and expression analysis using Affymetrix 430v 2 array as such Steinbrink will inherently measuring all the gene markers of table 2.
The claims are enabled to the extent of the specification in order to provide compact prosecution Steinbrink is provided as it teaches the positive active steps of the claims.
Claims 3-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinbrink (OFID 2019:6, Suppl 2, p. 1-2).
Steinbrink teaches mice were separated into six experimental groups. Steinbrink teaches healthy mice, mice exposed to corticosteroids, cyclophosphamide (claims 15-19). Steinbrink teaches exposing the mice to Aspergillus fumigatus (see methods). Steinbrink teaches measuring gene expression by microarray analysis of blood samples (see methods) (claims 5-7). Steinbrink teaches expression analysis of all gene markers in table 2 because the microarray analysis of Steinbrink is the same analysis of the instant specification. Both Steinbrink and the instant specification encompass analysis of blood samples and expression analysis of the 187 gene classifier as such Steinbrink inherently anticipates the gene markers of table 2.
The claims are enabled to the extent of the specification in order to provide compact prosecution Steinbrink is provided as it teaches the positive active steps of the claims.
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.
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.
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.
Claim 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Steinbrink (2020, cited on IDS) in view of Aucoin (US2014/0178884)
Steinbrink teaches mice were separated into six experimental groups. Steinbrink teaches healthy mice, mice exposed to corticosteroids, cyclophosphamide (claims 15-19). Steinbrink teaches exposing the mice to Aspergillus fumigatus (see methods). Steinbrink teaches measuring gene expression by microarray analysis of blood samples (see methods) (claims 5-7). Steinbrink teaches expression analysis of all gene markers in table 2 because the microarray analysis of Steinbrink is the same analysis of the instant specification. Both Steinbrink and the instant specification encompass analysis of blood samples and expression analysis of the 187 gene classifier as such Steinbrink inherently anticipates the gene markers of table 2. Steinbrink does not teach administering an antifungal treatment.
However, Aucoin teaches treating Aspergillus infections in a subject (sese para 243).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to improve the method of identifying an Aspergillus infection in a subject as taught by Steinbeck and include treatment including antifungal treatments as taught by Aucoin to improve the method by Steinbeck et al.. The ordinary artisan would have been motivated to improve the method with a reasonable expectation of success to include treating subjects with Aspergillus infection with an antifungal treatment as taught by Aucoin to allow for an effective therapy of subject with Aspergillus infection. Because both Steinbeck and Aucoin teach infections with Aspergillus, it would have been obvious to one skilled in the art to include a known step, administering antifungal treatment in the method of identifying Aspergillus infection as taught by Steinbeck in order to achieve the predictable result of treating a subject with Aspergillus infection after selecting a subject with Aspergillus infection.
Claim 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Steinbrink (2019) in view of Aucoin (US2014/0178884)
Steinbrink teaches mice were separated into six experimental groups. Steinbrink teaches healthy mice, mice exposed to corticosteroids, cyclophosphamide (claims 15-19). Steinbrink teaches exposing the mice to Aspergillus fumigatus (see methods). Steinbrink teaches measuring gene expression by microarray analysis of blood samples (see methods) (claims 5-7). Steinbrink teaches expression analysis of all gene markers in table 2 because the microarray analysis of Steinbrink is the same analysis of the instant specification. Both Steinbrink and the instant specification encompass analysis of blood samples and expression analysis of the 187 gene classifier as such Steinbrink inherently anticipates the gene markers of table 2. Steinbrink does not teach administering an antifungal treatment.
However, Aucoin teaches treating Aspergillus infections in a subject (sese para 243).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to improve the method of identifying an Aspergillus infection in a subject as taught by Steinbeck and include treatment including antifungal treatments as taught by Aucoin to improve the method by Steinbeck et al.. The ordinary artisan would have been motivated to improve the method with a reasonable expectation of success to include treating subjects with Aspergillus infection with an antifungal treatment as taught by Aucoin to allow for an effective therapy of subject with Aspergillus infection. Because both Steinbeck and Aucoin teach infections with Aspergillus, it would have been obvious to one skilled in the art to include a known step, administering antifungal treatment in the method of identifying Aspergillus infection as taught by Steinbeck in order to achieve the predictable result of treating a subject with Aspergillus infection after selecting a subject with Aspergillus infection.
Response to Arguments
The response traverses the rejections under 35 USC 102 and 103 on pages 18-19. The response asserts that Steinbrink is not available as prior art according to the exception of 35 USC 102(b)(1)(A). The response asserts that Steinbrink was published on 2/20/2020 which is less than one year from 2/24/2020, the filing date of the provisional application (‘478). This response has been reviewed but not found persuasive. Because the provisional application, ‘478 does not provide support for FLCN or CNPY3 gene the instant claims effective filing date is not 2/24/2020 but 2/23/2021, as such Steinbeck is more than one year from the effective filing date of the instant claims and is prior art. For these reasons and reasons of record this rejection is maintained.
Conclusion
No claims are allowable.
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.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699