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 .
This action is in response to applicants correspondence mailed 08/04/2025. The amendment to the claims mailed 08/04/2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-11 and 22-31, elevated levels of SLC7A11 and mRNA in the reply filed on 08/04/2025 is acknowledged.
Claims 3-5 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/04/2025.
Claims 1-2, 6-8, 10-11, 22-25, 27-31 is under examination with respect to elevated levels of SLC7A11 mRNA.
Drawings
The drawings filed 09/12/2022 are acceptable.
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 1-2, 6-8, 10-11, 22-25, 27-31 are rejected under 35 U.S.C. 101 because the claimed invention are directed to judicial exceptions without significantly more.
Claims 1, 11, and 30 recites an abstract idea that is a mental process. Claim 1 recites identifying or having identified a sample as glutaminase inhibitor-sensitive when elevated levels of SLC7A11 mRNA compared to an appropriate control and selecting a glutaminase inhibitor-sensitive sample so identifies as providing a glutaminase inhibitor sensitive sample, thereby selecting a treatment for a subject. Claim 11 recites identifying or having identified a sample as glutaminase inhibitor-sensitive when elevated levels of SLC7A11 mRNA compared to an appropriate control. Claim 30 recites “identifying” elevated levels of SLC7A11 mRNA compared to an appropriate control. Each of these steps of “identified” or “having identified”, “selecting” and the comparison of elevated levels of SLC7A11 mRNA to control are all mental processes. Neither the specification or the claims set forth limiting definition for identified, having identified, selecting, and comparing. The claims do not set forth how each of these steps are accomplished and the broadest reasonable interpretation is a step that can be accomplished mentally be evaluating data and critical thinking process such that one mentally reads information in a database or report regarding expression of SLC7A11 mRNA then draws a mental conclusion. Such identified, having identified, selecting, comparison encompass process that may be performed mentally and this is an abstract idea.
The claims recite a law of nature/natural phenomenon. Claim 1 recites a law of nature/natural phenomenon. Claim 1 and 11 recite identifying or having identified said sample as glutaminase inhibitor sensitive when elevated levels of SLC7A11 mRNA as compared to an appropriate control. 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.
This judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application. 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.
Claim 1 recites selecting a glutaminase inhibitor for treatment, however selecting is an mental process and the broadest reasonably interpretation of selecting encompasses mental process. Claim 11 recites having administered a glutaminase inhibitor to the subject thereby treating or preventing cancer. Claims 7, 11, and 30 encompasses both administering a therapy and previously administered, i.e. not actively administering treatment by the recitation of “having administered” which encompasses administering in the past. These additional elements of having administered therapy do not apply the judicial exception.
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 or having administered a glutaminase inhibitor” 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 therapy regimens and further does not require administering the therapy to the subject as the claims recite “having administered”. Having administered could have happened in the past and not part of the method. Additionally the treatment limitations do not appear to have a significant relationship to the exception. For example claim 11, requires identifying an elevated level of SLC7A11 mRNA but does not require administering a glutaminase inhibitor the subject that has been identified has having an elevated level of SLC7A11 mRNA.
In addition to the judicial exceptions the claims recite type of cancer (claim 2, 22, 24-25) type of therapy (claim 6, 8, 23, 27-28, 29, 31) and subject (claim 10). 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 and further limit the judicial exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. 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 identifying elevated levels of SLC7A11mRNA compared to an appropriate control 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 pg. 20-21).
The step of determining a biomarker expression in a sample constitutes a data gathering step required to apply the law of nature/natural phenomenon. It is acknowledged that the claims name particular biomarkers, SLC7A11 mRNA 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 prior art of Muir (WO2018145109A1) demonstrate determining SLC7A11 mRNA levels in cancer cells to determine therapy response (see pg. 2, lines 16-19, lines 30-31, pg. 3 lines 1-2). Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine expression of SLC7A11 mRNA in biological samples. 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.
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.
Claims 1-2, 6-8, 10-11, 22-25, 27-31 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.
Claim 1 and 11 are indefinite for the recitation of having provided a sample and having identified said sample as glutaminase inhibitor-sensitive. Claim 7, 11, and 30 are indefinite over the recitation of having administered. Each of these steps are not active process steps and the recitation of having provided, having identified or having administered are not active process steps. As such the claims encompass an embodiment wherein no active process steps are performed. Additionally, it is unclear how or when the sample was provided, identified and treatment administered and how this would relate to the method of selecting, treating or preventing a cancer. The metes and bounds of the claimed invention are indefinite and one of ordinary skill in the art would not be apprised of infringing on the claimed method. Reciting a method comprising obtaining a sample from the subject, detecting elevated levels of SLC7A11 mRNA compared to a control sample, and administering a glutamine inhibitor to the subject that has elevated levels of SLC7A11 would overcome this rejection.
Claims 2, 6-8, 10, 22-23 depend from claim 1 and are indefinite for the reasons applied to claim 1.
Claims 24-25, 27-29 depend from claim 11 and are indefinite for the reasons applied to claim 11.
Claim 31 depends from claim 30 and is indefinite for the reasons applied to claim 30.
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 1-2, 6-8, 10-11, 22-25, 27-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muir (WO2018145109A1).
With regard to claim 1, 11, and 30, Muir teaches cancer cells are sensitive to glutaminase
inhibitor therapy when SLC7A11is expressed (see pg. 2 lines 16-20, 30-31, pg. 3 lines 1-2) (elevated levels of SLC7A11). Muir teaches screening for patients who are sensitive to therapy. Muir teaches determining whether the subject is sensitive to glutaminase inhibitor therapy by measuring SLC7A11 (see pg. 16, lines 7-10, pg. 17, lines 1-5). Muir teaches measuring mRNA of SLC7A11 for expression analysis (see pg. 17, lines 14-22) Muir teaches the level of SLC7A11 present in a sample is assessed by comparison to a control (See pg. 19, lines 20-24).
(providing a sample, identifying sample as glutamines inhibitor sensitive by elevated levels of SLC7A11 mRNA). Muir teaches administering a glutaminase inhibitor and cystine in an effective amount to treat the subject (see pg. 15, lines 10-11) (selecting a glutaminase inhibitor for treatment, administering glutaminase inhibitor). Muir teaches the composition can be administered to prevent progression to a neoplastic or malignant state (see pg. 22, lines 24-25).
With regard to claims 6, 23, 27-28, and 31, Muir teaches glutaminase inhibitors include BPTES, CB-839, and DON (see pg. 11, lines 3-7).
With regard to claim 10, Muir teaches biological samples from animals, including humans, and encompass fluids, solid, tissues, saliva, and urine (see pg. 18, lines 8-11).
With regard to claim 8 and 29, Muir teaches methods for treating cancer by administering glutamines inhibitor in combination with other anti-cancer treatment including chemotherapy.
With regard to claim 2, 22, and 23, Muir teaches cancer that are treated include esophageal, lung, gastric, pancreatic cancer (solid cancers) and hematological neoplasms (hematopoietic cancers) (see pg 22, lines 6-23). Muir teaches cancers include primary or metastatic (see pg. 18 line 4).
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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