DETAILED CORRESPONDENCE
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 the papers filed April 7, 2025. Currently, claims 124-125, 127-134 are pending.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant's election without traverse LTBP1, TPM1, AMIGO2, and ITGB1, Claims 124-125, 127-136 ,138-143 in the paper filed October 23, 2024 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application
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The provisional application does not teach the elected gene of ITGB1 in Figure 2E. Thus, the claims are entitled the benefit of December 1, 2017.
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 124-125, 127-134, are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Question 1
The claimed invention is directed to a process that involves a natural principle and a judicial exception.
Question 2A Prong I
The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon.
Claim 124 and the claims dependent thereupon are directed to a method of treating metastatic cancer by determining the presence of an increased expression and administering an aggressive cancer treatment. The determining step is a mental process that may be completed in the mind. Claim 124 requires performing the step of “determining the presence of an increased expression”; “comparing a change in expression of the one or more genes”. Neither the specification nor the claims set forth a limiting definition for "determining" and the claims do not set forth how “determining” is accomplished. As broadly recited the determining step may be accomplished mentally by thinking about gene expression data. The claim encompasses looking at data from a database and determining the expression.
The claim also recites an increased expression of at least two genes. Claim 128 explicitly requires a comparison to a normal, non-diseased counterpart tissue. This recitation requires a comparison to determining the presence of an increased expression. A comparison between the expression level and a control that is deemed an abstract idea (see MPEP 2106.04(a)(2)(III)(A); • claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014)). Comparisons are abstract ideas.
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. Claim 124 requires administering an aggressive cancer treatment to the subject having the increased expression, however this step is not particular. The treatment must be particular, i.e. specifically identified so that it does not encompass all applications of the judicial exception. Here the treatment using any aggressive cancer treatment is not particular and is instead merely instructions to “apply “the exception in a generic way. With respect to Claim 125, the claim recites a topoisomerase inhibitor, a pyrimidine antimetabolite and a humanized monoclonal antibody. These treatments are not specific to the judicial exception and are directed to generic cancer treatments. Thus, the administration step does not integrate the mental analysis step into a practical application.
Accordingly, the claims are directed to judicial exceptions.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. That is, the step of determining the gene expression of two or more genes was known in the art.
The steps which are set forth in the claims must be taken or used by others to apply the disclosed law of nature, and they encompass using any of a variety of well-understood techniques in the prior art for detection.
The claims are set forth at a high level of generality such that all methods for determining of the natural products are encompassed. The “determining” steps are insufficient to make the claims patent eligible.
The determining step is a mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the genotype of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the gene expression through whatever known processes they wish to use.
Further it is noted 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.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
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)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Response to Arguments
The response traverses the rejection. The response asserts the claims are directed to treating metastatic cancer using particularly early-stage aggressive cnacer therapies, including chemotherapy and radiation. The response argues “aggressive cancer therapy” is a particular treatment. This argument has been considered but is not convincing because the generic statement of “aggressive cancer therapy” is not particular. Chemotherapy and radiation generally are not “aggressive cancer therapy” without more. The newly issued 101 Examples (July 2024), Example 49, claim 1 discusses “administering an appropriate treatment”. Adding words “apply it” with the judicial exception is not indicative of integration into a practical application. The administering an “aggressive cancer therapy” does not provide any information as to how the patient is to be treated or what the treatment is but instead covers any possible treatment that a medical professional deems “aggressive”. The specification and Claim 125 provides that radiation generically is an aggressive therapy but not all radiation treatments are aggressive treatments. As such there are no meaningful constraints on the administering step such that a particular treatment would apply because it is not limited to any particular manner or type of treatment. The limitation is at most an instruction to “apply” the judicial exception.
Thus, for the reasons above and those already of record, the rejection is maintained.
New Matter
Claims 124-125, 127-134 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
In the amended claims, reference to “determining the presence of an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1 and administering an aggressive treatment to the subject having an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1” are included. The amendment does not point to any citation that teaches analyzing the combination of 4 genes and detecting an increased expression in each of the genes in a single subject. The specification does not describe or discuss any combination of genes that includes each of the 4 genes. Instead, the specification lists a lot of gene markers for analysis without providing any indication that any subset or particular gene is related to highly aggressive and metastatic cancer. The response argues the references in the 103 rejection suffers from the same fault (see page 9, of response filed April 7, 2025). As argued by the response, a laundry list of genes without the particular subset does not support determining the presence of an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1 and administering an aggressive treatment to the subject having an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1. The concept of “determining the presence of an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1 and administering an aggressive treatment to the subject having an increased expression of LTBP1, TPM1, AMIGO2 and ITGB1” does not appear to be part of the originally filed invention. Therefore, the recitation constitutes new matter. Applicant is required to cancel the new matter in the reply to this Office Action.
Conclusion
No claims allowable over the art.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682 April 21, 2025
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