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 July 26, 2024. Currently, claims 16-26 are pending.
Priority
This application is a 371 of PCT/CN/2023/072984, filed January 18, 2023 and claims priority to CHINA 292219192924, filed January 27, 2022.
It is noted that a translation of the foreign document has not been received.
Drawings
The drawings 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 16-23 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. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
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.
Claims 16-23 are directed to “a method for diagnosing a risk of depression recurrence or evaluating a therapeutic effect of depression recurrence”. Claim 19 is further directed to “when the expression level…is significantly higher than…it indicates that the subject has a high risk of depression recurrence. Claims 20-22 are similarly directed to abstract ideas and natural phenomenon.
The claims are directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “diagnosing a risk”, a comparison of a level to a reference value and “indicates that the subject has a high risk of depression recurrence”) and a law of nature/natural phenomenon (i.e. the natural correlation between the level of HIF-1alpha protein and risk of depression recurrence).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, the claims 16-23 involve the patent-ineligible concept of an abstract process. Claim 16 requires “diagnosing a risk of depression recurrence or evaluating a therapeutic effect of depression recurrence”. Neither the specification nor the claims set forth a limiting definition for "diagnosing" and the claims do not set forth how “diagnosing” is accomplished. As broadly recited the diagnosing may be accomplished mentally by thinking about a subject’s expression level and assessing whether the subject has risk of depression recurrence. Thus, the diagnosing constitutes an abstract process idea.
Claim 19-22 further recite 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)).
A correlation that preexists in the human is an unpatentable phenomenon. The association between level of expression and risk of depression recurrence is a law of nature/natural phenomenon. The wherein clauses which tells users of the process to predict risk of depression recurrence in the sample, amounts to no more than an "instruction to apply the natural law". This wherein clause is no more than a mental step. Even if the step requires something more such as to verbalize the discovery of the natural law, this mere verbalization is not an application of the law of nature to a new and useful end. The wherein clause does not require the process user to do anything in light of the correlation. The wherein clause fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
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. While the claim recites detecting a level of HIF-1alpha protein in a tested sample, this is not an integration of the exception into a practical application. Instead, these elements are data gathering required to perform the method. Thus, the claim is “directed to” the exception.
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. The measuring expression is 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 biomarkers 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 detecting step essentially tells users to determine the markers through whatever known processes they wish to use.
The step of determining the expression levels was well known in the art at the time the invention was made. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any expression analysis assay, to determine the expression. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, and conventional nature of additional elements because it teaches that the additional elements were well known. Specifically, the specification teaches the experiments for quantitative detection of the protein level are well-known in this field (see para 80).
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.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 16-26 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 pre-AIA the applicant regards as the invention.
A) The claims are indefinite. It is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of Claim 16 is directed to a method for diagnosis or monitoring cancer. However, the claim only provides for comprising detecting a level of a depression recurrence risk marker. Thus, it is not clear if applicant intends to cover any method for detecting a level of a depression recurrence risk marker, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If the claim requires something
more, it is unclear what additional active process step the method requires and it appears that the claims are incomplete. The claims fail to provide any active steps that clearly accomplish the goal set forth by the preamble of the claims. Claims 17-23 are similarly indefinite
B) Claim 19 is indefinite over “the reference value C0” because “the reference value C0” lacks proper antecedent basis. Claim 16 does not provide any basis for the reference value C0. Further, it is unclear what C0 refers to. It is unclear whether C0 is a gene or whether any reference value is encompassed by the claim. Correction is required.
C) Claim 20 is indefinite over “the HSP90” protein quantity because “the HSP90” lacks proper antecedent basis. Claim 16 does not refer to “the HSP90 protein”. Claim 21 and 22 are similarly indefinite. Correction is required.
D) Claims 24-26 are indefinite over the “expression level C1 or the marker with the reference value C0”. These recitations lack proper antecedent basis. The claims do not refer to an expression level. Further it is unclear what C1 and C0 refer to. Clarification is required.
Claim Rejections - 35 USC § 102
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.
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 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.
Claim(s) 16-17, 19-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gabryelska et al (J. of Clinical Sleep Medicine, Vol. 16, NO. 10, October 15, 2020).
Gabryelska teaches obtaining peripheral blood and evaluating HIF-1alpha expression on protein in blood serum (abstract). Thus, Gabryelska teaches the only active method step required by Claim 16.
With respect to Claim 17, Gabryelska teaches blood samples were collected and serum was stored (page 1762, col. 2). The serum HIF-1alpha protein concentration was assessed by ELISA.
With respect to Claims 19-22, the wherein clauses recite inherent properties and do not require any additional method steps. Further, the claims are conditional “when” and “if”, thus the determination is not required.
With respect to Claim 23, the patients studied were without depression and/or susceptible to depression.
With respect to Claim 24-26, Gabryelska teaches a device what determines risk marker, inputs, makes comparisons and outputs, as required by the claims. Gabryelska teaches comparison and correlations were determined using Spearman’s rank correlation.
Claim(s) 16, 19-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiaohu et al. (China Academic J. of Electronic Publishing House, 470-471, 2013 – cited in IDS).
Xiaohu teaches expression of hypoxia-inducible Factor 1alpha in brain and myocardial tissues of depression model rats. Xiaohu teaches analysis of HIF-1a protein expression using Western blotting.
With respect to Claim 17, Gabryelska teaches blood samples were collected and serum was stored (page 1762, col. 2). The serum HIF-1alpha protein concentration was assessed by ELISA.
With respect to Claims 19-22, the wherein clauses recite inherent properties and do not require any additional method steps. Further, the claims are conditional “when” and “if”, thus the determination is not required. Xiaohu, however, teaches HIF-1alphan in the brain and myocardial tissues of the depression model group were significantly increased with a statistically significant difference.
With respect to Claim 23, the subjects studied were with and without depression and/or susceptible to depression.
Claim(s) 24-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rokutan et al. (US 2004/0185474, September 23, 2004).
Rokutan teaches a system or device for diagnosing depression where the personal information database stores information. As seen in Figure 12, the keyboard is an input module for inputting risk data. The computer also provides a processing module and an output module. Rokutan teaches depression is evaluated by storing information in a database, comparing the expression data for the subject with those for healthy individuals and analyzing the results of the comparison. The computer is allowed to determine which of the expression patterns are more similar to the subject’s expression data, thereby diagnosing the conditions. Rokutan teaches the analysis is performed using PCR and sequencer (para 15 and 55).
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Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shibata et al. (Progress in Neuro-Psychopharmacology, & Biological Psychiatry, Vol. 43, pages 222-229, 2013) teaches analysis of mRNA HIF-1 in mood disorder patients. Shibata suggests analysis of protein would be of interest.
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
August 18, 2026
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