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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated March 2, 2026, has been received. By way of this submission, Applicant has elected, with traverse, Group I: claims 14-18 and 25-26.
Applicant's election with traverse of Group I in the reply filed on March 2, 2026 is acknowledged. The traversal is on the ground(s) that the groups are all part of the use of the SQSTM1/p62 biomarker in an integrated approach to personalized medicine, and thus are so linked as to form a single general inventive concept under PCT Rule 13.1. This is not found persuasive for reasons stated in the previous Restriction Requirement, mailed December 31, 2025, as the groups are drawn to both processes and kits that are not capable of performing said processes; the kit of Group III cannot be used to perform the methods of Groups I, II, IV, and V. See 37 CFR 1.475.
Should Applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, Applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the Examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 14-29 are pending in the application. Claims 19-24 and 27-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on March 2, 2026.
Claims 14-18 and 25-26 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 15, 17, 33, and 36. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 14-18 and 25-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a law of nature, a natural phenomenon, or an abstract idea. This judicial exception is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981); see also Bilski v. Kappos, 561 U.S. 593, 604, 95 USPQ2d 1001, 1007 (2010). "Phenomena 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, 70, 175 USPQ 673, 676 (1972). The Supreme Court does acknowledge that it is possible to transform an unpatentable law of nature, but one must do more than simply state the law of nature while adding the words "apply it." See, e.g., Gottschalk at 71–72. Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, the neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious [pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978); see also Bilski: "[T]he prohibition against patenting abstract ideas 'cannot be circumvented by' . . . adding 'insignificant post-solution activity'" (quoting Diehr, at 191-192).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
The first step under this guidance is determining if the claim is directed to one of the four statutory categories (process, machine, manufacture, or composition of matter). In this case, the claims are a method (process). The second step is determining if the claims recite or involve judicial exception(s), such as laws of nature, natural phenomena, natural products, or an abstract idea. In this case, the claims are drawn to methods for predicting in vitro the resistance of a tumor to a therapy and for predicting the survival rate of a patient afflicted by a tumor, comprising evaluating the presence or the absence or the amount of an SQSTM1/p62 protein in a biological sample originating from the tumor and drawing a conclusion based upon the levels of SQSTM1/p62 detected as they relate to immune checkpoint inhibitor therapy. This is a natural correlation/observation of a natural phenomenon, the correlation between levels of SQSTM1/p62 resistance to therapy with an immune checkpoint inhibitor, which is a judicial exception.
Furthermore, the judicial exceptions are not integrated into a practical application, as the claims do not rely on or use the exceptions in a further step. See MPEP 2106.04(d). Thus, it must be determined if the claim as a whole recites something significantly more than the judicial exceptions.
The methods recite a step of evaluating the presence or the absence or the amount of an SQSTM1/p62 protein in a biological sample. This is 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), as evidenced by Applicant's specification at page 6, lines 9-13 and 30-34. Also see Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017). Using known methods disclosed in the specification such as immunohistochemistry, immunoblotting, immunofluorescence in situ, or flow cytometry to detect a protein in a sample would have been a routine, conventional choice, and as such does not offer significantly more than the exception itself.
The claimed method does not affect any treatment step, or any steps at all beyond abstract ideas and observation of a natural phenomenon, and well-known, conventional methods to perform said observation.
The remaining claims further characterize the exception itself, e.g., additional details for the sample or patient, and do not add significantly more.
Therefore, claims 14-18 and 25-26 are patent ineligible.
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 14-18 and 25-26 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Regev (US20200157633A1).
Regev teaches a method for predicting response to checkpoint blockade therapy by identifying a gene signature (para. 0008). Regev further teaches methods of detecting immune checkpoint inhibitor resistance, comprising detecting the expression or activity of an SQSTM1 polypeptide, wherein low levels of gene expression are correlated with higher levels of immune checkpoint inhibitor resistance (para. 0010-0011, also see para. 0080 and Figure 12).
Regev also teaches that gene expression may be compared to a control (para. 0071).
Regev further teaches that this method may be performed in situ (para. 0150, 0499, and 0009), which is pertinent to claim 15.
Regev further teaches that detection of immune checkpoint inhibitor resistance is useful in predicting rates of survival (para. 0430), which is pertinent to claim 16. Regev also teaches that detecting an immune checkpoint inhibitor resistance signature indicates a 10-year survival rate of less than 40%, and not detecting the signature indicates a 10-year survival rate of greater than 60% (para. 0021).
Regev further teaches evaluation of levels of CD8+ T lymphocytes (para. 0497) and PD-L1 (para. 0506), which is pertinent to claim 17.
Regev further teaches that this method may be performed on a tissue biopsy (para. 0405 and 050), which is pertinent to claim 26.
While Regev does not teach SEQ ID NO: 1, Applicant's specification at page 4 states that SEQ ID NO: 1 is the human SQSTM1 protein sequence. As Regev teaches human SQSTM1 (para. 0241), Regev inherently teaches SEQ ID NO: 1 and the subject matter of claim 25.
It is noted that the transitional term "comprising" used in the instant claims is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. MPEP 2111.03(I). A practitioner testing all of the genes recited in the gene signature of Regev would also test for SQSTM1.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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