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 16, 2026, has been received. By way of this submission, Applicant has cancelled claims 1-4, 6, 8-9, 11- 12, 14-16, 20, 22-23, 34, 37-38, and 40-41, and introduced new claims 54-69, and elected, without traverse, HspA1A as the species of Hsp70 family member; arimoclomol as the species of therapy; and Niemann Pick Disease, Type C (NPC) as the species of disease.
Claims 54-69 are pending in the application and 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 page 66. 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 Objections
Claim 54 is objected to because of the following informalities: the word “sample” appears to be missing from the claim at line 3. Appropriate correction is required.
Claim 68 is objected to because of the following informalities: there is a typographical error in the claim: “… wherein the disease in NPC.”. Appropriate correction is required.
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.
Claim 59 is 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 59 recites multiple preferential ranges for the amount of HspA1A and HspA1B in the PBMC sample. This creates ambiguity in the claim, as it is not readily apparent if these ranges are meant to be limiting.
Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. MPEP 2173.05(d).
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 54-69 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims recite a natural phenomenon, a method for diagnosing a disease based upon levels of Hsp70. This judicial exception is not integrated into a practical application because the claimed data gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity. 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 Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). "Laws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U.S. 175, 185 (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, 67 (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., Benson, 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". Flook, 437 U.S., at 590; see also Bilski, 561 U. S.: "[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 "[a] method for diagnosing a disease" or "[a] method for monitoring disease progression", comprising the steps of: providing a peripheral blood mononuclear cell (PBMC) from the patient, detecting Hsp70 in the PBMC sample; and quantifying or determining the level of Hsp70 in the PBMC sample. This is a natural correlation/observation of a natural phenomenon, the relationship between levels of Hsp70 in a sample and diagnosis of a disease, which is a judicial exception. Furthermore, the judicial exception is not integrated into a practical application, as the claims do not rely on or use the exception 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 use of assays such as ELISA to determine levels of a biomarker has been characterized by the Court as "mere data gathering" and "insignificant extra-solution activity". Determining the level of a biomarker in blood by any means has been recognized by the courts 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. 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). MPEP 2106.05 (II). Using this method to make such a diagnosis would have been a routine, conventional choice, and as such does not offer significantly more than the exception itself.
Detecting levels of Hsp70 proteins in a sample merely instructs the skills artisan to use any detection method. When recited at this high level of generality, there is no meaningful limitation that distinguishes it from routine and conventional data gathering activity performed by scientists. The claims lack any elements that transform the exception into a patent-eligible application of the exception.
The remaining claims further characterize the exception itself, e.g., additional details for quantifying Hsp70 levels. These specifics are also a) directed to the data gathering step and b) routine choices when practicing the well-established assays for detecting a protein in a sample.
Therefore, claims 54-69 are patent ineligible.
Conclusion
The closest prior art is Jensen (US20110286993A1, cited in IDS). Jensen teaches a method for treatment of a lysosomal storage disease by increasing the intracellular concentration and/or activity of Hsp70 in individuals in need thereof (para. 0017). Jensen further teaches that the lysosomal storage disease may be Niemann-Pick disease (para. 0023). However, Jensen does not teach that levels of Hsp70 in peripheral blood mononuclear cells are useful in diagnosing Niemann-Pick disease or monitoring progression of said disease.
No claim is allowed.
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/PETER JOHANSEN/ Examiner, Art Unit 1644
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