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 18, 2025, has been received. By way of this submission, Applicant has elected, without traverse, Group I: claims 1-12, and the species of an inflammatory disease.
Claims 1-14 are pending in the application. Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 March 18, 2025.
Claims 1-12 are therefore under examination before the Office.
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 1-12 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 testing adult Still's disease, comprising measuring a denatured CRP concentration in a blood sample collected from a subject, and comparing the measured denatured CRP concentration and/or an index value based on the denatured CRP concentration with a reference value. This is a natural correlation/observation of a natural phenomenon, the correlation between levels of denatured CRP and Still's disease, which is a judicial exception. The judicial exception is 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. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
The methods recite a step of measuring a denatured CRP concentration in a blood sample collected from a subject. 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 para. 0024 and 0034. 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). Additionally, Liao (US20190345555A1) teaches the use of a biomarker to detect the occurrence and prognosis of adult-onset Still's disease (para. 0005). As such, this does not offer significantly more than the exception itself.
The claimed method does not affect any treatment step, or any steps at all beyond observation of a natural phenomenon, and well-known, conventional methods to perform said observation. Therefore, the exception is not integrated into a practical application, nor do the claims recite additional elements that amount to an inventive concept.
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 1-12 are patent ineligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 12 is directed to a method that requires the use of a denatured CRP-specific antibody. However, said antibodies are defined by only requiring 90% identity to the sequences recited within the claim. This creates a vast genus of antibodies, not all of which would possess the required property of binding denatured CRP.
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three complementarity determining regions (CDRs), which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function. For example, Vajdos (J. Mol. Biol. (2002) 320, 415-428) states that antigen binding is primarily mediated by the CDRs more highly conserved framework segments which connect the CDRs are mainly involved in supporting the CDR loop conformations and in some cases framework residues also contact antigen (page 416, left col). The high degree of polymorphism in antibody generation evidences a lack of structure-function correlation for antibodies.
The instant disclosure does not describe how one of ordinary skill may be able to determine which antibodies within the claimed genus would have the required property of binding denatured CRP and which would not, besides trial and error. The instant disclosure only describes three possible antibodies within the genus. Given the breadth of the genus of antibodies within the scope of the claim, it would require undue experimentation to perform the claimed method with a reasonable expectation of success.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary, the limited working examples, the nature of the invention, the unpredictability of the art, and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
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 6 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 6 recites the claim limitation of "the CRP value". There is insufficient antecedent basis for this claim limitation in parent claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Benedetto (PLoS One. 2020 Jul 9;15(7):e0235326) teaches that patients with adult onset Still's disease have high levels of C-reactive protein (CRP) during disease flares (page 2, last paragraph). However, Benedetto does not teach denatured CRP.
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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