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 .
DETAILED ACTION
Claim Status
Applicant’s amendment September 18, 2024:
Claims 3, 7, 12, 20, 23, 30, 34, 37-39, 42, 48, 54, 60, and 66 were amended.
Claims 4-5, 8-11, 13-19, 21-23, 25-30, 32-34, 36, 40-41, 43-47, 49-53, 55-59, 61-65, and 67-68 were canceled.
Claims 69-70 were added.
Claims 1-3, 6-7, 12, 20, 24, 31, 35, 37-39, 42, 48, 54, 60, 66, and 69-70 are currently pending and under consideration.
Election/Restrictions
Applicant's election without traverse of Group I: claims 1-3, 6-7, 12, 20, 24, 31, 35, 37, and 66, in the reply filed April 27, 2026 is acknowledged.
Claims 38-39, 42, 48, 54, 60, and 69-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 April 27, 2026.
Claim 66 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 66 has been amended and is drawn to a method of detecting and/or quantifying Nfl comprising contacting the sample with the binding agent of claim 42.
Claim 42 falls under the invention of Group III as indicated in the Restriction Requirement mailed February 25, 2026. Applicant elected without traverse the invention encompassed by Group I in the reply received April 27, 2026.
Accordingly, claim 66 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions 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 inventions 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 invention.
Claims 1-3, 6-7, 12, 20, 24, 31, 35, and 37 are under consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/US22/15998 filed February 10, 2022, which claims priority to U.S. Provisional Application 63/197,826 filed June 7, 2021, which claims priority to U.S. Provisional Application 63/183,417 filed May 3, 2021, which claims priority to U.S. Provisional Application 63/147,833 filed February 10, 2021.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted 4/02/2024 and 5/14/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings filed August 10, 2023 are objected to because the graph depicted in Figure 23 is obscured/blanked out. This error occurs in both the black and white and color drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12(ix) - should read “HJ30.11 or an antigen binding fragment thereof”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 12, 24, and 35 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 12 recites HJ30.1, HJ30.2, HJ30.13, HJ30.4, HJ30.7, and HJ3011 or antigen fragments thereof, which are internal designations for antibodies generated from hybridomas deposited with ATCC. However, one of ordinary skill in the art would not know what these antibodies are by such designations as no amino acid sequences for the variable heavy chain and variable light chain of said antibodies have been disclosed.
Claim 24 recites the method further comprises cleaving the enriched Nfl isoforms with a protease. However, neither the claims nor disclosure specify what portion or positions the Nfl is cleaved or what protease(s) are to be used to obtain the instantly claimed Nfl isoforms.
Claim 24 recites the term “optionally”, which renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(h).
For purposes of examination, the “optional” steps of desalting the cleavage products for LC/MS analysis and quantifying proteolytic peptides in the sample are not considered necessary limitations of the instant invention.
Claim 35 is drawn to determining if the amount of the quantified biomarker (i.e. Nfl isoform) is reduced in comparison to its level in control subjects. It is unclear why a person of ordinary skill in the art would want to determine if the levels of Nfl isoforms in a samples were reduced. The data and figures presented in the instant specification demonstrate increased levels of Nfl isoforms are indicative of neuronal damage or neurodegenerative disease, not decreased levels.
For purposes of examination, the claim is being interpreted as determining if there is an increase of the quantified biomarker in comparison to control subjects.
Claim Rejections - 35 USC § 112(a)
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.
Written Description
Claims 2-3, 6-7, and 12 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim contains 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP § 2163.
Claims 2-3, 6-7, and 12 are drawn to an epitope binding agent(s) that specifically bind isoforms of neurofilament light chain (Nfl).
The claims encompass a large genus of molecules that bind to neurofilament light chain (Nfl), comprised of different amino acid sequences, which represent structurally distinct polypeptides. The instant specification defines an “epitope-binding agent” as an antibody, an aptamer, a nucleic acid, a peptide, a protein, a lipid, a metabolite, a small molecule, or a fragment thereof [00126] which encompasses literally any molecule that recognizes and binds to a given epitope of Nfl. When limiting the epitope-binding agent to encompass only antibodies, the state of the art teaches that antibody variable regions are composed of a heavy and light chain, each involved in providing for binding specificity. Variability in the antigen binding site is achieved by V(D)J recombination via heavy and light chain pairing, with the most diverse regions being the 6 CDR regions in the heavy and light chain. As taught by Janeway et al. (2001), the antibody repertoire in humans is at least 1011, with a large degree of diversity in both heavy and light chains. See also Rabia et al. (2018; pg. 4), which teaches that the maximal chemical diversity of antibody CDRs is unimaginably large and is extremely challenging to define the sequence determinant of antibody specificity.
The state of the art is such that antibody production is extremely complex and requires a deep understanding of protein-engineering techniques, mechanisms of action and resistance, and the interplay between the immune system. The development of candidate antibodies involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (Scott et al., 2012; pg. 278-279). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (Scott, pg. 278). Furthermore, antibodies can have various effector functions including receptor blockage, reducing signaling, or in vivo cell depletion, and that antibody isotype alone is not predictive of in vivo function (Chan et al., 2010, pg. 307).
The art recognizes that antibody binding is extremely complex and unpredictable. The in vivo impact of a therapeutic monoclonal antibody is determined by both its epitope specificity (e.g., blocking or non‐blocking of ligand interactions) and heavy‐chain constant region (Fc) effector function (e.g., depleting or non‐depleting). Varying the Fc properties of an antibody can significantly affect the biological impact in vivo, and mutations in the heavy chain constant region have been shown to have highly divergent Fc effector function, without changing antibody specificity (Huss et al., 2016, p. 276).
The specification discloses monoclonal anti-Nfl antibodies HJ30.1, HJ30.2, HJ30.4, HJ30.7, HJ3011, and HJ30.13 generated from hybridomas deposited with the ATCC [00209]. However, no structure (i.e. amino acid sequence) is disclosed for any antibody that binds an Nfl isoform(s). Therefore, the instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description’ inquiry, whatever is now claimed." (See Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116).
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Given the claimed broad class of antibodies that bind the recited epitopes of Nfl isoforms, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making antibodies with the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
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, 24, 31, 35, and 37 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 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements, which are recited at a high level of generality, provide conventional assays and samples that do not add meaningful limits to practicing the law of nature and abstract idea.
The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). See MPEP 2106.
The first step of the analysis asks whether the claimed invention is directed to a statutory category of invention. The instant claims recite a method of detecting neurofilament light chain (Nfl) in a biological sample as a way to measure neuronal damage in a subject by enriching for one or more Nfl isoforms. The claims are directed to a method, which is a statutory category of invention.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception (see MPEP 2106). Based upon an analysis with respect to the claims as a whole, the instant claims are determined to be directed to a law of nature/natural principle and an abstract idea. The relationship between the recited naturally occurring Nfl and presence of neuronal damage is a natural principle, which is a judicial exception. This method describes correlation of a particular biomarker with a particular natural disease state, which is comparable to concepts identified by the Supreme Court in Mayo. (see Mayo 101 USPQ2d at 1966). The use of the biomarkers and correlation with disease could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).
Third, a claim that is directed to a natural principle and/or abstract idea must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo 101 USPQ2d at 1966. Adding steps to a natural biological process that only recite well-understood, routine, conventional activity previously engaged in by researchers in the field would not be sufficient. See id. At 1966, 1970. The claims identify sample types (e.g. blood or CSF) for testing, subjects to be tested, and well-known assays for protein purification and quantification. The identification of sample types and subjects from which the samples are to be collected is routine in the art of medical testing. As stated in MPEP 2106.05(d), 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. Determining the level of a biomarker in blood by any means has been determined as one of the well-understood, routine, conventional activity: 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). Regarding the methods to detect and quantify Nfl isoforms using LC/MS, the method steps claimed (e.g. cleaving and desalting) are routine in the art for detecting and quantifying proteins using mass spectrometry. This is acknowledged by the instant specification, which indicates that Nfl can be detected and optionally quantified by other methods known in the art [00167]. Therefore, the additional features of the claims (i.e., measuring the level of the recited Nfl, identifying the source of the sample for screening, or comparing values from a healthy donor sample) do not ensure that the claims amount to significantly more than the natural principle itself. The claims use conventional means to observe a natural correlation and therefore the steps of the claimed methods are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities. This is also supported by the findings of the in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 115 USPQ2d 1152 (Fed. Cir. 2015), wherein the Federal Circuit held that claims that measure biological substances using methods that are routine and conventional do not amount to more than reliance on a correlation that is a law of nature for patentability.
The question of whether identification of the patient population amounts to significantly more than the judicial exception is addressed in Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S., 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, 1965-66 (2012) (citing Diehr, 450 U.S. at 187, 209 USPQ at 7), when the Supreme Court determined that process claims reciting a correlation may inhibit further discovery by improperly tying up future use of laws of nature, even though the laws of nature at issue are narrow laws that may have limited applications. After measurement of the correlation, the claims can tie up a doctor's subsequent treatment decisions, whether treatment does or does not change in light of inference the doctor has drawn using disclosed correlations, since the claims threaten to inhibit development of more refined treatment recommendations that combine the patentee's correlations with later discovered features, and since the correlation step of the claims is set forth in highly general language covering all processes that make use of the correlation. Further, the steps simply refer to a relevant patient population, which is a pre-existing audience; doctors wish to determine whether a particular patient has a disease, or if the disease has/has not progressed. The claims inform a relevant audience about certain laws of nature; and 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 the parts taken separately. Even though the laws of nature at issue are narrow laws that may have limited applications, the claim does not amount to significantly more than the natural law itself.
Claim Rejections - 35 USC § 102
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.
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 1, 31, 35, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brureau et al. (Neurobiol Dis, 2017; 104:73-84; cited IDS 5/14/2025) (“Brureau”).
The instant claims are drawn to a method for detecting neurofilament light chain (Nfl) in a biological sample, the method comprising (a) providing a biological sample selected from a blood sample or a CSF sample; (b) enriching for one to a plurality of Nfl isoforms in the biological sample; and (c) detecting one to a plurality of Nfl isoforms enriched in step (b), wherein the biological sample is obtained from a subject having or at risk of having neuronal damage and the biomarker is the one to the plurality of Nfl isoforms detected in step (c). Further comprising determining if the amount of the quantified biomarker is reduced in comparison to its level in control subjects who are cognitively normal.
Brureau discloses methods of detecting neurofilament light chain (NF-L) in CSF or blood that can be used as a biomarker of neurodegeneration [pg. 74, col. 1].
Brureau collected CSF and blood from transgenic mice with neurodegeneration. Samples were enriched for NF-L using a commercially available ELISA. Denatured samples containing the immuno-captured NF-L from CSF were then subjected to Western blot analysis using a rabbit monoclonal anti-NF-L antibody for detection [pg, 75, Section 2.8.2]. Samples were compared to control samples (CSF from control mice) and recombinant bovine NF-L. Western blot analysis revealed that the NF-L in the CSF samples was not full length, but a cleaved 10 kDa form of the NF-L protein [pg. 82, col. 1; Fig. 6] (instant claims 1, 31, 35).
Brureau further discloses that increased levels of NF-L in the CSF and blood correlate with ongoing neurodegeneration and neuronal loss and extent of neuronal damage and thus can be used as a biomarker of the neurodegenerative process that could be used to stratify patients and to monitor the progression of neurodegeneration and the efficacy of neuroprotective therapies [pg. 74, col. 1] (instant claim 37).
Therefore, absent a showing of any difference, the methods disclosed by the prior art are deemed to anticipate the claimed methods.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected independent claim, but would be allowable if rewritten in independent form including all of the limitations of the independent claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 20 is drawn to Nfl isoforms selected from amino acid sequences:
(a) amino acids 1 to 90 of SEQ ID NO: 1
(b) amino acids 1 to 92 of SEQ ID NO: 1
(c) amino acids 1 to 124 of SEQ ID NO: 1
(d) amino acids 1 to 135 of SEQ ID NO: 1
(e) amino acids 1 to 137 of SEQ ID NO: 1
(f) amino acids 1 to 146 of SEQ ID NO: 1
(g) amino acids 1 to 162 of SEQ ID NO: 1
(h) amino acids 1 to 222 of SEQ ID NO: 1
(i) amino acids 1 to 223 of SEQ ID NO: 1
(j) amino acids 1 to 234 of SEQ ID NO: 1
(k) amino acids 1 to 252 of SEQ ID NO: 1
(l) amino acids 1 to 271 of SEQ ID NO: 1
(m) amino acids 1 to 281 of SEQ ID NO: 1
(n) amino acids 1 to 323 of SEQ ID NO: 1
(o) amino acids 1 to 339 of SEQ ID NO: 1
(p) amino acids 1 to 359 of SEQ ID NO: 1
(q) amino acids 1 to 396 of SEQ ID NO: 1
(r) amino acids 1 to 399 of SEQ ID NO: 1
(s) amino acids 1 to 420 of SEQ ID NO: 1
(t) amino acids 1 to 436 of SEQ ID NO: 1
(u) amino acids 1 to 528 of SEQ ID NO: 1
There is no prior art that teaches or suggests a method for detecting neurofilament light chain (Nfl) in a blood or CSF sample comprising enriching for one or more of the Nfl isoforms with the specific amino acid sequences as recited in claim 20. The closest prior art, Brureau et al. (Neurobiol Dis, 2017; 104:73-84; cited IDS 5/14/2025), discloses methods of detecting truncated Nfl in CSF and blood samples, however, does not disclose the amino acid sequence of the cleaved Nfl product.
Conclusion
No claim is allowed.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
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