DETAILED ACTION
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 .
Formal matters
1. The Art Unit location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Art Unit 1675.
Election/Restrictions
2. Applicant's election without traverse of Group I in the reply filed on September 16, 2025 is acknowledged. Further, Applicant’s election with traverse of species A)a and B)a in the reply filed on September 16, 2025 is also acknowledged. The traversal is on the ground(s) that claims 1-9 and 12 of Group I are readable on the elected species and all species should be examined. Applicant’s arguments with respect to election of species have been fully considered and found to be persuasive. The election of species requirement has been withdrawn.
3. Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 16, 2025.
4. Claims 1-9 and 12 are under examination.
Claim Objections
5. Claims 1-4 are objected to because of the following informalities: the claims recite steps a-1, b-1 and c-1 in claim 1, steps a-2, b-2 and c-2 in claim 2 and so on. Applicant is advised that claims 1-4 are independent claims, and therefore the numbering of steps in each claim must be independent from other claims. 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.
6. Claims 1-9 and 12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
7. Claims 1-4 and 12 are vague and indefinite insofar as they employ the term “a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of pathologies. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction”, an artisan cannot determine if a disease which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
8. Next, claims 1 and 2 and vague and indefinite as being directed to methods that recite identical steps to achieve different and/or opposite results. Specifically, claim 1 encompasses determination of a risk to develop a disease and the presence of the disease, while claim 2 encompasses determination of a severity of the disease all by finding the same diagnostic measure of higher concentration of DARPs in a biological sample obtained from a subject under testing. Thus, by broadest reasonable interpretation and consistent with the specification as filed, the higher concentration of DARPs stands for the risk to develop a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction in the future, such as not have it at the moment, for the diagnosis of the disease, such as to have the disease, and also for various severe forms of the disease. This makes the claims mutually exclusive renders the claims indefinite.
9. Claim 2 recites the limitation "DARP autoantibodies" in step (a-2) of claim 2. There is insufficient antecedent basis for this limitation within the claim.
10. Also, claim 2 is vague and ambiguous in step (b-2), which appears to recite a control a subject suffering from a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction, thus making the definition of a “control” meaningless.
11. Claim 12 is vague and indefinite in recitation of “searching for dominant negative peptide to” DARP autoantibody without providing any physical, objective and repeatable steps to support the limitation. Further, it is not obvious whether the searched peptide is the same as an agent for treating a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction.
12. Claims 5-9 are indefinite for being dependent from indefinite claim(s).
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.
13. Claims 1-9 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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.
Claims 1-9 and 12 specifically require possession of polypeptides termed drebrin A related protein (DARPs), their fragments and splice variants. Claim 9 requires possession of an antibody that recognized a drebin A specific epitope. The claims do not require that these proteins, fragments and epitopes possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of polypeptides that is defined only by reference to the term DARPs, and to antibodies that are defined by the binding ability. However, the instant specification fails to describe the entire genus of proteins and antibodies, which are encompassed by these claims.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. From the specification, it is clear that Applicant has possession of a human drebrin A protein which has the amino acid sequence of SEQ ID NO: 1 and a protein identified as Ins2 translational sequence of SEQ ID NO: 2. The specification teaches at p. 15 that “DARPs may be any fragment or splice variant of drebrin A having at least a portion of Ins2 translation sequence […] of SEQ ID NO:2.” However, there is no further information provided what portion of the amino acid sequence of SEQ ID NO: 2 is essential to the function of DARPs as to support the utility of the claimed methods.
The instant claims are drawn to DARPs, their fragments and splice variants. Thus, the claims are not limited to a protein with a specific amino acid sequence. The specification only describes a protein having the amino acid sequence of SEQ ID NO: 1, and a protein having the amino acid sequence of SEQ ID NO: 2, and fails to teach or describe any other protein which lacks these sequences and has the activities specifically required to practice the instant invention. Similarly, the specification provides selective examples of antibodies that bind drebin A but fails to describe the entire genus of antibodies that recognize “a drebrin A specific epitope.”
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factor present in the claim is a reference to the term DARPs and its epitope. There is not even identification of any particular portion of the structure that must be conserved. As stated above, it is not even clear what region of the encoded polypeptide has the disclosed activity. The specification does not provide a complete structure of those drebrin A related proteins, their fragments, splice variants, specific epitopes and antibodies that bind to it, and fails to provide a representative number of species for the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 page 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 at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of proteins, including DARP40, DARP60, DARP70, DARP90 and DARP100, which relate to molecular weight but not the structural characteristic of the protein, and genus of antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Further, claims 3 and 4 encompass methods of screening for a prophylactic agent for a disease a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction by using a non-human animal synaptic dysfunctional model and cultured cell synaptic dysfunction model. However, the instant specification is devoid of any evidence that Applicant was in possession of even a single operable embodiment of the claimed methods.
As stated in M.P.E.P. § 2163(II)(A)(3), a specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) (“[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim.”); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) (“[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose.”); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves).
Whereas a reduction to practice of an uncomplicated invention such as a simple mechanical or electrical device can be achieved by merely providing a diagram of the device wherein one skilled in the relevant art can predict the likely operability of the device by reviewing the diagram, the operability of the claimed invention cannot be predicted by merely reviewing diagrams or illustrations. To demonstrate the reduction to practice of a method of screening for a useful drug specifically by using an animal model or a cell model requires either a working embodiment, a demonstration of operability of the screening method when applied to the animal model or cell model of the condition to be treated wherein that animal model or cell model has been shown to be reliably predictive of efficacy in the treatment of the condition, or a demonstration that the parameter employed therein reasonably correlates with the presence of the condition being treated. In the instant case, Applicant has provided none of these. Consequently, Applicant has failed to demonstrate possession of the claimed methods as of the earliest effective filing date of the instant application.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
14. Claims 1-9 and 12 are further 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.
Claims 1, 2 and 5-9 are directed to methods of diagnosis of a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction by measuring the levels of DARPs in a biological sample obtained from a subject. Claims 3 and 4 encompass methods of screening for useful drugs to treat a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction. Claim 12 is a method of searching for a dominant negative peptide to a DARP autoantibody. However, the specification does not provide sufficient guidance to enable practice the full scope of the claimed invention without undue experimentation.
The enablement requirement is met when one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d at 1336 (Fed. Cir. 2013). The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses the structure of a human drebrin A of SEQ ID NO: 1, and teaches that DARPs are fragments and splice variants of the drebrin A at p. 15. The specification goes to explain that “drebrin A is leaking into the blood from neurons in Alzheimer’s disease patients,” p. 4 and thus can be used as a diagnostic marker. The working examples demonstrate differential expression of various DARPs in blood and CSF of patients with Alzheimer’s disease, corticobasal syndrome and Parkinson’s disease, which appear dependent on specific antibodies against DARP and processing of the samples, see pp. 23-29.
The nature of the invention places it in the class of invention which the Federal Circuit has characterized as "the unpredictable arts such as chemistry and biology." Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
The prior art recognizes a role of drebrin protein (DBN1) in neurodegeneration, Gan et al. 2019, reference 4 of IDS filed on 12/19/2022, for example. However, finding of various fragments and variants of drebrin in association with a group of disorders termed “[diseases] caused by synaptic dysfunction or [diseases] accompanied by synaptic dysfunction” has not been reported.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation. “During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).”
As such, the broadest reasonable interpretation of the claimed methods of claims 1, 2 and 5-9 is that they allow the determination of a risk to develop, the diagnosis, and assessment of severity of any pathology “caused by synaptic dysfunction” or “accompanied by synaptic dysfunction,” by measuring the higher levels of protein that are not adequately described in any biological sample obtained from a subject under testing. Claims 3, 4 and 12 allow to screen for a useful therapeutic agent to treat any pathology that meets the limitations of a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction by measuring the changes in the concentration of DARPs in samples obtained from an animal model or a cell model for the disease, which a skilled artisan does not know how to produce and/or how to evaluate.
Applicant has left those skilled in the art with too much experimentation to research and discover for themselves the structure/function correlation between the DARPs and diseases caused by synaptic dysfunction or diseases accompanied by synaptic dysfunction, specific critical levels of DARPs and their fragments or splice variants in samples obtained from subjects under testing, and evaluate the choice of biological samples suitable to practice the claimed methods. The art does not teach what specific diseases meet the limitation of “a disease caused by synaptic dysfunction or a disease accompanied by synaptic dysfunction,” or what particular drebrin A proteins are directly associated with the pathology. The specification does not teach how to make decisions about specific non-human animal models suitable for screening the test agents, or how to search for dominant negative peptide to a DARP autoantibody. As such, Applicant has merely provided a starting point for research and experimentation and not a meaningful enabling disclosure of how to practice the claimed invention. Therefore, the claimed methods clearly lack enablement, as disclosed. In fact, the specification does not describe a single embodiment that satisfies the claims’ limitations.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure.” The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art,” “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.”
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
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, 2 and 5-9 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. Method claim(s) 1, 2 and 5-9, directed to a diagnosis and assessment of severity of a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction, set forth laws of nature by reciting relationship between changes in the levels of naturally occurring factors and the pathology itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. , 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws 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. (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." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, 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, supra, 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."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1, 2 and 5-9 are determined to be directed to a judicial exception without significantly more. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1, 2 and 5-9 are directed to a process. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, 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.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355. In the recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims 1, 2 and 5-9 encompass changes in the levels of drebrin A related proteins during pathology termed “a disease caused by synaptic dysfunction or disease accompanied by synaptic dysfunction,” the process that is governed by a law of nature, and thus is a judicial exception. The DARPs of the instant invention are all naturally occurring factors that are expressed differently during pathology of Alzheimer’s or Parkinson’s disease, for example, and apart from any human action. (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the steps of the claimed methods are limited to only those that measure naturally occurring factors during a naturally occurring pathology. (Step 2A/2: No).
Finally, claims 1, 2 and 5-9 do not recite any elements, or combinations of elements to ensure that the claim as a whole amounts to significantly more than the judicial exception because the active steps of the claims—measuring the concentration of DARPs—represent routine steps that are recited at a high level of generality and encompass well-understood and purely conventional routine techniques in the art (see the specification at pp. 15-16, for example). (Step 2B: No).
Thus, for reasons fully explained above, claims 1, 2 and 5-9 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Conclusion
15. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
June 24, 2026
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