DETAILED ACTION
Status of Claims
Receipt is acknowledged of the Applicants’ Amendments and Remarks, filed June 10, 2026 which have been entered on the record.
Claims 1-9, and 28-29 are pending and under consideration.
Claims 10-27 are cancelled by Applicant.
Claims 2 remains withdrawn as explained below in the Election/Restriction section.
Claims 28-29 are new.
Claims 1, 3-9, and 28-29 are under consideration in the instant office action as explained below in the Election/Restriction section
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 election without traverse of Group I, claims 1-9, drawn to a method of treating CNS-related conditions comprising administering an effective amount of a compound that lowers the levels of one or more BCAAs or metabolites thereof in the reply filed on October 31, 2025 is acknowledged.
New claims 28-29 are dependent on claim 1 and directed towards the subject matter of claim 1; therefore, are elected.
Applicant’s election of BT2 (3,6-dichlorobenzo[b]thiophene-2-carboxylic acid) as a species of a compound that lowers the levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof or any pharmaceutically acceptable salt and Alzheimer’s Disease as a species of a CNS-related condition in the reply filed on October 31, 2025 is acknowledged.
The Examiner contacted by phone on December 1, 2025 the Attorney of Record, Edwin S. Flores, Ph. d., J.D. to clarify that the election of BT2 as a species of a compound is 3,6-dichlorobenzo[b]thiophene-2-carboxylic acid (See Interview Summary).
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The species reads on claims 1 and 3-9.
The species does not read on claim 2, which is directed towards where the compound is a (S)-alpha-chloro-phenylpropionic acid.
The examiner notes that claims 10-27 are cancelled by Applicant.
Therefore, Claim 2 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 October 7, 2025.
Claims 1, 3-9, and 28-29 are under consideration and are the subject of this Office Action.
Information Disclosure Statement
No additional information disclosure statements have been submitted.
WITHDRAWN OBJECTIONS
The examiner withdraws objections to claim 4 based on claim amendments furnished by Applicant.
WITHDRAWN REJECTIONS
The examiner withdraws rejections to claim 1 under 35 USC § 112(b) on basis of improper Markush grouping of alternatives as a result of claim amendments furnished by Applicant.
The examiner withdraws rejections to Claims 1 and 3-9 under 35 U.S.C. 112(b) based on claim amendments to claim 1 remedying the lack of antecedent basis, which have overcome the rejection.
MAINTAINED/MODIFIED REJECTIONS
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.
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.
Claims 1 and 3-9 remain 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 claims 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.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states 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, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn “a method of treating CNS-related conditions, comprising: administering an effective amount of a compound that lowers the levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof.”
A description of the term "one or more branched-chain amino acids (BCAAs) or metabolites thereof " may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”.
Hence, an adequate written description of the components requires more than a mere statement that it is part of the invention.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984).
Accordingly, claiming “a compound to lower the levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof ", in the absence of knowledge as to what Applicant regards as “one or more branched-chain amino acids (BCAAs) or metabolites thereof” is not a description of “one or more branched-chain amino acids (BCAAs) or metabolites thereof”. Especially of concern are which metabolites Applicant has contemplated or actually obtained possession of.
However, there is no definition or description of what Applicant regards as “one or more branched-chain amino acids (BCAAs) or metabolites thereof” within Applicant’s disclosure. Therefore, Applicant fails to adequately describe as to what Applicant defines or considers “one or more branched-chain amino acids (BCAAs) or metabolites thereof”.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of “a compound that lowers levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof.”
The specification does not clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed (see Vas-Cath at page 1116).
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).
To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing.
Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. See MPEP 2163, I
The examiner notes that claims 28-29 are not included in this rejection as they fulfill the written description requirement.
Therefore, Claims 1 and 3-9 are rejected on grounds of lacking written description.
Claims 1, 3-9, and 28-29 are/remain 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art could not practice the invention without being burdened with undue experimentation based on the information provided by the applicant.
A discussion of these factors they relate to the pending claims follows.
Breadth of Claims and Nature of the Invention
Claims 1, 3-9 and 28-29 are directed to “A method of treating CNS-related conditions, comprising: administering an effective amount of a compound that lowers the levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof, or any pharmaceutically acceptable salt thereof, wherein the CNS-related conditions is selected from the group consisting of Alzheimer's disease and dementia.
Claims 3-5 are directed towards “wherein the compound is a benzothiopene-2-carboxylic acid (BT2) compound.”
Claims 6 is directed towards administration methods.
Claim 7 is directed towards formulations of the compound.
Claim 8 is directed towards where the condition is Alzheimer’s Disease.
Claim 9 is directed towards “further comprising obtaining a biological sample from
the patient with the CNS-related condition and determining if the biological sample has an
increase in BCAAs or metabolites thereof when compared to a sample from a subject without the
CNS-related condition.”
Claims 28-29 are directed to “wherein the BCAAs are selected from leucine, isoleucine, and valine” and “wherein the BCAA metabolites are selected from HMG:3-
methylglutaryl, ketoisovalerate, ketoisocaproate, Methyl-melonatesemialdehyde, 2-
methylpropanoicacid, and 3-OH-Propanoate.”
Applicant has provided no definitions for what constitutes a patient or subject.
Applicant has also provided no definitions for what constitutes treating.
Additionally, claim 1 recites “a compound that lowers the levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof,” which is broad with respect to pharmacological agent being administered and biomarkers being measured.
As per MPEP 2111, “the pending claims must be "given their broadest reasonable
interpretation consistent with the specification."
As per MPEP 2111.01, I: “Under a broadest reasonable interpretation (BRI), words of the
claim must be given their plain meaning, unless such meaning is inconsistent with the
specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and
customary meaning of a term may be evidenced by a variety of sources, including the
words of the claims themselves, the specification, drawings, and prior art.”
Consequently, it is reasonable to conclude that the claims are broad with respect to the patient population, compound, disease, and “treatment.”
The state of the prior art
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05 (a).
To the best knowledge of the examiner, there is no compound known to treat the Alzheimer’s and dementia based on simply lowering the levels of BCAAs or metabolites thereof. It is not reasonable to claim that any compound that can lower levels of BCAAs or metabolites would be capable for treatment purposes based on the wide range of parameters that are involved in drug design and treatment development (i.e: efficacy, pharmacokinetics and other various well-known factors in the pharmaceutical arts).
By example only, in the case of Alzheimer’s, Pluta et al explains that: “Alzheimer’s disease is an age-related disorder characterized clinically by gradual memory loss and cognitive impairment. The disease affects more than 47 million people worldwide, and this number is expected to reach over 131 million by 2050. Alzheimer’s disease is considered the most common cause of dementia (1, 2), covering about 60–80% of dementia cases worldwide (3). Available data indicate that the incidence of sporadic Alzheimer’s disease is common and reaches 10–50% persons over the age of 65 (4). Factors that may be involved in the development of the disease include lifestyle habits such as diet, exercise, education, cognition and aging, immunosenescence, chronic infections and inflammation, latent infections, vascular factors, sleep problems and more (5–9). It has been suggested that intestinal microorganisms and ischemic episodes may also be involved in the development of this disease (10–13). Heritability of this form of dementia is high and estimated at 70–79% based on twin-studies. However, most evidence points to a heterogeneous etiology, with the disease resulting from a combination of many genetic, environmental, vascular and other currently unknown factors (5, 6, 10, 14–16). One particular genetic factor, the epsilon allele in the apolipoprotein E gene, has been identified as being associated with an increased risk of sporadic Alzheimer’s disease, but a large percentage of the genetic risk remains unidentified. Alzheimer’s disease is the leading cause of acquired disability in the world, affecting 1 in 2 in women and 1 in 3 in men (17). Alzheimer’s disease is described as one of the unsolved problems of modern medicine (18), one which has a significant impact on the global economy, society and the families of the sick (19) (Pluta R, Ułamek-Kozioł M. Tau Protein-Targeted Therapies in Alzheimer’s Disease: Current State and Future Perspectives. In: Huang X, editor. Alzheimer’s Disease: Drug Discovery [Internet]. Brisbane (AU): Exon Publications; 2020 Dec 18. Chapter 4. Available from: https://www.ncbi.nlm.nih.gov/books/NBK566118/).
Consequently, Alzheimer’s in considered an unsolved problem with heterogenous etiology and many unknowns still being investigated.
Pluta additionally explains “Today we know that the onset of Alzheimer’s disease begins between 15 (in familial cases) and 20–30 years (in sporadic cases) before any clinical symptoms appear (2, 8, 22). By the time the clinical phenotype is recognized, significant neuronal and synaptic degeneration and massive neuroinflammatory changes have already occurred. Though the cause of Alzheimer’s disease is not completely certain, it has been proven by diagnostic methods based on the analysis of the patient’s brain images that the accumulation of amyloid in the brain precedes the appearance of clinical symptoms and indicates a number of pathological factors that are ultimately not defined.”
Consequently, Pluta illustrates a challenge with Alzheimer’s is diagnosis. Diseases that a challenging to diagnose ultimately have a low likelihood of prevention. Pluta also further teaches that there are numerous pathological factors not well-understood in the field.
In terms of current pharmacological treatments, Pluta explains that “Drugs available on the market for the treatment of Alzheimer’s disease show only low symptomatic efficacy and phase 3 clinical trials against amyloid have been negative over the past 20 years. As dysfunctional tau protein is more closely correlated with dementia than amyloid, targeting tau protein may be more effective in improving cognitive function in cases of Alzheimer’s disease. It should be emphasized that the development of tau protein therapy is in many ways more complicated than the development of anti-amyloid therapy.”
In terms of chemoprevention and treatment, Pluta explains that “There is no prophylactic or causal therapy for the disease, and the lack of knowledge about etiology and when or why the disease really begins, significantly complicates the work of physicians (24). Currently available treatments for Alzheimer’s disease are only aimed at mitigating clinical symptoms and delaying cognitive decline. The development of a therapy for Alzheimer’s disease has resulted in only a few approved drugs that provide temporary symptomatic relief in some patients. None of these clinically used drugs stop or slow the progression of the disease.”
Therefore, Pluta teaches that there are no pharmacological agents to date for prophylactic therapy and that no drugs can slow the disease.
In terms of tau protein research, Pluta explains that: “Per the studies and data noted in this chapter, the status of tau protein targeting therapy in the treatment of Alzheimer’s disease is unclear due to lack of evidence or mutually exclusive observations. The small number of studies, and variable non-uniform measures of results suggest the field to be in its infancy and limit the possibility of making generalized conclusions. Although Alzheimer’s disease is a real challenge for the pharmaceutical industry, there has been no clear progress in treatment options in the past few years. Current drugs on the market show only low effectiveness, and clinical studies from the last 20 years have ultimately proven to be negative in phase 3.”
Pluta also teaches that combination therapy will likely be required and monotherapy will likely be ineffective: “Although both amyloid and tau protein are very important, their relationship in causing Alzheimer’s disease remains unknown. Treatment directed to amyloid and tau protein may be individually effective, but the convergent progression of amyloid and tau protein pathology suggests that combination therapy may eventually be required, especially in late stages when both are abundant. While ongoing works focused on single-goal therapies, the approach to double-targeting amyloid and tau protein is more likely to lead to a breakthrough.”
Therefore, it is reasonable to conclude that the current state of the art is highly unpredictable, indicating that more details, working examples and guidance would be required to practice the invention as disclosed for cancer prevention and for the general treatment of cancer as claimed.
(D) The level of one of ordinary skill
The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP § 2141.03 (I)
The invention described pertains to medicine and pharmacology. One of ordinary skill would be a person with training in oncology, pharmacology, biochemistry or a related technical discipline.
(E) The level of predictability in the art
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. See MPEP § 2164.03.
Consequently, technologies involving physiological activity as opposed to mechanical or electrical inventions are generally regarded as being unpredictable sciences.
As aforementioned, there is no general compound capable of treating Alzheimer’s disease and dementia as recited in claim 1. By example only, Alzheimer’s is a disease characterized by heterogenous etiologies and pathologies, many of which remain unknown to experts in the field. Alzheimer’s drugs have also experienced a high failure rate. Additionally, it is likely that combination therapy not monotherapy would be required.
Based on these culminative factors, it is reasonable to conclude that predictability in the art is low.
Consequently, the applicant would need to provide more details, working examples and guidance in order for the claimed invention to be enabling based on the scope and nature of the claimed invention.
The existence of working examples
The applicants’ working examples are directed towards:
Studies only focused on Alzheimer’s disease. Applicant themselves on page 18 of the specification admit that “the role of BCAAs in AD pathogenesis is poorly understood.” (page 6, Figures 1A to 1F ). Applicant has also provided no details on the individuals in terms of patient population and if they are human patients.
Studies on BCAA metabolism in transgenic AD mice (Fig 2A to 2F)
However, Applicant’s working examples are primarily focused on studying the role of BCAAs in AD, but there are no methods of administering a compound to actually treat AD or dementia.
As exemplified with Alzheimer’s, such disorders face challenges with diagnosis, and have unknown, heterogenous etiologies and pathologies. Many diseases have also experienced high failure rates in drug development. In some cases, increasing BCAA levels may be beneficial instead of decreasing them such as for autism or BCAA levels may be irrelevant.
Applicant is reminded as per MPEP 2164.02, I: “The issue of "correlation" is related to the issue of the presence or absence of working examples. "Correlation" as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples."
Applicant has provided no examples shown actual administration of any compound to an actual patient and has only provided examples focused on studying BCAA metabolism and BCAA levels.
Additionally, many of the examples provided are described in an ambiguous manner and it is not clear if these examples are prophetic or not such as Example 1, page 18 of the specification.
Applicant is reminded as per MPEP 2164.02, IV. “When prophetic examples are described in a manner that is ambiguous or that implies that the results are actual, the adequacy and accuracy of the disclosure may come into question. If the characterization of the results, when taken in light of the disclosure as a whole, reasonably raises any questions as to whether the results from the examples are actual, the examiner should determine whether to reject the appropriate claims based on an insufficient disclosure under the enablement and/or written description requirements of 35 U.S.C. 112(a) following the guidance in MPEP §§ 2164 and 2163, respectively. When such a rejection(s) is made, the applicant should reply with the results of an actual test or example that has been conducted, or by providing relevant arguments and/or declaration evidence that there is strong reason to believe that the result would be as predicted, being careful not to introduce new matter into the application.”
On this basis and the prior discussion, the working examples are both not commensurate with the scope of protection sought and are not enabling. One ordinarily skilled in the art would unable to simply translate the evidence provided by the applicant into an actual method of treatment to treat Alzheimer’s and dementia as claimed without undue experimentation.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As aforementioned, the quantity of experimentation depends on the prior art, the predictability of the art, and the direction provided by the inventor, which are factors that were already discussed.
In order for one ordinarily skilled in the art to practice the invention as disclosed, some attributes one would require, but are not limited to:
Studies demonstrating administration of actual compounds that lower BCAA levels as an actual treatment method Alzheimer’s and dementia. Applicant has not provided support for an actual method of treatment through administering any compound, instead focusing on studying the role of BCAA in AD.
Consequently, the examiner concludes that one ordinarily skilled in the art would require undue experimentation in order to practice invention based on the details provided and scope of invention defined in Claims 1, 3-9
Consequently, Claims 1, 3-9, and 28-29 remain rejected for lacking enablement.
Response to Arguments
The Remarks of June 10, 2025 have been fully considered but are not fully persuasive for the reasons below.
35 USC 112(a)
Applicant’s Arguments:
“The Office Action rejected claims 1 and 3-9 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. Applicant(s) respectfully traverse the rejections and claims 1 and 3-9 are allowable under 35 U.S.C. § 112, first paragraph. Briefly, even a minimally skilled artisan will know that BCAA are leucine, isoleucine, and valine (see [0052] of the present specification). Further, the same minimally skilled artisan could see that metabolites include those in FIG. 1 and the description thereof. New claims 28 and 29 find express support in FIG. 1 and [0052] of the specification as filed and thus, do not include new matter. As such, the specification provides more than sufficient written description to support the claims. Reconsideration and withdrawal of the rejections are respectfully requested.”
Examiner’s Response:
The examiner respectfully disagrees.
Although the examiner agrees that BCAAs are well-known to be leucine, isoleucine and valine, as emphasized in the written description rejection, the issue is what metabolites Applicant has contemplated or actually obtained possession of, and furthermore what compounds meet the function as claimed of lowering levels of one or more branched-chain amino acids or metabolites thereof.
Applicant is further reminded that as per MPEP 211: “During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification."
Additionally, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As aforementioned, Applicant has provided no description or guidance of what metabolites have been contemplated. Moreover, in the context of full claim, Applicant has provided no guidance or criteria to determine how to evaluate what compounds would lower levels of one or more branched-chain amino acids or metabolites as claimed. Based on the present disclosure, one of skill in the art would not recognize from the disclosure that the applicant was in possession of “a compound that lowers levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof.”
For the purposes of responding to Applicant’s argument, the Examiner cites Manoli (Manoli, I. and Venditti, C.P., 2016. Disorders of branched chain amino acid metabolism. Translational science of rare diseases, 1(2), pp.91-110) who teaches that “Branched chain amino acids (BCAAs), leucine, isoleucine and valine, are three of the nine essential amino acids and account for 35–40% of the dietary indispensable amino acids in body protein and 14% of the total amino acids in skeletal muscle. They share common membrane transport systems and enzymes for their transamination and irreversible oxidation.”
Manoli also teaches biochemical pathways of BCAA metabolism as seen in Figure 1.
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Through simply evaluating just these BCAA pathways, it is clear there are numerous metabolites involved in these complex biochemical pathways. Again, Applicant’s claims are directed towards “a compound that lowers levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof.”
Applicant has failed to provide adequate written description showing possession and demonstrating what one must do to meet the limitations of the claims, particularly in terms of metabolites and in determining which compounds meet the limitations of the claims.
As per MPEP 2163.I.A: “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).”
Furthermore, “Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).”
To this aim, Applicant’s claims to “a compound that lowers levels of one or more branched-chain amino acids (BCAAs) or metabolites thereof,” constitute a laundry list as no specific guidance is provided that would lead a person of ordinary skill in the art to any particular species in terms of both what compound to select and what is being measured.
Notably, the lack of written description in terms of what compounds meet the limitations of claim 1 is not clarified through new claims 28-29, which only narrow the scope for specific BCAAs and specific metabolites.
Therefore, claims 1, 3-9, and 28-29 are/remain rejected on grounds of written description.
Applicant’s Arguments:
“The Office Action rejected claims 1 and 3-9 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. Applicant(s) respectfully traverse the rejections and claims 1 and 3-9 are allowable under 35 U.S.C. § 112, first paragraph. Briefly, even a minimally skilled artisan will know that BCAA are leucine, isoleucine, and valine (see [0052] of the present specification). Further, the same minimally skilled artisan could see that metabolites include those in FIG. 1 and the description thereof. New claims 28 and 29 find express support in FIG. 1 and [0052] of the specification as filed and thus, do not include new matter. As such, the specification provides more than sufficient enablement to support the claims. Reconsideration and withdrawal of the rejections are respectfully requested.”
Examiner’s Response:
The examiner respectfully disagrees and reminds Applicant that a written description rejection is different from an enablement rejection.
Applicant has not submitted any arguments to address the enablement rejection as set forth by the Examiner, and has failed to address the comprehensive Wands factor analysis provided by the Examiner as is the standard test for enablement. Please see MPEP 2164.01 for further details.
As per MPEP 2164.05, “Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973).”
Consequently, the burden falls on Applicant to address the Wands factors and provide appropriate arguments and/or evidence. Applicant has failed to do so.
As per MPEP 2164.05: “To overcome a prima facie case of lack of enablement, applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing. This does not preclude applicant from providing a declaration after the filing date which demonstrates that the claimed invention works. However, the examiner should carefully compare the steps, materials, and conditions used in the experiments of the declaration with those disclosed in the application to make sure that they are commensurate in scope; i.e., that the experiments used the guidance in the specification as filed and what was well known to one of skill in the art at the time of filing. Such a showing also must be commensurate with the scope of the claimed invention, i.e., must reasonably enable the full scope of the claimed invention. See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).”
Consequently, Applicant is further reminded that any arguments and/or support must demonstrate enablement commensurate with the full scope of the claimed invention.
Therefore, the rejection is maintained and Applicant is invited to submit a proper response and/or evidence to overcome the rejection.
Therefore, for these reasons, Applicant’s arguments remain unpersuasive.
Conclusion
Claims 1, 3-9, and 28-29 are under consideration and are rejected.
No claims are allowed.
Applicant's amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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