DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-9 and 20 are examined herein.
Claims 10-19 are withdrawn (see restriction/election below).
Priority
This application is filed 10/18/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 05/23/2023 have been considered unless marked with a strikethrough.
Election/Restrictions
While it is acknowledged that restriction requirements in applications entering the U.S. national phase under 35 USC § 371 do not require a showing of search burden, the present claims nevertheless present issues that would also be applicable under standard U.S. examination practice.
Applicant elects group I, claims 1-9 and 20 without traverse in the reply filed on 02/17/2026 is acknowledged.
Claims 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
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Applicant’s election of species of (5-(2-(3-methyl-3H-imidazo [4,5-b]pyridin-2-yl)ethyl)-3-((1-methylpiperidin-4-yl)methyl)-1,2,4- oxadiazole) as recited in claim 6 in the reply filed on 02/17/2026 is acknowledged.
Claims 1-6 and 8-9 read on the elected species and will be examined on their merits.
If the elected specie is not identified in the prior arts, the elected specie would be allowable if an independent claim were drafted with that specie alone, and Examiner expanded the search to additional species of the genus per MPEP 802.03.
The elected specie is not identified in the prior art; thus, Examiner expanded his search to other species in claim 7, read on the expanded specie as well. Accordingly, claim 20 is withdrawn as not reading on both the elected and expanded species.
Claims 1-9 read on the expanded specie(s) and will be examined on their merits. Claim 20, directed to the composition, will be examined. With respect to the extended species, the species are rejected under 35 USC 112, 102 and 103 below.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because:
The images are not clean, well-defined, sufficiently dense and dark, and well defined in Figure(s) 2, 4A, 4B, 4D, 4F, 5, 6, 7A, 9, and 10. See 37 CFR 1.84(l) and (q).
Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 4, line 4: PDB name has not been provided.
Page 13, line 4: PMID number is shown as “XXX”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, Written Description
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 1-5, 8, 9 and 20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed.
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
With respect to claims 1, 9 and 20, the claims recite a composition comprising one or more agents capable of inhibiting the interaction between CD44 and FERM protein interaction, and/or inhibiting TDP-43 activity, wherein the agent is a small molecule, an antibody, nucleic acid molecule (e.g., siRNA, antisense oligonucleotide, an aptamer), or a mimetic peptide.
The claims encompass a broad genus of therapeutic agents spanning multiple fundamentally distinct molecular classes, including small organic/inorganic molecules, biologic antibodies, nucleic acid therapeutics, and peptide mimetics. However, the specification fails to disclose the species across the full scope of the claimed genus, and further fails to identify structural features or common structural characteristic that correlate with the claimed functional activities.
The claims define the agents primarily by their functional capability of inhibiting CD44-FERM protein interaction and/or TDP-43 activity. However, the specification does not disclose sufficient structural guidance or structure/function relationships that would enable a person of ordinary skill in the art to determine which molecules within the broad person of ordinary skill in the art to determine which molecules within the broad molecular classes recited in the claims would possess the claimed functional properties.
Mori et. al. (Structural Basis for CD44 Recognition by ERM Proteins, J. Biol. Chem., 283(43), 29602–29612, pub’d 07/23/2008) demonstrates the interaction between CD44 and ERM family proteins occurs through specific structural recognition between the cytoplasmic tail of CD44 and the FERM domain of ERM proteins (result section, Figure 2, 3 and 5). These studies show that the interaction depends on precise structural features at the protein-protein interface (discussion section). Moreover, Arkin et al. (Small-molecule inhibitors of protein-protein interactions: progressing towards the reality, Chem. Biol., 21(9), 1102–1114, pub’d 09/18/2014) explains that the development of inhibitors targeting protein-protein interactions is particularly challenging and unpredictable due to the large and complex interaction surfaces involved (summary section).
In view of the structural complexity and unpredictability associated within inhibitors of protein-protein interactions explained by Mori and Arkin, one of ordinary skill in the art would expect that successful inhibition of the CD44-FERM interaction would depend on specific structural motifs capable of interacting with the defined binding interface. Instant specification does not provide sufficient information of structurally diverse species demonstrating inhibition across the full scope of the claimed genus. Accordingly, the specification does not reasonably convey to those skilled in the art that the inventors were in possession of the full scope of the invention as required by the written description requirement.
With respect to claim 2, the claim recites the agent is capable of one or more of inhibiting interaction between CD44 and one or more of FERMT2, Ezrin, Radixin and Moesin; inhibiting microglial communication to neurons upregulated in AD related to CD44 and FERM protein interaction; inhibiting microglial communication to neurons upregulated in AD related to CD44 and Moesin protein interaction; inhibiting the interface of CD44 and FERM protein interaction; inhibiting the interface of CD44 and Moesin interaction; inhibiting communication between CD44 and FERM proteins; and inhibiting communication between CD44 and Moesin.
The specification does not provide a sufficient description of agents capable of inhibiting these specific protein-protein interactions. In particular, the specification does not identify representative inhibitory compounds, binding domains, structural motifs, or other structural features associated with agents capable of inhibiting the CD44, FERM, Moesin or TDP-43 interactions recited in the scope of claim 2.
As discussed above, in view of the structural complexity and unpredictability associated within inhibitors of protein-protein interactions explained by Mori and Arkin, structural studies have shown that binding between CD44 and ERM family proteins occurs through specific structural recondition between the cytoplasmic tail of CD44 and the FERM domain of ERM proteins (result section, Figure 2, 3 and 5 in Mori), and the development of inhibitors targeting protein-protein interactions is particularly challenging and unpredictable due to the large and complex interaction surfaces involved (summary section in Arkin). These studies indicate that inhibition of such protein-protein interactions depends on precise structural features at the interaction interface, and small structural features may produce substantial and unpredictable changes in inhibitory activity. Accordingly, claim 2 would depend on specific structural motifs of binding features capable of interacting with the defined protein interface.
The limited experimental disclosure in the specification mainly relates to targeting the CD44-Moesin interaction. The specification does not provide adequate expiations or experimental support demonstrating inhibition of interactions involving other FERM proteins recited in the claims such as agents interacting with CD44-FERMT, CD44-FERMT2, CD44-Ezrin, or CD44-Dadixin. Accordingly, the specification fails to demonstrate possession of agents capable of inhibiting the full range of protein-protein interactions recited in claim 2.
With respect to claims 3-5, the claims recite that the agent is selected from FERM1-10 or P-8, or agents having particular chemical structures or structural class.
The specification does not describe these compounds in sufficient structural detail to demonstrate possession of the claimed subject matter. The specification disclosures FERM1-10 are selected from virtual screening using a small molecule library of 50,000 compounds from Chembridge Inc. (targeting CD44/FERM in silico section in the instant specification), as described in the section relating to in silico targeting of the CD44-FERM interaction.
According to the view of the structural complexity and unpredictability explained by Mori and Akin, inhibition of the CD44-FERM interaction would depend on structural motifs or binding features capable of interacting with defined interface. The current disclosure does not provide a complete structural description, synthetic methods, or common structural classes associated with these compounds that would enable a person or ordinary skill in the art to recognize the structural characteristic of the claimed agents.
With respect to claim 8, the claim recites that “the agent is capable of interacting, engaging, and/or binding with one or more of the amino acids shown in Fig. 7”. The terms of “interacting”, “engaging”, and “binding with one or more of the amino acids” lack clear objective boundaries are defined in the agent primarily in terms of its functional capability, rather than by specific structural characteristics. (see MPEP 2173.05(g)) Such functional claim language, without sufficient structural guidance or representative species, does not demonstrate possession of the full scope of the claimed invention.
The MPEP states that “Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite…. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167”. (see MPEP 2173.05(g))
The specification fails to provide the limitations of structural characteristic of agents capable of interacting with the referenced amino acid residues, and structural of experimental evidence demonstrating that the compounds FERM 1-10 or P-8, recited in claim 3. Also, The specification does not to provide the measurable criteria or structural limitations for determine whether this limitation is satisfied.
As discussed above, in view of the structural complexity and unpredictability associated within inhibitors of protein-protein interactions explained by Mori and Arkin, the specification fails to provide sufficient structural guidance or representative examples demonstrating possession of agents capable of performing the claimed interaction. Accordingly, the specification fails to provide sufficient structural guidance or representative examples demonstrating possession of agents capable of performing the claimed functional interactions.
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), 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 2161.01).
Therefore, in the view of the broad functional scope of the claims, the lack of structural guidance, the absence of the representative number of species, and the unpredictability associated with inhibitors of protein-protein interactions, the specification fails to demonstrate possession of the claimed invention for claims 1-5, 8, 9 and 20 at the time of filing.
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.
See MPEP 2173. rejections under this section are made when the scope of the claimed subject matter is not clear.
Claims 3-9 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.
Regarding claim 3, the claim recites that the agent is selected from FERM1-10 or P-8. However, the claim does not clearly define what “FERM1-10” or “P-8” refer to. The terms “FERM1-10" and “P-8” in claim 3 is a relative term which renders the claim indefinite. The term “FERM1-10" and “P-8” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification do not provide sufficient structural or functional definitions for these terms. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Accordingly, the meaning and boundaries of “FERM1-10 or P-8” are unclear and render claim 3 indefinite. (see MPEP 2173.02)
Regarding claims 4-7, the claims recite a specific or class of compound as well as compounds that are “or similar”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 4-7 recite the broad recitation “or similar" compounds as a class, and the claim also recites specific compounds in the claim which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In particular, the specification fails to describe whether the structures encompassed the limitations include structures having the same configuration, structures performing the same function, or structures having equivalent components or arrangements. Accordingly, the scope of claims is unclear and renders the claim indefinite. For purposes of examination, these claims will be interpreted under its broadest reasonable interpretation (BRI) consistent with MPEP §2111.
Regarding claim 8, the claim recites that the agent is capable of interacting, engaging, and/or binding with one or more of the amino acids shown in Fig. 7.
MPEP 2173.05(s) states that “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)”
Therefore, the term “Fig. 7” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 9, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation nucleic acid, and the claim also recites siRNA which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Moreover, the phrase "e.g." is synonymous as “for example”, which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Accordingly, claims 3-9 are rendered indefinite.
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.
Claim(s) 1, 2, 8 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Annor-Gyamfi et. al (Fused tetrahydroquinolines (THQ): potential PAINS compounds in a recent HTS for moesin-CD44 pathway inhibitors, DOI 10.5281/zenodo.4685121, pub’d 04/13/2021).
With respect to claims 1 and 9, the claims recite that “a composition comprising one or more agents capable of inhibiting CD44 and FERM protein interaction, and/or inhibiting TDP-43 activity.”, and “an agent is defined as a small molecule, an antibody, nucleic acid molecule (e.g., siRNA, antisense oligonucleotide, an aptamer), or a mimetic peptide” in the instant claim 9.
Annor-Gyamfi teaches that the identification of small molecule compounds capable of disturbing the Moesin (MSN)-CD44 interaction that inhibit the MSN-CD44 protein interaction via a high throughput screening assay (paragraph 2 and 3 in page 1). Annor-Gyamfi furtherer teaches that three fused tetrahydroquinoline (THQ) analogues (i.e., small molecules) are identified to interrupt the MSN-CD44 protein-protein interaction (paragraph 3, and figure 1 in page 1) as recited in claim 1.
With respect to claim 2, the claim recites that the agent is capable of inhibiting interaction between CD44 and one or more FERM proteins, including Moesin, and inhibiting communication related to CD44-FERM interaction in Alzheimer’s disease.
Annor-Gyamfi teaches that Moesin is a FERM domain protein, and co-crystal structures of Moesin and the related FERM protein EPB41L3 to demonstrate how the intracellular tail of CD44 (i.e., a transmembrane receptor) binds to MSN and related proteins (paragraph 1 and 2 in page 1). Annor-Gyamfi further teaches that disruption of the MSN-Moesin interaction shows a therapeutic strategy in Alzheimer’s disease (AD, paragraph 1 and 2 in page 1). Accordingly, Annor-Gyamfi discloses the agent inhibits the interface of CD44 and FERM protein (i.e., Moesin) interaction and the biological pathway associated with AD pathology as recited in claim 2.
With respect to claim 8, the claim recites that the agent is capable of interacting, engaging, and/or binding with one or more of the amino acids.
Annor-Gyamfi teaches THQ compounds identified through high throughput screening as inhibitors of the moesin-CD44 pathway, which corresponding to inhibition of CD44-FERM interactions. In order to this interaction, the disclosed compounds necessarily interact with residues located at the CD44-Moesin binding interface.
Such interactions between small molecule inhibitors and proteins commonly involve non-covalent interactions with amino acid residues located at the protein interface, Accordingly, the compounds disclosed in Annor-Gyamfi would inherently interact with one or more amino acid residues at the CD44-FERM interface in order to produce the inhibitory activity described in the reference. For example, the compound, UNC10302820A, in Annor-Gyamfi is a tetrahydroquinoline that COOH and NH as functional groups, and the compound may bind HIS, PHE, LEU, and/or MET in CD44-FERM domain (instant application Figure 7) using an ionic interaction, pi-pi interaction and/or hydrogen bonding interaction.
Therefore, the limitation reciting that the agent is capable of interacting, engaging, and/or binding with one or more of the amino acids associated with the CD44-FERM interface is inherently satisfied by the compounds disclosed in Annor-Gyamfi.
Claim(s) 1, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by commercial chemical databases (e.g., Chemical Abstracts Service RN:1309514-63-9, entered STN database on 06/13/2011).
With respect to claim 7, the claim recites a composition wherein the agent has the specific chemical structure. The commercial chemical databases (e.g., Chemical Abstracts Service) discloses the identical compound having the same chemical structure as that recited in the instant claim 7.
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Although the prior art reference does not explicitly disclose the functional property for the instant application, the prior art compound is structurally identical to the claimed compound. A prior art compound that is structurally identical to the claimed compound is presumed to possess the same inherent properties as the claimed compound. The discovery of a previously unrecognized property of a prior art compound does not render the old compound patentable. (See MPEP 2112)
Conclusion
Claims 1-9 and 20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621