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 .
Application Status
Applicant’s response and amendments to the specification and claims filed December 8, 2025 are acknowledged. Claims 1-2, and 11 were amended. Claims 1-20 are pending.
Restriction/Election
Applicant’s election of Group I (claims 1-9) without traverse in the reply filed December 8, 2025 is acknowledged. Accordingly, claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-9 are under consideration hereinafter.
Priority
Applicant’s priority claim to Application No. 63/196,363 is acknowledged. Claims 1-9 find support in Application No. 63/196,363. The effective filing date of the claims under examination is June 3, 2021, accordingly.
Specification
The specification is objected to because of the following informalities:
The specification and abstract recite “proteniopathy.” The disclosure should be amended to recite the correct spelling, i.e., “proteinopathy.”
The use of terms which are trade names or marks used in commerce has been noted in this application, e.g., “PrestoBlue,” “LIVE/DEAD,” “FlowJo,” “Triton,” “Vectashield,” and “ProteoStat” (see at least pgs. 45, 70, 103-105, and 133). Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The terms, including the exemplary terms above, should be accompanied by the generic terminology. Furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Appropriate correction is required.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
Claims 1 and 9 recite “proteniopathy.” The claims should be amended to recite the correct spelling, i.e., “proteinopathy.”
Claim 1 (b) recites “pathologic protein.” It is clear that this term refers to the previously recited “pathological protein” in (a)((iii), and thus, it would be preferable to amend (b) to recite “pathological protein.”
Appropriate correction is required.
Claim Interpretation- 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
In the instant case, claims 1 and 9 recite “means for determining…,” which is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) fail(s) to recite sufficient structure, materials, or acts to entirely perform the recited function.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 2 recites “validation means.” This claim limitation is nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function (“said validation means is at least one of: (a)… (d)….”).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claims 1-9 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.
The limitation “means for determining” recited in claims 1 and 9 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph as described above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification describes that “means” refers to “any cellular and non-cellular means, specifically, any natural or artificial cell or cell parts, organs, tissues or any equipment, facility, instrument, machine, program, required for determination, quantitation, recording, computing, visualizing, and evaluating the accumulation of the metabolite…” (pg. 31). This definition encompasses virtually any means, of any structure, material, or act, and therefore, does not clearly set forth the structure, material, or acts required for “determining.” The claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 2-8 are rejected for depending from claim 1 and failing to remedy the indefiniteness.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 7 recites “The system according to claim 1, wherein said… protein aggregation disorder….” Claim 1 recites “at least one proteinopathy and/or protein misfolding disorder.” Claim 1 does not recite a “protein aggregation disorder,” or the term “aggregation.” A “protein aggregation disorder” is not inherent to claim 1, either, given that aggregation is not a feature of all proteinopathy or protein misfolding disorders based on the definition on pgs. 56-57. The phrase “said… protein aggregation disorder” lacks sufficient antecedent basis in claim 7, accordingly.
Claim 8 recites “The system according to claim 7, wherein… said proteinopathy and/or neurodegenerative disorder….” Claim 7 recites that the “proteinopathy and/or protein misfolding… disorder” is “a neurodegenerative disorder or any signs or symptoms associated therewith.” Claim 8 is confusing, therefore, because it is no longer clear whether the “proteinopathy and/or protein misfolding… disorder” is limited to a neurodegenerative disorder or any signs or symptoms associated therewith as would be understood from claim 7 from which it depends. The scope of disorders encompassed by claim 8 is unclear, accordingly.
Claim 9 recites “(iii) said yeast cell/s endogenously and/or exogenously express at least one proteinopathy associated with beta-amyloid protein aggregation.” The specification describes “proteinopathy” as a “protein conformational disorder, or protein misfolding disease…,” e.g., “Alzheimer’s disease, Parkinson’s disease, amyloidosis,” etc. (pg. 56). The specification appears to provide that Alzheimer’s disease (AD) and age-associated cognitive decline (ACD) are proteinopathies associated with beta-amyloid protein aggregation (pg. 74). The structure of yeast cell(s) which endogenously and/or exogenous express at least one of Alzheimer’s disease or age-associated cognitive decline is not clear. For example, it is not clear whether this limitation intends to require that the yeast cells express a protein associated with these proteinopathies, or whether the yeast cells express “features” of the proteinopathies, or something else entirely. The claim is indefinite, accordingly, because the structure of the yeast cells which meet the conditions of (iii) would not be apparent to the skilled artisan.
It is noted that claim 9 appears to be a specific species of the system of claim 1. Claim 1 recites “(iii) said yeast cell/s endogenously and/or exogenously express at least one pathological protein associated with said proteinopathy and/or protein misfolding disorder.” Amending claim 9 to recite, for example, “(iii) said yeast cell/s endogenously and/or exogenously express at least one pathological protein
Claim Rejections - 35 USC § 102 - Laor
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.
Claims 1-4, and 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laor (Laor et al., 8 January 2019, Nature Communications, (2019)10:62, pg. 1-11 and Supplemental Information).
Claim 1 is interpreted as a system comprising (a) a yeast cell, cell line, or population that displays accumulation of at least one metabolite. The yeast cell, cell line, or population must also meet one or more of the following limitations:
(i) carry at least one manipulation and/or modification in at least one yeast metabolic pathway that leads to accumulation of the metabolite;
(ii) grow under conditions that result in accumulation of the metabolite, which is interpreted as a functional limitation of the yeast, which requires that the yeast be capable of growth under such conditions; and/or
(iii) endogenously and/or exogenously express at least one pathological protein associated with a proteinopathy and/or protein misfolding disorder, which is interpreted as requiring that the yeast express a protein related to the pathology of a proteinopathy and/or protein misfolding disorder, which is interpreted as any disease or disorder in which proteins assume an abnormal conformation (specification, pg. 56-57).
The system may optionally comprise (b) at least one reagent or means for determining the accumulation of the metabolite and/or at least one phenotype associated with accumulation of the metabolite or pathological protein. In view of the indefiniteness above, the reagent or means for determining is interpreted as any reagent or means which determines accumulation of the metabolite of at least one phenotype associated with the metabolite or pathological protein.
Finally, the claim body recites a structurally complete invention, and therefore, the preamble phrase “for screening of candidate therapeutic compound/s for treating… at least one proteinopathy and/or protein misfolding disorder” is interpreted as an intended use which does not structurally limit the claim.
Regarding claim 1, Laor teaches a system comprising yeast cells (“aah1∆apt1∆”) that display accumulation of at least one metabolite, i.e., adenine (“In vivo model for adenine accumulation and toxicity,” pg. 3; “we generated an adenine salvage mutant by disruption of both APT1 and AAH1 genes,” pg. 3; “the toxic effect on cell growth due to adenine accumulation…,” pg. 3; “Intracellular concentration of adenine determined by GC-MS,” Fig. 1; on SD media in the presence of the metabolite, adenine levels were indeed significantly higher in the salvage mutant as compared to the wild-type strain,” pg. 5).
Laor teaches the yeast cells (i) carry at least one manipulation and/or modification in at least one yeast metabolic pathway that leads to accumulation of the metabolite (“we generated an adenine salvage mutant by disruption of both APT1 and AAH1 genes,” pg. 3). Laor teaches the yeast cells (ii) grow under conditions that result in accumulation of the metabolite (“on SD media in the presence of the metabolite, adenine levels were indeed significantly higher in the salvage mutant as compared to the wild-type strain,” pg. 5, right col.). Laor teaches the yeast cells (iii) endogenously express at least one pathological protein (“Hsp104 chaperon”) associated with a proteinopathy and/or protein misfolding disorder (i.e., “Alzheimer’s disease and Huntington’s disease”)(“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively. To test whether the toxicity following adenine accumulation in the salvage mutant is mediated b Hsp104, cell growth upon adenine addition was examined…,” pg. 5, right col.).
Laor also teaches at least one reagent or means for determining the accumulation of the metabolite (“To quantify the intracellular concentrations of adenine, gas chromatography mass-spectrometry (GC-MS) was used,” pg. 3, right col.; GC-MS, pg. 9), and at least one reagent or means for determining at least one phenotype associated with accumulation of the metabolite (“To verify the toxic effect observed for the salvage mutant… single copy plasmids carrying both genes were introduced to the mutant cells by transformation,” pg. 3, right col.; Yeast growth assays, pg. 9).
Regarding claim 2, the claim recites the structures of the “validation means” in (a)-(d), and no such “candidate therapeutic compound” is actually required of the system of claim 1 (i.e., it is recited in a phrase reciting an intended use as described above). Therefore, the phrase “for said therapeutic compound” is interpreted as an intended use which does not structurally limit the “validation means” selected from at least one of (a)-(d).
Laor teaches the system further comprises (a) at least one unicellular organism (“hsp104∆ aah1∆apt1∆”) that display accumulation of said metabolite and/or accumulation of said pathological protein (“The sensitivity of the salvage mutant to adenine feeding is independent of Hsp104,” Supplementary Figure 6; “To test whether toxicity following adenine accumulation in the salvage mutant is mediated by Hsp104, cell growth upon adenine addition was examined in… a hsp104∆ mutant background,” pg. 5, right col.).
Regarding claim 3, the phenotype determined by the at least one reagent or means for determining at least one phenotype associated with accumulation of the metabolite is cell toxicity (“To verify the toxic effect observed for the salvage mutant… single copy plasmids carrying both genes were introduced to the mutant cells by transformation,” pg. 3, right col.; Yeast growth assays, pg. 9).
Regarding claim 4, the metabolite, adenine, is a nucleobase.
Regarding claim 7, as stated above, Laor teaches the yeast cells (iii) endogenously express at least one pathological protein (“Hsp104 chaperon”) associated with a proteinopathy and/or protein misfolding disorder (i.e., “Alzheimer’s disease and Huntington’s disease”)(“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively. To test whether the toxicity following adenine accumulation in the salvage mutant is mediated b Hsp104, cell growth upon adenine addition was examined…,” pg. 5, right col.). Alzheimer’s disease and Huntington’s disease are neurodegenerative disorders, and thus, Laor’s system meets the limitations of claim 7.
Regarding claim 8, Alzheimer’s disease and Huntington’s disease are characterized by beta-amyloid protein aggregation, and huntingtin aggregation, respectively (“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively,” pg. 5, right col.). Laor’s system meets the limitations of at least claim 8 option (a), and option (b), which is understood to refer to option (a).
Claim Rejections - 35 USC § 102 – Laor as evidenced by Pareek
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laor (Laor et al., 8 January 2019, Nature Communications, (2019)10:62, pg. 1-11) as applied to claims 1-4, and 7-8, as evidenced by Pareek (Pareek et al., February 2021, Crit Rev Biochem Mol Biol., 56(1): 1-16).
Regarding claim 5, the limitations are interpreted as encompassing any amino acid residue, and any derivatives, intermediate products, or metabolites thereof. Pareek teaches that Laor’s metabolite, adenine, is a metabolite of amino acid residues (“Purines are… synthesized de novo from PRPP, utilizing building block substrates generated by other metabolic processes,” “Gln,” “Gly,” “Asp,” “Ser,” Fig. 1A-B and Description). Thus, Laor’s metabolite, as evidenced by Pareek, meets the limitations of claim 5.
Claim Rejections - 35 USC § 102 – Kumar as evidenced by Laor
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar (Kumar et al., 17 June 2011, Journal of Biological Chemistry, Vol. 286, No. 24, pg. 21779-21795) as evidenced by Laor (Laor et al., 8 January 2019, Nature Communications, (2019)10:62, pg. 1-11)).
The interpretation of claim 1 is described above in paragraph 20 and applied hereinafter. It is noted that “CYS4” and “STR4” both refer to a yeast cystathionine beta-synthase 4 gene. See NIH entry for Gene ID: 853059 (“Also known as: … STR4,”; CYS4 cystathionine beta-synthase CYS4, Saccharomyces cerevisiae S288C, Gene ID: 853059, updated on 4-Feb-2026). Kumar refers to the yeast cystathionine beta-synthase 4 gene as STR4 (“STR4,” cystathionine β-synthase homolog in yeast,” Fig. 1; “str4,” “str4∆”). Given the equivalency between these names based on the art, the instant claim’s terminology is used hereinafter.
Regarding claims 1, 4-6, and 9, Kumar teaches a system comprising yeast cells (“str4∆”) that display accumulation of homocysteine (“the intracellular homocysteine levels increased more than 18-fold… after 16 h of homocysteine treatment (Table 1),” pg. 21783; “Intracellular concentrations of homocysteine and methionine in str4∆,” Table 1).
Kumar teaches the yeast cells (i) carry at least one genetic manipulation in the cystathionine beta-synthase 4 gene (CYS4), which reduces expression of CYS4, and leads to accumulation of homocysteine (“using a strain (str4∆) that lacks the expression of cystathionine β-synthase,” pg. 21780, right col.; “Intracellular concentrations of homocysteine and methionine in str4∆,” Table 1). Laor teaches the yeast cells (ii) grow under conditions that result in accumulation of Hcy, i.e., under conditions of Hcy supplementation (“the intracellular homocysteine levels increased more than 18-fold… after 16 h of homocysteine treatment (Table 1),” pg. 21783; “Intracellular concentrations of homocysteine and methionine in str4∆,” Table 1).
Kumar is silent as to (iii). However, Laor teaches the yeast cells (iii) endogenously express at least one pathological protein (“Hsp104 chaperon”) associated with a proteinopathy and/or protein misfolding disorder (i.e., “Alzheimer’s disease and Huntington’s disease”)(“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively,” pg. 5, right col.). Thus, Kumar’s yeast cells meet the limitations of (iii) as evidenced by Laor.
Kumar also teaches at least one reagent or means for determining the accumulation of homocysteine (“the intracellular concentration of homocysteine was measured using HPLC,” pg. 21782), and at least one reagent or means for determining at least one phenotype associated with accumulation of homocysteine (“Effect of Homocysteine and Its Derivative on Yeast Growth,” pg. 21782; Fig. 2).
Regarding claim 2, Kumar teaches the system further comprises (a) at least one unicellular organism (“str4∆ Pcup1-GPX1… PGPD1-GPX1… Pcup1-TSA1.. PGPD1-TSA1,” Yeast Strain and Growth Conditions, pg. 21780, right col.) that display accumulation of said metabolite (“We also checked if overexpression of antioxidant genes could rescue the growth defects of yeast… we constructed str4∆ strain with regulatable and constitutive overexpression of two important antioxidant genes… they continued to show growth inhibition similar to that observed in str4∆ strains,” pg. 21785-21787).
Regarding claim 3, the phenotype determined by the at least one reagent or means for determining at least one phenotype associated with accumulation of the metabolite is cell toxicity (“Effect of Homocysteine and Its Derivative on Yeast Growth,” pg. 21782; Fig. 2; “These results suggest that the mechanism by which AdoHcy and homocysteine mediate toxicity in yeast might be distinct,” pg. 21791, right col.).
Regarding claim 7, as stated above, Kumar as evidenced by Laor teaches yeast cells which (iii) endogenously express at least one pathological protein (“Hsp104 chaperon”) associated with a proteinopathy and/or protein misfolding disorder (i.e., “Alzheimer’s disease and Huntington’s disease”)(“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively,” pg. 5, right col.). Alzheimer’s disease and Huntington’s disease are neurodegenerative disorders, and thus, Kumar’s system meets the limitations of claim 7.
Regarding claim 8, Alzheimer’s disease and Huntington’s disease are characterized by beta-amyloid protein aggregation, and huntingtin aggregation, respectively, as evidenced by Laor (“The Hsp104 chaperon was previously shown in yeast to play a pivotal role in the formation of numerous aggregates by structurally unrelated proteins and its deletion partially restored the viability of cells expressing Aβ and polyQ in yeast models for Alzheimer’s disease and Huntington’s disease, respectively,” pg. 5, right col.). Thus, Kumar’s system meets the limitations of at least claim 8 option (a), and option (b), which is understood to refer to option (a).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Application No. 17/345,248
Claims 1-5, and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 21 of co-pending Application No. 17/345,248 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 1 recites “A yeast screening system of candidate therapeutic compounds for treating, ameliorating, reducing or delaying the onset of at least one IEM disorder associated with accumulation and aggregation of at least one metabolite, said system comprising: (a) a yeast cell and/or yeast cell line, and/or yeast cell population, that carry at least one manipulation in at least one yeast metabolic pathway, that leads to accumulation and aggregation of at least one metabolite, wherein accumulation and aggregation of said at least one metabolite is associated with at least one inborn error of metabolism (IEM) disorder; and optionally (b) at least one reagent or means for determining at least one of, the accumulation and aggregation of said metabolite and at least one phenotype associated with accumulation and aggregation of said metabolite.”
The interpretation of instant claim 1 is described above in paragraph 20 and applied hereinafter. Instant claim 1 is anticipated by co-pending claim 1, because the co-pending system comprises: (a) a yeast cell, cell line, or population that displays accumulation of at least one metabolite, wherein the yeast cells (i) carry at least one manipulation and/or modification in at least one yeast metabolic pathway that leads to accumulation of the metabolite; and (b) at least one reagent or means for determining the accumulation of the metabolite and/or at least one phenotype associated with accumulation of the metabolite.
Co-pending claims 2-4 anticipate the limitations of instant claims 2-5.
Co-pending claim 9 recites that the system comprises “(a) a yeast cell and/or yeast cell line, and/or yeast cell population, that carry at least one manipulation in at least one yeast metabolic pathway that leads to accumulation and aggregation of at least one of homocysteine and any derivative thereof; and optionally, (b) at least one reagent or means for determining at least one of, the accumulation and aggregation of said homocysteine and at least one phenotype associated with accumulation and aggregation of said homocysteine and any derivate thereof.” Instant claim 9 is anticipated by co-pending claim 9.
Claims 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 21 of co-pending Application No. 17/345,248 in view of Kumar (Kumar et al., 17 June 2011, Journal of Biological Chemistry, Vol. 286, No. 24, pg. 21779-21795) as evidenced by Laor (Laor et al., 8 January 2019, Nature Communications, (2019)10:62, pg. 1-11). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending claim 9 does not recite yeast cells (I) comprising the specific genetic manipulation recited in instant claim 6, or (II) endogenously and/or exogenously expressing at least one pathological protein associated with a proteinopathy which is a neurodegenerative disorder characterized by beta-amyloid protein aggregation or huntingtin aggregation as recited in instant claims 7-8.
The teachings of Kumar as evidenced by Laor are described above and applied hereinafter.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the generic yeast cells comprising a manipulation in at least one yeast metabolic pathway of the co-pending claims, for the yeast cells comprising a manipulation of CYS4 described by Kumar. It would have amounted to a simple substitution of yeast cells comprising a generic manipulation, for yeast cells comprising a specific manipulation known to bring about the claim’s desired outcome (i.e., accumulation of homocysteine). The skilled artisan would have had a reasonable expectation of success and would have been motivated to make the substitution because Kumar teaches a similar system to the co-pending claims in which yeast cells comprising a genetic manipulation of CYS4 accumulate homocysteine.
As described above, as evidenced by Laor, Kumar’s yeast cells meet the structural limitations of instant claims 7-8. Thus, the co-pending claims in view of Kumar and Laor render obvious instant claims 6-8.
Conclusion
No claims are allowed.
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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600