Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-18, 20-22, 24-25, and 31-48 are canceled. Claims 19, 23, 26-30, and 49-53 are pending and under consideration in this action.
Priority
The instant claims are entitled to an effective filing date of 10/01/2019.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(modified to address amendment) Claims 19, 23, 26-30 and 49-53 are rejected under 35 U.S.C. 103 as being unpatentable over Ruvkun (US 2019/0255124 A1), with evidence from “What Is a Geriatrician and When Should I See One?” Cleveland Clinic, (hereafter Cleveland Clinic).
Regarding claim 19, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction. See [0136]. Symptoms of mitochondrial disease can include loss of motor control (e.g. a decline in muscle function) and muscle weakness (e.g. a decline in muscle function). See [0139]. Disorders associated with impaired mitochondrial function include metabolic disorders, neurodegenerative disorders, and aging related disorders. See [0141]. Metabolic disorders include, for example, hyperlipidemia, e.g. dyslipidemia (e.g. dysregulation of lipid metabolism). See [0153]. In example 1, Ruvkun teaches assessing the effect of Gluconacetobacter spp. feeding (e.g. administration) on the mitochondrial function in aging worms (e.g. subject). Worms fed on Gluconacetobacter sp. have significantly higher ATP content. See [0325]. Ruvkun teaches a composition comprising a measured amount of bacteria. See claim 1 of Ruvkun. The bacterium is selected from a list that includes Gluconoacaetobacter spp. See claim 3 of Ruvkun. Ruvkun teaches a bacterium selected from a list that includes Gluconoacetobacter hansenii, Gluconobacter oxydans, and Acetobacter aceti. See [0010]. In example 3, Ruvkun teaches growing worms on G. hansenii. See paragraph [0396]. Ruvkun discloses that Gluconacetobacter hansenii increases ATP production compared to worms fed on E. coli OP50. See [0326]. Moreover, Ruvkun teaches compositions that can be administered in a form containing one or more pharmaceutically acceptable carriers, such as excipients. See [0197]. Ruvkun teaches excipients such as starch. See [0199].
Ruvkun does not explicitly teach administering an ingestible item comprising an excipient.
Ruvkun does not explicitly teach at least one age-associated symptom or condition that is or comprises (i) a decline in muscle function of the subject, (II) a decline in neuromuscular function of the subject; and/or (iii) dysregulation of lipid metabolism. However, Ruvkun teaches the motor control and muscle weakness amongst a list of symptoms, and Ruvkun teaches hyperlipidemia amongst a list of metabolic disorders.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to select Gluconacetobacter hansenii from the list of bacteria taught by Ruvkun, and to further combine the G. hansenii with an excipient prior to administering it to the subject for the purpose of treating a symptom associated with a mitochondrial disease, such as loss of motor control or muscle weakness, or to treat a metabolic disorder, such as hyperlipidemia. One of ordinary skill in the art would have been motivated to select G. hansenii because Ruvkun suggests that it increases ATP production. There would have been a reasonable expectation of success because Ruvkun demonstrates growing worms on G. hansenii in example 3 (paragraph [0396]). One of ordinary skill in the art would have been further motivated to include a starch excipient because Ruvkun suggests starch may also serve as a prebiotic (see paragraphs [0199]). There would have been a reasonable expectation of success because Ruvkun demonstrates administering Gluconacetobacter to a subject and suggests using excipients. Moreover, a person of ordinary skill in the art has good reason to pursue the known options within their technical grasp. In the instant case, Ruvkun provides a finite list of symptoms and disorders to choose from. As such, one of ordinary skill in the art could reasonably select loss of motor control, muscle weakness and/or hyperlipidemia from the lists of Ruvkun.
Regarding claim 23, Ruvkun discloses that a treatment is considered effective if any one or all of the symptoms, or other clinically accepted symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223].
Ruvkun teaches a substantially identical composition, as compared to the instantly claimed ingestible item. MPEP 2112.01(II) states that "products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15.
Regarding claims 26-29, Ruvkun suggests that the subject may be a non-mammal animal, a human or non-human mammal [0107]. The subject may be of any developmental age including geriatric [0107]. Evidentiary reference Cleveland Clinic indicates that the term geriatric encompasses individuals over the age of 65. Furthermore, Ruvkun teaches using excipients such as starch or lactose. See paragraphs [0198-0199]. Therefore, Ruvkun teaches administering Gluconacetobacter to a subject, wherein the subject may at least 30 years old (relevant to instant claim 26), an elderly subject (relevant to instant claim 27), a mammal (relevant to instant claim 28), and a human (relevant to instant claim 29)
Regarding claim 30, Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells. See [196]. Ruvkun teaches prebiotics for the survival, colonization and persistence of the bacterial composition [0183]. Thus, Ruvkun teaches administering sufficient amounts of a microorganism to colonize a subject’s microbiome, absent evidence to the contrary.
Regarding claim 49, Ruvkun indicates that in example 1, the worms are orally administered Gluconacetobacter because Ruvkun teaches feeding the Gluconacetobacter spp. to aging worms. See [0325]. Furthermore, Ruvkun teaches oral compositions for the purpose of oral therapeutic administration. See [0198]. Ruvkun teaches compositions for oral administration. See claim 10.
Regarding claims 50 and 52, in example 1, Ruvkun teaches Gluconacetobacter as a feed for worms. See [0325]. Ruvkun teaches a composition formulated as a food, beverage, feed, probiotic, nutritional supplement or a pharmaceutical composition. See claim 7.
Regarding claim 51, Ruvkun teaches a composition formulated as a beverage (e.g. liquid). See claim 7. Ruvkun teaches incorporating the active compound with excipients and used in the form of tablets, lozenges, pastilles, troches, or capsules, e.g. gelatin capsules. See [0198].
Regarding claim 53, Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11.
Response to Arguments
Applicant’s arguments filed 02/18/2026 have been fully considered but they are unpersuasive.
§103 rejection
Applicant argues that Ruvkun provides exhaustive lists of bacteria and various types of conditions (Ruvkun [0137]-[0181]). Ruvkun discloses more than 75 diseases and disorders that fall under broad disease categories. Furthermore, Ruvkun discloses over 50 different bacteria that belong to the Acetobacteriaceae family. Ruvkun discloses one or more compositions or bacterial extracts as described herein comprises an engineered microbe (Ruvkun [0165]). See the remarks p. 6 paragraph 1. Applicant argues that a person would not be motivated to specifically select at least one bacterial strain, wherein the at least one bacterial strain is Gluconacetobacter hansenii, Gluconobacter oxydans, Acetobacter aceti, or a combination thereof as presently recited in the claims, from the over 50 bacteria that belong to the Acetobacteriaceae family disclosed. A person of ordinary skill in the art reading Ruvkun would be presented with over 3750 different combinations of a disease and a bacterial strain. A person would not be motivated to arrive at the specific combination of bacterial strains and age-associated symptom or condition recited in claim 19. See the remarks p. 6 last passage.
This argument is not persuasive because it is not commensurate in scope with the instant claims. Instant claim 19 recites the open-ended term “comprises” on line 3, so the claim as a whole encompasses any number of bacterial strains as long as Gluconacetobacter hansenii, Gluconobacter oxydans and/or Acetobacter aceti are present. Applicant argues that Ruvkun provides no motivation to select at least one of the claimed bacterial strains (see the remarks page 6 last paragraph). However Ruvkun does provide specific motivation for selecting Gluconacetobacter hansenii because, in paragraph [0326], Ruvkun discloses that G. hansenii increases ATP production more than E. coli OP50. Applicant argues that Ruvkun presents over 3750 different combinations of diseases and bacterial strains. But this argument is unpersuasive because an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The composition of Ruvkun is capable of performing the claimed intended use, because the composition meets every claimed structural limitation and MPEP 2112.01(II) states that "products of identical chemical composition can not have mutually exclusive properties."
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.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. US 10,973,860 B2 to Ruvkun (hereafter referred to as Ruvkun ‘860), in view of Ruvkun (US 2019/255124 A1).
Patent claim 1 of Ruvkun ‘860 recites a composition comprising a measured amount of a bacterial species that comprises and expresses nucleic acid sequences encoding membrane-bound PQQ-dependent glucose dehydrogenase (mGDH), ubiquinol-cytochrome c reductase iron-sulfur subunit, TonB-dependent receptor, carbon-nitrogen hydrolase, and ubiquinol oxidase subunit II, or an extract or fraction derived therefrom, wherein the extract or fraction of the bacterial species comprises membrane-bound PQQ-dependent glucose dehydrogenase (mGDH), ubiquinol-cytochrome c reductase iron-sulfur subunit, TonB-dependent receptor, carbon-nitrogen hydrolase, and ubiquinol oxidase subunit II expressed from the nucleic acid sequences, wherein the bacterial species is from the Acetobacteriaceae family, and wherein one or more of the nucleic acid sequences are exogenous nucleic acid sequences.
Patent claim 2 of Ruvkun ‘860 recites the composition of claim 1, wherein the bacterium is Gluconobacter spp, Acetobacter spp., Gluconoacaetobacter spp., Acidomonas spp, Ameyamaea spp., Asaia spp., Granulibacter spp., Kozakia spp., Neoasaia spp., Neokomagataea spp., Saccharibacter spp., Swaminathania spp., or Tanticharoenia spp.
Patent claim 3 of Ruvkun ‘860 recites the composition of claim 1, wherein the measured amount of the bacteria is lyophilized.
Patent claim 5 of Ruvkun ‘860 recites the composition of claim 1, wherein the composition is formulated as a food, a beverage (e.g. a liquid), a feed composition, a probiotic, a nutritional supplement, or a pharmaceutical composition.
Patent claim 6 of Ruvkun ‘860 recites the composition of claim 1, which further comprises a prebiotic.
Patent claim 7 of Ruvkun ‘860 recites the composition of claim 1, further comprising a pharmaceutically acceptable carrier (e.g. excipient).
Patent claim 8 of Ruvkun ‘860 recites the composition of claim 1, wherein the composition is formulated for oral administration.
Patent claim 9 of Ruvkun ‘860 recites the composition of claim 8, wherein the composition is an enteric-coated formulation.
Patent claim 10 of Ruvkun ‘860 recites a method for increasing cellular ATP production in at least one cell type of a subject in need thereof, the method comprising administering to the subject the composition of claim 1 effective to increase cellular ATP production in at least one cell type compared to a subject without the administration.
Patent claim 12 of Ruvkun ‘860 recites the method of claim 10, wherein the subject is human.
Patent claim 17 of Ruvkun ‘860 recites the method of claim 10, wherein cellular ATP production is increased by at least 10% compared to the cellular ATP production prior to administration of the composition.
The patent claims of Ruvkun ‘860 lack reducing, or delaying the onset of at least one age-associated symptom or condition comprising administering to a subject an ingestible item wherein the ingestible item comprises: (a) at least one bacterial strain wherein the at least one bacterial strain is Gluconacetobacter hansenii, Gluconobacter oxydans, Acetobacter aceti or a combination thereof; and (b) an excipient; wherein the at least one age-associated symptom or condition is or comprises: (i) a decline in muscle function of the subject, (ii) a decline in neuromuscular function of the subject; and/or (iii) dysregulation of lipid metabolism (relevant to instant claim 19). The patent claims of Ruvkun ‘860 lack at least one age-associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The patent claims of Ruvkun ‘860 lack a human subject at least 50 years old (relevant to instant claims 26-29). The patent claims of Ruvkun ‘860 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30).
However, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction, such as metabolic disorders including hyperlipidemia, e.g. dyslipidemia. See [0136] [141] and [0153]. Symptoms of mitochondrial disease can include loss of motor control and muscle weakness. See [0139]. Ruvkun teaches a bacterium selected from a list that includes Gluconoacetobacter hansenii, Gluconobacter oxydans, and Acetobacter aceti. See [0010]. Ruvkun discloses that G. hansenii induces increases ATP production compared to worms fed on E. coli OP50. See [0326]. Moreover, Ruvkun teaches excipients, such as starch. See [0197] and [0199] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223]. Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to have modified the administration method recited in the patent claims of Ruvkun ‘860 by administering the Gluconacetobacter hansenii of Ruvkun as the Gluconacetobacter species of Ruvkun ‘860 and to further combine the G. hansenii with the excipient of Ruvkun in order to reduce or delay the onset of a dysregulation of lipid metabolism.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,957,723 B2 to Amaranath (hereafter Amaranath ‘723) in view of Ruvkun US 2019 / 0255124 A1, with evidence from Healey (2018, August 1, Diagnosing ALS: Symptoms, Clinicians & Tests. Massachusetts General Hospital)
Patent claim 1 of Amaranath ‘723 recites a method of treating or preventing amyotrophic lateral sclerosis [i.e. a neuromuscular disease as evidenced by Healey page 1], the method comprising: administering to a subject in need thereof a composition comprising Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve.
Patent claim 2 of Amaranath ‘723 recites the method of claim 1, wherein the subject is a mammal.
Patent claim 3 of Amaranath ‘723 recites the method of claim 1, wherein the subject is a human.
Patent claim 4 of Amaranath ‘723 recites the method of claim 1, wherein the composition comprises seven or more microbial strains.
Patent claim 6 of Amaranath ‘723 recites the method of claim 1, wherein the composition is administered topically, orally, subcutaneously, intravenously, intramuscularly, intracerebrally, intrathecally, rectally, opthalmically, intravitreally, or suprachoroidally.
Patent claim 7 of Amaranath ‘723 recites the method of claim 6, wherein the composition is administered orally.
Patent claim 9 of Amaranath ‘723 recites the method of claim 1, wherein the composition is formulated as a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.
Patent claim 12 of Amaranath ‘723 recites the method of claim 1, wherein Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve are administered to modulate the microbiome of the subject.
Patent claim 13 of Amaranath ‘723 recites the method of claim 1, wherein Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve are administered to maintain the microbiome of the subject.
The patent claims of Amaranath ‘723 lack an ingestible item wherein the ingestible item comprises: (b) an excipient (relevant to instant claim 19). The patent claims of Amaranath ‘723 lack at least one age- associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The patent claims of Amaranath ‘723 lack a subject at least 50 years old (relevant to instant claims 26-27). The patent claims of Amaranath ‘723 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30). The patent claims of Amaranth ‘723 lack an enteric-coated formulation (relevant to instant claim 53).
However, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction. See [0136] [141] and [0153]. Symptoms of mitochondrial disease can include loss of motor control and muscle weakness. See [0139]. Moreover, Ruvkun teaches excipients, such as starch. See [0197] and [0199] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223]. Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30). Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11 (relevant to instant claim 53).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the method recited in the patent claims of Amaranth ‘723 by combining the G. hansenii containing composition of Amaranth ‘723 with the enteric-coating excipient of Ruvkun in order to reduce or delay the onset of a decline in neuromuscular function.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-10, 16-28, and 149 of copending Application No. 18/604,196 to Govindan (hereafter Govindan ‘196) in view of Ruvkun US 2019 / 0255124 A1, with evidence from Cleveland Clinic. (2022, Parkinson’s disease).
Copending claim 1 of Govindan ‘196 recites a method of treating or preventing Alzheimer's Disease (AD), or Parkinson's Disease (PD) [i.e. a disease that involves the loss of muscle control, as evidenced by Cleveland Clinic], the method comprising: administering to a subject in need thereof a composition comprising microbial strains Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve.
Copending claim 5 of Govindan ‘196 recites a method of claim 1, wherein the subject is a mammal.
Copending claim 6 of Govindan ‘196 recites the method of claim 1, wherein the subject is a human.
Copending claim 24 of Govindan ‘196 recites the method of claim 23, wherein the composition is administered orally.
Copending claim 26 of Govindan ‘196 recites the method of claim 1, wherein the composition is formulated as a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.
The copending claims of Govindan ‘196 lack an ingestible item that comprises: (b) an excipient (relevant to instant claim 19). The copending claims of Govindan ‘196 lack at least one age-associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The copending claims of Govindan ‘196 lack a subject at least 50 years old (relevant to instant claims 26-27). The copending claims of Govindan ‘196 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30). The copending claims of Govindan ‘196 lack an enteric-coated formulation (relevant to instant claim 53).
However, Ruvkun teaches excipients, such as starch. See [0197] and [0199] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223] (relevant to instant claim 23). Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30). Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11 (relevant to instant claim 53).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the copending claims of Govindan ‘196 by combining the composition of Govindan ‘196 with the enteric-coating excipient of Ruvkun in order to reduce or delay the onset of a decline in muscle function.
This is a provisional nonstatutory double patenting rejection.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11, 13, 19, 23-24 of copending Application No. 18/244,685 to Govindan (hereafter Govindan ‘685) in view of Ruvkun US 2019 / 0255124 A1, and Wang (Nutrients. 2016 Oct 22;8(10):663).
Copending claim 1 of Govindan ‘685 recites a method of treating or preventing an eye disorder, the method comprising: administering to a subject in need thereof a composition comprising microbial strains Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella atypica, and Bifidobacterium breve, and wherein the eye disorder is Age-related Macular Degeneration (AMD).
Copending claim 6 of Govindan ‘685 recites the of claim 1, wherein the subject is a human.
Copending claim 19 of Govindan ‘685 recites the method of claim 1, wherein the composition is administered topically, orally, opthalmically, intravitreally, or suprachoroidally.
Copending claim 22 of Govindan ‘685 recites the method of claim 1, wherein the composition is formulated as a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.
The copending claims of Govindan ‘685 lack reducing, or delaying the onset of at least one age-associated symptom or condition comprising administering to a subject an ingestible item wherein the ingestible item comprises: (b) an excipient; wherein the at least one age-associated symptom or condition is or comprises: (i) a decline in muscle, (ii) a decline in neuromuscular function of the subject; and/or (iii) dysregulation of lipid metabolism (relevant to instant claim 19). The copending claims of Govindan ‘685 lack at least one age- associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The copending claims of Govindan ‘685 lack a subject at least 50 years old (relevant to instant claims 26-27). The copending claims of Govindan ‘685 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30). The copending claims of Govindan ‘685 lack an enteric-coated formulation (relevant to instant claim 53).
However, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction, such as metabolic disorders including hyperlipidemia, e.g. dyslipidemia. See [0136] [141] and [0153]. Wang discloses that dyslipidemia is associated with the formation of drusen, which are likely to develop into early age-related macular degeneration. See the first full paragraph on page 2. Moreover, Ruvkun teaches excipients, such as starch. See [0197] and [0199] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223]. Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30). Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11 (relevant to instant claim 53).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the copending claims of Govindan ‘685 by combining the composition of Govindan ‘685 with the enteric-coating excipient of Ruvkun in order to reduce or delay the onset of a lipid metabolism dysfunction.
This is a provisional nonstatutory double patenting rejection.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-9, 11, 13, 19, 23-24 of copending Application No. 18/073,511 to Chatter (hereafter Chatter ‘511) in view of Ruvkun US 2019 / 0255124, with evidence from Healey (2018, August 1, Diagnosing ALS: Symptoms, Clinicians & Tests. Massachusetts General Hospital).
Copending claim 1 of Chatter ‘511 recites a method of treating, reducing the risk, improving, or preventing a Vagus nerve-associated disease, disorder, or condition, the method comprising: administering to a mammalian subject in need thereof a composition comprising microbial strains Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus catus, Lactobacillus plantarum, Veillonella, and Bifidobacterium breve wherein the Vagus nerve-associated disease, disorder, or condition is Amyotrophic lateral sclerosis (ALS) [i.e. a neuromuscular disease as evidenced by Healey page 1].
Copending claim 4 of Chatter ‘511 recites wherein improving or preventing a Vagus nerve-associated disease, disorder, or condition comprises improving or preventing one or more of nerve cell damage, nerve ending damage, nerve fiber damage, brain damage, Vagus nerve associated organ damage, or combinations thereof in the mammalian subject.
Copending claim 6 of Chatter ‘511 recites the method of claim 1, wherein the subject is a human.
Copending claim 23 of Chatter ‘511 recites the method of claim 1, wherein the composition is administered topically, orally, subcutaneously, intravenously, intramuscularly, intracerebrally, intrathecally, rectally, opthalmically, intravitreally, or suprachoroidally.
Copending claim 24 of Chatter ‘511 recites the method of claim 21,wherein the composition is administered orally.
Copending claim 26 of Chatter ‘511 recites the method of claim 1, wherein the composition is formulated as a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.
The copending claims of Chatter ‘511 lack an ingestible item that comprises: (b) an excipient (relevant to instant claim 19). The copending claims of Chatter ‘511 lack at least one age- associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The copending claims of Chatter ‘511 lack a subject at least 50 years old (relevant to instant claims 26-27). The copending claims of Chatter ‘511 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30). The copending claims of Chatter ‘511 lack an enteric-coated formulation (relevant to instant claim 53).
However, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction, such as metabolic disorders including hyperlipidemia, e.g. dyslipidemia. See [0136] [141] and [0153]. Symptoms of mitochondrial disease can include loss of motor control and muscle weakness. See [0139]. Moreover, Ruvkun teaches excipients, such as starch. See [0197] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223]. Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30). Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11 (relevant to instant claim 53).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to modify the copending claims of Chatter ‘511 by combining the composition of Chatter ‘511 with the enteric-coating excipient of Ruvkun in order to reduce or delay the onset of a decline in neuromuscular function.
This is a provisional nonstatutory double patenting rejection.
(modified to address amendment) Claims 19, 23, 26-30, and 49-53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 63-71, and 85-95 of copending Application No. 17/673,581 to Govindan (hereafter Govindan ‘581) in view of Ruvkun US 2019 / 0255124 A1.
Copending claim 63 of Govindan ‘581 recites an ingestible item comprising a plurality of microbial strains, wherein the plurality of microbial strains comprises microbial strains from six or more different genera; and wherein the plurality of microbial strains consist of six or more of Gluconacetobacter sp., Terrisporobacter glycolicus, Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, and Acidaminococcus sp; and wherein the ingestible item is a food, beverage, or pharmaceutical composition suitable for human consumption.
Copending claim 67 of Govindan ‘581 recites the ingestible item of claim 63, wherein the plurality of microbial strains comprise six or more of Gluconacetobacter hansenii, Terrisporobacter glycolicus, Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus barengoltzii, Veillonella atypica, Bifidobacterium sp. Bacillus subtilis and Acidaminococcus sp.
Copending claim 71 of Govindan ‘581 recites the ingestible item of claim 67, wherein the ingestible item comprises a pharmaceutical composition.
The copending claims of Govindan ‘581 lack a method for treating, reducing, or delaying the onset of at least one age-associated symptom or condition comprising administering to a subject an ingestible item wherein the ingestible item comprises: (b) an excipient; wherein the at least one age-associated symptom or condition is or comprises: (i) a decline in muscle function, (ii) a decline in neuromuscular function of the subject; and/or (iii) dysregulation of lipid metabolism (relevant to instant claim 19). The copending claims of Govindan ‘581 lack at least one age- associated symptom or condition that is reduced or delayed in the subject by at least 20%, as compared to that of a comparable subject without administration of the composition ingestible item (relevant to instant claim 23). The copending claims of Govindan ‘581 lack a human subject at least 50 years old (relevant to instant claims 26-29). The copending claims of Govindan ‘581 lack administering a sufficient amount of the at least one bacterial strain to colonize the subject’s microbiome (relevant to instant claim 30). The copending claims of Govindan ‘581 lack an enteric-coated formulation (relevant to instant claim 53).
However, Ruvkun teaches methods and compositions for the treatment or prevention of diseases and/or disorders involving or characterized by mitochondrial dysfunction, such as metabolic disorders including hyperlipidemia, e.g. dyslipidemia. See [0136] [141] and [0153]. Symptoms of mitochondrial disease can include loss of motor control and muscle weakness. See [0139]. Moreover, Ruvkun teaches excipients, such as starch. See [0197] and [0199] (relevant to instant claim 19). Ruvkun effective treatments in which symptoms or markers of a disease associated with mitochondrial dysfunction are reduced, e.g. by at least 10%. See [0223]. Ruvkun teaches human subjects. See [0107]. The subject may be of any developmental age including geriatric (e.g. 65 years old). See [0107] (relevant to instant claims 26-29). Ruvkun teaches an effective amount of cells in a composition comprising at least 1x105 bacterial cells; and Ruvkun teaches prebiotics for colonization of the bacterial composition. See [196] and [0183] (relevant to instant claim 30). Ruvkun teaches a composition that is an enteric-coated formulation. See claim 11 (relevant to instant claim 53).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the ingestible item recited in the copending claims of Govindan ‘581 with the enteric-coating excipient in order reduce or delay the onset of a metabolic disorder such as dyslipidemia.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are unpersuasive.
Double Patenting Rejections
Applicant argues that none of the cited patents ( Ruvkun ‘860 or Amaranth ‘723) or the cited applications (Govindan ‘196, Govindan ‘685, Chatter ‘511, or Govindan ‘581) teach or suggest methods of reducing or delaying the onset of at least one age-associated symptom or condition by administering an ingestible item as recited in the pending claims. Additionally, Applicant asserts that the pending claims are patentable over Ruvkun, for reasons presented above. That is, Applicant submits that there is no teaching or suggestion or motivation in Ruvkun to specifically reduce or delay the onset of at least one age-associated symptom or condition that is or comprises (i) a decline in muscle function, (ii) a decline in neuromuscular function and/or (iii) dysregulation of lipid by administering Gluconacetobacter as recited in amended claim 19. See the remarks page 8 paragraph 1.
This argument is unpersuasive because the patent claims of Amaranth ‘723, the copending claims of Chatter ‘511, the co-pending claims of Govindan ‘196 and the co-pending claims of Govindan ‘685 teach or suggest treating or preventing at least one of the instantly claimed age-associated symptom or condition. Specifically, the patent claims of Amaranth ‘723 and the co-pending claims of Chatter ‘511 teach treating or preventing amylotrophic lateral sclerosis, which is an example of a neuromuscular disease as evidenced by Healey. Therefore, Amaranth ‘723 and Chatter ‘511 teach treating or preventing a decline in a neuromuscular function, which is one of the instantly claimed age-associated symptoms or conditions. The co-pending claims of Govindan ‘196 teach a method of treating or preventing Parkinson’s disease, which is understood to be associated with a decline in muscle function in view of evidentiary reference Cleveland Clinic. The co-pending claims of Govindan ‘685 teach a method of treating or preventing an eye disorder, wherein the eye disorder is age-related macular degeneration (AMD). According to Wang, AMD is associated with dyslipidemia (e.g. lipid metabolism dysfunction) and dyslipidemia is one of the metabolic disorders taught by Ruvkun. As such, the argument that Amaranth ‘723, Chatter ‘511, Govindan ‘196 and Govindan ‘685 do not teach the age-associated symptom or condition is unpersuasive because the argument is not commensurate in scope with the instantly claimed age-associated symptoms or conditions. Furthermore, the argument is unpersuasive because one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The non-statutory double patenting rejections and provisional double patenting rejections discussed above are all obvious-type rejections based on the combination of the conflicting patent or co-pending claims and Ruvkun.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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