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 .
The response filed on December 22, 2025 is received.
Claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30, 42, 101, 102, 108 and 118 are pending in this application, claim 42, 101, 102, 108 and 118 are withdrawn (See Restriction/Election), and claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30 are being examined.
Restriction/Election:
Applicant’s election of Group I, claims 1, 2, 4, 6, 8, 10-13, 25, 26 and 28-30, in the reply filed on 12/22/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 42, 101, 102, 108 and 118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/22/2025.
Objection(s):
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (See for example, paragraphs [0385] and [0386]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejection - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30 are rejected under 35 U.S.C. 101 because,
Claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30 are drawn to a pharmaceutical composition comprising a pharmaceutical agent, wherein the pharmaceutical agent comprises (a) bacteria and/or microbial extracellular vesicles (mEVs) and; (b) at least one component of spirulina.
The broadest reasonable interpretation of instant claim 1 includes bacteria and/or secreted (naturally occurring) microbial extracellular vesicles (see e.g. instant specification pages 27-28) and at least one component of spirulina, which would include spirulina itself and components that occur naturally in spirulina (see [0010]). Also, the claimed bacteria naturally occurring (Gut microbes) (see for example, paragraph 63 of Goodman et al.).
The claim does not recite any additional elements to amount to significantly more than a natural product.
The combination of bacteria and/or microbial extracellular vesicles mEVs and at least one component of spirulina does not result in a marked difference when compared to these two naturally occurring components in their natural state.
Therefore, claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30 are not subject matter eligible.
Claim Rejection - 35 USC § 102
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, 2 and 10-13 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by over WO 2019/173763 A1 (also cited in IDS filed on 05/09/2024).
Regarding claims 1 and 2, WO 2019/173763 A1 disclose a pharmaceutical composition comprising: a pharmaceutical agent, wherein the pharmaceutical agent comprises (a) bacteria and (b) at least one component of spirulina (a composition or dosage form comprising non-pathogenic bacterial strain, wherein the dosage form can also comprise spirulina). It should be noted that spirulina nucleic acids, proteins and small molecules not explicitly disclosed are inherently present (See for example, p. 29 paragraphs [0111], [0112] and [0142]).
Regarding claim 10, WO 2019/173763 A1 disclose the pharmaceutical agent comprises bacteria (bacterial strains including of genus Prevotella) (See for example, p. 20 paragraph [0083]).
Regarding claim 11, WO 2019/173763 A1 disclose wherein the bacteria are hemoglobin-dependent bacteria (for example Prevotella copri) (See for example, p. 20 paragraph [0083]).
Regarding claim 12, WO 2019/173763 A1 disclose the bacteria are of the genus Actinomyces, Alistipes, Anaerobutyricum, Bacillus, Bacteroides, Cloacibacillus, Clostridium, Collinsella, Cutibacterium, Eisenbergiella, Erysipelotrichaceae, Eubacterium/Mogibacterium, Faecalibacterium, Fournierella, Fusobacterium, Megasphaera, Parabacteroides, Peptoniphilus, Peptostreptococcus, Porphyromonas, Prevotella, Propionibacterium, Rarimicrobium, Shuttleworthia, Turicibacter, or Veillonella (for example Prevotella copri) (See for example, p. 20 paragraph [0083] and [0084]-Continued p. 21).
Regarding claim 13, WO 2019/173763 A1 disclose the bacteria are of the genus Fournierella or Prevotella (for example Prevotella copri) (See for example, p. 20 paragraph [0083]).
WO 2019/173763 A1 therefore anticipates the claimed composition.
Claim Rejection - 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4, 6, 8, 10-13, 25, 26, 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Goodman et al. (WO 2019/051380 A1, which is cited in IDS filed on 05/09/2024) and Park et al. (Molecules. 2018, Vol. 23, 2065, p. 1-11) and Gutiérrez-Salmeán et al. (Nutr Hosp. Vol. 32, No. 1, p. 34-40).
Regarding claims 1 and 25, Goodman et al. (WO 2019/051380 A1) teach a pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs) (a pharmaceutical composition that comprises EVs made form bacteria and/or bacteria, the modified EV obtained from bacteria for drug targeting and to enhance oral delivery, etc.) (See for example, p. 21 paragraphs [80] and [81], and p. 22 paragraph [82], and p. 101 paragraph [99]).
Regarding claim 10, Goodman et al. teach the pharmaceutical agent comprises bacteria (bacterial cells combined with EV administration) (See for example, p. 192 paragraph [420]).
Regarding claim 11, wherein the bacteria are hemoglobin-dependent bacteria (for example, treatment with live Prevotella histicola) (See for example, p. 188 paragraph [407]).
Regarding claim 12, the bacteria are of the genus Actinomyces, Alistipes, Anaerobutyricum, Bacillus, Bacteroides, Cloacibacillus, Clostridium, Collinsella, Cutibacterium, Eisenbergiella, Erysipelotrichaceae, Eubacterium/Mogibacterium, Faecalibacterium, Fournierella, Fusobacterium, Megasphaera, Parabacteroides, Peptoniphilus, Peptostreptococcus, Porphyromonas, Prevotella, Propionibacterium, Rarimicrobium, Shuttleworthia, Turicibacter, or Veillonella (for example Prevotella histicola) (See for example, p. 188 paragraph [407]).
Regarding claim 13, the bacteria are of the genus Fournierella or Prevotella (for example Prevotella histicola) (See for example, p. 188 paragraph [407]).
Regarding claim 26, Goodman et al. teach the mEVs are secreted mEVs (smEVs) or processed mEVs (pmEVs) (P. histicola-derived EV) (See for example, p. 188 paragraph [406]).
Regarding claim 28, Goodman et al. teach the mEVs are from hemoglobin-dependent bacteria (for example Prevotella histicola, which is hemoglobin-dependent bacteria) (See for example, p. 188 paragraph [407]). .
Regarding claim 29, Goodman et al. teach the mEVs are from bacteria of the genus Actinomyces, Alistipes, Anaerobutyricum, Bacillus, Bacteroides, Cloacibacillus, Clostridium, Collinsella, Cutibacterium, Eisenbergiella, Erysipelotrichaceae, Eubacterium/Mogibacterium, Faecalibacterium, Fournierella, Fusobacterium, Megasphaera, Parabacteroides, Peptoniphilus, Peptostreptococcus, Porphyromonas, Prevotella, Propionibacterium, Rarimicrobium, Shuttleworthia, Turicibacter, or Veillonella (for example, bacteria of genus Prevotella, i.e., P. histicola-derived EVs) (See for example, p. 188 paragraph [406]).
Regarding claim 30, Goodman et al. teach the mEVs are from bacteria of the genus Fournierella or Prevotella (P. histicola-derived EVs) (See for example, p. 188 paragraph [406]).
Goodman et al. do not teach the composition comprises a component of spirulina (claim 1), at least one component of spirulina comprises a spirulina nucleic acid, a spirulina protein, or a spirulina small molecule (claim 2), wherein the spirulina nucleic acid comprises DNA having a sequence encoding C-phycocyanin alpha subunit (cpcA) or chlorophyll a synthase (claim 4), the spirulina protein is phycocyanin (claim 6), and the spirulina small molecule is a spirulina pigment (claim 8).
In this case, although Goodman et al. do not teach the composition comprises a component of spirulina, however Goodman et al. teach the microbial/bacterial EVs can be used in combination with other therapeutic agents (See for example, p. 21 paragraph [81], and p. 133 paragraph [191]).
Moreover, regarding a component of spirulina, before the effective filing date of the invention, Park et al. teach spirulina components in spirulina powder, as pharmaceutical agents due to their health benefits and protective properties against human disorders associated with oxidative and inflammatory stress (spirulina powder product as a drug resource, C-phycocyanin or C-PC and pigments) and C-phycocyanin or C-PC are important health contributors, antitumor, antiviral, and antioxidant benefits, carotenoids pigments, etc.) (See for example, p. 1 “1. Introduction” -Continued on p. 2 1st-3rd paragraphs).
In addition, regarding claim 2, Park et al. teach the at least one component of spirulina comprises a spirulina nucleic acid, a spirulina protein, or a spirulina small molecule (C-phycocyanin or C-PC and carotenoids, etc.) (See for example, p. 1 “1. Introduction” -Continued on p. 2 1st-3rd paragraphs).
Regarding claim 4, Park et al. teach the spirulina nucleic acid comprises DNA having a sequence encoding C-phycocyanin alpha subunit (cpcA) or chlorophyll a synthase (ChIG) (C-phycocyanin or C-PC) (See for example, p. 1 “1. Introduction” -Continued on p. 2 1st-3rd paragraphs). It should be noted that according to Gutiérrez-Salmeán et al. spirulina powder taught by Park et al. comprises spirulina nucleic acid among others (nucleic acids content in Spirulina per dry weight, etc.) (See for example, p. 36 right-hand column 2nd paragraph below Table II “Nucleic acids”, and also p. 35 Table 1).
Regarding claim 6, Park et al. teach the spirulina protein is phycocyanin (C-phycocyanin or C-PC) (See for example, p. 1 “1. Introduction” -Continued on p. 2 1st-3rd paragraphs).
Regarding claim 8, Park et al. teach the spirulina small molecule is a spirulina pigment (carotenoids) (See for example, p. 4 paragraph 2.2.).
Therefore, a person of ordinary skill in the art before the effective filing date of the invention would have been motivated to apply the teaching of prior art and combine a component of spirulina including taught by the prior art to have beneficial health benefits with the pharmaceutical agent comprises bacteria and/or microbial extracellular vesicles (mEVs) taught by Goodman et al. with a reasonable expectation of success in order to provide the claimed pharmaceutical composition. The motivation for example, as taught by Goodman et al. would be because Goodman et al. teach the microbial/bacterial EVs can be used in combination with other therapeutic agent, and because Park et al. teach spirulina components comprising spirulina nucleic acid, a spirulina protein, or a spirulina small molecule including C-phycocyanin, phycocyanins, pigments, etc., as pharmaceutical agents because of their health benefits and protective properties against human disorders associated with oxidative and inflammatory stress.
Conclusion(s):
No claim(s) are allowed at this time.
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/KADE ARIANI/Primary Examiner, Art Unit 1651