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
1. Applicant’s response filed on May 7, 2026 is acknowledged. Claims 2-4, 138 and 144 have been amended. Claims 2-12, 138, 144, and 159-165 are currently pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 2-12 and 159-165 in the reply filed on May 7, 2026 is acknowledged. Claims 138 and 144 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 May 7, 2026. Claims 2-12 and 159-165 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 27, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claims 2-12 and 159-165 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.
Claims 2-4 are rendered vague and indefinite by the use of the phrase “or a functional fragment or variant thereof”. It is unclear what is meant by said phrase, as it is not explicitly defined in the specification. What constitutes a “functional fragment or variant thereof”? What core features/structures must be maintained to enable the bacterium’s ability to metabolize one or more bile acids or bile salts? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim Rejections - 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.
5. Claim(s) 2, 5-10, 159 and 160 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Asahi, JP 3201483B2; Published: 8/20/01.
Independent claim 2 is drawn to a bacterium comprising one or more transgenes that increase or enable the bacterium’s ability to metabolize one or more bile acids or bile salts, wherein the one or more transgenes comprise:
(i) a transgene encoding a 3α-hydroxysteroid dehydrogenase (3α-HSDH), or a functional fragment or variant thereof, having at least 80% identity to an amino acid sequence encoded by SEQ ID NO: 18; and/or
(ii) a transgene encoding a 3β-hydroxysteriod dehydrogenase (3β-HSDH), or a functional fragment or variant thereof, having at least 80% identity to an amino acid sequence encoded by any one of SEQ ID NOs: 28, 30, 32 or 36.
Asahi discloses an invention characterized by being transformed with a recombinant plasmid having DNA encoding 3α-hydroxysteroid dehydrogenase according to microorganisms belonging to, for example, transformed E. coli. The present invention provides a method for producing 3α-hydroxysteroid dehydrogenase, which comprises culturing a microorganism belonging to E. coli and then collecting 3α-hydroxysteroid dehydrogenase from the culture (see paragraph 0005; meets claim 2(ii)).
Selection of the presence or absence of introduction of the desired recombinant DNA into the host microorganism is performed by culturing the host microorganism in a selective medium based on a drug resistance marker of a vector constituting the recombinant DNA and selecting a host microorganism to grow.
Then, using this radioactive oligonucleotide probe, a gene DNA coding for 3α-hydroxysteroid dehydrogenase is selected from the chromosomal DNA library according to a conventionally used method. Next, from the transformed host microorganism containing the gene DNA of interest and can be used to prepare a recombinant plasmid (Pseudomonas) containing DNA encoding 3α-hydroxysteroid dehydrogenase (see FIG. 4).
Next, an expression vector incorporating a gene DNA encoding 3α-hydroxysteroid dehydrogenase is constructed from the chromosomal DNA library. As the expression vector, a vector constructed for gene recombination from a phage or plasmid (i.e. E. coli) capable of autonomous growth in a host microorganism is suitable (see paragraph 0011).
As it pertains to claims 5-10, 159 and 160, the bacterium of the prior art is identical to the bacterium as claimed, said bacteria, absent evidence to the contrary, is necessarily capable of:
a) achieving a rate of metabolism of the one or more bile acids or bile salts of greater than 0.5 mM/hour in a subject's gut;
b) capable of achieving a rate of metabolism of the one or more bile acids or bile salts of greater than 0.8 mM/hour in a subject's gut;
c) ate of metabolism is maintained for at least 6 hours, at least 12 hours, at least 24 hours, at least 36 hours, at least 48 hours, at least 60 hours, at least 72 hours, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, or at least 1 year;
d) capable of converting at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the one or more bile acids or bile salts to one or more different bile acid or bile salt products in a subject's gut;
e) converts at least 70% of the one or more bile acids or bile salts to one or more different bile acid or bile salt products in a subject's gut; and
f) conversion is maintained for at least 6 hours, at least 12 hours, at least 24 hours, at least 36 hours, at least 48 hours, at least 60 hours, at least 72 hours, at least 1 week, at least 2 weeks, at least 3 weeks, at least 4 weeks, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, or at least 1 year.
Since the Office does not have the facilities for examining and comparing applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Conclusion
6. No claim is allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571) 272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 June 26, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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