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. Claims 1, 2, 4-7, 9-11, 13-15, 17, 20-25, and 27 are currently pending.
Election/Restrictions
2. Applicant’s election without traverse of Group I, claims 1, 2, 4-7, and 9 in the reply filed on August 4, 2025 is acknowledged. Claims 10, 11, 13-15, 17, 20-25, and 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 August 4, 2025. Claims 1, 2, 4-7, and 9 are currently under examination.
Claim Objections
3. Claim 9 is objected to because of the following informalities: said claim is objected to for depending upon a rejected based claim. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claim(s) 1 and 4-7 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Nilius, US 2004/0106564 A1; Published: 06/03/04.
Independent claim 1 is drawn to a composition comprising a microorganism comprising an exogenous nucleic acid encoding a protease inhibitor.
Nilius discloses a pharmaceutical composition comprising an expressible nucleic acid which codes for the effective material of secretory leucocyte protease inhibitor (SLPI) contained in a living, non-pathogenic microorganism (see paragraph 0037&0050; meetings claim 1, and 4-5). Further, Nilius discloses that in a preferred embodiment the isolated and purified effective material contained in the effective material is administered orally (see paragraph 0053; meets claim 7). As it pertains to claim 6, the composition of Nilius contains identical components to that which is claimed, particularly as it pertains to the protease inhibitor. Said inhibitor necessarily inhibits the activity of a protease selected from the group consisting of trypsin-1, trypsin-2, trypsin-3, chymotrypsin like elastase 2A, chymotrypsin like elastase 3B, chymotrypsin, a kallikrein, plasmin, thrombin, and combinations thereof, absent evidence to the contrary.
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.
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.
5. Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nilius, US 2004/0106564 A1; Published: 06/03/04 as applied to claims 1 and 4-7 above, and further in view of Picataggio et al., WO 2011/006126 A2; Published: 01/13/11.
Independent claim 1 is drawn to a composition comprising a microorganism comprising an exogenous nucleic acid encoding a protease inhibitor.
Dependent claim 2 is drawn to the composition of claim 1, wherein said microorganism is selected from the group consisting of Alistipes putredinis, Ruminococcus bromii, Alistipes finegoldi, Alistipes shahii, Collinsella aerofaciens, Alistipes onderdonkii, Eubacterium siraeum, Odoribacter splanchnicus, Adlercreutzia equolifaciens, Barnesiella intestinihominis, Parabacteroides goldsteinii, and Roseburia hominis.
Nilius teaches a pharmaceutical composition comprising an expressible nucleic acid which codes for the effective material of secretory leucocyte protease inhibitor (SLPI) contained in a living, non-pathogenic microorganism (see paragraph 0037&0050; meeting claims 1, and 4-5). Further, Nilius teaches that in a preferred embodiment the isolated and purified effective material contained in the effective material is administered orally (see paragraph 0053; meets claim 7). As it pertains to claim 6, the composition of Nilius contains identical components to that which is claimed, particularly as it pertains to the protease inhibitor. Said inhibitor necessarily inhibits the activity of a protease selected from the group consisting of trypsin-1, trypsin-2, trypsin-3, chymotrypsin like elastase 2A, chymotrypsin like elastase 3B, chymotrypsin, a kallikrein, plasmin, thrombin, and combinations thereof, absent evidence to the contrary.
Nilius do not specifically teach their microorganism is selected from the group consisting of Alistipes putredinis, Ruminococcus bromii, Alistipes finegoldi, Alistipes shahii, Collinsella aerofaciens, Alistipes onderdonkii, Eubacterium siraeum, Odoribacter splanchnicus, Adlercreutzia equolifaciens, Barnesiella intestinihominis, Parabacteroides goldsteinii, and Roseburia hominis.
Picataggio teaches microorganisms selected often and suitable for genetic manipulation and often can be cultured at cell densities useful for industrial production of a target product. The term "engineered microorganism" as used herein refers to a modified microorganism that includes one or more activities distinct from an activity present in a microorganism utilized as a starting point (hereafter a "host microorganism"). An engineered microorganism includes a heterologous polynucleotide in some embodiments, and in certain embodiments, an engineered organism has been subjected to selective conditions that alter an activity, or introduce an activity, relative to the host microorganism. Thus, an engineered microorganism has been altered directly or indirectly by a human being. A host microorganism sometimes is a native microorganism, and at times is a microorganism that has been engineered to a certain point.
In certain embodiments, an engineered microorganism is a prokaryotic microorganism (e.g., bacterium), and in certain embodiments, an engineered microorganism is a non-prokaryotic microorganism. In some embodiments, an engineered microorganism is a eukaryotic microorganism (e.g., yeast, fungi, amoeba) (see page 12). Lastly, any suitable prokaryote, specifically, Ruminococcus bromii, may be selected as a host microorganism, engineered microorganism or source for a heterologous polynucleotide (see page 13).
It would have been obvious before the effective filing date of the presently claimed invention to employ bacteria useful for the production of a targeted product with a reasonable expectation of success. The claim would have been obvious because the substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
Accordingly, the subject matter of claim 2 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary B Nickol can be reached at 571-272-0835. 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 October 23, 2025
/BRIAN GANGLE/Primary Examiner, Art Unit 1645