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 .
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.
Claim 8 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. Claim 8 invokes a method claim in the preamble, however does not provide steps or actions to be performed and, instead, recites a product. Explicitly, by saying, “A method for degrading uric acid, comprising” a method claim is invoked. The claim body is then written as “the engineered probiotic according to claim 1”. This statement contains no steps or actions. Therefore, the metes and bounds of the claim are unclear. (Packard, 751 F.3d 1307, 1312, 110 USPQ2d 1785, 1788 (Fed. Cir. 2014)). The applicant can re-write the claim into an acceptable method claim by redrafting as; “A method for degrading uric acid comprising, adding the engineered probiotic of claim 1 to a solution containing uric acid”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
Claims 1-2, 4-5, 7, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CA 3161863 A1.
CA 3161863 A1 discloses, “Example 2. "Escherichia coli strain Nissie cells genetically engineered to overexpress Escherichia coli YgfU uric acid transporter and Arthrobacter globiformis uricase induced by low oxygen conditions" (paragraph 0324) Additionally, A synthetic plasmid encoding an expression cassette comprising the Escherichia coli YgfU uric acid transporter operably linked to a promoter induced by the oxygen level-dependent FNR protein from N. gonorrhoeae (see, e.g., Isabella et al, BMC Genomics 12:1471-2164 (2011)) (a promoter that is induced by low-oxygen or anaerobic conditions); and, with translation terminated hy the synthetic Bha_B1006 terminator, and with said operon flanked hy 50 bp sequences facilitating homologous recombination into the lacZ locus.” (paragraph 0327). Importantly, “This fragment is flanked by appropriate unique Notl restriction sites. This fragment is excised from a large-scale preparation of the plasmid, purified, and used to transform E. coli Nissle cells.” (paragraph 0328). Finally, they say, “Lambda red recombination is used to make chromosomal modifications, e.g., to express Escherichia coli YgfU uric acid transporter in E.coli Nissle. Lambda red recombinase mediated recombineering is a procedure using recombination enzymes from a bacteriophage lambda to insert a piece of custom (e.g., synthetic) DNA into the chromosome of E. coli.” (paragraph 0329). Therefore, they have described an engineered probiotic defined as E. coli Nissle that has YfgU uric acid transporter integrated into its genome by the lambda red method. This anticipates claim 1 and claim 2. They have also outlined the method of introducing a recombinant expression vector (which contains synthetic genes and originated outside of E. coli) for expression into E.coli. Importantly, it is clear they constructed the vector themselves because they chose the genes to insert (including the promoter and terminator sequences), and the location to integrate the genes (as shown by the 50bp flanking arms). This anticipates claim 4 and claim 5. The disclosure goes on to detail the methods used to construct the probiotic. “The constructs comprising the desired urate catabolism genes and transpm1ers are transformed into E. coli Nissie comprising pKD46.” In the same paragraph they disclose, “The electroporator is set to 2.5 kV. 0.5 µg of the constructs comprising the desired urate catabolism genes and transporters is added to the cells, mixed hy pipetting, and pipetted into a sterile, chilled cuvette. The dry cuvette is placed into the sample chamber, and the electric pulse is applied. 1 mL of room-temperature SOC media is immediately added, and the mixture is transferred to a culture tube and incubated at 37° C. for 1 hr.” paragraph 0333). This anticipates claim 7 and 13 because the method of transformation has been disclosed as electroporation. It also anticipates claim 11 because the pKD46 plasmid was designed for use in bacteria, specifically E. coli. (See genbank file for more information, disclosure date 9/11/2001).
Claims 9-10 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over CA 3161863 A1.
Claims 9-10, and 14 include method claims (claim10) and composition claims (claims 9,14). All the theses claims specify using the product described in claim 1. Claim 1 is anticipated by the citation of exemplary embodiment #2 in CA 3161863 A1 (see above).
CA 3161863 A1 discloses, “a method of treating or preventing hyperuricemia in a subject, comprising administering to the subject the engineered microbial cell of any of the foregoing aspects and embodiments, in an amount effective to treat or prevent hyperuricemia in the subject. (paragraph 0033). This anticipates claim 10 as it discloses a method for treating an elevated uric acid disease using an effective amount of any of the disclosed probiotics in the source, one of which anticipates claim 1 (aka exemplary embodiment #2). Claim 9 is a composition containing the probiotic described in claim 1. Claim 14 states the composition of claim 9 also have one or more pharmaceutically acceptable carriers, excipients, and/or diluents. CA 3161863 A1 discloses, “The present disclosure encompasses the preparation and use of pharmaceutical compositions comprising an engineered microbial cell… of the disclosure as an active ingredient…. the pharmaceutical composition may comprise the active ingredient and one or more pharmaceutically acceptable carriers…” (paragraph 0272). Therefore, they disclose a composition containing an engineered probiotic disclosed (eg: exemplary embodiment #2) as the active ingredient and including a pharmaceutically acceptable carrier. Importantly, a 103 rationale of rejection is as follows. The citation teaches the method and the composition and provides a suggestion/motivation to use the specific microbial probiotic that anticipates claim 1(found in exemplary embodiment 2) for the following reason. E. coli is a universal common natural resident of the human gut ecosystem (Chaudhuri, R. et al. (2012)). Thus, it will be well tolerated by the body and immune system of virtually the entire world population. Therefore, it has the largest potentially treatable population and it will be more effective for far longer durations because it’s in a natural environment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kovach, M et al. 1995 further in view of CA 3161863 A1.
Claim 12 depends on claims 1, and 5 and adds the further limitation that plasmid identity be pBBR1MCS-2. Importantly, CA 3161863 A1 anticipates claim 1 and claim 5 (see above discussion). However, it does not disclose the use of pBBR1MCS-2.
Kovach, M et al. 1995 discloses, “Four new antibiotic-resistant derivatives of the broad-host-range (bhr) cloning vector pBBRIMCS have been constructed. These new plasmids have several advantages over many of the currently available bhr vectors in that: (i) they are relatively small (< 5.3 kb), (ii) they possess an extended multiple cloning site (MCS), (iii) they allow direct selection of recombinant plasmid molecules in Escherichia eoli via disruption of the LacZct peptide, (iv) they are mobilizable when the RK2 transfer functions are provided in trans and (v) they are compatible with IncP, IncQ and IncW group plasmids, as well as with ColE1- and P15a-based replicons.” (Summary).
Kovach, M et al. 1995 provides a teaching/suggestion to use the pBBR1MCS plasmid in place of the pKD46 plasmid that was used in the CA 3161863 A1 disclosure, example 2 method. pBBR1MCS is superior for the introduction and expression of exogenous genes that function together to maintain uric acid homeostasis and mitigate cellular damage caused by the pathways waste product H2O2. (rendering claim 12 obvious) according to the following rationales. They possess an extended Multiple Cloning Site (MCS) expanding the flexibility and versatility of using molecular cloning to insert a much wider range and number of transgenes that would otherwise be incompatible, including the lambda red recombination proteins. They are designed to be selectable by disruption of the LacZ peptide. This selection process is superior to antibiotic selection because it results in lower amounts of false positives, and rapid screening that is performed visually (colorimetrically). Additionally, they are compatible with p15A plasmids, therefore allowing the stable retention of two distinct expression plasmids in one cell. This is advantageous for tunable control of expression of various transgenes that work in combination together.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closet prior art found is CN114480455A, however, it does not teach SEQ ID NO: 1-5 used together.
Claim 6 is objected to as being dependent upon a rejected base claim, claim 4, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closet prior art found is CN114480455A, however, it does not teach SEQ ID NO: 1-5 used together.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638