DETAILED ACTION
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.
Claims 4 and 10 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.
Regarding claim 4, the term “preferably” renders the claim indefinite because it is unclear whether the limitations after the term are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, the parenthetical phrase “(decanter)” renders the claim indefinite because it is unclear whether the limitations within the parentheses are part of the claimed invention. See MPEP § 2173.05(d).
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)(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.
Claim(s) 1-2, 4-7, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fierfort, Nicolas, and Eric Samain. "Genetic engineering of Escherichia coli for the economical production of sialylated oligosaccharides." Journal of Biotechnology 134.3-4 (2008): 261-265 (Fierfort).
Fierfort previously described a microbiological process for the conversion of lactose into 3’-sialyllactose and other ganglioside sugars by living Escherichia coli cells expressing the appropriate recombinant glycosyltransferase genes (Abstract). Fierfort demonstrated that sialylated oligosaccharides can be economically produced by bacterial fermentation to produce 3’-sialyllactose (page 262). Fierfort teaches that sialyllactose was purified from the culture of strain DC7, which had been continuously fed with lactose (page 263, 2.4 Purification of sialyllactose). At the end of the culture, the extracellular fraction was separated from the cells by centrifugation. The pH of the extracellular fraction was lowered to 3.0 by the addition of a strong cation exchanger resin. This resulted in the precipitation of proteins, which were removed by centrifugation. The pH of the clear supernatant was then adjusted to 6.0 by the addition of a weak anion exchanger (Dowex 66 free base form) and half of the supernatant was then loaded on a Dowex 1 (HCO3 form) column (5 cm × 20 cm). Sialyllactose was retained by Dowex 1 resin and, after washing with distilled water, was eluted with a 0–500 mM continuous NaHCO3 gradient. The same procedure was repeated with the other half of the supernatant. Eluted fractions containing sialyllactose were pooled and the NaHCO3 was removed by treating with Amberlite IR120 (H+ form) until pH 3.0 was reached. The pH was then adjusted to 6.0 with NaOH and the sialyllactose was freeze-dried. For purification of the intracellular fraction, the cells were permeabilized by heating (100 °C, 45 min) and re-suspended in the same volume as the initial culture medium. Oligosaccharides freely diffused outside the cells and were recovered in the supernatant after centrifugation. The purification of sialyllactose was then carried out using the same protocol as for the extracellular fraction.
Thus, Fierfort teaches a method for purification of 3’-sialyllactose from a suspension (e.g., a fermentation broth) containing one or more of a biomass and proteins, the method comprising 1) pretreating the suspension via pH-adjustment (e.g., to pH 3) and/or heat treatment (e.g., heating at 100 °C, 45 min); 2) centrifuging the suspension after the pretreatment, thereby forming a clarified supernatant containing the purified HMO; and 3) further purifying the clarified supernatant obtained after centrifuging by treatment with an ion exchange resin and/or chromatography on a neutral solid phase.
Regarding the clause(s) “wherein the dilution…volume of the suspension” in claim 5, “wherein the bio-wet-mass…less than 20%” in claim 6, “wherein the heat treatment…to 45-120 °C” in claim 7, “wherein the dilution…of the suspension” in claim 19, and “wherein the heat treatment…to 60-90 °C”, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04.
Fierfort teaches all of the instantly claimed elements. Thus, claims 1-2, 4-7, and 18-20 are anticipated.
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(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fierfort, Nicolas, and Eric Samain. "Genetic engineering of Escherichia coli for the economical production of sialylated oligosaccharides." Journal of Biotechnology 134.3-4 (2008): 261-265 (Fierfort) as applied to claims 1-2, 4-7, and 18-20 above, and further in view of Matwiejuk et al. US 2018/0002363 A1 (Matwiejuk).
Fierfort differs from the instantly claimed invention in that Fierfort differs from the instantly claimed invention in that Fierfort does not teach a method wherein the clarified supernatant obtained after centrifuging is further purified by ultrafiltration or nanofiltration; however, this deficiency would have been obvious in view of the teachings of Matwiejuk.
In the instant case, the references may be combined to show obviousness because Fierfort and Matwiejuk are each drawn to the purification of sialylated oligosaccharides from a fermentation broth. They are from the same field of endeavor, and/or are reasonably pertinent to a method for purification of a human milk oligosaccharide (HMO) from a suspension containing one or more of a biomass and proteins.
Matwiejuk relates to the isolation and purification of sialylated oligosaccharides from a fermentation broth in which they are produced by a microorganism [0001]. Matwiejuk teaches a method for separating and purifying a sialylated oligosaccharide from an aqueous medium, the aqueous medium being a fermentation broth or an enzymatic reaction mixture containing said sialylated oligosaccharide which aqueous medium can optionally be pre-treated, comprising a treatment of said aqueous medium or said pre-treated aqueous medium with a strong anion exchange resin and a strong cation exchange resin [0009]. In one embodiment, the separation/purification method further comprises a step of ultrafiltration (UF), preferably to separate biomass and/or enzymes from the aqueous medium, nanofiltration (NF), preferably to concentrate the sialylated oligosaccharide in the aqueous medium and/or reduce an inorganic salt content of the aqueous medium, and/or activated, charcoal (AC) treatment, preferably to decolorize the aqueous medium [0013 – 0016]. Matwiejuk teaches that preferably, the UF step is performed before any of the NF and AC steps and the ion exchange resin treatment. Matwiejuk teaches that the NF and AC steps and the ion exchange resin treatment can be conducted in any order. The sialylated oligosaccharide can be collected after any of the NF and AC steps and the ion exchange resin treatment.
In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 218 USPQ 871 (Fed. Cir. 1983); Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983).
It would have been obvious to further purify the sialylated oligosaccharide of Fierfort via ultrafiltration and/or nanofiltration in view of the teachings of Matwiejuk. Matwiejuk teaches ultrafiltration (UF) to separate biomass and/or enzymes from the aqueous medium and nanofiltration (NF) to concentrate the sialylated oligosaccharide in the aqueous medium and/or reduce an inorganic salt content of the aqueous medium. The selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination. One would have had a reasonable expectation of success as Matwiejuk teaches the use of UF and NF to purify sialylated oligosaccharides from a fermentation broth.
All of the instant limitations are taught by the combination of Fierfort and Matwiejuk. A person of ordinary skill in the art would have had a reason to combine the teachings of Fierfort and Matwiejuk. A person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of Fierfort and Matwiejuk. Thus, claims 11-12 would have been obvious based on the preponderance of the evidence.
Conclusion
Claims 1-20 are pending. Claims 1-2, 4-7, 10-12, and 18-20 are rejected. Claims 3, 8-9, and 13-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No claims are allowed.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shaojia Jiang can be reached at (571) 272-0627. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/