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 .
Applicant's arguments filed 2/19/26 have been fully considered but they are not persuasive to overcome the obviousness rejection.
Applicant argues “The rejection asserts that it would have been obvious to combine acetyl-CoA enhancement (Becker and/or WO'713) with glycosylation or sialylation pathways (EP2090648 and WO'225). However, the Office Action does not articulate a reasoned basis why a person of ordinary skill in the art would have modified a cell producing a disaccharide, oligosaccharide, or Neu(n)Ac-containing bioproduct to further enhance acetyl-CoA synthesis. The cited references address different metabolic objectives: Becker enhances acetyl-CoA in the context of terpenoid and aromatic compound production; WO'713 enhances carbon flux through acetyl-CoA for production of small bioderived molecules;EP2090648 concerns glycosylation of polypeptides in micro-algae; and WO'225 focuses on modulation of enzymes within the sialic acid pathway and disabling competing reactions. The Office Action does not identify any teaching in these references that acetyl-CoA availability limits production of disaccharides, oligosaccharides, or Neu(n)Ac-containing bioproducts. Nor does it identify any disclosure suggesting that increasing acetyl-CoA synthesis would improve yield of such carbohydrate compounds. Absent such a teaching, the proposed combination requires selecting acetyl-CoA enhancement from references directed to unrelated product classes and applying it to carbohydrate-producing systems without any articulated reason why such modification would have been expected to improve the claimed products. A rejection under 35 U.S.C. §103 requires more than identifying known elements in isolation; it requires an articulated rationale explaining why the specific combination claimed would have been made with a reasonable expectation of success. The present Office Action does not provide such an explanation for combining enhanced acetyl-CoA synthesis with production of the claimed compound classes.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the claims only require any disaccharide or oligosaccharide in combination with the prior art taught (below rejections) enhanced synthesis of acetyl-Coenzyme A. Applicant's arguments have been considered however a showing to overcome a prima facie case of obviousness must be clear and convincing( In re Lohr et al. 137 USPQ 548) as well as commensurate in scope with the claimed subject matter ( In re Lindner 173 USPQ 356; In re Hyson, 172 USPQ 399 and In re Boesch et al., 205 USPQ 215 (CCPA 1980).
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.
Claims 61- 121 are rejected under 35 U.S.C. 103 as being unpatentable over Becker and & 713 (as in the 102 rejections) and EP2090648 & WO 2018/122225.
Becker discloses an E.coli strain, here E.coli RFO5S-M40,possessing a pathway for the production of a compound, said E.coli over-expresses acetyl-CoA synthase which enhanced acetyl-CoA production (p. 182 col 1). Becker also discloses oligo- & poly-carbohydrate pathways (Fig. 1) as well as some compounds produced in E.coli such as 2'-FL (Table 1). They also teach examples of genes involved or those to be removed for the production of sugar oligomers such as e.g. 2'-FL (Fig. 2, p. 184 col. 2) by engineering a fucose biosynthetic pathway, elimination of lactose degradation and other enzymes, expression of fucosyltransferase and acetate recycling (Table 1, p. 182 col 1). D1 also teaches expressing manB, manC, gmd-wcaG, fkp, futC, B-1,3-galactosyltransferase (p. 184 col. 2), glucose-1-phosphate uridyltransferase (p. 185 col 2). D1 also teaches a method for producing 2'-FL with lactose as a feed (p. 184 col 2), chromosomal integration of the expression cassette (p. 184 col 2). D1 teaches a method of producing a compound using the E.coli over-expresses acetyl-CoA synthase (p. 182 col 1).
713 teaches discloses a micro-organism with enhanced acetyl-CoA production (p 1), said micro-organism over-expresses acetyl CoA ligase (p. 3). 713 also teaches
exemplary metabolic pathways for acetyl CoA production, including enzymes
such as pyruvate formate lyase, pyruvate dehydrogenase or acetate kinase
(Fig. 1). 713 teaches expression of other genes required for sugar uptake such
as glf, glk, galP (p. 13, penultimate §), fruA, ManP, NagP (p. 15), increase in enzymes such as pyruvate dehydrogenase or pyruvate formate lyase or pyruvate decarboxylase complex (p. 19) increase in acetyl-CoA and/or PEP (p. 35), the micro-organism is E.coli, B. subtilis or S. cerevisiae (p. 42- 43). 713 teaches a method of producing a compound (p. 69), including isolating the compound (p. 69).
Neither Becker nor 713 teach all of the genetic modification in the “secondary pathways” claimed by applicant, e.g. from instant claim 69 or all the specific culture additives or exact amounts claimed however it would have been obvious at the time the invention was filed to add any know secondary genetic modification to the over-expresses acetyl-CoA synthase modification of Becker and 713 to produce the expected products such a change would knowingly cause. Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Notably, W02018122225 teaches an engineered cell suitable for the production of as well as a method of production of a bio-product a bio-product and comprising
a glycosyltransferase (at least p. 1-11). 225 teaches N-acylglucosamine 2-epimerase, UDP-N-acetylglucosamine 2-epimerase, N-acetylmannosamine-6-phosphate 2-epimerase, bifunctional UDP-GIcNAc 2- epimerase/kinase, N-acylneuraminate-9-phosphate synthetase, phosphatase,CMP sialic acid synthase, sialyltransferase, a phosphatase (p. 28), HAD-phosphatase. 225 further teaches the cell can be E.coli or S.cerevisiae the compound can be isolated (p. 11-12) by e.g. nanofiltration disruption of fac, nag, nan and man operon (Table A), a glucose or sucrose phase and a lactose phase (p. 10), 10g/I lactose.
Also, EP2090648 shows a cell comprising a glycosyltransferase ([0020]) suitable
for producing N-glycosylated polypeptide ([0071]), N-acylglucosamine 2-epimerase, UDP-N-acetylglucosamine 2-epimerase, N- acetylmannosamine-6-phosphate 2-epimerase, bifunctional UDP-GIcNAc 2-epimerase/kinase, N-acylneuraminate-9-phosphate synthetase, phosphatase, CMP sialic acid synthase, sialyltransferase [0019], [0021], [0105], [0115],[0129]. 648 also teaches a pharmaceutical composition [0037], fermentation where the pH is between 3-7, the temperature is between 20-80°C [0142].
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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