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
This application claims benefit of provisional application 63/364975, filed May 19, 2022. Claims 1-20 are pending in this application and examined on the merits herein.
Drawings
The drawings are objected to because the text of the drawings is presented at such low resolution as to not be fully legible. This is especially the case in claims 2, 4, 5, 9, 12, and 16. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 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 1-3, 19, and 20 refer to a “levansucrase (LS) selected from…” but then recite a list of various bacterial strains. As written it is unclear whether this limitation is meant to require the addition of a levansucrase enzyme, or whether it requires the presence of a whole bacterium of one of the recited strains expressing said enzyme, rendering the claims indefinite. Dependent claims 4-18 further depend from claim 1 and are therefore also indefinite.
Additionally, claims 1, 2, 19, and 20 refer to the bacteria as including Bacillus amyloliquefaciens (ATCC 23350) and Gluconobacter oxydans (strain 621H). It is unclear whether the parenthetical indicator of a specific strain is intended as a further limitation or merely an optional, exemplary limitation, additionally rendering the claims indefinite.
Claim 18 refers to “a polyaminated crosslinker (PEI).” It is unclear whether the parenthetical expression (PEI) which likely refers to polyethyleneimine, is intended to further limit the scope of the polyaminated crosslinker or merely to provide a nonlimiting example thereof.
Claim 16 contains the trademark/trade names “Relizyme™” and “Sepabeads™.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a glyoxal/agarose solid support and, accordingly, the identification/description is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This claim depends from claim 1 and further specifies that the source of lactose is a dairy product. However, neither base claim 1 nor dependent claim 9 describes a step of isolating or otherwise producing the lactose, and claim 1 already includes the proviso “from a dairy starting material” in its preamble. There is nothing of record indicating any difference between lactose obtained from a dairy product or which is itself a dairy product from lactose obtained by other means such as chemical or chemoenzymatic synthesis. Therefore this claim is not seen to further limit the base claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This claim depends from base claim 1, which claims a process comprising a step of combining sucrose, lactose, and a levansucrase. However, claim 19 is directed to a kit, which is defined as comprising a levansucrase and a solid support. The claim involves no process steps, and does not even require all of the ingredients utilized in the process of claim 1 or the intended product of said process. A solid-supported levansucrase would not necessarily infringe claim 1. Therefore claim 19 does not include all of the limitations of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 4, 5, 8-10, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tian et al. (Reference included with PTO-892)
Independent claim 1 is directed to a process for producing lactosucrose from a dairy starting material, comprising contacting lactose and sucrose with a levansucrase selected from one of a number of bacterial strains including Bacillus amyloliquefaciens ATCC 23350. As discussed previously under 35 USC 112(b), it is unclear from the wording of the claims whether the process requires the use of whole bacterial cells, or merely the purified enzyme. This limitation is therefore given its broadest reasonable interpretation, which includes methods using enzymes isolated from or substantially identical to the levansucrase enzymes from any of the recited strains. Furthermore the “dairy starting material” recited in the preamble of this claim is reasonably considered to be any substance that can be isolated from a dairy source, for example lactose. Dependent claim 2 further narrows the particular bacterial strain from which the levansucrase is isolated. Dependent claims 4, 5, and 8 further specify that the reaction produce a fructooligosaccharide and an oligomer or polysaccharide. Dependent claims 9-10 further specify the source of lactose, including for example whey permeate. Dependent claim 12 further specifies the source of sucrose. Independent claim 20 claims an enriched dairy product containing a levansucrase.
Tian et al. discloses production and isolation of a levansucrase from B. amyloliquefaciens ATCC 23350. (p. 72 sections 2.1-2.3) This enzyme was then reacted with various substrates including sucrose as a donor and lactose as an acceptor. (p. 73 section 2.7) This reaction produced the polysaccharide levan (p. 76 left column second paragraph) as well as fructooligosaccharides including kestose and nystose. (p. 76 left column last paragraph) When lactose was used as the acceptor small amounts of lactosucrose were also observed. (p. 78 right column first paragraph) Therefore Tian et al. anticipates the present claims.
Furthermore regarding the discussion of a “dairy” starting material in claim 1 or a “dairy product” in claim 9, in the absence of a specific description in the present disclosure as to the particular characteristics used to define a dairy material, this is considered to be a product-by-process limitation that merely requires that the product is one which could have been derived from mammalian milk, for example bovine milk. Therefore in the broadest reasonable interpretation lactose itself is considered to be a dairy material or dairy product as it can be extracted from milk. Still further pure lactose is a “lactose enriched mixture” as recited in claim 10 as it is enriched compared to the amount of lactose present in milk.
Regarding the reference to “white sugar” in claim 12, this is reasonably considered as including pure sucrose.
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.
Claims 1-3, 9-12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Corzo-Martinez et al. (Reference included with PTO-892) in view of Hill et al. (Reference included with PTO-892) in view of Thoma et al (Reference included with PTO-892)
Independent claim 1 is directed to a process for producing lactosucrose from a dairy starting material, comprising contacting lactose and sucrose with a levansucrase selected from one of a number of bacterial strains including Vibrio natriegens NBRC 15636. As discussed previously under 35 USC 112(b), it is unclear from the wording of the claims whether the process requires the use of whole bacterial cells, or merely the purified enzyme. This limitation is therefore given its broadest reasonable interpretation, which includes methods using enzymes isolated from or substantially identical to the levansucrase enzymes from any of the recited strains. Furthermore the “dairy starting material” recited in the preamble of this claim is reasonably considered to be any substance that can be isolated from a dairy source, for example lactose. Dependent claims 2 and 3 further narrow the particular bacterial strain from which the levansucrase is isolated. Dependent claims 9-11 further specify the source of lactose, including for example whey permeate. Dependent claim 12 further specifies the source of sucrose. Independent claim 20 claims an enriched dairy product containing a levansucrase.
Corzo-Martinez et al. discloses that lactosucrose is an important prebiotic with useful applications. (p. 2 first paragraph) Corzo-Martinez further discloses a method for enzymatically synthesizing lactosucrose by treating cheese whey permeate and tofu whey with levansucrase. (p. 2 third paragraph, p. 4 first paragraph) The result of said reaction mixture would be, for example, an enriched cheese whey mixture containing levansucrase and a source of sucrose as described in claim 20. Regarding claim 12, in some embodiments the source of sucrose is simply purified sucrose, which is reasonably considered to be “white sugar” according to this claim.
Corzo-Martinez et al. differs from the claimed invention in that the levansucrase used is from Bacillus subtilis rather than one of the particular strains described in the present claims. However, Hill et al. discloses a study of various levansucrase enzymes suitable for enzymatic synthesis of oligosaccharides. (p. 2 third paragraph) Enzymes studied included those derived from Vibrio natriegens and Gluconobacter oxydans (p. 17 section 3.1) as well as Bacillus amyloliquefaciens. (p. 18 section 3.4.1) All of the enzymes studies were capable of making the prebiotic lactosucrose using lactose as an acceptor. (p. 16 third paragraph, p. 15 fig 10) Thoma et al. discloses that V. natriegens ATCC 14808, also known as NCBR 15636, is commercially available and commonly used. (p. 381 last paragraph p. 382 first paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use a levansucrase from V. natriegens ATCC 14808, also known as NCBR 15636, as the enzymatic catalyst in the method described by Corzo-Martinez et al. One of ordinary skill in the art would have concluded based on the disclosures of Hill and Thoma that the enzyme form V. natriegens NCBR 15636 would be an equivalent usable for the same purpose as the B. subtilis enzyme described by Corzo-Martinez.
Therefore the invention taken as a whole is prima facie obvious.
Claims 13-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. as applied to claims 1-3, 9-12, and 20 above, and further in view of Hill et al. 2015. (Reference included with PTO-892, distinct form Hill et al. cited above)
The disclosures of Corzo-Martinez et al., Hill et al., and Thoma et al. are discussed above. Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. does not disclose immobilization of the enzyme on a solid support such as glyoxal agarose.
Hill et al. 2015 discloses attempts to increase the stability of levansucrase for use in oligosaccharide synthesis. (p. 2440 right column) In particular, both Sepabeads® and crosslinked agarose were used as solid supports. (p. 2441 left column second paragraph) In particular, the process of attaching the enzyme to the support utilizes iminodiacetic acid, optionally including a metal cation, sodium sulphide, triethylamine, and ethylenediamine. In one embodiment, the IDA/metal is IDS/Cu. (p. 2442 right column first paragraph) The solid supported agarose was further treated with high pH in order to stabilize the bonding to the support. (p. 2442 right column last paragraph – p. 2443 left column first paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to attach the levansucrase used in the method of Corzo-Martinez to a solid support as described by Hill 2015. One of ordinary skill in the art would have seen such a modification as improving the stability of the enzyme and therefore would have regarded it as obvious based on a rational of applying a known improvement to a prior art process ready for improvement.
Therefore the invention taken as a whole is prima facie obvious.
Claims 13, 14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. as applied to claims 1-3, 9-12, and 20 above, and further in view of Hill et al. 2017. (Reference included with PTO-892, distinct form Hill et al. cited above)
The disclosures of Corzo-Martinez et al., Hill et al., and Thoma et al. are discussed above. Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. does not disclose immobilization of the enzyme on a solid support such as glyoxal agarose.
Hill et al. 2017 discloses attempts to increase the stability of levansucrase for use in oligosaccharide synthesis, and to allow for reuse of the enzyme. (p. 63 right column second paragraph) In particular, both Sepabeads® and crosslinked agarose were used as solid supports. (p. 2441 left column second paragraph) In particular, the process of attaching the enzyme to the support utilizes iminodiacetic acid and Cu. (p. 64 left column first paragraph) The solid supported agarose was further treated with high pH in order to stabilize the bonding to the support. (p. 56 left column first paragraph) PEI was also used as a crosslinker to stabilize the enzyme. (p. 65 right column first paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to attach the levansucrase used in the method of Corzo-Martinez to a solid support as described by Hill 2017. One of ordinary skill in the art would have seen such a modification as improving the stability of the enzyme and therefore would have regarded it as obvious based on a rational of applying a known improvement to a prior art process ready for improvement.
Therefore the invention taken as a whole is prima facie obvious.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. as applied to claims 1-3, 9-12, and 20 above, and further in view of Cutrim et al. (Reference included with PTO-892) in view of Nunez-Lopez et al. (Reference included with PTO-892)
The disclosures of Corzo-Martinez et al., Hill et al., and Thoma et al. are discussed above. Corzo-Martinez et al. in view of Hill et al. in view of Thoma et al. does not disclose further including a polyphenol in the reaction which is thereby glycosylated.
Cutrim discloses the beneficial effects of incorporating polyphenols into dairy products. (abstract) Polyphenols discussed include gallic and caffeic acids (p. 566 figure 1) and catechin. (p. 570 right column fifth paragraph, p. 572 left column third paragraph) Nunez-Lopez et al. discloses that polyphenols are known to possess useful biological properties but that aglycones are hindered by poor water solubility which limits their bioavailability. (p. 19 left column first paragraph) Nunez-Lopez further discloses the use of a levansucrase to fructosylate various polyphenols including for example gallic acid, caffeic acid, and catechin. (p. 20 left column third and fourth paragraphs)
It would have been obvious to one of ordinary skill in the art at the time of the invention to add one or more polyphenolic compounds to the whey product described by Corzo-Martinez et al., such that the polyphenol is fructosylated by the levansucrase. One of ordinary skill in the art would have been motivated to do so because of the disclosure by Cutrim that polyphenols are useful to include in dairy products, and the disclosure by Nunez-Lopez that enzymatic glycosylation can be used to improve the bioavailability of these compounds.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ERIC OLSON/ Primary Examiner, Art Unit 1693 10/1/2025