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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-3, 10, and 11, drawn to a method comprising contacting a-D-glucose-1-phosphate (G1P) with a beta (b)-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans, wherein the bGP has an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16; including wherein the method additionally comprising the step of contacting a substrate with an alpha(a)-glucan-phosphorylase (aGP) in the presence of inorganic phosphate to produce the glucose-1-phosphate, wherein the aGP has an amino acid sequence at least 80% identical to SEQ ID NO: 1, 2, 3, 4, 5, or 18; and including wherein the substrate has a degree of polymerization (DP) equal to or greater than 4.
Group II, claim(s) 1, 2, 4, 10, and 11, drawn to a method comprising contacting a-D-glucose-1-phosphate (G1P) with a beta (b)-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans, wherein the bGP has an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16; including wherein the method additionally comprising the step of contacting a substrate with an alpha(a)-glucan-phosphorylase (aGP) in the presence of inorganic phosphate to produce the glucose-1-phosphate, wherein the aGP has an amino acid sequence at least 80% identical to SEQ ID NO: 1, 2, 3, 4, 5, or 18; and including wherein the substrate is selected from the group consisting of maltodextrin, starch liquefact, trehalose, sucrose, cellulose, cellodextrins, cellobiose, and combinations thereof.
Group III, claim(s) 1, 2, 5, 10, and 11, drawn to a method comprising contacting a-D-glucose-1-phosphate (G1P) with a beta (b)-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans, wherein the bGP has an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16; including wherein the method additionally comprising the step of contacting a substrate with an alpha(a)-glucan-phosphorylase (aGP) in the presence of inorganic phosphate to produce the glucose-1-phosphate, wherein the aGP has an amino acid sequence at least 80% identical to SEQ ID NO: 1, 2, 3, 4, 5, or 18; and including wherein the bGP G1P contacting step is carried out at a pH between 6.0 and 7.5 and/or the substrate aGP contacting step is carried out at a pH between 6.5 and 8.0.
CLAIM 1 LINKS INVENTIONS I-III
Group IV, claim(s) 6 and 7, drawn to a composition comprising a bGP having an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16; a G1P; and a primer molecule; including wherein the composition additionally comprises a 1,2-beta-oligoglucan, a phosphatase inhibitor, a buffer, and/or a reducing agent.
Group V, claim(s) 6 and 8, drawn to a composition comprising a bGP having an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16; a G1P; and a primer molecule; including wherein the primer molecule is selected from the group consisting of D-glucose, sophorose, laminaribiose, cellobiose, gentiobiose, and combinations thereof.
CLAIM 6 LINKS INVENTIONS IV AND V
Group VI, claim(s) 12, drawn to a 1,2-beta-oligoglucan composition produced by a method comprising contacting a-D-glucose-1-phosphate (G1P) with a beta (b)-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans, wherein the bGP has an amino acid sequence at least 80% identical to SEQ ID NO: 10, 11, 13, 15, or 16, wherein the composition has a polydispersity between 2 and 40, a degree of polymerization (DP) of about 6-150, and a viscosity between 800 and 1200 mPas at 50 0C.
Group VII, claim(s) 15 and 17, drawn to a vector comprising a nucleic acid encoding a polypeptide at least 80% identical to SEQ ID NO: 5, 11, 13, or 16, and a cell comprising the vector.
Linking Claims
Claim 1 link(s) inventions I-III, and claim 6 links inventions IV and V. The restriction requirement between the linked inventions is subject to the nonallowance of the linking claim(s), claim 1 or claim 6. Upon the indication of allowability of the linking claim(s), the restriction requirement as to the linked inventions shall be withdrawn and any claim(s) depending from or otherwise requiring all the limitations of the allowable linking claim(s) will be rejoined and fully examined for patentability in accordance with 37 CFR 1.104 because unity of invention will have been restored. Claims that require all the limitations of an allowable linking claim will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
Applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, the allowable linking claim, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Where a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Election of Species
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
For Groups I-III, there are two elections of species; Applicant should elect one sequence from SEQ ID NOs: 10, 11, 13, 15, and 16; and Applicant should elect one sequence from SEQ ID NOs: 1, 2, 3, 4, 5, and 18.
For Groups IV and V, Applicant should elected one sequence from SEQ ID NOs: 10, 11, 13, 15, and 16.
Four Group VII, Applicant should elected one sequence from SEQ ID NOs: 5, 11, 13, and 16.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, there are no generic claims.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Inventions I-VII lack unity of invention because even though the inventions of these groups require the technical feature of a method comprising contacting a-D-glucose-1-phosphate (G1P) with a beta(b)-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans or a composition for practicing this method, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Abe et al. (J. Appl. Glycosci. (2015) Vol. 62; pp. 47-52) and GenPept Accession WP_145318654.1 (2019) (see rejection under 35 USC 103, below). Because the shared technical feature lacks an inventive step over the prior art, it can not be relied upon to provide unity of invention.
Election by Phone
During a telephone conversation with Kate E. Helmich on Sept. 22, 2026, a provisional election was made to prosecute the invention of Group II, claims 1, 2, 4, 10, and 11; and the species of SEQ ID NOs: 11 and 5. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-8, 10-12, 15, and 17 are pending and claims 3, 5-8, 12, 15, and 17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected inventions.
Inventorship
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Potential for Rejoinder
In addition to the linking claims, the examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claim 2 is objected to because of the following informalities: the current wording of “additionally comprising” makes it seem it would be the second step in the biosynthesis when it is actually first step. Applicant is advised to reword the claim as follows: The method of claim 1, additionally comprising the step of producing the G1P by contacting a substrate with an alpha(a)-glucan-phosphorylase (aGP) in the presence of inorganic phosphate, wherein the aGP has an amino acid sequence at least 80% identical to at least one of SEQ ID NOs: 1, 2, 3, 4, 5, or 18. Appropriate correction is requested. Equivalent language would be acceptable as long as it makes it clear the method step of claim 2 is performed before the method step of claim 1.
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, 2, 4, 10, and 11 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. All dependent claims are included in these rejections unless they have a limitation that overcomes the deficiencies of the parent claim.
Claim 1 recites “… wherein the bGP has an amino acid sequence at least 80% identical to at least one of SEQ ID NOs: 10, 11, 13, 15, and 16.” Claims 2 and 10 have analogous claim language for the aGP. It is unclear how a protein can have an amino acid sequence with at least 80% identity to multiple sequences. The recited sequences are not close to one another in sequence identity, so it is likely impossible to have 80% identity to two of the recited sequences. SEQ ID NO: 10 has 3.1% identity to SEQ ID NO: 11, SEQ ID NO: 13 has 25.9% identity to SEQ ID NO: 11, SEQ ID NO: 15 has 3.2% identity to SEQ ID NO: 11, and SEQ ID NO: 16 has 26.2% identity to SEQ ID NO: 11. It is unclear how a bGP enzyme can have at least 80% identity to “at least one of” the recited sequences.
Claim 2 includes both a broad and a more narrow recitation for the required phosphate. Claim 2 recites “… inorganic phosphate (e.g., sodium phosphate or potassium phosphate)…” and it is unclear if the claim is limited to using sodium phosphate or potassium phosphate or if the claim encompasses using any inorganic phosphate.
Claim 11 is directed to the “composition or method of claim 1” and this is confusing because it is unclear if claim 11 encompasses a method or if it encompasses a product. If it is a product, it is unclear which product recited in claim 1 is the correct “composition” for antecedent basis.
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.
Claim(s) 1 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (J. Appl. Glycosci. (2015) Vol. 62; pp. 47-52) in view of GenPept Accession WP_145318654.1 (2019). NOTE: the Examiner does not have an unprotected PDF of the Abe reference. The Examiner will send a PDF of the Abe reference with a Miscellaneous communication as soon as she gets it.
The claims are drawn to a method comprising contacting a-D-glucose-1-phophate (G1P) with a b-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans wherein the bGP has an amino acid sequence at least 80% identical to at least one of SEQ ID NOs: 10, 11, 13, 15, and 16 or at least 90% identical to SEQ ID NO: 11, 13, or 16 (claim 11).
Abe teaches a method for making b-(1,2)-glucans by contacting a 1,2-b-oligoglucan phosphorylase with G1P (Abe 47 1).
Abe does not teach a bGP with at least 80% or 90% identity to SEQ ID NOs: 10, 11, 13, 15, and 16.
GenPept teaches a cellobiose phosphorylase from Rhizobium that has 100% sequence identity with SEQ ID NO: 11.
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to substitute any known oligoglucan phosphorylase for the oligoglucan phosphorylase taught by Abe. This is the substitution of a known equivalent. Abe teaches that some protobacteria, including Rhizobium, produce cyclic b-1,2-glucans (Abe 48). This would have led one of ordinary skill to specifically look for a phosphorylase from Rhizobium.
Claim(s) 1, 2, 4, 10, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (J. Appl. Glycosci (2015) Vol. 62; pp. 47-52) in view of GenPept Accession WP_145318654.1 (2019) as applied to claims 1 and 11, above, and further in view of Nakajima et al (Analytical Biochemistry (2021) Vol. 632; pp. 1-4), and further in view of GenPept Accession WP_184619716 (2021) referred to hereafter as GenPept2.
The claims are drawn to a method comprising contacting a-D-glucose-1-phosphate (G1P) with a b-glucan-phosphorylase (bGP) to produce 1,2-beta-oligoglucans wherein the bGP has an amino acid sequence at least 80% identical to at least one of SEQ ID NOs: 10, 11, 13, 15, and 16 (claim 1) or at least 90% identical to SEQ ID NO: 11, 13, or 16 (claim 11), including wherein the method comprises a step for making G1P by contacting a substrate with an alpha (a)-glucan-phosphorylase (aGP) in the presence of inorganic phosphate wherein the aGP has at least 80% identity to SEQ ID NO: 1, 2, 3, 4, 5, or 18 (claim 2) or at least 90% identity to SEQ ID NO: 1, 2, or 5 (claim 10); including wherein the substrate is maltodextrin, starch liquefact, trehalose, sucrose, cellulose, cellodextrins, cellobiose, and combinations thereof (claim 4).
Abe in view of GenPept teach a method comprising contacting G1P with bGP to produce 1,2-beta-oligoglucans (see rejection, above).
Abe and GenPept do not teach a method of contacting an aGP with a substrate in the presence of inorganic phosphate to produce G1P, nor do they teach an aGP with at least 80% identity to SEQ ID NO: 1, 2, 3, 4, 5, or 18.
Nakajima teaches that G1P can be obtained from a reaching of sucrose with sucrose phosphorylase (Nakajima 1).
GenPept2 teaches a glycogen/starch/alpha-glucan phosphorylase.
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to provide the G1P substrate needed for Abe’s reaction by reacting a sugar or starch with a phosphorylase. Nakajima teaches that this is an inexpensive way to obtain G1P. The phosphorylase taught by GenPept2 would have been the substitutions of an equivalent with a predictable result.
Reference not Relied Upon but Made of Record
The Examiner is providing Mizanur et al. (Archaea (2007) Vol. 2; pp. 169-176) to demonstrate that maltodextrin phosphorylases were known in the art, and they were known to produce G1P.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached M-F 9:00 - 5:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
