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
Preliminary Amendment
1. Applicant's preliminary amendment filed October 23, 2023 is acknowledged and has been entered. Claims 3, 13, 16, and 18-22 have been cancelled. Accordingly, claims 1-2, 4-12, 14, 15, 17, and 22-26 are pending and are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a). Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/GB2021/053106 filed 11/29/2021, is November 27, 2020 which is the filing date of Foreign Application UNITED KINGDOM 2018713.4 filed 11/27/2020 from which the benefit of foreign priority is claimed.
Specification
4. The disclosure is objected to because of the following informalities: a brief description of the drawings appears to be missing. Appropriate correction is required.
Information Disclosure Statement
5. The information disclosure statement filed May 26, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. In this case, neither a copy nor a statement of relevancy has been provided for Foreign Patent document: EP 1377220. It has been placed in the application file, but the information referred to therein has not been considered.
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.
6. Claims 1-2, 4-12, 14, 15, 17, and 22-26 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.
Claim 1 is indefinite in reciting “A composition … including a non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2 and at least at one bond formed between vitamin B12 and the target molecule” because the claim is directed to a composition as a product claim; however, the limitation defines a functional feature that describes a linking configuration of binding interactions between components while in use in a method. Accordingly, it is unclear what chemical and/or structural components should comprise the claimed composition.
Claim 1 is also vague and indefinite in reciting “A composition for labeling, detection, immobilization, and/or isolation of at least one target molecule, said composition including a non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2 and at least at one bond formed between vitamin B12 and the target molecule in use” because it is unclear how the claimed composition is capable of labeling and detection, absent recitation of a label that produces a detectable signal for detecting a target molecule. In particular, it is unclear how the complex or conjugate of claim 1 can be used for “labelling a target molecule” and “detecting a target molecule” because the composition does not appear to have incorporated therein, a label. See also claim 8.
Claim 1 is further vague and indefinite in reciting “coupling or binding between vitamin B12 binding protein BtuG2 and at least at one bond formed between vitamin B12 and the target molecule” because it implies but fails to clearly define that the BtuG2 couples or binds directly to the vitamin B12 component of the vitamin B12 conjugated to the target molecule.
Claim 1 is indefinite in reciting “A composition … including a non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2 and at least at one bond formed between vitamin B12 and the target molecule in use” because it is unclear what other components are comprised in the “composition” other than those that are intended to be “included” albeit, unrecited in the claimed composition. Perhaps, Applicant intends, “comprising.” See also claim 26.
Claim 2 has improper antecedent basis problem in reciting “A composition according to claim….” Perhaps, Applicant intends “The composition according to claim….” See also claims 4-12, 14, 15, 17, and 22-25.
Claim 8 is ambiguous relative to claim 1 from which it depends in reciting, “wherein vitamin B12 is conjugated to one or more fluorescent protein target molecules” because it is unclear what essential structural and/or functional cooperative relationship exists between the instant “fluorescent protein target molecules” and the “at least one target molecule which formed a bond with vitamin B12 in the composition of claim 1.
Claim 26 in lines 3-4 lacks antecedent basis and appears incomplete in reciting “the non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2.”
Claim 26 is vague and indefinite in reciting “forming at least one bond between vitamin B12 and the target biological molecule and utilising the non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2, said interaction between BtuG2 and vitamin B12” because it implies but fails to clearly define that the BtuG2 couples or binds directly to the vitamin B12 which has formed a bond with the target molecule.
Claim 26 is vague and indefinite in reciting “forming at least one bond between vitamin B12 and the target biological molecule and utilising the non-covalent affinity, coupling or binding between vitamin B12 binding protein BtuG2, said interaction between BtuG2 and vitamin B12 enabling labeling … and/or detection of the target molecule” because it is unclear how the interaction between BtuG2 and vitamin B12 enables labeling and detection of the target molecule, absent recitation of a label that produces a detectable signal for detecting a target molecule. In particular, it is unclear how the complex or conjugate formed in claim 26 can be used for “labelling a target molecule” and “detecting a target molecule” because the complex formation does not appear to include a label.
Claim Interpretation
7. Although the components of the claimed composition are not clearly defined in claim 1, it is deemed that the composition comprises a conjugate of vitamin B12 binding protein BtuG2 (BT1954 B. thetaiotaomicron homolog) bound to vitamin B12 (cobalamin) via non-covalent binding, wherein the vitamin B12 is further conjugated to a target protein molecule, the target protein molecule bound to the BtuG2 via the vitamin B12.
Prior Art
8. Claims 1-2, 4-12, 14, 15, 17, and 22-26 are free of the prior art of record.
The prior art of record fails to teach or fairly suggest a composition comprising: a complex of a vitamin B12 binding protein BtuG2 and a vitamin B12 conjugated to a specific target molecule; wherein the BtuG2 is coupled via non-covalent affinity to the vitamin B12 conjugated to the specific target molecule which is any one of a biological molecule, a peptide, a protein, an antibody or a fluorescent protein. The composition is for use in labeling, detection, immobilization, and/or isolation of at least one target molecule.
Closest Prior Art
9. Wexler et al. (Human gut Bacteroides capture vitamin B12 via cell surface-exposed lipoproteins. Microbiology and Infectious Disease (September 18, 2018)- IDS) teach that BtuG binds vitamin B12 with femtomolar affinity and can remove B12 from intrinsic factor, critical B12 transport protein in humans (Abstract). Wexler et al. teach that BtuG2 (BT1954 B. thetaiotaomicron) directly binds to vitamin B12 with femtomolar affinity; thereby, enabling it to acquire the vitamin from the B12 transport protein in vivo. However, Wexler et al. does not teach or suggest forming a composition comprising
a complex of a vitamin B12 binding protein BtuG2 and a vitamin B12 conjugated to a specific target molecule- the BtuG2 being coupled via non-covalent affinity to the vitamin B12 which is conjugated to a specific target molecule; the complex being enabled for use in labeling, detection, immobilization, and/or isolation of at least one target molecule.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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/GAILENE GABEL/ Primary Examiner, Art Unit 1678
December 8, 2025