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 .
CONTINUING DATA
This application is a 371 of PCT/US2021/052550 09/29/2021
PCT/US2021/052550 has PRO 63/086,546 10/01/2020
Applicant's election with traverse of Group I, claims 1-7, 14, and 21-23 in the reply filed on November 10, 2025 is acknowledged. The traversal is on the ground(s) that the ‘271 compound cited by the examiner is a salt. This is not found persuasive because additional references teaching compounds of claim 1 are made of record in this office action. It is noted that claim 14 was mistakenly included in Group I although it is a method of preparing a compound. Claim 14 is examined along with Group I.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-13, 15, and 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 10, 2025.
Claim Interpretation
Claim 1 recites a drug. The specification does not define “drug,” so the broadest reasonable definition of the term is the ordinary definition. A drug is a medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body.
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Claim 1 recites a hexose. The specification does not define “hexose,” so the broadest reasonable definition of the term is the ordinary definition. A hexose is a monosaccharide containing six carbon atoms in a molecule.
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Specification
The disclosure is objected to because of the following informalities: compounds on page 3, 5-11, 19, and 21-22, are pixelated and difficult to read.
Appropriate correction is required.
Drawings
The structures in Figure 7 are pixelated and difficult to read.
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 1-5 and 21 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 recites 1DG6P of formula D1. 1DG6P presumably refers to 1-deoxyglucose-6-phosphate. A phosphate is understood to be -OPO(OH)2. The structure of formula (D1) in claim 1 is shown as follows:
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This compound is not a phosphate because it does not contain -OPO(OH)2. Only three oxygen atoms are connected to P. It is unclear whether this is the actual structure intended to be claimed, or if there is an error in the structure. Claims 2-4 depend from claim 1 and incorporate the same limitation by reference. Likewise, claim 5 recites a number of compounds which are described as phosphates, but are not actually phosphates. Claim 21 also contains compounds which are not actually phosphates. It is unclear whether the structures are drawn as intended, or if there are errors in the structures.
Claims 5 and 21 recite that the drug is conjugated to the fluorinated hexose phosphate which can be 3-deoxy-3,3,-difluoroglucose or 2-deoxy-2-fluoroglucose. This limitation is unclear because these compounds are not phosphates.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 and 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for compounds wherein the hexose phosphate is a hexose-6-phosphate and the drug is an antibiotic, does not reasonably provide enablement for other compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a compound comprising a drug conjugated to a fluorinated hexose phosphate or 1DG6P. The drug is not defined or limited in the specification. The fluorinated hexose phosphate is not defined or limited in the specification. The conjugation can take place via any linker [0053]. Thus, the claims taken together with the specification imply that the claimed compounds encompass hexose molecules substituted with a phosphate group at any position and at least one fluorine atom at any position, and that the claimed conjugates include any molecule which can be considered a drug, and the drug may be conjugated to the hexose at any position using any linker.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
As noted in the current specification, the UhpT system is conserved in many bacteria. Hexose phosphates induce expression of UhpT, which facilitates uptake of the antibiotic through UhpT. Paragraph [0052]. 3FG6P and 4FG6P were shown to facilitate uptake of certain antibiotics. Fann teaches that UhpT acts to exchange internal inorganic phosphate for external hexose 6-phosphate (see abstract).
Chemical reactions are generally understood to be unpredictable (MPEP 2164.03).
(5) The relative skill of those in the art:
The skilled artisan is a research chemist.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided guidance for synthesis of 3FG6P and 4FG6P and their conjugation to specific antibiotics.
However, the specification does not provide guidance for the synthesis of other fluorinated hexose phosphates or conjugation with other drugs.
(8) The quantity of experimentation necessary:
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. If little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.
The chemical and biotechnology arts are unpredictable. Fann teaches that UhpT acts on hexose-6-phosphate, but Fann does not teach that other hexose phosphates (such as, for example, a hexose-3-phosphate) are utilized. The skilled artisan would not know how to use the claimed hexose phosphates which are other than hexose-6-phosphates because hexose-6-phosphates in particular are suitable for the UhpT system. The specification does not provide guidance for preparing hexoses substituted at any position by phosphate, fluorine, and an unspecified linker, and chemical reactions are unpredictable.
Considering the state of the art, particularly with regards to the breadth of the claims and the unpredictability in the art, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
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 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loibner (DE 3834877A1, 1990, original document and machine translation) as evidenced by Roopashree (Journal of Functional Foods 87 (2021) 104724).
Loibner teaches the following compounds (structures obtained from the CAS record) Examples 6-7.
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The drugs in Loibner’s compounds are fatty acid derivatives. Roopashree illustrates that medium chain fatty acids have physiological effects. See abstract.
Claim(s) 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sadamoto (JP2005097268, 2005, original document and machine translation).
Sadamoto teaches the following compound on page 37 of the original document:
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The drug in this instance is a peptide. The compound is described as antibacterial (see abstract of machine translation).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Claim 14 is allowed. The closest prior art for claim 14 is Sadamoto or Lee. Sadamoto teaches an antibiotic conjugate with a fluorinated hexose phosphate, but does not teach that the antibiotic is linezolid. Lee teaches a conjugate of linezolid with a saccharide (see Figure 1), but the saccharide is not a fluorinated hexose phosphate.
Conclusion
Claims 1-7 and 21-23 are rejected. Claim 14 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/Primary Examiner, Art Unit 1693