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/Restrictions
Applicant’s election without traverse of species linker molecule 21A in the reply filed on 12/01/2025 is acknowledged.
Claim Rejections - 35 USC § 112
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 27-40 and 43-46 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 labelling polynucleotides using a linker based on an analogue of S-adenosyl-L-methionine cofactor, does not reasonably provide enablement for labelling polynucleotides using a linker comprising a broad structure in claim 27 and of general formula FG-Z-A-B-C-Y-LG (see claim 32 for example) because of the high numbers of substituents for FG, Z, A ,B, C, Y and LG . 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 instant claims encompass a linker for labeling any biomolecule represented by a broad structure comprising a first functional group comprising a reactive center, a second functional group comprising a reactive center, and a cleavable moiety (see claim 27) and of general formula FG-Z-A-B-C-Y-LG, covering a very wide range of compounds because of the parameters FG, Z, A ,B, C, Y and LG.
The invention is a linker represented by a general formula (see claims 27 and 32 for example) that is useful for DNA capture, DNA complexation, drug attachment, and/or fluorescent labelling applications (see Page 1 and Page 39).
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Since there are only 2 examples for the linker (linker 21A and 21B), and no written description of the groups included in the generic definition of FG-Z-A-B-C-Y-LG, the amount of experimentation is very high and burdensome. Therefore, it is not seen where the instant specification enables the ordinary artisan to make and/or use the instantly claimed invention.
Additionally, the application shows that for reversibly labelling polynucleotides a linker based on an analogue of S-adenosyl-L-methionine cofactor can be used. In addition, reversible labelling requires the use of a methyltransferase for labelling followed by hydrolyzing the hydrolysable moiety. Step e. has not been exemplified. For reversibly labelling of a peptide a single further linker was shown to be able to label peptides, more particularly, the thiol moiety. Also, for this linker step e. was not exemplified.
Contrarily to the results shown in the description the claims do not define the chemical structure of the linker, the type of biomolecule to be labelled nor which molecule is obtained after step e. (the nature of the further molecule is unknown). The method claimed appears to be merely speculative as it is not proven to be generally applicable with any linker and any biomolecule combination.
MPEP 2164.01 (a) states, "A conclusion of lack of enablement means that based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed.Cir. 1993)." That conclusion is clearly justified here. Thus, undue experimentation will be required to practice Applicants' invention.
Claims 27-40 and 43-46 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the Written description requirement, applicant must convey with reasonable clarity to one skilled in the art, as of the filing date that applicants were in possession of the claimed invention. Applicant’s claims are drawn a linker for labeling any biomolecule represented by a broad structure comprising a first functional group comprising a reactive center, a second functional group comprising a reactive center, and a cleavable moiety (see claim 27) and of general formula FG-Z-A-B-C-Y-LG, covering a very wide range of compounds because of the parameters FG, Z, A ,B, C, Y and LG.
The invention is a linker represented by a general formula (see claims 27 and 32 for example) that is useful for DNA capture, DNA complexation, drug attachment, and/or fluorescent labelling applications (see Page 1 and Page 39).
The expression of generic groups /moieties FG represents the second functional group comprising a reactive center; Z represents a non-reactive group of an aliphatic linkage or an aromatic linkage; A-B-C together represent the cleavable moiety; Y represents a non-reactive group of an aliphatic linkage or an aromatic linkage; LG represents a first functional group comprising a reactive center, for the parameters . FG, Z, A ,B, C, Y and LG, does not convey to one of ordinary skill in the art that applicants were in possession of the claimed subject matter. The functional language recited without any correlation does not meet the written description requirement, as one of ordinary skill in the art could not recognize or understand which groups/moieties are included by the mere recitation of the generic term. Claims employing generic term language at the point of novelty, such as applicants’, neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The expression could encompass myriads of groups/ moieties and applicants claimed expression represents only an invitation to experiment regarding possible combinations and compounds.
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 27-40, 43-46 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 27 and 46 are vague and indefinite because it is unclear what exactly are the metes and bounds for the “further molecule” (claim 27 step e; claim 46 step e).
Claim 46 recites the limitation "the second functional group" in line 5 and the cleavable group” in line 7. There is insufficient antecedent basis for these limitations in the claim.
Note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Also see In re Van Geuns, 988 F.2d 1181,26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In re Zetz, 13 USPQ2d 1320,1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 16 February 2026