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
Claims 1-22 are pending in the instant application.
Priority
This application claims priority to the foreign applications JP2023-012581 filed on 1/31/2023 and JP2022-099159 filed on 6/20/2022.
Information Disclosure Statement
The information disclosure statements (IDS) dated 6/16/2023 and 1/11/2024 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Claim Interpretation
A meaningful interpretation of the chemical structures and reactions described could not be generated. As a result, the material within was not treated further on the merits. See 112(b) and 112(a) rejections for further details.
Objections to the Claims
Claim 1 uses parentheses to define variables beginning with the recitation of “wherein”. Please remove the parentheses.
Claim 2 contains redundant limitations already specified in the base claim. Please replace, “The labeled polypeptide according to claim 1, wherein the labeled polypeptide is a fusion polypeptide of an antibody, with a peptide tag that comprises the side chain containing glutamine residue” with “The labeled polypeptide according to claim 1, wherein the labeled polypeptide is fused to an antibody”.
Claim 3 uses parentheses to define variables. Please remove the parentheses.
Claim 4 contains redundant limitations already specified in the base claim. Please replace, “The modified polypeptide according to claim 3, wherein the modified polypeptide is a fusion polypeptide of an antibody, with a peptide tag that comprises the side chain-containing glutamine residue” with “The modified polypeptide according to claim 3, wherein the modified polypeptide is fused to an antibody”.
Claim 7 uses parentheses to define variables. Please remove the parentheses.
Claim 9 claims a closed range using open language. Please replace “The polypeptide according to claim 1, wherein the straight chain alkylene group has 2 or more and 10 or less carbon atoms” with “The polypeptide according to claim 1, wherein the straight chain alkylene group has 2 to 10 carbon atoms”.
Claim 10 pluralizes biotin. Please replace “biotins” with “biotin”.
Claim 13 uses parentheses to define variables. Please remove the parentheses.
Claim 14 uses parentheses to define variables. Please remove the parentheses..
Claim 17 uses parentheses to define variables. Please remove the parentheses.
Claim 19 claims a closed range using open language. Please replace “The production method according to claim 13, wherein the straight chain alkylene group has 2 or more and 10 or less carbon atoms” with “The production method according to claim 13, wherein the straight chain alkylene group has 2 to 10 carbon atoms”.
Claim 22 uses unfamiliar language and redundant language. Please replace, “claim 20, wherein the label owned by the labeled polypeptide is a fluorescent dye or a fluorescent protein, and, the signal is detected, in the detecting step, by flow cytometry in which the immune complex is introduced into a flow cell of a flow cytometer” with “claim 20, wherein the label is a fluorescent dye or a fluorescent protein, and is detected by flow cytometry”.
Correction is required. See MPEP § 608.01(m).
Claim Rejections – 35 USC § 112(b)
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 1-22 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
Claim 1 is drawn to variable C being the alpha carbon of glutamine. The structure as drawn prevents this carbon from being the alpha carbon because in order to satisfy the limitation of comprising a glutamine residue, it requires the circled atoms to be either a carbonyl or amine functionality as shown below:
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This claim is rendered indefinite because it is impossible to satisfy the limitations of the structure of Formula (I), while also satisfying variable C being the alpha carbon of the glutamine residue. Dependent claims 2, 5-12, and 20-22, fail to cure these deficiencies, thus are also rendered indefinite.
Claim 3
Claim 3 is drawn to variable C being the alpha carbon of glutamine. The structure as drawn prevents this carbon from being the alpha carbon because in order to satisfy the limitation of comprising a glutamine residue, it requires the circled atoms to be either a carbonyl or amine functionality as shown below:
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This claim is rendered indefinite because it is impossible to satisfy the limitations of the structure of Formula (II), while also satisfying variable C being the alpha carbon of the glutamine residue. Dependent claim 4 fails to cure these deficiencies, thus is also rendered indefinite.
Claim 13
Claim 13 describes a chemical reaction involving Formula (VI) containing a glutamine residue, however this formula is represented by NH2-X-Y-SH, wherein neither variables X and Y are glutamine. Because it is impossible to generate a chemical structure that satisfies both Formula (VI) and the limitation of comprising a glutamine residue, this claim is rendered indefinite. Dependent claims 15-19 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 13
A chemical reaction could not be meaningfully interpreted given the description in claim 13. The instant specification also fails to depict what chemical reaction is taking place. The specification describes using transglutaminase to functionalize the glutamine amide with a primary amine (pg 2, para 3). This description has been inferred to refer to the following reaction below.
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However, in the description of the chemical reaction in claim 13, (i) one of the reagents is impossible to generate as described in the 112(b) rejection immediately above, (ii) there is no primary amine reagent invoked to perform the inferred reaction above; and (iii) there is no described product showing what new chemical bond was made in order to infer what chemical reaction has taken place. As a result, one of skill in the art would not know what was being made or how it was being made, rendering this claim indefinite. Examiner recommends explicitly drawing out an A + B [Wingdings font/0xE0] C diagram. Dependent claims 15-19 fail to cure these deficiencies, thus are also rendered indefinite.
Claim 14
Claim 14 describes a chemical reaction involving Formula (VI) containing a glutamine residue, however this formula is represented by NH2-X-Y-SH, wherein neither variables X and Y are glutamine. Because it is impossible to generate a chemical structure that satisfies both Formula (VI) and the limitation of comprising a glutamine residue, this claim is rendered indefinite.
Claim 14
Claim 14 is drawn to method of making a product wherein the first step involves the same uninterpretable chemical reaction as claim 13, followed by a secondary step of either appending a maleimide, or wherein there is only one step and the maleimide group already present somehow. The claim language fails to make clear what the reagents are, what the products are, and how many steps are involved. As a result, one of skill in the art would not know what was being made or how it was being made, rendering this claim indefinite. Examiner recommends explicitly drawing out an A + B [Wingdings font/0xE0] C diagram.
Claim 20
Claim 20 is drawn to “A measurement method for a target substance” however what is measured is not described, thus rendering this claim indefinite. It is inferred from the claim language that applicant is claiming a method of detection as opposed to a method of measuring. In which case, Examiner recommends replacing “A measurement method for a target substance, the method comprising: forming an immune complex of the labeled polypeptide according to claim 2, with a target substance; and detecting a signal generated by the label contained in the immune complex” with “A method of detecting a target substance comprising a forming step of contacting a target substance with the labeled polypeptide of claim 2 to generate an immune complex, followed by a step of detecting the label of the immune complex”. Dependent claims 21-22 fail to cure these deficiencies, thus are also rendered indefinite.
Claim Rejections – 35 USC § 112(d)
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 12 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.
Claim 12
Claim 12 is drawn to a reagent comprising no other components or structural elements other than the polypeptide of claim 1. Thus claim 12 fails to further limit the scope parent claim 1 as the term “reagent” fails to add any further structure.
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 § 112(a)
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 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
All claims
Claims 1-22 are drawn to an indefinite chemical structure, an indefinite antibody fusion protein, and indefinite reactions with both of these. Applicant can meet the written description requirement by (i) supplying a representative number of species; or (ii) by supplying the core structure necessary to demonstrate possession of the claimed properties.
Regarding (i) applicant failed to provide a single exemplary structure of the product or the reactants (so that a desired product could be inferred).
Regarding (ii) applicant provided structural elements that were indefinite and incomplete as described in the 112(b) rejections above. The most explicit structures are on pg 23 and 32, however those structures do not describe any of the compounds of Formula (I)-(V), nor do they describe how applicant intended to fuse that structure to an antibody. Critically, what is lacking is an explicit primary amine that is implicitly invoked by the reaction with transglutaminase in claims 13-19. In the structure below, Q is either CO, NH, or possibly absent altogether if applicant actually isn’t claiming a glutamine residue; and R2 is entirely undefined.
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The variables with arrows are entirely undefined by the claims and the specification. Claims 13-19 infer the structure below, however the identity of R1 is never disclosed.
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Because the succinimide unit is unavailable for conjugation to an antibody, it is unclear how these structures are fused to an antibody without invoking substantially more structure than is provided. For example one could envisage conjugating the antibody to the glutamine residue presuming the steps of (i) adding an N-glycan to the as aparine residues, (ii) converting the asparagine residues to aspartic acid using PNGase F, (iii) combining the antibody in step ii with a primary amine containing a label, wherein that structure comprises the elements of Formula I, as in the process below (Dennler, Fig 2, doi: 10.1021/bc400574z).
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A similar process is taught by Sadiki (doi: 10.1021/acs.bioconjchem.4c00013), shown below (Abstract).
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However, none of these steps have been described and the structure of Formula (I) lacks a primary amine functionality to generate either of the antibody fusion proteins shown above. Because applicant has failed to describe either (i) or (ii), it is found that Applicant has failed to meet the written description requirement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/
Supervisory Patent Examiner, Art Unit 1675
Prosecution Insights