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 .
Status of the Claims
Claims 1-10 are have been amended in the claim set submitted 10/30/23 and have been examined on the merits.
Priority
This application is a 371 of PCT/FR2022/050830, filed 04/29/2022, and claims the benefit of foreign priority to an FRANCE 2104538, filed 04/30/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/5/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Applicant’s substitute specification, submitted 5/2/24, is acknowledged and has been entered.
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 1-10 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 the structure:
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, however it is unclear where the linker is connecting. While there can be multiple connection points possible, the definition of X does not provide any clarity as to where it should be, nor does it make clear that R1 (or R2) is the (linker)-(HPB Vector). The claim only indicates that R1 and R2 can be H or absent (only one can be), and when R2 is absent, X is selected from recited compounds, and likewise that when R1 is absent, X is selected from a list of compounds. However, this does not define what R1 or R2 is specifically or clearly. It appears that perhaps the intent is that when R1 is X or absent, R2 is selected from the linkers recited (or when R2 is absent, R1 is selected from the listed linkers), but this is not recited in the claims, nor is it clearly present. Further, it is unclear how R2 could be H, or if the inference that the connection is to the linker X in some embodiments, as there is no indication in the claim that N can be charged, as it would have 4 bonds and be N+, and the compound does not appear to have any counter ion balancing.
Claims 5 and 9 recite the limitation "compounds C or E". There is insufficient antecedent basis for this limitation in the claim. Claim 8 (and claim 1) do not recite compounds C and/or E. C and E are parts of the names of the linkers, but not compounds of the claim.
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 1-10 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 recites the structure:
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399
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, however it is unclear where the linker is connecting. While there can be multiple connection points possible, the definition of X does not provide any clarity as to where it should be, nor does it make clear that R1 (or R2) is the (linker)-(HPB Vector). The claim only indicates that R1 and R2 can be H or absent (only one can be), and when R2 is absent, X is selected from recited compounds, and likewise that when R1 is absent, X is selected from a list of compounds. However, this does not define what R1 or R2 is specifically or clearly. It appears that perhaps the intent is that when R1 is X or absent, R2 is selected from the linkers recited (or when R2 is absent, R1 is selected from the listed linkers), but this is not recited in the claims, nor is it clearly present. Further, it is unclear how R2 could be H, or if the inference that the connection is to the linker X in some embodiments, as there is no indication in the claim that N can be charged, as it would have 4 bonds and be N+, and the compound does not appear to have any counter ion balancing.
Without knowing the connectivity points of the linker to the compound, and the absence of real definitions of R1 and R2 within the claims- including whether it is in fact that R1 (or R2) is the (linker)-(HPB Vector), one could not make, or use, the compounds without undue burden.
Furthermore, in claim 3, meloxicam is an anti-inflammatory agent, and there is no art recognition that it is a drug that can treat any/all diseases/conditions. Treatment of conditions requires a precise understanding of the at least the patient, etiology, pathology, expected and desired outcomes, and ‘treating’ a patient as in claim 3 does not provide any guidance, and while one might be able to treat inflammation (e.g. claim 4), and thus one would be unduly burdened to determine the breadth of diseases/conditions treatable with the compound, and one would not be able to practice the method as claimed without undue experimentation.
Claims 1-10 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.
Claim 1 recites the structure:
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, however there are no definitions for R1 or R2 that would lead one to show applicant was in possession of the compounds. Without knowing the definitions for R1 and R2, one would not know if they were in possession of the compounds and compositions as claimed, or those made, or used, in the claimed methods.
Claim Objections
Claims 4, 6, and 10 are objected to because of the following informalities:
Claim 4 should be redrafted to conform with US practice. The administering does not comprise treating, but rather the claim should say “The method of claim 3, wherein the treating is treating inflammatory joint disease.” Please note, this does not address the 112a issue above in claim 3.
Claim 6 recites “as defined above”, however US practice is to reference the appropriate claim from which it depends (e.g. claim 1), or because the claim already depends from claim 1, it would not need to be included. recitation of ‘as defined above’ could lead to ambiguity as to where the reference “above” begins or ends.
Claim 10 would more clearly recite, “wherein the derivative is in the form of a salt, and the salt is select from…” to ensure clarity for the antecedent basis for the claim.
Appropriate correction is required.
Conclusion
A search of the prior art indicates that compounds where Meloxicam is coupled to a HPB Vector through a linker is free of the prior art, however due to the outstanding 112 issues and claims objections, above, the claims are not allowable.
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew D Kosar whose telephone number is (571)272-0913. The examiner can normally be reached Monday-Friday, 7am-3:30pm.
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/Andrew D Kosar/ Supervisory Patent Examiner, Art Unit 1625