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
Application status
Claims 1-20 are pending in this application.
No claim(s) are withdrawn
Priority
It is acknowledged that the instant application claims the priority benefit to a US provisional application 63/494,950. Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(e) to a provisional application filed on 04/07/2023.
Claim Objections
Claim 1 is objected to because of the following informalities: The term CCL20 is introduced without the actual term being stated in full. All information must be disclosed that CCL20 is representative of “chemokine motif C-C ligand 20”.
Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Applicant introduces an abbreviation for “CCL20 locked dimer” for the first time, as “CCL20LD”. Applicant should first introduce this abbreviation when they first use the term “CCL20 locked dimer” in Claim 1 or not use the abbreviation in any claim(s).
Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Applicant uses the abbreviation “CCL20LD”, as this abbreviation is not used in other claims other than claim 10, applicant should use the full term “CCL20 locked dimer”.
Appropriate correction is required.
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.
Claim(s) 9-12 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.
Regarding claim 9-10, the phrase “reduces a sign or symptom” and the phrase “reducing the likelihood”, respectively, are relative phrases which renders the claim indefinite. The term “reduces” or “reducing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim(s) 11 and 12 are rejected as being indefinite, as they have all the trappings of claim(s) 10 and when read independently from the rejected claim(s) 10, would be rejected in its entirety. To read claim(s) 11 and 12 as independent from claim(s) 10, they would still invoke the terminology of claim(s). Whereas “the method of claim 10”, it would instead read “a method of reducing the likelihood” on both claim(s) 11 and 12. As explained in the above paragraph, the term(s) “reduces” or “reducing”, is not defined in the specification and does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Therefore claims 9-12 are rejected for being indefinite.
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.
Claim(s) 1-4, 9-13, and 18-20 are rejected under U.S.C. 35 112(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.
The applicants have not provided the structure of all species (mutants and variants) of CCL20 encompassed in the claims. The specification must convey with reasonable clarity that the inventor was in possession of the claimed invention at the time of filing. This means, for a broad claim covering multiple species (e.g., CCL20 mutants and variants), the specification must describe a reasonable number of species or a representative subset that is reasonably believed to cover all species claimed. Applicant only discloses a method of using CCL20 having the structure of SEQ IDNO: 1 or an amino acid sequence with at least 95% sequence identity to SEQ IN NO: 1 and a S64C mutation relative of SEQ ID NO: 1.
Applicant claim(s) “a method of treating graft versus host disease (GVHD) (acute, chronic, and ocular) in a subject in need thereof, the method comprising: administering a therapeutically effective amount of a composition comprising a CCL20 locked dimer to the subject to treat oGVHD”, claim(s) 1-4, 9-13, and 18-20. Each of the claim(s) state the entire genus of a CCL20 locked dimer, nowhere does it associate the claim(s) with SEQ ID NO: 1or an amino acid sequence with at least a 95% sequence identity to SEQ ID NO:1 and a S64C mutation relative to SEQ ID NO:1
The specification is limited to teaching only SEQ ID NO:1 or an amino acid sequence with at least 95% sequence identity to SEQ IN NO: 1 and a S64C mutation relative of SEQ ID NO: 1..
No examples, assays, clinical data, or mechanistic studies are provided to demonstrate therapeutic efficacy of using any or all species of CCL20 whose structure is well described. The specification offers a general statement that CCL20 lock dimer “can be beneficial” without defining the effective dosage and any “working” examples showing actual treatment efficacy. There is no support or evidence that one skilled in the art would reasonably understand the inventor possessed the claimed method at the filing date.
No detailed structural information of all the species encompassed in the claimed method, formulation protocols, or corroborating experimental support for the claimed method is included, and the specification does not incorporate references to prior art that could establish known efficacy. Functional terms like “treating” and “effective amount” are unbounded and unsupported by the disclosure.
Therefore claim(s) 1-4, 9-13, and 18-20 are rejected due to lack of written description. Claim(s) 5-8 and 14-17 are dependent on claim(s) 1-4 and 9-13, respectively and inherit those claim(s)’ deficiency, therefore claim(s) 5-8 and 14-17 are rejected.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-17 are rejected under 35 U. S.C. 102(a)(1) and (a)(2) as being anticipated by US 10738095 B2; patent granted 11 August 2020, claiming the domestic benefit to a US Provisional application filed on 6-3-2015-(Examiner cited), hereafter regarded as Volkman, et al.
In the instant case, applicants’ claims are directed to a method of treating graft versus host disease (GVHD) in a subject in need thereof, the method comprising: administering a therapeutically effective amount of a composition comprising a CCL20 locked dimer to the subject to treat GVHD in the subject; claim(s) 1. The subject suffers from either acute, chronic, and ocular, aGVHD, cGVHD, and oGVHD, respectively; claim(s) 2-3, and 13, and has previously failed steroid treatments or considered steroid refractory; claim(s) 4. Applicant states that the method of treatment is to use the CCL20 locked dimer comprises two CCL20 monomers, wherein at least one of the CCL20 monomers comprises SEQ ID NO: 1; claim(s) 5 and 14, wherein the CCL20 locked dimer comprises two monomers covalently linked together, wherein each monomer comprises SEQ ID NO: 1 or an amino acid sequence with at least a 95% sequence identity to SEQ ID NO:1 and a S64C mutation relative to SEQ ID NO:1; claim(s) 6 and 15. Each monomer either consists or comprises of SEQ ID NO: 1; claim(s) 7-8 and 16-17. The applicant also claims that the method of treatment of CCL20 locked dimer is administered to a subject prior to receiving an allogeneic stem cell transplant or a subject who has received allogeneic stem cell transplant but shows no signs or symptoms of GVHD; claim(s) 11-12.
Regarding claim(s) 1-4, 9, and 11-13, Volkman, et al. teaches that in one embodiment, the CCL20 locked dimer (invention) provides a method for treating an autoimmune disease, the method comprising administering a therapeutically effective amount of a composition comprising a CCL20 locked dimer polypeptide to a subject having or at risk of having an autoimmune disease; [col. 13, line 36-42].
Regarding claim(s) 1-4, 9, and 11-13, Volkman, et al. also teaches that by “autoimmune disease” we mean illness generally understood to be caused by the over-production of cytokines, lymphotoxins and antibodies by white blood cells, including in particular T-cells. Such autoimmune diseases include but are not limited to, any other human illness that T-cells play a major role in, such as tissue graft rejection; [col. 13, line 43-51].
Regarding claim(s) 5, 7-8, 14, and 17-18, Volkman, et al. teaches that in the present invention a kit comprising a CCL20 locked dimer polypeptide wherein the dimer preferably comprises at least one monomer having the amino acid sequence of SEQ ID NO: 1, a pharmaceutically acceptable carrier or diluent, and instructional material; [col. 3, line 1-7].
Regarding claim(s) 5, 7-8, 14, and 17-18, Volkman, et al. also teaches that the inventors have engineered a novel CCL20 locked dimer polypeptide comprising two monomers linked together and in one preferred embodiment the dimer comprises two monomers bound together, wherein at least one monomer has the amino acid sequence as shown in SEQ ID NO:1; [col. 2, line 57-64].
Regarding claim(s) 6 and 15, Volkman, et al. teaches that in a preferred embodiment, S64 is replaced with cysteine residues to create at least one symmetrical, intermolecular disulfide bond between opposing α-helices. The terms “locked CCL20 dimer” and “locked CCL20 dimer polypeptide” are used herein interchangeably. Other residue(s) besides S64 in CCL20 could be mutated to cysteines in order to form the locked dimer similar to the one of the present invention; [col. 6, line 4-12 and Fig 3A (col. 4, line 5-12)].
Regarding claim(s) 5-8, and 14-17, Volkman, et al. also teaches the identical structure of SEQ ID NO: 1, being ASNFDCCLGYTDRILHPKFIVGFTRQLANEGCDINAIIFHTKKKLSVCANPKQTWVKYIVRLLCKKVKNM, wherein the S64 is mutated to a C, [col. 2, line 65-67].
Therefore, as described above, Volkman, et al. anticipates claim(s) 1-17.
Conclusion
Claim(s) 1-20 are rejected in this application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH RICCI MATTHEWS whose telephone number is (571)270-7306. The examiner can normally be reached Mon - Fri (8:00a - 5:00p).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N Rao can be reached at (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH RICCI MATTHEWS/
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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