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 .
Claim Amendments
Claim 1 has been amended to replace “a soft bone disease” with “Phosphoethanolamine/Phosphocholine Phosphatase 1 (PHOSPHO1) deficiency” and specify that the PHOSPHO1 deficiency “causes impairment of bone volume in the subject”. Moreover, claim 34 has been amended to define the dental disorder as “teeth hypomineralization, or a periodontal disorder”, while claim 41 further limits the dental disorder to “teeth hypomineralization”. Claims 8-10, 37, and 40 were also amended to resolve claim objections.
Drawings
RE: Objection to the drawings
The replacement drawings for Figures 14A-14F meet the requirements under 37 C.F.R. 1.84 section (p)(3). Thus, the objection to the drawings has been withdrawn.
Claim Objections
RE: Objection to the claims
The minor informalities in claims 1, 9-10, 34, 37, and 40 have been corrected. The claim objections have therefore been withdrawn.
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.
(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.
RE: Rejection of claims 1-4, 6-10, 12, 15, 18-19, 34-37, and 39-41 under 35 U.S.C. 102(a)(2) as being anticipated by Miyake et al.
Traversal of rejections based on amendments that require treatment of PHOSPHO1 deficiency in claim 1 or dental disorder that is either teeth hypomineralization or a periodontal disorder in claim 34. Applicant argues that Miyake et al. does not teach treating either one of the specified conditions.
Applicant’s traversal has been fully considered and is found partly persuasive. It is conceded that the cited prior art only teaches administering a gene therapy vector comprising a polynucleotide encoding a TNALP fusion protein in order to increase expression of TNALP, thereby treating a bone disease or disorder like hypophosphatasia, odontophyophosphatasia, and osteomalacia. These bone diseases are caused by mutations in the ALPL gene which results in deficiency of TNALP (not caused by PHOSPHO1 deficiency). Hence, the rejections on claims 1-4, 6-10, 12, 15, and 18-19 are withdrawn.
However, claim 34 and its dependent claims are drawn to a method of treating a dental disorder that is either teeth hypomineralization or a periodontal disorder. Miyake et al. teaches using the disclosed gene therapy vector to treat odontophyophosphatasia. Since odontophyophosphatasia is characterized by defective mineralization of dental tissues (i.e., it disrupts the body’s ability to deposit calcium and phosphorous into developing teeth and bones), it is considered a type of teeth hypomineralization. Thus, Miyake et al. still reads on claims 34-37 and 39-41.
But in light of claim amendments, the rejections on claims 34-37 and 39-41 have been modified as set forth below.
Modified rejections
Claims 34-37 and 39-41 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Miyake et al. (Pub. No. WO 2022/201074 A1; IDS-cited).
Miyake et al. discloses gene therapy vectors and compositions comprising polynucleotides encoding tissue nonspecific alkaline phosphatase (TNALP) fusion proteins, as well as methods of using said vectors and compositions (Abstract).
An aspect of the gene therapy vectors is a vector comprising a polynucleotide having a promoter like a CAG promoter that is operably linked to a nucleic acid encoding a fusion protein comprising TNALP and a deca-aspartate (D10) amino acid sequence (par. [0009]). In certain aspects, the compositions are formulated as a pharmaceutical composition comprising the vector and a pharmaceutically acceptable carrier (par. [0017]).
One embodiment of the methods of use is directed to treating a bone disease or disorder including hypophosphatasia (HPP), rickets, odontohyophosphatasia, and osteomalacia (par. [0066], [0175], [0196]). The method comprises administering Miyake et al.’s vector or pharmaceutical composition to the subject in need thereof. In some aspects, the administration is intramuscular injection (par. [0021], [0175], [0194]).
Miyake et al.’s method reads on the instant application’s methods as follows:
Regarding claim 34: treating a bone disease or disorder such as odontohyophosphatasia, which is the characterized by premature loss of permanent teeth and abnormal tooth development (i.e., a dental disorder), is analogous to “A method of treating a subject with a dental disorder” and satisfies “wherein administering the viral vector treats the dental disorder” and “wherein the dental disorder is teeth hypomineralization, or a periodontal disorder”.
Intramuscular injection of the gene therapy vector or pharmaceutical composition containing said vector to the subject in need thereof, wherein said vector comprises a polynucleotide comprising promoter and a fusion protein of TNALP (par. [0021], [0175], [0194]) is akin to “administering a viral vector comprising a mineral-targeted alkaline phosphatase under the control of a tissue non-specific promotor to the subject in an intramuscular injection”.
TNALP is a tissue non-specific alkaline phosphatase found in bones that facilitates bone mineralization, thereby fulfilling “wherein the mineral-targeted alkaline phosphatase comprises TNAP”.
Regarding claim 35: the promoter being a CAG promoter (par. [0011], [0052]) is the same as “wherein the tissue non-specific promotor comprises a CAG promotor”.
Regarding claims 36-37: the gene therapy vector being an AAV like AAV8 (par. [0015], [0059]) corresponds to “wherein the viral vector comprises an adeno-associated vector” and “wherein the viral vector comprises an AAV8 vector”, respectively.
Regarding claims 39-40: the D10 amino acid sequence at the C-terminus of TNALP (par. [0018], [0058], [0106]-[0108]; SEQ ID NO: 9 in Table 2, pages 35-36) corresponds to “wherein the mineral-targeted alkaline phosphatase further comprises a sequence for bone targeting linked to the C-terminus of TNAP” and the additional limitation “wherein the bone targeting sequence is a D10 sequence”.
Regarding claim 41: odontohyophosphatasia is considered a mild form of tooth hypomineralization and therefore meets “wherein the dental disorder is teeth hypomineralization”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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