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
Claim status
Claims 2-9 are pending
Claims 2-9 are under examination
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/01/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to the Specification
The disclosure is objected to because of the following informalities: page 6, paragraph 2 in reference to Figure 6, describe elements in the figure with colors (i.e., green). However, Applicant has not submitted drawings executed in color.
Furthermore, Applicant is reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Allowable Subject Matter
The prior art does not teach or fairly suggest the nucleic acid composition encoding the claimed truncations of diacylglycerol kinase kappa (DGKk) nor its use in a method to treat Fragile X syndrome, wherein the nucleic acid sequence encodes DGKk with the claimed N-terminal deletions in the proline rich domain (Pro) and/or the EPAPE repeat region ((EPAPE)10) (see Applicant’s Figure 1 below).
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Although the DGKkappa gene was well known, as was the regulation of its mRNA by the RNA binding protein FMRP, how FMRP specifically interacted with DGKk mRNA remained to be defined and DGKk mRNA was not known to contain motifs that would have readily establish a FMRP binding site (p. E3263, last para. of Tabet et al., PNAS, 2016, E3619-E3626, see IDS filed 3/01/2023), Surprisingly, Applicant has demonstrated that the claimed N-terminal deletions in the proline rich region (DPro) and/or the EPAPE repeat region (DEPAPE) of DGKkappa bypass the need to be regulated by the RNA binding protein FMRP, and allow the mRNA to be expressed so as to be successfully used for gene therapy to treat FXS (p. 7, last para., see Examples 2 & 3, and Figs. 5 & 6 of Applicant’s specification).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 2-9 are rejected on the grounds of nonstatutory double patenting over claims 1-13 of U.S. Patent No. 11,597,936 (Moine et al., Patented 3/07/2023).
The subject matter claimed in the instant application is fully disclosed in the referenced patent as follows: the composition and method for treating Fragile X comprising 5’ deletions in the DGKkappa polynucleotide of SEQ ID NO:1 of cited patent anticipates the compositions and methods of instant application. It is clear that all the elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the cited patent claims are much more specific with respect to SEQ ID NO:1. Thus the invention of said claims of the cited patent are in effect “species” of the “generic” invention of the instant claim. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Since the instant application claims are anticipated by over cited patent claims, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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