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 .
Applicant’s amendment and response filed on 12/9/2025 has been received and entered into the case.
Claims 1-62, 65-67, 73-75 have been canceled, claims 83-91 are newly added, and claims 63-64, 68-72, 76-91 have been considered on the merits. All arguments have been considered.
Claim Objections
Claim 63 is objected to because of the following informalities: the term “msGAD55” in line 14 should be “hypermethylated secreGAD55” as it is not representing “m” (i.e. hypermethylated)” gene. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (New Rejection)
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 63-64, 68-72, 76-91 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.
The term “msGAD55” in claim 63, line 14, is not clear what it is. As it encodes a secreted from of GAD65, it is considered as a gene or a plasmid, however, it is not clear what the scope of “msGAD55” encompasses. Applicant explained that “m” stands for methylation, and “s” is understood as “secreted”, however, there is no explanation with regard to the scope of this term. The specification discloses that pSG5-GAD plasmid was hypermethylated at CpG motifs, and this plasmid is referred as “msGAD55” (para. 133). However, there is no definition given to the term, and thus, the scope of this term is not clear if it is limited to pSG5-GAD or any gene capable of encoding sGAD55. According to the specification, the claimed second vector is msGAD55, however, the claim discloses that the second vector comprises a polynucleotide encoding a secreted form of GAD65 encoded by msGAD55, and thus, it is interpreted that the second vector contains msGAD55. Clarification is required.
Applicant is advised to amend the claim; for example:
63. A method of suppressing type 1 diabetes onset …
a first vector comprising a promoter operably linked to a first expression cassette encoding BCL2 associated X apoptosis regulator (BAX); and
a second vector comprising a promoter operably linked to a second expression cassette comprising hypermethylated CpG motifs and encoding secreted form of glutamic acid decarboxylase 65 (sGAD65), in an amount therapeutically effective…”
Claim Interpretation
Claims 63, 71, 78 discloses a step of 1) measuring a blood glucose level to determine whether the patient has severe hyperglycemia, and 2) administering the vector system to the patient if the patent has severe hyperglycemia.
The second step of the claims is a contingent limitation, and the claim does not require the second step if the patient does not have sever hyperglycemia. Thus, the administering step is not required for the claim. MPEP2111.04(II) states “[t]he broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.”
As the first step of measuring a blood glucose level is the only step that must be performed, and the second step is not required as discussed, claim 63, 71 or 78 is interpreted as a method of measuring a blood glucose level of a patient. The intended purpose of “to determine whether the patient has severe hyperglycemia” does not require any other active step than measuring a blood glucose level, and thus, it does not limit the claimed method of measuring a blood glucose level of a patient.
The dependent claims (claims 64, 68-70, 72, 76-77, 79-84, 86-87) are directed to the second step of claims 63, 71 and 78, and the results obtained by the second step of claims 63, 71 and 78. As the second step does not limit the claimed method due to its contingency nature, the dependent claims are interpreted the same as their corresponding independent claim.
Claim Rejections - 35 USC § 102 (New Rejection)
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.
Claim(s) 63-64, 68-72, 76-91 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Escher (US20080194510A1; IDS ref.; “Escher’510” hereinafter).
Escher’510 teaches a step of selecting an organism susceptible to developing the immune-mediated inflammatory disorder, and if the immune-mediated inflammatory disorder is diabetes, the selection can be made by identifying in the patient the presence of increasing hyperglycemia (para. 38). Escher’510 teaches a method of measuring fasting blood glucose in mice (para. 47). It is submitted that the measured fasting blood glucose level would inherently indicate whether the mice (patients) have hyperglycemia including severe hyperglycemia. Thus, the teaching of Escher’510 meets the subject matter of the instant claims.
As discussed above under “claim interpretation”, the limitations directed to the contingent limitation, i.e. the step of administering the claimed vector system, do not provide any weight in determining patentability.
Regarding claims 85, 88 and 91 directed to the blood glucose level measurement being a morning blood glucose measurement, this limitation is interpreted the same as measuring “fasting” blood glucose level, and as discussed above, Escher’510 teaches the limitation.
Thus, the reference anticipates the claimed invention.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Based on the instant amendment, the claim rejections under 35 U.S.C. 112, 102 and 103 presented in the previous OA have been withdrawn but new claim rejections are necessitated due to the instant amendment as discussed above.
Conclusion
No claims are allowed.
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.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631