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 .
Application Status
Applicant’s remarks, replacement drawings, Declaration under 37 C.F.R. § 1.132, and amendments to the claims filed June 16, 2026 are acknowledged. Claims 1, 5, 14, 21, 27, 32, 34, and 41 were amended, claims 3-4, and 40 were cancelled, and claims 42-44 were introduced. Accordingly, claims 1-2, 5-6, 8-9, 11, 13-14, 21, 24, 26-27, 32, 34, 38, and 41-44 are pending.
Restriction/Election
Claims drawn to the elected invention are allowable for the reasons described in paragraph 13 below. The restriction requirement as set forth in the Office action mailed on September 5, 2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is maintained because the nonelected claims do not require all the limitations of an allowable claim.
Specifically, with respect to Group II (claims 32 and 34), while the claims require a nucleic acid encoding a split intein-reporter polynucleotide construct comprising the features of the split intein-reporter polynucleotide construct of the allowable claims, the claims do not require I) the gene comprising an exon into which the construct is inserted, II) the specific RNA splice product, or III) the expression product of the split intein-reporter polynucleotide construct, which are required features of the allowable claims. Claim 38 of Group III depends from claim 32 of Group II, and, similarly, does not recite all the limitations of an allowable claim.
Accordingly, claims 32, 34, and 38 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-2, 5-6, 8-9, 11, 13-14, 21, 24, 26-27, and 41-44 are under consideration hereinafter.
Priority
Applicant’s priority claims to Application Nos. LU101118 and PCT/EP2020/052985 are acknowledged. Claims 1-2, 5-6, 8-9, 11, 13-14, 21, 24, 26-27, and 41-44 find support in Application No. LU101118 and therefore, the effective filing date of the claims under examination is February 6, 2019.
Withdrawn Rejections
Applicant’s remarks, Declaration under 37 C.F.R. § 1.132, and amendments have been thoroughly reviewed. The amendments to the claims overcome the claim objections and § 112(d) rejections raised in the prior action. These objections and rejections are withdrawn, accordingly.
Applicant’s remarks regarding the § 112(a) Scope of Enablement rejections raised in the prior action, as well as the content of the Declaration under 37 C.F.R. § 1.132, have been reviewed. The remarks and Declaration under 37 C.F.R. § 1.132 are sufficient to overcome the § 112(a) Scope of Enablement rejections raised in the prior action. The Declaration cites evidence from the prior art (i.e. Selgrade et al., and Carvajal-Vallejos et al.; both of record) that the recited split inteins, i.e., gp41-1 as set forth in SEQ ID NOs: 2 and 4, and NrdJ-1 as set forth in SEQ ID NOs: 1 and 3, would be predicted to function in the context of the recited split intein-reporter polynucleotide construct. This is supported by evidence in the specification, which shows that the recited split inteins function in diverse exon contexts, when flanking diverse reporter polynucleotides representative of those instantly claimed (i.e., NanoLuc, HaloTag, scAvidin, firefly luciferase). The remarks also cite evidence in the specification (i.e., Example 2) that coiled-coil domains improve the method, but are not required for the method. Taken together, the Declaration and Applicant’s remarks provide sufficient evidence that the methods are sufficiently enabled across their scope. The § 112(a) Scope of Enablement rejections raised in the prior action are withdrawn, accordingly.
Applicant’s remarks and amendments are not persuasive to place the claims in condition for allowance for the reasons that follow. Any objection or rejection not reiterated herein has been overcome by amendment.
Claim Objections
Claims 5 and 13 are objected to because of the following informalities:
Claim 5 appears to be missing the term “and” between the last two phrases and should be amended to recite, “or Renilla luciferase, and wherein, when the reporter protein is a genetically encoded receptor….”
Claim 13 should be amended to recite “step(ii).”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 5 is 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 rejection that follows is new and necessitated by Applicant’s amendments to the claims.
Claim 5 recites “HaloTag.” Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name “HaloTag” is used to describe a modified haloalkane dehalogenase designed to bind synthetic ligands. Accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The rejection that follows is new and necessitated by Applicant’s amendments to the claims.
Claim 5 recites “wherein, when the reporter protein is a genetically encoded receptor for multimodal contrast agents it comprises single chain Avidin or HaloTag.” Claim 1 recites “a genetically encoded receptor for multimodal contrast agents selected from the group consisting of Avidin, Streptavidin, and a modified haloalkane dehalogenase designed to bind synthetic ligands.” The grouping of “genetically encoded receptor for multimodal contrast agents” recited in claim 1 is not “open” due to the phrase “selected from the group consisting of.” The phrase “comprises single chain Avidin or HaloTag” expands the grouping, and therefore, claim 5 is of improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
It would be remedial to the aforementioned § 112(b) and § 112(d) issues in claim 5, to amend claim 1 to recite the following, for example:
“wherein the reporter polynucleotide encodes a reporter protein, wherein the reporter protein is a fluorescent protein, a bioluminescence-generating protein, Avidin, Streptavidin, single chain Avidin, green fluorescent protein, Cypridina luciferase, Firefly luciferase, Renilla luciferase, or a protein set forth in one of SEQ ID NOs: 33-40….”
The suggested amendment above sets forth each of the alternatives recited in claims 1, 5, and 41. Should Applicant adopt the suggestion above, Applicant should cancel claims 5 and 41.
Allowable Subject Matter
A thorough search of the prior art failed to uncover any teaching or suggestion of the instantly claimed methods. The closest prior art to the claimed methods is described by Muller (of record). However, as described in the previous actions, Muller’s method detects a specific protein splicing event. Neither Muller, nor the remaining prior art reviewed during the course of examination suggests the use of Muller’s method, or any other similar prior art method, for detecting a specific RNA splice event of a gene as instantly claimed. As described above in paragraph 5, the specification provides sufficient working examples and guidance in view of the prior art to achieve the claimed methods’ outcome. Claims 1-2, 5-6, 8-9, 11, 13-14, 21, 24, 26-27, and 41-44 are free of the prior art considered during examination and sufficiently enabled across their scope.
Conclusion
Claims 1-2, 6, 8-9, 11, 13-14, 21, 24, 26-27, and 41-44 are allowable.
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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/JENNA L PERSONS/Examiner, Art Unit 1637
/Soren Harward/Primary Examiner, TC 1600
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