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 arguments filed 1/8/2026 have been fully considered.
Claims 2-4, 6-9, 11-14, 16, 20, 22-29, 31-34, 37-66, 68-70, 75, 77-80, 83-85, and 87 have been cancelled. Claims 89-90 have been newly added.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 12/19/2023 is again acknowledged. The requirement was made final in the Office action dated 4/1/2024.
Claims 71-74, 76, 81-82, and 86 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/19/2023.
For clarity of the record, the species election set forth in the written restriction mailed 10/24/2023 concerning the consensus motifs for the beta solenoid domains has been withdrawn.
Specification
The replacement sequence listing submitted 1/8/2026 is acknowledged. The corrections to SEQ ID NOS: 148 and 150 are acknowledged.
Claim Objections
Claim 90 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 36. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
New claim 90 is directed to a concatemer comprising a sequence selected from the group consisting of SEQ ID NOS: 29-32 and 158-162.
Claim 36 as amended is directed to a concatemer comprising a sequence selected from the group consisting of SEQ ID NO: 29-32 and 158-162 wherein the concatemer comprises a first beta solenoid domain and at least a second beta solenoid domain, wherein the at least two beta solenoid domains are linked by a flexible linker formed from amino acid residues, wherein the beta solenoid domains and linker are able to be transcribed and translated as a single unit.
The sequences recited in claims 36 and 90 implicitly have the structural features detailed in claim 36. They are directed to concatemers of the same scope. Claims 36 and 90 are duplicate claims.
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.
Claims 17 and 88 are rejected under 35 U.S.C. 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.
Claim 17, part iii, has been amended to recite “where X₁ is a polar residue, optionally selected from C, R, H, K, D, E, S, T, N, or Q.”
Claim 17, part v, has been amended to recite “where X₁ is a hydrophobic residue, optionally selected from G. A, V, L, I, P, F, M or W.”
The claim is considered to be new matter as the choices of amino acids at the referenced position in part iii and part v are not optional. They must be selected from the named amino acids. The claim language introduced by applicant implies that there are other choices. There are not. See permitted variants set forth in SEQ ID NOS: 151 and 153.
Claim 17 constitutes new matter.
Claim 88 is currently directed to the concatemer of claim 36 consisting of two or more of the sequences according to SEQ ID NO: 29-32 and 158-162. Claim 88 is not an original claim. It was added by amendment on 8/1/2024. No specific basis has been pointed to for this claim and none is apparent. Each of the recited sequences is itself a concatemer comprising at least two beta solenoid domains linked by a flexible linker. At least for example, an embodiment where the concatemer of SEQ ID NO: 29 is fused to the concatemer of SEQ ID NO: 158 does not appear to have basis.
Claim 88 constitutes new matter. Applicant’s arguments that the amendments to claim 36 address this rejection are incorrect.
Amending claim 88 to recite “The concatemer of claim 36 consisting of a sequence selected from the group consisting of SEQ ID NO: 29-32 and 158-162” would place claim 88 in condition for allowance.
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 1, 5, 10, 15, 17-19, 21, 30, 35, and 88-89 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.
Claim 1 is confusing in reciting “beta solenoid domains in the first and second domains comprise an amino acid sequence.” Inclusion of the phrase “in the first and second domain” appears to be a word processing error as the claim was amended to remove the first domain and second domain language. Deleting this phrase would place claims 1, 5, 10, 15, 18-19, 21, and 35 in condition for allowance.
Claim 30 is confusing in reciting “and/or.” This claim language is not proper Markush group language and confusing. It appears that the claim should recite only “and” (i.e. solvent selected from the group consisting of: a) buffer selected from… and b) an organic solvent…”
Claim 88 does not make clear how the concatemer having multiple concatemer sequences recited in this claim are assembled. Claim 88 depends upon claim 36. At least for example, does claim 88 require that the entirety of the concatemer consisting of two or more of the recited concatemer sequences be transcribed and translated as a single unit via a flexible linker(s) formed from amino acids? At least for example, does the claim intend that the concatemer of SEQ ID NO: 29 be used to the concatemer of SEQ ID NO: 158 with a flexible linker? (Note that there does not appear to basis for a construct having the format SEQ ID NO: 29 fused to flexible linker fused to SEQ ID NO: 158 s set forth above.) Applicant’s response does not address this. The claim is confusing.
New claim 89 is confusing. The claim is directed to:
The concatemer of claim 1, wherein at least one of the capping sequences comprise
(a) a sequence that conforms to the consensus sequence of SEQ ID NO: 82 and/or SEQ ID NO: 83, optionally wherein the first cap conforms to SEQ ID NO: 82 and the second cap conforms to SEQ ID NO: 83; and/or
(b) any one or more of SEQ ID NO: 2, 3, 84-104 and 105-125
optionally wherein at least one of or both of or all of the capping sequence comprises a sequence with (i) at least 80% homology, optionally at least 85% homology, optionally at least 90% homology, optionally at least 95% homology, optionally at least 96% homology, optionally at least 97% homology, optionally at least 98% homology, optionally at least 99% homology, optionally 100% homology to SEQ ID NO: 2, 3, 84-104 or 105-125.
First of all, claim 1 recites capping sequences at the first end and the second end of each beta solenoid domain. It does not refer to a first cap or a second cap. There is no antecedent basis in claim 1 for the first cap and second cap. Secondly, claim 1 requires at least four capping sequences (located at the first and second end of each of the at least two beta solenoid domains, i.e. two capping sequences for each beta solenoid domain). Claim 89 does not clearly identify which of the four capping sequences required by claim 1 is being referenced. Reciting “both of” is ambiguous as to which capping sequences are intended. Finally, the use of “and/or” in multiple places in the claim is confusing as some of the combinations are mutually exclusive, particularly in view of the optional possibilities. At least for example, a particular capping sequence cannot conform to both SEQ ID NO: 82 and SEQ ID NO: 83 at the same time. At least for example, a particular capping sequence cannot conform to both SEQ ID NO: 82 and all sequences having 80% homology to SEQ ID NO: 125. It appears that all of the “and/or” references should have the “and” portion deleted.
Claims 36 and 67 are allowable.
While not explicitly recited in independent claims 1 and 67, the capping sequences must also be transcribed and translated as a single unit with the beta solenoid domains and linker.
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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