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
This Office Action is a response to Applicant’s Amendment and Remarks filed December 8, 2025.
Claims 81, 84, 90, 91 and 99 are pending in the present application.
Accordingly, claims 81, 84, 90, 91 and 99 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
Applicant's information disclosure statement (IDS) filed December 8, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant's IDS filed February 20, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Priority
Applicant is reminded that the present application has been afforded priority to the filing date to Provisional Application 62561939, filed 9/22/2017. For further explanation, see the previous Office Action mailed July 23, 2025 at pages 5 and 6.
Claim Rejections - 35 USC § 112
In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were 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. This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection Applicants traverse and argue that the application meets the Written Description requirements by teaching a person of ordinary skill in the art with exemplary types of bicyclic peptides (such as "a constrained bicyclic peptide") and exemplary sources of bicyclic peptide (such as "bicycles from Bicycle Therapeutics"). Applicants point the Examiner to para. [0262] of the application as filed. Applicant submit that before the afforded priority date the present application, step-by-step protocols for the isolation of bicyclic peptide ligands using phage display has been summarized by review articles and methods for making and screening combinatorial libraries of bicyclic peptides are known in the art. Applicants submit that a person of ordinary skill in the art would readily understand that Applicant was in possession of the claimed invention and requests withdrawal of the rejection.
Applicant’s arguments have been fully considered by the Examiner, however they are not found persuasive because similar to the University of Rochester v. G.D. Searle & Co. (2004) case, the present application has failed to describe or identify any specific compound that functions as claimed (e.g. induces skipping of an exon from a pre-mRNA transcript to generate a mRNA transcript that encodes a functional dystrophin protein). The Federal Circuit has held that merely disclosing a method for isolating or screening for a compound, without disclosing the compound itself or its structure, does not provide adequate written description for a genus. In University of Rochester v. G.D. Searle & Co., 358 F.3d 918 (Fed. Cir. 2004), the court invalidated claims to a genus of compounds (inhibitors of PGHS-2) because the patent did not disclose the structure of any compounds, only the method to find them.
Like Rochester, the present application does not describe the actual compound (the "structure") that is isolated or used, only the desired function. Also, the instant application and art may describe screening combinatorial libraries of bicyclic peptides, but this disclosure fails to provide the actual molecules identified by that method. The court determined that a patent cannot claim a compound merely by describing a way to find one.
The written description requirement requires that the Specification show that the inventor had possession of the claimed invention at the time of filing. A mere wish or plan for obtaining the claimed invention does not satisfy the written description requirement. In Rochester, the court determined the Inventors did not possess the specific compounds claimed. The Examiner maintains that like Rochester, the claimed compound is not described in the application as filed.
Also see MPEP § 2163; In re Gosteli 872, F.2d at 1012, 10 USPQ2d at 1618; and In re Clarke for reasons why the present application does not disclose a representative number of species to adequately described the breadth of the claimed invention.
Claim Rejections - 35 USC § 103
In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under 35 U.S.C. 103 as being obvious over WO 2016/187425 A1 in view of WO 2017/192679 A1 and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection Applicants traverse and argue that a person of ordinary skill in the art would not have arrived at the claimed invention. Specifically, Applicants submit that none of the cited references, alone or in combination, discloses, teaches, or suggests the ratio between the bicyclic peptide and the PMO is 2-12 and therefore the claims are not obvious in view of the cited references. Accordingly, Applicant respectfully requests withdrawal of the rejection.
Applicant’s arguments have been fully considered by the Examiner, however they are not found persuasive because WO 2016/187425 makes several references to, “one or more of the peptide-oligonucleotide-conjugates” of their invention.
Also, WO 2017/192679 teach the polynucleic acids conjugated to a targeting moiety x (n), wherein the integer (n) is 1-1000.
Therefore, contrary to Applicant’s arguments, the prior art teaches and suggests a ratio between the bicyclic peptide and the PMO is 2-12.
Double Patenting
In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,994,020 (Patent ‘020) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘020 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,179,472 (Patent ‘472) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘472 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,311,627 (Patent ‘627) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘627 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11,400,163 (Patent ‘163) (and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘163 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12,064,483 (Patent ‘483) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘483 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,071,621 (Patent ‘621) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘621 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
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In the previous Office Action mailed July 23, 2025, claims 81, 84, 90, 91 and 99 were rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,359,202 (Patent ‘202) and further in view of Rhodes and Pei (Chem. Eur. J., 2017 Vol. 23:12690-12703). This rejection is maintained for the reasons of record set forth in the previous Office Action mailed July 23, 2025.
Response to Arguments
In response to this rejection, Applicant requests that the Office hold any double patenting rejection over Patent ‘202 in abeyance until an allowable set of claims has been identified, upon which time Applicant will consider submitting a terminal disclaimer if so required.
This request has been considered and the Examiner will hold the double patenting rejection in abeyance until allowable subject matter is identified.
THIS ACTION IS MADE FINAL. 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 Terra C. Gibbs whose telephone number is 571-272-0758. The examiner can normally be reached from 8 am - 5 pm M-F.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635