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 .
Claim Status
Claims 1, 8, 10, 22-26, 28, 31, 106-107, 115-116, 118-119, 122, 129, and 132 were previously pending.
A Non-Final Rejection office action was mailed 22 December 2025.
In response to that 22 December 2025 office action, Applicant filed an Amendment/Request for Reconsideration received 18 June 2026.
In that Amendment/Request for Reconsideration, Applicant amended claims 8, 10, 22-23, 106-107, 115-116, and 132 and cancelled claim 1. No claims were added.
Therefore, claims 8, 10, 22-26, 28, 31, 106-107, 115-116, 118-119, 122, 129, and 132 are now pending and currently under examination.
Priority
Applicant’s claim to the following priority is acknowledged:
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Withdrawn Objections/Rejections
I. The formatting of the claims was previously objected to. Applicant’s newly filed response is in compliance with 37 CFR 1.121(c)(1), so the previously held objection is now moot and hereby withdrawn.
II. Claims 8, 23-25, and 31 were previously objected to as being dependent upon a rejected base claim. Applicant’s cancellation of claim 1 and amendment to claim 8 was sufficient to overcome the previously held objection of claims 8, 23-25, and 31 and the objection is hereby withdrawn.
III. Applicant’s cancellation of claim 1 was sufficient to overcome the previously held rejection of: claims 1, 106, 107 and 132 under 35 USC 103 as being unpatentable over Beliveau (WO 2017/088058 A1; published 1 June 2017); and claims 22, 115-116, 118-119, 122, and 129 are rejected under 35 U.S.C. 103 as being unpatentable over Beliveau (WO 2017/088058 A1; published 1 June 2017) in further view of Prakash (“Evaluation of the effect of 2’-O-methyl, fluoro hexitol, bicyclo and Morpholino nucleic acid modifications on potency of GalNAc conjugated antisense oligonucleotides in mice,” published: 10 October 2028). Therefore, the aforementioned rejections under 35 USC 103 are hereby withdrawn.
IV. Applicant’s amendment to claim 10 was sufficient to overcome the previously held rejection of claim 10 under 35 USC 112(b). Therefore, this rejection, as it pertains to claim 10 only, is hereby withdrawn.
Maintained Claim Rejections
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.
Claims 26 and 28 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 26 recites, for example (emphasis added), the following limitation: “…wherein the peptide extender comprises an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or 100% identical to X1PPPAGSSPG (SEQ ID NO: 49)…wherein X1 is selected from lysine, 2-azido-acetyl lysine, D-lysine, L-lysine, N6-(2-azido-acetyl)-D-lysine, and N6-(2-azido-acetyl)-L-lysine.” However, the sequence listing submitted by the Applicant is as follows:
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Applicant has indicated the wildcard, X, can be any naturally occurring amino acid. What is claimed in instant claim 26 does not correspond with Applicant’s sequence submission (e.g., 2-azido-acetyl lysine is not naturally occurring) and therefore, claim 26 is indefinite as one of ordinary skill in the art could not determine the metes and bounds of the claim.
Claim 28 recites, for example (emphasis added), the following limitation: “…wherein the peptide extender comprises an amino acid sequence that is at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or 100% identical to XPPPAGSSPG (SEQ ID NO: 49)…wherein X is any amino acid.” However, the sequence listing submitted by the Applicant is as follows:
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Applicant has indicated the wildcard, X, can be any naturally occurring amino acid. What is claimed in instant claim 28 does not correspond with Applicant’s sequence submission (e.g., any naturally occurring amino acid vs. any amino acid) and therefore, claim 28 is indefinite as one of ordinary skill in the art could not determine the metes and bounds of the claim.
Response to Applicant Arguments
Applicant has set forth their amendment to the sequence listing is allegedly sufficient to overcome the previously held rejection under 35 USC 112(b) (see Remarks, p. 9). As emphasized above, SEQ ID NO: 49 was an example of the claim defect that was pervasive throughout the sequences recited in the rejected claims. Applicant has only amended the disclosure pertaining to a single SEQ ID NO when the same error was present in each recited sequence expressing a wildcard identifier. Applicant cannot identify the wildcard variable, X, as any naturally occurring amino acid in the sequence disclosure, but then attempt to broaden the scope of the wildcard in the claim by reciting X is any amino acid. It is improper to import the narrower disclosed embodiment into broader express claim language. Applicant is required to amend all sequences pertaining to this defect or otherwise reconcile the inconsistencies.
Conclusion
Claims 26 and 28 are rejected. Claims 8, 10, 22-25, 31, 106-107, 115-116, 118-119, 122, 129, and 132 are allowable.
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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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