Prosecution Insights
Last updated: July 17, 2026
Application No. 17/312,703

TRANSFERRIN RECEPTOR TARGETING PEPTIDES

Final Rejection §101§102§112§DP
Filed
Jun 10, 2021
Priority
Dec 14, 2018 — provisional 62/779,885 +3 more
Examiner
FISCHER, JOSEPH
Art Unit
1658
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Fred Hutchinson Cancer Research Center
OA Round
3 (Final)
43%
Grant Probability
Moderate
4-5
OA Rounds
0m
Est. Remaining
88%
With Interview

Examiner Intelligence

Grants 43% of resolved cases
43%
Career Allowance Rate
144 granted / 335 resolved
-17.0% vs TC avg
Strong +46% interview lift
Without
With
+45.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
24 currently pending
Career history
377
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
44.5%
+4.5% vs TC avg
§102
5.4%
-34.6% vs TC avg
§112
19.1%
-20.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 335 resolved cases

Office Action

§101 §102 §112 §DP
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 . Election/Restrictions – Modified based on Claim amendments Retained for the Record, Modified at End Applicant’s election without traverse of Group I in the reply filed on 6/21/24 is acknowledged. Claims 97-102 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/21/24. Applicant’s election of the single species without traverse is SEQ ID NO:67, Applicant stating on page 8 of the 6/21/24 reply as to this election, “as the engineered peptide (i.e., particular components of the composition of claim 1), which read on all the pending claims.” In that the Restriction Requirement clearly indicated election of a single species, identifiable by SEQ ID NO., the election of species is understood to be SEQ ID NO:67, that is the “engineered peptide” of claim 77 has (comprises, see Claim Interpretation below) a sequence that has 100 percent sequence identity with SEQ ID NO:67. The peptide of SEQ ID NO:67 does not comprise any of the additional features of claims 81-95. Claims 81-95 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/21/24. An engineered peptide comprising SEQ ID NO:67 was searched and found free of the art. In accordance with MPEP 803.02 III A, the search was extended to a first nonelected species. This first nonelected species is SEQ ID NO: 36, which as for SEQ ID NO:67 does not comprise any of the additional features of claims 81-95. SEQ ID NO:36 as the nonelected species is examined on the merits below for claims 77 to 80. See MPEP 803.02 III A. The prior art search is not extended unnecessarily to cover all nonelected species. After searching SEQ ID NO:36, the search was extended beyond SEQ ID NO:36 to SEQ ID NO:172 for compact prosecution. Based on 6/20/25 claim amendments, in which SEQ ID NO:36 is deleted, further in accordance with MPEP 803.02 III A, the search was extended to a SECOND nonelected species. This SECOND nonelected species is the fragment of SEQ ID NO: 136 between amino acids 20 and 51, inclusive, which as for SEQ ID NO:67 does not comprise any of the additional features of claims 81-95. This SEQ ID NO:136 fragment as the nonelected species is examined on the merits below. See MPEP 803.02 III A. The prior art search is not extended unnecessarily to cover all nonelected species. Because this second nonelected species fragment does not comprise a sequence of any one of SEQ ID NO:339-344 (see claim interpretation below), claim 78 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Additionally, based on the addition on 6/20/25 of new claim 103, which depends from claim 82, the previous withdrawal of nonelected species claims is amended as follows: Claims 81-95 and 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/21/24. Claim Status and Response to Applicant Remarks Regarding Withdrawn Claims Claims 1-76 are cancelled. Claims 77-103 are pending. Claims 97-102 are 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. Election was made without traverse in the reply filed on 6/21/24. Claims 78 and 81-96 and claim 103 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/21/24. Claims 77, 79 and 80 are pending and under examination. Claims 77, 79 and 80 are rejected. In response to applicant’s Remarks of 1/26/26 regarding Withdrawn Claims, the examiner acknowledges that upon identification of allowable subject matter in a claim from which withdrawn claims depend, rejoinder of such withdrawn claims will be considered. Priority The instant application, filed 06/10/2021 is a National Stage entry of PCT/US19/66376 , International Filing Date: 12/13/2019 PCT/US19/66376 Claims Priority from Provisional Application 62779885 , filed 12/14/2018 PCT/US19/66376 Claims Priority from Provisional Application 62836520 , filed 04/19/2019. Claim Interpretation – Modified in Accordance with Applicant’s 1/26/26 Remarks The claim limitations are given their broadest reasonable interpretation (BRI) consistent with the specification, MPEP 2111, and under the BRI, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification, MPEP 2111.01. The transitional term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements. See MPEP 2111.03. The claim 77 composition that comprises an “engineered peptide” is interpreted to be inclusive, so does not exclude additional unrecited elements in addition to the specifically recited “engineered peptide.” However, no additional unrecited elements are explicitly set forth in the composition. Additionally, Applicant’s use of “comprises” in line 2 of claim 77 is interpreted to mean that the “engineered peptide” does not exclude additional unrecited elements, here interpreted to mean amino acids of the engineered peptide, in addition to the specifically recited alternative subgenera listed in a), b), and c) of claim 77. Transitional phrases such as "having" must be interpreted in light of the specification to determine whether open or closed claim language is intended. See MPEP 2111.03. Paragraph 252 states that “comprising” and “having” “can be used interchangeably”, so supporting inclusive, open-ended interpretation of “having” in claim 77. Considering that “comprises” is already set forth on line 2 of claim 77 three words before “having”, and considering the listing of subgenera alternatives in a), b), and c) of the claim that include not only subgenera that fall within 90% sequence identity of listed SEQ ID numbers but also “or a variant or a functional fragment thereof” of such subgenera, and considering the specification, “having” is interpreted to indicate that the line 2 sequence, which is part of or is all of the “engineered peptide” depending on whether additional amino acids are in it (see interpretation of comprises above), 1) must possess at least 90% sequence identity with one of the listed SEQ ID numbers, or 2) must be a “variant” or a “functional fragment” of a sequence that meets the required “having” sequence identity. Given the positioning of “comprises” on line 2, the use of “having” does not limit the size of the sequence nor the “engineered peptide.” (The examiner notes that an alternative language for claim 77 could eliminate “having” on line 2 and insert “having” before “at least” in each of a), b) and c) subparts of claim 77. However, this would not alter the interpretation.) Further as to “variant thereof”, paragraph 260 on page 62 states: PNG media_image1.png 307 716 media_image1.png Greyscale This further supports that the scope of “engineered peptide” encompasses sequences longer than any of the claim 77 sequences identified by SEQ ID number, and indicates that “variant thereof”, interpreted to apply both to the 12 SEQ ID Number-specific sequences of claim 77 and any sequence having at least 90% sequence identity with these, encompasses a broad scope of peptide sequences that can have many insertions, deletions and substitutions relative to a listed sequence of which it is a variant, or to any sequence having at least 90% sequence identity with these, and based on these insertions, deletions and substitutions can include natural sequences. Considering the scope of possible insertions, deletions and substitutions possible for a variant, applicant is claiming every polypeptide. “Peptide”, “polypeptide” and “protein” “can be used interchangeably” per paragraph 250, so there is no size limit on the claim 77 “engineered peptide.” “Engineered” as applied to polypeptide, protein, or peptide is stated to be the following: PNG media_image2.png 438 714 media_image2.png Greyscale As to interpretation of what is claimed in claim 77, the above paragraphs 255 and 256 provide alternatives that extend in different ways what can be considered “engineered” – in one paragraph being found in a condition other than its native environment, so this including purification, in the other paragraph “distinct from a naturally occurring polypeptide structure, sequence or composition,” this inclusive of the engineered peptide being separated from the cell or tissue composition where it is normally found in nature, but also “distinct from a naturally occurring polypeptide structure, sequence or composition.” Which “naturally occurring polypeptide structure, sequence or composition” the “engineered” peptide is distinct from is not set forth, and this is interpreted to mean not the same, as to structure, sequence or composition, when compared to any naturally occurring peptide. The examiner notes that when a claimed peptide or protein genus encompasses a natural peptide or protein, or a claimed peptide or protein is identical in structure with a natural peptide or protein, merely stating that it is “engineered”, so it is “found in a condition other than its native environment”, or ‘distinct’ – without reference to what is being referred to, does not relieve applicant of US patent law as applicable to identical natural sequences. For example, please see MPEP 2106 and particularly its discussion of “isolated” as applied to DNA, including “claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception".” More particularly as to “engineered peptide” as claimed, a denatured peptide of the same sequence has a different structure than a non-denatured naturally occurring peptide, a peptide in aqueous solution in a vial has a different composition than a naturally occurring peptide in a cell or tissue space, and a specific peptide sequence that corresponds to a known naturally occurring peptide is distinct from another similar naturally occurring peptide having a somewhat different sequence, and is also distinct from less related peptides, the latter also meeting paragraph 256’s “from a naturally occurring polypeptide … sequence”. Response to Applicant 1/26/26 Arguments/Remarks The examiner accepts applicant’s claim interpretation as set forth beginning on page 9, and ending on the second line of page 10, of the Remarks of 1/26/26, and agrees that as amended 1/26/26 that claims 79 and 80 do “include the fragment thereof comprising at least 29 amino acids and … that the use of “comprises” and “the fragment thereof” includes longer sequences comprising any one of the amino acid sequences of the claim-listed SEQ ID numbers, or a shorter form (fragment) of any one of the amino acid sequences of the claim-listed SEQ ID numbers.” Therefore, the last paragraph of the examiner’s Claim Interpretation section in the 7/24/26 Non-final Office action is no longer considered relevant, and has been removed. Claim Rejections - 35 USC § 101 Applicant’s arguments, see pages 10-11, filed 1/26/26, and claim amendments, with respect to the rejection of claims 77, 79 and 80 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejection of claims 77, 79 and 80 under 35 U.S.C. 101 has been withdrawn. Claim Rejections - 35 USC § 112 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. Response to Arguments Applicant’s arguments, see pages 12-13, filed 1/26/26, and claim amendments, with respect to the rejection(s) of claim(s) 77 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. This withdrawal is based largely on the claim amendment to claim 77 now focusing the engineered peptide on binding transferrin receptor as opposed to previously binding transferrin. However, upon further consideration, and considering the aforementioned amendment, a new ground(s) of rejection is made in view of newly introduced claim limitation(s). The previous separate second rejection, of claim 79 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn based on applicant argument and claim amendment. Applicant’s arguments, see page 12, filed 1/26/26, with respect to the rejection of claim 79 based on 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, have been fully considered and are persuasive. This rejection of claim 79 has been withdrawn. Claims 77, 79 and 80 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 77 is directed to a composition comprising an engineered transferrin receptor-binding peptide, this comprising any of a number peptide genera that have at least 90% sequence identity with a stated SEQ ID Number and fragments thereof comprising at least 29 amino acids (and also at least 95% sequence identity with any of SEQ ID NO:1, 36, 136, 171 (see “d)”) or one of its fragments comprising at least 29 amino acids). While functional limitations may be properly used in claims, the boundaries imposed by a functional limitation must be clearly defined to be definite under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Here, there is no indication nor relevant limitations in the claims as what amino acid sequences or sub-sequences of the claimed peptides and their fragments must be retained, or can be modified but only by particular substitutions or additions (at least 90% sequence identity allows for up to 5 modified amino acids of the 51 amino acid peptides encompassed by the claim 79), and still meet the functional limitation of binding transferrin receptor. Additionally, given the line 2 transition “comprises” in claim 77 larger peptides can encompass any of the peptide/peptide fragments of claim 77 and be within the scope of the claim. There is no indication to what extent additional sequences need to be limited to retain the claimed function. In summary, particularly given the up to 10% substitutions that can be made to most listed sequences of claim 77, and given the lack of any requirements for limitations on structure to achieve the claimed function, claim 77 is unclear because the claim does not provide a discernable boundary on what sequences, structures, or arrangement of elements provides the ‘transferrin-receptor binding’ function to the peptide of the claimed composition. One of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claim. As such claim 77 is rejected as indefinite under this section. Claims 79 and 80, depending from claim 77 and not resolving this problem, also is rejected under this section. 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. Response to Arguments Applicant’s arguments, see page 13, filed 1/26/26, and claim amendments, with respect to the rejection(s) of claim(s) 77, 79 and 80 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), first paragraph, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, particularly in view of claim amendments, a new ground(s) of rejection is made in view of newly introduced claim limitation(s). The examiner also notes that he is concerned with what appears to him to be a discrepancy in what various subgenera of peptides including fragments set forth in the instant claims bind to. The examiner notes that in a corresponding EPO allowed application, EP 19 897 452.9, the claims are directed to some of the same subgenera as instantly claimed to be peptides that bind transferrin, whereas in the instant claims at least some of the same peptides of these subgenera are claimed to bind transferrin receptor. The examiner is concerned how at least for some of the same peptides, these are so structured as to bind both transferrin and at least one of its receptors, which would seemingly require different structures and chemical behaviors/linkages. Claims 77, 79 and 80 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. Remaining basis: The examiner notes that given the line 2 open transition “comprises” there is no size limit on the claim 77 “engineered peptide;” any number and types of amino acids can be added to one or both of the N- and the C-termini of the listed sequences and their claimed fragments. Thus, apart from the limitation as to binding transferrin receptor, what is claimed encompasses a huge and diverse genus of peptides/proteins. Applicant has demonstrated binding to transferrin receptor with a much smaller and closely related subgenus, none of these comprising substitutions approaching 10%, and also has not provided teaching or guidance or structure/function relationships across the claimed genus of what changes can be made and still provide a peptide that binds transferrin receptor. The claim scope – of possible peptides that bind transferrin receptor and fall within the respective 90% or 95% of respective sequences identified in claim 77 by SEQ ID Number, as well as fragments thereof having at least 29 amino acid residues, is much broader and much more diverse than the few species for which applicant shows such binding. As such, based on the lack of sufficient structure/function relationship, examples and relevant disclosure that are commensurate with the breadth of what is encompassed by the claim, the examiner concludes that applicant is not in possession of the full scope of the claimed genus. There is no indication that one of ordinary skill in the art could determine what structure/sequence must be maintained or retained to achieve this function of binding transferrin, such as based on knowledge in the art. Please note that although later-than-earliest-priority published Crook et al., Jl. Mol. Biol, 2020, 432, 3989-4009, previously provided (its authors including instant inventors), teaches the multiple steps to identify three particular peptides modified from a native protein portion that exhibit increased binding to transferrin receptor, see Figure 2 and associated text, neither applicant’s application as filed, nor when considering the knowledge in the art at the time of applicant’s filing, provide sufficient teachings to particularly point out and distinctly claim the subject matter for the genus of peptides meeting the structural limitations of the claims, where for various peptides up to five modifications along a 51 amino acid sequence are allowed given the at least 90% sequence identity, that also provide the now-required function of binding transferrin receptor. Further to this point for the benefit of applicant, the skilled artisan cannot envision the detailed chemical structure alternatives (i.e., amino acid sequences) of the encompassed peptides which have the respective required activity/function of binding transferrin without further testing, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. Adequate written description requires more than a mere statement that it is part of the invention. The compound itself is required; in this case at least a sufficient number of species that are representative of the diversity of each respective genus, and/or a disclosure of what is critical as far as sequence(s) and what does not work to achieve a particular claimed activity/function. Here, given the breadth of possible modifications across the length of a peptide encompassed by the genera of claim 77 (each SEQ ID Numbered sequence representing a starting point for a genus that can be modified to the claimed percentage identity), the skilled artisan is left to determine what range and types of modifications can still provide some level of the required transferrin binding (such as by pursuing approaches such as those in the Crook reference, however seeking what still falls within what is claimed). This is leaving completion of the invention to someone else. See also Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 (BPAI 1993). In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. §112, first paragraph. Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115). Based on the above claim 77 is rejected under this section. Claims 79 and 80 do not resolve the above issues and also are rejected under this section for the reasons set forth above for claim 77. Claim Rejections - 35 USC § 102 Response to Arguments Applicant’s arguments, see pages 13-14, filed 1/26/26, and claim amendments, with respect to the rejection of claim(s) 77, 79 and 80 under 35 U.S.C. 102(a)(1) as being anticipated by EMBL EDQ89138, 2 pages, published 2008 (EMBL, previously provided), as evidenced by Crook et al., Journal of Molecular Biology (2020) 432, 3989–4009 (Crook) have been fully considered and are persuasive. The rejection of claim(s) 77, 79 and 80 under 35 U.S.C. 102(a)(1) has been withdrawn. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Response to Arguments Applicant's arguments filed 1/26/26 have been fully considered but they are not persuasive. Applicant argues that instant claims 77, 79 and 80 are patentably distinct from claims 165 and 171 of the reference application, and copies a portion of the form paragraph of the rejection. This is not persuasive because there is a portion of the larger (2-part) peptide complex of reference application claim 165 that is identified as “a transferrin receptor-binding peptide,” and it is this, as evidenced in the rejection below, that is not patentably distinct from what is instantly claimed. The argument against the wording of the form paragraph statement is not persuasive particularly when considering whether a subcomponent of the reference application, identical to what is claimed, would render obvious to one of ordinary skill in the art what is instantly claimed (the answer to which, in the examiner’s opinion, is “yes”). Claims 77, 79 and 80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 165 and 171 of copending Application No. 18037923 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other at least because the peptide corresponding to instant SEQ ID NO:172 has at least 90% sequence identity to a peptide of reference application, stated to be transferrin receptor binding, corresponding to reference application SEQ ID NO:34 (actually, 100% sequence identity; and also 100% sequence identity to SEQ ID NO:98, comparison not shown; note that SEQ ID NO:34 is within the range of claim 171’s “SEQ ID NO:1 – SEQ ID NO:64”): PNG media_image3.png 775 744 media_image3.png Greyscale With regard to function, as to whether transferrin binding or transferrin receptor binding, the same peptide has the same properties. Regarding instant claim 79, SEQ ID NO:172, which is identical to reference application SEQ ID NO:34, is explicitly recited. Regarding instant claim 80, reference application SEQ ID NO:34 comprises six cysteines and would comprise at least two disulfide bonds in a medium with suitable oxidation conditions. As set forth above, the properties or functions associated with the same or similar peptide sequences are the same. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. 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 JOSEPH FISCHER whose telephone number is (571)270-7925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Wednesday-Friday and on Monday/Tuesday on alternating weeks, but will promptly answer messages upon his return to work. 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, MELISSA FISHER, can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JOSEPH FISCHER/Primary Examiner, Art Unit 1658
Read full office action

Prosecution Timeline

Jun 10, 2021
Application Filed
Jan 23, 2025
Non-Final Rejection mailed — §101, §102, §112
Jun 20, 2025
Response Filed
Jul 24, 2025
Non-Final Rejection mailed — §101, §102, §112
Jan 26, 2026
Response Filed
Jun 04, 2026
Final Rejection mailed — §101, §102, §112 (current)

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Prosecution Projections

4-5
Expected OA Rounds
43%
Grant Probability
88%
With Interview (+45.5%)
3y 4m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 335 resolved cases by this examiner. Grant probability derived from career allowance rate.

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