DETAILED ACTION
Applicant’s amendments filed on 6/3/26 has been entered. Claims 2-3 have been canceled. Claims 1 and 4-29 are currently pending and under examination in the instant application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Those sections of Title 35, US code, not included in this action can be found in the previous office action.
37 CFR 1.821-1.825
This application continues to fail to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. As stated in the previous office action, Figure 3 and Figure 61, and at least specification page 139 each contain one or more amino acid sequence disclosure(s) that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821 (a)(1) and (a)(2) and which are not identified by SEQ ID NO. Applicant was further encouraged to review the specification for additional sequences which are not identified by SEQ ID NO. The previous office action also noted that the Brief Description of the Drawings present in the specification also does not provide SEQ ID NOS for any of the amino acid sequences present in Figures 3 and 61. Compliance with 37 CFR 1.821-1.825 requires that the specification be amended to recite SEQ ID NOS. for each recitation of a sequence in the specification, including the drawings.
The applicant argues that they have complied with the sequence requirements set forth in 37 CFR 1.821-1.825 because the USPTO accepted the sequence listing submission as indicated by the filing receipt for the application issued on 12/6/23. The applicant also argues that Fig. 3 shows specific site-specific amino acid substitutions in the mature, human IGF2 peptide and that these variant peptides do not represent particular amino acid sequences per se but rather illustrates several potential amino acid sequences. In regards to Fig. 61, the applicant states that the sequences appearing in this figure are identified in the sequence listing as specific sequences. Finally, the applicant argues that 2 of the sequences disclosed on page 139 have specific SEQ ID NOS and that the third sequence is a combination of those 2 identified sequences.
In response, applicant’s arguments are not found persuasive because an accepted submission of a sequence listing is not sufficient to demonstrate compliance with 37 CFR 1.821. Specifically, 37 CFR 1.821(d) recites:
(d) Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing,” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5)), preceded by “SEQ ID NO:” or the like, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5)), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.823(a)(5)) in the Brief Description is clear.
The sequences present in the indicated Figures and on page 139 do not meet this requirement as the sequences in Figures 3 and 61 are neither identified in these Figures by SEQ ID NO nor identified by SEQ ID NO in the brief description of these Figures in the specification. In addition, applicant’s argument the sequences in Figure are variant sequences which are illustrative in not persuasive as each recitation of a sequence which meet the requirements set forth in 37 CFR 1.821(a), which each of these variants does, must be identified in the Figure or the brief description of the Figure. Applicant is also pointed to MPEP 2422 IV which states in regards to variant sequences:
Where the variant sequence meets the length thresholds of 37 CFR 1.821(a) and is disclosed by enumeration of its residues anywhere in an application, it must be presented in a “Sequence Listing” in a manner that complies with the requirements of the sequence rules.
Thus, the variant sequences which meet the length thresholds of 37 CFR 1.821(a) must each be presented individually in the sequence listing and assigned a SEQ ID NOS which must then be recited for each recitation of that sequence whether in the Figures or in the specification. Finally, applicant’s argument that the first two sequences lacking SEQ ID NOS on page 139 are present in the sequence listing does not meet the requirements of 37 CFR 1.821 because these sequences on page 139 do not include the appropriate sequence identifiers for those sequences. For the third sequence, which applicant argues is a combination of the other two sequences, this third sequence meets the length thresholds of 37 CFR 1.821(a) and must be presented individually in the sequence listing and assigned a SEQ ID NOS.
Therefore, as set forth in the previous office action, if the sequences are present in the paper and CRF listings, applicant may fully comply with 37 CFR 1.821 by amending the specification for page 139, or both of the drawings and brief description of the drawings for Figures 3 and 61 to include the appropriate SEQ ID NOS present in each of Figures 3 and 61. If the sequences are not present on the filed paper and CRF listings, then new paper and CRF sequence listings are required as set forth in the Notice to Comply mailed on 12/3/25. For clarity, the following instructions are provided:
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2) which are not present in the filed sequence listing.
Required response – Applicant must provide:
A "Sequence Listing" which contains each sequence which meets the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted as indicated above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If a "Sequence Listing" has previously been made part of the disclosure, applicant must provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement as indicated above.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
The objection to claims 13, 15, and 16 for informalities is withdrawn in view of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
The rejection of claim 13 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, is withdrawn in view of the amendments to the claims.
Pending and amended claims 1 and 4-29 remain 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. Note that previously rejected claims 2-3 have been canceled. Applicant’s amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record.
The applicant argues that the claims are defined by a structure and not by a function and that therefore the claims meet the requirements for written description. In response, this is not agreed. It is first noted that the specification does not provide a written description for any vIGF2 peptide sequence that meets both of the claimed requirements of 1) being at least 95% identical to one of SEQ ID NOS 90-103, and 2) being at least 98% identical to SEQ ID NO: 120 or SEQ ID NO:121 as recited by amended independent claim 1. SEQ ID NOS 120 and 121 are both 59 amino acid peptides which differ from one another by one amino acid. A sequence which is 98% identical to an amino acid sequence of SEQ ID NO 120 or 121 can only differ from the sequence of either SEQ ID NO 120 or 121 by 1 amino acid. SEQ ID NOS 90-103, however are either longer sequences -63 amino acids in length, or shorter sequence- 53 or 55 amino acids in length. SEQ ID NOS 120 and 121 do not share 95% sequence identity with any of SEQ ID NOS 90-130. SEQ ID NOS 90-103 only share between 74.2%- 84.5% sequence identity to SEQ ID NO 120, or 121. Further, even at 95% sequence identity to SEQ ID NOS 90-103, no sequence with this level of homology to any of SEQ ID NOS 90-130 can qualify as a sequence with 98% to SEQ ID NO:120 or 121 because 95% to homology to any one of SEQ ID NOS:90-103 allows for only between 2-3 amino acid differences which is not enough to achieve 98% identity to SEQ ID NOS 120 or 121 and vice versa. Further, the specification provides no description of any vIGF2 sequence that meets the parameters of amended claim 1, including SEQ ID NOS 120 and 121, as neither of these sequences is at least 95% identical to any of SEQ ID NOS 90-103. As such, claims 1 and 4-29 fail to describe the a genus of vIGF2 peptides which meet the limitations of independent claim 1.
A patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Further, possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features if there are any. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895. Applicant must instead convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show that Applicant was in possession of the claimed genus. As discussed above, based on the limitations of the claimed vIGF2, the specification does not disclose a single species which meets these parameters, and further based on the sequences and level of sequence identify between the sequences claimed, there does not appear to be any amino acid sequence, disclosed or nondisclosed, which can simultaneously be at least 95% identical to one of SEQ ID NOS 90-103 and 98% identical to SEQ ID NOS 120 or 121. Therefore, for the reasons set forth above, the skilled artisan would not have viewed the teachings of the specification as sufficient to show that the applicant was in possession of the claimed genus of variant IGF2 peptides or fusion proteins comprising these peptides.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 4, 7-11, 13-14, and 18-29 under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0193261 (6/23/22), hereafter referred to as Wilson et al., with an effective filing date of 4/30/19, is withdrawn in view of applicant’s amendments to the claims. While Wilson et al. teaches a vIGF2 peptide, SEQ ID NO:46, which is greater than 95% identical to instant SEQ ID NO:102 (Wilson et al., paragraph 62 and Table of vIGF2), this sequence is not at least 98% identical to SEQ ID NOS 120 or 121.
Claim Rejections - 35 USC § 103
The rejection of claims 1-2, 4, 7-11, 13-14, and 18-29 under 35 U.S.C. 103 as being unpatentable over US 2022/0193261 (6/23/22), hereafter referred to as Wilson et al., with an effective filing date of 4/30/19, in view of US 2016/0129126 (2016), hereafter referred to as Do et al., is withdrawn in view of the cancellation of, or the amendments to the claims.
While Wilson et al. teaches a number of nucleotide sequences encoding a vIGF2 peptide useful as part of the vIGF2-hGAA fusion protein, Wilson et al. does not specifically teach a vIGF2 peptide which is at least 98% identical to an IGF2 variant peptide with the sequence set forth in SEQ ID NOS 120 or 121. Likewise, while Do et al. teaches a vIGF2 peptide with sequence identified as SEQ ID NO:2 which is 98.5% identical to instant SEQ ID NO:106 (Do et al., paragraph 32 and Table II), the sequence taught by Do et al. is not at least 98% identical to SEQ ID NOS 120 or 121.
The rejection of claims 11-12, 15-16 under 35 U.S.C. 103 as being unpatentable over US 2022/0193261 (6/23/22), hereafter referred to as Wilson et al., with an effective filing date of 4/30/19, in view of US 2016/0129126 (2016), hereafter referred to as Do et al., as applied to claims 1-2, 4, 7-11, 13-14, and 18-29 above, and further in view of Gabig-Ciminska et al. (2015) Curr. Mol. Med., Vol. 15, 746-771, is withdrawn for the same reasons set forth above.
The rejection of claim 17 under 35 U.S.C. 103 as being unpatentable over US 2022/0193261 (6/23/22), hereafter referred to as Wilson et al., with an effective filing date of 4/30/19, in view of US 2016/0129126 (2016), hereafter referred to as Do et al., as applied to claims 1-2, 4, 7-11, 13-14, and 18-29 above, and further in view of Kan et al. (2014) Biochem. J., Vol. 458, 281-289, is withdrawn for the same reasons set forth above.
Double Patenting
The rejection of claims 1-2, 4, 7-11, 13-15, and 18-27 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,874,750, hereafter referred to as the ‘750 patent, is withdrawn in view of the cancellation of or amendments to the claims. Claim 1 as amended does not encompass a vIGF2 peptide comprising the sequence of SEQ ID NO:31 that binds to CI-MPR as recited in the ‘750 patent claims (see ‘750 claim 1). While SEQ ID NO:31 is greater than 98% identical to SEQ ID NO:109, SEQ ID NO:31 is not at least 98% identical to SEQ ID NO:120 or 121 as now claimed.
The rejection of claims 16-17 and 28-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,874,750, hereafter referred to as the ‘750 patent, in view of US 2022/0193261 (6/23/22), hereafter referred to as Wilson et al., with an effective filing date of 4/30/19, in view of Gabig-Ciminska et al. (2015) Curr. Mol. Med., Vol. 15, 746-771, and Kan et al. (2014) Biochem. J., Vol. 458, 281-289, is withdrawn for the same reasons as above.
The rejection of claims 1-2, 4, 7-11, 13-15, and 18-29 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,491,243, hereafter referred to as the ‘243 patent, is withdrawn in view of the cancellation of or amendments to the claims. Claim 1 as amended does not encompass a vIGF2 peptide comprising the sequence of SEQ ID NO:31 that binds to CI-MPR as recited in the ‘243 patent claims. While SEQ ID NO:31 is greater than 98% identical to SEQ ID NO:109, SEQ ID NO:31 is not at least 98% identical to SEQ ID NO:120 or 121 as now claimed.
The rejection of claims 16-17 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,491,243, hereafter referred to as the ‘243 patent, in view of Gabig-Ciminska et al. (2015) Curr. Mol. Med., Vol. 15, 746-771, and Kan et al. (2014) Biochem. J., Vol. 458, 281-289, is withdrawn for the same reasons set forth above.
No claims are 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 from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
