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 .
Status of the Application
The amendment and remarks of 10 June 2026 have been entered.
Applicants’ entry into the TrackOne program as of 18 February 2026 is acknowledged.
Claims 14 and 15 have been canceled. Claims 1-13 and 16-22 are pending and are being examined on the merits.
The Terminal Disclaimer over the co-pending 18/994,598 and 19/438,393 applications as filed on 10 June 2026 is entered and accepted.
The objection to the specification due to sequence compliance issues is withdrawn in light of the amendment filed 10 June 2026.
The rejection of claims 3 and 10 under 35 U.S.C. 112(b) is withdrawn in light of the amendment filed 10 June 2026.
The rejection of claims 1-5 and 11-15 under 35 U.S.C. 102(a)(2) as being anticipated by ‘278 is withdrawn in light of the amendment and remarks filed 10 June 2026.
The rejection of claims 2-4 and 14 under 35 U.S.C. 101 for statutory double patenting is withdrawn with respect to claims 4 and 14, but maintained with respect to claims 2 and 3, with the Examiner’s response found below.
The rejections for nonstatutory double patenting are withdrawn in light of the TDs filed 10 June 2026.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 2 and 3 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 2 of copending Application No. 18/994,598 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The ‘598 application shares the same effective filing date as the claimed invention. ‘598 claims an engineered peptide for treating AMD comprising a first peptide sequence of 80% or more homology to SEQ ID NO: 3, a second peptide of 80% or more homology to SEQ ID NO: 17, a linker separating the first and second peptides, a first junction region between the first peptide and the linker domain, and a second junction region between the second peptide and the linker domain (see e.g. claim 1). The ”for use in treating age-related macular degeneration (AMD)” in the preamble of ‘598 represents an intended use that is not considered to be patentable limitation per MPEP 2111.02. Therefore, ‘598 claims the same polypeptide as in claim 2: a first region of at least 80% identity to SEQ ID NO: 3, a linker, a second region of at least 80% identity to SEQ ID NO: 17, and a first junction region between the first region and the linker domain and a second junction region between the second region and the linker domain.
With respect to claim 3, ‘598 claims the same first and second junction regions (see e.g. claim 2).
Response to Arguments:
The Applicants argue that claim 1 is amended.
The Examiner agrees that claim 1 is amended, but notes that the text in the remarks does not actually reflect the current claim, as it maintains the intended use recitation and consisting essentially language. However, even disregarding this the claim as presented is not distinguished from the counterpart in ‘598.
Claim 1 as instantly claimed requires: a polypeptide, a first region comprising complement factor H domains SCR1-SCR7 having at least 80% identity to SEQ ID NO: 3, a second region comprising factor H-like protein 1 domains SCR6-SCR7 having at least 80% identity to SEQ ID NO: 17, and a linker between the first and second regions. This is (SEQ ID NO: 3) – linker – (SEQ ID NO: 17), where the first and second regions can be polypeptides of at least 80% identity to SEQ ID NOs: 3 and 17, respectively. Claim 2 adds in that that there is a first junction region between the first region and the linker domain and a second junction region between the second region and the linker domain: (SEQ ID NO: 3) – first junction – linker – second junction – (SEQ ID NO: 17). Claim 1 of ‘598 includes an intended use in the preamble, but otherwise recites a construct (SEQ ID NO: 3) – first junction – linker – second junction – (SEQ ID NO: 17), where the first and second regions can be at least 80% identical to SEQ ID NOs: 3 and 17, respectively. This is identical to what is found in claim 2. Instant claim 3 adds in that the first junction region is SEQ ID NO: 7 and the second junction region is SEQ ID NO: 13 or LKP. This again is identical to what is found in claim 2 of ‘598.
The Applicants argue in light of the amendments claims 2-4 and are not coextensive in scope with claims 1-3 of ‘598 due to the amendment to the intervening base claim.
The Examiner disagrees for the reasons found above. Even considering the amendment to claim 1, claims 2-3 are still drawn to the same scope as in claims 1-2 of ‘598.
The Applicants’ arguments have been considered but are not persuasive. The rejection is modified and maintained.
Allowable Subject Matter
Claims 1, 4-13 and 16-22 are allowed.
The following is an examiner’s statement of reasons for allowance: The claimed polypeptide comprising a first region having the amino acid sequence of complement factor H domains SCR1-SCR7 with at least 80% identity to SEQ ID NO: 3, a linker, and a second region comprising the amino acid sequence of Factor H-like protein 1 domains SCR6-SCR7 with at least 80% identity to SEQ ID NO: 17 is free of the prior art. The WO 2023/023278 A2 art is considered the closest prior art since it does not fully overlap with the claimed (FH SCR1-SCR7)-linker-(FH-like protein 1 SCR6-SCR7) format, but rather contains the first region where only a portion of the second region is present, and that second region is present within the first region (i.e. no linker is present nor the SCR6-SCR7 region). There is no other prior art that discloses or suggests a polypeptide as claimed. Therefore, the polypeptide and pharmaceutical compositions thereof are novel and unobvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J.M/Patent Examiner, Art Unit 1658 /SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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