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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The disclosure is objected to because of the following informalities: the disclosure has sequences listed without their SEQ ID number, note p35, 2nd and 3d paragraphs, for example. The MPEP states that "37 CFR 1.821(d) requires the use of the assigned sequence identifier in all instances where the description or claims of a patent application discuss sequences regardless of whether a given sequence is also embedded in the text of the description or claims of an application” (MPEP 2422.03).
Appropriate correction is required.
response to applicant’s arguments
Applicants argue that the disclosed sequences are intermediates, and that a person of skill in the art would understand that they will form SEQ ID 9.
Applicant's arguments filed 11 June, 2026 have been fully considered but they are not persuasive.
Applicants argue that the referenced sequences are intermediates. Applicants have pointed to no law, regulation, or court case stating that intermediate sequences are not subject to the sequence listing requirements.
Applicants argue that a person of skill in the art would understand that, after deprotection, these intermediates will form SEQ ID 9. There is no exception in the sequence listing requirements for sequences that can be recognized by a person of skill in the art.
Election/Restrictions
Applicants elected group I and SEQ ID 90 with traverse in the reply filed on 30 Jan, 2026. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 11 March, 2026.
Examiner’s Note
Applicant’s elected species, SEQ ID 90, was found to be novel and unobvious in the office action of 11, March, 2026.
Claims Status
Claims 1-28 are pending.
Claims 1-15, 20, and 27 have been amended.
Claims 1-10 and 12-28 have been withdrawn due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what is an analog of the specific sequences claimed is hereby withdrawn due to amendment.
The rejection of claim 11 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.
The rejection of claim(s) 11 under 35 U.S.C. 102(a)(1) as being anticipated by Harris et al (WO 2012083385) is hereby withdrawn due to amendment.
New Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 11 is rejected under 35 U.S.C. 101 because the claim reads on a judicial exception (natural phenomenon).
The Supreme Court has given a 2 part test for eligibility under this statute.
1) Is the claim drawn to a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test:
The claim is drawn to peptides, a composition of matter, passing the first test.
2a) Ishikawa et al (FEBS Lett. (1979) 99(1) p97-100) show that SEQ ID 98 of applicants is a fragment of adzuki bean proteinase inhibitor I (fig 1, p98, bottom of page, positions 50-60). Thus, this sequence is a natural phenomenon, as it occurs naturally.
2b) The claim can be met by just the polypeptide, so there are embodiments where there can be nothing beyond the judicial exception. Thus, the claim lacks patent eligibility.
Examiner’s Note
Under the broadest reasonable interpretation, claim 11 is interpreted as allowing for polypeptides that comprise the sequences of the Markush group. However, limiting the claims to polypeptides consisting of the sequences of the Markush group will not overcome the rejection under 35 USC 101, above. In Ass’n for Molecular Pathology v Myriad Genetics, the Supreme court stated that fragments of chromosomes are still patent ineligible, absent a showing of something beyond the judicial exception. This is interpreted to mean that the statute applies to fragments of biopolymers, such as polypeptides.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 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, or for failing to include all the limitations of the claim upon which it depends. Claim 10, from which claim 11 depends, requires that Xaa5’ be Ile or Gln, but SEQ ID 98, from claim 11, has Xaa5’=Lys. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by the Uniprot entry PO1058 entry version 90 (Dec, 2019).
The Uniprot entry shows the sequence of the adzuki bean proteinase inhibitor I (1st page). Note that the sequence comprises SEQ ID 98 (positions 50-60, 2nd page, section “sequence”). While it is not a claim limitation (although withdrawn claims list it), the two Cys resides of this segment are bound by a disulfide bond (2nd page, section “disulfide”).
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.
Claim 11 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of copending Application No. 18/870,356 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the competing claims anticipate the examined claims.
Competing claim 1 describes fusion proteins of insulin and a chymotrypsin inhibitory peptide. Competing claim 2 specifies a Markush group of chymotrypsin inhibitory peptides, including SEQ IDs 19 and 22, identical with SEQ IDs 90 and 98 of the examined claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephone 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 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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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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