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.
Election/Restrictions
Applicants elected SEQ ID 7 without traverse in the reply filed on 27 Aug, 2024. This species was found allowable in the office action of 24 Sept, 2024, but other rejections apply.
Claims Status
Claims 1-3, 15, 17, 21, 22, 26, 28, 30, 36, and 86 are pending.
Claims 1, 21, 26, 28, 30, and 36 have been amended.
Claim 86 is objected to.
Claims 15, 17, 21, 22, 26, 28, 30, and 36 have been withdrawn from consideration due to an election/restriction requirement.
Maintained/Modified Rejections
Claim Objections
Claim 86 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Withdrawn Rejections
The rejection of claims 1-5, 9, and 86-88 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph over cytotoxic compounds is hereby withdrawn due to amendment. Note that some withdrawn claims still have this issue.
The rejection of claims 4, 5, 87, and 88 under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), fourth paragraph, is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-3 and 9 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.
Applicants have amended claim 1 so that the RSPO domain consists of the RSPO domain of SEQ ID 7, which is short one domain from the wild type RSPO polypeptide, but have not pointed out where in their disclosure they have support for this amendment (MPEP 2163(II)(A)), nor did a search of the disclosure find such support. Nowhere is the RSPO segment limited to that of SEQ ID 7 except in SEQ ID 7, which is not support for all variants of that sequence maintaining just the RSPO segment constant. Thus, this limitation constitutes new matter.
response to applicant’s arguments
In their after final submission, applicants point to p11, which they say provides support for the amendment.
Applicant's arguments filed 16 Dec, 2025 and 7 April, 2026 have been fully considered but they are not persuasive.
The portion of the disclosure that applicants are pointing to describes SEQ ID 7 as a specific RSPO domain, an antibody Fc domain, and an LLQGA tag on the C-terminus. In other words, as more generally mentioned in the rejection, it describes SEQ ID 7, and does not show that applicants have considered variants with the same RSPO domain but different from SEQ ID 7.
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 1-3 and 9 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 1, and claims dependent on it, has been amended to require that the RSPO segment is identical to the same segment of SEQ ID 7. However, claim 1 is open, allowing for additional domains and linkers, in addition to the RSPO segment, the Ig Fc domain, and the cytotoxic therapeutic. The issue is that the cutoff between the RSPO segment, the various domains required by the claims, and any additional segments allowed by the open language of the claim is arbitrary. For example, assume a sequence with an RSPO domain identical with that of SEQ ID 7, attached via a few amino acids to an IgG Fc domain. The few amino acids could be considered part of the RSPO segment, could be considered part of the IgG segment, or could be an entirely separate linker – the difference is only in the mind of the person constructing the polypeptide.
response to applicant’s arguments
Applicants argue in their after final submission that RSPO domains are well known and defined by SEQ ID 7.
Applicant's arguments filed 16 Dec, 2025 and 7 April, 2026 have been fully considered but they are not persuasive.
Applicants argue that the RSPO domain is clear. This is an oversimplification. Applicants have not defined the RSPO domain. This means that in an embodiment comprising a mutated SEQ ID 7, with additional amino acids between the RSPO sequence and the Fc domain (or attached to the N-terminus of the construct), it is not clear if those additional amino acids are part of the RSPO domain or not – the distinction is in the mind of the person designing the construct. The open language of the claims allows for additional segments; so a determination if an embodiment meets the claim limitations is not as simple as looking for identity with SEQ ID 7.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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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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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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