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 human R-spondin-1 (SEQ ID 3) without traverse in the reply filed on 1 July, 2025.
Claims Status
Claims 1, 6, 10, 11, 13, 19, and 20 are pending.
Claim 1 has been amended.
Claims 10, 19, and 20 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claim 7 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty if the claim requires additional active method steps is hereby withdrawn due to amendment.
The rejection of claim(s) 1, 2, 6, 7, and 11-14 under 35 U.S.C. 103 as being unpatentable over Zhang et al (WO 2018140821, cited by applicants) in view of Tenenbaum et al (Cardiovasc. Diabeteol. (2003) 2) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al (WO 2018140821, cited by applicants), with evidentiary support from Welters et al (Trenads Endocrinol. Metabol. (2008) 19(10) p349-355) and Xu et al (J. Biol. Chem. (2015) 290(4) p2455-2465, cited by applicants).
Zhang et al discusses modulating the Wnt pathway (abstract) to treat diseases, including diabetes (paragraph 188). Note that there is only type 1 and type 2 diabetes, so a person of skill in the art can immediately envision treatment of type 1 diabetes. The patient may be human (paragraph 204). The therapeutic can be human R-spondin 1 (paragraph 9). Note that, as evidenced by a BLAST search of applicant’s SEQ ID 3, this sequence is a fragment of human R-spondin 1
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As this is the same therapeutic for the same disorder, it must inherently work by the same mechanism (beta cell proliferation), anticipating claim 1. Alternatively, as evidenced by Welters et al, activation of the Wnt pathway is known to increase beta cell proliferation (p352, 1st column, 2nd and 3d paragraphs). As evidenced by Xu et al, this polypeptide binds to LGR4, and, as a native sequence, must inherently bind identically as the native sequence. Thus, the reference anticipates claim 6. The material may be attached to PEG (paragraph 101), anticipating claim 11. The material can be administered IV (paragraph 202), anticipating claim 13.
response to applicant’s arguments
Applicants have filed no arguments with their response.
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.
first rejection
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26, 34, and 35 of copending Application No. 18/156,865 (US 20230340044) (reference application) in view of Thompson (UMass Memorial Health (2019)). 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 26 describes a polypeptide comprising SEQ ID 3 of the examined claims. Competing claim 34 specifies using this sequence to treat diabetes, which competing claim 35 specifies as type 1 or type II. While the competing claims do not specify a human patient, Thompson et al describes human patients with type I diabetes, making it obvious to treat these patients with the therapy of the competing claims, to treat the diabetes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
response to applicant’s arguments
Applicants have filed no arguments with their response.
second rejection
Claims 1, 2, 6, 7, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 10, and 21 of copending Application No. 18/578,952 (US 20240383952) (reference application) in view of Thompson (UMass Memorial Health (2019). 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 a polypeptide comprising several domains of an R-spondin protein, including R-spondin 1, while competing claim 8 requires properties of the protein overlapping with those of examined claim 7. Competing claim 10 specifies using these compounds to treat diabetes, which competing claim 21 specifies as type 1 or type II. While the competing claims do not specify a human patient, Thompson et al describes human patients with type I diabetes, making it obvious to treat these patients with the therapy of the competing claims, to treat the diabetes.
response to applicant’s arguments
Applicants have filed no arguments with their response.
Conclusion
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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