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
Applicant’s election without traverse of group I and a fusion protein with a mutation at position 36 of PTPσ in the reply filed on 18 Nov, 2025 and the phone call with Jae Youn Kim, applicant’s representative, on 15 Dec, 2025 is acknowledged.
Applicants elected a fusion protein with a mutation at position 36 of PTPσ. A search was conducted for this invention, and references rendering it obvious were found. As a result, claims 1, 2, 5, and 6 were examined and claims 3, 4, and 7-16 were withdrawn from consideration.
During examination, a reference was found that anticipated a non-elected embodiment. This reference is discussed below.
Claims Status
Claims 1-16 are pending.
Claims 3, 4, and 7-16 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 18 Nov, 2025 and the phone call with Jae Youn Kim, applicant’s representative, on 15 Dec, 2025.
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, 2, 5, and 6 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, requires a PTPσ derived protein attached to an IgG derived Fc domain. Applicants have not defined “derived,” so the dictionary definition (a compound that can be made from another, Merriam Webster online dictionary) is used. Note that this is any polypeptide. The issue is if the names of the proteins in the fusion are a functional limitation that the derived proteins maintain some properties of the original protein. Note that these proteins have more than one activity; the Fc domain binds to the Fc receptor and other Fc domains (dimerization). PTPσ binds to proteoglycans and phosphorylated tyrosine residues; if the name implies function, it is not clear which functions are required.
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.
first rejection
Claim(s) 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al (Science (2009) 326 p592-596, cited by applicants).
Shen et al looks at the binding of PTPσ to chondroitin sulfate (title). This used a fusion protein of PTPσ with an antibody Fc domain (p594, 2nd column, 1st paragraph), anticipating claims 1 and 2.
second rejection
Claim(s) 1, 2, 5, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Unverdorben et al (Mabs (2016) 8(1) p120-128) with evidentiary support from the DrugBank page for enanercept (downloaded 2025).
As evidenced by the DrugBank page for this drug, it is recombinant human TNFR at the N-terminus fused to an antibody Fc domain (2nd page, section “synonyms.”), and has a Ser residue at position 36 (2nd page, section “Sequences”). This is a fusion protein with an antibody Fc domain at the C-terminus, and a protein at the N-terminus that can be made by one or more insertions, substitutions, and deletions of the PTPσ extracellular domain, anticipating claims 1 and 2. Position 36 (Ile in PTPσ) is Ser, anticipating claims 5 and 6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al (Science (2009) 326 p592-596, cited by applicants) in view of Tang et al (Hum. Mutat. (2017) 38(9) p1132-1143).
Shen et al use a PTPσ-Fc fusion (p549 page, 2nd column, 2nd paragraph) to investigate binding to chondroitin sulfate (title). As noted above, this reference anticipates claims 1 and 2.
The difference between this reference and the remaining claims is that this reference does not have a mutation at I36.
Tang et al discusses whole protein alanine scanning (title). By mutating and examining every non-Ala and Gly residue with Ala, it is possible to comprehensively determine which residues are involved in binding (abstract).
Therefore, it would be obvious to run an alanine scanning experiment, as described by Tang et al, to the fusion protein of Shen et al, to determine which residues of PTPσ are involved in binding with chondroitin sulfate. As alanine mutation is commonly used for similar purposes, an artisan in this field would attempt this process with a reasonable expectation of success.
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.
Claims 1, 2, 5, and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 18/295,822 (US 20230293648) (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 a modified Ace2 protein, while competing claim 6 specifies an Fc fusion. As evidenced by p9 of the disclosure, position 36 of Ace2 is Ala.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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