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 group I and a fusion protein with a mutation at position 36 of PTPσ 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. In the response of 21 April, 2026, applicants amended the claims so they no longer read on this species.
Claims Status
Claims 1, 3, 4, and 7-16 are pending.
Claim 1 has been amended.
Claims 3, 4, 7, and 9-16 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 1, 2, 5, and 6 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due to uncertainty as to what is required for a PTPσ derived protein attached to an IgG derived Fc domain is hereby withdrawn due to amendment.
The rejection of claim(s) 1 and 2 under 35 U.S.C. 102(a)(1) as being anticipated by Shen et al (Science (2009) 326 p592-596, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claim(s) 1, 2, 5, and 6 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 (2017) 38(9) p1132-1143) is hereby withdrawn due to amendment.
The provisional rejection of claims 1, 2, 5, and 6 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. 18/295,822 (US 20230293648) is hereby withdrawn due to amendment.
New Rejections
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 and 8 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 requires both that the polypeptide comprise SEQ ID 1 and that various residues in that portion of the polypeptide be mutated. However, if a residue is mutated, it no longer comprises SEQ ID 1.
Based on applicant’s arguments, they intend this to be interpreted as comprising a mutated variant of SEQ ID 1. It may be clearer to use language such as “comprises the amino acid sequence of SEQ ID 1 with one or more mutations selected from . . . “ or some equivalent language.
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 8 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 8 lists specific residues that must be included in the Fc domain. However, claim 1, from which claim 8 depends, lists the same residues, so the claim does not further limit. 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 § 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 and 8 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 Berdougo et al (Gen. Eng. Biotech. News (2012) 32(12 p30-31).
Shen et al look 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).
The difference between this reference and the examined claims is that this reference does not discuss mutants of PTPσ.
Berdougo et al discuss high throughput alanine scanning (title). The authors have developed a high throughput alanine scanning process with high throughput analysis or epitope mapping and protein engineering for even structurally complex targets (2nd page, 3d paragraph). This allows every residue in a protein to be sequentially changed to alanine, or any other user defined amino acid (2nd page, 4th paragraph). The screen can be designed to find mutants with improved binding, expression or solubility (2nd page, 5th paragraph). This reference discusses alanine mutation screens
Therefore, it would be obvious to take the fusion protein of Shen et al, and alanine scan the sequence to find mutants with improved binding, expression, and/or solubility. As Berdougo et al discusses how to set up screens for such experiments, an artisan in this field would attempt this experiment with a reasonable expectation of success.
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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